cyrilzakka/clinical-trials huggingface dataset:
Effect of Electrical Stimulation With Functional Task Training on Balance and Motor Abilities in Children With Diplegia

The aims of the study are to:

1. Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on balance in children with diplegia.
2. Investigate the combined effect of functional task training with electrical stimulation of bilateral hip abductor muscles on motor abilities in children with diplegia.

Cerebral palsy (CP) is a group of permanent disorders of movement and posture. It is non-progressive lesion or abnormality of immature brain. The term cerebral refers to the brain and palsy refers to the loss or impairment of motor function.

Functional electrical stimulation (FES) is a subtype of neuromuscular electrical stimulation (NMES) in which the stimulation assists functional and purposeful movements. This is achieved by applying electrical stimulation to muscles that, when they contract, produce a movement that can be used functionally.The FES is used to provide electrical stimulation via the peripheral nervous system to activate muscle contractions to assist functional activities when nervous or musculo-skeletal systems are damaged.The common applications of FES include strengthening muscle, reducing muscle spasticity, increasing range of motion, improving upper extremity function and walking speed.

Eligibility Criteria:
Inclusion Criteria:

* Their ages will range from 7-11 years.
* Both genders will be included.
* Their degree of spasticity will range from 1 to 1+ according to Modified Ashworth Scale (Meseguer-Henarejos et al., 2018).
* Their motor function will be at level I \& II according to Gross Motor Function --- -Classification system (Palisano et al., 2008).
* They will be understanding instructions.

Exclusion Criteria:

* Children will be excluded from the study if they have any of the following criteria:

Musculoskeletal fixed deformities in upper limb, lower limb or spine.

* Visual or hearing problems.
* Epilepsy.
* Botulinium toxin therapy or orthopedic surgery within the past 6months or within the study period.
Negative Pressure Ventilation Imapcts Weaning Ventilator In Medical Intensive Care Units (ICUs)

This is a Quasi-experimental research design. The subjects are limited in intensive care unit within north medical center hospital. All subjects depend on ventilator and receive weaning plans. Experimental group is weaning with the support of negative pressure ventilator .The investigators collect basic personal variables in the questionnaire, APACHE Ⅱ scale, Dyspnea scale and arterial blood gas analysis and ventilator weaning index. Compare experimental group and control group data. Data will be Statistical analyzed by: descriptive statistics (such as: mean, standard deviation, median, frequency, percentage) and inferential statistics (such as: Independent T-test, Pair T-test, Mann-Whitney U test), P-value \<0.05 will consider to be statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* Acute respiratory failure patients in medical ICUs

Exclusion Criteria:

* Age\<20 years old
* Malignancy
* Pregnancy
Safety of the Sputnik V Vaccine in Health Personnel of Private Effectors of the City of Buenos Aires, Argentina

The main of the study is to describe the incidence in health personnel who present events supposedly attributed to vaccines and immunizations after having received the two components of the Sputnik V vaccine, with the information obtained thanks to the participation of health workers in actively reporting their health status.

The World Health Organization (WHO) recommends vaccination against coronavirus disease 19 (COVID-19) as a fundamental primary prevention tool to limit the health and economic effects of the pandemic. having effective and safe vaccines in the short term,will help to reduce the incidence of illness, hospitalizations and deaths related to COVID-19 and help to gradually restore a new normality in the functioning of our country.

On December 23, within the framework of Law 27573, the National Administration of Medicines, Food and Medical Technology submitted the report on the Sputnik V vaccine to the Ministry of Health of the Nation to advance in the Emergency Authorization.

The National Government ensures the processes to reach the standards of safety and efficacy for the entire Argentine territory, being vaccination in stages, free, voluntary and independent of the history of having suffered the disease.

For the surveillance of vaccine safety, the Strategic Plan proposes to health effectors "To develop a specific plan for intensified passive and active surveillance of vaccine safety, which allows the continuous analysis of the notifications of Events Supposedly Attributed to Vaccines and Immunizations.

