bioihbjkbjnl/mcl2 huggingface dataset:
Chemical Dependency and Smoking Cessation: Patient's Views - 1
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Observational

Summary: 
      The purpose of this study is to asses patient views on smoking cessation and tobacco harm
      reduction during drug treatment.
    

Detailed description: 
      Participants included 34 patients who had never voluntarily quit smoking for longer than 24
      hours (continuous smokers), 34 smokers who had quit smoking for at least 24 hours before but
      had relapsed (relapsers), and 10 former smokers who had been abstinent for at least the past
      6 months (successful quitters). We held 7 focus groups, 3 with continuous smokers and 4 with
      relapsers. Focus groups lasted 2 hours and were held at participants' clinics to preserve
      confidentiality. We conducted hour-long individual interviews with successful quitters. All
      participants completed a brief written survey immediately before their session. Survey items
      included questions on demographics, smoking behaviors, and motivation for cessation,
      reduction, and nicotine maintenance. We reimbursed all participants $40 and provided a meal
      to focus group attendees.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Substance abuse treatment patients
Repetitive Transcranial Magnetic Stimulation With H-coil in Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      Focal repetitive transcranial magnetic stimulation (rTMS) has been applied to improve
      cognition in Alzheimer's disease (AD) with conflicting results. In this study we aimed to
      explore feasibility, safety and efficacy of excitatory rTMS of bilateral DLPFC applied with
      H-coil in AD in a pilot randomized, placebo-controlled, double-blind study.
    

Detailed description: 
      Study Design The study was a double-blind, placebo-controlled paradigm, with randomization
      into a real rTMS group or a sham rTMS
    

Intervention name(s): rTMS with H-coil; Sham rTMS stimulation with H-coil
Intervention type(s): Device; Device
Intervention description(s): Deep repetitive transcranial manetic stimulation or sham stimulation with H-coil; Sham rTMS stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pilot Study Characterizing the Pharmacokinetic Profile of a Novel Encapsulated Caffeine Beverage in the Fed and Fasted States
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      Pilot study designed to characterize the plasma caffeine pharmacokinetic profile of
      encapsulated caffeine when consumed in the fasted and fed states.
    


Intervention name(s): 250 mg encapsulated caffeine
Intervention type(s): Other
Intervention description(s): Zero calorie 500 ml (16.9 oz) flavored, carbonated energy beverage
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: caffeine; plasma; encapsulated; beverage
Automated Fetal Heart Echocardiography by Five-Dimensional Ultrasound in the Third Trimester of Pregnancy
Condition: Fetal Heart Echocardiography by Five Dimensional Ultrasound
Study type: Observational

Summary: 
      The aim of the study to evaluate Five-Dimensional Ultrasound in automated assessment of the
      fetal heart from 20-36 weeks of gestation.
    

Detailed description: 
      This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain Shams
      University Maternity Hospital.

      90 pregnant women will be recruited from the Fetal Care Unit who will fulfill the inclusion
      criteria. They will be counseled to be included into the study.

      All cases will be subjected to:

        1. Full history taking including patient's age, parity, last menstrual period, estimated
           gestational age by dates, past history of medical disorders, clinical examinations
           (General and abdominal).

        2. Two-Dimensional Ultrasound and Five-Dimensional Ultrasound will be done for all cases
           for assessment of fetal Heart.

             -  90 consecutive patients will undergo 2D fetal echocardiography by one observer

             -  Then they will undergo blindly Five-Dimensional fetal echocardiography by another
                observer

             -  The data collected will be compared to evaluate the accuracy of Five-Dimensional US
                in fetal heart assessment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a Prospective pilot study that will be performed at the Fetal Care Unit at Ain
        Shams University Maternity Hospital.

        Ninety pregnant women will be recruited from the Fetal Care Unit who will fulfill the
        inclusion criteria. They will be counseled to be included into the study.
Adding Metformin to Insulin in Controlling Pregestational and Gestational Diabetes Mellitus
Condition: Gestational Diabetes Mellitus in Pregnancy
MeSH terms: Diabetes, Gestational; Pregnancy in Diabetics; Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of the study to prove benefits of adding metformin to insulin for controlling
      presentational and gestational diabetes mellitus and improving neonatal outcome.
    

Detailed description: 
      The current study was conducted at Ain Shams university maternity hospital during the period
      between June 2016 to December 2016.

      All patients were subjected to:

        1. History taking:

        2. General and Abdominal Examination:

           With particular emphasis on :

             -  Body mass index

             -  Blood pressure.

             -  Fundal height .

             -  Estimated fetal weight .

        3. Insulin and metformin doses :

           Insulin dose:

           0.7 IU/Kg (at the second trimester of pregnancy). 0.8 IU/Kg (at the third trimester of
           pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the
           target blood glucose concentration.

           Metformin dose :

           Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in
           addition to insulin.

           If the target blood glucose concentrations were not attained, the dose of metformin was
           raised to 2000 mg per day.

        4. Investigations:

      Fasting and two hours postprandial blood glucose levels were measured in two groups of
      pregnant women:

        1. Group I: pregnant women who received oral metformin in addition to insulin therapy.

        2. Group II: pregnant women who received insulin therapy only.
    

Intervention name(s): Insulin Mixtard; Metformin
Intervention type(s): Drug; Drug
Intervention description(s): Insulin dose:
0.7 IU/Kg (at the second trimester of pregnancy).
0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.; Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.
If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day.
Other intervention name(s): insulin mixtures; Metformin Hydrocloride
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin, pork; isophane insulin, pork drug combination 30:70
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group I: pregnant women who received oral metformin in addition to insulin therapy.
Group II: pregnant women who received insulin therapy only.
Masking: Single (Participant)
Primary purpose: Treatment
Validation of HRM Score for the GERD Diagnosis
Condition: Gastro Esophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional

Summary: 
      The goal of this prospective study is to validate a high resolution manometry score to
      predict pathologic GERD in patients with reflux symptoms. The main question it aims to answer
      is:

      Is it possible to predict GERD on high resolution manometry? Participants will be asked to
      undergo high resolution manometry and pH-study
    

Detailed description: 
      According to recent guidelines, high resolution manometry (HRM) has an ancillary role in the
      diagnosis of gastro-esophageal reflux disease (GERD). A recent multicenter study demonstrated
      the effectiveness of the straight leg raise (SLR) maneuver in predicting GERD, thus
      increasing the diagnostic value of HRM in patients with suspected pathological reflux. HRM
      parameters associated with GERD include esophageal body hypomotility such as ineffective
      esophageal motility (IEM), and esophagogastric junction (EGJ) metrics, particularly the EGJ
      contractile integral (EGJ-CI) that takes into consideration the presence or absence of a
      hiatal hernia (HH), and a hypotensive lower esophageal sphincter (LES). The combination of
      these four parameters might help to predict or exclude true GERD in patients undergoing HRM
      with the suspicion of GERD.

      In this multicenter international prospective study, we aimed to build a score to predict
      pathological esophageal acid exposure time (AET>6%).
    

Intervention name(s): High resolution manometry
Intervention type(s): Diagnostic Test
Intervention description(s): Standard chicago classification 4.0 HRM protocol
Intervention model: Single Group Assignment
Intervention model description: Prospective descriptive study
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: High Resolution Manometry; Gastroesophageal reflux disease; Esophagogastric junction; Inta-abdominal pressure; Straight leg raise maneuver
Different Dosage of Decompression Therapy on Symptoms of Lumbar Radiculopathy
Condition: Lumbar Radiculopathy
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      This study will provide evidence about how much dose of decompression more effective for the
      treatment of lumbar radiculopathy. As this hypothesis has no evidence about the dosage of
      decompression in literature till now.
    

Detailed description: 
      Decompression therapy differs from traction-based therapy in that the traction applied to the
      spine in decompression therapy is typically alternated between lower and higher levels of
      tension for predetermined periods of time. In either therapy, spinal tension is maintained
      for the period's typically extending 30-minutes or longer. This study will provide evidence
      about how much dose of decompression more effective for the treatment of lumbar
      radiculopathy. As this hypothesis has no evidence about the dosage of decompression in
      literature till now.
    

Intervention name(s): Decompression with 30%; Decompression with 40%; Decompression with 50%
Intervention type(s): Other; Other; Other
Intervention description(s): Hot Pack for 10 mins Soft Tissue Mobilization
Muscle Strengthening
Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks; Hot Pack for 10 mins Soft Tissue Mobilization
Muscle Strengthening
Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks; Hot Pack for 10 mins Soft Tissue Mobilization
Muscle Strengthening
Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pain; Radiculopathy; Lumbar; Decompression
Safety, Tolerability and Protective Efficacy of PfSPZ Vaccine in Gabonese Children
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a single site, randomized, double-blind, placebo-controlled trial. The trial
      will assess the safety, tolerability, immunogenicity and vaccine efficacy (VE) of PfSPZ
      Vaccine in Gabonese children that are naturally exposed to malaria parasites. Healthy
      children aged 1- 12 years living in the surrounding areas of Lambaréné and/or Fougamou
      Province in Gabon will be eligible for participation.
    

Detailed description: 
      The trial will be performed in 200 healthy Gabonese children, recruited across three
      age-strata: 7-12, 3-6 and 1-2 years (12-35 months). Within each age-stratum, volunteers will
      be randomized in a 2:1 ratio to receive three doses via direct venous inoculation (DVI) of
      either PfSPZ Vaccine (0.9x10^6) or normal saline (NS) on days 0, 7 and 28 respectively; a
      minimum of 40 and a maximum of 100 volunteers are included in each of these age-strata.

      In total, approximately 133 children will receive PfSPZ Vaccine and approximately 67 children
      will receive placebo. Randomization will be stratified by age-stratum, using permuted blocks
      of randomized size (3, 6, or 9). The start of inclusion into each age-stratum will be
      staggered, such that immunization of the first 3-6-year-olds will not commence until two
      weeks after start of immunization in the first 7-12-year-olds, and immunizations in the first
      1-2-year-olds will not commence until two weeks after start of immunization in the first
      3-6-year-olds. All volunteers will receive presumptive treatment with artemether-lumefantrine
      two weeks prior to final immunization (day 14). All volunteers will receive presumptive
      treatment with age-standardized 3-day course of oral artemether-lumefantrine (AL) ~two weeks
      prior to first immunization and again two weeks prior to final immunization.
    

Intervention name(s): PfSPZ Vaccine; Normal Saline
Intervention type(s): Biological; Other
Intervention description(s): Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine); 0.9% Sodium chloride
Other intervention name(s): NS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Plasmodium falciparum; PfSPZ Vaccine
The Platelet Aggregation After tiCagrelor Inhibition and FentanYl Trial (PACIFY)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      With potent analgesic properties, perceived hemodynamic benefits and limited alternatives,
      opiates are the analgesic mainstay for acute coronary syndrome (ACS) patients reporting
      peri-procedural pain or nitrate-resistant chest pain. However, large observational studies
      suggest that opiate administration during ACS may result in adverse cardiovascular outcomes.
      Complimenting this, a number of recent mechanistic studies have demonstrated delayed and
      attenuated effects of oral dual anti-platelet therapy (DAPT) on platelet inhibition endpoints
      among subjects receiving intravenous morphine. These studies support the hypothesis that
      morphine delays the gastrointestinal absorption of DAPT medications. However, no data exist
      on the impact of intravenous fentanyl, a systemic opioid analgesic routinely administered
      during percutaneous coronary intervention (PCI) procedures, on the platelet inhibition
      effects of DAPT. The investigators hypothesize that, similar to morphine, fentanyl
      administered at the time of PCI will reduce and delay the effect of DAPT on platelet
      function. As such, the primary aim of this study is to test the impact of intravenous
      fentanyl on residual platelet reactivity by randomizing patients undergoing PCI to a strategy
      of peri-procedural benzodiazepine plus non-systemic local analgesia or to the current
      standard of benzodiazepine plus intravenous fentanyl. Given the critical need for rapid and
      robust inhibition of platelet function during PCI, this trial has true potential to change
      clinical practice, particularly if the investigators demonstrate reduced DAPT absorption and
      elevated residual platelet reactivity among patients receiving fentanyl during PCI.
    


Intervention name(s): Removal of Fentanyl from peri-procedural analgesia; Fentanyl; Lidocaine; Midazolam
Intervention type(s): Other; Drug; Drug; Drug
Intervention description(s): Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI); IV peri-procedural analgesia; Local Anesthetic; IV sedation
Intervention MeSH terms: Lidocaine; Midazolam; Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Percutaneous Coronary Intervention; Blood Platelets; Fentanyl
TMC435350-TiDP16-C105: Phase I, 3-way Crossover, Drug-drug Interaction Between TMC435350 and Rifampin After Multiple Dosing.
Condition: Hepatitis C; HCV; Tuberculosis; Rifampin; Pharmacokinetics
MeSH terms: Hepatitis C; Tuberculosis; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the interactions seen when somebody doses with
      TMC435350 and Rifampin (commercial form of antibiotic).
    

