bioihbjkbjnl/mcl2 huggingface dataset:
High-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
Condition: Purpura, Thrombocytopenic, Idiopathic
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Study type: Interventional
Phase: Phase 4

Summary: 
      The project was undertaking by Qilu Hospital of Shandong University and other 11 well-known
      hospitals in China. In order to report the efficacy and safety of high-dose dexamethasone
      compared to conventional dose prednisone for the first-line treatment of adults with primary
      immune thrombocytopenia(ITP).
    

Detailed description: 
      The investigators are undertaking a parallel group, multicentre, randomised controlled trial
      of 300 adults with ITP from 11 medical centers in China. Part of the participants are
      randomly selected to receive high-dose dexamethasone treatment and the other part are
      selected to receive conventional dose of prednisone treatment. Platelet count, bleeding and
      other symptoms were evaluated before and after treatment. Adverse events are also recorded
      throughout the study. In order to report the efficacy and safety of high-dose dexamethasone
      compared to conventional dose prednisone for the first-line treatment of adults with ITP.
    

Intervention name(s): Prednisone; Dexamethasone
Intervention type(s): Drug; Drug
Intervention description(s): Prednisone, po, 1 mg/kg/d, for 4 weeks.; Dexamethasone, po, 40 mg/d, for 4 days.
Other intervention name(s): CD-PRE; HD-DXM
Intervention MeSH terms: Dexamethasone; Prednisone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Purpura, Thrombocytopenic, Idiopathic
Asacol Acute Diverticulitis(DIVA)Study
Condition: Diverticulitis
MeSH terms: Diverticulitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Asacol® 2.4 g/day (400 mg Mesalamine) is
      safe and effective in the treatment of diverticulitis.
    

Detailed description: 
      This study is designed to evaluate the safety and efficacy of Asacol® 2.4 g/day in generally
      healthy, adult patients who have had an attack of acute diverticulitis. The study will
      evaluate the safety and efficacy of a 12 week treatment with Asacol® followed a 9 month
      non-treatment observation period in approximately 180 patients with acute diverticulitis.
    

Intervention name(s): Mesalamine; Probiotic; Placebo; Dietary Advice; Antibiotic for Diverticulitis
Intervention type(s): Drug; Drug; Drug; Other; Drug
Intervention description(s): 6 - 400 mg tablets once daily; Once capsule daily Bifidobacterium infantis 35624 added at Visit 2 (Day 10 + 4 days); 6 placebo tablets for first 10 (+4) days followed by once daily placebo tablets.; Dietary advice; Physician recommended antibiotic for Diverticulitis taken for 10-14 days. Antibiotic not specified for study.
Other intervention name(s): Align
Intervention MeSH terms: Anti-Bacterial Agents; Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
EMDR in Spider Phobia: Work Mechanisms and Treatment Outcome
Condition: Spider Phobia
MeSH terms: Phobic Disorders
Study type: Interventional

Summary: 
      The goal of this study is to increase the efficiency of exposure in virtual reality (VR).

      Based on the EMDR research the investigators would like to show that the implementation of
      eye movements during the VR exposure results in a faster physiological relaxation response
      among probands with spider phobia, which has a positive effect on the subjective and
      behavioral efficacy of the VR exposure.
    

Detailed description: 
      The VR paradigm consists of one room with a spider in it. The proband is supposed to look at
      it for a few minutes. This exposure is repeated several times.

      In the experimental group a ball appears during the exposure, that moves horizontally across
      the room. The probands are supposed to follow this movement with their eyes.

      EDA, EKG and respiration are being recorded. Furthermore the subjective and behavioral spider
      phobia is measured before, during and after the exposure to determine occurring changes.
    

Intervention name(s): Eye Movement Desensitization and Reprocessing Therapy; Virtual Reality Exposure Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In 1989, Shapiro discovered that while talking about negative life events or thoughts, rhythmic eye movements on a horizontal axis can alleviate the associated vividness and burden (Shapiro, 1989). She established the psychodynamic-behavioral Eye Movement Desensitization and Reprocessing (EMDR) Therapy, which includes the induction of rhythmic eye movements as a central feature. EMDR is regarded as an efficient treatment tool. Several times it has also been successfully applied in the field of specific phobias (de Jongh, ten Broeke, & Renssen, 1999; de Jongh, Holmshaw, Carswell, & van Wijk, 2011; Lapsekili & Yelboga, 2014; Muris, Merckelbach, van Haaften, & Mayer, 1997) and there is a standard protocol for using EMDR on specific fears and phobias (de Jongh, 2015).; Exposure to fear-evoking stimuli is conducted more often in virtual environments using simulators or similar computer-technologies (Virtual Reality Exposure Therapy, VRET). One great advantage of using VR-technologies is that it is possible to create an environment which is highly controllable by its creators. Feared stimuli or scenarios can be varied on individual purposes and presented several times. This facili- tates the practice of exposure-based treatments especially for situations or places diffi- cult to access or requiring a considerable amount of time and/or money (e.g. being in war zones or a passenger on a flight), where in vivo exposures have often not been con- ducted or only in a limited manner (Mühlberger & Pauli, 2011).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sucralfate to Improve Oral Intake in Children With Infectious Oral Ulcers: a Randomized, Double-blind, Placebo-Controlled Trial
Condition: Herpangina; Gingivostomatitis; Hand, Foot and Mouth Disease
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Herpangina; Mouth Diseases; Oral Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if sucralfate, a medication commonly used for patients
      with stomach ulcers, may help pediatric patients with mouth ulcers decrease their pain level
      and improve their ability to drink.
    


