bioihbjkbjnl/mcl2 huggingface dataset:
Vision Care Intervention for Lower Grade School Children in Taiwan
Condition: Myopia; Outdoor Activity; Policy of Recess Outside Classroom
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is making use of school policy- recess outside classroom (ROC7-11)
      for increasing the time spent outdoor during recess and encouraging children spent time
      outdoor up to 11 hours in each week to investigate the vision change, myopia onset and
      progression in these schoolchildren.
    


Intervention name(s): Outdoor activity in recess time
Intervention type(s): Behavioral
Intervention description(s): Outdoor activity in recess time
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Myopia; Outdoor activity; Recess outside classroom
Volar Locked Plating Versus Bridging External Fixation
Condition: Distal Radius Fracture
MeSH terms: Radius Fractures; Wrist Fractures
Study type: Observational

Summary: 
      A randomized, prospective comparison of volar locked plating versus Hoffman II bridging
      external fixation supplemented by K-wire fixation in patients with comminuted distal radius
      fractures, AO/OTA type C2 & C3.

      Hypothesis:

      There is no significant difference in using volar plates compared to Hoffman II bridging
      external fixation supplemented by K-wire fixation in patients with comminuted distal radius
      fractures, AO/OTA type C2 & C3 as evaluated by a Quick-DASH score at 24 months follow-up.
    

Detailed description: 
      We have designed a randomized, prospective study for comparison of volar locked plating
      versus Hoffman II bridging external fixation supplemented by K-wire fixation in patients with
      comminuted distal radius fractures, AO/OTA type C2 & C3. On the basis of power analysis a
      total of 140 patients are to be included in this project. The follow-up period is 2 years and
      evaluation is based on x-ray analysis, grip strength, range of movement, pain and various
      tools to measure quality of life and satisfaction with the treatment (EQ-5d, SF-36,
      Quick-DASH).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients between the age of 18 and 70 diagnosed with a C2- or C3-type fracture
Study of the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics of PA1010 in HBV Patients
Condition: Chronic HBV Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety, tolerability, pharmacokinetic
      and pharmacodynamic characteristics of multiple ascending dose (MAD) of PA1010 tablets in
      Chinese adults with Chronic Hepatitis B.
    

Detailed description: 
      This is a multicenter, randomized, open-label, controlled, dose-escalation clinical trial,
      the objective is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic
      characteristics of PA1010 tablets in Chinese patients with Chronic Hepatitis B (CHB). There
      are three dose groups of PA1010 ( 5 mg, 10 mg, and 20 mg) proposed to be tested sequentially
      in this study. A total of 36 patients with CHB, either hepatitis B e antigen (HBeAg)-positive
      (+) or HBeAg-negative (-), are planned to be enrolled in this study and will be stratified by
      HBeAg status by the ratio of 2: 1, that is, 24 of HBeAg + and 12 of HBeAg- patients. Twelve
      subjects in each dose group were randomly assigned in a 3: 1 ratio to receive either PA1010
      tablets or or tenofovir disoproxil fumarate (TDF) tablets. All patients will be dosed for 28
      consecutive days, and the dose-related safety, PK, and antiviral efficacy of PA1010 will be
      evaluated.
    

Intervention name(s): PA1010
Intervention type(s): Drug
Intervention description(s): TDF as control
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Syndecan-4 as a Biomarker in Patients With Chagas Disease
Condition: Chagas Disease
MeSH terms: Chagas Disease
Study type: Observational

Summary: 
      The purpose of this study is to analyze the efficacy of syndecan-4 as a biomarker on the
      Chagas Disease prognosis. This analysis will be done through the correlation between the
      plasmatic levels of this molecule with functional and laboratory tests.
    

Detailed description: 
      Increased serum levels of syndecan-4 have been correlated to acute myocardial infarction and
      chronic heart failure, suggesting that this molecule can be an important biomarker in heart
      diseases. In spite of that, there are no studies that have investigated the role of this
      molecule in chronic chagasic cardiomyopathy yet.

      In this project, our objective is to demonstrate the potential role of syndecan-4 in the
      prognosis of chronic chagasic cardiomyopathy, seeking a better fitting of the treatment
      through the identification of patients with the worse prognosis.

