bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of the Teen Outreach Program in Hennepin County, Minnesota
Condition: Sexual Behavior; Pregnancy Early
Study type: Interventional

Summary: 
      This study tested the extent to which TOP®, when replicated with fidelity, produced impacts
      on sexual risk-taking behaviors in the short term and the longer term.
    

Detailed description: 
      This is a cluster randomized controlled trial. Teachers were randomized within schools to the
      treatment and control conditions. To assess the impact of offering TOP®, students were
      surveyed three times: at baseline, before the intervention began for the treatment group; 12
      months after baseline (short-term impacts); and 24 months after baseline (long-term impacts).
      Baseline data and subsequent follow-up data were collected using a Web-based survey. Paper
      surveys were used as back-up for baseline data collection. The pooled survey data from two
      school-year cohorts (school years 2011-2012 and 2012-2013) were used to estimate program
      impacts using an intent-to-treat (ITT) analysis. Program fidelity and interview data were
      used to describe program implementation.TOP® was delivered in middle schools, high schools,
      alternative schools, and public charter schools in Hennepin County. It was implemented during
      school hours in classes that spanned an entire school year with the same cohort of students.
      The subject of the class in which TOP® was placed differed across schools (for example,
      social studies, study hall, health).
    

Intervention name(s): Teen Outreach Program
Intervention type(s): Behavioral
Intervention description(s): TOP® is a youth development and service learning program for youth ages 12 to 17 designed to reduce teenage pregnancy and increase school success by helping youth develop a positive self-image, life management skills, and realistic goals. The TOP® program model consists of three components implemented in school, after school, or in community settings over nine consecutive months: (1) weekly curriculum sessions, (2) community service learning (CSL), and (3) positive adult guidance and support. The TOP® Changing Scenes® curriculum is separated into four age- and stage-appropriate levels, which range from Level 1, typically for youth ages 12 or 13, to Level 4, typically for youth age 17.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Teen pregnancy
Effect of Liver and Blood-stage Treatment on Subsequent Plasmodium Reinfection and Morbidity
Condition: Plasmodium Vivax Infection; Plasmodium Vivax Clinical Episode; Plasmodium Falciparum Infection; Plasmodium Falciparum Clinical Episode
MeSH terms: Infections; Communicable Diseases; Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      This study specifically seeks to quantify the contribution of relapes to the burden of P.
      vivax infections and disease by determining on the effect of radical pre-erythrocytic and
      erythrocytic clearance on subsequent rates of Plasmodium spp. infection and disease in
      children aged 5-10 years in a treatment to re-infection study design. In order the clear
      liver-stage/blood-stages G6PD-normal children were randomised to receive Chloroquine (3 days,
      standard dose) and Coartem (3 days, standard dose) plus either i) primaquine (20 days,
      0.5mg/kg) or ii) placebo (20days). These drugs were administered over a period of 4 weeks.

      In addition to this epidemiological data, the study will assess the natural acquisition of
      cellular and humoral immune responses to P. falciparum and P. vivax, thus assisting in the
      determination of correlates of clinical immunity to P. falciparum and P. vivax in PNG
      children aged 5-10 years.

      These data will not only be essential for development of future vaccines against P. vivax and
      P falciparum but provide invaluable insight into the contribution of long-lasting
      liver-stages to the force of infection with P. vivax that will contribute towards designing
      more rational approaches to the treatment of P. vivax both in the context of case management
      and future attempts at elimination.
    


Intervention name(s): Primaquine; Placebo; Chloroquine; Artemether Lumefantrine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sugar pills, appearance identical to Primaquine tablets
Other intervention name(s): Coartem
Intervention MeSH terms: Chloroquine; Lumefantrine; Artemether; Primaquine; Artemether, Lumefantrine Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Plasmodium vivax; Hypnozoites; Primaquine; Liver-stage; Blood-stage; Plasmodium falciparum
AUditive Direct In-utero Observation (AUDIO): Prenatal Testing of Congenital Hypoacusis
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      The objective of this randomized controlled study was to demonstrate whether fetal hearing
      can be assessed in utero.
    

Detailed description: 
      Unselected women at term of pregnancy (37-41 weeks of gestation) undergoing cardiotocography
      (CTG) according to routine clinical care and with a complete postnatal follow-up were
      consecutively recruited.

      The two groups of women were selected in a random way, and it was an unblended randomization
      controlled trial (RCT), according to a list created by the website ww.randomization.com.

      If the CTG was non-reactive for 10 minutes women who were eligible for the study were
      randomized into two groups.