Intervention name(s): Sucralfate; Placebo; Acetaminophen; Ibuprofen
Intervention type(s): Drug; Other; Drug; Drug
Intervention description(s): Will receive 20mg/kg/dose up to 1 gram.; Will received placebo solution of similar quantity to that of the weight based dose of sucralfate.; All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.; All patients will receive analgesia, either acetaminophen 15mg/kg or ibuprofen 10mg/kg depending on medication administration prior to arrival in the Emergency Department and at the discretion of the treating physician, in addition to either the experimental drug or placebo.
Intervention MeSH terms: Acetaminophen; Ibuprofen; Sucralfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Bioequivalence Study Of Diltiazem In 60 Mg Tablets As Tilazem 60® Made by Pfizer, S.A. De C.V., Versus Angiotrofin® 60 Mg Made by Amstrong Laboratorios De Mexico, S.A. De C.V.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will research the existance of actual bioequivalence between Diltiazem in 60 Mg
      Tablets As Tilazem 60® Made by Pfizer, S.A. DE C.V., Versus Angiotrofin® 60 Mg Made by
      Amstrong Laboratorios De Mexico, S.A. DE C.V.
    

Detailed description: 
      Bioequivalence of this particular drug
    

Intervention name(s): TILACEM; ANGIOTROFIN
Intervention type(s): Drug; Drug
Intervention description(s): At 08:00 hours on day 1, CIF-BIOTEC personnel will start to administer the study drug. Each volunteer will receive a single dose of 60 mg of Diltiazem. The study drugs will be ingested with 250 mL of drinking water. Research Pharmacy personnel will inspect the volunteer's oropharynx to ensure that he/she has swallowed the tablet and record their observations in the corresponding forms.; At 08:00 hours on day 1, CIF-BIOTEC Pharmacy personnel will start to administer the study drug. Each volunteer will receive a single dose of 60 mg of Diltiazem. The study drugs will be ingested with 250 mL of drinking water. Research Pharmacy personnel will inspect the volunteer's oropharynx to ensure that he/she has swallowed the tablet and record their observations in the corresponding forms.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: diltiazem; angiotrofin; bioequivalence
Vitamin A Kinetics and Mathematical Modeling in American Women
Condition: Vitamin A Kinetics
Study type: Interventional

Summary: 
      Women were given a vitamin A tracer, and blood was sampled to determine individual and group
      vitamin A kinetics. Data were subsequently modeled using compartmental analysis to determine
      effects of study length on model outcomes.
    

Detailed description: 
      This is a longitudinal study in which American women were given an oral, stable isotope
      tracer of vitamin A, and blood was sampled in a staggered, serial design to determine
      individual and group vitamin A kinetics. Data were subsequently modeled using compartmental
      analysis, and study truncation analysis was performed on data to investigate the factor of
      study duration on resulting vitamin A kinetic models and outputs related to vitamin A
      metabolism.
    

Intervention name(s): Vitamin A tracer
Intervention type(s): Other
Intervention description(s): A stable isotope tracer of vitamin A was given orally.
Other intervention name(s): 13C vitamin A; 13C retinyl acetate
Intervention MeSH terms: Vitamins; Vitamin A; Retinol palmitate; Retinol acetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of treatment using a
      combination of drugs (entecavir and pegylated interferon) in children ages 3-<18 years old
      with immunotolerant chronic hepatitis B.
    

Detailed description: 
      This single arm treatment study was conducted by the pediatric centers within the National
      Institute of Diabetes Digestive and Kidney Diseases (NIDDK)-sponsored Hepatitis B Research
      Network (HBRN). Children age 3-<18 years with immunotolerant chronic hepatitis B (CHB)
      infection who fulfilled the entry criteria received entecavir as monotherapy for 8 weeks and
      then combination therapy with entecavir and pegylated interferon by weekly subcutaneous
      injection until week 48. Children were to be followed for 48 weeks after discontinuation of
      therapy (week 96 for those who completed 48 weeks of treatment).