The Ministry of Health of Buenos Aires City articulated the public and private effectors for the epidemiological follow-up of the personnel vaccinated with the first vaccines in relation to the frequency of Events Supposedly Attributed to Vaccines and Immunizations.

The main of the study is to describe the incidence in health personnel who present events supposedly attributed to vaccines and immunizations after having received the two components of the Sputnik V vaccine, with the information obtained thanks to the participation of health workers in actively reporting their health status.

Eligibility Criteria:
Inclusion Criteria:

* health workers who agree to receive the sputnik V vaccine

Exclusion Criteria:

* health workers who have a contraindication to receive the sputnik V vaccine
External Validation of the 4C Mortality Score for Hospitalised Patients With COVID-19 in a Tunisian Cohort

Risk prediction scores are important tools to support clinical decision-making for patients with coronavirus disease (COVID-19). The objective of this paper was to validate the 4C mortality score, originally developed in the United Kingdom, for a tunisian population, and to examine its performance over time.

Coronavirus disease (COVID-19) caused by the Severe Acute Respiratory Syndrome Virus 2 (SARS-CoV-2) can progress to acute respiratory distress syndrome, multiorgan failure, and death in some cases. The clinical presentation and progression of COVID-19 in patients is highly variable, which makes it difficult for clinicians to triage patients and determine their prognostic risk. A simple, validated prognostic tool using data that is available at presentation can help clinicians better prognosticate and support clinical decision-making . Numerous tools to predict mortality in COVID-19 patients have been developed, but many are limited due to small derivation cohort sizes and/or inadequate validation.

The 4C mortality score is an accessible risk stratification score developed by the International Severe Acute Respiratory and Emerging Infections Consortium (ISARIC). It was derived and internally validated on a large, diverse cohort within the United Kingdom but requires external validity to confirm its generalizability.

The objective of this study was to validate the 4 C Mortality risk score to predict in-hospital mortality among adults hospitalised with COVID-19 in a Tunisian cohort.

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Eligibility Criteria:
Inclusion Criteria:

* patients ≥18 years old
* admitted to one of the participating hospitals with a confirmed case of COVID-19 defined by a positive reverse transcriptase-PCR (RT-PCR) assay of a nasopharyngeal swab associated with compatible clinical manifestations

Exclusion Criteria:

* under the age of 18
* Incomplete electronic records were excluded from the analysis.
Effects of Brain Network by Simultaneous Dual-mode Stimulation in Subacute Stroke Patients

Repetitive transcranial magnetic stimulation (rTMS) or transcranial direct current stimulation (tDCS) has been used for the modulation of stroke patients' motor function by altering the cortical excitability. Recently, more challenging approaches, such as stimulation of two or more sites or use of dual modality have been studied in stroke patients. In this study, simultaneous stimulation using both rTMS and tDCS (dual-mode stimulation) over bilateral primary motor cortices (M1s) was investigated to compare its modulatory effects with single rTMS stimulation in subacute stroke patients.

Investigators assessed each patient's motor function using the Fugl-Meyer Assessment (FMA) score and acquired their resting-state fMRI (rs-fMRI) data at two times: prior to stimulation and 2 months after stimulation. Changes in rs-fMRI network measures were investigated between groups.

Eligibility Criteria:
Inclusion Criteria:

* First-ever stroke patients
* Subacute stage (less than 4 weeks)
* Total Fugl-Meyer Assessment (FMA) score under 84

Exclusion Criteria:

* Major active neurological disease or psychiatric disease
* A history of seizure
* Metallic implants in their brain
Response to Anti-hypertensives in Pregnant and Postpartum Patients

In this study, the investigators will evaluate the blood pressure response to nifedipine and labetalol in pregnant and postpartum patients, who present with hypertensive disease in pregnancy with severe range blood pressure defined as greater than 160/110. These anti-hypertensives are first line therapy for management of severe range blood pressures in pregnancy and postpartum by the American Congress of Obstetricians and Gynecologist (ACOG). In addition at the Mount Sinai West site, the investigators will also analyze the ADRB1 and similar genes involved in beta blockade, genes involved in calcium channel blockade and other genes implicated in blood pressure response among pregnant and postpartum patients receiving labetalol and nifedipine. This analysis will be used to determine if a pharmacogenetic association exists between variant alleles in these receptors in the pregnant and postpartum population.

Hypertensive disease in pregnancy is a major cause of maternal morbidity and mortality. This condition is responsible for about 12% of the maternal deaths in the United States.

Currently, if pregnant patients present with severe hypertension they are either given IV labetalol, IV hydralazine of nifedipine based on individual provider preference. There are few studies in the literature comparing oral nifedipine and IV labetalol with mixed data showing either they are equally effective or a faster time to achieving target blood pressure for patients who received nifedipine.

In this study, the investigators will evaluate if there is a difference in time to achieve goal blood pressure in pregnant and postpartum patients who are treated with nifedipine and labetalol for severe range blood pressures defined as greater than 160/110. These anti-hypertensives are first line therapy for management of severe range blood pressures in pregnancy and postpartum by the American Congress of Obstetricians and Gynecologist (ACOG).

Eligibility Criteria:
Inclusion Criteria:

* pregnant patients from 20 weeks to up to 6 weeks postpartum
* between the ages of 18-55.
* persistent severe range blood pressures (2 readings or more within 15 minutes) of either 160mmHg systolic or 110mmHg diastolic.

Exclusion Criteria:

* multiple gestation
* patients with non-reassuring fetal heart rate (category 3)
* patients with abruptio placenta
* patients with renal impairment
* history of heart failure
* history of cardiac arrhythmia
* use of anti-hypertensive medications in the past 24 hours
* patients with allergies or medical contraindications to labetalol or nifedipine.
A Study to Learn About the Long-Term Health of Adult Participants From a Previous Study of a New Melanoma Treatment

This study is researching the long-term effects of a combination of experimental drugs called fianlimab and cemiplimab. The study is being conducted in patients with advanced skin cancer (melanoma) who had previously been treated with fianlimab and cemiplimab in the study called R3767-ONC-1613 (NCT03005782).

The aim of the current study is to see how safe and effective the study drugs are in a long-term follow-up. No study drug will be given during this study. Cancer status will be monitored, in addition to routine care. The study is also collecting information about general health status, and other treatments that may have been received since participation in study R3767-ONC-1613 (NCT03005782).


Eligibility Criteria:
Key Inclusion Criteria:

1. Participants with melanoma who enrolled in cohorts 6, 15, or 16 of study R3767-ONC- 1613 (NCT03005782)

Key Exclusion Criteria:

None

Note: Other protocol-defined Inclusion/ Exclusion criteria may apply
Effects and Dose-response of Manual Therapy in the ROM of the Ankle in Older People

Limitations of the joint range of the ankle in elderly people is usually common. One of the ways to treat this limitation is through manual therapy, although the effects it produces in dose-response terms are still not well understood. Because of this, this work on the one hand aims to determine the effects and effectiveness of manual therapy and, on the other hand, determine the dose-response necessary for the range of motion of the ankle to improve when applying techniques of manual therapy on the ankle in the older adult.


Eligibility Criteria:
Inclusion Criteria:

* Age
* Ankle dorsiflexion limitation

Exclusion Criteria:

* Do not sign the consent
* No injuries in the foot
* No acute pathology (3 months) in lower limb
Kids Intestinal Dysfunction in Congenital Heart Disease: the Kind Heart Study

Approximately 40,000 infants are born each year in the United States with congenital heart defects (CHD), and heart defects are the leading cause of birth defect-related deaths in the United States. While advances in surgical treatment, cardiac bypass, and post-operative management have improved mortality for children born with heart defects, these children continue to have significant morbidity related to post-operative malnutrition, multiple organ dysfunction (MODS), and sepsis. Proposed mechanisms for post-operative sepsis and MODS is via loss of intestinal epithelial barrier function (EBF) or intestinal micro biome diversity.

