cyrilzakka/clinical-trials huggingface dataset:
Haiti Rural School Feeding Study: Effect of Vita Mamba on Anemia and Hemoglobin Concentrations

This study applied a matched cluster, controlled design, using community cluster as the unit of randomization. Communities were first matched during the formative research phase and randomized into treatment (Vita Mamba + deworming) or control (deworming) groups, using a simple experimental 1:1 design. The principal investigator generated the random allocation sequence and assigned the cluster to groups. Children were followed longitudinally for Hb concentration and anthropometric measures were taken at baseline (November 2014) and endline (June 2015). Parents were surveyed at baseline for household-level socioeconomic and demographic information; environmental conditions including water, hygiene, and sanitation; and child diet and morbidities.

All children in the intervention schools received the Vita Mamba once per school day from November 2014 to June 2015, for approximately 26 weeks. Children in both groups received Albendazole at baseline in November 2014. Compliance was monitored by teachers and tracked by collection of empty packages. Lessons learned from another school feeding trial by the study team were applied to increase compliance such as opening the packages for the children immediately prior to consumption to discourage selling or sharing later with family members. Vita Mamba was developed for the urban school trial by the research team with representatives from Edesia (a US-based nonprofit manufacturer of ready-to-use foods with expertise in research and development) and Nutriset (the parent company in the PlumpyField network). Meds \& Food for Kids, a nonprofit manufacturer of ready-to-use foods in Haiti using locally produced peanuts, produced the Vita Mamba for this trial. Vita Mamba (50 g) contains 260 kcal and meets \>75% of the Recommended Dietary Allowance (RDA) for critical micronutrients (S1 Table).


Eligibility Criteria:
Inclusion Criteria:

* registration in the study school for 2014-2015 calendar; good health (no fever, congenital health condition, or peanut or soy allergy); and not severely malnourished (weight-for-height \[WHZ\] \<-3)

Exclusion Criteria:

* fever, congenital health condition, or peanut or soy allergy; severely malnourished (weight-for-height \[WHZ\] \<-3)
Narcotrend Versus Bispectral Index Monitoring During Sufentanil-Midazolam Anesthesia for Bronchoscopy

This study was aimed to determine whether narcotrend monitoring was better than bispectral index monitoring during sufentanil-midazolam anesthesia for bronchoscopy under conscious sedation. Patients were randomised to receive Narcotrend, Bispectral Index(BIS) monitoring or without monitoring. Midazolam was given by non-anaesthetist physicians to achieve moderate levels of sedation as assessed by the narcotrend index (NI; B and C) or bispectral index (BIS; between 70 and 85) or according to patient's tolerance assessed by physician . The primary end-point was dosage of midazolam. Other end-points included adverse events, patient tolerance and physician satisfaction.


Eligibility Criteria:
Inclusion Criteria:

ASA grade I-II

Exclusion Criteria:

1. psychological disorders
2. SpO2\<90% in ambient air
3. hypersensitivity or allergy to anaesthetic drugs or benzodiazepine
4. severe chronic obstructive pulmonary disease (forced expiratory volume in 1 s ,50% of predicted value, requirement for oxygen therapy)
5. unstable haemodynamic status
6. habitual alcohol consumption
Use of Saliva for COVID-19 Diagnosis

Aim of the study is to evaluate the presence of SARS-CoV2 RNA in the saliva of patients with suspected or confirmed COVID-19 in order to validate the analysis of this type of sample for the diagnosis of SARS-CoV2 infections.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age hospitalized in the COVID-19 wards of ASST Monza - San Gerardo Hospital with positive, weakly positive or negative nasopharyngeal swabs; initially assessed at the E.R.; symptomatic or asymptomatic with indication to hospitalization.
* Informed consent freely granted and acquired before the start of the study.

