cyrilzakka/clinical-trials huggingface dataset:
A Randomized Controlled Trial of Bilateral Movement-based Computer Games Training to Improve Motor Function of Upper Limb and Quality of Life in Sub-acute Stroke Patient

This study aims at investigating whether bilateral movement-based training with computer games could augment motor function of paretic upper limb and improve quality of life in sub-acute stroke patients.


Eligibility Criteria:
Inclusion Criteria:

* Age between 45-85
* Diagnosis of ischaemic brain injury or intracerebral hemorrhage by MRI or computed tomography 1 week to 6 months after the onset of current stroke
* Scoring \> 6 of 10 of Abbreviated Mental Test
* Ability of the paretic hand to hold the game controller (minimal control)
* Able to give informed consent of the study
* Can understand instructions given by English or Cantonese

Exclusion Criteria:

* Any additional medical, cardiovascular and orthopaedic condition that would hinder the proper assessment and treatment
* Having cardiac pacemaker
* Receptive dysphasia
* Undergoing drug studies or other clinical trials
The Study of Sarcopenia and Aging Biomarkers by the Metabolomics

With the rapid growth of the global elderly population, the studies of the biomarkers of the sarcopenia and aging are under investigation in different ways. The investigators use Metabolomics to explore the biomarkers of the sarcopenia and aging of the senior adults.

Metabolomics is the emerging platform technology to address the complexity of a living system. In translational research, metabolomics approaches may enable the detection of multiple disease risk factors and interactions, disease progression, and response of patients to a particular therapy with or without side effects. Metabolomics may provide comprehensive information and improve diagnosis and prognosis which are particularly promising in human complex degenerative diseases. The investigators use Metabolomics to explore the biomarkers of the sarcopenia and aging of the senior adults.

Eligibility Criteria:
Inclusion Criteria:

* residents of the Chang Gung Health and Culture Village
* mostly independent and do not require nursing assistance
* capable of managing their daily living activities
* aged ≧ 60

Exclusion Criteria:

* None.
Assessment and Prediction of Cetuximab-Induced Hypersensitivity Reactions Using Cetuximab Specific IgE Detection

1. Background Cetuximab (trade name Erbitux) is a murine-human chimeric monoclonal antibody to human epidermal growth factor receptor (EGFR). This drug has been used as a treatment for colorectal cancer and head and neck cancer. It is known that allergic reactions can occur in more than 5% of the patients, although the side effects are relatively low compared with other chemotherapeutic agents. It is known that cetuximab can induce hypersensitivity even at the first administration, unlike other anticancer drugs. In this study, we aimed to establish a model to predict patients with hypersensitivity reaction before administration of cetuximab and to provide safe chemotherapy.
2. Recruitment method and consent procedure The study is designed for analysis patients scheduled for administration of cetuximab for the first time. Patients matching the selection and exclusion criteria with voluntary agreement to the study will be enrolled. Enrolled patients will be tested for skin prick test and serum sIgE before cetuximab administration.

* Acquisition of agreement Agreement, explanation, and consent form for study of human derived sample those that approved by the IRB are obtained from patients who prospectively voluntarily participate in the study and provide human derived sample.
* Observation and evaluation values

  ① Serum Cetuximab-specific IgE measurement (ImmunoCAP, conventional ELISA) before administration of cetuximab

  ② Cetuximab Skin test using before cetuximab administration

  ③ Clinical symptoms after cetuximab administration through chart review (vital signs, occurrence of adverse drug reaction)

  ④ Check patient's underlying disease and allergy history
* Statistical analysis method Chi-square test, Fisher's exact test, Student t-test, Mann-Whitney test, Logistic regression test, Cox's regression test, and ROC curve will be used

Eligibility Criteria:
Inclusion Criteria:

* Adult men and women over 18 years of age
* Patients scheduled for cetuximab administration according to standard treatment guidelines for the treatment of underlying tumor disease.

