cyrilzakka/clinical-trials huggingface dataset:
Different Therapeutical Modalities Associated to Hamstring Flexibility Training

The purpose of this study is to compare the acute effect of the use of different thermal modalities associated to the training of passive flexibility of the hamstring muscles in the amplitude of motion of the knee extension.

Context: In the literature there is a disagreement of results and protocols regarding the use of thermal modalities associated with the training of flexibility of the hamstring muscles. Most studies on the subject, used the heat and cryotherapy prior to stretching these. Therefore, the investigators aimed to conduct an experimental study using the therapeutics term concomitant arrangements to passive static stretching these muscles.

Methods: Clinical trial randomized crossover, which will a sample of 42 subjects (healthy young men, aged 20 to 30 years). Were divided into 3 groups (Group 1 passive static stretching hamstrings, Group 2 heat + passive static stretching hamstrings and Group 3 cryotherapy + static stretching hamstrings passive) with 14 subjects each. Where the participants will control themselves, since all carry out the three interventions, only at different times. Each action will be performed every 7 days. Individuals will be subjected to active test of the range of motion of knee extension (goniometer) and hamstring muscle strength (dynamometer).

Eligibility Criteria:
Inclusion Criteria:

* Healthy men with knee extension range less than or equal to 160 degrees.

Exclusion Criteria:

* Have exercised in the last 48 hours before the intervention session;
* Previous neurological, muscular or articular disease that influences the performance of the training;
* Anterior lower limb surgery;
* Presence of painful symptoms or edema in the lower limbs;
* Hypersensitivity to ice or heat;
* Raynaud's syndrome;
* Loss of local thermal sensitivity;
* Have metallic implants;
* Use of cardiac pacemaker;
* Presence of malignant tumor;
* Arterial diseases;
* Deep venous thrombosis or phlebitis;
* Fever and inflammatory processes;
* Bleeding processes;
* Osteomyelitis;
* Epilepsy;
* Pulmonary and bone tuberculosis;
* Kidney or urinary tract infection;
* Cryoglobulinemia;
Multiplex PCR for Severe Respiratory Infections During the COVID-19 Pandemic

The hypothesis was that a retrospective investigation of the molecular virological tests in a University hospital could be informative, with the aim to identify non-COVID-19 respiratory viruses during the circulation of SARS-CoV-2, according to systematic population data for public health knowledge.

The hypothesis was that a retrospective investigation of the molecular virological tests in a University hospital could be informative, with the aim to identify non-COVID-19 respiratory viruses during the circulation of SARS-CoV-2, according to systematic population data for public health knowledge:

* the main goal was to perform a retrospective investigation of the molecular virological tests in a University hospital, in order to identify non-COVID-19 respiratory viruses from the beginning of 2021 to mid-2022 during the circulation of SARS-CoV-2, for public health knowledge;
* the secondary aim was to retrospectively analyze, for a small subgroup of patients from an intensive care unit, the files of patients with positive molecular virological tests for non-COVID-19 respiratory viruses from the beginning of 2021 to mid-2022, reporting the following standard-of-care data: (i) the identification of the viruses, (ii) bioclinical features, (iii) medical impact of virological results in real life.

Eligibility Criteria:
Inclusion Criteria:

* For adult patients, or minors 'via' parents, able to give consent - 18 intensive care patients

Exclusion Criteria:

* Non-inclusion in case of refusal
Mobility Opportunities Via Education/Experience (MOVE): Healthcare Impact Assessment

The purpose of this study is to determine whether participation in the Mobility Opportunities Via Education (MOVE) program is associated with reduced use of healthcare for individuals with developmental disabilities.

The purpose of this study is to determine whether participation in the Mobility Opportunities Via Education (MOVE) program is associated with reduced use of healthcare for individuals with developmental disabilities. The investigators will compare healthcare "events" and healthcare expenditures for children and adults during intervals of at least one year when the subjects were participating in the MOVE program versus intervals of at least one year when the same individuals were not participating in the MOVE program based on health insurance records (i.e. Medicaid). Healthcare events are those which required professional medical services (associated with International Classification of Disease (ICD-XX) codes) or prescription medications. Healthcare events and healthcare expenditures will be reviewed from healthcare records obtained by Medicaid, Medicare, or private insurers and data will be compared between intervals.

