bioihbjkbjnl/mcl2 huggingface dataset:
A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults (in Puerto Rico)
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first time in humans (FTiH) study designed to assess the experimental TDENV-PIV
      vaccine in a predominantly dengue-primed adult population. The study is designed to afford a
      first time in humans (FTiH) safety and immunogenicity assessment of three TDENV-PIV vaccine
      candidates, each formulated with a different adjuvant: either aluminum hydroxide, AS01E or
      AS03B (adjuvants used in GSK Biologicals' hepatitis B candidate vaccine, malaria candidate
      vaccine and pandemic flu vaccine, respectively). Each vaccine candidate will contain 1 µg of
      purified virus antigen per each of the four DENV types. Additionally, the study will evaluate
      an alum adjuvanted TDENV-PIV vaccine candidate containing 4 µg of purified virus antigen per
      each of the four DENV types. The control group will receive a saline placebo. All
      experimental vaccinations will be administered according to a 2-dose schedule, 28 days apart.
      There is a parallel FTiH study that is conducted in the United States in a dengue-naive
      population using the same investigational vaccines.
    


Intervention name(s): Biological/Vaccine: 4 µg TDENV-PIV with Alum adjuvant; Biological/Vaccine: 1 µg TDENV-PIV with AS03B adjuvant; Phosphate buffered saline; 1 µg TDENV-PIV with Alum adjuvant; 1 µg TDENV-PIV with AS01E adjuvant
Intervention type(s): Biological; Biological; Other; Biological; Biological
Intervention MeSH terms: Aluminum Hydroxide; Vaccines; Aluminum sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue; Dengue fever; Dengue Hemorrhagic Fever; Flavivirus
Azithromycin Versus Doxycycline on Restistin Level in Periodontitis Patients With Type 2 Diabetes
Condition: Periodontal Diseases; Type 2 Diabetes
MeSH terms: Periodontitis; Periodontal Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to evaluate the adjunctive effects of systemic antibiotics used in
      nonsurgical periodontal treatment (NSPT), compared with NSPT alone, on the periodontal
      clinical parameters and resistin level in diabetic patients with periodontitis, in order to
      identify which, one provides an additional effect to non-surgical periodontal therapy
    


Intervention name(s): Group I; Group II; Group III
Intervention type(s): Drug; Drug; Drug
Intervention description(s): First group are chronic periodontitis patients with diabetes mellitus type II who received scaling and root planning.; Second group will receive 250 mg of azithromycin per day for a period of 5 days, after an initial dose of 500 mg one hour before NSPT.; Third group are Type 2 DM patients who received doxycycline 20mg twice/day.
Gingival crevicular fluid will be collected at 0, 1, and 3 months to assess Serum Resistin using a human Resistin enzyme-linked immunosorbent assay Kit following the manufacturer's protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Japan. The aim of this trial is to assess the safety and
      tolerability of 20 µg/kg and 25 µg/kg liraglutide in healthy Japanese male subjects.
    


Intervention name(s): liraglutide; liraglutide; liraglutide; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One daily subcutaneous dose for 5 weeks. Dose is weekly incremented with 5 mcg/kg; One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg the third week, and finally 20 mcg for 2 weeks; One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg for 3 weeks; Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Laparoscopic Clip-Gastroplasty With The Use Of Bariclip
Condition: Obesity; Obesity, Abdominal; Surgery
MeSH terms: Obesity; Obesity, Abdominal
Study type: Observational [Patient Registry]

Summary: 
      Sleeve gastrectomy, the most commonly performed bariatric surgery procedure, carries
      limitations both short-term including postoperative complications such as hemorrhage and
      gastric fistula and long-term such as weight regain and gastro-esophageal reflux. A new
      procedure has been proposed to overcome many of these limitations: laparoscopic vertical clip
      gastroplasty (LVCG) with Bariclip. Primary outcome were major postoperative complications.
      Secondary outcomes included weight loss, incidence of de-novo GERD and comorbidity
      resolution.
    

Detailed description: 
      Methods. The investigators performed a review of data from a prospectively collected
      database. All patients submitted to primary LVCG were examined. Patients were submitted to
      LVCG Between July 2021 and March 2022. Collected data included demographic factors,
      pre-operative weight, pre-operative BMI, operative time, surgical complications, and clinical
      outcomes in terms of short and mid-term weight loss.
    

