cyrilzakka/clinical-trials huggingface dataset:
Assessing Impact of Active Learning on Student Outcomes: Texas Initiatives for Children's Activity and Nutrition (ICAN)

Background: Active learning is designed to pair physical activity with the teaching of academic content. This has been shown to be a successful strategy to increase physical activity and improve academic performance. The existing designs have confounded academic lessons with physical activity. As a result, it is impossible to determine if the subsequent improvement in academic performance is due to: (1) physical activity, (2) the academic content of the active learning, or (3) the combination of academic material taught through physical activity.

Methods / Design: The Texas I-CAN project is a 3-arm, cluster randomized control trial in which 28 elementary schools were assigned to either control, math intervention, or spelling intervention. As a result, each intervention condition serves as an unrelated content control for the other arm of the trial, allowing the impact of physical activity to be separated from the content. That is, schools that perform only active math lessons provide a content control for the spelling schools on spelling outcomes. This also calculated direct observations of attention and behavior control following periods of active learning.

Discussion: This design is unique in its ability to separate the impact of physical activity, in general, from the combination of physical activity and specific academic content. This, in combination with the ability to examine both proximal and distal outcomes along with measures of time on task will do much to guide the design of future, school-based interventions.


Eligibility Criteria:
Inclusion Criteria:

* students in 4th grade in a participating elementary school and their 4th grade teachers

Exclusion Criteria:

* none
Impact of the NO-donor Pentaerythrithyltetrantrate on Perinatal Outcome in High-risk Pregnancies

Pregnancies resulting in IUGR and also in preeclampsia are strongly associated with typical underlying placental pathology revealing small placentas and maldevelopment of the decidual blood vessels, suggesting under-perfusion from the maternal circulation. Since nitric oxide (NO) donors can improve decreased uteroplacental perfusion without any negative effects on fetal circulation, these may prevent negative pregnancy outcomes in patients at risk.

The aim of this study is to evaluate the effectiveness of the long-lasting NO donor pentarythrithyltetranitrate (PETN) to reduce the likelihood of adverse pregnancy outcomes (intrauterine growth retardation / IUGR, perinatal death, placental abruption, and preterm delivery) in women recognized to be at risk for this outcome by abnormal uterine flow in mid gestation.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women 190 to 236 weeks of gestation
* abnormal uterine Doppler as defined by bilateral notching, unilateral notching and increased impedance with mean resistance index (RI) \> 0.65 or with mean RI \> 0.7 without notching at time of enrollement
* informed consent

Exclusion Criteria:

* multiple gestation
* documented chromosomal or major fetal abnormalities
* rupture of membranes and/or clinical chorioamnionitis at time of enrolment
* maternal disease defined as contraindication for intake of PETN
Use of an Oxidized Regenerated Cellulose After Thyroid Surgery: A Prospective, Randomized Study

The purpose of this study is to evaluate the effects and safety of oxidized, regenerated cellulose as an absorbable adhesion barrier after thyroidectomy.


Eligibility Criteria:
Inclusion Criteria:

* operable thyroid neoplasm

Exclusion Criteria:

* a history of previous neck surgeries or uncontrolled medical diseases such as hyperthyroidism, diabetes, and hypertension
* administration of non-steroidal anti-inflammatory drugs (NSAIDs) or anti-platelet agents within 1 week before surgery
S1119 Peruvian H. Pylori Water Contamination Study

The objective of this study is to elucidate the role of drinking water derived from the public source in Lima, Peru and transmission of H. pylori infection using genotypic techniques.

The objective of this study is to detect the presence of Helicobacter Pylori in the drinking water derived from the public network by molecular and genomic techniques in districts of Lima (Brena, Chorrillos, Comas, El Agustino, La Victoria, Lince, Los Olivos, Miraflores, Puente Piedra, Rimac, San Isidro, San Juan de Lurigancho, San Martin de Porres, Villa El Salvador, and Villa Maria del Triunfo) with high and low incidence of gastric carcinoma. The secondary objective of this study is to establish correlations between the findings in water and those of the stomach of patients with symptoms of dyspepsia who live in those districts.

