cyrilzakka/clinical-trials huggingface dataset:
Kangaroo Mother Care With Plastic Bag (Trials 1A & 1B)

The purpose of this study is to determine whether the combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care reduces the incidence of moderate (32-36° C) or severe (\<32.0° C) hypothermia in preterm infants ≥ 32 to 36 6/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care.

The purpose of this study is to determine whether the combination of Kangaroo Mother Care (KMC) as continuously as possible together with the use of a plastic bag in combination with routine World Health Organization (WHO) thermoregulation care (warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling) reduces the incidence of moderate hypothermia (32-36° C) or severe (\<32.0° C) in preterm infants ≥ 32 to 36 6/7 weeks of gestational age (GA) when compared to KMC as continuously as possible together with routine WHO thermoregulation care, as practiced.

The investigators are proposing two trials, one protocol for infants 32-36 6/7 weeks (this one) and one for infants who are ≥37 weeks gestational age. This preterm infant trial will address the effectiveness of KMC in combination with plastic bags in decreasing hypothermia in preterm infants. The proposed trial will determine whether KMC with plastic bags prevents hypothermia in neonates born in a healthcare setting with limited resources where a high risk for hypothermia has been reported. Any intervention that decreases morbidity during the neonatal period has the potential to impact health beyond the neonatal period,and one that is highly cost-effective and easy to use is more likely to be implemented in the developing world.

Eligibility Criteria:
Inclusion Criteria:

* Estimated gestational age ≥32 0/7 - 36 6/7 weeks
* Delivery in the hospital

Exclusion Criteria:

* Abdominal wall defect or myelomeningocele
* Major congenital anomalies
* Blistering skin disorder
* Clinically unstable mothers secondary to cardiovascular and pulmonary conditions
* Infants requiring respiratory support beyond 10 minutes after birth
* Infant requiring NICU admission
* C/section
* Multiple gestation if the last delivering infant is not born within 10 minutes from the time of birth of the first infant
Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet

1. Objectives

   1. to verify effect of Korean red ginseng on cold hypersensitivity of hands and feet in women
   2. to establish scientific evidence for the use of Korean red ginseng by investigating changes of infrared thermography
2. Hypothesis The hypothesis is that Korean red ginseng will reduce cold hypersensitivity of hands and feet more effectively than placebo after 8 weeks administration of interventions- Korean red ginseng or the placebo.

Design

* This trial is a randomized, double blind, placebo controlled trial with 80 patients.
* The trial will be implemented at Kyung Hee University Hospital at Gangdong in Seoul, Korea.
* Participants will take Korean red ginseng or placebo for 8 weeks and will be followed up during 4 weeks.
* During the administration period, 6 capsules 2 times a day (1h after breakfast and dinner) of Korean red ginseng or its placebo will be provided.

Eligibility Criteria:
Inclusion Criteria:

1. Female aged 16 to 60 years
2. Women complaining cold hypersensitivity on hands and feet
3. Thermal deviation between the palm and the upper arm is higher than 0.3℃

Exclusion Criteria:

1. Skin ailment, radiculopathy, thrombophlebitis, and injuries affecting infrared thermography
2. Alcohol abuse and alcoholic
3. History of cancer within 5 years
4. Severe depression
5. Hypertension and diabetes
6. Pregnancy or breastfeeding
7. Abnormal finding from blood test at screening visit
8. Allergic to Korean red ginseng
9. Took herbal medicine or health functional food within a week Participated another clinical trials within 3 months
A Randomised Controlled Trial of Self-help Mindfulness-based Cognitive Therapy for Health Workers

This study examines whether a mindfulness-based self-help book is effective at reducing healthcare workers' levels of stress and improving their wellbeing.

This study is a randomised controlled trial (RCT) examining the efficacy of a mindfulness-based cognitive therapy self-help book ('Mindfulness: A practice guide to finding peace in a frantic world') relative to a wait-list control, in healthcare staff. It builds on a previous pilot RCT (http://www.isrctn.com/ISRCTN16486066). A battery of measures will be administered at baseline (week 0), post-intervention (week 9) and follow-up (week 21). This trial is designed to test the following hypotheses.

