bioihbjkbjnl/mcl2 huggingface dataset:
Single Ascending Dose (BMS-813160) Study
Condition: Accelerated Intimal Hyperplasia
MeSH terms: Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the safety and tolerability of single oral
      doses of BMS-813160 in healthy subjects
    


Intervention name(s): BMS-813160; BMS-813160; BMS-813160; BMS-813160; BMS-813160; BMS-813160; [14C] BMS-813160; Placebo; BMS-813160; BMS-813160
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral Solution, Oral, 5 mg, Single dose, 1 day; Oral Solution, Oral, 20 mg, Single dose, 1 day; Oral Solution, Oral, 60 mg, Single dose, 1 day; Oral Solution, Oral, 150 mg, Single dose, 1 day; Oral Solution, Oral, 300 mg, Single dose, 1 day; Oral Solution, Oral, 600 mg, Single Dose, 1 day; Oral Solution, Oral, 150 mg, Single Dose, 1 day; Oral Solution, Oral, 0 mg, Single Dose, 1 day; Oral Solution, Oral, 1200 mg, Single dose, 1 day; Oral Solution, Oral, 2000 mg, Single Dose, 1 day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants in Brazil
Condition: Vaccines, Pneumococcal Conjugate Vaccine
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study will be to analyze 13-valent pneumococcal vaccine given to healthy
      infants in Brazil for safety and tolerability, and to determine the immune response to the
      vaccines.
    


Intervention name(s): 13-Valent Pneumococcal Conjugate Vaccine (13vPnC); 7-Valent Pneumococcal Conjugate Vaccine (7vPnc)
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Pneumococcal conjugate vaccine
Basic and Clinical Research on Attention Deficit Hyperactivity Disorder (ADHD)
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      Children between 6-17 are evaluated for ADHD and and a blood sample is obtained for DNA
      extraction. If eligible, they participate in a 4 week, double blind, placebo controlled trial
      with weekly switches. In randomized order, children receive 18, 36, 54 mg. OROS
      methylphenidate and placebo. Each week, parent report measures, clinical interviews, and
      safety assessments are conducted.

      Hypothesis: Efficacy and adverse events will be dose dependent. Dopamine Transporter Genotype
      will predict response
    


Intervention name(s): OROS methylphenidate
Intervention type(s): Drug
Intervention description(s): 18, 36, 54 mg
Other intervention name(s): Concerta
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; side effects; sleep; dopamine; pharmacogenetics
Efficacy of Shotblocker in Spinal Needle Related Pain
Condition: Needle Phobia; Spinal Anesthesia; Pain
Study type: Interventional

Summary: 
      This was a single-blind, randomized controlled trial. Seventy-six patients who underwent
      spinal anesthesia for surgery were randomized into the Shotblocker group or Control group.
      Before the insertion of a 25-gauge spinal needle, Shotblocker was applied just before the
      spinal needle insertion in the Shotblocker group. 10-cm visual analog scale to evaluate the
      pain intensity of spinal needle insertion and a five-point scale for patient satisfaction
      were compared between the two groups.
    


Intervention name(s): Shotblocker; Placebo
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients spinal injections were performed with Shotblocker placed onto injection site; Patients spinal injections were performed without Shotblocker
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study of Galcanezumab (LY2951742) in Adults With Treatment-Resistant Migraine
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and efficacy of galcanezumab in people with
      treatment-resistant episodic or chronic migraine.
    


Intervention name(s): Galcanezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC.; Administered SC.
Other intervention name(s): LY2951742
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: prevention; prophylaxis; headache; treatment-resistant; treatment resistant
Comparison of Onset and Duration of Rocuronium Between 2nd Trimester Pregnant and Non-pregnant Women
Condition: Pregnancy
Study type: Observational

Summary: 
      Pregnancy is associated with major changes of the body's physiological status and
      composition.

      These changes may modify the pharmacologic and/or pharmacokinetic profile of some drugs.
      Pharmacodynamic and pharmacokinetic changes in the 1st trimester during pregnancy are
      attributed to the following factors; Increase in plasma volume, heart rate and cardiac
      output; decrease in blood pressure due to decrease of systemic resistance and relative
      decrease of hepatic circulation and the aggravation of hepatic dysfunction. These changes
      intensify as pregnancy progresses into the 3rd trimester and take their effect on the onset
      time and duration of muscle relaxants.

