bioihbjkbjnl/mcl2 huggingface dataset:
Study Of An FDA-approved Drug As Additional Therapy In Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a 12-week study for the treatment of chronic persistent symptoms in participants with
      schizophrenia. Participants on a stable, optimal dose of up to two atypical antipsychotics
      who fulfill the screening criteria will be randomized to receive either an FDA-approved drug
      or placebo in addition to the current treatment. Safety will be closely monitored through
      vital signs, various tests, and blood and urine samples.
    


Intervention name(s): lamotrigine
Intervention type(s): Drug
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: adjunctive; atypical antipsychotics; add-on; Schizophrenia; psychosis
A Phase 1/2 Trial of Multiple Oral Doses of OPC-167832 for Uncomplicated Pulmonary Tuberculosis
Condition: Pulmonary TB
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This trial will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of
      multiple oral doses of OPC-167832 in participants with uncomplicated, smear-positive,
      drug-susceptible pulmonary tuberculosis (TB).
    


Intervention name(s): 10 mg OPC-167832; 30 mg OPC-167832; 90 mg OPC-167832; 3 mg OPC-167832; RHEZ; 30 mg OPC-167832 + 300 mg delamanid; 30 mg OPC-167832 + 400 mg BDQ; 30 mg OPC-167832 + 300 mg delamanid + 400 mg BDQ
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Once daily oral dose of 10 mg OPC-167832 from Day 1 through Day 14.; Once daily oral dose of 30 mg OPC-167832 from Day 1 through Day 14.; Once daily oral dose of 90 mg OPC-167832 from Day 1 through Day 14.; Once daily oral dose of 3 mg OPC-167832 from Day 1 through Day 14.; RHEZ was used in both Stage 1 and Stage 2. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 400 mg pyrazinamide, and 275 mg ethambutol. Participants received a single-dose from Day 1 through Day 20. The total number of tablets per day was based on the pretreatment body weight:
Participants weighing 30 to 37 kg received 2 tablets per day
Participants weighing 38 to 54 kg received 3 tablets per day
Participants weighing 55 to 70 kg received 4 tablets per day
Participants weighing > 70 kg received 5 tablets per day; Once daily oral dose of 30 mg OPC-167832 plus 300 mg delamanid from Day 1 through Day 14.; Once daily oral dose of 30 mg OPC-167832 plus 400 mg BDQ from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. The dose of BDQ was 400 mg QD for Days 3 to 14.; Once daily oral dose of 30 mg OPC-167832 plus 300 mg delamanid plus 400 mg BDQ from Day 1 through Day 14. Participants received a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. The dose of BDQ was 400 mg QD for Days 3 to 14.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This will be a multiple-dose trial of OPC-167832 with 2 stages.
Stage 1 is a multiple ascending dose trial planned to be conducted in 4 sequential cohorts of 18 participants each. There will be 2 arms (OPC-167832, combination of rifampicin, isoniazid, ethambutol, and pyrazinamide (RHEZ)) in each cohort.
Stage 2 will be a parallel group comparison of 4 treatment regimens: 1) OPC-167832 plus Delamanid 2) OPC-167832 plus Bedaquiline 3) OPC-167832 plus Delamanid plus Bedaquiline 4) RHEZ.
Masking: None (Open Label)
Primary purpose: Treatment
Dexmedetomidine Combined With Hydromorphone in Tonsillectomy and Adenoidectomy
Condition: Agitated; State, Acute Reaction to Stress
MeSH terms: Stress Disorders, Traumatic, Acute
Study type: Interventional
Phase: Phase 4

Summary: 
      Tonsillectomy and adenoidectomy is one of the most common pediatric surgeries, and agitation
      and severe postoperative pain have been considered a very common complications.
      Dexmedetomidine mainly inhibits the release of norepinephrine by acting on the α-adrenergic
      receptor of the brainstem nucleus, which can produce good sedative effects. Hydromorphone has
      a longer duration of action than fentanyl, and it also has a certain sedative effect. The
      combination of the two is more conducive to the management of postanesthetic agitation and
      pain. This study was to compare the effect of different doses of dexmedetomidine combined
      with hydromorphone in the sedation and analgesia after pediatric tonsillectomy and
      adenoidectomy.
    

Detailed description: 
      The computer generates random numbers to allocate patients into different group. Trained
      research staff who are not involved in the study collect the data. The observer who only
      stayed in PACU was blinded to the allocation and responsible to record the data.