      An auditive stimulus was generated in group A. This stimulus was produced by hitting a
      diapason on an acoustic surface, at a distance of 2-3 cm from the mother's skin (in order to
      avoid mechanical vibration to reach the fetus) in the area near the fetus' head.

      The same procedure was repeated three times, waiting 30 seconds between one stimulus and the
      following one. The total duration of stimulation was about 2 minutes. Cardiac accelerations
      on the CTG and fetal movements perceived by the mother were recorded in the ten minutes after
      the stimulus was produced.

      No stimulation was produced in group B, but the CTG was prosecuted until the clinical
      criteria were satisfied. The total length of the CTG was variable from a minimum of 20
      minutes to a maximum of one hour.

      All the clinical variables were recorded in the Case Report Form (CRF) in particular the
      lapse of time needed for the first fetal cardiac acceleration and for the first fetal
      movement to occur.

      A complete postnatal follow-up was obtained through the examination of medical records and
      parental interview.

      A power analysis was carried out using Power Analysis Sample Size (PASS) software
      (Kaysville,UT,USA) and was conducted before the enrollment started. It was estimated that,
      for a survival comparison test (Log Rank), given the sample allocation ratio=1:1, 100 cases
      per group would be needed to validate a hazard ratio between group A and group B of 1.5 with
      a power of 80% and a Type I error of 5%.
    

Intervention name(s): acoustic stimulation
Intervention type(s): Behavioral
Intervention description(s): An auditive stimulus was produced by hitting a diapason on an acoustic surface, at a distance of 2-3 cm from the mother's skin (in order to avoid mechanical vibration to reach the fetus) in the area near the fetus' head.
The same procedure was repeated three times, waiting 30 seconds between one stimulus and the following one. The total duration of stimulation was about 2 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: RCT; prenatal testing of hypoacusis
Dose and Response of Dietary Nitrate in Healthy and Active Men
Condition: Healthy
Study type: Interventional

Summary: 
      It was shown by some researchers that dietary nitrate such as beet root juice can lower
      oxygen consumption in men and act as a performance enhancing supplement.

      It was not shown, what the optimal dosage is and if there is any difference in oxygen
      consumption comparing beet root juice and inorganic nitrate.

      Therefore, the aim of the study is to conduct a study ingesting different sodium nitrate and
      beet root juice dosages. We would measure nitrate and nitrite concentrations in the blood at
      different time points and the subjects have to perform an exercise test measuring oxygen
      consumption 3 hours after the ingestion of nitrate.
    

Detailed description: 
      1. The subjects have to ingest 7 different dosages of either beetroot juice or sodium
           nitrate on seven different occasions. Every hour a blood withdrawal is taken to measure
           nitrate and nitrite concentration in the blood.

        2. The subjects have to ingest 7 different dosages of either beetroot juice or sodium
           nitrate on seven different occasions. Three hours after the intake of the supplement the
           subjects have to perform an exercise test on a bicycle. They have to cycle 5 min at 50%
           of maximal oxygen consumption and 8min at 80% of maximal oxygen consumption separated by
           a 5min break. Oxygen consumption would be measured during the whole exercise test. Blood
           withdrawal is taken before the ingestion, after 3 hours and after the test.
    

Intervention name(s): sodium nitrate; Beetroot juice
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Ingestion of 3mmol, 6mmol and 12mmol sodium nitrate; concentrated beetroot juice (dosage 3mmol, 6mmol and 12mmol)
Other intervention name(s): Inorganic nitrate; Biotta beetroot juice shot
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dietary nitrate; beetroot juice; exercise performance; oxygen consumption
VIveve Treatment of the Vaginal Introitus to EValuate Effectiveness
Condition: Vaginal Laxity Following Childbirth; Sexual Function Following Childbirth
Study type: Interventional

Summary: 
      Outside United States (OUS) Post-Market Parallel Group Exploratory Study Design

      The objective of this study is to determine the safety and effectiveness of the Viveve System
      to treat the vaginal introitus in women following vaginal birth(s) and in so doing improving
      vaginal laxity.
    

Detailed description: 
      A prospective, longitudinal, randomized, single-blind, sham controlled clinical study is
      planned. This study is designed to demonstrate that the active treatment (i.e., Viveve
      Procedure) is superior to the sham treatment for the primary effectiveness and safety
      endpoints.

      Approximately 113 evaluable subjects will be randomized in a 2:1 ratio to either the active
      treatment group or sham group. The active treatment group will receive a treatment dose of 90
      J/cm2 and the sham group will receive a sub-treatment dose of ≤1 J/cm2.