      Rocuronium and the steroidal non-depolarizing muscle relaxant like vecuronium is mostly
      excreted with bile by hepatic metabolism and classified as the FDA pregnancy category B, and
      is widely used in general anesthesia of pregnant women. Previous studies reported onset time
      of rocuronium is affected by cardiac output, blood circulation time of the whole body, and
      muscle perfusion. Accordingly, many researches were conducted under the assumption of onset
      time and duration being affected by physiologic changes during pregnancy. For example, in the
      research where vecuronium was used as muscle relaxant for pregnant woman undergoing C-sec,
      onset of vecuronium was significantly shorter than that of the control group and duration was
      longer. In a study investigating rocuronium used for patients right after delivery, onset
      time was shorter and duration was longer than that of the control group.

      However, previous research mostly focused on the 3rd trimester, while there have been only a
      few studies of onset time and duration of rocuronium in non-obstetric surgery such as the
      transabdominal cervicoisthmic cerclage (TCIC) or Mcdonald surgery which are performed under
      general anesthesia during 2nd trimester. In this research, onset time and duration of
      rocuronium, which is widely used for general anesthesia in 2nd trimester pregnant females,
      will be compared with those of patients in the control group.
    


Intervention name(s): Rocuronium
Intervention type(s): Drug
Intervention description(s): comparison of onset time and duration of rocuronium using Train of Four watch
Intervention MeSH terms: Rocuronium
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled for Transabdominal cervicoisthmic cerclage under general anesthesia
      
Keywords: Transabdominal cervicoisthmic cerclage; Rocuronium; Pregnant Women
I SAVE - Irbesartan in Mild to Moderate Hypertensive Patients
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      -  To evaluate control rate of Blood Pressure ≤ 140/90 mm Hg in non-diabetic patients, and
           ≤ 130/80 mm Hg in diabetic patients.

        -  To determine percentage of patients achieving blood pressure control according to their
           profile (naïve, switch, patient history, etc…) at the end of the trial.
    


Intervention name(s): Irbesartan (Aprovel)
Intervention type(s): Drug
Intervention description(s): Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide) one tablet a day per os.
Intervention MeSH terms: Irbesartan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hot Snare Versus Hot Snare Polypectomy With Saline Injection for Colorectal Polyps
Condition: Polyp of Large Intestine
MeSH terms: Polyps
Study type: Interventional

Summary: 
      The complete removal of colorectal polyp is required to prevent tumor recurrence and
      development of potential interval cancers. However, several studies have shown high
      incomplete resection rate in endoscopic removal of neoplastic colorectal polyps larger than 5
      mm. The polypectomy techniques using hot snare are usually used for the removal of these
      polyps. However, the optimal technique for complete resection of these polyps is unknown.
      There are few data comparing hot snare polypectomy with hot snare polypectomy after saline
      injection for complete resection of colorectal polyps (5mm or larger). The aim of this study
      is to compare hot snare polypectomy with hot snare polypectomy after saline injection for
      removal of 5-10mm sized colorectal polyps.
    


Intervention name(s): hot snare polypectomy; hot snare polypectomy after saline injection
Intervention type(s): Procedure; Procedure
Intervention description(s): hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps; hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neoplastic colorectal polyp; hot snare polypectomy; hot snare polypectomy after saline injection
Assessment of Nasal Deposition and Clearance of Ketorolac Solution Administered Using the Valois Nasal Spray Device
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a randomised three-way crossover design study. The study consisted of three study
      periods each separated by a minimum 44 hour washout period. During the course of each study
      period, scintigraphic images were acquired at planned intervals after dosing. Subjects were
      able to leave the clinical unit after the completion of study specific procedures at 6 hours
      post-dose.

      The primary objective of the study was to determine whether any of the radiolabelled
      ketorolac formulation was deposited in the lungs of healthy volunteers following nasal
      inhalation under three different conditions (gentle sniff-inhalation with subject standing,
      vigorous sniff-inhalation with subject standing, gentle sniff-inhalation with subject
      semi-supine). The secondary objectives were to determine the deposition pattern of
      radiolabelled ketorolac solution in the nasal cavity, and clearance of the radiolabel over a
      six-hour period.
    


Intervention name(s): Ketorolac tromethamine; Ketorolac tromethamine; Ketorolac tromethamine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 30 mg ketorolac (15 mg (100 ul) per nostril) administered intranasally; 30 mg ketorolac (15 mg (100 ul) per nostril) administered intranasally; 30 mg ketorolac (15 mg (100 ul) per nostril) administered intranasally
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children
Condition: Orthomyxoviridae Infection; Influenza; Myxovirus Infection
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Orthomyxoviridae Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine
      to the standard Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

      Secondary Objectives:

        -  To describe the immunogenicity of of Investigational Fluzone vaccine to the standard
           Fluzone® vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.