      The primary measurement are pain scores, PAED scores, coughing was evaluated on a 9-point
      scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4
      times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times,
      9= laryngospasm), and extubation time. The secondary measurements are the time to discharge
      from the post-anaesthesia care unit, and the number of postoperative desaturation.

      A sample size of 57 was determined by analysis based on the assumption of the decline of
      extubation time from other similar study and α=0.05,β=0.2.

      The continuous variables were presented as means ± SD and the categorical variables were
      expressed as frequency.

      The outcome of interest is extubation time decline.
    

Intervention name(s): Dexmedetomidine 0.5μg／kg; Dexmedetomidine 1μg／kg
Intervention type(s): Drug; Drug
Intervention description(s): Group A received dexmedetomidine 0.5μg／kg (diluted to 100ml，influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg／kg as a bolus.; Group B received dexmedetomidine 1μg／kg (diluted to 100ml，influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg／kg as a bolus.
Other intervention name(s): Dexmedetomidine Hydrochloride Injection; Dexmedetomidine Hydrochloride Injection
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: dexmedetomidine; hydromophine; tonsillectomy and adenoidectomy
Study of ASP7374, Cell-culture-derived Influenza Vaccine
Condition: Influenza; Vaccine
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare immunogenicity and safety of ASP7374 (cell-culture
      derived influenza vaccine) with those of approved egg-derived trivalent inactivated vaccine
      (TIV) in adults ≥20 and <65 years.
    


Intervention name(s): ASP7374; approved egg-derived TIV
Intervention type(s): Biological; Biological
Intervention description(s): subcutaneous; subcutaneous
Other intervention name(s): Influenza HA vaccine "SEIKEN"
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: ASP7374; Approved egg-derived vaccine; Prevention of seasonal influenza
Efficacy of Prokinetics With Split Dose of PEG in Morning Colonoscopic Bowel Preparation
Condition: Colonoscopy; Bowel Preparation
Study type: Interventional
Phase: Phase 3

Summary: 
      In bowel preparation using split dose PEG, various adjuncts to colonic cleansing were
      proposed to improve colonic preparation cleansing. Prokinetics, as an adjunct, was included
      in a few studies. The investigators study was to show that sufficient dosage of prokinetics
      added to split dose of PEG improves the state of bowel preparation.
    

Detailed description: 
      This was a randomized, prospective, endoscopist-blinded clinical trial in which the efficacy
      of prokinetics coadministrated with split dose PEG on the bowel cleansing was inspected.

      Endoscopists, who were blinded to the study group of the patient, immediately completed the
      Ottawa scale and the fluidity scale after procedure
    

Intervention name(s): itopride
Intervention type(s): Drug
Intervention description(s): itopride, 10mg, twice per day, for 1 day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: colonoscopy; bowel preparation; PEG; Prokinetics
Discontinuation From Chronic Opioid Therapy For Pain Using a Buprenorphine Taper
Condition: Chronic Pain; Opioid Pain Medication
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Chronic opioid therapy for pain can be associated with significant risks, and a significant
      number of patients maintained on chronic opioids have continued pain and/or poor functioning.
      When patients need to or want to come off their opioid pain medications, there is little to
      guide physicians as to how to best help them do so, and it is not known how patients do after
      coming off opioid medications. The goals of this study are (1) to evaluate two medications in
      assisting patients in coming off their opioid pain medications and (2) determining outcomes
      after discontinuing opioids.
    


Intervention name(s): Buprenorphine Initiation - Phase I; Gabapentin + Buprenorphine - Phase II; Placebo + Buprenorphine - Phase II; Buprenorphine taper - Phase II
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol up to 16mg sublingually over an 8 hour induction window.; Subjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to oral gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to gabapentin will receive up to 1600mg gabapentin (double blinded) divided three times daily, titrated over the 2 week stabilization period and continued during the buprenorphine tapering period. During the 2 week stabilization period, buprenorphine will also be titrated up to 24mg as needed/tolerated.; Subjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to oral gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to placebo will receive up to 1600mg placebo (double blinded) divided three times daily, titrated over the 2 week stabilization period and continued during the buprenorphine tapering period. During the 2 week stabilization period, buprenorphine will also be titrated up to 24mg as needed/tolerated.; After a 2 week stabilization period where sublingual buprenorphine is titrated up to 24 mg/day and oral gabapentin/placebo is titrated up to 1600mg/day, subjects will enter a buprenorphine tapering period lasting up to 8 weeks. The suggested buprenorphine taper will be determined by stabilizing dose, but able to be altered by prescriber or participant based on symptoms.
Intervention MeSH terms: Buprenorphine; Gabapentin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pilot Study to Evaluate the Somnotouch Device to Quantify Spontaneous Baroreflex Sensitivity
Condition: Healthy; Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      To measure the spontaneous baroreflex sensitivity in ambulatory patient, a device made for
      measuring blood pressure beat by beat and continuously, the SOMNOtouch system, could be a
      useful tool. The SOMNOtouch system has never been used to assess the sensitivity of the
      baroreflex. A good correlation for measuring the baroreflex sensitivity between the system
      "SOMNOtouch" and digital photoplethysmography as a reference method is expected but should be
      evaluated. The main purpuse is to evaluate the SOMNOtouch system to quantify the spontaneous
      baroreflex sensitivity in healthy young subjects, in elderly healthy subjects and in subjects
      with heart failure. We will also evaluate the feasibility of measuring the baroreflex
      sensitivity in ambulatory conditions for 24 hours, the variations in sensitivity of the
      baroreflex sensitivity between day and night, the reproducibility of orthostatic tolerance
      test.
    


Intervention name(s): SOMNOtouch device (Somnomedics); Orthostatic test; Finapres Nova device (FMS system)
Intervention type(s): Device; Procedure; Device
Intervention description(s): In each arm, we will evaluate the capacity of SOMNOtouch to measure the baroreflex sensitivity compared to Finapre Nova (reference); For each arm we will proceed to an orthostatic test day one and day two with :
10 minutes in supine position
10 minutes in sitting position
5 minutes in standing position
5 minutes in supine position
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Volunteers
Efficacy of Low Dose hCG on Oocyte Maturity in Poor Responder Women Undergoing Intracytoplasmic Sperm Injection
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a prospective, randomized, parallel, controlled trial to assess the efficacy of
      the late follicular phase administration of low dose hCG on oocyte maturity for ovarian
      stimulation in 73 poor respond patients undergoing intracytoplasmic sperm injection (ICSI)
      treatment.
    

Detailed description: 
      In this study all eligible patients were randomly allocated into three study groups by a
      permuted block randomization method: group A (control group) received only recombinant FSH,
      group B received rFSH supplemented by 100IU hCG in the late follicular phase. Group C
      received rFSH supplemented by 200IU hCG in the late follicular phase.

      All of the patients underwent a standard long protocol and received GnRH-a (Suprefact), 0.5cc
      subcutaneous, started from the day 17 of the preceding cycle and ovulation induction was
      started 14 days thereafter.

      Patients were categorized according to the following stimulation protocols:

      Group A (control group): which 300 IU r-FSH was administered for the first 5 days of the
      stimulation cycle. Then the first ultrasound scan was performed to monitor response. At this
      stage the dose of rFSH adjusted according to the ovarian response and continued until the day
      of ovulatory hCG administration.

      Group B: rFSH supplemented with daily administration of 100 IU hCG in the late follicular
      phase based on the follicle size (14mm).

      Group C: rFSH supplemented with daily administration of 200 IU hCG in the late follicular
      phase based on the follicle size (14mm).

      To assess the pregnancy outcomes, serum hCG was measured 2 weeks after embryo transfer.
      Clinical pregnancy was defined by the observation of sac with fetal heart rate on
      ultrasonography 4 weeks after embryo transfer.
    

Intervention name(s): rFSH; hCG; hCG
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administration of rFSH for ovarian stimulation.; Administration of late follicular low dose hCG(100IU) for ovarian stimulation.; Administration of late follicular low dose hCG(200IU) for ovarian stimulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ICSI Ovarian stimulation; hCG low dose; Oocyte maturity; poor respond
Closing the Gap Between Self-reported and Accelerometer-based Physical Activity
Condition: Physical Activity
Study type: Interventional

Summary: 
      This study examines the effect of a video-based intensity level demonstration on
      self-reported physical activity in individuals aged between 40 and 75 years. Aim of the video
      demonstration is to achieve a better concordance of physical activity reports with
      accelerometer-based measurements.
    

Detailed description: 
      This study examines whether the demonstration of different intensity levels of physical
      activity by video in the context of a tablet PC (personal computer)-based survey can achieve
      a higher degree of concordance between self-reported and accelerometer-measured physical
      activity compared to an assessment without video demonstration. The recruitment of the study
      participants in the age range between 40 and 75 years takes place in a shopping center in the
      city Greifswald in Germany.

      Informed consent consists of: (i) activity recording over 7 days using an accelerometer, (ii)
      completion of standardized questionnaires, (iii) participation in a standardized measurement
      of weight and height as well as waist and hip circumference.

      Participants are asked to wear an accelerometer during the day for a period of 7 days.
      Subsequently, a questionnaire about the frequency, duration and intensity of physical
      activity in the last 7 days will be answered in the DZHK (Deutsches Zentrum für
      Herz-Kreislauf-Forschung)- examination center. Prior to the physical activity assessment the
      study participants are randomly assigned to the study conditions "Video" or "No Video" (ratio
      1:1). Optionally, participants may receive feedback on their physical activity measured by
      accelerometer upon completion of the study.
    

Intervention name(s): Video demonstration of physical activity intensity levels
Intervention type(s): Other
Intervention description(s): In the video demonstration, an approximately 50 year old male explains 1) light-intensity, 2) moderate-intensity, and 3) vigorous-intensity physical activity referring to differences in heart rate, breathing frequency and capability to talk normally. Simultaneously, on a treadmill he demonstrates the body signs of the three intensity levels. He gives examples and points out that there are individual differences in the intensity evaluation of comparable activities.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Video demonstration; Intensity levels; Physical activity; Self-report; Accelerometer
Safety and Efficacy Study of an A1-Adenosine Receptor Agonist to Slow Heart Rate in Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the safety of DTI-0009 in patients with atrial
      fibrillation and to find the dose of DTI-0009 that lowers heart rates in patients with atrial
      fibrillation with rapid ventricular response.
    


Intervention name(s): DTI-0009
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Self Focus in Bipolar Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study
Condition: Bipolar Disorder; Major Depression; Rumination
MeSH terms: Rumination Syndrome; Depression; Depressive Disorder; Bipolar Disorder; Depressive Disorder, Major
Study type: Observational

Summary: 
      The investigators propose to examine both resting state activity and functional activity
      during rumination and during self-processing to study the relationship between neural
      correlates of rumination/self-focus and self-processing in major depression and bipolar
      disorder.
    

Detailed description: 
      Negative rumination, a specific form of self-focus, characterized by repetitively focusing on
      one's symptoms of distress, and the possible causes and consequences of these symptoms, is a
      hallmark of depression. Nearly a decade of research has culminated in evidence that the
      tendency to engage in negative rumination is highly correlated with depressive symptoms.
      Rumination also plays a critical role in the etiology and maintenance of depressed states and
      predicts risk for mania in bipolar disorder. Despite the central role of rumination in major
      depression and bipolar disorder, there have been few studies to date investigating the
      functional neuroanatomy of negative rumination, and no studies of positive rumination. The
      few neuroimaging studies that have utilized measures of the tendency to engage in negative
      rumination have focused on brain functioning when performing tasks that involve processing
      emotional or self-referential stimuli, but they have not studied resting state activity or
      functional activity during negative and positive rumination. We are examining both resting
      state activity and functional activity during negative and positive rumination and during
      self-processing to study the relationship between the neural correlates of
      rumination/self-focus and self-processing in major depression and bipolar disorder.
    

Intervention name(s): Functional Magnetic Resonance Imaging (fMRI)
Intervention type(s): Other
Intervention description(s): Imaging will be performed on a 3T Siemens Trio scanner. Each MRI scanning session will last no more than 90 minutes.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy controls will be recruited through email announcements at MGH, internet website at
        Harvard, and flyers posted at the Massachusetts General Hospital and in the community
        (e.g., community centers, public libraries, coffee shops, restaurants, and laundromats).
        Subjects with major depression will be recruited through the Depression Clinic and Research
        Program at MGH and flyers posted at MGH. Subjects with bipolar disorder will be recruited
        through the Bipolar Clinic and Research Program at MGH and flyers posted at MGH.
      
Keywords: Bipolar Disorder; Major Depression; Rumination; Self Processing