cyrilzakka/clinical-trials huggingface dataset:
"Prescribing" Exercise to Cancer Patients At High-Risk for Falls

Falls are common and catastrophic in cancer patients. Cancer patients are vulnerable to falls due to muscle loss. In prescribing exercise in a data driven manner to cancer patients, our hypothesis is this "prescription" for exercise will eventually be demonstrated to reduce the occurrence of injurious falls.


Eligibility Criteria:
Inclusion Criteria:

* Any cancer diagnosis, as documented in medical record, other than non-melanoma skin cancer.
* No issues such as unstable angina or loss of a limb that would preclude exercise.

Exclusion Criteria:

* Diagnosis of non-melanoma skin cancer
* Unstable angina
* Loss of limb, which limits exercise capabilities at the discretion of the Principal Investigators
* Pregnant women
Efficacy of Activated Recombinant Human Factor VII in Healthy Volunteers Treated for Punch Biopsy Mediated Bleeding

This trial is conducted in the United States of the America (USA). The aim of this trial is to evaluate the effectiveness of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with clopidogrel (Plavix®).


Eligibility Criteria:
Inclusion Criteria:

* PT/PTT within normal laboratory range (e.g., PT: 9.4-12.0)
* Platelet count within normal laboratory range

Exclusion Criteria:

* The receipt of any investigational drug within 1 month prior to this trial
* Use of anticoagulation therapy-defined as vitamin K antagonists, platelet antagonists, heparin
* (or low molecular weight heparin), aspirin or NSAIDs (non-steroidal anti-inflammatory drug) within 30 days prior to trial
* African-American race
* Weight above or equal to 160 kg
Neural and Behavioural Bases of Action Simulation

The goal of this interventional study is to understand the neural and behavioural bases of action simulation and its links with action execution in healthy volunteers.

Hypotheses: Action simulation recruits neural networks that are largely similar to those activated by action execution, with some differences to avoid executing a movement while observing/imagining it.

Participants will be tested with TMS while doing motor imagery or action observation.


Eligibility Criteria:
Inclusion Criteria:

* healthy adult volunteers (more than 18 years old)

Exclusion Criteria:

* Participants taking anti-epileptic drugs
* pregnant or breastfeeding women cannot participate in this study
* people with a pacemaker
* people with a cochlear implant
* people with a metal part in the brain or any other medical implant in their body (pump, neurostimulator, valve,) cannot take part in this study.
Effects of Therapeutic Ultrasound Versus Shockwave Therapy in Medial Tibial Stress Syndrome in Recreational Runners

This project was a Randomized control trial conducted to check the effects of therapeutic ultrasound versus shockwave therapy on pain , range of motion and function in recreational runners with medial tibial stress syndrome so that we can formulate a better and most effective regime for treatment of medial tibial stress. Duration was of 6 months, convenient sampling was done, subject following eligibility criteria from Ghurki Trust teaching hospital, horizon hospital and surgimed hospital. Group A participants were given baseline treatment along with shockwave and Group B were given baseline treatment along with therapeutic ultrasound. Assesment was done at baseline and at 2nd week and 6th week post-interrvention . Assessment was done via, Numeric pain rating scale(NPRS), Lower Extermity functional scale LEFS ) and goniometric measurements of shoulder ranges, data was analyzed by using SPSS version 26.

Medial tibial stress syndrome (MTSS) is a common low leg injury. It is described as activity-induced pain along posterior medial border of leg approximately for 5 cm. Most commonly reported by runners and military personnel. Incidence of MTSS ranges between 13.6% to 20% in runners. Significant increase in loading activities or rigorous exercise causing high impact like skiping, jogging can induce MTSS which leads to stress fracture of tibia. Various risk factors are associated with the incidence of medial tibial stress syndrome which includes both intrinsic and extrinsic factors. Current study has involved comparison of therapeutic ultrasound versus shockwave therapy as there is limited knowledge about comparison of therapeutic ultrasound versus shockwave therapy.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* Pain at distal 2/3 of tibia
* Previous history of MTSS
* Recreational runner

Exclusion Criteria:

* History of lower limb fracture

  * Any lower limb surgical history
  * Any malignancy
  * Professional athlete
  * Cardiopulmonary insufficiency
Phase Ⅳ Clinical Trial to Evaluate of Renamezin in Patients With Chronic Renal Failure.

Renamezin Capsule (an oral adsorbent) lowers indoxyl sulfate levels in patient with chronic renal failure.

120 patients with chronic renal failure(baseline serum creatinine:1.5-5.0mg/dl).