Exclusion Criteria:

* Patients with significant clinical conditions which could interfere with the study in the opinion of the researchers.
Preoperative Level of Hemoglobin A1c and Acute Kindey Injury After Coronary Artery Bypass Grafting Surgery

Background: The development of acute kidney injury (AKI) is an important indicator of clinical outcomes after cardiac surgery. Elevated preoperative hemoglobin A1c level may be associated with acute kidney injury in patients undergoing coronary artery bypass grafting. This study will investigate the association of preoperative HbA1c levels with AKI after isolated coronary artery bypass grafting (CABG).


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status II-III
* scheduled to undergo isolated coronary artery bypass grafting

Exclusion Criteria:

* Patients with history of renal failure
* Patients with history of hepatic failure
* Patients with history of heart failure
* previous cardiac surgery
* cerebrovascular event in the last 30 days
* percutaneous coronary intervention in the last 30 days prior to operation
* peripheral arterial disease
* malignancy
* infectious diseases
* patients who required surgical revision
* patients who required postoperative intra-aortic balloon pump
* patients with CBP time \> 120 min or aortic cross clamp time \> 90 min
The Relevance Between the microRNA-30e in Plasma and the Prognosis of Schizophrenia Patients

This study investigates the relationship of circulating microRNA-30e and schizophrenia, and shows the relevance of the aberrant microRNA-30e expression in plasma with the variation disease status.

The plasma samples from 15 individuals with schizophrenia (with a diagnosis of ICD-10) and the equivalent healthy controls will be conducted with the quantification analysis of the microRNA-30e via real-time quantitative polymerase chain reaction(RT-PCR).

The 15 patients enrolled should be the first-episode and have not been treated, or were drug free 3 months recently at least.

This research measures the expression level of microRNA-30e in schizophrenia respectively before the beginning treatment with atypical psychotics or combined with MECT, after the 4-week treated , the 8-week treated compared with 15 healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Persons should be diagnosed with schizophrenia according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10)
* The first-onset or drug-free in the latest 3 months
* Between the ages of 17-40

Exclusion Criteria:

* Comorbid with other psychosis
* Have physical or neurological diseases such as traumatic brain injuries
* History of drug-abused or alcoholic
* Blood transfusion history in a month
* Been treated with Modified Electric Convulsive Therapy(MECT) in late 3 months
Physical Activity Interventions to Heal Chronic Low Back Pain

This study will advance understanding on the mechanisms that mediate improved outcomes for chronic low back pain and provide specific directions for optimizing physical activity interventions for this population.

In this study, participants with chronic low back pain will be randomized to receive a 12-week physical activity intervention (2 times per week with encouragement for home practice). The experimental condition will entail physical activity with components for strengthening emotion regulation skills, behaviors, and attitudes while the control condition will entail physical activity alone.

Eligibility Criteria:
Inclusion Criteria:

- Age \> 18;

Report of low back pain \>3 of last 6 months;

Willing to attend 12-weeks of yoga or stretching (twice per week);

Willing to complete 4 assessments;

English Literacy;

No changes in pain treatments in the past month;

Willing to not change pain treatments during study unless medically necessary;

Have not practiced yoga \> 2x in the last 12 months;

Exclusion Criteria:

- back surgery within the last 1 year;

back pain due to specific systemic problem (e.g., lupus);

lower extremity weakness (motor strength 4/5 of the quads, gluts, hamstrings, EHL);

sciatica or (+) straight leg raise (SLR);

coexisting chronic pain problem (migraine headaches, fibromyalgia);

Serious or unstable psychiatric illness (e.g. psychosis, mania, history of suicide attempt);

major coexisting medical illness (e.g., cancer, COPD, morbid obesity);

Positive Romberg test (with or without sensory neuropathy).
Assessment of Frozen Shoulder Treatment Using 432 Hertz Frequency Music: A Clinical Trial

The goal of this clinical trial is to determine the effect of listening to music during the treatment of frozen shoulder on pain, normal range of motion, functional activity status and quality of life.Upon recruitment, the subjects were randomly assigned to one of four treatment groups: Group 1 received Music + Mobilization + Exercise, Group 2 received Music + Exercise, Group 3 received Mobilization + Exercise, and Group 4 received Exercise only.

Forty individuals diagnosed with frozen shoulder were randomly allocated into four distinct treatment groups. Each participant received a total of eighteen treatment sessions, administered three days per week. Pain levels, range of motion of the shoulder joint, functional status, general health condition, and quality of life were measured and recorded for each participant both before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* idiopathic or primary adhesive capsulitis5,20,32,
* a diagnosis of stage 2-3,
* unilateral condition,
* age between 30 to 65 years,
* normal findings on radiographs within the previous 12 months,
* no previous shoulder surgeries to the affected shoulder,
* no previous manipulations under anesthesia of the affected shoulder,
* passive joint movements limited to 50-75% of the normal range of motion of the joint, - and no hearing loss.

Exclusion Criteria:

* have shoulder girdle motor control deficits associated with neurological disorders.
Perioperative ACT for Preventing CPSP: a Single-arm Non-randomized Pilot Trial

The present study aims to adapt and modify a brief perioperative Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Investigators will assess the acceptability, feasibility, and preliminary efficacy of the intervention via a non-randomized, non-controlled pilot trial.


Eligibility Criteria:
Inclusion Criteria:

* scheduled to undergo fusion, discectomy, vertebroplasty, kyphoplasty, or foraminotomy
* age 22 and older
* able to communicate fluently in English

Exclusion Criteria:

* inability to complete study procedures due to delirium, dementia, psychosis, or other cognitive impairment
* have a history of severe neurologic movement disorder
* are pregnant or intent to become pregnant during study
* have undergone previous spinal surgery
* have spinal deformity, pseudarthrosis, trauma, infection, or tumor as primary indication for surgery
* have undergone Acceptance and Commitment Therapy in last 2 years
An Exercise Intervention Study in Insulin-Resistant Adolescents

Hypothesis: Insulin-resistant African-American and Hispanic adolescents will show significant improvement of insulin sensitivity (SI) and positive changes associated with fibrinolytic markers and lipid profile after a two month supervised aerobic training.

The specific aims of the study are 1) To determine the effects of exercise on insulin sensitivity in insulin-resistant African-American and Hispanic adolescents; 2) To determine the effects of exercise on fibrinolytic markers in insulin-resistant African-American and Hispanic adolescents.

The hypothesis is that insulin-resistant African-American and Hispanic adolescents will show significant improvement of insulin sensitivity (SI) and positive changes associated with fibrinolytic markers and lipid profile after a 1 month pre-training period and two-months of supervised, moderate intensity aerobic exercise.

Part I. Insulin-resistant African American and Hispanic adolescents from the DC metro area will be recruited through various recruitment efforts. Potential participants will have 2 screening visits in which their medical history, physical activity level, body mass index, and fasting plasma glucose and insulin or OGTT results will determine eligibility.

Part 2. If inclusion criteria is met, the subjects will undergo a 2 week dietary stabilization period, treadmill exercise testing, IVGTT, blood draws for fibrinolytic and lipid markers, DEXA scan, and anthropometric measurements. Subjects will have a 1 month pre-training period and 2 months of supervised, moderate intensity aerobic exercise. All baseline testing will be repeated after the exercise period to see any significant differences.

Eligibility Criteria:
Inclusion Criteria:

* Must be between 14 to 18 years old
* Being African American or Hispanic
* Sedentary (exercising less than twice a week for less than 20 minutes)
* Non-smoker
* At high risk of developing insulin resistance
* BMI for age grater than or equal to the 95th percentile

Exclusion Criteria:

* History of chronic illnesses
* Thyroid dysfunction
* Taking medications know to affect metabolism
* Being pregnant or lactating
ME-WEL: eHealth Behaviour Change Intervention for Weight Management in Post-menopausal Women

In post-menopause, most women gain weight, and obesity rates are more prevalent in this particular group. In addition, there is an increased risk of cardiovascular disease, cancer, and diabetes. Given that this weight gain can be related to risk behaviours, healthy weight management (such as an increase in physical activity or healthy eating) is crucial to promote a healthy weight and well-being.

