cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Universal Prevention Curriculum for Schools in Peru

This randomized controlled trial was conducted to evaluate a universal prevention curriculum (UPC) training for Peruvian school administrators and teachers to reduce substance use among students. Twenty-eight schools were randomly assigned to intervention and control conditions (14 per condition). Substance use outcomes were assessed with repeated cross-sectional samples of students in 2018 and 2019. Multi-level analyses were conducted to assess intervention effects on students' substance use and related problems.

This randomized controlled trial was conducted to evaluate a universal prevention curriculum (UPC) training for Peruvian school administrators and teachers to reduce substance use among students. Twenty-eight schools were randomly assigned to intervention and control conditions (14 per condition). Prevention leadership action teams were formed at intervention schools to implement evidence-based school policies and positive school climate activities, and a classroom substance use prevention curriculum. Substance use outcomes were assessed with repeated cross-sectional samples of students in 2018 and 2019. Multi-level analyses were conducted to assess intervention effects on students' substance use and related problems.

Eligibility Criteria:
Inclusion Criteria:

* Students in participating schools aged 11 to 19

Exclusion Criteria:

* Not attending participating schools
Pharmacokinetic Drug Interaction Study of Dapagliflozin and Valsartan or Simvastatin in Healthy Subjects

Phase A - To assess the effect of simvastatin on the pharmacokinetics (PK) of dapagliflozin and to determine the effect of dapagliflozin on the PK of simvastatin, when simvastatin and dapagliflozin are coadministered in healthy subjects. Phase B - To assess the effect of valsartan on the PK of dapagliflozin and to determine the effect of dapagliflozin on the PK of valsartan, when valsartan and dapagliflozin are coadministered in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI = weight (kg)/\[height (m)\]2

Exclusion Criteria:

* Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product
* Abnormal urinalysis at screening (repeat urinalysis may be allowed for positive hematuria in women)
* Glucosuria at screening
* Abnormal liver functions tests (ALT, AST or total bilirubin \> 10% above ULN)
* Presence of edema on physical exam
* History of diabetes mellitus
* History of heart failure
* History of renal insufficiency
* History of chronic or recurrent UTI (defined as 3 occurrences per year) or UTI in the past 3 months
* History of recurrent (defined as 3 occurences per year) or recent vulvovaginal mycotic infections
* Positive urine screen for drugs of abuse either at screening or before dosing
* Positive blood screen for hepatitis C antibody, hepatitis C antibody, hepatitis B surface antigen, or HIV-1, -2 antibody
* History of allergy to SGLT2 inhibitors or related compounds
* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
* History of allergy or intolerance to valsartan or simvastatin (or related compounds)
* Prior exposure to dapagliflozin, valsartan or simvastatin within 3 months of Day -1
* Exposure to any investigational drug or placebo within 4 weeks of Day -1
* Use of any prescription drugs within 4 weeks or over-the-counter acid controllers within 2 weeks prior to any study drug administration
* Use of any other drugs, including over-the counter medications within 1 week and herbal preparations within 2 weeks prior to admission to the study facility
* Use of an oral, injectable or implantable hormonal contraceptive agent within 3 months of Day -1
Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Healthy Children and Adolescents

This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the trivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.

Subjects are randomly assigned in a 4:1 ratio to NBP607-QIV versus Agrippal S1. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 28 days post-vaccination. To assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination are assessed and reported. The serious adverse events are collected during 6 months post-vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children and adolescents aged 6 months to 18 years.
* Those who was born after normal pregnancy period(37 weeks) for aged 6 months to 2 years.
* Those whose legally acceptable representative have given written consent to participate in the study and comply with all study requirements.

Exclusion Criteria:

* Subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products.
* Subjects with immune deficiency disorder.
* History of Guillain-Barre syndrome.
* Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
* Subjects who experienced fever within 72 hours before vaccination or with the febrile disease(exceeding 38.0℃) on screening day or with any acute respiratory infection.
* Subjects who had received immunosuppressant or immune-modifying drug within 3 months before screening.
* Subjects who had received blood products or immunoglobulin within 3 months before screening.
* Subjects who had received influenza vaccination within 6 months prior to the screening.
* Subjects who had received other vaccination within a month before screening, or those who had another vaccination scheduled within a month after study vaccination.
* Subjects who had participated in other clinical trial within 4 weeks prior to study vaccination.
* Subjects who had done blood donation within a week prior to study vaccination or planned blood donation within 7 months after study vaccination.
* Subjects with clinically significant chronic disease or malignant cancer.
* Pregnant women, breast-feeding women.
* Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
12 Months Clinical Follow-up of Non-Carious Cervical Lesions Restored With New Injectable Composite

