bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      A clinical trial to study the efficacy and safety of an investigational drug in acutely
      psychotic people with schizophrenia. Participants in the study will either receive the drug
      being studied or a placebo. This study is accepting male and female participants between 13
      years old -65 years old who have been diagnosed with schizophrenia. This study will be
      conducted in 70 locations worldwide. The study will last up to 9 weeks total time.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, parallel-group, fixed-dosed study evaluating
      the efficacy and safety of two doses of SEP-363856 (50 and 75 mg/day) versus placebo over a
      6-week Treatment Period in acutely psychotic subjects with schizophrenia. This study is
      projected to randomize approximately 435 subjects (18-65 years) to 3 treatment groups
      (SEP-363856 50 mg/day, SEP-363856 75 mg/day, or placebo) in a 1:1:1 ratio. In addition, the
      study will randomize approximately 90 adolescent subjects (13-17 years) in a 1:1:1 ratio to
      the 3 treatment groups (with approximately 30 subjects per group) in a separate cohort.
      Treatment assignment will be stratified by country. Study drug will be taken once a day and
      may be taken with or without food.

      This study is designed to test the hypothesis that, treatment with SEP-363856 in adult
      subjects with schizophrenia will result in significantly greater reduction (i.e. improvement)
      in PANSS total score and CGI-S score at Week 6 from Baseline when compared to placebo. The
      overall Type I error is controlled for two hierarchical families of hypotheses. The first
      family includes hypotheses about the testing of change from Baseline in PANSS total score at
      Week 6 between each of the SEP-363856 dose levels vs. placebo. The second family of
      hypotheses are about the testing of change from Baseline in CGI-S score at Week 6 between
      each of the SEP-363856 dose levels vs. placebo.
    

Intervention name(s): SEP-363856 50mg; SEP-363856 75mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SEP-363856 50mg tablet dosed once daily; SEP-363856 75mg tablet dosed once daily; Placebo tablet dosed once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, parallel-group, placebo controlled, fixed-dose multicenter study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute psychosis; schizophrenia
Evaluating the AMH Levels During Natural Cycle
Condition: Anti-Mullerian Hormone Resistance
Study type: Observational

Summary: 
      To describe AMH serum levels dynamics during natural cycle using an automated assay.
    

Detailed description: 
      The potential benefit would be using an automated assay for AMH, the dynamics of serum levels
      during the natural cycle and to check the inter-cycle variations.

      Because of the many clinical decisions that are based on AMH levels alone the results of this
      study could bring reassurance to the continuous use of AMH in daily practice. More
      importantly, no studies to date have been performed on the newer automated assays evaluating
      variability of AMH levels.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy women with regular menstrual cycles.
      
Biospecimen description: 
      Anonymized samples will be obtained, nurses are those charged with patient blood extraction
      by venipuncture from a vein in the arm.
Pelvic Girdle Pain in Pregnant Women
Condition: Gestational Diabetes; Pelvic Girdle Pain; Pregnant Woman
MeSH terms: Diabetes, Gestational; Pelvic Girdle Pain
Study type: Observational [Patient Registry]

Summary: 
      Pelvic girdle pain and gestational diabetes mellitus are experienced in similar trimesters of
      pregnancy. The aim of this study is to examine the effect of gestational diabetes mellitus on
      the occurrence of pelvic girdle pain and the severity of symptoms of pelvic girdle pain in
      pregnant women.
    


Intervention name(s): Evaluation of pain; Application of pelvic girdle pain tests; Application of pelvic girdle questionnaire
Intervention type(s): Other; Other; Other
Intervention description(s): The presence of pain localization pelvic girdle pain will be questioned in the body chart. Inaddition to this, the level of the pelvic girdle pain will be evaluated by visual analog scale.; The tests will be applied sequentially to investigate the presence and severity of the pain (Tests: Posterior Pelvic Pain Provocation, Patriarch FABER, Long Dorsal Sacroiliac Ligament Pain Provocation, Simpsis Palpation, Modified Trendelenburg and Active Straight Leg Raise); Pelvic girdle questionnaire will be filled by pregnant women with pelvic girdle pain.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Pegnant women with gestational diabetes mellitus (first pregnancy) Pegnant women with
        gestational diabetes mellitus (second or third pregnancy) Pegnant women without gestational
        diabetes mellitus (first pregnancy) Pegnant women without gestational diabetes mellitus
        (second or third pregnancy)
      
Keywords: gestational diabetes mellitus, pregnancy pelvic girdle pain
A Bioequivalence Study of Two Nicotine Lozenges in Fasting Conditions in Healthy Smokers
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the bioequivalence of the test product (Nicotine Prototype Mini
      lozenge 2 milligrams [mg]) to a commercial reference product (nicotine polacrilex mini
      lozenge 2 mg) in healthy smokers under fasting conditions.
    

