bioihbjkbjnl/mcl2 huggingface dataset:
Metacognitive Intervention for Individuals With Severe Mental Disorders
Condition: Schizophrenia
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      The overall aim of this study was to develop a meta-cognitive group intervention in order to
      apply it and to understand and distinguish the components that influence participation among
      people with schizophrenia
    

Detailed description: 
      The overall aim of this study was to develop a Meta cognitive group intervention in order to
      apply it and to understand and distinguish the components that influence participation among
      people with schizophrenia. The specific objectives were to:

        1. Improve participation by increasing the effectiveness of cognitive strategy use and
           teaching clients to independently review performance and to examine the strategy's
           effectiveness.

        2. Compare the use of cognitive strategies between participants with schizophrenia and
           their matched controls following the Meta cognitive group intervention and to correlate
           the cognitive strategies use and participation following the Meta cognitive group.

        3. Examine whether symptoms moderate the association between metacognitive outcomes and
           participation among people with schizophrenia following the Meta cognitive group.
    

Intervention name(s): Metacognitive Group Intervention; Occupational therapy standard care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The investigators developed an initial Meta cognitive group intervention protocol based on the dynamic interactional model of cognition (Toglia, 2005), and specifically tailored it to individuals with schizophrenia.; Occupational therapy standard care
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Before and after intervention
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Executive function; Meta-cognition; Schizophrenia; Meta-cognitive intervention
A Study to Evaluate the Effect of Multiple Doses of Esomeprazole on the Pharmacokinetics of Isavuconazole
Condition: Pharmacokinetics of Isavuconazole; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple doses of esomeprazole on the
      pharmacokinetics of isavuconazole. In addition, safety and tolerability of isavuconazole
      alone and in combination with esomeprazole will be assessed
    


Intervention name(s): Isavuconazole; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): BAL4815; Nexium®
Intervention MeSH terms: Isavuconazole; Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Isavuconazole; Esomeprazole; BAL4815; BAL8728; Healthy Subjects
MR-based Models for Clinically Significant Portal Hypertension in Cirrhosis (CHESS1802)
Condition: Hypertension, Portal
MeSH terms: Hypertension, Portal; Hypertension
Study type: Interventional

Summary: 
      Clinically significant portal hypertension (CSPH) is associated with an incremental risk of
      esophageal varices and overt clinical decompensations in cirrhosis. However, hepatic venous
      pressure gradient (HVPG) measurement, the gold standard for defining CSPH (HVPG≥ 10mmHg) is
      invasive and therefore not suitable for routine clinical practice.

      This is a multi-center diagnostic trial conducted at high-volume liver centres designed to
      determine the accuracy of MR-based models (investigational technology) for noninvasive
      detection of a CSPH in patients with cirrhosis. Transjugular HVPG measurement by means of
      catheterization of a hepatic vein with a balloon catheter is the gold-standard method to
      assess the presence of CSPH.
    

Detailed description: 
      Clinically significant portal hypertension (CSPH) is associated with an incremental risk of
      esophageal varices and overt clinical decompensations in cirrhosis. However, hepatic venous
      pressure gradient (HVPG) measurement, the gold standard for defining CSPH (HVPG≥ 10mmHg) is
      invasive and therefore not suitable for routine clinical practice.

      This is a multi-center diagnostic trial conducted at high-volume liver centres (Zhongda
      Hospital, Medical School of Southeast University; Affiliated Lishui Hospital of Zhejiang
      University; Shandong Provincial Hospital affiliated to Shandong University; Beijing 302
      Hospital; Xingtai People's Hospital; Shunde Hospital, Southern Medical University; The First
      Hospital of Zhengzhou University; Shanghai Public Health Clinical Center, Fudan University;
      The First Hospital of Lanzhou University; Nanfang Hospital of Southern Medical University;
      Ankara University School of Medicine) designed to determine the accuracy of MR-based models
      (investigational technology) for noninvasive detection of a CSPH in patients with cirrhosis.
      Transjugular HVPG measurement by means of catheterization of a hepatic vein with a balloon
      catheter is the gold-standard method to assess the presence of CSPH.
    

Intervention name(s): Transjugular HVPG measurement; MR imaging
Intervention type(s): Procedure; Procedure
Intervention description(s): By means of catheterization of a hepatic vein with a balloon catheter.; MR images for the post-processing analysis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: clinically significant portal hypertension, hepatic venous pressure gradient, MR imaging
Healthy Term Infants Fed Milk-Based Formulas
Condition: Healthy Term Infant
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective is to assess the comparative fat and calcium absorption, and gastrointestinal
      (GI) tolerance in healthy normal term infants fed powdered milk-based formulas containing
      different fat blends.
    


