bioihbjkbjnl/mcl2 huggingface dataset:
BP101 for Adults With Female Sexual Dysfunction
Condition: Hypoactive Sexual Desire Disorder; Female Sexual Dysfunction; Sexual Desire Disorder
MeSH terms: Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to confirm efficacy and safety of study drug BP101 in female patients with with
      decrease or loss of sexual desire, which is equal to acquired generalized hypoactive sexual
      desire disorder (HSDD). Patients will be randomized in 1:1 ratio to either BP101 or placebo
      arms.
    


Intervention name(s): BP101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Investigational product BP101, nasal spray; Placebo to Investigational product BP101, nasal spray
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Randomized Phase II Trial to Compare the Safety and Neutralizing Activity of CL184 in Combination With Rabies Vaccine vs. HRIG or Placebo in Combination With Rabies Vaccine in Healthy Adult Subjects
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the safety of the monoclonal antibody cocktail CL184 in
      combination with rabies vaccine compared with human rabies immune globulin (HRIG) or placebo
      in combination with rabies vaccine in healthy adult subjects.
    


Intervention name(s): CL184; HRIG; Placebo matching CL184
Intervention type(s): Biological; Biological; Biological
Intervention description(s): CL184 20 IU/kg intramuscularly on Day 0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28; HRIG 20 IU/kg intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28; Placebo intramuscularly on Day0; in conjunction with rabies vaccine on Days 0, 3, 7, 14, and 28
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Rabies post-exposure prophylaxis
Bioequivalence Study of Paroxetine Tablets and Paxil® Under Fasting and Fed Conditions in Chinese Healthy Volunteers
Condition: Major Depressive Disorder; Obsessive-Compulsive Disorder; Panic Disorder; Social Anxiety Disorder; Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders; Depressive Disorder; Depressive Disorder, Major; Obsessive-Compulsive Disorder; Panic Disorder; Phobia, Social
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the rate and extent of absorption of paroxetine
      hydrochloride 20 mg tablets (test) and Paxil® (reference) administered as 20 mg tablet under
      fed conditions.
    

Detailed description: 
      The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence
      Study with a washout period of 14 days. During each session, the subjects will be
      administered a single dose of 20 mg Paroxetine (one Paroxetine Hydrochloride Tablet 20mg or
      one Paxil® Tablet 20 mg) under Fasting and Fed conditions. Venous blood samples will be
      collected at pre-dose (0 h), and up to 96 h post dose.
    

Intervention name(s): Paroxetine Hydrochloride Tablet 20 mg; Paxil® 20 mg
Intervention type(s): Drug; Drug
Intervention description(s): A generic product manufactured by Beijing Winsunny Pharmaceutical Co., Ltd.; Paxil® Tablet 20 mg will be used as a comparator drug for the bioequivalence study, manufactured by GlaxoSmithKline（Distributed by: Apotex Corp.）.
Other intervention name(s): Paroxetine Hydrochloride Tablet 20 mg
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study Comparing Drug Availability Of Methylprednisolone In Liquid Form Versus Methylprednisolone In Tablet Form
Condition: Biological Availability
Study type: Interventional
Phase: Phase 1

Summary: 
      A new formulation of methylprednisolone is being developed. A study is needed to determine
      the drug availability using the new formulation, a powder for reconstitution into a
      suspension, versus the current commercially available tablet formulation in healthy
      volunteers.
    


Intervention name(s): methylprednisolone; methylprednisolone; methylprednisolone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): powder for oral suspension 4 mg/mL single dose (8 mL); powder for oral suspension 4 mg/mL singe dose (8 ml); tablet 32 mg single dose
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Single dose bioavailability study of methylprednisolone powder for oral suspension (4mg/mL) versus methylprednisolone tablet (32 mg)
A Randomized, Double-blind, Parallel-group Assessment of the Safety and Efficacy of Telmisartan 40mg Plus Hydrochlorothiazide 12.5mg (Micardis Plus) in Comparison With Losartan 50mg Plus Hydrochlorothiazide 12.5mg in Taiwanese Patients With Mild to Moderate Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this trial is to compare the efficacy and safety of telmisartan 40
      mg/hydrochlorothiazide 12.5mg (Micardis Plus) with that of losartan 50 mg/hydrochlorothiazide
      12.5 mg, a reference AIIA combined with diuretic, in Taiwanese patients with mild to moderate
      hypertension.
    