      The patients included in the study must at first sign the written consent. They shall be
      accompanied in the specialized outpatient clinics for Chagas disease - Hospital São Rafael -
      Centro de Biotecnologia e Terapia Celular. They will be submitted to several tests,
      including:

        -  Collection of Blood samples for biochemical analysis;

        -  Electrocardiogram;

        -  Holter Electrocardiogram;

        -  Echocardiogram;

        -  Treadmill Test;

        -  X-Ray Imaging;

        -  Magnetic Resonance Imaging;

        -  Evaluation of the quality of life through the application of questionnaires (SF 36 and
           the Minnesota Living With Heart Failure Questionnaire).
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Tertiary Hospital
      
Biospecimen description: 
      Plasma, Serum, Whole Blood
    
Keywords: Syndecan-4; Chagas disease; Biomarkers
Rehabilitating Overweight People Back to Working Life
Condition: Obesity
MeSH terms: Overweight
Study type: Observational

Summary: 
      Obesity may have implications on the individual's participation in working life through
      different mechanisms such as comorbidity and loss of functional level. The investigators also
      know that when exiting the working force, it is difficult to get back later. As
      rehabilitation back to working life is often not a very focused aim with weight loss
      treatment, this study sets this as a primary aim by involvement in a 4 week stay at a
      rehabilitation clinic followed by 48 weeks work practice programme at one of three different
      companies.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Obese people where the obesity is the reason they are not actively taking part in working
        life.
Brainstem Grey Matter and Cerebral Autoregulation in Migraine With Aura.
Condition: Migraine With Aura
MeSH terms: Migraine Disorders; Migraine with Aura
Study type: Interventional

Summary: 
      Migraine with aura (MA) is an independent risk factor for stroke and is associated with
      silent brain infracts and T2 white matter hyperintensities on MRI. Previous studies using
      Transcranial Doppler (TCD) have shown an impairment of cerebral autoregulation in MA
      patients. Studies with positron emission tomography have demonstrated an activation of brain
      stem areas during migraine attack. An increased density of brain stem grey matter as measured
      on MRI with voxel based morphometry (VBM) has been found in MA patients. As brain arteries
      and arterioles are innervated by ascending tracts from aminergic brainstem nuclei, th study
      hypothesize a negative correlation between the density of brainstem nuclei and the efficiency
      of cerebral autoregulation in MA patients compared with controls.

      Brainstem grey matter density will be studied with a MRI Philips 3 Tesla with a 32-channel
      antenna and voxel-based morphometry (VBM) cerebral autoregulation will be measured in the
      time domain using Transcranial Doppler (TCD) and the Mx method.

      MA patients will be studied in a headache-free period. MRI and Transcranial Doppler (TCD) are
      non-invasive technics and will be performed on the same day.
    


Intervention name(s): Magnetic resonance imaging; Transcranial Doppler
Intervention type(s): Other; Other
Intervention description(s): Patients and controls will first be studied with MRI. The total duration of MRI is about 60mn. These technic is not invasive.; Patients and controls will first be studied with TCD. The total duration of TCD is about 60mn. These technic is not invasive.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cerebral autoregulation; MRI; VBM; Doppler Transcranial
Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients, using
      the PillCam Colon system.
    

Detailed description: 
      1. Primary Scientific Objective Evaluate the effectiveness of the PillCam COLON 2 Prep
           Regimen in CD patients.

           Secondary Objective To evaluate safety of the PillCam™ COLON 2 procedure in CD patients

        2. Study Hypothesis Crohn's Disease may be pan-enteric in nature and can affect the small
           bowel, the colon or both. PillCam COLON 2 may be used for visualization of both SB and
           colon mucosa in Crohn's Disease patients. However, bowel prep is required in order to
           evacuate all fecal matter prior to the exam and in order to propel the capsule and
           complete its traverse through the entire GI track within examination time.

        3. The study is designed to evaluate the effectiveness of the prep regimen in terms of
           transit, excretion and cleansing in CD patients

      All end points will be evaluated within 4 months from end of enrollment.
    

Intervention name(s): bowel prep regimen first boost 6 oz. and second boost 3 oz.; bowel prep regimen first boost 3 oz. and second boost 6 oz.
Intervention type(s): Other; Other
Intervention description(s): Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost); Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Known, active Crohn's disease; Iieocolonic or colonic involvement; proven patency of the GI tract
A Randomized Placebo- and Active Comparator-controlled Study to Evaluate the Photosafety of SAR441566
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center randomized parallel-group partially-blinded, 4-arm Phase 1 study to
      evaluate the phototoxic potential of two dose levels of SAR441566 treatment compared to
      placebo and the active comparator, ciprofloxacin, in healthy adults, 18 to 55 years of age.

      There will be two parts:

        -  Part I is a randomized placebo-controlled trial comparing sensitivity to ultraviolet
           (UV) light in participants treated with SAR441566 to those treated with placebo.

        -  Part II is an open label arm consisting of participants treated with ciprofloxacin which
           induces mild phototoxicity and serves as a positive control.
    

Detailed description: 
      The overall duration of the study for each participant will be up to approximately 48 days
    

Intervention name(s): SAR441566; Placebo; Ciprofloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet; Tablet; Tablet
Intervention MeSH terms: Ciprofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess Efficacy and Tolerability of Ketoprofen 40 mg Granules vs Placebo
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective:

      To assess the efficacy of OKITASK® 40 mg granules versus Placebo in patients with acute pain
      syndrome after removal of one molar tooth by comparing AUC0-6h of posttreatment pain profile
      measured by VAS.

      Secondary objectives:

      To assess the following efficacy and safety parameters of OKITASK® 40 mg granules versus
      Placebo in patients with acute pain syndrome after removal of one molar tooth:

        -  Time profile of pain and time profile of pain relief using VAS scales

        -  Time to first perceptible pain relief (TFPR) and time to meaningful pain relief (TMPR)

        -  Proportion of patients requiring rescue medication (analgesia) and time to rescue
           analgesia

        -  Patient's overall assessment

        -  Rate of adverse events (AE)
    

Detailed description: 
      This is a multicenter, double blind, randomised, parallel groups study to assess the efficacy
      and tolerability after single oral administration of Ketoprofen lysine salt 40 mg granules
      versus Placebo in male and female subjects with acute pain syndrome after removal of molar
      teeth.
    

Intervention name(s): Ketoprofen; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 40 mg KLS granules (corresponding to 25 mg ketoprofen); 0 mg KLS granules
Other intervention name(s): Okitask, ketoprofen lysine salt (KLS); Control
Intervention MeSH terms: Ketoprofen; Ketoprofen lysine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects
Condition: Hypercholesterolemia and High Risk for Cardiovascular Events
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to evaluate the effect of 12 weeks of subcutaneous evolocumab every
      2 weeks or every 4 weeks, compared with placebo, on percent change from baseline in
      low-density lipoprotein cholesterol (LDL-C) when used in addition to statin therapy in
      Japanese adults with hypercholesterolemia and high cardiovascular risk.
    


Intervention name(s): Evolocumab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Administered by subcutaneous injection; Administered by subcutaneous injection
Other intervention name(s): AMG 145; Repatha
Intervention MeSH terms: Evolocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Japanese, hypercholesterolemia, high risk for cardiovascular events
Prognostic Significance of Fine-Needle Aspiration Cytology Features in Papillary Thyroid Carcinoma
Condition: Thyroid Neoplasms
MeSH terms: Thyroid Neoplasms; Thyroid Diseases
Study type: Observational

Summary: 
      The purpose of this study is to investigate the relationship between prognosis and fine
      needle aspiration cytology character of papillary thyroid cancer.
    

Detailed description: 
      Papillary thyroid carcinoma is the most common thyroid malignancy worldwide. The influence of
      clinicopathologic features on prognosis has been examined, but the relationship between
      cytologic features obtained by fine-needle aspiration (FNA) and prognosis has been minimally
      studied. We retrospectively studied the cytologic features with computerized morphometry in
      83 patients with usual-type papillary thyroid cancer and followed them for more than 10 years
      except for one with metastasis at diagnosis. The cytologic features of FNA and recurrence of
      cancer were examined statistically.
    

Intervention name(s): Fine needle aspiration of the thyroid
Intervention type(s): Procedure
Observational model: Defined Population
Time perspective: Retrospective
Sympathetic and Blood Pressure Responses to Aerobic Exercise and Guided Respiration in Hypertensives
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Hypertension is serious health problem in Brazil and affects almost 30%of adult population.
      It is known that there are pharmacologic and nonpharmacologic strategies for treating
      hypertension. Aerobic exercise and slow breathing are nonpharmacologic methods that reduce
      blood pressure in an isolated form, but its combinations has never been studied. The aim of
      this study is to evaluate the association of both strategies and also the mechanisms involved
      in blood pressure reduction using slow breathing, in stages 1 and 2 hypertensives.
    

Detailed description: 
      The combination of drugs and no medication for hypertension treatment has been widely
      recommended, with emphasis on aerobic exercises (EXE), relaxation exercises, and the use of
      equipment designed to decrease the respiratory rate called Resperate®. This intervention has
      demonstrated a hypotensive effect in pressure measurements in clinical blood pressure and
      ambulatory blood pressure monitoring (ABPM) and home blood pressure monitoring (HBPM). It is
      unknown; however, if slow breathing (GRL) associated with other intervention, such as EXE,
      for example, may potentiate the blood pressure (BP) reduction. The aim of this study will be
      evaluate the acute responses of muscle sympathetic nerve activity (MSNA) and BP, in
      association of the slow breathing versus control (listening to calm music) and the 24 hour
      blood pressure response after the association of EXE and GRL. Twenty hypertensives will be
      evaluated between 18 to 60 years old, mens and woman, sedentary, non-obese, without target
      organs damage and associated comorbidities, after 4 weeks of placebo use (washout period).
      Participants will be randomly divided into 2 groups (GRL and GC) and both perform EXE on a
      cycle ergometer. Volunteers will make a ABPM before and after the experimental session. In
      this session will be recorded for 10 minutes, prior to the physical exercise, the systolic
      blood pressure (SBP), diastolic blood pressure (DBP), respiratory rate (RR) and heart rate
      (HR), after that, It will be held microneurography to register also the MSNA for 10 minutes,
      then they will perform either GRL or listened to music for 15 minutes. Variables will be
      measures for more 10 minutes. After finishing the session, volunteers will put the ABPM and
      will go away.
    

Intervention name(s): Resperate®-InterCure Ltda; Music group (GC)
Intervention type(s): Device; Other
Intervention description(s): The device-guided breathing - Resperate®-InterCure Ltda, uses sound to guide and therefore reduce the respiration rate in individuals.; The patients in this arm will hear slow music - Music group (GC).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; slow breathing; sympathetic nerve activity
First-in-Human Single Ascending and Multiple Dose of GLPG0778
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD)
      and multiple (MD) oral doses of GLPG0778 compared to placebo (with and without food).

      Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after single and multiple
      oral administration will be evaluated, and, if applicable, the maximum tolerated dose
      determined.
    


Intervention name(s): GLPG0778; placebo; GLPG0778; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single ascending doses, oral solution (10 to 800 mg/dose) and capsules (100 mg/dose); single dose, oral solution or capsule (matching corresponding study medication); multiple dose, capsule, 7 days; multiple dose, capsule, 7 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Safety; Tolerability; Pharmacokinetics
Effect of Pertubation on Pregnancy Rates Before Intrauterine Insemination Treatment
Condition: Infertility; Pertubation; Insemination
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      To demonstrate a possible beneficial impact of pertubation we designed a randomized
      prospective study, in which uterine washing was administered prior to insemination in
      patients diagnosed with unexplained infertility.
    


Intervention name(s): Pertubation
Intervention type(s): Procedure
Intervention description(s): a lavage procedure of the intrauterine cavity and bilateral fallopian tubes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Unexplained Infertility, Pertubation, Gonadotrophin, Ovulation Induction, Intrauterine Insemination
Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) vs. Escitalopram in Postmenopausal Women
Condition: Depression; Depressive Disorder; Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Desvenlafaxine succinate (DVS) is a potent and selective serotonin and norepinephrine
      reuptake inhibitor (SNRI). This study will investigate the safety, efficacy, and tolerability
      of DVS SR versus escitalopram in women with major depressive disorder (MDD) who are
      postmenopausal.
    


Intervention name(s): Desvenlafaxine succinate sustained-release (DVS SR); Escitalopram
Intervention type(s): Drug; Drug
Intervention description(s): flexible dose of DVS 50-100 or 200 mg every day during 56 days. Extension until 6 months.; Flexible dose of Escitalopram 10 or 20 mg every day during 56 days. Extension until 6 months.
Intervention MeSH terms: Desvenlafaxine Succinate; Escitalopram
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: MDD; Major Depressive Disorder; Depression