cyrilzakka/clinical-trials huggingface dataset:
A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.

The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.

The study objective is to evaluate the long-term efficacy and safety of SM-13496 (20-120 mg/day) in patients with bipolar I disorder.

Eligibility Criteria:
Inclusion Criteria:

Patients who completed the D1002001 study

・Patients who completed the D1002001 study and who are considered by the investigator to be eligible and without safety concerns.

Patients who did not participate in the D1002001 study

* Patients who were fully informed of and understand the objectives, procedures, and possible benefits and risks of the study and who provided written voluntary consent to participate in the study.
* Outpatients aged 18 through 74 years at the time of consent
* Patients meets DSM-IV-TR criteria for bipolar I disorder, most recent episode manic, hypomanic, or mixed with or without rapid cycling disease course (≥ 4 episodes of mood disturbance, but \< 8 episodes in the previous 12 months prior to screening).

Exclusion Criteria:

* Patients with imminent risk of suicide or injury to self, others, or property.
* Patients who are otherwise considered ineligible for the study by the investigator.
Role of Femoral Vein Wall Thickness and Inflammatory Markers in Patients With Behcet Disease

Evaluation of femoral vein wall thickness and inflammatory indices in patients with Behcet disease and assessment of their relation to the disease activity and related some clinical manifestations


Eligibility Criteria:
Inclusion Criteria:

* Patients fulfill the International Criteria for Behcet's Disease (ICBD)
* Age above 18 years old
* Patients cooperative and can answer questions
* Patients who are able and willing to give informed consent

Exclusion Criteria:

* Other rheumatological and vascular diseases
* Patients with abnormal hepatic or renal function tests , hyperlipidemia and impaired coagulation tests
* Patients with hypertension , diabetes mellitus , malignant and active infectious diseases
* Patients who are using aspirin and other platelet active drygs during the previous 6 months
* patients who are not able and willing to give written consent
Study of Next-Generation Recombinant Factor IX Variant in Adult Subjects With Hemophilia B

Phase 2b, single-center, open-label study designed to evaluate the pharmacokinetics, pharmacodynamics, efficacy and safety of subcutaneous (SC) prophylaxis treatment regimens with CB2679d in 6 adult, male subjects with severe congenital hemophilia B.

Single-center, open-label Phase 2b study will evaluate the PK, PD, efficacy and safety parameters of SC prophylaxis treatment regimens with CB2679d in adult subjects with hemophilia B. The study will enroll and dose subcutaneously, a total of 6 adult male subjects with severe congenital hemophilia B.

During the Treatment Period, the subject will receive an IV dose of 50 IU/kg followed 35 ± 5 minutes later by a SC dose of 100 IU/kg. Daily SC doses of 100 IU/kg will be administered until Day 28 (28 total SC doses). On Day 1, PK, PD, and safety assessments will be done at pre-IV dose and repeated 35 (± 5) minutes later prior to the SC dose. Subsequent PK, PD and safety assessments will be performed pre-dose on days 2, 3, 7, 14, 21 and 28.

During the Washout Period, PK, PD, and safety assessments will be done on Days 29, 30, 31, 32 and 33. Daily FIX activity levels will be measured, unless FIX activity level is known to be \< 5%, as measured by local laboratory.

An End of Study visit will occur 30 days (± 2 days) after the last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of severe (\<2%) congenital hemophilia B.
* Male, age 18 or older.
* Agreement to use highly effective birth control throughout the study.
* Affirmation of informed consent with signature confirmation before any trial-related activities.
* Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion Criteria:

* History or a family history of FIX inhibitors.
* Positive antibody to FIX detected by central laboratory at screening.
* Previous participation in and subsequent treatment in a clinical trial within the previous 30 days or 3-half-lives, whichever is longer, or absence of clinical effect.
* Have a coagulation disorder other than congenital hemophilia B.
* Factor IX gene mutation 128G\>A.
* Significant contraindication to participation.
Study of Electrophysiological Markers Related to the Cognitive and Affective Processes Behind Empathic Behaviour in Schizophrenic Spectrum Disorder

Disorders of social cognition, and empathy more specifically, are at the heart of schizophrenic pathology in that they are strongly linked to the social handicap of patients. It is therefore necessary to refine our knowledge of the cognitive and affective processes behind this empathic disorder and to identify objective and easily measurable markers (related to brain functioning collected by electroencephalography) of these processes with the subsequent aim of improving their management. It is also relevant to question the trait/status nature of these empathic disorders by studying these markers in individuals presenting more or less marked schizotypic traits and therefore more or less at risk of developing schizophrenia. Studying the possibility that empathy disorders may be part of the factors of developmental vulnerability for schizophrenia and identifying objective markers of this vulnerability could allow, in case of development of the pathology, a more rapid diagnosis and a more effective management.


Eligibility Criteria:
Inclusion Criteria:

* Common to all: good command of the French language, right-handed.
* Specific to patients: diagnosis of schizophrenia or schizoaffective disorder, clinical state stabilized according to the treating psychiatrist.

Exclusion Criteria:

* Common to all: having suffered a head injury with loss of consciousness lasting more than 5 minutes, participating in another project at the time of the present study, presenting an addiction to a toxic substance (excluding tobacco), presenting a mental retardation or neurological disorder (verified by a pre-recruitment interview and the administration of the Mini International Neuropsychiatric Interview for control subjects and on the basis of the information in the medical file for patients).
* Patient-specific: significant change (according to the doctor) in treatment in the previous month, currently hospitalized.
* Specific to controls: taking a psychoactive drug, having a mental disorder, being first-degree related to a patient with a disorder other than schizophrenia or schizoaffective disorder.
Transient Elastography of the Liver ( Fibroscan ) and Bariatric Surgery

To evaluate the effect of Bariatric surgery on the extent of liver fat and liver fibrosis and on different metabolic parameters in patients undergoing sleeve gastrectomy surgery.

The effect of bariatric surgery on the extent of fat and extent of liver fibrosis following sleeve gastrtrectomy is unknown. Methods : 60 obese NAFLD patients will undergo sleeve gastrectomy surgery. Measurements will be conducted at: baseline, and at 6 Month and will include: abdominal US, Fibroscan elastography , biochemical tests, anthropometric measurements, and questionnaires for demographic details, quality of life, food intake, food tolerance and habitual physical activity. Primary Outcome Measures: Liver fat quantification (controlled attenuation parameter;CAP ) and stiffness at baseline and at 6 months by fibroscan. The liver stiffness is measured by Fibroscan in a volume of approximates 1 cm wide and 4 cm long cylinder, representing 1/500 of liver tissue (100 times greater than a biopsy sample). The results of the Fibroscan will be expressed in KiloPascals (kPa). The Fibroscan XL probe reduces Fibroscan failure and facilitates reliable liver stiffness measurement in obese patients compared with the common M probe. Secondary Outcome Measures: metabolic parameters including insuline resistance, CRP, MDA, Paraoxonase, and bile acid levels. Quality of life and Food tolerance after bariatric surgery

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18-65 years old
* BMI \> 40 kg/m² or BMI \> 35 kg/m² with comorbidities
* Willingness to take a metformin once a day for 6 months
* Ultrasound diagnosed NAFLD patients
* Reading and speaking Hebrew

Exclusion Criteria:

* Subject with mental illness or cognitive deterioration
* Use of probiotic/antibiotic 3 mounts before surgery
* Use of other antibiotic for more than 1 week during the study
* Drug addiction
* Excessive alcohol consumption (≥ 30 g/day in men or ≥ 20 g/day in women)
* Treatment with drugs known to cause hepatic steatosis or elevation of liver enzymes (e.g. Corticosteroids, HAART, Amiodarone, high dose estrogens)
* Treatment with drugs or supplements that may improve hepatic steatosis or liver enzymes (Vitamin E, Milk thistle, ω-3 fatty acid, Ursodeoxycholic acid) 3 months prior to the initiation of the study
* Other causes of chronic liver disease ( e.g. viral hepatitis: HBV/HCV +, autoimmune hepatitis, Hemochromatosis, Wilson's disease)
* Diabetic patients who are treated with antidiabetic medications, except diabetic patients who are treated for at least 6 months exclusively with Metformin at a stable dose
* Subjects who began a new lipid reduction medications less than 6 months prior to the initiation of the study
* Subjects with chronic conditions that could interfere with our study: active cancer, organ transplant subjects, advanced kidney or liver disease, inflammatory bowel disease and other systemic inflammatory conditions
* Bariatric surgery in the past
Coaching for Confidence: Evaluating an Internet-based Program to Help Parents Help Children With Difficulty With Anxiety

The study is an open trial to evaluate a web-based intervention. The intervention focuses on supporting parents to help their children to overcome problems with anxiety. The children who are the focus of the study are in the age ranges of 4 - 12 and experience problems with separation anxiety, social anxiety, or generalized anxiety as identified by their parents. The program will exclude obsessive-compulsive disorder and post-traumatic stress disorder that are seen less often in this age group and require somewhat different interventions.