Exclusion Criteria:

* Patients who did not consent to the study voluntarily after IRB approval
* Persons who are vulnerable (including persons with disabilities, lack of physician capacity, pregnant status, persons who are accommodated in facilities, etc.)
* Those who can not read and understand the agreement
Telemonitoring and Teleintervention of Heart Failure and Decrease of Non-fatal Events.

The primary objective of the study is to determine the effect of automated daily selfreported symptom and weight, blood pressure and heart rate monitoring and clinical follow-up videoconference comigrate with clinical follow-up face in specialized hospital unit in reducing heart failure non-fatal events.

The insuﬁcie 'ncia Cardı´aca Optimitzacio ´ Remota (iCOR; Heart Failure Remote Optimization) trial was a singlecentre, randomized, open-label study designed to evaluate the eﬃcacy of the addition of telemedicine (telemonitorization and teleintervention using videoconference) to an existing specialized, multidisciplinary, nurse-based, hospitalprimary care integrated HF programme for high-risk patients with CHF. The organizational characteristics of the programme and the impact in health outcomes resulting from its implementation have been previously published.2 In this study we aimed to compare the strategy of providing nurse-based structured follow-up to high-risk CHF patients through planned contacts between health care providers and patients and/or caregivers in the basis of face-to-face on-site encounters (usual care in our HF programme) or provide the planned care using telemedicine with the combination of remote daily monitoring of signs and symptoms of HF (telemonitoring) and delivery of structured nursebased follow-up health care using videoconference (teleintervention). The main hypothesis of this study was that adding telemedicine to an existing HF programme would be associated with a reduction in the number of non-fatal HF events in high-risk patients with CHF. As a secondary hypothesis we assumed that adding telemedicine would translate into a reduction in health care resource utilization and subsequently in health care costs.

Eligibility Criteria:
Inclusion Criteria:

* Patients discharged from a heart failure hospitalization within 30 days of enrollment into the study.

Exclusion Criteria:

* Less than 18 years
* Long-term nursing home residence, irreversible medical conditions, Folstein Mini-mental State Exam score less than 20.
* No access to 3G line, currently scheduled for cardiac transplant, left ventricular assist device or valvular surgery,coronary intervention within 90 days of randomisation.
A Study to Assess the Pharmacokinetics of Ceftaroline in End Stage Renal Disease Patients and Matched Healthy Subjects

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of Ceftaroline in a group of patients with renal disease and matching healthy subjects with normal renal function

An Open-label, Nonrandomised, Phase I Study to Assess the Pharmacokinetics of Ceftaroline After Intravenous Administration of aSingle Dose of Ceftaroline Fosamil (200 mg) to Patients with End-stage Renal Disease Undergoing Haemodialysis when Compared to a Single Dose of Ceftaroline Fosamil (600 mg)

Eligibility Criteria:
Inclusion criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures
* Male and female subjects aged 18 to 75 years (inclusive) with suitable veins for cannulation or repeated venipuncture
* Women of childbearing potential must have a negative pregnancy test, be non-lactating, and be using a highly effective form of birth control for 3 months prior to enrollment, during the study, and for 3 months after completion of all study-related proceed
* Have a body mass index (BMI) between 18 and 35 kg/m2 and weigh at between 50 and 110 kg
* Haematocrit level higher than 30% at screening and baseline for each treatment period

Exclusion criteria:

* History or presence of gastrointestinal, hepatic, or any other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs
* Any clinically significant abnormalities in clinical chemistry, haematology, or urinalysis results, as judged by the investigator
* Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG that may interfere with the interpretation of QTc interval changes
* History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
* Receiving any dialysis treatment other than intermittent haemodialysis
Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®

A Phase 2, multi-center, randomized, controlled, open-label study to evaluate the effects of the intraperitoneal, liposomal formulation VS-01 in patients with an acute episode of hepatic and/or extrahepatic organ dysfunctions and failures in the presence of liver cirrhosis (Acute-on-Chronic Liver Failure, ACLF) and accumulation of fluid in the abdominal cavity (ascites)


Eligibility Criteria:
Inclusion Criteria:

1. Patients with ACLF Grade 1, 2, or 3a according to European Association for the Study of the Liver (EASL)-CLIF criteria;
2. Onset of ACLF not more than 14 days before Baseline (BL);
3. Presence of ascites requiring diagnostic or therapeutic paracentesis;
4. Patients with dry body weight ≥40 and \<140 kg;
5. Written informed consent obtained prior to the start of any study-related procedures.

Exclusion Criteria:

1. Presence of any of the following organ failure(s) as per the EASL-CLIF criteria and/or adapted from CLIF-C Organ Failure (CLIF-C OF)/CLIF- Sequential Organ Failure Assessment (CLIF-SOFA) scores:

   1. Respiratory failure necessitating invasive mechanical ventilation;
   2. Coagulation failure (INR \> 3.2 or platelet count ≤20 x 109/L);
   3. Severe cardiovascular failure requiring the use of high dose vasopressors;
2. ACLF grade 3b: Presence of four or more organ failures as per EASL CLIF criteria;
3. Presence of spontaneous or secondary bacterial peritonitis;
4. Presence of uncontrolled severe infection(with hemodynamic instability or shock);
5. Poorly controlled seizure disorder;
6. Patients with history of upper gastro-intestinal bleeding over the past 7 days prior to BL, acute bleeding or bleeding upon paracentesis at screening (SCR) or BL;
7. Contraindication for paracentesis;
8. Coagulation disorders such as disseminated intravascular coagulation or hemophilia;
9. Potential or known hypersensitivity to liposomes;
10. Potential or known risk factors for allergic/anaphylactoid like reactions (e.g., mastocytosis/elevated basal tryptase) or multiple hypersensitivities;
11. Patients after organ transplantation receiving immunosuppressive medication;
12. Any severe disease considered to be potentially detrimental at the discretion of the Principal Investigator. This includes but is not limited to hepatocellular carcinoma outside Milan criteria, cholangiocarcinoma, extrahepatic cancer over the past 2 years or people who inject drugs;
13. Need for Renal Replacement Therapy or any extracorporeal liver support device (e.g., MARS®, Prometheus®, plasmapheresis);
14. Alfapump® in place to manage ascites;
15. Pregnancy and lactation;
16. Women of child-bearing potential who are not willing to use adequate contraception;
17. Patients who participate in another clinical trial at the time of SCR or within 4 weeks prior to SCR.
Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of ACT-334441 in Subjects With Systemic Lupus Erythematosus

International trial to evaluate the biological activity and safety of cenerimod (ACT-334441) in systemic lupus erythematosus (SLE) patients.

This multicentre, double-blind, placebo-controlled study will have a staggered approach (Part A and B).

In part A, eligible patients will be randomly assigned (1:1:1:1) to once daily oral administration of cenerimod (0.5, 1, 2 mg) or placebo. After all patients have completed 4 weeks of treatment during part A, an Independent Data Monitoring Committee will review non-blinded data in an interim analysis to evaluate the safety profile of cenerimod and recommend whether the study could proceed to part B.

In part B, additional patients will be randomized (3:1) to once daily oral administration of cenerimod 4 mg or placebo.

All participants will receive study medication for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants aged 18 to 65 years with established SLE. Participants must have active SLE, Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score of at least 2 points for musculoskeletal or mucocutaneous manifestations and history or presence at screening of positive anti-nuclear antibodies (ANA) or anti-double-stranded DNA (anti-dsDNA) antibodies.
* Enrolled participants must be treated with background SLE medications.

Exclusion Criteria:

* Participants with significant medical conditions or therapies for such conditions (e.g., cardiovascular, pulmonary, immunological, hepatic, ophthalmological, infection and infection risks, history or presence of malignancy, history or presence of bone marrow or solid organ transplantation) or lactating or pregnant women.
* Participants with severe SLE disease or with clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study.
High-intensity Interval Training on Cardiorespiratory Fitness in Overweight Women

High-intensity interval training (HIIT) is currently considered one of the most effective strategies to improved cardiorespiratory fitness, which is recognized as a protective factor for cardiovascular diseases and metabolic diseases such as overweight and obesity. However, current evidence is still limited and requires clarity (frequency, time per session and intensity) regarding to greater increases attributed to HIIT.

The aim of this study is to compare the effect of a low-volume high-intensity interval training versus a moderate-intensity continuous exercise on maximal oxygen consumption in overweight women 18 to 44 years old.

Thirty-six women will be randomly assigned to one of two aerobic exercise on a real-life setting supervised for a physical activity instructor. The interventions will performed three times a week for ten-weeks (on alternate days).

The first two weeks will correspond to the conditioning period (30 minutes between 55-65% of maximum heart rate (HRmax). From week three, 18 participants will perform 30 minutes of continuous exercise at an intensity between 65-75 % of HRmax, and the remaining 18 will complete 21.5 minutes of interval exercise at an intensity between 90-95% of HRmax, with recoveries between 50-55% of HRmax.

All Participants will be evaluated to measure their maximal oxygen consumption, total body fat, waist circumference, body mass index, systolic blood pressure, diastolic blood pressure, prior to start the interventions and at the end of the program (week 11).

Eligibility Criteria:
Inclusion Criteria:

* Overweight (≥ 25 kg/m-2) women 18 to 44 years.
* Healthy volunteers.
* Perform ≤ 600 Met/min/week.

Exclusion Criteria:

* Perform high-intensity interval exercise in the last six month.
* Smoker.
* History of asthma.
* History of diabetes.
* History of hypertension.
* History of cardiovascular disease.
* History of coronary heart disease.
* Arrhythmias.
* Personal history of surgical procedures in the last three months
* Uncontrolled non-communicable diseases
* Under medical treatment with anticoagulants, beta-blockers, calcium antagonists, bronchodilators, and/or steroids.
* Psychological, neuromotor and/or osteo-muscular conditions that may affect participation in an exercise program.
* Psychoactive drug abuse.
The Influence of Balance Training on Postural Control in Elderly

Fall related injuries are major health problem which effect especially elderly population. After experiencing a fall, most of the elderly are unable to resume their previous mobility and the fear of future falls affects their daily life. Falls in elderly population are often related to balance or gait problems. The aim of this study is to assess the influence of balance training on postural and motor control of healthy elderly participants. The study is designed as a parallel interventional study with experimental and control group (allocation ratio 1:1). Participants' general health, balance abilities, fear of falling and gait stability and variability will be assessed on the baseline measurement, right after and 2 months after the completion of the training programme. Experimental group will undergo training focused on development of balance abilities and strength twice a week (60 minutes in length each) for 8 weeks. Participants will receive individualized exercises which will be focused on the main 4 types - stance exercises, gait and transition exercises and strength exercises especially focused on muscle strength of lower extremities.


Eligibility Criteria:
Inclusion Criteria:

* age 60+
* ability to stand and walk without aid or support
* participation in the institutional program "Falls risk and balance assessment" with successful completion of one year of observation for falls

Exclusion Criteria:

* neuromuscular or orthopaedic impairments that severely limit mobility and balance
* surgery or injury on the musculoskeletal system less than 2 years before baseline measurement
* any acute illness
Effectiveness of Accelerated Deep TMS in OCD

H-coil high-frequency deep transcranial magnetic stimulation (dTMS) over the medial prefrontal cortex (mPFC) and anterior cingulate cortex (ACC) has been approved by the Food and Drug Administration for use in treatment-resistant obsessive-compulsive disorder. At the same time, there are studies in the literature showing the effectiveness of intermittent theta burst stimulation application and the advantages of short treatment duration. However, there is no strong scientific evidence yet on the effectiveness and safety of iTBS (50 Hz) application with a double-cone coil in obsessive-compulsive disorder patients. The aim of this study is to evaluate the effectiveness of dTMS with ITBS protocol on the medial prefrontal cortex (mPFC) and anterior cingulate cortex (ACC) in OCD patients.

The current study aimed to investigate the effectiveness and safety of the ITBS protocol, which is applied to the mPFC and ACC for 5 sessions per day with a double-cone coil in treatment-resistant OCD patients. This study evaluated (I) the effectiveness of Itbs (50 Hz) stimulation of the mPFC and ACC with a double-cone coil and (II) the effectiveness of administering this protocol over 2 weeks rather than six weeks as approved by the FDA. Participants will be randomized into two parallel groups in a double-blind manner. In one group, ITBS (50 Hz) dTMS will be applied to mPFC and ACC, and in the other group, sham tms will be applied to the same regions. The application consists of a total of 50 sessions, 5 times a day. This application will last for a total of 10 days excluding weekends.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of obsessive-compulsive disorder
* Not having an adequate response to treatment despite the use of an SGI selective serotonin reuptake inhibitors at a sufficient dose and duration (at least 8 weeks) before the planned add-on treatment
* No dose or active substance changes have been made in the treatment regimen for at least 8 weeks
* Aged 18-65 years
* Able to read and write
* Not having a significant medical or neurological disease

Exclusion Criteria:

* Not providing consent to participate in the study
* Diagnosis of a psychiatric disorder, such as psychotic disorder, bipolar disorder, major depressive disorder \[Hamilton Depression Rating Scale (HDRS) score above 17\], mental retardation, alcohol-substance use disorder, and organic mental disorder (dementia, delirium, and head trauma, etc.)
* Diagnosis of an important medical or neurological disease (e.g., epilepsy);
* Mental retardation
* Illiteracy
* Having received electroconvulsive therapy (ECT) or TMS within the last six months;
* Having any prosthesis, such as an implant and pacemaker.
Nasogastric/Orogastric Tube Placement Confirmation in Neonates Utilizing Self-contained pH Device, a Feasibility Study

This study is looking at using a self-contained pH device that will assist in confirming placement of a nasogastric or orogastric tube placed in the stomach of hospitalized infants.


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the NICU at the University of Minnesota Masonic Children's Hospital, Minneapolis, MN requiring placement of an NG/OG tube are eligible to enroll.

Exclusion Criteria:

* Participant deemed unsuitable for study by the treating provider. Participants who are on the following medications: proton-pump inhibitor (PPI's) or H2 blockers within one week prior to the device assessment.
Prognostic Value of MRD Detection in CA125 Non-sensitive Ovarian Cancer Patients

Ovarian cancer ranks third in the incidence of gynecologic malignancies, while mortality ranks first. The tumor marker CA125 is the most concerned tumor marker in the clinical monitoring prognosis of ovarian cancer, and an elevated CA125 indicates a later stage and a worse prognosis. However about 20% of patients with ovarian cancer have low CA125 expression. Therefore, CA125 is not sensitive to some ovarian cancers with a high risk of recurrence. How to improve the diagnostic performance of these CA125-insensitive patients is a difficult problem in current research. Minimal residual disease (MRD) refers to the residual tumor components in the body of tumor patients after achieving complete remission through treatment. MRD detection is mainly achieved by liquid biopsy, and residual tumor components can be detected by circulating tumor DNA (ctDNA). This study aims to explore the value of MRD (ctDNA) in the risk assessment of CA125 non sensitive ovarian cancer populations by combining ctDNA with traditional imaging and serological tumor markers.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75;
* Pathologically confirmed ovarian cancer;
* CA125 ≤200U/ml at first diagnosis or recurrence;
* Physical condition score PS ≤ 2 points;
* Enough tumor samples for WES detection;
* Patients and their families can understand and are willing to participate in this study and provide written informed consent.

Exclusion Criteria:

* Patients unable to provide sufficient tissue / blood samples for research detection;
* Pregnant or lactating women;
* Other diseases considered by the research doctor to affect the prognosis and survival;