bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Arm Crank Versus Treadmill Exercises on Heart Rate Variability in Adult Subjects.
Condition: Heart Rate Variability
Study type: Interventional

Summary: 
      Cardiovascular response to exercise affects the capacity of all body organs depending upon
      intensity, duration and mode of exercises. The aim was to compare acute effects of arm crank
      with treadmill moderate intensity exercises on heart rate variability in normal participants.
    

Detailed description: 
      A one hundred thirty male volunteers were equally and randomly assigned to; Group-I:
      Sixty-five participated in an arm crank moderate intensity exercise for 40 minutes. Group-II:
      Sixty-five participated in a treadmill moderate intensity exercise for 40 minutes. Halter
      heart rate monitor and automatic sphygmomanometer were used to measure heart beat intervals
      and arterial blood pressure respectively.
    

Intervention name(s): Arm crank; Treadmill; Exercise
Intervention type(s): Device; Device; Other
Intervention description(s): Each participant practiced on arm crank (Hudson) from long sitting position for 40 minutes. Seat's height and distance were adjusted to achieve full extension of subject arms at horizontal shoulder-level position; Participant practiced on an electronic computerized treadmill for 40 minutes . participant began warming up with lowest speed treadmill exercise for 5 minutes at zero inclination. Treadmill speed was increased gradually to achieve the pre-determined individualized moderate intensity for 30 minutes
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel assignments
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Exercise ,Autonomic cardiac function ,Adult subjects
Rapid Urease Test for Diagnosis Helicobacter Pylori Infection
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections
Study type: Observational

Summary: 
      Nowadays, the gold standard examinations for diagnosing H. pylori infection are
      histopathology and culture examination. However, those examinations take long preparation so
      they are not suitable to be applied in daily practice. In progress, another examination is
      being developed to detect urease enzyme from tissue biopsy. It is relatively faster in
      diagnosing H. Pylori infection. Some commercial urease tests which are available in Indonesia
      are Helicotec® and Pronto Dry®.

      This study aims to determine the effectivity of Helicotec® in diagnosing H. pylori infection.
      It is expected to be scientific evidence that can be used as the basis daily routine of
      urease test in diagnosing H. Pylori infection.
    

Detailed description: 
      This study is a diagnostic study. There will be 97 dyspepsia patients who met the inclusion
      and exclusion criteria. They will answer the questionnaire about personal data and examined
      physically. They will also undergo endoscopy, biopsy, and urease test using Helicotec®
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        General population: Jakarta citizen Targeted population: Patients of endoscopy centre Cipto
        Mangunkusumo Hospital Sample: Targeted population who undergo endoscopy examination and met
        the inclusion and exclusion criteria
      
Keywords: helicobacter pylori; urease test; helicotec
Berberine Effects on Clinical Symptoms and Metabolic Disturbance in Patients With Schizophrenia
Condition: Schizophrenia; Therapeutics
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The study was a 8-week, randomized, double-blind, placebo-controlled trial. Berberine (300
      mg，three times a day), as an adjuvant therapy has been used on the basis of the
      Second-generation antipsychotics（SGAs） monotherapy. All participants were randomly divided
      into two groups.Any SGA + berberine (BBR) or any SGA +placebo.Positive and Negative Syndrome
      Scale (PANSS) has been used for psychiatric symptoms.The treatment Emergent Symptom
      Scale(TESS) has been used for evaluate adverse effects.Glucose and lipid profile,
      inflammatory factors，adiponectin，leptin were obtained at 0, 4,8 weeks.
    

Detailed description: 
      Glucose and lipid profile:Fasting blood samples for Fasting blood glucose(FBG),Insulin,
      Hemoglobin A1c(HbA1c), Total cholesterol(TC), Low-density lipoprotein
      cholesterol(LDL-C),High-density lipoprotein cholesterol(HDL-C), Triglycerides
      (TG),Apolipoprotein A(ApoA),Apolipoprotein B(ApoB),Lipoprotein-a(Lp-a) .

      Inflammatory factors:C-reaction protein(CRP),Interleukine-1 beta(IL-1β), Interleukine-6
      (IL-6), Tumor necrosis factor-α (TNF-α).
    

Intervention name(s): Berberine; atypical antipsychotic; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Berberine 300mg（three times a day） plus any atypical antipsychotic drug; Any atypical antipsychotic drug as the basic treatment; The placebo were matched to Berberine in shape, smell and colour and capsules were sealed in identical bottles
Intervention MeSH terms: Antipsychotic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia；berberine；symptoms；inflammation
The Effect of Use of Dermal Fat Graft as a Barrier Membrane
Condition: Unilateral Cleft Lip
MeSH terms: Cleft Lip
Study type: Interventional

Summary: 
      a study conducted to assess the use of dermal fat graft use as barrier membrane over grafted
      bone
    

Detailed description: 
      The study has two group in which the study will have in addition to the conventional bone
      grafting addition of dermal fat graft to protect the bone. The control will have just normal
      graft

      The results are assessed using computed tomography to assess the quality of the grafted bone.

      The Chisquare test was used to asses the results significance.
    

Intervention name(s): Addition of dermal fat graft as protection over bone graft
Intervention type(s): Procedure
Intervention description(s): A barrier membrane
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alveolar cleft grafting
A Study Investigating the Concentrations of Darapladib in Blood and the Safety of This Compound in Healthy Japanese Men
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to provide initial safety, tolerability, PK and PD data that
      will allow further studies with darapladib in Japanese patients
    


Intervention name(s): Darapladib (SB480848)
Intervention type(s): Drug
Intervention MeSH terms: Darapladib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: SB480848,; Japanese healthy volunteers; darapladib,
Adult Study Oxytocin - Behavioral
Condition: Schizophrenia; Oxytocin; Social Cognition; Psychotic Disorders
MeSH terms: Schizophrenia; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Early Phase 1

Summary: 
      In this study, investigators will examine the behavioral effects and neurophysiological
      mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset
      schizophrenia and other psychotic disorders. Such research is a necessary first step towards
      identifying whether intranasal oxytocin administration can serve as an adjunct treatment for
      social impairments in schizophrenia and other psychotic disorders.

      Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in
      patients with recent-onset schizophrenia.

      Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition
      (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved
      in emotional or sarcastic communication) after administration of oxytocin versus placebo.

      Hypothesis B: Patients and healthy comparison subjects will show increased attention to
      others' eyes and patients will exhibit increased facial affect expressivity after
      administration of oxytocin versus placebo.
    

Detailed description: 
      Part 2: A supplementary study will be added to the proposed parent study, which includes
      additional behavioral testing consisting of several social cognition computer tasks, clinical
      assessments, physiological measurements, and questionnaires. The study will be conducted with
      the same study arms and study interventions as in the proposed parent study. For this
      supplementary study, the inclusion criteria has broadened to include patients with bipolar
      disorder with psychotic features and brief psychotic disorder.
    

Intervention name(s): Oxytocin; Saline Nasal Spray
Intervention type(s): Drug; Drug
Intervention description(s): 40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.; 40 IU of the saline nasal spray will be administered once at the beginning of the visit.
Other intervention name(s): Syntocinon; Placebo
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Oxytocin; Syntocinon; Social Cognition; Schizophrenia; Psychosis; Schizoaffective Disorder; Schizophreniform Disorder; Psychotic Disorders
The Design and Evaluation of an Active Intervention for the Prevention of Non-contact ACL Injury
Condition: Athletic Injuries; Sprains and Strains; Wounds and Injuries; Knee Injuries
MeSH terms: Wounds and Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries; Athletic Injuries; Sprains and Strains
Study type: Interventional

Summary: 
      The overall goal of this project is to reduce the risk for anterior cruciate ligament
      injuries by designing a targeted intervention that will alter the known kinematic and kinetic
      risk factors associated with ACL injuries.
    

Detailed description: 
      This study will address the following specific aims: 1) To optimize a wearable, targeted,
      active training feedback device to reduce the risk of ACL injury among healthy subjects by
      inducing patterns of movement that alter the known kinematic and kinetic risk factors
      associated with ACL injuries. 2) To evaluate the efficacy of the active device and determine
      if the device reduces the risk of ACL injury among healthy subjects by effectively inducing
      patterns of movement that alter the known kinematic and kinetic risk factors associated with
      ACL injuries.
    

Intervention name(s): Activity Training with Feedback
Intervention type(s): Device
Intervention description(s): The feedback system consisted of three small inertial measurement units affixed on the chest, thigh, and shank segment respectively. These units were connected to a computer that recorded the signal from the inertial sensors at 240 Hz during the jump task. Using custom software, the knee flexion angle, trunk lean, and coronal thigh angular velocity were calculated immediately after the subject completed the jump trial. A projector was used to display the results of the jump analysis. It took less than 10 minutes to place this system on a subject and less than five seconds to analyze a jump.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Lidocaine in Antiarrhythmic Dosage on Postoperative Cognitive Dysfunction in Supratentorial Craniotomy Dysfunction in Supratentorial Craniotomy
Condition: Supratentorial Craniotomy Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the effect of lidocaine in antiarrhythmic dosage
      on postoperative cognitive dysfunction in supratentorial craniotomy.
    


Intervention name(s): lidocaine; saline
Intervention type(s): Drug; Drug
Intervention description(s): Lidocaine arm: lidocaine (2%) as an intravenous bolus (1.5 mg/kg) during induction followed by an intravenous infusion (2 mg. kg(-1).h(-1)) after induction until at the end of surgery; Saline arm: infused at the same rate as lidocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Supratentorial Craniotomy
Dexmedetomidine Sedation in Children With Respiratory Morbidities
Condition: Respiratory Morbidity
Study type: Observational

Summary: 
      This study aimed to determine the feasibility of dexmedetomidine in children with respiratory
      morbidities who required deep sedation for magnetic resonance imaging (MRI) scans.
    

Detailed description: 
      Electronic medical records of children with at least 3 characteristics of respiratory
      morbidities were retrospectively reviewed. All study patients received dexmedetomidine bolus
      over 10 min followed by a continuous infusion to achieve a minimum Ramsay Sedation Score of
      5. Patients were monitored for hemodynamics, total dose of dexmedetomidine received, adverse
      events experienced and sedation characteristics.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Children up to the age of 16 years requiring MRI under deep sedation with at least 3 characteristics of respiratory morbidities were identified as having increased risk for adverse respiratory events. Dexmedetomidine was administered as a first bolus of 1 mcg•kg-1 over 10 min, followed by a continuous infusion at 1.0 mcg•kg-1•h-1. Sedation level was assessed by Ramsay Sedation Scale and it was initially recorded at 1-min interval. If the child failed to achieve a minimum RSS of 5, this bolus was repeated once again and the continuous infusion was subsequently increased to 2 mcg•kg-1•h-1. In addition, propofol 0.5 mg.kg-1 iv. was allowed to be administered, in patients still exhibiting movement that could interfere with image acquisition.
Other intervention name(s): Dexdor
Intervention MeSH terms: Dexmedetomidine
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Children up to the age of 16 years with at least 3 characteristics of respiratory
        morbidities were identified as having increased risk for adverse respiratory events and
        they were eligible for participation in this evaluation.
      
Keywords: children; dexmedetomidine; magnetic resonance imaging scans; deep sedation; adverse respiratory events
Study to Evaluate GLPG0634 in Subjects With Renal Impairment Compared to Healthy Subjects
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open label study to assess the influence of renal impairment on the
      pharmacokinetics (PK) of GLPG0634 and its metabolite after once daily oral administrations of
      100 mg GLPG0634 for 10 days in subjects with renal impairment and matched healthy controls.

      Also, safety and tolerability of once daily oral doses of GLPG0634 for 10 days in subjects
      with renal impairment and matched healthy controls will be evaluated.
    

Detailed description: 
      The study will be divided in two parts.

      In Part 1, 3 subjects with severe renal impairment or end-stage renal disease (ESRD) not yet
      requiring dialysis (Group 1) will be recruited first. Thereafter, 3 subjects with normal
      renal function (Group 2) will be recruited. If a substantial effect on the PK in renal
      impaired subjects is observed on Day 10, the sponsor may elect to stop Part 1 of the study
      without enrolling the complete set of subjects and Part 2 will be initiated. In case no
      substantial effect on the PK is observed, 3 further subjects in both Group 1 and 2 will be
      recruited and analysed. If a substantial effect on the PK is observed, the study will proceed
      to Part 2. Part 2 of the study will not be conducted, if in Part 1 no substantial difference
      in PK is seen.

      In Part 2, Group 3 (mild renal impairment) and Group 4 (moderate renal impairment) will be
      recruited first. After completion of the mild and moderate impairment groups, Group 5 (normal
      renal function) will be recruited.
    

Intervention name(s): GLPG0634
Intervention type(s): Drug
Intervention description(s): 100 mg oral tablet, intake once daily for 10 days
Other intervention name(s): GLPG0634 tablets
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial of Oral Ganaxolone in Women With Postpartum Depression
Condition: Depressive Disorder; Depression; Depression, Postpartum; Behavioral Symptoms; Mood Disorders; Mental Disorder; Pregnancy Complications; Postpartum Blues; PPD; Postpartum Disorder
MeSH terms: Depression, Postpartum; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Mental Disorders; Mood Disorders; Behavioral Symptoms
Study type: Interventional
Phase: Phase 2

Summary: 
      A clinical study to evaluate safety, tolerability and efficacy of oral administration of
      ganaxolone in women with postpartum depression
    


Intervention name(s): Ganaxolone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Intervention MeSH terms: Ganaxolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postpartum Care; Postpartum Depression
A Single Arm Clinical Study of the Safety and Efficacy of the AURORA™ Endometrial Ablation System
Condition: Menorrhagia Due to Benign Causes
MeSH terms: Menorrhagia
Study type: Interventional

Summary: 
      This is a clinical study without a formal hypothesis. The primary objective of the study is
      to evaluate the use of the Aurora Endometrial Ablation System in achieving a return to normal
      menstrual blood loss at 12 months post-treatment, in premenopausal women with menorrhagia due
      to benign causes for whom childbearing is complete or no longer wish to retain fertility.
    


Intervention name(s): Aurora Endometrial Ablation System
Intervention type(s): Device
Intervention description(s): Ablation of the endometrial lining of the uterus using the Aurora System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Menorrhagia; Dysfunctional Uterine Bleeding; Endometrial Ablation
Low Dose Calcium to Prevent Preeclampsia
Condition: Pre-Eclampsia; Hypertension, Pregnancy-Induced; Dietary Calcium Deficiency
MeSH terms: Pre-Eclampsia; Eclampsia; Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess, in pregnant women with calcium-poor diets, what is
      the effectiveness of low-dose (500 mg/day) calcium supplements associated with an educational
      intervention, compared to the educational intervention alone, in the prevention of
      preeclampsia and hypertensive disorders during pregnancy.
    


Intervention name(s): calcium; Educational sessions
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): one chewable tablet daily, at bedtime, containing 500 mg elemental calcium (1250 mg calcium carbonate); Women will participate in at least 2 interactive group educational sessions lasting 30 minutes each. Session content: importance of calcium during pregnancy and how to modify their diets to include calcium-rich foods that are available locally
Other intervention name(s): Dietary counseling
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: cluster randomized
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Calcium; Dietary supplements; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Nutritional education; Diet therapy; Diet records; Hospitalization; Maternal mortality
Efficacy of a Mix of Probiotics in Athletes Performance
Condition: Healthy
Study type: Interventional

Summary: 
      Monocentric Crossover Study to Assess the Tolerability and the Efficacy of a Mix of Probiotic
      Strains Doses vs Placebo in Athletes Performance

      This study will intend:

      - To assess the tolerability and the efficacy of a food supplements into improving
      performance in a panel of athletes after repeated use for 4 consecutive weeks, under the
      normal conditions of use, compared to a placebo.
    

Detailed description: 
      The present study aimed at assessing the tolerability and the efficacy of a food supplements
      probiotics-based (L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047
      encapsulated in acid-resistant capsules) into improving performance in a panel of athletes
      after repeated use for 4 consecutive weeks, under the normal conditions of use, compared to a
      placebo.
    

Intervention name(s): Probiotic capsule; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): probiotic capsule (composition same as described above - L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules; placebo consisted of the same capsules filled with potato starch
Other intervention name(s): L. acidophilus FB0012, L. plantarum FB0015, and L. rhamnosus FB0047 encapsulated in acid-resistant capsules
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: athletes; probiotics; performance