The purpose of this multi-center observational cohort study is to understand the extent to which practice variation for routine post-operative care might worsen intestinal barrier dysfunction and reduce diversity of the intestinal microbiome for infants undergoing surgical correction of left sided cardiac obstructive defects. We will enroll 80 children with left sided obstructive congenital cardiac lesions across several US congenital cardiac centers to obtain clinical data and biological specimens. We will leverage existing differences in nutritional and antibiotic strategies at these centers to better understand how intestinal barrier function and the intestinal microbiome may contribute to post-operative multiple organ dysfunction syndrome.


Eligibility Criteria:
Inclusion Criteria:

* pre-operative diagnosis of left sided obstructive congenital cardiac defect

Exclusion Criteria:

* Corrected gestational age \< 37 weeks at time of surgery
* Short bowel syndrome
* Intestinal graft vs. host disease
* Inflammatory Bowel Disease (Ulcerative Colitis, or Crohn's disease)
* Candidate for intestinal transplant
* History of necrotizing enterocolitis (NEC)
* Previous Randomization into this study
Testing a Modified Family Planning Intervention for Postpartum Women in Uganda

The purpose of this study is to test whether offering incentives to encourage women to attend one-on-one family planning education sessions and offering free, onsite prescription contraceptive methods increases use and continuation of prescription contraception among postpartum women in Uganda. This intervention is modified from one that has been effective outside of Uganda.


Eligibility Criteria:
Inclusion Criteria:

* 18-45 years of age
* Not planning on getting pregnant in the next 4 months
* Less than 3 months postpartum
* No history of tubal ligation or hysterectomy
* No recent prescription contraceptive use (no pill, intrauterine device or implant use in the past 7 days or injection use in the past 3 months)
* Medically eligible to use prescription contraceptives
* Bringing baby to immunization clinic for the first time

Exclusion Criteria:

* Failure to meet the aforementioned inclusion criteria
Gastrointestinal Evaluation in Young Men With Iron Deficiency Anemia

Both upper gastrointestinal endoscopy and colonoscopy are recommended in men and post-menopausal women with iron deficiency anemia. Due to lack of data on the yield of these endoscopies in young men, they are currently investigated as older men. The aim of this study is to evaluate prospectively the prevalence of various gastrointestinal lesions in young men with iron deficiency anemia. Our hypothesis is that the diagnostic yield of colonoscopy in young anemic men without gastrointestinal symptoms is very low, especially if a potential lesion is detected during upper gastrointestinal endoscopy. Therefore, this study will try to identify predicting factors regarding the yield of both endoscopies. Another purpose is to evaluate the outcome of patients with negative endoscopic results, during a follow-up of two years.


Eligibility Criteria:
Inclusion Criteria:

* Men \< 40 years old of age with iron deficiency.
* hemoglobin level less than 13 gr/dl documented during the 2 years prior to entering the study with one of the following: 1) iron level less than 45 μg /dl and transferrin saturation less than 10%; 2) ferritin level less than 20 μg/L (both documented during the 4 months prior to entering the study).

Exclusion Criteria:

* Previously diagnosed disease that explain iron deficiency anemia
* Colonoscopy performed during the last 4 years
* Upper gastrointestinal endoscopy performed during the last 2 years
Clinical Trial to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg in Healthy Male Volunteers

This Phase I clinical study is to evaluate the safety and pharmacokinetics of DA-2802 319mg and Viread 300mg after a single oral dose in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 to 50, healthy male subjects(at screening)
* Body weight over 55kg, BMI between 18.0 - 27.0
* Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, neurology, immunology, pulmonary, endocrine, hematooncology, urinary, skeletomuscular, cardiovascular, mental disorder)
* Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
* Genetic disorders such as glucose-galactose malabsorption, Lapp lactose deficiency, galactose intolerance which is contraindication to Viread
* Volunteer who had hypersensitivity reaction to medicines including Tenofovir, Aspirin, or antibiotics
* exceed 1.5 times the normal range of AST, ALT at screening test before randomization
* history of drug abuse, or a positive urine drug screen
* having ETC drug or herbal medicines within 2 weeks before first administration or OTC drug or vitamin preparations within a week before first administration
* Participation in any other clinical trial involving investigational drugs within 3 months
* Volunteer who had whole blood donation in 2 months, or component blood donation or transfusion in 1 months
* Regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study
* Volunteers smoking over 10 cigarettes per day or who cannot abstain from smoking during the study(from 24hr before admission to discharge)
* Volunteers who had grapefruit containing foods from 24hr before admission to discharge or who cannot abstain from grapefruit containing foods
* Volunteers who are not using adequate contraception methods or have a pregnancy plan
* volunteers who cannot abstain from caffeine containing foods(coffee, tea, soft drinks etc) during the study
* any condition that, in the view of the investigator, would interfere with study participation
Adult Pulmonary Langerhans Cell Histiocytosis: a National Registry-based Prospective Cohort Study

The long-term outcomes of adult patients with pulmonary Langerhans cell histiocytosis (PLCH), particularly survival, is largely unknown. This is the first prospective study in the field evaluating the long-term outcomes of PLCH patients. This french countrywide registry-based study included a large cohort of PLCH patients followed for a sufficiently long period to address risk factors of long-term outcomes of PLCH patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Diagnosis of PLCH was either histologically confirmed on a biopsy of an involved tissue, or based on the combination of the following criteria: 1) an appropriate clinical picture; 2) a typical nodulo-cystic pattern on lung high-resolution computed tomography (HRCT) and 3) exclusion of alternative diagnoses

Exclusion Criteria:

-
A Clinical Test for the Treatment of Multifocal Lung Cancers Using Genome Sequencing

The investigators are doing this research to see if they can use small tissue samples or fluid to develop a test that will determine if the tissue samples are related or not related to each other. The test will use the patient's DNA, which is part of their unique genetic material that carries the instructions for the body's development and function. Cancer can result from changes in a person's genetic material that causes cells to divide in an uncontrolled way and, sometimes, to travel to other organs. Currently, researchers and doctors know some of the genetic changes that can cause cancer, but they do not know all of the genetic changes that can cause cancer.

A frequent clinical dilemma in lung cancer care is the management of multifocal lung cancers. The management decision is based on determining if multiple cancers represent true independent primary cancers or related metastasis. This determination is critical to the appropriate staging of the cancers and treatment. Indeed, this distinction represents the difference between aggressive local therapy with either surgery or radiation therapy for primary early stage lesions, or palliative chemotherapy or best supportive care with appropriate symptom management for advanced stage metastatic disease.

No existing pathologic or molecular test is currently capable of making the distinction between multiple independent lung primaries from metastatic disease with accuracy. The recent release of preliminary data from the NLST screening trial, suggesting survival benefit for screening high risk patients with CT scanning, will only increase the number of patients facing these treatment dilemmas. The research team has recently developed a test that allows this distinction with great accuracy. This test allows determination of lineage between two tumors using the identification of large genomic rearrangements using mate pair next generation sequencing (MP). The test has been developed using fresh frozen tissue from resected lung tumors and is currently being validated for a clinical test.

The investigators' goal is to develop the test using cytology and small biopsy specimens.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be \> 18 years of age
* Presumed or known lung cancer.
* Undergoing bronchoscopy, CT guided lung biopsy, or lung resection as part of their clinical care at the Mayo Clinic Rochester.
* PFT's and other clinical determinates that show the subject is capable of tolerating a lung biopsy or resection.
* Non-pregnant and non-lactating. Women of child-bearing potential must have a negative urine or serum pregnancy test to participate in the study.
* Subject must be able to understand and willing to sign an IRB-approved informed consent document.