Detailed description: 
      This study will be a single center, randomized, open label, single dose, two-way crossover in
      healthy smokers that smoke their first cigarette more than 30 minutes of waking. This study
      will consist of following Visits: Visit 1 (Screening), Visit 2 (Study Period 1), followed by
      a Washout period and Visit 3 (Study Period 2). Each participant will be treated with a single
      dose of the two study treatments (test and reference) in a randomized sequence. Participants
      will be confined in the study facility for approximately 60 hours during each study session
      (for 36 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic (PK)
      blood samples will be obtained. Participants are to abstain from smoking during the
      confinement periods and be subject to random measurements of expired carbon monoxide (CO) to
      confirm abstinence. The CO levels must be ≤10 parts per million (ppm) throughout the study
      session. There will be at least 5-day and not more than 7-day clinical furlough period
      between treatment periods. For each treatment period, the clinical confinement period with
      restriction of smoking is at least 36 hours prior to dosing.
    

Intervention name(s): Nicotine Prototype Mini lozenge; Nicorette Mini Lozenge
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of a prototype nicotine 2mg lozenge will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved.; A single dose of a 2 mg nicotine polacrilex mini lozenge (Nicorette Minis) will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I Trial to Evaluate the Safety and Immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 first-in-human clinical trial to assess the safety, tolerability, and
      immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted, in up to 48 healthy adult HIV-negative
      volunteers.
    

Detailed description: 
      This is a phase 1 first-in-human clinical trial to assess the safety, tolerability, and
      immunogenicity of eOD-GT8 60mer Vaccine, Adjuvanted, in up to 48 healthy adult HIV-negative
      volunteers. The study is a randomized, double-blind, placebo-controlled dosage-escalation
      Phase 1 study intended to evaluate the safety and immunogenicity of eOD-GT8 60mer Vaccine,
      Adjuvanted in a prime-boost regimen.
    

Intervention name(s): eOD-GT8 60mer + AS01B/ DPBS sucrose/IM; eOD-GT8 60mer + AS01B/ DPBS sucrose/IM; DPBS Sucrose
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 20 μg; 100 μg; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media
Condition: Otitis Media; Otitis Media With Effusion; Pneumococcal Infections
MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Pneumococcal Infections; Otitis; Otitis Media; Otitis Media with Effusion
Study type: Observational

Summary: 
      The aim of this study is to assess in France the impact of Prevenar on the possible evolution
      of the pneumococcal serotypes distribution and antibiotic resistance in NP samples of
      children with AOM.
    


Intervention name(s): Prevenar
Intervention type(s): Drug
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Screening, Cross-Sectional, Defined Population, Prospective Study
      
Keywords: Middle Ear Infection
A Comparison Between Lumen-apposing Metal Stent and Double-pigtail Plastic Stents for Treatment of Walled-off Necrosis
Condition: Walled-off Necrosis
MeSH terms: Necrosis
Study type: Interventional

Summary: 
      Walled-off necrosis (WON) is defined as an encapsulated collection of solid and liquid
      necrotic material that is usually formed 4 weeks after an episode of acute necrotizing
      pancreatitis. As the advances in endoscopic techniques and accessories, Endoscopic ultrasound
      (EUS)-guided transluminal drainage has evolved to become the treatment of choice for
      symptomatic pancreatic walled-off necrosis (WON). This article aims to compare the efficacy
      and safety of a double mushroom head metal stent and a double pigtail plastic stent in the
      treatment of encapsulated necrosis of the pancreas.
    

Detailed description: 
      According to the revised Atlanta classification, pancreatic fluid collections (PFCs) include
      acute peripancreatic fluid collections(APFCs) and acute necrotic collections(ANCs), which,
      over time, turn into pancreatic pseudocysts (PPs) and walled-off pancreatic necrosis (WON).
      Drainage of these PP and WON is required when they increase in size and become infected or
      become symptomatic.

      Traditionally, WON has been managed surgically, however, surgical necrosectomy is associated
      with substantial morbidity and mortality, particularly when pursued early. In recent years,
      with the development of minimally invasive techniques, Endoscopic ultrasound (EUS)-guided
      transluminal drainage has evolved to become the treatment of choice for symptomatic
      pancreatic walled-off necrosis (WON).

      Double-pigtail plastic stents(DPPS) is the earliest stent used for WON drainage in ultrasound
      endoscopy, however, These stents are limited by their small diameter leading to increased
      risk of stent obstruction. Recently, lumen-apposing metal stents (LAMS) have been
      increasingly used because of the advantage of better lumen apposition and wider diameter,
      improving access for endoscopic debridement. However, more adverse events(AEs) such as
      bleeding have been reported.

      This article aims to compare the efficacy and safety of DPPS and LAMS in the treatment of
      Walled-off necrosis
    

Intervention name(s): endoscopic ultrasound; lumen-apposing metal stent; double-pigtail plastic stents
Intervention type(s): Procedure; Device; Device
Intervention description(s): All patients were implanted with stents（DPPS or LAMS）under the EUS; In the LAMS group, patients were stented with LAMS; In the DPPS group, patients were stented with DPPS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: endoscopic ultrasound guided drainage; Lumen-apposing metal stent; double-pigtail plastic stents; Walled-off necrosis
Safety and Efficacy Study of EXC 001 to Improve the Appearance of Scars From Prior Breast Surgery
Condition: Reduction in Hypertrophic Skin Scarring
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will investigate the efficacy of various doses and regimens of EXC 001 in reducing
      skin scarring in subjects undergoing revision of scars from prior surgery. The study will
      also evaluate the safety and tolerability of EXC 001 and placebo.
    


Intervention name(s): EXC 001; EXC 001; EXC 001; EXC 001
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single-dose administered by injection four different times; Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1; Single reduced dose compared to Groups 1 and 2 administered by injection at the same four time periods as Groups 1 and 2; Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3
Allocation: Randomized
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Skin scarring; cicatrix; breast scar
Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants
Condition: Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator
      interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV
      (pressure support ventilation) and NAVA in delivering noninvasive ventilation through a nasal
      cannula, in premature infants postextubation. Patients will undergo a 30-min crossover trial
      of noninvasive PSV and NAVA, 15 minutes each. Diaphragm electrical activity (EAdi)and airway
      pressure (Paw) are recorded to derive neural and mechanical respiratory rate and timing,
      inspiratory trigger delays time of synchrony between diaphragm contraction and ventilator
      assistance, and the asynchrony index (AI).
    


Intervention name(s): noninvasive respiratory support with NAVA mode and PSV
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Preterm infant less than 32 weeks of gestation age; intubated more than 48 hours after birth; postextubation
The Learning Effects of Task-priority Strategy on Dual-task Weight Shifting and Brain Plasticity in Patients With Parkinson's Disease
Condition: Postural and Suprapostural Performance During Dual Tasking in Patients With Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      (1) postural and suprapostural performance of a dual task would be differently affected by
      the strategy of task prioritization and (2) the cortical activation is different according to
      attentional focus strategies.
    

Detailed description: 
      These hypothesis would be tested by gait performance, suprapostural accuracy and relative
      power spectrum of EEG.
    

Intervention name(s): Weight-shifting training
Intervention type(s): Behavioral
Intervention description(s): Postural task: Participants are standing with their weak side on the force plate. During the task, they wight-shift from side to side ranging from 10 to 90 percent of their body weight.
Suprapostural task: Participants hold a tray with their arms beside the body, 90 degrees of elbow flexion. They rotate the tray left and right for 45 degrees respectively.
During their task, participants should weight-shift and rotate the tray at the same time.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Parkinson; dual-task training; attention; electroencephalogram (EEG)
Psychosocial Treatment Intervention in Persons Newly Diagnosed With Rheumatoid Arthritis or Diabetes
Condition: Diabetes Mellitus; Arthritis, Rheumatoid; Coping Skills
MeSH terms: Arthritis; Arthritis, Rheumatoid; Diabetes Mellitus
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the results of psychosocial treatment in patients with
      newly diagnosed rheumatoid arthritis and/or diabetes.
    

