bioihbjkbjnl/mcl2 huggingface dataset:
Open Abdomen Study Comparing ABThera™ Open Abdomen Negative Pressure Therapy System and Barker's Vacuum Packing Technique
Condition: Open Abdomen
Study type: Observational

Summary: 
      This study is being done to gather data that will be used to compare two different TAC
      (Temporary Abdominal Closure) methods that your doctor may use. The two TAC methods being
      compared are the Barker's vacuum packing technique or BVPT and the Open Abdomen Negative
      Pressure Therapy System (ABThera) developed by the sponsor of this research (KCI, San
      Antonio, TX). The BVPT is made up of supplies that are stocked in most surgery rooms. The
      ABThera dressing is available commercially. Neither method will be supplied to the doctor
      (Principal Investigator), so that in no way would the subject's standard of care be different
      from what they would get if the study was not being done.

      This study is observational and only collects data about how the subject progresses after
      surgery TAC is used. When a study is observational it means that the subject's standard
      medical care will not be altered in any way, simply watched. The doctor will not change
      treatment of your open abdomen.
    

Detailed description: 
      This study is being done to gather data that will be used to compare two different TAC
      (Temporary Abdominal Closure) methods. The two TAC methods being compared are the Barker's
      vacuum packing technique or BVPT and the Open Abdomen Negative Pressure Therapy System
      (ABThera) developed by the sponsor of this research (KCI, San Antonio, TX). The BVPT is made
      up of supplies that are stocked in most surgery rooms. The ABThera dressing is available
      commercially. Neither method will be supplied to the doctor (Principal Investigator), so that
      in no way would the subject's standard of care be different from what they would get if the
      study was not being done.

      This study is observational and only collects data about how the subject progresses after
      surgery TAC is used. When a study is observational it means that the subject's standard
      medical care will not be altered in any way, simply watched. The doctor will not change
      treatment of your open abdomen.
    

Intervention name(s): NPWT; BVPT
Intervention type(s): Device; Device
Intervention description(s): ABThera Open Abdomen Negative Pressure Therapy System; Barker's Vacuum Packing Technique
Other intervention name(s): ABThera
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Emergent Care
      
Keywords: ABThera; Barker's Vacuum Packing Technique
A Study to Evaluate the Effectiveness of NuvaRing® to Prevent Pregnancies in Chinese Women (P06450)
Condition: Contraception
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to assess the effectiveness of NuvaRing® (SCH 900702) for the prevention of
      pregnancy in fertile Chinese women. The acceptability and safety of NuvaRing® will also be
      assessed and compared with that of Yasmin.
    

Detailed description: 
      The purpose of this study is to assess the contraceptive efficacy of NuvaRing in fertile
      Chinese women; to assess vaginal bleeding pattern (cycle control), general safety, and
      acceptability of NuvaRing; and to evaluate the NuvaRing's effect on dysmenorrhea.
    

Intervention name(s): ENG 120 µg + EE 15 µg intravaginal ring; DRSP 3 mg + EE 30 µg
Intervention type(s): Drug; Drug
Intervention description(s): 13 cycles of ENG-EE (NuvaRing) vaginal ring use. Each cycle 28 days, with a 21-day active treatment period followed by 7-day ring-free period. One ring per cycle, each ring containing 11.7 mg ENG and 2.7 mg EE, and releasing on average 120 mcg/day of ENG and 15 mcg/day of EE.; 13 cycles of DRSP-EE tablet use. Each cycle 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received total of 21 tablets per cycle, each tablet contained 3 mg DRSP and 30 μg EE.
Other intervention name(s): NuvaRing; Yasmin
Intervention MeSH terms: NuvaRing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Contraception; NuvaRing
SAD, MAD and Food Effect Evaluation of Safety, Tolerability, and PK of AQ280 in Healthy Subjects
Condition: Eosinophilic Esophagitis (EoE)
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The principal aim of this study is to obtain safety and tolerability data when AQ280 is
      administered orally as single and multiple doses to healthy subjects. This information,
      together with the pharmacokinetic (PK) data, will help establish the doses and dosing regimen
      suitable for future studies in patients.
    


Intervention name(s): AQ280; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dose form: capsule, hard
Strength: 3 to 100 mg
Method of administration: oral; Active substance: none
Dose form: capsule, hard
Strength/dose: not applicable
Method of administration: oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Wellness Enhancing Physical Activity for Young Children
Condition: Physical Activity
Study type: Interventional

Summary: 
      Wellness Enhancing Physical Activity for Young Children (WE PLAY) is a teacher training that
      is based online and was designed to support early childhood educators' efforts to promote
      physical activity (PA) through structured and unstructured active play with preschoolers. WE
      PLAY includes six components: (1) online training; (2) video library; (3) game sheets; (4)
      teacher self-assessment; (5) supervisor support; and (6) activity packs that are designed to
      work synergistically. The purpose of this study was to examine the impact of WE PLAY on
      children's levels of moderate to vigorous physical activity (MVPA) during school hours. We
      hypothesized that children whose teachers received WE PLAY would have higher levels of MVPA
      during school hours at post-intervention relative to pre-intervention and relative to
      children whose teachers did not receive WE PLAY. A second purpose was to examine the impact
      of WE PLAY on teacher outcomes (i.e., knowledge, intentions, perceived behavior control,
      subjective norms, perceived power beliefs, normative beliefs, and moral norms). We
      hypothesized that teachers who participated in WE PLAY would demonstrate higher scores on
      each of these variables at post-intervention relative to pre-intervention and to teachers in
      the control group. A cluster randomized controlled trial was used in this study. Six Head
      Start preschools were pair matched and randomized to the intervention (WE PLAY) or control
      groups. Preschool children (N=57) and their teachers (N=25) participated. Child MVPA was
      measured using accelerometers for 5-day periods at pre- and post-intervention. Teacher
      variables were measured using online surveys.
    


Intervention name(s): WE PLAY
Intervention type(s): Behavioral
Intervention description(s): WE PLAY is an online preschool teacher training that is based in theory and implementation science. It contains six components: (1) online training; (2) video library; (3) game sheets; (4) teacher self-assessment; (5) supervisor support; and (6) activity packs containing low cost physical activity equipment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Life Style Modification for Breast Canccer Survivors Using Mobile App-based Human Coaching Program
Condition: Breast Cancer Survivors
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This study is aimed to investigate whether mobile app-based human coaching program for 6
      months is effective for reducing BMI in breast cancer survivors with overweight and obesity.
    


Intervention name(s): mobile application program with human coach
Intervention type(s): Other
Intervention description(s): 6-months mobile application program with human coach for life-style modifiation including diet and exercise
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        breast cancer survivors with 25 and more than 25 of BMI
The Effects of Frequent Follow up on Compliance in Patients Receiving PAP Therapy Due to OSA (Pap: Positive Airway Pressure, OSA: Obstructive Sleep Apnea )
Condition: Patient Compliance; Sleep Disorder; Obstructive Sleep Apnea of Adult
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders
Study type: Interventional

Summary: 
      The investigators planned to investigate the effect of close monitoring on compliance and the
      factors affecting compliance among patients receiving PAP treatment due to OSA.This study was
      a single-center, prospective, randomized, controlled study approved by the hospital's ethics
      committee.One hundred twenty-eight patients were randomized as group one or two as group 1 is
      the study and group 2 is the control group. The first group was called by phone on the 15th
      day to ask if there were any complaints or problems with the device. Sequentially, they were
      called for controls at the end of the first, third, and sixth months.

      The second group was accepted as the control group, following our clinic's standard procedure
      in the first and sixth months. The patients who came to the control were asked if there were
      any problems with the device and any difficulties in use, and they were again informed about
      the devices and masks.
    


