cyrilzakka/clinical-trials huggingface dataset:
A Trial of Setmelanotide in Acquired Hypothalamic Obesity

The goal of this trial is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with acquired Hypothalamic Obesity (HO). To determine how well setmelanotide works and how safe it is, patients with HO will take a daily injection of either setmelanotide or placebo and complete trial assessments for 52 weeks on a therapeutic regimen.

A separate sub-study in patients with congenital HO is detailed under NCT06760546.


Eligibility Criteria:
Key Inclusion Criteria:

1. Documented evidence of acquired hypothalamic obesity (HO)
2. Age 4 years and older
3. Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients 4 to \<18 years of age
4. Agree to use a highly effective form of contraception throughout the study and for 90 days after the study

Key Exclusion Criteria:

1. Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET)
2. Weight loss \>2% in the previous 3 months for patients aged ≥18 years or \>2% reduction in BMI for patients aged 4 to \<18 years
3. Bariatric surgery or procedure within last 2 years
4. Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior
5. Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease
6. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
7. History or close family history of skin cancer or melanoma
8. Participation in any clinical trial with an investigational drug/device within 3 months prior to the first trial dose
9. Previously enrolled in a clinical trial involving setmelanotide or any previous exposure to setmelanotide
10. Inability to comply with once daily (QD) injection regimen
11. If female, pregnant and/or breastfeeding
12. Patients with obesity attributable to other genetic or syndromic conditions (eg, PPL \[POMC, PCSK1, LEPR, collectively\], BBS) prior to the hypothalamic injury.
13. If receiving hormone replacement therapy, dose has remained stable for at least 2 months before Screening

Other protocol defined Inclusion/Exclusion criteria may apply.
Assessment of Effects of Museum Prescription of A Montreal Museum of Fine Arts Visit Tour in Primary Care Patients

The objective of this study is to examine effects on mental and physical health and quality of life in primary care patients visiting the Montreal Museum of Fine Arts (MMFA), this visit being prescribed by their physician. To visit the MMFA and to complete after this visit a series of self-administered questionnaires within the two days after their visit at the museum

During the past decade, museums have become involved in the care of patients by using art to improve their quality of life and well-being. Museums have, thus, emerged as new partners in public health. Very few programs developed by museums have focused on primary care patients who are a target audience for museum health program preventions. For the development of appropriate museum programs based on visit tour, there is a need to improve knowledge the effects of a museum visit prescribed by a primary care physician in patients. The objective of this study is to examine effects on mental and physical health and quality of life in primary care patients visiting the Montreal Museum of Fine Arts (MMFA), this visit being prescribed by their physician. Based on a cross-sectional study it will be prescribed to all patients consulting their primary care physician to visit the MMFA and to complete after this visit a series of self-administered questionnaires within the two days after their visit at the museum. The period of recruitment will be one year. The outcomes are the scores of the different questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old
2. Home Internet access with an electronic device (computer, pad or cellular phone)
3. Patient without dementia
4. Speak the language of the recruitment centre (French or English)

Exclusion Criteria:

1. dementia
2. participation refusal
Band Ligation Versus Transjugular Intrahepatic Portosystemic Stent Shunt (TIPS) in Cirrhotics With Recurrent Variceal Bleeding Non Responding to Medical Therapy

Patients with liver cirrhoses and recent history of variceal bleeding, with HVPG documented non response to medical therapy with non selective beta blockers +/- mononitrates or variceal rebleeding during adequate medical therapy will be randomized to undergo either multi-session endoscopic multi-band ligation and continuation of medication or TIPS placement. Best treatment for this group of cirrhotic patients is not known so far.

Reduction of portal pressure are with oral intake of non selective beta blockers, often combined with mononitrates are the method of choice in secondary prophylaxis of esophageal variceal bleeding. However, studies have shown that this therapy is effective only in 20-50% of the patients, documented by a significant drop of the portal pressure with hepatic venous pressure (HVPG) measurements. The best method for secondary prevention in this high risk patient cohort is not known so far. In this randomized controlled study we hypothesise, that a group of 20 vs 20 patients is large enough to discriminate efficacy of prevention of rebleeding in patients receiving TIPS implantation or endoscopic band ligation in patients non responding to medical therapy as secondary prophylaxis of esophageal variceal bleeding.

