bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Metformin Hydrochloride 1000mg Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional

Summary: 
      The objective of this study was to evaluate the relative bioavailability of the test
      formulation of metformin hydrochloride 1000 mg tablets with an already marketed reference
      formulation GLUCOPHAGE® (metformin hydrochloride) 1000 mg tablets (Bristol-Myers Squibb
      Company) under fed conditions in healthy, male and female adult subjects.
    

Detailed description: 
      This randomized, single-dose, two-way, crossover study was conducted to compare the relative
      bioavailability of two formulations of 1000 mg metformin hydrochloride tablets under fed
      conditions. The study was conducted with 32 (30 completing) healthy adults in accordance with
      Protocol No. 10640303 (Revision 0). In each study period, a single dose (1 x 1000 mg tablet)
      was administered to all subjects following a standardized high fat breakfast preceded by an
      overnight fast of at least 10 hours. The test formulation was Ohm Laboratories, Inc's (A
      Group of Ranbaxy Pharmaceuticals Inc.) Metformin Hydrochloride 1000 mg Tablets and the
      reference formulation was GLUCOPHAGE® (metformin hydrochloride) 1000 mg Tablets
      (Bristol-Myers Squibb Company). The subjects received the test product in one study period
      and the reference product in the other period; the order of administration was according to
      the dosing randomization schedule. There was a 7-day interval between treatments.

      Blood samples were collected pre-dose and at intervals over 24 hours after each dose. The
      plasma samples for all subjects completing both periods of the study were sent to Helen
      Fassoulas, Director of Operations, Warnex Bioanalytical Services Inc., 3885 boul Industriel,
      Laval, Quebec, H7L4S3 Canada, Telephone: 450-663-6724, Fax: 450-975-8111 for determination of
      metformin concentrations.

      Statistical analysis was performed by Braulio Suarez, M.D., Novum Pharmaceutical Research
      Services, Wilcrest Green Office Park, 3320 Walnut Bend Lane, Houston, Texas 77042-4712, USA,
      Telephone: 832-251-8100, Fax: 832-251-7133.

      A total of 32 healthy adult subjects (30 completing).
    

Intervention name(s): metformin hydrochloride 1000 mg tablets
Intervention type(s): Drug
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence metformin hydrochloride 1000 mg tablets fed conditions
Clinical Implementation of Surface-guided Radiation Therapy in Vulvar Cancer
Condition: Vulvar Cancer
MeSH terms: Vulvar Neoplasms
Study type: Interventional

Summary: 
      This prospective study evaluated the clinical implementation value of an optical surface
      monitoring system (OSMS) in the radiotherapy setup for patients with vulvar cancer, compared
      to standard laser-based setup
    

Detailed description: 
      This was a prospective single-centre trial to investigate the value of OSMS, and we
      hypothesized that using OSMS would reduce setup error in vulvar cancer treatment compared to
      a standard laser-based setup. A dose of 45 Gy was delivered to the clinical target volume
      with intensity-modulated radiation therapy (IMRT) for a total of 25 fractions, followed by 16
      to 24 Gy of local electron beam supplementation. Marks were placed on each patient's skin to
      align the room lasers for presetup, and the setup was completed with information from the
      OSMS. The deviation values in three translation directions, lateral (Lat), longitudinal
      (Lng), and vertical (Vrt), and three rotation directions, Rtn (rotation along the z-axis),
      Pitch (rotation along the x-axis), and Roll (rotation along the y-axis) were obtained. The
      absolute values of setup error and error distribution of the standard laser-based setup and
      OSMS were compared.
    

Intervention name(s): optical surface monitoring system
Intervention type(s): Device
Intervention description(s): An optical surface monitoring system (OSMS) could achieve continuous monitoring of patient position through a nonradiographic and noninvasive technology, which has been widely applied to many sites of radiation therapy, including breast, intracranial, head and neck, abdomen, and extremities
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vulvar cancer; Setup error; Intensity-modulated radiation therapy; Optical surface monitoring system
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of ASP1941 in Healthy Male Taiwanese Subjects
Condition: Healthy; Pharmacokinetics of ASP1941
Study type: Interventional
Phase: Phase 1

Summary: 
      This study assesses the safety, tolerability, pharmacokinetics and pharmacodynamics of
      ASP1941 orally administered as single doses to healthy adult male Taiwanese subjects.
    

Detailed description: 
      The subjects will be administered a single dose of ASP1941 or placebo under fasting
      condition. Plasma and urine levels of ASP1941 and glucose will be measured to investigate
      pharmacokinetic and pharmacodynamic properties of ASP1941.
    

Intervention name(s): ASP1941; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): ipragliflozin
Intervention MeSH terms: Ipragliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: ASP1941; ipragliflozin; plasma glucose; urine glucose
Efficacy, Safety and Tolerability of Sulthiame in Patients With Obstructive Sleep Apnea (OSA)
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      multi-center, randomized, double-blind, placebo-controlled, dose-finding, 4-arm, parallel
      assignment study to evaluate the efficacy of three different doses of sulthiame (STM)
      compared to placebo on sleep apnea activity in adult patients with obstructive sleep apnea.
    

Detailed description: 
      Primary objective: To evaluate the efficacy of 3 different doses of Sulthiame (STM) compared
      to placebo on sleep apnea activity in adult patients with moderate to severe obstructive
      sleep apnea (OSA) after at least 12 weeks of treatment at target dose

      Secondary objectives: To evaluate the effect of 3 different doses of STM after at least 12
      weeks of treatment at target dose in patients with moderate to severe OSA on apnea/hypopnea
      events, hypoxic burden, sleep quality, daytime sleepiness, patient's perception of symptoms
      and well-being, comorbidity-related outcomes and safety and tolerability of STM

      Exploratory objective: To evaluate potential predictive biomarker (eg, blood gas analysis
      parameters or additional polysomnography [PSG] variables) with regard to efficacy
    

Intervention name(s): Sulthiame
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): Ospolot
Intervention MeSH terms: Sulthiame
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sulthiame; obstructive sleep apnea
Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma
Condition: Primary Central Nervous System Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      Idarubicin combined with high dose methotrexate and moderate dose radiotherapy will achieve
      similar survival outcomes but with reduced neurotoxicity compared to regimens using
      methotrexate with high dose radiotherapy.
    

Detailed description: 
      Combined modality therapy in PCNSL has improved survival outcomes but at the cost of
      unacceptable rates of neurotoxicity when high dose radiotherapy is used. Idarubicin has
      activity in systemic lymphomas and crosses the blood brain barrier and may add to the
      efficacy of methotrexate. By combining these 2 drugs with moderate dose radiotherapy survival
      outcomes should be optimal but with lower rates of neurotoxicity.

      Comparison: TROG has previously performed a phase 2 study using methotrexate with high dose
      radiotherapy and this will allow comparison of survival and neurotoxicity rates.
    

Intervention name(s): Idarubicin, Methotrexate, Filgrastim, intrathecal Ara-C; Radiation Therapy
Intervention type(s): Drug; Radiation
Intervention description(s): Idarubicin 15mg/m2 days 1, 22. Filgrastim 5mcg/kg until neutrophil recovery days 2, 23. Methotrexate 1g/m2 days 15, 36 and 50.; Whole brain Irradiation, 30Gy in 20 fractions over 4 weeks
Other intervention name(s): Radiation, Radiotherapy
Intervention MeSH terms: Methotrexate; Idarubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphoma; PCNSL; Primary CNS lymphoma
Ablation of Perimitral Flutter Following Catheter Ablation of Atrial Fibrillation: Impact on Outcomes
Condition: Atrial Fibrillation; Perimitral Flutter
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      This prospective, randomized study aims to compare the impact of ablation of perimitral
      flutter only versus cardioversion and repeat isolation of pulmonary veins with ablation of
      additional triggers, on procedure outcome.
    

Detailed description: 
      Background: In recent years, catheter ablation has been accepted as the treatment-of-choice
      for drug-refractory atrial fibrillation (AF). It is centered around isolating pulmonary veins
      (PVs) and its success rate in curing AF is very high (56%-85%) (1). However, despite
      isolation of this dominant source of triggers, recurrent tachyarrhythmia is the major
      complication of this procedure with peri-mitral atrial flutter (PMFL) being the most common
      macro-reentrant arrhythmia in context of AF ablation (2). These often drug-refractory
      arrhythmias are frequently associated with more severe symptoms than the original AF (3) and
      warrant the necessity for redo-ablation.

