bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users
Condition: Electronic Cigarettes
Study type: Interventional

Summary: 
      The purpose of this research study is to find out how different types of electronic
      cigarettes (ECIG) settings, combined with e-liquids of differing nicotine concentrations,
      affect blood nicotine levels, use behavior (how users puff), and how users feel.
    


Intervention name(s): ECIG Lab Session 15 watts, 10 mg nicotine; ECIG Lab Session 15 watts, 15 mg nicotine; ECIG Lab Session 15 watts, 30 mg nicotine; ECIG Lab Session 30 watts, 10 mg nicotine; ECIG Lab Session 30 watts, 15 mg nicotine; ECIG Lab Session 30 watts, 30 mg nicotine
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.; During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.).; During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.; During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.; During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.; During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Intervention MeSH terms: Nicotine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: The purpose of this study is to determine differences in nicotine delivery, use behavior (puff topography), carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers and experienced electronic cigarette users use an electronic cigarette with different settings (different voltage and resistance settings, which together determine power levels) and different e-liquid concentrations.
Masking: Single (Participant)
Primary purpose: Basic Science
Baerveldt (BGI) Valve Versus Ahmed(AGV) Valve in Management of Difficult Glaucoma Cases
Condition: Glaucoma, Open-Angle; Glaucoma Secondary; Glaucoma, Neovascular; Glaucoma, Angle-Closure
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Glaucoma, Angle-Closure; Glaucoma, Neovascular
Study type: Interventional

Summary: 
      Refractory glaucoma is a difficult subject as many glaucoma devices attempt to reduce IOP.
      Baerveldt implant is considered as a large implant, and, on the contrary, Ahmed implant is
      considered a small implant as many comparisons have showed. Investigators have previously
      used two models S2 and FP7 Ahmed implant. Currently, investigators use Baerveldt implant in
      refractory glaucoma cases in order to compare it with the Ahmed implant.
    

Detailed description: 
      Eighty-one participants with glaucoma after ocular surgery or secondary glaucoma with
      persistent and uncontrolled IOP > 21 mmHg were randomized for placement of Baerveldt implant
      or Ahmed implant models using a standardized surgical technique.

      The primary outcome was failure, which was defined as IOP >16 mmHg with glaucoma medication
      on 2 consecutive study visits. Secondary outcomes were IOP, medication use, visual acuity,
      complications, and interventions.
    

Intervention name(s): glaucoma implant procedure (Baerveldt); glaucoma implant procedure (Ahmed)
Intervention type(s): Device; Device
Intervention description(s): A 350 mm2 Baerveldt glaucoma implant was placed in the superotemporal quadrant in 25 patients randomized to BGI group. A limbus-based conjunctival flap was dissected, and the implant was sutured to sclera 10 mm posterior to the limbus. A scleral graft was used to cover the limbal portion of the tube, and the conjunctiva was closed.; A 184 mm2 Ahmed glaucoma implant was placed in the superotemporal quadrant in 56 patients randomized to AGV group. A fornix-based conjunctival flap was dissected, and the implant was sutured to sclera 10 mm posterior to the limbus. The Ahmed tube left patent and viscoelastic substance injected into anterior chamber. A scleral graft was used to cover the limbal portion of the tube, and the conjunctiva was closed.
Other intervention name(s): glaucoma valve surgery; glaucoma valve surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized to BGI model 101-350 placement (BGI group) or an AGV model FP7or S2 placement (AGV group). Follow-up visits were scheduled 1 day, 1 week, 1 month, 3 months, 6 months, 1 year postoperatively. The primary outcome measure was failure that defined as IOP >16 mmHg or less than a 20% reduction below baseline on 2 consecutive study visits.The IOP, the use of glaucoma medications, visual acuity (VA), visual fields, bleb morphology and rates of surgical complications were secondary outcome measures.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis
Condition: Nail Psoriasis; Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being conducted to assess the safety and efficacy of adalimumab in participants
      with nail psoriasis.
    


Intervention name(s): Adalimumab; Placebo
Intervention type(s): Biological; Other
Other intervention name(s): ABT-D2E7; Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nail Psoriasis; Plaque Psoriasis
Outcome Following Semitubular Plate vs. Polyaxial Locking Plates
Condition: Ankle Fractures
MeSH terms: Ankle Fractures
Study type: Interventional

Summary: 
      In this prospective study, all patients with distal fibula fractures (AO 44 B1.1, B1.2,
      B1.3), with indication for surgery were included. Patients were randomized to either the
      DePuy Synthes® one-third semitubular plate (Group I) or NEWCLIP TECHNICS, Active Ankle®
      polyaxial locking plate (Group II). In Group II early weight bearing was allowed after two
      weeks postoperatively. Primary outcome parameter was function of the ankle joint, assessed by
      the Olerud and Molander ankle score (OMAS), Foot and Ankle outcome score (FAOS) and Karlsson
      and Peterson Scoring System for Ankle function (KPSS). Secondary outcome parameter were
      postoperative complications. Superficial wound infection, delayed wound healing, mechanically
      prominent implant, skin irritations were considered as minor and deep wound infection,
      material loosening, loss of reduction were regarded as major complications requiring revision
      surgery. Clinical and radiological follow-up were performed 6 and 12 weeks, 6 months and 1
      year postoperatively.
    


Intervention name(s): ORIF non-locking; ORIF locking
Intervention type(s): Procedure; Procedure
Intervention description(s): Open reduction and internal fixation using 1/3 tubular plate; Open reduction and internal fixation using active ankle polyaxial locking plate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Can Fasting Ramadan in the Third Trimester in Pregnancy Affects the Fetal Growth.
Condition: Fasting; Fetal Growth Retardation, Antenatal (Disorder)
MeSH terms: Fetal Growth Retardation
Study type: Observational [Patient Registry]

Summary: 
      Prospective comparative cohort study including 159 pregnant women at the third trimester
      recruited from the antenatal clinic at EL-Demerdash outpatient clinic, and followed up during
      the holy month of Ramadan (from 18th June To 16th July 2015).

      The patients recorded their pattern of fasting during Ramadan then grouped into three groups
      A, B, C regarding fasting state A- Non fasting group B- Partially fasting group C- Totally
      fasting group

      .
    

Detailed description: 
      Many pregnant muslims women fast during Ramadan Since fasting during Ramadan is one of the
      five pillars of Islam and is a central part of Muslim culture, many women may fear a loss of
      connection with their communities or would feel guilty if they did not observe Ramadan. Each
      year, about 400 million out of 1 billion Muslims do this duty. Such tasks like eating,
      drinking, and smoking are forbidden from sunrise until sunset. Fasting during pregnancy has
      been always considered as a debatable condition.

      Many women ask their obstetricians if fasting is safe for their baby or not? There have been
      many studies on metabolic changes and different aspects of human health during and after
      Ramadan .but there have been few studies on the effect of fasting on pregnancy outcome and
      there are also some controversies in the findings of different studies.

      All mothers within the age range of 20 - 35 years and in the 3rd trimester pregnancy
      (starting from 28 weeks) which is going to be calculated according to the date of the last
      menstrual period & confirmed ultrasonically, normal healthy women with average body mass
      index (BMI) and Women included have no medical disorder.

      Women who fulfilled the eligibility criteria were subjected an ultrasound fetal biometry
      every 2 weeks till delivery and assess fetal weight after delivery.
    

Intervention name(s): Fasting
Intervention type(s): Behavioral
Intervention description(s): Totally or partially fasting the holy month of ramadan for muslims
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Prospective comparative cohort study including 159 pregnant women at the third trimester
        recruited from the antenatal clinic at EL-Demerdash outpatient clinic, and followed up
        during the holy month of Ramadan (from 18th June To 16th July 2015).

        The patients recorded their pattern of fasting during Ramadan then grouped into three
        groups A, B, C regarding fasting state A- Non fasting group B- Partially fasting group C-
        Totally fasting group
Harriet Lane Healthy Futures Program
Condition: Youth Coaching; Future Planning
Study type: Interventional

Summary: 
      The purpose of the Harriet Lane Clinic Healthy Futures Program is to increase academic or
      workforce development success among adolescents and young adults. To this end, the Healthy
      Futures educational intervention includes motivational interviewing and knowledge and skill
      building activities that will focus on improving educational, vocational, health, and self
      sufficiency outcomes for youth who attend the Harriet Lane Clinic. Goals of this youth
      development project include determining what factors are associated with school engagement,
      parental academic involvement, and future planning.
    

Detailed description: 
      This is a feasibility study to examine if an intervention in a primary care setting can
      recruit and retain adolescents and young adults and influence future planning behaviors.

      We will address the following research Aims:

        1. To assess the feasibility of a career development program provided to low income
           adolescents and young adults in a pediatric primary care setting.

        2. To assess the receptiveness of adolescents and young adults in pediatric primary care
           setting to future planning interventions.

        3. To assess the impact of a career development program in improving educational,
           workforce, and health attitudes and outcomes for adolescents and young adults.

      The Healthy Futures Program is an interactive, multi-session training program. There will be
      participants in 3 different intervention tracks (College/vocational school, Job, and Career
      Planning). Tracks are assigned to participants based on interest and age. During the
      screening process, participants who are 16 years old or older will be asked if they are
      interested in participating in a program designed to help them apply to college or job
      training services. Based on their preference, they will be assigned a college or job track.
      Participants who are 14 and 15 years old will automatically be assigned to the career
      planning track.
    

Intervention name(s): Career Counseling and Motivational Interviewing
Intervention type(s): Behavioral
Intervention description(s): The Healthy Futures Program is an interactive, multi-session training program. There will be participants in 3 different intervention tracks (College/vocational school, Job, and Career Planning). Activities for all three tracks will occur simultaneously. The intervention group will receive the interactive, multi-session training program including newsletters and workshops. Comparison group participants will receive newsletters and be invited to participate in college and career planning workshops.
Other intervention name(s): motivational interviewing; coaching
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Adolescent Violence Prevention
A Study to Evaluate the Effect of ORMD-0801 in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to explore the efficacy of ORMD-0801 compared to placebo on endogenous
      glucose production in subjects with type 2 diabetes (T2DM). Subjects will undergo an initial
      Screening Visit (Visit 0) to establish their eligibility to participate in the study. At
      Visit 1 (2 weeks after the Screening Visit), qualifying subjects will be randomized to either
      ORMD-0801 (8 mg) or matching placebo, study medication will be dispensed and subjects will
      dose, twice a day, once in the morning prior to breakfast and once at night prior to bedtime
    

Detailed description: 
      This study is designed to explore the efficacy of ORMD-0801 compared to placebo on endogenous
      glucose production in subjects with type 2 diabetes (T2DM). Subjects will undergo an initial
      Screening Visit (Visit 0) to establish their eligibility to participate in the study. At
      Visit 1 (2 weeks after the Screening Visit), qualifying subjects will be randomized to either
      ORMD-0801 (8 mg) or matching placebo, study medication will be dispensed and subjects will
      dose, twice a day, once in the morning prior to breakfast and once at night prior to bedtime.
      Doses will occur at 45 minutes (± 15 minutes) before breakfast and no later than 10 AM each
      morning, and at 8 PM (± 120 minutes) each night, and no sooner than 1 hour after dinner.
      Subjects will return to the clinic, 2 weeks later, for Visit 2. At this visit, subject
      compliance will be assessed, medication will be dispensed, a blood sample will be collected
      to measure HbA1c and subjects will be questioned for any adverse events. Subjects will be
      scheduled to return to the clinic in 2 weeks for morning admission (8 AM ± 120 minutes) to
      the PK unit (Visit 3). Subjects will be provided with standardized meals and the morning dose
      in-clinic. A light standardized dinner meal will be provided at 6 PM ± 30 minutes. At
      approximately 8 PM (± 60 minutes, and no sooner than 1 hour after dinner), subjects will be
      dosed with their study medication and will be started on a 16-hour infusion of
      [6,6-2H2]-glucose tracer.
    

Intervention name(s): ORMD-0801; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 8 mg capsules of ORMD-0801 (Oral Insulin); Placebo capsule (Fish Oil)
Other intervention name(s): Oral Insulin; Fish Oil
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The subject will receive either placebo or ORMD-0801
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Distance Education Versus Usual Care Qualification in Asthma Care
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of multifaceted educational
      interventions in the care of asthma, conducted remotely over the platform TelessaúdeRS in
      teams of the Family Health Strategy and the consequent clinical improvement patients.
    

Detailed description: 
      Cluster-randomized trial with follow-up of 6 months. The aim of this study is to determine
      whether multifaceted interventions performed at a distance for the care of asthma symptoms
      reduce overhead, improve asthma control and qualify the care provided to patients.
    

Intervention name(s): Continuing education; usual care
Intervention type(s): Behavioral; Other
Intervention description(s): Includes telemedicine, reminders, video conferences, educational materials for patients and consultants.; Received the usual care provided
Other intervention name(s): RESPIRANET
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Asthma; Continuing education; Primary health care
Gluten Intolerance in Patients With Diarrhea Predominant Irritable Bowel Syndrome
Condition: Diarrhea; Diarrhea Predominant Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Celiac Disease; Syndrome; Diarrhea
Study type: Interventional

Summary: 
      The specific hypotheses are:

      Gluten supplementation for four weeks increases small intestinal permeability and accelerates
      colonic transit in patients with irritable bowel syndrome with diarrhea (IBS-D) or functional
      diarrhea (FD) who are HLA-DQ2 positive.
    

Detailed description: 
      The study design is a double-blind, randomized, controlled, parallel-group, 6-week study
      comparing the effects of gluten rich versus gluten free diets in diarrhea or diarrhea
      predominant IBS patients. All participants will keep a daily bowel pattern diary throughout
      the study. All participants will have negative serum tissue transglutaminase (TTg) assay, and
      anti-endomysial antibody test, if TTg is positive or equivocal. All participants will have
      the following studies performed both before and after the 4-week dietary intervention:

        1. Stool samples to check markers of inflammation such as fecal calprotectin.

        2. Blood samples to check markers of inflammation and for genetic testing.

        3. After ingestion of the mannitol, lactulose and sucralose sugars, urine samples to
           indirectly measure small intestinal and colonic permeability.

        4. After sedation, upper gastrointestinal endoscopy and flexible sigmoidoscopy to obtain 6
           mucosal biopsies from the small bowel and sigmoid colon for immunohistochemical
           analysis.

        5. Scintigraphy to measure gastrointestinal transit.
    

Intervention name(s): Gluten free diet; Gluten rich diet
Intervention type(s): Other; Other
Intervention description(s): A 4-week gluten free diet provided; A 4-week gluten rich diet is provided
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Gluten; Diarrhea or diarrhea predominant irritable bowel syndrome; Colonic permeability; Small bowel permeability; Colonic inflammatory response; Small bowel inflammatory response
Moxibustion as an Adjuvant for Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms: a Pilot Study
Condition: BPH; Benign Prostatic Hyperplasia; Benign Prostatic Hypertrophy; Lower Urinary Tract Symptom
MeSH terms: Prostatic Hyperplasia; Hyperplasia; Hypertrophy; Lower Urinary Tract Symptoms
Study type: Interventional

Summary: 
      This study aims to explore the feasibility of moxibustion as a supplementary intervention and
      to assess the sample size for verifying the effectiveness and safety of integrative treatment
      involving moxibustion compared with conventional treatment for patients with benign prostate
      hyperplasia (BPH) accompanying moderate to severe lower urinary tract symptoms (LUTS).
    

Detailed description: 
      Patients who diagnosed as BPH with moderate to severe LUTS aged 20 to 80 years old will be
      divided into two groups, one is moxibustion plus conventional therapy group and the other is
      conventional therapy group.

      Patients who belong to moxibustion plus conventional therapy group will be treated
      moxibustion for eight times by a Korean Medicine doctor with conventional therapy by a
      urologist.

      Patients who belong to conventional therapy group will be treated with conventional therapy
      only, and they can receive moxibustion therapy after the clinical trial is finished.

      IPSS, post void residual volume (PVR) and peak urine flow (Qmax) will be checked to evaluate
      the effectiveness and safety.
    

Intervention name(s): Moxibustion
Intervention type(s): Procedure
Intervention description(s): In the moxibustion treatment group, 5 moxibustion points (bilateral SP6, LV3 and unilateral CV4) will be heated with indirect moxibustion (KangHwa, Korea).
The moxa pillars will be removed when the patient feel hotness and require to remove them.
The moxibustion will be conducted repeatedly unless patients feel the sense of heat up to seven times per session.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: moxibustion
MACE and First Operating Room Systolic Blood Pressure in Patients Undergoing Non-cardiac Surgery Implications for the Hypertension Threshold
Condition: Major Adverse Cardiac-cerebral-kidney Event
MeSH terms: Hypertension
Study type: Observational

Summary: 
      To find the threshold of First operating room SBP above which MACE risk increases.
    

Detailed description: 
      To find the threshold of First operating room SBP above which MACE risk increases. By
      reviewing data from 2012-2017 in PKU first hospital.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        90342 eligible surgeries among 71164 unique patients included