bioihbjkbjnl/mcl2 huggingface dataset:
A Relative Bioavailability Study of Propranolol Hydrochloride 160 mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is TO compare the relative bioavailability of Propranolol
      Hydrochloride Extended Release Capsules 160 mg (Actavis) with that of INDERAL® LA 160 mg
      Capsules (Wyeth Pharmaceuticals) following a single oral dose (1 x 160 mg) in healthy adult
      volunteers under fasting conditions.
    

Detailed description: 
      Study Type: Interventional Study Design: Randomized, single dose, two-way crossover study
      under fasting conditions

      Official Title: A Relative Bioavailability Study of 160 mg Propranolol Hydrochloride Extended
      Release Capsules Under Fasting Conditions

      Further study details as provided by Actavis Elizabeth LLC:

      Primary Outcome Measures:

      Rate and Extend of Absorption
    

Intervention name(s): Propranolol Hydrochloride Extended Release Capsules 160 mg; INDERAL® LA 160 mg Capsules, single dose
Intervention type(s): Drug; Drug
Intervention description(s): A: Experimental Subjects received Actavis formulated products under fasting conditions; B: Active comparator Subjects received Wyeth Pharmaceuticals formulated products under fasting conditions
Other intervention name(s): Propranolol; Propranolol
Intervention MeSH terms: Propranolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; Propranolol; Healthy subjects
Study of Duodenal-Jejunal Bypass(DJB) as a Potential Cure for Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Premise: Complete resolution of Type 2 Diabetes Mellitus with normalization of blood glucose
      and HbA1c in the abscence of medication support is possible with a surgical procedure named
      the "Duodenal-Jejunal Bypass (DJB)" a modification of an established duodenal switch
      procedure and is performed utilizing the laparoscopic approach.
    

Detailed description: 
      Hypothesis: The duodenum plays a major role in glucose homeostasis through mechanisms largely
      unknown at this time. Evidence of this hypothesis comes from accumulated data in bariatric
      surgery patients who underwent Roux-en-y Gastric Bypass or Biliopancreatic Diversion (BPD)
      with or without a Duodenal Switch. Current evidence strongly supports this hypothesis with a
      long term (over 10 years) Type 2 Diabetes Mellitus(T2DM) resolution rate of 84-86% following
      the gastric bypass and over 95% for the duodenal switch.

      The clinical resolution of T2DM is defined as independence of all anti-diabetic medications
      and maintaining a HbA1c less than 6.0. Recent rodent experiments by Francesco Rubino and
      subsequent human case reports by Cohen et al. supports the validity of this hypothesis. The
      modified procedure involved a roux-en-y bypass of the duodenum and 30-50cm of proximal
      jejunum, unaltering the stomach and pylorus resulted in resolution of T2DM with no weight
      loss in all subjects.
    

Intervention name(s): Duodenal-jejunal Bypass
Intervention type(s): Procedure
Intervention description(s): Patient has undergone a duodenal bypass and bypass of 60cm of proximal jejunum
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Surgery; Duodenal Bypass; Resolution; Surgical Procedures
1.2% Atorvastatin and 1.2% Simvastatin in Treatment of Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Background: Statins are the recently evolved agents that aid in periodontal regeneration and
      ultimately attaining periodontal health. Atorvastatin (ATV) and Simvastatin (SMV) are
      specific competitive inhibitors of 3-hydroxy-2-methyl-glutaryl coenzyme A reductase. The
      present study was designed to evaluate and compare the effectiveness of 1.2% ATV, and 1.2%
      SMV as an adjunct to scaling and root planing (SRP) in the treatment subjects with chronic
      periodontitis.

      Methods: Ninety six subjects were categorized into three treatment groups: SRP plus 1.2% ATV,
      SRP plus 1.2% SMV and SRP plus placebo. Clinical parameters; full mouth plaque index (PI),
      modified sulcus bleeding index (mSBI), probing depth (PD), and relative attachment level
      (RAL) were recorded at baseline before SRP and at 3, 6 and 9 months. Percentage radiographic
      defect depth reduction was evaluated using computer-aided software at baseline, 6 months and
      9 months.
    


Intervention name(s): 1.2% Atorvastatin local drug delivery; 1.2% simvastatin local drug delivery; Placebo local drug delivery
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Atorvastatin; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic periodontitis, Local drug delivery,
Bioequivalence of 5 Tablets of 100 mg Versus 2 Tablets of 250 mg TF3 of Tepotinib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigated the bioequivalence of the 100 milligrams (mg) and 250 mg dose
      strengths of tepotinib tablet formulation 3 (TF3) when administered at the same dose under
      fasted condition.
    


Intervention name(s): Tepotinib 100 mg; Tepotinib 250 mg
Intervention type(s): Drug; Drug
Intervention description(s): Participants received a single oral dose of test treatment of tepotinib TF3 (5 * 100 mg) in either treatment period 1 or 2.; Participants received a single oral dose of reference treatment of tepotinib TF3 (2 * 250 mg) in either treatment period 1 or 2.
Intervention MeSH terms: Tepotinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Tepotinib; Bioequivalence; Pharmacokinetics
Pharmacokinetic and Safety Study of Ceftolozane/Tazobactam in Pediatric Participants Receiving Antibiotic Therapy for Proven or Suspected Gram-negative Infection or for Peri-operative Prophylaxis (MK-7625A-010)
Condition: Proven or Suspected Gram-negative Bacterial Infection; Peri-operative Prophylaxis
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Gram-Negative Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to assess the pharmacokinetics, safety, and tolerability of a
      single intravenous dose of ceftolozane/tazobactam (MK-7625A) in pediatric participants. In
      each of the 6 age cohorts, an interim analysis of pharmacokinetics (PK) and safety data was
      conducted after approximately 3 participants had received the initially proposed dose. The
      interim analysis was to determine whether the initial dose was appropriate based on
      pre-defined criteria. If data from the interim analysis demonstrated that the initially
      proposed dose met the above criteria, enrollment was to continue with the same dose
      administered to approximately 3 additional participants of the same age range. However, if
      the interim analysis demonstrated that a new optimized dose was required, the new dose was to
      be administered to approximately 3 additional participants of the same age range.
    


Intervention name(s): Ceftolozane/Tazobactam 1000/500 mg; Ceftolozane/Tazobactam 30/15 mg/kg; Ceftolozane/Tazobactam 20/10 mg/kg; Ceftolozane/Tazobactam 18/9 mg/kg; Ceftolozane/Tazobactam 12/6 mg/kg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): A fixed dose combination (FDC) of 1000 mg ceftolozane and 500 mg tazobactam as a 60 minute infusion.; A FDC of 30 mg/kg of ceftolozane and 15 mg/kg of tazobactam as a 60 minute infusion.; A FDC of 20 mg/kg of ceftolozane and 10 mg/kg of tazobactam as a 60 minute infusion.; A FDC of 18 mg/kg of ceftolozane and 9 mg/kg of tazobactam as a 60 minute infusion.; A FDC of 12 mg/kg of ceftolozane and 6 mg/kg of tazobactam as a 60 minute infusion.
Intervention MeSH terms: Tazobactam; Ceftolozane; Cephalosporins; Ceftolozane, tazobactam drug combination; Penicillanic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Broad Spectrum HPV (Human Papillomavirus) Vaccine Study in 16-to 26-Year-Old Women (V503-001)
Condition: Cervical Cancer; Vulvar Cancer; Vaginal Cancer; Genital Warts; Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections; Condylomata Acuminata; Vulvar Neoplasms; Vaginal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of V503 in
      comparison to GARDASIL. The primary hypotheses tested in the study were 1) V503 administered
      to 16- to 26-year-old adolescents and young women is generally well-tolerated, 2) V503
      reduces combined incidence of Human Papillomavirus (HPV) Type 31/33/45/52/58-related disease
      compared with GARDASIL, and 3) V503 induces non-inferior geometric mean titers for HPV Type
      6/11/16/18 antibodies compared with GARDASIL.
    

Detailed description: 
      The study included a dose-finding evaluation of a 3-dose regimen of V503 and GARDASIL, a
      safety/efficacy evaluation of a 3-dose regimen of the selected V503 dose formulation and
      GARDASIL, and an extension consisting of 2 substudies: an evaluation of immune memory in
      participants receiving a fourth vaccination with V503 (Cohort 1), and an opportunity for
      participants who received GARDASIL in the Base Study to receive a 3-dose regimen of V503
      (Cohort 2).
    

Intervention name(s): Comparator: GARDASIL; Experimental: V503
Intervention type(s): Biological; Biological
Intervention description(s): GARDASIL (quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine), 0.5 mL injection in 3 dose regimen; V503 (9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine), 0.5 mL injection in 3 dose regimen (and a fourth injection for Cohort 1 only).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
The Supplementary Effects of the Extract of Agaricus Blazei Murril on Type II Diabetes Mellitus (DM)
Condition: Diabetes Mellitus, Type II
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine whether the extract of the Agaricus blazei Murill
      mushroom is effective in the supplementary treatment of type II DM patients.
    

Detailed description: 
      The researchers have the animal model that the extract of the Agaricus blazei Murill mushroom
      is effective in the treatment of type II DM mice conducted on 2002. The dose effects were
      also found. The researchers conducted the pilot study also showing the same effects in 2003.
      So the researchers designed this trial. The elixir of the Agaricus blazei Murill mushroom is
      popular in Taiwan for chronic diseases, such as type II DM.
    

Intervention name(s): Extract of Agaricus blazei Murill
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Agaricus Blazei Murill; type II DM; insulin index
Comparison Sacral Erector Spinae Block Versus Caudal Block
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this research study is to find the best way to decrease pain in children whom
      have had hypospadias surgery. Investigators will perform two technique; Caudal block or
      Sacral erector spinae block.

      The results of this study will help learn how to best control pain in children having surgery
      hypospadias surgery.
    

Detailed description: 
      Children aged 1-9 years undergoing hypospadias surgeries would be recruited in this
      randomized study.

      Children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood
      pressure.

      After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane
      inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered
      intravenously. Then laryngeal mask is inserted when conditions are satisfactory (jaw relaxed,
      lash reflex disappeared, no coughing, gagging, swallowing).After ethical committee approval,
      informed written consent will be obtained from all patients.

      Consenting patients scheduled to have hypospadias surgery will be randomised to sacral
      erector spinae block or caudal block at the begin of surgery.

      All patients heart rate,MAP and Oxygen saturation record intraoperatively. All patients will
      receive paracetamol if requirement for postoperative analgesia.All patient will transfer from
      PACU to day-surgery unit (DSU) if they achieved Modified Aldrete Score of ten.

      All patients will be assessed postoperatively by a blinded investigator: in the
      postanesthesia care unit and at 30 min 1,2, 4, 6, 12, 24, hour postoperatively.FLACC score
      will be used.
    

Intervention name(s): Ultrasound Guided Caudal Block; Sacral Erector Spinae Block
Intervention type(s): Procedure; Procedure
Intervention description(s): Postoperative pain procedure; Postoperative pain procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All Children will be randomly assigned to one of 2 groups of 20 patients each using a computer-generated number table.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Residual Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this 12-week study are to evaluate the efficacy, safety, and tolerability
      of AVP-786 as an adjunctive treatment compared with placebo in patients with residual
      schizophrenia.
    


Intervention name(s): AVP-786; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Negative Symptoms; Schizophrenia; AVP-786
Appropriate Timing of Surgery After Neoadjuvant Chemoradiation for Locally Advanced Rectal Cancer
Condition: Neoplasm, Rectum
MeSH terms: Rectal Neoplasms
Study type: Interventional

Summary: 
      This study aimed to compare the outcomes of early versus late surgical resection in patients
      who underwent curative total mesorectal excision after neoadjuvant chemoradiation. Half of
      the participants will undergo surgery before 8 weeks, while the other half will undergo
      surgery after 8 weeks.
    


Intervention name(s): Total mesorectal excision before 56 days (4-8 weeks); Total mesorectal excision after 56 days (8-12 weeks)
Intervention type(s): Procedure; Procedure
Intervention description(s): Low anterior resection or abdominoperineal resection; Low anterior resection or abdominoperineal resection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Locally advanced rectal cancer; Neoadjuvant chemoradiation
Pictorial Warning Labels and Memory for Relative and Absolute Cigarette Health-risk Information Over Time in Teens
Condition: Smoking Cessation; Smoking, Cigarette
Study type: Interventional

Summary: 
      Pictorial cigarette warning labels (PWLs) are thought to increase risk knowledge, but
      experimental research has not examined PWLs' longer term effects on memory for health risks.
      In this study, teens who have experimented with smoking or are considered vulnerable to
      smoking are repeatedly exposed to text-only vs. graphic warning labels paired with numeric
      risk information. This study will allow us to assess the extent to which reactions to
      warnings remain consistent over time and influence future smoking intentions. We will also
      assess the impact of graphic images on memory for smoking risk information presented in
      absolute and (a smokers lifetime risk of getting a smoking related disease), or relative (a
      smokers risk of getting a smoking related disease, compared to the risk of non-smokers)
      formats.
    


Intervention name(s): text-only PWL; graphic PWL; absolute risk; relative risk
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): control condition (no image); pictorial warning; Percentage risk information for smoking-related diseases for smokers; Percentage risk information for smoking-related diseases for smokers and non-smokers
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pictorial warning labels; risk knowledge; emotion; memory; risk perceptions; quit intentions
Conservative Management of CIN2 Lesions and Biomarkers Evaluation
Condition: CIN2
Study type: Observational

Summary: 
      Prospective study including women aged 25-45 years, adherent to the cervical screening
      program of four different centers of the Veneto region, with a diagnosis of CIN2 lesion.
      After enrollment according to predefined criteria, and informed consent to participate, the
      CIN2 lesions are managed by follow-up; cases with progressive lesions will be treated
      immediately, cases with CIN2 persistence for more than 12 months will be treated as well.
      Viral, molecular and immunocytochemical biomarkers will be studied, and evaluated in relation
      to the clinical outcome.
    

Detailed description: 
      Women aged 25-45 years, adherent to the organized population-based cervical screening
      program, with a histological diagnosis of CIN2 and fulfilling the inclusion criteria will be
      invited to participate to the study, previously providing specific information; in case of
      acceptance, informed consent is signed.

      STUDY PROTOCOL:

      The adherent women will attend periodical control visits:

        -  every 6 months up to 24 months, with performance of: pap test (PT) and colposcopy (with
           biopsy in case of visible alterations);

        -  at 6 and 12 months control visit: a liquid-based sample of cervical cells will be
           collected for the biomarkers' analyses.

      BIOMARKERS:

        1. - HPV search and partial HPV16/18 genotyping, by cobas 4800 high-risk HPV assay (Roche);
           PCR with MY09/MY11 consensus primers and full genotyping by restriction fragment length
           analysis, plus PCR with beta-globin primers (in-house);

        2. - methylation analysis of the cellular genes FAM194A and hsa-mir124-2, by
           methylation-specific quantitative PCR test (qMSP - QIAsure methylation test, Qiagen);

        3. - methylation analysis of the L1 and L2 viral genes of HPV types 16 and 18, by
           pyrosequencing;

        4. - immunocytochemical analysis for p16INK4A/Ki67 proteins (dual stain), by p16INK4A/Ki67
           immunocytochemical analysis by CINtec Plus kit (Roche).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women attending organized population-based cervical cancer screening with a histological
        CIN2 lesion, meeting the selection criteria and consenting to participate.
      
Biospecimen description: 
      Cervical cells and DNA extracted therefrom to be used for biomarkers analyses, retained for
      the duration of the study.
    
Keywords: biomarkers; HPV; methylation; clinical outcome
Long-Term Assessment of Quality of Life and Effectiveness of Onabotulinumtoxina Injections in Provoked Vestibulodynia
Condition: Vestibulodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Study type: Observational

Summary: 
      The study aims to assess and compare the pain in women suffering from provoked
      vestibulodynia, before treatment with botulinum injections, 3 months after treatment and 18
      months after treatment.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients suffering from provoked vestibulodynia, monitored in the Dermatology Department of
        the University Hospital of Besançon
      
Keywords: quality of life; botulinum toxin; provoked vulvodynia
Carnitine Supplementation and Skeletal Muscle Mass
Condition: Muscle Loss
Study type: Interventional

Summary: 
      The primary aim of the current research project is to investigate the effect of carnitine
      supplementation on muscle strength and body composition.

      A secondary aim of this project is to explore the effect of circulating trimethylamine
      N-oxide elevation, induced by carnitine supplementation on muscle strength and body
      composition.
    


Intervention name(s): L-carnitine
Intervention type(s): Dietary Supplement
Other intervention name(s): L-carnitine-L-tartrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Infrared Laser and Classical Ballerinas' Feet
Condition: Pain
Study type: Interventional

Summary: 
      Overuse injuries and painful symptoms in athletes and dancers (especially classical
      ballerinas) may lead to reduced functional performance. However, laser application may reduce
      pain and increase physical conditioning. The aim of the current study was to evaluate the
      immediate and long-term effects of infrared laser on classical ballerinas' feet. The
      hypothesis investigators was that the infrared laser would be able to reduce pain perception
      and enhance functional performance in ballerinas.
    

Detailed description: 
      High risk of injuries and painful symptoms in athletes and dancers (especially classical
      ballerinas) may lead to reduced functional performance. The use of photobiomodulation may
      improve functional performance in ballerinas that are affected by foot pain. An aluminum
      gallium arsenide (AlGaAs) diode laser device was uded. Infrared laser (808 nm) was applied on
      ballerina's feet twice a week during three months. Thermography, algometry and unipodal
      static standing balance test were performed. There were pain relief and improvement of
      functional performance in ballerinas.
    

Intervention name(s): Infrared Laser
Intervention type(s): Device
Intervention description(s): An aluminum gallium arsenide (AlGaAs) diode laser device (Twin laser, MMOptics, São Carlos, SP, Brazil) was used. The irradiation parameters were as follows: infrared laser (808 nm wavelength) with a spot area of 0.04 cm2, and an average optical power of 100 mW operated in a continuous mode during 1 minute per point, leading to an irradiance of 2,500 mW/cm2, energy of 6 J and fluence of 125 J/cm2 per point. The laser was applied on ballerina's feet twice a week during three months.
Intervention model: Single Group Assignment
Intervention model description: To evaluate the immediate and long-term effects of infrared laser on classical ballerinas' feet.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Feet; Ballerinas