Eligibility Criteria:
Inclusion Criteria:

* adults between the ages of 21-70 years old who have lived for more than 10 years in the Lima districts listed in protocol,
* who have a biopsy proven diagnosis of infection by H. pylori.
* participants must be in good general condition, mentally competent and able to provide informed consent;
* must not show evidence of dehydration or jaundice;
* must be willing to complete the patient questionnaires.
* participants must not have known allergies to any of the antibiotics used in the study.

Exclusion Criteria:

* pregnancy
Phase II Study of Dietary Cholesterol for Smith-Lemli-Opitz Syndrome

OBJECTIVES: I. Examine the intestinal absorption of dietary cholesterol in patients with Smith-Lemli-Opitz syndrome.

II. Measure the effect of dietary cholesterol on plasma sterol composition. III. Quantify basal cholesterol synthesis, turnover of cholesterol and 7-dehydrocholesterol, and the effects of dietary cholesterol on these parameters.

IV. Identify fecal bile acid excretion quantitatively and qualitatively in these patients.

V. Compare the incorporation of deuterated water into plasma cholesterol, 7-dehydrocholesterol, and other intermediates, and assess the effect of dietary cholesterol on this incorporation.

PROTOCOL OUTLINE:

Patients are treated with 2 dietary regimens for 1 to 3 weeks: high cholesterol and cholesterol-free. Cholesterol is provided in the form of egg yolk. The absorption and metabolism of cholesterol are evaluated with plasma and fecal studies. Deuterated water is given to patients followed by analysis of deuterium in plasma cholesterol and other intermediates, including 7-dehydrocholesterol.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

Smith-Lemli-Opitz syndrome
Effect of Phlebotomy on Heartrate in Polycythemia Patients

Single-centre, observational within-subject design: patients that undergo phlebotomies regularly for polycythemia will be measured continuously by wearables one week before until one week after a phlebotomy, for three phlebotomies.

Rationale: Little is known about the effect of a hemoglobin-shift on patients, anaemic, non-anaemic or even polycythaemic. It has been established that severe anaemia has deteriorating effects on the patient, which can be (partially) reversed by treatments like transfusion, erythropoietin stimulating agents or iron/vitamin supplements, depending of the etiology of the anaemia. However, the optimal haemoglobin target and threshold for such treatments has yet to be determined. It is therefore necessary to evaluate what the exact effect of various haemoglobin levels, and a shift therein, is on the physiology of patients. Only then can the benefits be weighed properly against the risks for individual patients when considering treatment for anaemia, safety of blood donation, or expected effect of phlebotomy for polycythaemia.

Primary Objective:

- Compare the per individual and per group effects of a reduction in Hb mass on physical functional outcomes (heart rate; activity parameters; QoL) in patients with polycythaemia.

Secondary Objectives:

- Compare the primary outcomes to data from the REMOTE-2 and FAINT-study (similar measurements in transfusion dependent patients and whole blood donors)

Study design: Within-subject design. Patients will be remotely monitored one week before phlebotomy until one week after.

Study population: Adult patients with a polycythaemia requiring phlebotomies on a regular basis.

Main study parameters: heart rate, blood pressure, activity parameters and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients with polycythaemia, requiring phlebotomy on a regular basis (at least every 4 months)
* Subjects aged ≥18 years
* In possession of a smartphone
* Life expectancy ≥ 3 months

Exclusion Criteria:

* Poor performance/functional status (Eastern Cooperative Oncology Group system ECOG ≥3)
* Participants with known arrhythmias or other significant cardiological conductivity disorders (Paroxysmal atrial fibrillation is allowed)
* Hospitalized subjects
* Subjects with a pacemaker.
* Subjects with a secondary polyglobulia due to eg smoking or other pulmonary issues.
* Scheduled oncological treatments or surgery during the study period.
A New Care Model for Patients With Complicated Multimorbidity

