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6,954 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
1. AD group :
- Male or female patient, aged ≥ 40 years old included at entry.
- Patients having a clinical diagnosis of probable AD according to DSM-IV TR
[F00.xx] and National Institute of Neurological and Communicative Disorders and
Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
criteria.
- Written informed consent obtained from the patient or, if appropriate, from legal
representative according to local laws and regulations.
- Evidence that brain imaging (either cerebral CT-scan or cerebral MRI) was
performed to settle the AD diagnosis, and that the results are compatible with AD
diagnosis.
- Neurological exam without any particularities or without any specific focal signs
likely to be related to other conditions than AD.
- Patient compliant with study procedures.
2. Non AD demented group :
- Male or female patient, aged ≥ 40 years old included at entry.
- Patients having a clinical diagnosis of dementia which can be one of the
following :
- VaD according to NINDS-AIREN criteria or,
- LBD according to McKeith's criteria, or,
- FTD according to Neary's or Lund & Manchester criteria or,
- PDD according to DSM-IV TR criteria [F02.x] or,
- Mixed dementia which is defined in this study as patients fulfilling DSM-IV TR
criteria [F02.8] for dementia with multiple aetiologies focussing on dementia of
Alzheimer type with secondary occurrence of vascular dementia.
- Written informed consent obtained from the patient or, if appropriate, from legal
representative according to local laws and regulations.
- Evidence that brain imaging (either cerebral CT-scan or cerebral MRI) was
performed to settle the diagnosis of dementia, and that the results are
compatible with the diagnosis of dementia.
- Absence of other signs or symptoms that may be better related to another type of
dementia than the current dementia diagnosis.
- Patient compliant with study procedures.
3. Cognitive impairment-free control group :
- Male or female subject, aged ≥ 60 years old included at entry.
- Written informed consent obtained from the subject.
- Absence of spontaneously reported significant cognitive complaints from the
subject at entry.
- MMSE ≥ 27 at entry.
- Subject with no impairment in daily living activities.
- Subject compliant with study procedures.
Exclusion Criteria:
1. AD group :
- Any pathology, medical condition or symptoms that may lead to reconsider the
initial diagnosis of probable AD, or that may rend the initial diagnosis of
probable AD doubtful at entry, according to the opinion of the investigator.
- Current or recent history of drug or alcohol abuse or dependence.
- Diagnostic of Mild Cognitive Impairment defined by subjective complaints from the
patient regarding memory and/or cognitive symptoms, objective memory and/or
cognitive impairment at testing but not meeting AD diagnostic criteria, and not
affecting daily living activities.
- Current diagnosis of brain tumour.
- Any current pathology or medical condition, for which blood sampling may involve
a risk for the patient's health, according to the opinion of the investigator.
- Pregnancy.
- Patient who is not registered at "Sécurité Sociale".
- Current participation in another study using an investigational non-marketed
product.
2. Non-AD demented group :
- Any pathology, medical condition or symptoms that may lead to reconsider the
initial diagnosis of dementia the patient is suffering from, or that may rend the
initial diagnosis of dementia doubtful at entry, according to the opinion of the
investigator.
- Diagnostic of Mild Cognitive Impairment defined by subjective complaints from the
patient regarding memory and/or cognitive symptoms, objective memory and/or
cognitive impairment at testing but not meeting the diagnostic criteria for
dementia, and not affecting daily living activities.
- Current diagnosis of brain tumour.
- Any current pathology or medical condition for which blood sampling may involve a
risk for the patient's health, according to the opinion of the investigator.
- Current or recent history of drug or alcohol abuse or dependence.
- Pregnancy.
- Patient who is not registered at "Sécurité Sociale".
- Current participation in another study using an investigational non-marketed
product.
3. Cognitive impairment-free control group :
- Subject spontaneously complaining from significant cognitive impairment.
- Known family history of dementia.
- Diagnosis of any type of dementia (either AD or non-AD dementia), Mild Cognitive
Impairment, or any current or past history of CNS pathology (including but not
limited to brain injury, brain tumour, stroke, normal pressure hydrocephalus,
Parkinson's disease, epilepsy, multiple sclerosis,…) that may be responsible for
the occurrence of dementia.
- History or current clinically significant psychiatric pathology (including but
not limited to psychotic disorders, bipolar disorder, personality disorders).
- Current major depressive disorder, either treated or not, associated with
clinically significant symptoms.
- Any current pathology or medical condition for which blood sampling may involve a
risk for the subject's health, according to the opinion of the investigator.
- Current or recent history (within one month) of clinically significant pathology,
medical condition (including hospitalization) or symptoms. However, chronic
diseases or medical conditions which are considered stable are accepted, provided
that they are compatible with other study selection criteria.
- Current or recent history of drug or alcohol abuse or dependence.
- Subject who is not registered at "Sécurité Sociale".
- Current participation in another study using an investigational non-marketed
product.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.
| Blood Gene Expression Signature in Patients Diagnosed With Probable Alzheimer's Disease Compared to Patients Suffering From Other Types of Dementia | NCT00880347 | Entailment |
4,105 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Inclusion Criteria:
- Specific inclusion criteria for RBD patients - to reach the diagnosis criteria of RBD
(International Classification of Sleep Disorders 2)
- Specific inclusion criteria for PD patients - to reach the diagnosis criteria of
idiopathic PD (Queen Square Brain Bank) - Hoehn Yahr score ≤ 2
Exclusion Criteria:
- Specific exclusion criteria for RBD patients - diagnosis of PD - other pathology
associated to RBD diagnosis - presence of antiparkinsonism medication
- Specific exclusion criteria for PD patients - clinical signs of parkinsonian syndrome-
Mini Mental State Examination < 24/30- gait disorder clinically observable
- Specific exclusion criteria for controls - neurological disease- gait disorder
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Gait and REM Sleep Behavior Disorder | NCT02554331 | Entailment |
4,549 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. Females and males between 18 to 55 years of age, inclusive
2. BMI between 18.5 to 32 kg/m2, inclusive
3. Self-reported history of diarrhea over the last 3 months, defined as > 5 BMs with the
majority (≥ 50%) of the BMs per week being Bristol stool form types ≥5, 6 or 7
4. Female participant is not of child bearing potential, which is defined as females who
have had a hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete
endometrial ablation, or are post-menopausal (natural or surgically with > 1 year
since last menstruation) OR,
Females of childbearing potential must agree to use a medically approved method of
birth control and must have negative urine pregnancy test results at screening and
baseline. A minimum of 3-months stable dose is required for females on a hormonal
birth control. Acceptable methods of birth control include:
I. Hormonal contraceptives including oral contraceptives, hormone birth control patch
(Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives
(Depo-Provera, Lunelle), or hormone implant (Norplant System) II. Double-barrier
method III. Intrauterine devices IV. Non-heterosexual lifestyle or agrees to use
contraception if planning on changing to heterosexual partner(s) V. Vasectomy of
partner (shown successful as per appropriate follow-up)
5. Healthy as determined by laboratory results, medical history and physical exam by QI
6. Agrees to comply with all study procedures
7. Agrees to refrain from the use of any home remedies to control GI issues if live
bacteria may be involved
8. Agrees to avoid NSAIDs and Steroids for 72 hours and Vitamin C and related supplements
for 24 hours prior to fecal zonulin sample collection
9. Agrees to maintain current level of physical activity and diet throughout the study
10. Agrees to provide written informed consent
Exclusion Criteria:
1. Women who are pregnant, breast feeding, or planning to become pregnant during the
trial
2. Allergy or sensitivity to investigational product's active or inactive ingredients
3. Clinically significant abnormal laboratory results at screening as assessed by QI
4. Chronic use of anti-diarrhea medications and supplements; occasional use is permitted
based on frequency of use and appropriate wash-out to be determined by QI
5. Currently undergoing pharmacological treatment for IBS, or history of active treatment
for IBS within the last 1 year
6. Clinically significant disease of the gastrointestinal tract (examples include but are
not limited to celiac disease, gluten intolerance/sensitivity, inflammatory bowel
disease)
7. Gastrointestinal surgery within the past 3 months. Gastrointestinal surgery > 3 months
ago, will be assessed by the QI on a case-by-case basis.
8. Major surgery in the past 3 months or individuals who have planned surgery during the
course of the trial. Minor surgery will be considered on a case by case basis by QI
9. Cancer, except skin cancers completely excised with no chemotherapy or radiation with
a follow up that is negative. Cancer in full remission for more than five years after
diagnosis are acceptable.
10. Verbal confirmation of autoimmune disease or if immune-compromised
11. Verbal confirmation of HIV, hepatitis B/C positive diagnosis
12. Metabolic syndrome or chronic diseases to be assessed by QI on a case by case basis
13. Type I or Type II diabetes
14. Significant cardiovascular event in the past 6 months. No significant cardiovascular
event on stable medication may be included after assessment by the QI on a case by
case basis
15. History or currently with kidney and liver diseases assessed by QI on a case by case
basis, with the exception of the history of kidney stones symptom-free for 1 year
16. Verbal confirmation of current or pre-existing thyroid condition. Treatment on a
stable dose medication for over 6 months will be reviewed on a case-by-case basis by
the QI
17. Blood or bleeding disorders, with the exception of a history of anemia caused by
deficiency of a mineral or vitamin, and no longer present
18. Current use or consumption of antibiotics in the 4 weeks prior to baseline
19. Current use or consumption of prebiotic or probiotic or synbiotic supplements in the 4
weeks prior to baseline
20. Current use of prescribed medications that may affect the study outcomes
21. Use of over-the-counter (OTC) medications or supplements or consumption of
foods/drinks that may affect the study outcomes, unless willing to undergo an
appropriate washout period prior to baseline is agreed upon after assessment by the QI
22. Use of medical marijuana
23. Chronic use of recreational marijuana; infrequent use (>30 days since last use) to be
assessed by QI
24. Use of tobacco products unless quit 90 days prior to baseline
25. Alcohol or drug abuse in the past year
26. High alcohol intake (average of >2 standard drinks per day or >10 standard drinks per
week)
27. Use of narcotics
28. Illicit drug use in the past 6 months as assessed by the QI
29. Participation in other clinical research trials 30 days prior to randomization or will
be participating in another investigation during the study
30. Participants who plan to donate blood during the study or within 30 days of completing
the study
31. Any known (choric or acute) medical or neuropsychological condition that, in the QI's
opinion, could interfere with study participation, or individuals who are cognitively
impaired and/or who are unable to give informed consent
32. Any other active or unstable medical condition, that, in the opinion of the QI, may
adversely affect the participant's ability to complete the study or its measures or
pose a significant risk to the participant
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | A Study to Investigate the Safety and Efficacy of a Probiotic on Gastrointestinal Health in Healthy Adults | NCT04223388 | Contradiction |
6,150 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- SARS-Co-V2 positivitity to the nasal-swab by reverse-transcriptase-polymerase chain-
reaction (RT-PCR) assay tested by the local diagnostic laboratory
- Age >18 and <85 years
- Presence of at least 3 of the following symptoms as present fever, cough, myalgia,
fatigue.
- Presence of radiological findings of pneumonia assessed by chest radiograph, computed
tomography, or pulmonary ultrasound.
- Peripheral capillary oxygen saturation (SpO2) > 92% on room air at screening
- PaO2/FiO2 >100-300 mmHg at arterial blood gas analysis.
Exclusion Criteria:
- Age < 18 and >85
- History of thrombophlebitis
- Latent tuberculosis infection (based on the positivity to QuantiFERON Plus positivity,
Qiagen, Germany)
- Pregnancy and lactation
- History of malignancies over the previous 5 years, current diagnosis of malignancy
- Inability or unwillingness to sign a written consent.
- Transaminases values 4-fold higher than the upper normal limit.
- HBV and HCV positivity.
- Current Herpes zoster infection.
- Evidence of concomitant bacterial infections.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Baricitinib Therapy in COVID-19 | NCT04358614 | Contradiction |
1,412 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- Subjects should be over 60 years of age with essential isolated systolic hypertension
(stage I-II base on recommendation of JNC-VII) for the hypertension group and normal
blood pressure in the healthy group. Good communication, independent physical
activity. The healthy subject should be non-smokers, non-obese, free of any signs or
symptoms of disease as revealed by medical history
Exclusion Criteria:
- Essential hypertension stage III or secondary hypertension, any history of respiratory
disease, heart disease, renal disease, blindness, cerebrovascular disease, exercise
limited by pain
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 60 Years old.
Subject must be at most 75 Years | Cardiovascular Responses to Static and Dynamic Exercise in Elderly With Isolated Systolic Hypertension | NCT02270216 | Contradiction |
5,081 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
Known AFF group
1. A subject must have experienced an incomplete atypical low trauma fracture of the
femoral shaft;
2. Is a patient at the UHN osteoporosis clinic.
Comparison Group
1. Must be scheduled for a bone mineral density scan at UHN
2. Have been on any bisphosphonate for 5 years or longer, and;
3. Have unexplained symptoms of leg, hip, thigh, or knee pain.
Exclusion Criteria:
- There are no exclusions
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Evaluation of IVA (SE Femur Scans) to Identify Incomplete AFFs | NCT01747304 | Contradiction |
2,938 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
1. Male or female subjects between 18-80 years of age, inclusive
2. Subjects with a diagnosis of probable or definite ALS in accordance with the Revised
El-Escorial Criteria
3. Subjects must be currently on an oral diet and able to take foods and liquids by mouth
equivalent to a score of 3 or above on the Functional Oral Intake Scale.
4. Subjects with no known allergy to barium, riluzole or inactive ingredients in ROSF
5. Subject or subject's legally authorized representative must be willing and able to
give informed consent/assent and HIPAA authorization.
6. Subject must have the ability to comprehend and be informed of the nature of the
study, as assessed by the Principal Investigator or Sub-Investigator.
7. Subjects prescribed riluzole at or before the dose of study drug. (The study was open
to subjects currently taking riluzole at screening, subjects who were not currently
taking riluzole at screening who had taken riluzole in the past, and subjects to be
newly started on riluzole (given as ROSF in this study).
8. Availability to volunteer for the entire study duration and willing to adhere to all
protocol requirements
9. Female subjects of childbearing potential (i.e. not surgically sterile, not 2 years
postmenopausal, or not with a sterile partner) must have a negative pregnancy test at
Screening and Visit 1, agree to abstinence, be practicing double barrier contraception
or using an FDA approved barrier method contraceptive (e.g., licensed hormonal or
barrier methods) for more than 2 months prior to the screening visit and commit to an
acceptable form of birth control for the duration of the study and for 30 days after
participation in the study.
Exclusion Criteria:
1. Subjects who score 2 or below on the Functional Oral Intake Scale.
2. Subjects with a prior swallowing study that has shown a Penetration Aspiration Scale
score of 3 or greater
3. Subjects with a history of 2 or more episodes of aspiration pneumonia requiring
hospitalization
4. Subjects with a history of clinically significant liver disease, renal disease, or any
other medical condition judged to be exclusionary by the Investigator
5. Subjects who were unwilling to sign informed consent or subjects who for any other
reason in the judgment of investigator were unable to complete the study
6. Female subjects who had a positive urine pregnancy test (βhCG) at screening or Visit
1, were trying to become pregnant, or were breastfeeding.
7. Subjects with active cancer within the previous 2 years, except treated basal cell
carcinoma of the skin
8. Subjects who had taken any experimental drug within 30 days prior to enrollment or
within 5 half-lives of the investigational drug -whichever was the longer period.
However, subjects who had previously completed other Aquestive Therapeutics-sponsored
ROSF clinical studies within the last 30 days prior to enrollment could be eligible
for consideration for entry into this study.
9. Subjects with known history of moderate or severe renal impairment as defined by a
calculated creatinine clearance of ≤50 mL/minute
10. Subjects currently taking riluzole with alanine aminotransferase levels greater than 5
times upper limit of normal or with evidence of clinical jaundice. (Riluzole should be
discontinued in these patients.)
11. Subjects who would be receiving riluzole for the first time who exhibited baseline
elevations of several liver function tests (especially elevated bilirubin). (These
findings at baseline should preclude the use of riluzole including ROSF).
12. Use of potentially hepatotoxic drugs: (e.g., allopurinol, methyldopa, sulfasalazine).
13. Subjects with clinically significant abnormal laboratory values in the judgment of the
Investigator
14. Use of strong or moderate CYP1A2 inhibitors (e.g., ciprofloxacin, enoxacin,
fluvoxamine, methoxsalen, mexiletine, thiabendazole, vemurafenib, zileuton) and CYP1A2
inducers (e.g. rifampin and barbiturates) in the previous 30 days before first drug
administration.
15. Anything else that, in the opinion of the Investigator, would place the subject at
increased risk or preclude the subject's full compliance with or completion of the
study.
16. Employee or immediate relative of an employee of the investigator, Aquestive
Therapeutics, any of its affiliates or partners, or inVentiv Health.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Riluzole Oral Soluble Film (ROSF) Swallowing Safety in Amyotrophic Lateral Sclerosis (ALS) | NCT03679975 | Entailment |
29 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Women age 18-55
- Hypopituitarism with documented central adrenal and gonadal deficiencies. Serum
testosterone level of < 20 ng/dl or free testosterone <1.5 pg/ml on conjugated equine
estrogen replacement
- No other significant medical condition
- Weight between 80 and 150% of ideal body weight
- Able to provide informed consent
- All races and ethnicities
- All patients regardless of marital status and relationship status
Exclusion Criteria:
- Physical disabilities that would prevent them from participating in the study
- Current use of testosterone or other androgenic steroids. Patients who are taking
testosterone, DHEA or other androgen precursors will discontinue these
medications/supplements three months prior to the study.
- Significant cardiopulmonary disease, renal disease (creatinine > 1.5 mg/dL), diabetes
mellitus, uncontrolled hypertension, malignancy (other than basal cell skin carcinoma)
or major psychiatric disease. Patients with depression or anxiety on a stable dose of
medication will be allowed to enroll.
- Current abuse of illicit drugs or heavy ethanol use
- History of breast or uterine cancer
- Those with significant liver function abnormalities defined as SGOT, SGPT or alkaline
phosphatase value of greater than one and one-half times the upper limit of normal in
our Clinical Pathology Laboratory or serum bilirubin levels of greater than 2 mg/dl
will be excluded.
- Those with history of hyperandrogenic disorders such as hirsutism and polycystic ovary
disease will be excluded. These conditions are rare in women with hypopituitarism.
Testosterone administration to these patients may exacerbate the underlying disorder.
- Women who are pregnant, seeking to become pregnant in the next 6 months, or breast
feeding
- Those who have previously experienced intolerance to other transdermal systems
- Drugs known to alter testosterone production such as Megace or ketoconazole
- Patients with untreated hyperprolactinemia or active Cushing's disease. Patients with
treated prolactinoma or Cushing's disease will be allowed to participate in the study.
- Hematocrit > 50%
- Male sex
- Not willing to answer all questions on surveys
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Baseline Sexual Function, Cognitive Function, Body Composition and Muscle Parameters and Pharmacokinetics of Transdermal Testosterone Gel in Women With Hypopituitarism | NCT00144404 | Contradiction |
2,868 | 21 | A 47-year-old man comes to the clinic for the follow up of his neuromuscular disease. He experienced gradual, progressive weakness of the left upper extremity over the last year. Over the last few months, he has also noticed weakness in the right upper extremity. BP is 120/75, PR is 80 and temperature is 37 C. Reflexes are brisk in the upper extremities, and the plantar responses are extensor. Mild gait ataxia is present. The patient is under treatment of Riluzole 50 mg BID with the diagnosis of ALS. | I've been suffering from a neuromuscular disease for a while now, and I went to my doctor's office. I'm now a 47-year-old man and over the past year I experienced a progressive and gradual weakness of my left upper extremity, and over the past month, I also noticed a weakness over my right upper extremity. My heart rate was 120/75, and my PR was 80 with 37°C for temperature. My reflexes are not good in my upper extremities, and I have trouble with my balance. I'm also under Exservan 50 mg for my sclerosis. | Inclusion Criteria:
1. Patients classified as having clinically definite, clinically probable, clinically
probable (laboratory-supported) or clinically possible ALS according to the
El-Escorial diagnostic criteria for ALS (see Appendix 2).
2. Able to comprehend and willing to sign Informed Consent Form (ICF).
3. Age 18 years of age or greater.
4. ALS Symptom onset of muscle weakness or speech impairment no more than 48 months prior
to screen visit. Fasiculations should not be considered.
