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3,807 | 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. Males and females between 40 and 75 years of age, inclusive
2. BMI between 18.5 to 29.9 kg/m2, inclusive
3. Female participant is not of child-bearing potential, defined as females who have
undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy,
bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal
for at least 1 year prior to screening Or,
Females of child-bearing potential must have a negative baseline urine pregnancy test
and agree to use a medically approved method of birth control for the duration of the
study. All hormonal birth control must have been in use for a minimum of three months.
Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control
patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable
contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing
to heterosexual partner(s)
- Vasectomy of partner at least 6 months prior to screening
4. Self-reported pain or swelling in target knee
5. The diagnosis of mild to moderate osteoarthritis as confirmed by the Qualified
Investigator using qualifiers based on physical exam, medical history and x-ray report
qualified as mild to moderate by the radiologist
6. Agrees to refrain from taking any pain relievers during the study, except
acetaminophen as a rescue medication specified by the study site
7. Agrees to refrain from taking rescue medication for 48 hours prior to study visits
8. Agrees to maintain current diet and current exercise routine throughout the study
9. Willingness to complete questionnaires, records, and diaries associated with the study
and to complete all clinic visits
10. Provided voluntary, written, informed consent to participate in the study
11. Healthy as determined by medical history, laboratory results, and physical exam as
assessed by the Qualified Investigator (QI)
Exclusion Criteria:
1. Allergy, sensitivity, or intolerance to the investigational product's active or
inactive ingredients
2. Allergy to rescue medication
3. Women who are pregnant, breast feeding, or planning to become pregnant during the
study
4. Clinically significant abnormal laboratory results at baseline as assessed by the QI
5. Individuals who are unable to give informed consent
6. Injury in the target knee within the past 3 months
7. Intraarticular injections in the target knee within the past 6 months, or plan to have
intraarticular injections during the study
8. Individuals with knee joint diseases, such as rheumatoid arthritis, gouty arthritis,
septic arthritis or any other infective arthritis
9. Self-reported history of gout or pseudo gout within the past 6 months
10. Skin defects (e.g. skin and soft tissue infections that cause necrosis of the skin, or
post-burn contractures) and ulcers around the affected knee joint, as assessed by the
QI
11. History of knee surgery or replacement in the target knee, or any non-knee surgical
procedures that may impact the study outcomes as assessed by the QI
12. Individuals with muscle or skeletal disorders as assessed by the QI
13. Unstable metabolic disease or chronic diseases as assessed by the QI
14. In a state of acute exacerbation or seizure of chronic disease
15. Type I or Type II diabetes
16. History of or current diagnosis with severe cardiopulmonary, kidney and/or liver
dysfunctions, with the exception of history of kidney stones in participants who are
symptom free for 6 months
17. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on
a stable dose of medication for at least 3 months will be considered by the QI
18. Current or history of any significant diseases of the gastrointestinal tract including
diarrhea or dysentery as assessed by the QI
19. Significant cardiovascular event in the past 6 months. Participants with no
significant cardiovascular event on stable medication may be included after assessment
by the QI on a case-by-case basis
20. Self-reported confirmation of medical or neuropsychological condition and/or cognitive
impairment that, in the QI's opinion, could interfere with study participation
21. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or
radiation with a follow up that is negative. Volunteers with cancer in full remission
for more than five years after diagnosis are acceptable
22. Verbal confirmation of blood/bleeding disorders as assessed by the QI
23. Individuals with an acute infectious disease, autoimmune disease or are
immune-compromised
24. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis
25. Current use of prescribed medications listed above
26. Current use of over-the-counter medications, supplements, foods and/or drinks listed
above
27. Use of medical cannabinoid products
28. Chronic use of cannabinoid products (>2 times/week) and is unwilling to stop use for
the duration of the study. Occasional use to be assessed by the QI on a case-by-case
basis
29. Alcohol or drug abuse within the last 12 months
30. High alcohol intake (average of >2 standard drinks per day)
31. Blood donation 30 days prior to screening, during the study, or a planned donation
within 30 days of the last study visit
32. Participation in other clinical research studies 30 days prior to screening
33. Any other condition, that, in the opinion of the QI, may adversely affect the
participant's ability to complete the study or its measures or pose significant risk
to the participant
Participants on the following concurrent prescribed medications and/or treatments will be
excluded during enrollment unless they have been taken off these therapies by their family
physician. In the latter event, the frequency and route of administration of use and/or
dosage may be considered by the QI on a case-by-case basis prior to recommending an
appropriate washout or their enrollment in the study.
1. Oral NSAIDs or topical application on the target knee
2. Narcotics
3. Oral corticosteroids or topical application on the target knee
4. Oral analgesics except acetaminophen as a rescue medication or topical application on
the target knee
5. Digoxin
6. Anti-hypertensive drugs
7. Anticoagulants or antiplatelet drugs
8. Medications used for OA treatment
9. Diazepam
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 | Safety and Efficacy of JointAlive™ on the Knee-joint Function in Adults With Knee Arthritis | NCT04395547 | Entailment |
6,306 | 46 | The patient is a 38-year-old man with cough and body ache that started 3 days ago. He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx. | I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat. | Inclusion Criteria:
- Patients newly diagnosed with COVID-19 at hospital setting or community screening,
confirmed with biological proof (RT-PCR)
Exclusion Criteria:
- Subjects opposed to the use of their data
- Minors, adults under guardianship, protected persons
- History of malignancy
- History of autoimmune disease
- Pregnancy
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| COVID-19, Aging, and Cardiometabolic Risk Factors Study | NCT04802044 | Entailment |
5,248 | 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. A diagnosis in accordance with Criteria for the Diagnosis of Primary Osteoporosis.
2. Other inclusion criteria as specified in the study protocol.
Exclusion Criteria:
1. Patients having secondary osteoporosis or another condition that presents low bone
mass.
2. Patients having findings that affect measurement of lumbar spinal bone mineral density
by DXA
3. Patients that have been administered bisphosphonate derivatives.
4. Other exclusion criteria as specified in the study protocol.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 45 Years old.
| Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan | NCT00212719 | Entailment |
4,604 | 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:
- Being between the ages of 18 and 45,
- PCR test result positive confirmed having COVID-19 infection,
- Women had at least one period of Menstrual cycle after COVID-19
- Being an Internet connection,
- To be able to speak and write in Turkish.
Exclusion Criteria:
- To be in the premenaposual/postmenopausal period (to be in the transition period to
menopause or in the period after menopause.)
- Having insufficient co-operation.
Female
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Menstrual Cycle-induced Pain, Fatigue and Anxiety in Women Suffered From COVID-19 | NCT04806815 | Entailment |
6,202 | 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:
- Adult patients with a differential diagnosis of COVID-19
Exclusion Criteria:
- Patients who are under 18 year-old
- Patients who have not either Thorax CT or SARS-CoV-2 RT-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.
| Decision Support System Algorithm for COVID-19 Diagnosis | NCT04479319 | Contradiction |
2,564 | 19 | A 7-year-old girl is brought to the emergency department by her parents for generalized rash. The mother reports that she was playing outside wearing a skirt and felt a sharp pain in her arm while seating on a mat, plying with her doll. Her mother suspects that something had stung her. The patient's blood pressure is 75/55 mm Hg and her heart rate is 122/min. Physical examination shows erythematous, raised plaques over the trunk, extremities, and face. Lung auscultation reveals bilateral expiratory wheezes. | I just brought my seven-year-old girl to the ER because she just developed a terrible rash. My little girl was playing outside and she was wearing a lovely little skirt and all of a sudden. She felt like a really sharp pain in her arm. She was sitting on a mat playing with her doll. I think that something stung her. They took her blood pressure, and it turned out to be 75 out of 55. Her heart rate was 122. Then they did a physical examination, and it showed rashes all around her trunk, extremities, and face. Her breath test revealed some high-pitched breathing. | - INCLUSION CRITERIA:
Males and females, age 3 months to 19 years old, (less than 18 years old).
Individuals referred to the NIH with a diagnosis of asthma, rhinitis, anaphylaxis,
urticaria, atopic dermatitis, food allergy, stinging insect allergy or other
allergic/inflammatory diseases.
Subjects must maintain a primary physician for protocol related and non-related long-term
follow-up and for any emergency medical treatment required.
INCLUSION CRITERIA FOR PARENTS:
Must be biological Parent
Must have a child with a diagnosis of allergic disease
EXCLUSION CRITERIA:
Inability to provide informed consent or assent. In the case of minors, unavailability of a
parent or guardian.
EXCLUSION CRITERIA FOR PARENTS:
Non-biological parent
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Months old.
Subject must be at most 19 Years | Clinical and Immunological Evaluation of Children With Allergies | NCT00102570 | Entailment |
4,489 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. 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 | Contradiction |
4,962 | 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:
- Able to Sign written informed consent in Hebrew.
- Patient agrees to attend all treatment procedures and follow-up evaluations and is
willing and able to comply with all study requirements.
- Patient with a clinical diagnosis of idiopathic PD, or ET for more than 3 years.
- Significant tremor for at least one upper limb causing distress or disability.
- Patient should be stable on anti-Parkinson's disease or anti-tremor medication for at
least one month prior to study enrollment.
Exclusion Criteria:
- Previous participation in another study with any investigational drug or device within
the past 90 days.
- Any active implant (cardiac or other).
- Current pregnancy or attempting to get pregnant (female patient).
- Patient has any major illness or medical condition that in the opinion of the
physician would interfere with participation in the study.
- Patient with other significant neurological or psychiatric disease other than
Parkinson Disease or Essential Tremor.
- Patient has any other condition expect for PD and ET that induce tremor.
- Patient is treated with drug that may induce tremor.
- Patient abuses drugs or alcohol.
- Any previous thalamotomy, pallidotomy or patient who has undergone a DBS procedure.
- Any anticipated need for surgery during the study.
- Any malignancy in the past 2 years.
- Patient has confirmation of diagnosis of a terminal illness associated with survival
<12 months.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | The Essential Tremor (ET) and Parkinson Disease (PD) Tremor Acute Stimulation Study | NCT01940406 | Entailment |
201 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Symptomatic testosterone deficiency
- Intend to undergo testosterone therapy at Men's Health Boston
- Total testosterone <350ng/dL or free testosterone <1.5ng/dL
Exclusion Criteria:
- Type 1 diabetes
- Use of exogenous testosterone or clomiphene citrate
- Known karyotype abnormalities
- Seizure disorders
- Malignancy
Male
Accepts Healthy Volunteers
Subject must be at least 20 Years old.
Subject must be at most 90 Years | Metabolomics During Testosterone Therapy | NCT01963390 | Entailment |
2,525 | 18 | A 2-year-old boy is brought to the office by his parents due to a rash that started 1 week ago. A similar red, itchy rash on the cheeks, trunk, and arms has occurred intermittently since infancy. The patient has had a few upper respiratory infections but no major illnesses. Vaccinations are up to date, and he takes no medications. He is on a balanced diet, and he is healthy in appearance. Vital signs and milestone examination are within normal limits. Similar findings are observed on the cheeks and proximal upper extremities. The diaper area is clear, and no mucosal lesions are present. | I just brought my two-year-old son to the doctor's office because he had a rash for like one week. His rash was on the cheeks, the trunk, and his arms. He already had this before, and it keeps coming back from time to time to time. In the past, he had some respiratory infections but he has never been this sick. His vaccinations are up to date, and he doesn't take any medication. He's healthy with a nice diet. The doctor told me his vitals and milestone examinations were normal. The doctor also said there was a rash around the cheek and the upper part of his arms. The diaper area is okay, and there are no lesions. | Inclusion Criteria:
- Children with eczema who visit UNC pediatric dermatology during study enrollment
(Summer 2018).
- Currently on a class 1 topical steroid or systemic immunosuppressive agent to control
his/her eczema at the time of recruitment.
- A history of, or current clinical evaluation by the attending dermatologist showing,
atopic dermatitis affecting at least 10% body surface area.
Exclusion Criteria:
- Child or family member with a sensitivity to bleach.
- Child has used bleach baths within the last 2 months.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 17 Years | Bleach vs. Bubbles: Assessing the Impact of the Bathroom Environment on Eczema | NCT03619161 | Entailment |
4,399 | 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:
- aged between 18 and 65 years
- presence of elbow pain lasting for less than three months
Exclusion Criteria:
- history of acute trauma or fracture on forearm
- congenital or acquired elbow deformities
- demyelinating diseases
- patients who had diagnosed as fibromyalgia
- presence of skin lesion on lateral aspect of the elbow
- presence of rheumatic disease
- presence of systemic infection
- presence of pregnancy
- presence of malignancy
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 | Bracing or Kinesio Taping in The Management of Lateral Epicondylitis | NCT04498533 | Contradiction |
269 | 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:
- Indications for IVF/ICSI include male factor, diminished ovarian reserve, tubal
factor, ovulatory dysfunction and unexplained infertility.
Exclusion Criteria:
- none
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 42 Years | Luteal Phase Estradiol Support for In Vitro Fertilization/Intracytoplasmic Sperm Injection Cycles | NCT02677259 | Contradiction |
560 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Caucasian subjects of either gender (male or female) with an age between 18 and 45
years (both inclusive).
2. Medical history and physical examination with no relevant abnormal findings.
3. No evidence of significant disease (organic or psychiatric) based on medical history,
physical examination and complementary tests.
4. Laboratory tests (complete hematology, clinical chemistry and urinalysis).
5. Vital signs (systolic and diastolic blood pressure, heart rate and temperature) and
electrocardiogram (ECG) record within normal range at screening.
6. Participating female volunteers must use a reliable contraception method not
containing hormones. List of accepted contraception method includes barrier methods
(i.e. female/male condoms, diaphragms, spermicides), voluntary sterilization (female
tubal occlusion) or non-medicated intrauterine devices (IUD) (i.e. inert or
copper-releasing). Abstention is not considered a reliable contraception method.
7. For female volunteers only: they must declare that they did not intend to become
pregnant in the last month prior to screening and they do not intend to become
pregnant during one month following the last study drug administration.
8. Voluntary participation in the study, with written informed consent from the
volunteer.
9. The subject agrees to abstain from beverages or food containing methylxanthines
(coffee, tea, cola, energy drinks, chocolate etc.), St John's Wort, vitamins, herbal
remedies and chewing-gum for 48 hours prior to study drug administration and during
each study period.
10. The subject agrees to abstain from beverages or food containing grapefruit for 14 days
prior to the first study drug administration and during the study (until last sample
from the last period).
Exclusion Criteria:
1. Background of allergy, idiosyncrasy or hypersensitivity to the study drugs or its
excipients.
2. Heavy consumer of stimulating drinks (>5 cups of coffee, tea, chocolate or cola drinks
per day).
3. Background of alcoholism or drug dependence in the last one year or daily consumption
of alcohol > 40 gr/day for men or > 24 gr/day for women.
4. Use of any medication within 15 days prior to taking the study treatment, including
over-the-counter medications and medicinal plants (except for the use of paracetamol
in short-term symptomatic treatments).
5. Positive serology for hepatitis B, C or HIV.
6. Background or clinical evidence of cardiovascular, respiratory, renal, hepatic,
endocrine, gastrointestinal, hematological or neurological disease or other chronic
diseases.
7. Smokers or ex-smokers that gave up smoking less than 1 year prior to the study (day 1
of period I)
8. Pregnancy or lactation status for female subjects.
9. Participation in another clinical trial during the 3 months before starting the
current trial.
10. Donate blood in the 8 weeks prior to starting the study.
11. Undergone major surgery during the previous 6 months.
12. Clinically significant abnormal ECG with clinical significance in accordance with the
CIM's clinical criterion
13. Restrictive vegetarian diet
14. Positive results to the breath alcohol test at screening or at Day -1
15. Positive results to the drug abuse checks (urine test for: amphetamines, cannabinoids,
opiates, benzodiazepines and cocaine) at screening or at admission on Day -1
16. Epidemiological risk of being infected by Loa loa or other filariases, defined as
those who have lived or have travelled to any of the following countries: Angola,
Cameroon, Central Africa Republic, Chad, Congo, Democratic Republic of the Congo,
Equatorial Guinea, Ethiopia, Gabon, Nigeria and Sudan.
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 45 Years | Bioavailability and Safety of Two Oral Fixed Dose Preparations Containing 18 mg Ivermectin (IVM 18 MG TABLETS, LICONSA S.A., Spain) Versus Reference Dosing (Weight Based) Containing 6 mg Ivermectin (REVECTINA®, Abbott Laboratórios do Brasil Ltda, Brazil) | NCT03173742 | Contradiction |
2,568 | 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:
- bilateral inguinal hernia
Exclusion Criteria:
- American Society of Anaesthesiology score >3
- complicated inguinal hernias
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Laparoscopic vs Open Bilateral Inguinal Hernia Repair | NCT04679116 | Contradiction |
2,964 | 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:
- Definite ALS.
Exclusion Criteria:
- Primary Lateral Sclerosis (PLS)
- Other forms of motor neuron disorders.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Quantitative Neuromuscular Ultrasonography in Amyotrophic Lateral Sclerosis (ALS) | NCT02507713 | Entailment |
1,334 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion criteria of Cohort 1- Newborn:
- Subjects aged 1-2 days
- Subjects with gestational age 37-42 weeks
- Subjects with stable clinical status (admitted to normal newborn nursery)
Inclusion criteria of Cohort 2 - Older children:
• Subjects aged 0-18 years
Inclusion criteria of Cohort 3 - Diseased children:
Subjects (no age limit) with ANY phenotype as below:
- Confirmed metabolic or genetic diseases
- Suspected metabolic or genetic diseases
- Episodic metabolic decompensation (e.g. hypoglycemia, hyperammonemia, metabolic
acidosis)
- Developmental regression
- Major congenital malformation
- Other unexplained symptoms of potential genetic origin
Exclusion criteria of Cohort 1 - Newborn:
- Subjects with gestational age <37 weeks or >42 weeks
- Subjects with overt signs of metabolic dysfunction, distress or genetic diseases
including hypoglycemia, hyperglycemia, sepsis/shock, hypoxemia, or major congenital
malformation
- Subjects with mothers whose pregnancies were complicated by gestational diabetes,
gestational hyperglycemia, gestational hypertension, preeclampsia, or any other major
disorders.