Primary Hypothesis

-Mindfulness-based cognitive therapy self-help (MBCT-SH) participants, in comparison to waitlist control participants, will show a reduction in symptoms of stress by the end of MBCT-SH (week 9).

Secondary Hypotheses

* The improvement detailed in the primary hypothesis will be maintained at a follow-up 12 weeks after the end of the MBCT-SH (week 21).
* MBCT-SH participants, in comparison to waitlist control participants, will show improvements in mindfulness, other-compassion, self-compassion, anxiety, depression, burnout and mental well-being by the end of MBCT-SH (week 9), and these improvements will be maintained at a follow-up 12 weeks after the end of the MBCT-SH (week 21).
* MBCT-SH participants, in comparison to waitlist control participants, will show a reduction in the number of sickness absence days from the three months preceding the intervention to the three months following the intervention.
* Increases in self-compassion and mindfulness from week 0 to week 9, will mediate the effects of MBCT-SH (relative to waitlist control) on levels of stress, depression, anxiety, wellbeing and burnout.

Eligibility Criteria:
Inclusion Criteria:

1. Being currently employed by Sussex Partnership NHS Foundation Trust (in the UK) in a role or roles that involve direct delivery of healthcare.
2. Having at least one day per week of direct contact with UK National Health Service service users.
3. Agreeing to refrain from engaging in another form of psychological therapy during the course of the study.
4. Having self-reported sufficient English language reading ability to read and understand the self-help book

Exclusion Criteria:

1. Being currently on leave of absence from work.
2. Having previously received a minimum dose (defined as 50% of a course or more) of a mindfulness-based intervention.
Oral Contraceptive vs Menstrual Cycle Ex Vivo Model

Despite comprising half the population, females are often left out of muscle research due to the impact of changing hormones during the menstrual cycle and when using oral contraceptives. This makes it hard to perform costly and invasive studies involving tracers to study muscle protein metabolism. Consequently, we lack a clear understanding of how these hormonal changes affect muscle growth.

There is a need for less invasive methods to study how sex hormones and oral contraceptives influence muscle protein metabolism. Ex vivo models, where serum from participants is applied to mouse muscle cell cultures, mimic the conditions of human muscle cells and can provide initial insights.

The aim of the study is to develop a non-invasive model using serum from both oral contraceptive users and non-users at various stages of their cycles, to understand if different cycle or pill stages affect how muscles process proteins.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 18.5-29.9 kg/m2 (I.e., non-obese).
* For OC users: on monophasic OCs for \> 3 months prior to study enrollment
* For non-OC users: regular menstrual cycles length (25-35 days) for at least 3 months prior to study and at least 6 months off of OCs.

Exclusion Criteria:

* Chronic disease diagnosis (cardiovascular, thyroid, diabetes)
* Current or recent remission of cancer
* Regular use of NSAID (except low-dose aspirin), anticoagulants
* Use of prescription drugs that would impact metabolism, e.g. Statins, Lithium, Attention-Deficit/Hyperactivity Disorder (ADHD) medication.
* Insertion of intrauterine device (IUD) - exception: copper
* Use of ergogenic aids such as creatine
* Regular Tabacco use
* Use of illicit drugs (growth hormones, testosterone)
* For non-OC users: Use of oral contraceptives for \> 6 months prior to study enrollment - to ensure return to regular menstrual cycle.
Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Third Trimester Medical Termination of Pregnancy Analgesia : a Randomized Study. (PCEA-IMG)

Background : Recently, delivery of local anaesthetics via Programmed Intermittent Epidural Bolus (PIEB) has been shown to improve labour epidural analgesia compared to delivery via Continuous Epidural Infusion (CEI).

Purpose : However, the superiority of PIEB compared to CEI has not been investigated for third trimester voluntary termination of pregnancy.

We hypothesized that PIEB administration would result in a better degree of satisfaction of the patients compared with CEI for third trimester legally induced abortion analgesia.

Abstract : The recent technical advances in antenatal diagnosis have led to an increase number of legally induced abortion at the third trimester of pregnancy. Psychological pain is frequently associated to physical pain in these kinds of interventions. So anaesthetists are more and more involved in voluntary termination of pregnancy analgesia.

In France, Patient Controlled Epidural Analgesia (PCEA) with CEI mode is usually used for voluntary termination of pregnancy analgesia. But recent studies have shown that PIEB mode as compared to CEI mode increases maternal satisfaction during labour. This may be attributed to a more extensive spread of epidural solution when delivered as a bolus rather than continuous infusion.

Few trials have been interested in investigating the best mode of PCEA for legally induced abortion analgesia.

This study includes women who undergo voluntary third semester termination of pregnancy. Patients are randomized to PIEB or CEI for pain analgesia. In this randomized, double-blind study, the investigators assess the degree of satisfaction of the patients (primary outcome), the incidence of motor block, total drug consumption and adverse events (secondary outcomes) between the two study groups.

The different values are collected during the intervention on a specific paper for each patient and the degree of satisfaction is reported on this paper just before the patient leaves the birth room (approximatively 2 hours after the expulsion).

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* ASA 1 or 2 (healthy women)
* pregnancy at third trimester
* willingness of voluntary interrupt the pregnancy
* women affiliated to french health social system
* written informed consent from every patient

Exclusion Criteria:

* contraindications to epidural analgesia
* opioids consumption within the last 24 hours
* patient's unwillingness
* inability to comprehend or comply with the procedure
Proprioceptive Neuromuscular Facilitation in the Flexibility and Strength of Flexor Muscles and Hamstrings

Introduction: The loss of normal values of ROM due to the lack of flexibility and strength in the hip flexors, quadriceps and hamstrings in soccer players can cause a loss of mobility of the hip and knee joint. Proprioceptive neuromuscular facilitation is an active-assisted stretching technique used to improve flexibility and therefore the ranges of joint mobility.

Aim. To assess the effectiveness of an intervention by proprioceptive neuromuscular facilitation in the improvement of flexibility and strength in the hamstring, hip flexor and quadriceps musculature compared to conventional stretches in football players.

Study design. Randomized, multicentric, single-blind clinical study. Methods. The 30 players will be randomly assigned to the study groups: experimental (proprioceptive neuromuscular facilitation and static stretches) and control (static stretches). The treatment will last 6 weeks, with two sessions a week of 5 minutes each. The study variables will be the range of hip mobility (using goniometry), hamstring flexibility (using the EPR test, inclinometer) and the strength of hip flexors, quadriceps and hamstrings (through the RM test). A descriptive statistical analysis will be carried out calculating the main statistical characteristics and after calculating the normality of the sample (test Kolmogorov- Smirnov), the differences between evaluations in each group (t-student test) and the intra- and intersubject effect will be calculated (ANOVA of repeated measures).

Expected results. Improved hip mobility, hamstring flexibility and strength in hip flexors, quadriceps and hamstrings muscles.


Eligibility Criteria:
Inclusion Criteria:

* Volleyball players
* Male
* From 18 to 30 years old
* Federated in the Royal Federation of Football of the Community of Madrid
* Not had any musculoskeletal injuries in the last 3 months.

Exclusion Criteria:

* Impossibility, for work or academic reasons, to comply with the requirements of the study (interventions and evaluations);
* Under pharmacological treatment
* Who are exercising a physiotherapy treatment parallel to the development of the study
* Not sign the informed consent document.
The Study on Profile and Genetic Factors of Aspirin Resistance (ProGEAR Study)

The purpose of this study is to determine the clinically meaningful definition and prevalence of aspirin resistance based on data linking aspirin-dependent laboratory tests to recurrent vascular events in cardiovascular patients taking aspirin.

Primary Outcomes: The primary endpoint is the composite outcomes of cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, percutaneous coronary angiography, thromboembolism, and death caused by cardiovascular disease.

Secondary Outcomes: Platelet aggregation induced by collagen and arachidonic acid, serum thromboxane B2, urine 11-dehydrothromboxane B2, platelet thrombus formation under flow conditions (sub-study only at the National Cardiovascular Center)

The primary objective of this study is to determine the markers for aspirin resistance. To achieve this objective, platelet aggregation, serum thromboxane B2, and urine 11-dehydrothromboxane B2 are measured in patients receiving usual therapeutic doses of aspirin, who experienced acute coronary syndrome, cerebral infarction, or transient ischemic attack occurred in a period between the past 1 month and the past 2 years. This is a multi-center, prospective study.

Eligibility Criteria:
Inclusion Criteria:

Adult males or females who met the criteria listed below:

* Patients who had acute coronary syndrome, cerebral infarction (except cardioembolic stroke), or transient ischemic attack between past 28 days and the past 2 years
* patients who receive long-term aspirin therapy (at least 28 days)
* Patients who are \>=20 years of age
* Patients willing and able to give written informed consent

Exclusion Criteria:

* Malignancy or suspected malignancy
* Patients who showed platelet counts less than 100,000/uL or more than 450,000/uL
* Congenital bleeding tendency
* Patients who receive other antiplatelet drugs or warfarin
* Patients with atrial fibrillation
* Patients who received surgical operation or catheter intervention within the past 2 weeks
* Patients who received anticoagulation drug therapy including heparin ( low-molecular weight heparin) and danaparoid.
* Patients with more than modified Rankin scale 4
Subclinical Cardiac Involvement in Patients With Inflamatory Bowel Disease

Aim of the study is to determine the prevelance of subclinical cardiac involvement in patients with inflamatory bowel disease.

Cardiovascular manifestations in patients with IBD mostly occur as immune-related consequences and include the following: pericarditis, myocarditis, venous and arterial thromboembolism, left ventricle impairment, arrhythmias and conduction disorders and valvulopathy .

The prevalence of classical cardiovascular risk factors is relatively lower in IBD patients than in the general population . However, the risk of coronary heart disease is higher in IBD patients .

The pathophysiology of cardiac involvement may be Systemic inflammation for prolonged periods that can cause platelet aggregation and endothelial dysfunction leading to the development of atherosclerosis and CVD .

The chronic inflammatory condition found in IBD is the key element in the pathogenesis of arrhythmias.

In IBD, inflammation causes mitral and aortic valvulopathies , excess TNF-α causes the thickening and shortening of the leaflets, resulting in regurgitation .

Medications of IBD may be involved in pathogenesis of cardiac involvement as follows 5-ASA and its derivatives can cause myopericarditis . Atrial fibrillation and prolonged QT interval may occur during azathioprine use .

Cyclosporine is associated with increased risk of hypertension, arrhythmias, acute coronary syndrome, and heart failure .

Biological molecules are associated with increased arrhythmogenic risks . Primary preventive measures of arterial thromboembolism include maintaining the remission, strict control of cardiovascular risk factors .

The diagnostic modalities to find out cardiac involvement include; The 12-lead electrocardiogram . Transthoracic echocardiography which represent the method of choice to evaluate both systolic and diastolic functions of Lt ventricle.

Methodology:

All Patints will be subjected to the followings :

Full history taking including

* Duration of illness
* Symptoms of disease activity
* Symptoms of extraintestinal manifestation
* Family history of cardiac disease
* History of traditional cardiovascular risk factors diabetes,hypertension,Dyslipidaemia,cigarette smooking)
* Therapeutic history Examination
* Body mass index.
* Vital signs( pulse,blood pressure,temperature).
* Cardiac examination.

Labaratory investigations

* Complete blood count - serum electrolytes
* ESR - CRP
* lipid profile - blood glucose level
* TSH,T3,T4

ECG

* Ischaemic changes
* Any type of arrythmia
* Prolonged QT interaval

Holter ECG

Echocardiography

* Systolic and diastolic dysfunctions
* Wall motion abnormalities
* Valvular heart disease
* Ventricular hypertrophy
* Atrial and ventricular dimentions

Eligibility Criteria:
Inclusion Criteria:

* Inflamatory bowel disease patients without previous history of cardiac disease.