Eligibility Criteria:
CHILDREN: Inclusion Criteria

* Males and females 5-21 years old.
* Participated in the MOVE program pre-COVID and post-COVID.
* Did not participate for at least 4 months in the MOVE program during COVID.
* Has a healthcare payor(s) who makes healthcare records available upon request.
* Subjects whose legal guardians are willing to give informed consent to obtain and review healthcare records from the subject's primary (and secondary, if applicable) payors.

CHILDREN: Exclusion Criteria

* Subjects who did not participate in the MOVE program through the duration of Interval #1 and Interval #3.
* Subjects whose legal guardians are unwilling to cooperate with the requests to obtain and review healthcare records and expenditures from the subject's primary (and secondary, if applicable) payors.

ADULTS: Inclusion Criteria

* Males and females 22-65 years old.
* Participated in the MOVE program during Interval #1 and Interval #3.
* Did not participate for at least 4 months in the MOVE program during Interval #2.
* Has a healthcare payor(s) who makes healthcare records available upon request.
* Subjects who are willing to give informed consent and/or subjects' legal guardians who are willing to give informed assent to obtain and review healthcare records from the subject's primary (and secondary, if applicable) payors.

ADULTS: Exclusion Criteria

* Subjects who did not participate in the MOVE program through the duration of Interval #1 and Interval #3.
* Subjects who are unwilling to give informed consent and/or subjects' legal guardians who are unwilling to give informed assent to cooperate with the requests to obtain and review healthcare records and expenditures from the subject's primary (and secondary, if applicable) payors.
Effectiveness of Mindfulness Based Intervention in Reducing Stress Levels of Anesthesiology and Intensive Therapy Residents at the Faculty of Medicine, University of Indonesia

This study was conducted to determine the effectiveness of MBI technique in reducing the stress level of anesthesiology and intensive therapy residents at the Faculty of Medicine, University of Indonesia.

This research was an experimental study with paired one group design. The research subjects were anesthesiology and intensive therapy residents at the Faculty of Medicine, University of Indonesia in 2019. The MBI program lasted four weeks, consisted of one formal face-to-face training and informal training through homework carried out every day for four weeks. 13 study subjects met the inclusion criteria and did not enter the exclusion criteria. 1 study subject must be excluded because it did not complete the informal training. Data collection on the Perceived Stress Scale 10 Item (PSS-10) was conducted in July and August 2019.

Eligibility Criteria:
The inclusion criteria for participation were being anesthesiology and intensive therapy resident stationed in Cipto Mangunkusumo Hospital, having a PSS-10 score ≥ 14, and agreeing to fully participate in the study.

The exclusion criteria for this study were: (1) residents who used narcotic/psychotropic drugs during the study period and (2) residents who were not able to complete the study or attend the formal face-to-face training as scheduled due to conflicting work schedule.
Exercise Consultation in Obese Youth

Exercise consultation, an intervention approach based on the transtheoretical model has been successful in promoting physical activity (PA) among adults. It is unknown whether this approach would be efficacious with youth. The purpose of this pilot study was to assess whether exercise consultation would increase PA levels and improve anthropometric measures and metabolic markers in obese adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents
* BMI greater than or equal to the 95th percentile for age (2000 CDC growth charts)

Exclusion Criteria:

* Pregnancy
* Underlying medical condition, physical or cognitive disability that will impair individual's ability to participate in physical activity
Assessment of Autonomic Co-regulation Between Newborn and Parent During Kangaroo Care Sessions in Neonatal Intensive Care Units

Mother-infant separation, as a result of hospitalization, leads to stress and anxiety for both parent and infant, lowers feelings of maternal competency and corrupts bonding process.

