cyrilzakka/clinical-trials huggingface dataset:
A Study to Test the Effects of BMS-986036 on the Body in Healthy Japanese and Non-Japanese Subjects

The purpose of this study is to evaluate safety, and tolerability of BMS-986036 and the effects the drug has on the body


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
* Body mass index (BMI) of 25 to 40 kilogram / square meter (kg/m2), inclusive
* Additional criterion for Japanese subjects: Subjects must be first generation Japanese (born in Japan and not living outside of Japan for \> 10 years, and both parents are ethnically Japanese)

Exclusion Criteria

* Presence of any factors that would predispose the subject to infection (extensive periodontal disease that warrants surgical or medical treatment, unhealed open wounds)
* Any bone trauma (fracture) or bone surgery (hardware placement, joint replacement, bone grafting, or amputation) within 3 months of study drug administration
* Known or suspected autoimmune disorder, excluding vitiligo

Other protocol defined inclusion/exclusion criteria could apply
Eosinophilic Esophagitis Databank

This study will establish a registry for participants with eosinophilic esophagitis (EoE) and create a research resource that will provide further insights into EoE.

Eosinophilic esophagitis (EoE) is a newly recognized chronic disease that is increasingly being diagnosed in children and adults. Many patients with EoE also have food allergies. EoE is characterized by inflammation and accumulation of a specific type of immune cell, called an eosinophil, in the esophagus. While there have been several large studies of EoE, very few have focused on the roles the immune system, genetics/heredity, and the environment in EoE.

The samples and information collected from participants will help to identify and understand the genetic mechanisms underlying eosinophilic esophagitis.

The Cincinnati Children's Hospital Medical Center will serve as the Central Laboratory for genetic characterization studies.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent/assent from participant and consent from parent/guardian for minors with agreement for genetic testing;
* Documented diagnosis of EoE at any time confirmed by study team (pathology report describing greater than or equal to 15 eosinophils/hpf in peak field of an esophageal biopsy. Participants with eosinophilia in extra-esophageal tissue are permitted).

Exclusion Criteria:

* Participants with known infectious causes of esophageal eosinophilia such as esophageal fungus, gastric H. pylori, or systemic parasites;
* Participants with a history of persistent eosinophilia greater than 1500 cells/mcl of blood.
The Effect of Education Given to Nursing Students on Their Environmental Attitudes: A Randomized Controlled Study

This study is conducted to examine the effect of climate change and global warming-based education given to nursing students on their environmental attitudes. The research was planned as a randomized controlled experimental. According to the posthoc power analysis, it was determined that the type one error amount was 0.05 with a medium effect size and the power of the study was 94% when 110 participants were taken. The data were included from the 2nd, 3rd and 4th grades of a nursing faculty in eastern Turkey. Assignments were made to experimental and control groups by randomization. Personal information form and environmental attitude scale were used to collect data.

Climate change and global warming are a global public health problem. This situation, which affects all masses, also deeply affects human life. Future nurses need to have high awareness of this situation and educate and inform the society about this situation. Nurse students' environmental attitudes, knowledge and behavior towards the environment need to be increased. The aim of this research is to determine the effect of global warming and climate change-based education given to nursing students on their environmental attitudes.The research was planned as a randomized controlled experimental. According to the posthoc power analysis, it was determined that the type one error amount was 0.05 with a medium effect size and the power of the study was 94% when 110 participants were taken. The data were included from the 2nd, 3rd and 4th grades of a nursing faculty in eastern Turkey. Assignments were made to experimental and control groups by randomization. Personal information form and environmental attitude scale were used to collect data.

Eligibility Criteria:
Inclusion Criteria:

* volunteering to participate in research
* have verbal communication skills

Exclusion Criteria:

-
Parent Therapist Partnership to Provide Early, Intensive Exercise in Perinatal Stroke

A prospective, single blind, parallel group, randomized control trial to determine if early, intensive lower extremity activity delivered by a physical therapist and a parent in partnership improves gross motor function more than usual care.

A mixed-methods randomized controlled trial at 3 healthcare centres: Edmonton, Calgary and Ottawa. The period of participation for each child is 12 months. The Immediate Group will have 3 months of intervention and 9 months follow-up. The Delay Group will be followed for 6 months (waitlist-control period), then given the opportunity to receive the same intervention and followed for 3 months after the intervention.

The intervention will be delivered by clinicians in the rehabilitation centres in partnership with the child's parents. Therapists will provide training 2 days a week and will coach the parents to provide the training at home for 2 days a week.

The intervention is ELEVATE (Engaging the Lower Extremity Via Active Therapy Early) and consists of child-initiated, intensive leg activities for one hour a day, four days a week for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* children ages 8 months to 3 years
* medical history and physical exam consistent with perinatal stroke
* hemiparesis in the upper and/or lower extremity
* parental agreement to adhere to the training and testing schedule

Exclusion Criteria:

* bilateral motor impairment
* epileptic seizures that could interfere with training
* cognitive, behavioural or developmental impairments that preclude participation in the protocol
* botulinum toxin A injections or surgery in the lower extremities within the previous six months
* concurrent casting during the intervention phase (including constraint-induced movement therapy with casting)
* diagnosis associated with neurological/developmental regression
* parent unable to communicate (verbal and written) in English or French
Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population

Single-site non-significant risk, open-label clinical investigation designed to validate the usability, adherence, and preliminary diagnostic performance of a novel technology to detect neutropenia. Study participants will be managed as per the standard of care practice with a baseline and nadir visit including laboratory determinations. Participants will also be evaluated with the device at both time points and with daily measurements during the two-week period in between.


Eligibility Criteria:
Inclusion Criteria

1. Study subjects, or their parent/legal guardian for subjects \<18 years, must be able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. Subjects between the ages of 7 and 17.9 years must provide assent.
2. Male or Female aged 7 years to 65 years.
3. Adults (\> 18 years) diagnosed Diagnosed with Hodgkin/Non-Hodgkin Lymphoma or breast cancer.
4. Children and adolescents (7 - 18 years) with liquid or solid tumors.
5. Scheduled treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia (table 1) 30.
6. Able (in the investigator's opinion) and willing to comply with all study requirements.

Exclusion Criteria

1. Participants with amputations, congenital malformations, or any severe abnormalities of the hands as determined by the investigator.
2. Participants with a history of vasculitis, Raynaud syndrome, scleroderma, mixed connective tissue disease, or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold.
3. Participants with circulating tumor cells in previous or current lab determinations.
4. Adult (\>18 years) participants with leukemia of all types and pediatric (7-18 years) participants with leukemia that are either not in remission or in the minimal residual disease category.
5. Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).
6. Unstable participants (pediatric or adults) or adult participants with hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg).
7. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
8. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.
Stereotactic Body Radiation Therapy (SBRT) for Prostate Cancer

The purpose of this study is to evaluate a short course (five radiation treatments) of very focused ("stereotactic") external beam radiation therapy for the treatment of early stage prostate cancer.

External beam radiation therapy for prostate cancer, while effective, takes up to 9 weeks to deliver on a Monday through Friday basis. Recent phase I/II studies from Seattle and Palo Alto using stereotactic guidance to deliver high doses of radiation to the prostate over a 1 to 2 week period of time suggest that outcomes may be equal or superior to standard approaches. These data, combined with markedly improved convenience for patients, make radiosurgery (SBRT) for early-stage prostate cancer an enticing option. The goal of this study is to offer a radiosurgical option to patients within the Sharp system under the umbrella of an IRB-approved study.

Eligibility Criteria:
Inclusion Criteria:

* Male with any age (typically 50 to 70 years old) with a low risk disease. This is defined as a Gleason's score of 6 or less, clinical stage of T2a or less, and a PSA of less than 15. We will also include patients with Gleason's score of 3+4=7 if there are fewer than 2 cores positive, with no more than 5mm of tumor in aggregate dimension.

Exclusion Criteria:

* Prior surgery or radiotherapy for prostate cancer, PSA over 10, Gleason scores 7, 8, 9, or 10 (except Gleason 7 as noted, above), or clinical stage T2b, T2c, T3, or T4.
A Study Comparing Geriatric Co-Management With Geriatric Guided Supportive Care in Older Patients Receiving Chemoradiation Therapy for Their Head and Neck Cancer

The researchers are doing this study to see whether geriatric co-management or geriatric guided supportive care are good approaches for managing side effects in older patients who have head and neck cancer and are receiving chemoradiation therapy. This study will provide valuable information about different ways to manage side effects in older patients receiving chemoradiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65
* Pathologically (histologically or cytologically) diagnosis of head and neck cancer of oral cavity, oropharynx, larynx, or hypopharynx
* Patient will receive a 6 to 7 week course of intensity modulated radiation therapy and concurrent chemotherapy either in definitive or post-operative setting
* Able to read and understand English
* Able to provide informed consent

Exclusion Criteria:

* Patients who have previously consulted with or are followed by a geriatrician
* Inability to use telemedicine if unable to present to clinic visits in person
* Inability to complete the eRFA (patient is unable to comprehend or answer questions included on the eRFA)
* Treatment with proton therapy
* Patients on therapeutic clinical trials of experimental therapies or those not receiving standard of care
Evaluation of Postoperative Cognitive Function, Anxiety, Depression and Quality of Life in Patients With Unruptured Intracranial Aneurysms

This prospective single-center cohort study aims to identify the incidence of cognitive dysfunction after unruptured aneurysm operation and explore the influencing factors. The primary end point is the cognitive dysfunction at 6 months after operation.The features of cognitive function, mental status, neurological function recovery, and quality of life of patients with unruptured intracranial aneurysms at different time points would be analyzed.

This main topics is to identify and screen the patients with unruptured aneurysm who likely to suffer from cognitive dysfunction. All examinations were administered by a trained neuropsychologist.The assessment of cognitive function and mental state would be performed before operation and 6 months after operation, with the use of Montreal Cognitive Assessment Scale (MoCA) for the cognitive function, the Hamilton Anxiety Scale (HAMA) and the Hamilton Depression Scale (HDMA) tests for the mental state. The Cognitive dysfunction at 6 months after operation would be the primary end point, and the underlying factors responsible for the declined cognitive function would be analyze. The assessment of neurological function and quality of life would be performed before operation,3 months after operation and 6 months after operation, with the use of the Modified Rankin Scale(mRS) and the Functional Activities Questionnaire(FAQ) for the neurological function, the Richards-Campbell Sleep Questionnaire(RCSQ) and the 36-item short from health survey(SF-36) tests for the quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. At least one imaging (CTA / MRI / DSA) study to confirm unruptured intracranial aneurysms for the patients who would undergo surgical treatment for the first time.;
2. Patients who live independent with minimal care support, mRS score ≤3 points;
3. Age \> 14 years old;
4. Han ethnicity, Right handed, can complete the test;
5. Patient or family agrees to sign informed consent.

Exclusion Criteria:

1. Other cerebrovascular diseases，such as ischemic stroke, arteriovenous malformation, etc;
2. With an unexplained subarachnoid hemorrhage;
3. History of Neurological disease surgery;
4. Previous psychiatric and dementia history that cannot communicate with other people;
5. Patients who refused to follow up.
Conversational Artificial Intelligence (AI) to Improve PeRiconception Care Access

The goal of this project, Conversational Artificial Intelligence (AI) to Improve PeRiconception Care Access (CIRCA), is to engage patients in care early in pregnancy (before prenatal care starts) and safely triage concerns to PEACE to reduce unnecessary emergency department visits.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant
* Seeking to establish care at the Hospital of the University of Pennsylvania OR seeking care in the Emergency Department or Perinatal Evaluation Center.
Efficacy and Safety of a New Polypectomy Snare for Cold-polypectomy for Small Colorectal Polyps

Colorectal cancer is a major cause of morbidity and mortality in Western countries. Scientific studies have shown that endoscopic polypectomy is efficacious in preventing CRC incidence and mortality.

Endoscopic polypectomy carries a risk of major complications, such as bleeding or bowel perforation, so that a careful balance between efficacy and safety appears to be clinically relevant.

Most of the polypectomies are performed for diminutive (\<5 mm) or small (6-9 mm) lesions, which represent over 90% of all the polyps.

To minimize the risk of complications when removing \<10 mm polyps, cold-polypectomy techniques - i.e. without electric current - by means of biopsy forceps or snare, have been proposed.

Although the risk of perforation is virtually excluded by cold-polypectomy, the lack of electrocautery may result in an increased risk of bleeding. The safety of cold-snare polypectomy has however been recently shown in controlled trials.

Regarding the efficacy of cold-polypectomy for subcentimetric polyps, very few studies have assessed the post-polypectomy completeness of the removal of polyp tissue (i.e. residual disease), and no studies have compared it to conventional polypectomy.

The investigators perform this study to assess both the efficacy and safety of a novel snare (Exacto™) for polyp removal.


Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients undergoing colonoscopy, with at least one and no more than 5 polyps \<10 mm.
* The patient is at satisfactory risk to undergo abdominal surgery.
* The patient must understand and provide written consent for the procedure.

Exclusion Criteria:

* Patients with inflammatory bowel disease.
* Patients undergoing standard snare resection (with cautery) of polyps larger than 10 mm.
* Patients with a personal history of polyposis syndrome.
* Patients with suspected chronic stricture potentially precluding complete colonoscopy.
* Patients with diverticulitis or toxic megacolon.
* Patients with a history of radiation therapy to abdomen or pelvis.
* Patients with a history of severe cardiovascular, pulmonary, liver or renal disease.
* Personal history of coagulation disorders or use of anticoagulants/clopidogrel/aspirin/ticlopidine.
* Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Hetrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia

The purpose of this study is to investigate the efficacy, safety of Hetrombopag in children with previously treated chronic immune thrombocytopenia who are between 6 and 17 years of age. This is a 2 part study. In part A, patients will receive Hetrombopag for 8 weeks. In part B, all patients will receive Hetrombopag for 24 weeks.

This is a two-part, double-blind, randomized, placebo-controlled, and open-label Phase III study to investigate the efficacy, safety of Hetrombopag in pediatric patients with previously treated chronic ITP. In Part A, patients will receive Hetrombopag for 8 weeks. After completing Part A, patients will begin Part B, in which they will be randomized to receive Hetrombopag or placebo in a 12 week double-blind, placebo-controlled treatment period, following an open-label 12 week treatment period.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 6 years old and ≤ 17 years old,both sexes.
2. Part A:Confirmed diagnosis of ITP ≥6months; Part B: Confirmed diagnosis of ITP ≥12months;Platelets \<30×10\^9/L twice in a row,and platelets \<30×10\^9/L before taking the medicine.
3. Subjects who are refractory or have relapsed after at least one prior ITP therapy.
4. Birth control during and 28 days after the trial.
5. Written informed consent must be obtained from the patient's guardian and accompanying informed assent from the patient (for children over 8 years old).

Exclusion Criteria:

1. No evidence of other causes of thrombocytopenia.
2. Diagnosis as Evans or Wiskott-Aldrich comprehensive.
3. Patients with any prior history of arterial or venous thrombosis, or diagnosis as thrombophilia.
4. Suffering from serious, progressive, uncontrolled kidney, liver, gastrointestinal, endocrine, lung, heart, nervous system, brain, or mental illness.
5. ALT, AST, or ALP\> 1.5 x upper limit of normal (ULN), DBLI, or Scr \> 1.2 x upper limit of normal (ULN).
6. Active HIV or HCV-Ab positive,HBsAg positive.
7. PT result exceeds normal by more than ±3s, APTT result exceeds normal by more than ±10s
8. Participated in clinical trials of other drugs (received experimental drugs) within 3 months prior to medication.
9. The inestigators determined that other conditions were inappropriate for participation in this clinical trial.
To Evaluate the Efficacy of Eleutherococcus Senticosus for Subjects Under Renal Dialysis

This is a randomized, double-blind, placebo-controlled, parallel comparison trial to evaluate the efficacy and safety of Eleutherococcus Senticosus taken orally by patients under regular dialysis. Eligible subjects with written consent were randomized into one of the two groups: A. Acanthopanax senticosus (30mg/vial); B. Placebo. After 2-4 weeks of run-in period, the study subjects were asked to take the investigational products orally for 90 days in order to evaluate the effects of oral Eleutherococcus Senticosus liquid on the markers of inflammation, anemia, and safety, and to compare the efficacy among oral Acanthopanax senticosus and placebo.


Eligibility Criteria:
Inclusion Criteria:

* Under regular dialysis for at least 3 months
* Hemoglobin (Hb) \<11 g/L after regular Erythropoietin (EPO) treatment
* Subjects with written informed consent form

Exclusion Criteria:

* Use of steroid or high dose of antiplatelet drug (e.g. Aspirin \>300mg) within one month
* Had surgery, myocardial infarction, or tumor within 12 weeks
* Currently use of antibiotic treatment for acute infection
* Pregnant women
* Reticulocyte\>40 x 10\^9
* Anemia (ferritin \<100ng/mL and Transferrin Saturation (TSAT) \<20%)
* Urea reduction ratio \<65% or single pool Kt/V \< 1.0 (hemodialysis patients) or total weekly Kt/V\<1.7 (peritoneal dialysis patients)
* Sudden change of eating habit within one month
* Expected life less than six months or with unstable medical conditions
* Known history of allergic reaction to the investigational products
* With acute diseases and judged by the investigator to be ineligible to participate
* Received melatonin, androgen therapy or blood transfusion within two months
* Received any trial medications within 30 days
Measurement of Patient Reported Outcomes in Renal Transplant Patients With And Without Gastrointestinal (GI) Symptoms

This study will access the GI complaints on patients reported outcomes and to determine the improvement in quality of life in patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient received kidney transplant at least 1 month prior to study with MMF as a part of the treatment for at least 2 weeks.
* Eligible to convert to myfortic because of GI complaints or not currently experiencing GI complaints and stable on current immunosuppressive regimen.
* At least 18 years of age;
* Willing to provide written informed consent; and
* Able to meet all study requirements including completing paper questionnaires and completing two study visits.

Exclusion Criteria:

* GI symptoms assumed or known not be caused by MPA therapy and have recent acute rejection at least 1 week prior to the study.
* Breast-feeding or pregnant woman.
* Patients with psychiatric illness.
* Underlying acute medical intervention or hospitalization
* Receiving investigational drug within 30days prior to study.