Patients with complex multimorbidity experience a high treatment burden, fragmentation of care and poor clinical outcomes. General practice is the key organizational setting in terms of offering these patients integrated, longitudinal, and patient-centered care. Therefore, we propose a new general practice based model to improve overview, patient involvement and integration of care. The new care model consist of a teaching session on multimorbidity for the health care professionals, a prolonged overview consultation for patients with complex multimorbidity with the general practitioner, resulting in an individual care plan shared with the municipalities and secondary care, access to cross-sectoral video conferences with secondary care specialists and. Control practices provide health care as usual. We evaluate the care model in a cluster-randomized non-blinded, parallel-group trial in general practice. Fourteen general practices are allocated 1:1 to either intervention or control. We evaluate the effectiveness of the intervention with patient-reported questionnaire at baseline, 6-month follow-up, and 12-month follow-up. Primary outcome measure is the Patient Assessment of Chronic Illness Care (PACIC). Secondary outcome measure includes patient-reported quality of life and the treatment burden for the patients with multimorbidity. Furthermore, the project include a process evaluation of the complex intervention with the objective to assess how the intervention is delivered and to identify important facilitators and barriers for implementing the intervention. The new model is integrated into the existing health care system structures and has the potential for a sustainable improvement in care for patients with complex multimorbidity.


Eligibility Criteria:
Inclusion Criteria:

1. Has more than one of the 3 common chronic diseases (diabetes, chronic obstructive pulmonary, chronic heart conditions)
2. Has been hospitalised, or visited an outpatient clinic due to their chronic diseases during the previous year
3. Take at least five different prescription drugs assessed from the Shared Medicine Card recording in the general practice
4. The general practitioner or the nurse in the practice recognise the patient as a "demanding" patient with complicated multimorbidity that will benefit from an overview consultation.

Exclusion Criteria:

* Patients who cannot speak Danish,
* Patients who cannot give informed consent,
* Patients who have a life expectancy of less than 12 months
Migrant Workers' Responses to the COVID-19 Pandemic

Rumors circulate widely during public health crises and have deleterious consequences. In this study, we seek to document the base rates of migrant workers' rumor exposure and identify predictors of rumor hearing, sharing and belief.

Rumors circulate widely during public health crises and have deleterious consequences. Vulnerable populations such as migrant workers tend to lack access to accurate health information, which can put them at higher risk for receiving and spreading misinformation.

In this study, we seek to document (i) the base rates of migrant workers' rumor exposure and (ii) identify predictors of rumor hearing, sharing and belief. These predictors include trust in institutions, risk perceptions, online habits and socio-demographic variables.

Data was taken from the COVID-19 Migrant Health Study, a cross-sectional study of male migrants employed in manual labor jobs within Singapore.

Eligibility Criteria:
Inclusion Criteria:

* At least 21 years old
* Holds a government work permit identifying their employment status

Exclusion Criteria:

* NIL
Seasonal Variation of Ambulatory Blood Pressure

This is a prospective study to evaluate the change in 24 hour ambulatory blood pressure during winter and summer in well controlled treated hypertensives.

Two 24hour ambulatory blood pressure monitorings, 4 to 6 months apart, will be performed on hypertensive subjects on a stable antihypertensive drug therapy for at least 4 weeks.

The correlation of weather and temperature with the 24hour ambulatory blood pressure monitoring will be explored.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 40 yrs
* Treated hypertension on stable treatment for at least 8 weeks
* Average home blood pressure (at least 5 days, 20 readings) \< 130/80 mmHg

Exclusion Criteria:

* Congestive heart failure
* Use of loop diuretics
Early Detection of Myocardial Ischaemia in Suspected Acute Coronary Syndromes by Apo J-Glyc

The objective of the study is to assess the performance characteristics of Apo J-Glyc as a novel biomarker for the early detection of myocardial ischaemia in patients with suspected acute coronary syndromes.

This in vitro diagnosis clinical validation will test the Performance Characteristics of Apo J-Glyc measured with a novel in vitro diagnostic (IVD) test. Blood samples from eligible consenting subjects will be collected at hospital admission, throughout different post admission times (1h, 3h, 24h and 72h or discharge). The quantification of circulating Apo J-Glyc levels will be analysed in correlation with clinical data providing information about Apo J-Glyc as an ischaemia biomarker and its diagnostic and 6-months prognostic value.

Eligibility Criteria:
Inclusion Criteria:

* Age equal or above 18 years old
* Chest pain of suspected cardiac origin
* Signature of informed consent
* Able and willing to comply with study requirements

Exclusion Criteria:

* Prior inclusion in the same study
* Life expectancy less than 6 months
* Previous inclusion in a therapy-related clinical trial (except clinical trials testing Medical Devices such as stents and/or balloons)
Corneal Biomechanics Study

The goal of the study is to investigate relationship between the corneal response to a temporary increase in intraocular pressure and corneal mechanical properties.