      This study aims to compare the impact of two different redo-ablation strategies on the
      procedure outcome; (1) ablation of the perimitral flutter only and (2) cardioversion and
      repeat isolation of pulmonary veins (PV) with ablation of additional triggers.

      Study method: A total number of 65 AF patients presenting for redo-ablation and PMFL will be
      randomized to perimitral flutter ablation only or cardioversion and re-isolation (PVI) plus
      ablation of additional triggers. Additional triggers will be identified with the help of
      post-ablation drug provocation with isoproterenol. Patients will enter a follow-up period of
      12 months after the ablation procedure, when they will be monitored for recurrence of
      arrhythmia detected either by in-clinic or remote device interrogation at 1, 3, 6 and 12
      month post-procedure.
    

Intervention name(s): catheter ablation; catheter ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): perimitral flutter ablation by blocking the mitral isthmus; cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Characterisation of the Immune Responses of 2 Experimental Malaria Vaccines
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, two experimental malaria vaccines (with adjuvants) are tested to evaluate and
      characterise how the vaccine exactly works on the immune system by comparing it to a control
      (without adjuvant). The Protocol Posting has been updated in order to comply with the FDA
      Amendment Act, Sep 2007.
    


Intervention name(s): GSK Malaria vaccine 257049
Intervention type(s): Biological
Intervention description(s): Three-dose vaccination by slow intramuscular injection. Three different formulations of this vaccine are tested (without adjuvant, with adjuvant AS01B, with adjuvant AS02A).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Adjuvant; Malaria; Safety; Immunogenicity
A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in
      treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.
    

Detailed description: 
      Ketorolac tromethamine is a non-steroidal anti-inflammatory drug (NSAID) that is widely used
      in the Emergency Department (ED) for the treatment of moderate-to-severe pain. Ketorolac is
      available in both oral and parenteral forms and possess significant analgesic potency.
      However, ketorolac provides few advantages over other currently available analgesics and its
      use is limited by a virtue of having an "analgesic ceiling" with the dose being 10mg as well
      as having a range of severe side effects, of which gastrointestinal hemorrhage is most
      concerning.The concept of an analgesic ceiling is that doses beyond this value (10mg) do not
      provide additional analgesia and do contribute to side effects. In spite of this, the
      majority of research conducted on ketorolac in the ED and recommendations in Tintinalli's
      Emergency Medicine Textbook advocating for use of three-to-six fold higher dosages.

      Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in
      treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.
    

Intervention name(s): 10 mg of Ketorolac; 15 mg of Ketorolac; 30 mg of Ketorolac
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Patients will receive 10 mg of Ketorolac for pain control.; Patients will receive 15mg of Ketorolac for pain control.; Patients will receive 30mg of Ketorolac for pain control.
Other intervention name(s): Toradol; Toradol; Toradol
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pilot Study Combining Temozolomide, Oncovin, Camptosar and Oral Antibiotic in Children and Adolescents With Recurrent Malignancy
Condition: Lymphomas; Tumors
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan, with
      weekly vincristine, temozolomide and vantin; to evaluate the feasibility of repetitive cycles
      of this chemotherapy and to estimate the response rate to this combination in children and
      adolescents with recurrent solid tumors and lymphomas.
    

Detailed description: 
      Determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan, with
      weekly vincristine, temozolomide and vantin; to evaluate the feasibility of repetitive cycles
      of this chemotherapy and to estimate the response rate to this combination in children and
      adolescents with recurrent solid tumors and lymphomas.

      Temozolomide is given by mouth one hour prior to each daily irinotecan dose days 1-5 of each
      cycle. 100 mg/m2/day. Irinotecan is given IV in dose escalation (minimum of 3 and up to 6
      patients per cohort) starting at 15 mg/m2/day daily for 5 days for 2 weeks. Vincristin is
      given IV 1.5 mg/m2/dose (max dose 2mg) days 1 and 8 of each cycle. Vantin is given 10
      mg/kg/day divided in 2 oral doses (max dose 400 mg/day) started 48 hours prior to the start
      of each treatment cycle and continued for 48 hours after last irinotecan dose. Cycle repeated
      every 28 days.