Exclusion criteria of Cohort 2 - Older children:
- Subjects with confirmed metabolic or genetic diseases
- Subjects with suspected metabolic or genetic diseases
- Subjects with episodic metabolic decompensation (e.g. hypoglycemia, hyperammonemia,
metabolic acidosis)
- Subjects with developmental regression
- Subjects with major congenital malformation
Exclusion criteria of Cohort 3 - Diseased children No.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Genetic and Metabolic Disease in Children | NCT02650622 | Contradiction |
2,497 | 17 | A 67-year-old man comes to the clinic with slowly worsening vision in both eyes. He is not able to drive at night, as the symptoms are worse at night. His pupils are normal in diameter both in the light and darkness. Other medical history is unremarkable. Ocular examination shows loss of the red reflex and blurry vision. Acuity testing shows 50/100 vision in both eyes with normal visual field testing. His blood pressure is 130/70 and pulse is 68/min. the other physical examinations are normal. | I am a 67 years-old man, and I haven't been able to drive at night due to my vision getting worse. My vision is not the best in general, but night makes it even worse. The ophthalmologist told me that my pupils were normal. However, I have slow reflexes and blurry vision. My acuity test came back with 50/100 vision in both of my eyes. They also took my blood pressure, which was 130/70 with a 68 pulse. My other exams came back just fine. | Inclusion Criteria:
- the ability to speak English and/or Mandarin, have adequate hearing with/without
hearing aids to respond to normal conversation, not currently undergoing regular
assessment/care with an ophthalmologist (at least yearly), have the ability to undergo
visual acuity testing and provide reliable results, and visual acuity of 6/12 or worse
in either eye after best correction
Exclusion Criteria:
- refused informed consent and any other contraindication(s) as indicated by the general
practitioner responsible for the participant
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 80 Years | Randomized Controlled Trial Evaluating an Incentive-based Community Eye-care Programme | NCT03264885 | Entailment |
6,710 | 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%. | Prevention Trial, Inclusion Criteria:
- Male children >/= 4 months of age.
- Severe hemophilia A (FVIII < 0.01 U/ml)
- No previous bleed or surgery requiring treatment (except circumcision)
- No previous factor VIII product (except for circumcision)
- Willingness to comply with weekly prophylaxis for 48 weeks
- Willingness of parent/caregiver to keep a personal diary of bleeding frequency and
factor treatment.
- Willingness to make monthly visits and coagulation testing at weeks 4, 12, 24, 36, and
48 (end of study)
Prevention Trial, Exclusion Criteria:
- Acquired hemophilia.
- Any bleeding disorder other than hemophilia A.
- Treatment with clotting factor previously, other than circumcision.
- Presence of an inhibitor to factor VIII.
- Use of an experimental drug(s).
- Surgery anticipated in the next 48 weeks.
- Life expectancy less than 5 years.
- Inability to comply with study requirements.
Eradication Trial, Inclusion Criteria:
- Male adults or children with no age limitation.
- Severe hemophilia A (FVIII <0.01 U/ml).
- Presence of an inhibitor to FVIII (anti-FVIII > 5.0 B.U.)
- Willingness to comply with study drugs for up to 48 weeks.
- Willingness to keep a personal diary of bleed frequency and drug treatment.
- Willingness to make monthly visits and coagulation testing at weeks 4, 12, 24, 36, and
48 (end of study).
Eradication Trial, Exclusion Criteria:
- Acquired hemophilia.
- Any bleeding disorder other than hemophilia A.
- Current use of Emicizumab, or if used, > 8 weeks since last treatment.
- Use of an experimental drug(s).
- Surgery anticipated in the next 48 weeks.
- Life expectancy less than 5 years.
- Inability to copy with study requirements.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 4 Months old.
Subject must be at most 99 Years | Hemophilia Inhibitor Clinical Trials (INHIBIT) Platform | NCT02196207 | Contradiction |
1,134 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | No eligibility criteria
Male
No healthy subjects accepted to join the trial.
Subject must be at most 100 Years | Genetic Analysis of Familial Hypertrophic Cardiomyopathy | NCT00005251 | Entailment |
2,225 | 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:
More than 18 years old Able to sign informed consent Indication of long-term treatment with
allopurinol Acute gout crisis
Exclusion Criteria:
Les than 18 years-old Unable to consent Contra-indication to allopurinol
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.
| Allopurinol in Acute Gout | NCT01775098 | Entailment |
1,187 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
- Diagnosis of histologically or cytologically documented, malignant pleural effusions
(primary non-small-cell lung carcinoma, mesothelioma, and other histologies), who have
free pleural space (partial or total) that permits the intrapleural drug instillation.
This includes cytologically negative pleural effusion in conjunction with
histologically proven malignancy involving the pleura.
- Age must be ≥ 18 years.
- All acute toxic effects of any prior radiotherapy, chemotherapy, or surgical
procedures must have resolved to Common Terminology Criteria for Adverse Events
(CTCAE, Version 4.0) Grade ≤ 1.
- Any surgery, where general anesthesia was administered, must have occurred at least 14
days prior to study enrollment.
- Chemotherapy, radiotherapy or immunotherapy must have stopped more than 7 days prior
to receiving study drug; however, small field palliative radiotherapy, TKI therapies
and hormonal therapies are allowed.
- Patients with stage IV malignancy (non-mesothelioma) must have had a brain scan (MRI
or CT with contrast) showing no evidence of disease progression within 8 weeks of
study enrollment.
- ECOG Zubrod ≤ 2.
- Required baseline laboratory data include:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109 [SI units 10^9/L],
- Platelets ≥ 100 ×10^9 [SI units 10^9/L],
- Hemoglobin ≥ 9.0 g/dL [SI units gm/L],
- Serum creatinine ≤ 1.5 × upper limit of normal (ULN),
- Bilirubin ≤ 1.5 × ULN,
- AST/ALT ≤ 2.5 × ULN (≤ 5 × ULN in the presence of liver metastases)
- Negative pregnancy test for females of childbearing potential.
Exclusion Criteria:
- Pregnant or breast-feeding women.
- Patients with fever or any active systemic infections, including known HIV, hepatitis
B or C.
- Patients on immunosuppressive therapy or with immune system disorders, including
autoimmune diseases.
- Concurrent steroid use of more than an equivalent of 20 mg/day prednisone (or
equivalent).
- Prior splenectomy.
- Previous organ transplant.
- Patients with clinically significant dermatological disorders, e.g., eczema or
psoriasis, as judged by the principal investigator, or any unhealed skin wounds or
ulcers.
- Clinically significant cardiac disease (New York Heart Association, Class III or IV).
- Dementia or altered mental status that would prohibit informed consent.
- Other severe, acute, or chronic medical or psychiatric condition or laboratory
abnormality, that may increase the risk associated with study participation or study
drug administration, or may interfere with the interpretation of study results and, in
the judgment of the principal investigator, would make the patient inappropriate for
this study.
- Known allergy to ovalbumin or other egg products.
- Prior gene therapy treatments or prior therapy with cytolytic virus of any type.
- Concurrent therapy with any other investigational anticancer agent.
- Concurrent antiviral agent active against vaccinia virus (e.g. cidofovir, vaccinia
immunoglobulin) during 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.
| Intra-pleural Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients With Malignant Pleural Effusion: Primary, Metastases and Mesothelioma | NCT01766739 | Entailment |
6,745 | 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:
- Male and female hemophilia A patients.
- Patients for whom the decision to treat with Kovaltry was determined prior to
enrollment in the study.
Exclusion Criteria:
- Patients participating in an investigational program with interventions outside of
routine clinical practice.
- Patients with an additional diagnosis of any bleeding/coagulation disorder other than
hemophilia A
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Drug Use Investigation of Kovaltry in Hemophilia A Patients | NCT02941783 | Contradiction |
73 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria: hypogonadotropic hypogonadism
- decreased serum testosterone concentration below the normal range (serum T <
300ng/dL),
- FSH and LH levels within or below the normal range,
- absence of a pituitary or hypothalamic mass lesions on MRI, presence of gonadotropin
response to repetitive doses of GnRH,
- normal smell test and normal karyotypes
Exclusion Criteria:
- previous androgen treatment,
- history of smoking,
- presence of bilateral anorchia,
- intellectual deficiency,
- diabetes mellitus,
- arterial hypertension or dyslipoproteinemia,
- medication of any kind and drug abuse. Because of possible confounding effects,
patients with other hormone deficiencies were excluded.
Participants with iron, vitamin B12 or folate deficiency were also excluded.
Male
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 30 Years | Effects of Medications in Patients With Hypogonadism | NCT01601327 | Contradiction |
5,061 | 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:
- Elderly subjects (> or equal to 65 years old)without any disease mentioned in the
exclusion criteria.
- BMI ≥ 25Kg/meters squared
Exclusion Criteria:
- Exclusion criteria include: diabetes, subjects with impaired glucose tolerance on
medication, presence of a chronic disease or major organ failure such as severe heart
failure, kidney or liver failure, conditions or intake of medications known to affect
bone metabolism, rickets or osteomalacia, history of kidney stones, a baseline vitamin
D level of less than 10 ng/ml and history of fragility fractures or an overall
fracture risk based on FRAX of >10% .
- Subjects with impaired glucose tolerance on no medications will not be excluded.
- The classification of individuals as diabetics or having impaired glucose tolerance
will be based on the American Diabetes Association criteria for diagnosis.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 65 Years old.
Subject must be at most 95 Years | Hypovitaminosis D : A Link Between Bone/Mineral and Fat/Fuel Metabolism | NCT01315366 | Contradiction |
3,759 | 30 | A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee. | I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee. | Inclusion Criteria:
- Knee-OA detected by x-ray (Kellgren & Lawrence grade 1 or greater)
- KOOS4 of ≤ 75
- Considered not to be a candidate for Total Knee Replacement (TKR) by the orthopedic
surgeon.
- The participant is > 18 years of age.
- The participant can provide relevant and adequate, informed consent.
Exclusion Criteria:
- Prior TKA ipsilateral
- Rheumatoid arthritis
- Mean VAS > 60mm the last week on a 0-100mm scale
- Possible pregnancy or planning pregnancy;
- Inability to comply with the protocol;
- Inadequacy in written and spoken Danish.
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.
| Structured Non-operative Treatment of Knee Osteoarthritis | NCT01535001 | Contradiction |
6,445 | 47 | A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21. | I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21. | Inclusion Criteria:
- Moderate to severe erythematotelangiectatic rosacea with moderate to severe erythema
of facial lesion
- Generally healthy excluding rosacea
- Presence of telangiectasia
- Five or less facial inflammatory lesions
- Able to restrict diet in order to avoid foods/drinks (including alcohol) that are
known to exacerbate the signs/symptoms of rosacea
- Females of childbearing potential must have negative serum pregnancy test and agree to
use one form of contraception
Exclusion Criteria:
- Diagnosis of skin disorders, including psoriasis, acne vulgaris, perioral dermatitis
or atopic dermatitis that would interfere with the clinical evaluations of rosacea
- Using and unable to discontinue use of phosphodiesterase (PDE) 4 inhibitors,
theophylline, niacin greater than 500 mg/day
- Known or suspected excessive alcohol intake
- Sensitivity to tetracyclines
- Ocular rosacea and/or blepharitis/meibomianitis
- Pregnant or breastfeeding
- Perimenopausal and has symptoms that cause flushing that may affect rosacea
- Initiated hormonal method of birth contraception within 4 months of baseline,
discontinues use during the course of the study, or changes hormonal method within 4
months
- Active mycobacterial infection of any species within 3 years
- History of mycobacterium tuberculosis infection
- History of recurrent bacterial infection
- Congenital or acquired immunodeficiency common variable immunodeficiency (CVID),
Hepatitis B surface antigen positive or Hepatitis B core antibody positive
- Human immunodeficiency virus (HIV) infection
- Positive for hepatitis C antibodies
- Malignancy or has had a history of malignancy greater than 3 years prior
- Will continue to use any of the following treatments during the study: Systemic
retinoids, therapeutic vitamin A supplements of greater than 10,000 units/day,
systemic steroids, systemic antibiotics known to have an impact on the severity of
facial rosacea, systemic treatment for acne, topical steroids, topical retinoids,
topical acne treatments including prescription and over-the-counter (OTC)
preparations, topical anti-inflammatory agents, topical antibiotics, topical imidazole
antimycotics, cryodestruction or chemodestruction, dermabrasion, photodynamic therapy,
acne surgery, intralesional steroids, X-ray therapy, pulse-dye laser, intense pulse
light, astringents, abrasives, benzoyl peroxide products, sulfur containing washes,
eye washes, Beta blockers, vasodilators, vasoconstrictors and/or chronic use (>14
days) of topical or systemic anti-inflammatory agents
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 Study of Laropiprant (MK-0524) in Participants With Moderate to Severe Erythematotelangiectatic Rosacea (MK-0524-155) | NCT01451619 | Entailment |
5,067 | 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:
- A woman between 60 and 75 years of age with a medical diagnosis of osteoporosis by
means of a femur or lumbar densitometry of less than 2.5 standard deviations (SD) of
peak bone mass.
- No history of previous fracture in the last 10 years.
Exclusion Criteria:
- Secondary osteoporosis.
- Having suffered a bone fracture in the last year.
- Present primary osteoporosis but who presented juvenile osteoporosis in adolescence or
youth.
- Uncontrolled arterial hypertension.
- Severe acute respiratory failure.
- Uncontrolled orthostatic hypotension.
- Diabetes mellitus with acute decompensation or uncontrolled hypoglycemia.
- Endocrine, hematological and other associated rheumatic diseases.
- Mental health problems (schizophrenia, dementia, depression, etc.) or not being in
full mental capacity.
- Patients with pharmacological treatments of glucocorticoids, anticoagulants and/or
diuretics.
- Patients with coagulation problems or previous cardiac pathology.
- People with a body mass index (BMI) equal to or higher than 30.
- Subjects who present a systemic disease or any other pathology in which therapeutic
exercise could be contraindicated.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
Subject must be at most 75 Years | EFFECT OF FLOW RESTRICTION ON BONE QUALITY WITHIN A MULTICOMPONENT EXERCISE PROGRAM FOR OLDER WOMEN WITH OSTEOPOROSIS. | NCT04760145 | Contradiction |
5,105 | 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. postmenopausal women (normally over 50 years old and years since menopause over than 1
year) in Peking.
2. participants without any fracture in 2007 PK-VF study were included in the prospective
study investigating the association of bone turnover markers/BMD/25(OH)D with fracture
incidence.
Exclusion Criteria: participants with years since menopause less than 1 year.
Female
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 108 Years | A 5-Year Follow-up Study Investigating Factors Associated With Osteoporotic Fracture in Chinese Postmenopausal Women | NCT02247011 | Contradiction |
243 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
1. Women aged 18-50 years, inclusive
2. General good health, by volunteer history and per investigator judgment
3. History of regular menstrual cycles of 24-35 days (inclusive), by volunteer report
4. History of Pap tests and follow-up consistent with standard medical practice or
willing to undergo a Pap test at Visit 1.
5. Protected from pregnancy by female tubal sterilization
6. Willing to abstain from or engage in intercourse with and without condoms and to
abstain from other vaginal activity as required in the protocol
7. In a mutually monogamous relationship for at least the last four months with a male
partner who:
1. Is at least 18 years old;
2. Has no known risk for STIs;
3. Is willing and able to comply with protocol requirements including sexual
activity/ abstinence and condom use requirements; and
4. Can engage in vaginal intercourse with the participant, with and without condoms,
as specified in protocol
8. Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
easy colposcopy and genital tract sample collection
9. Willing to give voluntary consent, sign an informed consent form and comply with study
procedures as required by the protocol
Exclusion Criteria:
1. History of hysterectomy
2. Vasectomy in male partner
3. Sterility or known history of sperm dysfunction in male partner
4. Within two calendar months from the last pregnancy outcome. Note: If recently pregnant
must have had at least two spontaneous menses since pregnancy outcome.
5. Current use of any hormonal contraceptive or a copper IUD, or use of Depo-Provera
within the last 120 days
6. Currently breastfeeding or having breastfed an infant in the last two months, or
planning to breastfeed during the course of the study
7. Significant gynecological abnormalities (including abnormal vaginal bleeding or
excessive vaginal discharge)
8. Either device does not appropriately fit volunteer, as determined by clinician
9. Inability of the volunteer to insert, position, and/or remove either device, even with
assistance
10. History of sensitivity/allergy to nonoxynol-9 or to silicone or any other component of
Ovaprene™ or Caya, for either the volunteer or her male partner
11. In the last four months, either the volunteer or her male partner diagnosed with or
treated for any STI or pelvic inflammatory disease. Note: Women or male partners with
a history of genital herpes or condylomata who have been asymptomatic for at least six
months may be considered for eligibility
12. Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis,
or HIV
13. Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or
vesicles suspicious for a sexually transmitted infection
14. Chronic or acute vulvar or vaginal symptoms (pain, irritation, spotting, etc.)
15. Known current drug or alcohol abuse which could impact study compliance. (This is
defined as any illicit drug use or more than 15 alcoholic drinks per week)
16. Participation in any other investigational trial within the last 30 days or planned
participation in any other investigational trial during the study
17. History of gynecological procedures (including genital piercing) on the external
genitalia, vagina or cervix within the last 14 days
18. Abnormal finding on laboratory or physical examination or a social or medical
condition in either the volunteer or her male partner which, in the opinion of the
investigator, would make participation in the study unsafe or would complicate
interpretation of data
19. Nugent score greater than or equal to 7
20. Systemic use in the last two weeks or anticipated use during the study of antibiotics
(other than those used to treat UTI, vaginal candidiasis, or BV diagnosed at Visit 1,
or to treat UTI or vaginal candidiasis after Visit 1) or topical antivirals (e.g.,
acyclovir or valacyclovir). Note: Participants should avoid non-steroidal
anti-inflammatory drugs (NSAIDs) and Tylenol except for occasional use, as in
treatment of headaches or dysmenorrhea.
21. Grade 2 or higher abnormality per the March 2017 update of the Division of AIDS
(DAIDS), National Institute of Allergy and Infectious Disease (NIAID) Table for
Grading of the Severity of Adverse Events or clinically significant lab abnormalities
as determined by the investigator (see Section 13.5 for link to DAIDS table)
22. Inability to achieve adequate cervical mucus in two attempts at the baseline cycle
23. Inadequate sperm in endocervical aspirate during baseline testing without any device,
despite adequate mucus and presence of sperm in vaginal pool
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 50 Years | Safety and Acceptability Study of a Non-Hormonal Ring | NCT03598088 | Contradiction |
6,299 | 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:
- Age >=18 years
- Positive test for SARS-CoV-2
Exclusion Criteria:
- Due to the non-interventional design of the registry there are no specific exclusion
criteria.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Austrian COVID-19 Registry | NCT04351529 | Entailment |
2,825 | 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:
- Definite ALS
Exclusion Criteria:
- Primary Lateral Sclerosis (PLS)
- Other forms of motor neuron disorders
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Ultrasonography of the Neuromuscular Degeneration Behavior in Amyotrophic Lateral Sclerosis | NCT03683875 | Entailment |
6,527 | 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 70 years
- Subjects with severe hemophilia A (< 1% factor VIII [FVIII]:C)
- Subjects with equal or greater than 150 exposure days (EDs) with any FVIII in total
- Subjects who have been on-demand treatment with a minimum of 1 relevant bleed per
month or have been on secondary prophylaxis treatment with not more than a 3x/week
schedule
- Subjects with bleeding events and/or treatments during the last 6 months prior to
study entry which are documented in the subjects medical records
- Subjects with no measurable inhibitor activity
- Subjects with no history of FVIII inhibitor antibody formation
- Written informed consent by subject and parent / legal representative, if < 18 years
Exclusion Criteria:
- Subjects who are receiving primary prophylaxis
- Subjects on prophylaxis with documented requirements of > 75 IU/kg/week
- Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand
disease)
- Subjects with abnormal renal function
- Subjects with elevated hepatic transaminases
- Subjects on treatment with immunomodulatory agents within the last 3 months prior to
study entry or during the study
- Subjects with known hypersensitivity to the active substance, mouse or hamster
protein, liposomes or polyethyleneglycol (PEG)
- Subjects who require any pre-medication for FVIII injections
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
Subject must be at most 70 Years | BAY79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A | NCT00623727 | Contradiction |
1,020 | 4 | A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes. The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief. Past medical history is notable for hypertension and hypercholesteremia. Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints. | I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints. | Inclusion Criteria:
- Patients with unilateral and bilateral knee OA
- O.A with grade 2-3(Kellgren and Lawrence system for classification of osteoarthritis
of knee)
- Experiencing Pain for more than 1 month
Exclusion Criteria:
- Rheumatic diseases, inflammatory arthritis, septic arthritis
- Intra-articular corticosteroid injection during the past month
- Patients with fracture
- Patients with any carcinoma
- if patient having any other systemic illness.