Eligibility Criteria:
Inclusion Criteria:

* liver cirrhosis
* bleeding from esophageal varices within the last 6 months
* sufficient medical therapy (at least 80 mg propranolol per day)
* signed written informed consent

Exclusion Criteria:

* bleeding of gastric varices
* portal vein thrombosis
* insufficient medical therapy (less than 80 mg propranolol per day)
* exclusion criteria for TIPS/band ligation (anatomy, impaired coagulation parameters, severe encephalopathy, severe liver failure (bilirubin \> 10 mg/dl)) congestive heart failure, pulmonary hypertension, polycystic liver disease, presence or suspicion of active systemic, biliary or ascitic fluid infection, known cavernous portal vein occlusion
* Budd Chiari syndrome
Radiofrquency Ablation Combined With Cytokine-induced Killer Cells for the Patients With Ovarian Carcinoma

The purpose of this study is to determine whether combining of radiofrequency ablation (RFA) and cytokine-induced killer cells (CIK) transfusion can prolong survival of patients with ovarian carcinoma.

The primary objective is to evaluate whether RFA followed by CIK transfusion can prolong survival of patients with ovarian carcinoma.

Eligibility Criteria:
Inclusion Criteria:

1. patients diagnosed with FIGO stage II ovarian carcinoma;
2. cytoreductive surgery performed and 6 courses of platinum-based chemotherapy completed;
3. medical records maintain comprehensive data on treatment and follow-up;
4. no history of previous malignancies.

Exclusion Criteria:

1. neoadjuvant chemotherapy applied;
2. less than 6 courses of chemotherapy or more than 6 courses of chemotherapy completed;
3. medical records maintain incomplete data on treatment or follow-up;
4. history of previous malignancy.
Safety and Efficacy of Treatment With Interferon Beta-1a Rebif® in Patients With Crohn's Disease

The purpose of this study is to determine the safety and efficacy of interferon beta-1a in maintaining remission in patients with Crohn's disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with an established diagnosis of Crohn's disease who went into remission using corticosteroids within 4 weeks before the study

Exclusion Criteria:

* Any other treatment for the maintenance of remission of Crohn's disease
A Study of Cataract Surgery With the Femtosecond Laser

The purpose of this study is to evaluate the feasibility of using the Femtosecond Laser System to perform surgical maneuvers during cataract extraction surgery.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to comply with the treatment/follow-up schedule and requirements
* Able to understand and provide written Informed Consent
* 3. ETDRS visual acuity equal to or worse than 20/30 (best corrected)
* Patient age between 50 and 80 years old
* Pupil dilates to at least 8 mm
* Patient able to fixate
* 1-3+ nuclear sclerotic cataract(This criterion does not apply to subjects who will receive post-IOL corneal relaxing incisions)
* Axial length between 22 and 26 mm

Exclusion Criteria:

* Pregnant, intending to become pregnant during course of study, less than 3 months postpartum or less than 6 weeks after completion of breast feeding
* Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
* Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study
* Anterior chamber depth less than 2.5 mm via Optical Coherence Tomography (Visante, Zeiss) or IOL Master (Zeiss) measurements
* History of prior ocular surgery
* History of ocular trauma
* Co-existing ocular disease affecting vision
* Astigmatism greater than five diopters (D.)
The Study for Evaluating the Clinical Effectiveness and Safety of Respiratory Rehabilitation Software 'Redpill Breath'(COPD, Asthma, Lung Cancer, Etc.)

The purpose of the study is to prove the clinical superiority of respiratory rehabilitation software "Redpill Breath" and evaluate the clinical improvement effect by 6-minute walk test of the software, compared to the manual rehabilitation management for those who need respiratory rehabilitation(COPD, Asthma, Lung Cancer, etc.)


Eligibility Criteria:
Inclusion Criteria:

1. 19 to 80 years-old
2. Subject who has difficulty in respiratory symptoms and routine with the criteria as below 1) mMRC(modified Medical Research Council Dyspnea Scale) 1 point at least 2) In accordance with Pulmonary function test(PFT/LET/EEG) examined, if there is in one of the following cases as below \[a lung cancer patient\] (FVC or FEV1 \< 80%), \[No lung cancer patient\] (Post-bronchodilator FEV1/FVC \< 0.7) and (Post-bronchodilator FEV1 \< 80%)
3. Subject with an Android smartphone (OS 8.0 or higher, internal memory (HDD) of 32GB or higher) or iPhone (iOS 13.0 or higher, internal memory (HDD of 32GB or higher)
4. Subject who can use effectively smartphone and mobile software
5. Subject who brings their smartphone for a walking test during 12 weeks of the clinical trial.
6. Subject who makes the decision voluntarily for participating in the clinical trial and to write their signature to the consent of subject's explanation.
7. Subject who complies with the clinical protocol

Exclusion Criteria:

1. Subject who has respiratory distress syndrome, caused by a kind of Neuromuscular disease, Spinal cord injury, Thoracic deformation, etc.
2. Subject who participate in respiratory rehabilitation treatment within 6 months of the screening date
3. Subject who undergoes respiratory-related symptoms deteriorate within 2 weeks of the screening date to the point where they need additional antibiotics or steroids
4. Subject who has an unstable cardiovascular disease (unstable angina pectoris, Acute myocardial infarction, severe coarctation of aorta, etc.)
5. a pulmonary arterial hypertension subject
6. Subject prescribed physical(e.g. lower-leg joint surgery, neurological limitation) or cognitive factors(e.g. psychical disorder)
7. Pregnant or lactating women
8. Subject who is unable to read text and tough to communicate
9. Subject who has participated in other clinical trials within 90 days of the screening date or participating in other clinical trials.
10. Subject who is determined to inappropriate to perform this study according to clinical research associate's opinion(e.g if someone has a bearing on the result of the clinical trial ethically or clinically)
Falls Prevention Program for Adults With Osteoarthritis

Purpose: To report the feasibility and to obtain preliminary data on the effects of using an enhanced Otago Exercise Programme to reduce fall risk in individuals with osteoarthritis (OA).

Participants: Ten participants from the Johnston County Osteoarthritis Project who have OA, are at risk for falls, and are 65+ years old.

Procedures (methods): All participants will receive the 6-month enhanced Otago program. The investigators will assemble data: quantifying participant adherence to and safety of the intervention, ascertaining retention of participants for 6 months, determining acceptability of the program, and other validated measures (e.g., number of falls and fall severity, balance measures).


Eligibility Criteria:
Inclusion Criteria:

* history of falls
* knee or hip radiographic OA
* 65+ years of age
* normal cognitive function (based on the Mini-Mental State Examination)
* current knee/hip symptoms

Exclusion Criteria:

* hospitalized for stroke, myocardial infarction, or coronary artery revascularization in past 3 months
* diagnosis of metastatic cancer in the past 3 months
* terminal illness
* progressive neurological disorders
* rheumatoid arthritis
* severe fibromyalgia
* other systemic rheumatic disease
tDCS and Motor Training and Motor Deficit After Stroke

This study investigated the combined effects of anodal tDCS and intensive motor training (MT) vs. sham stimulation with MT (control intervention) on grip strength, motor performance and functional use of the affected arm in population of chronic stroke patients.

A growing body of evidence are available regarding the effectiveness of anodal transcranial direct current stimulation (tDCS) in patients with chronic hand motor impairment as a stroke consequence.

This study investigated the combined effects of anodal tDCS and intensive motor training (MT) vs. sham stimulation with MT (control intervention) on objective evaluation of fine and gross motor hand function using simulated activities of daily living (Jebsen-Taylor hand function test), grip strength, motor performance and functional use of the affected arm in this population of patients.

Patients with chronic hand motor deficits after stroke (\> 12 months) are randomly assigned to active stimulation or a control intervention arm in a double-blinded, sham-controlled, parallel design. Each group received intensive MT for 45 min/day, 5 days/week, for 2 weeks, which was preceded by 20 minutes of 2 milliampere of anodal tDCS over the ipsilesional M1 vs. sham tDCS.

Outcome measures are tested at baseline (T0), and after the intervention Day 1 (T1), after stimulation protocol completion Day 10 (T2) and 30 days later (T3).

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of stroke made by clinical features and documented by neuroimaging studies (CT or MRI scans
* stroke duration \> 12 months
* severe hand deficit at stroke onset (Medical Research Council grade \<2) and
* subsequently recovered to the level moderate hand deficit with presence of hand movements evaluated by the Fugl-Meyer upper-extremity Assessment (FMA) of Motor Recovery after Stroke between 28-50 points (max. 66 pts),
* spasticity between 0-2 assessed on the Modified Ashworth Scale

Exclusion Criteria:

* any clinically significant or unstable medical disorder,
* diagnosis od major depression,
* diagnosis odf substance or alcohol abuse or any neurological disorder other than stroke, including neglect, aphasia, hemianopsia and serious cognitive impairment (Mini-Mental State Examination \< 24).
* any contraindications to tDCS, including histories of seizure, cerebral aneurysm, and prior surgery involving metallic implants
Effectiveness of Neck Stabilization Training Program With Conventional Therapy in Management of Text Neck Syndrome

1. To compare the effectiveness of neck stabilization training program with conventional physical therapy in management of neck pain and disability in individuals with text neck syndrome.
2. To compare the effectiveness of neck stabilization training program with conventional physical therapy in improving muscle strength and range of motion of cervical spine in individuals with text neck syndrome.

The text neck syndrome was described as a compilation of signs and symptoms due to the repetitive load, stress and pain in the body regions including; neck, shoulder joints, shoulder muscles, and thoracic region initiated by the excessive usage of smartphones for the prolonged time. The text neck syndrome is also called as 'Turtle neck neck syndrome' or 'anterior head syndrome.

Neck flexion in forward direction for using any smart phone could directly affects the cervical and upper thoracic spine. It is stated that increased tilt of the head forward to fifteen degrees exaggerate about 13 Kgs of mechanical force on the cervical spine.

Likewise it progresses to 18 Kgs at 30 degrees, 23 Kgs at 45 degrees and 28 Kgs at 60 degrees of forward neck flexion. The pathological consequences caused by incase of not managing the text neck could be alike to occupational overuse disease or repetitive stress and strain pathology.

Eligibility Criteria:
Inclusion Criteria:

* Gender (both men and women)
* Age: 18-30 years
* Participants using smart phones, laptops and tablets with screen time \>3 hours daily, for \>6 months.
* Patient diagnosed with text neck syndrome
* Trigger points in cervical muscles (trapezius, levator scapulae and scalene muscles)

Exclusion Criteria:

* Patient diagnosed with neck pain other than text neck syndrome
Axillary Staging in Early Breast Cancer: SNB Vs PET/MRI

The gold standard of surgical treatment for patients with early breast cancer (BC) is breast conservation and sentinel node biopsy (SNB). Ongoing randomized trials are evaluating to omit surgery at all when axillary imaging is negative. However, the available diagnostic tools still have several limitations in accuracy.

Combining the specificity of PET, with the superior sensitivity of MRI, hybrid PET/MRI might be a non-invasive, one-stage, operator-independent imaging method to accurately define nodal status and, whenever negative, might replace surgery for axillary staging.

The project includes patients with \<3 cm BC without overt nodal involvement who will undergo PET/MRI prior to surgery. The primary aim is to compare the staging power between SNB and PET/MRI in detecting axillary lymph node macrometastases (\>2 mm). Additionally, general concordance and diagnostic accuracy of PET/MRI vs SNB, eventual correlation with BC molecular subtypes and MRI findings will be evaluated.

SNB is the gold standard for axillary staging in early BC patients. Although being a minimally invasive, it is time consuming both for surgeon and pathologist, it may add a further scar and is not free from complications: seroma, limitation of shoulder movement, nerve injury, lymphedema. To date, patients undergoing breast conserving surgery (BCS) with 1 to 2 positive nodes can be treated with SNB alone (ACOSOG Z011 trial NCT00003855\[2-4\]) and researchers are evaluating within large randomized trials to even omit surgery at all when axillary imaging is negative (SOUND (Sentinel node biopsy vs Observation after axillary Ultra-souND), PI and Study Chair Dr.O.Gentilini,MD, NCT02167490 and INSEMA (Intergroup-SEntinel-MAmma) trial NCT02466737.

While the role of surgery is decreasing, the role of preoperative imaging is increasing. In the future, imaging might even replace surgery in the axillary staging of BC patients, still providing an appropriate level of information to guide medical treatments which are more and more tailored on biology rather than on nodal status. In this context, an unmet need is to achieve the most accurate preoperative imaging assessment of the axilla in order to decide the appropriate treatment for each patient.

The hypothesis of this project is that PET/MRI might provide a single, one-stage, non-invasive, operator independent imaging modality in patients with small BC allowing to select the proper treatment for patients. PET/MRI is a relatively new imaging tool and its field of application is still object of scientific speculation.

Eligibility Criteria:
Inclusion Criteria:

* signed Informed Consent
* age \> 18
* non palpable lymph nodes
* no suspicious nodes at A-US (Axillary- ultrasound)
* candidate to mastectomy or breast conserving surgery and BLS (Sentinel Node Biopsy)

Exclusion Criteria:

* pregnancy
* distant metastasis
* inflammatory cancer
* claustrophobia
* allergy to contrast agent
* severe renal insufficiency
BURCH Colposuspension or Transobturatuar Tape (TOT)

Stress urinary incontinence surgery combined with hysterectomy can often be applied to patients in the same session. The aim of this study was to determine which urinary incontinence surgery would be a better option for patients who would have hysterectomy.

The aim of this study was to retrospectively review the data of 69 patients between the ages of 2014 and 2017 who underwent total laparoscopic hysterectomy and anti-incontinence surgery (TOT and Burch) for benign indications (uterine pathology) and stress urinary incontinence (SUI). In addition to demographic data and preoperative examination findings, operative times, postoperative hemogram values, postvoiding residual amounts and complications were examined.

In addition, FSI test results of women with sexual activity were compared with ICIQ-UI and UDI-6 interrogations related to urinary incontinence.


Eligibility Criteria:
Inclusion Criteria:

* tlh operation with benign reasons and planned,
* concurrent stress describing urinary incontinence,
* Women between the ages of 40-65

Exclusion Criteria:

* planned operation with malignant causes,
* urinary tract infection,
* medication area for incontinence