The preliminary theoretical study in which the corneal geometry at different intraocular pressure (IOP) levels is investigated using a theoretical biomechanical cornea model found changes in both conventional refractive error (sphere and cylinder) and irregular astigmatism i.e. higher order aberrations (e.g. spherical aberration, trefoil and quadrafoil). This is due to the mechanical characteristics of the cornea determined largely by interaction between collagen fibrils organization and extrafibrillar matrix material properties. Corneal geometry and the material properties are the two main factors that contribute to the changes in corneal aberrations with IOP elevation. These aberration changes due to the variation of IOP and the material properties of the cornea can be measured routinely with corneal topography systems (UR) and Brillouin ocular scanner (MGH), respectively and can guide the investigators to study their impact on optical and biomechanical behaviors of the cornea.

Eligibility Criteria:
Inclusion Criteria

A person is eligible for inclusion in the study if he/she:

* Is an adult between the ages of 18 and 55.
* Is under 250 pounds.

Exclusion Criteria

A person will be excluded from the study if he/she:

* Is under the age of 18 or over the age of 55 yrs.
* Weighs more than 250 pounds.
* Has clinically significant dry eye.
* Has glaucoma.
* Has hypertension.
* Has prior CVA.
* Has cardiovascular disease.
* Has lower extremity joint injury, damage, or replacement.
* Has baseline bradycardia.
* Has any orthopaedic injuries.
* Is pregnant.
* Has hiatal and ventral hernias.
* Has vertigo.
* Has acid reflux (GERD).
* Is undergoing myopia control treatment (e.g. atropinisation, Ortho-K, bifocal contact lenses etc.).
* Has conditions or has undergone procedures resulting in significant corneal irregularity (e.g. keratoconus, corneal transplant, etc.). This does not include astigmatism and basic refractive errors.
* Has any ocular or systemic diseases that, in the opinion of the PI/SI, would interfere with obtaining a measurement.
Evaluate and Compare the Rate of Para-Stomal Herniation After Permanent Stoma Formation

This study is being done to evaluate the use of a material (Alloderm collagen mesh) during the stomal formation operation (surgery that will create a mouth-like opening on the surface of the body to an internal organ). The main purpose of this research study is to see if using this material will lower the hernia rate compared to normal repair without this material. The secondary purpose is to evaluate if using this material will increase or decrease complication rates.

This study seeks to examine the ability of an implantable collagen matrix to reduce the incidence of parastomal hernia formation. Patients will be randomized preoperatively by a computer generated random allocation to either receive collagen mesh at the time of stoma formation, or to have stoma formation without mesh. Stomas without mesh will be made in the standard surgical fashion dictated by the type of stoma: ileostomy, colostomy, ileal conduit. Patients randomized to receive mesh will undergo stoma formation in an identical fashion, and will have a 8 cm x 12cm piece of AlloDerm mesh placed as a tissue reinforcement at the stoma site and extending under the midline incision. Patients will be followed with physical examinations at approximately 2weeks post-op, 3, 6, 9, 12, 24 months post-op, and will undergo CT scanning of the abdomen and pelvis at 12 and 24months to determine hernia occurrence.

Eligibility Criteria:
Inclusion Criteria:

1. Patients will be at least 18 years of age.
2. Male or female (excluding pregnant females).
3. Patients will require stoma formation.
4. Patients with ASA \< 3.
5. Patients informed about the study, and will have read; understood and signed the patient informed consent and authorization to use their PHI, as applicable.
6. Patients will be willing and able to submit to postoperative follow-up evaluations.

Exclusion Criteria:

1. Patients that have had prior surgical treatment parastomal herniation.
2. Patients that refuse stoma formation.
3. Patients with ASA \> 3.
4. Patients who have certain metabolic conditions (e.g., chronic hepatic or renal disease).
5. Patients with evidence of pre-existing systemic or local infections.
6. Patients with wound-healing or autoimmune disorders.
7. Patients who, in the surgeon's opinion, would have a difficult time comprehending or complying with the requirements of the study.
8. Patients with any conditions that were not suspected preoperatively and are only discovered at the time of the operation.
Zinc-L-Carnosine Prevents Dysphagia in Breast Cancer Patients Undergoing Adjuvant Radiotherapy

Irradiation of level III and IV draining nodes in breast cancer patients is often associated with dysphagia, requiring treatment with FANS and/or steroids. The present randomized phase III trial determined whether Zinc-L-Carnosine ( Hepilor), prevents or delays the onset of dysphagia in these patients.