- Allergic reaction to KT
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 60 Years | Effects of Kinesio-taping in Knee Osteoarthritis Patients. | NCT04585373 | Entailment |
1,122 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Syncope of uncertain etiology or
- Pre-syncope of uncertain etiology or
- Palpitations of uncertain etiology or
- Management of known AF/SVT patients
Exclusion Criteria:
- Any abnormal or friable skin over the anterior thorax and upper abdomen
- Sternal incision within 3 months from the date of enrollment
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.
| The Simple ECG Monitoring Trial (Comparison of a Novel Recording System With a Standard Holter Monitor) | NCT01382953 | Entailment |
2,067 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- Patients with a confirmed diagnosis of Pulmonary Fibrosis
- Patients had to be medically stable to participate in such a programme
Exclusion Criteria:
- Any orthopaedic or neurological condition affecting mobility
- If they required oxygen therapy this had to be used
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.
| Effects of Pulmonary Rehabilitation on Functional and Health Status Measures in Pulmonary Fibrosis | NCT03542318 | Entailment |
4,666 | 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:
- Have the indication for hysterectomy for a supposed benign uterine disease
- Have a giant uterus of 500g or more
- Estimation of uterine weight more than 500g
- Uterine myoma size at 4 months or more after pregnancy due to pelvic examination
- The length of the long axis of one uterine myoma is more than 8cm or the length of the
long axis for over 2 uterine myomas is more than 6cm
- Have been not pregnant at the time of presentation
- Have been appropriated medical status for laparoscopic surgery (surgery (American
Society of Anesthesiologists Physical Status classification 1 or 2)
Exclusion Criteria:
- Have a suspicion of malignancy or malignant tumors (cervical cancer, ovarian cancer,
fallopian tube cancer, peritoneal cancer, Endometrial cancer)
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 55 Years | Comparison of TLH and LAVH With Over Than 500g | NCT03146299 | Entailment |
185 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Male subjects with a prior documented definitive diagnosis of hypogonadism as
evidenced by previously documented:
- Hypothalamic, pituitary or testicular disorder or age related idiopathic
hypogonadism
- Screening serum testosterone of less than or equal to 300 ng/dL (based on the
average of two morning samples taken at least 30 minutes apart)
- Were currently receiving treatment for hypogonadism in accordance with approved
labelling, or in the Investigator's opinion are eligible to receive such treatment
- Body Mass Index (BMI) < 35.0 kg/m^2
- Haemoglobin levels at screening greater than or equal to 11.5 g/dL
- Adequate venous access on left or right arm to allow collection of a number of samples
by venipuncture
- Ability to communicate with the trial staff, understand the Trial Information Sheet
and sign the Written Informed Consent Forms; willing to follow the Protocol
requirements and comply with Protocol restrictions and procedures
Exclusion Criteria:
- Current use of long acting testosterone injectables such as Nebido®
- Any significant history of allergy and/or sensitivity to the drug products or their
excipients, including any history of sensitivity to testosterone and/or sunscreens
- Any clinically significant chronic illness or finding on screening physical exam
and/or laboratory testing that makes it undesirable for the Investigator to enrol the
trial subject in the trial and/or that in the Investigator's opinion, would interfere
with the trial objectives or safety of the subject
- Chronic skin disorder (e.g. eczema, psoriasis) likely to interfere with transdermal
drug absorption
- Men with suspected reversible hypogonadism
- Any man in whom testosterone therapy was contraindicated, which included those with:
- Known or suspected carcinoma (or history of carcinoma) of the prostate or
clinically significant symptoms of benign prostatic hyperplasia and/or clinically
significant symptoms of lower urinary obstruction and International Prostate
Symptom Scores (IPSS) scores of greater than or equal to 19
- Known or suspected carcinoma (or history of carcinoma) of the breast
- Severe liver disease (i.e. cirrhosis, hepatitis or liver tumours or liver
function tests >2 times the upper limit of the normal range values)
- Active deep vein thrombosis, thromboembolic disorders or a documented history of
these conditions
- Current significant cerebrovascular or coronary artery disease
- Untreated sleep apnoea
- Haematocrit of > 51
- Untreated moderate to severe depression
- Men with clinically significant prostate exam (such as irregularities or nodules
palpated) or clinically significant elevated serum Prostate Specific Antigen (PSA)
levels (>4 ng/mL), or age adjusted reference range of PSA values
- Current or history of drug or alcohol abuse (more than 4 standard drinks per day
and/or abnormal liver function tests >2 times the upper limit of the normal range
values)
- Men taking concomitant medications (prescribed, over-the-counter or complementary)
that would affect sex hormone binding globulin (SHBG) or testosterone concentrations
or metabolism, warfarin, insulin, opiates, Gonadotropin-releasing hormone (GnRH), 5
alpha reductase inhibitors, propanolol, oxyphenbutazone, corticosteroids (except for
physiological replacement doses), estradiol
- Men involved in sport in which there is screening for anabolic steroids
- Men with uncontrolled diabetes (haemoglobin A1c [HbA1c] greater than or equal to 10%)
- Men currently taking any investigational product, or have received an investigational
product within 28 days prior to screening or 5 half-lives
- Any contraindication to blood sampling
- Subjects intending to have any surgical procedure during the course of the trial
- Subjects with a partner of child bearing potential who are not willing to use adequate
contraception for the duration of the trial
- Subjects whose partners are pregnant
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| A Titration Trial to Determine the Effectiveness of Testosterone MD-Lotion (Cutaneous Solution) Formulations | NCT00702650 | Entailment |
2,753 | 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:
- Clinical diagnosis of inguinal hernia
Exclusion Criteria:
- Femoral hernia
- Emergency cases
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
Subject must be at most 80 Years | Effectiveness of Topical Antibiotic Prophylaxis in Inguinal Hernia Repair | NCT01273818 | Entailment |
3,601 | 28 | A 23-year-old woman comes to the emergency department with a history of nosebleeds lasting for 1 hour. She has a history of heavy menses as well as occasional gum bleeding following dental procedures. Her mother also has a history of menorrhagia. Laboratory tests reveal increased bleeding time and slightly increased partial thromboplastin time. She has no other medical conditions and is otherwise healthy. Her coagulation study shows CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. She is not smoking or using any kind of illicit drugs. She uses alcohol occasionally and is in ra elationship with her boyfriend for the past 2 years. | I had to rush to the ER because of a non-stop nosebleed that had been on for 1 hour. As a 23-year-old, I always had heavy periods, and sometimes, my gums would bleed after going to the dentist or brushing my teeth. I thought that it was not very alarming since my mom also had heavy periods. I did some lab tests that showed that I had increased bleeding time and long clotting time. Otherwise, I'm pretty healthy, and I don't smoke or take any kind of drugs. I drink only at parties from time to time. I have been with my boyfriend for the last 2 years. I did a coagulation study and I got the following results: CB = 0.30 IU/mL and FVIII:C = 0.37 IU/mL. | Inclusion Criteria:
- Anyone over the age of 18 with a generalized complaints able to provide consent
Exclusion Criteria:
- Anyone under 18 yrs and anyone with a very specific, system based complaint.
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.
| Utility of the History and Physical Exam in the Emergency Department | NCT01154517 | Contradiction |
6,826 | 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:
- hemophilia A, any severity, with documented history of high-titer inhibitor (>5BU);
current use of bypassing agents (PCCs, aPCCs or rFVIIa) for treatment of bleeds; >/= 6
bleeds requiring bypassing therapy in the previous 6 months
Exclusion Criteria:
- concomitant immune tolerance therapy; clinically symptomatic liver disease, platelet
count less than 100,000
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 24 Months old.
| Efficacy Study of Activated Prothrombin Complex for Prevention of Bleeds in Hemophilia A With Inhibitors | NCT00221195 | Entailment |
2,617 | 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:
- Patients who underwent inguinal hernia repair with the 3D dynamic responsive device
named ProFlor
- Patients undergoing recurrent inguinal hernia repair after primary repair with the 3D
dynamic responsive device named ProFlor
- Patients undergoing surgical procedure in the groin area after inguinal hernia repair
with the 3D dynamic responsive device named ProFlor
Exclusion Criteria:
- immunosoppressive therapy, > ASA 4 classification
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 85 Years | Neo-angiogenesis in Inguinal Henia Implant ProFlor | NCT04541316 | Contradiction |
3,079 | 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:
- students with ID (mild category) aged 8-18 years old from special education schools
including primary and secondary schools;
Exclusion Criteria:
- students without physical disability.
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 18 Years | Effectiveness of Active Video Games in Children With Intellectual Disabilities | NCT04277130 | Entailment |
3,070 | 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:
- molecular documentation of FMR1 full mutation
- ages 6-17 yrs, inclusive
- sexually active subjects are required to use a medically acceptable form of birth
control
Exclusion Criteria:
- non-English or Spanish speaking subjects
- concomitant systemic steroid, vigabatrin, felbamate and ketoconazole
- changes in medications within last 2 months
- clinically unstable medical disease, progressive CNS disease/disorder
- history of recurrent status epilepticus
- unwilling to withhold grapefruit or grapefruit juice for the duration of the study
- actively suicidal
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 17 Years | Ganaxolone Treatment in Children With Fragile X Syndrome | NCT01725152 | Entailment |
3,258 | 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:
- Demonstrates understanding of the study procedures, restrictions and willingness to
participate as evidenced by voluntary written informed consent and has received a
signed and dated copy of the informed consent form
- Good general and mental health with, in the opinion of the investigator or medically
qualified designee no clinically significant and relevant abnormalities in medical
history or upon oral examination
- Subject with stable and controlled condition with no overt medical conditions which
would contraindicate participation (in the opinion of the Investigator or medically
qualified designee) and no clinically significant and relevant abnormalities of
medical history or oral examination which would interfere with the conduct of the
study
- All subjects should report having a feeling of a dry mouth according to the DMSQ.
(Subject must answer at least 2 out of the 4 questions with 'agree a little', 'agree'
or 'strongly agree'
- Participation in another clinical study (including cosmetic studies) or receipt of an
investigational drug within 14 days of the screening visit
- Previous participation in this study
- Recent history (within the last 1 year) of alcohol or other substance abuse
- An employee of the sponsor or the study site or members of their immediate family
- Subjects with Sjögren's Syndrome along with reporting having a feeling of dry mouth
according to the DMSQ, should also have a confirmed diagnosis of their condition as
shown by a positive salivary gland biopsy or SS-A (anti-Ro antibody) or SS-B (La
antibody) or a letter from a physician if diagnosis was made more than 3 years ago OR
Subjects reporting having a feeling of dry mouth due to other diseases or conditions
excluding Sjögren's Syndrome
- Understands and is willing, able and likely to comply with all study procedures and
restrictions.
Exclusion Criteria:
- Women who are known to be pregnant or who are intending to become pregnant over the
duration of the study
- Women who are breast-feeding
- Subject is currently undergoing radiotherapy and/or chemotherapy treatment
- Any condition the investigator identifies that can confound the subject's ability to
properly participate in the study e.g. Alzheimer's Disease
- Subjects with untreated oral mucosal disease which in the opinion of the investigator
could interfere with the study (e.g. current oral ulceration)
- Evidence of gross intra-oral neglect or need for extensive dental therapy
-. Denture wearer (complete dentures)
- Subjects not on stable doses of prescription systemic parasympathetic medications
(e.g. Pilocarpine), for the treatment of the feeling of dry mouth
- Known or suspected intolerance or hypersensitivity to the study materials (or closely
related compounds) or any of their stated ingredients
- Participation in another clinical study (including cosmetic studies) or receipt of an
investigational drug within 14 days of the screening visit
- Previous participation in this study
- Recent history (within the last 1 year) of alcohol or other substance abuse
- An employee of the sponsor or the study site or members of their immediate family
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 | Potential of an Experimental Mouthwash Formulation to Reduce Dry Mouth Symptoms | NCT02641912 | Entailment |
1,462 | 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. | Healthy Cohort:
132 individuals with no history of swallowing impairment or any health conditions known to
impact swallowing function will be included in this study to serve as a comparative control
group or reference standard group here and in future studies.
Inclusion criteria:
1. Adults aged 18-90.
2. No history of stroke, head and neck cancer or other disorder that might contribute to
a swallowing impairment.
3. No COVID-19 symptoms within the past 14 days, nor has been around someone testing
positive for COVID-19 in the past 14 days.
4. Not pregnant.
5. No allergies to barium.
Exclusion criteria:
1. Individuals under the age of 18 or over the age of 90.
2. History of stroke, head and neck cancer or other disorder that might contribute to a
swallowing impairment.
3. Within the past 14 days, individuals with COVID-19 symptoms or a positive COVID-19
test, or who have been exposed to someone with confirmed COVID-19.
4. Pregnant women.
5. Individuals with allergies to barium.
Disordered Cohort:
132 individuals with an underlying condition documented to lead to dysphagia will be
enrolled in this study.
Inclusion criteria:
1. Adult participants aged between 18 and 90 years.
2. Confirmed medical diagnosis associated with an increased risk of dysphagia including
but are not limited to: head and neck cancer, neurologic (e.g., stroke, traumatic
brain impairment), neurodegenerative (e.g., Parkinson's disease, amyotrophic lateral
sclerosis), neuromuscular disorders (e.g., myotonic dystrophy, Pompe disease,
inclusion body myositis) rheumatologic diseases (e.g., dermatomyositis, inclusion body
myositis, scleroderma), chronic respiratory illnesses (e.g., chronic obstructive
pulmonary disease), structural (e.g., mass or trauma to the upper aerodigestive tract)
and iatrogenic conditions (e.g., post-surgical such as anterior cervical
discectomy/fusion or cardiac, post-radiation treatment to the upper aerodigestive
tract).
3. No COVID-19 symptoms within the past 14 days, nor has been around someone testing
positive for COVID-19 in the past 14 days.
4. Not Pregnant.
5. No allergies to barium.
Exclusion criteria:
1. Individuals under the age of 18 or over the age of 90
2. Within the past 14 days, individuals with COVID-19 symptoms or a positive COVID-19
test, or who have been exposed to someone with confirmed COVID-19.
3. Pregnant women.
4. Individuals with allergies to barium.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 90 Years | Improving Diagnostic Standards in Dysphagia | NCT04773184 | Entailment |
4,462 | 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:
- Individuals with clinical evidence of lateral or medial epicondylitis of the elbow.
- Age 18 or higher
- Minimum of 4 on Question 5 of BPI
Exclusion Criteria:
- Peripheral neuropathy of any origin in the index limb
- Cubital tunnel syndrome in patients with medial epicondylitis
- Cortisone injection in the last 4 weeks into the index limb
- Surgical intervention in the past for the epicondiitis
- Participants in any other clinical trial in the last 30 days
- Known allergy to lidocaine, tetracaine, NSAIDs or PABA
- Uncontrolled pain in the upper extremity or neck that may interfere with evaluation of
study drug's response as deemed by the investigator
- Patient who is deemed to be medically unstable by the principal investigator including
but not limited to Liver disease or Cardiac arrhythmias
- Patients who are pregnant, lactating or breast feeding
- Vaccination within the last weeks or planning on any vaccinations during the study or
for 4 weeks after the study completion.
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 | Study to Evaluate the Efficacy of the Synera Patch Compared to Naproxen Sodium for Epicondylitis of the Elbow | NCT01525043 | Contradiction |
3,743 | 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. ethnic Chinese;
2. aged 60 years or above;
3. ability to comprehend Chinese;
4. fulfilling any 3 of the following criteria: i. morning stiffness </= 30 min; ii.
crepitus on active joint motion; iii. bone tenderness; iv. bone enlargement; or v. no
palpable joint warmth (This classification yielded 84% sensitivity and 89% specificity
for OA knee diagnosis (Altman et al., 1986);
5. having knee pain for at least 3 months;
6. Knee pain ≥4 on a Likert pain scale from 1-10; and
7. willing to provide informed consent.
Exclusion Criteria:
1. medical diagnoses or conditions that preclude individuals from active participation
(e.g. dementia, post-stroke syndrome, alcohol or drug abuse);
2. knee pain related to other conditions (cancer, fracture, rheumatoid arthritis,
rheumatism) as screened according to the red flags for further investigation or
referral in the National Clinical Guideline Centre 2014 Guidelines for Osteoarthritis
of the knee (National Clinical Guideline Centre, 2014);
3. presence of skin lesions or infections at the treatment sites;
4. ever had knee replacement surgery or knee joint implant; and
5. ever received moxibustion, electromoxibustion or steroid injection for knee pain over
the past 6 months; Further investigation or referral, either at the screening or
during the study, will be made when necessary.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 60 Years old.
| Electromoxibustion and Knee Health Education for Knee Osteoarthritis in Older Adults | NCT04034394 | Contradiction |
4,524 | 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:
- healthy white women aged 21-42 who were planning to become
pregnant
-women enrolled in the 1982-1986 North Carolina Early Pregnancy
Study (EPS) at the time they discontinued all methods of birth control
Female
No healthy subjects accepted to join the trial.
Subject must be at least 21 Years old.
Subject must be at most 42 Years | Factors Influencing Fertility or Pregnancy Health | NCT04595760 | Contradiction |
5,188 | 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:
- Aged between 55 and 85 years
- Postmenopausal (have not had any menses in the last 5 years)
- Have a bone mineral density scan (DXA) that can be evaluated at the spine AND at the
hip with a T-score equal to or below -2.5 at the spine or the femoral neck or total
hip OR T-score equal to or below -2.0 at the spine or the femoral neck or total hip
and have at least one of the following risk factors for fracture: (a) age > 65 years;
(b) history of postmenopausal fracture (nonvertebral or vertebral); or (c) maternal
history of hip fracture
- Willing and able to self-administer daily injections
Exclusion Criteria:
- Have used estrogen (oral or patch) for more than 1 month in the last 6 months or more
than 12 months in the last 2 years
- History of more than 12 months of bisphosphonate use ever, or any use (> 4 weeks)
within the past 12 months
- History of rhPTH (recombinant human PTH) use
- Any major life-threatening illnesses
- Type 1 or uncontrolled type 2 diabetes mellitus (defined as hemoglobin A1C > 10.0), or
currently using insulin
- Vitamin D level < 15 nanograms/ml
- History of kidney disease (creatinine > 2.0 mg/dl)
- Renal insufficiency (creatinine clearance < 40 mg/min)
- Any history of kidney stones
- Any history of hypercalciuria or currently have urine calcium/creatinine >300 mg
- History of hypercalcemia, sarcoidosis, or hyperparathyroidism
- History of active or treated tuberculosis or other granulomatous disorders
- History of breast cancer, melanoma, or hematologic malignancy that has required
treatment within the last 10 years
- History of bone cancer or any other metabolic bone disease that has required treatment
within the last 10 years
- History of any other nonskin cancer that has required treatment within the last 10
years
- History of symptomatic esophageal reflux, achalasia or esophageal stricture
- Currently taking > 7.5 mg systemic prednisone or equivalent per day
- Currently using > two puffs, four times/day of inhaled steroids
- Currently taking anticoagulants or anticonvulsants
- Have used Calcitonin within the past 3 months
- Have used Raloxifene in the last 6 months or for more than 12 months in the last 2
years
- Have used Tamoxifen in the last 6 months or for more than 12 months in the last 2
years
- Have used fluoride for at least a month within the past 5 years
- Currently taking > 1000 IU/day vitamin D or vitamin D analogues or metabolites
- Currently taking thyroid hormone replacement AND have a TSH < 0.1mIU/L
Female
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
Subject must be at most 85 Years | PaTH Study: Parathyroid Hormone and Alendronate for Osteoporosis | NCT00005005 | Entailment |
6,589 | 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:
- Females with severe (FVIII<0.01u/ml) or moderate (FVIII 0.01≤0.05 u/ml) hemophilia A
- Females with severe (FIX<0.01u/ml) or moderate (FIX 0.01≤0.05u/ml) hemophilia B
- Willingness to participate in the study.
Exclusion Criteria:
- Subjects who do not meet the inclusion criteria with respect to gender or hemophilia
severity.
Female
No healthy subjects accepted to join the trial.
| Females With Severe or Moderate Hemophilia A or B: an International Multi-center Study | NCT00936312 | Contradiction |
1,605 | 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. virgins.
2. Their age ranged from 18 to 25 years old
3. Their body mass index (BMI) ranged from 18 to 25 kg/m2.
4. They were clinically and medically stable during the study
5. Have regular menstrual cycle of 23 to 35 days duration
Exclusion Criteria:
1. cardiopulmonary or orthopaedic problems
2. women taking any hormonal drugs or drugs that affect hormones as antidepressnats
during the preceding 3 months before participation in the study
3. any abnormality in ovulation or those with pelvic inflammatory diseases (PID).
4. Women with endocrine abnormality as thyroid, pituitary or ovarian disorders
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 25 Years | Effect of Swimming on Premenstrual Syndrome | NCT03264612 | Contradiction |
6,614 | 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:
- 12 years of age or older (at least 18 years in Croatia, France and United Kingdom
(UK))
- Clinical diagnosis of congenital haemophilia A or B with a current positive inhibitor
titre and a known peak inhibitor of above 5 Bethesda units (BU) (present or in the
past) to human FVIII or IX and known antihuman FVIII or IX anamnestic response
- Minimum of 2 joint bleeds (haemarthroses of ankles, knees, or elbows) requiring
haemostatic drug treatment within the previous 6 months, or at least 4 joint bleeds
(hemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within
the previous 12 months at trial entry
Exclusion Criteria:
- Known allergy to rFVIIa, and/or suspected allergy to trial product
- Platelet count lower than 50,000 mm^3 based on medical records at trial entry (visit
1)
- Any clinical signs or history of thromboembolic events
- Advanced atherosclerotic disease
- Severe liver disease based on medical records within the past 12 months at trial entry
(Visit 1), as defined by alanine aminotransferase (ALAT) above 3 times the upper limit
of normal reference range
- Known active pseudo tumours (documented bleeding requiring treatment within the last 3
months
- Subject had any (major) surgical procedure in the 30 days prior to screening into the
trial. a. Catheter, ports and dental extractions do not count as surgeries and will
not exclude the subject
Male
No healthy subjects accepted to join the trial.
Subject must be at least 12 Years old.
| Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds | NCT00486278 | Contradiction |
5,187 | 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:
- Clinical diagnosis of osteoporosis patients
Exclusion Criteria:
- Any previous use of parathyroid hormone or sodium fluoride, use of anabolic steroids
or growth hormone within 6 months before trial entry or oral or intravenous systemic
corticosteroids within 12 months, and any previous use of strontium.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
Subject must be at most 70 Years | Kefir on Bone Mineral Density and Bone Metabolism in Osteoporotic Patients | NCT02361372 | Entailment |
5,199 | 39 | A 55-year-old white woman comes for a routine checkup. She has no significant medical history and does not use tobacco, alcohol, or illicit drugs. The patient's only medication is an over-the-counter multivitamin. Family history is notable for a hip fracture in her mother. Blood pressure is 130/80 mm Hg and pulse is 112/min. She has occasional back pain and lives a sedentary lifestyle with the BMI of 24 Kg/m2. Plain X-ray of the spine shows mild compression fracture at the level of T10. X-ray absorptiometry studies demonstrate abnormally low bone density in the lumbar vertebrae and T-score values below -2.5, which confirms the diagnosis of osteoporosis. | I'm a 55-year-old white woman and I recently visited my family doctor. I don't smoke anything or drink. I don't have any remarkable medical history. I only use over-the-counter multivitamins to keep myself fresh and energized. My mom had a hip fracture. The doctor took my blood pressure and it was 130/80 and my pulse was 112/min. I have annoying back pain from time to time and to be honest I don't exercise much or move much. My BMI is 24. I did a spine X-ray a while ago and my doctor showed me that I have a fracture on one of my vertebrae. I also have a low bone density in my lumbar vertebrae and T-score values below -2.5. The doctor diagnosed me with osteoporosis. | Inclusion Criteria:
- Ambulatory, postmenopausal women aged 55-85 years (at least 3 years have elapsed after
menopausal) are included at the time of entry into the trial. They have to be free of
severe or chronically disabling conditions other than osteoporosis.
- The patient should have a documented (X-ray) prevalent osteoporotic vertebral fracture
(defined as 3.4) or non vertebral fragility fracture (excluding major trauma).
- L-1 through L-4 vertebrae must be without artifacts, multiple vertebral fractures;
therefore at least 3 vertebrae should be without fractures, osteophytes, or other
abnormalities that would interfere with the analysis of the posterior-anterior lumbar
spine BMD measurement. The reading of the BMD, T-score should be in the range of - 2.0
and - 4.0 at least for one of the 2 sites measured (spine or hip). The initial lumbar
spine and femoral neck BMD assessment and the determination of the patient's
eligibility for entry into the screening phase will be made by the central quality
assurance for BMD. The central quality assurance center will determine the patient's
eligibility for enrollment into the treatment phase. If the L-1 through L-4 vertebrae
cannot be analyzed due to artifacts, vertebral fracture, osteophytes, or other
abnormalities, that vertebra should be excluded from the analysis.
- Women without language barrier, cooperative expected to return for all follow-up
procedures and who have given informed consent before entering the study and after
being informed of the risks, medications, and procedures to be used in the study.
- Normal or clinically insignificant abnormal laboratory values including serum calcium,
PTH(1-84) levels and alkaline phosphatase.
Exclusion Criteria:
- History of diseases which affect bone metabolism other than postmenopausal
osteoporosis such as Paget's disease, renal osteodystrophy, osteomalacia, any
secondary causes of osteoporosis, hypoparathyroidism, hyperparathyroidism, or
hyperthyroidism.
- Patients who have an increased baseline risk of osteosarcoma: Paget's disease of the
bone or unexplained elevations of alkaline phosphatase; Children and young adult with
open epiphyses; Patients who have received radiation therapy involving the skeleton.
- History of other malignant neoplasms in the 5 years prior to screening, with the
exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin
that has been definitively treated. Patients with carcinoma in situ of the uterine
cervix treated definitively more than 1 year prior to entry into the study may enter
the study.
- History of nephrolithiasis or urolithiasis in the 2 years prior to Visit 2. Patients
with any history of nephro- or urolithiasis must have an appropriate radiology study
within 6 months prior to Visit 2. This radiology study, such as an intravenous
pyelogram or a supine radiograph of the kidney-ureter-bladder, must document the
absence of active disease.
- History of sprue, inflammatory bowel disease, or malabsorption syndrome in the 1 year
prior to Visit 2.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 55 Years old.
Subject must be at most 85 Years | Comparison Medications in the Treatment of Postmenopausal Women With Osteoporosis | NCT00542984 | Entailment |
5,680 | 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. | Main Study Inclusion Criteria:
1. Pre-pubertal children aged ≥3 years , and not yet 11 years for girls or not yet 12
years with either isolated GHD, or GH insufficiency as part of multiple pituitary
hormone deficiency.
2. Confirmed diagnosis of GHD by two different GH provocation tests defined as a peak
plasma GH level of ≤10 ng/mL,
3. Bone age (BA) is not older than chronological age and should be less than 10 for girls
and less than 11 for boys.
4. Without prior exposure to any r-hGH therapy (naïve patients).
5. Impaired height and height velocity defined as:
- Annualized height velocity (HV) below the 25th percentile for CA (HV < -0.7 SDS)
and gender according to sponsor calculator using Tanner, Prader, and Hermanussen
- The interval between 2 height measurements should be at least 6 months, but
should not exceed 18 months prior to inclusion
6. Baseline IGF-I level of at least 1 SD below the mean IGF-1 level standardized for age
and sex (IGF-1 SDS ≤-1)
7. Normal calculated GFR per updated bedside Schwartz formula
8. Children with multiple hormonal deficiencies must be on stable replacement therapies
(no change in dose) for other hypothalamo-pituitary-organ axes for at least 3 months
prior ICF signing
9. Normal 46XX karyotype for girls.
10. Provide consent/assent
LT-OLE Inclusion Criteria:
11. Completion of the main study (12 months of treatment) with adequate compliance.
12. Provide consent/assent
13. Agree to refrain from sexual activity
Main Study Exclusion Criteria:
1. Children with prior history of leukemia, lymphoma, sarcoma or any other forms of
cancer.
2. History of radiation therapy or chemotherapy
3. Malnourished children defined as BMI < -2 SDS for age and sex
4. Children with psychosocial dwarfism
5. Children born small for gestational age (SGA - birth weight and/or birth length <-2
SDS for gestational age)
6. Presence of anti-hGH antibodies at screening
7. Any clinically significant abnormality likely to affect growth or the ability to
evaluate growth, such as, but not limited to, chronic diseases like renal
insufficiency, spinal cord irradiation, etc.
8. T2 and T1 diabetic patients, who in the opinion of the investigator are not receiving
standard of care treatment or are non-compliant with their prescribed treatment or who
are in poor metabolic control.
9. Chromosomal abnormalities including Turner's syndrome, Laron syndrome, Noonan
syndrome, Prader-Willi syndrome, Russell-Silver syndrome, SHOX mutations/deletions and
skeletal dysplasias.
10. Concomitant administration of other treatments that may have an effect on growth such
as anabolic steroids, or sex steroids, with the exception of ADHD drugs or HRT
(thyroxin, hydrocortisone, desmopressin)
11. Children requiring glucocorticoid therapy (e.g. for asthma) that are taking
chronically a dose greater than 400 μg/d of inhaled budesonide or equivalent
12. Major medical conditions and/or presence of contraindication to r-hGH treatment.
13. More than one closed epiphyses
14. Known or suspected HIV-positive patient, or patient with advanced diseases such as
AIDS or tuberculosis.
15. Drug, substance, or alcohol abuse.
16. Known hypersensitivity to the components of study medication.
17. Other causes of short stature such as celiac disease, uncontrolled primary
hypothyroidism and rickets.
18. Possible non-compliance in respect to study conduct
19. Participation in any other trial of an investigational agent within 30 days prior to
consent
20. Study enrollment has been met or study is closed by sponsor prior to completion of
screening process.
LT-OLE Exclusion Criteria:
21. Concomitant administration of other treatments that may have an effect on growth such
as anabolic steroids, or sex steroids, with the exception of ADHD drugs or HRT
(thyroxin, hydrocortisone, desmopressin)
22. Change in medical condition during the treatment period (such as, but not limited to,
development of a serious inter-current critical illness, a severe adverse drug
reaction, etc.)
23. Positive pregnancy test
24. Unresolved drug related (Genotropin or MOD-4023) SAE from the treatment period as per
medical monitor judgement.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 11 Years | Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children | NCT02968004 | Contradiction |
1,670 | 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:
- Is the individual a healthy, normal adult man and women who volunteers to participate?
- Is s/he within 18 and 45 years of age, inclusive?
- Is his/her BMI between 19 and 30, inclusive?
- Is she willing to avoid pregnancy by abstaining from sexual intercourse with a
non-sterile male partner, or by the use one of the following methods: diaphragm +
spermicide or condom + spermicide (at least 14 days before dosing), intra-uterine
contraceptive device or hormonal contraceptives (at least 4 weeks prior to dosing), or
has she been surgically sterile or post-menopausal at least six months prior to
entering into the study?
- Is s/he considered reliable and capable of understanding his/her responsibility and
role in the study?
- Has s/he provided written informed consent?
A no answer to any of the above questions indicates that the individual is ineligible for
enrollment
Exclusion Criteria:
Does the individual have a history of allergy or hypersensitivity to desloratadine?
- Does s/he have clinically significant laboratory abnormalities that would interfere
with the conduct or interpretation of the study or jeopardize his/her safety?
- Does s/he have significant history or clinical evidence of auto-immune,
cardiovascular, gastrointestinal, hematological, hematopoietic, hepatic, neurological,
ongoing infection, pancreatic, or renal diseases that would interfere with the conduct
or interpretation of the study or jeopardize his/her safety?
- Is she nursing?
- Does s/he have serious psychological illness?
- Does s/he have significant history (within the past year) or clinical evidence of
alcohol or drug abuse?
- Does s/he have a positive urine drug screen or a positive HIV-1, or hepatitis B or C
screen, or a positive pregnancy test?
- Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or
beverages during periods beginning 48 hours prior to study drug administration and
ending when the last blood sample has been taken in each study period? .
- Has s/he used any prescription drug, other than hormonal contraceptives, during the
14-day period prior to study initiation, or any OTC drug during the 72-hour period
preceding study initiation?
- Is s/he unable to refrain from the use of all concomitant medications, other than
hormonal contraceptives, during the study?
- Has s/he donated or lost blood, or participated in a clinical study which involved the
withdrawal of a large volume of blood (480 mL or more), during the six week period
preceding study initiation?
- Has s/he donated plasma during the two week period preceding study initiation?
- Has s/he used any tobacco products in the 3 months preceding drug administration?
- Has s/he received an investigational drug during the 30 day period preceding study
initiation? A yes answer to any of the above questions indicates that the individual
is ineligible for enrollment.
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 45 Years | Bioavailability Study of Dr. Reddy's Desloratadine Tablets, 5 mg Under Fasting Conditions. | NCT01314339 | Entailment |
2,565 | 19 | A 7-year-old girl is brought to the emergency department by her parents for generalized rash. The mother reports that she was playing outside wearing a skirt and felt a sharp pain in her arm while seating on a mat, plying with her doll. Her mother suspects that something had stung her. The patient's blood pressure is 75/55 mm Hg and her heart rate is 122/min. Physical examination shows erythematous, raised plaques over the trunk, extremities, and face. Lung auscultation reveals bilateral expiratory wheezes. | I just brought my seven-year-old girl to the ER because she just developed a terrible rash. My little girl was playing outside and she was wearing a lovely little skirt and all of a sudden. She felt like a really sharp pain in her arm. She was sitting on a mat playing with her doll. I think that something stung her. They took her blood pressure, and it turned out to be 75 out of 55. Her heart rate was 122. Then they did a physical examination, and it showed rashes all around her trunk, extremities, and face. Her breath test revealed some high-pitched breathing. | Inclusion Criteria:
- Patients <= 12 years of age who have wheezing at the time of study as confirmed by the
physicians' auscultation.
Control:
- Patients <= 12 years of age without history of asthma or other pulmonary conditions,
and who are without wheezing on physical exam.
Exclusion Criteria:
- Medical problems that would contraindicate Wz% measurement.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at most 12 Years | WheezoMeter® Correlation Study | NCT01556958 | Entailment |
1,540 | 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:
Controls-Group 1:
Healthy Diagnosis;
21-80 years;
No Cigarette Smoking;
Plasma Cotinine less than 3 ng/mL;
No olanzapine or risperidone
Smoker Patients-Group 2:
Diagnosis of Schizophrenia;
21-50 years;
Cigarette Smoking greater than 20 per day and greater than 5 years;
Plasma Cotinine greater than 100 ng/mL;
Olanzapine or risperidone greater than 6 mo. and same dose for 2 weeks
Non-Smoker Patients-Group 3:
Diagnosis of Schizophrenia;
21-50 years;
No Cigarette Smoking;
Plasma Cotinine less than 3 ng/mL;
Olanzapine or risperidone greater than 6 mo. and same dose for 2 weeks
Smoker Controls-Group 4:
Healthy Diagnosis;
21-50 years;
Cigarette Smoking greater than 20 per day and greater than 5 years;
Plasma Cotinine greater than 100 ng/mL;
No olanzapine or risperidone
Non-Smoker Controls-Group 5:
Healthy Diagnosis;
21-50 years;
No Cigarette Smoking;
Plasma Cotinine less than 3 ng/mL;
No olanzapine or risperidone
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
| Imaging of Brain Receptors in Healthy Volunteers and in Patients With Schizophrenia | NCT00061789 | Contradiction |
2,220 | 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:
Subjects to be included in the study are:
- Outpatients of either gender, age 18 or older
- Diagnosed with symptomatic gout refractory to conventional therapy or unable to
tolerate conventional therapy (for example: having one or more tophi and/or having
experienced a gout flare within the previous 6 months and/or having chronic, gouty
arthritis)
- Hyperuricemic: screening serum uric acid must be >=8 mg/dL.