Intervention name(s): study group; control group
Intervention type(s): Other; Other
Intervention description(s): Calling with phone frequently(15.th day, 1 month , 3 month, 6 month ) and face to face interwiew on first, 3 th and 6th month; first and sixth month face to face interwiew
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Osteogenic Potential of Cissus Quadrangularis Alveolar Ridge Distraction
Condition: Distraction of Bone; Dental Implant
MeSH terms: Diastasis, Bone
Study type: Interventional
Phase: Phase 2

Summary: 
      Deficient alveolar mandibular ridge corrected distraction osteogenesis to facilitate dental
      implant placement. Patients grouped into 2 groups: one group received Cissus quadrangularis
      during the consolidation period, and the other group received placebo.
    

Detailed description: 
      OPGs were taken immediately after distractor placement, at end of activation period, at
      1st,2nd month of consolidation period, and at end of consolidation period. Change in bone
      height was evaluated immediately after distractor placement, at end of activation and end of
      consolidation periods.

      CBCT were taken immediately after implant installation, and 6 months later to evaluate change
      bone density and marginal bone level about the dental implant.

      histological evaluation was done by biopsy obtained, by trephine bur, from implant site
      during its preparation. The bone biopsy fixed in 4% formalin solution for 7 days, rinsed in
      water, and dehydrated in sequent phases of ethanol (70, 80, 90, and 100%) and then specimens
      were stained by hematoxylin- eosin for microscopic evaluation.

      Radiographic evaluation
    

Intervention name(s): Cissus Quadrangularis
Intervention type(s): Drug
Intervention description(s): Drug with osteogenic potential given to the patients after consolidation period. dose was two capsules once /day with meals for 6 weeks
Other intervention name(s): Hadiod capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alveolar; Bone; Distraction
Limberg and Karydakis Flap in Recurrent Pilonidal Sinus Disease
Condition: Recurrent Pilonidal Sinus Disease
MeSH terms: Pilonidal Sinus; Paranasal Sinus Diseases; Recurrence
Study type: Interventional

Summary: 
      It was investigated whether there is a factor that can aid determination of the preferred
      technique by comparing the early Limberg flap and Karydakis procedure techniques for the
      treatment of recurrent pilonidal sinus.
    

Detailed description: 
      Sacrococcygeal pilonidal sinus is common in young men and may recur overtime after surgery.

      It was investigated whether there is a factor that can aid determination of the preferred
      technique by comparing the early Limberg flap and Karydakis procedure techniques for the
      treatment of recurrent pilonidal sinus.
    

Intervention name(s): Limberg flap; Karydakis procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients were divided into two groups, group 1 were treated with Limberg flap technique (n= 37) . Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions; Patients were divided into two groups, group 2 were treated with Karydakis flap (n= 34). Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Karydakis procedure; Limberg flap; recurrent pilonidal sinus
Safety And Immunogenicity Of Novel Candidate Blood-Stage Malaria Vaccine P27A : Phase Ia/Ib
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      P27A study is designed as a randomized phase Ia/Ib trial to evaluate the safety and
      immunogenicity of the blood stage candidate vaccine P27A against P. falciparum - P27A antigen
      and associated adjuvant (Alhydrogel or GLA-SE) - in malaria non exposed European
      volunteers(Switzerland; phase Ia) and malaria exposed African volunteers (Tanzania; phase
      Ib).
    


Intervention name(s): CH-Alum50; CH-GLA2.5/50; TZ Ver; TZ Alum 50; TZ GLA 2.5/10; TZ GLA5/50; TZ GLA2.5/50
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): intramuscular administration to Swiss volunteers of Alhydrogel and P27A antigen (50 microg); intramuscular administration to Swiss volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg); intramuscular administration of Rabies vaccine Verorub TM to in Phase IIb only to 8 Tanzanian volunteers in three injections; intramuscular administration to Tanzanian volunteers of Alhydrogel and P27A antigen (50 microg); intramuscular administration to Tanzanian volunteers of GLA-SE (2.5 microg ) together with the P27A antigen (10 microg); intramuscular administration to Tanzanian volunteers of GLA-SE (5 microg) together with the P27A antigen (50 microg); intramuscular administration to Tanzanian volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg)
Intervention MeSH terms: Aluminum sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: plasmodium falciparum; long synthetic peptide; antibody; T cell; cytokine; vaccine; safety; phase 1
A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants
Condition: SARS-CoV-2 Infection; COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, randomized, observer-blind study in healthy individuals.

      The primary study will evaluate the safety, tolerability, and immunogenicity of the
      SARS-CoV-2 RNA vaccine candidate (BNT162b2):

        -  As a 30-microgram dose, administered from 1 of 4 manufacturing lots (batches)

        -  As a 20-microgram dose, administered from 1 of the manufacturing lots

        -  As a 2-dose (separated by 21 days) schedule

        -  In people 12 through 50 years of age

      The booster study will evaluate the safety, tolerability, and immunogenicity of 2 SARS-CoV-2
      RNA vaccine candidates (BNT162b2 and BNT162b2.B.1.351):

        -  Each as a 30-microgram dose

        -  Each as a 1-dose booster vaccine, administered approximately 3 months after Dose 2

        -  In people 18 through 50 years of age
    


Intervention name(s): BNT162b2; BNT162b2.B.1.351
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection; Intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: COVID-19; Coronavirus; Vaccine; SARS-CoV-2; RNA Vaccine; BNT162b2; BNT162B2.1.B.351
SB-480848 In Subjects With Coronary Heart Disease
Condition: Atherosclerosis
MeSH terms: Heart Diseases; Atherosclerosis; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial of SB-480848 in approximately 920 subjects with Coronary Heart Disease (CHD) or
      CHD-risk equivalent will examine whether SB-480848 produces sustained inhibition of plasma
      Lp-PLA2 activity, explore the effects of SB-480848 on other circulating biomarkers associated
      with cardiovascular risk, and evaluate the pharmacokinetics, safety and tolerability of
      SB-480848 over 12 weeks of once-daily oral dosing. Subjects will first be randomized 1:1 to
      double-blind atorvastatin 20 mg or 80 mg once daily for a minimum of 3 weeks. Subjects will
      then be randomized 1:1:1:1 to oral doses of SB-480848 40 mg, 80 mg, 160 mg or placebo once
      daily for 12 weeks. Blood samples will be collected at various timepoints. Vital signs,
      electrocardiograms, clinical laboratory safety tests and adverse event assessments will be
      performed to evaluate the safety and tolerability of SB-480848.
    

Detailed description: 
      A multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging
      study of SB-480848, an oral lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibitor, in
      subjects with stable coronary heart disease (CHD) or CHD-risk equivalent to examine chronic
      inhibition of Lp-PLA2, effects on circulating biomarkers associated with cardiovascular risk,
      safety and tolerability over 12 weeks
    

Intervention name(s): SB-480848; placebo
Intervention type(s): Drug; Drug
Intervention description(s): SB-480848; placebo
Intervention MeSH terms: Darapladib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: CHD; Lp-PLA2; SB-480848
Nicotinic Agonist Effects on BMI and Neuronal Response
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      Obesity is a serious and growing health problem in the United States. Obesity is associated
      with health problems such as type-2 diabetes and cardiovascular disease, leading to decreased
      quality of life and increased mortality. Given the health and quality-of-life effects of
      obesity, developing effective treatments clearly is an important goal.

      This study plans to learn more about the effects of an investigational new drug (DMXB-A
      (3-(2,4-dimethoxybenzylidene anabaseine)) and its effects on obesity. The study drug has
      similar effects to nicotine. Since nicotine has been found to affect appetite, the
      investigators are interested in studying effects of the study drug, which has some
      similarities to nicotine, on how your brain responds to such things as pictures of food. The
      study drug has not been approved by the Food and Drug Administration (FDA), and is considered
      experimental.
    


Intervention name(s): DMXB-A; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.; Placebo capsules b.i.d. for 12 weeks
Other intervention name(s): 3-(2,4-dimethoxybenzylidene anabaseine
Intervention MeSH terms: 3-(2,4-dimethoxybenzylidene)anabaseine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to evaluate the safety and efficacy of up to 26 weeks of
      treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat
      pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque
      psoriasis.
    


Intervention name(s): Calcitriol
Intervention type(s): Drug
Intervention MeSH terms: Calcitriol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment