cyrilzakka/clinical-trials huggingface dataset:
Functional Effects and Impact on Motor Neuronal Activity of Early and Intensive Motrice (Hand and Arm Bimanual Intensive Therapy Including Lower Extremities: HABIT-ILE) Reeducation in Children With Pre-school Bilateral Cerebral Palsy

One of the urgent priorities in the field of pediatric neuro-rehabilitation is the development of efficient early motor interventions for children with cerebral palsy (CP). Animal studies suggest that early intensive interventions are likely to have a significant impact on the organization of the brain and corticospinal tracts, reducing motor impairments and their medium and long-term consequences in children with cerebral palsy. Although most of the growth, development and cortical organization takes place in the time course of the first 2 years of life, most studies investigating the effectiveness of intensive rehabilitation and associated neurophysiological mechanisms have been conducted in school-aged children (\> 6 years). In addition, the vast majority of these studies were conducted in children with unilateral CP, while the bilateral form of the pathology has the highest prevalence. It is therefore a priority to investigate the effectiveness of early interventions on the overall motor function of children with CP, especially in children with bilateral form of CP.

Hand and Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) makes it possible to apply the concepts of structured motor learning and intensive treatment to both the upper limbs and the lower limbs and demonstrated improvements at both levels in school-aged children with unilateral CP and bilateral and then at all three International Classification of Functioning and Disability levels. The principles and content of HABIT-ILE can be applied to pre-school children and this method is promising for early neuro-rehabilitation.

The main objective of this study is to evaluate the effect of 10 days (i.e. 50 hours) of early HABIT-ILE (HABIT-ILE) on the overall motor function of children aged 1 to 4 with bilateral cerebral palsy in comparison to 10 days (50h) of spontaneous overall motor activity including usual rehabilitation (control group).

Eligibility Criteria:
Inclusion Criteria:

* Child with bilateral cerebral palsy proven to be spastic or dyskinetic
* 1 to 4 years old inclusive (12 to 59 months) (age corrected if premature) able to follow instructions and to be able to carry out all the assessments, in accordance with his age
* Being matched to a child according to age, etiology of CP / classification of motor function (GMFCS)
* Signature of consent by the two holders of parental authority

Exclusion Criteria:

* Exceed 4 years and 11 months (59 months) during the internship evaluation period.
* Uncontrolled epilepsy.
* History of toxin injection or surgery in the 6 months preceding the study period or scheduled within 3 months (during the study period).
* Visual or cognitive deficit preventing the child from seeing the games and interacting
* Usual contraindications to magnetic resonance imaging (MRI) such as metal implants.
The Efficacy of Denosumab in Decreasing Periprosthetic Bone Loss in Patients With Total Knee Arthroplasty

This study evaluates the effect of Denosumab in decreasing the periprosthetic bone resorption after Total Knee Arthroplasty compared to placebo in 60 patients (30 placebo and 30 Denosumab) within a year after surgery.

Periprosthetic bone resorption after Total Knee Arthroplasty occurs as a consequence of prosthetic implant on the bone. Some of this patients (up to 13%) develop an aseptic failure of the prosthesis needing revision surgery.

2 groups of patients are treated with Placebo and Denosumab in a double blind prospective trial. Densitometry, Knee society score (KSS), Western Ontario McMaster University Osteoarthritis Index (WOMAC) and the Medical Outcomes Study Short Form 36 (SF-36) were done in both groups at 0,3,6 and 12 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Knee Osteoarthritis treated with Total Knee Arthroplasty

Exclusion Criteria:

* Patients allergies to Denosumab
* Patients with previous Osteoporosis treatment
* Patients with renal failure
* Patients with previous Bisphosphonate treatment for more than 5 years
Immobilization in Reverse Shoulder Prosthesis

Reverse shoulder prostheses are the treatment of choice in elderly patients with rotator cuff arthropathy. Traditionally these patients have been immobilized for 3 weeks in the immediate postoperative period in order to have good pain control. However, there are no studies that determine the most appropriate period of immobilization. In fact, patients undergoing this type of surgery begin rehabilitation exercises within 24 hours of surgery without experiencing increased pain or requiring specific analgesic treatment. There is a demand in the elderly to limit immobilization time as much as possible, as some live alone and need to be self-sufficient and others have dependents. It would be good to know if it is really necessary to make an immobilization in these patients undergoing this type of surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing primary surgery of inverted prosthesis for rotator cuff arthropathy.
* age between 65-85 a.
* without inflammatory pathologies (rheumatoid arthritis, psoriatic arthritis, ...)
* acceptance to be part of the study.

Exclusion Criteria:

* prosthetic surgery prior to the affected limb.
* other indications of reverse prosthesis other than rotator cuff arthropathies (acute fractures, sequelae fractures, tumor surgery, prosthetic revision surgeries).
* no acceptance to participate in the study.
CHIME: Comparing Health Interventions for Maternal Equity

The goal of this comparative effectiveness trial is to compare how three different approaches to overcome barriers to resources and provide nutrition and physical activity counseling improve maternal healthy weight in pregnancy and postpartum.

The main question it aims to answer is which of the two multi-level, multi-component interventions has greater effectiveness in reducing maternal postpartum weight retention at 12-months postpartum.

Hypothesis (primary): Both multi-level, multi-component interventions will have greater effectiveness reducing maternal postpartum weight retention at 12-months postpartum than the usual care group.

Hypothesis (secondary): The community-based intervention will have greater effectiveness than the self-management intervention.

Participants will be asked to participate in one of the study interventions from early pregnancy until 12 months postpartum and complete five research visits. General procedures include completion of:

* Questionnaires
* Dietary recalls
* In-depth interviews
* Anthropometric measurements
* Collection of blood via finger stick or blood panel


Eligibility Criteria:
Inclusion Criteria:

* Maternal age 18 years or older
* Maternal gestational age ≤ 20 weeks with viable singleton pregnancy documented on first trimester ultrasound with an intention to continue pregnancy to term
* Plans to continue receiving antenatal care at the recruitment site/network
* Maternal characteristics include at least one of the following:
* Self identifies as Black/African American
* Self identifies as Hispanic/Latino/a/e/x
* Insured by Medicaid
* Maternal ability to speak English or Spanish
* Completion of baseline data collection (maternal survey data, weight, and height measurement prior to randomization)

Exclusion Criteria:

* Age \< 18 years at baseline because of unique developmental differences of adolescents and regulations regarding age of consent
* Underweight (BMI \<18 kg/m2) at pre-pregnancy period
* Underlying disease/treatment that might impact weight status (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)
* Unwillingness or inability to complete study visits or intervention components
* Unwillingness or inability to commit to intervention components for self or infant, including plans to move more than 100-mile radius from recruitment site
* Multiple gestations
Feasibility of Isolating P16 Expression

Expression of the cell cycle regulator p16INK4a increases with age and toxic stressors. In mice, both radiation and chemotherapy are known to increase p16. Due to its influence on age-related regenerative capacity, p16 is an excellent candidate biomarker of physiologic reserve that may identify patients able to withstand the stressor of chemotherapy (low p16) from those unlikely to tolerate chemotherapy (high p16). That is, expression of p16 may predict physiologic, rather than chronologic, age. Such findings could have implications for care of cancer survivors and treatment decision-making in cancer patients.

STUDY OBJECTIVE: This is an observational pilot study to determine the feasibility of isolating p16INK4a in CD3+ T lymphocytes in adults treated with chemotherapy for cancer during childhood.

At St. Jude Children's Research Hospital, survivors who meet the eligibility criteria will be identified from SJLIFE protocol participants. After signing consent, the subject will have a blood specimen collected at the same time as the blood draw for the SJLIFE protocol. These samples will have T cell isolation performed then placed on ice and stored until batch shipment for investigation of p16 expression.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the SJLIFE study at St. Jude children's Research Hospital.
* Survivor of childhood cancer.
* Is 18 years of age and older.
* No evidence of cancer recurrence.
* Received prior chemotherapy (prior radiotherapy is allowed).

Exclusion Criteria:

* Inability or refusal to give consent.
Intravenous Metoprolol in Septic Shock

A RCT designed to assess the effect of giving intravenous beta-blockers in patients with septic shock after achieving hemodynamic stability. The principle of this study is to control heart rate allowing for better diastolic filling and thus better perfusion.

A RCT, conducted at alexandria main university hospital, patients were divided into 2 groups, Control group which received the standard care for septic shock and metoprolol group which recieved intravenous metoprolol then patients were assessed for Blood pressure, heart rate, iv fluids needed, vasopressor doses and 28 days mortality

Eligibility Criteria:
Inclusion Criteria:

* The study population included adult patients (≥ 18 years) diagnosed with septic shock secondary to VAP with sinus tachycardia, from April 1, 2022, to April 31, 2023. Septic shock was defined according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). VAP was identified as per the guidelines provided by the American Thoracic Society and Infectious Diseases Society of America.

Exclusion Criteria:

* Patients were excluded if they had contraindications to beta-blockers, had a history of heart failure, or had been receiving beta-blockers prior to the septic shock. Patients were also excluded if they developed complications from beta- blockers administration.
MDR-TB Close Contacts Tracing in China (TCCT Study)

To investigate the incidence of etiologically confirmed or clinically diagnosed active tuberculosis in close contacts of MDR-TB patients.