Kangaroo Care (KC), is as a widespread procedure in which the naked newborn is placed on the parent's bare chest. KC is known to enhance neonatal outcome by improving temperature regulation, cardiorespiratory stability or psychomotor development. It also promotes mother-infant interactions and enhances parental psychological well-being.

Heart rate variability (HRV) analysis is a non-invasive tool able to consider autonomic nervous system activity. Previous studies have shown that pleasant feelings are associated with an increase of high frequencies variations index (HFnu index) reflecting a prevalence of parasympathetic activity. This one can be assess by a new monitor called NIPΣ (Neonatal index of parasympathetic activity) in newborns and ANI (Analgesic nociception index) in adults can provide a comfort index by quantifying the parasympathetic tone.

The investigators hypothesize that kangaroo care could induce an autonomic co-regulation between newborn and parent by increasing parasympathetic activity.

The study will involve 40 preterm or term newborns and their parent, performing a one hour kangaroo care session in intensive unit and neonatal intensive care unit from hospital of Saint-Etienne (France).


Eligibility Criteria:
Inclusion Criteria for the newborn :

* Neonates over 28 weeks of gestational age, under 3 months, hospitalized in neonatal intensive care units of the university hospital of Saint-Etienne (France),
* performing a one hour (or more) kangaroo care session with his parent.

Inclusion Criteria for the parent (father or mother) :

- To be a parent of a child eligible for the research protocol,

Exclusion Criteria for the newborn :

* Newborn sedated
* Newborn with a treatment known to alter the sympathetic or parasympathetic activity of the autonomic nervous system.
* Associated and severe brain pathology
* Anoxo-ischemic encephalopathy
* Unbalanced congenital heart disease,

Exclusion Criteria for the parents :

* Parent with a treatment known to alter the sympathetic or parasympathetic activity of the autonomic nervous system.
* Heart surgery or cardiac pathology
* History of psychiatric pathology
A Safety and Efficacy Trial of the Combination of Aliskiren / Hydrochlorothiazide (HCTZ)(300/12.5 mg and 300/25 mg) Compared to Aliskiren 300 mg in Hypertensive Patients

Evaluate the diastolic blood pressure lowering effect of combination of aliskiren 300 mg and HCTZ (12.5 mg and 25 mg) in hypertensive patients who do not show sufficient blood pressure response to aliskiren 300 mg.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients 18 years old or older.
* Patients with a diagnosis of hypertension.
* Patients who are eligible and consent to participate in the study

Exclusion Criteria:

* Severe hypertension
* Previous or current diagnosis of heart failure.
* History of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
* Other protocol-defined inclusion/exclusion criteria may apply
Cycling of Sedative Infusions in Critically Ill Pediatric Patients

The purpose of this study is to determine if the reduction of the total amount of sedative critically pediatric ill patients receive in the PICU will achieve a significant decrease in mechanical ventilation days and a decrease in the overall length of stay in the PICU and hospital.

Continuous sedative infusions have been associated with longer duration of mechanical ventilation, longer stay in the intensive care unit (PICU) and total hospital stay. Also, extended duration of continuous sedative infusions limits the ability to assess for adequate neurologic function.

There is, however, no published data on the use of daily interruption of continuous sedative infusions in pediatric patients, nor are there any recommendations from the leading pediatric critical care groups regarding this issue. Infants and children exposed to noxious stimuli (endotracheal tube, endotracheal suctioning, mechanical ventilation, indwelling catheters) in addition to an unknown environment are less likely to cooperate during normal daily interventions in the PICU. Continuous infusions of benzodiazepines and opioids in addition to as needed (PRN) bolus doses have been the standard of care in our institution for mechanically ventilated patients.

The study seeks to determine if reducing the total dose of sedatives, by holding them in a cyclical manner, will be a safe and effective intervention that will not increase adverse patient outcomes. This will be achieved by limiting the patient tolerance to the sedatives, decreasing the body total deposit of sedatives and subsequently decreases awakening time when patient is ready for extubation.

