bioihbjkbjnl/mcl2 huggingface dataset:
Postoperative Sleep Quality of Patients Sedation With i.v. Dexmedetomidine or Midazolam Undergoing TURP
Condition: Sleep Quality of Patients Undergoing TURP
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators designed a study to determine whether dexmedetomidine versus midazolam
      combined with spinal anesthesia would provide same postoperative sleep quality in patients
      undergoing transurethral prostatic resection.
    

Detailed description: 
      The investigators designed a study to determine whether dexmedetomidine versus midazolam
      combined with spinal anesthesia would provide same postoperative sleep quality in patients
      undergoing transurethral prostatic resection.The bispectral index score (BIS) was monitored
      during the operation and the first postoperative night
    

Intervention name(s): dexmedetomidine; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): The sedative solution administered intravenously started at rate of kg (weight of patient)*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)*0.15 ml/h through syringe pump to the end of surgery; The sedative solution administered intravenously started at rate of kg (weight of patient)*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)*0.15 ml/h through syringe pump to the end of surgery
Intervention MeSH terms: Midazolam; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: dexmedetomidine; midazolam; sleep quality; delirium
Treatment of Posttraumatic Stress Disorder and Aggressive Behavior in Soldiers and Ex-combatants
Condition: Posttraumatic Stress Disorder; Aggressive Behavior; Appetitive Aggression
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Aggression
Study type: Interventional

Summary: 
      Soldiers deployed in peace-keeping missions as well as ex-combatants in conflict or former
      conflict regions were and are often exposed to multiple traumatic events and situations in
      which they are forced to engage in violent behavior. The treatment program Formation,
      Orientation and Rehabilitation by means of Narrative Exposure Therapy (FORNET) is a
      short-term, culturally sensitive treatment approach that aims to reduce Posttraumatic Stress
      Disorder (PTSD) symptoms as well as the risk to engage in uncontrolled violent behavior.
      Addressing trauma-related mental disorders as well as emotions related to aggression by means
      of FORNET is expected to facilitate reintegration in civil life and reduce uncontrolled
      violence.

      The investigators want to provide evidence, that FORNET is an effective and efficient module
      to assist soldiers after deployment in Somalia and/or male and female ex-combatants who
      fought in the civil war in Burundi. In addition the investigators aim to explore how
      traumatic incidences and maltreatment during childhood may influence treatment outcomes.
    


Intervention name(s): FORNET
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Posttraumatic Stress Disorder; Aggressive Behavior; Appetitive Aggression; Treatment; FORNET
Vaginal Microbiota Among Postmenopausal Women
Condition: Vulvovaginal Atrophy
MeSH terms: Atrophy
Study type: Observational

Summary: 
      It is known that vaginal bacteria have an impact upon the health status of the host, in some
      cases protecting against infection and in other cases causing infection, depending on the
      bacterial types present. This study will compare the composition of vaginal bacteria to
      symptoms of vaginal dryness in order to try and identify if certain bacteria might cause some
      of the problems associated with vaginal dryness among post-menopausal women.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Postmenopausal women
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With r/r Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma
Condition: Diffuse Large B-cell Lymphoma(DLBCL); Mantle Cell Lymphoma (MCL); Follicular Lymphoma (FL)
MeSH terms: Lymphoma; Lymphoma, Follicular; Lymphoma, B-Cell; Lymphoma, Mantle-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the safety and tolerability of AMG 562 in adult subjects with DLBCL, MCL, or FL.
      Estimate the maximum tolerated dose (MTD) and/or a biologically active dose (e.g.,
      recommended phase 2 dose [RP2D])
    


Intervention name(s): AMG 562
Intervention type(s): Drug
Intervention description(s): AMG 562 is a BiTE® antibody construct that targets CD19 and is intended for the treatment of patients with B-cell malignancies.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Eradication of Prostate Cancer Using F-989
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to confirm the findings of an early study with prostate cancer
      and to expand our knowledge of treating prostate cancer using F-989.
    


Intervention name(s): Acetogenins
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Venlafaxine Augmentation in Treatment Resistant Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an assessment of the efficacy of venlafaxine-HCL augmentation with the neuroleptic
      quetiapine in treatment resistant depression.
    

Detailed description: 
      We examine the efficacy of Venlafaxine-HCL augmentation with the neuroleptic Quetiapine in
      treatment resistant depression in a double-blind randomized clinical trial. Secondary
      objective is the evaluation of pharmacogenetic factors contributing to drug efficacy in
      treatment resistant depression.
    

Intervention name(s): Venlafaxine; Quetiapine
Intervention type(s): Drug; Drug
Intervention description(s): Venlafaxine XR up to 450 mg/d during the complete trial (8 weeks); Quetiapine up to 200 mg/d for four weeks
Other intervention name(s): Trevilor retard; Seroquel
Intervention MeSH terms: Quetiapine Fumarate; Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Treatment resistant depression; Augmentation; Pharmacogenetics
Physiologic Adaptations to Interval and Continuous Running at Low Volume and Vigorous Intensity Over 14-Weeks.
Condition: Exhaustion - Physiological
Study type: Interventional

Summary: 
      The purpose of this study was to verify physiological responses to constant-load (continuous)
      vs. variable-intensity (interval) during 14 weeks of aerobic exercise on active men. The
      hypothesis was that would be differences in physiological variables on distinct modes of
      execution performed on the treadmill over a period of 14 weeks of training.
    

Detailed description: 
      Initially there were thirty five subjects, but due factors outside the present study, three
      individuals were excluded from the program. Two individuals during maximal exercise test
      (VO2) showed clinical impairment test being interrupted by the doctor and the third
      individual presented a plantar fasciitis in the early familiarization. Thirty two healthy and
      active males volunteered to participate in the study. All subjects exercised habitually, with
      at least 1 year experience aerobic training. The Human Ethics Committee of Rio de Janeiro
      Federal University approved this study (no 58659/02471312.8.0000.5257).The subjects performed
      a total of nine visits to the laboratory of the Brazilian Navy at City of Rio de Janeiro for
      physical tests on different days, except between visits I-II and VII-III. The interval
      between visits was one week between visits II-III-IV and VIII-IX, six weeks between the first
      day of training and visits V, four weeks between V-VI-VIII. All subjects from interval and
      continuous groups performed a total of 46 sessions of supervised running program.
    

Intervention name(s): running training
Intervention type(s): Other
Intervention description(s): The present study was designed to compare the physiological effects between the two training regimes and the control group.The subjects from interval and continuous group performed others activities as resistance training, swimming or soccer. Those activities wasn't controlled by our study, but the individual didn't do physical activities at least 3 hours before started our running sessions. The control group simply performed their normal physical activities (resistance training, swimming or soccer). But, each 3 weeks we had a contact with control group to check about any injury or illness that could affect the final results. None were found.
Other intervention name(s): Stochastic; aerobic; run
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: aerobic capacity; cardiorespiratory training; blood lactate concentration; heart rate
Expanding Health System Intervention Through The Women, Infants and Children (WIC) Program Partnership
Condition: Obesity, Childhood
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Pilot test the health system-based intervention to improve family beverage choices and
      promote water consumption, engaging WIC nutritionists to augment the intervention with
      follow-up and counseling of families at regularly-scheduled WIC appointments in a small
      randomized trial among 30 WIC-enrolled families.
    

Detailed description: 
      This is a pilot 2-arm randomized trial among 30 WIC enrolled families of children 6 months
      through 4 years old who currently over-consume sugary drinks. The study team will randomize
      families to either an intervention group, that will receive a behavioral intervention
      consisting of two educational videos, a water promotion toolkit, mobile phone app, series of
      educational phone calls and extra counseling from WIC nutritionists, or to a control group
      that will not receive this intervention. The study team will compare 6-month change in child
      and parental beverage consumption between groups. Exploratory analyses will examine child
      weight (kg) and Body Mass Index (BMI) z-score (BMIz) outcomes, and compare intervention
      effects across race/ethnic groups.
    

