bioihbjkbjnl/mcl2 huggingface dataset:
Cognitive Interference Task on Alcohol Craving and Consumption
Condition: Alcohol Drinking; Craving
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      The purpose of this study is to test a brief task of playing the game Tetris to reduce
      alcohol cravings and alcohol use. Women who are seen at primary care and recruited through
      the community will be asked to rate alcohol craving and use, and play the Tetris game on
      their phones daily for a 3-week period. Participants will also complete a cue-reactivity
      task, that involves viewing pictures of alcohol and rating cravings.
    


Intervention name(s): Tetris and Assessments; Assessment Only
Intervention type(s): Behavioral; Other
Intervention description(s): Participants will complete assessments on their phone to rate cravings for alcohol. Participants will complete a visual cognitive interference task (i.e., play Tetris on their phone) after endorsing a alcohol craving, and then re-rerate craving after the task.; Participants will complete assessments on their phone to rate cravings for alcohol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ecological momentary assessment; cognitive interference
Aripiprazole in the Treatment of Patients With Schizophrenia and Symptoms of Obsessive Compulsive Disorder (OCD)
Condition: Schizophrenia OCD; Obsessive Compulsive Disorder
MeSH terms: Schizophrenia; Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      To evaluate the effectiveness of flexible doses (15-30mg) of Aripiprazole in the treatment of
      patients with schizophrenia and co-morbid symptoms of OCD in the outpatient setting. The
      overall effectiveness of Aripiprazole will be evaluated by use of the Brief Psychiatric
      Rating Scale(BPRS), Yale-Brown OCD scale and Clinical Global Impression-Improvement(CGI-I)
      scale.
    

Detailed description: 
      Symptoms of OCD is a rather common co-morbid condition in patients with Schizophrenia. Some
      studies suggest that obsessive-compulsive symptoms may be present in 7.8-46% of schizophrenic
      patients and who seem to be poorly responsive to drug therapy. The serotonergic medications
      in combination with cognitive-behavioral therapy stil remain the preferred treatment for OCD
      symptoms. There are controversial data regarding effect of neuroleptics on symptoms of OCD.
      It was noted that the use of Risperdone, Quatiapine and Clozapine might aggravate OCD
      symptoms. Serotonin antagonism of these neuroleptics is believed to exacerbate
      obsessive-compulsive symptoms in schizophrenia. On the other hand, Pourovsky M. at(2000)
      reported three cases of Schizophrenia with symptoms of OCD successfully treated with
      Olanzapine.One of our patients with Schizophrenia and co-morbid symptoms of OCD who was
      unsuccessfully treated with various neuroleptics in combination with anti-obsessive
      agents,demonstrated significant improvement in both Schizophrenic and obsessive compulsive
      symptoms after she was switched to Aripiprazole. This result encouraged us to initiate pilot
      study of effectiveness of Aripiprazole in the treatment of specific population of
      schizophrenic patients with symptoms of OCD.
    

Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): Abilify, 5mg; 10mg; 15mg; 20mg; 30mg
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia with OCD; Schizophrenia with-comorbid symptoms of Obsessive Compulsive Disorder(OCD)
Disseminating and Implementing a Smoking Cessation Program for Pregnant and Postpartum Women
Condition: Smoking; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      This study tests whether a smoking cessation intervention for pregnant women that extends
      postpartum (Striving to Quit (STQ)) can be implemented and disseminated outside of the
      research environment that established its effectiveness (40% maintained biochemically
      verified 6-month abstinence). The research aim is:

      Is Striving to Quit more effective in achieving postpartum smoking cessation than "First
      Breath," the current standard of care for pregnant women in Wisconsin who smoke?

      250 women will be randomized into one of two study groups. Pregnant women in Group A (n=125)
      will receive the existing First Breath prenatal intervention. Those in Group B (Striving to
      Quit (STQ), n=125) will receive all Group A interventions, plus 1 additional prenatal home
      visit, 3 postpartum in-home smoking cessation counseling visits, 3 postpartum phone calls,
      and up to an additional $100 in gift cards. The primary outcome will be biochemically
      confirmed smoking cessation at 6-months postpartum.
    


Intervention name(s): brief pre-delivery smoking cessation counseling; additional pre-delivery smoking cessation counseling; post- delivery smoking cessation counseling; incentives
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Immunogenicity of Meningococcal Conjugate Vaccine in Healthy Adults Aged 19 to 55 Years Old
Condition: Infection, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I study to evaluate safety and immunogenicity in healthy adult subjects following a
      single dose administration of Meningococcal (Group A, C, W-135, and Y)-CRM197 Conjugate
      vaccine
    


Intervention name(s): Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine; Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5mL single intramuscular dose on Day 0; 0.5mL single intramuscular dose on Day 0
Other intervention name(s): EuMCV4; Menveo
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Cigarette and Gastric Contents
Condition: Variation of the Antral Area After Cigarettes Smoking or Not
Study type: Interventional

Summary: 
      The aims of this cross over prospective study are to demonstrate that smoking two cigarettes
      do not change the gastric contents and volume in fasting volunteers.
    


Intervention name(s): 2 cigarettes in 15 minutes
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Arterial Remodeling in Smokers
Condition: FMD; IMT; Smoking
Study type: Observational

Summary: 
      Cigarette smoking is the most important modifiable cardiovascular risk factor leading to
      endothelial dysfunction and was suggested to impair arterial regeneration.The aim of the
      study was to investigate the effect of smoking on vascular response to transradial coronary
      angiography (TCA).
    


Intervention name(s): smoke expose
Intervention type(s): Procedure
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        all subjects who underwent an TCA (trans radial catheterisation)
      
Keywords: TCA; FMD; IMT; Smoking
This Study Aims to Determine the Long-term Persistence of Antibodies Against Hepatitis B and to Evaluate the Immunogenicity and Safety of Hepatitis B Vaccine in Adolescents Vaccinated in Infancy With Infanrix™ Hexa
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the long-term persistence of immunity to hepatitis B
      in adolescents aged 12-13 years who were vaccinated with four doses of Infanrix™-Hexa in
      infancy and to assess the anamnestic response, immunogenicity, safety and reactogenicity of a
      single challenge dose of the hepatitis B vaccine Engerix™-B Kinder.
    


Intervention name(s): Engerix™-B Kinder
Intervention type(s): Biological
Intervention description(s): Single dose administered intramuscularly in deltoid region of non-dominant arm.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Infanrix™ hexa; Hepatitis B antibodies; Immunogenicity; Hepatitis B; Adolescents; Infancy; Engerix™-B Kinder; Safety
APC-231 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) in Pediatric Patients With Strep Throat
Condition: Pharyngitis
MeSH terms: Pharyngitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of APC-231 QD for 7 days in
      the bacteriological outcome at the Test of Cure Visit.
    


Intervention name(s): Amoxicillin Pulsatile Release Multiparticluate Sprinkle
Intervention type(s): Drug
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Pharyngitis; Strep throat
Iodine Nutrition During Pregnancy and Related Neonatal Physical Development
Condition: Pregnancy; Iodine Deficiency
Study type: Observational

Summary: 
      Recent studies have found, in both developed and developing countries, there is still a
      considerable number of pregnant women in iodine deficiency status.Our overall aim is to
      monitor iodine status of pregnant women in China, and to examine the correlation between
      maternal urine iodine concentration (UIC) and newborn physical development level.
    

Detailed description: 
      Background: Recent studies have found, in both developed and developing countries, there is
      still a considerable number of pregnant women in iodine deficiency status. Our overall aim is
      to monitor iodine status of pregnant women in China, and to examine the correlation between
      maternal urine iodine concentration (UIC) and newborn physical development level.

      Design: prospective cohort study

      Methods: During August - December 2015,250 participants(28-32 weeks' gestation) were selected
      to participate in the study.The investigators collect the spot urine samples(n=750) once
      every two weeks.

      Setting: Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine.

      Participants: 150 normal pregnant women and 100 pregnant women with gestational diabetes
      (28-32 weeks' gestation) and their newborns were selected to participate the study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        250 pregnant women recruited from antenatal outpatient clinics in Xinhua Hospital
        Affiliated to Shanghai Jiaotong University School of Medicine, China.
      
Biospecimen description: 
      spot urine sample of pregnant women
Clinical Study to Evaluate the Sun Protection Factor (SPF) of Sunscreen Products
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      The purpose of this study is to determine the static SPF of three sunscreen products
      (ChapStick Lip Moisturizer [CLM] Original, CLM Mint Flavour and CLM Black Cherry Flavour)
      using the methodology described in the Food and Drug Administration (FDA) Final Rule (2011).
    

Detailed description: 
      A single-center, randomized, controlled, intra-individual comparison, evaluator-blind,
      clinical study to determine the SPF of three sunscreen lip balms. Each participant will
      evaluate the three test products, an SPF standard and no treatment. Study treatments will be
      randomly assigned to 5 test sites delineated on the skin of the participant's back. Test
      sites will be exposed to doses of ultraviolet (UV) radiation and erytemal response evaluated
      16-24 hours later. Minimal erythema dose (MED) will be determined for protected and
      unprotected sites and used to determine the SPF value of each test product.
    

Intervention name(s): ChapStick Lip Moisturizer Original; ChapStick Lip Moisturizer Mint Flavour; ChapStick Lip Moisturizer Black Cherry Flavour; SPF Standard Sunscreen
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sunscreen lip balm.; Sunscreen lip balm.; Sunscreen lip balm.; SPF Standard (7 percent [%] Padimate-O and 3% Oxybenzone)
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Study of NS 2330 (Tesofensine) (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this exploratory study is to investigate the efficacy and safety of
      tesofensine in daily doses (from 0.125 mg to 1.0 mg) in comparison to placebo, over a 14-week
      treatment period in levodopa treated Parkinson patients with motor fluctuations.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, five parallel groups efficacy and
      safety exploratory of tesofensine versus placebo in levodopa treated Parkinson patients with
      motor fluctuations.

      Patients will be treated either with one of the 4 doses of tesofensine (0.125mg, 0.25mg, 0.50
      mg or 1.0 mg) or with placebo, once daily, over 14 weeks.

      The two co-primary efficacy endpoints are the change in off-time and the change in the
      Unified Parkinson Disease Rating Scale (UPDRS) II+III total score

      Study Hypothesis:

      The null hypothesis is that there is no difference between placebo and tesofensine.

      The alternative hypothesis is that treatment with tesofensine is superior to treatment with
      placebo.

      Comparison(s):

      For the primary comparison between tesofensine and placebo, change in percentage off-time
      during waking hours will be based on reports from patient's diary (completed at day -3 and
      day-2 prior to the study visits) and change in the UPDRS II+III will be based on UPDRS II
      averaged for on and off periods and UPDRS III evaluated at on periods during the study
      visits.
    

Intervention name(s): 1. Tesofensine (NS 2330)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Study of Diclofenac Capsules to Treat Pain Following Bunionectomy
Condition: Other Acute Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and
      effective for the treatment of bunionectomy pain.
    


Intervention name(s): Diclofenac Test (lower dose); Diclofenac Test (upper dose); Celecoxib; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsules; Capsules; 200 mg Capsules; Capsules
Intervention MeSH terms: Celecoxib; Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Laparoscopic Adjustable Gastric Banding Versus Laparoscopic Sleeve Gastrectomy
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional
Phase: Phase 3

Summary: 
      -  The investigators aim to determine the clinical and metabolic outcomes of two available
           bariatric restrictive procedures: laparoscopic adjustable gastric banding (LAP-BAND) and
           laparoscopic sleeve gastrectomy for the treatment of morbid obesity (BMI > 35 with
           comorbidities or BMI > 40) in VETERANS.

        -  The investigators hypothesize that the short and long term outcomes between laparoscopic
           adjustable gastric banding (LAP-BAND) and sleeve gastrectomy are similar in VETERANS.
    

Detailed description: 
      This is a bariatric surgery Phase 3 prospective trial.
    

Intervention name(s): Laparoscopic restrictive procedure
Intervention type(s): Procedure
Intervention description(s): Morbidly Obese VETERANS will receive one of two laparoscopic bariatric restrictive procedures.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Morbid obesity; Bariatric surgery; Obesity surgery; Gastric banding; Sleeve gastrectomy
Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis
Condition: Active Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate that import Mesalazine (Asacol®) is non-inferior to the reference drug,
      marketed Mesalazine, regarding the primary endpoint (reduction of UC-DAI score)in patients
      with active ulcerative colitis (UC) treated for 8 weeks.
    


Intervention name(s): Asacol®; Mesalazine
Intervention type(s): Drug; Drug
Intervention description(s): 400mg tablets; 400mg tablets
Other intervention name(s): Import Mesalazine; Marketed Mesalazine
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label, multicenter study to evaluate the systemic exposure and safety of
      topical tapinarof cream, 1% under conditions of maximal use in pediatric subjects with atopic
      dermatitis
    

Detailed description: 
      This is a 4-week open-label study in which subjects will be assigned to receive tapinarof
      cream, 1% once daily for 4 weeks. At the end of the 4-week study treatment, qualified
      subjects will have the option to enroll in an open-label, long-term extension study for an
      additional 48 weeks of treatment. Subjects who do not participate in the open-label,
      long-term extension study will complete a follow-up visit approximately one week after the
      end of treatment in this study.
    

Intervention name(s): Tapinarof cream, 1%
Intervention type(s): Drug
Intervention description(s): Tapinarof cream, 1% applied topically once daily
Other intervention name(s): DMVT-505
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: eczema; pediatric; tapinarof; phase 2; topical
Lifestyle Changes Reducing Type 2 Diabetes Risk Among Arab Canadian Muslim Women.
Condition: Lifestyle Risk Reduction; Type2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Aim: The purpose was to investigate whether modifiable risk factors for type 2 diabetes can
      be reduced by an intensive healthy lifestyle intervention designed for Arab Muslim women.

      Methods: Women were assigned randomly to either an Exercise and Nutrition Group (ENG) or a
      Control Group (CG). The ENG attended a women-only supervised exercise program that presented
      Arabic music and traditional Lebanese Dabka steps three times/week in the Mosque Gym for 12
      weeks. A nutritionist was available one hour/week for nutrition education. The CG followed
      their typical day.
    

Detailed description: 
      Women were assigned randomly using a computer-generated random numbers table to either an
      Exercise and Nutrition Group (ENG) or a Control Group (CG). The women received step-by-step
      instructions on how to complete a consecutive 3-day food record (including two week-days and
      one weekend day) and an exercise log for 7 days using a pedometer (YAMAX SW-200 Digi-Walker)
      to determine steps/day. The information and instruction were delivered to the women in
      English or Arabic. Body weight and height were measured to the nearest 0.1 kg and 0.1 cm,
      respectively. Women came to the lab after a 12 hour fast and a blood sample was drawn. Waist
      and hip measurements were taken along with resting blood pressure. Estimated fitness levels
      was measured by a trained kinesiologist using a Step Test (Siconolfi et al. 1985). All
      baseline measurements, including the 3-day food intake record and the 7-day pedometer step
      count log were repeated at the end of the 12-week intervention in both groups. The ENG group
      attended a supervised women-only exercise program that presented Arabic music and traditional
      dance steps (the Lebanese Dabka) three times a week in the London Muslim Mosque Gym and
      received nutrition education over the 12 weeks, one session per week.
    

Intervention name(s): Lifestyle intervention; Placebo - Control
Intervention type(s): Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: type 2 diabetes; risk reduction; lifestyle intervention; Arab Canadian Muslim women
The Baerveldt Versus ClearPath Comparison Study
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      This is a randomized prospective study of post-operative surgical outcomes and complication
      rates in patients with a Baerveldt 350 implant vs the Ahmed ClearPath implant. Each subject
      will be randomized to the Baerveldt group or ClearPath group at the time of consent for the
      study.
    


Intervention name(s): Baerveldt 350 implant; Ahmed ClearPath 350 implant
Intervention type(s): Device; Device
Intervention description(s): The Baerveldt implant is an FDA-approved silicone, non-valved implant.; The Ahmed ClearPath is a non-valved glaucoma drainage device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Baerveldt 350 implant; Ahmed ClearPath implant