      Assessment was undertaken at baseline, weeks 4, 8, 10, 12, 14, & 16, then every 4 weeks until
      week 48, and then 4, 8, 12, 24,36, and 48 weeks following treatment discontinuation
      corresponding to weeks 52, 56, 60, 72, 84 and 96 for those who received treatment for 48
      weeks. Blood work was drawn to measure markers of viral and liver disease status and for
      research biospecimen banking.

      Participants were to receive therapy until week 48 and enter 48 weeks of follow-up
      thereafter. Participants who experienced a sustained elevation of alanine aminotransferase
      (ALT) were eligible to receive treatment as recommended by their hepatologist and continued
      to complete the study protocol.
    

Intervention name(s): Entecavir and peginterferon
Intervention type(s): Drug
Intervention description(s): Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 µg/1.73m2 subcutaneously once weekly for 40 weeks beginning 8 weeks after entecavir monotherapy).
Other intervention name(s): PEGASYS, peginterferon alfa 2a, Baraclude
Intervention MeSH terms: Peginterferon alfa-2a; Entecavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis B; HBV
Exercise-induced Muscle Damage is Reduced in Resistance Trained Athletes by Branch Chain Amino Acids
Condition: Exercise-induced Muscle Damage
Study type: Interventional

Summary: 
      It is well documented that exercise-induced muscle damage (EIMD) decreases muscle function
      and causes severe soreness and discomfort. Branched-chain amino acid (BCAA) supplementation
      has been shown to increase protein synthesis and decrease muscle protein breakdown, however,
      the effects of BCAAs on recovery from EIMD are unknown. Thus, the aim of this study was to
      examine the effects of a BCAA supplement on markers of muscle damage.
    


Intervention name(s): Branch Chain Amino Acid (BCAA); Placebo - asparmate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Supplementation lasted for a total of 12 days; this was based on previous research showing a positive with BCAA supplementation on markers of muscle damage. Participants ingested 10 g, twice per day (morning and evening) of BCAA . The BCAA supplement contained a ratio of 2:1:1 (leucine, isoleucine and valine, respectively). The BCAA was in powder form where each serving was mixed with ~300 ml of water.; Supplementation lasted for a total of 12 days. Participants ingested an equivalent looking volume to 10 g of BCAA, twice per day (morning and evening) of placebo (aspartame based artificial sweetener). The BCAA supplement contained a ratio of 2:1:1 (leucine, isoleucine and valine, respectively). The artificial sweetener was in powder form where each serving was mixed with ~300 ml of water.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Development and Feasibility Test of an Ecological Momentary Intervention (EMI) - ReApp, to Increase Reappraisal.
Condition: Stress
Study type: Interventional

Summary: 
      The aim of the current project is to develop and test Ecological Momentary Interventions
      (EMIs) to promote and improve stress resilience, specifically, an EMI to increase positive
      reappraisal.

      EMIs are mostly smartphone-based applications that deliver interventions to people as they go
      about in their daily lives. The EMI tested here is based on theoretical and empirical
      findings and consists of several items and repeated training using various individual
      scenarios from participants' life that will be presented to participants via an app on their
      smartphones.

      This study tests the efficacy of the EMI on a change in (i) reappraisal and (ii) indices of
      perceived stress. One hundred twenty healthy student participants, aged 18-29 will be invited
      to the study. Participants will be screened and those who score below 13 points of
      reappraisal skills in a Cognitive Emotion Regulation Questionnaire, will be included in the
      study. This is necessary in order to avoid a ceiling effect on reappraisal skills, which may
      be high in students.

      Then, the participants will be randomly assigned to experimental (reappraisal EMI in regular
      and burst design) and control conditions (control EMA) and fill in questionnaires. The
      reappraisal EMI groups will be taught reappraisal skills and will be asked to apply them to
      personal situations repeatedly. The control EMA group will have the same app consisting of
      Ecological Momentary Assessment only. The training will last 21 consecutive days and the app
      will send (i) 5 prompts per day to ask about the current mood of the user in control and both
      experimental groups and (ii) at least two prompts per day resulting in a total of min. 42
      reappraisal training sessions in the regular experimental group or 28 reappraisal training
      sessions in the burst experimental group. What is more, every participant has the possibility
      to trigger the EMA or EMI anytime they wish to. After using the app, participants will fill
      in some questionnaires again. The whole study will be conducted remotely (Video calls and app
      use) to avoid unnecessary COVID-related risks for participants.
    


Intervention name(s): Reappraisal training; Ecological Momentary Assessment
Intervention type(s): Device; Device
Intervention description(s): The EMI developed and tested here is based on theoretical and empirical findings and consists of several items and repeated training using various individual scenarios from participants' life that will be presented to participants via an app on their smartphones.; The EMA tested here collects data on participants' mood and behavior.
Other intervention name(s): ReApp; EMA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: stress; health; resilience
A Study of Experimental Medication BMS-986231 in Patients With Different Levels of Kidney Function
Condition: Myocardial Failure; Cardiac Failure; Congestive Heart Failure; Kidney Failure; Renal Failure
MeSH terms: Renal Insufficiency; Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate experimental medication BMS-986231 in patients
      with different levels of kidney function.
    


Intervention name(s): BMS-986231
Intervention type(s): Drug
Intervention description(s): Intravenous infusion administration
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
STN-Stimulation Versus Best Medical Treatment in Advanced PD
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Assessment of the therapeutic effect of deep brain stimulation of the subthalamic nucleus
      compared with drug treatment alone in patients with advanced Parkinson's disease.
    

Detailed description: 
      Patients are randomized either to medical treatment or subthalamic stimulation. The
      observation period was 6 months. The primary outcome criterium: PDQ-39 and UPDRS III.
    

Intervention name(s): Implantation of stimulation electrodes in the STN
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Acute Pyelonephritis With Gram Negative Strains in Infants and Children Less Than 3 Years Old
Condition: Pyelonephritis
MeSH terms: Pyelonephritis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to demonstrate the equivalence of the therapeutic efficacy of
      cefixime by mouth (PO) 10 days (d) and ceftriaxone intravenous route(IV) 4d followed by
      cefixime PO 6d on renal scars 6 months after a first acute pyelonephritis episode.

      The investigators hypothesize that treatment with cefixime PO will allow no more renal scars
      than intravenous route (IV) treatment of pyelonephritis in infants and children less than 3
      years old, 6 months after the first episode. If it is true, treatment will no longer need
      hospitalisation and the advantages for children, families and the health system will be very
      important.
    

Detailed description: 
      Guidelines for treatment of acute pyelonephritis in infants and children are different from
      one country to another. The main question is the incidence of renal scars.

      intravenous route (IV) treatment is supposed to give the best results, but no previous study
      has ever given the incidence of renal scars after PO treatment.

      This multicenter, randomised trial is an equivalence study of PO and intravenous route (IV)
      treatments.
    

Intervention name(s): antibiotic; antibiotics
Intervention type(s): Drug; Drug
Intervention description(s): cephalosporine by oral route : cefixime; cephalosporine : ceftriaxone by intra venous route and cefixime by oral route
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infant; children; pyelonephritis; Renal scars; DMSA scan
Treatment of Acute Lymphoblastic Leukemia (ALL) in Younger Adults
Condition: Leukemia, Lymphocytic
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a multicenter trial of treatment for young ALL patients. All ALL patients will
      receive the same steroid pre-phase in order to evaluate sensitivity or resistance. Then,
      patients will be included into 3 specific trials according to biological features
      (immunophenotype, cytogenetics, and molecular biology).

      Group for Research on Adult Acute Lymphoblastic Leukemia (GRAALL) 2005:

        -  T ALL or B ALL non Ph (N=810 patients planned).

        -  GRAALL 2005 R: B ALL non Ph CD20+ (N=220 patients planned).

        -  GRAAPH 2005: ALL Ph+ (N=270 patients planned)
    

Detailed description: 
      GRAALL 2005: T ALL or B ALL non Ph

      Randomization between standard versus intensified cyclophosphamide administration during a
      4-drug, 4 week chemotherapy and late intensification.

      (N=810 patients planned)

      GRAALL 2005 R: B ALL non Ph CD20+

      Randomization between standard versus intensified cyclophosphamide administration during a
      4-drug, 4 week chemotherapy and late intensification.

      Randomization between Mabthera (rituximab) or no Mabthera during all induction and
      consolidation courses.(N=220 patients planned)

      Allogenic transplantation will be performed depending on unfavourable risk factors.

      GRAAPH 2005: ALL Ph

      Randomization between an imatinib-based induction and a chemotherapy + imatinib induction.
      (N=270 patients planned)

      Allogenic transplantation will be systematically performed in the presence of related or
      unrelated donors.

      Autologous transplantation could be performed in the absence of a donor in case of Molecular
      Residual Disease (MRD) ≤ 10-4.

      Consolidation therapy will be performed in the absence of a donor in case of MRD > 10-4.
    

Intervention name(s): Rituximab; Imatinib Mesylate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Rituximab; Imatinib Mesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ALL,; young patients,; chemotherapy,; Mabtera,; Imatinib,; allogeneic transplant