Intervention name(s): laparoscopic vertical clip gastroplasty (LVCG) with Bariclip.
Intervention type(s): Procedure
Intervention description(s): The investigator performed laparoscopic vertical clip gastroplasty, This procedure consists of a nonadjustable clip that is vertically placed around the stomach, parallel to the lesser curvature, mimicking the effect of sleeve gastrectomy. The clip restricts oral intake, the anatomy of the stomach is not permanently changed, the small bowel remains untouched, the digestive pathway is not diverted, no stapling or resection are required and the magnitude of restriction is supposed to remain constant during the years. The vertical clip is thus placed without risks of staple line leak, malabsorption side effects, changes in anatomy, and is potentially reversible [9]. creating a 4-cm window to enter the lesser sac while lifting the stomach to create sufficient space to be able to suture. Plication of the antrum for 3-5 cm is performed. Fluid testing for patency is performed with methylene blue or normal saline and the procedure is terminate.
Other intervention name(s): Bariclip
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators performed a review of data from a prospectively collected database. All
        patients submitted to primary LVCG were examined. Patients were submitted to LVCG Between
        July 2021 and March 2022. Collected data included demographic factors, pre-operative
        weight, pre-operative BMI, operative time, surgical complications, and clinical outcomes in
        terms of short and mid-term weight loss.
      
Keywords: Bariclip; B-clamp; GERD; Bariatric Surgery; Obesity Surgery
The Effect of Buprenorphine Delivered by Buprenorphine Transdermal System (BTDS) on QT Intervals in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the effect of buprenorphine on QT interval corrected
      for heart rate (QTc) in healthy subjects.
    

Detailed description: 
      Drugs in this opioid class have been associated with prolonging QT interval/QT interval
      corrected for heart rate (QTc).
    

Intervention name(s): Buprenorphine transdermal patch; Matching placebo transdermal patch; Avelox (moxifloxacin hydrochloride) tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Buprenorphine transdermal patch 5, 10, 20, and 2 * 20 mcg/h.; Placebo transdermal patch to match BTDS 5, 10, 20, and 2 * 20.; Moxifloxacin 400 mg tablet; 1 tablet taken orally on days 6 and 13
Other intervention name(s): Butrans™; Avelox
Intervention MeSH terms: Moxifloxacin; Buprenorphine; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy subjects; Opioid; Transdermal
Community Web Health Portal for Diabetes Prevention
Condition: Obesity; Health Knowledge
Study type: Interventional

Summary: 
      This study supports the development of a diabetes prevention and control community web
      portal. The portal will feature an innovative personalized impediment profiling tool and
      reward program. The program, "Nutrition Navigation on-Line Edge," or NnoLEDGE, will be used
      by community consortiums for weight loss and diabetic health interventions within their
      communities.

      The Specific Aims are:

        1. Recruitment of local community organizations to participate as a community health
           consortium

        2. Development of a comprehensive community health web portal consisting of a web portal,
           impediment profiler, community toolbox, and rewards system

        3. Final evaluation of the system with regard to participants' attitudes and perceptions of
           using NnoLEDGE as a tool for weight control and diabetes prevention to determine
           feasibility.
    


Intervention name(s): www.princetonlivingwell.com
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
B244 Topical Spray for the Treatment of Pruritus in Adults With a History of Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema; Pruritus
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, randomized, vehicle-controlled study to assess the efficacy, safety,
      and tolerability of 2 doses of B244 for the treatment of pruritus in adults with a history of
      atopic dermatitis. Subjects who meet the study entry criteria will be randomized in a 1:1:1
      ratio to receive twice daily topical doses of B244 O.D. 5.0, B244 O.D. 20.0, or vehicle
      (placebo) for 4 weeks.
    

Detailed description: 
      This is a Prospective, Vehicle Controlled, Double-Blind, Multicenter, Randomized Phase II
      Trial, comparing the effect of twice daily B244 applications for 4 weeks vs vehicle
      applications on treatment of mild to moderate pruritus associated with atopic dermatitis.

        -  Approximately 576 subjects may be enrolled.

        -  The total duration of the study will be approximately 11 weeks. Participants will report
           for a Screening visit and if all inclusion/exclusion criteria are met, subjects will go
           through a two-week washout phase before reporting for a Baseline visit.

        -  After screening and baseline, participants will be randomized to one of two doses of
           B244 or vehicle application for 4 weeks.

        -  Randomization will be 1:1:1 so that an equal number of patients will be treated in each
           Arm of the study.

        -  All B244 randomized subjects will be treated at the dose of O.D. 5.0 or O.D. 20.0

        -  Subjects must be willing and able to complete diary within a consistent time frame on a
           daily basis and to comply with restrictions on allowable therapies for the duration of
           the study.

        -  All subjects will attend a screening visit not more than 21 days prior to Baseline (Day
           0).

        -  Subjects will be required to return to the clinic at Baseline, Day 14 (Week 2) and Day
           28 (Week 4) visits. All subjects will be asked to attend a Week 8 follow-up visit 4
           weeks (28 (±3) days) after the last dose of study medication.

        -  Subjects will apply a total of 10 pumps of IP per application across all affected areas
           twice-a-day (i.e. 10 pumps in the morning and 10 pumps again at night) for 4 weeks.

        -  Safety evaluations will consist of review of participant's medical history at screening
           and on-going assessment of adverse events reported throughout the study duration.
    

Intervention name(s): B244; Vehicle
Intervention type(s): Biological; Biological
Intervention description(s): B244 suspension; Vehicle suspension
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Oxygen Reserve Index (ORi) Expanded Data Set Validation of INVSENSOR00025
Condition: Healthy
Study type: Interventional

Summary: 
      ORi is a unitless index that could help clinicians with their assessments or normoxic and
      hyperoxic states by scaling the measured absorption information between 0.00 and 1.00. An ORi
      of 0.00 corresponds to PaO2 values of 100mmHg and below and an ORi of 1.00 corresponds to
      PaO2 values of 200mmHg and above. In this study, the PaO2 is varied by controlling the
      concentration of oxygen the study volunteer breathes. Changes in ORi values are analyzed by
      comparing it to corresponding changes in PaO2 measurements from blood samples.
    


Intervention name(s): INVSENSOR00025
Intervention type(s): Device
Intervention description(s): Noninvasive pulse oximeter sensor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of Tipranavir (With Ritonavir) Capsule and Liquid Formulation on Cytochrome P450 and P-glycoprotein Activity in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary: To quantify the influence of single-dose and steady-state tipranavir/ritonavir
      500/200 mg on intestinal and hepatic cytochrome P450 (CYP) and P-glycoprotein (P-gp)
      biomarkers, as a means of predicting drug interactions. The AUCs for biomarkers caffeine,
      warfarin, omeprazole, dextromethorphan, midazolam, and digoxin will be assessed.
    


Intervention name(s): Tipranavir capsule; Tipranavir solution; Ritonavir capsule; Caffeine; Warfarin sodium; Vitamin K; Omeprazole; Dextromethorphan hydrobromide; Midazolam injection; Midazolam oral solution; Digoxin tablet; Digoxin injection
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Vitamin K; Ritonavir; Tipranavir; Digoxin; Midazolam; Dextromethorphan; Caffeine; Omeprazole; Warfarin; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Multiple Dose Safety and Efficacy Study Evaluating CNS 7056 Versus Midazolam in Patients Undergoing Colonoscopy
Condition: Sedation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this dose-response study is to assess the safety and efficacy of CNS 7056
      compared with midazolam to maintain suitable sedation levels in patients undergoing
      colonoscopy.
    

Detailed description: 
      This is a double-blind, randomized, parallel group, dose-response study to assess the safety
      and efficacy of three dose levels of CNS 7056 compared with midazolam to maintain suitable
      sedation levels in patients undergoing colonoscopy.

      Safety assessment will include physical examinations, vital signs, ECGs, pulse oximetry
      measurements, capnography, clinical chemistry and hematology laboratory tests, routine drug
      and ethanol screening, urinalysis, pregnancy test, pain on injection using a verbal scale,
      and monitoring of adverse events.
    

Intervention name(s): A. CNS 7056; B. CNS 7056; C. CNS 7056; D. Midazolam
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Initial low dose plus supplemental doses as necessary.; Initial intermediate dose plus supplemental doses as necessary.; Initial high dose plus supplemental doses as necessary.; Initial standardized dose plus supplemental doses as necessary.
Other intervention name(s): CAS No. 1001415-66-2; Remimazolam; CAS No. 1001415-66-2; Remimazolam; CAS No. 1001415-66-2; Remimazolam; CAS No. 59467-96-8
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: CNS 7056; Procedural Sedation; Colonoscopy
Treatment of Obsessive-Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to find the best treatment for Tourette's Syndrome (TS)-spectrum
      obsessive-compulsive disorder (OCD), which includes symptoms of TS, e.g., repeated and
      involuntary body movements (tics).

      There are 2 parts to this study: In Part 1, patients are placed into 1 of 2 groups based on
      type of OCD, determined by medical history and family member interviews. In Part 2, patients
      are treated with fluvoxamine (FVX) for 8 weeks. If patients do not respond to FVX alone,
      either haloperidol or an inactive placebo will be added to the FVX regimen; patients will
      take this drug combination for 4 weeks. Patients will be monitored throughout the trial.
    

Detailed description: 
      To advance the neurobiology and treatment of obsessive-compulsive disorder (OCD) by focusing
      on Tourette's Syndrome (TS)-spectrum OCD as a possible homogeneous form of OCD, and
      investigating the relevance of intact 5-hydroxytryptamine (5-HT) function to the mechanism of
      anti-OC drug action. The validity of TS-spectrum OCD as a distinct subtype is assessed using
      a detailed clinical, family, drug treatment response profile in adult OCD patients.

      In Study I, patients are divided prospectively into 2 putative subtypes (TS-spectrum and
      non-TS-spectrum OCD) on the basis of clinical history and direct, structured interviews of
      family members (approximately 400 interviews).

      In Study II, patients enter an 8-week single-blind trial with the potent and selective 5-HT
      reuptake inhibitor fluoxetine (FX). Patients with an incomplete response to FX alone
      (approximately 64 patients) are randomized to a 4-week double-blind trial of FX in
      combination with the dopamine (DA) 2 antagonist olanzapine (OLA) or placebo (PLA).
    

Intervention name(s): olanzapine + fluoxetine; placebo + fluoxetine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olanzapine; Fluoxetine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Adolescence; Adult; Antipsychotic Agents; Dopamine Antagonists; Female; Fluvoxamine; Haloperidol; Human; Male; Middle Age; Obsessive-Compulsive Disorder; Placebos; Serotonin Uptake Inhibitors; Tourette Syndrome; Tryptophan; Drug Combinations; Antipsychotic Agents -- *therapeutic use; Fluvoxamine -- *therapeutic use; Haloperidol -- *therapeutic use; Obsessive-Compulsive Disorder -- *drug therapy; Obsessive-Compulsive Disorder -- physiopathology; Serotonin Uptake Inhibitors -- *therapeutic use
Rehabilitation Following Lumbar Disc Surgery
Condition: Lumbar Disc Herniation; Radiculopathy
MeSH terms: Intervertebral Disc Displacement; Radiculopathy
Study type: Interventional

Summary: 
      The proposed study will be a randomized clinical trial designed to determine the most
      effective physical therapy program for individuals who have undergone lumbar discectomy
      surgery. The study will compare two different post-operative physical therapy programs
      (general strengthening or general + specific strengthening). Both groups will begin treatment
      2 weeks post-surgery. Subjects in both groups will receive weekly treatment sessions for 8
      weeks with a treatment program emphasizing exercises shown to activate the large trunk
      muscles without imposing potentially harmful compression or shear forces. The general +
      specific strengthening group will also receive exercises shown to isolate activation of the
      deep trunk muscles, in particular the multifidus, with training augmented by the use of
      diagnostic ultrasound biofeedback. Patient assessments will be conducted pre- and
      post-surgery, as well as 10 (post-treatment) and 26 weeks after surgery.
    


Intervention name(s): Rehabilitation following lumbar disc surgery (discectomy)
Intervention type(s): Other
Intervention description(s): Exercise: walking, range of motion, and general trunk strengthening with or without specific trunk muscle motor control exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Human African Trypanosomiasis: First in Man Clinical Trial of a New Medicinal Product, the Fexinidazole
Condition: Human African Trypanosomiasis
MeSH terms: Trypanosomiasis; Trypanosomiasis, African
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is aimed at assessing the tolerability and pharmacokinetic parameters of the
      fexinidazole in healthy volunteers. In animal models of both acute and chronic experimental
      Trypanosomiasis infections, fexinidazole shows highly promising efficacy.
    

Detailed description: 
      The present study is designed to obtain safety, tolerability and PK data after single and
      multiple oral administration of increasing doses of fexinidazole in healthy male sub-Saharan
      African subjects. This study will also assess the relative bioavailability of fexinidazole
      administered as a tablet in comparison with oral suspension, and to assess the impact of
      concomitant food intake on the relative bioavailability of fexinidazole after single oral
      dose administration.

      The study will be divided in 3 successive parts. Study Part I will be a randomized,
      double-blind, placebo-controlled, single ascending dose study with fexinidazole administered
      as an oral suspension.

      Study Part II will be a comparative bioavailability study of a fexinidazole tablet vs. the
      oral suspension and assessment of food effect, according to a three-way cross-over design.
      Clinical part will be conducted in open conditions and bioanalysis in blind conditions.

      Study Part III will be a randomized, double-blind, placebo-controlled, multiple ascending
      dose study with fexinidazole administered either as an oral suspension or as a tablet,
      depending on Part II results. Dosage regimen will be either q.d. or b.i.d., depending on Part
      I and Part II results for the unchanged drug and the metabolites. Treatment duration will be
      14 days.

      Bioanalysis will be performed in open conditions for Study Part I and Study Part III.
    

Intervention name(s): Fexinidazole/Placebo
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: neglected disease; africa; new drug; oral drug; parasite