bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Participant Responses to Educational Counseling About Different Combined Hormonal Contraceptive Choices (P06557)
Condition: Contraception
Study type: Observational

Summary: 
      Physicians counsel women participants who are candidates for hormonal contraception about
      available combined hormonal contraceptive methods (the combined pill, the contraceptive
      vaginal ring [i.e., the etonogestrel + ethinylestradiol vaginal ring] and the contraceptive
      transdermal patch). Effects of this counseling on women's contraceptive use decisions are to
      be evaluated by 1) recording which method is chosen after information is provided about all
      three available combined hormonal methods, 2) comparing the final chosen contraceptive method
      used by a participant after counseling with the method originally intended to be used by that
      participant before the counseling, and 3) evaluating the criteria used by women participants
      to choose their contraceptive method after the counseling, including evaluation of social and
      demographic predictors of contraceptive choice. The differences among participants in the
      number of contacts made by the participants to physician offices for purposes of obtaining
      information regarding the use of their final chosen hormonal contraceptive (e.g., requests
      for clarification, questions, expressing doubt or reservations for using the method, or
      requests for other help/advisement by the physician) will also be evaluated over four months
      following the physician counseling.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy women ≥ 18 years of age and < 40 years of age who consult their physician for
        information on contraception choices
      
Keywords: hormonal contraceptive methods; combined hormonal contraceptive methods; physician counseling
R-21 Colorectal Cancer Screening (CRCS) Pilot Trial
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      The goal of this study is to test patient education program for decision making about
      colorectal cancer (CRC) screening in community health centers.
    

Detailed description: 
      Baseline Visit:

      If you agree to take part in this study, you will complete a questionnaire that asks
      demographic questions (such as your age and sex) and questions about colorectal cancer. It
      should take about 10-15 minutes to complete.

      You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups. If you are in
      Group 1, you will view a colorectal cancer program. If you are in Group 2, you watch a
      program on Essential Hypertension.

      You will watch the program on a laptop in the clinic. The program is about 30 minutes long.
      After you watch the program, you will complete a questionnaire that asks what you thought
      about the program and some questions about understanding medical information. It should take
      about 5-10 minutes to complete the questionnaire.

      You will be called 1-3 weeks after your baseline visit to complete a questionnaire by phone.
      The call should last about 20-25 minutes. You will be asked if you discussed colorectal
      cancer screening tests with your doctor, your preferences for colorectal cancer screening
      tests, and if any colorectal cancer screening tests were ordered.

      At Month 3, your medical record will be reviewed by the study staff.

      Length of Study:

      You will be off study after your medical record is reviewed at Month 3.

      This is an investigational study.

      Up to 180 participants (90 Hispanic and 90 African-American) will take part in this study.
      All participants will be enrolled from the Harris County Hospital District and Kelsey-Seybold
      outpatient clinics.
    

Intervention name(s): CRCS patient decision aid (PtDA) video; Questionnaires; Essential Hypertension video
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participant views PtDA program video in same room as research assistant who offers instruction as needed.; Up to 3 questionnaires (baseline demographics, post-intervention evaluation, and follow up) taking from 5 to 25 minutes to complete each.; Participant views Essential Hypertension video in same room as research assistant who offers instruction as needed.
Other intervention name(s): survey
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Colorectal Neoplasms; Promoting Health Literacy; Patient education program; Colorectal Cancer Screening; CRCS; Patient decision aid; PtDA; Video; Questionnaires; Surveys
Effect of Spontaneous Breathing on Atelectasis During Induction of General Anesthesia in Patients in Infants
Condition: Atelectasis
MeSH terms: Pulmonary Atelectasis
Study type: Interventional

Summary: 
      spontaneous breathing on occurrence of atelectsis in infants
    

Detailed description: 
      Keeping the spontaneous breathing during the anesthesia for 5 minutes and occurrence of
      atelectasis
    

Intervention name(s): spontaneous breathing
Intervention type(s): Other
Intervention description(s): spontaneous breathing during induction of anesthesia in infants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
A Study to Evaluate the Absorption, Metabolism, and Excretion and Absolute Bioavailability of Xevinapant in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine absorption, metabolism, and excretion of a single
      oral dose of [14C]-xevinapant. This information will enable assessment of absorption and
      clearance mechanisms of [14C]-xevinapant as well as identify metabolites. In addition, the
      study will allow to determine absolute bioavailability of xevinapant and understand its
      intravenous pharmacokinetics.
    


Intervention name(s): Radiolabelled Xevinapant 200 mg (Oral Solution); Radiolabelled Xevinapant 100 μg (IV Solution); Xevinapant 200 mg (Oral Solution)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): [14C]-Xevinapant 200 mg administered as an oral solution on Day 1 of Part 1, containing approximately 100 microcurie (μCi) [3.7 megabecquerel (MBq)] in fasted conditions.; 100 μg [14C]-xevinapant single dose administered as an IV bolus on Day 1, containing approximately 0.2 μCi [7.4 kilobecquerel (kBq)].; Xevinapant 200 mg administered as an oral solution on Day 1 of Part 2 in fasted conditions
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Xevinapant; Absorption, Distribution, Metabolism and Excretion (ADME); Mass balance; Absolute bioavailability
Clinical Trial Comparing the Efficacy and Safety of DA-3803 and Ovidrel
Condition: Hyperovulation Induction for Assisted Reproduction Treatment
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy and safety of DA-3803(r-hCG) and Ovidrel
      for inducting final follicular maturation and early luteinization in women undergoing
      ovulation induction for assisted reproduction treatment
    

Detailed description: 
      This is an single-blind, randomized, comparative multicentric, phase III study to evaluate
      the safety and efficacy of DA-3803(r-hCG) in comparison with Ovidrel in the induction of
      final follicle maturation and early luteinization in 180 Korean female subjects undergoing
      superovulation. The study is organized on an outpatient basis in subjects undergoing assisted
      reproductive technologies (ART). The subjects are randomized into 2 groups. One group receive
      DA-3803(r-hCG) 250mcg and the other group receive Ovidrel®(r-hCG)250mcg. Each subject in both
      groups receives a single injection of hCG when the follicular development was judged to be
      adequate. Oocytes are retrieved 34-38 hours after r-hCG injection and fertilized in vitro.
      Not more than 4 embryos are to be replaced. Progesterone is administered daily according to
      center's normal practice, starting after the oocyte pick up and continuing until appropriate
      time. The subject is followed up and the treatment outcome (negative pregnancy test or
      pregnancy) is recorded.
    

Intervention name(s): r-hCG
Intervention type(s): Drug
Intervention description(s): r-hCG(250mcg) injection subcutaneously
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Impact of Telephone and Short Message System Based Education on Bowel Preparation for Colonoscopy
Condition: Bowel Preparation
Study type: Interventional
Phase: Phase 3

Summary: 
      Inadequate bowel preparation results in decreased rates of cecal intubation, increased rates
      of missing important lesions, increased patient discomfort, higher risk of complications,
      prolonged procedure time and increased health-care cost. Recent study reported that
      Telephone-based re-education (TRE) on the day before colonoscopy significantly improved the
      quality of bowel preparation and polyp detection rate. However, there is no study to compare
      the effect of telephone with short message system (SMS) based re-education on the quality of
      bowel preparation in health screened population. Our goal is to improve the quality of bowel
      preparation with telephone or SMS based re-education for outpatients undergoing screening
      colonoscopies. The investigators hypothesise that efforts to improve education and maximise
      patient compliance during the preparatory period will enhance the efficacy of bowel
      preparation.
    


Intervention name(s): Telephone based re-education; Short message system based re-education
Intervention type(s): Other; Other
Intervention description(s): The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as telephone based re-education by one investigator on the day before colonoscopy.; The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as short message system based re-education by one investigator on the day before colonoscopy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Bowel preparation
Arterial Inflammation and E-Cigarettes
Condition: Arterial Inflammation
MeSH terms: Arteritis; Inflammation
Study type: Interventional

Summary: 
      Arterial inflammation will be compared using PET scanning in 3 groups: 1) Non-smokers, 2)
      Tobacco cigarette smokers, 3) Electronic cigarette users.
    

Detailed description: 
      Qualified participants will undergo a singe PET/CT to detect arterial inflammation.
    

Intervention name(s): No drug or device, only a test. The test is called a PET/CT
Intervention type(s): Other
Intervention description(s): A single PET/CT scan will be performed
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: arterial inflammation; electronic cigarettes; PET scan
A Study of Probiotics in IBS Subjects
Condition: IBS
Study type: Interventional

Summary: 
      For the current study, the primary outcome is to evaluate the effect of IP on abdominal pain.

      The secondary outcome is to assess the effect of IP on IBS-Symptom Severity, IBS-related
      quality of life, stool form and consistency and on mental status.

      Thus providing an effective objective in improving the gut health and symptomatic relief in
      IBS patients.
    

Detailed description: 
      This study aims to determine the effect of probiotics, as the investigational products (IPs)
      in subjects satisfying the Rome IV criteria for IBS. Three hundred and sixty six subjects
      between 18 to 70 years of age and with a positive diagnosis of Rome IV IBS criteria (IBS-C,
      D, M and U types) and moderate to severe abdominal pain intensity will be recruited in a
      multi-center, double-blind, parallel group, placebo-controlled randomized trial.
    

Intervention name(s): Probiotic 1; Probiotic 2; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): The product under investigation is a unique probiotic.; The product under investigation is a unique probiotic.; Microcrystalline Cellulose
Other intervention name(s): Bifidobacterium lactis; Lactobacillus acidophilus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Study in Patients Suffering From Heartburn and Backward Flow of Stomach Liquid Into the Esophagus
Condition: Functional Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study researchers want to learn more about the effectiveness of Iberogast® in
      patients with irritable stomach and concomitant chronic or recurrent heartburn and backward
      flow of stomach liquid into the esophagus. 60 patients in the age range from 18 - 80 year
      will be treated over 4 weeks with Iberogast® or placebo - an inactive substance which looks
      identical to Iberogast®. Patients completed diaries will provide researchers with detailed
      information on the change of stomach and intestinal symptoms during the treatment period. In
      addition information on the acidity of the esophagus and stomach liquid will be collected.
    


Intervention name(s): STW5 (Iberogast®, BAY98-7411); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The medication was applied daily per os (orally, p.o.) from day 0 to day 28. The dosage was 20 drops three times daily before the meals.; The medication was applied daily p.o. from day 0 to day 28. The dosage was 20 drops three times daily before the meals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Levetiracetam in Post-Traumatic Stress Disorder
Condition: Post-Traumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the short-term efficacy and safety of levetiracetam
      in post-traumatic stress disorder (PTSD) and to evaluate continuation effects of
      levetiracetam in preventing PTSD relapse. The hypothesis is that levetiracetam will be safe
      and effective in preventing relapse of PTSD.
    

Detailed description: 
      This is an investigator-initiated, single site study, consisting of two phases: 8 weeks of
      open label treatment with levetiracetam (500-2000 mg/day) in patients with PTSD, and in those
      who demonstrate at least minimal improvement, 12 weeks of randomized, double-blind treatment
      with either levetiracetam or matching placebo.
    

Intervention name(s): levetiracetam; Placebo; Levetriracetam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, dosage 500 mg each ( 1-6 tablets/day)for20 wks; Placebo, Tablets, no active ingredient in the tablets, (1-6tablets/day)for 12 wks in the 2nd phase of the study.; Tablets, 500 mg each (1-6 tablets/day) for 8 wks during the open label phase and for 12 wks during the 2nd phase of the study.
Other intervention name(s): Keppra; Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PTSD; Anxiety; Pharmacotherapy; Levetiracetam; Relapse prevention
Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Moderate to Severe Nasolabial Folds
Condition: Correction of Moderate to Severe Nasolabial Folds (NLFs)
Study type: Interventional

Summary: 
      Effectiveness: The purpose of this study is to demonstrate the non-inferiority of Radiesse
      (CaHA) to Restylane (HA) following subdermal implantation for the correction of moderate to
      severe facial wrinkles and folds, such as NLFs.

      Safety: To evaluate the incidence and type of adverse events and serious adverse events.
    


Intervention name(s): Radiesse injectable implant (dermal filler); Restylane injectable implant (dermal filler)
Intervention type(s): Device; Device
Intervention description(s): Subdermal injection.; Subdermal injection.
Other intervention name(s): Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.; Hyaluronic acid
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Split-face
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Ritodrine in Oral Maintenance of Tocolysis After Active Preterm Labor
Condition: Pregnancy
MeSH terms: Obstetric Labor, Premature
Study type: Interventional

Summary: 
      This is a trial comparing the efficacy of oral ritodrine in the form of sustained release
      capsules for the maintenance of uterine quiescence after successfully treated episode of
      threatened preterm labor.
    

Detailed description: 
      We randomized 120 women with singleton pregnancy who were successfully treated for threatened
      preterm labor before 34 completed weeks to receive either maintenance tocolysis with two 40
      mg ritodrine sustained release capsules three times a day (study group, n=62) or no treatment
      (control group, n=58) for three days. The primary outcome measure was the recurrent episode
      of threatened preterm labor within 72 hours, which was defined as regular palpable uterine
      contractions and change in cervical effacement and/or cervical dilatation on clinical
      examination. Secondary outcome measures included the incidence of preterm birth, neonatal
      adverse outcomes, and maternal side effects.
    

Intervention name(s): efficacy of oral ritodrine in maintaining uterine quiescence
Intervention type(s): Drug
Intervention MeSH terms: Ritodrine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pre term labor; therapy; maintenance
Multiple-Dose Pharmacokinetics (PK), and Pharmacodynamic (PD) Effect of NSI-189 Phosphate in Depression Patient Subjects
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Escalation in depressed
      human subjects study.
    


Intervention name(s): NSI-189 Phosphate; microcrystalline cellulose capsules
Intervention type(s): Drug; Drug
Intervention description(s): The first cohort will be administered 40 mg once daily (q.d). The second cohort will be administered 40 mg twice daily (b.i.d). The third cohort will be administered 40 mg three times daily (t.i.d).; The first cohort will be administered 40 mg once daily (q.d). The second cohort will be administered 40 mg twice daily (b.i.d). The third cohort will be administered 40 mg three times daily (t.i.d).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Neurogenesis; hippocampal stem cells; depression; stroke
Acute Consumption of Pecan-enriched Meal
Condition: Healthy
Study type: Interventional

Summary: 
      Pecans are a nutrient-dense food, but it is unknown whether substituting pecans for a portion
      of the butter in a traditional breakfast meal improves post-meal responses.
    

Detailed description: 
      This study was a randomized, double-blind control trial consisting of 2 study visits for 2
      different treatments. The treatments were high-fat breakfast muffins containing either butter
      (control) or pecans. The investigators recruited healthy, normal-weight adults between the
      ages of 15 and 45y. Study visits were completed in a random order with at least 72 hours
      between each visit. Anthropometrics, questionnaires, and fasting and postprandial blood
      samples were collected at each visit.

      Hypothesis: The pecan-enriched meal will blunt the post-meal increase in glucose, insulin,
      triglycerides (TG), and lipid peroxidation while improving all measures of subjective
      appetite and TAC compared to the traditional meal without nuts.
    

Intervention name(s): Control; Pecan
Intervention type(s): Other; Other
Intervention description(s): Participants in this group received a traditional muffin with butter as the predominant source of fat.; Participants in this group received a muffin in which part of the butter was substituted out for pecans.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other