Non-carious cervical lesions are defined as loss of pathological material not associated with caries in the enamel-cement junction of the tooth. The etiology of these lesions has been defined as brush abrasion, acid-induced erosion and abstraction due to microstructure losses due to stress concentration in a particular region of the tooth. These lesions should be restored using minimally invasive techniques. The necessity of restorative treatment is directly related to the size of the lesion, sensitivity and aesthetic requirements. However, restorative procedures are often challenging because the cavity preparation does not provide adequate retention, and often the cervical end margin is positioned under the gingiva. This leads to contamination of the operation site with blood, saliva and gingival fluid.

Several restorative options have been proposed for the treatment of cervical caries-free lesions. However, due to their high aesthetic properties, improved adhesive capacity and mechanical properties, composites have been accepted as the most suitable choice. Clinical studies have demonstrated that marginal adaptation, marginal discoloration, and roughening methods for retention are the most important factors in the clinical performances of composite restorations in cervical lesions. Therefore, injectable composites with wettability and better adaptability to cavity margins have been introduced. However, the low filler contents of fluid composites and their weak mechanical properties compared to conventional composites have led researchers to doubt their use in caries-free cervical lesions. As a result of the developed material technology, injectable composites with high filler which have reduced polymerization shrinkage have been developed with simplified filler procedure. However, investigators have not encountered any studies investigating which etching technique this material will exhibit better clinical performance and comparing it with traditional pasty composites. The aim of this study is to evaluate the clinical performance of traditional paste type and injectable composites which will be made by using two different etching techniques.


Eligibility Criteria:
Inclusion Criteria:

* Patients with cervical lesions in the mouth with multiples of 4 and 4,

  * Patients over 18 years of age and in permanent dentition,
  * Patients who do not have a pulpal or endodontic lesion on their teeth to be treated,
  * Patients without sensitivity to percussion in the teeth to be treated.

Exclusion Criteria:

Patients with any systemic disease,

* Pregnant or suspected pregnancy and also breastfeeding patients,
* Patients who are allergic to any dental material,
* Patients with any periodontal disease,
* Patients with poor oral hygiene,
* In cases where the teeth are exposed to excessive load due to excessive rupture,
* Cervical caries lesions,
* Patients who continue orthodontic treatment,
* Desensitizing agents or fluoride treatment.
Prevention of Obesity at Universities: A Randomized Trial

This is a nutrition and behavior-based intervention conducted at Drexel University and the University of Pennsylvania with college women during their freshman year. It involves attending groups where life skills and eating behaviors are taught to help them control their weight and physical health.


Eligibility Criteria:
Inclusion Criteria:

* A variety of risk factors for later life weight gain

Exclusion Criteria:

* Current or past history of eating disorder
Immediate Implant With Cusomized Healing Abutment

evaluate clinically and radiographically the effect of customized healing abutment on peri-implant osteogenesis following immediate implant placement.

Now a day most people want to make immediate implant after extraction, which save them time and eliminates the need of second surgery. The problem is that the jummping gap between the implant and the bone that needs bone graft, this increase the cost on the patient. In this experiment we tend to evaluate this technique which may help us in growing autogenous bone and stop the need for bone grafting.

The aim of this study is to evaluate clinically and radiographically the effect of customized healing abutment on peri-implant osteogenesis following immediate implant placement.

A clinical trial was carried out on 8 patients (20-40 years old) with freshly extracted mandibular molars. Implants were placed immediately after extraction and a customized healing abutment will be fabricated. Patients were followed up clinically and radio graphically for 6 months.

Eligibility Criteria:
Inclusion criteria:

* Age range: 20 - 40 years
* Good oral hygiene
* A freshly extracted socket in the mandibular molar area.
* The gap between the implant and the bone will be at least 3-4 mm.

Exclusion criteria:

* Acute infection (periodontitis or mucosal infection)
* Patients on radiotherapy or chemotherapy.
* Alcohol or drug abuse.
* Patient with the systemic disorder (uncontrolled Diabetes mellitus, autoimmune diseases, bone diseases, etc.)
* Smokers.
* Parafunctional habits.
2D 4K vs. 3D HD in Bariatric Laparoscopic Surgery

Laparoscopy has become an indispensable part of modern surgery. Vision is an important and defining element of laparoscopy and significantly affects the outcome of an operation in regard to time, mistakes and precision. Several new imaging systems have become available for laparoscopic surgery, including three-dimensional (3D) high-definition (HD), and two-dimensional (2D) ultra-high-resolution (4K) monitors. In experimental and clinical settings, several studies have been published in recent years suggesting that 3D systems present a number of potential benefits for surgeons and patients compared to the conventional 2D systems. The 3D HD system significantly reduces operation time and blood loss, and additionally shortens hospital stay. However, the performance of 3D systems against the new, ultra-high-definition 4K systems is barely known and highly controversial. There is a paucity of studies comparing these two imaging systems in clinical settings. The goal of this clinical trial is to compare 2D 4K versus 3D HD imaging systems in a complex bariatric surgery, more precisely a gastric bypass operation. The investigators aim to investigate the hypothesis stating that the use of the 3D HD system yields a significant improvement in operating time compared to a 2D 4K system in bariatric laparoscopic surgery. Furthermore, in order to give a comprehensive overview of the comparison of 2D 4K and 3D HD laparoscopy in a clinical setting, the investigators will assess the workload of the surgeon as well as the intraoperative and postoperative complications including the hospitalization time.


Eligibility Criteria:
Inclusion Criteria:

* Patients with the indication for gastric bypass according to SMOB guidelines: BMI \> 35, Age \> 18 and Cumulative two years of controlled conservative dieting without weight loss
* Informed Consent signed by the patient

Exclusion Criteria:

* Patients who do not have an indication for gastric bypass due to one or more of the criteria listed here: BMI \> 50, Lack of adequate weight loss therapy for two years, Malignant disease, Liver cirrhosis Child A, Morbus Crohn, Carcinoma patients, Serious mental illness requiring treatment (not attributable to obesity), Chronic abuse of drugs, Lack of compliance (missed appointments, inability to cooperate), Lack of understanding of the requirements and conditions of postoperative therapy and treatment (confirmed by the specialist)
* Patient does not sign Informed Consent
Prevalence of Sleep Disturbances in Psoriasis

The purpose of this study is to compare the sleep quality of patients with psoriasis to patients without psoriasis.

In psoriasis, the burden of disease extends well beyond physical manifestations and can be associated with significant physical, social and psychological impairments. The impact of psoriasis on quality of life has been extensively investigated and demonstrates a negative affect on activities of daily living including sleep. Sleep abnormalities have also been reported in other dermatologic diseases including atopic dermatitis. However, there is relatively little data on the impact of psoriasis on sleep quality and what factors are likely to cause sleep disturbances. Obtaining this information is important because both psoriasis and sleep disorders are associated with cardiovascular disease. A better understanding of sleep problems in psoriasis may help to further our knowledge of psoriasis co-morbidities.

Certain factors associated with psoriasis, including pruritus, depression, and sleep-disordered breathing (obstructive sleep apnea) can independently affect sleep. It would be of particular interest to assess the effect of these factors on sleep quality in psoriasis subjects and the control group to determine what type of sleep problems exist among patients with psoriasis.

This study involves the use of six questionnaires to be given to subjects with psoriasis covering \>10% BSA and 40 subjects without psoriasis matched for age, gender and BMI, as a control population. The questionnaires will be given to subjects when they come for their scheduled appointments. The surveys will be completed anonymously and will be collected by a staff member when they are done. A physician will determine the participants' disease severity using the Psoriasis Area and Severity Index (PASI) and will attach the score to their questionnaire.

The questionnaires will cover sleep quality, depression, pruritis, insomnia, hypersomnia, and sleep-disordered breathing. Subjects will be given standard instructions to follow written directions on each questionnaire and will be given an unlimited amount of time to complete the surveys.

Eligibility Criteria:
Inclusion Criteria:

* Chronic plaque psoriasis (at least 6 months)

Exclusion Criteria:

* Active depression
Sepsis Clinical Decision Support [CDS] Master Enrollment Study Protocol

This protocol will collect real-world data retrospectively from the electronic health record (EHR) as data obtained from the delivery of routine medical care to develop a machine learning (ML)-based Clinical Decision Support (CDS) system for severe sepsis prediction and detection.

The purpose of this study is to gather data for the clinical development of the Sepsis Onset Warning System (SOWS) Software as Medical Device (SaMD) product to support a De Novo FDA submission and commercialization in the United States. Product development of SOWS is funded in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority.

