cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Upper Extremity Functions in Obesity Hypoventilation Syndrome Patients

Obesity Hypoventilation Syndrome (OHS) is a disease characterized by daytime hypercapnia and sleep-related respiratory disturbances in individuals with a body mass index (BMI) greater than 30 kg/m², without any other condition that could lead to hypoventilation. Although various mechanisms play a role in the pathogenesis of OHS, the most significant one is the altered respiratory system mechanics due to obesity. Obesity also leads to a decrease in peripheral muscle strength and exercise capacity. It has been reported that in obese individuals, not only general body movements and lower extremities but also upper extremity movements are negatively affected. Specifically, it has been observed that during activities against gravity, movement speed is low while the duration of movement is high. In OHS patients, daily living activities, physical activity, and exercise capacity are also negatively impacted. Supported or unsupported arm movements are of great importance in performing daily living activities. The muscles activated during both simple arm lifting and combined movements also function as accessory respiratory muscles. In individuals with cardiopulmonary diseases, an increase in the respiratory workload, especially during unsupported arm movements, has been observed. It is thought that in OHS patients, both the effects of obesity and the respiratory system may limit upper extremity functions. However, no studies have evaluated upper extremity functions in these individuals. Therefore, the aim of investigators study is to evaluate upper extremity functions in OHS patients.

The study will include patients diagnosed with Obesity Hypoventilation Syndrome, who are followed at the Department of Chest Diseases, Istanbul University Faculty of Medicine. The study will be conducted in accordance with the Helsinki Declaration, and an informed consent form will be obtained from the participants who are willing to take part in the study. Before the study begins, the participants will be informed about the purpose of the study and provided with all relevant details. Participants who agree to participate will be invited to the Chest Diseases Department of Istanbul University Faculty of Medicine. Demographic information of the participants will be recorded, followed by the evaluation of body composition, upper extremity functional exercise capacity, grip strength, and activities of daily living. The main aim of the study is to comprehensively investigate the upper extremity functions in patients with OHS.

Eligibility Criteria:
Inclusion Criteria:

* Individuals between the ages of 18-65
* Individuals diagnosed with OHS by a Chest Disease Specialist

Exclusion Criteria:

* Individuals with neurological or orthopedic problems that prevent them from performing the tests or understanding the scales applied within the scope of the study
* Additional pulmonary disease
* Uncontrolled cardiovascular disease
* Presence of uncontrolled diabetes
Rapid T-cell Analysis Test in Patients With Chronic HBV and HBV/HDV Disease

Prospective, non-pharmacological, single-center, non-profit observational study.

The study design allows longitudinal evaluation of the immune response during the natural history of the infection and/or treatment, correlating the data with the outcome of the disease and antiviral therapies, which will be collected as study variables from the source documents.

The study population will be patients suffering from chronic HBV infection with or without HBV-HDV co-infection followed at the Division of Gastroenterology and Hepatology of Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico.

The present study is part of an international cooperation project between the Division of Gastroenterology and Hepatology, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (Milan, Italy) and the Duke-NUS Medical School, Singapore, financed by a grant (project MAECI-2023-23683653) and divided into two specific Work Packages:

* WP 1 Milan team (WP1.1 - Clinical and virological phenotyping of CHB and CHD patients; WP1.2 - Clinical evaluation of rapid HBV T cell test in CHB and CHD populations)
* WP 2 Singapore team (WP2.1 - Applicability of the rapid T cell assay approach; WP 2.2 - Optimization of the rapid T cell assay protocol)

The primary objective of the study is to define the prevalence of specific T cell responses in patients with chronic HBV and HBV-HDV infection, through the application of a specific rapid T cell assay.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* ability to understand and sign the informed consent
* chronic HBV infection or HBV-HDV co-infection defined by positivity of HBsAg antigen (HBV) and HDV RNA (HBV-HDV co-infection) for at least 6 months

Exclusion Criteria:

* Co-infection with other hepatotropic viruses (HCV, HIV)
* Treatment with immunosuppressive/immunomodulatory drugs
* Other congenital and/or acquired immunodeficiency conditions
Prehabilitation for Prostate Cancer Surgery

Radical prostatectomy is the most common and effective treatment for localized prostate cancer. Unfortunately, radical prostatectomy is associated with significant adverse effects, such as urinary incontinence, sexual dysfunction, and reduced physical function that collectively diminish health-related quality of life which may persist for up to two years postoperatively. The primary objective of this trial is to assess the feasibility of conducting of a multi-site randomized controlled trial to test the effect of a comprehensive prehabilitation program versus standard care for men with prostate cancer undergoing radical prostatectomy. We hypothesize that men with prostate cancer undergoing radical prostatectomy in the comprehensive prehabilitation program (full-body exercises and pelvic floor muscle exercises) will report better health-related quality of life, urological symptoms, and physical fitness, physical activity, and pain, as well as a shorter postoperative length of stay than participants receiving standard preoperative care (pelvic floor muscle exercises alone). Our secondary objective is to report estimates of efficacy on several clinically important outcomes for this population that will be used for sample size calculations in an adequately powered trial.


Eligibility Criteria:
Inclusion Criteria:

* Men with localized prostate cancer (stage cT1- cT2) who have consented for radical prostatectomy
* between the ages of 40 and 80 years.

Exclusion Criteria:

* i) severe coronary artery disease (Canadian Cardiovascular Society class III or greater);
* ii) significant congestive heart failure (New York Heart Association class III or greater);
* iii) uncontrolled pain;
* iv) neurological or musculoskeletal co-morbidity inhibiting exercise;
* v) diagnosed psychotic, addictive, or major cognitive disorders;
* vi) no more than two of the following Coronary Risk Factors as defined by the American College of Sports Medicine : family history of coronary disease, cigarette smoking, hypertension (SBP \> 140 mmHg; DBP \> 90 mmHg), known dyslipidemia, known impaired fasting, glucose (\>110 mg/dL), obesity (BMI \> 30 kg/m2 or waist circumference \> 102cm), or physically inactive (\<150 min of moderate intensity physical activity per week).
Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant

In lower limb peripheral arterial disease, the stage of intermittent claudication has a prevalence of more than 5% over the age of 60, and affects patients who are often still active. Frequent anatomical lesions are strictures / occlusions of the superficial femoral artery.

There is a current low level of evidence for the treatment modalities of long lesions (15-25 cm) of the superficial femoral artery and in particular no clinical trial comparing the femoro-popliteal bypass to the endovascular procedure whose patency in retrospective series. appears lower than that of surgery but nevertheless appears in the European recommendations for first-line treatment, with the absence of a dedicated trial being highlighted.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Effective contraception for the duration of research for fertile women of childbearing age
* Unilateral Rutherford 2 or 3 symptomatic Lower Extremity Artery Disease (LEAD) arteritic patient with a lesion of the superficial femoral artery Trans-Atlantic Inter-Society Consensus (TASC) C or D between 15 and 25 cm
* Patient eligible for bypass surgery and endovascular procedure
* No alteration of the upstream flow (iliac flow preserved or restored)
* Patient with at least one patent artery below the knee
* Patient informed and having signed the information and consent form to participate in the study

Exclusion Criteria:

* Known pregnancy or breastfeeding
* Iliac flow altered upstream
* History of surgery or stent on the affected superficial femoral artery
* Concomitant bacteremia (positive blood cultures in the 7 days preceding the procedure)
* Known intolerance to antiaggregants or heparin
* Contraindication to the endovascular procedure (severe renal failure contraindicating the injection of contrast product despite prior hydration, known severe allergy to iodinated contrast product \[unless the center chooses to use carbon dioxide injection\]) or bypass surgery (cardiovascular, respiratory or other comorbidities, contraindicating general anesthesia, local contraindications for bypass: skin lesion at the operative site)
* No affiliation to a social security regime or to another social protection regime
* Patient deprived of liberty or under legal protection (guardianship, trusteeship)
* Inability, according to the investigator, to understand or refusal to sign the informed consent to participate in the study (non-French speaking patient, cognitive disorders)
* Ongoing participation in another research protocol Participation in non-interventional research is authorized

