cyrilzakka/clinical-trials huggingface dataset:
Sedentary Behavior Breaks With Isometric Exercise in Cardiovascular Health Indicators

The goal of this study is to analyze the chronic effects of sedentary behavior breaks using the leg extension isometric exercise in the cardiovascular health indicators of healthy adults exposed to prolonged time in the sitting position. The patients recruited will be randomized into two groups: leg extension isometric training (TIE) and control group (CG). The TIE group will perform 12 weeks of isometric training. The CG will be advised not to change their routine activities, especially diet and physical activities.In the pre and post-intervention periods cardiovascular measures will be obtained.

Long periods in sedentary behavior promote deterioration of vascular function, which is directly associated with the occurence of chronic noncommunicable diseases. In this context, the execution of interruptions in this behavior (breaks) is recommended. Studies have shown benefits of isometric training in vascular function, which could be useful to minimize the consequences of time spent in sedentary behavior. Thus, the goal of this study is to analyze the chronic effects of sedentary behavior breaks using leg extension isometric exercise in the cardiovascular health indicators of adults exposed to prolonged time in the sitting position. The target population of the study will consist of healthy subjects above 18 years of age of both genders. All subjects will be submitted to measurements of endothelial function, blood pressure and cardiac autonomic modulation. After these measurements, the subjects will be randomized into two groups: leg extension isometric training group (TIE) and control group (CG). After 12 weeks both groups will be submitted to the same measurements from pre-intervention.

Eligibility Criteria:
Inclusion Criteria:

* No diagnostic of cardiovascular diseases or diabetes
* Do not present high cardiovascular risk
* Do not participate in an exercise program in the previous six months
* Occupational activity that requires more than six hours of sitting time per day
* Do not be a smoker or make use of medications

Exclusion Criteria:

* Adherence to the training sessions inferior to 85%
* Adherence to another supervised exercise program
* Change the characteristics of the occupational activities
LeucoPatch™ Study A Multicenter Study on the Effect of LeucoPatch™ in Diabetic Foot Ulcers

The LeucoPatch™ study goal is to investigate whether the fully autologous growth factor-containing dressing LeucoPatch™ has a positive effect on healing rates of diabetic foot ulcers. The study seeks to gather data for comparison with previous data from similar wounds (historical controls). By subgrouping of the treated wounds (similar to the historical controls used) an assessment of which of the patient and wound-related factors that might indicate a beneficial effect of LeucoPatch™ is sought.

Summary: Treatment Study

The goal of the LeucoPatch ™ study is to investigate the effect of LeucoPatch ™ in diabetic foot ulcer. LeucoPatch ™ is a biologically active dressings which are made solely by the patient's own blood (autologous). It is produced in the CE (European Conformity) marked LeucoPatch™ Device and contains no additives. In this treatment study up to 75 typical diabetic patients with foot ulcers are included. These wounds are typically chronic and lead to reduced quality of life and ability to work, and extensive treatment costs. Furthermore, these wounds often lead to amputations.The study is a multicenter study in which up to 10 wound clinics are expected to be involved.

The primary endpoint is time to complete healing, the secondary endpoint is change in wound size.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Type I or Type II Diabetes
* Age of wounds \> 6 weeks
* Wound area \<10 cm2
* Wounds: Texas degree ≤ type IIa
* Perfusion status: toe pressure\> 30 mmHg, or transcutaneous oxygen measurement (TcPO2)\> 30 mmHg on the foot (measured within the last 3 months) or palpable foot pulse (equivalent to\> 60 mmHg)
* Diabetes control: HbA1c \<12%
* Adequate off-loading (Walker, therapy sandals etc.)
* The patient can adhere to the treatment protocol and is expected to conclude the study
* Written informed consent

Exclusion Criteria:

* Non-Danish or Swedish speaking
* Dementia
* Pregnant or nursing women
* The patient cannot tolerate blood donation
* Hemoglobin : \< 6,5 mmol/l or 105 g/l
* Haemophilia, Sickle cell anemia, severe thrombocytopenia, and leukemia or blood dyscrasias.
* Patient on dialysis
* Clinical signs of infection - including osteomyelitis (probe to bone).
* Necrosis of the wound
* 40% change (+/-) in ulcer area in a 2-week run-in period with optimal therapy.
* Blood vessel reconstruction within the last 4 weeks.
* Participation in other clinical wound healing studies in the last 30 days.
* Failure to comply with study protocol in the 2-week run-in period.
Single-operator Wire-guided Endoscopic Retrograde Cholangiopancreatography Cannulation Technique

The single-operator wire-guided cannulation technique doesn't require an experienced assistant and precise coordination between the assistant and endoscopist.

A new single-operator wire-guided cannulation technique was performed on all patients. All procedures were performed by the same experienced endoscopist, but with different assistants in two groups (with an experienced one in Group A, and a new trained one in Group B). The number of attempts at cannulation, cannulation time, success rate, and procedure-related complications were compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* hospitalized patients with pancreas and biliary diseases referred to the authors for ERCP

Exclusion Criteria:

* previous endoscopic sphincterotomy,
* surgically altered anatomy (e.g. Billroth II gastrectomy) or
* diagnostic duodenoscopy
A Study of ARQ 171 in Patients With Advanced Solid Tumors

This is an open label, dose escalation study of ARQ 171 administered via intravenous infusion (IVI) into a peripheral vein weekly.

Patients with advanced solid tumors, who are refractory to available therapy or for whom no standard systemic therapy exists, will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent must be obtained and documented prior to study-specific screening procedures.
* A histologically or cytologically confirmed advanced solid tumor
* ≥ 18 years of age
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors
* Karnofsky performance status ≥ 70%
* Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after participation.
* Females of childbearing potential must have a negative serum pregnancy test.
* Laboratory results must meet study criteria.

Exclusion Criteria:

* Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first infusion
* Surgery within 4 weeks prior to first infusion
* Known untreated brain metastases
* Pregnant or breastfeeding
* Uncontrolled intercurrent illness, or uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements
* Other cancer within the last five years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin
New Options for Treating Knee Osteoarthritis Pain

This study will be a single-site, four-arm, randomized, placebo-controlled clinical trial. Knee osteoarthritis patients (N=164) will be randomized to Reiki, Sham Reiki (placebo control), mindfulness meditation (active control), or a waitlist control condition. The three active interventions will be applied for 20 minutes, once a week, for four consecutive weeks in a university laboratory setting.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis in at least one knee
* Report a WOMAC pain score average \>/= 2
* Not using any kind of energy therapy different from the proposed study
* Ability to read, understand and speak English

Exclusion Criteria:

* Knee arthroplasty in the previous year
* Have cognitive impairment as determined by clinical interview
Study to Evaluate the Efficacy and Safety of Andecaliximab Combined With Nivolumab Versus Nivolumab Alone in Adults With Unresectable or Recurrent Gastric or Gastroesophageal Junction Adenocarcinoma

The primary objective of this study is to evaluate and compare the efficacy of andecaliximab (GS-5745) in combination with nivolumab versus nivolumab alone in adults with recurrent gastric or gastroesophageal junction (GEJ) adenocarcinoma.


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed inoperable locally advanced or metastatic adenocarcinoma of the stomach or GEJ which have progressed on at least 1 prior systemic therapy or line of treatment for unresectable/metastatic disease
* Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 1
* Measurable disease according to Response Criteria in Solid Tumors (RECIST) v1.1
* Tumor sites that can be accessed for repeat biopsies
* Archival tumor tissue, preferably obtained from the most recent available biopsy; there must be adequate tissue for a Cochran-Mantel Haenszel (CMH) test stratified by programmed death ligand 1 (PD-L1) stratification test, as assessed by central pathologist
* Individuals not receiving anticoagulant medication must have an international normalized ratio (INR) ≤ 1.5 and activated partial thromboplastin (aPTT) ≤ 1.5 x upper limit of normal (ULN)
* Required baseline laboratory data as outlined in protocol

Key Exclusion Criteria:

* Individuals who have received only neoadjuvant or adjuvant therapy for gastric adenocarcinoma
* Radiotherapy within 28 days of randomization
* Uncontrolled intercurrent illness as outlined in protocol
* History of a concurrent or second malignancy except for those outlined in protocol
* Major surgery, within 28 days of first dose of study drug
* Known positive status for human immunodeficiency virus (HIV)
* Known acute or chronic-active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
* Chronic daily treatment with oral corticosteroids (dose of \> 10 mg/day prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
* Known or suspected central nervous system metastases
* Documented myocardial infarction or unstable/uncontrolled cardiac disease within 6 months of randomization
* Serious systemic fungal, bacterial, viral, or other infection that is not controlled or requires intravenous antibiotics
* Current or history of pneumonitis or interstitial lung disease
* Active known or suspected autoimmune disease with exceptions noted in protocol.
* History of bone marrow, stem cell, or allogenic organ transplantation

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
A Study Of The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-05180999 In Healthy Adults

The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of 14 days of treatment with PF-05180999 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

male or female of non-childbearing potential,

Exclusion Criteria:

Evidence of clinically significant medical illness, history of seizures, any condition possibly affecting drug absorption
Study to Test an Approved Product in the Early Treatment of Migraine (0462-066)

The purpose of this study is to test the effectiveness of an approved drug in the early treatment of migraine.


Eligibility Criteria:
Inclusion Criteria:

* Six month history of migraine; attacks typically mild when they begin with 1-4 migraine attacks per month.

Exclusion Criteria:

* Heart disease
* High blood pressure
Effect of the Intra-abdominal Pressure on the Risk of Delirium in Mechanically Ventilated Patients.

intra-abdominal hypertension (IAH) and delirium are serious, high-frequency complications in intensive care unit (ICU) patients. The consequences of the complication range from high morbidity and mortality to a greater need for nursing care. We hypothesize that there could be a correlation between IAH and incidence of delirium.


Eligibility Criteria:
Inclusion Criteria:

* Patients of both genders on mechanical ventilation

Exclusion Criteria:

* age under 18 years, use of muscle relaxants, abdominal operation within the previous 3 months, acute peritonitis, and abdominal mass, acute injury to the urinary bladder, acute cystitis, neurogenic bladder, pelvic hematoma, and pelvic fracture.
Intervention Effects of Optimized Carbohydrate Diet in Patients With Type 2 Diabetes

This study is a multi-center, randomized, crossover investigator-initiated trial conducted at Shanghai Sixth People's Hospital and other centers. Each participant will undergo two 12-week dietary intervention phases, separated by a 6-week washout, for a total study duration of 30 weeks. Participants will be randomly assigned in a 1:1 ratio to one of two intervention order: (1) optimized carbohydrate diet-washout-conventional diabetes diet, or (2) conventional diabetes diet-washout-optimized carbohydrate diet. The optimized carbohydrate diet is a modified diet with adjusted carbohydrate composition and proportions, while the conventional diabetes diet adheres to an energy-matched protocol in accordance with diabetes dietary guidelines. The study aims to explore the effects of the optimized carbohydrate diet on blood glucose control and glucose metabolism in patients with type 2 diabetes, and to systematically assess its impact on cognitive function and a range of physiological and psychological indicators (such as depression, anxiety, appetite, sleep, bowel habits and others).


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with type 2 diabetes according to the ADA diagnostic criteria
2. HbA1c ≥ 7% and \< 9%
3. Antidiabetic medication has been stable for at least 3 months before recruitment
4. Aged 35-70 years
5. Signed the informed consent form

Exclusion Criteria:

1. Treatment with insulin
2. Treatment with GLP-1 receptor agonists or DPP-4 inhibitors
3. Occurrence of diabetic ketoacidosis, lactic acidosis, hyperosmolar coma, or recurrent severe hypoglycemia within the past year
4. Having one or more severe chronic diabetic complications, including advanced diabetic retinopathy, macroalbuminuria (urine albumin-to-creatinine ratio ≥300 mg/g), or impaired renal function (eGFR ≤60 ml/min/1.73 m²)
5. Presence of cardiovascular events (e.g., myocardial infarction, stent placement, unstable angina, heart failure, cardiac dysfunction) or cerebrovascular diseases (e.g., intracerebral hemorrhage, ischemic stroke) within the past 6 months
6. Diagnosis of acute or chronic gastrointestinal diseases (e.g., ulcers), hyperthyroidism or hypothyroidism, uncontrolled hypertension, active malignancy not in remission, or other life-threatening diseases
7. Recent use of antibiotics, probiotics, or prebiotics within the past 3 weeks or need for long-term use
8. Unstable medication regimen or use of prescription medications affecting metabolism (e.g., thyroid hormones, glucocorticoids)
9. Pregnancy, breastfeeding, or planning pregnancy
10. Presence of a pacemaker or metal implants, claustrophobia, or other contraindications to fMRI
11. Psychiatric disorders impairing cooperation
12. Expected poor compliance
13. Current or recent (within 4 weeks prior to study initiation) participation in other clinical trials
Safety Evaluation of Edoxaban in Elderly Patients With Frailty Criteria

The aim of the present study is to prospectively evaluate the safety of Edoxaban.

The aim of the present study is to prospectively evaluate the safety of Edoxaban in daily clinical practice in Spain in elderly patients with nonvalvular atrial fibrillation who meet the criteria for frailty and who have been prescribed the drug recently (\<6 months prior to inclusion).

The study will provide us with a clear and real-life picture of bleeding and ischemic complications and possible treatment interruptions with Edoxaban in real life and in a large subgroup, although underrepresented in the studies.

Eligibility Criteria:
Inclusion Criteria:

* Patients 75 years of age or older with a diagnosis of NVAF.
* Patients in whom treatment had been started in the 6 months prior to enrollment in the study with Edoxaban for prevention of stroke and systemic embolism after diagnosis of NVAF and according to the drug's technical data sheet.
* Frailty criteria according to the FRAIL scale (score of 3 to 5 points).
* Written informed consent to participate in the study prior to any intervention.

Exclusion Criteria:

* Creatinine clearance according to the CKD-EPI formula less than 15 ml/min/m2
* Moderate or severe hepatic insufficiency (Defined as grade B or C of the Child-Pugh classification.
* Contraindication to receive Edoxaban according to the Technical Data Sheet.
* Participation in any clinical drug trial in the 2 months prior to the initial visit.
* Absence of recorded patient or treatment information.
* Surgical or percutaneous occlusion of the left atrial appendage or intention to perform such intervention at the time of inclusion.
* Any circumstance that, in the opinion of the investigator, affects patient follow-up (including life expectancy of less than two years or inability to perform follow-up).
* Persons who are legally incapacitated or unable to understand informed consent.
Safe Return to Play After Concussion

This study will evaluate a combination of a novel Dual-task regime together with other already known tests in terms of defining when an athlete is ready to return to play after a concussion.

In this prospective study, we will evaluate a combination of a novel facilitating agility Dual-task regime together with sport concussion assessment tool -5 (SCAT5), Vestibular/Ocular-Motor Screening for Concussion, Agility T-test, Joint repositions error test and Pain Catastrophizing Scale (PCS) in terms of defining when an athlete is ready to return to play after a concussion. We will investigate if a novel facilitating agility Dual-task test together with already widely used tests, can identify more athletes that after a concussion still isn't ready to return to play, due to a physiological deficit. We will test as many athletes as possible each season and when an athlete suffer a concussion, we will follow them to see when they reach their baseline level. As previous studies show a over representation of new injuries in athletes returning to play after a concussion, we will also register injuries from all included subjects in terms of injuries each year, to evaluate if athletes following our recommendations have a lower injury rate after returning to play after a concussion. We also hope to be able to get more knowledge about how pain catastrophizing is related to duration of concussions symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Athletes participating in sports at least 1xweek

Exclusion Criteria:

* injury that limits the participants ability to conduct the tests If the participant don't speak and understand Danish or English Other diseases or conditions that could interfere with one or more of the tests.
Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change

The purpose of this study is to evaluate the change in patient-reported treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9).


Eligibility Criteria:
Inclusion Criteria:

* Patients must be diagnosed with relapsing remitting MS (RRMS) as defined by 2005 revised McDonald criteria.
* Patients who explicitly agree to be assigned to a treatment group that may receive fingolimod or DMT after having been informed about their respective benefits and possible adverse events by the investigator.
* An Expanded Disability Status Scale (EDSS) score of 0-5.5 inclusive.
* Must have received continuous treatment with a single approved and indicated MS DMT for a minimum of 6 months prior to the screening visit. Patients must continue with this MS DMT until the randomization visit.
* Naïve to treatment with fingolimod.

Exclusion Criteria:

* A manifestation of MS other than those defined in the inclusion criteria.
* A history of chronic disease of the immune system other than MS or a known immunodeficiency syndrome.
* History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
* Patients with uncontrolled diabetes mellitus (HbA1c \> 7%).
* Diagnosis of macular edema during Screening Phase.

Other protocol-defined inclusion/exclusion criteria may apply
Quality of Life in Chronic Arthritis

Chronic joint complaints are prevalent in clinical practice. If chronic arthritis such as rheumatoid arthritis (RA) or ankylosing spondylitis (AS) is not adequately controlled, it can not only affect patient's working ability but also produce indirect cost in patient's family. Quality of life will also be affected. Health-related quality of life issues are assuming increasing importance in chronic rheumatic diseases. However, studies on quality of life in rheumatic patients are limited. Factors related to quality of life are not clear. Application of quality of life measurement for improving clinical care of RA and AS patients is still difficult. The objective of this study was to evaluation the validity of EQ-5D life quality measurement in chronic arthritis patients in Taiwan. Factors associated with life quality will be addressed. This will also provide useful information for public health policy making.


Eligibility Criteria:
Inclusion Criteria:

* Patients with rheumatoid arthritis or ankylosing spondylitis

Exclusion Criteria:

* Patients with mental illness which interfered with questionaire answering
Upper Extremity Post-op Splints: Do They Improve Post-operative Pain?

The goal of this study is to determine if applying a rigid splint helps to reduce pain following operative fixation of upper extremity fractures. Orthopedic trauma surgeons currently vary in their application of rigid post-operative splints versus soft dressings after certain surgical procedures based on personal preference. In this study, 100 patients undergoing operative fixation of isolated both bone forearm, radial head, olecranon, distal humerus, or humeral shaft fractures will either receive a splint or soft dressing post-operatively. Their pain, medication usage and function will be tracked over the 2- week postoperative period to see if splinting has any impact on outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to participate in study and complete consent
* Will undergo operative fixation of an isolated both bone forearm, radial head, olecranon, distal humerus fracture, or humeral shaft fracture.

Exclusion Criteria:

* Pregnant women
* Patients with concomitant TBI or MR
* Polytrauma patients
* Pathologic Fractures
* Patients undergoing treatment for malignancy
* NYU SoM Students, Residents, Faculty
* Prisoners
* IV drug users or patients on chronic narcotics
* Gun shot wound victims