      Subjects will be followed up at 72 hrs, 10 days, and one, two, three, and six months post
      treatment.

      Final data will be reported at 6 months for active and sham treatments.
    

Intervention name(s): Active Treatment Viveve; Sham Treatment Viveve
Intervention type(s): Device; Device
Intervention description(s): Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus; Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Vaginal laxity; Sexual Function
A Study to Evaluate the Safety, Tolerability, and PK in Healthy Volunteers and HCV Genotype 1 Infected Patients
Condition: Healthy; Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      A Safety Study to Evaluate the Safety, Tolerability, and Pharmacokinetics in HCV Genotype 1
      Infected Patients
    

Detailed description: 
      A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study in Healthy East Asian and
      Caucasian Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics Profiles of
      Single and Multiple Ascending Oral Doses of TG-2349, and Followed by a Dose-Ranging Study in
      Hepatitis C Genotype 1 Infected Patients.
    

Intervention name(s): TG-2349; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Supplied as oral liquid formulation in pre-filled glass syringe. Two dose strengths, 25 mg TG-2349 (25 mg/mL in PEG 400, 1.1 mL fill) and 200 mg TG-2349 (50 mg/mL in PEG 400, 4.1 mL fill), are filled into 5-mL type 1 glass syringes. Required doses during clinical study are to be dispensed using the combination of the two dose units. The entire content of the syringe is to be taken by mouth.; Available in two different unit doses, 1.1 mL and 4.1 mL PEG 400 in 5-mL type 1 glass syringes. They are identical in appearance and similar in weight to TG-2349 oral liquid syringes.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
End-tidal Carbon Dioxide Monitoring in Low Tidal Volume Ventilation
Condition: Ventilation; End-Tidal Carbon Dioxide
Study type: Interventional

Summary: 
      In cases where there is no ventilation-perfusion problem, the end-tidal carbon dioxide
      (ETCO2) value is closely associated with partial arterial carbon dioxide pressure (PaCO2);
      therefore, the PaCO2 value can be estimated using ETCO2 measurements in patients without
      significant cardiopulmonary disorders. The aim of the investigator's study is to evaluate the
      reliability of pulmonary ventilation monitoring with ETCO2 value and to investigate at what
      tidal volume values ETCO2 monitoring provides reliable information.
    

Detailed description: 
      The patients were grouped as follows: Group 1, if the tidal volume is 4 ml/kg; Group 2, if
      TV=6 ml/kg; Group 3, if TV=8 ml/kg; and Group 4, if TV=10 ml/kg. It was determined how many
      breaths per minute (minute ventilation) would be given with tidal volume x respiratory rate=6
      L. The patients were ventilated with the same ventilation parameters for 30 minutes and then
      arterial blood gas analysis was performed. Arterial blood gas was collected at t1 for group
      1, t2 for group 2, t3 for group 3, and t4 for group 4. The ETCO2 value, Peak pressure
      (Ppeak), Plateau pressure (Pplato), mean airway pressure (Pmean) values were recorded at the
      time of arterial blood gas collection. Systolic blood pressure (SBP), diastolic blood
      pressure (DBP), mean arterial pressure (MAP), peak heart rate (PHR) values were evaluated.
      The patients with a mean arterial pressure of less than 65 mmHg were excluded from the study.
      Partial arterial oxygen pressure (PaO2), partial arterial carbon dioxide pressure (PaCO2),
      oxygen saturation (SO2) values were recorded from the arterial blood gas analysis. P (a-ET)
      CO2 gradient value was calculated.

      The groups were compared, in each patient, under the same conditions, when the different
      tidal volume was applied, how the ETCO2 monitorization, PaO2 values and hence the P (a-ET)
      CO2 gradient changed.
    

Intervention name(s): if the ventilation parameter caused desaturation or hypercapnia we will change the parameter
Intervention type(s): Other
Intervention description(s): we will increased fi02
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: sequential
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: End-Tidal Carbon Dioxide; P(a-ET)CO2 gradient; ETCO2; low tidal volüm; mekanical Ventilation
Evaluation of the Pharmacokinetic Interaction Between PA-824 and Midazolam
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and tolerability of PA-824 when given
      with a single dose of midazolam, and to determine whether PA-824 inhibits CYP3A to a
      clinically important degree as measured by the effect of PA-824 on the pharmacokinetics of
      midazolam, a known CYP3A substrate.
    

