cyrilzakka/clinical-trials huggingface dataset:
Myocardial Injury in Patients With Cardiac Implantable Electronic Devices Undergoing Defibrillation Threshold Testing

Researchers are trying to determine if heart injury occurs in patients with a cardiac implantable electronic device (CIED) who undergo a defibrillation threshold testing (DFT) procedure.

CIED devices that deliver defibrillation can provide life-saving therapy to patients who have cardiac conditions that make them prone to develop a serious arrhythmia. Currently, there are two main CIED devices that deliver defibrillation therapy - transvenous internal cardioverter-defibrillator (ICD) and subcutaneous ICD. Conventional wisdom indicates that defibrillation causes myocardial injury. However, some studies including one by the present investigators have reported that external direct current cardioversion does not result in myocardial injury. There have been studies showing that ICD shocks results in myocardial injury. The concern with previous studies using transvenous ICDs is that the measurement of injury was done during DFT testing at the time of ICD implantation or when the patient came into hospital after an ICD shock. The confounder with DFT testing is that myocardial injury could have occurred during ICD implantation when the lead is screwed into the myocardium rather than during the testing. With hospitalization, the precipitating event that caused the arrhythmia stimulating the ICD discharge (e.g. an acute coronary syndrome) might also be the cause of myocardial injury. We plan to eliminate these confounders by recruiting patients who are undergoing a DFT procedure electively, remote from their ICD implantation date or clinical events.

In terms of the subcutaneous ICD implantation (in which the leads are not screwed into the myocardium), there is little data about myocardial injury when a shock is delivered. The investigators will attempt to determine if subcutaneous ICD shocks cause myocardial injury by assessing their troponin levels at the time DFT is performed during implantation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are undergoing elective defibrillation threshold testing of their transvenous ICD or defibrillation threshold testing of the subcutaneous ICD at the time of implantation

Exclusion Criteria:

* Patients under age 18
* Patients with myocardial infarction, coronary artery bypass grafting or any invasive cardiac procedure in the previous six weeks
* Pregnant patients
* Patients who cannot provide informed consent because of cognitive dysfunction
Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia

The aim of this study is to compare effective analgesia with continuous wound infiltration of ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to spinal anesthesia, after elective Caesarean delivery.

Double blind, 3 groups

* Control group: Rachi 0,1 ml saline, Infusion 300ml saline
* Group rachi-morphine: 0,1ml =100µg morphine/300ml saline
* Group KT: 0,1 ml saline/300 ml naropin 0.2%

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and more, ASA 1 or ASA 2, pregnant with at least 34 weeks of gestational age, admitted for a planned caesarian with a Pfannenstiel incision and having signed the informed consent form.

Exclusion Criteria:

* Refusal of the patient or contra-indication to locoregional anesthesia
* Allergy to the products used
* ASA 3
* ASA 4
* Sleep apnea syndrome and/or obesity (BMI \> 35)
* Size inferior to 155cm
* existence of a language barrier
A Study of Treatment-free Remission in Chronic Phase Chronic Myeloid Leukemia

To evaluate the efficacy of asciminib adding on tyrosine-kinase inhibitors (TKI) to achieve treatment-free remission (TFR) in chronic myeloid leukemia (CML) patients in chronic phase who failed prior cessation study of TKI

We expect that patients who lost MR3.0 after stopping TKIs, thus failed to maintain treatment-free remission can achieve second sustainable MR4.5 by sustainable MR4.5 for more than 3 years once regained and prolong MRFS by adding asciminib to TKIs. Patients will be restarted on TKIs when they fail sustaining MR3.0 after cessation because restarting TKIs when loss of MR3.0 is reasonable in this situation.

Eligibility Criteria:
Inclusion Criteria:

1. 19 year or older
2. CP-CML patients who are taking current TKIs (imatinib, nilotinib or dasatinib) for 5 years or more
3. Patients who have failed maintaining MR3.0 after 1 or more cessation trial of TKIs.
4. Patients who regained MR3.0 or deeper molecular response by TKIs retrial after TKI cessation failure at the time of screening
5. Taking TKIs over 12 weeks for the retrial of TKIs after TKI cessation failure
6. Patients who agree with stopping asciminib and TKIs after maintaining 23 year-duration of MR4.5
7. Adequate end organ function as defined by:

   * Total bilirubin (TBL) \< 3 x upper limit of normal (ULN); patients with Gilbert's syndrome may only be included if TBL ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN
   * Creatinine clearance (ClCr) ≥ 30 mL/min as calculated using Cockcroft-Gault formula
   * Serum lipase ≤ 1.5 x ULN. For serum lipase \> ULN - ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis
8. Patients who can sign the informed consent of their own free will

Exclusion Criteria:

1. Patients who experienced grade 3 or higher adverse events with TKIs (imatinib, dasatinib, and nilotinib).
2. Patients who are receiving any other investigational agents.
3. Patients who currently have uncontrolled infections
4. Patients who previously received Chimeric antigen receptor T-cell (CAR-T cell) therapy, allogeneic hematopoietic stem cell transplantation (allo-HSCT) or biologic therapy.
5. Patients with clinically significant cardiovascular disease or gastrointestinal dysfunction.
6. Patients who have a history of thromboembolic episodes within 3 months prior to the study enrollment.
7. Patients with active hepatitis B or C with uncontrolled disease activity.
8. Patients who have active malignancies requiring treatment other than CML.
9. Patients with any severe and/or uncontrolled medical conditions or other conditions that could adversely impact on patients' ability to participate in the study.
10. Patients with psychiatric illness/social situations that would limit compliance with study requirements.
11. Pregnant women are excluded from this study Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with asciminib and TKIs, breastfeeding should be discontinued if the mother is treated with asciminib and TKIs.
Effect of Singing in Abdominal Surgery Patients

Patients who have undergone abdominal surgery are given a prompt in the postoperative period and asked to sing the song they remember. Vital signs, pain and anxiety levels are measured before and after singing.

This study is of a randomized controlled type. Patients who have undergone abdominal surgery are divided into experimental and control groups in the early postoperative period. No intervention is made to the control group by the researchers. Vital signs, pain and anxiety levels are measured half an hour apart as pre-test and post-test.

Patients in the experimental group are given a prompt in the postoperative period and asked to sing the song they remember. Pre-test before singing and post-test after singing, vital signs, pain and anxiety levels are measured. It is expected that singing will calm patients, stabilize their vital signs, and reduce anxiety and pain.

Eligibility Criteria:
Inclusion Criteria:

* Abdominal surgery patiens
* 18 and more than age

Exclusion Criteria:

* No abdominal surgery patients
* under 18 age
Dose-ranging Study of PRX-102 in Adult Fabry Disease Patients

This is the first human treatment with PRX-102, an enzyme being developed as a long-term enzyme replacement therapy in patients with a confirmed diagnosis of Fabry disease (alpha galactosidase deficiency). The safety, tolerability, and exploratory efficacy will be evaluated in this study of increasing doses. Patients will be treated with infusions every two weeks for 12 months.

Under the PB-102-F01 study protocol, patients will be enrolled into one of three PRX-102 dosing groups (0.2 mg/kg, 1.0 mg/kg, 2.0 mg/kg) and receive PRX-102 as an intravenous infusion every 2 weeks for 12 weeks (3 months). Patients who finish the PB-102-F01 study will be enrolled in the PB-102-F02 extension study and receive the same dose they had received in the PB-102-F01 study for an additional 38 weeks (9 months).

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic adult Fabry patients (≥18 yrs)
* Males: plasma and/or leucocyte alpha galactosidase activity (by activity assay) less than lower limit of normal (LLN in plasma=3.2 nmol/hr/ml, LLN in leucocytes=32 nmol/hr/mg/protein)
* Females: historical genetic test results consistent with Fabry mutations
* Globotriaosylceramide (Gb3) concentration in urine \> 1.5 times upper normal limit
* Patients who have never received enzyme replacement therapy (ERT) in the past, or patients who have not received ERT in the past 6 months and have a negative anti alpha galactosidase antibody test
* eGFR ≥ 60 mL/min/1.73m2
* The patient signs informed consent
* Female patients and male patients whose co-partners are of child-bearing potential agree to use a medically acceptable method of contraception, not including the rhythm method

Exclusion Criteria:

* Participation in any trial of an investigational drug within 30 days prior to study screening
* Chronic kidney disease stages 3-5 (CKD 3-5) (Appendix 7)
* History of dialysis or renal transplantation
* Angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) therapy initiated or dose changed in the 4 weeks prior to screening
* Severe myocardial fibrosis by MRI (≥2 late-enhancement \[LE\] positive left ventricular segments) (Weidemann et al. 2009)
* History of clinical stroke
* Pregnant or nursing
* Presence of HIV and/or HBsAg and/or Hepatitis C infections
* Known allergies to ERT
* Known allergy to Gadolinium based contrast agents
* Presence of any medical, emotional, behavioral or psychological condition that, in the judgment of the Investigator and/or Medical Director, would interfere with the patient's compliance with the requirements of the study
Nutritional and Metabolic Evaluation of a Tube Feeding Immune Enhancing Diet in ICU Patients

Comparison of metabolic and nutritional effects of an enteral immune enhancing diet with those of a standard polymeric one, in ICU patients


Eligibility Criteria:
Inclusion Criteria:

* 18\<age\<89, ASA score\<4 , SAPS II score\>10
* requiring the administration of an exclusive tube feeding nutrition during 7 days and beginning at the latest in the three days following the aggression
* ICU patients hospitalized for:
* neurologic affections
* pneumopathy
* major abdominal surgery or serious acute pancreatitis
* written informed consent

Exclusion Criteria:

* pregnancy or breast feeding
* immunosuppressive therapy
* radiotherapy or chemotherapy in the last six month
* uncontrolled septic choc
* auto-immune disease
* hepatic,renal or digestive insufficiency
* hyperlipidemia
* diabetes mellitus type 1
* digestive malabsorption
* life threatening situation
* treatments with growing hormone, glutamine or its metabolites or precursors such as ornithine alpha keto glutarate
CAM in Post Surgical Management in Cardiothoracic Surgery

This is a randomized controlled clinical trial in which the combination of 4 different CAM modalities (Complementary \& Alternative Medicine) will be applied during the postoperative period to patients undergoing open heart- or lung surgery and expected to be hospitalized for more than 5 days.

Elective and Urgent surgical patients will be randomly assigned to a treatment - and to a control group. The treatment group will be treated with a combination of 4 different CAM modalities (Homeopathy, Osteopathy, and Acupuncture \& Reflexology) . The control group will be treated with Homeopathic placebo medication.

The main Outcome measurement in the study will be the Quality of recovery 40 questionnaire (QoR- 40) that will be filled out on postoperative days: 3, 5, and 7 respectively. Secondary outcome measurements will be Blood \&Saliva Cortisol levels, DHES levels in the blood as surrogates of stress, IL-2 levels as measures of the immune system. Further parameters to be measured include: LOS (length of stay), Level of Pain, mobility, level of satisfaction, GI symptoms (nausea, first bowel movement), post-operative complications\& side effects.

All patients participating in the trial will sign an informed consent form . The trial is expected to be conducted over a period of 12 months. Prior to the trial a pilot study will be conducted on a group of 30 patients in order to determine the needed sample size for the trial.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Patients planned to undergo a surgical procedure which will require an estimated hospitalisation of at least 5 days
* Patients speaking Hebrew or English
* Informed Consent signature

Exclusion Criteria:

* patients unable to comply with the study protocol
* Participation in another clinical trial
* Thrombocytopenia (\< 15.000 for acupuncture treatment
Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the Knee

The purpose of this study was to evaluate the safety, pharmacokinetics and pharmacodynamics of FX006 in patients with osteoarthritis of the knee.

This study was a double-blind, randomized, parallel-group, active comparator design. The study was conducted in male and female patients ≥35 years of age with symptomatic OA of the knee.

Twenty-four (24) patients with knee OA were randomized (1:1:1:1) and treated with a single IA injection of either 10, 40, or 60 mg of FX006 or 40 mg of TCA IR.

Each patient was evaluated for a total of 6 weeks following a single IA injection. Following screening, safety, PK and pharmacodynamics (PD) were evaluated during one (1) 48-hour in-patient period (Day -1 to Day 2), two (2) 24-hour in-patient periods (Day 14-15 and Day 42-43) and seven (7) out-patient visits (Days 3, 4, 5, 8, 22, 29 and 36).

Eligibility Criteria:
Main Inclusion Criteria:

* Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions
* Male or female \>=35 years of age
* Diagnosis of unilateral or bilateral OA of the knee for at least 6 months prior to Screening with confirmation of OA according to American College of Rheumatology Criteria for Classification of Idiopathic OA of the Knee (clinical and radiological) based on an X-ray performed within 6 months prior to Screening or during the Screening period
* Body mass index (BMI) ≤ 40 kg/m2
* Willingness to abstain from use of the protocol-specified restricted medications

Main Exclusion Criteria:

* History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease, sarcoidosis or amyloidosis
* History of arthritides due to crystals (e.g., gout, pseudogout)
* History of infection in the index joint
* Clinical signs and symptoms of active knee infection or crystal disease of the index knee
* Presence of surgical hardware or other foreign body in the index knee
* Unstable joint (such as a torn anterior cruciate ligament)
* IA corticosteroid (investigational or marketed) in any joint within 3 months of Screening
* IA hyaluronic acid (investigational or marketed) in the index knee within 6 months of Screening
* Oral, inhaled or intranasal corticosteroids (investigational or marketed) within 1 month of Screening
* Prior arthroscopic or open surgery of the index knee within 12 months of Screening
* Planned/anticipated surgery of the index knee during the study period
* History of or active malignancy, with the exception of resected basal cell carcinoma, squamous cell carcinoma of the skin, or resected cervical atypia or carcinoma in situ within 5 years
* Insulin-dependent diabetes
* History of or active Cushing's syndrome
* Any other clinically significant acute or chronic medical conditions (e.g., uncontrolled diabetes)
* Skin breakdown at the knee where the injection would take place
* Women of child-bearing potential not using effective contraception or who are pregnant or nursing
Assessment of CMV-specific ELISPOT Assay for Predicting CMV Co-infection in Patients With Pneumocystitis Pneumonia (ACE-PCP)

PCP (Pneumocystis jiroveci pneumonia) is one of the important opportunistic infections in immunocompromised patients including HIV-infected patients, transplant recipients, and immunosuppressant users. About one third of non-HIV patients with PCP have the evidence of co-infection with CMV. In this difficult clinical situation, physicians have difficulty to decide on whether anti-CMV treament will help patients with any evidence of CMV co-infection. However, there is no objective test to differentiate true co-infection of CMV from innocent bystander of CMV in those with PCP. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in patients with PCP to differentiate true co-infection of CMV from inocent bystander of CMV. This findings may guide physicians to decide anti-CMV treatment in patients with PCP and CMV co-infection.

PCP (Pneumocystis jiroveci pneumonia) is one of the important opportunistic infections in immunocompromised patients including HIV-infected patients, transplant recipients, and immunosuppressant users. About one third of non-HIV patients with PCP have the evidence of co-infection with CMV. In this difficult clinical situation, physicians have difficulty to decide on whether anti-CMV treament will help patients with any evidence of CMV co-infection. However, there is no objective test to differentiate true co-infection of CMV from innocent bystander of CMV in those with PCP. The investigators thus evaluate the usefulness of CMV-specific ELISPOT assay in patients with PCP to differentiate true co-infection of CMV from inocent bystander of CMV. This findings may guide physicians to decide anti-CMV treatment in patients with PCP and CMV co-infection.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PCP based on PCP immunohistochemistry or PCP PCR
* age 16 or more
* agree with written informed consent
* WBC count 2000/uL or more

Exclusion Criteria:

* HIV infection
Investigator Initiated Clinical Study to Explore the Efficacy and Safety of Human Placenta Hydrolysate in the Chronic Fatigue Patients

GCJBP Laennec Injection contains a variety of cytokines derived from human placenta, amino acids, peptides, nucleobases, and carbohydrates. This product is approved for improving liver function. Also, it has been prescribed for lots of diseases such as menopausal disorders, atopic dermatitis, skin cares as well as fatigue for long time. Although its action mechanism and clinical effectiveness are not still clear, there are reports which say a strong probability of its clinical effectiveness in the chronic fatigue patients.

This study aims to investigate the safety and efficacy of GCJBP Laennec Inj. (Human placenta hydrolysate) in the chronic fatigue patients through a randomized controlled tial.


Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with chronic fatigue syndrome or idiopathic chronic fatigue
* Given written informed consent
* Male or female aged between 20 and 65
* Patient who can read and answer to written questionnaires
* Patient who agrees to visit clinic for study drug injection 3 times per a week for 6 weeks

Exclusion Criteria:

* Patient who has been administrated with any other investigational product for 28 days prior to screening visit
* Patient who is pregnant or childbearing potential female patient who does not consent for contraception during the study
* Patient who has a hypersensitivity provoked by study drug or others drived from animals
* Patient who has been received with any human placenta product for 6 months before study participation
* Abnormal liver function
* Abnormal renal function
* Back Depression Inventory (BDI) II is more than 29
* Underlying disease/conditions, in the investigator's judgment, which will be unable to participate in the study
Promoting Nutrition and Physical Activity in Family Child Care

The CHEER study takes advantage of a natural experiment happening in South Carolina (SC). The South Carolina Department of Social Services implemented new healthy eating and physical activity standards through a state-wide policy for family child care homes that participate in the ABC Grow Healthy program. Thus, CHEER is a quasi-experimental, two-group, pre-test/post-test design study.

The overall goal of the study is to evaluate new healthy eating and physical activity standards targeting family child care homes in South Carolina. To accomplish this goal, we are assessing the effects of the standards on the dietary intake and physical activity levels of racially diverse low-income children in family child care homes. The specific aims of the "CHEER" study are as follows:

Aim 1. Evaluate the extent to which the new regulatory standards impact children's dietary intake assessed via direct observation in homes and 24-hour recalls with parents, and physical activity and sedentary behavior assessed via accelerometry.

Aim 2. Evaluate the extent to which the new regulatory standards impact children's body mass index computed from researcher-measured height and weight.

Secondary Aim. Evaluate the extent to which family child care homes in the SC ABC Child Care Program comply with the new healthy eating and physical activity regulatory standards, compared to family child care homes not participating in the program.

We hypothesize that most homes will comply with the new standards, yielding improvements in children's healthy eating and physical activity levels. As an exploratory aim, we will examine the effects of the standards on children's weight status.

Eligibility Criteria:
Inclusion Criteria:

* Having a child in care between the ages 2 and 4 years at recruitment
* The family is planning to stay in the same care arrangement for the next few years

Exclusion Criteria:

* Family planning to leave the care arrangement in next few years
Chinese Pediatric Massage on Children With Acute Diarrhea: a Randomized Sham Massage Controlled Trial

The purpose of this study is to evaluate the efficacy of Chinese pediatric massage as an add-on therapy while comparing with sham massage both on the basis of usual care for 0-6 years old children with acute diarrhea.

Chinese pediatric massage has been practised as an option for the treatment of pediatric diarrhea for hundreds of years (since Ming Dynasty). The history of Chinese pediatric massage for health promotion is much longer, it can be traced back to more than one thousand years ago (652 AD). Many of the acupoints adopted in Chinese pediatric massage are unique if it is compared with those for adult massage. The manipulation is found to be easily accepted by children, as the strength of massage is gentle and soft. No severe adverse reaction in regards of Chinese pediatric massage was reported, the mild adverse reaction such as skin abrasion can be completely avoided with correct operating instructions.

Eligibility Criteria:
Inclusion Criteria:

1. Subject's symptoms meet the diagnosis criteria of acute diarrhea.
2. The occurrence of diarrhea is no more than 72 hours.
3. Stool frequency is equal or more than 5 times a day.
4. Subject has not been involved in any other clinical trials at the same period of time.
5. Subject's guardian may coordinate during the clinical trial.
6. Subject's guardian have signed the informed consent.

Exclusion Criteria:

1. A history of experiencing Chinese pediatric massage on hands
2. Subject has cholera or malaria
3. Subject with the following conditions on the manipulating part: phlebitis，open wound，fracture，tissue damage
4. Subject has the follow complications: severe dehydration，metabolic acidosis，disorders of consciousness, seizures or twitching, shock, azotemia