bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Behavioral Training on Physiological Responses to Smoking Cues, Affect and Cortisol
Condition: Smokers
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is ancillary. Participants will be recruited as part of a separate clinical trial
      on effects of two intensive behavioral training programs that evaluates feasibility and
      efficacy of a behavioral treatment that includes mindfulness techniques (MT) in comparison to
      traditional behavioral therapy (CBT) for smoking cessation. The investigators propose to
      compare the effect of MT to that of traditional CBT on a physiological marker of stress,
      salivary cortisol concentration, and physiological responses to smoking cues in tobacco
      smokers. The investigators will use electrophysiological reactivity to smoking cues in the
      form of audio recordings of personalized scripts describing the scenarios associated with the
      strongest urges to smoke that will provide a physiological validation to a behavioral
      intervention. The investigators will also explore correlations between these biological
      markers and self report of stress, craving and negative affect to supplement self report and
      behavioral outcome measures with biological and physiological markers to represent
      improvement attributed to the intervention.
    


Intervention name(s): Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT)
Intervention type(s): Behavioral
Intervention description(s): 60 smokers will enter a separate 4 wk group sessions trial that evaluates efficacy of MT in comparison to CBT for smoking cessation. During the parent study, participants will receive bi-weekly sessions of either MT or CBT, for 4 weeks and to set a quit date at the end of the 2nd week. In this context, we will examine participants at two points:
Week 0-1 of MT/CBT: development of smoking scripts based participant's descriptions of situations that trigger tobacco craving.
Then participants will undergo pre-treatment (week 0-1) and post treatment (week 4) psychophysiological activation to smoking-related cues using the script driven imagery technique, in vivo cues, salivary cortisol testing and to complete a computerized SST protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: cue reactivity; physiologic activation; craving; smoking cues; Behavioral therapy
A Study to Evaluate GBT021601 in Single and Multiple Doses in Healthy Participants
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      This first in human study is designed to evaluate the safety, tolerability, pharmacokinetics
      (PK), and food effect of GBT021601, a hemoglobin S (HbS) polymerization inhibitor, in healthy
      participants.
    

Detailed description: 
      This is a randomized, double-blind, placebo controlled, single and multiple ascending dose
      study in healthy participants.
    

Intervention name(s): GBT021601
Intervention type(s): Drug
Intervention description(s): Administered orally with water as a single dose in the morning.
Other intervention name(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation
Condition: Heart Failure; Mitral Regurgitation
MeSH terms: Heart Failure; Mitral Valve Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      Improvement of heart failure with moderate to severe mitral regurgitation using a
      percutaneously delivered implanted device.
    


Intervention name(s): PTMA (Percutaneous Transvenous Mitral Annuloplasty) Implant
Intervention type(s): Device
Intervention description(s): Percutaneous access from right or left subclavian vein with placement of assessment and placement of PTMA Implant into the coronary sinus, great cardiac vein. Device remains accessible from a subclavicular pocket.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: heart failure; mitral regurgitation
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)
Condition: Uterine Fibroids; Heavy Menstrual Bleeding
MeSH terms: Leiomyoma; Myofibroma; Menorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      This study seeks to evaluate the efficacy, safety and tolerability of elagolix alone and in
      combination with estradiol/norethindrone acetate for the management of heavy menstrual
      bleeding associated with uterine fibroids in premenopausal women.
    


Intervention name(s): Elagolix; Placebo for Estradiol/Norethindrone Acetate; Estradiol/Norethindrone Acetate; Placebo for Elagolix
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Film-coated tablets; Placebo capsules; Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.; Film-coated placebo tablets
Other intervention name(s): ABT-620; elagolix sodium; E2/NETA
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Elagolix; Elagolix Sodium; Heavy uterine bleeding; Heavy menstrual bleeding (HMB); Leiomyomata; Menorrhagia; ABT-620; Elagolix + E2/NETA (Elagolix + Norethindrone acetate)
Gingival Crevicular Fluid Levels of Sclerostin, Osteoprotegerin (OPG) and RANKL in Health, Disease and After Treatment
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The primary objective of this case-control intervention study to explore the effectiveness of
      non surgical periodontal therapy on the gingival crevicular fluid (GCF) levels of sclerostin
      in patients with chronic periodontitis (CP) so as to get a more detailed insight into its
      diagnostic and prognostic potential as a biomarker of periodontal disease.
    