Intervention name(s): Experimental powdered milk-based infant formula with an alternate fat blend; A powdered milk-based infant formula, standard fat blend
Intervention type(s): Other; Other
Intervention description(s): formula to be consumed ad lib; formula to be consumed ad lib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cleanser Versus Only Water
Condition: Premature Birth
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      The aim of this study is to determine the effect of the newborn's first bath with a cleaning
      product and only water on the barrier function of the skin.
    

Detailed description: 
      Studies in the literature on the effects of newborn bath types on the effects of body
      temperature on newborn crying times, on the effects of newborn behavior and stress, the views
      and practices of mothers with newborn babies on baby bathing, and the effects of bath types
      on the umbilical cord in term babies, and the effects of bath products on newborns. It seems
      that there are studies done. However, although studies on the effect of the cleaning product
      used in the first bath of late preterm and term newborns on the skin barrier are limited in
      number for term newborns, there are almost no studies for late preterm newborns. The
      hypotheses of this study are as follows; 1. In late preterm and term newborns, the first bath
      with cleaning product protects the newborns' Transepidermal Fluid Loss better than the first
      bath with only water. 2. In late preterm and term newborns, the first bath with cleansing
      product keeps the skin pH levels of newborns at a more optimal level compared to the first
      bath with only water.
    

Intervention name(s): Bathing With Baby Cleanser and water; Bathing With only Water
Intervention type(s): Procedure; Procedure
Intervention description(s): Late preterm and term newborns, whose informed consents are obtained by their parents to participate in the project, will be given their first baths according to the intervention group they are assigned to. Before the first bath / after birth, preterm newborns in all groups will be wiped only once with a clean towel without removing the vernix caseosa. Newborns who were bathed before the application of the study will be excluded from the study. As the most appropriate time for bath time, 30 minutes after the end of the feeding and treatment of the newborns, the bath application will be made at any time between 9 pm and 3 pm.; Preterm infants will have their first baths only with water.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Skin Barrier Function; First Bathing; Baby Cleanser; Transepidermal Water Loss; Skin pH
Extracorporeal Support for Respiratory Insufficiency (ECMO)
Condition: Acute Respiratory Failure; Lung Diseases
MeSH terms: Lung Diseases; Respiratory Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate indications for the use and efficacy of extracorporeal membrane oxygenators
      (ECMO's) for the support of patients with potentially reversible acute respiratory failure.
    

Detailed description: 
      BACKGROUND:

      The report of the Task Force on Respiratory Diseases identified a clinical syndrome of acute
      respiratory insufficiency (ARI) and estimated that approximately 60,000 Americans die of ARI
      yearly. ARI was not precisely defined; indeed, the Task Force realized that pathologists do
      not recognize ARI. The Task Force pointed out that no diagnostic tests for early detection of
      ARI exist, that the incidence and prevalence of the disease are not known, and that existing
      therapy is supportive and nonspecific (diuretics, corticosteroids, etc.). The pathogenesis of
      the syndrome, the mechanism of interstitial edema, the defenses of the lung against agents
      causing ARI, and the ultrastructural pathology and natural history of the disease were
      virtually unknown. The Task Force indicated a need for Respiratory Care Centers with highly
      trained personnel that could reduce mortality from ARI.

      This clinical trial grew out of the Task Force report. Nine participating centers defined ARI
      in clinical and physiological terms and agreed to a prospective randomized study for 3 years
      to compare treatment of severe ARI by conventional means with treatment by extracorporeal
      membrane oxygenators.

      Animal studies have shown that ECMO's can provide one to two weeks' support for the lungs
      without serious blood damage, in contrast to bubble oxygenators, which allow complete
      pulmonary bypass for approximately 6 hours, after which severe blood damage occurs at the
      direct blood-gas interface. If patients with hypoxia secondary to acute reversible lung
      injury can be supported with ECMO's until the lung lesion heals, improvement in survival
      rates and avoidance of the hazards of conventional therapy may result. The trial, now
      completed, was conducted at nine clinical centers in the United States.

      DESIGN NARRATIVE:

      Randomized, non-blind, fixed sample; 90 eligible patients were randomly assigned to a group
      receiving extracorporeal membrane oxygenation plus conventional therapy or to a group
      receiving conventional therapy.

