bioihbjkbjnl/mcl2 huggingface dataset:
A Drug Interaction Study Between Simvastatin, Atorvastatin, Rosuvastatin, and GSK2248761 in Healthy Subjects.
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase I, open-label, single-sequence drug interaction study to evaluate the
      effect of repeated doses of GSK2248761 on the pharmacokinetics of simvastatin, atorvastatin,
      and rosuvastatin in healthy adult subjects. In this study, approximately 14 subjects will
      receive single doses of simvastatin, atorvastatin, and rosuvastatin on two occasions, once
      alone and once following administration of repeated doses of GSK2248761. Safety evaluations
      and serial PK samples will be collected during each treatment period. A follow-up visit will
      occur 7-14 days after the last dose of study drug.
    

Detailed description: 
      ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of
      updating systems to reflect the change in sponsorship.
    

Intervention name(s): GSK2248761; Simvastatin; Atorvastatin; Rosuvastatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 200mg once daily; 20 mg Simvastatin single dose; 20 mg atorvastatin single dose; 10 mg rosuvastatin single dose
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Simvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: GSK2248761, atorvastatin, rosuvastatin, simvastatin, drug interaction, pharmacokinetics
Mitigating ACEs in Pediatric Primary Care: Cohort #2 With 6-24 Month Old Children
Condition: Parenting; Violence; Child Abuse
Study type: Interventional

Summary: 
      The aim is to determine if a brief intervention can affect parents' attitudes about physical
      punishment and other parenting behaviors.
    

Detailed description: 
      A public health problem that needs to be solved is how to educate more parents about healthy
      discipline options. The investigators aim to mitigate adverse childhood experiences (ACEs) by
      integrating evidence-based parent training into pediatric primary care. Some of the most
      modifiable ACEs are associated with parenting behaviors that can lead to child abuse. The
      investigators define unhealthy parenting behaviors such as spanking, threatening, yelling,
      and humiliation. For adults in the original ACEs study, it was exposure to these behaviors
      that led to the categorization of child abuse/neglect and that were associated with heart
      disease, obesity, depression, smoking, drug use, violence, and many other problems. This
      study may help change policy and practice related to mitigating ACEs in primary care. To
      accomplish this goal, randomized controlled trials are needed to test brief screening tools
      and evidence-based resources. A population-based approach is needed to reach all parents
      (i.e. primary prevention). In the study, parents in the intervention group will receive 3
      minutes of education about healthy discipline strategies.
    

Intervention name(s): Discipline education; Cavity Prevention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Discipline education using the Play Nicely program.; Cavity prevention using a 2 page handout.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Prevention
Candesartan Effectiveness Study in Pro-B Type Natriuretic Peptides (BNP)
Condition: Hypertension; Left Ventricular Hypertrophy
MeSH terms: Hypertension; Hypertrophy, Left Ventricular; Hypertrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate effect of candesartan based therapy on percent
      change of B type natriuretic peptides(BNP) level in the subjects with hypertension and left
      ventricular hypertrophy.
    


Intervention name(s): Candesartan; Candesartan; Felodipine; Felodipine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 16 mg once daily in oral tablet form; 32 mg once daily in oral tablet form; 5 mg once daily in oral tablet form; 10 mg once daily in oral tablet form
Other intervention name(s): Atacand; Antacand
Intervention MeSH terms: Felodipine; Candesartan; Candesartan cilexetil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: LVH
Nutritional Status in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      A cross sectional observation study of body composition in COPD patients consecutively
      hospitalized with acute exacerbation.
    

Detailed description: 
      Skeletal muscle dysfunction and changes in body composition are important extra-pulmonary
      manifestations of chronic obstructive pulmonary disease (COPD) that occur in all stages of
      disease and are associated with poor outcome. In patients with COPD, bioelectrical impedance
      analysis (BIA) has usually been used to estimate fat-free mass (FFM) and body composition
      through predictive equations. Very few studies had focused on raw BIA data. The aim of this
      study is first describe the measurement of phase angle in patients with with acute
      exacerbation and second to determine the validity of phase angle in this group by assessing
      its relationship with established markers of function, disease severity and prognosis.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients diagnosed with COPD according to Global Initiative for Chronic Obstructive Lung
        Disease (GOLD)
      
Keywords: Diet; Nutritional Status; Acute Exacerbation; Phase Angle
Unilateral vs Bilateral Total Hip Arthroplasty
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis, Hip
Study type: Observational

Summary: 
      The purpose of the present study was to determine whether unilaterally operated total hip
      arthroplasty (THA) patients were superior to bilaterally operated THA patients with respect
      to aerobic endurance capacity, muscle strength and gait patterns 3-5 years after surgery, and
      to what extent medial femoral head offset (FO) influenced hip abductor strength.
    