5. Slow Vital Capacity (SVC) greater than or equal to 50% predicted for sex, age and
height at screen.
6. Has the ability to swallow tablets/capsules whole at study entry.
7. Subject with clinical laboratory findings within the normal range or, if outside the
normal range, determined by the Investigator at the Screening visit to be not
clinically significant.
8. If the subject is taking Riluzole the dose must be stable for 30 days prior to the
randomization visit. Riluzole cannot be initiated during the study.
9. If the subject is receiving Edaravone therapy, the dose must be stable for at least 1
cycle of infusion treatments before the randomization visit.
Exclusion Criteria:
1. History of laryngeal spasm, dystonia, or akathisia.
2. Diagnosis of ongoing symptomatic Restless Leg Syndrome or undergoing current treatment
for Restless Leg Syndrome. If subject has symptoms that resemble or have the potential
to be Restless Leg Syndrome, then further investigation should be undertaken to
confirm or rule out diagnosis of Restless Leg Syndrome.
3. Any history of moderate or severe traumatic brain injury as defined by a Glasgow Coma
Scale Score of less than 13/15 at any time point following a head injury without
sedation or other reason for a decreased level of consciousness.
4. History of neuroleptic malignant syndrome.
5. History of hypersensitivity or serious adverse reaction(s) to a neuroleptic
medication.
6. History of hyponatremia < 130 mmol/L
7. Subject with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value
>3.0 times the upper limit of normal at the Screening visit.
8. Current heparin or warfarin use.
9. History of hepatic and/or renal impairment that may affect pimozide metabolism
10. History of current pregnancy, or breastfeeding women, or women planning to become
pregnant. Female subjects of childbearing potential (sexually mature female who has
not undergone a hysterectomy or who has not been post-menopausal for 12 consecutive
months), must practise effective contraception during the study and be willing and
able to continue contraception until the Follow-up phone visit after discontinuing
study medication. Abstinence can be considered an acceptable method of contraception
at the discretion of the investigator.
11. Current antipsychotic use
12. Presence of central nervous system depression, comatose states, liver disorders, renal
insufficiency, and blood dyscrasias
13. Presence of Parkinson's syndrome
14. Presence of major depressive disorders as determined by site Investigator.
15. History of clinically significant ECG abnormalities at screen visit, including
QTc>500ms.
16. History of congenital long QT syndrome or with a family history of this syndrome and
in patients with a history of cardiac arrhythmias or Torsade de Pointes.
17. Presence of acquired long QT interval, and/or concomitant use of drugs known to
prolong the QT interval (TCAs, opioids such as methodone, quinolone antibiotics
(ciprofloxacin), antimalarials (quinine), Detrol, azole antifungals, Class 1A, III and
1C antiarrhythmics, and macrolide antibiotics.
18. Presence of clinically significant bradycardia (heart rate < 50 beats per minute)
19. Presence of hypokalemia or hypomagnesemia.
20. The concomitant use of CYP 3A4-inhibiting drugs such as azole antimycotics, antiviral
protease inhibitors, macrolide antibiotics and nefazodone.
21. The concomitant use of CYP 2D6-inhibiting drugs such as quinidine is also
contraindicated.
22. Concomitant use of serotonin reuptake inhibitors, such as, sertraline, paroxetine,
citalopram and escitalopram.*
23. Has taken any compound under current or known future study as a potential therapy
(including Withania) for ALS less than 30 days prior to dosing OR history of exposure
to stem cell therapy for treatment of ALS at any time.
24. Current Neurological impairment due to a condition other than ALS:
1. Subject in whom causes of neuromuscular weakness other than ALS have not been
excluded.
2. Subject with a diagnosis of other neurodegenerative diseases (e.g., Parkinson's
disease, Frontotemporal dementia, Alzheimer's disease, etc.)
25. Use of non-invasive ventilation (BiPAP or CPAP) prior to Baseline visit at any time.
26. Cognitive impairment as determined by the Site Investigator, subject must not have an
impaired ability to provide informed consent and must be able to understand study
processes and comply with study procedures.
27. Extrapyramidal Symptom Rating Scale (ESRS) Parkinsonism score of 2 on 2 items or a
score > 3 on 1 item; OR Dystonia score of >3 on at least 1 item or a score of 2 on 2
items; OR Tardive Dyskinesia score of >3 on at least 1 item or a score of 2 on 2
items. Do not consider scores greater than 3 for Tremor in any region if due to Benign
Essential, Exaggerated, or Physiological Tremor.
28. The concomitant use of SSRIs and tricyclic antidepressants (e.g. amitriptyline,
amoxaprine, desipramine, doxepin, imipramine, nortriptyline, protripyline,
trimipramine) - and Tolterodine (Detrol) CYP2D6 inhibitor.
- Prohibited medications such as tricyclic antidepressants, antimalarials, and
serotonin reuptake inhibitors,(ie sertraline, paroxetine, citalopram, fluoxetine,
vilazodone and escitalopram) may be weaned to full discontinuation at the
screening visit after consent has been signed (no study procedures including
adjustments to medication may occur until informed consent has been provided).
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Clinical Trial of Pimozide in Patients With Amyotrophic Lateral Sclerosis (ALS) | NCT03272503 | Entailment |
4,737 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. Age between 40 and 70 years.
2. Uterine weight more than 280gm. the weight will be estimated sonographically using
algebraic formula by Kung and Chang expressed in weights and measurements: weight(g)=
50+(4/3 x π(Pi) x L/2 x W/2 x AP/2) where (L) is the length of the uterus from the
dome of the fundus to the level of the external os and (W) is the maximum width of the
uterus at the level of the cornua and (AP) is the anteroposterior diameter of the
uterus . Both (W) and (AP) will be taken perpendicular to the axis of the uterine
length.
3. Presence of a benign cause for hysterectomy. e.g: fibroid uterus, simple endometrial
hyperplasia not responding to medical treatment and adenomyosis.
Exclusion Criteria:
1. Patients medically unfit for laparoscopy as severely compromised cardiac patients.
2. Obese patients (BMI>30).
3. Presence of endometriosis.
4. Previous myomectomy
5. Presence of adnexal mass
6. Known or suspected gynecological malignancy.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 70 Years | Vaginal Hysterectomy Versus Laparoscopically Assisted Vaginal Hysterectomy for Large Uteri | NCT02826304 | Entailment |
2,421 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Diagnosis of DMD based on a clinical phenotype presenting by age 5, with increased
serum CK and decrease of dystrophin on a muscle biopsy
- Presence of a nonsense mutation in the dystrophin gene
- Physical examination or radiographic imaging documenting the presence of EDB or TA
muscles in both legs
- Ability to ambulate, or if non-ambulatory, then not requiring ventilator support
- Male sex
- Age ≥ 5 years
- Willingness to abstain from sexual intercourse or employ a barrier or medical method
of contraception during the study drug administration and follow-up periods in
subjects known to be sexually active
- Willingness and ability to comply with scheduled visits, drug administration plan,
laboratory tests, study restrictions, and study procedures (including muscle biopsies,
myometry, and PK sampling)
- Ability to provide written informed consent (parental/guardian consent if
applicable)/assent (if <18 years of age)
Exclusion Criteria:
- Prior or ongoing medical condition (e.g., concomitant illness, psychiatric condition,
alcoholism, drug abuse), medical history, physical findings, ECG findings, or
laboratory abnormality that, in the investigator's opinion, could adversely affect the
safety of the subject, makes it unlikely that the course of treatment or follow-up
would be completed, or could impair the assessment of study results
- Clinical symptoms and signs of congestive cardiac failure
- Positive hepatitis B surface antigen, hepatitis C antibody test, or human
immunodeficiency virus (HIV) test
- Hemoglobin <10 g/dL
- Serum albumin <2.5 g/dL
- Abnormal GGT or total bilirubin (>laboratory's upper limit of normal)
- Abnormal renal function (serum creatinine >1.5 times laboratory's upper limit of
normal)
- History of solid organ or hematological transplantation
- Ongoing immunosuppressive therapy (other than corticosteroids)
- Exposure to another investigational drug within 28 days prior to start of study
treatment
- Ongoing participation in any other therapeutic clinical trial
- Ongoing use of thiazolidinedione peroxisome proliferator-activated receptor gamma
(PPAR γ) agonists, e.g., rosiglitazone (Avandia® or equivalent) or pioglitazone
(Actos® or equivalent)
- Change in systemic corticosteroid therapy (e.g., initiation of treatment; cessation of
treatment; change in dose, schedule, or type of steroid) within 3 months prior to
start of study treatment.
- Treatment with systemic aminoglycoside antibiotics within 4 weeks prior to start of
study treatment
Male
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
| Safety and Efficacy Study of PTC124 in Duchenne Muscular Dystrophy | NCT00264888 | Entailment |
2,261 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Written informed consent from parent or legal guardian prior to participation and, for
patients who are 7 years of age, written assent from patient
- Diagnosis of DMD based on a clinical phenotype with increased serum CK and the
presence of a mutation in the dystrophin gene known to be associated with a DMD
phenotype
- Ability to walk independently (assistive devices are permitted)
- Adequate immunization for influenza and varicella
Exclusion Criteria:
- Use of corticosteroids within prior 6 months of treatment initiation or planning to
initiate steroid therapy within the next 6 months
- Other prior or ongoing significant medical conditions
- Exposure to another investigational drug (such as eteplirsen or idebenone) within 28
days prior to start of study treatment or ongoing participation in any other
therapeutic clinical trial
- Note: There are separate criteria for patients who participated in Part A versus
newly enrolling patients. New patients must meet all of the Part A entry criteria
to participate in Part B.
Patients who participated in Part A must meet the following criteria to participate in Part
B:
- Completed Part A
- Continue to meet all of the Part A entry criteria, including an absence of safety
concerns (however, patients may be ≥8 years of age)
There are no entry criteria for Part C; all patients who complete Part B will automatically
continue in Part C
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 7 Years | Phase 1/2 Study in Boys With Duchenne Muscular Dystrophy | NCT02439216 | Contradiction |
5,235 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Ambulatory, postmenopausal women aged 55-85 years (at least 3 years have elapsed after
menopausal) are included at the time of entry into the trial. They have to be free of
severe or chronically disabling conditions other than osteoporosis.
- The patient should have a documented (X-ray) prevalent osteoporotic vertebral fracture
(defined as 3.4) or non vertebral fragility fracture (excluding major trauma).
- L-1 through L-4 vertebrae must be without artifacts, multiple vertebral fractures;
therefore at least 3 vertebrae should be without fractures, osteophytes, or other
abnormalities that would interfere with the analysis of the posterior-anterior lumbar
spine BMD measurement. The reading of the BMD, T-score should be in the range of - 2.0
and - 4.0 at least for one of the 2 sites measured (spine or hip).
The initial lumbar spine and femoral neck BMD assessment and the determination of the
patient's eligibility for entry into the screening phase will be made by the central
quality assurance for BMD. The central quality assurance center will determine the
patient's eligibility for enrollment into the treatment phase. If the L-1 vertebra cannot
be analyzed due to artifacts, vertebral fracture, osteophytes, or other abnormalities, that
vertebra should be excluded from the analysis.
- Women without language barrier, cooperative expected to return for all follow-up
procedures and who have given informed consent before entering the study and after
being informed of the risks, medications, and procedures to be used in the study.
- Normal or clinically insignificant abnormal laboratory values including serum calcium,
PTH(1-84) levels and alkaline phosphatase.
Exclusion Criteria:
- History of diseases which affect bone metabolism other than postmenopausal
osteoporosis such as Paget's disease, renal osteodystrophy, osteomalacia, any
secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, or
hyperthyroidism.
- Patients who have an increased baseline risk of osteosarcoma: Paget's disease of the
bone or unexplained elevations of alkaline phosphatase; Children and young adult with
open epiphyses; Patients who have received radiation therapy involving the skeleton.
- History of other malignant neoplasms in the 5 years prior to screening, with the
exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin
that has been definitively treated. Patients with carcinoma in situ of the uterine
cervix treated definitively more than 1 year prior to entry into the study may enter
the study.
- History of nephrolithiasis or urolithiasis in the 2 years prior to Visit 2. Patients
with any history of nephro- or urolithiasis must have an appropriate radiology study
within 6 months prior to Visit 2. This radiology study, such as an intravenous
pyelogram or a supine radiograph of the kidney-ureter-bladder, must document the
absence of active disease.
- History of sprue, inflammatory bowel disease, or malabsorption syndrome in the 1 year
prior to Visit 2.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 85 Years | PTH Comparison in Post Menopausal Women | NCT00543218 | Entailment |
6,465 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
1. Male or female
2. 18 years of age or older
3. Clinical diagnosis of rosacea
4. Moderate to severe persistent facial erythema associated with rosacea at baseline, as
determined by: a grade of greater than or equal to 3 on the 5 point grading scale1
(Figure 1)
5. No known medical conditions that may interfere with study participation
6. Willingness to not use any products on their face for the duration of the study
7. Read, understand, and sign informed consent forms
8. Willingness to sign photography release form
9. Willing and able to comply with all follow-up requirements
10. Willingness to undergo treatment using Mirvaso® Gel and Dysport®
Exclusion Criteria:
1. Any significant skin disease at treatment area
2. Any medical condition which could interfere with the treatment
3. Inability or unwillingness to follow the treatment schedule
4. Inability or unwillingness to sign the informed consent
5. Pregnant or lactating
6. Allergy to cow's milk protein
7. Previous or current use of Mirvaso® Gel
8. Known hypersensitivity to Dysport® , Mirvaso® Gel or any of their ingredients
9. Previous Dysport® treatment 6 months prior to the screening visit
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Mirvaso® Gel and Dysport® for Erythema and Flushing of Rosacea | NCT03508869 | Entailment |
5,705 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Turner Syndrome Females:
Inclusion Criteria:
- Turner Syndrome confirmed by chromosomal testing
- On standard therapy (growth hormone and or estrogen)
Exclusion Criteria:
- Type 1 or Type 2 diabetes
- Polycystic Ovarian Syndrome
- Pregnancy
- On any medications that alter blood sugar
Healthy Female Controls:
Inclusion Criteria:
- Healthy
Exclusion Criteria:
- Type 1 or Type 2 diabetes
- Polycystic Ovarian Syndrome
- Pregnancy
- On any medications that alter blood sugar
Female
Accepts Healthy Volunteers
Subject must be at least 6 Years old.
Subject must be at most 22 Years | Risk of Diabetes in Young Turner Syndrome Patients | NCT02160717 | Entailment |
6,449 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
1. Healthy male or non-pregnant female aged ≥ 18 years with a clinical diagnosis of
facial papulopustular rosacea.
2. Subjects must have provided IRB approved written informed consent.
3. Subjects must have at least 15 and not more than 50 inflammatory facial lesions (i.e.,
papules/pustules) at screening and baseline visits. For the purposes of study
treatment and evaluation, these lesions should be limited to the facial treatment area
including those present on the nose. Lesions involving the eyes, and scalp will be
excluded from the count.
4. Subjects must have no more than 2 nodulocystic lesions on the face at Screening and
Baseline visits.
5. Subjects must have a definite clinical diagnosis of facial papulopustular rosacea
severity grade 3 or 4 as per the Investigator Global Assessment (IGA) (per Table 1
below) at screening and baseline visits.
6. Subjects must have persistent erythema on the face with moderate (2) score or higher
(per table 2 below) at screening and baseline visits.
7. Subjects must have a mild (1) to moderate (2) score for telangiectasia on the face.
(per table 3 below) at screening and baseline visits.
8. 8. Subjects must be willing to minimize external factors that might trigger rosacea
flare-ups (e.g., spicy foods, thermally hot foods and drinks, hot environments,
prolonged sun exposure, strong winds and alcoholic beverages)
9. Subjects must be willing to refrain from using all other topical medications for
rosacea during the 12-week treatment period, other than the investigational product.
10. Female Subjects of childbearing potential (excluding women who are or premenarchal,
surgically sterilized (by hysterectomy) or postmenopausal for at least 1 year prior to
screening), in addition to having a negative urine pregnancy test, must be willing to
use an acceptable form of birth control during the study from the day of the first
dose administration to 30 days after the last administration of study drug. For the
purpose of this study the following are considered acceptable methods of birth
control: oral or injectable contraceptives, contraceptive patches, Depo-Provera®
(stabilized for at least 3 months prior to screening), NuvaRing® (vaginal
contraceptive), Implanon™ (contraceptive implant), double-barrier methods (e.g. condom
and spermicide), IUD, or abstinence with a 2nd acceptable method of birth control
should the Subject become sexually active. Subjects on hormonal contraception must be
stabilized on the same type for at least three months prior to screening and must not
change the method during the study. A sterile sexual partner is NOT considered an
adequate form of birth control.
11. All male Subjects must agree to use accepted methods of birth control with their
partners, from the day of the first dose administration to 30 days after the last
administration of study drug. Abstinence is an acceptable method of birth control.
Female partners should use an acceptable method of birth control as described in the
above Item Number 10.
12. Subjects who use make-up must have used the same brands/types of make-up for a minimum
period of 14 days prior to screening and must agree to not change make-up brand/type
or frequency of use throughout the study.
13. Subjects must be willing and able to understand and comply with the requirements of
the protocol, including attendance at the required study visits.
14. Subjects must be in good health and free from any clinically significant disease,
including but not limited to, conditions that may interfere with the evaluation of
facial rosacea. Such conditions include but are not limited to the following:
autoimmune disease; acne vulgaris on the face; seborrheic dermatitis on the face;
perioral dermatitis; corticosteroid-induced acne; carcinoid syndrome; mastocytosis;
acneiform eruptions caused by make-up, medication, facial psoriasis and facial eczema.
Exclusion Criteria:
1. Female Subjects who are pregnant, nursing or planning to become pregnant during study
participation.
2. Subjects with a history of hypersensitivity or allergy to ivermectin, propylene glycol
and/or any of the study medication ingredients and its excipients.
3. Subjects with the presence of other forms of rosacea (rosacea conglobata, rosacea
fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other dermatoses
that may be confounded with papulopustular rosacea, such as peri-oral dermatitis,
facial keratosis pilaris, seborrheic dermatitis and acne.
4. Subjects with excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that
would interfere with diagnosis or assessment of facial rosacea.
5. Subjects with moderate or severe rhinophyma, dense telangiectases (score 3, severe),
or plaque-like facial edema.
6. Subjects with a severe irritation (score 3 = severe (marked/intense)) for dryness,
pruritus, or stinging/burning.
7. Subjects with ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of
sufficient severity to require topical or systemic antibiotics.
8. Subjects who currently have or have recently had bacterial folliculitis on the face.
9. Subjects who have unstable medical disorders that are clinically significant or have
lifethreatening diseases. Subjects who have clinically significant abnormal laboratory
values according to the investigator at screening.
10. Subjects who had within 14 days prior to screening:
1. wax depilation of the face
2. cosmetic procedures (e.g., facials) which may affect assessment of facial rosacea
3. exposure to excessive UV radiation or the subject is planning exposure during the
study (e.g. occupational exposure to the sun, planned holidays in the sun during
the study, phototherapy, tanning salon),
4. used a sauna.
11. Subjects who have used any of the following procedures on the face within 1 month
prior to screening:
1. cryodestruction or chemodestruction,
2. dermabrasion,
3. photodynamic therapy,
4. acne surgery,
5. intralesional steroids, or
6. X-ray therapy.
12. Subjects who have used any of the following topical treatments on the face within 1
month prior to screening:
1. retinoids
2. benzoyl peroxide
3. immunomodulators
4. antibiotics (e.g., metronidazole and macrolides)
5. corticosteroids
6. other topical rosacea treatment (e.g., azelaic acid, metronidazole) or topical
erythema treatment (e.g. brimonidine)
13. Subjects who have used any of the following systemic treatments within 1 month prior
to screening:
1. corticosteroids,
2. systemic antibiotics known to have an impact on the severity of facial rosacea
(e.g., containing tetracycline and its derivatives, erythromycin and its
derivatives, sulfamethoxazole, or trimethoprim),
3. other systemic treatments that affect erythema: alpha-blockers (e.g.,
mirtazapine), beta-blockers (e.g., propranolol), alpha 2 agonist (e.g.,
clonidine), or
4. other systemic treatment for rosacea.