      The study completion date listed in this record was obtained from the Query/View/Report (QVR)
      System.
    

Intervention name(s): extracorporeal membrane oxygenation
Intervention type(s): Procedure
Allocation: Randomized
Primary purpose: Treatment
Prevention of Injuries in Young Athletics (Track and Field) Athletes
Condition: Sports Injury
MeSH terms: Wounds and Injuries; Athletic Injuries
Study type: Interventional

Summary: 
      The long-term purpose of an on-going participatory action research program "The KLUB-study"
      in Sweden, that involves scientists and representatives from all levels of athletics, is to
      develop a sustainable framework for safe athletics (track and field) training for child
      athletes born 2002-2006. The first part of the research program, a 1-year longitudinal study
      analysing training and injury data, was completed in November 2017. The present study sets
      out to evaluate a website that aims to support coaches and caregivers in their role as adult
      key stakeholders to foster young athletes to become adult athletes who possess the tools to
      maintain a healthy sporting lifestyle.
    

Detailed description: 
      The intervention will be implemented in youth athletics and evaluated in a randomised
      controlled trial (RCT). It will follow the consensus guidelines for studies in athletics and
      be reported according to the CONSORT checklist. The participating clubs will be randomly
      allocated into active and control group. The active group will be provided the intervention
      program, i.e. access to a website, aimed to support coaches, caregivers´ and athletes' and
      improve knowledge and health literacy to make more informed choices that promote health. The
      control group will continue to train according to their routines and will get access to the
      website after 4 months.

      The participants will be assessed at three times, at the beginning of the study (T1), after
      four months (T2), at ten months (T3) and additional prospective data on training and injury
      will be collected during the first four months (T1b).
    

Intervention name(s): Active group
Intervention type(s): Other
Intervention description(s): For this study, the Frisk.Friidrott (Healthy.Athletics/Track&Field) website has been developed. The purpose of the website is to provide an easy-to-use tool that can assist coaches and parents involved in youth athletics with information how to structure training and recovery planning, provide guidance on possible injuries, and provide other information on health for youth athletes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Effect of Omeprazole on the Pharmacokinetics of Dasatinib in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of omeprazole on the pharmacokinetics of
      dasatinib in healthy subjects and to assess the safety and tolerability of a single dose of
      dasatinib before and after 5 days of dosing with omeprazole in healthy subjects
    


Intervention name(s): Dasatinib + Omeprazole
Intervention type(s): Drug
Intervention description(s): Tablet/Capsule, Oral, (Dasatinib 100 mg)/(Omeprazole 40 mg), once daily, 7 days
Other intervention name(s): Sprycel
Intervention MeSH terms: Dasatinib; Omeprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Healthy Subjects
A Study of CAT-1004 Biomarkers in Healthy Subjects
Condition: Assessment of Mechanistic Blood Biomarkers in Healthy Humans
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to assess mechanistic blood biomarkers of CAT-1004 in healthy
      humans.
    


Intervention name(s): CAT-1004; Salsalate + DHA; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Salicylsalicylic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Pharmacokinetics Study of ALO-02 and OxyContin
Condition: Management of Moderate to Severe Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      To characterize the single- and multiple-dose pharmacokinetics of oxycodone following the
      administration of ALO-02 40 Mg Twice Daily, ALO-02 80 Mg Once Daily or Oxycontin 40 Mg Twice
      Daily in Healthy Volunteers
    


Intervention name(s): ALO-02; Naltrexone block; ALO-02; Naltrexone block; OxyContin; Naltrexone block
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Day 1 (40 mg ALO-02 capsule, single dose) Days 2-5 (40 mg ALO-02 capsule, twice daily); Naltrexone Hcl 50 mg tablet will be administered (1) 12.5 hours prior to, 30 minutes prior to, and 11.5 hours after Day 1 dosing, (2) 30 minutes prior to each dose of study drug on Days 2-5 dosing, (3) 11.5 hours after Day 5 PM dosing; Day 1 (80 mg ALO-02 capsule, single dose) Days 2-5 (80 mg ALO-02 capsule, once daily); Naltrexone Hcl 50 mg tablet will be administered (1) 12.5 hours prior to, 30 minutes prior to, and 11.5 hours after Day 1 dosing, (2) 30 minutes prior to each dose and 11.5 hours after the AM dosing on Days 2-5, (3) 23.5 hours after Day 5 dosing.; Day 1 (40 mg OxyContin tablet, single dose) Days 2-5 (40 mg OxyContin tablet, twice daily); Naltrexone Hcl 50 mg tablet will be administered (1) 12.5 hours prior to, 30 minutes prior to, and 11.5 hours after Day 1 dosing, (2) 30 minutes prior to each dose of study drug on Days 2-5 dosing, (3) 11.5 hours after Day 5 PM dosing
Intervention MeSH terms: Naltrexone; Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: single- and multiple-dose pharmacokinetics; ALO-02; OxyContin
Butyrate/Hexanoate in Metabolic Health
Condition: Metabolic Disease
MeSH terms: Metabolic Diseases
Study type: Interventional

Summary: 
      In this study, we aim to identify a well consumable butyrate/hexanoate-enriched oil that
      increases circulating SCFA concentrations and improves postprandial substrate metabolism,
      which could be further used for a long-term study.
    


Intervention name(s): Placebo; butyrate and hexanoate amount 1; butyrate and hexanoate amount 2; butyrate and hexanoate amount 3
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): acute intake of 0 mg butyrate and hexanoate; acute intake of 650 mg butyrate and hexanoate; acute intake of 1325 mg butyrate and hexanoate; acute intake of 2000 mg butyrate and hexanoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Pilot Study to Assess Effects of Self-Administered Nitrous Oxide (SANO) on Urodynamic Study (UDS) Parameters
Condition: Lower Urinary Tract Symptoms
MeSH terms: Lower Urinary Tract Symptoms
Study type: Interventional
Phase: Phase 4

Summary: 
      A urodynamic study (UDS) is a common procedure done to learn more about the cause of urinary
      symptoms. For some patients, UDS can be associated with anxiety or discomfort. Nitrous oxide
      (or laughing-gas) is a well-known sedative which is frequently used in dental offices and for
      pediatric procedures to reduce anxiety and pain. This study is being done to see if giving
      low-dose (25-50%) nitrous oxide at the time of UDS affects the measurements taken during the
      procedure, such as how much volume your bladder can hold, and pressures during urination. If
      the measurements are the same with and without self-administered nitrous oxide (SANO), it
      could be suggested that nitrous oxide may be a useful way of reducing patient anxiety and
      pain during UDS.
    

Detailed description: 
      The urodynamic study (UDS) procedure will consist of catheter placement and two "runs".
      Before the start of the procedure, a study staff member will assist the participant with
      putting on a plastic gas mask. SANO and oxygen will be given through this mask. The dose will
      be adjusted based on the participant's comfort level but they will not be able to request
      more gas than allowed. SANO will be administered during catheter placement at the start of
      the UDS. During the two runs, the participant will either receive SANO (run 1) then oxygen
      (run 2), or oxygen (run 1) then SANO (run 2).

      Before the day of the UDS, participants will be asked questions related to demographics and
      medical history to determine study eligibility and experience of the treatment. During the
      UDS, participants will be asked to describe their anxiety and pain levels. Afterwards, they
      will be asked to complete a 15-20 minute structured interview with a study staff member to
      learn more about patient experience during UDS.
    

Intervention name(s): Self-Administered Nitrous Oxide; Oxygen
Intervention type(s): Drug; Other
Intervention description(s): Nitrous oxide administered at concentrations of mild sedation (20-50%); 100% oxygen at 10 Liters/minute
Other intervention name(s): nitrous oxide
Intervention MeSH terms: Nitrous Oxide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each participant will undergo urodynamic study (UDS) with two fills. The participant will receive SANO during one fill, and oxygen during the other fill. Participants will be randomized to the order in which they receive SANO or oxygen.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: urodynamic study; nitrous oxide; neurogenic bladder; overactive bladder; ambulatory; patient experience of care
Trazodone for SSRI-sexual Dsyfunction
Condition: Sexual Dysfunction
Study type: Interventional

Summary: 
      The aim of this study is to investigate the efficacy of trazodone in the treatment of
      selective serotonin reuptake inhibitor(s) associated sexual dysfunction. The secondary
      domains assessed were the relationship between 5-HT2A polymorphism and treatment efficacy.
    


Intervention name(s): Trazodone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg/d trazodone was upwardly titrated to 100 mg/d over one week and then maintained; Placebo
Intervention MeSH terms: Trazodone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: trazodone; SSRI; sexual dysfunction; 5-HT2A polymorphism