Intervention name(s): telmisartan 40 mg/hydrochlorothiazide 12.5 mg; losartan 50 mg/hydrochlorothiazide 12.5 mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Losartan; Hydrochlorothiazide; Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Effects of Brain Stimulation During a Daytime Nap on Memory Consolidation in Older Adults
Condition: Older Adults (50-90 Years)
Study type: Interventional

Summary: 
      The beneficial effect of nocturnal as well as daytime sleep on memory consolidation is
      well-documented in young, healthy subjects. Slow wave sleep (SWS), in particular, with its
      slow oscillating activity have shown to enhance declarative, hippocampus-dependent memory
      representations. This impact of sleep on memory performance can be additionally enhanced by
      exogeneous induction of transcranial slow oscillating stimulation (tSOS) within the frequency
      range of SWS in humans (0,7- 0,8 Hz) during sleep, as has been demonstrated in young, healthy
      subjects. If older adults that commonly experiencing cognitive decline, including long-term
      retention of declarative memory - benefit from transcranial slow oscillatory stimulation
      (tSOS) during sleep in the same way has not been studied so far. The primary goal of the
      study is therefore to investigate the impact of oscillating current stimulation (tSOS) during
      a daytime nap on declarative memory consolidation in older adults.
    


Intervention name(s): brain stimulation; Sham Stimulation
Intervention type(s): Device; Device
Other intervention name(s): oscillating direct current brain stimulation; no stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: aging; cognitive decline; brain stimulation; tSOS; tDCS; sleep; nap; daytime sleep; memory; memory consolidation
Safety and Efficacy of Dinoprostone (Propess) in the Women With Premature Rupture of Membrane or Gestational Age <38
Condition: Induction of Labor
MeSH terms: Fetal Membranes, Premature Rupture; Rupture
Study type: Interventional
Phase: Phase 2

Summary: 
      Dinoprostone(propess) is commonly used for induction of labor in the pregnant women who has
      intact membrane after 38weeks of gestational age. The investigators study safety and efficacy
      of dinoprostone in the pregnant women with premature rupture of membrane or GA<38weeks
    


Intervention name(s): Propess insertion group
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Crossover Bioequivalence Study of Quetiapine Fumarate 25 mg Tablets Under Fasted Conditions
Condition: Treatment for Bipolar I Disorder
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Roxane Laboratories'
      Quetiapine Fumarate 25 mg Tablet under fasted conditions.
    


Intervention name(s): Quetiapine Fumarate
Intervention type(s): Drug
Intervention description(s): 25 mg tablet
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
IL-38 Evaluation as a Biomarker in Pediatric Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The aim of this study is to investigate the associations between serum IL-38 levels and
      different variables of asthma in children such as laboratory variables, pulmonary function
      test results, the diagnosis of asthma, and in correlation with disease severity.
    


Intervention name(s): Il-38 serum level
Intervention type(s): Diagnostic Test
Intervention description(s): measurement of serum levels of IL-38
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Phase IIa Study to Investigate the Efficacy and Safety of AZD7624 in Chronic Obstructive Pulmonary Disease (COPD) Patients While on Maintenance Therapy
Condition: Chronic Obstructive Pulmonary Disease COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether AZD7624 can reduce acute Chronic
      Obstructive Pulmonary Disease (COPD) exacerbations in patients on COPD maintenance therapy
      with a history of frequent acute exacerbations.
    


Intervention name(s): AZD7624 1.0 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled AZD7624 solution, 11 mg/mL; Inhaled placebo solution
Intervention MeSH terms: AZD7624
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease; COPD patients; Exacerbations; ICS; LABA
Prevalence of Food Allergies to Proteins From Different Legumes
Condition: Food Allergy
MeSH terms: Hypersensitivity; Food Hypersensitivity
Study type: Observational

Summary: 
      The objective of the study is to assess the prevalence of a sensitization to proteins from
      legumes by skin prick test using commercial extracts (peanut, soy, and pea) and raw material
      (lupin) in atopic and healthy subjects.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Male and female subjects. Age: 18 to 75 years. Subjects with Atopy or non-atopic subjects.
      
Keywords: lupin; peanut; soy; pea; legumes; cross-reactivity; sensitization; atopy
Sleep Infra-slow Oscillations III
Condition: Healthy
Study type: Interventional

Summary: 
      In young healthy subjects, we will apply sensory stimuli at specific times during sleep to
      evaluate the probability that the stimulus evokes an arousal.
    


Intervention name(s): Sensory stimulation during sleep
Intervention type(s): Other
Intervention description(s): Sensory stimulation during sleep
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Promotion of Physical Activity in Adolescents With Intellectual and Developmental Disabilities
Condition: Adolescent Behavior; Intellectual Disability; Down Syndrome; Physical Activity
MeSH terms: Down Syndrome; Intellectual Disability
Study type: Interventional

Summary: 
      The objective of this study is to compare the effect of two strategies to increase MVPA in
      adolescents with intellectual and developmental disabilities (IDD): a single level
      intervention delivered to the adolescent only, and a multi-level intervention delivered to
      both the adolescent and a parent .
    