Detailed description: 
      Research and clinical experience show that adaptation to chronic disease is affected by
      individuals' psychological and social situations and subjective experiences of threat to
      identity, autonomy, and life. It is important to identify persons whose psychosocial
      situation and reaction to the diagnosis is such that they may not be able to adjust to the
      illness or take adequate responsibility for adherence to treatment.

      The purpose of this study is to identify such at-risk persons, and with the help of
      psychosocial treatment, strengthen their resistance resources and help them work through
      emotional and social problems that hinder adequate adaptation and adherence to treatment.

      Beginning in 2001, 200 consecutive patients between 18 and 65 years who are newly diagnosed
      with either rheumatoid arthritis (n = 100) or diabetes (n = 100) at the Karolinska Hospital,
      Solna, Sweden, will be included in the study. Each person will be interviewed by a medical
      social worker about their psychosocial situation and possible problems. Every other patient
      with psychosocial problems will be offered intensive, personalized psychosocial treatment.
      The rest of the patients with problems will be given minimal required measures. The
      psychosocial well-being and medical situation of all patients (intensive treatment group,
      minimal treatment group, and the group without need of psychosocial measures) will be
      followed for 2 years and evaluated at the conclusion of that time.
    

Intervention name(s): Intensive individualized psychosocial treatment; Minimal treatment arm
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Each person was given psychosocial treatment and support by a medical social worker a maximum of one time each week for a period of up to 2 years after inclusion. Treatment was designed by a medical social work on the basis of the individual's personal needs.; Minimal social measures were provided to individuals in this arm. No treatment that included conversational therapy was given.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Arthritis, Rheumatoid; psychosocial aspects; Patient Adherence; Social Work; Coping Behavior; Coping Skills; Adaptation, Psychological
Clinical Study to Investigate Effect of Macitentan on Riociguat Pharmacokinetics
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Both macitentan and riociguat are indicated in the treatment of pulmonary arterial
      hypertension (PAH) and may be administered concomitantly. The primary objective of this study
      is to evaluate the effect of macitentan administered for 11 days on the pharmacokinetics (PK)
      (i.e., amount and time of presence in the blood of riociguat) of a single dose of riociguat
      in healthy male subjects.
    


Intervention name(s): Riociguat (Adempas); Macitentan (Opsumit)
Intervention type(s): Drug; Drug
Intervention description(s): Riociguat film-coated tablets for oral administration at a strength of 1 mg; Macitentan film-coated tablets for oral administration at a strength of 10 mg
Other intervention name(s): ACT-064992
Intervention MeSH terms: Macitentan; Riociguat
Intervention model: Single Group Assignment
Intervention model description: All the subjects included in the study will be included in a single group and will receive the drugs according to the same sequence
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetics; macitentan; riociguat
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
Condition: Barrett's Esophagus
MeSH terms: Barrett Esophagus
Study type: Observational

Summary: 
      This is a feasibility study without a primary study hypothesis or statistical comparison.
    

Detailed description: 
      The purpose of this study is to assess the safety, feasibility, and performance of the C2
      Focal Cryoablation Device in patients with Barrett's Esophagus (BE). At 6 to 8 weeks, the
      patient will receive a follow-endoscopy to assess stricture formation along with biopsy
      samples taken.

      Post-operative pain will be noted. Additionally, biopsy samples will be evaluated for the
      presence of residual Barrett's Esophagus. Through evaluation of the histological results,
      treatment parameters for the ablation of human esophageal epithelium will be better
      understood.

      Evaluations include, but are not limited to the following:

        -  Deployment ease/scope compatibility.

        -  Device malfunctions.

        -  Time of catheter deployment.

        -  Adverse events.

        -  Stricture formation at 6 to 8 weeks.

        -  Patient Pain.

        -  Histological evaluation of treatment zone at 6 to 8 weeks for presence of residual
           Barrett's Esophagus.
    

Intervention name(s): Focal Cryoballoon Ablation System - 6 seconds; Focal Cryoballoon Ablation System - 8 seconds; CryoBalloon Focal Ablation System - 10 seconds
Intervention type(s): Device; Device; Device
Intervention description(s): Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications."; Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications."; Ablation of Barrett's Esophagus using the Focal CryoBalloon Ablation System. The System is a Class II device "intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications".
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Barrett's esophagus with or without dysplasia