cyrilzakka/clinical-trials huggingface dataset:
Basic Research Study to Examine the Relation Between Muscle Insulin Resistance and Lipid Production in the Liver.

The purpose of this study was to examine the pathophysiology of insulin resistance and the relation to the metabolic syndrome in humans.

In this study insulin resistant (IR), young offspring of parents with type 2 diabetes (18-46 years) and healthy, lean elderly individuals (65-90 years) underwent 1H/13C MRS measurements of liver and muscle lipid and glycogen content before and after a high carbohydrate meal challenge. Hepatic de novo lipogenesis was determined as the incorporation of deuterium, from deuterium labeled water (2H2O), into plasma triglycerides 5. These metabolic studies were performed in 2 sets: Study Part 1: Resting, Study Part 2: After 1 bout of 45 minutes exercise.

The study has been completed and published as two papers: August 16, 2011 and July 24, 2012.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index \< 29 kg/m2
* No regular exercise routine
* Non-smokers
* Absence of systemic and organ disease.

Exclusion Criteria:

* Hematocrit \< 35 vol%
* History of claustrophobia
* Ferromagnetic implants
* Regular exercise regimen
* Not weight stable
* Any significant hematological, neurological, musculoskeletal or endocrine disease (including diabetes mellitus)
* Any significant cardiovascular condition, including confirmed CAD and prior cardiovascular events
* Taking coumadin as anticoagulant therapy.
Role Of Parent-Child Interaction Therapy Towards Management Of Language And Behavioral Problems Among Children

maltreatment are particularly vulnerable towards child abuse and developing mental and physical health issues.

parent child interaction therapy (PCIT)) is one of those interventions which can address these vulnerabilities by improving parent to child relation and interaction, primarily improving parenting skills and helping parents cope with their parenting stress and child's behavioral problems.

PCIT is empirically validated to decrease parenting stress, couple conflict and enhance parent child interaction, resulting in better coping skills while parenting for a child with disability.

This research is very vital as it measures the efficacy of parent child interaction.

In Pakistan mostly parents are bringing their children to clinic without any support from government therefore it is not possible for everyone to get daily based therapeutic intervention.

The area of Parent-child Interaction Therapy and the acceptance of these treatments are new and emerging in Pakistani Health Care, apart from above; this research will also assist in identifying further areas of research.

The objective of this study is to determine the efficacy of parent-based intervention in Pakistan.

Parent-Child Interaction Therapy PCIT in treating the behavior problem and language problem due to behavioral disturbances in young children more than usual treatments.

1. To assess efficacy of PCIT intervention program.
2. To translate the Eyeberg Child Behavior Inventory (ECBI), Child-Parent Relationship Scale, Child Behavior Checklist (CBCL) , Test of Early Language-3rd edition (TELD-3) and applications in Urdu language.
3. To translate Child-Parent Relationship Scale and applications in Urdu language.
4. To translate Child Behavior Checklist (CBCL) and applications in Urdu language.
5. To translate Test of Early Language-3rd edition (TELD-3) and applications in Urdu language.
6. To translate parenting relation questionnaire (PQR) in Urdu language.
7. To translate parent stress index (PSI) in Urdu.
8. To determine the reliability and validity of the Urdu translated interventional and assessment tools.
9. To determine prior to and at the conclusion of the intervention performance on measures of parenting relation, parenting tress, children compliance.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria for children:

* Participants of the study age between 2to 7years however both the genders are included
* Referred cases for language delay, behavioral or attention/hyperactive problems
* ECBI score of greater than 120
* Parental consent to the study

Inclusion Criteria for Parents:

* Biological Parents
* Minimum education: high school
* Willing to participate

Exclusion Criteria:

Exclusion Criteria for children:

* Mental retardation or pervasive developmental disorder in the child.
* Should not be under any other kind of the therapeutical intervention .

Exclusion Criteria for Parents:

* Psychosis or serious drug abuse in parents
* Lack of sufficient proficiency in parents to fill in the questionnaires
Hyperprolactinemia and Adrenal Steroidogenesis

The purpose of this study is to explore the effects of prolactin on adrenal steroid profiles in patients with hyperprolactinemia due to prolactinomas before and after initialisation of treatment.

Prolactin is known to influence many biological processes. One potential target is the adrenal gland, where prolactin may stimulate the production of adrenal steroid hormones. Conditions of increased prolactin production(hyperprolactinemia) could, therefore, increase concentrations of adrenal steroids. One of the potential implications would be false doping accusations of athletes engaging in elite sports.

This interaction between prolactin and adrenal steroidogenesis, however, remains poorly understood, and the available research findings are conflicting.