- The patient must be willing and able to give informed consent and adhere to
visit/protocol schedules (Consent must be given before any study procedures are
performed)
- Women of childbearing potential must have a negative serum pregnancy test and must use
an approved birth control method during their participation in the protocol. Such
methods include oral, injectable, or implantable contraceptives; IUDs and barrier
contraceptives in combination with spermicide
Exclusion Criteria:
Subjects to be excluded are those for whom any of the following apply:
- Unstable coronary artery disease or uncontrolled hypertension
- History of end stage renal disease requiring dialysis
- History of liver disease, as defined by baseline serum transaminase elevation >3X the
upper limit of normal in the absence of any other known cause
- Organ transplant recipient requiring immunosuppressive therapy
- Concurrent use of prednisone at a dose >10 mg qd (or equivalent) at or within one week
before dosing
- Concurrent use of uric acid-lowering agents
- Prior treatment with Puricase® or other recombinant uricase
- An acute gout flare within one week prior to first treatment with Puricase® (exclusive
of chronic synovitis/arthritis) requiring use of medication which violates the
protocol
- glucose-6-phosphate dehydrogenase deficiency
- A history of anaphylactic reaction to a recombinant protein or porcine derivatives
- Lactation
- Has taken an investigational drug within 4 weeks prior to study drug administration or
plans to take an investigational agent during the study
- Known allergy to urate oxidase or PEGylated products
- Has any other medical or psychological condition which, in the opinion of the
investigator, might create undue risk to the patient or interfere with the patient's
ability to comply with the protocol requirements
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 | A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy | NCT00080210 | Contradiction |
4,917 | 38 | A 60-year-old man comes to the clinic complaining of hand tremor that started few months ago. It is most bothering when he wants to drink from a glass or pour from a bottle. He does not smoke, but drinks occasionally. He recently started consuming more alcohol as his tremor subsides somewhat when he drinks small amounts of alcohol. Family history is significant for similar problems in his mother. Vital signs are normal and the patient has no other medical conditions. Neurologic examination shows bilateral tremor in the upper extremities. The diagnosis of essential tremor is confirmed. | I'm only a 60 years old man but I already suffer from shaky hands. It started a few months ago, and it really bothers me when I want to pour myself a glass or even while drinking. I don't smoke, but I drink alcohol from time to time. To be honest, I've been drinking a little more lately since it helps me with the shaking. My mom had the same issue when she was my age. The doctor took my vitals, and they were normal. I don't have any other medical issues. I underwent neurological exams and it showed that I’m shaky from both sides. The doctor diagnosed me with essential tremor. | Inclusion Criteria:
1. Men and women age 22 years or older;
2. A diagnosis of ET and PD as confirmed from clinical history and examination by a
neurologist or neurosurgeon specialized in movement disorder;
3. Intolerance to side effects of medication or poor response to medication, severe and
disabling tremor;
4. Regarding PD patients, the ratio of mean Unified Parkinson Disease Rating Scale
(UPDRS) tremor scores to the mean UPDRS postural instability/gait disorder scores
equal or greater than 1.5;
5. Able to communicate sensations during the ExAblate TcMRgFUS treatment;
6. All MRI examination performed according to study protocol;
7. Having complete medical history and clinical follow up;
8. Imaging data can be processed.
Exclusion Criteria:
1. Subjects with unstable cardiac status;
2. Severe hypertension (diastolic BP > 100 on medication);
3. Subjects with standard contraindications for MR imaging such as non-MRI compatible
implanted metallic devices including cardiac pacemakers, size limitations, etc;
4. Known intolerance or allergies to the MRI contrast agent (e.g. Gadolinium or
Magnevist) including advanced kidney disease;
5. Patient with severely impaired renal function;
6. History of abnormal bleeding and/or coagulopathy;
7. History of immunocompromise including those who are HIV positive;
8. History of intracranial hemorrhage;
9. Cerebrovascular disease (multiple CVA or CVA within 6 months);
10. Subjects with uncontrolled symptoms and signs of increased intracranial pressure
(e.g., headache, nausea, vomiting, lethargy, papilledema);
11. Individuals who are not able or willing to tolerate the required prolonged stationary
supine position during treatment (can be up to 4 hrs of total table time);
12. Significant claustrophobia that cannot be managed with mild medication;
13. Presence of any other neurodegenerative disease such as Parkinson-plus syndromes
suspected on neurological examination;
14. Presence of significant cognitive impairment;
15. Subjects with life-threatening systemic disease;
16. Subjects with a history of seizures within the past year;
17. Subjects with presence or history of psychosis. -
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 22 Years old.
Subject must be at most 99 Years | Imaging Study of Tremor Disorders | NCT04570046 | Entailment |
66 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
- Healthy men between the ages of 21- 45 that were recreationally active.
Exclusion Criteria:
- Above 30% body composition, not in the age range, history of asthma, diabetes,
hypoglycemia, or took any hormonal supplements such as testosterone or anabolic
steroids.
Male
Accepts Healthy Volunteers
Subject must be at least 21 Years old.
Subject must be at most 45 Years | The Efficacy of Fenugreek Supplementation on Men's Health | NCT03528538 | Contradiction |
921 | 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:
- Stage I - III osteoarthritis / traumatic arthritis of the thumb.
Exclusion Criteria:
- Exclusion criteria were diabetes mellitus, kidney insufficiency, OA in the STT joint,
or malignancy within the past 10 years.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 25 Years old.
Subject must be at most 95 Years | Allograft Meniscal Arthroplasty for the Treatment of Basal Joint Arthritis of the Thumb | NCT01542515 | Entailment |
4,412 | 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:
1. Adult between 18 and 60 years old that is able to speak English.
2. Report of at least 6 weeks of elbow (i.e. lateral epicondyle) and dorsal forearm pain,
consistent with lateral epicondylitis:
3. Patient has not had physical therapy, massage therapy, chiropractic treatment or
injections for elbow pain in the last 6 months:
4. Diagnosis of lateral epicondylitis, defined as two of more of the following:
1. Pain on palpation over the lateral epicondyle and the associated common extensor
unit
2. Pain on gripping a hand dynamometer
3. Pain with stretching or contraction of the wrist extensor muscles
Exclusion Criteria:
1. Report of red flags to manual physical therapy to include: severe hypertension,
infection, uncontrolled diabetes, peripheral neuropathy, heart disease, stroke,
chronic ischemia, edema, severe varicosities, tumor, metabolic disease, prolonged
steroid use, fracture, RA, osteoporosis, severe vascular disease, malignancy, etc.
2. Report of Previous surgery of the elbow, history of elbow dislocation, elbow fracture
and/or tendon rupture
3. Report of systemic neurological disorders and/or neurological deficits to include the
following:
1. Nerve root compression (muscle weakness involving a major muscle group of the
upper extremity, diminished upper extremity deep tendon reflex, or diminished or
absent sensation to pinprick in any upper extremity dermatome)
2. Cervical spinal stenosis (exhibited bilateral upper extremity symptoms)
3. Central nervous system involvement (hyperreflexia, sensory disturbances in the
hand, intrinsic muscle wasting of the hands, unsteadiness during walking,
nystagmus, loss of visual acuity, impaired sensation of the face, altered taste,
the presence of pathological reflexes)
4. History of whiplash injury within the previous 6 weeks
4. History of surgery to the head/neck or affected upper extremity.
5. Psychiatric disorders or cognitively impaired
6. 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 60 Years | Dry Needling, Manipulation and Stretching vs. Manual Therapy, Exercise and Ultrasound for Lateral Epicondylalgia | NCT03167710 | Contradiction |
4,723 | 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:
- They are adult female volunteers, 18 to 45 years of age, who have signed an informed
consent form following a detailed written explanation of participation in the
protocol.
- They are volunteers who are in good health as determined by medical history, physical
examination and clinical judgement.
- They are available for the duration of the study.
- They are women who, if capable of becoming pregnant during the study, have agreed to
have a pregnancy test immediately before immunisation, and to use appropriate
contraception methods during the whole study period. Appropriate contraception shall
include physician-prescribed oral hormonal agents, barrier contraceptives, regular and
consistent use of condoms without spermicidal agents, or intrauterine devices only.
Progesterone-only contraceptives are not suitable due to the lack of a regular
menstrual cycle.
- They have agreed not to undertake any vaginal practices other than receptive
intercourse with a male or use of sanitary tampons during menses. Use of condoms
without spermicidal agents is encouraged.
- They have not donated blood during 3 months prior to study entry and agree to not
donate for 3 months after the end of their participation in the study.
Exclusion Criteria:
- They have hypersensitivity to any component of the vaccine used in this study.
- They are found to be HIV antibody or HIV proviral DNA positive at the time of initial
screening.
- They have a known or suspected history of cervico-vaginal disease, malignancy or
abnormality discovered at time of screening.
- They present in the samples obtained at the screening visit:
- a clinically significant amount of protein or haemoglobin in the urine sample,
determined by urine dipstick.
- a clinically significant abnormality in the haematological or biochemical assays.
- Positive tests for Hepatitis B and/or C infection An abnormal value will be defined by
the ranges quoted by The Doctors Laboratory for the Vaccine Institute site and
Pathology Department, York Hospital for the York site.
- They have a known or suspected impairment of lung, heart, liver, kidney, diseases,
blood disorders or immune dysfunction.
- They are receiving immunosuppressive therapy (including systemic steroids).
- They are receiving any medications via vaginal route.
- They have any acute infections (including fever greater than or equal to 38°C) or any
chronic disease.
- They present a current problem with substance abuse or with a history of substance
abuse which, in the opinion of the investigator, might interfere with participation in
the study.
- They have any condition which, in the opinion of the investigator, might interfere
with the evaluation of the study objectives.
- They have received an investigational agent within 3 months prior to study entry.
- They cannot speak fluent English, or are planning to leave the area of the study site
prior to the end of the study period, or are likely not to complete the study.
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years | Reactogenicity and Immunogenicity of Vaginal CNgp140 | NCT00637962 | Entailment |
1,361 | 8 | A 7-month-old boy is brought to emergency by his parents due to irritability and inability to defecate for the past 3 days. The patient has had constipation and discomfort with bowel movements since birth. His symptoms worsened after eating semi-solid foods. Vital signs are normal. Abdominal examination shows distension and tenderness to palpation with presence of bowel sounds. Xray with barium shows a narrow rectum and rectosigmoid area. The rest of the colon proximal to this segment is dilated. Digital rectal exam revealed burst of feces out of the anus. The biopsy showed absence of submucosal ganglia in the last segment of the large intestine. | My baby boy just turned 7 months old but my wife and I cannot get a hold of him! He has not been able to poop for 3 days! My poor little thing has been having constipation and bowel problems since birth. But since he ate some semi-solid food it has just been worse! The doctor said his vitals are normal but his belly is tense and tender with his bowels making noise. They did an X-ray and found out that he had a narrow rectum. His colon is dilated. They also performed a touch rectal exam and he could finally poop! The biopsy revealed that there is no submucosal ganglia in his large intestine. | Inclusion Criteria:
- Children 3-7 years old
- Occurrence less than three bowel movement per week
- Medical history from at least two months]
- Ineffective laxative treatment at least two months
- The parents approval for child participation in the study and for the treatment
Exclusion Criteria:
- Well-known, organic cause of constipation (i.e. hypothyroidism, Hirschprung disease,
cystis fibrosis)
- Anatomic defects of the alimentary canal
- The surgery of the alimentary canal in the past
- Treatment of antibiotics/probiotics during last two weeks before start of the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 3 Years old.
Subject must be at most 7 Years | Lactobacillus Reuteri in Children With Constipation | NCT01388712 | Contradiction |
6,298 | 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. Individuals with a confirmed COVID-19/influenza viral infection, as determined by a
qualified laboratory test. A nasal swab or saliva test analyzed by qPCR for COVID19 or
rapid flu test from nasal swab for influenza.
2. Individuals who agree to abstain from sexual intercourse, or agree to use condoms or
vaginal diaphragms or other devices designed to prevent contraception, during the
entire course of the study
Exclusion Criteria
1. Viral infections other than COVID-19 or influenza.
2. Clinically significant cardiac disease including uncontrolled congestive heart failure
and unstable angina
3. Pregnancy
4. Females of child bearing potential age not on adequate contraception or lactating
5. Subjects receiving systemic corticosteroid treatment within one month of Screening
Visit
6. Subjects Less than 18 years of age
7. Hospitalization within last 6 months due to acute exacerbation of airway disease
8. Subjects with a clinically significant abnormal chest x-ray within past 12 months
9. Medication changes within one month of study entry
10. Subjects who have participated in another investigation drug treatment study within
the previous month.
11. Subjects with a current history of alcohol or recreational drug abuse.
12. Subjects who have taken dietary supplements containing pyruvate within 24 hours prior
to the screening visit.
Inclusion of Women and Minorities Every attempt will be made to include all genders, and
minorities that present with an active COVID-19 or flu infection that are not exempted due
to exclusion criteria.
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Sodium Pyruvate Nasal Spray Treatment of COVID-19 and Influenza Infections | NCT04824365 | Entailment |
361 | 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:
- Infertile female or infertile male. Infertile female means diverse infertility
etiologies including tubal disease (excepting hydrosalpinx) and so called "unexplained
infertility"
- Suitable for ART: IVF undergoing first or second attempt, ICSI undergoing first
attempt
- 18-35 years old, body mass index (BMI) less than or equal to 27 kilogram per square
meter (kg/m^2), non smoking
- Normal ovarian status (FSH less than or equal to 9.45 International Units per Liter
[IU/L], E2 less than or equal to 40 picogram per milliliter [pg/mL], Anti-Mullerian
Hormone [AMH] greater than or equal to 18 picomole/liter [pmol/L]; within normal
laboratory range values, normal ovaries sonography and uterine echo doppler)
- No history of active genito-urinary infection
- Normal thyroid function (or adequate substitution for at least 3 months)
- Negative cervical papanicolaou test within the last 12 months prior to study entry
- No hormonal therapy, including gonadotropins and progesterone, for at least 2 months
prior to the study
- In couple with female infertility, male partner with normal sperm or moderate
oligoasthenospermia in semen analysis and negative semen culture less than 6 months at
the study entry
- Willingness and ability to comply with the protocol for the duration of the study
- Written informed consent prior to any study related procedure not part of normal
medical care, with the understanding that consent may be withdrawn by the subject at
any time without prejudice to their future medical care
Exclusion Criteria:
- Subjects with ongoing pregnancy, any pregnancy within 3 months prior to study entry,
or any contraindication to pregnancy or carrying pregnancy to term
- Subjects with uterine malformation, diethylstilbestrol syndrome, adenomyosis, synechia
- Subjects with history of previous OHSS
- Subjects with polycystic ovarian syndrome (PCOS) according to the revised Rotterdam
Consensus 2003
- Subjects with extra-uterine pregnancy during the previous 3 months
- Subjects with recurrent miscarriages (early or late, more than 2)
- Subjects having known infection with human immunodeficiency virus (HIV), hepatitis B
or C virus, for subject or partner
- Subjects with abnormal gynecological bleeding of undetermined origin
- Subjects with history of major thromboembolic disease
- Subjects with endometriosis
- Subjects with presence or history of malignant tumors and related treatment
- Subjects with clinically significant systemic disease or clinically significant
abnormal hematology, chemistry, or urinalysis results at screening
- Subjects with known allergy or hypersensitivity to Gonal-f® or Ovitrelle®
- Subjects with any active substance abuse or history of drug, medication or alcohol
abuse in the past 5 years
- Subjects who have participated within 3 months prior to study entry in another
clinical trial
Female
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 35 Years | EXpression PRofile Endometrium Samples Study | NCT01210144 | Contradiction |
5,071 | 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:
- Members of the Harvard Pilgrim Health Plan
Exclusion Criteria:
- Individuals who are not members of the Harvard Pilgrim Health Plan
Female
No healthy subjects accepted to join the trial.
Subject must be at least 50 Years old.
Subject must be at most 64 Years | Comparison of Osteoporosis Disease Management Strategies (0000-039) | NCT00145080 | Contradiction |
2,106 | 12 | A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea. Other medical conditions include hypertension and osteoarthritis. The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs. He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs. Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled pulmonary fibrosis that is most predominant in the lower lobes, characterized by the presence of asbestos bodies (golden-brown beaded rods with translucent centers). | I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there. | Inclusion Criteria:
- Completion of informed consent.
- Adults over the age of 18.
- Diagnosis of IPF per ATS guidelines.
- Clinically stable at the time of enrollment defined as no antibiotics within the past
month, with the exception of those patients currently listed for Lung Transplantation.
- No changes in immunosuppressive regimens (if applicable) over past month.
Exclusion Criteria:
- Inability to understand or complete paper and pencil questionnaires.
- Patient not planning to return to Stanford for clinic visits.
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.
| Prospective Validation of Cough, Dyspnea, and Quality of Life Questionnaires in Patients With Idiopathic Pulmonary Fibrosis (IPF) | NCT01874223 | Entailment |
143 | 1 | A 19-year-old male came to clinic with some sexual concern. He recently engaged in a relationship and is worried about the satisfaction of his girlfriend. He has a "baby face" according to his girlfriend's statement and he is not as muscular as his classmates. On physical examination, there is some pubic hair and poorly developed secondary sexual characteristics. He is unable to detect coffee smell during the examination, but the visual acuity is normal. Ultrasound reveals the testes volume of 1-2 ml. The hormonal evaluation showed serum testosterone level of 65 ng/dL with low levels of GnRH. | I'm 19 years old guy and I just went to see a doctor at the clinic after I just got with my girlfriend. I'm kinda worried because she thinks that I have a baby face and to be honest, I'm way less muscular than my classmates. I don't have much hair down there, and yes, I don't have that macho look. The doctor made me smell some coffee and I couldn't smell anything special. I also had some eyesight checkups and the doctor told me everything was normal. I got my test results back and it says: testes volume is 1-2 ml and serum testosterone level of 65 ng/dL with low GnRH levels. | Inclusion Criteria:
1. Adult male whose age is between 18 and 80 years, inclusive, at the time of screening.
2. Considered by the investigator to be in good general health as determined by medical
history, clinical laboratory test results, vital sign measurements, 12-lead
electrocardiogram (ECG) results, and physical examination findings at screening.
3. Meets the study definition of clinical hypogonadism, as evidenced by serum
testosterone concentrations:
1. Two serum testosterone concentrations < 300 ng/dL collected in the morning
(between 0630 hours and 1000 hours local time) on at least 2 days separated by a
minimum of 48 hours.
2. Presence of at least 1 sign or symptom that may be related to low testosterone
values and is/are consistent with hypogonadism
4. Naïve to testosterone replacement, clomiphene, compounded or over-the-counter
androgenic steroid derivatives and dehydroepiandrosterone, including investigational
products that may affect the reproductive hormonal system within the past 2 months.
5. Willingness and the ability to apply topical testosterone gel as instructed by the
study staff and comply with the requirements of this study protocol.
6. Intact skin surfaces on the upper arms and shoulders where the topical testosterone
will be applied.
Exclusion Criteria:
1. Two testosterone concentrations < 100 ng/dL during screening.
2. Prolactin concentration > 1 x upper limit of normal (ULN).
3. Current or recurrent ulcer, erosion, lichenification, inflammation psoriasis, eczema
or use of topical corticosteroids on the upper arms and shoulders. Tattoo application
or removal in the region of study drug application.
4. Known skin intolerance to alcohol or allergy to any of the ingredients of the study
drug.
5. History of treatment with growth hormone, anti-estrogen or estrogen treatment within
90 days prior to screening.
