cyrilzakka/clinical-trials huggingface dataset:
Family-based Health Education Program and Zinc Supplementation for Stunted Mother

Background :

It is important to tackle the issue of malnutrition at an early stage. A stunted mother has a tendency of having adverse neonatal outcomes including growth restriction. The multidisciplinary intervention followed by micronutrient supplementation is developed to prevent these adverse outcomes. Zinc has been associated with better neonatal growth and brain growth. This study aims to assess the impact of family-based health education programs plus zinc supplementation on the important biomarker of pregnancy and neonatal growth.

Objective :

1. To assess the impact of Family-based health education programs plus zinc supplementation on the outcome of pregnancy in stunted mother
2. 1. To assess the impact of Family-based health education programs plus zinc supplementation on the outcome of neonatal growth in stunted mother

Methodology :

A Quasi-experimental study involving stunted pregnant mother with parallel intervention

Hypothesis :

Mother who receives the intervention will have the better maternal and neonatal outcome

Details of Family-Based Health Education Program + Zinc :

1. Home-visit and health promotion by trained midwives
2. Supervision by health volunteer
3. Zinc Supplementation

General target population :

1. Stunted pregnant mother on the third trimester of pregnancy
2. Conducted in Primary Health Care Center

Design of Study :

two arms quasi-experimental study with one group receiving the intervention and comparison receiving standard Antenatal Care. The baseline measurement is conducted at the beginning of the third trimester, followed by the day of delivery and 6 months after delivery (for assessing the outcome of the infant). Participants are matched by certain variables

Variable :

1. Sociodemographic information
2. Food recall using Food Frequency Questionnaire

List of outcomes

1. Zinc level in breastmilk and blood of mother and infant
2. Insulin-like growth factor 1 (IGF-1) level of mother and infant
3. Hemoglobin level of mother and infant
4. Infant and placental anthropometry
5. Tumor growth Factor Beta 1 (TGF beta 1) in infant
6. Brain-derived neurotrophic factor (BDNF) in infant

Sample size using the difference between two means of neonatal birth weight who received zinc and did not receive zinc according to a study in Iran

1. Type 1 error 5%
2. Effect size: 0.4486
3. Power of study: 80%
4. With the equal allocation ratio, the total sample needed is 126

Proposed statistical analysis

1. Independent T-test
2. Linear Mixed Model

Eligibility Criteria:
Inclusion criteria

1. Body height is less than 150 cm
2. Upper Arm Circumference less than 23.5 cm
3. Family income is less than Rp 2,500,000,- following the minimum wage of targeted area
4. 24-26 weeks pregnant.

Exclusion Criteria

1. has pregnancy complications
2. multiple infants
3. refuse to follow the protocol
Patient Derived Vascularized MicroTumor Model of Gastrointestinal Peritoneal Carcinomatosis

This is a pilot study gathering and using samples and data from patients with gastrointestinal peritoneal carcinomatosis. Participants will be asked for permission to provide blood and ascites/peritoneal wash fluid, tumor samples during their planned surgical procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a GI tumor
* Must have planned standard of care surgical procedure
* Age ≥ 18 years.
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

- Pattens who are unable to comply with the study protocol
Low Intensity Resistance Training With Partial Blood Flow Restriction for Quadriceps Strengthening

The objective of the proposed research is to assess the efficacy of an eight-week, efficient and tolerable, low-intensity resistance-training program with concurrent application of partial blood flow restriction (PBFR) for improving quadriceps strength and volume in women with risk factors for incident symptomatic or progressive knee OA. This specific aim will be achieved through a randomized, controlled trial, comparing low intensity training with and without PBFR. There have been numerous reports of exercise interventions in people with knee osteoarthritis. However, this research is novel in that it will be the first to use a low intensity regimen that will minimize forces on the knee while still having the potential to lead to clinically meaningful strength gains in older adults with risk factors for incident symptomatic or progressive knee OA.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 45-60
* BMI less than 37 and greater than or equal to 25 kg/m2, or a history of a knee joint injury or surgery, or knee symptoms (pain, aching, or stiffness) on most of the last 30 days, or knee osteoarthritis

Exclusion Criteria:

* Resistance training at any time in the last 3 months prior to study
* 5° malalignment of a knee
* Bilateral knee replacement
* Lower limb amputation
* Lower limb surgery in the last 6 months that affects walking ability or ability to exercise
* Back, hip or knee problems that affect walking ability or ability to exercise
* Unable to walk without a cane or walker
* Unable to ascend at least 2 stairs (to enter our building)
* Inflammatory joint or muscle disease such as rheumatoid or psoriatic arthritis or polymyalgia rheumatica
* Multiple sclerosis
* Known neuropathy
* Self-report of Diabetes
* Currently being treated for cancer or having untreated cancer
* Terminal illness (cannot be cured or adequately treated and there is a reasonable expectation of death in the near future)
* Peripheral Vascular Disease
* History of myocardial infarction or stroke in the last year
* Deep Venous Thrombosis
* Chest pain during exercise or at rest
* Use of supplemental oxygen
* Inability to follow protocol (e.g. lack of ability to attend visits or understand instructions)
* Staff concern for subject health (such as history of dizziness/faintness or current restrictions on activity)
* Concurrent study participation (such as the MOST study)
* Planning to be away for more than one week during the study
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-VII: Sirolimus-eluting (Ultimaster) vs. Everolimus-Eluting Stents (Xience)