Eligibility Criteria:
Inclusion Criteria:

* Less than or equal to 18 years of age
* Intubated and mechanically ventilated
* Expected to require continuous infusions of sedatives for at least 48 hours
* Parent or legal guardian available for informed consent
* Males and females of any race are eligible

Exclusion Criteria:

* Less than 72 hours after surgery
* Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt
* Critical airway (according to PICU Attending)
* Ventilator dependent (including noninvasive) on PICU admission
* Greater than 48 hours of continuous sedation infusion(s)
* Neuromuscular respiratory failure
* Managed by patient controlled analgesia (PCA) or epidural catheter
* Known allergy to any of the study medications (fentanyl or midazolam)
* Family/Medical team have decided not to provide full support (patient treatment considered futile)
* Patient requires ECMO
* Head trauma requiring intracranial pressure monitoring
* Pregnancy
* Following resuscitation from cardiorespiratory arrest whose initial pH is \< 6.9
* ICU Attending judgment that patient should be excluded for safety reasons
Early Clinical, Laboratory and Microbiological Predictors of Treatment Outcomes in Infective Endocaridtis

The investigators conduct a prospective observational study on consecutive patients being admitted to a tertiary care-centre with infective endocarditis. The investigators' primary aim is to identify baseline clincal, laboratory and microbiological predictors of in-hospital events, mortality and 6-month mortality.

Mortality and major complications among infective endocarditis remain high. In addition developing nations are crippled with a high incidence of culture-negative endocarditis and lack of wide availability of transesophageal echocardiography. We intended to identify predictors among admission clinical features, laboratory paramters and culture reports that can help risk stratify patients early in the course of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Fulfillment of modified Duke criteria

Exclusion Criteria:

* No consent
* inadequate baseline data
Comparison of Kinesiology Taping and Instrument Assisted Soft Tissue Mobilization in Cervicogenic Headache

To compare the effects of kinesiology taping and Instrument Assisted Soft Tissue Mobilization in cervicogenic headache

Cervicogenic headache (CGH) is a clinical syndrome characterized by primarily unilateral pain that originates in the neck, typically provoked by neck movement or pressure over tender points in the neck, with reduced range of movement of the cervical spine . It is characterized by unilateral headache with signs and symptoms of neck involvement, such as, pain by movement, by external pressure over the upper cervical, and/or sustained awkward head positions . Functional impairments (diminished strength and endurance) in the cervical muscles and poorer muscle control of the deep cervical flexors have been shown in patients with cervicogenic headache . The International Headache Society (IHS) has declared CGH as a secondary type of headache.The main cause of CGH is dysfunction in the upper cervical spine, and the mechanism of headache involves nociceptive structures such as the disks, upper cervical spinal nerves, facet joints, ganglia, muscles, and ligaments , pain most commonly arises from the second and third cervical spine (C2/3) facet joints, followed by C5/6 facet joints This sign and symptoms are described as the pain being unilateral or bilateral, affecting the head or face but has most commonly affected the occipital region, frontal region, or retro-orbital region, commonly associated with suboccipital neck pain, but can also be associated with ipsilateral arm discomfort. Other symptoms associated with CGH include dizziness, nausea, lightheadedness, inability to concentrate, retro-ocular pain, and visual disturbances.

Eligibility Criteria:
Inclusion Criteria:

Clinically diagnosed cervicogenic headache patients.

* Headache with neck stiffness and pain
* Positive flexion rotation test with restriction 6-10 degree.
* Unilateral headache with referred pattern
* Age between 30-44 years
* Both males and females

Exclusion Criteria:

* Head and neck surgery
* Congenital deformity
* Erosive bone diseases
* Obese
* Disc pathologies
* Malignancy and infection of neck region
* Osteoarthritis
* Rheumatoid arthritis
* Dislocation of vertebraes
Fenretinide in Treating Patients With Leukoplakia of the Mouth

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of or treat early cancer. Fenretinide may be an effective drug in treating leukoplakia.

PURPOSE: Randomized phase II trial to study the effectiveness of fenretinide in treating patients who have leukoplakia of the mouth.