The investigators, therefore, seek to explore the relationship between prolactin and adrenal steroidogenesis by monitoring prolactin levels and blood and urinary steroid profiles of patients with hyperprolactinemia due to prolactinomas before and after treatment initialisation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Female and pre-menopausal
* Serum prolactin \> 150 ng/ml

Exclusion Criteria:

* Corticotropic and/or thyreotropic insufficiency
* Pregnancy, planned pregnancy or breastfeeding
* Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
* Incapacity to give informed consent
Evaluating the Effects of Tasimelteon in Individuals With Autism Spectrum Disorder (ASD) and Sleep Disturbances

This is a multicenter, open-label study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon in treating sleep disturbances in pediatric and adult participants with ASD.


Eligibility Criteria:
Inclusion Criteria:

* Ability and acceptance to provide written informed consent of the participant or legal guardian (and assent as required).
* A confirmed clinical diagnosis of Autism Spectrum Disorder (ASD) and a recent history of sleep disturbances.
* The sleep disturbance must not be a result of another diagnosable disorder or medication.
* Male or female between 2 and 65 years of age, inclusive.
* Willing and able to comply with study requirements and restrictions.

Exclusion Criteria:

* Inability to dose daily with tasimelteon or previous intolerance to tasimelteon.
* Indication of impaired liver function.
* Evidence of increased risk of self-harm.
* Pregnant or lactating females.
* A positive test for drugs of abuse.
* Other diagnosable causes of sleep disorders or use of medications that may cause sedation or stimulation.
A Methodological Open Label Cross-Over Controlled Study To Assess The Effect Of Drugs On Ventricular Repolarization and QT Interval At Fixed Heart Rate Under Autonomic Blockade

To assess the effects of GTN on QT and QTc in subjects with And without atrial pacing. This will be done with and without autonomic blockade at two different pacing rates. Moxifloxacin effect on QT and QTc will also be assessed in atrially paced patients at two different pacing rates with and without autonomic blockade


Eligibility Criteria:
Inclusion Criteria:

* Patients with pace-makers but otherwise normal ventricular function

Exclusion Criteria:

* Nitrates, beta blockers
Disease Management for Coronary Artery Patients

This randomized controlled trial was conducted with 58 patients hospitalized in the cardiology clinic of a state hospital. Personal Information Form, Anthropometric measurements, Framingham risk score, and compliance questionnaire (CQ) were used to collect the data.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 and over,
* diagnosed with coronary artery disease for at least 2 months,
* no hearing and vision problem,
* no perception and expression deficiency,
* not diagnosed with any psychiatric disease,
* living in Kilis province,
* voluntary to participate in the study.

Exclusion Criteria:

* aged 18 under,
* diagnosed without coronary artery disease for at least 2 months,
* hearing and vision problem,
* perception and expression deficiency,
* diagnosed with any psychiatric disease,
* no living in Kilis province,
* no voluntary to participate in the study.
A Vignette-based Randomized Controlled Trial to Evaluate the Impact of Research Climate on Research Practices of Doctoral Students

This study aims to evaluate the impact of research climate on PhD students' research practice (i.e., an environment where their peer (i.e., a post-doc researcher) had detrimental practice in a similar situation)

PhD students are the next generation of researchers and will present the field in the future. However, several environmental factors might influence their research practice. In this study, the investigators will evaluate the impact of research climate on PhD students' research practice (exposure to an environment where their peers commit a detrimental practice).

Objective: To evaluate the impact of research climate on PhD students' research practice

Design: A randomized controlled trial

1. Intervention: Participants will be shown two case vignettes describing dilemma situations in research reported with and without research climate factor.
2. Participants: The participants will be PhD students in all biomedical disciplines.
3. Sample size will be 300 participants
4. Primary outcome: In each vignette, participants will have to indicate which solution they prefer on a semantic differential scale, rated from - 5 to -1 (preference for solution A) and from 1 to 5 (preference for solution B). Participants will be forced to make a choice between the 2 solutions. The primary outcome will be the mean preference score.
5. This study is approved by ethics review regulations by INSERM (CEEI-IRB): IRB00003888

Eligibility Criteria:
Inclusion Criteria:

* PhD students in biomedical disciplines

Exclusion Criteria:

* NA
Impact of Handover of Anesthesia Care on Adverse Postoperative Outcomes

Our goal is to conduct a prospective, national, randomized-controlled, multicenter trial to investigate the effect of handover of anesthesia care on the occurrence of adverse outcomes in the perioperative period.

Intraoperative handover of anesthesia care frequently occurs in clinical routine. Communication between the two anesthesiologists plays a pivotal role for the continuation of anesthesia care. The outgoing clinician must inform the incoming clinician in a short period of time about the important pre- and intraoperative facts and about the surgery while continuing to provide patient care. Contributing factors to inadequate communication during handoffs include insufficient or misleading information, busy and distractive environment, ineffective communication methods, lack of time, lack of standardized procedures, and insufficient staffing. It is estimated that the majority of adverse events in health care involve miscommunication during the handoff between physicians and perhaps other health care practitioners (https://www.jointcommission.org/hot_topics_toc/).

