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495 | 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:
- Gestation up to 63 days
- General good health
- Willingness to provide contact information for follow-up
- Absence of conditions which contraindicate the use of mifepristone and misoprostol for
pregnancy termination
Exclusion Criteria:
- Ectopic pregnancy
- Intrauterine device (IUD) in place
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Acceptability and Feasibility of Medical Abortion Using Mifepristone and Buccal Misoprostol | NCT00386282 | Contradiction |
942 | 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:
- knee osteoarthritis according to the criteria of knee osteoarthritis of American
College of Rheumatology.
- Having felt a painful push in the last 6 months.
- Visual Analogic Scale pain > 4 on a 0 to 10 scale.
- having a Radiographic score of OARSI (Osteoarthritis Research Society International
Score) from 2 to 3 whether it is for the presence of a joint space narrowing or the
presence of an osteophyte
Exclusion Criteria:
- Patello-femoral degenerative osteoarthritis isolated.
- Incapacitated to consider the position in schuss for the realization of the
radiography.
- Valgus > in 5 °
- Secondary degenerative osteoarthritis
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 80 Years | Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model | NCT03294408 | Entailment |
2,986 | 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
Inclusion criteria for healthy volunteers:
1. Ages 18-65
2. Either gender and all ethno-racial categories
3. Capacity to provide informed consent
4. Female participants are expected to use an effective method of birth control
throughout the study which includes: hormonal methods (birth control pills, patches,
injections, vaginal ring or implants), barrier method (condom or diaphragm) used with
spermicide, intrauterine device (IUD), or abstinence (no sex)
5. Can travel to Stanford for 2 scan days.
Inclusion criteria for individuals with FXS:
1. Males who are physically healthy
2. Aged between 18 and 30 years inclusive
3. Can travel to Stanford for a 2-day visit.
4. IQ between 40 and 80 points.
5. Ability to remain seated for more than 10 minutes.
6. Have an established genetic diagnosis of FXS (full mutation with evidence of aberrant
methylation of the FMR1 gene, confirmed by genetic testing).
EXCLUSION CRITERIA
Exclusion criteria for healthy volunteers:
1. Any current or lifetime psychiatric diagnosis
2. Current or past use of psychotropic medication for purposes of treating a mental
illness
3. Pregnant or nursing females
4. Major medical or neurological problem, including anemia (Hb , 12 g/dl in women and <14
g/dl in men) (e.g., unstable hypertension, seizure disorder, head trauma)
5. Current diagnosis of vasculopathy or Raynouds
6. Participant is unable to tolerate being off of anticoagulant medication during study
7. Positive urine screen for illicit drugs
8. Presence of metal in the body that is contraindicated for MRI scans
9. Current exposure to radiation in the workplace, or history of participation in nuclear
medicine procedures does not exceed defined annual limits
10. Stanford University student status (i.e., we will exclude students such as undergrads,
grad students and postdocs that currently attend at Stanford University)
Exclusion criteria for individuals with FXS:
1. Any contraindication for MRI scanning procedures (metal in body, braces,
claustrophobia, etc.)
2. No history of with substance abuse, traumatic brain injury and
3. BMI greater than 18.5
4. Diagnosis of a known genetic disorder (other than FXS).
5. Active medical problems such as unstable seizures, congenital heart disease, endocrine
disorders.
6. Significant sensory impairments such as blindness or deafness.
7. DSM-5 diagnosis of other severe psychiatric disorder such as bipolar disorder or
schizophrenia.
8. Pre-term birth (<34 weeks' gestation) or low birth weight (<2000g).
9. Current use of benzodiazepines. Individuals who are taking concomitant psychoactive
medications will be tracked and examined in post-hoc analyses, given that it is
extremely difficult to recruit individuals who are medication-free or who are willing
to go off those medications prior to entering the study.
10. Current exposure to radiation in the workplace, or history of participation in nuclear
medicine procedures does not exceed defined annual limits
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 | Novel Clinical Target in Fragile X Syndrome | NCT04314856 | Contradiction |
4,209 | 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:
Healthy Volunteers:
- Over 18 years old
- Measurable cough reflex sensitivity
- No current or past history of chronic cough or chronic respiratory disease.
- No symptoms of gastro-oesophageal reflux disease, asthma or post-nasal drip.
Chronic Cough Patients
- Over 18 years old
- Chronic persistent cough (> 8 weeks) despite investigation and/or treatment trials for
cough variant asthma/post nasal drip and gastro-oesophageal reflux disease.
- Normal CXR
- Normal lung function
- Measurable cough reflex sensitivity
Exclusion Criteria:
- Recent Upper Respiratory Tract Infection (4 weeks)
- Pregnancy/breast feeding
- Current smokers or ex-smokers with < 6 months abstinence or cumulative history of > 10
packyears
- Diabetes Mellitus
- Opiate or ACE Inhibitor use.
- Any centrally acting medication which has the potential to alter cough reflex
sensitivity.
- Significant and ongoing chronic respiratory, cardiovascular (in particular
hypertension), gastro-intestinal, haematological (porphyria), neurological or
psychiatric illness.
- Drug or alcohol abuse
- History of allergy or reaction to ketamine of other NMDA receptor antagonists.
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 80 Years | Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity | NCT00858624 | Contradiction |
3,929 | 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: - Diagnosed with knee OA as determined by American College of
Rheumatology (ACR) criteria - Pain defined by a level of greater than 30 mm on a 100 mm
Visual Analogue Scale (VAS) - No evidence of active effusion or inflammatory flare,
confirmed by investigator - Must exhibit radiographic evidence of tibio-femoral compartment
knee OA within 12 months of screening - Stable doses of any non-prescribed supplements
(e.g. glucosamine or chondroitin sulphate, shark cartilage, diacerhein, soya extract) for
at least 2 months prior to screening - Unchanged use of physical therapy, biomechanical
devices or orthotic support within at least 2 months of screening - Subjects on
nonsteroidal anti-inflammatory drug (NSAID) therapy must discontinue NSAIDs 3 days prior to
baseline (Day 1) - Before any study-specific procedure is performed, the appropriate
written informed consent for participation in the study must be obtained Exclusion
Criteria: - Malignancy within the previous 5 years, except for basal cell or in situ cancer
- Significant hematologic disease - Active infection or history of recurrent or chronic
infections - Known diagnosis of HIV, hepatitis B, or hepatitis C infection - Uncontrolled
diabetes or cardiovascular disease and hypertension - Inflammatory arthropathy including
secondary OA - Isolated OA of the patellofemoral joint (bi or tri-compartmental involvement
are not exclusions) - End-stage ("bone-on-bone") OA (Kellgren Lawrence score of 4) - OA of
the hip ipsilateral to the index knee - Total white cell count less than 2.0 x 109/L and/or
platelet count less than 100 x 109/L observed within 1 month preceding screening - Prior IA
injection of anakinra or experimental interleukin-1 (IL-1) inhibitor therapy - Concurrent
treatment with subcutaneous (SC) anakinra - Concurrent or recent (less than or equal to 1
month) use of experimental therapy - Prior IA corticosteroid injection within 1 month of
study - Prior viscosupplement therapy within 3 months of study - Contraindication(s) to IA
injections - Subjects who are pregnant or breast-feeding, or plan to become pregnant during
the study - Subject is not using adequate contraception - Known allergy to E coli-derived
products - Unable to understand informed consent - Concerns regarding subject's compliance
with the protocol procedures - Subject will not be available for follow-up assessment -
Active substance abuse
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.
| Treatment for Patients With Osteoarthritis (OA) of the Knee | NCT00110916 | Entailment |
703 | 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:
- adults over 18 who agreed to participate in the study and signed an informed consent
form.
- Patients who went through partial or complete arthroplasty of the hip due to traumatic
or degenerative changes - respectively.
Exclusion Criteria:
- The refusal of the patient to use sampling for any reason, including the desire for
burying the organ / tissue
- rheumatic - autoimmune diseases that may affect the hip joint (eg: psoriasis,
rheumatoid arthritis, stc')
- Any chonic medications usage that might affect bone and cartilage (eg: Bifosfantim,
Alendronate, Risedronate, Ibandronate)
- Any suspected pathology of bone: malignancies, infections, Avascular Necrosis etc'
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 120 Years | The Histological Effect of Various Microfracture Techniques on Human Chondral & Sub-chondral Tissue - an Ex-Vivo Study | NCT03016299 | Contradiction |
2,996 | 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:
- Volunteer has a confirmed learning disability (permanent intellectual impairment);
- Registered with a general practice in Leicester, Leicestershire or Rutland, UK;
- Participant and/or carer has sufficient English language skills to enable fully
informed consent to be obtained.
Exclusion Criteria:
- Confirmed diagnosis of Type 2 diabetes or Type 1 Diabetes;
- Malignancy or terminal illness;
- Pregnancy or breast feeding;
- Severe systemic disease that may interfere with measurement and interpretation of
HbA1c.
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 74 Years | Diabetes Screening & Prevention for People With Learning (Intellectual) Disabilities:STOP Diabetes Study | NCT02513277 | Contradiction |
2,737 | 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:
- Inguinal hernia with surgical indication for surgical repair
Exclusion Criteria:
- History of urologic surgery and/or radiotherapy
- Recurrence of inguinal hernia
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | Testicular Vascular Evaluation in Patients Undergoing Inguinal Hernia Repair | NCT03056027 | Entailment |
3,044 | 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:
- Hospitalization on General Internal Medicine ward at St. Michael's Hospital
Exclusion Criteria:
- Transfer to another service
- Death during admission
- Remains in hospital past dates specified in study protocol
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Automated Versus Conventional Hospital Discharge Summaries and Prescriptions | NCT00670865 | Entailment |
2,116 | 13 | A 24-year-old man comes to the office complaining of infertility. He and his wife have been trying to conceive for the last 18 months. Medical records of his wife showed no abnormalities. The patient doesn't smoke and takes no medications. Height is 185 cm and weight is 77 kg. Heart and lung sounds are normal. There is bilateral gynecomastia and bilateral descended firm testes. The lower extremities appear abnormally long. His karyotype evaluation shows 47, XXY consistent with Klinefelter syndrome. | I'm only a 24 year old man but I’m already struggling with infertility. I went to a clinic with my wife the other day because we've been trying to have a baby for at least 18 months. The medical records of my wife are totally normal. For me I don't smoke or take any medication. I'm 185 cm and 77 kg. Everything was normal when the doctor inspected my lungs and my heart. The doctor said that I have enlarged breasts for a man. My testicles seem normal. The doctor noticed that my legs were abnormally long compared to the rest of my body. I also had a karyotype evaluation which led the doctor to diagnose me with Klinefelter syndrome. | Inclusion Criteria:
- All couples consisting of male and female partner undergoing CC or letrozole cycle
plus IUI at a single infertility center (Midwest Fertility Specialists)
- The female partner must be aged 21-39
- Infertile couples include those with a diagnosis(s) of unexplained infertility, mild
male factor, ovulatory dysfunction, or anovulation
- Evidence of a normal uterus and at least unilateral tubal patency on saline infusion
sonogram or hysterosalpingogram within the last 2 years
- Semen analysis for male partner must have minimal sperm concentration of 10 million
per milliliter
Exclusion Criteria:
- Recurrent miscarriages
- Nursing mothers
- Diagnoses of primary ovarian failure, diminishing ovarian reserve (as indicated by
blood follicle stimulating hormone >10 milliInternationalUnits/mL and/or
anti-mullerian hormone level <0.5), abnormal uterine bleeding of undetermined origin,
ovarian cyst of undetermined origin, stage IV endometriosis, or sex-hormone dependent
tumors
- Documented bilateral tubal obstruction or other uncorrected uterine anomalies (e.g.
uterine septum)
- Previous gonadotropin use and/or previous treatment with in vitro fertilization
- Abnormal semen analysis (sperm concentration less than 10 million per mL) or
ejaculatory dysfunction in male partner
- Other uncorrected medical condition in female partner that would be a contraindication
to attempting elective ovulation induction (e.g., uncontrolled diabetes, intracranial
lesion, thyroid or adrenal disease)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 39 Years | Study Evaluating the Timing of Intrauterine Insemination in Relation to Positive Home Ovulation Prediction Kit | NCT02294773 | Contradiction |
4,961 | 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:
- Essential tremor
Exclusion Criteria:
- MRI-incompatible metal objects in the body (e.g. cardiac pacemakers)
- other main neuropsychiatric co-morbidity
- 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 | tSMS in Essential Tremor | NCT03780426 | Entailment |
6,396 | 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:
- Fever and/or
- Cough and/or
- Dyspnoea
Exclusion Criteria:
- No one
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.
| Accuracy of Lung Ultrasound in the Diagnosis of covid19 Pneumonia | NCT04370275 | Entailment |
1,552 | 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:
- Solid mass lesions under going endoscopic ultrasound (EUS)
Exclusion Criteria:
- Coagulopathy
- Age below 18 years
- Cystic or solid-cystic lesions.
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.
| Comparison of "Wet Suction" Technique to Contemporary "Dry Suction" Technique Using a 22 Gauge Needle for EUS FNA | NCT01720745 | Contradiction |
6,264 | 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 with an acute SARS-CoV-2 infection, confirmed by PCR or typical CT images,
requiring hospitalization in a COVID unit at the Rouen University Hospital (pneumonic
form requiring oxygen therapy < 4 L/min.)
- Rouen University Hospital staff free of any symptomatology compatible with an
SARS-CoV-2 infection (fever, cough, fatigue, loss of taste, loss of smell) since
February 1, 2020
- Age ≥ 18 years old
- Adult patient who has read and understood the information letter and signed the
consent form
- Affiliation to a social security scheme
Exclusion Criteria:
- Patient with PCR-confirmed SARS-CoV-2 infection and hospitalized in intensive care
units (acute respiratory distress and/or organ failure, whose pathogenesis may differ
from the more frequently described forms with secondary aggravation (5)).
- Patient with PCR-confirmed but non-hospitalized SARS-CoV-2 infection (non-acute form,
managed by confinement)
- A person participating in a therapeutic trial that may interfere with the procedures
being investigated, including lymphocyte response prior to D+56±14 days.
- Known Pregnancy
- Person deprived of liberty by an administrative or judicial decision or person placed
under judicial protection / subtutorship or guardianship
- Staff at the Rouen University Hospital with SARS-CoV-2 infection confirmed by PCR
and/or typical scan images during the epidemic period.
- Hospital staff who were exposed to the virus (working in a Covid unit)
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 80 Years | Antiviral T Lymphocyte Immunity During Acute COVID-19 Infection | NCT04707820 | Contradiction |
5,128 | 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 Indian postmenopausal women with osteoporosis
- greater than 5 years postmenopausal
- aged 55 to 75 years old
- absolute bone mineral density value consistent with a T-score less than -2.5 and
greater than - 4.0 at the either the lumbar spine or total hip, as measured by dual
energy x-ray absorptiometry. Subjects with a T-score less than or equal to -4.0 are at
very high risk for fracture and will be excluded.
Exclusion Criteria:
- previous or current metabolic bone disease, Paget's or Cushing's disease, or
hyperprolactinemia
- current hypo- or hyperparathyroidism or hypo- or hyperthyroidism unless on stable
thyroid replacement therapy and TSH level meets criteria
- rheumatoid arthritis
- cirrhosis of the liver or unstable liver disease or ALT or AST greater than or equal
to 2.0 times the upper limit of normal, or alkaline phosphatase and bilirubin greater
than or equal to 1.5 times the upper limit of normal
- medications used to treat osteoporosis, defined for type and duration of use, and
including IV and oral bisphosphonates
- medications that affect bone metabolism including parathyroid hormone or derivatives;
anabolic steroids or testosterone; glucocorticosteroids; systemic hormone replacement
therapy; selective estrogen receptor modulators; tibolone, calcitonin, and calcitriol
or vitamin D derivatives; other bone active drugs including anticonvulsives (but not
benzodiazepines) and heparin; chronic systemic ketoconazole, androgens, ACTH,
cinacalcet, aluminum, lithium, protease inhibitors, methotrexate, and
gonadotropin-releasing hormone agonists
- malignancy within 5 years except certain resected types
- malabsorption syndrome or gastrointestinal disorders associated with malabsorption
- abnormal calcium level
- vitamin D deficiency
- any laboratory abnormality that will prevent the subject from completing the study or
interferes with interpretation of study results
- oral or dental conditions including current or past history of osteomyelitis or
osteonecrosis of the jaw; active dental or jaw condition with requires oral surgery;
planned invasive dental procedure; un-healed dental or oral surgery
- any disorder that compromises the ability of the subject to give written informed
consent or to comply with study procedures
- any physical or psychiatric disorder that will prevent the subject from completing the
study or interferes with study results
- known to have tested positive for HIV
- less than two lumbar vertebrae evaluable for DXA measurements
- height, weight, or girth that may preclude accurate DXA measurements
- drug or alcohol abuse within 12 months that interferes with understanding or
completing the study
- known sensitivity to mammalian cell-derived drug products
- use of an investigational drug or device within 30 days of enrollment or currently
receiving other investigational agent(s)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 75 Years | A Study in Indian Postmenopausal Women With Osteoporosis to Evaluate the Efficacy and Safety of Denosumab | NCT01495000 | Contradiction |
995 | 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 aged ≥ 40 years with symptoms of knee osteoarthritis
Exclusion Criteria:
rheumatoid arthritis, spondyloarthropathy
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 62 Years | Strontium Ranelate and KOA | NCT03937518 | Entailment |
1,831 | 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:
- Healthy volunteers
- Patients undergoing clinical indicated MRI
Exclusion Criteria:
- Patients with contraindication for MRI
- Pregnant women will be excluded from this study
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Clinical Testing of New MR Pulse Sequences | NCT00590252 | Entailment |
5,660 | 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:
- Ages 8 to 17 years old
- Overweight, defined as BMI ≥ 85th%tile for age and gender
- At least two CV risk factor typical of the metabolic syndrome including insulin
resistance, high or borderline blood pressure, low HDL, high TG
- Insulin > 10 u/L
- Able to attend study visits once a week at participant's home, and eat meals provided
by the Children's Hospital CTSA Boston MA as supplied for most meals and snacks
- Non-smoker
- Able to understand/speak English
- Informed consent to participate from a parent or legal guardian. Adolescents must also
provide written assent to participate in the study.