OBJECTIVES: I. Determine modulation by fenretinide of surrogate endpoint markers of oral mucosal carcinogenesis in patients with oral dysplastic leukoplakia. II. Determine whether fenretinide will cause significant modulation of intermediate endpoint markers and significant regression of oral dysplastic leukoplakia in this patient population. III. Compare the ability of fenretinide and placebo to modulate surrogate endpoint biomarkers in this patient population. IV. Document the degree of recurrence of oral dysplastic leukoplakia after the administration of fenretinide, both at the same site and at new sites.

OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive oral fenretinide daily (except days 1-3 each month) for 6 months. Arm II: Patients receive oral placebo daily (except days 1-3 each month) for 6 months. Patients then receive oral fenretinide daily (except days 1-3 each month) for 6 months. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven dysplastic leukoplakia greater than 1 cm in diameter

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 125,000/mm3 Hemoglobin at least 12.0 g/dL Hepatic: Bilirubin less than 1.5 mg/dL SGOT less than 2 times upper limit of normal (ULN) Renal: Creatinine less than 1.7 mg/dL Cardiovascular: No symptomatic coronary artery disease No uncontrolled hypertension No prior coronary artery bypass No acute myocardial infarction in the past year Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception for 1 month prior, during, and for 12 months after study Fasting serum triglyceride less than 2 times ULN Cholesterol less than 350 mg/dL No hypersensitivity to vitamin A or retinoids No active malignancy No concurrent acute or chronic medical or psychiatric condition that would preclude compliance or toxicity assessment No concurrent and severe night blindness

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 3 months since prior chronic high dose (greater than 30,000 IU/day) vitamin A (retinol) At least 1 month since other prior retinoids
Treatment Efficacy of Low FODMAP Versus Low Lactose Diet in IBS Patients

A low FODMAP diet (LFD) has become a standard treatment in irritable bowel syndrome (IBS) patients. Compliant adherence to a LFD is challenging. The investigator looked at the effect of a LFD compared to a less restrictive low lactose diet (LLD) in a randomized cross-over trial with IBS patients.

Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder. It affects 10 - 20% of the adult population. Pharmaceutical therapy as bulking agents, anticholinergics, antispasmodics, and antidiarrheals are mostly unsatisfactory and many gastroenterologists recommend therefore dietary management. Most patients note that various foods elicit abdominal symptoms and therefore restrict their diet .

The low fermentable oligosaccharide, disaccharide, monosaccharide and polyol (FODMAP) diet has currently the greatest evidence for efficacy in IBS. The rationale behind the LFD is the exclusion of poorly absorbed short-chain carbohydrates which would create an osmotic load, drag fluid into the small intestine and would be fermented by the colonic microbiome, both leading to abdominal distention and increased luminal influx. FODMAPs do not cause symptoms in healthy adults as they neither show these abnormalities in gut physiology nor suffer from visceral hypersensitivity .

It is not known however whether change in symptoms is induced by a reduction in all FODMAPs or simply a single component as for example lactose. If there is a lactase deficiency, as it is the case in 2-20% of Central- / Northern Europeans, lactose cannot be hydrolysed and causes the above mentioned symptoms. Many IBS patients avoid lactose, even though only few have a lactase deficiency. Lactose intolerance but not lactase deficiency is more frequent in patients with IBS. The investigator wanted to examine if the demanding LFD is more effective than elimination of lactose alone.

Our study, comparing in detail the effects of low FODMAP versus low lactose diet in IBS patients is a novelty, analysing a clinically highly relevant topic.

Eligibility Criteria:
Inclusion Criteria:

* functional bowel symptoms as defined by the Rome IV criteria
* subjective lactose intolerance

Exclusion Criteria:

* pharmacologic agents to alter symptoms (laxatives, antidiarrheal agents)
* smoking
* antibiotic therapy within the last 4 weeks
* gastrointestinal diseases (Celiac disease was excluded by negative serologic testing while on a gluten containing diet
* any type of food allergy