cyrilzakka/clinical-trials huggingface dataset:
BivaLirudin versUS Heparin in Extracorporeal Membrane Oxygenation

The goal of this open label randomised clinical trial is to compare Bivalirudin versus Heparin for anticoagulation in patients requiring extracorporeal membrane oxygenation support.

The main question it aims to answer are include the ability to maintain anticoagulation within defined therapeutic range, bleeding and thrombotic complications and a comparison of the total cost of anticoagulation care.

Participants will be randomised to either anticoagulation with Bivalirudin or anticoagulation with Unfractionated Heparin.

Rationale:

Anticoagulation whilst on extracorporeal membrane oxygenation (ECMO) is required. Bleeding and thrombotic complications whilst on ECMO are common and may effect the patient outcome. The optimal anticoagulant for ECMO patients is not clear and there exists no randomised control trial data comparing anticoagulants on ECMO. This Phase 2b trial will provide data to enable larger definitive phase III trials to determine the best anticoagulant whilst on ECMO.

Hypothesis: Hypothesis: In adults ECMO patients'; anticoagulation with Bivalirudin results in more samples within therapeutic range than unfractionated Heparin. Total anticoagulation costs with Bivalirudin are similar to unfractionated Heparin.

The objectives of this study is to assess anticoagulation protocol of bivalirudin versus unfractionated heparin and assess the to the cost of each protocol.

Eligibility Criteria:
INCLUSION CRITERIA

* Patients receiving ECMO
* Age: 18 years or older
* Ability to randomise the patient within 4 hours of ECMO support initiation

EXCLUSION CRITERIA

* Post-cardiotomy ECMO patients
* Contraindication to heparin or bivalirudin at time of randomisation e.g., active bleeding
* Heparin induced thrombotic thrombocytopenia syndrome
* Where the patient is expected to be disconnected from ECMO in the next day after cannulation.
* Limitations of care put in place either through patient wishes or the treating medical teams
* Other reason where the treating physician deems the study is not in the patient's best interest
* Patients who are suspected or confirmed to be pregnant
* Inherited bleeding or thrombotic disorders, Systemic Lupus Erythematosus patients
The Different Running Speeds of Strike Patterns

The purpose of this research is to investigate the differences of landing patterns while running in different speed with barefoot and wearing shoe.

Running speed will be adjusted with physical strength and circumstance. When speed changes, whether the landing patterns change or not may be one factor of sports injuries. Therefore, the purpose of this research is to investigate the differences of landing patterns while running in different speed with barefoot and wearing shoe.

Eligibility Criteria:
Inclusion Criteria:

* To jog at least three times a week, each time lasted for more than 20 minutes
* No smokers
* No musculoskeletal diseases within 6 months

Exclusion Criteria:
Assessment of Quality of Life, Bone Density and Safety in Postmenopausal Breast Cancer Patients With Letrozole Therapy

To compare the overall QoL (Quality of Life) using Trial Outcome index (TOI) of FACT-B questionnaire for 3 years from baseline.

1. TOI is the sum of the scores from the physical and functional well-being and the breast cancer subscales.
2. To assess incidence of adverse events (including cardiovascular, cerebrovascular, and endocrine, musculoskeletal) in Korean postmenopausal breast cancer patients in early adjuvant setting.
3. To assess the effect of letrozole (Femara) on BMD in early adjuvant setting.
4. To assess the effect of letrozole (Femara) on total cholesterol in early adjuvant setting.

Eligibility Criteria:
Inclusion Criteria:

1. Patients have undergone surgery of the breast cancer and proven histologically to be breast cancer with postmenopausal women older than 45 years. Postmenopausal state was defined the following conditions, at least one of a, b, c.

   1. serum FSH ≥ 30 mIU/mL
   2. amenorrhea ≥ 1 year
   3. oophorectomy
2. patients with estrogen receptor(+) and/or progesterone receptor(+)
3. WHO(ECOG) performance status 0-2
4. Adequate haematological function, renal function, hepatologic function.
5. No evidence of metastasis.

Exclusion Criteria:

1. patient with hormone receptor negative.
2. Patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell / squamous cell carcinoma of the skin.
3. Other hormone therapy given within the previous 4 weeks.
4. Patients with other aromatase inhibitor and chemotherapy
5. Uncontrolled infection, medically uncontrollable heart disease
6. Other serious medical illness or prior malignancies
7. Patients with BMD T-score ≤-2.5
8. Patients who were treated with bisphosphonate
9. Patients with postmenopausal state induced chemotherapy
10. Estimated life expectancy of \<12 months
Assessment of Anterior Cruciate Ligament (ACL) Degeneratio Mucosa Treatment

Anterior Cruciate Ligament (ACL) Degeneratio Mucosa is a condition resulting from mucoid degeneration of ACL. Exact etiology is unknown, however ACL Degeneratio Mucosa impairs everyday functioning. In the literature there were some reports of treatment by ACL excision and subsequent reconstruction, however such treatment brings risk of deteriorated function. In this study the investigator will evaluate the technique of ACL "decompression" by the means of longitudinal incisions and evacuation of extrafibrous mucoid tissue.


Eligibility Criteria:
Inclusion Criteria:

* patients with ACL degeneratio mucosa decided to undergo a surgical treatment
* range of motion impairment caused by mucoid or cystic changes in ACL confirmed by MRI

Exclusion Criteria:

* non-adherence to the study protocol
* active knee inflammation
* range of motion impairment due to other extra- and intra-articular reasons
Investigation of the Effects of Medium Cut-off Dialyzers Versus High-Flux Dialyzers on Clinical and Laboratory Parameters of Prevalent Hemodialysis Patients

In this study, the investigators aimed to observe the effects of medium cut-off dialysis filters and high-flux dialysis filters on malnutrition inflammation score, uremic itching, restless leg syndrome, anemia, and ESA treatment, which are prominent complications in hemodialysis, and routine follow-up parameters.

The study is designed as a single-center, prospective, observational research. A total of 50 stable-course chronic hemodialysis patients over 18 years of age and treated for at least 3 months will be included in the study and the study period will be planned for 12 months. 25 of the 50 chronic hemodialysis patients planned to be included in the study will use MCO-membrane and the other 25 will use high-flux membrane. The distribution of patients to the high-flux membrane and MCO membrane groups will be done randomly (sequentially single-pair number method). Then, the standard 12-hour (3x4 hours/week) hemodialysis treatment will continue. At the beginning of the study (0.), at the end of the third (3.) month and at the end of the sixth (6.) month;

Monthly laboratory tests routinely performed on hemodialysis patients (tests routinely performed in hemodialysis patient follow-up) 5 ml blood samples will be taken from the hemodialysis set to determine the levels of medium-large molecule-weight toxins-wastes and inflammatory parameters before and after dialysis, and the sera will be separated and stored at -80oC for use at the end of the study.

Automatic blood pressure measurement will be performed before and after hemodialysis to evaluate arterial stiffness.

The Malnutrition Inflammation Score will be applied to evaluate the nutritional status (the MIS form is given in the appendix) Visual Analog Scale will be used for appetite Visual Analog Scale will be used for uremic pruritus Depression scale screening (Beck's scale)

Eligibility Criteria:
Inclusion Criteria:

* Chronic hemodialysis patients
* Patients continuing the hemodialysis program for at least 3 months
* Patients over 18 years of age

Exclusion Criteria:

* Patients with advanced heart failure, malignancy, terminal illness
* Patients with active infectious disease
* Acute hemodialysis patients
* Patients vascular access dysfunction
Clinical Trial of High Dose CoQ10 in ALS

The purpose of this study is to determine the efficacy and preferred dose of CoQ10 in individuals with ALS for a possible future phase III study.

Amyotrophic lateral sclerosis (ALS) is a progressive and devastating neurodegenerative disorder. Available treatment for ALS remains scarce. Oxidative stress and mitochondrial dysfunction have been implicated in the pathophysiology of ALS. Oxidative stress refers to the effects of cell-damaging reactive oxygen species, also known as free radicals. Oxidative stress is thought to contribute to nerve cell loss in ALS. Mitochondria are organelles within each cell that are sometimes called "powerhouses of the cell" because cellular energy metabolism is located within the mitochondria.

Coenzyme Q10 (CoQ10), a mitochondrial cofactor known for its antioxidant properties, has prolonged survival in the mouse model of ALS and has slowed functional decline in another neurodegenerative disorder, Parkinson's disease. The goals of this double-blind, placebo-controlled, two-dose comparison phase II study are to obtain preliminary efficacy data and to select the preferred dose for a larger phase III study.

Participants were randomly assigned to CoQ10 (at two different dose levels) or placebo in the first stage, then the 2,700 mg dose was selected in the second stage. Duration of the trial was 9 months with a total of 7 visits.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of definite, probable, or laboratory-supported probable ALS
* Negative pregnancy test for women of childbearing age and adequate birth control measures
* Subjects must be able and willing to give informed consent and must be capable of complying with the trial procedures
* Forced Vital Capacity (FVC) \>/= 60% of predicted
* Age 21 to 85 years, inclusive
* Disease duration of less than 5 years
* Subjects may take riluzole (without change in dose for more than 30 days before enrollment)
* Patients who have taken CoQ10 in the past will be eligible if they stop at least 30 days before enrollment
* Patients who have taken vitamin E in the past will be eligible if they stop at least 14 days before enrollment

Exclusion Criteria:

* Dependency on mechanical ventilation (non-invasive ventilation \> 23 hours)
* Severe and unstable concomitant medical or psychiatric illness
* Insufficiently controlled diabetes mellitus
* Concomitant warfarin therapy
* Women who are breast feeding or have a high likelihood of pregnancy
* Significant hepatic dysfunction
* Forced Vital Capacity (FVC) less than 60%
* Exposure to CoQ10 within 30 days of enrollment
* Exposure to other experimental medications within 30 days of enrollment
* Exposure to vitamin E within 14 days of enrollment
* Sensitivity to color additive FD\&C Yellow No. 5
* Sensitivity to aspirin
Sensor and Software Use for Improved Glucose Control in MDI Managed Diabetes

To understand if Multiple Daily Injections (MDI) managed subjects can improve glycaemic control by;

1. regularly checking and understanding Continuous Glucose data \& trend arrows at times other than the standard pre-meal bolus calculation test times and
2. review of their glucose profiles (inc. hypoglycaemic risks) with their Health Care Professional (HCP) and adjusting behaviours \& therapy from interpretation of the Continuous Glucose profiles.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and over
* Type 1 diabetes on MDI with bolus injections for \>6 months prior to study enrolment or Type 2 diabetes treated with 2 or more insulin injections daily.
* In the investigator's opinion, thought technically capable of using FreeStyle Navigator GM System device.
* HbA1c between 7.5 and 12.0% (58 to 108 mmol/mol) for previous test obtained within 6 months prior to point of enrolment

Exclusion Criteria:

* Concomitant disease or condition that may compromise patient safety, including unstable coronary heart disease, cystic fibrosis, serious psychiatric disorder, or any uncontrolled chronic medical condition
* Female subject is pregnant or planning to become pregnant within the planned study duration. Subjects who become pregnant during the study will be discontinued from the study.
* Currently using / has previously used a Continuous Glucose Monitoring System within the last 6 months.
* Currently using Continuous Subcutaneous Insulin Infusion (CSII)
* Currently using basal/long acting insulin only.
* Participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
* Known allergy to medical grade adhesives
* In the investigators opinion is unsuitable to participate due to any other cause/reason.
A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy

This study will be conducted to compare Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 12 years at the time of signing the ICF.
* Active, moderate to severe cGVHD, requiring systemic immune suppression.
* Participants with refractory or recurrent cGVHD who have received at least 2 lines of systemic therapy, including corticosteroids and ruxolitinib.
* Concomitant use of systemic corticosteroids is allowed. Participants on systemic corticosteroids must be on a stable dose of corticosteroids for at least 2 weeks prior to C1D1. Topical and inhaled corticosteroid agents are allowed.
* Participants must accept to be treated with one of the following BAT options on C1D1: CNI (cyclosporine or tacrolimus), ECP, MMF, an mTOR inhibitor (everolimus or sirolimus), rituximab, pentostatin, proteasome inhibitors, imatinib, or ibrutinib.
* History of allo-HCT from any donor HLA type (related or unrelated donor with any degree of HLA matching) using any graft source (bone marrow, peripheral blood stem cells, or cord blood). Recipients of myeloablative, nonmyeloablative, or reduced-intensity conditioning are eligible.

Exclusion Criteria:

* Receipt of more than 1 prior allo-HCT. Prior autologous HCT is allowed.
* Evidence of relapse of hematologic disease or treatment for relapse after the allo-SCT was performed, including DLI for the treatment of molecular relapse. Note: Participants who have received a scheduled DLI as part of their transplant procedure and not for management of malignancy relapse are eligible.
* Systemic treatment with CNIs or mTOR inhibitors started within 2 weeks prior to C1D1.
* Severe renal impairment, that is, estimated creatinine clearance \< 30 mL/min measured or calculated by Cockcroft-Gault equation in adults and Schwartz formula in pediatric participants, or end-stage renal disease on dialysis.
* Impaired liver function, defined as total bilirubin \> 1.5 × ULN and/or ALT and AST \> 3 × ULN in participants with no evidence of liver cGVHD.
* History of acute or chronic pancreatitis.
* Active, symptomatic myositis.
* Pregnant or breastfeeding.

Other protocol-defined Inclusion/Exclusion Criteria may apply.
"Light" Versus "Deep" Bispectral Index (BIS) Guided Sedation for Colonoscopy

In this trial, patients undergoing elective colonoscopy under sedation will be randomised to BIS-guided sedation targeting either "light" (bispectral index \[BIS\] 70-80) or "deep" (BIS\<60) sedation. Sedation will be achieved with a standardised regimen of target-controlled infusion of propofol and fentanyl bolus. The primary end point will be the incidence of procedure recall in each group - this will be assessed at the conclusion of the procedure. The procedural conditions, cardio-respiratory complications and recovery including cognitive function will be assessed during and immediately after the procedure. The incidence of dreaming and patient satisfaction with anaesthesia care will be recorded immediately after the procedure. The study will be complete when the patient leaves the hospital on the day of the procedure.

Controversy exists about the need for deep sedation or light sedation during elective colonoscopy. Deep sedation ensures amnesia for the procedure and may ensure better operating conditions, but may result in cardiorespiratory side effects and prolonged recovery. Differences exist between countries regarding the prevailing depth of sedation with deeper sedation in general being administered in Australia than the United States. This study aims to explore that controversy.

Eligibility Criteria:
Inclusion Criteria:

* Plan for elective outpatient colonoscopy under sedation
* Able and willing to provide written informed consent for study entry and completion of all study related procedures
* American Society of Anesthesiologists' (ASA) physical status grade 1-3

Exclusion Criteria:

* Colonoscopy and gastroscopy booked as joint procedures
* Colonoscopy on emergency patients and/or inpatients
* Inadequate English comprehension (verbal and written to understand the Participant Information and Consent Form)
* Intellectual or psychiatric disability that prevents consent to and comprehension of study procedures
* Significant cognitive impairment that prevents independent conduct of activities of daily living or results in 3rd party procedural consent being obtained
* ASA physical status grade 4-5
Talar Avascular Necrosis: Surgical Angiogenesis vs. Core Decompression

The purpose of this study is to determine if surgical angiogenesis performed in talar avascular necrosis by free microvascular bone grafts from the medial femoral condyle is a superior technique compared to core decompression and nonvascularized osseous autografts.

The aim of this prospective randomized clinical trial is the comparison of two surgical treatment options for talar avascular necrosis (analogical to Ficat and Arlet stage II and III). The randomized study design allows direct comparability of the outcome after either core decompression and nonvascularized osseous autografting from the iliac crest or core decompression and osseous autografting with a free microvascular medial femoral condyle.

Talar avascular necrosis is caused by osseous malperfusion leading to malnutrition and destruction of the talar bone. The extend of this malperfusion is variable and can be categorized in 4 stages. The osseous defects can remain without consequences (stage I) or lead to irreversible talar destruction. The current treatment option for stage II and III is the core decompression followed by osseous auto grafting from the iliac crest. Reducing the intraosseal pressure and filling the drill holes with the nonvascularized bone graft can lead to reperfusion of the talus.

A new technique is to fill the drill hole with a vascularized bone graft from the medial femoral condyle, using microvascular anastomosis. This procedure has already been approved for the treatment of avascular necrosis and malperfusion of the carpus (lunate and scaphoid) as well as the femoral head.

Patients are examined preoperative as well as 3, 6 and 12 month after operation, documenting the active range of motion and pain sensation while resting and on activity. Well established scores like the AOFAS Ankle-Hindfoot Score and the Lower Extremity Functional Scale are used to get subjective and objective informations about patients' daily life and postoperative satisfaction. X-Rays are taken at the same stages. MRIs of the ankle joint with contrast agent are performed before as well as 6 and 12 months after surgery.

Statistical analysis is performed using the Statistical Package for the Social Sciences (SPSS). The Study protocol has been approved by the Ethics Commission of Rheinland-Pfalz. Interventions are done according to the declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* patients with talar avascular necrosis without response to non-surgical treatment (immobilization) and with need for surgical intervention (Ficat and Arlet stage II and III; Berndt and Harty stage II and III)

Exclusion Criteria:

* talar avascular necrosis stage I (without need for surgical intervention)
* surgical revascularization in the past
* participation in a different study
* pregnancy
* peripheral artery occlusive disease
* drug associated talar avascular necrosis
* ongoing steroid therapy or chemo therapy
Lifestyle Internet-Based Intervention On Hypertensive Patients With Overweight Or Obesity

This study aims to analyze the effects of a 3 months duration self-applied online program, composed of 9 modules focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on obese or overweight adults with hypertension. Participants will be recruited from a hypertension unit of a public hospital. These patients will be randomized allocated into two interventional groups: experimental group will receive audiovisual instructions from their hypertension specialist doctor, and the control group from a doctor outside the patient. Assessment will include: body composition (BMI), blood pressure, levels of physical activity, functional capacity, fall risk, and quality of life.

Hypertension and obesity or overweight related, even other associated comorbidities, involve a worrying public health problem. The evidence shows that healthy eating and regular physical exercise, monitored by different means (internet, face to face, exercise diaries), play an important prevention role to maintain health while ageing. In this way, Information and Communication Technologies (ICTs) have been demonstrated as a useful tool to promote health, working on barriers at the same time, such as low motivation and difficulties to maintain regular exercise or healthy eating habits. ICTs also allows to reach a wider audience at a lower cost, due to their good cost-benefit relationship and the possibility of increasing the efficiency of interventions. Therefore, this study aims to analyze the effects of a 3 months duration self-applied online program, composed of 9 modules focused on promoting healthy lifestyle habits (healthy eating and increased physical activity), on obese or overweight adults with hypertension. Participants will be recruited from a hypertension unit of a public hospital. These patients will be randomized allocated into two interventional groups: experimental group will receive audiovisual instructions from their hypertension specialist doctor, and the control group from a doctor outside the patient. Assessment will include: body composition (BMI), blood pressure, levels of physical activity, functional capacity, fall risk, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Hypertension
* Overweight or obesity (25 ≤ BMI ≤ 35 kg/m2)
* Aged between 18-75 years

Exclusion Criteria:

* Not having access to the Internet or lack of information about it.
* Treatment with more than 3 antihypertensive drugs.
* Meet the criteria of the DSM-IV-TR of a Food Disorder.
* Presenting some type of severe psychiatric disorder.
* Disability that prevents or hinders physical exercise.
* Receiving some treatment for weight loss.