cyrilzakka/clinical-trials huggingface dataset:
Effect of Seat Height and Angle on Wheelchair Foot Propulsion

The purpose of the project is to explore the effect of differences in seat height and seat angle on bilateral foot propulsion using a manual wheelchair. The objectives of the study are to determine whether differences in seat height and seat angle impact: a) propulsion speed; b) knee range of motion used during propulsion; c) effectiveness of foot propulsion gait; and d) perceived difficulty with foot propulsion.

A repeated measures designs allows comparison between 5 different seat height conditions and 4 different seat angle conditions to determine whether there are significant differences in outcome, and if so, which conditions provide better outcomes. Participants will propel a customized MWC through a standardized course using each seat configuration; the sequence will be randomized to reduce any learning effects.


Eligibility Criteria:
Inclusion Criteria:

* student in College of Rehabilitation Sciences enrolled in Master of Occupational Therapy, Master of Physical Therapy, or Bachelor of Respiratory Therapy program at the University of Manitoba.
* Able-bodied individuals

Exclusion Criteria:

* Students whose hip width exceeds 21 inches or lower leg length is shorter than 16 inches will be excluded as the test manual wheelchair will not accommodate these dimensions.
Single IV Administration of TB-402 for Prophylaxis of Venous Thromboembolic Events (VTE) After Total Hip Replacement Surgery

The purpose of this study is to evaluate the safety and efficacy of two doses of TB-402 administered as a single intravenous infusion for the prevention of VTE in subjects undergoing total hip replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects aged ≥ 18 years.
2. Written informed consent.
3. Willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures

Exclusion Criteria:

1. Pregnancy at the time of screening.
2. Indication for anticoagulation other than post-operative thromboprophylaxis.
3. Active bleeding or high risk of bleeding.
4. Anticipated continued use of neuraxial catheter after surgery.
5. Clinical laboratory findings at screening of thrombocytopenia or prolonged aPTT or PT.
6. Uncontrolled hypertension.
7. Impaired liver function (transaminase \>3 X ULN) or history of hepatic insufficiency.
8. Creatinine clearance \<30 mL/min.
9. Antiplatelet agents other than low dose aspirin (\< 200mg).
10. The use of intermittent pneumatic compression.
11. Known hypersensitivity to contrast media or rivaroxaban.
12. Known drug or alcohol abuse.
13. Active malignant disease or current cytostatic treatment.
14. Stroke within the previous month.
15. Participation in an investigational drug study within the past 30 days or previous participation in this study.
16. Any condition that in the opinion of the investigator would put the subject at increased risk from participating in the study or expected inability to comply with the protocol.
The Hemodynamic Effects of SGLT2i in Acute Decompensated Heart Failure

The main purpose of this study is to observe hemodynamic effects of initiating sodium-glucose co-transporter 2 inhibitors (SGLT2i) in patients admitted to the intensive care unit (ICU) with acute decompensated heart failure.

The exact mechanism of cardiovascular benefit from SGLT2i continues to be the source of further research. The investigators hypothesize that heart failure patients with acute decompensated heart failure will similarly benefit from the SGLT2i-associated natriuresis and diuresis. This mechanism should improve invasive hemodynamics during an inpatient ICU stay.

This is a prospective, randomized controlled study to assess cardiac benefit of SGLT2i in 40 consecutive patients admitted to University of Chicago Cardiac Intensive Care Unit (CCU) Advanced Heart Failure Service. Subjects will be randomized 1:1 to one of two routine care arms: treatment with an SGLT2i \[dapagliflozin 10 mg daily\] or no SGLT2i. After randomization, your SGLT2i and heart failure care will be managed according to routine care, and the investigators will collect the subject's medical data. The patient's treating physician will be able to override randomization assignment if they determine that the assignment is not in the patient's best interest.

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years old
2. Heart Failure Reduced ejection fraction (HFrEF) of 40 or less
3. Estimated glomerular filtration rate (eGFR) \> 30milliliters(ml)/minute(min)/1.73 meter(m)2
4. Admitted to CCU by advanced heart failure service for decompensated heart failure requiring continuous hemodynamic monitoring with a pulmonary artery catheter

Exclusion Criteria:

1. Diagnosis of type 1 diabetes mellitus
2. eGFR \< 30ml/min/1.73m2
3. age \< 18 years old
4. Jehovah's witnesses
5. Diagnosis of group 1 pulmonary arterial hypertension
6. Insulin requirement above standard low dose sliding scale
7. Patients with a history of diabetic ketoacidosis (DKA)
8. Allergies to SGLT2i medications
9. History of intolerance to SGLT2i medications
10. Patients listed for cardiac transplantation or on mechanical support
11. Pregnant or breastfeeding
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility

Comparative study of two information modalities during the care course, aiming to propose the preservation of fertility to young women with breast cancer (but not yet under treatment): standard oral information during the PF consultation vs. an online decision support tool, consulted prior to the PF consultation, during which the standard oral information is provided.