This study is a prospective observational cohort study. MDR-TB patients from multi-centers in China were continuously evaluated one by one, their close contacts were screened for elibgility. All subjects were followed for the same length of time: 80 weeks after enrollment. The symptoms and signs of tuberculosis were followed up to monitor the occurrence of tuberculosis.

The primary objective is to investigate the incidence of etiologically confirmed or clinically diagnosed active TUBERCULOSIS in close contacts of MDR-TB patients.

The secondary objective is to assess latent TB infection rates in close contacts of MDR-TB patients; evaluate the high risk factors of TUBERCULOSIS in close contact population; assess the loss rate of close contacts within 80 weeks; assess the 80-week mortality rate among close contacts; isolate the mycobacterium tuberculosis from all patients with active tuberculosis and analyze drug resistance to evaluate the homology and drug-resistant transmission pattern of Mycobacterium tuberculosis.

Eligibility Criteria:
The index patient:

Inclusion Criteria:

1.18-70 years old; 2.Has smear-positive pulmonary tuberculosis with initial laboratory results with resistance to rifampicin confirmed by GeneXpert; 3.Have an identifiable address and stay in the area during the study period.

Exclusion Criteria:

1. Combined extrapulmonary tuberculosis;
2. HIV antibody positive and AIDS patients;
3. Critically ill patients, and according to the judgment of the research physician, it is impossible to survive for more than 4 months.

Termination/termination criteria:

1. The patient requests to withdraw from the visit;
2. Misdiagnosis and error.

The close contacts:

Inclusion Criteria:

1. Willing to participate in trial treatment and follow-up and can give informed consent;
2. Willing to carry out HIV testing;
3. More than 6 hours of cohabitation per week in the 2 weeks prior to diagnosis of the index case.

Exclusion Criteria:

1. Patients with active tuberculosis confirmed clinically or etiologically;
2. Mental illness and severe neurosis;
3. The researchers determined that there were any ineligible conditions.

Termination/termination criteria:

1. The patient requests to withdraw from the visit;
2. Find a violation of inclusion or exclusion criteria during treatment.
The Effect of Zinc, β-carotene, and Vitamin D3 in Preterm Delivery Through Placental MyD88, TRIF, NFkB, and IL-1β

This study is a controlled trial which compares the effect of zinc, beta-carotene, and Vitamin D3 supplementation in pregnant women which has preterm birth. The measured outcome is zinc, vitamin A, and 25(OH)D level in serum and placenta, MyD88, TRIF, NFκB, and IL-1β levels in placenta.

The research will be held in Cipto Mangunkusumo General and Budi Kemuliaan Hospital.

Each participant of each group will be given the medication of preterm birth hospital protocol, which includes nifedipine 4x10 mg as tocolytic agent, dexamethasone 2x6 mg intravenous for 2 days which aims to support lung maturation, and antibiotic. Then, the blood sample is obtained for zinc, vitamin A and 25(OH)D levels examination. Subjects will be divided into 2 groups which are group whose given the oral zinc 50 mg/day, oral beta-carotene 25,000 IU and oral vitamin D3 50,000 IU/week supplementation, and group who is not given the intervention. Each participant will be observed until delivery. After delivery, level of zinc, vitamin A, and 25(OH)D in serum and placenta will be measured, as well as level of MyD88, TRIF, NFκB, and IL-1β in placenta.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who has preterm birth in 26-36 weeks gestational age

Exclusion Criteria:

* Multiple pregnancy
* Drug allergy
* Intra Uterine Growth Retardation (IUGR) is detected
* Congenital malformation in fetus was found
* Preterm Premature Rupture of Membrane (PPROM)
* Maternal complication such as gestational hypertension, preeclampsia, gestational diabetes mellitus, heart disease, infection, and autoimmune disease
The Relationship Between Emotional Intelligence, Social Behavior, Sleep Quality and Academic Success in Students Studying in Health-Related Departments

This study aims to examine the relationships between emotional intelligence, positive social behavior, sleep quality, and academic achievement among students enrolled in health-related academic programs. Specifically, the study will investigate how emotional intelligence levels influence students' social behaviors and academic performance, while also assessing the role of sleep quality in these variables. Data will be collected using the Emotional Intelligence Scale, the Positive Social Behavior Scale, and the Epworth Sleepiness Scale. The findings of this study are expected to provide valuable insights into how emotional intelligence and sleep quality impact students' academic success and social behavior.


Eligibility Criteria:
Inclusion Criteria:

* Being a university student in health-related departments

Exclusion Criteria:

* Having any diagnosed physical or psychological illness
The Association Between Sedentary Behaviour and Cardiometabolic Health in Trained Athletes

Physical inactivity is one of the major contributing factors for the development of chronic diseases and highly correlated with increased all-cause mortality. In the last decade an exponential growth in research concerned with the study of sedentary behaviour and the potential for detrimental effects on health have been published. In this field increasing evidence suggests that prolonged periods of sedentary time, independent of the amount of physical activity, also increases the risk for the development of several chronic conditions and all-cause mortality. Here, sedentary behaviour is defined as "any waking behaviour, characterized by a low energy expenditure (≤1.5 METs), while being in a sitting or reclining posture". Interestingly, the advised moderate-to-vigorous bouts of exercise recommended by the various guidelines cannot compensate the negative impact on health risks arising from prolonged periods of sitting. In other words, it seems that people compensate their total amount of physical activity after exercise training by decreasing their physical activity levels throughout the rest of the day. Here, it appears that frequent, even low-intensity interruptions of periods of sitting are required for good cardiometabolic health. Therefore, not only physical activity but also prolonged sitting should be targeted to optimize cardiometabolic health. Nevertheless, a recent harmonized meta-syntheses indicated that the association between self-reported sitting with all-cause and cardiovascular disease mortality are only partially independent of physical activity, but were particularly evident in those who undertake insufficient physical activity (\<150min/week). However, it is unclear whether high amounts of objectively measured physical activity attenuates or even eliminates the detrimental effects of prolonged sitting. In addition, it is still unclear whether high amounts of physical activity can preserve a healthy cardiometabolic risk profile, despite prolonged sitting. Therefore, in this study we want to investigate the association between sedentary behaviour, physical activity and cardiometabolic health in highly physically active adults.


Eligibility Criteria:
Inclusion Criteria:

* Active individuals with at least 4 training hours per week

Exclusion Criteria:

* pregnancy
* Any known contradiction for physical activity
* Systolic blood pressure \>160mmHg, diastolic blood pressure \>100mmHg
* More than 20 alcohol consumptions per week
* Participants diagnosed with any known chronic disease
Use of MonitorMe in COPD

MonitorMe is a telephone device intended for the non-critical monitoring of vital signs in a domestic environment with the ability to automatically transmit data to a remote location via basic telephone connectivity.

MonitorMe's low-cost, call automation and simple to use technology (i.e. based on the principles of an ordinary plug-in telephone) make it appropriate for a wide number of care pathways. It eliminates the need for a modem or broadband and avoids the challenges of less reliable smart phone technology. Typical use scenarios include remote monitoring of individual or multiple chronic disease states such as COPD to improve patient outcomes including prevention of emergency admissions.

There is growing interest in the use of home telemonitoring in COPD in order to facilitate the management of the increasing numbers of patients and pressures on the NHS. Despite the positive effects of telemonitoring in conditions such as heart failure, benefits remain unproven in COPD and further work is required before wide-scale use.

Furthermore, until now the evaluation of telecare and telehealth developments has focused mainly on effectiveness and efficiency, whereas their social, and ethical implications in particular, have not been explored in depth. We will also explore ethical issues related to the use of telehealth systems, from both the patients' and the healthcare professionals' perspective.

The current feasibility study is designed to assess the acceptability, usability and validity of MonitorMe within one of its intended purposes i.e. remote monitoring of individual or multiple chronic disease states such as COPD.


Eligibility Criteria:
Inclusion Criteria:

Patients

* Adults diagnosed with any severity of COPD (according to British Thoracic Society criteria, i.e. \>10 pack year smoking history and post bronchodilator spirometry FEV1/FVC ratio \<0.70 and FEV\<80%)
* Listed on referral lists or COPD registers within Lincolnshire Community Health Services NHS Trust or NHS South West Lincolnshire CCG

Health care professionals

* Involved in implementing the device within Lincolnshire Community Health Services NHS Trust or NHS South West Lincolnshire CCG
* Provide informed consent to participate in an interview

Exclusion Criteria:

Patients

* Inability or unwillingness to sign informed consent
* No active telephone line in home
* COPD exacerbation within the previous 6 weeks.
* Mental health, cognitive or neurological conditions that would make study participation inappropriate
* Life expectancy \< 6 months
* Implanted pacemaker
* Hearing or visual ailments that would preclude the use of the MonitorMe device
* Inability to use both hands (i.e. hold handset in one hand and use keypad with the other at same time)
* Inability to understand verbal English

Health care professionals

* Not involved in implementing the device within Lincolnshire Community Health Services NHS Trust or NHS South West Lincolnshire CCG
* Unable/unwilling informed consent to participate in an interview