The ME-WEL (MEnopause and WEigth Loss) project (ref. SFRH/BD/144525/2019), entails an eHealth intervention for weight management and well-being in post-menopausal women with overweight or obesity, based on two theoretical models of behavioral change - the Health Action Process Approach (HAPA), and the Health Belief Model (HBM), and applying the Behaviour Change Techniques (BCT) Taxonomy and Oxford Food and Activity Behaviors (OxFAB) Taxonomy.

This group's eHealth intervention lasts 8 weeks. Each week there is a different theme to be addressed, taking into account the behavioral change models mechanisms, in articulation with different BCT´s and weight strategies.

Subjective well-being, self-esteem, weight loss, implementation of weight management strategies, and changes in eating behavior and physical activity/exercise were evaluated, through follow-ups at 3- and 6- post-intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age (45-65 years);
* Post-menopausal women (which starts after menopause/last period, confirmed by 12-month amenorrhea);
* Women with a Body Mass Index (BMI) of 25 kg/m2 or more (overweight) or women with a BMI of 30 kg/m2 or more (obesity);
* Nationality (Portuguese or dual nationality);

Exclusion Criteria:

* Specifical diseases and/or medical reasons to limit activity (stroke, cancer, diabetes, heart disease, epilepsy, musculoskeletal problems that severely compromise mobility; loss of functional ability);
* Diagnosis of mental health illness or recent hospitalization for mental health reasons;
* History of alcohol dependence;
* History of addiction to illicit substances;
* Suicidal ideation
Safety and Efficacy of S-707106 in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control With Metformin Therapy

The purpose of this study is to evaluate the safety and efficacy of S-707106 co-administered with metformin in subjects with type 2 diabetes mellitus.

Based on the unmet clinical need for more safe and effective type 2 diabetes mellitus therapies, together with the nonclinical efficacy and safety profile of S-707106, Shionogi USA, Inc. is initiating studies to further assess the efficacy, clinical pharmacology and safety profile of S-707106 in preparation for full clinical development as a novel treatment for type 2 diabetes mellitus. It is anticipated that S-707106 will provide clinicians and patients with a new therapeutic option to treat type 2 diabetes mellitus with potential advantages over existing therapy.

Eligibility Criteria:
Main Inclusion Criteria:

* Subjects with type 2 diabetes mellitus receiving a stable dose of metformin for the past 3 months (with no other medication for glycemic control) and who are clinically stable as determined by medical history
* Body mass index (BMI) ≥25.0 and \<45.0 (kg/m2) using http://www.bmicalculator.org/ as the BMI calculator
* No clinically significant abnormal laboratory tests as determined by the investigator except Hemoglobin A1c level ≥7.5% and ≤11.0% and C peptide level \>1.0 ng/mL

Main Exclusion Criteria:

* Type 1 diabetes mellitus or gestational diabetes mellitus within last 6 months
* Use of any medication for glycemic control other than metformin during the past 3 months or thiazolidinediones within the past year
* Congestive heart failure as defined by New York Heart Association class III or IV
* Fasting glucose \>270 mg/dL
* Creatinine clearance is \<60 mL/minute
* History of myocardial infarction within the past 3 months, history of clinically significant cardiac arrhythmia, clinically significant hypotension or hypertension, or clinically significant abnormal electrocardiogram as determined by the investigator
Effects of Abdominal Hot Compresses on Indocyanine Green Elimination in Healthy Subjects

We investigated, whether abdominal hot compresses effect hepatic blood flow. Our hypothesis was, that the hot compresses might either by local vasomotor-reflex or by decreasing the tone of the sympathetic nerve system increase hepatic blood flow.

Abdominal hot compresses are traditionally used by patients with liver diseases as self help. This study investigated the effect of abdominal hot compresses on hepatic blood flow measured by elimination of indocyanine green (ICG), a non-toxic green dye. It was presumed, that abdominal hot compresses increase hepatic blood flow either by local vasomotor-reflex or by decreasing the tone of the sympathetic nerve system.

In healthy volunteers ICG elimination was measured with and without hot compress at two investigations in a weekly interval. At each investigation ICG was injected as bolus after a rest period of 10 minutes. After the injection blood was taken in regular intervals for analysis of ICG concentration over a period of 40 minutes and half life was calculated.

The time interval between the investigations was 8 days, the sequence was randomly assigned.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* iodine allergy
* any acute or chronic disease \[with exception of pollinosis because it is common\]
* elevated levels of alanine amino transferase \[ALT\], aspartate amino transferase \[AST\], gamma glutamyltransferase \[GGT\] or bilirubin
* heat urticaria
* pregnancy
* alcohol intake \>30 g/d
* any medication except contraceptives
* body mass index (BMI) \>30 kg/m2
The Impact of Texas Senate Bill 42 on Middle School Children's Level of Physical Activity

The purpose of this study was twofold: 1) to assess awareness of and adherence to Texas SB42 among a representative sample of public middle schools in Texas; and 2) to assess the impact of SB42 on the frequency of school PE class, the quality of school PE, and prevalence of child self-reported physical activity behaviors and child overweight along the Texas-Mexico border.

Childhood overweight is a significant public health issue in Texas. In response to this problem, the 79th Texas legislature passed Senate Bill 42 (SB 42), which promotes healthier school environments in middle schools, in June, 2005. As a result of SB 42, all Texas public middle schools must require students to engage in at least 30 minutes of daily physical activity or a total of 135 minutes of physical activity per week, beginning in the 2006-2007 school year. The purpose of this study was to determine the barriers and facilitators of implementation and the ultimate impact of this mandate on school PE, child physical activity, and child overweight in Texas public middle schools, and specifically among children living in the Lower Rio Grande Valley (LRGV) of South Texas. Questionnaires with key informants (school principals, PE teachers, and school district PE and health education directors) were conducted in a random sample of middle schools to assess the implementation of SB 42 (2006-2007). In addition, a more detailed evaluation of SB 42 was accomplished with a representative sample of middle schools in the LRGV, a low-income Latino area of the state. Measurements in the LRGV schools included observed and measured child physical activity, self-reported physical activity behaviors, and child overweight (BMI).

Eligibility Criteria:
Inclusion Criteria:

* The study sample consisted of a representative sample of Texas public middle schools (112 schools) as well as a representative sample of Lower Rio Grande Valley middle schools (17 schools).

Exclusion Criteria:

* Middle schools that did not participate in the 2004-2005 School Physical Activity and Nutrition Project.
Multi-center Observational Study to Evaluate Epidemiology and Resistance Patterns of Common ICU-Infections (MOSER)

Most literature on ICU infections and the resistant patterns comes from the western literature. This data may not truly reflect the incidence, epidemiology and resistance patterns in developing countries such as India. However, empiric antibiotic therapy is generally initiated using western guidelines. This can potentially lead to inadequate, inappropriate and ineffective empiric antibiotic therapy for ICU infections in the Indian setting. Hence in this multi-center observational study, we seek to:

1. To determine the incidence of ICU-related infections (VAP, CAUTI and CRBSI) in India
2. To explore the microbiology, resistance and treatment patterns of these infections


Eligibility Criteria:
Inclusion Criteria:

1. ICU stay \>48 hours
2. One of the following infections (VAP, CAUTI or CRBSI)

Exclusion Criteria:

1. Index ICU stay \< 48 hours
2. Re-admissions to the ICU within the same hospitalization
3. Age \>18 years or \<70 years
4. Known HIV serology positivity
5. Burns
6. Solid organ or Bone-marrow transplant
7. No ICU-acquired infections (specifically VAP, CAUTI and CRBSI)