Intervention name(s): total hip arthroplasty one side; total hip arthroplasty both sides
Intervention type(s): Procedure; Procedure
Intervention description(s): unilateral total hip arthroplasty; bilateral total hip arthroplasty
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects selected from orthopaedic out-patient department
Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the
      treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric
      participants between the ages of 5 to 17 years to determine if 1 or more doses were safe and
      effective.
    


Intervention name(s): OnabotulinumtoxinA
Intervention type(s): Biological
Intervention description(s): OnabotulinumtoxinA injected into the detrusor wall on Day 1.
Other intervention name(s): BOTOX®; botulinum toxin Type A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      The purpose of this study is to prospectively follow the next 200 patients who undergo
      catheter ablation of atrial fibrillation for symptoms and signs of esophageal injury.
    

Detailed description: 
      The purpose of this study is to prospectively follow the next 200 patients who undergo
      catheter ablation of atrial fibrillation and endoscopy. If any signs of esophageal injury are
      seen on endoscopy the patients will be treated with omeprazole and sucralfate and they will
      have repeat endoscopy in two weeks. Patients who do not have any esophageal injury will be
      contacted by telephone in two weeks to be assessed for GI symptoms.

      Specific Aims: The specific aims of the study are to:

        1. Assess the incidence of visible transmural esophageal injury following extensive
           ablation in the posterior left atrium as measured by endoscopy1

        2. Assess whether early detection of esophageal injury by endoscopy and treatment will
           prevent development of more serious injury such as left atrial-esophageal fistula

        3. Identify predictors of esophageal injury. In particular, to assess if esophageal
           temperature rises during ablation correlate with development of esophageal injury and if
           the absence of esophageal temperature rise during ablation correlate with the absence of
           esophageal injury.
    

Intervention name(s): Endoscopy in group I (all patients)
Intervention type(s): Procedure
Intervention description(s): Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients 18-80 scheduled to undergo catheter ablation of atrial fibrillation
      
Keywords: Esophageal injury; Catheter Ablation; Atrial Fibrillation
Dietary Protein Requirement of Elderly Men and Women
Condition: Age
Study type: Interventional

Summary: 
      The purpose of this study was to assess the effect of age on the estimated average
      requirement and adequate allowance for dietary protein.
    


Intervention name(s): Lower Protein; Medium Protein; Higher Protein
Intervention type(s): Other; Other; Other
Intervention description(s): Each subject completed an 18-day periods (trials) of strict dietary control of consuming a lower protein diet.; Each subject completed an 18-day periods (trials) of strict dietary control of consuming a medium protein diet.; Each subject completed an 18-day periods (trials) of strict dietary control of consuming a higher protein diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: assess the effect of age on the EAR and RDA for protein
Safety, Tolerability, Immunogenicity and Efficacy of NDV-3A Vaccine in Preventing Recurrent Vulvovaginal Candidiasis
Condition: Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Candidiasis, Vulvovaginal
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a multi-center, randomized, double-blind, placebo-controlled study intended to assess
      the safety, tolerability and humoral and cellular immune response over a 12-month period
      after receiving one dose of either the NDV-3A vaccine, NDV-3 vaccine, or placebo. In
      addition, the clinical efficacy of NDV-3A vaccine in lowering the recurrence rate of
      vulvovaginal candidiasis (VVC) in patients with recurrent VVC (RVVC) will be evaluated
      relative to placebo.
    