Exclusion Criteria:

* Patients known to have previous cardiac disease.
Efficacy of Two Therapeutic Exercise Modalities for Patients With Persistent COVID

Symptoms of long-standing sequelae and complications of COVID-19, termed Long COVID19 or persistent COVID, have been reported worldwide. However, the etiology underlying the prolonged or fluctuating symptomatology is limited and there is no uniform and widely accepted definition.Patients describe persistent COVID as a fluctuating disease with variable and persistent symptoms.Most of the effects correspond to clinical symptoms such as fatigue, headache, arthralgias, hyposmia, gustatory sensations, etc. Fatigue is the most common and prolonged symptom of persistent COVID. Knowledge of the pathophysiological mechanisms of fatigue in COVID-19 disease, as well as the therapeutic approach, remains limited due to the relatively recent onset of this pathology. In particular, muscle strength training has been shown to improve muscle function and fatigue, not only during treatment, but also at long-term follow-up.

Objective: To evaluate the effects on the perception of fatigue in patients with persistent COVID, who undergo a supervised and directed therapeutic exercise program in a health center compared to a home therapeutic exercise program.

Methods: Randomized pilot study. Subjects who are included in the study will perform a therapeutic exercise program which will last 8 weeks and 2 sessions per week of 1h duration. The participants assigned to the supervised group will carry out the program at the health center, while the participants assigned to the home group will receive telematic supervision (by videoconference). Both groups will be under the supervision of the assigned physiotherapist.

The components that will form part of the exercise program will be: muscular strength training and continuous-variable aerobic training or HIIT type with loads between 70-90% of maximum heart rate. The main variables are fatigue.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients diagnosed with LongCOVID19 or persistent COVID19.
* Agree to participate and sign the informed consent form.

Exclusion Criteria:

* Patients with comorbidities associated with having fatigue (e.g. cancer survivors, severe cardiovascular or respiratory disease prior to persistent COVID).
* Taking medication of drugs that may interfere with the perception of fatigue.
* Patients with mental disorders or cognitive impairment prior to persistent COVID.
* Patients who regularly practice intense sports (\>4h/week).
* Any illness that may condition understanding and compliance with the study.
Development of a Digital Tool, MyInspiration, for the Improvement of Spiritual Well-Being in Patients with Cancer

The purpose of this study is to pilot a beta version of a digital resource that supports the religious and spiritual beliefs of cancer patients, "MyInspiration".After receiving a cancer diagnosis, survivors are encouraged to make major life-altering decisions related to their treatment and care. The availability of spiritual/religious resources during cancer treatment may positively impact patient outcomes, feelings of well-being, and be essential components of holistic, patient-centered care. MyInspiration is a digital tool focused on spiritual and/or religious guidance and support that can be customized based on patient preferences and administered to cancer patients and their family members during cancer treatment. MyInspiration may help improve spiritual well-being in patients with cancer.

PRIMARY OBJECTIVES:

I. Conduct a pilot of MyInspiration to determine acceptability, feasibility, and general satisfaction by its end-users.

II. Explore the qualitative opinions of patients who participated in the feasibility trial more in-depth using 1-on-1 interviews.

OUTLINE: Single-group feasibility pilot.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Capacity to sign an informed consent form
* Eligible for a surgical procedure (defined with International Classification of Diseases \[ICD\]-10 codes) that will require an in-patient stay at the Ohio State University Comprehensive Cancer Center (OSUCCC)-James
* Diagnosed with cancer
* Ability to read English (however, we will make all possible considerations to include non-native English speakers)
* Access to some form of internet (webpage, smartphone, tablet, etc.)
Longitudinal Multimodal Neuroimaging Studies in Patients With First Episode Psychosis

The purpose of this study is to investigate the structural, functional and chemical brain abnormalities in patients with first episode psychosis and assess the evolution of these abnormalities during the course of the disease.

The purpose of this study is to investigate the structural, functional and chemical brain abnormalities in patients with first episode psychosis and assess the evolution of these abnormalities during the course of the disease.

The study design is case-control, there are no interventions.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of first episode of a psychotic disorder
* Healthy controls with no psychiatric disorder history

Exclusion Criteria:

* Significant neurological or medical illness history
* Ages \<18 or \>45