Exclusion Criteria:
- Pre-existing physician diagnosis of a major medical illness or history of a major
medical illness including but not limited to heart, kidney or liver disease, cancer,
endocrinopathy including thyroid disorder, genetic syndrome or psychiatric illness,
also including vasculitides such as Kawasaki disease or rheumatologic disorder;
diabetes type I or II, evidence of severe fatty liver, hypertension requiring
pharmacologic treatment, history of or current diagnosis of an major eating disorder
- Current or anticipated pregnancy
- Weight more than 275 lbs (125 kg)
- Abnormalities on initial screening assessment requiring pharmacotherapy urgent
treatment, such as familial hyperlipidemia, end organ effects of hypertension, or
metabolic abnormalities such as diabetes
- Taking any prescription medication or non-prescription substance that affects
cholesterol levels, blood pressure, or insulin sensitivity (including but not limited
to oral glucocorticoids, oral contraceptives, neuropsychiatric agents,
anti-epileptics, HMG-CoA reductase inhibitors, bile acid binding cholesterol transport
inhibitors among others) and the use of alcohol or illicit substances.
- Anticipated difficulty with participatory requirements of the study including food
allergies, significantly restricted food preferences, or other difficulties as
assessed by research staff.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 8 Years old.
Subject must be at most 17 Years | Nutritional Treatment of Overweight Adolescents With Cardiovascular Risk Factors (PowerUp) | NCT00477477 | Contradiction |
3,394 | 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. Type 2 diabetes patients
2. HbA1C > 7%
3. Duration of diabetes: 0.5 to 10 years
4. Subjects ≥ 30 and ≤70 years of age
5. BMI: 22 to 35 kg/m2
6. Diet controlled diabetic. Only treatment with metformin will be allowed
7. Normal liver and kidney function
8. Normal thyroid function
9. Acceptable health beside diabetes based on interview, medical history, physical
examination, and laboratory tests
10. Stable physical activity pattern during the three months immediately preceding study
11. Usually wakes up between 06:00 and 07:00 and goes to sleep between 22:00 and 24:00.
12. No shift work within 5 years of the study
13. Did not cross time zones within 1 month of the study
14. Read and understood the informed consent form and signed it voluntarily
Exclusion Criteria:
1. Type 1 diabetes
2. Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric,
infectious, malignant disease
3. Abnormal liver function tests defined as an increase by a factor of at least 2 above
the upper normal limit of alanine aminotransferase (ALT) and/or aspartate
aminotransferase (AST)
4. Pregnancy or lactation
5. Illicit drug abuse or alcoholism
6. Treatment with antidiabetic drugs, insulin or GLP-1 analogs
7. Subjects taking anoretic drugs during the month immediately prior to study
8. Subjects on steroid treatment
9. Those with eating disorders
10. Subjects after bariatric surgery, will be excluded
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 | Meal Timing on Postprandial Glucose, Insulin and GLP-1 in Type 2 Diabetes | NCT01977833 | Contradiction |
6,788 | 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 diagnosed with severe Hemophilia A.
- Age ≥18 years old
- Patients able to read and write
- Patients receiving Factor VIII substitute therapy, either on-demand or as secondary
prophylaxis.
- Patients under the same therapeutic strategy (On Demand or Secondary Prophylaxis) for
at least 6 months prior to enrolment.
Exclusion Criteria:
- Patients that have developed inhibitors against factor VIII.
- Patients participating in an investigational program with interventions outside of
routine clinical practice.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| 2-cohort Study of Adult Patients With Severe Hemophilia A in Greece | NCT02319070 | Entailment |
4,062 | 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:
- Signed informed consent.
- Completed the SH-NEN-0003 study with relief of upper GI symptom. Relief is defined as
"last 7 days with a diary assessment of None or Minimal, but allowing up to 2 days to
be rated as Mild during the 7-day period".
- A clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid
arthritis) that requires continuous daily NSAID treatment for at least 6 months. Daily
NSAID treatment is defined as taking the prescribed dose for at least 5 of 7 days in
any given week and can include COX-2 selective NSAIDs, multiple NSAIDs, and high-dose
NSAIDs.
- Daily NSAID treatment dose and type:
- Must have been stable for at least 9 weeks prior to inclusion
- Are expected to remain stable for the duration of the study.
- Must be administered orally. If more than one type of NSAID treatment is used, at
least one type must be administered orally.
- Hp negative on Histology performed at baseline endoscopy in the study SHNEN-0003.
Exclusion Criteria:
- Discontinuation from study SH-NEN-0003
- Pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved
by defecation.
- Pain, discomfort or burning in the upper abdomen not associated with the use of
NSAIDs, including COX-2 selective NSAIDs.
- Pregnancy or lactation. Women of childbearing potential must maintain effective
contraception during the study period as judged 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.
| Esomeprazole for Prevention of Upper Gastrointestinal Symptoms Associated With Continuous Use of NSAIDs | NCT00241553 | Entailment |
6,621 | 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:
- The study population will consist of all patients diagnosed with hemophilia (D66.9
(hemophilia A) D67.9 (hemophilia B) in International Statistical Classification of
Diseases and Related Health Problems (ICD-10) that have been registered in the Malmö
Hemophilia Register since 1977 and that have had at least one registered prescription
of BeneFIX or ReFacto/ReFacto AF in the MHR since market authorization of the
respective product
Exclusion Criteria:
- No exclusion criteria in this study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Treatment Patterns And Outcomes In Patients Treated With Benefix Or Refacto/Refacto AF - A Swedish Cohort Study | NCT02740413 | Contradiction |
3,914 | 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:
- Men or women
- Women of child bearing potential must not be pregnant during the study and must use
two forms of birth control
- Men and their female partners must use two forms of birth control
- Clinical and radiographic evidence of chronic knee osteoarthritis
- An average NPRS score of >=5 and <=9 over a 4-7 day washout period of their previous
osteoarthritis medications
- Ambulatory
- Have provided written 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 40 Years old.
Subject must be at most 80 Years | A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee | NCT01554579 | Entailment |
2,181 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
1. Has negative results of an FDA Emergency Use Authorized COVID-19 molecular assay for
detection of SARS-CoV-2 RNA from a respiratory specimen;
2. History of symptomatic gout defined as:
1. ≥ 3 gout flares within 18 months of Screening or
2. Presence of ≥ 1 gout tophus or
3. Current diagnosis of gouty arthritis
3. At the Screening Visit: male age 21 - 80 years, inclusive, or female of
non-childbearing potential age 21-80 years, inclusive, where nonchildbearing potential
is defined as:
1. > 6 weeks after hysterectomy with or without surgical bilateral
salpingo-oophorectomy or
2. Post-menopausal (> 24 months of natural amenorrhea or in the absence of >24
months of amenorrhea, one documented confirmatory FSH measurement)
4. Has chronic refractory gout defined as having failed to normalize sUA and whose signs
and symptoms are inadequately controlled with any of the xanthine oxidase inhibitors,
or for whom these drugs are contraindicated for the patient;
5. Has at the Screening Visit SUA ≥ 7 mg/dL
6. Negative serology for HIV-1/-2 and negative antigen to hepatitis B and negative
antibodies to hepatitis C;
Exclusion Criteria:
1. Has a history of anaphylaxis, severe allergic reactions, or severe atopy;
2. Has a history of any allergy to pegylated products, including, but not limited to
pegloticase (Krystexxa®), peginterferon alfa-2a (Pegasys®), peginterferon alfa-2b
(PegIntron®), pegfilgrastim (Neulasta®), pegaptanib (Macugen®), pegaspargase
(Oncaspar®), pegademase (Adagen®), peg-epoetin beta (Mircera®), pegvisomant
(Somavert®) certolizumab pegol (Cimzia®), naloxegol (Movantik®), peginesatide
(Omontys®), and doxorubicin liposome (Doxil®);
3. Is taking and cannot discontinue known major CYP3A4/P-gp inhibitors or major
CYP3A4/P-gp inducers at least 14 days before dosing. Patients must remain off these
medications for the duration of the study, including natural products such as St.
John's Wort or grapefruit juice.
4. Is taking drugs known to interact with rapamycin (sirolimus - Rapamune®) such as
cyclosporine, diltiazem, erythromycin, ketoconazole, posaconazole, voriconazole,
itraconazole, rifampin, verapamil unless they are stopped 14 days prior to dosing and
will not be used/prescribed during the trial.
5. Is a post-menopausal woman that has initiated or had a change in dose of hormone
replacement therapy (HRT) less than 1 month prior to the Screening Visit or during the
Screening Phase.
6. Had a gout flare during Screening that was resolved for less than 1 week prior to
first treatment with study drug (exclusive of chronic synovitis/arthritis) unless the
patient has a history of inter-flare intervals of < 1 week.
7. Has uncontrolled diabetes at Screening with HbA1c ≥ 8.5%;
8. Has fasting Screening glucose > 240 mg/dL;
9. Has fasting Screening triglyceride > 500 mg/dL;
10. Has fasting Screening low-density lipoprotein (LDL) > 200 mg/dL;
11. Has glucose-6-phosphate dehydrogenase (G6PD) deficiency;
12. Has uncontrolled hypertension defined as blood pressure > 170/100 mmHg at Screening
and 1 week prior to dosing
13. Individual laboratory values which are exclusionary
- White blood cell count (WBC) < 3.0 x109/L
- Serum aspartate aminotransferase (AST) or alanine amino transferase (ALT) > 3x
upper limit of normal (ULN) in the absence of known active liver disease
- Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2
- Urine albumin creatinine ratio (UACR) > 3.0
- Hemoglobin (Hgb) < 9 g/dL
- Serum phosphate < 2.0 mg/dL
14. Is receiving ongoing treatment for arrhythmia, including placement of an implantable
defibrillator, unless considered stable and on active treatment;
15. Has evidence of unstable cardiovascular disease or unstable cerebrovascular vascular
disease. This includes patients who have had a cardiac/vascular event(s) in the last 3
months including heart attack, stroke or vascular bypass surgery or patients who are
deemed, by their physician or PI, to have active cardiovascular, cerebrovascular or
peripheral vascular symptoms/disease inadequately controlled by medication;
16. Has congestive heart failure, New York Heart Association Class III or IV;
17. Unless clinically stable and/or appropriately treated, electrocardiogram (ECG) with
evidence of clinically significant arrhythmia or other abnormalities that, in the
opinion of the investigator, are consistent with significant underlying cardiac
disease;
18. History of significant hematological disorders within 5 years or autoimmune disorders,
and/or patient is currently immunosuppressed or immunocompromised;
19. Prior exposure to any experimental or marketed uricase (e.g., rasburicase (Elitek,
Fasturtec), pegloticase (Krystexxa®®), pegadricase (SEL 037))
20. Patient has received a live vaccine in the previous 6 months.
21. Patient is planning to receive any live vaccine during the study.
22. History of malignancy within the last 5 years other than basal skin cancer;
23. Patients with a documented history of moderate or severe alcohol or substance use
disorder within the 12 months prior to randomization.
24. History of or evidence of clinically severe interstitial lung disease
25. Immunocompromised state, regardless of etiology
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
Subject must be at most 80 Years | A Study of SEL-212 in Patients With Gout Refractory to Conventional Therapy II | NCT04596540 | Contradiction |
5,807 | 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:
- Subjects whose age was above 15 years old.
Exclusion Criteria:
- Subjects having problem in opening their mouth (due to non-oral ulcer cause) or
undergoing intermaxillary fixation where oral examination was not possible.
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.
| Oral Ulcer Prevalence: Hospital-based Cross-sectional Study | NCT03167632 | Entailment |
684 | 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:
- Patiens newly diagnosed having Hereditary Hemochromatosis
Exclusion Criteria:
- Age < 18 yrs.
- Not obese (BMI <30)
- Not consuming alchol beverages,
- Not affected by systemic diseases and known hepatic viruses
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 75 Years | Clinical Management of Hereditary Hemochromatosis: Phlebotomy vs. Erythrocytoapheresis | NCT00440986 | Entailment |
3,469 | 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:
- In order to be eligible for the study, the individual must be 40 years of age or
older; have a DRG Code of T2DM, GFR of 15-89 ml/min/1.73m2 and a BMI >30 kg/m2. The
participant's physician of record will have verified that his/her patient can safely
participant in an intervention study that involves weight loss and a goal of 150
minutes/week of moderate physical activity (comparable to brisk walking).
Exclusion Criteria:
- Those with the following characteristics will be excluded by the investigators:
1. unable or unwilling to provide informed consent; (2) unable to participate
meaningfully in an intervention that involves group sessions (e.g., due to
uncorrected hearing impairment, non-English-speaking); (3) unable to read or
otherwise use an iPad to monitor dietary intake, physical activity, and weight
(e.g., blind, illiterate); (4) unwilling to accept randomization assignment; (5)
pregnant, or plans to become pregnant in the next 12 months, less than 3 months
postpartum, or nursing or within 6 weeks of having completed nursing; (6) weight
loss of > 10% in the past 6 months except for postpartum weight loss; and (7)
individuals who are institutionalized (e.g., in a nursing home or personal care
facility, or those who are incarcerated and have no control over their diet).
will exclude from the study those with underlying diseases which would increase the risk of
participating in an intervention involving caloric restriction and physical activity. Such
individuals would include those requiring treatment for cancer, exclusive of skin cancer
other than melanoma, in the past 2 years; infectious diseases including untreated AIDS and
active tuberculosis; uncontrolled hypertension of >190 mmHg SBP or >105 mmHg DBP despite
treatment; stroke or TIA in the past 6 months; conditions requiring the use of home oxygen;
or other chronic disease or condition likely to limit life span to < 1 year. A recent
Institute of Medicine report suggests that reducing dietary sodium below 1,840 mg/day in
those with mid- to late-stage heart failure may increase adverse events or mortality. Thus
investigators will exclude those with heart failure.
Because of the dietary requirements of a pregnant woman, and the nature of weight loss and
gain with pregnancy, inclusion of pregnant women in the study would confound the study
results. Those who become pregnant during the study will be withdrawn from 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 40 Years old.
| Diabetes CKD Lifestyle Technology Study | NCT02266823 | Entailment |
5,972 | 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:
- Willing and able to sign informed consent
- Persistent GERD symptoms after minimum 8 week trial on daily PPI
Exclusion Criteria:
- Unwilling to sign informed consent
- Prior anti-reflux 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.
| A Prospective, Observational Study of the PPI Non-responder | NCT03282084 | Entailment |
1,044 | 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:
To be considered eligible for enrolment into the study, subjects must;
1. Be aged 30 to 75 years (inclusive),
2. Be willing to provide informed consent,
3. Have a BMI between 18.5 and 32 kg/m2,
4. Have documented diagnosis of primary osteoarthritis (OA) of the target knee made at
least 12 months prior to Screening,
5. Have radiographic evidence of OA in the tibio-femoral compartment of the target knee
with at least 1 definite osteophyte and a measureable joint space, as diagnosed by
standard X-rays taken no longer than 18 months,
6. Have mild to moderate pain not adequately or completely controlled with
anti-inflammatory drugs,
7. Be able to perform the 20-meter walking test and to understand all questions from the
WOMAC questionnaire.
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the below criteria;
1. Females are pregnant, lactating or wish to become pregnant during the study. Female
subject is currently either of:
- non-childbearing potential (i.e., physiologically incapable of becoming pregnant,
including any female who is post-menopausal or any female who is surgically sterilized
(via documented hysterectomy or bilateral tubal ligation). (For purposes of this
study, postmenopausal is defined as one year without menses), OR
- child bearing potential, the subject is eligible to enter and participate in this
study if she is not lactating and has a negative urine pregnancy test at the screening
visit, visit 2 and upon completion of the study at visit 5. The subject must also
agree to one of the following methods of contraception: i. Complete abstinence from
intercourse two weeks prior to administration of study drug, throughout the clinical
trial, until the completion of follow-up procedures or for two weeks following
discontinuation of the study medication in cases where subject discontinues the study
prematurely. (Subjects utilizing this method must agree to use an alternate method of
contraception if they should become sexually active and will be queried on whether
they have been abstinent in the preceding 2 weeks when they present to the clinic for
the Final Visit.) or, ii. Has a male sexual partner who is surgically sterilized prior
to the Screen Visit and is the only male sexual partner for that subject or, iii.
Sexual partner(s) is/are exclusively female or, iv. Oral contraceptives (either
combined or progestogen only) with double-barrier method of contraception consisting
of spermicide with either condom or diaphragm. (Women of child-bearing potential using
an oral contraceptive in combination with a double-barrier method of contraception are
required to continue to use this form of contraception for 1 week following
discontinuation of study medication).
v. Use of double-barrier contraception, specifically, a spermicide plus a mechanical
barrier (e.g. male condom, female diaphragm). The subject must be using this method
for at least 1 week following the end of the study or, vi. Use of any intrauterine
device (IUD) with published data showing that the highest expected failure rate is
less than 1% per year. The subject must have the device inserted at least 2 weeks
prior to the first Screen Visit, throughout the study, and 2 weeks following the end
of the study.