In recent decades, the incidence of breast cancer has increased significantly among young women. Between 1980 and 2012, there was an increase of 59% and 53% in the 30-39 age group and the 40-49 age group, respectively. However, both diagnostic and therapeutic advances made it possible to significantly reduce mortality, at the cost of potentially deleterious chemotherapeutic treatments for reproductive function. These treatments may therefore be the cause of a chronic pathology "infertility" that may negatively impact the quality of life of young breast cancer survivors.

Since 2004, in France, the preservation of fertility (PF) is part of the different laws of bioethics. The latest cancer plans have highlighted the importance of quality of life in patients cured of cancer. For young women, this often involves the possibility of accessing maternity, using their own gametes. Thus, access to an onco fertility consultation should be systematically proposed, ideally before the initiation of any cancer treatment.

While the importance of oncofertility consultations is now recognized, they raise a certain number of ethical questions, particularly as to the nature of the information to be transmitted, whether it is generalizable or not, and how it is delivered and supported.

Very little data on the value of decision support tools in PF for women with breast cancer are available, while the concept of "shared medical decision" is becoming increasingly important in the doctor-patient relationship.

The only available studies have shown that these tools can reduce the level of decisional conflict and regret over fertility-related treatment options, and improve knowledge about fertility and satisfaction among young women.

This study aims to compare two modalities of delivery of information to breast cancer patients (not yet under treatment): standard oral information during the prevention of fertility (PF) consultation vs. an online decision support tool, consulted prior to the PF consultation, during which the standard oral information is provided.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years women
* with breast cancer
* cancer treatment not started, no antecedent of chemotherapy
* speaking French
* affiliated in Social Insurance

Exclusion Criteria:

* recurrence of breast cancer
* metastatic breast cancer
* pregnancy in progress
* Adults protected (wardship, guardianship, protection of justice)
Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer

The aim of this study was to compare the therapeutic efficacy between simultaneous gemcitabine administration and IRE and IRE alone for locally advanced pancreatic cancer (LAPC)

in the GEM- IRE group, before the IRE ablation started, patients received 1000 mg/m2 gemcitabine hydrochloride \[Qilu pharmaceutical (Hainan) Co., Ltd. Haikou, China\] intravenously (over approximately 30 min).

In the IRE group, the IRE ablation was performed without gemcitabine intravenous infusion before IRE.

The aim of this study was to evslusted the overall survival (OS), objective response rate (ORR) and adverse events after simultaneous therapy.

Eligibility Criteria:
Inclusion Criteria:

* Radiologic confirmation of unresectable locally advanced pancreatic cancer by at least CT of chest and abdomen
* Screening must be performed no longer than 2 weeks prior to study inclusion
* Maximum tumor diameter ≤ 5 cm
* Histological or cytological confirmation of pancreatic adenocarcinoma;
* Age ≥ 18 years
* PS-classification 0 - 2
* Life expectancy of at least 12 weeks
* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to definite inclusion;
* Hemoglobin level ≥ 115 g/L
* Platelet count ≥ 100\*109/l
* Neutrophil count ≥ 2×109/L;
* White blood cell count ≥ 4 ×109/L;
* ALT and AST ≤ 2.5 x ULN
* Serum creatinine ≤ 1.5 x ULN or a calculated creatinine clearance ≥ 50 ml/min
* Prothrombin time or INR \< 1.5 x ULN
* Written informed consent

Exclusion Criteria:

* Resectable pancreatic adenocarcinoma as discussed by our multidisciplinary hepatobiliary team
* History of epilepsy
* History of cardiac disease:
* Cardiac arrhythmias requiring anti-arrhythmic therapy or pacemaker (beta blockers for antihypertensive regimen are permitted)
* Compromised liver function (e.g. signs of portal hypertension, INR \> 1,5 without use of anticoagulants, ascites)
* Uncontrolled infections (\> grade 2 NCI-CTC version 3.0)
* Pregnant. Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment
* Allergy to contrast media
* Any implanted stimulation device
* Any implanted metal stent/device within the area of ablation that cannot be removed
Effect of Zinc and Selenium Supplementation on HIV+ Individuals on Antiretroviral Treatment.

The aim of this study is to evaluate the effect of zinc gluconate and/or selenium yeast supplementation during six months on clinical (glucose, cholesterol, triglycerides, bone mineral density and body composition) and immunological (oxidative stress, CD4+ count and pro-inflammatory cytokines) parameters in a population with HIV diagnosis on antiretroviral treatment.

HIV-infected individuals on antiretroviral treatment have lowest risk of AIDS events and more life expectancy. However, antiretroviral treatment does not fully restore the immune system in all individuals due to persistent immune activation and inflammation, increasing the risk of non-AIDS complications, such as insulin resistance, diabetes, hypertension, dyslipidemia, obesity, low bone mass density, oxidative stress and micronutrient deficiencies. Several studies showed that HIV+ patients present zinc and selenium deficiency. Those micronutrients are involved in the pathogenesis of metabolic complications and have a major role in maintaining immune system function. It remains unknown the effect of zinc and selenium supplementation on metabolic and immunological parameters associated to non-AIDS complications.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected
* \>200 CD4+ cells/mL
* \>2 years under antiretroviral treatment
* \>2 years under virology control (HIV RNA \<40 copies/mL)

Exclusion Criteria:

* Patients with opportunistic infection
* Patients taking vitamin-mineral supplements
* Patients with moderate or high cardiovascular risk (Framingham score higher than 10%) and cholesterol LDL \>190 mg/dL or triglycerides \>500 mg/dL.
* Patients with diabetes or hypertension diagnosis.
* Patients taking drugs for diabetes, hypertension, dyslipidemia or low bone mass density.
* Low adherence to supplementation.
Reliability, Validity, and Responsiveness of the Turkish Version of Eating Assessment Tool-10 for Patients With Primer Sjögren's Syndrome

Evaluations will be made by researchers following the guidance of individuals with primary Sjögren's Syndrome who receive diagnosis, routine medical care, and treatment management.

In addition, for the reliability of the Turkish Eating Assessment Tool-10, the Turkish Eating Assessment Tool-10 will be repeated on patients at least one-fifth of the number of individuals included, after one week.

For the sensitivity of the scale, an exercise that is routinely applied in the Rheumatological Rehabilitation Unit of Hacettepe University Faculty of Physical Therapy and Rehabilitation will be invited and after 3 months, the same evaluations as applied in the first measurement will be made again on individuals at least one-fifth of the number of individuals included.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Primary Sjögren's Syndrome
* 18 years or older

Exclusion Criteria:

* Patients with Secondary Sjögren's Syndrome,
* Patients who are diagnosed with other uncontrolled/clinically important diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.),
* Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.
Elbow Artery Embolization for Tennis Elbow

The purpose of this clinical research study is to examine whether embolization treatment of an elbow artery is a safe and effective way to treat elbow pain, specifically pain from tennis elbow. Embozene is a medical device made by Varian marketed in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery to block the flow of blood to a specific region. One of the causes of pain in the setting of tennis elbow is increased blood flow going to the specific area of pain. In this study, we will investigate an experimental procedure to decrease the blood flow (embolize) to the specific region of the elbow that is causing the pain. This will be done by infusing Embozene particles into the specific blood vessel supplying the area of pain in the elbow. This is an investigational study to evaluate the safety and efficacy of elbow artery embolization (EAE) for the treatment of symptomatic lateral epicondylitis (tennis elbow).

This is a single-center, prospective, single arm investigational study to evaluate the safety of elbow artery embolization (EAE) for treatment of symptomatic lateral epicondylitis. In addition, the improvement as part of efficacy will be reported. All patients will have either failed or be intolerant to conservative management. Patients will be considered enrolled in the study once they have provided informed consent and have been determined to meet all eligibility criteria. A total of 25 patients will be enrolled in the single treatment arm of the study and will be followed for 24 months.

The study will involve a screening period in which patient eligibility is determined. Once eligibility is confirmed, subjects will undergo EAE with Embozene microspheres (75 micron). Following treatment, subjects will return for follow-up visits at 1 week, 1 month (± 2 weeks), 3 months (± 2 weeks), 6 months (± 4 weeks), 12 months (± 4 weeks), and 24 months (± 4 weeks) post-procedure. At these visits, subjects will undergo a directed physical examination, report any new adverse events (AEs), and complete questionnaires. At 12 months of follow-up, subjects will also undergo elbow MRI and x-ray.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and less than 80 years
* Diagnosis of lateral epicondylitis based on history and physical exam
* Ability to provide informed consent
* Life expectancy greater than 12 months
* Moderate-severe lateral elbow pain as determined by visual analog scale \> 4 (based on average severity during physical activity)
* Resistant/failed conservative treatment (e.g. NSAIDS/physical therapy/steroid joint injection) for at least 6 months.

Exclusion Criteria:

* Mild elbow pain as determined by visual analog scale \< 4
* Chronic renal insufficiency (serum creatinine \>2 mg/dL)
* Allergy to iodinated contrast agents that is not responsive to steroid management
* Active Infection or malignancy
* Prior elbow surgery in the subject elbow
* Uncorrectable bleeding diathesis
Magnetic Correction of Eye Lid Paralysis

Objective 1: Determine the safety and feasibility of externally mounted magnets for extended management of chronic eyelid movement disorders by measuring visual acuity and corneal and skin integrity and comfort over 8 weeks of wear. Objective 2: Collect preliminary data on the relative efficacy of external magnetic devices by comparing them to externally mounted lid weights and ptosis crutches using rating scales and video analysis of blink biomechanics.

Two major types of eye lid movement disorders include lagophthalmos (incomplete closure of the eyelids) and blepharoptosis (incomplete opening of the eyelids). Both of these conditions occur because of a disruption in the normal agonist-antagonist neuro-muscular complex balance. Generally paralysis of the eyelid or facial muscles is responsible for the abnormality (the eyelids can close but not open, or open but not close). An external device, if able to generate an appropriately balanced force, could restore eyelid movement by performing the paralyzed function; for example, a ptotic (droopy) eyelid could be opened, and the functioning eyelid closure muscle could overcome the device's force. In prior work the investigators established proof-of-concept data demonstrating safety and efficacy for temporary management of ptosis up to 2 hour per day for 2 weeks. Preliminary data suggest similar safety for lagophthalmos. This study will expand on this preliminary work to examine longer wear times, home use, and feasibility for a wider range of eye lid disorders.

Eligibility Criteria:
Inclusion Criteria:

* Presence of an eyelid movement disorder for at least one eye, moderate cognitive function or better defined as greater than or equal to 18 out of 30 on a pre-screening of the Mini-Mental State Exam, age 5 or older.

Exclusion Criteria:

* Absence of an eyelid movement disorder or presence of a corneal ulcer. Those with a corneal ulcer are at risk for permanent loss of vision and should be managed with proven methods. Age less than 5, Severe Cognitive impairment defined as Mini-mental score \<18, behaviors consistent with delirium (combinations of disorientation, hallucinations, delusions, and incoherent speech), or lethargy. These individuals must be excluded since participation requires competent self-care, reliable responses and cooperation during fitting of the devices.
Safety and Efficacy of IV Infusion of Investigational Agent (TZP-101) in Patients With Diabetic Gastroparesis

The purpose of this study is to determine whether TZP-101 is safe in people with diabetes. Also to determine if TZP-101 is effective in increasing the gastric emptying rate in diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* Subject has type 1 or type 2 diabetes mellitus
* Subject has documented diagnosis of gastroparesis by:
* Delayed gastric emptying (gastric retention ≥60% at 2h and ≥10% at 4 h; based on scintigraphy -4h standardized radionuclide solid meal)
* A minimum 3 month history of chronic upper abdominal discomfort (two or more: chronic postprandial fullness, bloating, epigastric discomfort, early satiety, belching after meal, postprandial nausea, vomiting)
* Subject has normal upper endoscopy
* If female, must be permanently sterilized or postmenopausa.

Exclusion Criteria:

* Patient has received any investigational drug within the preceding 30 days
* Patient is taking unstable doses of medication that affects gastric motility
* Patient has co-morbid condition
* Patient has a positive laboratory test result for hepatitis B, hepatitis C, HIV, or controlled substances.
* Patient has a history of a psychiatric disorder (including drug or alcohol addiction) requiring care by a psychiatrist or psychologist within the preceding 12 months.
* Patient has a recent,adult history of clinically significanthypersensitivity reaction(s) to any drug.
* Patient has known history of alcoholism
Efficacy and Safety of Darunavir and Cobicistat for Treatment of COVID-19

The study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia

There is no vaccine or antiviral treatment for human coronavirus, so this study aims to evaluate the efficacy and safety of darunavir and cobistastat in the treatment of COVID-19 pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* The participants were diagnosed as COVID-19 pneumonia, according to the notice on printing and distributing the diagnosis and treatment plan of pneumonia with new coronavirus infection (trial version 4 or update version) made by National Health Commission of the People's Republic of China.
* Written the informed consent

Exclusion Criteria:

* Hypersensitivity to darunavir, cobicistat, or any excipients
* Patients with severe liver injury (Child-Pugh Class C)
* Concomitant medications that are highly dependent on CYP3A clearance, and the elevated plasma concentrations are associated with serious or life-threatening events.
* Subjects were considered to be unable to complete the study, or not suitable for the study by researchers

Exit criteria:

* Subjects asked to withdraw the study
* Subject will benefit if withdraw according to researchers' suggestions
Aripiprazole for Schizophrenia Outpatients Completing BMS Clinical Trials

The purpose of this study is to provide aripiprazole to schizophrenic outpatients and Community Treated Patients who are currently receiving aripiprazole therapy on another BMS sponsored clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Currently receiving aripiprazole at time of screening
* Men and women ages 18 to 70

Exclusion Criteria:

* All patients previously discontinued from an aripiprazole study for any reason
* Active alcohol or substance abuse
* Patients who represent a significant risk of committing suicide
* Patients with clinically significant abnormal laboratory test results, vital signs or ECG findings