. This is a randomized phase III prospective placebo-controlled trial with patients recruited from one single university teaching hospital. Inclusion criteria were: age ≥18 years, breast cancer patients who were candidates for post-operative RT by means of HeT to the breast /chest wall and SC/IC nodes (III-IV levels).Exclusion criteria were: pregnancy or lactation, known or suspected hypersensitivity or allergy to ZLC or to any of the excipients in its oral solution.

All patients were randomized by a pre-determined computer code to two groups.

1. HEPILOR arm: patients received ZLC solution
2. Placebo arm: patients received a placebo solution Toxicity was assessed weekly in all patients immediately before or after the RT session. Acute toxicity was defined as occurring during RT or in 30 days after it ended and assessed using the Common Terminology Criteria for Adverse Events (CTCAE 4.0 scale). Dysphagia was assessed weekly by means of EAT 10, a self-administered questionnaire

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* breast cancer patients who were candidates for post-operative RT by means of HeT to the breast /chest wall and SC/IC nodes (III-IV levels).

Exclusion Criteria:

* pregnancy or lactation
* known or suspected hypersensitivity or allergy to ZLC or to any of the excipients in its oral solution.
Efficacy and Safety Study of Combination of Ginkgo Extract and Ginseng Extract in Children With ADHD(Attention Deficit Hyperactivity Disorder)

This study will evaluate clinical efficacy and safety of treatment with YY-162 in children with ADHD.

This is Double-Blind, two arms, multi-center, Interventional, 8 weeks study starting with YY-162(Combination of Ginkgo extract and Ginseng extract)in children with ADHD. Assessment of efficacy and safety will be performed at the baseline, weeks 2, 4 and 8. At the first visit, a full psychiatric history, demographic date and physical examination will be undertaken. Throughout the study, the following procedures, documentations and evaluations will performed; K-ARS, IOWA conner's rating scale, CGI-S/I, ATA, Children's color trails test and stroop test, intelligence test(from KEDI-WISC)and adverse event reporting.

Eligibility Criteria:
Inclusion Criteria:

* Mele and female subjects aged from 6 to 15
* Subjects must meet DSM-IV criteria for ADHD based-on the K-Schedule for affective disorder and schizophrenia(K-SADS-PL-K)interview
* Subjects signed a written consent form voluntarily
* Patient's assent to participate in the study and written informed consent form signed by one of the parents, parent surrogates or legal guardian.
* Subjects who can keep visit schedule and whose parent/parent surrogates or legal guardian can willingly complete assessments defined in the study protocol.
* Subjects/parents, parent surrogates or legal guardian who can understand the participation of the study and voluntarily withdraw from the study at any time.

Exclusion Criteria:

* Subjects who have difficulty swallowing tablet.
* Subjects who have known allergy to plant extracts.
* Subjects who meet DSM-IV diagnostic criteria for current major depressive disorder or anxiety disorder requiring drug therapy.
* Subjects who have any history of bipolar disorder, psychotic disorder, and substance use disorder, have been diagnosed with a pervasive developmental disorder, organic brain disease and seizure disorder.
* Subjects who have significant suicidal ideation.
* Subjects with mental retardation.
* Subjects with Tourette's syndrome requiring drug therapy.
* Subjects who have been administrated Methylphenidate or Atomoxetine within recent 3 months and Ginkgo extract or Ginseng extract within recent 1 month.
* Subjects who currently have a significant medical conditions(e.g. diseases of cardiovascular, hepatic, renal, respiratory, glaucoma)
* Subjects who have abnormalities in the ECG or show clinically significant abnormalities of laboratory results including serum chemistries and hematology.
* subjects who are currently taking alpha-2 adrenergic receptor agonist, antidepressant, antipsychotic, benzodiazepines, modafinil, anticonvulsant.
* subjects who receive psychosocial treatment during the drug trial.
* Subjects who are not able to swallow the study drug.