Intervention name(s): Pilot Intervention to reduce SSB consumption in children and families enrolled in WIC
Intervention type(s): Behavioral
Intervention description(s): A 6-month intervention based on the use of 5 components: 2 educational videos, provision of a water-promotion "toolkit," a mobile phone application (app), a series of 14 computerized interactive voice response (IVR) phone calls to parents and 2 counseling sessions by a WIC nutritionist to compare families' SSB's consumption behaviors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
The Effect of New Zealand Blackcurrant (NZBC) Supplementation on Recovery Following Strenuous Exercise
Condition: Muscle Damage
Study type: Interventional

Summary: 
      The study aims to examine the effect of a New Zealand blackcurrant (NZBC) supplement on
      markers of muscle damage and recovery following strenuous resistance exercise. The
      investigation will compare responses between an experimental (NZBC capsule, 300 mg/day) and
      placebo (PLA capsule, 300 mg sugar) group. Participants will attend a screening session where
      they will consent to the study, complete a pre-activity medical questionnaire and have their
      height, weight and resting blood pressure measured. If the participants meet the inclusion
      criteria they will perform a familarisation session on the muscle strength assessment.
      Participants will be randomized to NZBC or placebo groups, and consume one capsule in the
      morning (between 6-10 am) for 12 days. This is a double-blinded study, which means that the
      participant and the study team will not know which group the participants are assigned to
      until the study is over. On day 8 participants will perform a strenuous bout of upper body
      resistance exercise on the isokinetic dynamometer (exercise device). Muscle strength and
      soreness, arm circumference, and elbow range of motion will be measured, and a fasted blood
      sample will be collected, before and 24, 48, 72 & 96 hours after the muscle fatigue protocol
      (on days 9, 10, 11 & 12). A marker of muscle damage (creatine kinase [CK] concentration) will
      be measured in the blood samples. Participants will also be asked to complete a 6-day dietary
      record, beginning on day 7 and ending on the final day of testing (day 12).
    


Intervention name(s): New Zealand blackcurrants (NZBC); Placebo (PLA)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): NZBC capsules containing anthocyanin-rich blackcurrant extract; Placebo capsules containing microcrystalline cellulose
Other intervention name(s): NZBC extract supplement (Health Currancy Ltd [UK] / CurraNZ Ltd [NZ]); Placebo capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, parallel design.
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Exercise-induced muscle damage; Recovery; Supplementation; Oxidative stress; Anthocyanin; New Zealand blackcurrant
A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Obstructive Airway Disease; COPD
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease.
      This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659
      in patients with Chronic Obstructive Pulmonary Disease (COPD).
    


Intervention name(s): placebo; active comparator; Low Dose PF-03635659; Mid Dose PF-03635659; High Dose PF-03635659
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral inhaled formulation, single dose; oral inhaled formulation, single dose; oral inhaled formulation, single dose, low dose; oral inhaled formulation, single dose, mid dose; oral inhaled formulation, single dose, high dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Safety; Pharmacokinetics; Pharmacodynamics; PF-03635659; COPD
Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX
Condition: Colon Staining in Preparation for Colonoscopy
Study type: Interventional
Phase: Phase 2

Summary: 
      To describe and evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after
      total oral doses of 150 or 200 mg in patients undergoing a full colonoscopy for various
      reasons.
    

Detailed description: 
      Objectives:

      To describe and evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after
      total oral doses of 150 or 200 mg in patients undergoing a full colonoscopy for various
      reasons.

      Primary end-point(s):

      To evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after total oral
      doses of 150 or 200 mg.

      Secondary end-point(s):

      Bowel cleansing quality evaluated according to the validated Boston Bowel Preparation Scale
      (BBPS) after intake of 150 or 200 mg of Methylene Blue MMX® tablets during the intake of the
      bowel cleansing preparation.

      To collect data about safety and tolerability of Methylene Blue MMX® tablets after
      administration of single oral doses of 150 or 200 mg.

      Methodology:

      Open label, staining efficacy exploratory study.
    

Intervention name(s): Methylene Blue MMX 25 mg modified release tablets
Intervention type(s): Drug
Intervention description(s): Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation.
Intervention MeSH terms: Methylene Blue
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Open label, staining efficacy exploratory study.
Masking: None (Open Label)
Primary purpose: Diagnostic
Surgery Checklist and Process Improvement Surrounding Endoscopic Sinus Surgery
Condition: Chronic Rhinosinusitis
Study type: Observational

Summary: 
      The purpose of this clinical trial is to evaluate the effectiveness of a new surgical
      checklist in the setting of sinus surgery for patients with chronic rhinosinusitis (CRS) and
      to measure the frequency of compliance by surgical personnel at OHSU with specific daily
      safety protocols before and after introduction of the checklist. The investigators
      hypothesized that the use of an ESS specific surgical checklist will improve the frequency of
      compliance by surgical personnel at OHSU to internal safety concerns and protocols.
    