        -  To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone®
           vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years.
    


Intervention name(s): Split, Inactivated, Trivalent Influenza Vaccine; Split, Inactivated, Trivalent Influenza Vaccine; Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation); Split, Inactivated, Trivalent Influenza Vaccine ( Fluzone® 2006/2007 Formulation)
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Vaccine (infant dose); Vaccine (children dose); Vaccine (infant dose); Vaccine (children dose)
Other intervention name(s): Fluzone® 2006/2007 Formulation.; Fluzone® 2006/2007 Formulation.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Orthomyxoviruses; Inactivated Split-virion influenza vaccine; Infants; children.
Intraoperative ERCP Versus Therapeutic Splitting in Cholecysto-, Choledocholithiasis
Condition: Cholelithiasis, Common Bile Duct
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones; Choledocholithiasis
Study type: Observational

Summary: 
      At our hospital (Kepler University Hospital Linz) we perform all variants of ERCP
      (preoperative, intraoperative, postoperative ERCP). In cases of simultaneous cholecysto- and
      choledocholithiasis. Hardly any other hospital in Austria prefers intraoperative ERCP or
      offers it at all. We have established a standardized procedure with implemented logistics. We
      want to compare intraoperative and postoperative ERCP.
    

Detailed description: 
      At our hospital (Kepler University Hospital Linz) we perform all variants of ERCP
      (preoperative, intraoperative, postoperative ERCP). In cases of simultaneous cholecysto- and
      choledocholithiasis, we prefer an intraoperative ERCP followed by a preoperative ERCP. We
      have a high level of expertise in endoscopy and an interdisciplinary endoscopy team (surgical
      and internal medicine department) makes this high level of effort possible. Hardly any other
      hospital in Austria prefers intraoperative ERCP or offers it at all. We have established a
      standardized procedure with implemented logistics.

      The aim of this study is to demonstrate and compare the advantages of both procedures at KUK
      from 1.1.2020 to 30.6.2023 (intraoperative and postoperative ERCP) in terms of morbidity,
      endoscopic success and the better way for patients and surgeons in our clinic.
    

Intervention name(s): endoscopic retrograde cholangiopancreatography
Intervention type(s): Procedure
Intervention description(s): endoscopical clearance of the common bile duct
Other intervention name(s): ERCP
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients undergoing surgery and ERCP in context to cholecysto-, choledocholithiasis in
        out hospital
Safety and Tolerability of Once-daily Oral Aripiprazole in Children and Adolescents With Tourette's Disorder
Condition: Tourette's Disorder; Tic Disorder
MeSH terms: Tic Disorders; Tics; Tourette Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of the current trial is to determine safety of Once-daily aripiprazole in reducing
      Total Tic Severity in children and adolescents with Tourette's Disorder.
    

Detailed description: 
      Tourette's Disorder is a neuropsychiatric condition that is characterized by the appearance
      of tics that can be simple or complex in nature. A tic is a sudden, rapid, recurrent,
      non-rhythmic, stereotyped motor movement or vocalization. There are a very limited number of
      medications approved for the treatment of Tourette's Disorder. The goal of the current trial
      is to obtain additional efficacy, safety, and tolerability data in a controlled condition of
      a Once-daily aripiprazole formulation in children and adolescents with Tourette's Disorder.
      The trial is a 52-week extension to the double-blind trial.

      The Once-daily tablet formulation that will be evaluated in this trial represents a daily
      dosage regimen that is intended to be administered to children and adolescents.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Open Label: Once-Daily formulation of aripiprazole flex dose regimine
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tourette Syndrome; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Tic Disorders; Tics; Movement Disorders; Mental Disorders; Aripiprazole
A Study to Compare the Pharmacokinetic Profile of a Proprietary Curcumin Forumulation to a Comparator Curcumin Product
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is investigating the pharmacokinetic profile (i.e. the way the product is
      processed by the body) of a proprietary curcumin formulation compared to an unformulated
      curcumin product. Subjects will take a single dose of either the proprietary formulation or
      comparator product and the blood levels of curcumin and curcumin metabolites will be measured
      over a period of 48 hours.
    


Intervention name(s): Proprietary Curcumin Formulation; Unformulated Comparator Curcumin Product
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Curcumin; Pharmacokinetic
Evaluation of Oxidative Stress and Effect of Levothyroxine Treatment on Oxidative Stress in Hashimoto Disease
Condition: Hashimoto Disease
MeSH terms: Hashimoto Disease
Study type: Observational

Summary: 
      Oxidative stress leads to or accompanies with numerous disease. Oxidative balance in
      subclinical hypothyroid or euthyroid state in Hashimoto disease are not known. Effect of
      levothyroxine therapy on oxidative balance are also not known in hashimoto disease.
    

Detailed description: 
      oxidative stress markers will be measured initially(TAS,TOS,OSI,PARAOXONASE,ARYLESTERASA,PON1
      PHENOTYPİNG,LİPİDPEROXİD).After 3 months therapy with levothyroxine measurements will be
      repeated except PON1 phenotyping.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult with Hashimoto disease in euthyroid or subclinical hypothyroid state and healthy
        control.
      
Biospecimen description: 
      after overnight fasting state,venous blood will be taken to obtain serum.speciemens stored
      -70 cantigrade celcius untillanalysing.
Computer-Based Treatment for Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

Summary: 
      The present study is an open trial that seeks to examine the feasibility, acceptability,
      mechanism, and efficacy of a recently developed computer-based therapy in individuals with
      social anxiety disorder (SAD)
    

Detailed description: 
      This randomized clinical trial examines the feasibility, acceptability, mechanism, and
      relative efficacy of two "doses" (standard 4-week/8 session vs. extended 8-week/12-session)
      of a recently developed computer-based therapy in individuals with social anxiety disorder
      (SAD). The purpose of this study is to assess whether a brief computer-based research
      treatment, provided in 30 minutes sessions, helps improve social anxiety symptoms, and by
      what mechanism. The study will also assess the effect of research treatments on brain
      activity using magnetic resonance imaging (MRI).
    

Intervention name(s): computer-based treatment
Intervention type(s): Behavioral
Intervention description(s): 30 minute sessions of free viewing of faces and listening to music
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Computer-based task involving free viewing of faces and listening to music
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: SAD; Social Anxiety; Social Phobia
Role of Negative Pressure Wound Therapy in Latissimus Dorsi Flap Donor Site Seroma Prevention
Condition: NPWT; Latissimus Dorsi Flap; Breast Reconstruction
MeSH terms: Seroma
Study type: Interventional
Phase: Phase 1

Summary: 
      The use of NPWT as a post-operative dressing significantly reduces the incidence of seroma
      formation after harvesting LD flap.
    

Detailed description: 
      NPWT was left in place on donor site with constant pressure between -125 and -80 mmHg to
      reduce seroma formation
    

Intervention name(s): The negative pressure wound therapy
Intervention type(s): Device
Other intervention name(s): NPWT
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Frequency of Denture Cleanser Use and Denture Cleanliness
Condition: Denture Cleansers
Study type: Interventional

Summary: 
      This method development study will be a two treatment arm, randomized, cross over study in a
      population with edentulous upper arch restored with a maxillary complete denture. The lower
      may be a partial or full edentulous mandibular arch that may be restored with a stable
      complete, partial or implant supported denture.
    

Detailed description: 
      This is a single-center, 2 treatment periods, examiner-blind, randomized, 7 day crossover
      study in adult participants with a complete maxillary denture. This is a method development
      study to investigate the changes in the level of denture plaque, microbial counts, microbial
      composition and stain on the maxillary dentures after daily denture cleanser use versus
      dentures that are cleaned weekly.
    

Intervention name(s): Denture Cleanser Daily Use Period; Denture Cleanser Weekly Use Period; Water
Intervention type(s): Device; Device; Other
Intervention description(s): One denture cleansing tablet will be soaked in a cup of very warm water (150 ml) with dentures for Day 0 to Day 7 for 15 mins. Brush dentures for 30 seconds using the solution, rinse under running water for 10 seconds.; One denture cleansing tablet will be soaked in cup of very warm water (150 ml) from Day 0 to Day 6 for 15 mins; and in cup of very warm water (150 ml) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Brush dentures for 30 seconds using the solution, rinse under running water for 10 seconds.; A cup of very warm water will be used to soak one denture cleansing tablet and dentures for per day (Day 0 to Day 7) or weekly (Day 0 and Day 7) treatment regimen.
Other intervention name(s): Corega tablet; Corega tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science