This study compares angiographic and clinical outcomes in patients with long coronary lesions treated with sirolimus-eluting stent (Ultimaster stent) or everolimus-eluting stent (Xience Alpine stent). The study uses a randomized, multicenter, controlled design approach.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must be at least 19 years of age.
2. Significant native coronary artery stenosis (\>50% by visual estimate) with lesion length of more than 25mm, which requiring at long stent placement without intervening normal segment.
3. Patients with silent ischemia, stable or unstable angina pectoris, ad Non-ST-elevation myocardial infarction (NSTEMI)
4. The patient or guardian agrees to the study protocol and the schedule of clinical and angiographic follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.

Exclusion Criteria:

1. Any contraindication to any of the following medications: aspirin, heparin, clopidogrel, stainless steel, contrast agents, sirolimus, or everolimus
2. An elective surgical procedure is planned that would necessitate interruption of antiplatelet drugs during the first 6 months post enrollment.
3. Acute ST-segment-elevation MI or cardiogenic shock
4. Terminal illness with life expectancy \<1 year
5. In-stent restenosis at target vessel (either bare metal stent or drug-eluting stent segment). However, non-target vessel ISR is permitted.
6. Patients with EF\<30%.
7. Serum creatinine level ≥ 2.0mg/dL or dependence on dialysis.
8. Patients with left main stem stenosis (\>50% by visual estimate)
Evaluation of Post-voiding Residual Urine: a Before-after, Post-partum Study

The primary objective of this study is to evaluate the impact of systematic catheter-drainage of urine for parturient women immediately in the delivery room on the occurrence of post-voiding urine residue.

Secondarily, we will evaluate the impact of systematic catheter-drainage of urine for parturient women immediately in the delivery room on the occurrence of acute urine retention (first voiding volume \> 500cc) and on post-partum bacteriuria rates.

Eligibility Criteria:
Inclusion Criteria:

* Paturient women admitted to the delivery room

Exclusion Criteria:

* Patients who have been catheterized during the third trimester of the current pregnancy
* History of surgery on the urinary tract
Risk Stratification-directed Therapy for AML With t(8;21) /AML1-ETO+

Acute myeloid leukemia with t(8;21) /AML1-ETO-positive (AE AML) is a heterogeneous disease entailing different prognoses. There were significant differences in the therapeutic effect between different subgroups of AE AML. Therefore, risk stratification-directed therapy is very necessary for AE AML.

Acute myeloid leukemia with t(8;21) /AML1-ETO-positive (AE AML) is a heterogeneous disease entailing different prognoses.There were significant differences in the therapeutic effect between different subgroups of AE AML. For example, patients with c-kit mutation had higher relapse rate and lower overall survival, compared with those without c-kit mutation. Therefore, risk stratification-directed therapy is very necessary for AE AML. The purpose of this study is to establish risk stratification-directed therapy for AE AML.

Eligibility Criteria:
Inclusion Criteria:

* AE AML aged 14-70
* No abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Expected survival time is more than 2 months

Exclusion Criteria:

* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)
* Patients with any conditions not suitable for the trial (investigators' decision)
The Effects of Caffeine on Physical Performance of Ice Hockey Players

To date, only one study has evaluated the effect of caffeine supplementation on athletic performance in ice hockey players finding a lack of ergogenic effect. This lack of effect is surprising as caffeine has been suggested to be an effective and safe nutritional supplement to improve physical performance in both trained and untrained individuals. Therefore, the aim of the present study is to evaluate the effect of acute caffeine ingestion (3mg/kg body mass). Thirteen elite adult ice-hockey male players will perform specific ice hockey performance tests in two separate days. On both occasions players will ingest 330 ml of water with lemon powertabs isostar® (86 kcal / 19g of carbohydrates) tablets, which will include in one of these days 3 mg/kg body mass of anhydrous caffeine. Players will perform a 35-m sprint, an agility test (Weave agility - slalom with puck), and a reaction test.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years,
* Male
* Play in the Spanish ice hockey first division.

Exclusion Criteria:

* Participants taking drugs containing ephedrine or antibiotics.
* Having suffered a musculoskeletal injury in the 3 months prior to the tests.
Modulation of Reinforcement Learning

This study aims to examine the modulation of neuronal and behavioural parameters of social reinforcement learning.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 26 years
* male
* IQ\>80
* written informed consent
* proband understands character, extent and individual consequences of the study
* competent persons who are able to follow the instructions of the study personnel
* for ASD patients: assured ASD diagnosis, comply of the ASD criteria ADI-R/ADOS-G

Exclusion Criteria:

* prosopagnosia
* anaphylaxis of oxytocin or other chemical substances
* metal inside the body or other contraindications of mri scan
* physical illness which can affect the examinations or endanger the proband
* actual or assumed drug or alcohol abuse
* persons who are accommodated in an institution because of court or administrative order
* persons with a relationship of dependence to the sponsor or investigator
* healthy probands: psychiatric disorder according to ICD-10-WHO F at the moment and in history, continuous drug-intake at time of measurements
* patients with ASD: psychiatric disorder according to ICD-10-WHO F (except ASD disorder in patient group) during the last 12 month being not treated, continuous drug-intake at time of measurements (psychotropic medication), exception: stimulants used for treatment of attention disorders, if they can come off for the measurements
Evaluating the Tolerability and Effects of Berberine on Major Metabolic Biomarkers: A Pilot Study

Berberine is a dietary supplement that comes from the roots, stems, and bark of various plants and has been used for centuries in traditional Chinese medicine. It may help lower cholesterol, lower blood sugar, and reduce inflammation.Very few studies have been done in the United States to show how berberine effects cholesterol and blood sugar. This study is looking to see how berberine changes cholesterol and blood sugar, and to see how well it is tolerated.Berberine is not a prescription medication but it appears to have similar actions to common prescription medications to lower cholesterol like statins, and to lower blood sugar like metformin. We are studying berberine to see if it may be a good option for people that do not want to take prescription medications.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and older
* Current LDL-C of ≥80 mg/dL or higher
* Current fasting triglyceride level of ≥300 mg/dL
* Meets current criteria for metabolic syndrome (≥3 of the following):

Waist circumference ≥ 35" female or ≥40" for male:

Triglycerides ≥ 150 mg/dL:

Low HDL-c \<40 mg/dL male or \<50 mg/dL female:

Elevated blood pressure ≥ 130/85 mmHg (or on BP medication):

Elevated fasting blood glucose ≥100 mg/dL

* A male or a non-pregnant female
* Mentally competent to understand study rationale and protocol
* Able to speak and read English

Exclusion Criteria:

* Currently taking any lipid-altering agents including but not limited to statins, niacin (\>500 mg), bile-acid sequestrants, ezetimibe, fibrates, and Omega-3 fish/krill oils (\>1000 mg EPA/DHA).
* Prior evidence of a vascular event (e.g. stroke, myocardial infarction, revascularization, peripheral vascular disease)
* Current use of any oral hypoglycemia agent or parenteral medication for diabetes mellitus (e.g. GLP-1 agonists, insulin)
* Currently taking any drugs with the potential to interact with berberine, including but not limited to cyclosporine, simvastatin, lovastatin, metformin, saquinavir, darunavir, tacrolimus, sirolimus.
* Previous history of diabetes mellitus, HbA1c ≥ 6.5%, or FPG \> 126 mg/dL
* Chronic disease involving, hepatic, renal, or coronary heart disease, systemic infection (e.g. HIV) or organ transplantation
* Currently taking systemic steroidal drugs
* Dependence on alcohol (\> 10 drinks per week) or illicit drugs
* Pregnant or lactating
* Participation in any other clinical trial within the last 30 days
* Presence of any medical or psychological condition that in the opinion of the investigator will compromise safe subject participation for the duration of the study
* Acute or chronic GI conditions (e.g. irritable bowel syndrome, ulcerative colitis)
Cryoablation with or Without Serplulimab in Treating Patients with Stage I-IIA Non-small Cell Lung Cancer

Cryoablation is a minimally invasive technique that utilizes very low temperature to eliminate tumour cells for patients ineligible for surgery. It has been reported that cryoablation may enhance immune response and synergize with immunotherapy.

This study is a multicenter, randomized, controlled, exploratory trial, and is expected to enroll a total of 134 patients. The enrolled patients were stage Ia, Ib, or IIa lung cancer with negative driver gene mutations, who are considered high-risk for surgery or refuse surgery based on multidisciplinary evaluation. Eligible patients will be randomly assigned in a 1:1 ratio to receive either cryoablation alone (CA group) or cryoablation combined with immunotherapy (I-CA group). The study aims to evaluate the safety and clinical benefits of combining immunotherapy with cryoablation in the treatment of early-stage NSCLC by comparing progression-free survival (PFS), objective response rate (ORR), overall survival (OS), and the incidence of adverse events between the two groups.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically diagnosed as primary peripheral non-small cell lung cancer, preoperative staging suggested stage Ia, Ib, or IIa (size≤5 cm, T1-T2N0M0), according to the 9th edition of the TNM classification for lung cancer;
2. Negative driver gene mutation: driver genes were defined as EGFR, ALK, etc;
3. Age ≥18 years old;
4. The ECOG PS score is 0-2;
5. Expected survival ≥3 months;
6. Patients who are considered high-risk for surgery/radiotherapy or refuse surgery/radiotherapy based on multidisciplinary evaluation;
7. Patients who have not received previous immunotherapy with PD-1, PD-L1 or CTLA-4 antibodies;
8. All patients must agree to receive cryoablation (with or without Serplulimab) as an initial therapy and sign a study-specific consent form.