Detailed description: 
      A total of 200 unidentified, non-randomized endoscopic sinus surgery cases will be observed
      and reviewed by research personnel (T.L.S, J.C.) within the Oregon Sinus Center, located
      within the Center for Health and Healing on the South Waterfront Campus of OHSU, under the
      direction of Timothy L. Smith, MD, MPH (PI). The first 100 surgical cases will be evaluated
      as "pre-intervention" cases by research personnel while the second 100 surgical cases will be
      evaluated as "post-intervention" cases after the introduction and discussion of the surgical
      checklist to operating room staff.
    

Intervention name(s): Checklist introduction / Pause
Intervention type(s): Behavioral
Intervention description(s): Operating room staff will be introduced to a new checklist specifically designed to address concerns around protocols for endoscopic sinus surgery to raise awareness and attention to 11 specific areas of interest.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Resident and fellow surgeons.
      
Keywords: Sinusitis; Disease; Chronic; Sinonasal
Effects of Vitamin B12 on the Body's Internal Clock
Condition: Sleep Disorders, Circadian Rhythm
MeSH terms: Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
Study type: Interventional

Summary: 
      Circadian rhythms are 24-hour cycles that influence natural functions in the body such as
      heart rate, blood pressure, and body temperature. Circadian rhythms provide the body with an
      internal clock and affect sleep patterns. The purpose of this study is to determine the
      effects of vitamin B12 supplements on circadian rhythms and sleep-wake regulation.
    

Detailed description: 
      Individuals with circadian rhythm sleep disorder suffer from recurrent patterns of disrupted
      sleep that can significantly affect their daily functioning. Evidence suggests that vitamin
      B12 supplements may have a beneficial effect on sleep patterns. However, research on the
      effects of vitamin B12 supplements on sleep is limited. This study will determine the effects
      of vitamin B12 supplements on circadian rhythms and sleep-wake regulation.

      This study will last 47 days. Participants will undergo a 3-week medical and psychological
      screening prior to study entry. Eligible participants will be admitted to the General
      Clinical Research Center where they will live in a private study room for the duration of the
      study. The room will be a time-free environment with no windows, clocks, television, or
      radio. Participants will not be able to make or receive telephone calls, and their bedtimes,
      wake times, and mealtimes will be determined by study researchers. Participants will be
      randomly assigned to receive three capsules of either vitamin B12 or placebo daily. Blood and
      saliva collection will occur daily to determine core body temperature and hormone levels.
      Performance tests to determine participants' cognitive abilities will be administered at
      regular intervals throughout each day. Participants' sleep will be recorded every night with
      polysomnography, which will monitor brain and muscle activity and breathing patterns during
      sleep.
    

Intervention name(s): Vitamin B12
Intervention type(s): Drug
Intervention MeSH terms: Vitamin B 12; Hydroxocobalamin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Circadian Rhythm; Biological Clock; Complementary and Alternative Medicine
Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether oral etrasimod is a safe and effective
      treatment for moderately to severely active ulcerative colitis.
    


Intervention name(s): Etrasimod; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment; Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment
Other intervention name(s): APD334
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ulcerative Colitis; Etrasimod; APD334
A Study Comparing MB02 and Avastin® in Subjects With Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, multinational, double-blind, 1:1 randomized, parallel-group,
      equivalence Phase 3 study to compare the efficacy and safety of MB02 plus chemotherapy
      (carboplatin and paclitaxel) versus Avastin® plus chemotherapy (carboplatin and paclitaxel)
      in subjects with Stage IIIB/IV non-squamous NSCLC
    

Detailed description: 
      Efficacy parameters, safety profiles and immunogenicity will be compared between MB02
      (Bevacizumab Biosimilar Drug) and European (EU)-approved Avastin®
    

Intervention name(s): MB02 (Bevacizumab Biosimilar Drug); EU-approved Avastin®; Carboplatin; Paclitaxel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 15 mg/kg IV every 3 weeks on Day 1; 15 mg/kg IV every 3 weeks on Day 1; Carboplatin Area under the curve (AUC) 6 IV every 3 weeks on Day 1 for 6 cycles; Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles
Other intervention name(s): Bevacizumab; Bevacizumab; Taxol
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment