bioihbjkbjnl/mcl2 huggingface dataset:
Cariprazine: Comparison of Slow- and Immediate-release Forms
Condition: Pharmacokinetic Profile
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators are doing this study to compare blood levels and side effects of
      cariprazine when it's taken as one of two 'slow release' tablets, or as an 'immediate
      release' capsule. The investigators will also find out if food affects the absorption of
      cariprazine into the bloodstream after a 'slow release' tablet.
    

Detailed description: 
      Comparison of blood levels and side effects of cariprazine when it's taken as one of two
      'slow release' tablets, or as an 'immediate release' capsule. We'll also find out if food
      affects the absorption of cariprazine into the bloodstream after a 'slow release' tablet.
    

Intervention name(s): Cariprazine prolonged release tablet A; Cariprazine prolonged release tablet B; Cariprazine capsule; Cariprazine PR tablet A; Cariprazine PR tablet B
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Cariprazine prolonged release tablet A - fasted; Cariprazine prolonged release tablet B - fasted; Cariprazine capsule - fasted; Cariprazine Prolonged Release tablet A - fed; Cariprazine Prolonged Release tablet B - fed
Intervention MeSH terms: Cariprazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Semi-recumbent Position on Treatment of Shoulder Pain Seen After Laparoscopic Cholecystectomy
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional

Summary: 
      This study was carried out to determine the effect of placing the semi-recumbent position in
      reducing pain in patients who developed shoulder pain after laparoscopic cholecystectomy.

      HO: The application of the semi-recumbent position to patients who develop shoulder pain
      after laparoscopic cholecystectomy has no effect on reducing pain.

      H1: The application of semi-recumbent position in patients who develop shoulder pain after
      laparoscopic cholecystectomy has an effect on reducing pain.
    

Detailed description: 
      In addition to pharmacological interventions for the relief of postoperative complications
      such as pain in patients undergoing laparoscopic cholecystectomy, non-pharmacological
      applications; It is evaluated that it will be beneficial in increasing patient satisfaction,
      reducing the need for analgesic drugs, reducing the cost of hospitalization due to the side
      effects of drugs and increasing the quality of care. With the results of this research, it is
      evaluated that the effect of positioning, which is one of the independent activities of
      nurses who base their care on evidence-based practices, on pain will be beneficial to
      increase the evidence-based nursing knowledge in the literature.
    

Intervention name(s): Positioning the patient
Intervention type(s): Other
Intervention description(s): The patients' vital signs, pain and analgesic drug use were recorded in the "Pain Follow-up Form" at the time they came to the clinic, at the 6th and 12th hours after the surgery, by recording from the end-of-operation file. In case the patient had pain, the time when the pain started was recorded, the experimental group was given the semi-recumbent position with analgesic drug and the patient was asked to maintain this position for 2 hours. If the patient has pain again, this position is given again. "Patient Satisfaction Evaluation Form" was filled in at the 12th hour after the surgery for the patients in the experimental group.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: The type of this study is a quasi-experimental clinical study.
Masking: None (Open Label)
Primary purpose: Other
Keywords: laparoscopic cholecystectomy; shoulder pain; semi-recumbent position; pain
Safety and Effectiveness of Two Doses of ABT-874 as Compared to Placebo in Subjects With Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the trial is to study the safety and effectiveness of ABT-874 administered
      weekly or every other week in patients with relapsing remitting and secondary progressive
      multiple sclerosis as compared to placebo. Effectiveness will be measured based on MRI scans
      done periodically throughout the study.
    

Detailed description: 
      This study was done in subjects with relapsing remitting MS or secondary progressive MS with
      the objective of assessing the safety and efficacy of 200 mg of ABT-874 weekly or QOW versus
      placebo. There were 3 phases to the study, 24 week double blind followed by 24 weeks of an
      active extension, followed by 48 weeks of double blind active extension. The trial was
      discontinued by Abbott in Aug 2006.
    

Intervention name(s): ABT-874/Human monoclonal antibody against IL-12; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Antitussive Effects of FP01 Lozenges in Subjects With Cough Due to Upper Respiratory Tract Infection
Condition: Acute Cough
MeSH terms: Respiratory Tract Infections; Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to learn how effective and safe FP01 lozenges are when
      given to subjects with a cough due to an upper respiratory tract infection. The study will
      include subjects who have an upper respiratory tract infection, with a cough of less than six
      weeks duration.
    


Intervention name(s): FP01
Intervention type(s): Drug
Intervention description(s): Lozenge 3 times per day, low dose, high dose, or placebo for 48 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Lifestyle-modification Induced Weight Loss on Sexual and Urinary Function, and Quality of Life in Obese Men
Condition: Sexual Dysfunction; Endothelial Dysfunction; Quality of Life; Inflammation
MeSH terms: Inflammation; Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to evaluate the extent to which weight loss of 5-10% from baseline, induced
      by exercise and diet, improves metabolic and inflammatory profile, endothelial function,
      erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in
      obese men.
    

Detailed description: 
      This study aims to evaluate the extent to which weight loss of 5-10% from baseline, induced
      by exercise and diet, improves metabolic and inflammatory profile, endothelial function,
      erectile function, sexual desire, lower urinary tract symptoms (LUTS), and quality of life in
      obese men.Men aged 30-65 years, with body mass index (BMI) ≥ 27.5 kg/m2, will be recruited
      from referrals to the Sports Medicine Centre in Changi General Hospital. The study will be
      conducted at the Sports Medicine Centre by trained medical investigators, dieticians and
      sports trainers.At baseline, 12 and 24 weeks, fasting glucose and lipids, insulin,
      testosterone, sex-hormone binding globulin, serum C-reactive protein and interleukin-6 are
      measured, endothelial function is measured by the non-invasive EndoPAT method, and validated
      questionnaires administered to assess changes in erectile function, sexual desire, LUTS and
      quality of life
    

Intervention name(s): Exercise and diet
Intervention type(s): Behavioral
Intervention description(s): 24 weeks of exercise and diet counselling
Other intervention name(s): Diet advice; Exercise training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: obesity; men; sexual function; urinary tract symptoms; endothelial function; inflammation; quality of life
PK And Safety Study Of PF-04171327 In Healthy Japanese And Western Subjects In Fasting And Fed Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study is the first clinical trial in Japanese subjects. This study is designed
      to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of
      PF-04171327 oral tablet in healthy adult Japanese and Western subjects in fasting and fed
      conditions.
    


Intervention name(s): PF-04171327; PF-04171327; PF-04171327; Placebo; PF-04171327; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral single 5 mg dose as one 5 mg tablet; Oral single 10 mg dose as one 10 mg tablet; Oral single 30 mg dose as three 10 mg tablets; Oral single dose as matching placebo; Oral multiple 20 mg doses as two 10 mg tablets for 12 days; Oral multiple doses as matching placebo for 12 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Phase 1; Pharmacokinetics; food effect; Healthy Japanese; rheumatoid arthritis
Study of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia
Condition: Gout; Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, 3-period 3-treatment crossover followed by a 2-period
      2-treatment crossover, phase 2 study in patients with documented hyperuricemia to evaluate
      the effect of tranilast on allopurinol pharmacokinetics (PK) and pharmacodynamics (PD) and to
      evaluate the effect of allopurinol on tranilast PK and PD as measured by reduction in serum
      uric acid levels.
    


Intervention name(s): Tranilast; Allopurinol; Combination - Tranilast and Allopurinol; 400 mg Allopurinol; High dose combination
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tranilast tablets, 300 mg, QD; Allopurinol tablets 300 mg, QD; Tranilast, 300 mg QD; Allopurinol 300 mg QD; 400 mg Allopurinol administered once daily for 7 days; Combination of Tranilast 300 mg once daily for 7 days plus Allopurinol 400 mg once daily for 7 days
Intervention MeSH terms: Tranilast; Allopurinol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Gout; Hyperuricemia
PREMIUM Migraine Trial
Condition: Migraine Headaches; Patent Foramen Ovale
MeSH terms: Migraine Disorders; Foramen Ovale, Patent; Headache
Study type: Interventional

Summary: 
      The Purpose of this study is to evaluate the impact of percutaneous closure of a patent
      foramen ovale (PFO) (a hole in the heart), using the AMPLATZER PFO Occluder, on the incidence
      of migraine headaches.
    

Detailed description: 
      The objective of this study is to evaluate whether percutaneous PFO closure is effective in
      reducing the incidence of disabling migraine headaches in patients who are refactory to
      medical treatment.
    

Intervention name(s): Sham Procedure; AMPLATZER PFO Occluder
Intervention type(s): Other; Device
Intervention description(s): Will not receive the closure device, and will be treated with the current standard of care medical treatment. Will undergo Intracardiac Echo (ICE) in cardiac catheterization lab and simulate PFO closure procedure (sham procedure). Participants completing 1 year follow-up are eligible for PFO closure with the AMPLATZER PFO Occluder.; Patients in this arm will receive the AMPLATZER PFO Occluder device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; PFO; Migraine Headache; patent foramen ovale
Single Dose Escalations Study of Amphotericin B Colloidal Dispersion In Healthy Subjects in China
Condition: Invasive Fungal Disease
MeSH terms: Mycoses; Invasive Fungal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to evaluate the pharmacokinetics of single intravenous of
      Amphotericin B Colloidal Dispersion(ABCD)in Chinese healthy subjects.
    

Detailed description: 
      Primary Objective: Evaluation the pharmacokinetics, safety and tolerability of single
      intravenous of ABCD in Chinese healthy subjects.

      Secondary Objective: Evaluation the safety and tolerability of single intravenous of ABCD in
      Chinese healthy subjects.

      Exploratory Objective:Evaluation the effect of single intravenous ABCD on early renal injury
      indicators (KIM-1 and cystatin C) in Chinese healthy subjects.
    

Intervention name(s): ABCD
Intervention type(s): Drug
Intervention description(s): Intravenous infusion of dexamethasone 5mg before ABCD intravenous administration; Single infusion.
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilates and the Pelvic Floor: A Quasi-experimental Study
Condition: Pregnancy; Perineum; Injury; Pilates Method; Episiotomy Wound
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      In this paper, it is postulates that in pregnant women, the practice of PM led by a qualified
      professional for a period of four weeks can reduce the incidence of pelvic floor dysfunction
      (PFD) by decreasing the number of birth injuries.
    

Detailed description: 
      It is postulated that in pregnang women, the practice of PM can reduce the severity of birth
      injuries.

      Our main objective was to determine the effectiveness of a PM program to reduce the incidence
      and degree of intrapartum perineal injuries as a way to reduce the incidence of female PFD.

      Secondary objectives were:

      Assess the role of a MP program on the systolic and diastolic blood pressure. Determine the
      effect of a MP program on body weight (BMI).

      It is a parallel group clinical trial with an allocation ratio of 1:2.

      All pregnant women will be informed about the nature of the clinical trial. There will be no
      differences in the pregnant´s follow-up because it will be performed by two same Pilates
      monitor with the same formation.

      Once the pregnant women is assigned to an arm of the study, those assigned to the
      intervention group will be sent to the Pilates monitor to explain and initiate the exercise
      of MP program while the control group will be informed to maintain their usual monitoring of
      pregnancy.

      In the initial visit, the type of physical activity will be evaluated by filling in the
      international physical activity questionnaire (IPAQ).
    

Intervention name(s): PILATES METHOD
Intervention type(s): Other
Intervention description(s): It is intended that the Pilates program have a duration of four weeks and its realization does not suppose an excessive consumption of resources. Therefore, it must have a series of characteristics: low supervision and easily realizable by all patients, which implies flexibility in the schedule. In this sense the sessions of Pilates is adjusted to these assumptions and the Pilates monitor offers several schedules on diferent days of week.
The pregnant women assigned to the intervention group will be supervised by the midwifery of reference and trained by a Pilates monitor who will explain the training program and resolve the doubts raised by the women.
The therapeutic control will be carried out by telephone call and clinical history review between the eighth and tenth day.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The professionals who assessed the progress of labor in the delivery room and completed the medical history did not know whether the woman belonged to the intervention or the control group.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Nursing; Midwifery; Nurse; Pilates Method; Pelvic floor; Injuries; Episiotomy; Pregnancy
Investigation of the Pharmacokinetics of NNC172-2021, at Two Different Dose Levels, in Healthy Japanese Subjects
Condition: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B; Healthy
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the
      pharmacokinetics (how the trial drug is distributed in the body) of NNC172-2021 administered
      subcutaneously, at two different dose levels, in healthy Japanese subjects.
    


Intervention name(s): NNC172-2021; placebo
Intervention type(s): Drug; Drug
Intervention description(s): One injection administered subcutaneously (s.c., under the skin). Injection of maximum 1.2 mL; One injection administered subcutaneously (s.c., under the skin)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Peace-Building Interventions for Israeli and Palestinian Youth
Condition: Healthy
Study type: Interventional

Summary: 
      The investigators expect an intervention that focuses on actual dialogue and familiarity with
      members of the other culture, discussion of empathy, generosity, and kindness, and focus on
      adaptive and reciprocal modes of conflict resolution will alter both physiological,
      behavioral, and mental response to the pain of the other, increase empathy, and reduce
      hostility.
    

Detailed description: 
      We hypothesized that the intervention will impact perspective taking (PT) on the national
      conflict, reducing the tendency to view justice only on one's side. Such increase in PT would
      initiate a chain leading to greater behavioral empathy.

      Second, we hypothesize that change in oxytocin (OT) levels and empathic behavior (less
      withdrawal and tension and more synchrony) would be impacted by the intervention and the
      degree to which it altered youth PT on the conflict.

      Finally, we suggest a 3-path model charting the multi-dimensional pathways leading to
      behavioral empathy toward outgroup member. First, individual differences in OT functionality
      will shape empathy so that youth with higher OT levels at pre-intervention and greater PT
      will show more empathic dialogue at post-intervention. Second, dispositional cognitive
      empathy, as tested by the Interpersonal Reactivity Index questioner (IRI), at
      pre-intervention will predict higher behavioral empathy at T2, both directly and as mediated
      by reduction in ethnocentric attitudes following the intervention. Finally, we hypothesize
      that the intervention will influence empathy by initiating a chain that begins with
      increasing PT, which, in turn, will lead to reduction in tension during interaction with
      outgroup, and culminating in greater empathy during face-to-face encounters
    

Intervention name(s): Peace-Building Intervention Process
Intervention type(s): Behavioral
Intervention description(s): The eight sessions include (1) presentation of the self to others members (2) getting familiar with the other culture (3) what is a conflict - how do conflicts come about, what are adaptive and non-adaptive modes of resolving conflict (4) getting to know the "Other" - preconceived notions about the other side (5) on dialogue- what is dialogue, can dialogue offer means for conflict resolution, what are the benefits of dialogue to inter-cultural and inter-racial conflicts, (6) empathy, generosity, and kindness (7) wrapping up - hopes for the future at the personal and community levels, practical suggestions (8) goodbye and summary - what have we learned ,"gift giving", summary of process by group leaders.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: jewish, arab, israel, teenagers
cTBS/fMRI Study of Hierarchical Control in the PFC
Condition: Transcranial Magnetic Stimulation
Study type: Interventional

Summary: 
      The objective of this study is to examine the effect of transcranial magnetic stimulation
      (TMS) on the prefrontal cortex and posterior parietal cortex.
    

Detailed description: 
      The Comprehensive Control Task (CCT) was designed to examine hierarchical control in a
      single, well-controlled factorial task. On each trial, participants view a letter surrounded
      by a colored shape at a particular screen location. Color cues the relevant feature, letter
      or location, for a block of trials. The first trial of a block requires a decision of whether
      the stimulus is the first position of a circular sequence (sequence start). Subsequent trials
      require a decision of whether the viewed stimulus follows the previous stimulus in a circular
      sequence (sequence 1-back). The letter sequence (C-O-M-I-C) and spatial sequence (Top
      Left-Top Right-Bottom Left-Bottom Right-Top Left) are difficulty-matched.

      Shape cues the task to perform. Squares indicate the standard baseline task, and each block
      begins and ends with baseline trials. Different shapes indicate sub-tasks. In Switching
      blocks, shape-switches (e.g. from square to circle or circle to square) cue the sequence
      start task. Shape-repeats cue the sequence 1-back task. In Planning blocks, triangle shapes
      indicate that the stimulus can be ignored (automatic "no" response). All the while, the last
      square-shaped stimulus must be retained as a reference for the next square-shaped stimulus.
      Finally, in Dual blocks, diamond shapes indicate switching (sequence start) and also
      planning. The reversion back to square shapes requires sequence matching to the distal,
      previous square.

      The design is factorial with stimulus-domain x contextual control x temporal control
      orthogonally manipulated. Full details of the CCT have been previous described in Nee &
      D'Esposito, 2016; 2017.

      The focus in this study will be comparison of FPl-TMS, MFG-TMS, and S1-TMS in an interleaved
      fMRI-TMS-fMRI design. The logic is to test the apical status of the FPl/MFG through the
      extent to which TMS impacts other PFC areas and behavior.

      Each experiment will begin with 1 session of the CCT with fMRI to localize PFC targets. Each
      participant will then perform 3 counter-balanced sessions wherein a different site will be
      targeted by TMS followed immediately by fMRI on the CCT.
    

Intervention name(s): transcranial magnetic stimulation
Intervention type(s): Device
Intervention description(s): Transcranial magnetic stimulation delivered to the scalp targeting specific brain structures via stereotactic guidance.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science