Detailed description: 
      All individuals underwent a full-mouth periodontal examination, which included probing pocket
      depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI),
      bleeding on probing (BOP). Individuals were categorized into three groups: individuals with
      clinically healthy periodontium (group 1), patients with chronic periodontitis (group 2), and
      group 3 consisted of the patients with chronic periodontitis (group 2), treated by scaling
      and root planning. GCF samples in grup 1 were taken at baseline. In group 2, GCF samples were
      taken before and after non- surgical periodontal treatment. Sclerostin, OPG and RANKL levels
      were determined using the enzyme-linked immunosorbent assay.
    

Intervention name(s): non surgical periodontal treatment
Intervention type(s): Other
Intervention description(s): SRP under local anaesthesia, in a total of four clinical visits
Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Sclerostin; OPG; RANKL
Comparison of Routine and Core-stability Exercises on Dynamic Sitting Balance and Trunk Control in Stroke Patients
Condition: Ischemic Stroke, Acute
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional

Summary: 
      This is ROM trail study. Data collected from Rabbani Hospital Lahore . in this study total
      two groups included control and experimental and sample size was 48 and 24 persons divided in
      each groups as well. Informed consent was taken from the recruited subjects. Two scales BBS
      and TIS used to measure the outcomes. Data analyse by ssps V21.0 with a significant level of
      p valued 0.05. Results were in the favour of experimental group.
    

Detailed description: 
      This is ROM trail study. Data collected from Physiotherapy department of Rabbani Hospital
      Lahore . In this study total two groups included control and experimental and sample size was
      48 and 24 persons randomly allocated in each groups as well. In control group conventional
      therapy given while in experimental group core-stability exercises with conventional therapy
      given to the patients. while the duration of therapy was 45 minutes per day for 8 weeks.
      Informed consent was taken from the recruited subjects. Two scales BBS and TIS used to
      measure the outcomes. Only having first episode of sub-acute stoke patients and diagnosed by
      Neuro-physician were included in study. Data entered and analysed by SSPS V21.0 with a
      significant level of p valued 0.05. and the results were in the favour of study means
      experimental group.
    

Intervention name(s): Physiotherapy
Intervention type(s): Other
Intervention description(s): TWO GROUPS CONTROL ND EXPERIMENTAL
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups control and experimental included
Masking: Single (Care Provider)
Primary purpose: Other
Partner-Specific HIV Risk Reduction Intervention for Drug-Using Adolescents
Condition: Sexually Transmitted Diseases; Substance-Related Disorders
MeSH terms: Sexually Transmitted Diseases; Substance-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to develop and pilot test a partner-specific HIV risk reduction
      intervention for currently or recently incarcerated adolescents who report problematic
      substance use.
    

Detailed description: 
      Incarcerated adolescents represent a group at high risk for health consequences associated
      with risky sexual behaviors. Condom use is more common with non-main than main sex partners
      and substance use in conjunction with sexual risk also appears to vary by partner type. The
      research team will conduct a small randomized trial to pilot test a partner-specific HIV risk
      reduction intervention for currently or recently incarcerated adolescents who report
      problematic substance use. Participants will be randomized to a 5 session HIV risk reduction
      group intervention based on the Information-Motivation-Behavioral Skills model, or a 5
      session healthy lifestyles psychoeducation intervention, and then reassessed 3 months after
      their access to the general community is reinstated. The main hypothesis is that participants
      in the HIV risk reduction intervention condition will have lower levels of sex-related HIV
      risk behavior and of substance use in conjunction with sexual risk, relative to those in a
      healthy lifestyles psychoeducation intervention.
    

Intervention name(s): Partner-Specific IMB-based HIV risk reduction intervention; Healthy Lifestyle
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 5 session partner-specific HIV risk reduction group intervention based on the Information-Motivation-Behavioral Skills model.; 5 session psychoeducational group, designed to provide equivalent time and attention, that focuses on the importance of maintaining a good diet, exercise, and developing health skills.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Adolescent; Adolescent behavior; Health behavior; Sexual Behavior; Incarceration; Behavioral Intervention; Risk Reduction Behavior
Plasma Disc Decompression Versus Conservative Care
Condition: Decompression, Surgical
Study type: Interventional

Summary: 
      The purpose of this study is to compare the plasma disc decompression (PDD) procedure to
      conservative care (physiotherapy) for the treatment of patients with radicular pain
      originating from a disc protrusion. Treatment efficacy and rate of improvement is evaluated
      at 8 weeks after treatment start and followed-up for 1 year after treatment start.
    


Intervention name(s): Plasma Disc Decompression/Nucleoplasty; Conservative Care (physiotherapy)
Intervention type(s): Procedure; Procedure
Intervention description(s): Subjects assigned to the PDD Group will be scheduled to receive the plasma disc decompression procedure using the Coblation® method.
Similarly to in Conservative Care group, subjects will be followed-up at 2, 8 weeks, 6 and 12 months (calculated from the date of the PDD procedure). The follow-up visits will consist of a brief physical examination in the clinic and completion of study questionnaires.; Subjects assigned to the Conservative Care Group will be scheduled to receive physical therapy according to standard and customary care locally.
Subjects will be followed-up at 2, 8 weeks, 6 and 12 months . (Calculated from the time of first going through the individual training programme).The follow-up visits will consist of a brief physical examination in the clinic and completion of study questionnaires.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevention of Obesity at Universities: A Randomized Trial
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This is a nutrition and behavior-based intervention conducted at Drexel University and the
      University of Pennsylvania with college women during their freshman year. It involves
      attending groups where life skills and eating behaviors are taught to help them control their
      weight and physical health.
    


Intervention name(s): Healthy Eating Behaviors Training
Intervention type(s): Behavioral
Intervention description(s): The intervention group (other group is a control without any intervention) involves 6 one-hour group sessions teaching healthy eating habits and weight gain prevention tools.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Determining the Glycemic Effects of Sunflower Pasta
Condition: Potential Abnormality of Glucose Tolerance; Appetitive Behavior
MeSH terms: Congenital Abnormalities
Study type: Interventional

Summary: 
      This study investigated the effects of five types of pasta on the glycemic responses
    

Detailed description: 
      This study aimed to 1.determine the glycemic index and glycemic load of five types of pasta
      (tagliatella control, 5% sunflower tagliatella, 16% sunflower tagliatella, 16% sunflower
      penne and 16% sunflower fusilli) and 2. investigate the effects of these pasta types on
      postprandial glycemic responses in healthy subjects
    

Intervention name(s): Glucose as reference food; Tagliatella control; 5% sunflower tagliatella; 16% sunflower tagliatella; 16% sunflower penne; 16% sunflower fusilli
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Fifteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g glucose diluted in 300ml water, tested three times, in different visits, within 5-10min. Fingertip capillary blood glucose samples and measurements from continuous glucose monitoring system were taken at baseline, 15, 30, 45, 60, 90 and 120 min.; Fifteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from tagliatella control, tested once, in different visits, within 10min. Fingertip capillary blood glucose samples and measurements from continuous glucose monitoring system were taken at baseline, 15, 30, 45, 60, 90 and 120 min.; Fifteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from 5% sunflower tagliatella, tested once, in different visits, within 10min. Fingertip capillary blood glucose samples and measurements from continuous glucose monitoring system were taken at baseline, 15, 30, 45, 60, 90 and 120 min.; Fifteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from 16% sunflower tagliatella, tested once, in different visits, within 10min. Fingertip capillary blood glucose samples and measurements from continuous glucose monitoring system were taken at baseline, 15, 30, 45, 60, 90 and 120 min.; Fifteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from 16% sunflower penne, tested once, in different visits, within 10min. Fingertip capillary blood glucose samples and samples from continuous glucose monitoring system were taken at baseline, 15, 30, 45, 60, 90 and 120 min.; Fifteen healthy, normal weight subjects after 10-14 hours fast, consumed 50g available carbohydrates from 16% sunflower fusilli, tested once, in different visits, within 10min. Fingertip capillary blood glucose samples and measurements from continuous glucose monitoring system were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: blood glucose; pasta; glycemic index; glycemic load
Bioclinical Profile of Adenotonsillar Hypertrophy in the Pediatric Population
Condition: Enlargement of Tonsil or Adenoid
MeSH terms: Hypertrophy
Study type: Observational

Summary: 
      Adenotonsillar hypertrophy is the principal cause of obstructive sleep apnea of childhood,
      yet little is known with regard to its pathophysiologic and molecular mechanisms. The present
      trial examines potential bioclinical markers of the disease.
    