1. Patient with secondary OA (due to a known disorder)
2. Has modified Kellgren-Lawrence Numerical Grading System of grade IV in the
patello-femoral compartment of the target knee confirmed by standard X-rays taken
no longer than 12 months prior to Screening, and before any baseline assessment,
3. Has clinically apparent tense effusion of the target knee or other joint,
4. Has had viscosupplementation in any joint including the target knee or other
joint within 9 months prior to Screening,
5. Subject is taking any anti-inflammatory steroid medications, salicylates
(aspirin) or Propionic acid derivatives (ibuprofen), for 2 weeks prior to study
entry,
6. Has concomitant inflammatory disease or other condition that affects the joints
(e.g. rheumatoid arthritis, metabolic bone disease, psoriasis, gout, symptomatic
chondrocalcinosis and active infection, etc.),
7. Symptomatic OA of the contralateral knee that is not responsive to paracetamol
and requires other therapy,
8. Taking any calcium supplements (4-week washout) or other supplement e.g.
glucosamine, chondroitin,
9. Any medical condition deemed exclusionary by the Principal Investigator/Study
doctor,
10. Subject has a history of drug and / or alcohol abuse at the time of enrolment,
11. Change of dietary habit within the preceding month,
12. Subject with known organic disease, including an inflammatory bowel disease, a
benign or malign tumour of intestine or colon and significant systemic disease,
13. Subject currently involved in any other clinical trial or having participated in
a trial within the preceding 90 days,
14. Subject with known allergy to components of the test product,
15. Subject has any concurrent medical or psychiatric condition that, in the opinion
of the Investigator, would compromise his/her ability to comply with the study
requirements,
16. Subject has a history of cancer within the last 5 years, except basal cell
carcinoma, non-squamous skin carcinoma, prostate cancer or carcinoma in situ with
no significant progression over the past 2 years,
17. Subject has a significant cardiovascular, pulmonary, renal, liver, infectious
disease, immune disorder, or metabolic/endocrine disorders or other disease that
would preclude supplement ingestion and/or assessment of safety and the study
objectives,
18. Current illnesses which could interfere with the study (e.g. prolonged severe
diarrhea, regurgitation/severe, difficulty swallowing).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 30 Years old.
Subject must be at most 75 Years | An Intervention Study Evaluating the Effects of a Raspberry Leaf Extract in an Osteoarthritic Population. | NCT03703024 | Entailment |
4,745 | 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:
- right-handed subjects
- 19-65 years of age
- debilitating unilaterial or bilateral tinnitus
- Experiencing the presence of phantom auditory preception for >6 months
- Tinnitus Handicap Questionnaire score of >30
Exclusion Criteria:
- significant neurological disease
- acoustic neuromas or glomus tumors
- active Meniere's disease
- profound hearing loss
- non English speaking
- personal or family history of epilepsy
- personal history of head injury, aneurysm, stroke, previous cranial neurosurgery,
neurological or psychiatric disorders, metal implants in the head or neck, a
pacemaker, pregnancy, migraines,
- medications that lower seizure threshold and are contraindicated
- individuals who have been taking certain medications
- claustrophobia
- patients who do not exhibit significant cortical asymmetries on PET
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
Subject must be at most 65 Years | Using PET-CT to Target and Validate Low-frequency TMS as Treatment for Tinnitus | NCT00329524 | Contradiction |
5,559 | 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:
- Growth hormone deficiency clinically and biochemically demonstrated
Exclusion Criteria:
- Children affected by multiple pituitary hormone deficiency or receiving any other kind
of hormonal replacement therapy or drug and GHD children with a shorter follow-up
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 12 Years | Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children | NCT03033121 | Contradiction |
6,643 | 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 suffering from moderate or severe hemophilia A (FVIII <5%, ≥ 12 years old)
- factor treatment with ADVATE© or ADYNOVI©
- use of myPKFiT
Exclusion Criteria:
- patients suffering from other coagulopathies
- participants without written consent
- participants < 12 years old
- joint surgery like arthroscopy, synovectomy up to six months before study
- suffering from different rheumatologic diseases like M. Bechterew, Psoriasi or other
local or generalized joint infections (Borreliosis, septic arthritis)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
| Association Between Individual Clotting Factor Level Monitoring and the Risk of Bleeding Whilst Physical Active Conditions | NCT04845555 | Contradiction |
6,016 | 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:
1. Men and women ages 18-75.
2. Willing to participate and sign an inform consent.
3. Having heartburns, acid regurgitations and/or chest pain at least twice a week for at
least 3 months.
4. Ability to stop anti-acid and anti-pain medications for at least two weeks.
Exclusion Criteria:
1. History of upper gastrointestinal surgery.
2. Concomitant diseases that may affect esophageal perception (diabetes mellitus,
neuropathy).
3. Concomitant medications that may affect esophageal perception (anti-inflammatory,
anti-depressants drugs).
4. Pregnancy.
5. Severe conditions such as cardiac failure, renal failure and other that may be
contraindication for upper endoscopy.
6. Erosive esophagitis on upper endoscopy or pathological result of ambulatory 24-hour pH
monitoring.
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
Subject must be at most 75 Years | A Comparison of Factors of Symptoms Generation and Evaluation of Role of Biofeedback in Patients With Different Types of Functional Esophageal Disorders (Functional Heartburn and Functional Chest Pain) | NCT00471796 | Entailment |
5,803 | 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
This study will recruit a convenience sample of 50 volunteers (25 current smokers with at
least 5 years of smoking history, 25 never smokers). Current smokers are defined as
individuals who have smoked more than 100 cigarettes in their lifetime and have smoked 5 or
more cigarettes in the last 24 hours. Recent use of other tobacco products (pipe, cigar,
snuff, cigarillos, and chewing tobacco) is an overall exclusion, but use in the remote past
(> 6 month ago) is acceptable in smokers. Never smokers are defined as individuals who have
never smoked cigarettes nor used any other tobacco products including pipe, cigar, snuff,
cigarillos, or chewing tobacco.
The ethnic mix of the clinic is roughly 50% Caucasians and 50% African- Americans with a
small number of unspecified or other racial groups. The median age is about 50 and the
gender mix consists of an equal number of men and women. We therefore will select smokers
and frequency match to non-smokers based on ethnicity (White, African-American), gender
(male, female), and age (above or below the median, estimated to be 50).
EXCLUSION CRITERIA
We will exclude pregnant women and other racial groups because they may represent very
small numbers and thus be difficult to match. Hormonal changes associated with pregnancy
and unique cultural habits associated with specific ethnic groups could be associated with
highly unique or variable microbiome patterns, and therefore reduce the power to detect
differences associated with smoking which is our primary goal. We will also exclude
subjects with antibiotic usage in the last three months and subjects with previous
diagnosed major periodontal disease or cancer because they might be potential confounders.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 25 Years old.
Subject must be at most 80 Years | Cigarette Smoking and Oral Microbiota | NCT01862809 | Entailment |
5,309 | 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:
- new pain in spine (within 6 months)
- x-ray verified low energy spinal fracture(s)
Exclusion Criteria:
- less than 20% or more than 90% reduction of the vertebral height
- lack of pain at fracture level
- no need for continuous analgesic treatment
- patient no able to communicate
- general anaesthesia contraindicated
- MRI not possible
- coagulopathy (not adjustable)
- spondylitis
- discitis
- spinal metastasis
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Percutaneous Vertebroplasty Versus Conservative Treatment of Pain | NCT00203554 | Entailment |
6,655 | 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:
- Congenital hemophilia A; FVIII </=5% or congenital hemophilia B; FIX </=5%;
- Birth date on or after January 1, 2010;
- Care established at one of the participating HTCs;
- Co-enrollment in the ATHNdataset; and
- Parent or authorized guardian can provide informed consent
Exclusion Criteria:
- Patients who are referred to the HTC with no record of bleed and factor utilization
data
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 13 Years | ATHN 8: PUPs Matter Study | NCT03818529 | Contradiction |
2,884 | 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:
- Subjects referred to the electromyography laboratory for ALS.
Exclusion Criteria:
- Patients with known comorbid myopathy or neuropathy will be excluded from the study.
- Patients unable to provide their own consent will be excluded.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Neuromuscular Ultrasound in ALS | NCT01785550 | Entailment |
4,625 | 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. | Patient Inclusion Criteria:
- Age ≥ 18 years old
- Sign the informed consent form
- BMI ≤ 40
- A.S.A. Class < III or IV
Disease Inclusion Criteria:
- Ovarian cyst (enucleation/oophorectomy)
- Prophylactic bilateral oophorectomy
- Ectopic pregnancy (salpingotomy/salpingectomy)
- Tubal inflammatory disease (salpingotomy/salpingectomy)
- Infertility and sterility (treatment of endometriosis, chromo-salpingography, etc.)
- Benign uterine disease (Fibromatosis, Adenomyosis)
- Endometrial hyperplasia
- Stage Ia G1-2 Endometrial tumors
- Precancerous lesions of the uterine cervix
- Stage Ia uterine cervical tumors
- Pelvic endometriosis
Patient Exclusion Criteria:
- Pregnancy
- Liver disease
- Coagulation disorders
- Patient internal or anatomical criteria that preclude a laparoscopic approach
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Robotic Assisted Surgery for Treatment of Gynecological Diseases: Pilot Study | NCT03093675 | Entailment |
356 | 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:
- Subfertile women undergoing frozen-thawed embryo transfer with at least previously
failed one ICSI cycle.
- Age between 20-35 years.
- Women with endometrium thickness between 8-14 mm on D15 of the frozen embryo transfer
cycle
Exclusion Criteria:
- Women with a thin endometrium (≤ 7 mm) on day 15 of the cycle.
- Women with known hematological or immunological disorders
- Women with uncontrolled endocrine or other medical conditions, such as
hyperprolactinemia or thyroid diseases.
- Women with uterine abnormalities e.g. Asherman syndrome, myomas, uterine septum,
bicornuate uterus.
- Women who refuse to participate in the study.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 35 Years | Assessment of Endometrial and Sub-endometrial Vascularity Before and After PRP Infusion in Frozen Embryo Transfer Cycles | NCT04247204 | Contradiction |
5,384 | 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:
- Non-pregnant, non-planning pregnancy, non-lactating non-menopausal females at least 18
years of age.
- Patients with a clinical diagnosis of functional Menorrhagia during the last 6 months.
- Patients who are eligible and able to participate in the trial and who consent to do
so in writing after the purpose and nature of the investigation have been explained to
them.
Exclusion Criteria:
- History of endometrial ablation or dilatation and/or curettage within the 3 months
prior to screening
- Copper - coiled-intrauterine device or LNG releasing IUS use within 2 months prior to
screening
- Abnormal liver function or jaundice
- Renal insufficiency
- Other hormonal treatment (sexual steroids),
- Organic causes of abnormal uterine bleeding (presence of endometrial polyps, submucous
myomas of any size, or myometrial myomas > than 3 cm, adenomyosis, atypical
hyperplasia, carcinoma)
- Abnormal uterine morphology
- Presence of ovarian cyst > 3 cm
- Lower genital tract infection
- Current or recurrent PID (present or recurrent pelvis infection (including history of
postpartum endometritis, infected miscarriage) during the past 3 months
- Uncontrolled hypertension
- Congenital or acquired valvular disease (including corrections with prosthetic valves)
- Known or suspected pregnancy
- Known or suspected hormone-dependent tumor
- BMI > 30
- Abnormal Pap smear test or other evidence of cervical/endometrial mancy
- Unexplained amenorrhea
- Known hypersensitivity to device material and/or Levonorgestrel
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Therapeutic Equivalence Trial of Two Hormonal-IUDs in Patients With Heavy Menstrual Bleeding | NCT01695902 | Entailment |
2,284 | 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:
- Evidence of signed and dated informed consent/assent document(s) indicating that the
participant (and/or his parent/legal guardian) has been informed of all pertinent
aspects of the trial.
- Phenotypic evidence of duchenne muscular dystrophy (DMD) based on the onset of
characteristic clinical symptoms or signs (for example, proximal muscle weakness,
waddling gait, and Gowers' maneuver) and an elevated serum creatine kinase (CK).
Medical documentation of phenotypic evidence of DMD needs to be provided upon request
by the Sponsor's medical monitor.
- Documentation of the presence of a nonsense point mutation in the dystrophin gene as
determined by gene sequencing. Review and approval of documentation by sponsor or
designee is required prior to enrollment.
- Willing to undergo muscle biopsy.
Exclusion Criteria:
- Ongoing intravenous (IV) aminoglycoside or IV vancomycin therapy.
- Known contra-indication to muscle biopsy (such as bleeding or clotting disorders).
- Prior or ongoing therapy with ataluren.
- Known hypersensitivity to any of the ingredients or excipients of the study drug (for
example, refined polydextrose, polyethylene glycol 3350, poloxamer 407, mannitol 25C,
crospovidone XL10, hydroxyethyl cellulose, colloidal silica, magnesium stearate).
- Exposure to another investigational drug within 2 months prior to start of study
treatment, or ongoing participation in any interventional clinical trial.
- Requirement for daytime ventilator assistance or any use of invasive mechanical
ventilation via tracheostomy. Evening non-invasive mechanical ventilation such as use
of bilevel positive airway pressure (Bi-PAP) therapy is allowed.
- Elevated serum creatinine or cystatin C levels at screening.
- Prior or ongoing medical condition (for example, concomitant illness, psychiatric
condition, behavioral disorder), medical history, physical findings or laboratory
abnormality that, in the investigator's opinion, could adversely affect the safety of
the participant, makes it unlikely that the course of treatment or follow-up would be
completed, or could impair the assessment of study results.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 2 Years old.
Subject must be at most 7 Years | A Study to Assess Dystrophin Levels in Participants With Nonsense Mutation Duchenne Muscular Dystrophy (nmDMD) | NCT03648827 | Contradiction |
4,849 | 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. | Inclusion Criteria:
- Patients with a confirmed diagnosis of Cushing's Disease (persistent or recurrent) as
evidenced by increased 24-hour urine free cortisol (UFC), normal or increased morning
plasma Adrenocorticotropic Hormone (ACTH), and pituitary origin of excess ACTH.
- Patients with de novo Cushing's disease can be included only if they are not
considered candidate for surgery
Exclusion Criteria:
- Patients treated with mitotane 6 months prior to Visit 1
- Patients with compression of the optic chiasm
- Patients with a known inherited syndrome as the cause for hormone over secretion
- Patients with Cushing's syndrome due to ectopic ACTH secretion or adrenal Cushing's
syndrome
- Patients with pseudo-Cushing's syndrome
- Patients who are not biochemically euthyroid
- Diabetic patients with poorly controlled diabetes (HbA1c >9%)
- Women of child-bearing potential, defined as all women physiologically capable of
becoming pregnant, unless they are using highly effective methods of contraception
during dosing and for 1 week after completion of dosing.
- Patients who have received pituitary irradiation within five years prior to Visit 1.
- Patients with risk factors for QTc prolongation or Torsade de Pointes.
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 75 Years | Safety and Efficacy of LCI699 in Cushing's Disease Patients | NCT01331239 | Contradiction |
3,893 | 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:
1. Subjects diagnosed with osteoarthritis of unilateral or bilateral knee osteoarthritis
who meet the criteria defined by the American College of Rheumatology for at least 4
months prior to the study. In bilateral knee osteoarthritis, only the knee with more
symptoms will be treated.
2. Arthrosis grade 2 or 3 according to the Kellgren - Lawrence Classification System
(radiological classification)
3. Persistence of symptoms despite conservative treatment (NSAIDS, Physical Therapy,
lifestyle changes, etc.) for more than 4 months
4. Subjects aged between 40 and 70 years
5. BMI (Kg/m²) 20-32
6. For female subjects: postmenopausal women with at least 1 year documented in the
medical record.
Exclusion Criteria:
1. Arthrosis grade 0 or 4 according to the Kellgren - Lawrence Classification
2. History of allergy to any of the Hydrogel components
3. History of previous treatment with corticosteroid injections less than 4 months prior
to entry into this clinical study
4. History of previous treatment with hyaluronic acid viscosupplementation
5. History of open or arthroscopic surgery in the knee to be treated less than 9 months
6. Severe chronic progressive disease
7. Insulin-requiring diabetes
8. Rheumatic diseases (rheumatoid arthritis, psoriasis, gout, pseudo-gout, fibromyalgia)
9. History of septic arthritis
10. History of psychiatric illness that makes it impossible to understand and sign the
informed consent
11. History or presence of severe peripheral vascular disease
12. Deseje over 15° valgus or varus movement
13. Pregnant or breastfeeding women
14. BMI (kg/m²)> 32
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 70 Years | New Hydroxyethyl Cellulose Hydrogel for the Treatment of the Pain of Knee Arthrosis | NCT04061733 | Entailment |
5,102 | 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. | Vertebral compression fracture Inclusion Criteria:
older than 65 years osteoporosis diagnosed by a bone mineral density test of the lumbar
spine (T-score < -2.5; T: peak bone mass) thoracic-lumbar VCF on radiography without
displacement
Vertebral compression fracture Exclusion Criteria:
other spinal diseases that might also cause back pain (such as scoliosis, lumbar
spondylolisthesis, lumbar disk disease, and spinal stenosis) a history of diabetes a
history of neurological disease (such as cerebral vascular disease, peripheral neuropathy
and vestibular disease).
Control Inclusion Criteria:
None the control participants had evidence of gait, postural, or spine disorders.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 75 Years | The Spine Kinematics and Center of Pressure Excursion During Functional Task Vertebral Compression Fractures Subjects | NCT04135755 | Contradiction |
2,002 | 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. Age between 18 to 75 years old
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or
poorly differentiated) confirmed pathologically by endoscopic biopsy
3. Locally advanced tumor in the middle third stomach（cT1-4a, N-/+, M0 at preoperative
evaluation according to the AJCC(American Joint Committee on Cancer) Cancer Staging
Manual Seventh Edition）
4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby
in the preoperative examinations
5. Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
6. ASA (American Society of Anesthesiology) class I to III
7. Written informed consent
Exclusion Criteria:
1. Pregnant and lactating women
2. Suffering from severe mental disorder
3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
4. History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal
Dissection/Endoscopic Mucosal Resection )for gastric cancer)
5. Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative
imaging including enlarged or bulky No.10 lymph node
6. History of other malignant disease within the past 5 years
7. History of previous neoadjuvant chemotherapy or radiotherapy
8. History of unstable angina or myocardial infarction within the past 6 months
9. History of cerebrovascular accident within the past 6 months
10. History of continuous systematic administration of corticosteroids within 1 month
11. Requirement of simultaneous surgery for other disease
12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by
gastric cancer
13. FEV1<50% of the predicted values
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 75 Years | Randomized Controlled Trials on Clinical Outcomes of Totally Laparoscopic Versus Laparoscopy Assisted Total Gastrectomy for Gastric Cancer | NCT03006263 | Entailment |
3,572 | 27 | A 31-year-old woman comes to the office due to 3 days of rash on her left arm. The lesion is mildly pruritic but not painful. She is otherwise healthy and occasionally takes ibuprofen during the first few days of her menstrual period. Temperature is 37 C, blood pressure is 110/75 mm Hg, and pulse is 95/min. The lesion is like a target sign known as erythema migrans. She recently went for an adventure trip in New Hampshire. The patient is diagnosed with Lyme disease. | I went to the clinic because I had a rash on my left arm for three days, and the lesion started to be putrid, but it was not painful. I'm a 31-year-old healthy woman and the only medication I use is ibuprofen when I get my periods. They took my temperature, which turned out to be 37°C and took my blood pressure which was 110/75 and my pulse 95. My lesion is round like a target sign. I just came back from a New Hampshire road trip with my friends. Unfortunately, the doctor diagnosed me with Lyme disease. | - INCLUSION CRITERIA:
- Clinical diagnosis of active Lyme disease at the time of the initial NIH evaluation
based on the CDC case definition. Study physician will review history to confirm
probable cases.
- Subjects must maintain a private physician for non-protocol related medical complaints
and for emergency medical treatment required for these or other of their disorders.
EXCLUSION CRITERIA:
- Post treatment Lyme disease syndrome.
- Unacceptably poor compliance, which, in the opinion of the investigator, would
interfere with one's ability to study or provide quality medical care for the patient.
ELIGIBILITY CRITERIA TO UNDERGO APHERESIS:
- Age 18 years or above.
- Weight greater than 110 pounds.
- No known heart, lung, kidney disease, or bleeding disorders.
- Negative HIV, HCV and HBsAg serologies.
- Female subjects should not be pregnant or nursing.
- Patients will have a CBC performed up to 2 weeks before the procedure. In order to be
able to undergo the procedure, patient must fulfill all of the below:
- Hemoglobin greater than 11 g/dL for males and greater than 10 g/dL for females.
- Platelets greater than 150 k/mm(3).
- WBC greater than 3.5 x 10(3) uL.
- MCV above 80.
Women who are able to conceive children must have a negative pregnancy test within 2 weeks
before the procedure.
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.
| Evaluation, Treatment, and Follow-up of Patients With Lyme Disease | NCT00028080 | Entailment |
5,257 | 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 - LONGITUDINAL STUDY GROUP:
- For the respective groups, individuals need to be either:
1. Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy
for at least 5 years
2. Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy
for less than 1 year
3. Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy
for 1 to 5 years
4. No Diagnosis of Osteoporosis or Osteopenia AND have never received bisphosphonate
therapy
- Inclusion Criteria In Common Will Be:
1. Age 50 or older
2. Ambulatory
3. Living independently
EXCLUSION CRITERIA - LONGITUDINAL STUDY GROUP:
- Exclusion Criteria Will Be:
1. Inability to provide informed consent
2. Cognitive Impairment (MCI/dementia)
3. Current diagnosis of cancer including: breast, prostate, lung, colon, stomach,
bladder, uterus, rectum, thyroid, and kidney
4. Previous bilateral hip fractures
5. Pregnancy
6. Small bowel resections
7. Malabsorption
8. Paget s Disease of the Bone
9. Preexisting osteomalacia, active malignancy, prior bone metastasis, osteogenesis
imperfecta, fibrous dysplasia, history of kidney failure.
INCLUSION CRITERIA - GENETICS STUDY GROUP:
For the respective groups, individuals need to be either:
1. Diagnosis of atypical femur fracture within the past 10 years, regardless of
bisphosphonate use.
OR
2. Diagnosis of Osteoporosis or Osteopenia AND have received bisphosphonate therapy
for at least 5 years without atypical femur fracture.
- Inclusion Criteria In Common Will Be:
1. Age 45 or older
2. Ambulatory
3. Living independently
EXCLUSION CRITERIA - GENETICS STUDY GROUP:
- Exclusion Criteria will be:
1. Inability to provide informed consent
2. Cognitive Impairment (MCI/dementia)
3. Current diagnosis of cancer including: breast, prostate, lung, colon, stomach,
bladder, uterus, rectum, thyroid, and kidney
4. Pregnancy
5. Small bowel resections
6. Malabsorption
7. Paget s Disease of the Bone
The following information pertains to individuals in the Longitudinal Group.
Individuals who currently have thigh pain will not be excluded from this study. As the goal
of this study is to correlate medication usage with a radiographic feature, individuals
concurrently with thigh pain will still be considered, but we will take note of the
duration of medication usage and the start of thigh pain per participant history. Duration
of thigh pain prior to fracture will likewise be considered. If a current fracture is found
on radiographs or suspicion is high for a fracture, selected participants will be sent for
MRI of bilateral femurs and participant will be referred back to their primary provider for
additional evaluation and treatment.
Individuals who have previously had a unilateral hip fracture or arthroplasty will also not
be excluded. As several previous studies have shown, bilateral fractures are not uncommon.
We will continue to monitor the progress on the contralateral hip. We will query for
details regarding history of first fracture and medication usage. These participants will
be subanalyzed for medication usage and time between fractures. Individuals with bilateral
(but not unilateral) fractures and bilateral arthroplasty initially will be excluded.
However, individuals who are found to have unilateral or bilateral fractures during
radiographic studies or undergo unilateral or bilateral arthroplasty during their three
years of participation will be allowed to remain in the protocol, and we will assess for
change in their anatomy.
Individuals who are being treated with corticosteroids or other types of medications will
not be excluded from this study. These variables will be considered confounders and will be
analyzed by univariate analysis.
Individuals with anatomical variations such as coxa vara or coxa valga will not be
excluded. We will assume that they will be equally distributed into control and treatment
groups. These individuals may be at higher risk for atypical fractures, and will be
subanalyzed with appropriate femoral-angle matched controls.
Controls that choose to begin bisphosphonate during the study will not be excluded from the
study, but will be included in a subanalysis of individuals with less than 3 years of
bisphosphonate exposure. Likewise, participants who choose to discontinue bisphosphonate
usage will also not be dropped from the study. Analysis will be carried through with groups
designated by intent to treat. Users who have taken the drug for 5 years and more who are
currently on a drug holiday are eligible (because the drug stays in the bone for so long).
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
| Bisphosphonate Users Radiographic Characteristics of the Hip (BURCH) Study | NCT01360099 | Entailment |
1,564 | 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:
- to be diagnosed according to CASPAR or ACR/ EULAR 2010 criteria for patient groups
- taking regular medication for patient groups,
- have complaints related to hand / wrist joints for patients groups,
- have no complaints related to upper extremity for asymptomatic healthy group.
- have any rheumatologic disease and OA diagnosed according to traditional criteria
Exclusion Criteria:
- finger infection and / or finger amputation,
- using orthoses,
- to report a diagnosis of neurological disease,
- to report a history of trauma or surgery involving the upper extremity,
- to report a psychiatric and / or cognitive problem
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Comparison of Hand Functions and Wrist Proprioception in Patients With and Without Psoriatic Arthritis | NCT04553302 | Contradiction |
765 | 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:
- Men and women of all races
- Capable of giving informed consent
- Age 18-60 years
- Body mass index (BMI) between 30-40 kg/m2
- Hypertension defined as two or more seated blood pressure readings >130/80 mmHg or use
of anti-hypertensive medications
- Satisfactory history and physical exam
Exclusion Criteria:
- Age ≤ 17 or ≥ 61 years
- Pregnant or nursing women
- Decisional impairment
- Prisoners
- Alcohol or drug abuse
- Current smokers
- Highly trained athletes
- Subjects with >5% weight change in the past 3 months
- Evidence of type I or type II diabetes (fasting glucose > 126 mg/dL or use of
anti-diabetic medications)
- History of serious cardiovascular disease (e.g. myocardial infarction within 6 months,
symptomatic coronary artery disease, presence of angina pectoris, significant
arrhythmia, congestive heart failure, deep vein thrombosis, pulmonary embolism, second
or third degree heart block, mitral valve stenosis, aortic stenosis, hypertrophic
cardiomyopathy) or cerebrovascular disease (e.g. cerebral hemorrhage, stroke,
transient Ischemic attack).
- History or presence of immunological or hematological disorders
- Impaired hepatic function (AST or ALT levels >2 times upper limit of normal range)
- Impaired renal function (serum creatinine >2.0 mg/dl)
- Anemia
- Treatment with serotonin-norepinephrine reuptake inhibitors (SNRIs) or norepinephrine
transporter (NET) inhibitors
- Treatment with phosphodiesterase-5 inhibitors
- Treatment with anticoagulants (e.g. warfarin)
- Treatment with chronic systemic glucocorticoid therapy (>7 consecutive days in 1
month)
- Treatment with any investigational drug in the 1-month preceding the study
- Inability to give, or withdraw, 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 60 Years | Angiotensin 1-7 in Obesity Hypertension | NCT03604289 | Contradiction |
2,381 | 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:
- Confirmed diagnosis of DMD
- Male.
- Four years of age or older.
- Ability to walk independently for five minutes to 10 minutes at self-selected speed.
- Ability to cognitively understand directions for testing procedures.
Exclusion Criteria:
- Female
- Nonambulatory
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
Subject must be at most 21 Years | Biomechanical Analysis of Gait in Individuals With Duchenne Muscular Dystrophy | NCT00312247 | Entailment |
6,329 | 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. Both sexes aged 18 years and older.
2. Clinically diagnosed influenza or ARVI mild or moderate severity.
3. Patient's body temperature ≥37.5ºС and at least 1 symptom from Modified Jackson Scale
estimated more than 2 points.
4. Uncomplicated course of influenza or ARVI based on clinical estimations.
5. The first 36 hours from the beginning of symptoms of influenza or ARVI.
6. Women of reproductive age (who are not in menopause and who have not undergone
surgical sterilization) and men who have sexual activity should use a reliable method
of contraception (acceptable methods of contraception in this study are: intrauterine
devices, oral contraceptives, contraceptive patch, long-acting injectable
contraceptives, a double barrier method (condom and diaphragm with spermicide)
throughout the study period.
7. Compliance with the treatment regimen, visits and laboratory examinations provided by
the protocol.
8. Signed Informed Consent Form.
Exclusion Criteria:
1. Complications of influenza or ARVI (including the presence / development of bacterial
infection).
2. The need for inpatient treatment of influenza and ARVI.
3. Hypersensitivity to excipients of the drug XC221 or placebo.
4. Antiviral medications 7 days prior to screening (antiviral agents, interferons and
interferon inducers, drugs that have immunomodulating action) or anti-infective agents
of systemic or local action.
5. Severe infection with signs of cardiovascular insufficiency development and other
manifestations of infectious-toxic shock, as well as with the presence of
neuroinfection syndrome (encephalic and meningoencephalic reactions,
polyradiculoneuritis, neuritis).
6. Signs of of viral pneumonia symptoms (the presence of two or more of the following
symptoms): dyspnea, chest pain when coughing, systemic cyanosis, dullness of
percussion sound with a symmetrical evaluation of the upper and lower sections of the
lungs).
7. Infectious diseases during the last week before including into the study.
8. Bronchial asthma, COPD, pulmonary emphysema in history.
9. History of increased convulsive activity.
10. Severe, decompensated or unstable somatic diseases (any diseases or conditions that
are life-threatening or may worsen the patient's prognosis, and make him/her
ineligible for the clinical study).
11. History of oncological diseases, HIV, tuberculosis.
12. Drug or alcohol abuse.
13. Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
14. Participation in any other clinical trial in the last 90 days.
15. Pregnancy or lactation.
16. Military or prison populations.
17. Impossibility or inability to comply with the study procedures.
18. A member of the investigator's family or other person interested in the results of the
study.
19. Deviations from laboratory standards, which prevent the inclusion of the patient in
the study according to the Investigator.
20. A history of kidney failure.
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 Assess Efficacy and Safety of XC221 200 mg in the Treatment of Influenza or Other ARVI | NCT03830905 | Entailment |
3,960 | 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:
- Symptomatic knee osteoarthritis presenting to physician's office
- Radiographic evidence of knee osteoarthritis
- Age 18 years or older
- Failed minimum of 3 months of non-operative treatment, including, but not limited to,
Tylenol, anti-inflammatory medication, cortisone injection, physical therapy, bracing,
and/or heel wedge
- Symptoms for at least 3 months
Exclusion Criteria:
- Associated ligamentous instability
- History of deep knee infection
- Candidate for total knee arthroplasty or arthroscopy
- Peripheral neuropathy.
- X-rays that are completely negative and only MRI evidence or arthroscopic evidence
(from previous arthroscopy) of OA.
- Prior HA injections at any point in the past
- Chondrocalcinosis
- Patients with precautions or contraindications for viscosupplementation use
- Cortisone injection within past 3 months
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 | Prediction of Response to Intra-articular Injections of Hyaluronic Acid for Knee Osteoarthritis | NCT01557868 | Entailment |
2,731 | 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:
- 18-75 years old
- groin hernia repair
- written consent
- ASA 1-3
- BMI 18-35
Exclusion Criteria:
- unable to communicate in Danish
- relevant drug allergy
- pain medication in the last 24 hours
- pregnancy
- alcohol or/and drug abuse
- daily opioid intake
- infection at injection site
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 75 Years | The Efficacy of Transversus Abdominis Plane Block After Groin Hernia Repair | NCT01052285 | Entailment |
1,660 | 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:
- fluent in English, capacity to provide consent,
- over the age of 18 years old, with no previous injury to either hand or wrist
Exclusion Criteria:
- pregnancy and presence of neurological disorders, rheumatoid arthritis or comorbid
health conditions that preclude completion of study measures
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Dynamic 4DCT to Examine Wrist Carpal Mechanics | NCT04402502 | Entailment |
6,355 | 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:
- Gender: Either male or non-pregnant, non-lactating female aged > 18-70
- Patients with RT-PCR confirmed diagnosis of COVID-19
- Patients with mild to moderate COVID-19 infection having either one of the following
criteria: oPaO2/FiO2:200-300 OR Respiratory rate ? 24/min and SaO2/SpO2 > 90% on room
air
- Subjects willing to give written informed consent
- Subjects able to take the drug orally and comply with the study protocol
- Women of child bearing potential must have a negative urine pregnancy test prior to
study entry
Exclusion Criteria:
- Patients with persistent vomiting
- Critically ill patients
- P/F ratio less than 200 (moderate-severe ARDS)
- Shock (Requiring Vasopressor to maintain a MAP more than 65 mm of hg or MAP below 65)
- Patients with known active hepatitis, tuberculosis and definite bacterial or fungal
infections
- Patients with altered mental state
- Patients with multiple organ failure requiring ICU monitoring and treatment
- Patients with respiratory failure and requiring mechanical ventilation
- Patients with any concurrent medical condition or uncontrolled, clinically significant
systemic disease (e.g. heart failure, hypertension, liver disease, diabetes, anemia
etc.) that, in the opinion of investigator precludes the subject's participation in
the study or interferes with the interpretation of the study results.
- Patients with history of serology tests positive for hepatitis B, hepatitis C, or
human immunodeficiency virus.
- Patients who have received specific antiviral drugs ritonavir/lopinavir, or
chloroquine, hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week
before admission
- Patient who have participated in another investigational study within 3 months prior
to enrollment in this study
- Investigators, study personnel, sponsor's representatives and their first-degree
relatives.
- Pregnant subjects
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 | Effect of a Combination of Treatment of Reginmune Capsule and Immunofree Tablets in the Treatment of Mild to Moderate COVID-19 Patients | NCT04494204 | Entailment |
4,914 | 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:
- Severe essential tremor despite the optimal medical management
- Age between 18 and 75 years
- Normal MRI scan
- Mattis Dementia Rating Scale (MDRS) score ≥ 130
- Affiliation to the social security
- Signed informed consent
Exclusion Criteria:
- Depression (Beck Depression Inventory scale > 20)
- Contra-indication to surgery or general anesthesia
- Cerebral atrophy on MRI scan
- Pregnant or breastfeeding women
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 75 Years | Optimization of VIM Targeting in Essential Tremor Surgery | NCT03760406 | Entailment |
2,331 | 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 confirmed
- Ambulant
- Corticosteroid therapy for at least one year prior to study day 1 and on a stable dose
and schedule for at least 6 months prior to study day 1
- Evidence of muscle weakness by clinical assessment
Exclusion Criteria:
- Any previous treatment with another investigational product within 6 months prior to
study day 1
- Any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic,
metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or
other major disease that is not related to DMD
- Inability to perform a whole body dual x-ray absorptiometry (DXA) scan
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Years old.
| Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy | NCT01099761 | Entailment |
4,146 | 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:
- Males with no elongated spermatids or spermatozoa present but with round spermatids
present on TESE (Testicular Sperm Extraction)
- Male diagnosed with non-obstructive Azoospermia
- Male partner ≥18
- Female partner greater than 18 years of age and less than 38 years of age or Anti
Mullerian Hormone (AMH) greater than 2 ng/ml.
Exclusion Criteria:
- Males with obstructive azoospermia
- Males with presence an adequate number of elongated spermatids or spermatozoa
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Experimental Round Spermatid Injection (ROSI) to Treat Infertile Couples | NCT04298255 | Contradiction |
4,457 | 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:
- Confirmed diagnosis of lateral epicondylitis based on 2 or more of the following
diagnostic criteria: tenderness over the lateral epicondyle; pain with resisted wrist
extension; pain with resisted long finger extension.
- Symptoms lasting a minimum of 6 weeks
- Pain score of >= 3/10 using the Visual Analog Scale (VAS)
- Age >= 18 years
Exclusion Criteria:
- History of prior elbow surgery
- History elbow fracture within the past year
- Elbow instability on physical examination
- Elbow arthritis on radiographs
- Compressive neuropathy in the affected extremity (i.e.carpal tunnel, cubital tunnel)
- Evidence of cervical myelopathy, radiculopathy or brachial plexopathy
- History of systemic inflammatory condition (i.e. rheumatoid arthritis or systemic
lupus erythematosus)
- Allergy to study administered medications (steroid or lidocaine)
- Neoplasm
- Non-English speaking patients
- Inability to comply with study protocols and follow up.
- Pregnant female
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.
| Comparison of Intra-articular and Intra-tendinous Injections for Treatment of Lateral Epicondylitis | NCT02986646 | Contradiction |
4,526 | 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:
- Having low back pain LBP during menstrual phase (days 1-6) of the menstrual cycle.
- Suffering from low back pain during all menstrual cycles in the year before the study.
- No back pain or low back paiun at times other than the menstrual phase.
- Pain intensity during menstrual LBP greater than 5 in Numeric Pain Scale
Exclusion Criteria:
- History of spinal surgery, spinal or pelvic fracture and hospitalization for severe
trauma or car accident, urinary tract infection, vaginal infection and known
neurological disorders.
- Pain intensity lesser than 5 in Numeric Pain Scale
Female
Accepts Healthy Volunteers
Subject must be at least 19 Years old.
Subject must be at most 39 Years | Effect of Functional Lumbar Stabilization Exercises in Women With Menstrual Low Back Pain | NCT01932723 | Contradiction |
3,514 | 26 | A 33-year-old woman comes to clinic complaining of progressive fatigue, decreased appetite, and 11-lb weight loss in the past 2 months. She uses levothyroxine because of the previously diagnosed Hashimoto disease. She has no other medical conditions and does not use tobacco, alcohol, or illicit drugs. Physical examination shows a generalized increase in pigmentation of the skin. Measurement of serum cortisol before and after administration of exogenous adrenocorticotropic hormone (ACTH) shows no difference in the levels. Stable glucocorticoid replacement therapy starts for her with the diagnosis for primary adrenal insufficiency (Addison disease) | I went to the clinic because I was really suffering from fatigue and decreased appetite and I also lost 11 pounds over the past two months. I'm just 33 years old so that's not normal, especially for a woman. I take levothyroxine because I have been diagnosed with Hashimoto disease. I don't have any other medical condition, and I don't smoke I don't drink, and I don't do drugs. They also did my physical examination and they saw that I had an increase in pigmentation of my skin. They measured my cortisol level before and after giving me some ACTH hormone, and the results came back with no difference whatsoever. The doctor told me I have Addison disease and put me under glucocorticoid therapy. | Inclusion Criteria:
- Previously diagnosed (e.g. more than 6 months ago) primary adrenal insufficiency with
a stable daily glucocorticoid substitution dose for at least 3 months prior to study
entry
- Signed informed consent to participate in the study.
Exclusion Criteria:
- Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory,
Hepatobiliary, pancreatic disease
- Clinically significant renal dysfunction
- Clinical or laboratory signs of significant gastrointestinal emptying or motility
disease
- Any medication with agents which could interfere with hydrocortisone kinetics
- Pregnant or lactating women
- Regular dehydroepiandrosterone (DHEA) medication for the past 4 weeks
- Oral oestrogen medication for the past 4 weeks
- Deranged mineralocorticoid status
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.
| Once-daily Oral Modified Release Hydrocortisone in Patients With Adrenal Insufficiency | NCT00915343 | Contradiction |
1,629 | 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:
1. Healthy male voluntary subject, aged 18 to 40 inclusive.
2. Right-handed subject verified by the Edinburgh test.
3. Body mass index (BMI) between 18 and 25 kg/m2 inclusive.
4. Blood pressure and heart rate considered clinically normal by the investigators.
5. Having benefited from a medical examination before participating in the research.
6. Volunteer with a wrist circumference between 14.5 and 21 cm (wrist compatible with the
size of the bracelet).
7. Adults, having expressed their consent to research, affiliated to a social security
scheme and registered in the national file of people who lend themselves to biomedical
research
Exclusion Criteria:
1. Any history or presence of chronic disease.
2. Volunteer presenting chronic pain and / or headache.
3. Metal or silicon allergy.
4. Volunteer with a piercing or an implanted metallic material on the internal face of
the right wrist.
5. Volunteer with a tattoo on the inside of the right wrist.
6. People with contraindications to MRI.
7. Taking treatment that could impact the physiological measurements recorded.
8. Consumption of analgesics or anti-inflammatory drugs during the week before each MEG
examination.
9. Surgical intervention within the last 3 months.
10. Alcohol consumption within the last 24 hours, for each visit.
11. Achievement of a sporting effort within the last 24 hours, for each visit.
12. Volunteer with difficulties to be cooperative during the study in the opinion of the
investigator (i.e.: language problem, poor mental development, etc.).
13. Volunteer in period of exclusion from another study.
14. Volunteer deprived of liberty by a judicial or administrative decision, subject to
psychiatric treatment, or major subject subject to a legal protection measure
(guardianship, guardianship and safeguard of justice) referred to in articles 1121-6
to 1121-8 of the French public health code.
15. Volunteer who would receive more than 4,500 euros in compensation as a result of his
participation in other research involving the human person in the 12 months preceding
this study.
16. Volunteer who cannot be contacted in case of emergency.
17. Volunteer who have already used an millimeter wave emitter before the study.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Study of Somatosensory Responses During Millimeter Waves Application | NCT04801550 | Contradiction |
6,234 | 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:
- COVID-19 positive PCR test
- a COVID-19 ICD-10-CM diagnosis code during a healthcare visit, or a COVID-19 positive
antibody test
- Must be a patient in one of the 21 participating healthcare systems
Exclusion Criteria:
- N/A
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| The C3I COVID-19 Project | NCT04506528 | Contradiction |
5,003 | 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:
- Patients suffering from severe and disabling ET with serious impact on their quality
of life (QoL).
- 18-70 years old
- Free of evolutive and untreated psychiatric disorder
- Tremor must be predominant in the upper limbs although it can affect the lower limbs,
head and voice.
- Affiliation to a social security system
- Written informed consent signed by the participant and the investigator (prior to any
examination required by research)
Exclusion Criteria:
- Parkinsonian tremor
- Pregnancy or lactating women
- Severe co-morbidity (cardiac, renal or respiratory failures, evolutive cancer)
- Impaired cognitive functions (score <130 on Mattis scale).
- Patients with severe atrophy or lesions on MRI
- Depression (Beck > 10)
- Participation in another clinical research for 18 months (after 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 70 Years | Thalamic LFPs and VIM DBS in Essential Tremor: Correlation, Evolution, and Therapeutic Perspectives | NCT02264925 | Entailment |
5,529 | 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 for Classification criteria:
1. Adult patients aged >18 years. There is no upper age limit.
2. Ability to give informed consent. If the patient is unable to give informed consent as
a result of death or physical incapacity, then informed assent from next of kin.
3. Presumed diagnosis of a primary systemic vasculitis.
Exclusion criteria for classification criteria:
1. Patients < 18 years of age.
2. Inability to provide informed consent.
3. Hepatitis B or C
4. Co-morbidities that explain the clinical symptoms and signs on which the diagnosis of
vasculitis is made. E.g. infection, tumour, other inflammatory condition, etc.
Inclusion criteria for diagnostic criteria:
1. Adult patients aged >18 years. There is no upper age limit.
2. Ability to give informed consent. If the patient is unable to give informed consent as
a result of death or physical incapacity, then informed assent from next of kin.
3. Suspected diagnosis of a primary systemic vasculitis
Inclusion criteria for controls group for diagnostic criteria:
1. Adult patients aged >18 years. There is no upper age limit.
2. Ability to give informed consent. If the patient is unable to give informed consent as
a result of death or physical incapacity, then informed assent from next of kin.
3. Patients presenting to secondary care with one of the following clinical
presentations: I.Multi-system disease. Presentation of disease with at least 2 organs
involved. II.Pulmonary-renal syndrome. Defined as haemoptysis / pulmonary haemorrhage
with acute renal impairment. III.Acute renal failure IV.Acute respiratory distress.
V.Chronic upper airways symptoms and signs. VI.Inflammatory polyarthritis. VII.Fever
of unknown origin. VIII.Acute or chronic abdominal pain IX.Hypertension. X.Referred to
secondary care with suspicion of vasculitis but confirmed not to have vasculitis.
XII.New onset headache. XIII.Jaw or tongue pain. XIV.Sudden visual loss. XV.Limb
claudication. XVI.Aortic aneurysm >5cm.
Exclusion Criteria for diagnostic criteria:
1. Patients under the age of 18
2. Patient or next of kin unable or unwilling to provide informed consent or assent.
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.
| American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Diagnostic and Classification Criteria for Primary Systemic Vasculitis | NCT01066208 | Entailment |
1,573 | 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:
1. Is male or female <17 years of age at the time of dosing.
2. Subject 2 to <17 years of age, be in at least the 25% for weight according to the
Center for Disease Control pediatric growth charts and weighs at least 28 lb at the
time of dosing with study drug.
3. Is generally healthy as documented by medical history (except for the condition for
which the procedure is being performed); physical examination (including, but not
limited to, the cardiovascular, gastrointestinal, respiratory, and central nervous
systems); vital sign assessments; 12-lead electrocardiograms; clinical laboratory
assessments; and general observations. Has a negative serum pregnancy test at
Screening and predose check in for females of childbearing potential.
4. Is an outpatient for a surgical procedure and is expected to remain hospitalized for
at least 24 hours after dosing with study drug.
5. Is anticipated to have postsurgical pain requiring a parenteral analgesic regimen
using a short-acting opioid analgesic and is anticipated to be switched to an oral
opioid for at least 1 dose (according to institution standard of care).
6. Has an indwelling access catheter for blood sampling.
7. Agrees to comply with all protocol requirements. If not old enough, the legally
responsible parent(s) or legal guardian(s) must agree to comply with all protocol
requirements.
8. Has been informed of the nature of the study and informed consent and assent (as
appropriate) have been obtained from the legally responsible parent(s) or legal
guardian(s) and the subject, respectively, in accordance with institutional review
board requirements.
Exclusion Criteria:
1. Has the presence or history of a clinically significant disorder involving the
cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic,
endocrine, or neurologic system(s) or psychiatric disease (except for the condition
for which the procedure is being performed) as determined by the clinical
investigator.
2. Has any clinical laboratory test result outside the normal range.
3. Has a positive test result for hepatitis B surface antigen, hepatitis C antibody, or
human immunodeficiency virus antibody.
4. Had a clinically significant illness, except for the condition for which the procedure
is being performed, in the 28 days before dosing with study drug as determined by the
clinical investigator.
5. Is a lactating or breastfeeding female.
6. Uses any medication known to be an inhibitor or inducer of CYP3A4 within 14 days (for
inhibitors such as the azole-antifungal agents voriconazole and ketoconazole,
macrolide antibiotics such as erythromycin, and protease inhibitors such as ritonavir)
or 28 days (for inducers such as rifampin, carbamazepine, and phenytoin) of dosing
with study drug. Use of all other prescription medications, except required pre-op
medications and birth control, is prohibited within 3 days of dosing with study drug.
Use of any over-the-counter medications (including herbal or dietary supplements and
therapeutic doses of vitamins), except for required pre-op medications, is prohibited
within 24 hours of dosing with study drug, with the exception of topical spermicide.
Use of St. John's wort is prohibited from 28 days before dosing until 14 days after
dosing. Standard daily dose multivitamins (nontherapeutic doses) may be taken until
enrollment into the study but will be restricted during the study.
7. Consumes alcohol-, caffeine-, or xanthine-containing products within 48 hours before
dosing and during periods when blood samples are collected.
8. Consumes grapefruit, grapefruit products, Seville oranges, or pomelo-containing
products within 14 days of dosing. Fruit juices, with the exception of apple and
grape, will be prohibited during the study.
9. Is a smoker or has used nicotine or nicotine-containing products within 30 days of
dosing.
10. Has a history of alcohol or drug addiction or abuse within the last year.
11. Subject 2 to <17 years of age, has a positive urine test result for drugs of abuse
(amphetamines, barbiturates, cannabinoids, cocaine metabolites, opiates,
phencyclidine, and benzodiazepines) or alcohol at Screening (not required for subjects
less than 2 years of age).
12. Donated blood within 28 days or plasma within 14 days of dosing or plans to donate
them within 4 weeks after completing the study.
13. Has a history of relevant drug allergies, food allergies, or both (i.e., allergy to
oxycodone, allergy to related drugs, or any significant food allergy that could
interfere with the study).
14. Is intolerant to direct venipuncture.
15. Received an investigational drug within 28 days of dosing.
16. Has taken oxycodone or oxymorphone within the 48 hours before anticipated dosing with
study drug.
17. Is not suitable for entry into the study in the opinion of the investigator.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 17 Years | Evaluate The Pharmacokinetics and Safety Of Oxycodone Oral Solution In Pediatric and Adolescent Subjects | NCT01959204 | Contradiction |
1,782 | 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:
- A consecutive series of patients with symptoms suggestive of GERD were enrolled from
the Gastroenterology outpatient clinic in our institution. The typical GERD symptom
was defined as heartburn and/or acid regurgitation of at least three episodes per week
for a minimum of three months.
Exclusion Criteria:
- Patients who received concurrent PPI treatment, had a medical contraindication to
rabeprazole therapy, reported a history of peptic ulcer disease or gastrointestinal
surgery, peptic ulcer disease or malignancy proven by endoscopy, the presence of alarm
features (e.g., dysphagia, weight loss, bleeding, abdominal mass, and/or anemia), or
who were unwilling or unable to provide informed consent were excluded from 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 80 Years | CYP2C19 Genetic Polymorphism on the Accuracy of Proton-Pump Inhibitor Testing | NCT00354757 | Contradiction |
4,093 | 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:
- DSM 5 Parasomnia Disorder
- at least one parasomnia event per week
- daytime fatigue or sleepiness
- 6 months in duration
Exclusion Criteria:
- current use of agents known to triggers parasomnias such as Lithium carbonate,
Thioridazine, Chlorpromazine, Perhphenazine, Methaqualone, or Amitriptyline,
- for participants taking benzodiazepines or Prazosin, a stable dose regime for the past
4 weeks,
- excessive alcohol consumption defined as the consumption of > 10 alcoholic beverages
per week
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 90 Years | Impact of Cognitive Behavioral Therapy on Parasomnias | NCT04633668 | Entailment |
6,938 | 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:
- Patients with memory or other cognitive impairments suggestive of dementia syndrome
- those with a formal diagnosis of dementia, of any type.
Exclusion Criteria:
- Patients and carers who are already involved in concurrent research
- If the key professional feels that an approach to the person with dementia or their
carer would be inappropriate, for example the dementia is very severe, or that an
approach may increase distress
- and any other important reason that the key professional may have for why the person
with dementia or their carer should not be contacted.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Dementia Early Recognition and Response in Primary Care | NCT00866099 | Entailment |
4,167 | 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. A history of episodic wheezing, chest tightness, or shortness of breath consistent
with asthma, or physician diagnosed asthma.
2. Specific allergy to house dust mite Dermatophagoides farinae confirmed by positive
immediate skin test response.
3. Provocative concentration of methacholine of 10 mg/ml or less producing a 20% fall in
FEV1 (PC20 methacholine) by the method used in a separate screening protocol
(98-CEMLB-293) that is already approved by the UNC IRB.
4. FEV1 of at least 80% of predicted and FEV1/FVC ratio of at least .70 (without use of
bronchodilating medications for 12 hours), consistent with lung function of persons
with mild episodic or mild persistent asthma.
Exclusion Criteria:
1. Any chronic medical condition considered by the PI as a contraindication to the
exposure study including significant cardiovascular disease, diabetes requiring
medication, chronic renal disease, or chronic thyroid disease.
2. Subjects with a history of immunologic disease, or undergoing therapeutic immune
suppression for cancer or other diseases.
3. Physician directed emergency treatment for an asthma exacerbation within the preceding
12 months.
4. Use of systemic steroid therapy within the preceding 12 months for asthma or the
following asthma symptoms; cough, wheeze, shortness of breath.
5. Use of inhaled steroids, cromolyn or leukotriene inhibitors (Montelukast or
Zafirlukast) within the past month (except for use of cromolyn exclusively prior to
exercise).
6. Use of daily theophylline within the past month.
7. Use of medications that might alter the response to methacholine or antigen challenge
including anti-inflammatory and anti-histamine agents within one week of challenge.
8. Subjects using tricyclic antidepressants such as doxepin and MAO inhibitors.
9. Subjects using beta-adrenergic blockers or any other medications known to interfere
with the treatment of anaphylaxis.
10. Inability to withhold inhaled or oral bronchodilating medications for 12 hours prior
to allergen challenge.
11. Pregnancy (positive urine pregnancy test at the baseline visit) or nursing a baby.
Pregnant women are excluded due to the risk of fetal exposure to radiation.
12. Women of child bearing potential who are not using dependable contraception (such as
birth control pill, IUD, estrogen patches) or who are not completely abstinent.
13. Cigarette smoking >0.5 packs per week within the past 12 months.
14. Nighttime symptoms of cough or wheeze greater than 1x/week at baseline (not during a
clearly recognized viral induced asthma exacerbation) which would be characteristic of
a person of moderate or severe persistent asthma as outlined in the current NHLBI
guidelines for diagnosis and management of asthma.
15. Exacerbation of asthma more than 2x/week which would be characteristic of a person of
moderate or severe persistent asthma as outlined in the current NHLBI guidelines for
diagnosis and management of asthma.
16. Daily requirement for albuterol due to asthma symptoms (cough, wheeze, chest
tightness) which would be characteristic of a person of moderate or severe persistent
asthma as outlined in the current NHLBI guidelines for diagnosis and management of
asthma. (Not to include prophylactic use of albuterol prior to exercise).
17. Viral upper respiratory tract infection within 4 weeks of challenge.
18. Any acute infection requiring antibiotics within 2 weeks of challenge (or 4 weeks in
the case of azithromycin due to the prolonged half-life).
19. Participating in any study utilizing an investigational agent within 4 weeks of this
challenge.
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 50 Years | Study of Dust Mite Inhalation in Humans | NCT00448851 | Contradiction |
5,961 | 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:
- persistent or recurrent symptoms despite continuous medical treatment, at least one
typical reflux symptom (heartburn/ regurgitation/dysphagia/epigastric pain) and/or at
least one atypical reflux symptom (cough/ asthma/hoarseness/distortion of taste),
pathologic esophageal acid exposure as documented by a reflux-related DeMeester score
≥14.7, and symptom correlation ≥50%, and/or reflux episodes >73.
Exclusion Criteria:
- any distinct hiatal hernia detectable by gastroscopy or barium radiography, dysphagia,
esophageal strictures, poor physical status (American Society of Anesthesiologists
(ASA) scores III and IV) and pregnancy.
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Full-Thickness-Gastroplication For The Treatment Of Gastroesophageal Reflux Disease GERD | NCT01453985 | Contradiction |
6,664 | 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 aged 12 to 50 years (US and Argentina)
- Males aged 18 to 50 years (other countries)
- Subjects with severe hemophilia A (<1% FVIII:C) as confirmed by the central lab from a
sample obtained at least 96 hours after FVIII administration wash-out. Allow for the
inclusion of a maximum of 10% (n=8) of patients with 1-2% FVIII:C baseline levels as
long as they exhibit clinical severity and comply with all other inclusion criteria.
- Subjects with at least 150 prior exposure days with any FVIII
- Subjects who have been on episodic treatment and no known regular prophylaxis
treatment for more than 12 consecutive months in the previous 5 years
- Subjects with 6 to 24 bleeding events and/or treatments in the previous 6 months prior
to study entry which are documented and available in the subjects medical records.
Documentation can include records from previous physicians, specific home treatment
records, emergency room or hospital records, x-ray reports, etc. The investigator can
also document with a detailed note the number of bleeds reported by the subject in the
last 6 months.
- Subjects with inhibitor formation surveillance (inhibitor or recovery testing) over
the ten years prior to enrollment documented by the investigator and who do not have a
history of any of the following:
- A positive inhibitor titer of 5.0 Bethesda Unit (BU) or greater by either BU
assay system at any time since first exposure to exogenous factor VIII
- A positive inhibitor test result of 1.0 or greater performed by the original BU
assay at any time in the past 10 years (A subject can have more than one positive
inhibitor test of 0.6 or greater by the original BU assay test but all must be
less than 1.0 BU using the original BU assay.)
- A positive inhibitor test result of 0.6 or greater performed by the Nijmegen
method at any time in the past 10 years
- Subjects with no inhibitor activity by Nijmegen-modified Bethesda assay, either
positive (> 0.6 BU is considered positive) or borderline (> 0.3 and < 0.6 BU is
considered borderline) as measured in the current study reference laboratory
Exclusion Criteria:
- Subjects with any other bleeding disease besides hemophilia A (i.e. von Willebrand
disease)
- Subjects with thrombocytopenia (platelets < 100,000/mm3)
- Subjects with abnormal renal function (Cockcroft-Gault Creatinine Clearance value of
60 mL/min or lower)
- Subjects with active hepatic disease (Aspartate aminotransferase [AST] or Alanine
aminotransferase [ALT] > 5xUpper Limit of Normal (ULN))
- Subjects on treatment with immunomodulatory agents within the last 3 months prior to
study entry or during the study (the following drugs are however allowed: interferon-a
treatment for Hepatitis C virus (HCV), Highly active anti-retroviral therapy (HAART)
therapy for human immunodeficiency virus (HIV) and/or a total of two courses of pulse
treatment with steroids for a maximum of 7 days at 1mg/kg or less)
- Subjects with an absolute CD4 lymphocyte cell count < 200 cells/mm3 (due to HIV, HCV
or another suspected medical condition)
- Subjects with known hypersensitivity to rFVIII, mouse or hamster proteins
- Subjects who are receiving or had received other experimental drugs within 1 month
prior to study entry
- Subjects who require any pre-medication to tolerate FVIII injections (e.g.
anti-histamines)
- Subjects who are unwilling to comply with study visits or either of the possible
treatment regimens
- Subjects who have a planned orthopedic intervention to be performed during the study
that may substantially affect bleeding (e.g. surgical or chemical or radiological
synovectomy)
- Subjects who are not suitable for participation in this study for any reason,
according to the Investigator
- Subjects who have poor joint status as defined by routine need for a wheelchair or
unable to ambulate without the assistance of a brace, cane or crutches
- Three or more joints that are already fused or "frozen" also called ankylosis
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 50 Years | Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment | NCT00623480 | Contradiction |
308 | 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:
- a history of ovarian surgery;
- previous treatment using conventional protocols that yielded less than three oocytes;
- antral follicle count of less than 5 on menstrual cycle day 2-3; and basal serum FSH
concentration between 10 and 19 IU/l.
Exclusion Criteria:
- ovarian failure including basal FSH above 20 IU/l or no antral follicle by ultrasound
examination;
- Endometriosis grade 3 or higher;
- Any contraindications to ovarian stimulation treatment.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 55 Years | GnRh Antagonist Protocol With Delayed Start Stimulation in Patients With Poor Ovarian Response | NCT03134690 | Contradiction |
4,143 | 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. Diagnosis of cancer
2. Dyspnea with an average intensity level >3/10 on the numeric rating scale over the
past week
3. Clinical or radiologic history of lung/pleural involvement (primary or metastatic),
lymphangitic carcinomatosis or airway involvement secondary to tumor infiltration
4. Outpatients at MD Anderson Cancer Center seen by the Supportive Care, Rehabilitation
Service, Thoracic Oncology or Pulmonary Medicine
5. Able to communicate in English
6. Karnofsky performance status >=40%
7. Age 18 or older
8. Permission from the attending medical oncologist if the patient is currently on an
interventional cancer therapy trial.
Exclusion Criteria:
1. Delirium (i.e. Memorial delirium rating scale >13)
2. Oxygen saturation <90% despite supplemental oxygen >6L/min
3. Previous allergic reactions to dexamethasone
4. Uncontrolled hyperglycemia as defined by any blood glucose of >300 mg/dl in the past
two weeks
5. Severe anemia (Hb <7g/L) not corrected prior to study enrollment (bloodwork is not
required if patient did not have recent chemotherapy within last 2 weeks)
6. Post-surgical open wound that has not been healed at the time of enrollment
7. Any infection requiring parenteral antibiotics within the past 2 weeks
8. Major surgery within the past 2 weeks
9. Megestrol use at the time of study enrollment
10. Neutropenia (absolute neutrophil count < 1.0) (bloodwork is not required if patient
did not have recent chemotherapy within last 2 weeks)
11. Currently on or expected to start cytotoxic chemotherapy with in 1 week of study
enrollment
12. Chronic obstructive pulmonary disease (COPD) exacerbation at the time of study
enrollment
13. Heart failure exacerbation at the time of study enrollment
14. Chronic systemic corticosteroid use (>14 days) at the time of study enrollment
15. Unwilling 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.
| Dexamethasone Dyspnea Study | NCT01670097 | Contradiction |
5,216 | 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:
- Osteoporosis patients
Exclusion Criteria:
- eGFR < 15
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.
| The Relationship Between the Residual Renal Function and Osteoporosis Treatment | NCT02304887 | Entailment |
6,270 | 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:
- Pneumonia confirmed by CT scans
Exclusion Criteria:
- a history of chronic renal failure;
- a history of kidney transplantation;
- intake of substances with a history of renal toxicity (no later than a month before
inclusion);
- patients with a single kidney;
- refusal of the patient to participate in the study;
- absence of SARS-CoV-2 virus smear from the nasopharynx in PCR.
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.
| Kidney Injury Severity and COVID-19 | NCT04386564 | Contradiction |
689 | 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:
- Age ≥ 18 < 75 years
- Ferritin > 250 ng/ml and/or stainable iron at biopsy
- NAS ≥ 2 and/or NAS 1 and stage≥1 at liver histology
- Willingness to maintain diet and exercise during the full course of the study
- Written informed consent to participate to the study and to have the specific genetic
tests performed
- Ability to comply with all study requirements
Exclusion Criteria:
- Pregnant or lactating female
- Diagnosis of or a history of:
- Type 1 diabetes, diabetes that is a result of pancreatic injury, or secondary forms of
diabetes, e.g. Cushing's syndrome or acromegaly
- Acute metabolic complication such as ketoacidosis or hyperosmolar state within the
past 6 months
- Alcohol consumption > 20 g/day for females and > 30 g/day for males
- BMI ≥ 35 Kg/ m2
- Other liver disease such as viral hepatitis, autoimmune hepatitis, Wilson disease, as
defined by ceruloplasmin below normal limits and liver histology consistent with
Wilson disease. Alpha-1-antitrypsin deficiency as defined by alpha-1-antitrypsin level
less than 80 mg/dl or PiZ/PiZ or PiZ/PiS genotype. *Hemochromatosis, as defined by
homozygosity for the C282Y HFE mutation or compound heterozygosity for C282Y/H63D
mutations or Hepatic Iron Index ≥ 1.9.
- Advanced liver disease (Child B/C cirrhosis), portal hypertension, hepatocellular
carcinoma.
- Congestive heart failure (NYHA I-IV) and unstable ischemic heart disease, systolic
dysfunction (ejection fraction < 45%)
- Any of the following ECG abnormalities: II or III degree Atrial Ventricular *Block,
QT>500msec, repolarization defect suggestive of ischemia
- Malignancy within the last 5 years
- Serum creatinine levels > 1.5 mg/dl males, > 1.4 mg/dl females
- TSH outside of normal range
- Use of drugs known to induce NAFLD: corticosteroids, methotrexate, zidovudine,
amiodarone, GH, estrogens, tamoxifene, tetracycline
- Lipodystrophy, dysbetalipoproteinemia, inflammatory bowel disease, HIV infection
- Basal hemoglobin levels < 11 g/dl
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 | Effect of Iron Depletion by Phlebotomy Plus Lifestyle Changes vs. Lifestyle Changes Alone on Liver Damage in Patients With Nonalcoholic Fatty Liver Disease With Increased Iron Stores | NCT00658164 | Entailment |
2,200 | 14 | A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain. The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint. Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis. | I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis. | Inclusion Criteria:
1. Adult men or women ≥18 years of age.
2. Uncontrolled gout, defined as meeting the following criteria:
- Hyperuricemia during the screening period defined as sUA ≥6 mg/dL
- Failure to maintain normalization of sUA with xanthine oxidase inhibitors at the
maximum medically appropriate dose, or with intolerable side effects or a
contraindication to xanthine oxidase inhibitor therapy based on medical record
review or subject interview
- Symptoms of gout including at least 1 of the following:
- Presence of at least one tophus
- Recurrent flares defined as 2 or more flares in the past 12 months prior to
screening
- Presence of chronic gouty arthritis
3. Willing to discontinue all oral urate-lowering therapy at least 7 days prior to MTX
dosing at Week -4 and remain off of urate lowering therapy when receiving pegloticase
infusions during the study.
4. Able to tolerate MTX 15 mg for 4 weeks during the MTX Run-in Period prior to the first
dose of pegloticase.
Exclusion Criteria:
1. Current or chronic treatment with systemic immunosuppressive agents such as
MTX,azathioprine, or mycophenolate mofetil; prednisone ≥10 mg/day or equivalent dose
of other corticosteroid on a chronic basis (defined as 3 months or longer) would also
meet exclusion criteria.
2. Known history of any solid organ transplant surgery requiring maintenance
Immunosuppressive therapy unless treated and no chronic or active infection confirmed
by HBV serology.
3. Known history of hepatitis B virus surface antigen positivity or hepatitis B DNA
positivity, unless treated and viral load is negative and no chronic or active
infection confirmed by HBV serology.
4. Known history of Human Immunodeficiency Virus (HIV) positivity.
5. Glucose-6-phosphate dehydrogenase (G6PD) deficiency (tested at Screening Visit).
6. Severe chronic renal impairment (estimated glomerular filtration rate <40 mL/min/1.73
m2) at the Screening Visit based on 4 variable-Modification of Diet in Renal Disease
[MDRD] formula or currently on dialysis.
7. Non-compensated congestive heart failure or hospitalization for congestive heart
failure or treatment for acute coronary syndrome (myocardial infarction or unstable
angina) within 3 months of the Screening Visit, or current uncontrolled arrhythmia, or
current uncontrolled blood pressure (BP) (>160/100 mmHg) prior to Week -4.
8. Pregnant, planning to become pregnant, breastfeeding, planning to impregnate female
partner, or not on an effective form of birth control, as determined by the
Investigator.
9. Prior treatment with pegloticase (KRYSTEXXA), another recombinant uricase
(rasburicase), or concomitant therapy with a polyethylene glycol-conjugated drug.
10. Known intolerance to MTX.
11. Chronic liver disease.
12. Currently receiving systemic or radiologic treatment for ongoing cancer.
13. History of malignancy within 5 years other than non-melanoma skin cancer or in situ
carcinoma of cervix.
14. Known history of hypoxanthine-guanine phosphoribosyl-transferase deficiency, such as
Lesch-Nyhan and Kelley-Seegmiller syndrome.
15. Current pulmonary fibrosis, bronchiectasis or interstitial pneumonitis. If deemed
necessary by the Investigator, a chest X-ray may be performed during 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.
| Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate | NCT04511702 | Contradiction |
5,268 | 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
Patients must meet all of the following inclusion criteria below to be included as research
subjects:
1. The patient is at least 50 years of age
2. The patient has a score on the back pain visual analog scale (VAS) of ≥70 mm after 2
to 6 weeks of conservative care OR a VAS of ≥ 50 mm after 6 weeks of conservative care
3. The patient has an Oswestry Disability Index (ODI) score of ≥ 30%
4. The patient has radiographic evidence of one or two (1-2) A 1.1, A 1.2, A 1.3.
fractures as classified by the AO Spine Fracture classification, due to primary or
secondary osteoporosis in the thoracic and / or lumbar spine. Note that patients are
eligible if they have had treatment of or healed VCF(s) at any non-index level
5. The patient has central pain over the spinous process(es) upon palpation at the Index
level(s)
6. The Index fracture(s) is / are acute or persistent (not healed), as demonstrated by T2
weighted STIR MRI (or bone scan if patient is contraindicated for MRI
7. The Index fracture(s) has / have failed conservative care of at least 2 weeks but no
longer than 6 months
8. The Index fracture(s) shows radiographic evidence of at least 5% vertebral collapse
9. The pedicle identified for access to the index fracture has a diameter that is ≥ 6 mm
10. The patient is mentally capable and willing to sign a study-specific informed consent
as documentation of the informed consent process prior to any study procedures
11. The patient is willing and able to comply with all study requirements including
follow-up visits and radiographic assessments
Exclusion Criteria
Patients will not be allowed to participate in the study if they meet any of the exclusion
criteria below:
1. The index fracture(s) has/have been caused by high-energy trauma
2. The index fracture(s) has / have known tumor involvement
3. The index fracture(s) is/are diagnosed as an osteonecrotic fracture(s) by the treating
physician
4. The Index fracture(s) is a/are translational force fracture(s) (A2.1, 2.2, 2.3)
5. The index fracture(s) is a/are burst fracture(s) (A 3.3., B or C type) or pedicle
fracture(s) with posterior cortical wall disruption
6. The index fracture(s) has / have posterior vertebral wall displacement occupying more
than 20% of the cross sectional area of the spinal canal
7. The index fracture(s) has / have severe deformity with reduction of >75% in any height
and accompanying area, using adjacent level as comparison
8. The index level(s) has / have undergone previous surgical treatment for a vertebral
body compression fracture or other surgical procedure at the index level(s)
9. Angulation of index fracture(s) makes treatment with Kiva System impossible (at
discretion of surgeon)
10. The pedicle identified for access to the index fracture has a diameter less than 6 mm
11. The patient has Paget's disease
12. The patient has a BMI > 35
13. The patient has uncontrolled diabetes as characterized by hemoglobin HbA1c >7% and/or
blood sugar >180mg/dL
14. The patient has severe cardiopulmonary deficiencies
15. The patient has myelopathy
16. The patient is on long-term steroid therapy (steroid dose ≥ 30 mg /day for > 3 months)
17. A medical contraindication to spinal surgery and/or general anesthesia, such as
coagulopathy (with a threshold for normal being INR ≤ 1.5, PTT within lab normal
range, and platelet count > 100,000)
18. The patient has spinal canal compromise causing clinical manifestations of cord,
neural foramen, or nerve root compression at the level(s) to be treated;
19. The patient has neurologic symptoms or deficits or radiculopathy related to the VCF
20. The patient has pain based on clinical diagnosis of herniated nucleus palposus or
severe spinal stenosis (progressive weakness or paralysis)
21. The patient has indications of instability related to the index fracture (≥ 30 degrees
of kyphosis, translation >4mm, interspinous process widening, > Grade 1
spondylolisthesis and/or > 25 degrees of scoliosis if the index level is included in
the curve)
22. The patient has planned spine surgery for any disorder during or up to 30 days after
the study treatment
23. The patient has had spine surgery for any disorder in the 30 days prior to enrollment
24. The patient has a documented active systemic or local infection, such as osteomyelitis
or discitis, with a WBC > 15.0 x 10^3/µL and a temperature > 101.5°F
25. The patient has a known allergy to the investigational device materials and / or
acrylics / polymethylmethacrylate (PMMA) or a hypersensitivity to monomers
26. The patient has been diagnosed with hemorrhagic diathesis
27. The patient has uncontrolled psychiatric illness or severe dementia
28. The patient has a baseline back pain visual analog scale (VAS) of <50 mm if patient
has at least 6 weeks of conservative care or <70 mm if patient has 2-6 weeks
conservative care
29. The patient has a baseline Oswestry Disability Index (ODI) score of <30%
30. The patient is currently on anti-cancer therapy or anti-HIV therapy
31. Patient has autoimmune or inflammatory rheumatic disease
32. Patient's life expectancy is less than the study duration or undergoing palliative
care
33. The patient is known to be a current alcohol or drug abuser
34. The patient is known to be involved in medical litigation including Workmen's
Compensation
35. The patient is a prisoner
36. The patient is participating in another investigational study that has a potential for
effect to the study treatment or the study endpoints
37. The patient is pregnant or considering getting pregnant during study participation
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.
| The Kiva® System as a Vertebral Augmentation Treatment | NCT01123512 | Entailment |
2,403 | 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:
- Patients undergoing a muscle biopsy for IRB11-00203.
Male
No healthy subjects accepted to join the trial.
| Sedation During Muscle Biopsy in Patients With Duchenne Muscular Dystrophy | NCT01645098 | Entailment |
1,739 | 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:
- The subject is male or female, aged ≥18 and <50.
- The subject is in good general health with no evidence of any medical problems.
- The subject has both wrist circumferences between 14 and 22cm.
- The subject has provided informed consent and is willing to comply with the study
procedures.
Exclusion Criteria:
- The subject is obese (BMI>30).
- The subject has a known history of heart disease, lung disease, kidney or liver
disease.
- Diagnosis of asthma, sleep apnea, or use of CPAP.
- Subject has diabetes.
- Subject has a clotting disorder.
- The subject a hemoglobinopathy or history of anemia, per subject report or the first
blood sample that in the opinion of the investigator, would make them unsuitable for
study participation.
- The subject has any other serious systemic illness.
- The subject is a current smoker.
- The subject has piercings that may cause air leaks during the test
- The subject has any injury, deformity, or abnormality at the sensor sites that in the
opinion of the investigators' would interfere with the sensors working correctly.
- The subject has a history of fainting or vasovagal response.
- The subject has a history of sensitivity to local anesthesia.
- The subject has a diagnosis of Raynaud's disease.
- The subject has unacceptable collateral circulation based on exam by the investigator
(Allen's test).
- The subject is pregnant, lactating or trying to get pregnant.
- The subject is unable or unwilling to provide informed consent, or is unable or
unwilling to comply with study procedures.
- The subject has a resting heartrate over 120, Systolic BP is over 150, diastolic BP is
over 90 or room air SpO2 is less than 94%.
- The subject has carboxyhemoglobin over 3% as measured by Lab blood gas analysis.
- The subject has any other condition, which in the opinion of the investigators' would
make them unsuitable to participate.
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 49 Years | Accuracy of ScanWatch Pulse Oximeter With Profound Hypoxia | NCT04380389 | Entailment |
3,159 | 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:
- Be at least 18 years of age;
- Provide written informed consent;
- Have a reported history of dry eye;
- Have a history of use of eye drops for dry eye symptoms;
Additionally for Part 2
Symptoms of dry eye syndrome including:
- Ocular discomfort
- Conjunctival redness
- Tear film break up time
- Schirmer test score
Signs of dry eye syndrome including:
Conjunctival staining score
Exclusion Criteria:
- Have any clinically significant slit lamp findings at entry visit ;
- Be diagnosed with an ongoing ocular infection;
- Have any significant ocular lesion that could interfere with assessment of safety or
efficacy or prevent study conduct in the opinion of the PI;
- Have any planned ocular and/or lid surgeries over the study period;
- Have an uncontrolled systemic disease;
- Be a woman who is pregnant, nursing or planning a pregnancy;
- Be a woman of childbearing potential who is not using an acceptable means of birth
control;
- Have a known allergy and/or sensitivity to the test article or its components;
- Have a condition or be in a situation which the investigator feels may put the subject
at significant risk, may confound the study results, or may interfere significantly
with the subject's participation 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 18 Years old.
| Safety and Efficacy of TOP1630 for Dry Eye Syndrome | NCT03088605 | Contradiction |
867 | 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 between the ages of 40-75 with a diagnosis of moderate to severe
osteoarthritis of the knee, consistent with the American College of Rheumatology (ACR)
Clinical Classification Criteria for Arthritis of the Knee:
- Current knee pain
- Less than 30 minutes of morning stiffness with or without crepitus on active
motion.
- Confirmation either by arthroscopy or radiologist's report (X-rays showing
osteophytes, joint space narrowing or subchondral bone sclerosis {eburnation})
within five years prior to entry into the study.
2. C-reactive protein (CRP) < 8 ug/ml (if available at local lab) or erythrocyte
sedimentation rate (ESR) < 40 mm/hr
3. Total WOMAC (Western Ontario and McMaster University Osteoarthritis Index) Pain
Subscale Score of > 150 mm at Baseline corresponding with moderate to severe
Osteoarthritis.
4. Oral and written language comprehension at a level sufficient to comply with the
protocol and complete study-related materials.
5. Research Ethics Board (REB) approval of the written Informed Consent Form in Spanish
or English which was signed and dated by the patient and Investigator, prior to study
participation.
Exclusion Criteria:
1. Known rheumatoid arthritis or any other rheumatoid disease.
2. Secondary arthritis i.e. any of the following: septic arthritis; inflammatory joint
disease; gout; pseudogout; Paget's disease; joint fracture; acromegaly; fibromyalgia;
Wilson's disease; ochronosis; haemochromatosis; osteochondromatosis; or collagen gene
mutations.
3. Evidence of effusion greater than 15 cubic centimetre (cc) upon physical examination
of the joint at Baseline (Visit 1).
4. Body Mass Index (BMI) ≥ 38.
5. Major illness, requiring hospitalization during the 3 months before commencement of
the screening period.
6. The patient was unwilling to stop taking pain medication (for arthritis or other types
of pain) or was unwilling to stop taking other medications for the treatment of
osteoarthritis (OA).
7. Previous failure or discontinuation (due to adverse events) of tramadol hydrochloride
(HCl) therapy.
8. Treatment within the last 3 weeks with any of the following medications: monoamine
oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g.
cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors;
or any other drug that reduces seizure threshold.
9. Treatment with another investigational agent within the last 30 days.
10. A history of seizure disorder other than Infantile Febrile Seizures.
11. Previous or current opioid dependency.
12. Bowel disease causing malabsorption.
13. Pregnancy or lactating or childbearing potential and unwilling to utilize a medically
approved method of contraception during participation in this clinical trial.
14. Significant liver disease, defined as active hepatitis or elevated liver enzymes >3
times the upper boundary of the normal range.
15. Significant renal disease, defined as creatinine clearance <30 mL/min as estimated by
the method of Levey et al., 1999.
16. Current substance abuse or dependence, other than nicotine.
17. Allergy or adverse reaction to tramadol or any structurally similar drugs e.g.
opiates.
18. Any other condition, that, in the opinion of the Investigators, would have adversely
affected the patient's ability to complete the study or its measures.
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 | A Four-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol Once a Day 100, 200 and 300 mg Versus Placebo for the Treatment of Pain Due to Osteoarthritis of the Knee | NCT00832416 | Entailment |
5,194 | 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:
- Three or more years after menopause
- Bone mineral density T-score < or = -2.0 by dual-energy x-ray absorptiometry (DXA) of
vertebrae or femoral neck, or by quantitative computerized tomography (QCT) of
vertebral body trabeculae
Exclusion Criteria:
- Cannot walk without assistance
- Significant heart, kidney, liver, or malignant disease
- Current alcohol abuse
- Major psychiatric disorders
- Other current or past disorders known to affect bone
- Use of medications known to affect bone for > 7 days in the past 12 months
- Use of bisphosphonates or fluoride
- Abnormal blood calcium, PTH, 25-hydroxy vitamin D, creatinine, liver function tests,
or complete blood count
- Elevated calcium levels in 24-hour urine collection
Female
No healthy subjects accepted to join the trial.
Subject must be at least 46 Years old.
Subject must be at most 85 Years | Parathyroid Hormone (PTH) for Osteoporosis in Postmenopausal Women | NCT00086619 | Entailment |
1,942 | 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:
- Control group
- those who were between 25 and 80 years old and did not have any evidence of
gastric cancer and gastric dysplasia, esophageal tumor and MALToma in upper
gastrointestinal endoscopy
- Gastric cancer group
- Patients diagnosed as gastric cancer in the upper gastrointestinal endoscopy at
the time of participating in the study between 25 and 80 years old.
Exclusion Criteria:
- history of previous gastrointestinal surgery,
- any other malignancy
- cardia cancer
- who do not perform endoscopic biopsy
- pathologically proven gastric dysplasia
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 25 Years old.
Subject must be at most 80 Years | OLGA and OLGIM Stage System for Gastric Cancer | NCT03380052 | Entailment |
489 | 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:
- Females with history of recurrent pregnancy loss
- for control group healthy females with history of at least one uncomplicated full
pregnancy.
Exclusion Criteria:
- no history of endocrinal disorders
- no history of immunological diseases
- no history of pelvic pathology
- no history of uterine anomalies or cervical incompetence As a cause of recurrent
pregnancy loss
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | JZ Thickness as a Predictor of Recurrent Unexplained First Trimesteric Pregnancy Loss. | NCT03054558 | Contradiction |
1,505 | 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:
- referral by a physician for swallowing evaluation because of suspected dysphagia
- complaint of difficulty swallowing
- aspiration or penetration of the laryngeal vestibule with liquids or semisolids OR
post-swallow residue visible in the oral cavity, valleculae, or pharynx that is
instrumentally documented by a participating SLP during a standard clinical
videofluoroscopic swallowing study
- between the ages of 21 and 95
- ability to perform the exercise protocol independently or with the assistance of a
caregiver
- physician approval of medical stability to participate
- decision-making capacity to provide informed consent (confirmed through discussion
between the participating SLP and the subject's primary physician)
Exclusion Criteria:
- degenerative neuromuscular disease
- poorly controlled psychosis
- patient unable to complete the exercise program
- allergy to barium (used in videofluoroscopic swallowing assessment)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 95 Years | Study of Tongue Strengthening for Swallowing Problems | NCT01570023 | Entailment |
6,674 | 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%. | Main Inclusion Criteria:
- Participant and/or legal representative has/have voluntarily provided signed informed
consent
- Participant is 12 to 65 years old at the time of screening
- Participant is male with severe hemophilia A (Factor VIII (FVIII) clotting activity <
1%) as confirmed by central laboratory at screening after the appropriate washout
period or a documented FVIII clotting activity <1%
- Participant has been previously treated with plasma-derived FVIII concentrates or
recombinant FVIII for ≥150 documented exposure days (EDs)
- Participant is currently receiving prophylaxis or on-demand therapy with FVIII
- Participant is willing and able to comply with the requirements of the protocol
Main Exclusion Criteria:
- Participant has detectable FVIII inhibitory antibodies (≥ 0.6 Bethesda Units (BU)
using the Nijmegen modification of the Bethesda assay) as confirmed by central
laboratory at screening
- Participant has history of FVIII inhibitory antibodies (≥ 0.4 BU using the Nijmegen
modification of the Bethesda assay or ≥ 0.6 BU using the Bethesda assay) at any time
prior to screening
- Participant has been diagnosed with an inherited or acquired hemostatic defect other
than hemophilia A (eg, qualitative platelet defect or von Willebrand's disease).
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 65 Years | Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study) | NCT01736475 | Contradiction |
2,900 | 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:
- Able to provide informed consent.
- Diagnosis of clinically definite ALS, clinically probable-laboratory supported ALS,
clinically probable ALS, or clinically possible ALS based on the revised El Escorial
criteria.
- Patients with ALS ≤ 3 years since symptom onset. Symptom onset is defined as date of
first muscle weakness or dysarthria.
- Upright slow vital capacity (SVC)≥ 60% of predicted.
- If taking riluzole and/or Nuedexta®, stable regimen is required for ≥ 30 days prior to
screening.
- Medically (either independently or with caregiver assistance) able to comply with
study procedures, including subcutaneous (SC) injections of study medication and
adherence to concomitant medication restrictions.
Exclusion Criteria:
- Any medical condition known to have an association with motor neuron dysfunction which
might confound or obscure the diagnosis of ALS.
- Tracheostomy, diaphragm pacing, or ongoing need for assisted ventilation of any type
(e.g., bilevel positive airway pressure) for treatment of ALS-related respiratory
dysfunction (vital capacity of < 60% predicted, nocturnal desaturation, and/or
nocturnal hypoventilation). Patients on assisted ventilation for other reasons require
approval from the Medical Monitor. (Supplemental oxygen is acceptable).
- Recorded diagnosis or evidence of major psychiatric disorder.
- Clinically evident cognitive and/or behavioral impairment that in the opinion of the
Investigator would impair the ability of the patient to comply with the study
procedures.
- Therapies and/or Medications:
1. History of prior sensitivity to Acthar or other porcine protein products.
2. Chronic systemic corticosteroid use, defined as > 20 mg of prednisone or
equivalent systemic corticosteroid taken for more than 4 consecutive weeks within
6 months prior to randomization. Topical, inhaled, or intra-articular
corticosteroids are allowed.
3. Planned treatment with live or live attenuated vaccines once enrolled in the
study.
- Participation in another therapeutic (drug or device) investigational study within 30
days prior to screening.
- Type 1 or type 2 diabetes mellitus, or patients currently taking hypoglycemic
medication.
- Contraindication per Acthar Prescribing Information, Appendix D Section 4:
scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent
surgery, history of or the presence of peptic ulcer, congestive heart failure,
uncontrolled hypertension, primary adrenocortical insufficiency, or adrenal cortical
hyperfunction.
1. For the purposes of this study, osteoporosis is defined as a history of a lumbar
spine and/or femoral neck T-score ≤ -2.5 on bone densitometry (DXA), OR
osteoporosis requiring pharmacologic therapy, OR a history of non-traumatic low
impact hip or vertebral fracture, OR patient reported history of osteoporosis.
2. For the purposes of this study, history of peptic ulcer is defined as ≤ 6 months
prior to screening.
3. For the purposes of this study, uncontrolled hypertension is defined as mean
systolic blood pressure ≥ 140 mmHg and diastolic blood pressure ≥ 90 mmHg on ≥ 3
seated readings taken at least 5 minutes apart during the screening period.
4. For the purposes of this study, congestive heart failure is defined as New York
Heart Association Functional Class III-IV.
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 | A Study to Explore the Safety and Tolerability of Acthar in Patients With Amyotrophic Lateral Sclerosis | NCT01906658 | Entailment |
5,377 | 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:
1. Female subject, between the years 18-30, at the time of consent.
2. Subject is willing to participate and is capable of giving informed consent. (Note:
Consent must be obtained prior to any study-related procedures.)
3. Subject must be willing to comply with all study procedures and must be available to
participate for the duration of the study.
4. Subject agrees to avoid alcohol, unapproved medications (prescription, OTC, or other),
marijuana products, and illicit substances for 3 days prior to each urine collection.
Exclusion Criteria:
- 1. Subject is pregnant, or trying to or planning to become pregnant during the study.
2. Subject was pregnant within 1 year of beginning study, regardless of the outcome of
pregnancy.
3. Subject who is breastfeeding. 4. Subject who is not menstruating for any reason or
plans to undergo or change circumstances that might affect menstruation (e.g., certain
athletic training regimens, significant dietary changes).
5. History of recent or current irregular menstrual cycles (as self-reported by the
subject).
6. Subject reports she has been told by a medical professional that she is not
ovulating (i.e., has anovulatory periods) at any time during the previous 12 months.
7. Subject is using or planning to use any method to regulate her periods. 8. Subject
smokes (includes tobacco and marijuana) or vapes. 9. By history, subject has medical
problems that might influence the results of the study, such as endocrinologic, renal,
or hormonal problems.
10. Known polycystic ovarian syndrome (by history). 11. Subject is taking or planning
to take hormones or hormone- enhancing/manipulating pharmaceuticals (including
"morning after pill" [levonorgestrel], birth control pills, Clomid [clomiphene
citrate], Femara [letrozole], Cialis [tadalafil]*, Viagra [sildenafil]* and similar
medications) and/or agents to influence hormonal status such as herbal products or
nutritional supplements. (*Not approved for use and should be avoided by women.) 12.
Subject is using or planning to use hormonal contraceptives of any type, including
oral contraceptives and intrauterine devices.
13. Subject is using or planning to use hormonal therapies for acne vulgaris or other
conditions, including spironolactone, flutamide, metformin, or oral contraceptives
used as acne therapies, including Ortho Tri-Cyclen (combination of norgestimate and
ethinyl estradiol [EE]), Estrostep (combination of norethindrone acetate and EE), and
Yaz/Yasmin (combination of drospirenone and EE).
14. Subject is using or planning to use estrogen products, including topicals/creams,
for any purpose.
15. Subject is using or planning to use androgens or anabolic steroids (e.g.,
stanazolol/danazol) for any reason, including for training or athletic purposes..
16. Subject has attempted or taken IVF or IUI treatment within the prior six months.
17. Subject has uncontrolled diabetes or other significant medical disorder that
might, in the investigator's opinion, preclude completion of the study or suggest that
an exclusion criterion will ensue.
18. Subject reports difficulty handling biologic fluids, specifically urine, or gives
other reasons why she is hesitant to participate.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 30 Years | Alternating Urine Redox Status Of Consecutive Menstrual Cycles | NCT04157309 | Entailment |
4,545 | 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:
- The inclusion criteria for RIF group were: unexplained repeated implantation failure
(RIF) is defined as the absence of a gestational sac on ultrasound at 5 or more weeks
after embryo transfer (ET) after 3 embryo transfers with high quality embryos or after
the transfer of ≥10 embryos in multiple transfers.
The inclusion criteria for control group were: (1) age <35 years; (2) unregular menstrual
cycles of >37 days; (3) baseline follicle- stimulating hormone (FSH) < 9.0 IU/L; (4)
endometrial thickness ≥7.0 mm on the day of hCG administration.
Exclusion Criteria:
- The exclusion criteria were: (1) uterine abnormalities (double uterus, bicornuate
uterus, unicornuate uterus); (2) intrauterine adhesions（moderate - severe）,
endometriosis, adenomyosis, untreated hydrosalpinx, uterine fibroids (submucosal
fibroids, nonmucosal fibroids >4.0 cm and/or endometrial pressure) (3) history of
adverse pregnancy (including spontaneous abortion, stillbirth, and fetal
malformation).
Female
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 40 Years | Transcriptomic Profile of Endometrium in Different Histological Dating of Hormone Replacement Cycle | NCT03222882 | Contradiction |
1,897 | 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:
- Age between 18 to 75 years old
- Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or
poorly differentiated) confirmed pathologically by endoscopic biopsy
- Locally advanced tumor in the upper third or middle third of stomach without invading
the greater curvature (cT2-4a, N-/+, M0 at preoperative evaluation according to the
AJCC (American Joint Committee on Cancer) Cancer Staging Manual Seventh Edition)
- No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby
in the preoperative examinations
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- ASA (American Society of Anesthesiology) class I to III
- Written informed consent
Exclusion Criteria:
- Pregnant and lactating women
- Suffering from severe mental disorder
- History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
- History of previous gastric surgery (including ESD/EMR (Endoscopic Submucosal
--Dissection/Endoscopic Mucosal Resection )for gastric cancer)
- Enlarged or bulky regional lymph node （diameter over 3cm）supported by preoperative
imaging including enlarged or bulky No.10 lymph node
- History of other malignant disease within the past 5 years
- History of previous neoadjuvant chemotherapy or radiotherapy
- History of unstable angina or myocardial infarction within the past 6 months
- History of cerebrovascular accident within the past 6 months
- History of continuous systematic administration of corticosteroids within 1 month
- Requirement of simultaneous surgery for other disease
- Emergency surgery due to complication (bleeding, obstruction or perforation) caused by
gastric cancer
- FEV1<50% of the predicted values
- Splenectomy must be performed due to the obvious tumor invasion in spleen or spleen
blood vessels.
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 75 Years | Robotic Total Gastrectomy for Locally Advanced Proximal Gastric Cancer | NCT03524287 | Entailment |
4,153 | 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. | For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Healthy male subjects as determined by no clinically significant deviation from normal
in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body weight of at least 50 kg (110 lbs), Body mass index (BMI) of 18.0 to 32.0 kg/m2,
inclusive. Body mass index = weight (kg)/[height(m)]2
- Men, ages 18 to 50 years, inclusive
- Men who are sexually active with women of childbearing potential (WOCBP) (except those
with vasectomy with documented azoospermia 90 days after procedure) must agree to
follow instructions for method(s) of contraception for the duration of treatment plus
5 half-lives of the investigational drug (4 days) plus 90 days (duration of sperm
turnover) for a total of 94 days post-treatment completion
Exclusion Criteria:
- Any significant acute or chronic medical illness
- Current or recent (within 3 months of study drug administration) gastrointestinal
disease
- Current or recent history of constipation or irregular bowel movements (less than once
per 2 days)
- Any major surgery within 4 weeks of study drug administration
- Any gastrointestinal surgery that could impact upon the absorption of study drug,
including cholecystectomy
- History of Gilbert's Syndrome
- Donation of blood or plasma to a blood bank or in a clinical study (except a screening
visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
- Blood transfusion within 4 weeks of study drug administration
- Inability to tolerate oral medication
- Inability to be venipunctured and/or tolerate venous access
- Recent (within 6 months of study drug administration) history of smoking
- Evidence of organ dysfunction or any clinically significant deviation from normal in
physical examination, vital signs, ECGs, or clinical laboratory determinations beyond
what is consistent with the target population
- History of allergy to LPA1 antagonists or related compounds
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Absorption, Distribution, Metabolism and Excretion (ADME) Study of BMS-986020 | NCT02068053 | Contradiction |
5,366 | 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 diagnosed with Idiopathic Menorrhagia and Mirena inserted for a period no longer
than three months according to the assessment of the investigator and according to the
international and national guidelines. These women should also accept to be on
contraception during the time period that they have Mirena in situ
- Body Mass Index = 18-30
Exclusion Criteria:
- One or more of the following disorders: Current or recurrent pelvic inflammatory
disease; infection of the lower genital tract; postpartum endometritis; septic
abortion during the past three months; cervicitis; cervical dysplasia; uterine or
cervical malignancy; undiagnosed abnormal uterine bleeding; congenital or acquired
abnormality of the uterus including fibroids if they distort the uterine cavity;
conditions associated with increased susceptibility to infections; acute liver disease
or liver tumor; known hypersensitivity to any of the constituents of the product
- Nulliparity
- Consumption of Iron, Antiprostaglandins, hormonal drugs and any medication that could
effect bleeding should be stopped at least 3 months before the first visit and should
not be used during the course of the study.
- History of diabetes mellitus, cardiovascular disease and thyroid abnormalities
- Anticoagulation therapy
- Cancer history including breast cancer
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 49 Years | Survey on Patient Satisfaction Rate for Mirena Use in Heavy Menstrual Bleeding | NCT00874653 | Contradiction |
5,287 | 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:
1. Patient is at least 50 years old.
2. Patient must have a fracture due to diagnosed or presumed underlying primary or
secondary osteoporosis (Patients with AO type A1 fractures (all) may be included in
the study).
3. Patient must have confirmed acute pain and tenderness over the spine at or near the
level of x-ray compression deformity OR positive MRI evaluation.
4. Patient must NOT have more than (3) three vertebral compression fractures located
between T4 and L5.
5. Subjects affected vertebral body must have a loss of 0- 50% in vertebral height as
compared with the height of an adjacent normal vertebral body confirmed by
radiological evaluation.
6. Subject fracture is confirmed by MRI imaging including T1, T2 and STIR-weighted
studies to determine the type and presence of fracture(s).
7. Subjects affected vertebral body height and geometry is adequate for insertion of
access instruments of 5.2mm OD, as determined by the investigator.
8. Subjects pain score is equal to or greater than 5 according to the visual analog scale
(VAS).
9. Patient has been evaluated for hematologic disorders or other conditions affecting
blood coagulation.
10. Subjects are suitable candidates for standard vertebroplasty or kyphoplasty
procedures.
11. Subject is psychosocially, mentally, and physically able to fully comply with this
protocol including adhering to scheduled visits, treatment plans, completing forms,
and other study procedures.
12. Subject signed the Informed Consent Form prior to any study related procedures
indicating that he/she has been informed of all pertinent aspects of the trial.
13. Failure of conservative treatment prior to inclusion: a. failed conservative treatment
arm; b. acute therapy treatment arm.
Exclusion Criteria:
1. Patient has significant vertebral collapse, defined as > 50% of the original height of
the vertebral body, as measured against the nearest normal vertebral body. Degree of
collapse will be determined by using the height of the nearest normal vertebral body
to represent 100% and dividing the height of the collapsed vertebral body by the
height of the normal vertebral body.
2. Patient has compromised spinal canal.
3. Patient has symptomatic spinal stenosis.
4. Patient has painful VCF with fracture age greater than 6 months.
5. Patients has primary tumors of the bone (e.g., osteosarcoma) or solitary plasmacytoma
at site of the index VCF. Patients with these tumors in anatomic sites other than the
index VCF are eligible.
6. Patient has a fracture that extends into the posterior vertebral body wall.
7. Patient has neurological compromise (including myelopathy) and instability
8. Patient has a retropulsion severe enough to cause myelopathy, unless prior surgical
decompression is performed.
9. Patient with significant clinical comorbidity that may potentially interfere with
long-term data collection or follow-up (e.g., dementia, severe comorbid illness)
10. Patient requires the use of high-dose steroid, IV pain medication, or nerve block to
control chronic back pain unrelated to index VCF(s). Patients who receive high-dose
steroids for treatment of their cancer (for at least 30 days) are eligible.
11. Patient who may require allogenic bone marrow transplantation during the course of the
study.
12. Patient is in need of an open decompression.
13. Patient with burst fracture, and/or pedicle fracture at the treatment level.
14. Patient with a known or suspected allergy to PMMA or allergy to any device material
used in the treatment of vertebral fractures. Note that in subjects with allergy to
iodine-based contrast, other non-iodine contrast solutions may be used.
15. Patient does not have local pain and tenderness that correlates with MRI evaluation.
16. Patient has a coagulation disorder that cannot be corrected: a. for patients with
hematologic disorders or other conditions affecting blood coagulation, a platelet
count and internationalized normal ratio (INR), prothrombin time (PT), and partial
thromboplastin time (PTT) values should be available at time intervals typical of the
treatment center. The Investigator is to evaluate the ranges relative to the normal
values of the treatment center laboratory.
17. Patient has an active local or systemic infection.
18. Patient has a previous or current treatment for cancer at the affected level.
19. Patient has a previous spine surgery or previous injection of cement at the vertebral
levels of the surgical procedure.
20. Patient has diabetes mellitus.
21. Patient has an MRI contraindication (e.g., cerebral aneurysm clips, pacemaker,
implanted biostimulators, cochlear implants, penile prosthesis)
22. Patient has an unstable spine as indicated by neurologic deficit, kyphosis greater
than 30°, compression greater than 60%, translation greater than 4 mm,
interspinous-process widening.
23. Pre-existing conditions contrary to either PVA or vertebroplasty, such as: a.
Irreversible coagulopathy or bleeding disorder. Note regarding reversible
coagulopathies: Subjects on coumadin or other anticoagulants may participate.
Investigators should follow routine practices for perioperative discontinuation and
re-initiation of anticoagulants; b. Any evidence of VB or systemic infection.
24. Patient has a mental deficiency (e.g., psychiatric disorders, Alzheimer's disease,
presence of alcohol or drug abuse).
25. Patient is pregnant or is interested in becoming pregnant during the study duration.
26. Patient is a prisoner or ward of the state.
27. Patient expects to relocate more than 50 miles from the study center prior to
completion of the study follow-up period.
28. Patient has an AO classification A2, A3, B or C type fracture
29. Patient has hemangioma, malignant fracture, and/or multiple myeloma at the site of the
index VCF.
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.
| Clinical Evaluation of the Crosstrees Pod™ in the Treatment of Pathologic Fracture of the Vertebral Body (Levels T4 - L5) in Adult Patients | NCT00933036 | Entailment |
2,835 | 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. Age 18 through 80 years inclusive;
2. Geographically accessible to the site and able to come to the site once a week for 24
weeks;
3. Definite, probable, probable laboratory supported ALS diagnosis according to the
revised El Escorial criteria; 4) Disease duration 6 to 24 months from symptom onset;
5) Self sufficiency: Satisfactory bulbar and spinal function (score 3+ on the ALSFRS-R for
swallowing, cutting food and handling utensils, and walking); 6) Satisfactory respiratory
function (FVC ≥80% of predicted); 7) Documented progression of symptoms in the last three
months, as measured by the ALSFRS-R scale; 8) Ability to understand and comply with the
study requirements and to give written informed consent personally or via a legally
authorized representative; 9) Treatment with riluzole 50 mg twice/day for at least 1 month
prior to screening visit.
Self sufficiency: this term reflect independence in daily living activities. It is an
intuitive parameter to indicate preservation of key functional activities, and - not least
- it has shown to be a valid and reliable measure
Exclusion Criteria:
1. History of HIV, clinically significant chronic hepatitis, antecedent polio infection,
or other active infection;
2. Motor neuron disease (MND) other than ALS;
3. Involvement of systems other than motor possibly determining a functional impairment
(as measured by the end-points) for the entire duration of the study;
4. Other severe clinical conditions (e.g., cardiovascular disorders, neoplasms) with
impact on survival or functional disability in the next 12 months;
5. Renal insufficiency as defined by a serum creatinine > 1.5 times the upper limit of
normal;
6. Poor compliance with previous treatments;
7. Other experimental treatments in the preceding 3 months;
8. Women who are lactating or able to become pregnant (e.g. who are not post menopausal,
surgically sterile, or using inadequate birth control) and men unable to practice
contraception for the duration of the treatment and 3 months after its completion;
9. Unwillingness or inability to take riluzole; 10) Poor capability to use an inhalation
device;
10. Abnormal liver function defined as AST and/or ALT > 3 times the upper limit of the
normal.
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 | The Effect of RNS60 on ALS Biomarkers | NCT03456882 | Entailment |
339 | 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:
- Singleton pregnancy.
- 14-24 weeks gestation..
- Missed miscarriage
Exclusion Criteria:
- History of pulmonary, hepatic, renal, or cardiovascular diseases.
- History of previous cesarean section and other uterine surgeries as hysterotomy and
myomectomy.
- Inevitable abortion.
- Placenta covering internal os.
- History of any cervical surgery as cervical amputation, cauterization or dilatation.
- Premature rupture of membranes.
- Any vaginal bleeding.
- Contraindications for misoprostol as hypersensitivity to misoprostol, chronic adrenal
insufficiency and inherited porphyrias.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Fetal Fibronectin as a Predictor of Successful Induction of Mid-trimester Abortion | NCT02694198 | Contradiction |
4,900 | 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:
- Clinical diagnosis of Parkinson's Disease (PD)
- Healthy
Exclusion Criteria:
- Subject does not have clinical diagnosis of PD, however, has another neurological
disorder/disease that manifests with symptoms of tremor or dysphonia
- Subject diagnosed with PD does not have dysphonia and tremor
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| A Study to Analyze Symptoms Prevalent in Early PD (Dysphonia, Tremor) | NCT04288804 | Contradiction |
6,809 | 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 diagnosed with hemophilia A or B.
- Patients over 18 years of age.
Exclusion Criteria:
- Patients with neurological or cognitive impairments that hinder oral and written
comprehension.
- Patients who have not signed the informed consent document
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 65 Years | Development of a Specific Measure for Assessing Adherence in Adult Patients With Hemophilia. | NCT02197611 | Entailment |
640 | 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:
- Male individuals aged between 18 and 40 years old
- Body mass index (BMI) between 18 and 25
- Normal at clinical examination
- Normal biological variables
- Written informed consent
Exclusion Criteria:
- Mutation C282Y of the HFE gene
- Iron metabolism abnormality
- Inflammatory syndrome
- Chronic pathology or ongoing treatment
- Tobacco smoking, alcohol consuming more than 30g/day
- History of transfusion or blood-giving within 3 months
- Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Study of the Effects of Muscular Activity on Iron Metabolism | NCT00378469 | Contradiction |
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