Exclusion Criteria:

1. Patients with poor cardiopulmonary function or other comorbidities who cannot tolerate multimode thermal therapy;
2. Patients whose chest CT indicated that the lung lesions could not be reached percutaneously or transbronchially;
3. Severe liver and kidney function and coagulation function abnormalities, platelet count \&lt;70×109/L;
4. Patients who have received other anti-tumor drugs in the past 6 months or have used immune checkpoint inhibitors before;
5. The patient has an uncontrolled disease (including but not limited to active infection, symptomatic congestive heart failure, unstable angina, arrhythmia, mental illness, etc.);
6. Primary immune deficiency or autoimmune diseases (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.);
7. Pregnant and lactating women;
8. Long-term use of steroid;
9. Other circumstances considered inappropriate for participation in this study.
Comparing Amlodipine/Atorvastatin Co-Administration To Amlodipine Alone In Patients With Hypertension And Dyslipidemia

To evaluate efficacy of the dual therapy of atorvastatin + amlodipine vs. amlodipine alone .


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of both hyperlipidemia and hypertension.

Exclusion Criteria:

* Subjects with Type 1 diabetes mellitus or Type 2 diabetes mellitus.
* Subjects with other atherosclerotic disease.
4D-flow MRI to Assess Left Ventricular Obstruction in Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is a frequent cardiac pathology with an estimated prevalence of 1/500 in France. The main risk factor for sudden death in this pathology is the presence and extent of left ventricular obstruction. To date, the only method allowing a reliable assessment of the extent of left ventricular obstruction is Doppler echocardiography. All patients with HCM should undergo cardiac magnetic resonance imaging (MRI) to confirm the diagnosis and for the detection of fibrosis, but conventional sequences cannot reliably assess the obstruction. 4D-flow MRI provides a complete coverage of an entire volume with the ability to simultaneously measure the outputs of all vessels within that volume in a single sequence and might be able to quantify left ventricular obstruction.

The main objective of this study is to compare the quantification of left ventricular obstruction in hypertrophic cardiomyopathy by Doppler echocardiography and 4D flow MRI.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Presence of a Hypertrophic cardiomyopathy (HCM)
* Affiliation to a social security program
* Ability of the subject to understand and express opposition

Exclusion Criteria:

* Major obesity (\> 140 kg) not allowing the patient to enter the tunnel of the machine whose diameter is less than 70cm,
* Age \< 18,
* Person under guardianship or curators,
* Pregnant woman,
* Allergy to gadolinium chelates,
* Claustrophobia,
* Any contraindications to MRI
Effect of the Use of a 3D Scanner Application on a Smartphone to Mold Garchois Orthotic Device in Neuromuscular Diseases Patients With Scoliosis

Neuromuscular scoliosis is the consequence of general hypotonia involved in certain neuromuscular diseases. Thoracic braces are necessary to slow down the deformation. In France, Garchois brace is largely used in this context because of a better pulmonary tolerance.

Historically, molding of thoracic orthotic brace was based on a plaster cast directly on the patient. He/she is suspended in a frame or is lying on an examining table, and is held by 4 therapists (a physician, an orthoprosthesist, a nurse and a doctor). The position during molding could be very uncomfortable and anxious.

With the development of new technologies, a 3D scan application on smartphone to obtain the volume and deformations of the patient was developed. This tool enables digital acquisition of trunk and head volume while bypassing the seated patient. No plaster strips are used. The resulting negative is digitally filled to obtain a positive. The positive is then corrected before the corset is made, either digitally or after 3D scanning, in plaster or foam. This application was first used in our department in 2017.

The aim of this retrospective monocentric study is to show that this application can be used to produce brace that are as corrective and reliable as braces made after plaster casting, while improving the satisfaction of children, their families and professionals during impression taking. as their parents and of the professionals present during the molding.


Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicion or genetically confirmed neuromuscular disease
* Neuromuscular scoliosis, with Garchois brace indication
* Under 18 at the time of the first Garchois brace molding

Exclusion Criteria:

* Other neuro-orthopaedic disease such as cerebral palsy
* Other thoracic brace than Garchois
* Any spine surgery