The goal is to conduct a prospective, national, randomized-controlled, multicenter trial to investigate the effect of handover of anesthesia care on the occurrence of adverse outcomes in the perioperative period. The investigators hypothesizes that handover of anesthesia care does increase the risk for adverse outcomes. The primary outcome parameter is a combined endpoint consisting of all-cause mortality, readmission to any hospital, or major postoperative complications (including prolonged postoperative ventilation ≥ 48 h, major disruption of surgical wound, bleeding, pneumonia, atrial fibrillation, moderate or severe acute kidney injury, new onset of hemodialysis, cardiac arrest, myocardial infarction, sepsis, stroke, pulmonary embolism, deep venous thrombosis, shock, unplanned return to operating room) within 30 days of index surgery. Secondary endpoints are the individual criteria of the primary endpoint, hospital length of stay, ICU admission, and ICU length of stay. As the currently available data on handover of anesthesia care have not been obtained from prospective, randomized controlled trials, the results of the Handicap trial will bring new insights to anesthesia care to improve patients' outcome.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Major surgeries with a duration of at least 2 h (requirement of postoperative admission to hospital for at least 1 night)
* ASA 3-4
* Informed consent

Exclusion Criteria:

* Previous surgery within the same surgical subgroup within the last 6 months
* Pregnancy, breastfeeding
* Patients participating in another interventional trial within the last 3 months
* Persons with any kind of dependency on the investigator or employed by the investigator
Impact of Minimally Invasive Restorative Techniques on Pregnant Women Oral Health Related Quality of Life

Aim of the study was to compare the effect of chemo-mechanical caries removal methods using Papacarie-Duo and alternative restorative treatment (ART) on the Oral Health Related Quality of Life (OHRQoL) of pregnant women.

A randomized controlled clinical trial was conducted in 2019 and included 162 pregnant women visiting family health centers in Alexandria, Egypt with mild to moderate dental pain due to caries. Participants were randomly assigned into Papacarie-Dup group (n=82) and ART group (n=80). The outcome variable was percent change in OHRQoL measured by OHIP-14.

Eligibility Criteria:
Inclusion Criteria:

* Having at least one carious lesion involving dentine with lesion accessible to hand instruments (International Caries Detection and Assessment System score= 5 or 6).
* Suffering from at least mild dental pain as identified by a score of at least 5mm on a Visual Analogue Scale (VAS) 100-mm-long.

Exclusion Criteria:

* Pregnant women with acute pulpitis, swelling or fistula.
* Uncooperative patients and those who refused to participate.
Evaluating the Influence of the Strategy Intraoperative Anesthetic (Desflurane Versus Propofol) on Cognitive and Psychomotor Functions in Output Post Interventional Room Monitoring - COGNIDES

The recovery of cognitive and psychomotor functions is best performed under anesthesia after desflurane when propofol in that obtaining a Aldrete score\> 8/10 output of the allowing SSPI.

The principal objective is to compare the cognitive and psychomotor status of patients recovered an Aldrete score\> 8/10 according to the anesthetic agent (propofol or desflurane) using three tests (Stroop test, Digit Symbol Substitution task and a test of verbal memory (visual verbal learning test) made SSPI.

The day before surgery, patients sign the consent and will be randomized. Then 3 tests (Stroop test, Digit Symbol Substitution Task and visual verbal learning test) will be performed. No anxiolysis will be given to the patient. The anesthetic induction will be with IV propofol (2-3 mg / kg). The maintenance will anesthetic, desflurane by for a minimum alveolar concentration of between 2% and 6% or propofol for intravenous anesthesia user target controlled. In SSPI, the Aldrete score will be evaluated every 5min. Upon obtaining a Aldrete score\> 8/10, the day before the tests will be carried out again

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 80 years
* ASA I, II
* General anesthesia provided
* Scheduled orthopedic surgery
* Duration of surgery between one and three hours
* Patient has given its written consent
* Patient receiving medical health insurance

Exclusion Criteria:

* MMS (Mini Mental State) ≤ 24
* Patient does not speak or read or do not understand the French
* Previous surgery within seven days
* Coronary insufficiency, renal, hepatic
* Chronic pulmonary disease
* Obesity (BMI\> 35)
* Addiction
* Chronic alcoholism
* Hematocrit \<25%
* Personal and family history of malignant hyperthermia
* Taking benzodiazepines or psychotropic within 24 hours preoperative
* Psychiatric pathology being
* Psychological or neurological disorder causing difficulties in understanding the study
* Chronic pain and / or taking analgesics 3.
* Pregnancy or breastfeeding
* Disorder of hemostasis: platelets \<80,000 / mm3, PT \<50% TCA\> 1.5 times the control.
* Hypersensitivity to propofol or desflurane or any of the excipients
* Patients allergic to soy and peanuts
* History of liver disease, jaundice, unexplained fever, eosinophilia after administration of a halogenated anesthetic
* Hypersensitivity to egg lecithin.
National Evaluation of Quality of Childcare (C0682)

This evaluation seeks to assess the impact of a training program on childcare center environments and child/caregiver wellbeing in El Salvador. Through a longitudinal, randomized control trial, over 200 childcare centers participating in the program will be assigned to various treatment arms receiving different components of the program. A community comparison cohort will also be enrolled.

Whole Child International (WCI) is a U.S.-based non-governmental organization. Its focus is on improving the caregiving environments for vulnerable children by effecting changes within child care centers and orphanages.

This evaluation will assess the impact of an educational training and technical assistance program offered by WCI in collaboration with the El Salvadoran government. The program consists of a series of educational trainings (for local government officials, directors of childcare and residential centers, and center caregivers) and technical assistance including infrastructural changes within centers.

To evaluate this intervention, a longitudinal, randomized controlled trial will be used to assign participating centers to one of seven treatment arms that will receive different components of the intervention. A community comparison cohort will also be enrolled to identify selection effects as well as local norms and standards. The central research question is, "Does providing training for institution providers and caregivers improve child outcomes?"

Ethnographic research will also explore local cultural norms regarding child caregiving, and seek to understand how the intervention is received within communities.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 6 months-4 years old at baseline, who are currently attending government-run childcare centers in El Salvador, will be eligible for enrollment in this study. One parent/guardian and center caregiver for an enrolled child will also complete assessments.
* In the comparison group, for every 5th center-attending child enrolled, the nearest neighboring child between the ages of 6 months and 4 years at enrollment, and who does not attend the center, will be eligible for enrollment. One parent/guardian of the comparison child will also complete assessments.

Exclusion Criteria:

* Children with known disabilities, who are unlikely to show developmental changes over time, may be excluded from the study.
Use of Fc-MBL to Detect and Monitor the Presence of PAMPs During Septic Shock

Use Mannose Binding Lectin (MBL) as a biomarker to measure levels of Pathogen- Associated Molecular Patterns (PAMP) during septic shock. This will allow evaluating interest of this biomarker to monitor and manage a septic shock. Consecutive patients admitted for sepsis in Intensive Care Unit Department will be included. This biomarker will be compared to all the parameters monitored usually for these patients in standard care.

Septic shock still represent a major cause of admission in intensive care unit, incidence of severe sepsis is increasing, even in western countries, due to aging populations and comorbidities. Definition of septic shock was revised in 2016 by a task force, which emphasizes the need for future iterations. Indeed, there are no simple clinical or biological criteria ton diagnose septic patients with high risk of shock, or to prognose its severity. C-reactive protein (CRP) and procalcitonin (PCT) are the wider biomarkers used to monitor septic patients. But they do not correlate with sepsis severity and moreover do not distinguish unequivocally between infection and noninfected systemic inflammatory response syndrome (SIRS). Each microorganism has number of PAMPs, cell wall components (lipopolysaccharide endotoxin, peptidoglycan, outer membrane vesicles), flagella, mannan... High levels of these pathogen fragments are released in the bloodstream during sepsis. They trigger release of inflammatory cytokines that drive the sepsis cascade. Mannose binding lectin plays a pivotal role in innate immunity, binding with surface sugars of wide range of pathogens and their fragments. Thus MBL promotes opsonophagocytosis and activates the lectin-complement pathway. Fc-MBL, an engineered version of MBL has been developed to capture microorganism and treat sepsis. An ELISA, using Fc-MBL was developed to measure PAMPs in whole blood during sepsis. This assay will use Fc-MBL ELISA to quantify PAMPs during septic shock, to improve diagnostic and monitoring. But also, identifying patients with high levels of PAMPs for dialysis-like sepsis therapies.

PAMP's level will be compared to clinical, biological, microbiological and therapeutic outcomes. Its sensitivity will be evaluated by its kinetic among a septic shock (defined with Sepsis-3 criteria) and by correlation with CRP (C-Reactive Protein) and PCT (Procalcitonin). Its specificity will be evaluated by comparing its levels during septic and non-septic shocks.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Hospitalized in Intensive Care Unit for sepsis of any etiology
* Patients with shock criteria: defined by a hypotension, hyperlactatemia, the use of vasopressive drugs.
* Patient affiliated to a social security scheme- Patient giving consent

Exclusion Criteria:

* Minor patients
* Organ transplant
* Immunosuppressive drugs, other than corticosteroids
* Patients who decline participating to the assay
* Persons placed under legal protection, guardianship
* Pregnant woman
* Subject participating in another search including a exclusion period still in progress at pre-inclusion