      Therapy will continue for a minimum of two cycles unless there is progression of disease or
      unacceptable toxicity and may be continued as long as patient tolerates therapy and there is
      continued disease control up to one year of therapy.
    

Intervention name(s): Irinotecan
Intervention type(s): Drug
Intervention MeSH terms: Irinotecan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Recurrent solid tumors; recurrent lymphomas; Pediatrics; Adolescents
Safety of SPD465 in Treating Adults With ADHD.
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and effectiveness of SPD465 in the
      treatment of ADHD. The study will also look at how SPD465 affects sleep.
    


Intervention name(s): Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate.
Intervention type(s): Drug
Intervention MeSH terms: Amphetamine; Dextroamphetamine; Adderall
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intradiscal Gelified Ethanol and Pulsed Radiofrequency Versus Gelified Ethanol Injection for Discogenic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Many different minimally invasive techniques have been used for the treatment of chronic
      discogenic low back pain refractory to conservative treatments, with various results. The aim
      of this study is to assess the efficacy of the combination of intradiscal pulsed
      radiofrequency and gelified ethanol versus gelified ethanol alone, on pain and quality of
      life of patients sufferring from chronic discogenic low back pain.
    


Intervention name(s): Gelified ethanol combined to pulsed radiofrequency; Gelified ethanol
Intervention type(s): Drug; Drug
Intervention description(s): Gelified ethanol (Discogel) is a sterile, implantable medical solution which is administered within the affected intervertebral disc nucleus pulposus, via a fine needle which is guided into the center of the disc, transdermally. Pulsed radiofrequency treatment is performed intradiscally for the management of chronic discogenic low back pain. The intradiscal pulsed radiofrequency is first applied and then combined to gelified ethanol injection via the same radiofrequency needle.; Gelified ethanol is a sterile, implantable medical solution which is administered within the affected intervertebral disc nucleus pulposus, via a fine needle which is guided into the center of the disc, transdermally.
Other intervention name(s): Discogel; PRF; Discogel
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: pulsed radiofrequency; gelified ethanol
Effect of Grape Seed Extract Plus Ascorbic Acid on Endothelial Function
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      A pilot study of 15 subjects will be conducted to confirm an acute effect of grape seed
      extract on endothelial function. We then will perform a a randomized, double blind, placebo
      controlled crossover study designed to investigate the benefit of grape seed extract/vitamin
      C treatment on endothelial function. Participants (n=40) will take a food supplement
      containing 450 mg of grape seed extract and 1500 mg of vitamin C or matching placebo for four
      weeks and then cross over to the alternative treatment (active supplement or placebo) for
      four weeks. We will examine endothelial function before and after each of the two treatment
      periods. The study will provide information about the vascular effects of these compounds.
    


Intervention name(s): Grape seed extract and ascorbic acid
Intervention type(s): Dietary Supplement
Intervention description(s): Grape seed extract 450 mg and ascorbic acid 1500 mg daily
Intervention MeSH terms: Ascorbic Acid; Grape Seed Extract
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: endothelium; antioxidants; flavonoids
Evaluation of Universal Prevention Curriculum for Schools in Peru
Condition: Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This randomized controlled trial was conducted to evaluate a universal prevention curriculum
      (UPC) training for Peruvian school administrators and teachers to reduce substance use among
      students. Twenty-eight schools were randomly assigned to intervention and control conditions
      (14 per condition). Substance use outcomes were assessed with repeated cross-sectional
      samples of students in 2018 and 2019. Multi-level analyses were conducted to assess
      intervention effects on students' substance use and related problems.
    

Detailed description: 
      This randomized controlled trial was conducted to evaluate a universal prevention curriculum
      (UPC) training for Peruvian school administrators and teachers to reduce substance use among
      students. Twenty-eight schools were randomly assigned to intervention and control conditions
      (14 per condition). Prevention leadership action teams were formed at intervention schools to
      implement evidence-based school policies and positive school climate activities, and a
      classroom substance use prevention curriculum. Substance use outcomes were assessed with
      repeated cross-sectional samples of students in 2018 and 2019. Multi-level analyses were
      conducted to assess intervention effects on students' substance use and related problems.
    

Intervention name(s): Universal Prevention Curriculum Training for Schools
Intervention type(s): Other
Intervention description(s): School administrators and teachers participated in UPC training and formed prevention leadership action teams
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention