cyrilzakka/clinical-trials huggingface dataset:
A Single Ascending Dose Clinical Trial to Find the Maximum Tolerable Dose of HL237 in Healthy Male Subject

HL237 is a new autoimmune therapeutic agent for rheumatoid arthritis, including the basic structure of biguanide in metformin, an existing diabetes drug.

The immune modulating activity of HL237 was demonstrated in animal model. HL237 is a STAT3 inhibitor and STAT3 is well known for an important regulator inhibiting Th17 cells and activating Treg cells.

Therefore, when STAT3 activity is inhibited, it is expected to be able to treat autoimmune diseases such as rheumatoid arthritis.

This is the first clinical trial to be conducted for the development of HL237 and this clinical trial is for determining the maximum oral dose of HL237 and assessing safety, tolerability, and pharmacokinetic characteristics for each dose group.


Eligibility Criteria:
Inclusion Criteria:

* A healthy adult male aged 20 years or older and 45 years old at the time of the screening test
* Those who weigh more than 55kg but weigh less than ± 20% of ideal body weight
* Proper contraception during the clinical trial period
* After hearing the detailed explanation of the clinical trial, those who decide to participate voluntarily and write agreement

Exclusion Criteria:

* Clinically significant, a person with a history of neurological, psychiatric, malignant, cardiovascular, respiratory, kidney, endocrine, hematologic, digestive or central disease
* a person with a history of gastrointestinal disorders that may affect the absorption of pharmaceuticals for clinical trials (Crohn's disease, ulcers, etc.) or gastrointestinal surgery (except for simple cecal surgery or hernia surgery)
* a person with a history of hypersensitivity or clinically significant hypersensitivity to the clinical trial drug or additives
* a person judged to be inappropriate for the subject by health screening (history of disease, physical examination, vital signs, electrocardiogram, laboratory test, etc.)
Physical Fitness in Autism

Although there are some studies investigating the physical activity levels of children with autism in the literature, no comprehensive study investigating the relationship between posture and physical fitness parameters, family anxiety level and quality of life of individuals with autism who have continued physical activity program has not been found. The aim of our study is to compare postural disorders and physical fitness parameters, family anxiety level and quality of life between individuals with autism and healthy individuals attending physical activity program.


Eligibility Criteria:
Inclusion Criteria:

1. Being diagnosed with mild to moderate autism,
2. To have the ability to emulate,
3. To have a cognitive level and cooperation capacity that will not hinder the implementation of assessment scales,

Exclusion Criteria:

1. Having any systemic chronic disease and neurological disorder
2. During the last 6 months, individuals wih autism in the process will affect physical fitness for fracture, surgery and so on.
Case Volume and Adenoma Rate During Screening Colonoscopy

Screening colonoscopy has been established as the most effective means of colorectal cancer prevention. This is based on the fact that colonoscopy detects and removes colonic polyps (adenomas) which are known to progress to cancer if left untreated. The present study examines the question whether case volume (i.e., the number of colonoscopies performed per year) correlates with colonoscopy quality, i.e., adenoma detection rate.

21 private practice gastroenterologist endoscopists from Berlin performed a prospective quality assessment study including at least 10.000 screening colonoscopies. After informed consent, patients data are included (age, sex, family history, colonoscopy performance parameters and findings, therapy performed, histology of biopsies and/or polypectomies, complications (immediate and late) and patient acceptance. The latter was retrieved by patient questionnaires returned after a minimum of 2 weeks. Data were centrally collected in an anonymized way

Primary outcome parameter:

* Correlation of adenoma detection rate with case volume and other confounding factors (e.g., withdrawal time)

Secondary outcome parameters:

* Complications and method of assessment (immediate recording versus later questionnaire enquiry)
* Quality of bowel preparation in relation to outcome Patient acceptance in relation to procedural factors (e.g., sedation)
* Quality of pathology reports and histologic outcome of polypectomy

Later follow-up (after 5-10 years) of the preventive effect of colonoscopy is planned and has been part of the protocol and patient consent form.

Eligibility Criteria:
Inclusion Criteria:

* all persons willing and able to undergo screening colonoscopy over the age of 55 years

Exclusion Criteria:

* any condition not compatible with the definition of screening colonoscopy
Pregabalin In Partial Seizures (PREPS): An Open-Label, Multicenter Add On Therapy Trial

The purpose of this study is to assess the clinical improvement by partial seizures reduction, safety and tolerability of subjects having partial epilepsy related to the adjunction of pregabalin BID (75 to 300mg day titration, BID) to existing standard AED (Antiepileptic drugs).

This study was terminated on 17 March 2009 due to delayed enrollment. The decision to terminate the trial was not based on any safety concerns, but rather on timelines and the difficulty in enrolling patients in this open label, single group study.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female who are diagnosed of partial seizure (simple partial, complex partial, partial seizure secondarily generalized) as defined in the international league of epilepsy classification of seizure.

Exclusion Criteria:

* Patients having a treatable cause of seizure, currently receiving vigabatrin, having a progressive neurological or systemic disorder.
Effects of Renal Transplantation on Uraemic Cardiomyopathy

Chronic kidney disease (CKD) is associated with a high risk of death and morbidity due to cardiovascular disease. Much of this is caused by left ventricular disease characterised by abnormal muscle thickness and scaring. This process appears to start early in the course of CKD and causes heart failure and dangerous abnormal heart rhythms. Previous work suggests that the process may be reversible by kidney transplantation but almost all of the studies are small, retrospective and lack scientific rigour. Furthermore, they almost all use echocardiography, which is inaccurate in patients with CKD. The investigators plan to perform the first large, prospective, controlled, blind-analysed study using cardiac magnetic resonance imaging to determine whether CKD associated cardiomyopathy is reversed by kidney transplantation and if so, whether factors such as blood pressure and mediators of metabolic bone disease/fibrosis are important in effecting this change. Greater understanding of the mechanisms responsible for CKD associated cardiomyopathy could lead to future strategies and treatments to improve the high cardiovascular mortality associated with this condition.


Eligibility Criteria:
Inclusion Criteria:

1. Patients registered on the kidney transplant waiting list at the University Hospital Birmingham NHS Foundation Trust.
2. Ages over 18 years

Exclusion Criteria

1. Non-standard anti-rejection treatment, post transplant.
2. Previous history of being unable to tolerate MRI scanner.
3. Contraindication to MRI - eg metal fragments in ey
Body Composition of Infants: Follow-up to Placenta and Cord Blood Analyses

Investigators will characterize the body composition and metabolism of infants born from lean, overweight or obese mothers from whom they had previously obtained a placenta and/or cord blood as part of the earlier placenta and cord blood study (#111576)


Eligibility Criteria:
Inclusion Criteria:

* mother's prior participation in study #111576 with successful collection of placenta
* infant age 12 months (+/- 9 months)

Exclusion Criteria:

* mother did not participate in study #111576
* mother did participate in study #111576, but collection of placenta was not successful
* infant not age 12 months (+/- 9 months)
A Study of Subcutaneous Lecanemab in Healthy Participants

The primary purpose of this study is to determine the absolute bioavailability and pharmacokinetic (PK) profile of a single dose of lecanemab when administered subcutaneously (SC) in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

Participants must meet all of the following criteria to be included in this study:

1. Non-smoking, male or female, age greater than or equal to (\>=) 18 years and less than or equal to (\<=) 65 years old at the time of informed consent. To be considered non-smokers, participants must have discontinued smoking for at least 4 weeks before dosing.
2. Japanese participants (age \>=20 years) must have been born in Japan of Japanese parents and Japanese grandparents, must have lived no more than 5 years outside of Japan, and must not have changed their lifestyle or habits, including diet, while living outside of Japan.
3. Body Mass Index (BMI) \>=18 and less than (\<) 30 kilogram per square meter (kg/m\^2) at screening.

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from this study:

1. Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing.
2. Evidence of disease that may influence the outcome of the study within 4 weeks before dosing; example, psychiatric disorders and disorders of the gastrointestinal tract, liver, kidney, respiratory system, endocrine system, hematological system, neurological system, or cardiovascular system, or subjects who have a congenital abnormality in metabolism
3. Exposure within the last 14 days before dosing to an individual with confirmed or probable corona virus disease-2019 (COVID-19) or symptoms within the last 14 days that are on the most recent Centers for Disease Control and Prevention list of COVID symptoms or any other reason to consider the participant at potential risk for COVID-19 infection
4. Participants who had received COVID vaccine but are not 14 days post full vaccination before dosing
5. Currently enrolled in another clinical study or used any investigational drug or device within 28 days or 5 half-lives of the other investigational drug, whichever is longer, preceding informed consent
6. Prior exposure to lecanemab
7. Hypersensitivity to lecanemab or any of the excipients, or to any monoclonal antibody treatment

NOTE-Other protocol defined Inclusion/Exclusion criteria may apply.
Efficacy and Safety of 'Immuncell-LC Group' and 'Non-treatment Group' in Nexavar Treated Patients for Advanced HCC

"Immuncell-LC" in aspects of therapeutic efficacy and safety when administered with Nexavar to advanced Hepatocellular carcinoma patients when compared with the control group who did not receive administration of the drug.

* primary outcome Compare clinical efficacy of group treated with cell therapeutic Immuncell-LC evaluated by progression free survival with that of untreated group
* secondary outcome compare clinical efficacy of group treated with Immuncell-LC, a drug for treating advanced hepatocellular carcinoma evaluated by overall survival, disease control rate, changes of Alpha Feto Protein(AFP) figures from baseline to the last observation date and that of untreated group and evaluate adverse reactions, clinical pathological tests and its safety.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have consented to the study by providing signature of self, guardian or legal representative
* The patient is more than 20 and less than 80 years old
* The patient is diagnosed as hepatocellular carcinoma by pathological/radiological test and in the stage of III or IV
* Child-Pugh Score should be A
* ECOG Performance Status (ECOG-PS) is less than 2 or equal to
* Patients who receiving or ready for Nexavar treatment
* Patients who satisfy the following conditions of the blood test and kidney function test

  * Absolute granulocyte count is bigger than 1,000/µL
  * Hemoglobin is bigger than 8.5 g/dL
  * Platelet count is bigger than 5x10\^10/L
  * Blood Urea Nitrogen(BUN) or Creatinine 1.5xupper normal limit

Exclusion Criteria:

* Patients who are immune deficient or have a history of auto-immune diseases (Ex. Rheumatoid Arthritism, Systemic Lupus Erythematosus, Vasculitis, Multiple sclerosis, Adolescent Insulin-Dependent Diabetes Mellitus, etc.)
* Patients who have a history of malignant tumors in the recent 5 years prior to the study with the exception of basal cell carcinoma, local prostate cancer, and cervical cancer, liver cancer.
* Patients who had anti-cancer medication before the study with the exception of Nexavar
* Patients who has serious dysfunction in other organs by sub-investigator's opinion
* Patients has serious allergic-history by sub-investigator's opinion
* Patients has serious mental disease sub-investigator's opinion
* Pregnant women, nursing mother of having intention of being pregnant during the study
* Patients who participated in other clinical trial within 4 weeks before this study
Ambispective Study Evaluating the Clinical Results of SAGITTA EVL R Revision Stems

This clinical study is conducted to collect data on hip arthroplasty with the SAGITTA EVL-R revision femoral stems manufactured by SERF. In order to reflect current practice, a comprehensive and continuous series of patients will be included.

This study will confirm the performance and safety of the SAGITTA EVL R revision femoral stems within the framework of MDR 2017/745 and in relation to the recommendations of the MEDDEV guide 2.7.1. Rev 4 (Clinical Evaluation Guide), which provides for a systematic procedure to monitor clinical data in order to verify the claimed performance of medical devices.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old at the time of surgery,
* Patient implanted with a SAGITTA EVL R revision femoral stem within its indications between 01/01/2016 and 31/12/2018,
* Affiliated to French health insurance system

Exclusion Criteria:

* Patient who has not expressed consent for data collection and participation in the study,
* Patient unable to understand the surgeon's instructions or to perform postoperative follow-up.
* Patient with a contraindication to the use of the SAGITTA EVL R revision femoral stem
* Patient implanted with a SAGITTA EVL R revision femoral stem outside its indication
Examining the Feasibility and Impact of a Clinic-based Food Farmacy and Digital Culinary Medicine Program Among Cancer Survivors Treated in a Safety Net Hospital

The goal of this study is to develop and test the feasibility of a theory-driven digital culinary medicine program among food insecure cancer survivors referred from the University of Texas MD Anderson Cancer Center Oncology Clinic at LBJ to the LBJ Food Farmacy program.

Primary Objective:

Determine the feasibility of study recruitment goal, intervention adherence rate, attrition rate, data completion rate, and program satisfaction rate.

Secondary Objective:

Assess the preliminary efficacy of the digital culinary medicine intervention to improve diet quality, food security, quality of life, and downstream biological indicators of cardiometabolic health from baseline to post-intervention, as well as from baseline to 6 month follow up, among food insecure cancer survivors.

Eligibility Criteria:
Inclusion Criteria:

* Cancer survivors treated at the MD Anderson Oncology Program at LBJ Hospital over 18 years of age.
* Screen positive for food insecurity using the 2 question clinic-screener (Hunger Vital Signs)
* Receive referral to the LBJ Food Farmacy.
* Are within the first 5 years off of acute cancer treatment.
* Self-report having internet access.
* Self-report as being able to speak and read English or Spanish.
* Willing to complete study assessments.

Exclusion Criteria:

* Unwilling or unable to complete study assessments
* Anyone under 18 years of age
* Self-report to not speak or read English or Spanish
Erlotinib in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether erlotinib is more effective than a placebo in treating non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying erlotinib to see how well it works compared to a placebo in treating patients with stage III or stage IV non-small cell lung cancer.

OBJECTIVES:

Primary

* Compare survival of patients with stage IIIB or IV non-small cell lung cancer that is not suitable for first-line chemotherapy treated with erlotinib vs placebo.

Secondary

* Compare progression-free survival and response rate.
* Compare toxicity.
* Compare the quality of life.
* Compare cost-effectiveness.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral erlotinib once daily for up to 24 months.
* Arm II: Patients receive oral placebo once daily for up to 24 months. Quality of life is assessed periodically.

After completion of study treatment, patients are followed periodically for survival.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 664 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed non-small cell lung cancer

  * Advanced disease (stage IIIB or IV)
  * Diagnosis within 62 days prior to randomization
* Not suitable for first-line chemotherapy, as defined by the following criteria\*:

  * ECOG performance status 2-3
  * ECOG performance status 0-1 AND creatinine clearance \< 60 mL/min
* NOTE: \*These criteria do not imply that all such patients are unsuitable for chemotherapy; patients are considered unsuitable on a case by case basis
* No symptomatic brain metastases

PATIENT CHARACTERISTICS:

* Estimated life expectancy of at least 8 weeks
* Able to take oral medication
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No severe uncontrolled infection
* No unstable angina
* No myocardial infarction within the past month
* No uncontrolled inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
* No acute renal failure
* Bilirubin \< 2 times upper limit of normal (ULN)
* Transaminases \< 2 times ULN (5 times ULN if liver metastases are present)
* Creatinine \< 5 times ULN
* No evidence of other significant laboratory finding or uncontrolled medical illness that would interfere with study treatment or results comparison or render the patient at high risk from treatment complications
* No other prior or current malignant disease likely to interfere with study treatment or comparisons

PRIOR CONCURRENT THERAPY:

* No prior chemotherapy
* No prior biological anticancer therapy (e.g., gefitinib, thalidomide, or cetuximab)
* No prior palliative radiotherapy

  * Prior palliative radiotherapy to bone metastases allowed within the past 2 weeks
* No concurrent cyclooxygenase-2 inhibitors
Optical Coherence Tomography Guided Antithrombotic Treatment After Endovascular Thrombectomy of the Posterior Circulation

Evidence regarding the role of early (\<24 hours) antithrombotics post-revascularization with either intravenous thrombolysis (IVT), endovascular thrombectomy (EVT), or a combination of both remains scarce. In 2018 the American Heart Association/American Stroke Association changed their recommendation, stating that the risk of antithrombotic therapy within the first 24 hours after treatment with IVT (with or without EVT) is uncertain. This was changed after data emerged that early antithrombotics may be safe and may improve outcomes in select patients undergoing EVT.

Recently the investigators showed for the first time that significant residual basilar thrombus can exist after EVT despite complete angiographic revascularization using endovascular optical coherence tomography imaging. This residual thrombus could cause ongoing function-limiting strokes with occlusion of vital basilar perforators after EVT. Therefore, the investigators propose a prospective,non-randomized safety study to evaluate optical coherence tomography guided antithrombotic management for patients with confirmed residual thrombus after EVT for basilar occlusion.


Eligibility Criteria:
Inclusion Criteria:

- All patients deemed candidates for endovascular thrombectomy(EVT) for basilar artery occlusion. As no robust guidelines exist for the role of EVT in patients with acute basilar artery occlusion, the decision for EVT is made by a team of stroke neurologist and neuro-interventionalist at our regional stroke center.

Exclusion Criteria:

* High-density lesion consistent with hemorrhage of any degree.
* Significant established infarct size.
* Contraindication to receiving post-revascularization antithrombotics for any reason (history of major hemorrhage in the past six months, hereditary or acquired bleeding diathesis, major surgery within last three months, platelets \<100 X 109 /L, coagulation factor deficiency, already on anticoagulant that would not allow administration of UFH)
* Informed consent is not or cannot be obtained.
* Females of childbearing potential who are known to be pregnant and/or lactating or who have positive pregnancy tests on admission.
* Other serious, advanced, or terminal illness.
* Patients who require hemodialysis or peritoneal dialysis.
* Uncontrolled hypertension defined as systolic blood pressure\>185 mm Hg or diastolic blood pressure\>110mm Hg that cannot be controlled except with continuous parenteral antihypertensive medication
Occupational Therapy With Ayres Sensory Integration Approach for School-age Children

Introduction:

Sensory Integration (SI) is a theory and framework conceptualized by Dr. Jean Ayres, a highly experienced occupational therapist, with its main objective as enhancing the brain's capacity to perceive and organize sensory information to produce a more normal, adaptive response; thus, to provide the foundation for mastering academic tasks (Case-Smith and O'Brien, 2010).

Objectives:

The aim of the study is to investigate the effectiveness of ASI interventions for school-aged children with sensory modulation and sensory processing deficits.

Methodology:

A cross-clustered single-blinded randomized controlled trial was conducted in 5 occupational therapy outpatient department within Hospital Authority, to assess the difference in clinical outcomes between subjects in experimental group (received ASI) and control group (on usual waitlist for treatment). Participants in experimental group (EG) would receive 16 sessions (45 minutes each) of individualized ASI. The sessions were scheduled on weekly basis and would be completed within five months once treatment was initiated. Post-assessment outcomes would be measured at this time-point. Post-assessment outcomes would also be measured for subjects in control group (CG) at the same time-point. ASI would then be initiated for participants in CG according to usual clinical scheduling.


Eligibility Criteria:
Inclusion Criteria:

* aged between six and 12 years old, and attending mainstream primary school
* identified as having problems with sensory modulation and/or sensory processing, according to the Sensory Integration and Praxis Test (SIPT) and the Chinese Sensory Profile completed by their main caregivers for pre-treatment evaluation (definite differences on at least three out of seven of the factor summary or section summary)
* absence of serious emotional or behavioral disturbance
* intelligence quotient no lower than limited (scores range from limited to average or above average).

Exclusion Criteria:

* any neurological problem, such as cerebral palsy
* a history of visual and/or auditory defects or physical problems