6. Currently taking glucocorticoids > 7.5 mg prednisone equivalent per day (eg,
hydrocortisone 30 mg, methylprednisolone 6 mg, or dexamethasone 1.2 mg) for 1 week
before SV1 and through Day 1, and any use of opioids within 5 half-lives prior to Day
1.
7. Currently taking, unstable doses within 14 days prior to first administration of study
drug or anticipated to receive any antihypertensive medications, over-the-counter
medications, supplements or herbal medicines known to affect blood pressure during
study participation. These medications or supplements include diet pills (eg,
phenylpropanolamine, sibutramine), nasal decongestants (eg, phenylephrine
hydrochloride, pseudoephedrine, naphazoline hydrochloride), certain stimulants (eg,
amphetamine, methylphenidate dexmethylphenidate, dextroamphetamine), monoamine oxidase
inhibitors (MAO), atypical antipsychotics (eg, clozapine, olanzapine).
8. History of prostate (current or in the past) or breast cancer.
9. Severe lower urinary tract symptoms as indicated by an International Prostate Symptom
Score (I-PSS) > 19.
10. Prostate-specific antigen (PSA) > 3.0 ng/mL; men treated with 5-alpha reductase
inhibitors (eg, dutasteride, finasteride) are eligible for participation as long as
PSA levels are not > 1.5 ng/mL.
11. Body mass index > 50 kg/m2.
12. Sitting SBP < 80 mm Hg and > 150 mm Hg or sitting DBP < 50 mm Hg and > 100 mm Hg at
any point during screening.
13. HbA1c > 11% at screening.
14. A current condition, therapy, laboratory abnormality, history of clinically
significant medical or psychiatric conditions or other circumstance or reasons which,
in the opinion of the investigator or the study staff, might pose a risk to the
subject, make participation not in the subject's best interest, confound the results
of the study (eg, if subject cannot comply with requirements of the study), make the
subject an unsuitable candidate to receive study drug, or interfere with the subject's
participation for the full duration of the study.
15. History, suspicion, or evidence of significant drug or alcohol abuse or illicit
steroid use within the previous 12 months prior to screening, as determined by the
investigator.
16. The subject is a smoker or has used nicotine or nicotine-containing products (eg,
snuff, nicotine patch, nicotine chewing gum, mock cigarettes, or inhalers) within 6
months before the first dose of study drug.
17. Clinical laboratory analysis shows any of the following abnormal results:
- Hematocrit > 50%
- Alanine aminotransferase or aspartate aminotransferase > 3 × ULN
18. Severe or end-stage chronic kidney disease documented by eGFR < 30 mL/min.
19. Subject works night shifts.
Male
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years | Vogelxo(R) ABPM Study in Hypogandal Men | NCT04558567 | Contradiction |
1,909 | 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... | Can tolerate the cT1~3N0~1M0 phase II type II esophageal gastric junction adenocarcinoma
patients with the corresponding operation, the past or present without radiotherapy,
chemotherapy, nearly 5 years without any other malignant tumor history. According to the
research design, random access to minimally invasive surgery group or traditional open
surgery group. The follow-up procedure, if the cause of the disease or the treatment of the
disease has been confirmed, such as the need for adjuvant chemotherapy, should be treated
accordingly, according to the statistics appear to be accompanied by the interference to
explain and deal with.
Inclusion Criteria:
A. under 70 years of age (taking into account the follow-up period); B. was performed in
patients with cT1~3N0~1M0 type II type cTNM, C., F., D., e., and 5 years.
Exclusion Criteria:
I A., type III esophageal gastric junction adenocarcinoma; B. major organ function can not
tolerate surgery; C. advanced patients.
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 70 Years | Minimally Invasive Sweet Esophagectomy for Patients With Siewert Type II Adenocarcinoma of the Esophagogastric Junction | NCT02741778 | Entailment |
4,582 | 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:
- Not postmenopausal women aged 30 to 50,
- Accepting to give consent informed in writing,
- Suffering from a symptomatic pelvic endometriosis (menorrhagia isolated or associated
with pain)
- Diagnosis information, confirmed the adenomyosis (T2-weighted) MRI and/or transvaginal
ultrasonography, in the 6 months preceding the inclusion-having a score of bleeding
(PBAC) > 100 from J1 to J8 of the menstruation before the visit of inclusion,
- With an index of body mass (IMC) ≥18 and < 40,
- Using a reliable method of non-hormonal contraception (non-hormonal intrauterine
device (IUDs), sexual abstinence, diaphragm, condoms or vasectomy by the partner, or
having undergone a surgical sterilization),
- Willing and able to complete auto-questionnaires in french
- Had no difficulties to understand and communicate with the investigator and his
representatives
- Affiliation to a social security or assign.
Exclusion Criteria:
- Patient with a hormonal oral contraceptive or with a hormonal intrauterine Device
(IUD) contraceptive
- Patient with a history of surgery (other than a caesarean or a cervical conization)
uterus, ablation endometrial or uterine artery embolization,
- With other than the endometriosis endometrial pathology,
- Suffering of myoma of type 0, 1, 2 or 3,
- Requiring a transfusion or having a ≤6g/dL hemoglobin
- Existence of systemic coagulation,
- History of thromboembolism
- Progestagen taking severe disorders in the month preceding the tour selection, and
corticosteroids and aspirin in the previous week,
- Existence of Pathology renal, respiratory or cardiac severe or progressive,
- Having a disturbed liver function (defined by the aspartate aminotransferase (ASAT),
Alanine Amino Transferase (ALAT), γGlutamylTranspeptidase, alkaline phosphatase or
total bilirubin above 2 times the upper limit of normal),
- Existence or suspicion of malignancy,
- Considering pregnancy in the coming year,
- Pregnant patient or nursing
- Any clinical condition that the investigator considers incompatible with the conduct
of the study in terms of acceptable security,
- Participation in courses at another clinical study
- Patient whose accession to the test procedures may be insufficient or for which a long
term follow-up seems difficult to achieve
- Person under authorship or curators under safeguard of justice
- History of hypersensitivity to the ulipristal or any of the excipients of ESMYA ® 5 mg
tablet.
Female
No healthy subjects accepted to join the trial.
Subject must be at least 30 Years old.
Subject must be at most 50 Years | Adenomyosis and Ulipristal Acetate | NCT02587000 | Contradiction |
3,303 | 24 | A 4-year-old boy comes to the office for the follow up of his confirmed oculocutaneous albinism. The patient was born at 38 weeks gestation with no complications. Vital signs are normal. Weight and height are at the 50th percentile. On examination, iris transillumination is present, and there are no apparent foveae on funduscopic examination. Optic nerves are small and gray. All the hairs including eyebrows and lashes are white. | I brought my four-year-old son to his follow-up consultation for his albinism. All his hair is white, even lashes and eyebrows. My baby was born at 38 weeks pregnant with no complications whatsoever. During the consultations his vitals were normal and now his weight and height are at the 50th percentile. The doctor did an eye exam and it seems that his iris has a kind of transillumination, and there are no foveae. The doctor told me that his optic nerves are small and gray. | Inclusion Criteria:
- Age of 12 years old and older
- Clinical and/or genetic diagnosis of ocular or oculocutaneous albinism
- Ocular media allowing acceptable visualization of the retina.
- Ocular media allowing acceptable quality of the ocular coherence tomography (OCT)
and/or fundus autofluorescence (FAF) scans.
- At least one reliable central macular pigment optical density (MPOD) measurement
captured on the enrollment visit in at least one eligible eye
- Best corrected visual acuity of 20/200 or better in one or both eligible eyes (eyes
that confirmed to be eligible by the MPOD testing).
Exclusion Criteria:
- Persons taking lutein and/or zeaxanthin supplements over the past 6 months
- Pregnant or planning to become pregnant
- Evidence of present or past retinal macular condition other than congenital foveal
hypoplasia
- History of gastrointestinal disease that would interfere with absorption of lutein and
zeaxanthin
- Participation in a clinical trial requiring visual testing or administration of a drug
(marketed or investigational) within 60 days before entry in the study (the day
informed consent is signed)
- Inability to communicate or cooperate with the investigator due to cognitive
impairment or poor general health
- Any other condition which, in the opinion of the investigators, is likely to interfere
with the successful collection of the measures required for 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 12 Years old.
| The Effects of Lutein and Zeaxanthin Supplementation on Vision in Patients With Albinism | NCT02200263 | Contradiction |
3,896 | 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) patients of either gender with primary knee OA of one or both knees fulfilling the
diagnostic criteria for knee OA by the American College of Rheumatology,
- 2) Kellgren-Lawrence score of two to four,
- 3) reported NPRS pain intensity of at least four on most or all days of the past week
- 4) pain resistant to conventional treatments which may include but is not limited to
medications (e.g. acetaminophen, oral or topical non-steroidal anti-inflammatory
drugs, opioids), physical therapy, and intra-articular injections (e.g.
corticosteroids, hyaluronic acid, platelet-rich-plasma) for at least 3 months. In the
case of bilateral knee OA, the most symptomatic knee will be treated and studied.
Exclusion Criteria:
- 1) age <35 years,
- 2) non-English speaking patients,
- 3) body mass index greater than 40,
- 4) previous radiofrequency ablation procedure for the knee,
- 5) active systemic or local infections at the site of needle/cRFA probe placement,
- 6) previous knee joint replacement surgery,
- 7) autoimmune or inflammatory cause of knee arthritis such as rheumatoid or psoriatic
arthritis,
- 8) non-ambulatory patients,
- 9) patients who are unable to provide their own consent (e.g. dementia),
- 10) unstable medical or psychiatric illness,
- 11) patients with pacemakers, spinal cord stimulators, deep brain stimulators, or
similar devices,
- 12) patients seeking care as a part of workman's compensation or have litigation
pending
- 13) a negative response to diagnostic geniculate nerve lidocaine injections.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 99 Years | Fluoroscopic Versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: A Randomized Control Trial | NCT04472702 | Entailment |
2,499 | 17 | A 67-year-old man comes to the clinic with slowly worsening vision in both eyes. He is not able to drive at night, as the symptoms are worse at night. His pupils are normal in diameter both in the light and darkness. Other medical history is unremarkable. Ocular examination shows loss of the red reflex and blurry vision. Acuity testing shows 50/100 vision in both eyes with normal visual field testing. His blood pressure is 130/70 and pulse is 68/min. the other physical examinations are normal. | I am a 67 years-old man, and I haven't been able to drive at night due to my vision getting worse. My vision is not the best in general, but night makes it even worse. The ophthalmologist told me that my pupils were normal. However, I have slow reflexes and blurry vision. My acuity test came back with 50/100 vision in both of my eyes. They also took my blood pressure, which was 130/70 with a 68 pulse. My other exams came back just fine. | Inclusion Criteria:
- Aged 55-85
- At least 20/200 corrected visual acuity
- Greater than 20° visual field with no lower visual field loss
- Stable health
- Male or female
- Normal color vision
- Normal hearing
Exclusion Criteria:
- Extreme chronotype
- Sleep disorders
- Dementia
- Smoker
- Depression
- Alcohol abuse
- Use of illegal drugs
- Use of sleep/wake altering drugs on an acute or as needed basis (including
nutraceuticals, antihistamines)
- Use of light sensitizing drugs
- Self-reported history of nocturia (>3 times per night)
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 55 Years old.
Subject must be at most 85 Years | Light to Maximize Vision, Minimize Insomnia | NCT01712243 | Entailment |
1,833 | 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:
- Pathologic finding by gastric endoscopy: confirmed gastric adenocarcinoma
- Age: older than 20 year old, younger than 80 year old
- Cancer core: located at the middle or lower part of stomach
- Preoperative cancer stage (CT, GFS stage): cT2N0M0, cT2aN1M0, cT2bN1M0, cT3N0M0
- ASA score: ≤ 3
- Informed consent patients (explanation about our clinical trials is provided to the
patients or patrons, if patient is not available)
Exclusion Criteria:
- Concurrent cancer patients or patient who was treated due to other types of cancer
before the patient was diagnosed as a gastric cancer patient
- Patient who was treated by other types of treatment methods, such as chemotherapy,
immunotherapy, or radiotherapy
- Patient who was received upper abdominal surgery (except, laparoscopic
cholecystectomy)
- Patient who was treated because of systemic inflammatory disease
- Pregnant patient
- Patient who suffer from bleeding tendency disease, such as hemophilia or patient
taking anti-coagulant medication due to deep vein thrombosis
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 80 Years | Comparison of the Laparoscopy-Assisted Distal Gastrectomy and Open Distal Gastrectomy for Advanced Gastric Cancer | NCT00741676 | Entailment |
6,997 | 50 | A 70-year-old man comes to the office accompanied by his wife. The patient has experienced progressive memory loss over the last years. He needs help with some of his routine activities, such as paying bills. The patient's wife says, "He used to be such an independent person, but now he needs help with many things, even finding direction to home!" Medical history includes hypertension, hyperlipidemia, and type 2 diabetes mellitus. Family history includes Alzheimer disease in his father. MRI reveals diffuse cortical and hippocampal atrophy. The diagnosis of AD is made using the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria. | I am a 70-year-old man, and I paid a visit to the doctor with my wife the other day. I noticed that I tend to forget small things and that my memory has decreased over the past few years. I even ask my wife to help me out with my daily routine. I used to be the one paying the bills, but now she has to give me a hand. My wife mentioned to the doctor that I used to be independent and that I tend to forget where we live. I suffer from hypertension, high cholesterol, and type 2 diabetes. My poor dad was suffering from Alzheimer disease, so I hope I'm not going to end the same way! I did an MRI and they found out that some part of my brain was decreasing. I also did an Alzheimer test. | Inclusion Criteria:
1. Any patient has a definite diagnosis of AD dementia according to the NIA-AA criteria
for intermediate-to-high levels of biological evidence of probable and possible AD
dementia (McKhann et al. 2011).
2. Dementia onset before age 65 years old.
3. Age between 50-75 years old for patient and control group.
4. The severity of dementia is limited to mild to moderate stage in current project. The
definition of mild to moderate stage of dementia is based on the clinical dementia
rating scale (CDR) from 0.5-2.
5. Cognitively normal controls MMSE≧24, CDR should be 0.
6. Informed consent provided by the patient and family.
Exclusion Criteria:
1. Any subject has a definite diagnosis of epilepsy or history of seizure attack.
2. Current or past history of clinically significant neurological insults affecting brain
structure or function like completed stroke, head injury or brain tumor.
3. Any subject has clinically significant or unstable medical diseases including
metabolic, renal, liver, lung or cardiovascular disorders including metabolic, renal,
liver, lung or cardiovascular disorders
4. Any subject has current alcohol or other substances abuse and/ or dependence within
the recent one year, or previously prolonged history of substances abuse
5. Any females who is pregnant or lactating
6. General MRI, TMS and/or PET exclusion criteria including subjects who had received
brain aneurysm surgery, or implanted pacemaker, mechanical valves, cochlear implant or
other metal devices/ objects that are not magnetic resonance (MR) compatible in the
body.
7. Any subject has allergic reaction to 18F-florbetapir or 18F-FDG radiotracers.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 50 Years old.
Subject must be at most 75 Years | Theta-burst Stimulation on Cognitive Function in the Patients With Young-onset Alzheimer's Disease Dementia | NCT04042532 | Entailment |
2,916 | 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:
- Patients with diagnosed ALS of any type or duration
- Current or previous treatment with oral riluzole tablets, or patients who have never
taken riluzole oral tablets, or patients who have successfully completed a clinical
trial with BHV-0223 and were not withdrawn prematurely due to adverse events
- Swallowing difficulties, or patient or caregiver report choking one or more times per
week, or investigator deems appropriate to treat with sublingual BHV-0223 because
(s)he deems the patient cannot be satisfactorily treated with Rilutek®
- Adequate hepatic function
Exclusion Criteria:
- Patient with history of severe hypersensitivity reaction to riluzole oral tablets or
BHV-0223
- Patient is known to have any other acute or chronic liver disease
No condition on gender to be admitted to the trial.
Subject must be at least 18 Years old.
| Expanded Access Protocol of BHV-0223 for Patients With Amyotrophic Lateral Sclerosis (ALS) | NCT03537807 | Entailment |
2,735 | 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:
- Diagnosis of unilateral inguinal hernia.
- Male or Female.
- Older tan 16 years.
- Accept to participate in the study.
Exclusion Criteria:
- Chronic Obstructive Pulmonary Disease.
- Obesity.
- Diabetes Mellitus.
- Cirrhosis.
- Diseases involving collagen deficiency.
- Previous surgery in the groin.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 16 Years old.
| Comparison of Postoperative Inguinal Pain Between the Onstep Technique and the Lichtenstein Technique | NCT04138329 | Entailment |
2,593 | 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:
Bilateral congenital inguinal hernia (CIH), recurrent cases, unilateral cases with
questionable other side, parental request and cases with CIH associated with umbilical
hernia.
