bioihbjkbjnl/mcl2 huggingface dataset:
Phase IV Long-term Maintenance Study of Aripiprazole in the Treatment of Irritability Associated With Autistic Disorder
Condition: Irritability Associated With Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether pediatric participants with irritability
      associated with autistic disorder who have responded to aripiprazole treatment will
      experience a relapse significantly later when continuing therapy with aripiprazole than will
      participants who receive placebo
    

Detailed description: 
      Phase 1: Single blind/ Phase 2: Double blind
    

Intervention name(s): Aripiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 2-15 mg, once daily, 13-42 weeks; Tablets, Oral, 0 mg, once daily, 16 weeks
Other intervention name(s): BMS-337039; Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Plantar Pain, Balance and Foot Function in Individuals With Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      Diabetes Mellitus (DM) and increase of body mass index (BMI) are two one of the most common
      risk factors for plantar pain and related disability. The aim of our study was to evaluate
      the relationship between plantar pain, balance and foot function in diabetic DM patients has
      with different BMI.
    


Intervention name(s): balance test
Intervention type(s): Diagnostic Test
Intervention description(s): balance test
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Diabetes Mellitus
      
Keywords: Diabetes Mellitus; plantar pain; body mass index; obesity; balance; foot pain; disability
Knowledge-based Iterative Model Reconstruction at Low-kilovoltage (kV) Cardiac Computed Tomography (CT)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational

Summary: 
      The purpose of this study was to compare FBP-, hybrid IR-, and IMR techniques to assess their
      role in the identification of coronary artery disease and abnormalities in cardiac
      structures.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        We enroll consecutive patients.
      
Keywords: Computed tomography
fMRI Connectivity in Fracture Hip Patients
Condition: Postoperative Delirium; Postoperative Cognitive Dysfunction
MeSH terms: Emergence Delirium; Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The long-term goal of this study is to evaluate cognitive function preoperatively and develop
      techniques of intervention in the perioperative period which would optimize brain function
      and functional recovery following surgery.
    

Detailed description: 
      In this protocol, subjects who are anticipated to be operated for hip fracture will be
      studied after surgery. Brief cognitive exam will be done followed by fMRI of connectivity and
      diffusion tensor imaging (DTI). Connectivity (neuronal changes) and DTI (Anisotropy and mean
      diffusivity) data will be compared with age matched controls and correlated with subjective
      measures of cognition.
    

Intervention name(s): fMRI; Montreal Cognitive Assessment (MoCA); Digital Clock Drawing Test Command and Copy; Wide Range Achievement Test reading subtest; Hopkins Verbal Learning Test (HVLT); General Depression Scale (GDS)
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): fMRI for measuring function connectivity and DTI will be done between day 2 to day 5.; A measure of general cognition; A measure of current cognition using digital pen technology; A measure of premorbid intellectual estimate; A measure of declarative memory; A measure of the of presence of depression.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Insulin Glargine Combination Therapies in Type II Diabetics
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin
      versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of
      change of HbA1c (baseline to endpoint) to show non-inferiority of insulin glargine plus
      glimepiride and metformin.
    


Intervention name(s): Insulin Glargine; Glimepiride; Metformin; Insulin monotherapy with premixed insulin NPH 30/70
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): In the morning to target FBG ≤ 100 mg/dl; Glimepiride 3 or 4 mg; At least 850 mg od; Given before breakfast and before dinner, target of pre-prandial BG ≤ 100 mg/dl
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Glimepiride; Isophane Insulin, Human; Insulin, Isophane; Isophane insulin, beef
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vascular and Metabolic Effects of Rosuvastatin
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that rosuvastatin does-dependently worsens insulin sensitivity.
    


Intervention name(s): placebo; rosuvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: insulin resistance
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of UCB0942 in Healthy Japanese and Caucasian Subjects
Condition: Healthy Japanese and Caucasian Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of
      UCB0942 in Japanese and Caucasian subjects.
    


Intervention name(s): UCB0942; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Pharmaceutical form: Film-coated tablet
Route of administration: Oral use; Pharmaceutical form: Film-coated tablet
Route of administration: Oral use
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy Japanese subjects; Healthy Caucasian subjects; UCB0942
The Influence of Smoking Status on Prasugrel and Clopidogrel Treated Subjects Taking Aspirin and Having Stable Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being conducted to determine if smoking will influence the platelet aggregation
      inhibition ability of clopidogrel and prasugrel. It will also determine if smoking has any
      effect on the plasma concentrations of the active metabolite of prasugrel and the active and
      inactive metabolites of clopidogrel.

      The primary hypothesis is that smoking status will influence the antiplatelet effects and
      active metabolite concentrations of clopidogrel but will have no impact on prasugrel's
      antiplatelet effects or active metabolite concentrations.
    

Detailed description: 
      Subjects will be stratified according to smoking status prior to being randomized to 1 of the
      2 treatment sequences: prasugrel 10 mg daily for 10 days followed by clopidogrel 75 mg daily
      for 10 days or clopidogrel 75 mg daily for 10 days followed by prasugrel 10 mg daily for 10
      days. There will be a 14-day Washout Period between Active Treatment Period 1 (when subjects
      receive the first drug of the sequence) and the second Active Treatment Period 2 (Period 3)
      (when subjects receive the second drug of the sequence). All subjects will remain on the same
      dose of aspirin from baseline throughout the study.
    

Intervention name(s): Prasugrel; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.; One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.
Other intervention name(s): Effient; Plavix
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: thienopyridine; antiplatelet; prasugrel; clopidogrel
Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander
Condition: Safety Issues; Quality of Life
Study type: Interventional

Summary: 
      The experimental hypothesis of this randomized controlled study was to demonstrate that early
      drain removal in patients who underwent immediate breast reconstruction with tissue expander
      is a safety procedure to improving clinical outcomes and quality of life (QoL). The mechanism
      of action underlying the proposed approach was intuitive. The early drain removal allows to:
      1) avoid continuous seroma development caused by active suction of drain (stopping the circle
      "drain itself may perpetuate the drainage" with vacuum mechanism); 2) reduce the risks
      connected to "foreign body reaction" as tissue inflammation and infection; 3) improve QoL
      reducing pain, length of hospital stay and limitations of daily activities.
    


Intervention name(s): breast drain removal
Intervention type(s): Procedure
Intervention description(s): Investigators remove the drains when the suction drain flow was less than 30 ml/day for at least 2 days or at discharge, with no further signs of infection, fluid collection or impaired wound healing ("complicated", see below). Ultimately, we removed drains 3 weeks postoperatively (21 days post op) even if the flow was higher than 30 ml/day. However, leakage or severe patient discomfort led to immediate drain removal at any time during postoperative care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Food Intake and Blue Dishware in Residents Living With Dementia
Condition: Food Preferences; Eating Behavior
MeSH terms: Dementia
Study type: Interventional

Summary: 
      Blue dishware was alternated with white dishware for lunch and dinner for residents living
      with dementia. Food consumption occurred in the home dining room and food was weighed before
      and after consumption to determine proportion consumed. Eating challenges were also noted.
      Within-participant comparisons were made to determine if food intake and eating challenges
      improved with the blue dishware condition.
    


Intervention name(s): Blue dishware
Intervention type(s): Other
Intervention description(s): blue dishware is used for plates and bowls
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: participant meals were randomized to blue or white dishware conditions, matched for food choices
Masking: None (Open Label)
Primary purpose: Prevention
The Effects of Group Exercise and Basketball on Obese Children
Condition: Childhood Obesity; Physical Activity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      This study aimed to compare the effects of group exercises under physiotherapist control and
      basketball program on body composition and motor skills of obese children. 45 obese children
      aged 10 years were randomly included to the physiotherapy (n=15), basketball (n:15), and
      control group (n:15). The children were assessed before and after 12-week study duration.
      Body Mass Index (BMI), the percentage of body fat, and circumference values of the children
      were recorded. Bruininks-Oseretsky Test of Motor Proficiency-Brief Form (BOTMP-BF) was used
      to determine motor skills of children.
    

Detailed description: 
      The roles of active physiotherapy programs and sport programs on the management of the
      problems arising from childhood obesity should be determined. Although the effects of
      exercise and various sport branches on decrease obesity and obesity related problems, the
      effects of group exercises managed by physiotherapists and team sports on body composition
      and motor skills of obese children are not clear so health professionals may have
      difficulties while suggesting better physical activity for this population.

      Thus, body composition and motor skills of the included children were recorded at the
      beginning. They were then grouped into three in order to compare the effects of group
      exercises and basketball. Children in the control group did not participate in any of them.
      Intervention lasted 12 weeks so they were then taken to the assessments at the end of this
      duration.
    

Intervention name(s): Physiotherapy group exercises; Basketball program
Intervention type(s): Other; Other
Intervention description(s): Physiotherapy exercises had aerobic, balance, strength exercises with music.; Basketball education presented the techniques about playing basketball and basketball games were played.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obese children; motor skills; physiotherapy; basketball
A Study in Healthy People to Test How BI 425809 is Taken up in the Body When Taken With or Without Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the potential effect of food on the
      pharmacokinetics of BI 425809 following administration of the intended Commercial Formulation
      (iCF) with food (Test treatment, T) and without food (Reference treatment, R).
    


Intervention name(s): BI 425809
Intervention type(s): Drug
Intervention description(s): BI 425809
Intervention MeSH terms: BI 425809
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Erector Spinae Plane Block for Postoperative Pain Management
Condition: Pain; Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic
      analgesic activity at paraspinal muscles. This study aims to examine the postoperative
      analgesic efficacy of ESP block after cesarean section (CS) with Pfannenstiel incision under
      spinal anesthesia.
    

Detailed description: 
      The study included 54 patients with mild systemic disease (ASA II patients) who would undergo
      elective CS under spinal anesthesia. They were randomly divided into an ESP block group
      (Group E) and a control group (Group C). After the surgery, Group E patients underwent
      ultrasound-guided bilateral ESP block with 20 ml of 0.25% bupivacaine at the lateral
      decubitus position, while Group C received no intervention. Patients in both groups received
      parenteral patient-controlled analgesia. The patients' post-operative 24-hour opioid
      consumption, regular Visual Analogue Scale (VAS) measurements, and need for rescue analgesics
      were evaluated. Statistical analysis was performed using SPSS 21 program. Demographic and
      other data were assessed using independent samples t-test, Mann-Whitney U test, and
      Chi-square analysis.
    

Intervention name(s): Control; Erector spinae plane block
Intervention type(s): Procedure; Procedure
Intervention description(s): No block was performed; Erector spinae plane block was performed, tramadol was administered with patient-controlled analgesia (PCA) and all patients were followed in the ward.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; postoperative analgesia; Erector spinae plane block; cesarean section
HIPACE High Frequency Low Energy Pacing to Terminate Fast Ventricular Arrythmias
Condition: Arrhythmias
MeSH terms: Arrhythmias, Cardiac
Study type: Interventional

Summary: 
      People that have survived, or are at high risk of a lifethreatening ventricular arrhythmia
      are routinely offered a defibrillator (ICD). An ICD is an implanted device which can
      recognise a ventricular arrhythmia and then try to treat it, either by rapidly pacing the
      heart or by shocking the heart. Currently, very fast ventricular arrhythmias, known as VF,
      can only be treated with a shock. Patients find shocks painful and this study is intended to
      find out whether it is possible to pace the heart at very high rates during VF. It is hoped
      that if this is possible, further research could lead to effective treatment of VF with
      pacing rather than shocks, and therefore better outcomes for patients.
    


Intervention name(s): Cardiac Resynchronisation Defibrillator
Intervention type(s): Device
Intervention description(s): Defibrillation testing of cardiac defibrilator
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Prophylactic Norepinephrine Infusion for Spinal Hypotension and Inferior Vena Cava Collapsibility Index
Condition: Adverse Effect
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the preventive effect of norepinephrine on
      post-spinal hypotension and the effect of norepinephrine on inferior vena cava collapsibility
      index (IVC-CI).
    

Detailed description: 
      Post-spinal hypotension is a frequent complication during spinal anesthesia for cesarean
      delivery. It affects nearly 50-60% of patients without appropriately treat. Vasopressors has
      been highly recommended for routine prevention and/or treatment of post-spinal hypotension.
      Norepinephrine is new vasopressor that has been suggested as a potential alternative to
      phenylephrine and was recently introduced in obstetric anesthesia because of the minimal
      cardiac depressant effect. The purpose of this study is to investigate the preventive effect
      of norepinephrine on post-spinal hypotension and the effect on inferior vena cava
      collapsibility index (IVC-CI).
    

Intervention name(s): normal saline; Norepinephrine
Intervention type(s): Drug; Drug
Intervention description(s): a bolus of normal saline was given followed by normal saline infusion; a bolus of norepinephrine was given followed by norepinephrine infusion
Other intervention name(s): NS; Vasopressors
Intervention MeSH terms: Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Norepinephrine; Hypotension; Inferior Vena Cava Collapsibility Index; Cesarean Delivery
Community Trial of Zinc Supplementation on Preschool Child Mortality and Morbidity in Southern Nepal
Condition: Nutrition
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether daily supplementation of young children in
      Nepal with either zinc, iron-folic acid, or both can reduce mortality and morbidity. Young
      children in Nepal have numerous nutritional deficiencies and high rates of morbidity and
      mortality. Zinc and/or iron supplementation may be a cost-effective method for reducing these
      risks.
    

Detailed description: 
      Mortality rates among preschool age children in Nepal and many other developing countries
      remain high despite significant progress made over the past 20 years. There remain
      significant nutritional deficiencies in these populations, especially important are vitamin
      and mineral deficiencies.

      Comparisons: In this study, we are comparing the morbidity and mortality experience for
      children 1-36 months of age randomized to one of four daily supplementation regimens:
      placebo, zinc alone, iron-folic acid alone, zinc + iron-folic acid.
    

Intervention name(s): zinc sulphate dietary supplement; iron sulphate-folic acid dietary supplement
Intervention type(s): Drug; Drug
Intervention MeSH terms: Folic Acid; Zinc Sulfate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Prevention
Keywords: zinc; child mortality; child morbidity; community trial; prevention trial; dietary supplement
A Study of the Effects of a New Antidepressant Treatment (GSK561679) in Females With Major Depressive Disorder
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This six-week study will evaluate the efficacy, safety and tolerability of GSK561679 compared
      to placebo in female subjects with major depressive disorder
    

Detailed description: 
      This is a double-blind placebo controlled study to assess the CRF1 receptor antagonist,
      GSK561679, for treatment of depression in adult females diagnosed with Major Depressive
      Disorder (MDD). A treatment regimen of 350mg/day will be utilized to assess both efficacy and
      tolerability. Subjects will be randomized in equal numbers (n=75/arm) to the treatment arm
      and the placebo arm for a 6-week treatment period.

      Efficacy will be assessed by determining the change from baseline in symptoms of MDD and
      anxiety utilizing the Bech Melancholia scale (Bech), Hamilton Rating Scale for Depression
      (HamD17), Inventory of Depressive Symptomatology-Self-Report (IDS-SR), Clinical Global
      Impression - Severity of Illness (CGI-S), Clinical Global Impression - Global Improvement
      (CGI-I), Medical Outcomes Study 12-item Sleep Module (MOS 12), Cohen Perceived Stress Test
      (PSS), Hamilton Anxiety Scale (HamA), and Dexamethasone Suppression Test (DST). Safety and
      tolerability will be assessed by determining the incidence of adverse events (AEs), vital
      signs, BMI, weight, clinical laboratory parameters, including ECGs, during the treatment and
      pre & post-treatment phases, and Discontinuation Emergent Signs and Symptoms (DESS). In
      addition, the incidence of suicidality will be assessed by the Columbia Suicide Severity
      Rating Scale (C-SSRS).
    

Intervention name(s): GSK561679; Placebo
Intervention type(s): Drug; Other
Intervention description(s): GSK561679; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depressive Disorder, Major