Data will be obtained from passive prospective collection of patient encounter data throughout the duration of the planned study to support the product development life cycle activities associated with developing the Sepsis Onset Warning System (SOWS) for severe sepsis risk detection. Inputs from patient health records in combination with proprietary hematology parameters developed by Beckman Coulter, such as Monocyte Distribution Width (MDW), will be used. The SOWS tool will look to use clinical measurements which are commonly and reliably available in the EHR as structured data elements, such as heart rate, temperature, blood pressure, and laboratory results and account for changes in these values over time.

Eligibility Criteria:
Inclusion Criteria:

* All races, ages and ethnicities
* All patients admitted to the hospital or presenting to the Emergency Department

Exclusion Criteria:

* Patients not presenting to a hospital setting (e.g. urgent care, outpatient clinic excluded).
The Effect of Household-based Screening on Blood Pressure Changes in South Africa

This study will evaluate the effect of household-based screening and care encouragement for blood pressure on subsequent changes in blood pressure. The study uses a quasi-experimental regression discontinuity design with existing population-based secondary data from the 2008, 2010, 2012, 2014, and 2017 waves of the National Income Dynamics Study in South Africa.

Household-based screening and referral to care for blood pressure may improve blood pressure control at the population level in many low- and middle-income countries.

This observational study will use a quasi-experimental regression discontinuity design to evaluate the effect of household-based screening for blood pressure with care encouragement for potentially hypertensive individuals on subsequent changes in blood pressure over time.

Individuals had their blood pressure measured in the household as part of the National Income Dynamics Study data collection. If individuals had a measured blood pressure in the hypertensive zone, they were told that they had elevated blood pressure, that high blood pressure can lead to life threatening consequences, and that they should seek further care. The study exploits the fact that individuals were given this information based on a hard blood pressure cutoff. Therefore, the investigators will evaluate the causal effect of this household-based intervention in the absence of randomization by comparing individuals with a baseline blood pressure just above and below the cut off.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 30
* Valid blood pressure measurements

Exclusion Criteria:

* Prior diagnosis of hypertension
* Currently taking medication for blood pressure
* Measured with a blood pressure above 140 mmHg systolic or 90 mmHg diastolic in a previous wave of data
A Study of the Drug Interactions Between Danicopan and Cyclosporine, Tacrolimus, Antacids, and Omeprazole in Healthy Adults

This was a 3-part study with each part being an open-label, fixed-sequence, 2-period study in healthy adult participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at Screening.
* Female participants must have been of non-childbearing potential and not needing to employ a method of contraception.
* Non-sterile male participants must have agreed to abstinence or used a highly effective method of contraception.
* No clinically significant history or presence of electrocardiogram findings at Screening and Day -1 of Period 1.

Key Exclusion Criteria:

* Evidence of any clinically significant deviation from normal in clinical laboratory evaluations.
* History of any medical or psychiatric condition or disease that might have limited the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
* History or presence of drug or alcohol abuse within 2 years prior to first dosing; current tobacco/nicotine users and smokers; positive drugs-of-abuse and/or alcohol screen at Screening or Day -1 of Period 1.
* Any previous procedure that could have altered absorption or excretion of orally administered drugs.
* A history of significant multiple and/or severe allergies or had had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
* Body temperature ≥ 38°Celsius at Screening, on Day -1, or Day 1 prior to first dosing; history of febrile illness, or other evidence of infection, within 14 days prior to first dosing.
* Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days before first dosing, whichever was longer.
* Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing; receipt of blood products within 6 months prior to first dosing.
* Part 3 Only: Genotyped as poor metabolizer of cytochrome P450 2C19.
Diagnostic Pilot Study of Dual Energy Absorptiometry in the Detection of Osteopenia or Osteoporosis in Patients With Thalassemia Major

OBJECTIVES:

I. Determine the frequency and severity of osteopenia and osteoporosis in patients with thalassemia major who undergo dual energy x-ray absorptiometry, and correlate these findings with other relevant endocrinologic measurements.

PROTOCOL OUTLINE:

Patients undergo dual energy x-ray absorptiometry for bone density measurements, height (sitting and standing) and weight measurements, comprehensive endocrinologic examination, and assessment of the severity of iron overload at baseline, and then at years 1 and 2.

Eligibility Criteria:
* Diagnosis of thalassemia major with iron overload
* Not pregnant
* Negative pregnancy test