14. Subjects who have used any of the following topical treatments within 6 weeks prior to
screening:
1. corticosteroids,
2. antibiotics for rosacea,
3. medications for rosacea (e.g., azelaic acid, metronidazole),
4. over-the-counter preparations for rosacea, or
5. anti-inflammatory agents. Note: Non-steroidal anti-inflammatory drugs (NSAIDs)
and aspirin use on an as needed basis and if not used consecutively for > 14 days
prior to screening and/or during the study is acceptable. Note: Low dose (81 mg)
aspirin taken daily is acceptable.
15. Subjects who have used or changed their use of estrogens or oral contraceptives within
the 3 months prior to screening.
16. Subjects who have received radiation therapy and/or anti-neoplastic agents within 3
months prior to screening.
17. Subjects who have used within 6 months prior to screening antiandrogens such as
Spironolactone, oral retinoids (e.g. Accutane®), or therapeutic vitamin A supplements
of greater than 10,000 units/day (multivitamins are allowed).
18. Subjects who have had laser therapy (for telangiectasia or other conditions),
electrodessication and phototherapy (e.g., ClearLight®) to the facial area within 6
months prior to study entry (Visit 1 Screening Visit).
19. Subjects who engage in activities that involve excessive or prolonged exposure to
sunlight or weather extremes, such as wind or cold.
20. Subjects who consume excessive amounts of alcohol (greater than two drinks per day) or
use drugs of abuse (including, but not limited to, cannabinoids, cocaine and
barbiturates).
21. Subjects who have participated in an investigational drug study (i.e., Subjects have
been treated with an investigational drug) within 30 days prior to screening will be
excluded from study participation. Subjects who are participating in non-treatment
studies such as observational studies or registry studies can be considered for
inclusion.
22. Subjects who have been previously enrolled in this study.
23. Subjects who live in the same household with subjects currently enrolled in this
trial.
24. Subjects who have a history of being unresponsive to topical ivermectin therapy.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Bioequivalence Study of Ivermectin Cream 1% in Treatment of Moderate to Severe Facial Rosacea | NCT04106726 | Entailment |
5,486 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion Criteria:
- Age of 50 years or older
- Social insurance
- Diagnosis of AION, characterized by sudden and painless loss of vision, of less than
one week, accompanied by pallid swelling of the optic disc
- Diagnosis of GCA based on ACR 1990 criteria, i.e. 3 of 5 criteria among : 1) age ≥ 50
years, 2) new headache, 3) abnormal temporal artery, 4) erythrocyte sedimentation rate
≥ 50 at 1 hour or C reactive protein ≥ 20, 5) artery biopsy showing vasculitis
Exclusion Criteria:
- Other ocular involvements related to GCA (central retinal artery occlusion, posterior
ischemic optic neuropathy, transient ocular manifestations, occipital stroke), if not
associated with AION
- Biological targeting therapy within 3 months preceding the study
- Evidence of active infection
- History of any malignant neoplasm except adequately treated basal or squamous cell
carcinoma of the skin or solid tumors treated with curative therapy and disease-free
for at least 5 years
- History of recurrent infections, diverticulitis or intestinal ulceration and ASAT/ALAT
> 5 * upper limit of normal, according to the Summary of Product Characteristics of
tocilizumab
- Contraindication to steroids and/or aspirin administrated in the treatment
- Breastfeeding women and women with childbearing potential without highly effective
contraception.
- Pregnant or nursing (lactating) women confirmed by a positive βHCG laboratory test at
the inclusion
- Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using highly effective methods of contraception
during study treatment and for 3 months after the last administration of tocilizumab.
- Cytopenia, as defined by platelet count < 100 × 109/L (100,000/mm3), hemoglobin < 85
g/L (8.5 g/dL; 5.3 mmol/L), absolute neutrophil count < 2.0 × 109/L (2000/mm3),
absolute lymphocyte count < 0.5 × 109/L (500/mm3)
- Insufficient liver function (Child Pugh C )
- Insufficient kidney function, as defined by a serum creatinine of more than 3 mg/dL or
creatinine clearance of 20 ml/min or less
- Patients with previously untreated tuberculosis, previously known TDM/radiographic
evidence suggestive of active and/or sequellar tuberculosis
- HIV infected, hepatitis C infected, or a positive hepatitis B surface antigen if known
before study inclusion
- Contraindication to and precaution in use of tocilizumab according to the summary
product description
- Inability to provide informed consent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Efficacy of Tocilizumab for the Treatment of Acute AION Related to GCA | NCT04239196 | Contradiction |
917 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Male or female at least 18 years of age at time of screening.
2. Ability to comply with study procedures and visit schedules and able to follow oral
and written instructions.
3. Patients with symptomatic OA in one knee from 3 months
4. A standing knee radiograph showing a K-L grade of 2 to 3 and an absence of severe
osteoarthritis (defined as advanced stage osteoarthritis, including large osteophytes,
chronic fractures or bone remodeling, severe deformity or bone attrition, and/or
bone-on-bone contact indicative of severe osteoarthritis/full thickness cartilage
loss).
5. Body mass index ≤ 40 kg/m2.
6. A WOMAC LK 3.1 pain subscale total score ≥ 9 and ≤ 19.
7. Has undergone at least one prior conservative OA treatment (e.g. physical therapy,
simple analgesics).
8. Signed an ethics committee-reviewed an approved informed consent form.
Exclusion Criteria:
1. Presence of clinically observed active infection or severe inflammation in the index
knee joint or skin disease/breakdown or infection in the area of the planned injection
site of the index knee.
2. Presence of symptomatic OA in the non-study knee at screening; if unclear then the
WOMAC LK 3.1 pain subscale for the non-index knee must be ≤ 5.0.
3. Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout,
ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; Human
Immunodeficiency Virus (HIV), viral hepatitis; chondrocalcinosis, Paget's disease, or
villonodular synovitis.
4. Diagnosed with leukemia, known presence of metastatic malignant cells, or ongoing or
planned chemotherapeutic treatment.
5. Disease of spine, hip or other lower extremity joints judged by the investigator to be
contributing to the pain in the index knee (e.g. sciatica, nerve pain, hip OA). Note:
Patients with contralateral knee replacement, or hip replacement in either hip, may be
enrolled provided there is sufficient pain relief after knee replacement or hip
replacement that analgesics are not required.
6. Untreated symptomatic injury of the index knee (e.g., acute traumatic injury, anterior
cruciate ligament injury, clinically symptomatic meniscus injury characterized by
mechanical issue such as locking or catching).
7. Presence of surgical hardware or other foreign body intended to treat arthritis or
cartilage-related pathology in the index knee. Note: this does not include small
hardware (e.g. screws).
8. Presence of venous or lymphatic stasis in the index leg.
9. Orally administered systemic steroid use within 2 weeks prior to screening
10. Planned/anticipated surgery of the index knee during the study period.
11. Major surgery of the index knee within 12 months prior to screening.
12. Minor surgery (e.g. arthroscopy) of the index knee within 6 months prior to screening.
13. Any documented clinically significant degree of cognitive impairment or other
condition, finding, or psychiatric illness at screening, which, in the opinion of the
investigator, could compromise patient safety or interfere with the assessment of the
safety and treatment effects of the study injection.
14. Pregnant or nursing mothers or women planning to become pregnant during the time they
will be participating in the study.
15. Know hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations.
16. Previously documented failed treatment with OOT or Sinovial
17. Known drug or alcohol dependence currently or within the last year.
18. Use of any investigational drug or device within 30 days prior to screening.
19. Use of any investigational biologics within 60 days prior to screening.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Intra-articular Oxygen-ozone Therapy for the Treatment of Knee Osteoarthritis Compared With Hyaluronic Acid | NCT04426721 | Entailment |
649 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
- patients who are eligible for a primary Roux- en -Y gastric bypass and who have no
pre-existing iron deficiency (serum ferritin between 20-200 micrograms/L)
Exclusion Criteria:
- blood transfusion one month before ans in the study period. The use of iron containing
nutritional supplements, except our standardized multivitamin supplements. Decreased
function of the kidney with a GFR of < 30ml/min and a serum creatinin below 50
micromol/L. Hb< 7.4 mmol/L in females en Hb< 8.4 mmol/L in males. Accumulation of
iron. Hypersensitivity for ons of the medicinal products. Psychiatric illness.
Pregnancy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Iron Absorption Trial | NCT02228902 | Contradiction |
3,855 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Knee osteoarthritis
Exclusion Criteria:
- WOMAC less than 4
- Use of braces
- Uncontrolled hypertension
- Significant psychiatric or psychotic disorder
- Not able to attend 75% of sessions
- Any other reason that would prevent participation
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years | An Innovative Mind-motor Exercise Approach to Osteoarthritis Treatment | NCT02753634 | Entailment |
1,058 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- At least one documented spontaneous VVS during preceding 12 months or one syncope in
history leading to injury and minimum 2 presyncopal events during preceding 12 months,
refractory to all recommended types of standard treatment.
- In case of lack of ECG documentation during spontaneous syncope and history suggesting
reflex syncope, at least 3 seconds of asystole due to sinus arrest or
atrio-ventricular block with syncope or bradycardia <40 beats per minute with syncope
or presyncope during baseline tilt test
- Sinus rhythm during ECG and tilt test
- Significantly decreased quality of life due to syncope
- Positive response to atropine test
- Obtained written informed consent.
Exclusion Criteria:
- Other possible and treatable causes of syncope such as significant cardiac disease,
cardiac arrhythmia or abnormalities of vertebro-basiliar arteries
- History of stroke or TIA
- History of cardiac surgery
- Contraindications to ablation in the right or left atrium
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Cardioneuroablation for Reflex Syncope | NCT03903744 | Contradiction |
6,143 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
1. Group A: Mild to moderate COVID-19 (non-pregnant)
• Current male or female COVID-19 infected (age 18-60 years old) with mild to moderate
illness
2. Group B: Severe to critical COVID-19 (non-pregnant)
• Current male or female COVID-19 infected (age 18-60 years old) with severe to
critical illness
3. Group C: Controls (non-pregnant)
• Male of female uninfected (age 18-60 years old) who have no history of COVID-19
symptoms or illness
4. Group D: Pregnant or postnatal with COVID-19
- Current pregnant or postnatal COVID-19 infected (age 18-50 years old)
- Pregnant or postnatal (within 6 weeks since birth) who were diagnosed with
COVID-19 less than 4 months previously (age 18-50 years old)
- Singleton pregnancy
5. Group E: Pregnant or postnatal with influenza
- Current pregnant or postnatal influenza infected (age 18-50 years old)
- Pregnant or postnatal (within 6 weeks since birth) who were diagnosed with
influenza less than 4 months previously (age 18-50 years old)
- Singleton pregnancy
6. Group F: Pregnant and have received the influenza vaccine
- Current pregnant who has received the influenza vaccine (age 18-50 years old)
- Singleton pregnancy
Exclusion Criteria:
1. Group A, Group B and Group C:
- Patients unable to understand verbal or written information in English, regarding
the study. Lack of capacity to consent at the point of recruitment
- Pregnant
- Participants who have previously been part of any SARS-CoV-2 vaccine trial
- Evidence of HIV infection
- Participants on medication that may significantly affect their immune system such
as chemotherapy drugs
- Vulnerable patients with known safe-guarding issues
- Pregnant with more than one baby
2. Group D, E and F:
- Patients unable to understand verbal or written information in English, regarding
the study.
- Lack of capacity to consent at the point of recruitment
- Participants who have previously been part of any SARS-CoV-2 vaccine trial
- Evidence of HIV infection
- Participants on medication that may significantly affect their immune system such
as chemotherapy drugs other than steroids, which have been given for fetal lung
maturity
- Vulnerable patients with known safe-guarding issues
- Pregnant with more than one baby
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 60 Years | Evaluation of Humoral Immunity Following COVID-19 in Pregnancy | NCT04568044 | Contradiction |
6,460 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
- Subject is male or female aged 18 to 80 years inclusive.
- Subject with papulopustular rosacea (11 to 40 papules or pustules) and an IGA of
moderate or severe.
- For subjects using medications to treat a concurrent medical condition, type and dose
must have been stable for at least 90 days prior to study entry.
Exclusion Criteria:
- Female subjects who are pregnant, nursing or planning a pregnancy during the study.
- Subject has any other active dermatological condition on the face that may interfere
with the conduct of the study.
- Subject uses or has recently used any medication which may interfere with the
absorption, distribution, or elimination of study medications, or may interfere with
the assessments of efficacy or safety of the study medications.
- Subject has a known allergy to any of the components of the study products, and/or a
known hypersensitivity to tetracyclines or metronidazole.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo | NCT01426269 | Entailment |
6,932 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Clinical diagnosis of Alzheimer's Disease
- Patients with increased risk for developing dementia
- Must be able to give their consent
Exclusion Criteria:
- Contra-indications for MRI scanning
- Substance abuse
- Severe medical conditions
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 60 Years old.
Subject must be at most 85 Years | Tablet-based Cognitive Training | NCT04452864 | Entailment |
3,098 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- mild/moderate intellectual disability
- students at the upper secondary schools for intellectual disability students
Exclusion Criteria:
- severe intellectual disability
- obesity related syndromes
- major physical disabilities
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 22 Years | School Intervention With Daily Physical Activity and Healthy Food for Students With an Intellectual Disability. | NCT01291238 | Entailment |
5,768 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
- Adults with definite or probable dermatomyositis or polymyositis and pediatric
patients five years of age and over with definite or probable juvenile dermatomyositis
(JDM) by Bohan and Peter criteria. Diagnosis of JDM based on an age of onset (i.e.,
first symptom of myositis or dermatomyositis rash) is less 18 years of age
- Refractory myositis, defined by intolerance to or inadequate response to
corticosteroids plus an adequate regime of at least one other immunosuppressive agent.
Intolerance is defined as side effects that require discontinuation of the medication
or an underlying condition that precludes further use of the medication.
- Baseline manual muscle testing which is based on a maximum MMT-8 (Manual Muscle Test)
score of 150:Adult subjects with dermatomyositis (DM) or polymyositis (PM) must have a
score that is no greater than 125/150 in conjunction with 2 other abnormal core set
measures.
Subjects with a diagnosis of Juvenile Dermatomyositis (JDM) must meet either of the
following criteria:
1. An MMT-8 (Manual Muscle Test) score that is no greater than 125/150 in conjunction
with 2 other abnormal core set measures.
OR
2. If MMT (Manual Muscle Test) score is greater than 125/150 the patient MUST meet at
least 3 abnormal core set measures.
- Background therapy with at least 1 non-corticosteroid immunosuppressive agent at
a stable dose for at least 6 weeks prior to screening
- Able and willing to complete self-report questionnaires. Parents of pediatric
participants will be required to complete the questionnaires on behalf of their
children.
- Willing to use acceptable forms of contraception for the duration of the study
for patients of reproductive potential.
- Parent willing to provide informed consent, if applicable
- Willing to forgo immunization with a live vaccine for the duration of the study
Exclusion Criteria:
- Drug-induced myositis. Patients who have myositis or myopathic syndromes caused by
taking medications known to induce myositis-like syndromes, including but not limited
to statin agents, fibric acid derivatives, colchicine, and hydroxychloroquine.
- Juvenile polymyositis
- Inclusion body myositis
- Cancer-associated myositis, defined as the diagnosis of myositis within 2 years of the
diagnosis of cancer. Patients with basal or squamous cell skin cancer or carcinoma in
situ of the cervix are not excluded, if it has been at least 5 years since excision.
- Myositis in overlap with another connective tissue disease that may preclude the
accurate assessment of a treatment response
- Live viral vaccine within 4 weeks prior to study entry
- Any joint disease or other musculoskeletal condition that may interfere with muscle
strength testing
- Known hypersensitivity to mouse proteins
- Any concomitant or life-threatening non-myositis illness that, in the opinion of the
investigator, may interfere with the study
- Known or suspected history of drug or alcohol abuse within the last 6 months prior to
study entry, as determined by medical record or patient interview
- Anticipated poor compliance with study requirements
- Participation in another clinical trial within 30 days prior to screening
- Any history or evidence of any severe illness or other condition that, in the opinion
of the investigator, may interfere with the study
- Previously received rituximab
- Evidence of prior infection with hepatitis B or hepatitis C virus
- Initiation of an exercise program within 4 weeks of screening OR initiation of an
exercise program during the study
- Consumed any creatine-containing, over-the-counter products in the form of dietary
supplements 30 days prior to screening visit and for the duration of the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 5 Years old.
| Rituximab for the Treatment of Refractory Adult and Juvenile Dermatomyositis (DM) and Adult Polymyositis (PM) | NCT00106184 | Contradiction |
2,355 | 15 | An 8-year-old boy is brought to the clinic by his parents because of weakness and difficulty of standing up from a sitting position. The mother is healthy but had a brother who died in his 20th after being disabled and using wheelchairs in the last few years of his life. Physical examination shows 3/5 lower extremity muscle strength and enlarged calf muscles. The other physical examination and vital signs are unremarkable. Muscle biopsy showed absence of dystrophin protein. The patient is diagnosed with DMD. | I brought my 8-year-old son to the doctor's clinic. He was struggling to stand up from a chair for the past few days. My wife is healthy but she was pretty worried since his brother died in his 20s after being disabled and using a wheelchair for the last years of his life. The doctor did an exam which highlighted weakness in the leg muscles and unusually large calf muscles. The rest of the exam was fine, and his vitals were normal. My son did a muscle biopsy, and it showed that the protein important for muscle strength and function is missing. The doctor diagnosed him with Duchenne muscular dystrophy. | Inclusion Criteria:
- Boys age ≥7 years with DMD confirmed clinically and by mutation analysis able to
undergo cardiac magnetic resonance (CMR) without sedation
- LV EF ≥45% (+/-5%) by clinically-acquired echocardiography, nuclear scan or cardiac
MRI done within 2 weeks of enrollment
Exclusion Criteria:
- Non-MR compatible implants
- Severe claustrophobia
- Gadolinium contrast allergy
- Kidney disease
- Prior use of or allergy to aldosterone antagonist
- Use of other investigational therapy.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 7 Years old.
| Therapeutic Potential for Aldosterone Inhibition in Duchenne Muscular Dystrophy | NCT02354352 | Entailment |
6,197 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Patient hospitalized for CoViD-19 infection during the health crisis, in a short-stay
service of Reims University Hospital and included in Covid-19 Cohort
- Age > 18 years
- Patient who benefit from the national health insurance coverage
- patient agree for participation (consent form signed)
Exclusion Criteria:
- Patient protected by law
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| CoViD-19 Patient in Reims University Hospital in March to April 2020 | NCT04553575 | Contradiction |
4,080 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Inclusion Criteria:
---
Exclusion Criteria:
Participants with a history of neurological disorders or of sleep disorders will be
excluded.
Participants who do not believe they would be able to fall asleep in the lab will be
excluded.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 35 Years | The Effects of Direct Context Reactivation During Sleep on Memory | NCT04702152 | Contradiction |
3,424 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
- Male or female subjects, age 20 to 75 years, inclusive with type 2 diabetes mellitus.
- At Visit 2/Period 1/Day 1, subjects will have been treated for their diabetes by
metformin (≥1000 mg/day; any type and regimen), metformin and a DPP-4 inhibitor (
Dipeptidyl-Peptidase)-4), metformin and an SGLT-2 (Sodium-glucose co-transporter 2)
inhibitor, metformin and TZD (Thiazolidinediones), or metformin and sulfonylurea.
Subjects will have been on a stable regimen of metformin (defined as the same
metformin dose and type) and other treatments for at least 8 weeks prior to Visit
2/Period 1/Day 1.
- Body Mass Index (BMI) between 25 and 40 kg/m2, inclusive, at Screening.
- Hemoglobin A1c (HbA1c) between ≥7.5 and ≤10.5% at Screening.
- Fasting serum glucose greater than or equal to 126 mg/dL at Screening.
- Females of childbearing potential must have a negative serum pregnancy test result at
Screening and a negative urine pregnancy test at Visit 2/Day 1 for all study Periods.
- Females who are not of childbearing potential are defined as:
i. Postmenopausal (defined as at least 12 months with no menses in women ≥45 years of
age) ii. Has had a hysterectomy and/or bilateral oophorectomy, bilateral
salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to
screening; OR iii. Has a congenital or acquired condition that prevents childbearing.
- Females of childbearing potential agree to avoid becoming pregnant while receiving
study treatment and for 14 days after the last dose of study treatment by complying
with one of the following:
i. practice abstinence† from heterosexual activity OR ii. Use (or have her partner
use) acceptable contraception during heterosexual activity.
Exclusion Criteria:
- Usage of anti-diabetic agents other than metformin, sulfonylurea, SGLT-2 inhibitors,
TZD, or DPP-4 inhibitors within 6 weeks prior to Visit 2/Period 1/Day 1.
- Presence of any clinically significant endocrine disease according to the Investigator
(euthyroid subjects on replacement therapy will be included if the dosage of thyroxine
is stable for at least six weeks prior to Screening).
- Clinical diagnosis of type 1 diabetes.
- Fasting serum glucose >300 mg/dL at Screening; a single repeat test is allowable.
- Evidence of unawareness of hypoglycemia, a documented plasma glucose ≤50 mg/dL in the
absence of symptoms of hypoglycemia at Screening.
- Presence of any clinically significant condition (in the opinion of the Investigator)
that might interfere with the evaluation of study medication, such as significant
renal, hepatic, gastrointestinal (GI), cardiovascular (CV), immune disease, blood
dyscrasias or any disorders causing hemolysis or unstable red blood cells, or
clinically important hematological disorders (i.e. aplastic anemia, myeloproliferative
or myelodysplastic syndromes, thrombocytopenia) at Screening.
- Presence or history of cancer within the past 5 years of Screening, with the exception
of adequately-treated localized basal cell skin cancer or in situ uterine cervical
cancer.
1. A subject with a history of malignancy >5 years prior to Screening should have no
evidence of residual or recurrent disease.
2. A subject with a history of melanoma, leukemia, lymphoma, or renal carcinoma is
excluded.
- Laboratory abnormalities at Screening including:
1. C-peptide < 1.0 ng/mL;
2. Positive pregnancy test in females of childbearing potential (at Screening and
Visit 2/Periods 1-3/Day 1);
3. Abnormal serum thyrotropin (TSH) levels below the lower limit of normal or >1.5X
(1.5 times) the upper limit of normal
4. Elevated liver enzymes (alanine transaminase (ALT), alanine aminotransferase
(AST), alkaline phosphatase) >2X the upper limit of normal.
5. Very high triglyceride levels (>600 mg/dL); a single repeat test is allowable.
6. Any relevant abnormality that would interfere with the efficacy or the safety
assessments during study treatment administration.
- Positive history of active liver disease (other than non-alcoholic hepatic steatosis),
including chronic hepatitis B or C, primary biliary cirrhosis, or active symptomatic
gallbladder disease.
- Positive history of HIV.
- Use of the following medications:
1. History of use of insulin for more than 1 week within 6 months prior to and none
within 6 weeks prior to Visit 2/Period 1/Day 1.
2. History of use of aprotinin at any time prior to Screening (e.g., Trasylol, any
type or dose).
3. Administration of thyroid preparations or thyroxine (except in subjects on stable
replacement therapy) within 6 weeks prior to Screening.
4. Administration of systemic long-acting corticosteroids within two months or
prolonged use (more than one week) of other systemic corticosteroids or inhaled
corticosteroids (if daily dosage is > 1,000 μg equivalent beclomethasone) within
30 days prior to Screening. Intra-articular and/or topical corticosteroids are
not considered systemic.
5. Use of medications known to modify glucose metabolism or to decrease the ability
to recover from hypoglycemia such as oral, parenteral, and inhaled steroids (as
discussed above), and immunosuppressive or immunomodulating agents.
- Subject is on a weight loss program and is not in the maintenance phase, or subject
has started weight loss medication (e.g., orlistat or liraglutide), within 8 weeks
prior to Screening. Subjects who have had bariatric surgery are also excluded.
- Subject is pregnant or breast-feeding.
- Subject has a Screening systolic blood pressure ≥165 mmHg or diastolic blood pressure
≥100 mmHg. Subjects will be allowed to take a BP rescue medication.
- Subject is a user of recreational or illicit drugs or has had a recent history (within
1 year of Screening) of drug or alcohol abuse or dependence. (Note: Alcohol abuse
includes heavy alcohol intake as defined by >3 drinks per day or >14 drinks per week,
or binge drinking) at Screening.
- Any clinically significant ECG abnormality at Screening or cardiovascular disease.
Clinically significant cardiovascular disease will include:
1. History of stroke, transient ischemic attack, or myocardial infarction within 6
months prior to Screening,
2. History of or currently have New York Heart Associate Class II-IV heart failure
prior to Screening, or
- One or more contraindications to metformin.
- At the Principal Investigator's discretion, any condition or other factor that is
deemed unsuitable for subject enrollment into the study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 75 Years | A Study of Single and Multiple Doses of Oral Insulin or Placebo in Subjects With Type 2 Diabetes Mellitus | NCT02954601 | Entailment |
5,925 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Eligible participants included patients ≥20 years with either overweight (BMI of 25-30
kg/m2) or obese (BMI > 30 kg/m2), who had undergone panendoscopy due to typical
clinical symptoms of either acid regurgitation, heartburn sensation, or both. By the
results of panendoscopy, patients with the severity of grade A or B esophageal reflux,
according to the Los Angeles classification, are enrolled.
Exclusion Criteria:
- Patients are excluded if they have taken antisecretory agents, including histamine-2
receptor antagonist and PPI, within two weeks prior to the panendoscopy. The following
conditions are also excluded: the presence of peptic ulcers, pregnancy, major medical
problems (including hypertension, liver cirrhosis, COPD, asthma, renal failure and
congestive heart failure), or previous gastric surgery. Patients who have an allergy
history to dexlansoprazole or lansoprazole are also excluded.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 95 Years | Treatment Effect Between Dexlansoprazole and Double-dose Lansoprazole in Obesity Patients With Reflux Esophagitis | NCT02759393 | Contradiction |
6,293 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Confirmed diagnosis of SARS-CoV-2 disease, detected by PCR or antigen test, performed
72 h prior to patient inclusion in the study.
- Acceptance to sign the informed consent document.
- Possession of a Smartphone or Tablet with Internet connection.
- Possession of mental faculties to participate in the study.
Exclusion Criteria:
- Age below the age of health majority (16 years).
- Lack of digital skills to use the Home App.
- Cognitive impairment that prevents the patient from participating in the study.
- Disabling pathology of the upper limb.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 16 Years old.
| Clinical Decision Support System Based on Non-invasive Tele-monitoring of COVID-19 Patients | NCT04802018 | Entailment |
4,859 | 37 | A 47-year-old man comes to the office due to weight gain and fatigue. He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father. Blood pressure is 165/90 mm Hg and pulse is 85/min. On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities. Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit. Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels. Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome. | I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome. | PROTOCOL ENTRY CRITERIA:
- Adults and teenagers with untreated, spontaneous active Cushing's syndrome
- Diagnosis verified at the University of Michigan Medical Center, including the
following: Excessive cortisol secretion measured by urinary-free cortisol, cortisol
secretion rate, and plasma cortisol level
- Lack of normal circadian cortisol secretion and failure to suppress following 2 mg of
dexamethasone
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
Subject must be at most 80 Years | Hippocampal Complex Volume and Memory Dysfunction in Cushing's Syndrome | NCT00004326 | Entailment |
1,135 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | - INCLUSION CRITERIA:
The following is a representative list of the types of patient presentations and potential
diagnoses eligible for this protocol:
1. Coronary artery disease with angina or inducible myocardial ischemia as determined by
noninvasive testing.
2. Cardiomyopathies including congestive phenotypes.
3. Peripheral artery disease with intermittent claudication or limb-threatening ischemia.
4. Renovascular disease with uncontrolled hypertension, intermittent pulmonary edema, or
evidence of ischemic nephropathy.
5. Upper extremity peripheral artery disease.
6. Diabetes with heart failure.
7. Pulmonary hypertension.
EXCLUSION CRITERIA:
Pregnancy, for those patients who require catheterization-based diagnostics.
Inability to provide informed consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Evaluation of Patients With Known or Suspected Heart Disease | NCT00001313 | Entailment |
4,967 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
1. Male or female patients aged ≥ 25 and ≤ 80 years
2. Patients with Essential Tremor according to the criteria of the consensus statement of
the movement disorders society (Deuschl et al. 1998) are included with a medical
treatment resistant and disabling postural and/or intentional tremor.
3. FTMTRS to be completed within 42 days prior surgery
4. Stable tremor medication for at least 3 months prior inclusion
5. Written informed consent
Exclusion Criteria:
1. Major Depression with suicidal thoughts or suicidal thoughts in history
2. Dementia (Mattis Dementia Rating Score ≤ 130)
3. Acute psychosis
4. Patient incapability
5. Nursing care at home
6. Surgical contraindications
7. Medications that are likely to cause interactions in the opinion of the investigator
8. Known or persistent abuse of medication, drugs or alcohol
9. Persons who are in a relationship of dependence/employment with the sponsor or the
investigator
10. Fertile women not using adequate contraceptive methods: female condoms, diaphragm or
coil, each used in combination with spermicides; intra-uterine device; hormonal
contraception in combination with a mechanical method of contraception;
11. Current or planned pregnancy, nursing period
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 80 Years | Deep braIn Stimulation for Tremor TractographIC Versus Traditional | NCT02491554 | Entailment |
1,565 | 10 | A 19-year-old girl comes to the clinic due to a left wrist mass. She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns. Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms. | I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms. | Inclusion Criteria:
- A cancer survivor of breast, prostate, lung, colorectal, cervical or oral cancer
survivor and live within the Baltimore Maryland area.
- Finished your active cancer treatment at least three months ago.
- Overweight or obese and do not exercise daily.
- Do not have any physical limitation to do mild to moderate physical activities.
- Have a smart phone (iPhone or Android device) with Wi-Fi internet connection at home.
- Actively using an email account
- Willing to accept the random study assignment.
- Willing to wear a Fitbit band 'a physical activity tracking device' on your wrist for
five weeks every single day.
- Willing to have an Echo speaker 'a smart home speaker with voice assistant' installed
in your home and use the digital voice assist for four weeks.
- Willing to receive daily text messages on your phone for four weeks.
- Willing to provide us with access to your Fitbit physical activities data.
- Willing to sign the consent form.
Exclusion Criteria:
- Already doing moderate to high physical activities in their daily life (rapid
screener).
- Planning to relocate within the next 4-5 weeks.
- Stage 4 cancer.
- Already using physical activity tracker or part of a physical activity program.
- Part of another study that may interfere with our outcome of interest, unstable mental
condition.
- Mental condition that prevents patient from performing the study activities and
requirements.
- Pregnancy.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Physical Activities by Technology Help (PATH) | NCT03212079 | Contradiction |
5,057 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- The study will enroll 40 postmenopausal women with a T score < -2 either at the lumbar
spine or the femoral neck: 20 who decide to begin anti-resorptive therapy (treated
group), and 20 women who decline such therapy (control group). We will attempt to
match the patients and the controls for T score (within 0.3) and age (within 5 years).
- All study participants will be:
- at least 3 years past the last menstrual period,
- not on HRT, Raloxifene or calcitonin for at least 6 months.
Exclusion Criteria:
- All study participants will not be on bisphosphonates during the previous 12 months.
- Women with secondary causes of osteoporosis will be excluded.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 59 Years old.
| Texture Analysis for Postmenopausal Osteoporosis | NCT00145977 | Contradiction |
4,430 | 34 | A 17-year-old male comes to the office due to several months of right elbow pain. The pain is worse with activity and limits his workouts and activities. He has tried over-the-counter medications with limited relief. Medical history is notable for eczema, and current medications include a topical hydrocortisone ointment. He is sexually active with his girlfriend and uses condoms. He does not smoke or drink alcohol. He plays tennis most of the days of the week. The comprehensive evaluation shows pain on the lateral side of the elbow, made worse by pressure applied on the lateral epicondyle of the humerus and when making a fist with the elbow joint straightened. The patient has this pain since last year and had several courses of physical therapy. | I'm 17, and I had to go to the doctor because I've been suffering from my right elbow for several months. The pain is even worse when I do sports and it kind of limits me for my workouts and activities. I tried over-the-counter medications but it didn't work much. I had eczema before and my medication is ointments that contain cortisone. I am sexually active as a 17-year-old guy, and I have a girlfriend, and we use condoms. I don't smoke or drink. I play tennis most days of the week. I did an exam that showed pain on the side of my elbow and it was worse when they applied some pressure on it and when I was putting my hand as a fist. I have had this pain since last year, and I had several sessions of physical therapy already. | Inclusion Criteria:
- Patients aged >18 years
- A symptom duration of >3 months
Exclusion Criteria:
- Bilateral symptoms
- Rheumatologic diseases affecting the elbow and the wrist
- Musculoskeletal disorders due to connective tissue diseases
- Diffuse pain syndrome
- Cervical radiculopathy
- Nerve compression syndromes involving upper extremity
- Undergone surgery at the affected arm
- Received an LE treatment in the last 6 months
- An inability to perform the exercises
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Investigating the Effects of Neuromobilization in Lateral Epicondylitis | NCT04219488 | Contradiction |
1,881 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Histological diagnosis of adenocarcinoma of the stomach, gastro-esophageal junction
(GEJ), or lower third of the esophagus.
- The tumor must be deemed by the team to be potentially resectable. This includes
imaging studies (detailed below) to clinically stage the tumor and rule out the
presence of metastatic disease, and includes a preoperative laparoscopic evaluation.
- Stage IB (T1N1 only), II, IIIA, IIIB, and IV (T4N1 only)
- Life expectancy greater than 3 months
- ECOG performance status of 0-2 (i.e. restricted in physically strenuous activity but
ambulatory and able to carry out work of a light or sedentary nature, e.g., light
house work, office work).
- Adequate hematologic reserve: Platelet count greater than or equal to 100,000
microlitre, WBC greater than or equal to 2000 microlitre,
- Creatinine clearance greater than or equal to 30 ml/min, AST & ALT less than or equal
to 2 ULN, Alkaline phosphatase less than or equal to 2.5 ULN, bilirubin less than or
equal ULN
Exclusion Criteria:
- Prior systemic therapy for gastric cancer
- Prior docetaxel-containing chemotherapy
- Pre-existing medical conditions precluding treatment, including any contraindication
for major surgery
- Pregnancy or lactating mothers. Women of childbearing age must use contraception
during and for 3 months following treatment
- Inability to give informed consent
- Inability to maintain nutrition by oral consumption of food alone must have additional
enteral feeding.
- Macroscopic disease noted at laparoscopy
- ECOG peformance status of 3 or higher
- Unwillingness to undergo investigations and/or treatment as outlined on the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Pilot Study of Perioperative Docetaxel, Oxaliplatin, and 5-Fluorouracil (FLOT) in Gastroesophageal Adenocarcinoma | NCT01932580 | Entailment |
705 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- over 50 years of age
- Osteoarthritis > Grade 3 on the Kellgren-Lawrence scale
- Presence of at least two of the following findings:
- morning stiffness that resolves within 60 minutes
- pain > 3/10 on a numerical pain rating scale
- asymmetrical mobility in either contralateral elevation and/or glenohumeral rotation,
or notable crepitus with active motion.
Exclusion Criteria:
- medical co-morbidities (diabetes and rheumatoid arthritis)
- adhesive capsulitis
- fractures
- scapulothoracic paresis
- surgery in past year
- inability to speak English language
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 90 Years | Effectiveness of Manual Therapy and Exercise in Shoulder OA | NCT02587559 | Contradiction |
803 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
1. Males or females at the age of 40-75 years old
2. Conforming to the diagnosis standard of the American College of Rheumatology in 2009：
knee pain and osteophyte determined with X-ray, and at least one of the following
items：
- above 50 years old
- morning stiffness less than 30 minutes
- knee joint with fricative when moving
3. The studying knee has score of 40-90 mm on a 100 mm measured VAS and the other side
was less than 40mm when walking on flat ground.
4. The studying knee has score of 1, 2 or 3 determined by radiological Kellgren-Lawrence
grading scale.
5. Patients who have treatment requirements and can obey the therapeutic schedule
6. Body mass index(BMI) ≤35kg/m2。
7. Able to follow the clinical observation and follow up.
8. The subjects are able to understand and sign the informed consent after fully
understand this study, the disease, investigational drugs, the therapeutic schedule
and the potential risks.
Exclusion Criteria:
1. Positive signs of swelling or floating patella test，and there are obvious effusion of
knee joint in clinical.
2. Other inflammatory pain diseases of knee joint, such as rheumatism/ rheumatoid
arthritis, psoriatic arthritis, gout, hemophilic arthritis, etc.
3. Pain diseases of knee joint, except for osteoarthritis, such as intra-articular tumor,
villonodular synovitis, joint trauma, etc.
4. Pregnant or lactating females.
5. Participants who suffer from serious cardiovascular disease (Sudden cerebral
infarction with sequela or myocardial infarction within recent 6 months), hepatic
disease, kidney disease；Participants whose ALT and AST are twice or more than twice
than that of the upper limit of normal value；Participants whose serum creatinine
exceed the upper limit of normal value；Participants who suffer from dysfunction of
blood coagulation (thrombocytopenia, bleeder disease, etc.)
6. Participants who have systemic infection or infectious disease.
7. Participants who suffer from serious skin defect or ulcer around the studying knee
joint.
8. Participants who suffer from typical varus or valgus deformities or lack of articular
cavity.
9. Participants with diabetes and have to inject insulin or who are not good enough to
control the blood glucose (FBG ( fasting blood-glucose) ≥10mmol/L.)
10. Participants who suffer from cancer (within 5 years) or Alzheimer's disease.
11. Participants with score 0 or 4 of the studying knee joint evaluated by radiological
Kellgren-Lawrence grading scale.
12. Participants who have hormone drugs within 2 weeks or analgesic drugs within 1 week
before this trial or take part in other clinical trials.
13. Participants whose studying knee receives articular cavity therapy within 3 months,
containing intra articular administration, articular irrigation and arthroscopic
surgery
14. Participants with an allergy to the experimental drugs.
15. Participants who are not suitable for this trial judged by the researchers.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years | Medical Chitosan or Sodium Hyaluronate for Knee Osteoarthritis (CHOOSE) | NCT02323451 | Entailment |
653 | 3 | A 51-year-old man comes to the office complaining of fatigue and some sexual problems including lack of libido. The patient doesn't smoke or use any illicit drug. Blood pressure is 120/80 mm Hg and pulse is 70/min. Oxygen saturation is 99% on room air. BMI is 24 kg/m2. Skin examination shows increased pigmentation. Genotype testing is consistent with homozygosity for the C282Y mutation. Laboratory study shows transferrin saturation of 55% and serum ferritin of 550 μg/L. He is diagnosed as a case of hemochromatosis. | I am 51 years old and I just came back from the doctor's office. I'm sick and tired of being that exhausted, reaching the point where me and my lovely wife are not touching each other anymore! I'm not smoking or doing drugs! My blood pressure was 120/80 mm Hg, and pulse was 70/min and my oxygen saturation 99%. My BMI is 24. My skin also turned a bit darker lately. He tested my genes and told me that I have a mutation of the C282Y gene. I also did lab tests where my transferrin saturation was 55% and serum ferritin was 550 μg/L. The doctor diagnosed me with iron overload. | Inclusion Criteria:
- - Patients treated with iron chelators;
- Patients treated with erythroid growth factors (erythropoietin);
- Patient with excessive alcohol consumption (> 20g/day and > 30 g/day for women and men
respectively);
- Patients with chronic haematological condition;
- Patients having uncontrolled chronic blood loss (of digestive or gynaecological
origin);
- Patients with chronic kidney failure;
- Patients with a diagnosis of cancer or history of cancer in the last year;
- Pregnancy or breast feeding.
- Patient who are included in another research protocol
- Adults legally protected (judicial protection, guardianship, or supervision), persons
deprived of their freedom.
- with C282Y homozygous HFE hemochromatosis;
- having finished the initial phase of HFE hemochromatosis treatment and in maintenance
treatment for at least one year;
- having signed an informed consent form.
Exclusion Criteria:
- Patients treated with iron chelators;
- Patients treated with erythroid growth factors (erythropoietin);
- Patient with excessive alcohol consumption (> 20g/day and > 30 g/day for women and men
respectively);
- Patients with chronic haematological condition;
- Patients having uncontrolled chronic blood loss (of digestive or gynaecological
origin);
- Patients with chronic kidney failure;
- Patients with a diagnosis of cancer or history of cancer in the last year;
- Pregnancy or breast feeding.
- Patient who are included in another research protocol
- Adults legally protected (judicial protection, guardianship, or supervision), persons
deprived of their freedom.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Impact of Transferrin Saturation Guided Maintenance Treatment on Quality of Life in HFE Haemochromatosis | NCT04779593 | Contradiction |
2,763 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- Unilateral inguinal hernia (diagnosed by physical examination or imaging)
- Sexual Active
- Male gender
- aged between 18 and 65
- ASA 1-2
- EHS Classification (Primary, lateral or medial, 1 and 2)
Exclusion Criteria:
- Patients with previous abdominal and inguinal hernia surgery
- ASA 3-4
- Sexually inactive
- Emergency patients (Etrangule inguinal hernia)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 70 Years | COMPARISON OF LAPAROSCOPIC TOTAL EXTRAPERITONEAL HERNIA REPAIR AND LICHTENSTEIN HERNIA REPAIR | NCT03935503 | Entailment |
3,302 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Inclusion Criteria:
- Patient should suffer from Optic Nerve Atrophy diseases like diabetic retinopathy and
retinal pigmentation.
- Age in between 18-55 years old
- Willingness to undergo bone marrow derived autologous cell therapy.
- Ability to comprehend the explained protocol
- Ability and willingness to regularly visit to hospital for protocol and follow up
Exclusion Criteria:
- Patients with preexisting or current systemic disease such as lung, liver,
gastrointestinal, cardiac, immunodeficiency, syphilis, or clinically relevant
polyneuropathies.
- History of life threatening allergic or immune- mediated reaction
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Treatment of Optic Neuropathies Using Autologous Bone Marrow-Derived Stem Cells | NCT02638714 | Contradiction |
4,785 | 36 | A 47-year-old woman comes to the clinic complaining of dizziness. She also has occasional nausea and ringing in her right ear. The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal. The dizziness improves spontaneously, and she feels fine between episodes. Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl. She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago. | The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now. | Inclusion Criteria:
1. Ability to provide informed consent.
2. Eighteen years-of-age or older at the time of implantation.
3. Presence of single-sided deafness as follows:
1. Poorer ear (ear to be implanted):
- severe to profound sensorineural hearing loss, defined as pure-tone
thresholds 80 dB HL or greater for the frequencies 500, 1000, 2000, 3000,
and 4000 Hz.
- Monosyllabic word understanding, as measured using the CNC Word Test at 60
dBA under earphones, less than or equal to 10%.
2. Better ear (contralateral ear):
- Normal or near-normal hearing, defined as pure-tone thresholds no poorer
than 30 dB HL at 250, 500, 1000, 2000, and 3000 Hz and no poorer than 40 dB
HL at 4000 Hz.
- Monosyllabic word understanding, as measured using the CNC Word Test at 60
dBA under earphones, of greater than or equal to 90%.
4. Duration of severe to profound sensorineural hearing loss of at least 6 months (to
ensure stability of hearing loss) but no greater than 10 years.
5. English spoken as a primary language.
Exclusion Criteria:
1. Alleviation of tinnitus as the stated primary or sole motivation for seeking
implantation by the subject and/or investigator.
2. Actively using an implantable device in the poorer ear.
3. Onset of severe to profound hearing loss < 6 years-of-age.
4. Evidence of active middle-ear pathology based on otologic examination and/or
immittance testing.
5. Medical or psychological conditions that contraindicate undergoing surgery.
6. Ossification or any other cochlear anomaly at the implant ear that might prevent
complete insertion of the electrode array.
7. Hearing loss of neural or central origin, including auditory neuropathy.
8. Unrealistic expectations on the part of the subject regarding the possible benefits,
risks, and limitations inherent to the surgical procedure and prosthetic device.
9. Unwillingness and/or inability of the candidate to comply with all investigational
requirements including, but not limited to, study protocol and surgical procedure, as
determined by the investigator.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Implantation of the Cochlear® Nucleus® System in Adults With Single-Sided Deafness | NCT01670006 | Entailment |
2,529 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
- Chronic urticaria
- Eczema & dermatitis group
- Atopic dermatitis
- Prurigo group: Acute prurigo, Prurigo subacuta, Chronic prurigo
- Pruritus cutaneous: Systemic pruritus cutaneous, Topical pruritus cutaneous
- Giving informed consent
- Children who have 2 grades or more pruritus score when assessed by the investigator or
sub-investigator with the criteria for the diurnal or nocturnal pruritus score in the
patient diary.
- Children with a pruritus severity of "2.Mild" or severer on the first day of the
treatment period.
Exclusion criteria:
- have a history of drug hypersensitivity
- are pregnant, lactating or possibly pregnant female children.
- have asthma that requires the treatment with corticosteroid.
- cannot avoid the use of external steroid classified into "strong", "strongest" or
"very strong".
- have pruritus only on face and head.
- have inappropriate complication of dermal disorder that may influence on the
evaluation of the study drug.
- are undergoing specific desensitization therapy or immunomodulation therapy or
phototherapy.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 14 Years | Study Of Cutaneous Disease Accompanied With Pruritus In Pediatrics | NCT00257582 | Entailment |
5,063 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- - Two osteoporotic vertebra compression fractures in the low thoracic or lumbar spine
- men and women > 18 years old
- patients with healthcare insurance
- signed and dated informed consent
Exclusion Criteria:
- men and women < 18 years
- pregnant or breastfeeding women
- patients under trusteeship or guardianship or patients under the protection of court
- bad comprehension or cooperation
- bleeding disorders
- local or general infection
- intracerebral or severe cardiac affections
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Efficacy of Fluoroscopy-guided Epidural Anesthesia for Osteoporotic Vertebral Compression Fracture Treated by Percutaneous Vertebroplasty | NCT03621527 | Contradiction |
2,537 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
1. Patients aged 2 years or older at the time of consent.
2. Patients may be male or female.
3. Patients may have any skin phototype.
4. Patients with a clinical diagnosis of atopic dermatitis according to the Hanifin and
Rajka criteria. Atopic dermatitis diagnosis must be stable at least for 1 month per
caregiver or patient.
5. Atopic dermatitis affecting at least 5% of the patient's body surface area with at
least two distinct lesional sites.
6. Atopic dermatitis must meet a score of mild to moderate on the baseline Investigator's
Static Global Assessment (iSGA).
7. If greater than or equal to 18 years old at the time of consent, is able to provide
written informed consent and will comply with all study procedures. If less than 18
years old at the time of consent, parent or guardian is able to provide written
informed consent with all children greater than or equal to 7 years old at the time of
consent also providing written assent, and will comply with all study procedures.
Exclusion Criteria:
1. Patients less than 2 years old at the time of consent.
2. Patients unable to provide written informed consent.
3. Patients must not have used systemic biologic therapy, systemic immunosuppressive
therapy, or systemic immunomodulating therapy within three months of baseline visit.
4. Patients must not have had phototherapy within three months of baseline visit.
5. Patients must not have used topical corticosteroids or topical calcineurin inhibitor
within 28 days of baseline visit.
6. Patients must not have previously been treated with topical phosphodiesterase-4
inhibitor.
7. Patients must not have a known hypersensitivity reaction to crisaborole or any of its
known vehicle components.
8. Patients must not have any active skin infection at the time of screening.
9. Patients must not have any other overlying inflammatory disease such as psoriasis.
10. Patients must not be currently pregnant, breastfeeding or planning pregnancy during
the study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 2 Years old.
| Characterizing Skin Microbiome Change in Atopic Dermatitis | NCT04800185 | Entailment |
3,839 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Male or female ≥40 years and ≤75 years.
- Willingness and ability to comply with the study procedures and visit schedules and
ability to follow verbal and written instructions.
- Diagnosis of knee osteoarthritis (OA) Grade 2 or 3 according to the Kellgren-Lawrence
scale
- Body mass index (BMI) ≤ 40.
- Failed at least 1 conservative OA therapy
- Signed an independent ethics committee (IEC) approved informed consent form (ICF).
Main Exclusion Criteria:
- Intra-articular Hyaluronic (HA) injection within 6 months- On Day 1 (pre-injection),
presence of active infection or abnormal effusion in the knee as noted by a physical
examination (e.g., erythema, redness, heat, swelling).
- Presence of symptomatic OA in the non-study knee.
- Diagnosed with rheumatoid arthritis (RA), Reiter's syndrome, psoriatic arthritis,
ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory
diseases (e.g., inflammatory bowel disease [IBD], sarcoidosis, or amyloidosis) or of
metabolic origin.
- Diagnosis of isolated patella-femoral joint osteoarthritis.
- Valgus/varus deformity judged by the investigator to be clinically significant.
- Disease of spine, hip or other lower extremity joints of sufficient degree to affect
assessment of the signal knee. Patients with TKR at the contra-lateral knee or THR in
either hip may be enrolled provided sufficient pain relief after TKR or THR which does
not require additional analgesic relief.
- Untreated acute traumatic injury of the index knee.
- Presence of a symptomatic meniscal tear in the index knee
- Limited daily activity for reasons other than OA.
- Presence of surgical hardware or other foreign body in the index knee.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 75 Years | APSS-33-00: A Multicenter, Pilot Study of Autologous Protein Solution (APS) in Knee Osteoarthritis (OA) | NCT02138890 | Entailment |
533 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- healthy pregnant women candidate for surgical evacuation
- 1st trimesteric pregnancy loss with gestational age 12 weeks or less (diagnosis was
confirmed using transvaginal ultrasound according to the following criteria:
Crown-rump length {CRL} of 7 mm or more and no heartbeat, Mean sac diameter {MSD} of
25 mm or more and no embryo, absence of embryo with heartbeat 2 wk or more after a
scan that showed a gestational sac without a yolk sac and absence of embryo with
heartbeat 11 days or more after a scan that showed a gestational sac with a yolk sac)
- closed and firm cervix
Exclusion Criteria:
- evidence suggesting spontaneous onset of abortion (vaginal bleeding or and uterine
cramps), previous trial to induce abortion or the use of any cervical ripening agent
during the current pregnancy, presence or suspicion of septic abortion (fever > 38
degree Centigrade, offensive vaginal discharge & leukocytosis), Uterine anomalies or
history of any cervical surgery or manipulation.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Misoprostol Versus Effox as Cervical Ripening Agent Prior Surgical Evacuation | NCT02738177 | Contradiction |
3,219 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is diagnosed with Sjogren's Syndrome;
- Meibomian gland score of ≤ 9 (out of 15);
- OSDI ≥ 23;
- Willing to maintain the use of OTC medications throughout the course of the study
- Have not worn contact lenses within the past 3 years
Exclusion Criteria:
- Is participating in any concurrent clinical or research study;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition, other than Sjogren's Syndrome and its associated conditions,
that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications, other than those indicated for Sjogren's
Syndrome and its associated conditions, that in the opinion of the investigator may
affect a study outcome variable;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment;
- Is aphakic;
- Has undergone refractive error surgery; * For the purposes of this study, active
ocular disease is defined as infection or inflammation which requires therapeutic
treatment. Lid abnormalities (blepharitis, meibomian gland dysfunction, papillae),
corneal and conjunctival staining and dry eye are not considered active ocular
disease. Neovascularization and corneal scars are the result of previous hypoxia,
infection or inflammation and are therefore not active.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 17 Years old.
| Effect of Debridement-scaling on the Relief of Dry Eye Signs and Symptoms in Sjogren's Syndrome | NCT02203188 | Entailment |
5,755 | 43 | A 27-year-old woman comes to the dermatology clinic with skin rash and oral ulcers. The rashes are mildly itchy. The patient has no other medical conditions and takes no medications. Vital signs are normal. On examination, there are pink papules symmetrically distributed over the anterior surfaces of the shins and ankles. There are some white ulcerated papules on her buccal mucosa. She is in relationship with her boyfriend and has only one sexual partner. Her boyfriend uses condoms. She smokes 1 to 2 cigarettes a day and drinks a beer daily. Biopsy reveals prominent hyperkeratosis with a thickened granular layer. There is an infiltration of mononuclear cells in the superficial dermis that involves the overlying epidermis. The rete ridges have a sawtooth appearance. | I went to the dermatologist because I had rashes on my skin and ulcers in my mouth. The rashes were not that itchy. I don't get it! I'm 27, I don't take medication, nor I don't have any other illnesses. My vitals were normal. My doc told me there were pink spots on the back of my throat. I'm heterosexual and have been only with my boyfriend and he uses condoms. I smoke 1 or 2 cigarettes a day and I drink a beer to accompany it. I had a biopsy and it showed some thick and grainy skin texture. The doc said it's an immune reaction. | Inclusion Criteria:
1. Patients free from any systemic disease according to the detailed questionnaire of the
modified Cornell Medical Index 34.
2. Patients not receiving any medication either topical or systemic that could cause
lichenoid reaction during the 3 months before the study.
3. Patients diagnosed by a dermatologist and oral medicine specialist as suffering from
OLP.
4. Patients clinically and histopathologically diagnosed as suffering from OLP according
to World Health Organization's (WHO's) clinic-pathological diagnostic criteria for
LP35.
5. Patients who agree for the biopsy in undiagnosed cases.
6. Patients who are willing to participate in this study (will give informed consent) and
have the ability to complete the study.
- Exclusion criteria:
(1) Patients taking systemic drugs such as systemic steroid, other immunosuppressive
therapy for at least 8 weeks prior to the study.
(2) Patients treated with any oral topical medications for at least four weeks prior to the
study.
(3) Patients with suspected restoration-related reaction. (4) Pregnant and lactating
mothers.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
Subject must be at most 70 Years | Clinical and Biochemical Assessment of the Effect of Topical Use of Coenzyme Q10 Versus Topical Corticosteroid in Management of Symptomatic Oral Lichen Planus: Randomized Controlled Clinical Trial | NCT04091698 | Contradiction |
6,027 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Adults with complaints of GERD, reflux, and/or heartburn symptoms
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Effectiveness of Diaphragmatic Breathing on Reflux Symptoms in Outpatients | NCT04120025 | Entailment |
3,023 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Partners-affiliated pediatric practice providers utilizing Longitudinal Medical Record
(LMR), which is an electronic health record system. Also the parents of the patients
of the above noted pediatric providers.
Exclusion Criteria:
- Non-Partners providers, or Partners providers who do not use LMR. Parents of patients
not seen by Partners-affiliated pediatric providers who use LMR.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Improving Pediatric Safety and Quality With Health Care Information Technology | NCT00134823 | Entailment |
978 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Patients with symptomatic knee OA (patellofemoral)
- Exclusion Criteria:
- Not using the brace as requested;
- Study abandonment;
- No adaptation to brace;
- Skin and vascular complications by use of the brace;
- Failure to complete the consumption of drugs between inclusion and bracing;
- Obesity class II, III or morbid;
- Patients who cannot read or understand the informed consent or the WOMAC
questionnaire;
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 70 Years | Bracing for Patellofemoral Osteoarthritis | NCT02984254 | Entailment |
6,131 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | INCLUSION CRITERIA:
1. Provide written informed consent before initiation of any study procedures.
2. Age greater than or equal to 18 years old and less than or equal to 70 years old.
3. Subjects must not be symptomatic, must be afebrile for ≥14 days, beyond 28 days of the
resolution of their acute COVID-19 illness, and must enroll within 18 months of onset
of illness, and must meet at least 1 of the following:
- History suggestive of resolved COVID-19-like illness (e.g., prior fever, dry
cough, and shortness of breath). OR
- History of positive test for SARS-CoV-2 (either serologic or RT-PCR) OR
- Documented anti-SARSCoV-2 neutralizing antibody titer of at least 1:80
4. Current anti-SARS-CoV-2 neutralizing antibody titer of at least 1:80
5. Females must have a negative anti-HLA screening test
6. Weight greater than or equal to110 pounds (50 kg)
7. Meets FDA-approved criteria per local blood collector for plasmapheresis for plasma
donation
8. Adequate peripheral venous access for plasma donation (as judged by the examiner)
9. Willingness to have samples stored
EXCLUSION CRITERIA:
1. Any sign of active illness of any kind including COVID-19 illness (as judged by the
investigator), including but not limited to:
- Subjective or documented fever (greater than or equal to 38°C)
- Dry cough
- Shortness of breath
2. Participation in medical research that includes:
- Protocols that are currently ongoing or will start during the duration of this
study that require more than 100 mL of blood to be given in any 8-week period of
time
- Administration of any unlicensed drug within the last 1 month or during the
duration of this study, per investigation discretion
- Administration of any unlicensed vaccine within the last 12 months or during the
duration of this study.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 70 Years | Collection of Anti-SARS-CoV-2 Immune Plasma | NCT04344977 | Contradiction |
3,484 | 25 | A 50-year-old woman comes to the clinic with intermittent ear discharge and sense of hearing loss on her left ear. Past medical history is significant for obesity, hyperlipidemia, and diabetes mellitus. Her medications include Metformin, Atorvastatin and Vit D supplement. Vital signs are normal. BMI is 37. Otoscopy shows a small perforation in the left tympanic membrane and a pearly mass behind the membrane. Conduction hearing loss is noted in the left ear. The remainder of the ear, nose, and throat examination is normal. | I went to the clinic the other day because I had some fluid in my ear and I felt like I could not hear as well as I used to in my left ear. I'm a 50-year-old woman, and I have been obese for a while now. I have diabetes and cholesterol. I take some medication. I take metformin, atorvastatin, and vitamin D supplements. When I was admitted, my vitals were normal. My BMI is 37. When they looked into my ears, they said that my left tympanic membrane was broken and there was some fluid behind the membrane. During the hearing test, they could assess that my left ear suffers from hearing loss. They also performed ear, nose, and throat examinations that turned out to be normal. | Inclusion Criteria:
1. A known history of Type 2 Diabetes receiving either diet alone or oral antidiabetic
drugs (OAD) including insulin secretagogues, pioglitazone, DPP4 inhibitors, or
metformin as monotherapy or in combination therapy, or low-dose insulin at <0.5
unit/kg/day.
2. Males or females between the ages of 18 and 80 years discharged after hospital
admission from general medicine and surgery services (non-Intensive Care Unit
setting).
3. Subjects with an admission / randomization BG < 400 mg/dL without laboratory evidence
of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary
ketones).
4. Admission HbA1c between 7% and 10%
5. BMI range: > 25 Kg/m^2 and < 45 Kg/m^2
Exclusion Criteria:
1. Age < 18 or > 80 years
2. Subjects with increased blood glucose (BG) concentration, but without a history of
diabetes (stress hyperglycemia)
3. Subjects with a history of type 1 diabetes (suggested by BMI < 25 Kg/m^2 requiring
insulin therapy or with a history of diabetic ketoacidosis and hyperosmolar
hyperglycemic state, or ketonuria).
4. Treatment with high-dose (>0.5 unit/kg/day) insulin or with GLP-1 RA during the past 3
months prior to admission.
5. Patients that required ICU care during the hospital admission.
6. Recurrent severe hypoglycemia or hypoglycemic unawareness.
7. Subjects with gastrointestinal obstruction, gastroparesis, history of pancreatitis or
those expected to require gastrointestinal suction.
8. Patients with clinically relevant pancreatic or gallbladder disease.
9. Patients with unstable or rapidly progressing renal disease or severe renal impairment
(creatinine clearance < 30 ml/min)
10. Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage
liver disease),
11. History of hypersensitivity to exenatide
12. Treatment with oral or injectable corticosteroid (equal to a prednisone dose >5
mg/day), parenteral nutrition and immunosuppressive treatment.
13. Patients with history of heavy alcohol use (female > 2 drinks per day, male > 3 drinks
per day) or drug abuse within 3 months prior to admission.
14. Mental condition rendering the subject unable to understand the nature, scope, and
possible consequences of the study.
15. Female subjects who are pregnant or breast feeding at time of enrollment into the
study.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Exenatide Inpatient Trial: A Randomized Controlled Pilot Trial on the Safety and Efficacy of Exenatide (Byetta®) Therapy for the Inpatient Management of Patients With Type 2 Diabetes | NCT02455076 | Entailment |
6,359 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Patients must be 18 years of age or older, of either gender
- Patients must be tested positive for SARS-CoV-2 by RT-PCR
- Patients must exhibit typical symptoms of COVID-19 disease at screening such as fever,
fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of
breath, mucus or phlegm, sore throat, headache, chills, sometimes with shaking, loss
of smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular
pain etc.
- Patients must be in the early stage of COVID-19 disease who do not require
hospitalisation at the time of screening
- Patients must be under the care of a Physician for diagnosis of COVID-19
- Patients who have signed informed consent
Exclusion Criteria:
- Patients with proven hypersensitivity or allergic reaction to quercetin
- Patients with known chronic kidney disease with estimated creatinine clearance < 50
mL/minute or need for dialysis
- Patients who are severely hypotensive defined as needing hemodynamic pressors to
maintain blood pressure
- Patients with moderate or severe thrombocytopenia (platelet count <100 × 10⁹/L);
- Pregnant patients
- Patients declining to participate
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study to Investigate the Clinical Benefits of Dietary Supplement Quercetin for Managing Early COVID-19 Symptoms at Home | NCT04861298 | Entailment |
4,252 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- >18 years
- Participation in more than 80% during training and matches of the competitive season.
- First, intermediate, Pre-intermediate A and Pre-intermediate B categories of the
University teams of Córdoba, Old Resian and Los Matreros, belonging to UAR member
unions.
Exclusion Criteria:
- Lost patient data
Male
Accepts Healthy Volunteers
| Impact and Burden of Rugby Injuries in Argentina. A Complete Season Retrospective Multicentric Study. | NCT04402567 | Entailment |
4,095 | 31 | A 25-year-old woman comes to the clinic with her roommate. The roommate says that the patient has twice fallen asleep while they were talking. The patient has regularly fallen asleep in the afternoon while reading or watching television but typically feels refreshed after a brief nap. She also reveals that she sometimes hears a voice prior to falling asleep. She also complains of some episodes of clumsiness that cause her to drop objects or fall. MSLT showed that the sleep latency was less than 8 min and that the patient enters rapid eye movement (REM) sleep almost immediately. | I brought my roommate to the clinic because she kept falling asleep when we were having a conversation. We're both 25 and usually healthy girls. She usually takes a nap in the afternoon while reading or watching TV, but usually, she is quite energetic afterward. She told me that she sometimes hears a voice before falling asleep. How weird! And sometimes she's the clumsiest! She keeps dropping all her stuff. The doctor did a sleeping test and she found out that it takes her less than 8 min to fall asleep. | Inclusion Criteria:
Study participants:
- Subjective complaints of Excessive daytime sleepiness (EDS) and/or Hypersomnia (H) as
defined above
- EDS and/or H present daily or almost daily for at least 1 month prior to the
consultation
- Ability and consent to undergo electrophysiological routine assessment
- Ability to give informed consent
Healthy controls:
- Age and gender matched healthy subjects
- Including blood related relatives of study participants
- Ability and consent to undergo electrophysiological routine assessment
- Ability to give informed consent
Controls with Sleep disordered breathing (SDB):
- Subjective complaints of EDS with Epworth Sleepiness Scale (ESS) > 10 (adults) and/or
H due to SDB: Presence of clinically significant and untreated obstructive sleep apnea
(OSA) as determined by the investigator with an apnea-hypopnea-index >30/h
- Multiple sleep-latency test (MSLT) mean sleep latency ≤ 8min
- Subjective and objective improvement of EDS and/or H within 3 months after treatment
with
- Positive airway pressure (PAP) therapy with documented
- Reduction of apnea-hypopnea index below <10/h
- Reduction of ESS by ≥ 25%
- MSLT mean Sleep Latency > 12min
- Ability and consent to undergo electrophysiological routine assessment
- Ability to give informed consent
Exclusion Criteria:
Study participants and controls:
- SDB for study participants and healthy controls: Presence of clinically significant
and untreated obstructive sleep apnea (OSA) or central sleep apnea (CSA) as determined
by the investigator or documented previously; or documentation of one of the
following:
- Apnea index (AI) > 10 if on OSA treatment or untreated; or
- Clinically significant hypoventilation; or
- Noncompliance with primary OSA therapy
- except if NT1 has been diagnosed including decreased or missing cerebrospinal
fluid (CSF) hypocretin
- SDB for control population with SDB:
- Central Sleep Apnea (CSA)
- Noncompliance with primary OSA therapy and/or
- No reported improvement of EDS and/or H within 3 months of positive airway
pressure (PAP) treatment
- The following disorders/conditions that on clinical grounds are considered to be the
cause of EDS / H
- Other sleep disorders (e.g. Restless legs syndrome (RLS) with periodic leg
movement syndrome (PLMS), sleepwalking, clear-cut circadian disorder)
- Other neurological disorders (e.g. stroke, multiple sclerosis, parkinsonism,
severe traumatic brain injury)
- (Auto-)immune and systemic disorders (such as Hashimoto Thyroiditis, Chron's
Disease, ulcerous colitis, Diabetes mellitus type I, Systemic lupus
erythematosus)
- Malignancy (except: Status in Remission for at least > 10 years)
- Instable psychiatric disorder (e.g. acute psychotic, acute suicidal, episode of
major depression requiring in-hospital treatment, active substance abuse)
- Active infectious disease at screening
- Permanent medications / drugs
- Chronic infectious diseases (such as Hepatitis B/C, HIV)
- Chronic use of antibiotics
- Recent use (< 8 weeks) of immune-modulating drugs
Healthy controls additional:
- Subjective complaints of EDS and / or H
- ESS > 10
- Polysomnography (PSG) with AI > 10/h and / or PLMS Index > 30/h
- MSLT mean Sleep Latency < 12 min
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 16 Years old.
Subject must be at most 70 Years | Swiss Primary Hypersomnolence and Narcolepsy Cohort Study | NCT04330963 | Entailment |
3,606 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
Each woman enrolled in the trial must meet the following inclusion criteria:
- Competent to provide informed consent to participate in the trial and has done so.
- At least the minimum age is 18 to 45 years old.
- Had sex 1 to 4 days in past month and expects to continue at that frequency for the
next 6.5 months.
- At low risk for sexually transmitted infection (STI), operationally meaning that
neither she nor her partner to her knowledge has had any of the following:
- More than one sexual partner currently or any expectation of having more than one
sexual partner in the next 6.5 months
- Diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or
hepatitis C
- Treatment for a STI within the past 6 months, excluding recurrent genital herpes
or condyloma
- Sharing of illicit injection drug equipment ever in the past.
- Willing to use the study regimen as her only contraceptive method for the next 6.5
months (except that she may also use condoms if needed for protection from STIs).
- Wants to avoid pregnancy for at least the next 6.5 months.
- Willing to accept an uncertain risk of pregnancy during the study.
- Gives correct answers to the informed consent quiz.
- Willing and able to follow all study requirements.
Exclusion Criteria:
To be eligible for enrollment, a woman must not meet any of the following exclusion
criteria:
- Pregnant as verified by a pregnancy test at enrollment.
- Has an indication of current subfecundity, specifically:
- Her last pregnancy ended within the last 8 weeks, or she has had fewer than two
menstrual periods since resolution of last pregnancy
- She has not had normal monthly menses for the past 2 months
- She is currently breastfeeding
- She has used any hormonal contraceptive other than emergency contraceptive pills
since the onset of her last menstrual period
- Has received an injection of a long term injectable contraceptive in the last 9
months
- Currently has an intrauterine device
- Has had a sterilization procedure or ectopic pregnancy
- Has been diagnosed by a clinician as having a fertility problem
- Her partner has had a sterilization procedure or infertility diagnosis, to her
knowledge.
- She currently has known contraindications to progestin-only pills, specifically
including the following conditions:
- Unexplained abnormal vaginal bleeding
- Deep venous thrombosis or pulmonary embolus
- Active viral hepatitis
- Decompensated cirrhosis
- Liver tumor
- History of breast cancer within the past 5 years.
- Has a breast mass on examination.
- Has a personal or family history suggestive of predisposition to thrombosis.
- Has a serious contraindication to pregnancy (medical condition or use of chronic
medication such as isotretinoin or thalidomide).
- Taking drugs that are known to interact with progestins (such as rifampicin or
anticonvulsant medications).
- Has previously participated in this study.
- Currently participating in another medical research study.
- The site investigator or designee perceives another reason to exclude her from the
trial.
Female
Accepts Healthy Volunteers
Subject must be at most 45 Years | Pericoital Oral Contraception With Levonorgestrel | NCT00922233 | Entailment |
6,747 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Males age 18 years or older.
- Confirmed diagnosis of hemophilia A as evidenced by their medical history with plasma
FVIII activity levels < 1% of normal or at screening.
- Have >150 exposure days (EDs) to FVIII concentrates (recombinant or plasma-derived).
If on prophylaxis, are required to be willing to stop prophylactic treatment at specified
time points throughout the study or If on-demand: should have had > 4 bleeding events in
the last 52 weeks
- Agree to use reliable barrier contraception.
Exclusion Criteria:
- History of allergic reaction to any FVIII product.
- Clinically relevant findings in the physical examination considered critical by the
treating physician, including obesity with BMI > 35 kg/m*2
- Current evidence of measurable inhibitor against factor VIII, as assessed by the
central laboratory and/or prior history of inhibitors to FVIII protein.
- Evidence of active hepatitis B or C.
- Currently on antiviral therapy for hepatitis B or C.
- Significant underlying liver disease.
- Serological evidence of HIV-1 or HIV-2 with CD4 counts ≤200/mm*3; HIV+ and stable
participants with CD4 count >200/mm*3 and undetectable viral load are eligible to
enroll.
- Detectable antibodies reactive with AAVhu37capsid.
- Participant with another bleeding disorder that is different from hemophilia A (e.g.,
von Willebrand disease, hemophilia B).
- Participated in a gene transfer trial within the last 52 weeks or in a clinical trial
with an investigational product within the last 12 weeks.
- Known or suspected hypersensitivity or allergic reaction to trial product(s) or
related FVIII products or any component of BAY2599023 (DTX201), or a contraindication
to prednisolone
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Study to Test the Safety and How Well Patients With Severe Hemophilia A Respond to Treatment With BAY 2599023 (DTX 201), a Drug Therapy That Delivers a Healthy Version of the Defective Factor VIII Gene Into the Nucleus of Liver Cells Using an Altered, Non-infectious Virus (AAV) as a "Shuttle". | NCT03588299 | Contradiction |
6,505 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
- legally competent,
- at least 18 years of age
- persons able to read and understand spoken and written information in Danish or
English.
- One or more facial telangiectasia
Exclusion Criteria:
- wounds or ulcers in area of facial telangiectasia
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| D-OCT of Facial Telangiectasia Treated With IPL | NCT04274842 | Entailment |
3,128 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Suffer from at least two of the following ocular symptoms: burning, stinging,
excessive tearing, dryness, grittiness, foreign body sensation ( including patients
suffering from blepharitis).
- Use artificial tears or any other treatment for these symptoms three or more times a
day.
Exclusion Criteria:
- Known hypersensitivity to Phenoxyethanol.
- Pregnant and lactating women.
- Receive other ophthalmic medication (except for eyelid hygiene preparations).
- Graft-versus-host disease patients.
- Participated during the last month in another clinical trial.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 85 Years | Study to Assess the Safety and Patients' Satisfaction of Tears Again* in the Treatment of Dry Eye Symptoms | NCT00535054 | Contradiction |
6,929 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
1. Adult males or females Aged 45 years through 85 years (have not had their 86th
birthday)
2. Men and women with a diagnosis of Alzheimer's disease according to the clinical
criteria
3. Women must be of non-childbearing potential, surgically sterile, or willing to use
adequate birth control; men who are sexually active will also be required to use
adequate birth control
4. Able to give consent for participation on their own or through their Legally
Acceptable Representative
5. MRI/CT scan assessment within six months before baseline, corroborating the clinical
diagnosis of AD and excluding other potential causes of dementia, especially
cerebrovascular lesions
6. MMSE score in between 11 to 26 in case of mild to moderate stage of Alzheimer's
disease
6. Absence of major depressive disease according to Geriatric Depression Scale (GDS) of < 5
7. Previous decline in cognition for more than six months as documented in subject's
medical records 8. Subject, who are on stable treatment with any of AD drugs are also
eligible to participate in this study 9. Formal education for eight or more years 10.
Subjects living at home or nursing home setting, without continuous nursing care 11.
General health status acceptable for participation in a 6-months clinical trial 12. A
caregiver available and living in the same household or interacting with the subject a
sufficient time each week and available if necessary to assure administration of drug 13.
Subjects with any other chronic conditions are stable and undergoing appropriate treatment
Exclusion Criteria:
1. Subjects who have a Mini Mental State Examination (MMSE) score of < 10
2. Subjects who have serious or unstable medical conditions that would exclude completion
of all procedures and data collection for the study, or would be likely to preclude
participation in a drug development trial
3. A current Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnosis of
active major depression, schizophrenia or bipolar disorder
4. Other infectious, metabolic or systemic diseases affecting the central nervous system
5. Subjects who have participated in a clinical trial investigating an anti-amyloid agent
6. Subjects who are currently participating in a clinical trial with an investigational
drug
7. Subjects who, in the opinion of the physician, are otherwise unsuitable for this study
8. Clinically significant, advanced or unstable disease that may interfere with outcome
measures, and which may bias the assessment of the clinical or mental status of the
subject or put the subject at special risk
9. History of or screening brain MRI scan indicative of significant abnormality,
including, but not limited to, prior hemorrhage or infarct > 1 cm3, >3 lacunar
infarcts, cerebral contusion, encephalomalacia, aneurysm, vascular malformation,
subdural hematoma, hydrocephalus, space-occupying lesion (e.g. abscess or brain tumor
such as meningioma)
10. Subject has had a myocardial infarction, unstable angina, stroke, transient ischemic
attack or required intervention for any of these conditions within 6 months of
Screening
11. Clinical or laboratory findings consistent with:
1. Other primary degenerative dementia,
2. Other neurodegenerative condition
3. Seizure disorder
12. Subjects, who are already taking sedatives, antidepressants, antipsychotics and
antihistaminic medications
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
Subject must be at most 85 Years | PMZ-1620 (Sovateltide) in Mild to Moderate Alzheimer's Disease | NCT04052737 | Entailment |
4,030 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- knee osteoarthritis >3 months in clinical and radiographic signs
- VAS for pain >50mm
Exclusion Criteria:
- Hepatitis B
- Hepatitis C
- HIV
- pregnancy
- drug abuse
- other intra-articular injections <6 months
- surgery on affected knee <12 months
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
| Autologous Conditioned Serum: Functional and Clinical Results | NCT03850080 | Entailment |
6,732 | 48 | A 20-year-old man comes to the emergency due to bleeding after a tooth extraction. The bleeding has persisted for approximately 30 minutes despite constant direct pressure. He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%. | I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%. | Inclusion Criteria:
- Patients with diagnosis of haemophilia A, treated with KOGENATE Bayer/FS as their only
source of FVIII, decision taken by the investigator to administer KOGENATE Bayer/FS.
For pretreated patients with more than 100 exposure days an inhibitor assessment
within three months prior to enrollment should be available; for pretreated patients
with less than 100 exposure days an inhibitor assessment at baseline should be
available.
Exclusion Criteria:
- Exclusion criteria must be read in conjunction with the local product information.
Male
No healthy subjects accepted to join the trial.
| EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS | NCT00874926 | Contradiction |
350 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Informed consent form (ICF) dated and signed.
2. Age: ≥18 and <40 years old.
3. AFC ≥5 and <20.
4. AMH ≥1.1 ng/mL and <2.5 ng/mL, performed in the 12 months prior to inclusion.
5. Body Mass Index (BMI): ≥18.5 Kg/m2 and <30 Kg/m2.
6. Weight: ≥50 kg and <80 kg.
7. First or second ART cycle or fertility preservation cycle.
8. Regular menstrual cycles (between 22 and 35 days).
9. Two ovaries present.
10. Pregnancy-wish.
11. Planned for single blastocyst transfer.
Exclusion Criteria:
1. Simultaneous participation in another clinical study.
2. Previous history of poor ovarian response (<4 oocytes retrieved) with a maximal dose
of OS (≥300 IU/day) or OHSS, regardless of gonadotropin dose.
3. Known reasons for impaired implantation (i.e. hydrosalpinx, fibroid distorting the
endometrial cavity, Asherman's syndrome, thrombophilia or endometrial tuberculosis).
4. Repeated miscarriages (>2 previous biochemical pregnancies or >2 spontaneous
miscarriages).
5. Recurrent implantation failure (>3 failed cycles with good quality embryos).
6. Polycystic ovary syndrome (PCOS).
7. Tumours of the ovary, breast, uterus, pituitary or hypothalamus.
8. Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause.
9. Ovarian cysts or enlarged ovaries.
10. Fibroid tumours of the uterus incompatible with pregnancy.
11. Malformations of the reproductive organs incompatible with pregnancy.
12. Primary gonadal failure.
13. Renal impairment defined as estimated glomerular filtration rate of 90 ml/min/1.73 m2
determined by the Modified Diet and Renal Disease (MDRD) equation at screening.
14. Previous antibiotic hypersensitivity reactions (streptomycin and/or neomycin).
15. Risk factors for thromboembolic events, such as a personal or family history, severe
obesity or thrombophilia.
16. Moderate or severe hepatic impairment.
17. Untreated and uncontrolled thyroid dysfunction.
18. Current use of oral contraceptive, anti-depressants, anti-psychotics, steroids,
anti-epileptics or chemotherapy.
19. Administration of exogenous Estradiol (E2), Progesterone (P4) or gonadotropins in the
preceding menstrual cycle.
20. Active female smoking.
21. Acceptors of donated oocytes/embryos.
22. Ongoing pregnancy.
23. Women who have previously enrolled in the trial.
24. Those unable to comprehend the investigational nature of the proposed study.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 39 Years | Effect of Different Ovarian Stimulation Protocols on Endometrial Receptivity | NCT03755973 | Contradiction |
6,052 | 44 | A 48-year-old man comes to the office complaining of heartburn and acid reflux. He has taken over-the-counter antacids but sees no relief. Other medical history is unremarkable. The patient does not use tobacco, alcohol, or illicit drugs. Vital signs are within normal limits. BMI is 31 kg/m2. Physical examination is positive for mild tenderness in upper stomach. Chest x-ray shows an air-fluid opacity behind the heart. A barium swallow study reveals approximately 1/3 of the stomach herniating through the esophageal hiatus. | I went to my doctor's office because of a non-stop heartburn and some acid reflux. I took over-the-counter medications, but it keeps going strong! I don't smoke, take drugs or drink alcohol, I'm healthy! The doctor took my vitals, which turned out normal. My BMI is 31, which might be a bit too much for a 48-year-old guy like me. They examined my stomach and found a mild tenderness in the upper part. I also did some X-rays, and they found out that I have an air-fluid opacity behind my heart. I did another X-ray, and it turns out that a part of my stomach went up my chest through a hole in my diaphragm! | Inclusion Criteria:
- Patients have heartburn with non-erosive gastroesophageal reflux disease.
Exclusion Criteria:
- Patients have diseases which interfere with evaluation of the efficacy and safety in
this study.
- Patients are receiving and/or have received prior to the enrollment the treatment
which interfere with evaluation of the efficacy and safety in this study.
- Patients have severe cardiovascular, hepatic, renal and hematological disorders.
- Patients are allergic to or have a history of drug allergy to H2RA.
- Patients have or have a history of malignant tumors.
- Patients are pregnant or a lactating mother.
- Patients have participated in other clinical studies less than 12 weeks prior to
submitting the informed consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
| Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease | NCT00141960 | Entailment |
251 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Women at or under the age of 35 years.
- Normal thyroid stimulating hormone and prolactin levels.
- Normal ovulatory cycles (25-35 interval days), together with proven patent fallopian
tubes at hysterosalpingography or laparoscopy done within six cycles preceding the
ICSI cycle.
- Presence of both ovaries with normal findings as assessed by trans-vaginal ultrasound
and laparoscopy.
- All male partners had a normal semen analysis according to WHO criteria (WHO, 2010),
done within 6 months preceding the ICSI cycle
Exclusion Criteria
- Chronic medical disorders such as diabetes.
- Previous inadequate response to ovulation induction.
- Polycystic ovary syndrome.
- Women who performed ovarian surgery and cases of endometriosis diagnosed by
laparoscopy or suspected by ultrasound or CA-125 assay.
- Abnormal pelvic pathology or congenital anomalies.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 35 Years | Poor Ovarian Stimulation Response in In Vitro Fertilization (IVF) Program | NCT02640976 | Contradiction |
1,481 | 9 | A 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough. Her other medical problems include hypertension, dyslipidemia, and osteoarthritis. She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg. The patient's breath smells bad. Other physical examinations are normal. A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus. | I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus. | Inclusion Criteria:
- (1) age over 65 years old; (2) does not use enteral tube feeding; (3) no serious
mental or cognitive conditions; no aphasia
Exclusion Criteria:
- (1) age under 65; (2) use enteral tube feeding; (3) subjects with serious mental or
cognitive conditions or aphasia (4) Allergy to barium sulfate suspension
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| The Accuracy of Swallowing Disturbance Questionnaire in Screening Inpatient Elderly | NCT03816098 | Entailment |
4,258 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Male infertile patients with a pathological spermiogram according to WHO criteria
Exclusion Criteria:
- Drugs affecting sperm quality
- Patients with chromosomal anomalies affecting sperm quality (e.g. Klinefelter-
Syndrome)
- Severe Psychiatric disorder defined as psychotic disorder (schizophrenia, bipolar
disorder) or substance-related disorder
- Patients currently in psychotherapeutic or psychiatric therapy
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Expressive Writing in Male Infertility | NCT00385346 | Entailment |
4,195 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
- Normal: People with no lung lesions in chest X-ray and St. George's Respiratory
Questionnaire score <25, and post bronchodilator FEV1/FVC (forced expiratory volume at
one second/forced vital capacity) >= 0.7 and FEV1 >= 80% and FVC >= 80%.
- Chronic obstructive pulmonary disease: Patients with over 10 pack-years of smoking
history and post bronchodilator FEV1/FVC <0.7 and FEV1 < 80%, and no other reason for
decline of lung function.
- Asthma: Patients with FEV1/FVC < 0.85 and increase in over 12% and 200mL of FEV1 by
bronchodilator inhalation. Patients with P20 < 16mg/dL by bronchial provocation test.
- Idiopathic pulmonary fibrosis: Shows usual interstitial pneumonia according to chest
CT and has no other reasons such as systematic diseases or medication history.
Exclusion Criteria:
- Subjects who refused for enrollment in the study
- Subjects who experienced an acute exacerbation within 1 month.
- Subjects under age of 19.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
| Impact of Air Pollution on Chronic Respiratory Diseases | NCT03813810 | Contradiction |
1,803 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
- Male or female age 65 and older
- Non-smokers
- Weight loss >3% body weight over 6-12 months
- BMI ≤ 25
- Living independently or in an assisted living facility
Exclusion Criteria:
- Medical conditions that would lead to weight loss
- Active cancer undergoing treatment (chemotherapy, radiation therapy, or planned
surgical intervention)
- CKD stage IV-V (eGFR <30) based on medical records within the last 12 months
- Presence of dysphagia or odynophagia
- Actively taking blood thinner such as Warfarin
- Known history of cirrhosis with presence of ascites
- History of a surgical procedure for weight loss (e.g. gastroplasty, gastric
bypass, gastrectomy or partial gastrectomy, lap-band)
- Any abnormal lab findings outside of normal limits as determined by the
investigator
- Dietary conditions
- Diet restrictions including vegetarianism, veganism, soy-free diet,
- Fish and/or fish oil allergy or intolerance
- Milk allergy excluding lactose intolerance
- Follows a kosher diet
- Medications
- Use of appetite stimulants (including megestrol, dronabinol and cyproheptadine).
- Does not include medications used for depression (e.g. mirtazapine, paxil) if
patient has been on a stable dose of this medication for at least 3 months prior
to the start of this study
- If participant is already taking a fish oil supplement, he/she must be willing to
either stop the supplement or take the supplement the investigators are using in
the study depending on the randomization assignment
- Additional
- Patient has implantable device such as a pacemaker or ICD
- Unable to complete 6-minute walk test at baseline
- Hospitalization within the last 30 days
- Participation in a therapeutic research study within 30 days of baseline
- Living in a skilled nursing facility or long-term care facility
- Any other medical condition that principal investigator or co-investigators deem
would preclude the patient from study participation
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
| Nutritional Supplementation in the Elderly With Weight Loss | NCT04350762 | Contradiction |
3,843 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Pain in the knee joint during more than a half day assessed by Visual Analog Pain
Scale (score more than 40 mm)
- At least three of the following 6 criteria: 20-85 years of age, stiffness lasting less
than 30 minutes, crepitus, bony tenderness, bony enlargement, no warmth to the touch
- Patient is able to walk without assistance
- Patient is familiar with Participant information sheet
- Patient signed informed consent form
Non-inclusion Criteria:
- Medical history of endoprosthetic knee replacement
- Medical history of lower extremity osteotomy
- Medical history of knee surgery (including arthroscopy) during preceding 1 year prior
to enrollment
- Medical history of intraarticular injections during preceding 6 months prior to
enrollment
- Secondary osteoarthritis of the knee joint: posttraumatic osteoarthritis (developed
after clinically significant injury), intra-articular fractures, clinically
significant varus or valgus deformities of lower limbs, septic arthritis, joint's
inflammatory disorders, gout, advanced chondrocalcinosis, Paget's disease, ochronosis,
acromegaly, hemochromatosis, Wilson's disease, primary synovial osteochondromatosis,
osteonecrosis, hemophilia
- Patients prescribed for immunosuppressive treatment
- Medical history of systemic autoimmune and inflammatory diseases
- Significant weight loss (> 10% of body weight in the previous year) of unknown
etiology
- Medical history of venous thromboembolism or estimated high risk of venous
thromboembolism
- Patients prescribed for systemic corticosteroids or other medications treatment with
proven impact on bone or cartilage tissue metabolism
- Clinically significant abnormalities in results of laboratory tests
- Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and
alcohol abuse etc.)
- Participation in other clinical trials (or administration of investigational drugs)
during 3 months prior inclusion
- Patients with malignant tumors including postoperative period, patients receiving
chemotherapy and/or radiotherapy.
- Patient's activated partial thromboplastin time exceeds normal levels more than 1,8
times
- Patients prescribed for anticoagulants treatment or patient received anticoagulants at
least one hour prior liposuction
- Medical history of heterotopic ossifications
- Patients prescribed for glycoprotein inhibitors treatment
Exclusion Criteria:
- Patient's refusal from the further participation in trial
- Patient's refusal from compliance with the requirements of contraception during the
participation in research
- Chronic kidney disease IV- V stages (creatinine clearance < 30 mL/min estimated by
Cockcroft-Gault formula)
- Confirmed syphilis, HIV, hepatitis B or C infections
Dropout Criteria:
- Pregnancy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 85 Years | The Evaluation of Safety and Effectiveness of Intraarticular Administration of Autologous Stromal-Vascular Fraction of Adipose Tissue Cells for Treatment of Knee Joint Arthrosis | NCT04050111 | Entailment |
5,658 | 42 | A 9-year-old girl is brought to the office for evaluation of short stature and overweight body habitus. The patient's mother and father are 170 cm and 181 cm tall, respectively. On physical examination, the patient's height is in the 5th percentile of her age. Other findings include low-set ears, a high arched palate, a webbed neck, and cubitus valgus. Chromosomal analysis reveals a 45, XO karyotype. | I took my 9-year-old daughter to the doctor because my mother-in-law kept saying she seemed small and overweight. My husband and I are 170 cm and 181 cm tall, respectively. The physical health highlighted that she is in the 5th percentile of her age. The doctor said that she has low-set ears, a high-arched palate, a webbed neck, and cubitus valgus. She also did a chromosomal analysis, which revealed a 45, XO karyotype. | Inclusion Criteria:
- Chronological age (CA) between 3 and 10 for girls
- Chronological age between 3 and 12 for boys
- Height for CA below - 2 SD
- Birth length for CA below -2SD
Exclusion Criteria:
- Endocrine disease except well-substituted hypothyroidism
- Sever chronic disease
- Skeletal dysplasia
- Known chromosomal aberration
- Ongoing treatment with steroids
- Known intrauterine infection
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 12 Years | Genotropin Treatment in Short Prepubertal Children With Intra-Uterine Growth Retardation | NCT01073605 | Contradiction |
2,431 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- Age group of 18 to 65 years
- Clinicoradiological suspicion of sarcoidosis where EBUS-TBNA is being planned
- Enlarged hilar and mediastinal lymph nodes >10 mm (any axis) on computed tomography of
the chest
Exclusion Criteria:
- Hypoxemia (SpO2 <92% on FiO2 of 0.3)
- Treatment with systemic glucocorticoids for >2 weeks in the preceding three months
- Diagnosis of sarcoidosis possible with another minimally invasive technique such as
skin biopsy or peripheral lymph node biopsy
- Failure to provide informed consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 Years | Effect of the Number of Needle Revolutions Inside the Node on the Diagnostic Yield of EBUS-TBNA in Sarcoidosis | NCT02875756 | Contradiction |
3,651 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:Clinical diagnosis of Menorrhagia
- Must be able to swallow tablets
Exclusion Criteria:
- Endometrial abnormality
- Pelvic infection
- Pregnancy
- Breast Feeding
- Requirement for birth control
- Known intolerance/lack of effect of tranexamic acid
Female
Accepts Healthy Volunteers
Subject must be at least 15 Years old.
Subject must be at most 50 Years | The Assessment of Tranexamic Acid in Women With Menorrhagia Who Have Bleeding Disorders | NCT00904709 | Entailment |
2,496 | 17 | A 67-year-old man comes to the clinic with slowly worsening vision in both eyes. He is not able to drive at night, as the symptoms are worse at night. His pupils are normal in diameter both in the light and darkness. Other medical history is unremarkable. Ocular examination shows loss of the red reflex and blurry vision. Acuity testing shows 50/100 vision in both eyes with normal visual field testing. His blood pressure is 130/70 and pulse is 68/min. the other physical examinations are normal. | I am a 67 years-old man, and I haven't been able to drive at night due to my vision getting worse. My vision is not the best in general, but night makes it even worse. The ophthalmologist told me that my pupils were normal. However, I have slow reflexes and blurry vision. My acuity test came back with 50/100 vision in both of my eyes. They also took my blood pressure, which was 130/70 with a 68 pulse. My other exams came back just fine. | Inclusion Criteria:
- Normal subjects, patients with deficient binocular vision, patients with color vision
disorders
Exclusion Criteria:
- phthisis, enucleations
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 1 Year old.
Subject must be at most 95 Years | Autostereoscopic Dynamic Near Vision Testing | NCT04606355 | Entailment |
3,016 | 22 | A 15-year-old boy with mild intellectual disability is brought to the office by his parents for a routine physical examination. The boy is going to a school for students with learning disabilities. The patient was adopted, and his immunizations are up to date. Review of the patient's medical records is notable for cytogenetic studies that showed a small gap near the tip of the long arm of the X chromosome, which is consistent with fragile X syndrome, an X-linked disorder. The defect is an unstable expansion of trinucleotide repeats (CGG) in the fragile X mental retardation 1 (FMR1) gene, located on the long arm of the X chromosome. He is not using any medications and vital signs are within normal levels. His blood chemistry analysis as bellow:
Blood Chemistry Value Normal Range Patient Value
Glucose 90-120 mg/dl 95 mg/dl
BUN (Blood Urea Nitrogen) 7-24 mg/dl 10 mg/dl
Creatinine 0.7-1.4 mg/dl 0.8 mg/dl
Calcium 8.5-10.5 mg/dl 9 mg/dl
Sodium 134-143 mEq/L 135 mEq/L
Potassium 3.5-4.5 mEq/L 3.7 mEq/L
Chloride 95-108 mEq/L 98 mEq/L
CO2 20-30 mEq/L 25 mEq/L
Blood pH 7.38-7.42 7. 39 | My husband and I brought our 15-year-old son to the clinic for his routine exam. My son is going to school for special needs students. We adopted him a few years ago. His vaccinations are up to date. He already passed some chromosome testing and they found that he has a fragile X syndrome. The doctor told us that it comes from repeats in the fragile X chromosome. My son is not using any medication and his blood pressure temperature and breathing were normal during the exam. He also did a blood test. The results came back and showed that his blood sugar urea creatinine calcium sodium potassium chloride CO2 and blood pH were all within the normal range. | Inclusion Criteria:
- Male subjects 18 to 50 years of age, inclusive.
- Molecular documentation of the full fragile X mutation.
Exclusion Criteria:
- Subjects with a history of seizure disorder who are, in the opinion of the
Investigator and Medical Monitor, not currently considered to be well controlled.
- Subjects currently being treated with psychoactive medications (including stimulants
and anxiolytics).
- Subjects with any condition, including alcohol and drug abuse, which might interfere
with the conduct of the study, confound interpretation of the study results, or
endanger their own well-being. 4. Subjects who plan to initiate or change
pharmacologic or non-pharmacologic interventions during the course of the study.
- Subjects who, in the Investigator's opinion, might not be suitable for the study
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 50 Years | A Study to Assess the Tolerability of a Single Dose of STX107 in Adults With Fragile X Syndrome | NCT01325740 | Contradiction |
772 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- the presence of knee osteoarthritis Grade 2 and Grade 3 based on Kellgren Lawrence
Classification,
- volunteering to participate in the study.
Exclusion Criteria:
- the presence of active synovitis,
- participation physiotherapy program in the last 6 months,
- systemic and cardiovascular diseases,
- neurological and orthopedic problems affecting walking and standing,
- lower extremity surgery
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Effects of Closed and Open Kinetic Chain Exercises | NCT04186143 | Contradiction |
6,961 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- Informed volunteer consent, patient consent
- Male or female, aged between 18 and 100 years of age
- Able (in the Investigator's opinion) and willing to comply with all study requirements
- Willing to allow his or her General Practitioner (GP) to be notified of participation
in the study
- Good understanding of written and verbal English
Healthy Controls-specific Inclusion Criteria
- No evidence of subjective or objective memory impairment on cognitive testing
- No major medical co-morbidity (outlined in detail in the exclusion criteria) or
medication use that could adversely affect cognition
MCI Patient-specific Inclusion Criteria
Clinical diagnosis of MCI made by a specialist* in a patient who fulfils the established
clinical consensus criteria for MCI [NIA/AA 2011] specifically:
- Concern regarding a change in cognition compared to the person's previous level, by
the patient and/or informant
- Objective evidence of impairment of one or more cognitive domains, greater than
expected for age, and educational background, over time if repeated measures are
available.
- Preserved independence of functional abilities and minimal to no impairment on complex
instrumental functions
- Not demented
Vascular Dementia Specific Inclusion Criteria
Clinical diagnosis of VascD made by a specialist* in a patient who fulfils the NINDS-AIREN
criteria for VascD, specifically:
- Cerebrovascular disease defined by the presence of focal signs on neurological
examination consistent with stroke and evidence of cerebrovascular disease on brain
imaging.
- One or more of:
- Onset of dementia within 3 months of a diagnosed stroke
- Abrupt deterioration in cognitive function
- Fluctuating, stepwise progression of cognitive deficits
Alzheimer's Dementia Specific Inclusion Criteria
Clinical Diagnosis of AlzD made by a specialist* in a patient who fulfils the NIA/AA
criteria for Probable AlzD, specifically:
- Meets the criteria for dementia
- The memory impairment and cognitive deficits cause significant impairment in
social or occupational functioning, and represent a significant decline from a
previous level of functioning, not explained by a delirium or a major psychiatric
disorder
- Impairment of at least two cognitive domains
- Insidious or gradual onset
- Clear history of worsening cognition by report or observation
- The initial and most prominent cognitive deficits are evident on history and
examination in one of the following domains:
- Amnestic: impaired learning and recall of recently learned information
- Non amnestic: language/visuospatial/executive dysfunction
- No evidence of substantial cerebrovascular disease, core features of dementia with
lewy bodies, features of frontotemporal dementia, prominent features of semantic
variant primary progressive aphasia, evidence of active neurological disease, a
non-neurological co-morbidity or medication that could affect cognition
- A specialist being defined as a psychiatrist or a geriatrician, or a specialist
mental health nurse with a specific interest or expertise in cognitive disorders.
Exclusion Criteria:
Exclusion Criteria
- Male or Female, aged under 18 years
- Unable (in the Investigator's opinion) or unwilling to comply with any study
requirements
- Female participants who are pregnant, lactating or planning pregnancy during the
course of the study
- Major co-morbidity likely to affect cerebral autoregulation; severe respiratory
disease, carotid artery stenosis, atrial fibrillation, severe cardiac failure (left
ventricular ejection fraction <20%), extreme frailty or multi-morbidity.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 100 Years | Cerebral Haemodynamic Changes During Cognitive Testing: A fTCD Study | NCT03134963 | Entailment |
5,170 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
Ambulatory male and female residents with osteoporosis or low bone mass (at risk for
fracture) ages 65 and older will be considered if:
- Reside in long-term care institution (nursing home or assisted living facility); and
- HaveOsteoporosis: (1) by bone density [spine, hip or forearm Bone Mineral Density
(BMD) T-score ≤ -2.5]; (2) A previous adult fragility fracture of the spine or hip; or
(3) Would be treated based on FRAX® and the National Osteoporosis Foundation (NOF)
treatment thresholds of a 10 year risk of ≥ 20% for a major fracture or ≥ 3% for hip
fracture suing femoral neck BMD.
Exclusion Criteria:
- Institutionalized residents with subacute illnesses who are not expected to survive or
who will be discharged in < 2 years.
- Non-ambulatory residents (those who cannot stand and pivot with assistance in order to
transfer to the DXA table).
- Those currently on therapy (including bisphosphonate, denosumab, or teriparatide) or
who have been on a bisphosphonate for > 1year during the previous 2 years because some
bisphosphonates are long acting.
- Those with a history of hypocalcemia or contraindication for treatment. We will screen
for these conditions by detailed history, chart review, and baseline laboratory
analyses.
- Those with vitamin D levels < 25ng/mL will be treated with vitamin D 50,000 IU/wk for
8 weeks; they will be enrolled if the follow-up vitamin D level is 25 ng/mL or more
(if after 2 rounds of vitamin D repletion their vitamin D level is not at least 25
ng/mL, they will not be eligible to be randomized into the study).
- Those on dialysis or with stage 5 chronic kidney disease (eGFR<15ml/min) will be
excluded at screening.
- Those requiring tooth extraction or oral surgery will not be enrolled until cleared by
a dentist.
- Patients will be allowed to continue on glucocorticoids and anticonvulsants because
their use is common in this population.
- Those on glucocorticoids and anticonvulsants will be allowed to continue in the study
because their use is common in this population.
- Those on hormone replacement therapy (HRT), raloxifene, or prescribed protective hip
pads by their Primary Care Physician (PCP) will be allowed to participate and continue
on these therapies.
- We will suggest that participants stop long-term calcitonin as it has been
discontinued in Europe due to cancer concerns.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 65 Years old.
| Preventing Osteoporosis Using Denosumab | NCT02753283 | Contradiction |
4,482 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
- Women with intact uterus, regular menstrual cycles and no previous or current
climacteric symptoms.
Exclusion Criteria:
- Pregnancy or lactation.
- Previous pelvic infections.
- Abnormal bleeding.
- Abnormal uterine cavity.
- Uterine polyps.
- Genital cancer.
- Liver diseases.
- Alcoholism or drug abuse.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 46 Years old.
Subject must be at most 51 Years | Assessment of the Transfer of Using Levonorgestrel Intrauterine System (LNG IUS) as a Contraceptive to Using it as Part of Hormone Replacement Therapy (HRT). | NCT00185458 | Contradiction |
6,933 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
- diagnosis of mild cognitive impairment or Alzheimer's disease
- availability of cohabitating study partner without cognitive impairment
- consent of primary care physician
Exclusion Criteria:
- history of stroke
- history of coronary artery disease
- history of pancreatitis
- untreated hypothyroidism or B12 deficiency
- history of renal disease or recurrent kidney stones
- history of liver disease
- insulin-dependent diabetes
- body mass index <18.5
- multiple food allergies
- follow strict diet (e.g., vegetarian, gluten-free)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| Dietary Treatments for Cognitive Impairment in Older Adults | NCT02521818 | Entailment |
6,287 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Outpatients ≥ 18 years presenting to Cleveland Clinic Health System in Ohio and
Florida who test positive for COVID-19 having any of the following symptoms
1. Fever or chills
2. Shortness of breath or difficulty breathing
3. Cough
4. Fatigue
5. Muscle or body Aches
6. Headache
7. New loss of taste
8. New loss of smell
9. Congestion or runny nose
10. Nausea
11. Vomiting
12. Diarrhea
Women of child bearing potential:
1. have had a menstrual period within the past 30 days, or
2. have had previous sterilization, or
3. are perimenopausal (less than 1 year) who have a negative pregnancy test, or
4. women of childbearing potential who do not meet the above and have a negative
pregnancy test.
Exclusion Criteria:
- Patients who are found to be positive during hospitalization
- Patients who reside outside Ohio or Florida.
- Pregnant women:
1. Current known pregnancy
2. Positive pregnancy test (women of child bearing potential who have not had
previous sterilization as defined as hysterectomy or tubal ligation)
- Women of childbearing potential who do not meet the above criteria, last menstrual
period greater than 30 days and have a positive pregnancy test.
- Lactating Women
- End stage kidney disease
- Advanced liver disease awaiting transplant
- History of Calcium Oxalate kidney stones.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Coronavirus 2019 (COVID-19)- Using Ascorbic Acid and Zinc Supplementation | NCT04342728 | Entailment |
2,586 | 20 | A 49-year-old man comes to the office because of the bulging in his groin. Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases. His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair. | I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair. | Inclusion Criteria:
- ages 4-10 years old
- undergoing elective umbilical or inguinal hernia repair surgery
- ASA Physical Status = 1
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 10 Years | The Impact of Medical Clowning on Pain and Stress Level in Pediatric Patients Undergoing Hernia Repair Surgery LAUGH Study. | NCT01622218 | Contradiction |
357 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Age of women from 18-40 years at the time of recruitment (not beyond 40th birthday)
- Absence of fever
- Gestation less than 12 completed weeks as defined by pelvic ultrasound
- Presence of intrauterine gestational sac(s) if an urine pregnancy test is first
positive within past 2 weeks
- Presence of intrauterine fetus(es) with crown-rump length of <7mm and no fetal
pulsation, or presence of intrauterine fetus(es) with positive fetal heart pulsation
confirmed on pelvic scanning
Exclusion Criteria:
- Age of women >40 years at the time of recruitment
- History of recurrent miscarriage defined as at least three consecutive spontaneous
miscarriages
- History of known parental chromosomal abnormalities
- Heavy vaginal bleeding requiring surgical intervention
- Severe abdominal pain requiring surgical intervention
- Absence of cardiac pulsation in a fetal pole with crown-rump length of >=7mm on
transvaginal scanning
- Use of hCG or progesterone treatment for threatened miscarriage prior to recruitment
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Randomized Double-blind Controlled Trial of Use of Dydrogesterone in Threatened Miscarriage | NCT02128685 | Contradiction |
5,534 | 41 | A 61-year-old man comes to the emergency department complaining of an acute vision disturbance. He had an episode of vision disturbance in the right eye that occurred suddenly and resolved spontaneously in 15 minutes. He also has right jaw pain while chewing. He also complains of fatigue and hip muscle aches over the last several months. The patient has a history of mild hyperlipidemia that has been controlled by diet and lifestyle modifications. On examination, his blood pressure is 130/70 mm Hg and pulse is 66/min. Neurological examination is unremarkable. Visual examination is also normal. ESR is 103 mm/h. Temporal artery biopsy shows multinuclear giant cells and internal elastic membrane fragmentation. | I’m a 61-year-old man and I came to the ER because I had a sudden episode where I couldn’t see out of my right eye. It only lasted about 15 minutes and went away on its own but it really scared me. I’ve also been having pain in my right jaw when I chew. For the past few months I’ve felt really tired and noticed my hips ache a lot. I have a history of mild cholesterol issues but I’ve been managing that with my diet and lifestyle. When the doctors checked me my blood pressure and pulse were normal and my vision and neurological exams didn’t show anything wrong. However they ran some tests and said my ESR levels were very high and a biopsy of my temporal artery showed some inflammation and damage. | Inclusion criteria
- Diagnosis of Giant cell arteritis (GCA) according to the revised American College of
Rheumatology criteria
- GCA diagnosis confirmed by either temporal artery biopsy revealing features of GCA; or
evidence of cranial GCA by doppler-ultrasound; or cranial Magnetic Resonance Imaging
or Magnetic Resonance Angiography; or other imaging modality upon agreement with the
sponsor
- Have new onset or relapsing GCA
- Have active GCA within 6 weeks of first study intervention: Active GCA: presence of
signs and symptoms of GCA and elevated erythrocyte sedimentation rate (ESR) greater
than or equal to (>=) 30 millimeter per hour (mm/hour), or C-reactive protein (CRP) >=
10 milligrams per liter (mg/L) (or 1 milligrams per deciliter [mg/dL]), attributed to
active GCA. ESR >= 30 mm/hour or CRP >= 10 mg/L (or 1 mg/dL) is not required if active
GCA has been confirmed by a positive temporal artery biopsy or ultrasound or other
imaging modality within 6 weeks of first study intervention
- Clinically stable GCA disease on a glucocorticoid (GC) dose between 20 and 60
milligrams per day (mg/day) (prednisone or equivalent) at randomization such that the
participant is able to safely participate in the protocol defined prednisone taper
regimen, in the opinion of the investigator
Exclusion criteria
- Has any known severe or uncontrolled GCA complications
- Has any rheumatic disease other than GCA such that could interfere with assessment of
GCA
- Has a current diagnosis or signs or symptoms of severe, progressive, or concomitant
medical condition that places the participant at risk by participating in this study)
- Has or has had any major ischemic event, within 12 weeks of first study intervention
- Has any comorbidities requiring 3 or more courses of systemic GCs within 12 months of
first study intervention, AND, inability, in the opinion of the investigator, to
withdraw GC therapy through protocol-defined taper regimen due to suspected or
established adrenal insufficiency, OR, currently on systemic chronic GC therapy for
reasons other than GCA and be GC dependent and have the potential to flare due to GC
tapering (e.g. unstable asthma, unstable COPD)
- Has a history of, or ongoing, chronic or recurrent infectious disease
- Has received within specified timeframe, or 5 half-lives (whichever is greater) , or
has failed treatment with any investigational or approved biologic agents or Janus
Kinase Inhibitor prior to first study intervention
- Use of any of the following systemic immunosuppressant treatments within the specified
timeframe prior to study start: Any cytotoxic agents (cyclophosphamide, chlorambucil,
nitrogen mustard, or other alkylating agents) with 6 months; Hydroxychloroquine,
cyclosporine A, azathioprine, tacrolimus, sirolimus, sulfasalazine, leflunomide with
cholestyramine washout or mycophenolate mofetil/mycophenolic acid within 3 months;
Intramuscular, intra-articular, intrabursal, epidural, intra-lesional or IV GCs within
6 week; and Methotrexate (MTX) within 12 weeks. If started MTX >12 weeks prior to
first study intervention MTX must have been at a stable dose for minimally 6 weeks and
must not be receiving more than 20 mg oral MTX (or 15 mg SC) per week
- Has chronic continuous use of systemic GCs for greater than (>) 4 years or inability,
in the opinion of the investigator, to withdraw GC treatment through protocol-defined
taper regimen due to suspected or established adrenal insufficiency
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| A Study to Evaluate Guselkumab for the Treatment of Participants With New-onset or Relapsing Giant Cell Arteritis | NCT04633447 | Entailment |
581 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Age 18 years+
- Diagnosis of IPUVI on initial ultrasound
Exclusion Criteria:
- Current mental health condition (anxiety, depression, eating disorder). The condition
will be considered current if it has required one or more consultations with a medical
professional (including a psychologist) over the past 6 months (women with past mental
health condition will not be excluded)
- The patient is planning a termination
- Multiple order pregnancies
- Women who in the opinion of the researcher by virtue of language or learning
impairment would be unable to give fully informed consent to the study
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Psychological Impact of Predicting Early Pregnancy Outcomes in Women With Pregnancy of Uncertain Viability | NCT03264170 | Entailment |
5,404 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Female
- Aged 18 years and over
- Regular menstrual cycles
- Owns a compatible smart phone i.e. iPhones® and AndroidTM phones equipped with
Bluetooth® 4.0/BLE
- Willing to use their own smartphone for the duration of this study and to download and
install the study app
- Willing to give informed consent
Exclusion Criteria:
- Currently trying to conceive
- Currently or recently pregnant or breastfeeding
- Taking any treatment which may affect the menstrual cycle (e.g. contraceptive pill,
fertility medications or hormone replacement therapy)
- Taking or undergoing any other medical treatment for fertility such as ovulation
drugs, artificial insemination and assisted fertility such as In vitro fertilization
(IVF) or Intracytoplasmic sperm injection (ICSI)
- Has abnormal liver or kidney function
- Taking antibiotics containing tetracycline
- Taking clomiphene citrate or other ovulation induction drugs
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Menstrual Cycle Symptom Tracking | NCT04756739 | Entailment |
3,234 | 23 | A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn. The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness. She also reports occasional joint pain. Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease. She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h) | I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR. | Inclusion Criteria:
- Diagnosis of moderate to severe dry eye syndrome with or without Sjogren's syndrome or
other autoimmune disease
Exclusion Criteria:
- Intraocular or refractive surgery in the study eye within 3 months prior to study
start
- Unwilling to discontinue use of contact lenses during the run-in and duration of the
study
- Pregnancy or lactation
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-005) | NCT00502073 | Entailment |
3,833 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- patients with knee osteoarthritis, treated by a participating physiotherapist within a
predefined period
Exclusion Criteria:
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Knee Osteoarthritis Care: A Quality Improvement Intervention in Physiotherapists | NCT02177162 | Entailment |
1,879 | 11 | A 63-year-old man comes to the clinic for recent unintentional weight loss. The patient also has epigastric discomfort after meals. He has no known medical problems and takes no medications. His blood pressure is 130/75 and pulse rate is 88/min. He is not febrile. Upper endoscopy shows a lesion in the stomach that shows typical features of diffuse-type adenocarcinoma presenting with signet ring cells that do not form glands. | I went to the clinic because I had been losing so much weight that it was concerning. I'm a 63-year-old guy, and it is something rather unusual. I'm always suffering from stomachache after every meal. I've never been sick, and I don't take any medicine. The doctor took my blood pressure and told me it was 130/75, and my pulse rate was 88/min. I'm not febrile! I also had to do an endoscopy, and they found a lesion in my stomach that shows typical features of stomach cancer. I'm totally devastated... | Inclusion Criteria:
1. The subject is Chinese
2. The subject is greater than 50 years of age
3. The subject satisfies one or more of the following criteria:
- has (had) a history of dyspepsia of at least 4 weeks or more. Dyspeptic symptoms
include bloating, epigastric discomfort and early satiety
- has a family history of gastric cancer
- has a medical condition for which an OGD is indicated.
4. The subject must have personally signed and dated the patient informed consent form
indicating that he/she has been informed of all pertinent aspects of the study.
5. The subject must be willing and able to comply with scheduled visits and other study
procedures
Exclusion Criteria:
1. The subject who has bleeding disorders, such as haemophilia, in whom biopsies are
contraindicated.
2. The subject with liver cirrhosis.
3. The subject with previous total or partial gastrectomy.
4. The subject with severe co-morbid illness, such as end-stage renal failure (ESRF),
congestive cardiac failure (CCF), severe osteoarthritis (OA) and rheumatoid arthritis
(RA) requiring long term non-steroidal anti-inflammatory drug (NSAID) therapy.
5. The subject has other severe acute or chronic medical or psychiatric condition or
laboratory abnormality that may interfere with the interpretation of study results and
in the judgment of the investigator would make the subject unsuitable for entry into
the study.
6. The subject is currently on anti-coagulant therapy such as warfarin. Patients on
aspirin, ticlopidine and clopidogrel must undergo a one-week washout period before
enroling in the study.
7. The subject has a history of bronchial asthma, or a known allergy to fluorescein.
8. The subject is unwilling or unable to provide signed informed consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
| Confocal Endomicroscopy Detection of Gastric Preneoplasia and Neoplasia | NCT01384201 | Entailment |
4,122 | 32 | A 30-year-old man who is a computer scientist came to the clinic with the lab result stating azoospermia. The patient is sexually active with his wife and does not use any contraception methods. They have been trying to conceive for the past year with no success. The patient has a past medical history of recurrent pneumonia, shortness of breath, and persistent cough that produces large amounts of thick sputum. The patient had multiple lung infections during childhood. He does not smoke, use illicit drugs or alcohol. The patient has no history of other medical conditions including allergies or any kind of surgery. On physical examination, the digits show clubbing. An ultrasound shows bilateral absence of the vas deferens, and FEV1 was 75% on the respiratory function test. | I'm a 30-year-old computer scientist. I did some lab tests that came back quite alarming, stating that I have azoospermia?! I'm sexually active with my wife and we don't use contraception. We've been trying to have a child for the past year. I have a medical history of pneumonia and shortness of breath and regular wet cough. I had several lung infections when I was a kid. That's why I'm very careful and don't smoke, do drugs, or drink. I don't have other medical conditions including allergies or any kind of surgery. The doctor did the clubbing test on my fingers, which was positive. I also did an ultrasound and it showed that I'm missing the tubes that carry sperm around. I also had a 75% for my respiratory function test. | Inclusion Criteria:
1. Having persistent cough that lasts longer than 3 weeks following URTI
2. Currently being a non-smoker
3. Having normal spirometry (FEV1>or= 80% predicted)
4. Obtain consent form
Exclusion Criteria:
1. Having cough more than 8 weeks
2. Having history of allergic or intolerance to β2 agonist
3. Having diagnosis of asthma by physicians
4. Presence of wheeze or rhonchi on physical examination
5. Having radiographic evidence of pneumonia, tuberculosis or sinusitis
6. Having significant gastroesophageal reflux symptoms suggested by GERD-Q questionnaire
(GERD-Q score > 8)
7. Currently taking ACE-inhibitor
8. Being active smokers
9. Refuse to participate in the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 15 Years old.
| Effect of Oral Procaterol on Postinfectious Persistent Cough | NCT02349919 | Contradiction |
2,098 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- Clinical symptoms consistent with IPF with onset between 3 months and 36 months prior
to screening
- Worsening as demonstrated by any one of the following within the past year:
1. >10% decrease in FVC % of predicted,
2. Worsening chest x-ray or
3. Worsening dyspnea at rest or on exertion
- Age 20 -79 years of age. Subjects aged 20-50 must have diagnosis by either open or
video-assisted thoracic surgery (VATS) lung biopsy
- Diagnosis must be made by (HRCT) showing definite or probable IPF AND either of the
following:
1. Open or VATS lung biopsy showing definite or probable usual interstitial
pneumonitis (UIP)
2. Non-diagnostic transbronchial biopsy to exclude other conditions (including
granulomatous disease and malignancies) AND abnormal pulmonary function tests
(reduced FVC or decreased DLCO or impaired gas exchange with rest or exercise)
AND 2 of the following:
1. Age >50 years
2. Insidious onset of otherwise unexplained dyspnea or exertion
3. Bibasilar, inspiratory crackles on examination
- FVC> 55% of predicted value at baseline
- DLCO > 35% of predicted value at screening
- PaO2 >60 mmHg (sea level) or 55 mmHg (altitude) at rest on room air
- Able to understand and willing to provide informed consent prior to any study
procedures
Exclusion Criteria:
- History of clinically significant environmental exposure known to cause pulmonary
fibrosis
- Diagnosis of connective tissue disease
- FEV1/FVC ratio < 0.6 at screening (post-bronchodilator)
- Residual volume > 120% predicted at screening
- Evidence of active infection
- Any condition other than IPF, which, in the opinion of the site principal
investigator, is likely to result in the death of the patient within the next year
- History of unstable or deteriorating cardiac or neurologic disease
- Women with child bearing potential
- Current treatment with corticosteroids, cytoxan, azathioprine, colchicines,
pirfenidone, interferon gamma or beta, anti-tumor necrosis factor therapy or with
endothelin receptor blockers.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 79 Years | Gleevec Idiopathic Pulmonary Fibrosis (IPF) Study | NCT00131274 | Entailment |
4,704 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | For participants with major depressive episode:
Inclusion criteria:
- female sex
- current diagnosis of a major depression episode
- minimum age of 18 years
- regular menstrual cycle.
Exclusion criteria:
- Pregnancy less than one year ago;
- women who are breastfeeding;
- bipolar disorder;
- acute suicidal tendencies;
- schizophrenic disorders (F20-29);
- substance use disorders
- psychotropic drugs in the last six months;
- chronic somatic diseases.
For participants without major depressive episode:
Inclusion criteria:
- female sex;
- minimum age of 18 years;
- regular menstrual cycle.
Exclusion criteria:
- current or lifetime mental disorder;
- pregnancy less than one year ago;
- women who are breastfeeding;
- psychotropic drugs in the last six months;
- chronic somatic diseases.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Depressive Symptoms and Subjective Stress in the Course of the Menstrual Cycle - an Ambulatory Assessment Study. | NCT04086316 | Entailment |
6,090 | 45 | A 15-week-old infant brought to the clinic for the follow up. The infant has flat facies, small ears, a single palmar crease, and upward slanting eyes. He was born on 39th week to a 39-year-old woman who didn't have prenatal care. The medical record confirms the trisomy of chromosome 21 (Down syndrome). The infant is otherwise healthy. | My newborn, who is only 15 weeks old, had one of his follow-up appointments. The doctor pointed out that my baby had a flat face, small ears, only one palm line, and small eyes. He was born on his 39th week, while I was 39. What a coincidence! To be honest, I did not go to the doctor during my pregnancy. The doctor diagnosed my baby with Down syndrome. Apart from that he's healthy. | Inclusion Criteria:
- Down syndrome without mosaicism
- age 3 to 30 months
- weight over 4 kg
- possible assessment by the revised Brunet-Lezine scale
Exclusion Criteria:
- history of leukemia
- West syndrome or non-stable epilepsy
- non-stable thyroxin treatment
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Months old.
Subject must be at most 30 Months | Efficacy Study of Folinic Acid to Improve Mental Development of Children With Down Syndrome | NCT00294593 | Entailment |
1,222 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- patients diagnosed as exudative pleural effusion according to Light criteria .informed
written consents were taken from all patients enrolled in the study
Exclusion Criteria:
- patients who refused participation ,patients unfit for medical thoracoscopy (MT) will
be excluded from the study such as:Uncooperative patient ,Severe uncorrected hypoxemia
in spite of continuous oxygen administration, because it's necessary to keep oxygen
saturation above 90 % during procedure ,patients who could not tolerate the lateral
decubitus position for a period long adequate to do the thoracoscopy, unstable
cardiovascular or hemodynamic condition, uncorrected Coagulation defects and small
pleural space
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Efficacy And Safety Of Thoracoscopic Cryobiopsy In Patients With Undiagnosed Exudative Pleural Effusion | NCT04761003 | Entailment |
5,411 | 40 | A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction. Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration. The patient has heavy menstrual cycles each month. She has no other medical problems and takes no medications. Her mother and grandmother have also had excessive bleeding during menstrual period. Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL. | I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels. | Inclusion Criteria:
- Women between the ages of 18-45 (inclusive) not intending to get pregnant during the
next year
- Women complaining of heavy menstrual bleeding over several consecutive cycles
- Women without structural or histological abnormality of the uterus, or with fibroids
less than 3 cm in diameter which are causing no distortion of the uterine cavity
(eligible for pharmaceutical treatment according to the NICE guideline 2007)
- Informed consent (where required by laws or regulations)
Exclusion Criteria:
- The contraindications and warnings of the respective Summary of Product
Characteristics (Mirena, combined oral contraceptives, oral/injectable progestogens,
non-steroidal anti-inflammatory drug, or anti-fibrinolytic agent) must be followed.
- Women taking hormone replacement therapy
- Women with symptoms such as intermenstrual or post-coital bleeding, unless an
endometrial biopsy has been performed and pathology excluded
- Women with fibroids that are palpable abdominally or who have intra-cavity fibroids
and/or whose uterine length as measured at ultrasound or hysteroscopy is greater than
12 cm (NICE guideline 2007)
- Women on anticoagulative therapy or other treatment (including e.g. Copper IUD use)
known to cause menorrhagia
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Mirena or Conventional Medical Treatment for Menorrhagia | NCT00864136 | Entailment |
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