Renamezin is administered 6.0mg/day. The treatment period is 2 months. The change in serum indoxyl sulfate will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. patients spontaneously written consent to participate in this clinical trial
2. men and women over age of 19
3. pre-dialysis patients with chronic renal failure stage patient for 3 months and patients for holding the stable state in serum creatinine 1.5mg/dl - 5.0mg/dl
4. patients who were no noticeable change for 12weeks before screening and are expected to change is not needed during therapy in the therapy of chronic renal failure(medication and dose -related, diet therapy)

Exclusion Criteria:

1. patients with passes through the digestive tract disorders
2. patients with uncontrolled constipation symptoms
3. patients suffering from digestive tract ulcers and esophageal varices
4. patients with untreated severe hypertension (DBP ≥ 120mmHg)
5. patients hospitalized with angina pectoris, cardiovascular disease or diagnosed with serious arrhythmia or cerebrovascular disease within 6 months
6. patients with hepatic impairment (2 times greater than the upper limit of normal levels of AST, ALT)
7. subjects with dependency on alcohol
8. patients with current infections
9. pregnant women, nursing mothers
10. Patients with a possibility of pregnancy (However, negative case can be registered)
11. patients participating in another clinical trial in addition to the current clinical trial
12. Patient who do not fit the clinical trial participation the legal and mentally
DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)

This study will find out if trastuzumab deruxtecan is safe and works for participants with gastric or gastroesophageal junction cancer.

They must have human epidermal growth factor receptor 2 (HER2)-positive gastric or gastro-esophageal junction (GEJ) cancer:

* that cannot be removed surgically
* that has moved to other parts of the body
* that got worse during or after treatment that included trastuzumab

The study will enroll about 80 participants. Sites will be in North America and the European Union.


Eligibility Criteria:
Inclusion Criteria:

* Men or women ≥18 years old (local regulatory guidelines apply)
* Has pathologically documented HER2-positive gastric or GEJ cancer that is unresectable or metastatic, and that progressed during or after treatment regimen containing trastuzumab
* Has at least one measurable lesion per RECIST v1.1, as confirmed by investigator review
* If of reproductive potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and 4 months for males after the last dose of study drug

Exclusion Criteria:

* Has had anticancer therapy after first-line treatment regimen containing trastuzumab
* Has uncontrolled cardiovascular disease, including any of the following: history of myocardial infarction (MI) within 6 months of first dose or symptomatic congestive heart failure (New York Heart Association Class II to IV), troponin levels consistent with MI as defined according to the manufacturer within 28 days of first dose, or corrected QT interval (QTc) prolongation to \>470 ms (females) or \>450 ms (male) based on screening triplicate 12-lead electrocardiogram (ECG)
* Has history of non-infectious interstitial lung disease (ILD)/pneumonitis that required corticosteroid therapy, or current ILD/pneumonitis that cannot be ruled out at screening
* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the first dose, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, pleural effusion, etc.), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjogren's, sarcoidosis, etc.), or prior pneumonectomy.
* Has pleural effusion, ascites, or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART)
* Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms (Note: participants with clinically inactive brain metastases may be included in the study as well as participants with treated brain metastases who are no longer symptomatic and no longer require treatment with corticosteroids or anticonvulsants.
Safety and Efficacy of the External Synchronized Vein Valve (ESVV) in Treatment of Chronic Venous Insufficiency (CVI)

The External Synchronized Vein Valve (ESVV), is intended for the treatment of Chronic Venous Insufficiency (CVI), incorporates an external apparatus that is aimed to replace the one-way venous valve and a sensor that identifies the movement of the calf muscles pump. The external device is located above the failed deep vein and exerts synchronized intermittent regulated pressure on it. Alteration in the vein structure is occurred and the blood flows in the cephalad direction, preventing the return toward the feet. The device is synchronized with the calf muscles pump to function as a one-way venous valve. This study was design in order to assess safety and efficacy of using the ESVV for treatment of consequences of deep chronic venous insufficiency.


Eligibility Criteria:
Inclusion Criteria:

* Males and females age 18 and up.
* Patient is diagnosed to have deep chronic venous insufficiency (CVI) proved by recent duplex examination.
* Patient able to comprehend and give informed consent for participation in this study.
* Patient must commit to both screening and treatment visits.
* Patient must sign the Informed Consent Form.

Exclusion Criteria:

* Acute deep vein thrombosis.
* Chronic deep vein obstruction.
* Peripheral arterial occlusive disease.
* Ankle edema that is not caused by chronic venous insufficiency
* Partial or complete immobility.
* Pregnancy.
* Known cognitive disorder.
* Drug abuse.
* Patient objects to the study protocol.
* Concurrent participation in any other clinical study.
Development of Health Management Model for Chinese Medical Preventive Medicine

The purpose of this project is to design a health management model of TCM preventive medicine that meets the need of healthy or suboptimal healthy people. This project will try to practice "Health management model of TCM preventive medicine" together with health promotion groups related to Taiwan Society of Health Promotion in the district of Shilin and Zhongzheng in Taipei city, and plan to recruit 100 people.

With regard to "Developing traditional Chinese medicine (TCM) Health Care", the goal of "Promoting the development of TCM health promotion service" was set and the strategy of "Promoting the development of TCM preventive medicine and health promotion services" was used to develop TCM preventive medicine, which is applied to preventing disease and improving physical fitness. By establishing the TCM health care prototype of "health promotion" and "preventive medicine," this project will push the systemic development of TCM preventive medicine forward and improve suboptimal health by early intervention, providing people with multiple model choices in self-health management.

This project will first form a multidisciplinary team to gather and analyze the domestic and international health promotion and management models of TCM or traditional medicine. Then systematically arrange and induct the literature references to establish the outline and draft of "Health management model of TCM preventive medicine." Furthermore, in July-September, this project will try to practice "Health management model of TCM preventive medicine" together with health promotion groups related to Taiwan Society of Health Promotion in the district of Shilin and Zhongzheng in Taipei city, and plan to recruit 100 people. The purpose of this project is to design a health management model of TCM preventive medicine that meets the need of healthy or suboptimal healthy people. The investigators expecte to bring out the prototype of "Health management model of TCM preventive medicine" and finish the follow-up promoting proposal of the draft in the meantime, which will discuss the possibility of applying this model to healthy or suboptimal healthy people and bring up concrete policy and implementation recommendations of "promoting the development of TCM preventive medicine and health promotion services."

Eligibility Criteria:
Inclusion Criteria:

* more than 20 y/o.
* can walk independently, without disability
* can communicate with Chinese or Taiwanese, and understand the purpose of the study

Exclusion Criteria:

* None
Fibroblast Growth Factor 23 and Sclerostin in Relation to Calcium in COVID-19 Patients

Hypocalcemia is associated with COVID-19 patients and is linked to poor prognosis, Fibroblast growth factor 23 (FGF23) and Sclerostin inhibit vitamin D activation and are linked to hypocalcemia.

Levels of FGF23 and Sclerostin in COVID-19 patients will be detected and correlated to calcium levels.

COVID 19 is a current worldwide pandemic caused by severe acute respiratory syndrome coronavirus 2 "SARS-CoV-2". Hypovitaminosis D and hypocalcaemia have been reported to be associated with COVID 19 infection, they are considered good biomarkers of clinical severity of COVID 19. Poor prognosis related to hypocalcemia is increased in elderly patients.

Fibroblast growth factor 23 and sclerostin are secreted from the bone, they decrease active vitamin D levels. Their levels and their relation to calcium levels in COVID-19 patients will be detected.

Eligibility Criteria:
Inclusion Criteria:

* Positive COVID 19 (Mild to moderate - severe to critical).

Exclusion Criteria:

* known diagnosis of CKD.
* Known parathyroid disease.
* Use of phosphate binder therapy within the past 3 months.
* Use of calcium therapy within the past 3 months
* Treatment with 25(OH) vitamin D or 1,25 (OH)(2) D
* Underlying metabolic bone disease.
* Underlying renal phosphate wasting disorder.
Remote Time-restricted EAting DeliverY

This study will evaluate the implementation and effectiveness of free-living TRE on biological and behavioural breast cancer risk factors.

TRE is an eating pattern where individuals consume ad libitum energy intake within a set window of time, commonly 8 hours, which induces a fasting window of 16 hours per day (i.e., 16:8 TRE). TRE is a simple and accessible lifestyle intervention with high adherence potential that may target both biological and behavioural mechanisms of breast cancer risk.

Eligibility Criteria:
Inclusion Criteria:

* Females
* No cancer history
* ≥50 years old
* Have metabolic dysfunction (defined as self-reported diagnosis of pre-diabetes, type 2 diabetes, or at least moderate Canadian diabetes risk (CANRISK) score)
* Access to an Ontario Lifelabs location
* Owns a smartphone with Bluetooth capability with Apple or Android operating system

Exclusion Criteria:

* Type 1 diabetes
* Taking exogenous insulin, sulfonylureas, or GLP-1 receptor agonists
* Self-reported history of an eating disorder
* BMI \<18.5 kg/m
* Working night or rotating shifts
* Eating window \<12 hours or consistently eating less than 3 meals/day in the past 3 months
* Major dietary changes within the past 3 months (i.e. calorie counting, ketogenic diet)
A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis

The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.

Ulcerative Colitis (UC) is a disorder involving the lining of the colon. A substance called "tumor necrosis factor" (TNF) naturally occurs in the body. TNF is thought to play an important role in the development of ulcerative colitis by causing some of the damage that is seen in the colon. "Antibodies" are normally made in the body and help fight off infection. Infliximab is an antibody that is made in a scientific laboratory, using parts of both mouse and human antibodies. It has been designed to attach to TNF, making it difficult for TNF to do any damage. This study will be done at centers in North America and Europe. Each child will first have a clinic visit (screening visit) to have some tests done to make sure the child is the type of patient who should be in this study. At the 2nd visit (week 0), the child will have the first treatment with infliximab. All children in the study will receive 5 mg/kg infliximab 3 times (at weeks 0, 2 and 6) over the first 6 weeks of the study. If the child's symptoms do not improve by the 8th week, the child will receive no further infusions, but will return for safety evaluations. If the child's symptoms do improve, the child will be randomly assigned (like the flip of a coin) to either 5 mg/kg infliximab every 8 weeks through week 46 or 5 mg/kg infliximab every 12 weeks through week 42. If the child gets worse after being randomly assigned, the amount of infliximab may be increased or the infliximab may be given more frequently. A final infusion will be given at either week 42 or week 46. There will be a safety evaluation at week 54 and a visit at week 62 to get a blood sample. Patients will receive 5 mg/kg of infliximab at weeks 0, 2 and 6 and then 5mg/kg infliximab either every 8 weeks or 12 weeks until weeks 42 or 46. Infliximab is given as an intravenous infusion over 2 hours.

Eligibility Criteria:
Inclusion Criteria:

* Have moderately to severely active ulcerative colitis
* Diagnosed with ulcerative colitis for 2 weeks before screening
* Male patients who are sexually active and female patients who are sexually active or of childbearing potential must use adequate birth control while participation in the study and for 6 months after the last infusion.

Exclusion Criteria:

* History of latent or active TB
* Have had a live viral or bacterial vaccination within 3 months before screening
* Have or have had serious infections within 3 months before screening
* Prior treatment with infliximab
AGED Diagnostics Liver Disease Assessment

Continue development of previously established methods to further validate candidate biomarkers that can discriminate steatosis from NASH and separately stage fibrosis from blood. The first assessment is to conduct test method verification to expand sample size to several hundred samples through whole genome sequencing methods. The second assessment is focused on biomarker validation by comparing targeted sequencing from patient plasma. Several sub- assessments will be conducted to support overall biomarker development efforts.

Aim 1: Test Method Verification, Whole genome bisulfite sequencing assessment for liver tissue and plasma Conduct whole genome bisulfite sequencing in patient liver tissue and patient plasma to identified candidate biomarkers that can discriminate between steatosis and NASH, and separately conduct a comparative analysis of patient liver tissue and patient plasma samples to assess NASH encompassing NASH with mild fibrosis, NASH with significant fibrosis and NASH with advanced fibrosis. The purpose of each is to identify a set of markers that have biological relevance on the liver and then identify epigenetic biomarkers in plasma derived from liver tissue. Note: both a subset of NASH specific biomarkers and fibrosis specific biomarkers have been previously reported for technical feasibility.

Aim 2: Biomarker Validation, Targeted Epigenetic Sequencing Assessment Select top NASH specific biomarkers and top fibrosis specific biomarkers and design, develop and test probes to assess overall performance of each candidate biomarker in plasma. Conduct comparative analysis between various targeted sequencing and PCR based modalities. Candidate biomarker performance will be evaluated based on sensitivity, specificity, AUROC and reproducibility, among several other assessments.

Eligibility Criteria:
Inclusion Criteria:

* Participant with liver biopsy over the past 1-2 years are permissible for study inclusion.
* Participant is considered to be a "Healthy Subject" relative to any form of liver disease OR
* Participant is suspected of having one of the following diagnoses: metabolic syndrome, NAFLD, fibrosis/cirrhosis, cardiovascular disease, chronic kidney disease.

Exclusion Criteria:

* Participant is known to have HIV, Hepatitis B or Hepatitis C
* Participant has any other known form of chronic liver disease (aside from NAFLD/liver fibrosis)
* Participant has excess alcohol intake, excess alcohol is defined as participants that exceed an average 20g of alcohol daily for females (140g weekly intake) and average 30g of alcohol daily for males (210g weekly intake)
* Participant has had a bone marrow transplant at any time
* Participant is on anti-coagulation or anti-platelet therapy
* Participant is known to be pregnant
* Participant is unable to provide informed consent