Detailed description: 
      This study is an open-label, fixed sequence design. 14 subjects will receive a single dose of
      2 mg midazolam, followed by a 2-day wash-out. Following the wash-out, all subjects will
      receive PA-824 once daily for 14 days. All patients will receive a single dose of 2 mg
      midazolam on the 14th day of PA-824 dosing. This study will evaluate 400 mg PA-824.
    

Intervention name(s): Midazolam; PA-824
Intervention type(s): Drug; Drug
Other intervention name(s): Dormicum; Hypnovel; Versed
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PA-824,; midazolam; drug-drug interaction; pharmacokinetics; pretomanid; CL-006
Tolerability of the Immersive Virtual Reality System Grail in Subjects Affected by Rett Syndrome
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Study type: Interventional

Summary: 
      The main goal of this study is to investigate the tolerability to the use of the GRAIL system
      in subjects affected by Rett syndrome, particularly referred to:

        1. Grail environment (training in dark conditions, interaction with wide and surrounding
           screen, positioning over the treadmill);

        2. time to prepare a set of body marker in order to execute a gait analysis;

        3. walking activity over treadmill, with immersive virtual reality;

        4. proprioceptive stimulatione provided by the GRAIL platform;

        5. cognitive-attentive span time to the activity proposed. The secondary goal is to
           understand if a training that avail of treadmill and virtual reality would be useful in
           the future in improving gait characteristics in subjects affected by Rett syndrome
    


Intervention name(s): GRAIL
Intervention type(s): Device
Intervention description(s): The subjects experiment GRAIL virtual reality for three days, during which they deal with 4 different activities.
In the first activity subjects are required to ask over the treadmill in a snow environment.
in the second they are required to stand over the moving platform in a simulation of a boat pitch.
in the third they have to walk over a bridge with a slope. in the fourth the subjects are required to try so interact with virtual reality and to ski between snowman.
if it is possible, on the last day a gait analysis is executed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Virtual Reality; Rett Syndrome; walk
Recombinant Human Alkaline Phosphatase in Healthy Japanese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Clinical Phase 1 study to investigate the pharmacokinetics and to assess the safety and
      tolerability of recAP after single and multiple intravenous doses in healthy Japanese
      subjects.
    

Detailed description: 
      This study is a randomized, double blind, parallel group, single-center trial, consisting of
      a single dose part and a multiple dose part in 32 healthy Japanese subjects. Since all these
      doses have been studied before and safety extensively evaluated in non-Japanese subjects and
      no ethnic sensitivity is expected, the groups can be dosed in parallel.

      Part A will have 3 parallel groups of 8 male subjects with N=6 on active and N=2 on placebo
      per group. Following baseline assessments, a single dose of recAP will be administered by a
      one-hour infusion followed by samplings for pharmacokinetic evaluation and routine safety
      assessments.

      Part B will have a single group of 8 male subjects with N=6 on active and N=2 on placebo.
      Following baseline assessments, recAP will be dosed on Days 1, 2 and 3 by one-hour infusions
      followed by samplings for pharmacokinetic evaluation and routine safety assessments.
    

Intervention name(s): single 1-hour IV infusion of 0.8 mg/kg recAP; single 1-hour IV infusion of 1.6 mg/kg recAP; single 1-hour IV infusion of 3.2 mg/kg recAP; 1-hour infusions of 1.6 mg/kg recAP on Days 1, 2 and 3; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Intravenous infusion; Intravenous infusion; Intravenous infusion; Intravenous infusion; Intravenous infusion
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the Low-Density Lipoprotein-Cholesterol (LDL-C) lowering efficacy and
      safety of ETC-1002 versus placebo in participants with hypercholesterolemia and a history of
      statin intolerance.
    


Intervention name(s): ETC-1002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Weeks 1-2, 60 milligrams per day (mg/day); Weeks 3-4, 120 mg/day; Weeks 5-6, 180 mg/day; Weeks 7-8, 240 mg/day; Placebo once daily for 8 weeks
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lipid-lowering drugs; statin intolerance
Study to Evaluate the Safety and Bioequivalence of Estradiol Vaginal Inserts, 10 mcg and Vagifem® 10 mcg and Compare to Placebo
Condition: Atrophic Vaginitis Due to Menopause
MeSH terms: Vaginitis; Atrophic Vaginitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the safety and efficacy of generic Estradiol Vaginal
      Inserts, USP 10 mcg to the reference product Vagifem® 10 mcg and to determined whether the
      efficacy of each of the 2 active treatments is superior to that of the placebo.
    


Intervention name(s): Estradiol Vaginal Tablets 10 mcg; placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Vagifem®
Intervention MeSH terms: Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment