cyrilzakka/clinical-trials huggingface dataset:
The Influence of AMH on Ovarian Responsiveness to Ovulation Induction With GnRH in Women With PCOS

The investigator suggests that PCOS women with high AMH levels are resistant to ovarian stimulation and may need adjustment of the dose of gonadotrophin.

There is a correlation between high levels of AMH and the severity of PCOS. Excessive AMH may have a negative effect on the sensitivity of the resting follicles to gonadotropins.

This is an observational prospective study to investigate the impact of circulating AMH on gonadotrophin induction in women with PCOS.

Eligibility Criteria:
Inclusion Criteria:

* Women of age 18 - 35 years
* BMI 20 - 30 kg/m2
* Anovulatory infertility
* Diagnosis of PCOS based on Rotterdam consensus criteria (two of three criteria: Oligo/anovulation, hyperandrogenaemia and sonographic appearance of polycystic ovaries)

Exclusion Criteria:

* Women Above 35 years or under 18 years
* Women with BMI above 30 kg/m2 or under 20 kg/m2
* Normally ovulating women
* Patients with marked hyperandrogenaemia were screened for congenital adrenal hyperplasia (by measuring serum concentration of 17alpha hydroxyl-progesterone) or Patients with Cushing syndrome (by measuring urinary free cortisol)
Resistance Exercise in Rheumatic Disease

People with rheumatic disease often have decreased strength, muscle mass, and bone mineral density due to repeated bouts of inflammation, normal effects of aging, disuse, and inactivity. The medications used to quell the disease process, such as prednisone, can also have detrimental effects on body composition, strength, and functional capacity. The investigators propose to investigate the feasibility, safety, and effects of resistance exercise in older patients with rheumatoid arthritis (RA) and vasculitis. The unique resistance protocol the investigators propose involves performing movements in a slow and controlled fashion (i.e., no acceleration or use of momentum in the lifting and lowering of the resistance) to minimize force on the joints and connective tissues. This will be conducted in an individually-supervised environment with a new generation of exercise equipment that will accommodate their musculoskeletal capabilities and allow for reproducibility of the exercise protocol. The investigators intend to investigate the feasibility, safety, musculoskeletal, and psychological effects of this resistance exercise protocol in older patients with rheumatoid arthritis and vasculitis by testing their strength, body composition, functional ability, mood, and quality of life before and after this 16-week resistance exercise intervention.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of rheumatoid arthritis OR systemic vasculitis (defined as granulomatosis with polyangiitis, Churg-Strauss, microscopic polyangiitis, Anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, or giant cell arteritis)

Exclusion Criteria:

* Non-English speaking
* Pregnancy
* Absolute cardiac or pulmonary contraindication to exercise
* pacemaker
A Clinical Study of ONO-1110 in Patients With Fibromyalgia

To Evaluate the Efficacy and Safety of ONO-1110 in Patients with Fibromyalgia


Eligibility Criteria:
Inclusion Criteria:

* Japanese (both sexes)
* Outpatient
* Patients who are considered capable of understanding the study procedures and completing the pain diary and questionnaires appropriately by the investigator (sub-investigator)
* Patients who meet the American College of Rheumatology Fibromyalgia Criteria

Exclusion Criteria:

* Patients with inflammatory arthritis, infectious arthritis, or autoimmune disease
* Patients with pain other than FM that may affect assessments in this study
* Patients with a past history of or concurrent neurologic diseases that may affect assessments in this study
* Patients with a past history of or concurrent malignant tumor within 3 years
* Patients who are pregnant, nursing, or possibly pregnant, or intending to become pregnant during the study period.
The Applicability of the Cumberland Ankle Instability Tool in Basketball Athletes.

The aim of our study is to evaluate the applicability, validity, and reliability of the Cumberland Ankle Instability Tool (CAIT) in basketball athletes. Given that a significant proportion of injuries in basketball occur in the ankle, our study holds importance for instability assessments conducted in this population. If the Cumberland Ankle Instability Tool is found to be applicable in basketball athletes, it may be utilized in future research.

The aim of our study is to evaluate the applicability, validity, and reliability of the Cumberland Ankle Instability Tool (CAIT) in basketball athletes. Since most injuries in basketball occur in the ankle, our study is significant for assessing instability in this population. If the Cumberland Ankle Instability Tool is found to be applicable in basketball athletes, it may be utilized in future research.

Hypotheses:

H₀ (Null Hypothesis): The Cumberland Ankle Instability Tool is not applicable, valid, or reliable in basketball athletes.

H₁ (Alternative Hypothesis): The Cumberland Ankle Instability Tool is applicable, valid, and reliable in basketball athletes.

The demographic information of the athletes, including height, age, weight, and years of sports experience, will be recorded. The Cumberland Ankle Instability Tool (CAIT) will be created using Google Forms and distributed to the athletes online.

To assess the reliability of the questionnaire, it will be administered twice to the athletes within a 3 to 7-day interval. The following reliability parameters will be calculated:

Internal consistency, Test-retest reliability, Standard error of measurement (SEM), Minimal detectable change (MDC). For validity assessment, the relationship between the Cumberland Ankle Instability Tool (CAIT) and the Foot and Ankle Ability Measure (FAAM) as well as the Identification of Functional Ankle Instability (IdFAI) will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Age between 16 and 45
* History of ankle sprain
* Participation in basketball training at least once per week

Exclusion Criteria:

* Participation in basketball training at least once per week
The Use of FLOSEAL to Reduce Bleeding in Total Knee Replacement Surgery

The purpose of this study is to determine if the agent, Floseal, can decrease the amount of blood patients lose after total knee replacement (TKR) surgery. If this product can be found to have an effect on bleeding, it may potentially reduce the problems associated with bleeding after knee replacement surgery such as pain, stiffness, and the need to have a blood transfusion. The subject's overall participation will be over a period of 6 weeks.

This is a prospective double blind randomized clinical trial of patients requiring unilateral total knee arthroplasty. The patients will be randomized intra-operatively to receiving Floseal or no treatment.

Both the patient and the observers will be blinded to whether the subject received Floseal or no treatment. Only the operating surgeons will be aware of whether Floseal or no treatment was given.

As was performed in the pilot study, randomization of Floseal or no treatment will be performed using the sealed envelope technique. Randomization will occur at the time of surgery. The statistician is responsible for maintaining the randomization schedule and issuing the sealed envelopes. The inner envelope will contain whether Floseal or no treatment is to be given on a card which will be counter-signed by the surgeon at the time of surgery. The inner envelope will then be sealed, followed by sealing of the outer envelope. Following the procedure, the surgeon will then take the sealed and signed envelope to surgeon who will store and file it in a locked cabinet in his office. The patients study number will be on the outside surface of the envelopes.

Eligibility Criteria:
Inclusion Criteria:

* Single Knee replacement for arthritis of the knee

Exclusion Criteria:

* No inflammatory arthritis (ie. Rheumatoid arthritis)
* No allergies to cow meat (bovine allergies
* No history of bleeding disorders
Evaluation of Efficiency of Ritalin in Multiple Sclerosis (MS) Patients

Scientific background:

Growing awareness and accumulating data regarding the cognitive impairment and its progression in multiple sclerosis (MS) patients has received an important place in neurological research in the last decade.

Scientific background:

Growing awareness and accumulating data regarding the cognitive impairment and its progression in multiple sclerosis (MS) patients has received an important place in neurological research in the last decade. Cognitive impairments occur frequently (43 to 65%) in MS. Moreover, in up to 50% of patients in whom no cognitive disturbances are found on routine neurological examination, cognitive impairments can be elicited using sensitive and disease specific neuropsychological tests. Even in patients with short disease duration of less than two years, discrete impairment of cognitive function may be found in up to 60% on neuropsychological testing without impacting activities of daily living.