Detailed description: 
      We will study adolescents with mild to moderate IDD. Each participant will have 1 designated
      parent who supports the participant during the physical activity (PA) intervention and in the
      adolescent and parent arm does the physical activity with the participant. Approximately 29
      participants/yr. over 4 yrs. will be randomized in a 1:1 allocation to a remote group-based
      program of MVPA delivered to the adolescent (AO) or a multi-level intervention delivered to
      both the adolescent and a parent (A+P). Both interventions will be 12 mos. (6 mos. active
      intervention, 6 mos. maintenance intervention) with a 6 mos. no-contact follow-up targeted to
      increase MVPA to the recommended 60 min/d. Both intervention will include real-time MVPA
      sessions delivered to groups of 5-7 adolescents in their homes using video conferencing
      software (ZoomTM) with homework assignments designed to increase MVPA on the non-group
      session days. Parents of adolescents in the A+P group will be asked to participate in the
      group video MVPA sessions and homework activity, and to attend sessions (0-6 mos. 2
      session/mo.; 7-12 mos. 1 session/mo.) with their adolescent and the health coach designed to
      educate/support parents regarding the role of MVPA in health and function and strategies for
      increasing MVPA and decreasing sedentary time in both their adolescent and themselves. All
      participants will monitor their daily PA using a Fitbit wireless activity tracker.
    

Intervention name(s): Group Exercise Sessions; Individual Support Sessions; Facebook Group
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Remote exercise sessions delivered over group video conference; Individual education/support/feedback sessions delivered over video chat; Facebook group for parents to provide additional support and education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
An Open-Label, Phase 2a Study to Evaluate Safety and Efficacy of GR-MD-02 for Treatment of Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      Study GT-030 is a phase 2a, single-center, open-label study of subjects with moderate to
      severe plaque psoriasis
    

Detailed description: 
      The overall objective is to establish the safety and efficacy of GR-MD-02 in patients with
      moderate to severe plaque psoriasis.

      Primary objective:

      The objective is to evaluate the number of patients with moderate to severe plaque psoriasis
      who have 75% improvement in Psoriasis Activity Severity Index (PASI-75) following 12 weeks of
      therapy with GR-MD-02

      Secondary objectives:

        -  To determine the PASI-50 and PASI-100 scores in patients with moderate to severe plaque
           psoriasis following the first 12 weeks of therapy with GR-MD-02

        -  To determine the PASI-50, PASI-75, and PASI-100 scores in patients with moderate to
           severe plaque psoriasis following an additional 12 weeks of therapy (total 24 weeks)
           with GR-MD-02

        -  To determine the durability of response to therapy in responders over a one year period
           following the end of therapy

        -  To determine whether there is any change in disease status of patients who also have
           psoriatic arthritis

        -  To determine the incidence of adverse events and vital sign and laboratory abnormalities
           during study treatment
    

Intervention name(s): GR-MD-02
Intervention type(s): Drug
Intervention description(s): IV infusion
Other intervention name(s): galactoarabino-rhamnogalacturonate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children
Condition: Influenza Caused by the Novel Influenza A (H1N1) Virus
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether CSL425 is a safe and effective vaccine for
      eliciting an immune response to H1N1 influenza in healthy children.
    


Intervention name(s): CSL425; CSL425
Intervention type(s): Biological; Biological
Intervention description(s): CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free; CSL's 2009 H1N1 Influenza Vaccine, thimerosal-free
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Effect of Oculo-Motor Exercises in Intermittent Exotropia
Condition: Intermittent Exotropia; Exercises
MeSH terms: Exotropia
Study type: Interventional

Summary: 
      In childhood strabismus, exotropia is most frequently seen with intermittent exotropia and
      convergence failure in the first decade of life. This situation adversely affects children's
      psychosocial development and creates worries about personal relationships and work life in
      their future lives. Patients' hesitant attitudes towards surgical treatment led to the
      out-of-surgery techniques such as exercise therapy. No studies have been found in the
      literature on the efficancy of the intermittent exotropia treatments with oculo-motor
      exercises. In our study, it was aimed to investigate the effects of oculo-motor exercises on
      intermittent exotropia in children.
    

Detailed description: 
      50 volunteer school-aged children between 2-17 years of age) were included in our study.
      Oculo-motor home exercise protocols were given to all participants for 2 sessions per day for
      6 weeks, and regular phone calls were made once a week. Participants were assessed
      cycloplegic refraction by autorefractometry, corrected and uncorrected visual acuity by
      snellen chart, ocular motility test, near and distant alternating prism cover test, streopsis
      test and patient satisfaction levels by intermittent exotropia survery.
    

Intervention name(s): Oculo-Motor Exercises (OME)
Intervention type(s): Behavioral
Intervention description(s): Oculomotor Exercises (OME); The saccadic eye movement exercise included moving the eyes horizontally between two stationary targets while keeping the head still.
The smooth pursuit exercise included moving the target horizontally and tracking it with the eyes while keeping the head still.
The adaptation X1 exercise included moving the head horizontally while keeping the stationary target in focus.
The adaptation X2 exercise included moving the head and target in opposite directions horizontally while tracking the target with the eyes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Intermittent Exotropia; Oculo-Motor Exercises; Physiotherapy; Intermittent Exotropia Survey
Assessing Success of MTA and Pre-mixed Bioceramic in Mature Teeth With Irreversible Pulpitis With Full Pulpotomy.
Condition: Pulpitis - Irreversible
MeSH terms: Pulpitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Although many pulpotomy agents are commercially available, there is a dearth of clinical
      research comparing the efficacy of these agents in treating individuals with irreversible
      pulpitis. Bioceramic and MTA both have similar clinical uses, but Bioceramic is distinguished
      from MTA by its superior chemical, physical, and biological properties. This study aims to
      address this knowledge deficit by assessing the performance of biocompatible materials in
      pulpotomy procedures for the treatment of symptomatic permanent teeth in adults with deep
      caries. For permanent teeth with a completed root and a diagnosis of irreversible pulpitis
      without apical periodontitis, this research will compare the success rates of MTA and EBRRM
      pulpotomy procedures in order to provide evidence-based clinical practice guidelines for the
      treatment of this disease.
    

Detailed description: 
      The goal of this observational study is to test and compare the success of full pulpotomy
      with Mineral Trioxide Aggregate (MTA) pre-mixed bioceramic in mature teeth with irreversible
      pulpitis. Participants in this study were patients with irreversible pulpitis without apical
      periodontal pathosis recruited from the waiting list at the School of Dentistry at Liaquat
      University of Medical and Health Sciences in Jamshoro. After obtaining informed consent,
      demographic information, clinical examination results, and binary variables were recorded
      pre- and intra-operatively. The study's primary aim was to assess postoperative pain, and
      secondary aims included assessing the presence of swelling, sinusitis, or fistula and
      detecting tooth mobility. Participants received either MTA or Endo Sequence Bioceramic Root
      Repair randomly allocated using a lottery system. Follow-up assessments were done initially,
      after 6 days, and after 6 months, and periapical radiography was done at 6 days and 6 months
      to detect radiolucency.
    

Intervention name(s): Pro Root MTA®; EBRRM®
Intervention type(s): Drug; Drug
Intervention description(s): Patients in this group will receive the pulpotomy with Pro Root MTA®.; Patients in this group will receive the pulpotomy with Endo Sequence Bioceramic Root Repair (EBRRM)®.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Efficacy of XT-150 for Facet Joint Osteoarthritis Pain
Condition: Facet Joint Pain; Back Pain; Inflammation
MeSH terms: Osteoarthritis; Arthralgia; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a safety and efficacy study of XT-150 in adult participants experiencing
      back pain due to inflammation of the facet joint, also known as facet joint osteoarthritis
      (FJOA), and who are eligible for intra articular glucocorticoid injection, or radiofrequency
      ablation of medial branches of the primary dorsal ramus of the exiting nerve root, which
      innervates the adjacent facet joints.

      Study drug will be administered at Day 0 and Day 90 by bilateral intra-articular (IA)
      injection into the facet capsule, at the affected spinal level (e.g. Lumbar [L]3-4, L4-5, or
      L5-Sacrum [S]1) as determined by imaging (e.g., Magnetic resonance imaging [MRI], Computed
      tomography [CT]), X-ray, etc.) and physical exam.

      Up to 72 participants will be randomized to placebo or one of two dose treatment groups (24
      participants per treatment group).

        1. 0.15 mg XT-150 (1.0 milliliter [mL] total delivered by two 0.5 mL injections)

        2. 0.45 mg XT-150 (1.0 mL total delivered by two 0.5 mL injections)

        3. Placebo (Sterile saline) (1.0 mL total delivered by two 0.5 mL injections)
    


Intervention name(s): XT-150; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): XT-150 is a plasmid Deoxyribonucleic acid (DNA) formulated in buffered, D mannose saline solution.; Phosphate-buffered saline for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: FJOA; Facetogenic Pain; Intra-articular Injection