Secondary exclusion criterion:

* Negative opinion from the anesthesiologist-resuscitator at the end of the pre-anesthetic consultation
* Positive pregnancy test from the pre-operative laboratory test (result received after obtaining consent, but before the surgical procedure)
Optivate in People With Von Willebrand Disease Undergoing Surgery

An open, multi-centre study in patients with von Willebrand Disease (VWD) undergoing surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent.
2. Be aged 12 years or older.
3. Have VWD of known type.
4. Be due to undergo surgery, in which the investigator believes a VWF concentrate will be required.
5. Have a known lack of, poor response to, or contraindication to, DDAVP, or require a type of surgery in which a plasma-derived product is appropriate.
6. Have a prothrombin time (PT) of not more than 3 seconds above the upper limit of the reference range.
7. Female patients of child-bearing potential, with the exception of pregnant patients undergoing Caesarean surgery or other modes of delivery, including normal vaginal delivery, must have a negative result on a human chorionic gonadotropin-based pregnancy test. If a female patient is or becomes sexually active, she must practice contraception by using a method of proven reliability for the duration of the study.

Exclusion Criteria:

1. Have a history of inhibitor development to VWF or FVIII or a positive result at screening (positive screen for VWF inhibitor; positive screen and a result of \>0.5 BU for FVIII inhibitor). A result at screening is not mandatory if the patient is to undergo emergency surgery and the local laboratory is unable to perform the analyses.
2. Patients with thrombocytopenia (platelets \<50 x 109/L).
3. Patients who have clinically significant renal disease (creatinine \>200 µmol/L).
4. Patients who have clinically significant liver disease (ALT levels greater than three times the upper limit of the reference range).
5. Presence of any other major systemic illnesses which would compromise the outcome of the study in the opinion of the investigator.
6. Known or suspected hypersensitivity to investigational medicinal product (IMP) or its excipients.
7. Have a recent history of alcohol or drug abuse.
8. Administration of a new chemical entity within the 4 months preceding enrolment.
9. Participation in any other clinical study in which investigational or marketed drugs were employed in the 30 days preceding enrolment (screening visit) into this study, with the exception of the BPL clinical study Protocol 8VWF01.
10. Female patients who are lactating.
11. In the opinion of the investigator, the patient is unlikely to comply with the study protocol.
Combination of Decitabine and Temozolomide in the Treatment of Patients With Metastatic Melanoma

The combination of TMZ and DAC may effect dual modulation of DNA repair genes resulting in improved clinical response.

Primary Objectives:

* Phase I: To determine the safety, tolerability, and Phase II recommended dose of the combination of extended schedule TMZ and DAC.
* Phase II: To determine the efficacy, as measured by overall response rate, of the combination of extended schedule TMZ and DAC given at the Phase II recommended dose to patients with metastatic melanoma.

Secondary Objectives:

* To determine pharmacokinetics of the combination of TMZ and DAC in patients with metastatic melanoma.
* To determine, in peripheral blood mononuclear cells (PBMC) and tumor tissue, the pharmacodynamic effects of the combination of TMZ and DAC on promoter methylation and expression of selected genes and correlate these with response.
* To determine the progression-free survival of patients treated with the combination of TMZ and DAC.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have non-resectable Stage IIIB or stage IV metastatic melanoma that have progressed despite prior therapies.
* Life expectancy of at least 12 weeks.
* ECOG performance status of 0, 1 and 2.
* ≥18 years of age.
* Patients who have not received any other chemotherapeutic, biological or investigational agent within 28 days of study drug administration.
* First line and active brain metastases (metastatic lesions to the brain that have been adequately treated with surgery and/or appropriate radiation therapy and that have documented stability for \>4 weeks or \>2 weeks if treated with stereotactic radiosurgery, remain eligible)

Exclusion Criteria:

* Any evidence of renal dysfunction (proteinuria, estimated creatinine clearance from serum creatinine test of \<60 ml/min).
* Impaired hepatic function (liver enzymes greater than twice the upper limit of normal or bilirubin \> 2.0 except in patients with Gilbert's syndrome).
* Prior treatment with alkylating agents (including TMZ and DTIC).
* Active brain metastases (metastatic lesions to the brain that have been adequately treated with surgery and/or appropriate radiation therapy and that have documented stability for \>4 weeks remain eligible).
* Active infections or serious general medical conditions.
* Female patients of child-bearing age who are not on adequate contraception, or are pregnant or breast-feeding.
Quality of Life Changes on Lower Extremity Lymphedema Patients Using an Advanced Pneumatic Compression Device (PCD)

Assessment of quality of life and symptoms changes in primary or secondary, unilateral or bilateral lower extremity lymphedema patients using an advanced pneumatic compression system.

Post-market, on label, multi-center, single arm, observational clinical trial of a prospective cohort of 300 subjects with primary or secondary, unilateral or bilateral, lower extremity lymphedema in the United States. All subjects will receive pneumatic compression treatment for 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Diagnosis of primary or secondary, unilateral or bilateral, lower extremity lymphedema
* Ability and willingness to participate in all aspects of the study including following prescribed care
* Ability to provide informed consent
* Must have a prescription for the Flexitouch (Flexitouch system or Flexitouch Plus)

Exclusion Criteria:

* Diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy or primary surgery for the treatment of cancer.
* Active skin or limb infection/inflammatory disease (acute cellulitis, or other uncontrolled skin or untreated inflammatory skin disease)
* Acute thrombophlebitis (in last 2 months)
* Pulmonary embolism within the previous 6 months
* Deep Vein Thrombosis (DVT) within the previous 3 months
* Severe peripheral artery disease (critical limb ischemia including ischemic rest pain, arterial wounds, or gangrene)
* Pulmonary edema
* Heart failure (acute pulmonary edema, decompensated acute heart failure)
* Patients with poorly controlled asthma
* Previous use of the study pneumatic compression device (PCD)
* Currently using multi-layer bandaging (MLB) unless bandages can be removed for limb circumference measurements
* Pregnant women or women of childbearing potential not on contraception
* Any condition where increased venous and lymphatic return is undesirable
* Currently participating in another medical device or drug clinical trial
* Signs of noncompliance at the week 4 visit including: using the device less than 3 times per week and/or not attending the scheduled visit.
Potential Impact of the Use of the Application VentilO After Cardiac Surgery

Mechanical ventilation is a vital support associated with the treatment of patients with acute respiratory failure and in other indications such as surgery under general anesthesia, coma or shock. Optimization of settings during mechanical ventilation and implementation of protective ventilation help to avoid ventilation-induced injury, ensure adequate oxygenation and maintain adequate carbon dioxide concentration to avoid respiratory acidosis or alkalosis.

Similarly, there is also no clear recommendation, to our knowledge, for the initial setting of the respiratory rate. Therefore, initial settings are not always adequate and in the literature the frequency of respiratory acidosis is very high, reaching about half of the patients receiving mechanical ventilation.

VentilO, is an application that is available on smart phones. This educational application provides clinicians with initial settings and optimization of these settings based on gender, height, weight, body temperature and patient type. The algorithm used is based on published data regarding ventilatory requirements in different populations and the anatomical and instrumental dead space of patients.

The purpose of our study is to:

Assess whether ventilatory settings after intensive care unit admission after cardiac surgery are appropriate to compare the ventilatory adjustments made by clinicians with those proposed by the VentilO application.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\> or = 18 years old)
* Intubated patients admitted to the ICU immediately postoperative from cardiac surgery
* Obtained a postoperative arterial gas within 1 hour of arrival in the ICU

Exclusion Criteria:

* Lack of patient anthropometric data (height and weight) available in the patient record
Trial Using CogWatch for Tea Making Training in Stroke Apraxia and Action Disorganisation Syndrome

Apraxia and action disorganization syndrome after stroke can disrupt activities of daily living (ADL). Occupational therapy has been effective in improving ADL performance, however, inclusion of multiple tasks means it is unclear which therapy elements contribute to improvement. This study evaluates the efficacy of a task model approach to ADL rehabilitation, comparing training in making a cup of tea with a gait training control condition.

Apraxia and action disorganization syndrome (AADS) after stroke can disrupt activities of daily living (ADLs). Occupational therapy has been effective in improving ADL performance, however, inclusion of multiple tasks means it is unclear which therapy elements contribute to improvement.

This trial evaluates the efficacy of a task model approach to ADL rehabilitation, comparing training in making a cup of tea with a stepping training control condition.

Stroke survivors with AADS participate in a cross-over randomized controlled study. Participants attend five 1-hour tea making training sessions in which progress is monitored and feedback given using a computer-based system which implements a Markov Decision Process (MDP) task model (CogWatch). In a control condition participants receive five 1-hour stepping sessions.

Analysis compares tea making training with stepping training effects on error reduction and time taken in making 4 different tea types. A complex tea preparation task (making two different cups of tea simultaneously) is used to test for generalisation of training effects.

Eligibility Criteria:
Inclusion Criteria:

* greater than 2 months post stroke; medically stable; failing at least one of four praxis items in the Birmingham Cognitive Screen (BCoS) or a document filing task.

Exclusion Criteria:

* recent stroke (less than 2 months post stroke); not medically stable
Safety, Tolerability, and Pharmacodynamics of IONIS-DGAT2Rx in Adult Patients With Type 2 Diabetes

The purpose is to assess the Safety, Tolerability, and Pharmacodynamics effect of IONIS DGAT2Rx in up to 45 Adult Patients with Type 2 Diabetes.

This short-term study will assess changes in hepatic steatosis over a 13-week treatment period in a patient population with higher risk for development of Nonalcoholic fatty liver disease (NAFLD) and Nonalcoholic steatohepatitis (NASH), obese type 2 diabetes mellitus (T2DM) with elevated HbA1c.

Eligibility Criteria:
Inclusion Criteria:

* Must have given written informed consent and be able to comply with all study requirements.
* Males or females aged 18-75, inclusive, at the time of Informed Consent.
* Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal.
* Males must be surgically sterile, abstinent or using an acceptable contraceptive method.
* Body mass index (BMI) ≥ 27.0 - ≤ 39.0 kilograms per square meter (kg/m\^2).
* Diagnosis of Type 2 Diabetes Mellitus with an Hemoglobin A1C (HbA1c) ≥7.3% and ≤9.5% at screening.
* Must have been on a stable dose of Oral Antidiabetic Therapy for a minimum of 3 months prior to Screening.
* ≥ 10% liver fat prior to randomization assessed by MRI-PDFF.
* Stable body weight for at least 3 months before screening.

Exclusion Criteria:

* Clinically-significant abnormalities in medical history or physical examination.
* Clinically-significant abnormalities in screening laboratory values that would render a participant unsuitable for inclusion, per Sponsor.
* Evidence of uncorrected hypothyroidism or hyperthyroidism results at Screening.
* History of solid organ transplantation or renal dialysis.
* Clinically-significant complications of diabetes.
* Treatment with another Study Drug, biological agent, or device within one-month of screening.
* Known history or evidence of liver disease with a positive test for human immunodeficiency virus (HIV), Hepatitis C virus (HCV), or chronic Hepatitis B virus (HBV), or chronic liver disease other than NASH.
* Recent history of, or current drug or alcohol abuse.
* Current use of concomitant medications known to significantly impact body weight or that may cause liver toxicity, per Investigator
* Use of anticoagulant/Antiplatelet agents unless the dose has been stable for 4 weeks prior to the first dose of study drug\]
* Use of non-steroidal anti-inflammatory drug nimesulide or any other drug influencing coagulation (except lose-dose aspirin).
* Use of obeticholic acid or ursodeoxycholic acid
* Considered unsuitable for inclusion by the Principal Investigator