We have recently reported that cognitive impairment occurred in 53.7% of patients with probable MS (evaluated within a mean of one month of the onset of new neurological symptoms). Verbal abilities and attention span were most frequently affected (43.3 and 41.8% respectively). An additional study demonstrated that MS patients within the first 5 years of disease onset presented attentional dysfunction only when the cognitive load of the attention task was high and when controlled information processing was required. This high rate of attention impairment found in MS patients early in the disease process may have a significant impact on quality of life and activities of daily living as attention is one of the most fundamental cognitive functions essential for normal daily activities and a requisite step towards conscious perception. Consequently, we suggest investigating whether treatment with Ritalin (methylphenidate) has an effect on patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of definite MS according to Poser criteria;
* Attention impairment defined as abnormal PASAT score;
* Written and signed informed consent;

Exclusion Criteria:

* Pregnancy or lactation;
* Steroid treatment;
* Persistent psychostimulant treatment;
* MS relapse;
Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye

Severe dry eye is a debilitating ocular disease resulting in loss of vision, reduced day-to-day function and significant discomfort. Tear substitutes are an important part of the treatment of all patients, however, even with aggressive us, the corneal(ocular)surface often remains very irregular due to poor surface healing.

The agent being evaluated in this study, Thymosin Beta 4, promotes healing of the corneal surface and has been studied in patients with recalcitrant corneal ulcers and erosions with significant success (Arch Ophthalmol. 2010;128(5):636-638., Ann of the NY Acad of Sci, May, 2010).

The study hypothesis is that Thymosin Beta 4, in its role as a modulator of corneal surface healing, may be able to promote healing of the corneal surface allowing for more conventional modalities to take over and maintain a smooth and regular ocular surface. The investigators hope to be able to demonstrate an improvement in visual acuity, surface healing and a reduction in dry-eye related symptoms.

See above

Eligibility Criteria:
Inclusion Criteria:

* Schirmers of \< 5 mm at 5 minutes
* TFBUT: less than 10 seconds
* Corneal staining of \>3 of 15: conjunctival staining of \>3 of 18
* Ocular Surface Disease Index of \> 50
* Presumed best corrected vision of 20/60 or better

Exclusion Criteria:

* Acute or inflammatory corneal disease
* Pregnancy or lactation
* Monocular status
* Punctal occlusion within 30 days
* Ocular surgery within 3 months
* Corneal thinning of \>50%
* Active corneal infection
* History of ocular malignancy
* Retinal neovascularization
* Current use of topical cyclosporin A
Effectiveness of the Treatment With Continuous Positive Airway Pressure(CPAP)in Stable Heart Failure With Ejection Fraction More Than 45% and Sleep Disordered Breathing

The respiratory sleep disorders are a major cardiovascular risk factor. In fact there is enough scientific evidence that supports the association between apnea-hypopnea syndrome (SASH) and cardiovascular disease (hypertension, stroke, heart failure ....The objective of this study is to estimate the effectiveness of the continuous positive pressure airway (CPAP) in patient with chronic heart failure with normal ejection fraction but dyastolic dysfunction and sleep disordered breathing during the sleep.


Eligibility Criteria:
Inclusion Criteria:

1. Ejection fraction\> 45%, which also ruled out significant left ventricular dilation
2. At least two abnormal indices of diastolic function.

Exclusion Criteria:

1. Not sinus rhytm
2. Severe lung disease (FEV1 or FVC less than 50%)
3. Significant valvular or congenital heart disease, primary
4. Unstable angina, myocardial infarction or cardiac surgery within three months prior to inclusion
5. Hypertrophic Cardiomyopathy
6. Presence of significant psychiatric disorders.
7. Severe Hypersomnia . (Epworth\> 20)
8. Severe pulmonary hypertension measured by Doppler,
9. Facial deformity and / or defect of nasal patency.
The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.

The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during which time supplemental analgesic medication (ibuprofen) will be provided to all subjects in addition to study drug.

Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Eligibility Criteria:
Inclusion Criteria:

* clinical evidence of chronic back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, osteoarthritis, or other, similar nonmalignant conditions.
* back pain treated with an opioid-containing analgesic at a dose equal to or less than the equivalent of 90 mg of oral morphine per day or 12 or fewer capsules or tablets of an opioid combination analgesic per day.

Exclusion Criteria:

* receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets per day of short-acting opioid-containing products.
* scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.

Other protocol-specific exclusion/inclusion criteria may apply.
Comparing the Hemodiafiltration On-line and Conventional Hemodialysis in Terms of Cost-benefit

The site where the clinical trial will be conducted is at the St-Luc hospital from the CHUM. This is a prospective randomized study that will compare the two treatment modalities, HD and HDF, through economics and pharmaco-economics parameters.

Patients, who had previously been randomized in the CONTRAST study, will remain in their respective group and monitoring will continue. The next patients will be randomized in the same way (1: 1) using the same inclusion and exclusion criteria. HDF randomized patients will receive post-dilution standard reinjection (at least 100ml/min or 6 liter/hr). In rare cases, HDF patients can briefly have reinjection on a pre-dilution mode (if heparin need to be avoided for example) and the reinjection flow should be adjusted accordingly (200ml/min).

Length and frequency of sessions will be the same in the 2 groups. Blood tests will not change and will be the same than those used as routine assessments. Metabolic control of patients will be maintained according to the guidelines. Patients will be monitored for a minimum of 3 years. A set of demographic and clinical data will be collected from patient medical records and throughout the study.

Biochemical data as part of the usual blood tests of dialysis patients will be collected each month as well as will be stored and analyzed information about the annual cardiac ultrasounds.

All events will be scored (hospitalizations, patterns, duration) and the list and cost of drugs will be compiled every three months. These data will be useful in the economic analysis comparing the two treatment modalities.


Eligibility Criteria:
Inclusion Criteria:

* more than 18 years old,
* able to consent,
* patient needs to be on hemodialysis more than 8-12 hours a week (2-3 sessions)

Exclusion Criteria:

* severe none compliance (often missing sessions without good reasons),
* life expectation less than 3 months,
* treated with high-flux filters in the last 6 months
Post-Market Clinical Evaluation of the Spiracur SNaP Wound Care System for Treatment of Acute Trauma and Acute Surgical Excision Wounds

The purpose of this study is to evaluate the efficacy of the Spiracur SNaP® Wound Care System for the treatment of acute trauma and acute surgical excision wounds. The secondary purpose will be to compare the prospective patients to retrospectively treated acute trauma wounds to further evaluate efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* Trauma wound, pressure ulcer, post operative wound, colostomy take-down site, or other acute wound deemed appropriate by study investigator(s) as the source of the wound on any part of the body including head and neck, torso, and extremities
* Wound \< 16 cm in greatest diameter
* Subject ≥ 18 years of age
* Exudate \< 25 ml/ day (estimate)
* Female subjects of child-bearing potential must be willing to take a urine pregnancy test prior to starting study
* Subject is willing and able to sign informed consent

Exclusion Criteria:

* Wound \> 45 days old
* Wound-related cellulitis
* Wound located in an area not amenable to forming an air-tight seal
* Subject has untreated osteomyelitis
* Subject is allergic to wound care products
* Wound has exposed blood vessels not suitable for negative pressure therapy
* Subject is pregnant
* Subject is actively participating in other clinical trials that conflict with current study
* Subject has fistulas
Personalized Therapy in Non-small Cell Lung Cancer

Excision repair cross complementing 1 (ERCC1) ribonucleotide reductase M1 (RRM1) and thymidylate synthase(TS) are molecular determinants that predict sensitivity or resistance to platinum agents 、 gemcitabine and pemetrexed respectively.

Tailored therapy using these molecular determinants suggested patient benefit in a previously reported phase 2 trial. Here, we designed a study for an individual patient analysis of prospectively accrued patients who were treated with the "personalized therapy" approach versus other standard approaches.

Patients who had nonsmall- cell lung cancer (NSCLC) performance status of 0/1 were accrued to 2 phase 2 clinical trials Trial A (carboplatin and chemotherapy individuation based on sensitivity marker ), Trial B (carboplatin non-individuation or chemotherapy non-individuation ).

Patients who were treated on Trials B were analyzed as the "standard therapy" group. Patients accrued to Trial A were called the "personalized therapy" group. disease free survival (DFS) was estimated using the Kaplan-Meier method.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed non-small cell lung cancer
2. age from 18 years to 75 years
3. ECOG Performance Status no more than 2
4. at least one appraisable lung focus of diameter≥ 10 mm by lung CT
5. Haemoglobin ≥10.0 g/dl, Absolute neutrophil count ≥(ANC) 1.5 x 109/L, platelets ≥100 x 109/L
6. Total bilirubin ≤1.5 x upper limit of normal (ULN)
7. ALT and AST \< 2.5 x ULN in the absence of liver metastases, or \< 5 x ULN in case of liver metastases
8. Creatinine clearance ≥60ml/min (calculated according to Cockcroft-gault formula)
9. Informed consent should be obtained before treatment.

Exclusion Criteria:

1. Mixed non-adenocarcinoma cell lung cancer histology
2. Previous treatment for Systemic chemotherapy or local radiotherapy
3. Be allergic to chemotherapy drugs
4. second active primary malignancy or serious concomitant medical disease
5. difficulties with adequate follow-up
Comparison of Lipophilic Versus Hydrophilic Statins on Patients With Heart Failure

There is a controversy whether statins are beneficial in patients with heart failure or not. Trials in which lipophilic statins have been used revealed positive results, unlike major studies where hydrophilic statins were administered. This trial is designed to compare the effects of lipophilic versus hydrophilic statin use in patients with heart failure.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years (of both sexes)
* diagnosed with stable chronic heart failure NYHA class II-III
* ejection fraction \< 40 % as assessed by 2D echocardiography
* who have been optimized on Guideline Directed treatment for heart failure for at least a month prior to enrolling.

Exclusion Criteria:

* Known hypersensitivity to statin
* Treatment with statins during the past month prior to study.
* Serum creatinine \> 3 mg/dl
* Significant liver disease: liver enzymes 2.5 folds the upper normal limit
* Malignancy
* Pregnancy or lactation
OBSERVational Registry on Long-term Outcome of ICD Patients

Multicentric, observational, retrospective registry including patients underwent ICD implantation for any indication. The primary aim of the registry is to evaluate the long-term outcome of patients receiving an ICD.

Multicentric, observational, retrospective registry including patients underwent ICD implantation for any indication in the period from 2010 to 2012. The aims of the registry are to evaluate the occurrence of complications related to ICD implantation (including ICD shocks and electrical storm), and the mortality during a long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* ICD implantation fo any indication;
* age \>18 years

Exclusion Criteria:

* life expectancy of less than one year
Alcohol Interaction Study

The purpose of this study is understand the effects of GSK114814 and alcohol in healthy volunteers when taken together.

The primary objective of this study is to investigate the CNS effects of co-administration of GSK1144814 with alcohol. Healthy volunteers who meet the eligibility criteria will be randomized to receive GSK1144814 or placebo with alcohol.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female
* Body weight 50 kg or higher and BMI within the range 19 - 29.9 kg/m2
* Willing to use appropriate contraception methods

Exclusion Criteria:

* Positive HIV, Hepatitis B surface antigen or Hepatitis C antibody result
* Any serious medical disorder or condition
* Any history of an endocrine disorder.
* Any clinically significant laboratory abnormality.
* History of psychiatric illness.
* Any history of suicidal attempts or behavior.
* Positive urine drug screen or positive blood alcohol
* Pregnant, nursing or potential to have a child
* Past history of alcohol dependence or abuse.
* History of increased sensitivity to the effects of alcohol or violent behaviour/aggression when intoxicated.
* smokers