Detailed description: 
      Background: Tonsils and adenoids comprise the main bulk of Waldeyer's ring, which is commonly
      enlarged in childhood, until the age of 11. Obstructive sleep apnea caused by adenotonsillar
      hypertrophy is a major contributing factor to cardiorespiratory morbidity in the pediatric
      population. It is also responsible for otitis media with effusion, the most frequent cause of
      children's hearing loss. Even so, there is scarce knowledge of its molecular pathogenesis.

      Objective: Identification of clinical/molecular markers of adenotonsillar enlargement and
      investigation of their participation in the process of tissue hypertrophy.

      Methods: A prospective cohort of children with adenotonsillar hypertrophy were recruited
      starting on 02/01/2017 and ending on 12/22/2017. Demographic and clinical data including age,
      gender, sleep apnea severity, tonsillar size, presence of middle ear effusion, family
      history, review of systems as well as tympanometric and complete blood count results were
      recorded. Blood samples and tissue specimens from the therapeutic adenotonsillectomy
      procedure were archived for future analyses. Children with chronic tonsillitis and/or
      adenoiditis, who also underwent excision of tonsils and/or adenoids served as study controls.
      Informed consent was obtained from parents of all study participants.
    

Intervention name(s): Complete Blood Count; Tympanometry; Tonsillectomy and/or adenoidectomy
Intervention type(s): Diagnostic Test; Diagnostic Test; Procedure
Intervention description(s): White blood cell subgroups count; Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance; Excision of palatine and/or pharyngeal tonsils.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All children presenting to the clinics of a Pediatric hospital.
      
Biospecimen description: 
      Blood was centrifuged and cells were separated from supernatants. Both were stored at -80
      degrees.

      Palatine and pharyngeal tonsillar tissue specimens were divided in half. One part was fixated
      in 4% formaldehyde for 24 hours and then stored in saline at 4 degrees. The other part was
      stored immediately at -80 degrees.
    
Keywords: obstructive sleep apnea; tonsillitis; middle ear effusion; pathophysiology; score
Cognitive Effects of Immunomodulatory Drugs in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The purpose of this study is to examine and compare changes in the specific thinking skills
      of patients with RRMS who are receiving treatment with one of three immunomodulatory
      medications (Avonex, Copaxone, or Rebif).
    

Detailed description: 
      In addition this study will compare the patients' personal view of how they are doing, any
      changes in physical disability, and the frequency and severity of relapses over the three
      year period.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Multiple sclerosis clinic
A Study of Aripiprazole in Patients With Bipolar I Disorder With a Major Depressive Episode
Condition: Bipolar I Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate several doses of aripiprazole in patients with
      bipolar depression.
    


Intervention name(s): Aripiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, Oral, 10mg (2 5mg tablets), Once daily, 8 weeks.; Tablets, Oral, 0 mg, Once daily, 8 weeks.
Other intervention name(s): Abilify
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: depressed
MI-BP: mHealth to Improve Blood Pressure Control
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This study seeks to evaluate a multicomponent mobile intervention to change multiple
      hypertension-related health behaviors in minorities and the underserved with uncontrolled
      hypertension. Half of the participants will receive a mobile intervention designed to improve
      physical activity, sodium intake, and medication adherence. The other half will receive usual
      care.
    


Intervention name(s): MI-BP
Intervention type(s): Other
Intervention description(s): MI-BP includes the following components: 1) Home blood pressure monitoring 2) Physical activity monitoring 3) Sodium intake self-monitoring 4) Physical activity and sodium intake goal setting 5) Educational messaging via push notification and in-app messaging 6) motivational messaging 7) tailored messaging relevant to individual participants and 8) medication reminders.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; mHealth