Exclusion Criteria:
Hernia of canal of Nuck in females, Inguinal hernia with undescended testis, Parental
refusal, Contraindications for laparoscopy as lower major abdominal surgery
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 3 Years | Laparoscopic Inguinal Hernia Repair in Infancy and Childhood | NCT02239185 | Contradiction |
6,629 | 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:
- Body weight greater than or equal to (>/=) 40 kilograms (kg) at screening
- Diagnosis of severe congenital hemophilia A or hemophilia A with FVIII inhibitors
- Participants using rFVIIa or willing to switch to recombinant activated factor VII
(rFVIIa) as primary bypassing agent for the treatment of breakthrough bleeds
- FVIII inhibitor test during screening with titer results available prior to first
administration of study drug
- Participants without FVIII inhibitors, that is with less than (<) 0.6 Bethesda unit
per milliliter [BU/mL];< 1.0 BU/mL only for laboratories with an historical
sensitivity cutoff for inhibitor detection of 1.0 BU/mL, who completed successful
immune tolerance induction (ITI) must have done so at least 5 years before screening
and must have no evidence of inhibitor recurrence (permanent or temporary) indicated
by detection of an inhibitor greater than (>) 0.6 BU/mL (> 1.0 BU/mL only for
laboratories with an historical sensitivity cutoff for inhibitor detection of 1.0
BU/mL) since ITI
- Adequate hematologic, hepatic, and renal function
Exclusion Criteria:
- Inherited or acquired bleeding disorder other than hemophilia A
- Ongoing or planned ITI therapy; participants in whom ITI has failed will be eligible
with a 72-hour washout period prior to the first emicizumab administration
- History of illicit drug or alcohol abuse within 48 weeks prior to screening, in the
investigator's judgment
- Participants who are at high risk for thrombotic microangiopathy (TMA) (for example,
have a previous medical or family history of TMA), in the investigator's judgment
- Previous (within the last 12 months) or current treatment for thromboembolic disease
(with the exception of previous catheter-associated thrombosis for which
anti-thrombotic treatment is not currently ongoing) or signs of thromboembolic disease
- Other conditions (for example, certain autoimmune diseases) that may currently
increase the risk of bleeding or thrombosis
- History of clinically significant hypersensitivity associated with monoclonal antibody
therapies or components of the emicizumab injection
- Known HIV infection with cluster of differentiation (CD) 4 cells counts <200 cells per
microliter (cells/mcL)
- Use of systemic immunomodulators (for example, interferon) at enrollment or planned
use during the study, with the exception of anti-retroviral therapy
- Concomitant disease, condition, significant abnormality on screening evaluations or
laboratory tests, or treatment that could interfere with the conduct of the study, or
that would, in the opinion of the investigator, pose an additional unacceptable risk
in administering study drug to the participant
- Pregnancy or lactation or intention to become pregnant during the study
- Women with a positive serum pregnancy test result within 7 days prior to initiation of
study drug
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.
| A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Emicizumab Given Every 4 Weeks in Participants With Hemophilia A | NCT03020160 | Contradiction |
1,046 | 5 | A 23-year-old man comes to the emergency department following an episode of syncope. He was working out when he felt dizzy and passed out without head injury. He has had 3 other episodes of light-headedness over the last year, all happening during physical activity. He never had this experience while resting. He has no other medical conditions. The patient does not use tobacco, alcohol, or illicit drugs. His father died suddenly at age 35. Vital signs are within normal limits. On physical examination, the patient has a harsh systolic murmur. The lungs are clear with no peripheral edema. Echocardiography shows asymmetric interventricular septal hypertrophy. | I'm 23, and I got admitted to the ER because I fainted all of a sudden. I was in the gym, working out, when all of a sudden, I just got dizzy and passed out. Hopefully, I didn't hit my head. It's not my first time having that kind of dizziness at the gym, never when I'm chilling at home tho. I don't have any special medical conditions and I'm not even smoking, drinking or doing drugs! My dad died suddenly when he was 35, so I'm kind of scared. My vitals were normal while at the ER and they did a physical exam and they told me my heart sounds abnormal. My lungs are ok, but I had to do an echography of my heart, and they told me it is bigger than average. | Inclusion Criteria:
- Obstructive sleep apnoea syndrome (>15 respiratory micro awakenings per hour of sleep)
with an indication for treatment
- Recurring vasovagal syncope episodes defined as follows: at least three vasovagal
syncopes during the last two years - OR- symptoms of orthostatic intolerance occurring
in the last 6 months (Symptoms are triggered by orthostatism and can include malaises
without loss of consciousness, asthenia, dizziness, visual disturbances, tinnitus,
palpitations, headache, limitations of physical activity)
Exclusion Criteria:
- Pathology that may explain syncope symptoms
- Cardiopathy
- Known disautonomia
- Hypotension of known origin
- Adrenal insufficiency
- Thyroid disorder
- History of sudden death in a first degree family member
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.
| Management of Sleep Apnoea Syndrome (SAS) in Patients With Vasovagal Syncope (VVS) | NCT04294524 | Contradiction |
6,083 | 45 | A 15-week-old infant brought to the clinic for the follow up. The infant has flat facies, small ears, a single palmar crease, and upward slanting eyes. He was born on 39th week to a 39-year-old woman who didn't have prenatal care. The medical record confirms the trisomy of chromosome 21 (Down syndrome). The infant is otherwise healthy. | My newborn, who is only 15 weeks old, had one of his follow-up appointments. The doctor pointed out that my baby had a flat face, small ears, only one palm line, and small eyes. He was born on his 39th week, while I was 39. What a coincidence! To be honest, I did not go to the doctor during my pregnancy. The doctor diagnosed my baby with Down syndrome. Apart from that he's healthy. | Inclusion Criteria:
- Trisomy 21
- Able to pull to stand but not walk
Exclusion Criteria:
- Additional developmental diagnoses
- Uncorrected vision or hearing impairments
- Previous orthotic intervention
- Previous treadmill intervention
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
Subject must be at most 36 Months | Treadmill Training and Orthotic Use in Infants With Down Syndrome | NCT00825175 | Contradiction |
3,985 | 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. | Key Inclusion Criteria:
- Males and females between 40 and 80 years of age, inclusive, in general good health
apart from their knee OA
- Ambulatory (single assistive devices such as canes allowed if needed less than 50% of
the time, subjects requiring a walker are excluded)
- Diagnosis of femorotibial OA in the target knee by standard American College of
Rheumatology (ACR) criteria at the Screening Visit (clinical AND radiographic
criteria); OA of the knee is not to be secondary to any rheumatologic conditions
(e.g., rheumatoid arthritis)
- Radiographic disease Stage 2 or 3 in target knee within 24 weeks of the Screening
Visit according to the Kellgren-Lawrence (KL) grading of knee OA as assessed by
independent central readers
- Qualifying mean score on the 24-h average pain score (0-10 numeric rating scale)
- Pain compatible with OA of the knee(s) for at least 26 weeks prior to the Screening
Visit
- Primary source of pain throughout the body is due to OA in the target knee
- Body mass index (BMI) ≤ 35 kg/m2 at the Screening Visit
- Negative drug test for amphetamine, buprenorphine, cocaine, methadone, opiates,
phencyclidine (PCP), propoxyphene, barbiturates, benzodiazepine, methaqualone, and
tricyclic antidepressants, unless any of these drugs are allowed per protocol and
prescribed by a physician to treat a specific condition
Key Exclusion Criteria:
- Pregnant women, breastfeeding women, and women who are not post-menopausal (defined as
12 months with no menses without an alternative medical cause) or permanently
surgically sterile (includes hysterectomy, bilateral salpingectomy, and bilateral
oophorectomy) who have a positive or indeterminate pregnancy test result at the
Screening Visit or Day 1
- Significant malalignment of anatomical axis (medial angle formed by the femur and
tibia) of the target knee (varus > 10°, valgus > 10°) by radiograph within 24 weeks of
the Screening Visit as assessed by independent central readers
- Partial or complete joint replacement in either knee
- Currently requires use of a lower extremity prosthesis, and/or a structural knee brace
(i.e., a knee brace that contains hardware)
- Any surgery (e.g., arthroscopy) in either knee within 26 weeks prior to Day 1
- Intra-articular (IA) injection into the target knee with a therapeutic aim including,
but not limited to hyaluronic acid, platelet-rich plasma (PRP), and stem cell
therapies within 26 weeks prior to Day 1; or IA glucocorticoids within 12 weeks prior
to Day 1 allowed
- Previous treatment with lorecivivint (SM04690)
- Subjects who have previously failed screening on this protocol and fail to meet
re-screening criteria
- Participation in a clinical research trial that included the receipt of an
investigational product or any experimental therapeutic procedure within 26 weeks
prior to the Screening Visit, or planned participation in any such trial
- Subjects requiring the use of opioids > 1x per week within 12 weeks prior to Day 1
- History of malignancy within the last 5 years; not including subjects with prior
history of adequately treated in situ cervical cancer or basal or squamous cell skin
cancer
- Clinically significant abnormal screening hematology values, blood chemistry values,
or urinalysis values as determined by the Investigator
- Any known active infections, including urinary tract infection, upper respiratory
tract infection, sinusitis, suspicion of IA infection, hepatitis B or hepatitis C
infection, and/or infections that may compromise the immune system such as human
immunodeficiency virus (HIV) at Day 1
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 Study Utilizing Patient-Reported Outcomes to Evaluate the Safety and Efficacy of Lorecivivint (SM04690) for the Treatment of Moderately to Severely Symptomatic Knee Osteoarthritis | NCT04385303 | Entailment |
3,106 | 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:
1. Patients must be aged 18 years or older.
2. Patients must have documented moderate to severe evaporative Dry Eye Syndrome for at
least 6 months.
3. Patients must have a Schirmer (with anesthesia) of ≤ 8 per 5 minutes in at least one
eye at Screening and Baseline (Day 1).
4. Patients must have a calculated overall score on the OSDI of >0.1 with no more than
three responses of not applicable (N/A) at Screening and Baseline (Day 1).
5. Patients must have normal lid position and closure.
6. Women must be post-menopausal ≥ 1 year, or surgically sterilized. If not, a negative
urine pregnancy test is required within 14 days of Day 1.
7. Informed consent must be provided.
Exclusion Criteria:
1. Patients with severe inflammatory Dry Eye Syndrome.
2. Patients with Dry Eye Syndrome secondary to Sjögren's Syndrome.
3. Patients with Schirmer (with anesthesia) of >8 per 5 minutes in both eyes.
4. Patients who are allergic to Civamide or any similar products, or excipients of
Civamide Nasal Solution 0.01%.
5. Patients with history of previous ocular surgery or trauma.
6. Patients who require concurrent ocular medication for any eye disorder.
7. Patients who have used Restasis®, serum tears, or oral omega 3 supplements during the
last 30 days or oral cyclosporine during the last 90 days.
8. Patients who are receiving or have received within 30 days any experimental systemic
medication.
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.
| Civamide Nasal Solution for the Treatment of Dry Eye | NCT02116244 | Contradiction |
1,319 | 7 | A 3-year-old girl is brought to the clinic by her parents for assessment of her short stature. Physical examination reveals short limbs and a relatively large head. She has a flat nasal bridge and a small midface. The girl's father exhibits similar physical features; however, her mother looks normal. The genetic testing reveals an autosomal dominant point mutation in the fibroblast growth factor receptor 3 (FGFR3) gene consistent with achondroplasia in both father and the child. The girl has not received any treatment yet, and it is her first visit after immigration to the US. The other mental and developmental examinations are unremarkable. | I just brought my little 3-year-old girl to the clinic to have her checked up by the doctor. I was worried sick because she was smaller than her classmates. The lovely doctor performed a physical exam and she told me that she has short limbs and a larger head. My girl also has a flat nasal bridge and a small midface. My baby just has the face of her father, unlike me! They performed some genetic testing on my child and my husband and found out that both my husband and her have a mutation of the FGFR3 gene, which led the doctor to diagnose them with dwarfism. My baby never received any treatment and it was our first visit to the doctor since we arrived in the US. The other tests regarding her mental and physical development were perfectly fine. | Inclusion Criteria:
1. Presenting clinical features suggestive of a genetic etiology, including intellectual
disability, seizures, multiple congenital anomalies, metabolic conditions, and
neurodegenerative conditions or idiopathic cerebral palsy.
2. A minimum of one biological parent is available and willing to provide a specimen for
WES, with a preference for two available parents. At least one parent consenting to
WES of the child.
4. Pediatric patients must have had at least one prior genetics appointment or evaluation
5. Pediatric patients may have had a single nucleotide polymorphism (SNP) array or
oligonucleotide array that did not provide a diagnosis.
Exclusion Criteria:
1. Prior WES performed for a clinical or research indication
2. Lack of phenotypic indication of a likely underlying genetic etiology
3. Both biological parents are unavailable.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at most 18 Years | Clinical Utility of Pediatric Whole Exome Sequencing | NCT03525431 | Contradiction |
6,851 | 49 | A 50-year-old woman comes to the clinic complaining of difficulty swallowing both liquids and solid foods, as well as occasional cough while eating. She also has difficulty lifting her arms above her head and getting up from a chair. The weakness seems to get worse gradually. The patient has no prior medical problems and takes no medications. Vital signs are normal. Physical examination shows an erythematous rash on the upper eyelids. There are some red papules over joints of her hands. The rest of the physical examination is unremarkable. Antinuclear antibodies, anti-Jo-1 antibodies and anti-MDA5 antibody are positive. Muscle biopsy shows perifascicular inflammation and atrophy of the fascicle and surrounding blood vessels. | I had to go to the clinic because of difficulty swallowing all kinds of food, liquid and solid. I also sometimes cough when I eat my dinner. At only 50 year old, I had some difficulties lifting up my arms and getting up from a chair! And it's only getting worse! I never had any medical issues in the past and I'm not under any medication, I just don't get it! My vitals were normal. The physical exam showed a red rash on my upper eyelids. I also have red papules on my hands' joints. After a blood test, they told me that my antinuclear antibodies, anti-Jo-1 antibodies, and anti-MDA5 antibodies were positive. I also did a muscle biopsy and it showed that I had an atrophy of my blood vessels around my muscle fibers and that I have an inflammation of these. | Inclusion Criteria:
- All patients who had a confirmed (muscular biopsy, electromyogram, magnetic resonance
imaging) or suspected clinically myositis. Myositis criteria are as follow:
- Dermatomyositis or polymyositis according to Bohan and Peter criteria (1975)
- Body inclusion myositis according to Griggs et al. criteria (1995)
- Necrotizing autoimmune myopathy according to Hoogendijk et al. criteria (2004)
- Drug-induced myositis
- Signature of the informed consent form for the study and for the biobank
- Age over 18 years old
Exclusion Criteria:
- None
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Clinical Database and Biobank of Patients With Inflammatory Myopathies: the MASC Project (Myositis, DNA, Serum, Cells) (MASC) | NCT04637672 | Entailment |
1,236 | 6 | A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea. The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease. He smokes 2 packs of cigarettes daily for the past 30 years. On examination, there are decreased breath sounds and percussive dullness at the base of the left lung. Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli. | I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli. | Inclusion Criteria:
1. Presence of symptomatic and moderate sized (>1/3 of hemithorax) MPE
2. Persistent malignant pleural effusion that is free-flowing
3. Symptomatic improvement after therapeutic thoracentesis
4. Life expectancy of at least three months (duration of study follow-up)
5. 90% radiographic apposition of parietal and visceral pleura
6. Residence within 30 minute radius from The Ottawa Hospital
Exclusion Criteria:
1. Previous lobectomy or pneumonectomy on affected side
2. Multiple loculations
3. Trapped or entrapped lung
4. Untreated pleural infection
5. Abnormal coagulation profile (INR>1.5 and / or platelet count <50 x 10*9/L)
6. Planned intrapleural chemotherapy (however participants may receive concomitant
systemic chemotherapy, mediastinal radiation therapy or steroids)
7. Life expectancy less than 3 months
8. Multiple co-morbidities limiting out-patient management of pleural effusion
9. Tetracycline / Doxycycline allergy
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
| Effectiveness of Doxycycline for Treating Pleural Effusions Related to Cancer in an Outpatient Population | NCT01411202 | Entailment |
5,343 | 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:
- Subjects must be adult males or females age 18 to 80 years (inclusive).
- Subjects must be able and willing to follow study procedures and instructions in
English.
- Subjects must have read, understood and signed an informed consent form in English.
- Subjects must have a maxillary premolar, canine, lateral incisor, or central incisor
with a restorative or periodontal hopeless prognosis (Kwok and Caton 2007), in which
an implant is indicated without any sinus lift required.
- Subjects undergoing implant placement should be in adequate periodontal health prior
to implant placement. This includes having probing depth ≤ 4 mm for all remaining
teeth at the same quadrant of the proposed implant placement. Patients with
periodontal probing sites with probing depths of up to 5 mm may also be included if
bleeding on probing in these sites is absent. Each subject should be considered to be
periodontally stable prior to the implant surgery.
Exclusion Criteria:
- Individuals who have a chronic disease with oral manifestations.
- Individuals who exhibit gross oral pathology.
- The use of either antibiotics or chronic use (more than 7 days) of NSAIDs within 1
month prior to screening examination.
- Individuals that require antibiotic prophylaxis prior to dental treatment.
- Chronic treatment (i.e. two weeks or more) with any medication known to affect
periodontal status (e.g. phenytoin, calcium antagonists, cyclosporine, Coumadin)
within 1 month prior to screening examination.
- Uncontrolled diabetes mellitus (HbA1c >7) within 3 months prior to screening
examination.
- Individual with uncontrolled parafunctional habits, such as clenching and bruxing on
objects, that could adversely impact implant survival.
- Individuals with a history of intravenous bisphosphonates.
- Individuals with active infectious diseases such as hepatitis, HIV or tuberculosis.
- Current cigarette smokers.
- Individuals who are known to be pregnant, breastfeeding or planning to become pregnant
within 6 months.
- Individuals with blood disorders (hemophilia) and /or currently taking anticoagulant
medications, such as heparin, warfarin, or clopidogrel.
- Individuals receiving any therapy known to affect healing, such as high dose
corticosteroids, radiation therapy or chemotherapy.
- Individuals allergic to topical or local anesthesia.
- Individuals who require maxillary sinus augmentation prior to dental implant therapy.
- Individuals with dehisced, fenestrated, or fractured labial/buccal alveolar bone plate
determined after baseline CBCT or after tooth extraction where more than 50% of the
buccal bone height is not present. In this case, if the surgeon determines that guided
bone regeneration (bone graft and membrane) is needed to repair the defect, it will be
done at no cost to the subject, but the subject will be excluded from the study
protocol.
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 | A Volumetric Analysis of Soft and Hard Tissue Healing for Ridge Preservation and Socket Seal After Tooth Extraction | NCT02844569 | Contradiction |
1,574 | 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:
- Overtly healthy males or females, as determined by medical history, physical
examination and vital signs.
- Body mass index (BMI) within the range of 19 to 35 kilograms per meter squared (kg/m²)
- Male participants are not required to adhere to contraceptive requirements and female
participants of childbearing potential must agree to be either remain abstinent or
stay in a same sex relationship without sexual relationships with males or must agree
to use a highly effective method of contraception and who underwent bilateral
salpingectomy. The Female participants not of childbearing potential are not required
to use contraception.
Exclusion Criteria:
- Have a positive pregnancy test at screening or Day -1, where applicable
- Are planning to become pregnant during the study or within 1 month of study completion
- Are women who are lactating
- Have known allergies to selpercatinib- or dabigatran-related compounds or any
components of the formulation of selpercatinib or dabigatran, or history of
significant atopy
- Have a history of allergic reactions to medications or food products
- Have a clinically significant abnormality of blood pressure and/or pulse rate as
determined by the investigator
- Have known bleeding disorder including prior personal or familiar history of abnormal
bleeding, hereditary or acquired coagulation or platelet disorder
- Clinically significant abnormalities on ECG as determined by the investigator or
prolongation of the QTcB or QTcF >450 msec on more than 1 ECG obtained during
screening only
- Have clinically significant active cardiovascular disease or history of myocardial
infarction within 6 months prior to the planned start of selpercatinib
- Are currently enrolled in any other clinical study involving an investigational
product or any other type of medical research judged not to be scientifically or
medically compatible with this study
- Have an average weekly alcohol intake that exceeds 21 units per week (males ≤65 years
old) and 14 units per week (females); 1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL
of wine; 1.5 oz or 45 mL of distilled spirit(s)
- Are smokers of more than 10 cigarettes or e-cigarettes, or 3 cigars or 3 pipes, per
day
- Consume excessive amounts of coffee, tea, cola, or other caffeinated beverages per day
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 | A Drug Drug Interaction (DDI) Study of Selpercatinib and Dabigatran in Healthy Participants | NCT04782076 | Contradiction |
4,097 | 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:
- Subjects with symptoms of narcolepsy with onset during the period between January 1st,
2009 and December 31, 2010.
Exclusion Criteria:
- Subjects younger than 6 months of age
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 6 Months old.
| Risk of Narcolepsy Associated With Administration of H1N1 Vaccine | NCT01394614 | Entailment |
3,405 | 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. Unilateral ISSNHL with onset within 72 hours prior to study treatment;
2. Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across the 3 most
affected contiguous air conduction audiometric pure tone frequencies ("pure tone
average", PTA);*
3. Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air
conducted PTA frequencies compared with the unaffected contralateral ear or reference
values from a pre-existing audiogram or ISO 7029;2000 norm values in case of
asymmetric hearing prior to the ISSNHL incident;
4. Age ≥ 18 and ≤ 65 years on the day of screening;
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
1. Bilateral ISSNHL;
2. Acute hearing loss from noise trauma, barotrauma or head trauma;
3. History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic
hydrops or Menière's disease in the affected ear;
4. History of chronic inflammatory or suppurative ear disease or cholesteatoma in the
affected ear;
5. History of acoustic neuroma or other retrocochlear damage in the affected ear;
6. History of otosclerosis in the affected ear;
7. Suspected perilymph fistula or membrane rupture in the affected ear;
8. Congenital hearing loss;
9. History of ISSNHL in the past 2 years;
10. Otitis media or otitis externa that is ongoing or ended within 7 days prior to study
treatment;
Other protocol-defined exclusion criteria may apply.
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 | AM-111 in the Treatment of Acute Inner Ear Hearing Loss | NCT02561091 | Contradiction |
5,928 | 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. Age > 18 years
2. Small hiatus hernia (< 2-3 cm)
3. Los Angeles Grade 'A' or 'B' Reflux Esophagitis or non erosive esophagitis
4. LES pressure <15 mm Hg
5. PPI dependent / refractory GERD
6. abnormal 24h esophagus pH-impedance monitoring
Exclusion Criteria:
1. Age < 18 years
2. Large hiatus hernia (> 3 cm)
3. Los Angeles Grade 'C' or 'D' Reflux Esophagitis
4. LES pressure > 15 mm Hg
5. Underlying coagulation disorder
6. Previous Esophageal or Gastric surgery
7. Pregnant
8. major esophagus motility disorder according to Chicago v3.0
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 Efficency and Safety of Stretta in GERD | NCT03574831 | Contradiction |
2,440 | 16 | A 39-year-old woman comes to the clinic complaining of arthralgias and nodules on her legs. She has no fever or other skin rashes. The prior medical condition is unremarkable, and she takes no medications. On physical examination, there is moderate hepatomegaly. The lesions on her legs are tender and present predominantly on the anterior surface of the lower extremities. She doesn't smoke and drinks alcohol occasionally. The patient has 2 male sexual partners. Vital signs are normal. Chest x-ray demonstrates enlarged hilar lymph nodes, and laboratory testing reveals an elevated ACE level. Biopsy of the skin lesion shows noncaseating granulomas that stain negative for fungi & acid-fast bacilli. | I'm just a 39-year-old young woman but lately I have noticed some underlying cysts on my legs and my joints were hurting so much. I don't have a fever. I don't have rashes. My medical history is totally clean and I don't take any medication. When I went to the clinic they did a physical examination where they found that my liver is enlarged. They also found that the lesions on my legs are kind of tender and they are located on the front side of my legs. I do not smoke and I drink alcohol occasionally. I have to male sexual partners. On the day of my visit my vitals were fine. I did an X-ray of my chest and I had swollen lymph nodes. I also has a blood test and it came back with a high ACE level. I also had a biopsy of my skin lesions that came back negative for fungi and AFB. | Inclusion Criteria:
- Subject is 18 years of age or older.
- Subject has a diagnosis of cutaneous sarcoidosis for greater than 6 months with a
physician global assessment score of at least 4. Diagnosis (based on the
recommendations of an expert panel 24) can be made by either:
- Skin lesions characteristic of sarcoidosis and a biopsy showing granulomas with no
evidence of mycobacteria, fungus, or malignancy.
- A biopsy that does not show granulomas, but the patient has characteristic skin
lesions and another clinical feature suggesting sarcoidosis (bilateral hilar
adenopathy, erythema nodosum, uveitis, raised ACE level, BAL lymphocytosis
(CD4:CD8>3.5), panda/lambda sign on gallium scan)
- If female of childbearing potential, subject will have a negative urine pregnancy test
at Screening and Week 0.
- If female, subject will be either post-menopausal for > 1 year, surgically sterile
(hysterectomy or bilateral tubal ligation), or practicing one form of birth control
(abstinence, oral contraceptive, estrogen patch, implant contraception, injectable
contraception, IUD, diaphragm, condom, sponge, spermicides, or vasectomy of partner).
Female subjects will continue to use contraception for 6 months following the last
infusion.
- Screening laboratory results are within the study parameters.
- Subject has been on a stable dose of antibiotics, thalidomide, antimalarials, oral
corticosteroids or other immunosuppressives, such cyclosporine, tacrolimus,
azathioprine, methotrexate, or mycophenolate mofetil over the previous 4 weeks.
Exclusion Criteria:
- Subject has evidence of a clinically significant, unstable or poorly controlled
medical condition including unstable systemic sarcoidosis.
- Subject has a chest X-ray consistent with an active infection or previous exposure to
TB and/or a positive purified protein derivative test at screening (>5 mm).
- Subject has a serious, active or recurrent bacterial, viral, or fungal infection. This
includes hepatitis B and C, and HIV.
- Subject has been hospitalized for infection or received IV antibiotics within the
previous 2 months prior to baseline.
- Subject has a history of tuberculosis at anytime or close contact with a person with
active tuberculosis within the previous 6 months.
- Subject has received a live vaccination within the previous 3 months.
- Subject has a history of a central nervous system disorder/demyelinating disease or
symptoms suggestive of multiple sclerosis or optic neuritis.
- Subject has current signs or symptoms or history of systemic lupus erythematosus.
- Subject has been diagnosed with a malignancy within the past 5 years except for
successfully treated non-melanoma skin cancer.
- Subject has signs or symptoms suggestive of a possible lymphoproliferative disease.
- Subject has a diagnosis of severe congestive heart failure (Class III or IV NYHA).
- Subject has had a substance abuse problem within the previous 3 years.
- Subject has any dermatologic disease in the target site that may be exacerbated by
treatment or interfere with examination.
- Subject has been treated with an anti-TNF biologic immune response modifier, such as
infliximab, adalimumab, or etanercept within the past 8 weeks.
- Subject has been treated with topical corticosteroids, tacrolimus, or pimecrolimus
within 2 weeks or intralesional corticosteroids within 4 weeks of baseline.
- Subject has been administered an investigational drug in another clinical study within
30 days prior to baseline (or 5 half-lives, whichever is longer).
- Subject has a known allergy to adalimumab.
- Subject is female and is pregnant, is considering becoming pregnant during the study
and for 6 months afterwards, or is nursing.
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 Determine the Efficacy of Adalimumab in the Treatment of Cutaneous Sarcoidosis | NCT00690911 | Entailment |
297 | 2 | A 32-year-old woman comes to the hospital with vaginal spotting. Her last menstrual period was 10 weeks ago. She has regular menses lasting for 6 days and repeating every 29 days. Medical history is significant for appendectomy and several complicated UTIs. She has multiple male partners, and she is inconsistent with using barrier contraceptives. Vital signs are normal. Serum β-hCG level is 1800 mIU/mL, and a repeat level after 2 days shows an abnormal rise to 2100 mIU/mL. Pelvic ultrasound reveals a thin endometrium with no gestational sac in the uterus. | I just turned 32 and last morning I woke up with strange blood stains on my underwear. My last periods were more than 2 months ago, which is unusual for me because I used to have regular periods lasting for 6 days every 29 days, more or less. I had several UTIs in the past. I also had appendicitis. I'm currently seeing several men and, to be honest, some of them do struggle to wear a condom. I went to the hospital to check myself up and they told me that my vitals were normal. I also had a blood test on Monday, and my β-hCG level was 1800 mIU/mL, and then on Wednesday, it went up to 2100 mIU/mL. The gynecologist also did an ultrasound and she told me that, hopefully, there was no ovule. | Inclusion Criteria:
- Age 18 - 50 years, inclusive
- General good health, by volunteer history and per investigator judgment
- History of regular menstrual cycles of 21 - 35 days (inclusive), by volunteer report
- History of a normal PAP smear or ASCUS with negative HPV testing within the previous
12 months
- Willing to abstain from intercourse and use of vaginal medications, lubricants, and
other products as required in the protocol
- Willing to use non-spermicidal, lubricated condoms for any vaginal intercourse from
the first day of each menstrual cycle until 72 hours before expected midcycle
- In a mutually monogamous relationship with a male partner who:
- Is at least 18 years old
- Has no known risk for sexually transmitted infections (STIs)
- Is willing and able to comply with protocol requirements including sexual
activity/ abstinence and condom use requirements
- Can engage in vaginal intercourse with the participant, with and without condoms,
as specified in protocol
- Protected from pregnancy by female surgical sterilization
- Vaginal and cervical anatomy that, in the opinion of the investigator, lends itself to
easy genital tract sample collection
- Willing to give voluntary consent, sign an informed consent form and comply with study
procedures as required by the protocol
Exclusion Criteria:
- History of hysterectomy
- Surgical sterility or known history of infertility in male partner
- Sterility or known history of sperm dysfunction in male partner
- Currently pregnant by urine pregnancy test at the enrollment visit, or within two
calendar months from the last pregnancy outcome. Note: If recently pregnant must have
had at least two spontaneous menses since pregnancy outcome
- Current use of any hormonal contraceptive or a copper or hormonal IUD, or use of
Depo-Provera in the last 120 days
- Currently breastfeeding or having breastfed an infant in the last two months, or
planning to breastfeed during the course of the study
- Significant gynecological abnormalities (including abnormal vaginal bleeding,
excessive vaginal discharge, or vulvar/vaginal pain or irritation)
- Current UTI, vaginal candidiasis, or symptomatic bacterial vaginosis
- History of sensitivity/allergy to ZB-06 film components, for either the volunteer or
her male partner
- In the last three months, either the volunteer or her male partner diagnosed with or
treated for any STI or pelvic inflammatory disease, or either partner with known risk
factors for sexually transmitted infections. Note: Women with a history of genital
herpes or condylomata who have been asymptomatic for at least six months may be
considered for eligibility
- Positive test for Trichomonas vaginalis, Neisseria gonorrhea, Chlamydia trachomatis,
or HIV at the screening visit
- Deep epithelial genital findings such as abrasions, ulcerations, and lacerations, or
vesicles suspicious for an STI
- Known current drug or alcohol abuse which could impact study compliance
- Participation in any other investigational trial within the last 30 days or planned
participation in any other investigational trial during the study
- History of gynecological procedures (including genital piercing) on the external
genitalia, vagina or cervix within the last 14 days
- Abnormal finding on laboratory or physical examination or a social or medical
condition in either the volunteer or her male partner which, in the opinion of the
investigator, would make participation in the study unsafe or would complicate
interpretation of data
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 50 Years | An Exploratory Study of ZB-06 as a Vaginal Contraceptive Film | NCT04731818 | Contradiction |
4,085 | 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:
- RBD patients:
- Men or women aged 30 to 80
- Patients with idiopathic and secondary RBD (including RBD associated with
Parkinson's disease, Narcolepsy, Multiple System Atrophy or other neurological
diseases) diagnosed according to the latest international criteria Classification
of Sleep Disorders (ICSD-3 ).
- Cooperation and understanding to strictly comply with the conditions laid down in
the protocol
- Affiliated to a social security system
- bedpartners
- Men or women aged 30 to 80
- Subjects sharing the same bed as the patient for ≥70% of the time (e.g. at least
5 nights / week, or 20 nights / month)
- -Cooperation and understanding to strictly comply with the conditions described
in the protocol
- Affiliated to a social security system
Exclusion Criteria:
-- RBD patients:
- Clinically defined dementia according to the criteria of DSM-V2 (Major Neurocognitive
Disorder)
- Untreated Obstructive Sleep Apnea Syndrome (OSAS) (with IAH> 15 / h at vPSG)
- Patients under tutorship or curatorship or safeguard of justice
- No change in treatment should have occurred during the 4 weeks prior to inclusion in
the study and no change in treatment should be expected a priori within one week of
inclusion
- Bedpartners
- Clinically defined dementia according to the criteria of DSM-V2 (Major Neurocognitive
Disorder)
- Patients under tutorship or curatorship or safeguard of justice
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 80 Years | French Validation of a Severity Scale in REM Sleep Behavior Disorder (SEV-TCSP) | NCT04071899 | Entailment |
2,326 | 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:
- Age 6-16 years - This age range was selected as there are accepted normative pulmonary
function data and children 6 years of age and older are generally able to reliably
perform pulmonary function tests. Children are followed in participating centres until
they reach 18 years of age (allowing two years of follow-up).
- Clinical phenotypic features consistent with DMD and confirmed by either: (1) Muscle
biopsy showing complete dystrophin deficiency; (2) Genetic test positive for deletion
or duplication in the dystrophin gene resulting in an 'out-of-frame' mutation; or (3)
Dystrophin gene sequencing showing a mutation associated with DMD.
- FVC ≥ 30% predicted - This range of pulmonary function was selected to exclude those
with severe restrictive respiratory impairment, who are less likely to be able to
reliably perform pulmonary function testing over a two year period.
- A caregiver willing to provide the therapy
- Fluency in English or French
Exclusion Criteria:
- Unable to perform pulmonary function tests and/or LVR manoeuvre
- Presence of an endotracheal or tracheostomy tube
- Already using LVR and/or the Respironics in-exsufflator between and during respiratory
infections
- Known susceptibility to pneumothorax or pneumomediastinum
- Uncontrolled asthma or other obstructive lung disease
- Symptomatic cardiomyopathy (ejection fraction less than 50% )
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 16 Years | Stacking Exercises Aid the Decline in FVC and Sick Time | NCT01999075 | Entailment |
6,351 | 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: Individuals entering into quarantine because of a positive Covid-19
test using either PCR or an authorized antigen assay. It is not necessary, but preferable,
for the participant to be symptomatic for Covid-19 -
Exclusion Criteria: Unwilling to do repeat PCR and/or antigen testing or to provide the
results of the repeat testing or the requested clinical data
-
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
| Inhalation of KELEA Excellerated Water in Covid-19 Infected Individuals | NCT04490824 | Entailment |
6,058 | 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. Patients referred for upper endoscopy for any reason including those with acid reflux,
dyspepsia, weight loss, Barrett's esophagus,suspected Helicobacter pylori infection.
2. Patients able to provide written informed consent.
Exclusion Criteria:
1. Lack of severe comorbid conditions precluding an upper endoscopy.
2. Patients with history of esophageal or gastric cancer.
3. Patients status post esophageal or gastric resection.
4. Patients with esophageal varices.
5. Patients with severe esophageal strictures.
6. Patients with acute upper gastrointestinal bleeding.
7. Inability to provide informed written consent.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
| Comparison of Acid Reflux at Two Levels in the Esophagus Using the BRAVO Capsule | NCT00579410 | Entailment |
4,586 | 35 | A 43-year-old woman, gravida 3 para 3, comes to the clinic complaining of recently painful menstrual cycles. The patient's last menstrual period was 2 weeks ago. Urine β-hCG is negative. Menarche was at age 12, and menstrual periods occur every 28 days and lasts for 5 days. She is sexually active with her husband and does not have pain with intercourse. BMI is 23 kg/m2 and Vital signs are normal. On physical examination, the uterus is uniformly enlarged and tender. She is candidate for hysterectomy with the diagnosis of adenomyosis. | I'm 43, and I paid a visit to my doctor because my last few periods were insanely painful. My last periods were 2 weeks ago. I already had three pregnancies that gave me the three lovely children. I did a urine test to check for potential pregnancy, and it came back negative. I started to have my periods at the age of 12, and I have been pretty regular with periods every 28 days for 5 days. I'm sexually active with my husband and I do not have any pain when we have sex. My BMI is 23 and my vitals were normal. The doctor performed a physical exam and found that my uterus was tender and enlarged. She proposed me a hysterectomy and diagnosed me with adenomyosis. | Inclusion Criteria:
1. Able and willing to provide written informed consent.
2. Agreed to take effective contraceptive measures during and 6 months after the end of
the study period.
3. Age between 18 to 40 years (inclusive).
4. Body weight ≥45 kg, body mass index (BMI) of ≥18 and ≤28 kg/m2,
5. Regular menstruation cycle (25 to 34 days, inclusive).
6. Healthy female volunteer, normal findings in medical history and physical
examinations.
7. Normal findings in sex hormone examinations unless the investigator considers an
abnormality to be clinically irrelevant for this study.
8. Negative for human immunodeficiency virus (HIV) I and II tests, hepatitis B surface
antigen (HBsAg), hepatitis C antibody and schaudinn's bacillus antibody at screening.
9. Normal uterus, presence of both ovaries, unless investigator considers an abnormality
to be clinically irrelevant for this study.
Exclusion Criteria:
1. Historic abuse of alcoholic beverages and drugs. Smoke ≥5 cigarettes or the equivalent
per day. Drug screen will include the minimum the following: amphetamines,
barbiturates, benzodiazepines, cannabis, cocaine, methadone, opiates.
2. History of hypersensitivity to FSH, or any documented or suspected allergy to KN015 or
the excipients of the KN015 formulation, or hypersensitivity to luteinizing hormone
releasing hormone agonist or something like that.
3. Any medical history of circulation, endocrine, nervous, digestive and respiratory
systems, hematology, immunology, psychiatry and metabolic disorders and other serious
disease history which can interfere with the test results of the study.
4. Polycystic ovary syndrome (PCOS).
5. Baseline of serum FSH ≥15 IU/L.
6. History of ovarian hyperstimulation syndrome (OHSS).
7. Experience in controlled ovarian stimulation (COS), or showed high response to FSH
stimulation or the number of follicles over 11mm in diameter is more than 30.
8. The history of ovarian, breast, uterus, hypothalamus, and pituitary disease was
determined by the investigators as clinical meaningful. Previous history of thrombosis
or tending to suffer from thrombotic disease.
9. History of malignant disease.
10. Failing to comply with the special requirements of diet during study.
11. Participation in a clinical study within 3 months prior to the study.
12. Any medical condition that, in the opinion of the investigator, would interfere with
safety of the subject or with the objectives of the study.
13. Abnormal physical examinational results which is determined as clinical significance
by the researchers of the study.
14. Abnormal vital signs and clinical significance.
15. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >1.5 x ULN.
16. Thyroid dysfunction which clinical significance by researchers of the study.
17. Other abnormal laboratory tests with clinically relevance.
18. Abnormal electrocardiogram [ECG] findings.
19. III/IV class endometriosis, submucous myoma of uterus, endocrine abnormalities within
6 months prior to the study.
20. Abnormal imaging examination and clinical significance judged by researchers of the
study.
21. Pregnancy or lactation period.
22. Alcohol and urine drug screening positive. -
Female
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 40 Years | Single Dose Recombinant Human Follicle Stimulating Hormone Fc Husion Protein (KN015) in Healthy Volunteers | NCT03192527 | Contradiction |
Subsets and Splits