Detailed description: 
      This is a Phase I, open-label, randomized, 3-way crossover trial in 18 healthy volunteers to
      investigate the potential drug-drug interaction between rifampin and TMC435350. TMC435350 is
      a protease inhibitor in development for treatment of chronic HCV infection. The goal is to
      assess the PK and safety data generated during 3 in-patients sessions. At each session the
      volunteer will receive one of 3 treatments. Rifampin is a medication commonly given to
      patients with Mycobacterium infections such as tuberculosis. Some patients have both chronic
      HCV and tuberculosis, therefore it is necessary to know how the medications will affect each
      other when they are taken together. Treatment A: TMC435350 200 mg q.d. for 7 days. Treatment
      B: rifampin 600 mg q.d. for 7 days. Treatment C: the combination of TMC435350 200 mg q.d. +
      rifampin 600 mg q.d. for 7 days. There will be a washout period of at least 10 days between
      subsequent sessions. Day 8 of a treatment session is the first day of the washout period.
      Full pharmacokinetic profiles of TMC435350 will be determined on Day 7 of Treatments A and C.
      Full pharmacokinetic profiles of rifampin and its active metabolite 25-deacetyl rifampin will
      be determined on Day 7 of Treatments B and C. Safety and tolerability will be monitored
      continuously throughout the trial. Volunteers will receive the dose regimens in Treatments A,
      B, C: Treatment A: TMC435350 200 mg q.d. for 7 days. Treatment B: rifampin 600 mg q.d. for 7
      days, Treatment C: the combination of TMC435350 200 mg+rifampin 600 mg both q.d. for 7 days.
      The volunteers will enter the testing facility the night before the first dosing in each
      session (on Day -1 = one day before the first dosing) and stay in the testing facility until
      72 hours after the last intake of medication on Day (10).
    

Intervention name(s): TMC435350; Rifampin; TMC435350+rifampin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200 mg taken by mouth once daily for 7 days; 600 mg taken by mouth once daily for 7 days; The combination of TMC435350 200 mg + rifampin 600 mg both taken by mouth once daily for 7 days.
Intervention MeSH terms: Rifampin; Simeprevir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TMC435350-TiDP16-C105; TMC435350-C105; Hepatitis C; HCV; Rifampin
A Multiple Dose Pharmacokinetic Study of Perampanel in Korean Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will consist of 2 phases: Pretreatment Phase and Treatment Phase. The Pretreatment
      Phase will have 2 time points: Screening and Baseline. Subjects will be admitted to the
      clinical study ward the day before starting the study drug administration (Day -1) for PK and
      safety assessments during Treatment Phase, and discharged at Day 33 (group A) and Day 47
      (group B). Post-test will be done at Day 37 (+/-1), Day 42 (+3) (group A) and Day 51 (+/-1),
      Day 56 (+3) (group B). Study medication will be administered with 240 mL of room temperature
      water
    


Intervention name(s): Perampanel; Perampanel
Intervention type(s): Drug; Drug
Intervention description(s): 2 mg up to 4 mg; 2 mg up to 6 mg
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy
Internet-Delivered Positive Affect Program in Managing Emotion in Young Adult Cancer Survivors
Condition: Cancer Survivor
Study type: Interventional

Summary: 
      This pilot clinical trial studies how well an internet-delivered positive affect (PA)
      intervention works in managing emotion in young adult cancer survivors. An internet-delivered
      PA intervention may teach younger cancer survivors healthy coping skills and help doctors to
      learn more about what effects mood may have on the health and well-being of young adults with
      cancer.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To adapt an individualized positive affect intervention that was developed for newly
      diagnosed HIV patients to use with young adult cancer survivors.

      II. To pilot test the positive affect intervention with young adult cancer survivors to
      determine its feasibility and acceptability.

      SECONDARY OBJECTIVES:

      I. To describe health related quality of life, psychological well-being, daily emotion
      reports, and health behaviors in young adult cancer survivors.

      OUTLINE:

      Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients
      complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic
      material and 20-30 minutes of daily online exercises.

      After completion of study, patients are followed up at 1 and 12 weeks.
    

Intervention name(s): Internet-Based Intervention; Quality-of-Life Assessment; Questionnaire Administration
Intervention type(s): Other; Procedure; Other
Intervention description(s): Complete online PA program; Ancillary studies; Ancillary studies
Other intervention name(s): Quality of Life Assessment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care