bioihbjkbjnl/mcl2 huggingface dataset:
Aspirin Use and Postoperative Bleeding From Dental Extractions in a Healthy Population
Condition: Bleeding Complication
MeSH terms: Hemorrhage; Postoperative Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if aspirin is associated with bleeding
      complications following a single tooth extraction
    

Detailed description: 
      Aspirin is a common chronically administered preventive treatment for cardiovascular disease,
      but is often discontinued prior to invasive dental procedures because of concern of bleeding
      complications. As the goal of aspirin is often to prevent MI and stroke, the risk of these
      CVD outcomes with discontinuation of aspirin must be weighed against the perceived adverse
      event of bleeding during or following an invasive dental procedure with continuation of
      aspirin. The current study is a randomized controlled trial evaluating bleeding complications
      of aspirin vs. placebo in healthy patients schedule for a single tooth extraction.
    

Intervention name(s): Aspirin
Intervention type(s): Drug
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Aspirin; Bleeding; Clinical Trial; Dental Extraction
Pharmacogenetics Informed Tricyclic Antidepressant Dosing (PITA)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      Tricyclic Antidepressants (TCA's) are the cornerstone of treatment for patients with severe
      Major Depressive Disorder (sMDD). Current dosing is guided by repeated measurements of blood
      levels. Compared to patients with a normal metabolization function, for those with increased
      CYP450 enzyme activity it takes longer to reach a therapeutic drug level. The consequent
      delay of drug efficacy is associated with a prolonged treatment period, increased risk of
      suicidal behaviour and eventually lower remission rates. For those with reduced CYP450
      activity higher rates of side effects are expected. An innovative TCA dosing strategy, taking
      the genetic variants of CYP2D6 and CYP2C19 into account may help to reduce the above
      mentioned problems. Up till now, the current guidelines for CYP450 pharmacogenetics based TCA
      dosing have not been systematically evaluated for effectiveness and cost-effectiveness in
      larger groups of patients. Such evaluation is necessary before broad implementation of these
      guidelines can be advocated. In the present study 200 patients with sMDD who are treated with
      nortriptyline, clomipramine or imipramine are randomized over two strategies: dosing based
      both on CYP450-genotype and blood level measurements and dosing as usual (standard doses plus
      blood levels). We hypothesize that genotype informed dosing results in faster attainment of
      therapeutic drug levels, lower rates of side effects, earlier symptom relief and lower levels
      of health- and working related costs.
    


Intervention name(s): TCA treatment
Intervention type(s): Drug
Intervention description(s): All patients fulfilling inclusion criteria will be genotyped for CYP2C19 and CYP2D6 genes. Based on the genetic test results patients will be classified into a metabolisation phenotype (UM, EM, IM or PM).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a randomized controlled clinical trial.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pharmacogenetics; Antidepressive Agents
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TAP311 in Healthy Subjects and Dyslipidemic Patients
Condition: Dyslipidemia; Healthy Volunteers
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, and effect of TAP311 on blood lipids in
      healthy subjects and in patients who have dyslipidemia. The effect of food on TAP311
      concentration in blood and effect of TAP311 administration on simvastatin concentration will
      also be assessed in healthy volunteers.
    


Intervention name(s): TAP311
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: High cholesterol levels; Hyperlipidemia; High-density Lipoprotein; Low-density Lipoprotein; Simvastatin
An Educational Intervention Based on the Teach Back Method on Self-care Practice Among Menopausal Women
Condition: Menopause
Study type: Interventional

Summary: 
      This study was conducted to assess the effects of an educational program that had designed
      based on teach back method in order to improve self-care competency among menopausal women.
    

Detailed description: 
      In this study 60 menopausal women randomly allocated to intervention group(n=30) and control
      group(n=30).

      Intervention group participated in an educational program that had designed in four sessions
      based on teach back method. Control group revived no education.
    

Intervention name(s): An Educational Program
Intervention type(s): Other
Intervention description(s): An educational program was designed for self-care during menopause using teach back method.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Comparison of Different Massage Techniques Plus Conservative Applications in Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to compare of different massage techniques plus conservative
      aplications in low back pain treatment.
    


Intervention name(s): "Connective tissue massage" and "Conservative applications"; "Classic massage group" and "Conservative applications"; "Sham massage group" and "Conservative applications"
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Connective tissue massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.; Classic massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.; Sham massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Triclosan-antibacterial Sutures Impact on the Incidence of Surgical Site Infection in Laparoscopic Surgeries.
Condition: Laparoscopic Surgery; Surgical Wound; Surgical Site Infection
MeSH terms: Infections; Communicable Diseases; Surgical Wound Infection; Surgical Wound
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparing the incidence of PSI in cases using coated Polyglactin 910 suture with Triclosan
      and cases using Polyglactin 910 suture without Triclosan in laparoscopic sleeve gastrectomy,
      laparoscopic appendectomy or laparoscopic cholecystectomy.
    

Detailed description: 
      In this prospective study, we will determine the incidence of PSI in Egypt as well as the
      impact of using coated polyglactin 910 sutures with Triclosan in lowering the incidence of
      PSI in laparoscopic sleeve gastrectomy, laparoscopic appendectomy or laparoscopic
      cholecystectomy.
    

Intervention name(s): Coated Vicryl plus; Coated vicryl
Intervention type(s): Drug; Drug
Intervention description(s): Vicryl plus (Coated Polyglactin 910 with Triclosan); Vicryl (Coated Polyglactin 910 without Triclosan)
Other intervention name(s): Coated Polyglactin 910 with Triclosan; Coated Polyglactin 910 without Triclosan
Intervention MeSH terms: Triclosan
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized-controlled
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Experimental Rabies Vaccine in Healthy Adults
Condition: Virus Diseases
MeSH terms: Virus Diseases; Rabies
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this first time-in-human (FTiH) study is to evaluate the safety,
      reactogenicity and immunogenicity of different dose levels of an experimental rabies
      glycoprotein G (RG) vaccine (RG-SAM [CNE] vaccine), made using a new technology, when
      administered intramuscularly (IM) on a 0, 2, 6 *-month schedule to healthy adults.

      * There will be no vaccinations with the third dose of any of the study treatments.
    


Intervention name(s): Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A); Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A); Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A); Lowest dose formulation of RG SAM (CNE) vaccine (GSK3903133A); Saline Placebo; RabAvert
Intervention type(s): Biological; Biological; Biological; Biological; Drug; Biological
Intervention description(s): Subjects in the low dose (Ld-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) low dose formulation, administered intramuscularlyat Days 1 and 61.; Subjects in the medium dose (Md-) RG SAM (CNE) group will receive 1 doses of RG SAM (CNE) medium dose formulation, administered intramuscularly at Day 1.; Subjects in the Lower dose (Lrd-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) lower dose formulation, administered intramuscularly, according to a 0, 2-month schedule (i.e. at Days 1 and 61); Subjects in the Lowest dose (Ltd-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) lowest dose formulation, administered intramuscularly, according to a 0, 2-month schedule (i.e. at Days 1 and 61); Subjects in the Saline Placebo group will receive 2 doses of saline Placebo, administered intramuscularly Day 1 and 61.; Subjects in the RabAvert Group will receive 2 doses of RabAvert vaccine, administered intramuscularly, at Days 1 and 61.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: First Time in Human; Vaccine; Healthy subjects; Rabies
High Definition Versus Chromoendoscopy for Dysplasia Detection in Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional

Summary: 
      Patients with ulcerative colitis (UC) have an increased risk for colorectal cancer (CRC)
      compared to the general population. Regular screening by colonoscopy is an internationally
      recommended cancer prevention strategy. Random sampling of the mucosa throughout the colon
      has been the mainstay of conventional surveillance practice to detect abnormalities, known as
      dysplasia which can progress to CRC. This requires multiple biopsies, to be taken and
      processed, a practice which is is tedious, expensive, time consuming and has a low pickup
      rate. Dysplasia in UC is typically flat and patchy and can be easily overlooked with standard
      conventional white light colonoscopy (WLC).

      Detection can be improved by the application of dyes which highlight more subtle
      abnormalities. This practice, known as chromoendoscopy (CE) is better than WLC at dysplasia
      detection but more time consuming for the patient and cannot guarantee that the whole colon
      is covered. CE has only been compared in clinical trials with standard definition endoscopy
      rather than the recently available high definition endoscopes with better resolution and
      picture. High definition (HD) endoscopy uses a high definition onitor and a high resolution
      CCD (charge coupled device) providing much better images than standard video endoscopy. HD
      colonoscopy promises therefore to provide an alternative to CE in UC surveillance without the
      need for the extra time and experience required for dye spraying for both endoscopists and
      nursing staff.

      The investigators plan to do a randomized trial to assess HD colonoscopy alone compared to
      chromoendoscopy (with HD colonoscopies) for dysplasia detection during surveillance for
      ulcerative colitis. There have been no trials comparing these two modalities and the
      investigators hope to provide evidence that the additional benefit of CE over HD colonoscopy
      would be marginal and therefore CE would be reserved for procedures using standard definition
      scopes.
    


Intervention name(s): High definition (HD) endoscopy; chromoendoscopy
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Pharmacology Study of JNS010 (Paliperidone Palmitate) in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (study of what the body does to
      a drug) and safety of paliperidone palmitate ranging from 75 to 150 milligram equivalents in
      repeated doses (4 injections) administered in the deltoid muscle (muscle in the shoulder) or
      gluteal muscle (group of muscles present in the buttocks) in participants with schizophrenia.
    

Detailed description: 
      This is a multicenter (study conducted at multiple sites), open label (all people know the
      identity of the intervention), randomized (the study medication is assigned by chance),
      parallel-group (each group of participants will be treated at the same time) study.
      Approximately, 60 participants will be enrolled in the study. This study will consist of a
      screening phase (maximum 14 days), an observation phase (92 days), and a follow-up phase (98
      days). Participants will be randomly assigned to treatment group A, B, or C. During the
      observation phase, participants will receive injections of paliperidone palmitate of
      concentration ranging from 75 to 150 milligram equivalents in the deltoid muscle or gluteal
      muscle as applicable on Days 1, 8, 36, and 64 alternating between sides (left/right). Safety
      evaluations will include assessment of adverse events, clinical laboratory tests,
      electrocardiogram, vital signs, physical examination, injection site reaction, drug-induced
      extrapyramidal symptoms scale, and visual analog scale which will be evaluated throughout the
      study. The total study duration for each participant will be approximately 190 days.
    

Intervention name(s): Paliperidone palmitate
Intervention type(s): Drug
Intervention description(s): Participants will receive 4 injections of paliperidone palmitate of concentration ranging from 75 to 150 milligram equivalents in deltoid or gluteal muscle as randomized to treatment group A, B, or C on Days 1, 8, 36, and 64.
Other intervention name(s): JNS010
Intervention MeSH terms: Paliperidone Palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; JNS010; Paliperidone Palmitate; Clinical Pharmacology
Comparison Between Propofol and Fentanyl for Prevention of Emergence Agitation in Children After Sevoflurane Anesthesia
Condition: Emergence Agitation
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional

Summary: 
      The occurrence of emergence agitation (EA) in pediatric patients who have received
      sevoflurane anesthesia is a common postoperative problem. The prevalence of EA varies between
      10% to 80% depending on the scoring system for evaluation and the anesthetic technique used.

      Many authors reported various strategies such as use of sedative premedication, change of
      maintenance technique of anesthesia, or pharmacological agents administered at the end of
      anesthesia to reduce the incidence and severity of EA, and to allow a smooth emergence from
      sevoflurane anesthesia. Among these strategies, the use of pharmacological agents at the end
      of anesthesia is not affected by anesthetic duration, and may not prolong recovery duration
      of anesthesia excessively when these agents are administered as subhypnotic or small dose.
      The typical agents that can be administered in this way are propofol and fentanyl.

      Previous studies demonstrated that the use of either propofol or fentanyl at the end of
      anesthesia could reduce the incidence of EA.

      The purpose of this study is to compare the preventive effect on EA and the characteristics
      of anesthesia recovery between propofol and fentanyl administered at the end of sevoflurane
      anesthesia.
    


Intervention name(s): Administration of propofol; Administration of fentanyl; Administration of saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Propofol 1 mg/kg will be administered to propofol group at the end of anesthesia.; Fentanyl 1 mcg/kg will be administered to fentanyl group at the end of anesthesia.; Saline will be administered to control group at the end of anesthesia.
Intervention MeSH terms: Fentanyl; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
A Study to Describe the Safety Profile and Compare the Immune Response of 4 Different Formulations of an Investigational Tdap Vaccine When Compared to Licensed Tdap Vaccine in Young Adults in Canada
Condition: Tetanus Immunisation (Healthy Volunteers); Diphtheria Immunisation (Healthy Volunteers); Pertussis Immunisation (Healthy Volunteers)
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study are:

        -  To describe the safety profile of each of the investigational vaccine formulations for
           all participants

        -  To describe the humoral and cell-mediated immune responses to all of the investigational
           vaccine formulations

        -  To evaluate the dose response to vaccine components

        -  To describe the magnitude, quality, and longevity of immune responses to each of the
           investigational vaccine formulations
    

Detailed description: 
      Study duration per participant is approximately 1 year, which will include a safety follow-up
      contact at 12 months after vaccination
    

Intervention name(s): Investigational Tdap vaccine Formulation B; Investigational Tdap vaccine Formulation C; Investigational Tdap vaccine Formulation A; Investigational Tdap vaccine Formulation D; Licensed Tdap vaccine
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Pharmaceutical form:Suspension for injection Route of administration: Intramuscular; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular; Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Modified double-blind: the study participant, the Investigator, and other study personnel remain unaware of the treatment assignments throughout the trial. An unblinded vaccine administrator will administer the appropriate vaccine but will not be involved in safety assessment and data collection.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of Effects of Fesoterodine in Men at High Risk for Overactive Bladder/Detrusor Overactivity Post Robotic-Assisted Lap. Prostatectomy
Condition: Prostate Adenocarcinoma
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators will assess the incidence of Overactive Bladder/Detrusor Overactivity
      (OAB/DO) post-operatively in patients post robotic assisted radical prostatectomy (RARP) and
      to investigate whether fesoterodine will alter the incidence of OAB/DO in these patients.
      Additionally, the correlation between OAB symptoms and urodynamic DO will be analyzed.
    


Intervention name(s): Fesoterodine; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): 4 mg; Placebo
Intervention MeSH terms: Fesoterodine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Male adult subjects; aged 30-90 years; RARP; American Urological Association symptom score greater than 7 will be included
UltraShape Power for Abdominal Fat and Circumference Reduction
Condition: Excess Abdominal Fat
Study type: Interventional

Summary: 
      Prospective, one arm, baseline-controlled, clinical study for the evaluation of the
      UltraShape Power treatment using the U-Sculpt Power Transducer for non-invasive abdominal fat
      and circumference reduction.
    

Detailed description: 
      Up to 120 healthy adult volunteers, seeking noninvasive abdominal fat and circumference
      reduction, male and females, 18 to 60 years of age from 6 investigational sites. Eligible
      subjects will receive 3 bi-weekly treatments (2 weeks interval) with the UltraShape Power
      device utilizing the U-Sculpt Power Transducer according to the study protocol. Subjects will
      return for 3 follow-up visits: four weeks (4wk FU), eight weeks (8wk FU) and 12 weeks (12wk
      FU) after the last treatment (Third Treatment).

      Each subject will be enrolled for total expected study duration of 16 weeks. Subject's
      abdominal fat thickness and circumference will be measured at the measurements points and
      will be assessed at each visit. Additionally, a subject questionnaire will be completed in
      each follow-up visit (4wk, 8wk and 12wk FU). Finally, photography will be performed under
      visible light conditions of the front, right, left and back view. Most of the assessments
      will occur at each of the visits (all treatments and all follow-up visits) to the clinic.
    

Intervention name(s): UltraShape Power
Intervention type(s): Device
Intervention description(s): Tissue selectivity is achieved by a proprietary knowledge of ultrasound parameters ensuring specific destruction of the fat cells only within the target area. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time
Other intervention name(s): UltraShape
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder; Substance Withdrawal Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determine the timeframe (relative to a stress task) that is
      most effective at attenuating the increase in symptoms of tobacco craving and withdrawal that
      occur when smokers are presented with stressful situations.
    


Intervention name(s): Nicotine lozenge
Intervention type(s): Drug
Intervention description(s): A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other