Detailed description: 
      The purpose of the Phase 1b portion of this study is to compare the NDV-3A vaccine, the NDV-3
      vaccine and the placebo head-to-head in the patient population of interest (women with RVVC)
      to evaluate safety and immunogenicity. The study size for comparing safety and immunogenicity
      (N=15 per group) is based on the dose comparison design used in study NDV3-001 (clinical
      trials.gov Identifier NCT01273922).

      The primary purpose of the Phase 2a portion of this study is to further evaluate safety,
      tolerability, and immunogenicity of the NDV-3A vaccine compared to placebo in a patient
      population of interest (women with RVVC). The secondary purpose is to determine whether the
      NDV-3A vaccine decreases the recurrence rate of VVC in 18-50 year old women with RVVC when
      compared to placebo. The study size for evaluating efficacy (N=87 per group) is based on
      assuming a 50% rate of VVC recurrences over the 6 month post-vaccination period in the
      placebo group and a 50% vaccine efficacy.
    

Intervention name(s): NDV-3A; NDV-3; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5mL injection IM; 0.5mL injection IM; aluminum hydroxide and buffered saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: recurrent vulvovaginal candidiasis; candida; NDV3; vaginal thrush; chronic yeast infection
Safety and Tolerability of CV8102 Alone and in Combination With a Rabies Virus Vaccine in Healthy Adults
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to investigate the safety and tolerability of IM
      administered CV8102 and an IM administered combination of CV8102 and rabies vaccine in
      humans.
    


Intervention name(s): CV8102; Rabipur; CV8102 + Rabipur
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Subjects will receive 2 intramuscular doses of CV8102 given 21 days apart; Subjects will receive 2 intramuscular doses of Rabipur given 21 days apart; Subjects will receive 2 intramuscular doses of CV8102+Rabipur given 21 days apart
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Impact of Virtual Reality on Peri-interventional Pain, Anxiety and Distress in a Pediatric Oncology Outpatient Clinic
Condition: Pediatric Cancer; Procedural Anxiety; Procedural Pain
MeSH terms: Pain, Procedural; Anxiety Disorders
Study type: Interventional

Summary: 
      Pain and anxiety-inducing interventions have a major impact on pediatric patients. Pain
      reduction by virtual reality (VR) during port and vein punctures is well studied. This study
      investigates peri-interventional reduction of pain, anxiety and distress using VR compared to
      the standard of care (SOC) in a pediatric oncology outpatient clinic.

      In a randomized, controlled cross-over design, patients aged 6-18 years experience
      potentially painful interventions accompanied by VR. All patients included in the study
      underwent port puncture or peripheral venous puncture in two observations : SOC (A) and VR
      (B) in a randomized order. Observational instruments include Numeral Rating Scale (NRS),
      Faces Pain Scale revised (FPS-r), Behavioral Approach Avoidance Distress Scale (BAADS),
      modified Yale Preoperative Anxiety Scale (mYPAS-SF). In addition, parents and staff are
      interviewed. Specific conditions for VR in an outpatient clinic setting are being discussed.
    


Intervention name(s): Virtual Reality
Intervention type(s): Device
Intervention description(s): Virtual Reality was used before and during punctures. For every observation patients underwent either port puncture or peripheral venous puncture. One examination was carried out according to the Standard-of-Care. The other one was carried out with the additional use of VR. Participants watched a passive distraction video.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Virtual Reality; Pediatric Oncoloy; Outpatient Clinic; Peri-interventional Pain
Sports Participation in Children and Adolescents With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      On the basis of a questionnaire the participation at sports activities of children and
      adolescents with type 1 diabetes mellitus will be studied. The occurrence of hypoglycemia and
      hyperglycemia will be evaluated, as well as the measures to prevent these complications.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children and adolescents with type 1 diabetes mellitus followed at the pediatric diabetes
        clinic of the Jessa Hospital
      
Keywords: type 1 diabetes mellitus; sports; child; adolescent
Posture in Abdominopelvic Training in Women SUI
Condition: Female Stress Incontinence
MeSH terms: Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      Measure effect of postural correction in abdominopelvic exercises on the improvement of the
      quality of life in patients with SUI. 42 women aged between 46-75 with SUI and
      stress-predominant mixed urinary incontinence. There were randomly assigned two groups of
      different treatment.

      Quality of life was measured by questionnaires: Incontinence Questionnaire Short Form
      (ICIQ-IU-SF) and King's Health Questionnaire (KHQ) global punctuation and incontinence
      impact. Treatment satisfaction was measured by VAS scale.
    

Detailed description: 
      The aim of this study was compare the effect of postural correction in abdominopelvic
      exercises on the improvement of the quality of life in patients with stress urinary
      incontinence (SUI).

      Was a randomized 2-treatment parallel design study. The sample consist in 42 women aged
      between 46-75 with stress urinary incontinence (SUI) and stress-predominant mixed urinary
      incontinence (IUM). They were randomly assigned to two groups: Group 1 (n=21) who received
      abdomino-pelvic training, and Group 2(n=21) who received the above treatment, guidelines
      about postural correction.

      Both groups received 12 treatment sessions in first session information regarding clinical
      and demographical aspects will be collected.

      To evaluate results of postural correction combined with abdominopelvic exercise women was
      assessed:at initial session, post- intervention and 3 months post-intervention
      treatment.Quality of life was measured by spanish validation questionnaires: International
      Continence Questionnaire Short Form (ICIQ-IU-SF) and King's Health Questionnaire (KHQ) global
      punctuation and incontinence impact. Treatment satisfaction was measured by Visual analogic
      scale (VAS).
    

Intervention name(s): abdominopelvic exercise and posture; abdominopelvic exercise
Intervention type(s): Other; Other
Intervention description(s): n=21 women received supervised abdominopelvic exercise with previous postural correction. During 12 sessions a specialized physiotherapist supervised to realization of progressive abdominopelvic exercises, previous explain postural correction pelvis, cervical and dorsal zone.; n=21 women received supervised abdominopelvic exercise. During 12 sessions a specialized physiotherapist supervised to realization of progressive abdominopelvic exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 aleatorized groups; control group (n=21) and intervention group
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: stress urinary incontinence; abdominopelvic exercise; quality of life
Evaluation of the 755nm Alexandrite Laser for the Treatment of Scars
Condition: Scars
Study type: Interventional

Summary: 
      Evaluate the safety and efficacy of removing unwanted scars using a 755nm Alexandrite laser.
    


Intervention name(s): 755nm Alexandrite Laser
Intervention type(s): Device
Intervention description(s): 755nm Alexandrite Laser
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intranasal Oxytocin in Antiosocial Personality Disorder and Psychopathy
Condition: Antisocial Personality Disorder
MeSH terms: Personality Disorders; Antisocial Personality Disorder
Study type: Interventional

Summary: 
      A pharmacoimaging study of oxytcoin in antisocial personality disorder and psychopathy
    

Detailed description: 
      Using a double-blinded, placebo controlled design, we explored similarities and differences
      in i) an important component of empathic processing (neural response to facial emotional
      expressions) and ii) decision-making in violent men with ASPD+/-Psychopathy, compared to
      healthy non-offenders (NO; n= 21 across studies), with placebo and after acute application of
      intranasal oxytocin, using functional Magnetic Resonance Imaging (fMRI).
    

Intervention name(s): Oxytocin nasal spray; Placebo spray
Intervention type(s): Drug; Other
Intervention description(s): Intranasal spray containing 40 IU of oxytocin; Application of inert placebo, identical in odor, color, and droplet size except for absence of oxytocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-binded placebo-controlled crossover trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Oxytocin; Psychopathy; Violent Offenders; Social Processing
Effect of Artronat on the Quality of Life of Patient With Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the nutritional supplement ARTRONAT
      improves the quality of life of patients with osteoarthritis.
    

Detailed description: 
      Osteoarthritis is a degenerative disease that greatly impairs the quality of life of
      patients. A nutritional supplement may help, in association with the normal treatment of
      osteoarthritis, improving the quality of life of such patients, in reducing pain and/or
      improving join flexibility.
    

Intervention name(s): ARTRONAT; PLACEBO
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary supplement containing Glucosamine, Chondroïtine and manganese. 6 per day for 8 months.; PLACEBO. 6 per day for 8 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Gonalgia; Quality of Life; Dietary supplement; Nutrition