Parents will be recruited for the study through stories in the media and notices sent through the schools to parents of school age children. The information will invite parents to contact the study staff if in their view their child is more anxious, fearful, shy or worried than most children of their age. Parents will be screened to insure that the child's problem is appropriate for the study. If the child and family are judged to be appropriate for the study they will be provided a user name and password to access a web-based program called Coaching for Confidence. In the first part of the program they review the consent form and decide if they wish to provide consent. If they provide consent they complete initial assessment measures describing their child and themselves. Once the assessment is completed they have access to the program through the internet. They are encouraged to complete the program over a period of 10 weeks. The program focuses on supporting the parent's understanding of child anxiety and the strategies they can take in helping their child to overcome limitations related to anxiety.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of social anxiety, separation anxiety, or generalized anxiety disorder
* judged by parent to have anxiety that interferes with functioning in the home or school.
* judged by clinician to have anxiety that interferes with functioning in the home or school.
* parent unable to read and write in English.
* parent unable to access the internet regularly - at least once a week

Exclusion Criteria:

* diagnosis of obsessive compulsive disorder
* diagnosis of post-traumatic stress disorder
* diagnosis of school refusal and not attending school at least half of the time
* diagnosis of selective mutism
* diagnosis of autism spectrum disorder
* diagnosis of pervasive developmental disorder
* child currently receiving psychosocial treatment for anxiety
Myocardial Infarction With Non-obstructive Coronary Arteries in Turkish Population

The objective of this study is to analyze the Demographics, Clinical Profiles, Management, in-Hospital and Long-Term Outcomes of Patients with Acute Coronary Syndrome Syndrome And Myocardial Infarction with Non-obstructive Coronary Artery Disease.

Acute coronary syndrome is leading causes of death worldwide. Although, \>90% of these patients had of culprit coronary lesion, a significant proportion of them had no any angiographic evidence of obstructive coronary arteries. Exact mechanism of the myocardial infarction remains unclear of these patients. However, MI registries have reported that the 5% to %10 of MI patients have no evidence of obstructive coronary artery disease.

There is lack of any data regarding prevalence, demographics, patients' profile, management, and outcome of this clinical entity in Turkish population. This registry aims to obtain these data in Myocardial Infarction with Non-obstructive Coronary Artery Disease patients in Turkish population.

Although there are huge data in this issue from different country and geographic areas, to date no any national data about prevalence, demographics, management and in-hospital outcomes of AF patients who admitting with cute coronary syndrome. With this rationale the registry also aims to obtain demographics, clinical profile, management, and in-hospital outcome of AF in Turkish Acute coronary syndrome population.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years
2. Evidence of an MI as defined any one of the following criteria:

   Detection of a rise and/or fall of cardiac biomarker values \[preferably cardiac troponin (cTn)\] with at least one value above the 99th percentile upper reference limit (URL) and with at least one of the following:

   i. Symptoms of ischaemia. ii. New or presumed new signiﬁcant ST-segment-T wave (ST-T) changes or new left bundle branch block (LBBB).

   iii. Development of pathological Q waves in the ECG. iv. Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.

   v. Identiﬁcation of an intracoronary thrombus by angiography.
3. Invasive diagnostic coronary angiography (IDCA) findings to allow determination of the presence /absence of obstructive coronary artery disease
4. Signed informed consent form to trial participation

Exclusion Criteria:

1. Inability/Refused to provide informed consent
2. Age below 18 years
3. Patients with unstable angina pectoris (ACS without increase and/or decrease of a cardiac biomarker, preferably high-sensitivity cardiac troponin, with at least one value above the 99th percentile of the upper reference limit)
4. Patients refused invasive diagnostic coronary angiography
5. Myocardial infarction associated with revascularization procedures
A Study of the Combination of Electrical Stimulation and Dysport® in Myofascial Pain Syndrome.

The purpose of this study is to determine whether electrical stimulation enhances the effect of botulinum toxin type A (Dysport®) on myofascial pain syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Chronic neck and shoulder pain for at least 6 months, refractory with other conservative treatments
* Presents at baseline with pain score greater than 50mm on 100mm length VAS. Pain score will be measured as overall pain over the 7 days preceding the visit during activities
* Active trigger point (TrP) defined as a tender spot localised in a taut band of muscle fibres associated with tenderness AND referred pain recognised by the patient into well-defined areas that are remote from the TrP area at palpation AND preferably local twitch response at palpation AND/OR jump sign at palpation

Exclusion Criteria:

* Disc/bone disease
* History of surgery on neck
* Neurological deficits, neuromuscular junction disorder, Motor Neuron disease
* Patient has received anesthetic injections to the target trigger point within 4 weeks of study enrolment, or corticosteroid injections within 3 months
* Systemic inflammatory disease
* Hypersensitivity to Dysport®
* Diffuse tender points, or diagnosed with fibromyalgia
* Previous electrical stimulation
* Previous injection of Dysport® within 6 months of study enrolment
Impact of a Video Explaining Epidural Analgesia in Obstetrics

The aim of this study was to investigate the impact of multimedia information on epidural anesthesia. Pregnant women were randomly assessed to get a video information in addition to an oral and written information on epidural anesthesia. Maternal satisfaction concerning the quality of the information as well their anxiety and understanding of the procedure were assessed and compared in both groups.

The information in anesthesia consultation is mandatory. Few studies have investigated the impact of multimedia preoperative information in terms of satisfaction, comprehension and anxiety, with conflicting results. None have evaluated the contribution of a video explaining epidural analgesia in obstetrics. This study compared two types of information given in anesthesia consultation: an oral and written information (group P) versus oral, written and video information (group V). The main objective was maternal satisfaction, the secondary objectives were understanding and anxiety.

This is a common care, prospective and randomized study, conducted between September 2015 and February 2016 in the Creteil Intercommunal Hospital Center (CHIC) and accepted by the ethics committee Paris V. After information, not opposition of women who accepted to participated was collected. Oral information on epidural analgesia was provided in consultation by the anesthesiologist, with delivery of a written information sheet. The video made at CHIC in 2015, was transmitted, in addition, by email to patients randomized in the group V for she could look it at their convenience. Satisfaction and anxiety were evaluated by numerical scale from 0 to 10 and comprehension by multiple choice questions with a final score of 10. These three criteria were also evaluated in an emergency context in which women received oral and written information (group U). Evaluation questionnaires were given during the anesthesia consultation and recovered during the hospitalization after childbirth.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman
* Affiliated to social security system
* Understanding French language
* Internet access
* \>18 years old and not subject to a measure of legal protection

Exclusion Criteria:

* Contre indications to epidural
* Refusal to participate in the study
* Not affiliated with the Social Security system
* No understanding French
* No access to Internet
* Patient minor or under legal protection
Ovarian Reserve Following Medical Therapy in Patients with Endometriosis

This study aims to investigate whether there is an effect on ovarian reserve from medical therapy for endometriosis.

Although the therapeutic efficacy of medical hormone therapy on ovarian endometriosis has been proven in many scientific studies, none of these has shown an effect on ovarian reserve.

The aim of this study is to investigate whether there is a difference in ovarian reserve as measured by biochemical and ultrasound parameters before and after therapy.

Endometriosis is a benign, chronic and recurrent condition characterised by the presence of endometrial glands and stroma outside the uterine cavity. Endometriosis is most frequently localised to the ovary (17 - 44%) and is found in 5-10% of women of childbearing age. In this group of patients, quantification of the ovarian reserve by means of serological and ultrasound markers, in particular antral follicular count (AFC) and blood levels of antimullerian hormone (AMH), is essential. Recent evidence shows that medical hormone therapy, currently the first choice of treatment, affects ovarian endometriosis in terms of volumetric reduction of endometriomas and reduction of local inflammation, but little is known about its effect on ovarian reserve.

Our study therefore aims to evaluate ovarian reserve in terms of AMH and AFC in patients with ovarian endometriosis treated with medical hormone therapy after discontinuation of the latter.

In the clinical trial, patients diagnosed with ovarian endometriosis with an indication for medical therapy undergo 3 blood samples for the determination of antimullerian hormone (AMH) at the same time as 3 medical examinations as per normal care procedure.

Eligibility Criteria:
Inclusion Criteria:

* Clinical and ultrasound diagnosis of ovarian endometriosis without indication for surgery
* Age between 18 and 40 years
* Patients desiring pregnancy
* Informed consent obtained

Exclusion Criteria:

* Endocrinological disorders (including thyroid dysfunction, hyperprolactinaemia and Cushing's syndrome)
* Previous ovarian surgery
* Suspected cyst malignancy
Clinical Evaluation of a Daily Wear Frequent Replacement Silicone Hydrogel Lens

The purpose of this clinical study is to demonstrate the safety and performance of an investigational soft contact lens compared to a commercially available soft contact lens when worn in a daily wear modality.

Subjects will be randomized to wear either the investigational contact lenses or the commercially available contact lenses in both eyes. Subjects will be expected to attend 6 scheduled study visits. Individual participation in the study will be approximately 3 months.

Eligibility Criteria:
Key Inclusion Criteria:

* Successful wear of spherical daily wear frequent replacement soft contact lenses for distance correction in both eyes during the past 3 months for a minimum of 5 days per week and 8 hours per day.
* Manifest cylinder ≤ 0.75 diopter (D) in each eye.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Wearing habitual contact lenses in an extended wear modality (routinely sleeping in lenses for at least 1 night per week) over the last 3 months prior to enrollment.
* Monovision contact lens wearers.
* Habitually wearing Biofinity® lenses.
* Other protocol-specified exclusion criteria may apply.