bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Effect of Lemborexant Versus Placebo on Driving Performance in Healthy Adult and Elderly Subjects
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo- and active-controlled, 4-period crossover study
      of lemborexant in healthy adult and elderly subjects to evaluate driving performance
    

Detailed description: 
      The study will have 2 phases, Prerandomization and Randomization. The Prerandomization Phase
      will consist of 2 periods that will last up to a maximum of 21 days: Screening and Baseline.
      The Randomization Phase will comprise of four, 9-day treatment periods (Treatment Period 1 -
      Treatment Period 4) with a minimum 14-day washout between treatment periods, and a follow-up
      interval of at least 14 days after Treatment Period 4 before the end-of-study (EOS) visit.
      Participants will be randomized to 1 of 12 sequences in an incomplete blocks design.
    

Intervention name(s): Placebo tablet matching lemborexant; Placebo tablet matching zopiclone; Zopiclone 7.5 mg; Lemborexant 2.5 mg; Lemborexant 5 mg; Lemborexant 10 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet form taken orally at bedtime.; Tablet form taken orally at bedtime.; 7.5 mg tablet taken orally at bedtime.; 2.5 tablet taken orally at bedtime.; 5 mg tablet taken orally at bedtime.; 10 mg tablet taken orally at bedtime.
Intervention MeSH terms: Lemborexant; Zopiclone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Port Wine Stains Treatment Matrix RF Study
Condition: Port Wine Stains
MeSH terms: Hemangioma, Capillary; Port-Wine Stain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of the Matrix RF for Port
      Wine Stains based on clinical and histological analyses.
    


Intervention name(s): Matrix RF; Matrix RF followed by Pulse Dye Laser; Pulse Dye Laser followed by Matrix RF
Intervention type(s): Device; Device; Device
Intervention description(s): Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week); Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week); Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: port wine stains; radiofrequency; Pulse Dye Laser
Determine the Bioequivalence of Two Formulations of Tamsulosin HCl Capsules in Fasted Male.
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      A bio-equivalence of 2 different capsule formulations in fasted subjects
    


Intervention name(s): tamsulosin capsules; tamsulosin HCl
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tamsulosin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Percutaneous Endoscopic Gastrostomy in Hands of ORL-HN Surgeon
Condition: Head and Neck Cancer; Percutaneous Endoscopic Gastrostomy; Complication
MeSH terms: Head and Neck Neoplasms
Study type: Observational

Summary: 
      PEG tubes are commonly used to provide nutritional support to patients with head and neck
      cancer. PEG insertions are typically carried out by gastroenterologists, but also
      otorhinolaryngologist - head and neck surgeons perform the procedure in some countries.
      Prospective studies on PEG tube placements in an ORL - HNS service are lacking. The
      investigators aim was to prospectively evaluate the preformance of ORL - HN surgeons in PEG
      tube insertions, and analyze the time gains and cost effectiveness achieved of the
      independency from other specialities.
    


Intervention name(s): percutaneous endoscopic gastrostomy
Intervention type(s): Procedure
Intervention description(s): PEG tube inserted with pull technique
Other intervention name(s): PEG
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        127 consecutive head and neck cancer patients, who underwent PEG placement at the
        Department of ORL - HNS, Helsinki University Hospital, between October 2011 and May 2013.
Developing World Study for RotaTeq™ (V260-015)(COMPLETED)
Condition: Vomiting; Diarrhea; Fever
MeSH terms: Vomiting; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the current study is to evaluate whether the vaccine is effective,
      well-tolerated and immunogenic among infants in developing countries.
    


Intervention name(s): RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent; Comparator: Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 2.0 mL oral dose of RotaTeq™. 14 week treatment period; Arm 2: Placebo. 14 week treatment period
Other intervention name(s): RotaTeq™; V260
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Brief Mindfulness-Based Intervention for Suicidal Ideation
Condition: Suicidal Ideation; Psychiatric Disorder; Addiction
MeSH terms: Suicidal Ideation; Mental Disorders; Problem Behavior
Study type: Interventional

Summary: 
      The primary aim of this study is to determine whether a Brief Mindfulness-Based Intervention
      for Suicidal Ideation (MB-SI) is feasible and safe to implement. The secondary aims are short
      and longer-term reduction in suicidal ideation (SI) and/or suicide-related behaviors (SRBs)
      as well as improvements in mindfulness and emotional regulation measures compared to
      Treatment as Usual (TAU).
    

Detailed description: 
      The study feasibility will be assessed through participant enrollment and retention numbers.
      The safety be monitored by the study personnel and include reporting any adverse effects. The
      intervention fidelity will be aided by standardizing the intervention and ensuring study
      personnel has the appropriate trainings. Participants will completed questionnaires assessing
      their SI and SRB as well as mindfulness and emotional regulation measures at three time
      points (preintervention, immediately postintervention, and 1-month postintervention) and
      their results will be compared between MB-SI and TAU groups. Additionally, the comparisons
      will also be conducted for the Emergency Department (ED) admissions, Inpatient Psychiatric
      Unit (IPU) admissions, and psychiatric ED admissions.
    

Intervention name(s): Brief Mindfulness Based Intervention
Intervention type(s): Behavioral
Intervention description(s): This intervention will consist of four, 45 minute individual mindfulness training sessions (one session per day, over a range of 12 subsequent days) provided by a trained mindfulness facilitator.
Other intervention name(s): MB-SI+ TAU
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mindfulness; suicide related behavior; Veterans; Veterans' Affairs; suicidal ideation
Pilot Study To Investigate The Association Between Acid Control And Heartburn Symptoms After Proton Pump Inhibitor Treatment
Condition: Heartburn
MeSH terms: Heartburn
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this pilot study is to investigate the association between gastric acid
      suppression and relief of 24 hour heartburn following treatment with the proton pump
      inhibitor (PPI) drug esomeprazole in frequent heartburn patients.
    


Intervention name(s): Esomeprazole 20 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate); Placebo capsules
Other intervention name(s): Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
To Evaluate Safety and Efficacy of a Radiofrequency Renal Denervation System in Treatment of Essential Hypertension
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional

Summary: 
      This is a prospective, multicenter, randomized sham-controlled trial to evaluate safety and
      efficacy of a multi-electrode radiofrequency renal denervation system (Netrod® System) in
      treating patients with uncontrolled essential hypertension.
    

Detailed description: 
      This is a prospective, multicenter, randomized sham-controlled trial. Patients with
      uncontrolled hypertension (office BP ≥150/90 and <180/110mmHg, and average SBP ≥135mmHg by
      24-hour ambulatory BP monitoring (ABPM), after taking ≥2 antihypertensive drugs with stable
      dose for ≥ 4 weeks) were screened after informed consent. All eligible patients first entered
      a lead-in period for ≥4 weeks of standardized medication (Nifedipine + hydrochlorothiazide),
      and those continued to meet definition of uncontrolled hypertension were randomized 2:1 to
      RDN group and sham control group (renal artery angiography only). All continued with the
      2-drug regimen and were evaluated at 7, 30, 60, 90 and 180 days post procedure. Both patients
      and site investigators who evaluate the patients were blinded to treatment assignment. The
      primary endpoint is office SBP change from baseline at 6 months post procedure. Secondary
      endpoints include changes from baseline of office DBP. 24-hour ABPM at 6 months post
      procedure and safety events.
    

Intervention name(s): Renal Artery Radiofrequency Ablation System (Generator and Catheter ); Antihypertensive Agents; Sham Procedure
Intervention type(s): Device; Drug; Device
Intervention description(s): A renal denervation system with a mesh 6-electrode radiofrequency ablation catheter and multi-channel radiofrequency generator; Calcium channel blocker, Diuretic; Catheterization without renal denervation
Other intervention name(s): Nifedipine and hydrochlorothiazide
Intervention MeSH terms: Hydrochlorothiazide; Antihypertensive Agents; Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; Renal Denervation
Safety of and Immune Response to an Experimental HIV Vaccine (VRC-HIVADV014-00-VP) in HIV Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of and immune response to an
      experimental HIV vaccine in HIV uninfected individuals.
    

Detailed description: 
      The HIV epidemic is a major global health challenge. People in developing nations have
      limited access to life-sustaining antiretrovirals and account for over 95% of the 5 million
      new HIV infections annually. The development of a safe, effective, and widely accessible HIV
      vaccine is paramount in these areas. The adenoviral vector vaccine VRC-HIVADV014-00-VP has
      been shown to elicit a CD8 cytotoxic lymphocyte (CTL) response believed to be crucial in an
      effective preventive HIV vaccine. The purpose of this study is to determine the safety and
      immunogenicity of VRC-HIVADV014-00-VP in HIV uninfected adults. In this study, HIV uninfected
      individuals with low levels of pre-existing adenovirus neutralizing antibodies will receive
      different doses of the preventive vaccine to determine its safety, tolerability, and
      immunogenicity.

      This study will last 1 year. Participants will be randomly assigned to one of two groups. At
      study entry, participants in each group will receive a single injection of either one of two
      doses of the adenoviral vector vaccine or placebo. Participants will record their temperature
      and other side effects in a symptom log on the day of vaccination and for 3 days thereafter.
      Participants will have seven clinic visits over 12 months. A physical exam, HIV and pregnancy
      prevention counseling, and blood and urine collection will occur at each visit. Participants
      will also be asked about side effects they may be experiencing and medications they are
      taking.
    

Intervention name(s): VRC-HIVADV014-00-VP
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: HIV Preventive Vaccine; AIDS Vaccines; Adenoviridae
Nasotracheal Tube Stenting by Nelaton Catheter in Pediatric Dental Surgery
Condition: Anesthesia Intubation Complication
Study type: Interventional

Summary: 
      The value of this study is to compare between stented endotracheal tube with nelaton catheter
      and non stented tube as regard nasotracheal related complications as epistaxis and nasal
      cavity injury.
    


Intervention name(s): Endotracheal tube; Nelaton catheter
Intervention type(s): Device; Device
Intervention description(s): Nasotracheal intubation will be done with endotracheal tube; plus nelaton catheter
Other intervention name(s): Stent
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Multiple Dose ASM8 in Mild Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To determine the safety and efficacy of multiple doses of ASM8 antisense oligonucleotides in
      asthmatics.
    

Detailed description: 
      This is a double-blind, placebo-controlled, crossover trial to evaluate the safety,
      tolerability and efficacy of inhaled ASM8 for the treatment of allergen-induced asthma.
      Individuals with stable, mild to moderate allergic asthma by American Thoracic Society (ATS)
      criteria (1), with a history of episodic wheeze and shortness of breath, will be eligible for
      enrolment. The study is divided into 2 parts.
    

Intervention name(s): ASM8
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Mild asthma
A Phase I Randomized Placebo-Controlled, Double-Blind Study to Evaluate Safety and Immunogenicity of AERAS-404 Administered as Different Amounts of Antigen and Adjuvant Combinations in HIV-Negative BCG-Vaccinated Adults Without Evidence of Tuberculosis Infection
Condition: Tuberculosis
MeSH terms: Tuberculosis; Latent Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I, randomized, double blinded, Placebo-controlled, immunogenicity and dose-range
      finding study of AERAS-404 in Bacille Calmette-Guerin (BCG) healthy adult male and sterile
      females.
    

Detailed description: 
      This ia a Phase I, randomized, placebo-controlled, double-blind study in three groups of
      healthy adult males or sterile females who are BCG-vaccinated, HIV-negative, and have no
      evidence of tuberculosis infection.

      Sixty-four subjects assigned to one of eight treatment groups to receive one of four
      different antigen/adjuvant combinations of study vaccine, or placebo control. Within each
      study group, subjects will be randomized to receive either a single-dose antigen/adjuvant
      regimen of study vaccine (vaccination with study vaccine on Study Day 0 followed by
      vaccination with placebo control on Study Day 56) or a two-dose antigen/adjuvant regimen of
      study vaccine (vaccination with study vaccine on Study Days 0 and 56).

      All subjects will be followed for safety and immunogenicity evaluations for 182 days.

      The sample sizes specified for each study group were selected because they are judged to be
      adequate for preliminary safety and immunogenicity evaluations for a Phase I study rather
      than for statistical reasons. If no SAE are observed among 56 subjects receiving active study
      vaccine, an approximation to the upper 95% confidence bound on the rate of SAE occurrence
      would be 5.4%.
    

Intervention name(s): AERAS-404; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): AERAS 404 (H4:IC31) contains a fusion protein of 2 mycobacterial antigens (Ag85B and TB 10.4) formulated in IC31 adjuvant.; Tris buffer saline consisting (10mM Tris and 169mM NaCI at pH7.4)
Other intervention name(s): H4; Tris Buffered saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: BCG Vaccinated; HIV Negative
Parent-delivered Massage for Children With Autism - Ages 6 to 11
Condition: Autism
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      Through funding from the U.S. Maternal and Child Health Bureau, Teaching Research Institute
      at Western Oregon University (WOU) will be conducting research on the effect of a
      parent-delivered massage program on measures of autism and general development in children
      ages 6 to 11 with autism. Families will participate in an initial training, and receive 24
      sessions of ongoing support and training from a trained therapist over the first nine months.
    

Detailed description: 
      Children will be randomly divided into treatment groups and wait-list control groups. The
      control groups begin treatment five months after the treatment groups begin.

      All children will be tested on three occasions in the first year: prior to beginning
      treatment, and five and twelve months later. Results will be shared with parents at the end
      of each year. Testers will remain blinded as to which group is currently receiving treatment.

      There is no cost to parents for participation in this research study. Families meeting the
      eligibility criteria will be accepted into the study on a first-come, first-served basis.
    

Intervention name(s): Parent massage tx group; Parent massage wait-list control group
Intervention type(s): Other; Other
Intervention description(s): The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.; The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Massage; effectiveness; autism; parent stress
An Evaluation of a Cytomegalovirus (CMV) Vaccine (ASP0113) in CMV-Seropositive and CMV-Seronegative Healthy Subjects and CMV-Seronegative Dialysis Patients
Condition: Dialysis; Healthy Subjects; Cytomegalovirus Infection
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine whether ASP0113 (a CMV deoxyribonucleic acid [DNA]
      vaccine) can be detected in plasma after intramuscular (IM) injections, and to determine
      whether CMV-seropositive healthy volunteers, CMV-seronegative healthy volunteers,
      CMV-seronegative dialysis patients mount an immune response to the CMV proteins produced by
      the vaccine after repeated ASP0113 IM injection.
    

Detailed description: 
      Part 1 is open-label with no randomization, and Part 2 is single-blind and randomized. The
      purpose of Part 1 is to obtain pilot pharmacokinetic data so as to optimize pharmacokinetic
      sample collection times in Part 2.
    

Intervention name(s): ASP0113; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): intramuscular injection; intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Cytomegalovirus; ASP0113; CMV-seropositive; Healthy subjects; CMV-seronegative; Dialysis
Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome
Condition: Tobacco Abstinence Syndrome
MeSH terms: Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate safety and efficacy of intranasal insulin in abstinent smokers.
      Groups' (placebo vs. insulin) cognitive function and stress response will be compared.
    


Intervention name(s): Intranasal Insulin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Interactions Between Cranberry Juice and Antibiotics Used to Treat Urinary Tract Infections
Condition: Urinary Tract Infections
MeSH terms: Infections; Urinary Tract Infections
Study type: Interventional

Summary: 
      The purpose of study is to determine whether cranberry juice interacts with antibiotics used
      to treat urinary tract infections (UTIs).
    

Detailed description: 
      Although evidence of its effectiveness is limited, cranberry juice is widely used to prevent
      urinary tract infections (UTIs). However, recent studies have shown that cranberry juice may
      affect the way the body absorbs and metabolizes antibiotics used to treat UTIs. This study
      will determine whether concurrent cranberry juice administration lowers the urinary
      concentrations of two commonly used antibiotics, amoxicillin and cefaclor.

      This study will involve children being treated for UTIs and adults without UTIs. All of the
      children will continue their prescribed amoxicillin/cefaclor treatment. After 7 to 10 days of
      antibiotic treatment, the children will be assigned to receive either cranberry juice for 2
      days or no additional treatment. Urine samples will be collected from all child participants
      before and after the administration of cranberry juice to examine the excretion of the
      antibiotics.

      Adult participants will receive two different doses of amoxicillin, with or without cranberry
      juice. Blood and urine samples will be collected to evaluate the effect of cranberry juice on
      the absorption and elimination of amoxicillin.
    

Intervention name(s): Cranberry juice; Amoxicillin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Amoxicillin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vaccinium macrocarpon
Novel Equation for Estimating Resting Energy Expenditure
Condition: Resting Energy Expenditure; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Observational

Summary: 
      The energy and nutrition states are closely associated with CKD patients complications and
      outcomes.To reach the energy balance target, we need the accurate resting energy expenditure
      level of patients. Traditional equations are not applicable to CKD patients,so we aim to
      develop and validate a equation for estimating resting energy expenditure in CKD patients.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        chronic kidney disease 3-5 stages