bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic, Safety, Tolerability, and Immunogenicity Study of SB8 in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of
      Bevacizumab
    

Detailed description: 
      A Randomised, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the
      Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Three Formulations of
      Bevacizumab (SB8, EU Sourced Avastin®, and US Sourced Avastin®) in Healthy Male Subjects
    

Intervention name(s): SB8; EU sourced Avastin®; US Sourced Avastin®
Intervention type(s): Biological; Biological; Biological
Intervention description(s): SB8, proposed bevacizumab biosimilar; EU sourced Avastin® (bevacizumab, Roche Registration Ltd.); US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intraoperative Findings and Complications in Bariatric Surgery
Condition: Bariatric Surgery; Complication of Surgical Procedure; Obesity, Morbid
MeSH terms: Obesity, Morbid
Study type: Observational

Summary: 
      Retrospective study with patients submitted to bariatric surgery between 2013 and 2016 at a
      single Institution. The objective was to analyze the incidence and causes of unexpected
      intraoperative findings and complications, change in surgical plan, extra surgeries and
      procedure interruption. All operative information was collected prospectively and aimed to
      describe any of the previous situations. Secondarily, a morbidity analysis was performed,
      correlating intraoperative complications with postoperative complications and length of stay.
    


Intervention name(s): Bariatric surgery
Intervention type(s): Procedure
Intervention description(s): The gastric bypass ("simplified technique") was performed in an antecolic fashion, with a calibrated 2 cm gastro-jejunal anastomosis (linear stapler); biliary and alimentary limbs measured 70 and 150 cm respectively [17] . Mesenteric defects were closed and the omentum divided. The sleeve gastrectomy was performed at 5-6 cm from the pylorus over a 36 Fr. bougie, with oversuture of the staple line (2-0 polypropylene). Methylene blue test and the use of drains were done routinely.
Other intervention name(s): Laparoscopic gastric bypass; Sleeve gastrectomy; Revisional surgery
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with obesity submitted to bariatric surgery (LGBP, LSG, and revisional surgery) in
        a single institution between January 2013 and March 2016.
Preventive Health Behavior in Women
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Observational

Summary: 
      The overall goal of the proposed research is to explore behavioral correlations between
      colorectal cancer screening and screening mammography.
    

Detailed description: 
      The overall goal of the proposed research is to explore behavioral correlations between
      colorectal cancer screening and screening mammography and to develop an innovative approach
      for reducing barriers colorectal cancer screening in women, using screening mammography, an
      existing non-colon cancer related screening test that has widespread public acceptance, as a
      "teachable moment." Although screening for colorectal cancer (CRC) has been shown to decrease
      the incidence of CRC and CRC associated mortality, adherence to screening guidelines from the
      American Cancer Society and the American Gastroenterological Association remains poor.1-5
      Barriers to adherence are not fully defined, but may include poor understanding of the
      relative benefits and risks of CRC screening, absence of physician recommendation, lack of
      insurance coverage for screening procedures, and poor patient acceptance of screening
      procedures. A potential challenge in increasing patient knowledge may be the milieu in which
      the educational intervention is administered. This study will be the first prospective study
      to evaluate the effectiveness of an educational intervention designed to increase CRC
      screening administered at a cancer screening visit unrelated to CRC.
    

Intervention name(s): Behavioral Study in Women
Intervention type(s): Behavioral
Intervention description(s): A Randomized study to assess the knowledge of womens health related issues
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who are scheduled for a screening mammogram at a University Medical Center who are
        between 50 and 75 years old will recruited.
Skydiving as a Model of Psychological Stress and Its Effect on Intestinal Barrier Function
Condition: Psychological Stress Due to Skydiving
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      In this study, it will be investigated how psychological stress evoked by skydiving affects
      the intestinal permeability in 20 healthy subjects. Participants attend two visits: 1)
      Skydiving visit, 2) Negative control visit. At all visits, saliva samples, blood samples, and
      faecal samples are collected, and the multi-sugar permeability test is performed. In this
      test, participants drink a sugar solution and then collect urine for 5 and 24 h. The ratio of
      the sugars detected in the urine is a reflection of the intestinal permeability. Saliva
      samples are collected for assessment of cortisol, a stress marker. Blood and faecal samples
      are collected for assessment of markers of intestinal barrier function and inflammation.
    


Intervention name(s): Skydiving
Intervention type(s): Other
Intervention description(s): Tandem skydiving (with an experienced instructor)
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: 1) Skydiving visit, 2) Negative control visit
Masking: None (Open Label)
Primary purpose: Basic Science
Postoperative Pain and PTN and Reciproc
Condition: Apical Periodontitis; Dental Pulp Necrosis
MeSH terms: Periodontitis; Periapical Periodontitis; Dental Pulp Necrosis; Pain, Postoperative; Necrosis
Study type: Interventional

Summary: 
      In this clinical trial, the researchers will investigate the effect of single-file
      reciprocating file system (Reciproc) versus multi-file rotational file systems (ProTaper
      Next) on the postoperative pain in adult patients who have necrotic pulp and apical
      periodontitis. The participants will be assigned by chance to separate groups that compare 2
      different treatments, reciprocating single-file system (Reciproc) and rotational multi-file
      system (ProTaper Next).
    

Detailed description: 
      The infected root canal treatments will be performed using one-visit approach with either a
      reciprocating single-file system or a continuous rotational multi-file system. Foraminal
      enlargement will be perfomed using either Reciproc or ProTaper Next file systems. The root
      canals will be completed in single-visit. The patients will record their postoperative pain
      during the follow-up period using a VAS scale.
    

Intervention name(s): Reciprocating single-file system; Rotational multi-file system.
Intervention type(s): Procedure; Procedure
Intervention description(s): After determining the working length, a flexible size 30 K-file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged.The device in the experimental group moves in CW and CCW direction with different angles. It is a single-file endodontic file system. The intervention is reciprocating single-file system. A Reciproc single-file will be used for enlarging apical foramen. In the active comparator group, a continuous rotational multi-file system, ProTaper Next, will be used in enlarging apical foramen.; After determining the working length, a flexible size 30 K-file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged. In this group, a continuous rotational multi-file system, ProTaper Next, will be used in enlarging apical foramen.
Other intervention name(s): Reciproc; ProTaper Next
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Single Ascending Dose Study of BTZ043
Condition: Tuberculosis; Tuberculosis, Pulmonary; Bacterial Infections; Lung Diseases; Mycobacterium Infections
MeSH terms: Infections; Communicable Diseases; Tuberculosis; Bacterial Infections; Mycobacterium Infections; Tuberculosis, Pulmonary; Lung Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, double-blind, placebo-controlled, single ascending dose study to
      evaluate safety, tolerability, and pharmacokinetics of single doses of BTZ043 in healthy
      adult volunteers. The study is conducted at a study centre in Germany. Up to 50 male and
      female participants will be included in this study in up to 5 cohorts; each cohort will
      consist of 10 subjects: in each cohort 8 subjects will be assigned to BTZ-043 and 2 to
      placebo. The doses tested will be: 125mg, 250mg, 500mg, 1000mg and 2000mg. Safety will be
      assessed via regular vital sign measurement, 12-lead ECG parameters, physical examination and
      safety laboratory assessments.

      Subjects will be hospitalized from Day -1 until discharge in the morning of Day 3. After
      completion of all Day 3 assessments of a cohort, blinded safety data will be reviewed and the
      next dose increment will be decided by the Trial Steering Committee (TSC).
    


Intervention name(s): BTZ-043; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Powder and solvent for oral suspension; Matching placebo: powder and solvent for oral suspension
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase 1; Anti-Bacterial Agents; Respiratory Tract Infections
Treatment of Keratosis Pilaris With 810 nm Diode Laser
Condition: Keratosis Pilaris (KP)
MeSH terms: Keratosis, Actinic; Abnormalities, Multiple; Darier Disease; Keratosis
Study type: Interventional

Summary: 
      The investigators hope to establish whether or not the diode laser, a longer-wavelength
      laser, is effective in treating keratosis pilaris, and hopefully opening a door into the
      discussion and management of this skin condition. The primary outcome of interest is the
      difference in the overall blind rater severity scores of the treated versus the untreated
      sites. The secondary outcome of interest is the change in the patient's self-rated severity
      score of the treated site. To account for potential natural disease progression or
      regression, the investigators will also compare patient mean changes to the mean changes in
      severity scores of the untreated site.
    


Intervention name(s): Diode Laser
Intervention type(s): Device
Intervention description(s): 810 nm diode laser
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Keratosis pilaris (KP)
Comparison of Repaglinide and Metformin Administered Alone or in Combination in Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Asia. The aim of this trial is to compare repaglinide and
      metformin administered alone or in combination in subjects with type 2 diabetes.
    


Intervention name(s): repaglinide; metformin; metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dose individually adjusted; Dose individually adjusted; Dose at 1000 mg/day
Intervention MeSH terms: Metformin; Repaglinide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Improving Tolerability of Bowel Preparation Laxative for Colonoscopy
Condition: Colonoscopy; Bowel Preparation
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the pattern of flavoring and drinking of
      laxatives for colonoscopy can improve the experience of patients when they are undergoing
      bowel preparation for the test.

      Investigators hypothesize that patients will have a better experience if patients taste the
      bowel preparation laxative with and without flavoring and then decide how they want to drink
      the rest of the laxative since taste preferences vary widely from person to person.
    


Intervention name(s): Pattern of flavoring of bowel laxative
Intervention type(s): Other
Intervention description(s): Unflavored bowel laxative versus entire bowel laxative flavored versus liberal flavoring as decided by patient
Intervention MeSH terms: Laxatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Bowel preparation solutions; Colonoscopy; Polyethylene glycol
LASIK Using the Alcon Allegretto Wavefront-Guided Excimer Laser vs AMO Visx Wavefront-Guided Excimer Laser
Condition: Myopia; Astigmatism
MeSH terms: Myopia; Astigmatism
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the results of LASIK surgery when using Alcon
      Allegretto wavefront-guided excimer laser system compared to AMO Visx Custom wavefront-guided
      excimer laser system in patients with nearsightedness with and without astigmatism.
    

Detailed description: 
      The patients will have a comprehensive eye examination once they express an interest in the
      study. This includes a slit lamp examination of the front of the eye and a dilated
      fundoscopic examination of the back of the eye. if there is any pathology noted that would
      exclude the patient from the study, then we will inform the patient and make an appropriate
      referral. If the patient is deemed appropriate for the study after a comprehensive
      examination included computerized videokeratography, then they can be enrolled. The patient
      will undergo bilateral simultaneous eye surgery. Which eye is treated with a wavefront-guided
      excimer laser and which eye is treated with wavefront-optimized will be randomized so there
      is a 50% chance for either eye to receive one treatment. The patients will be seen on the day
      of surgery, post op day one, post op day 4-7, one month, three months, six months and one
      year. The patient will receive topical antibiotics in each eye for one week following the
      procedure. LASIK treated eyes will receive pred forte 1% ophthalmic drops for one week after
      treatment. All of this is within the usual and customary standard of care for the treatment
      of patients undergoing lasik surgery.

      The research procedures are the least risky that can be performed consistent with sound
      research design.
    

Intervention name(s): Wavefront-guided LASIK - Allegretto; Wavefront-guided LASIK - AMO
Intervention type(s): Procedure; Procedure
Intervention description(s): Wavefront-guided LASIK using the Allegretto excimer laser for myopia.; Wavefront-guided LASIK using the AMO CustomVue excimer laser for myopia.
Other intervention name(s): Alcon Wavelight Allegretto Eye-Q 400 Hz excimer laser; AMO Visx CustomVue S4 IR excimer laser
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myopia; Astigmatism; Aberrations; Wavefront; LASIK; Wavefront LASIK
Noise Exposure and Near-Infrared Light
Condition: Hearing Loss, Noise-Induced
MeSH terms: Hearing Loss; Deafness; Hearing Loss, Noise-Induced
Study type: Interventional

Summary: 
      The primary objective of this work is to determine the effect noise has on the auditory
      system (both auditory health and performance) and also the degree to which the effect of
      pre-noise therapy such as Near Infrared (NIR) light can mitigate the effects of noise
      exposure.
    


Intervention name(s): Near Infrared Light; Noise Stimulus; Sham Near Infrared Light
Intervention type(s): Device; Other; Device
Intervention description(s): NIR Light Therapy will be administered with the Earlight Generation 1.4 device during 2 out of the 4 sessions. It will be administered to each ear individually for 30 minutes per ear.; Noise stimulus will be administered, open ear, to continuous broadband noise up to 25% of the allowable daily dose of noise per the AFI 48-127 Occupational Noise and Hearing Conservation Program.; Sham NIR Light Therapy will be administered with the Earlight Generation 1.4 device during 2 out of the 4 sessions. It will be administered to each ear individually for 30 minutes per ear.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Noise induced hearing loss; Near infrared energy; Hering test
Closed Loop Auditory Stimulus in Sleep and epilepsY
Condition: Temporal Lobe Epilepsy
MeSH terms: Epilepsy; Epilepsy, Temporal Lobe
Study type: Interventional

Summary: 
      This is a single-centre pilot study of a non-invasive auditory stimulation during sleep in
      participants with temporal lobe epilepsy.
    

Detailed description: 
      The primary objectives will be to pilot the use of home-based auditory stimulation during
      sleep in 10-20 participants with temporal lobe epilepsy using wireless devices.
    

Intervention name(s): Closed loop auditory stimulus
Intervention type(s): Device
Intervention description(s): 50ms of low volume pink noise delivered during slow wave sleep
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Within subject comparison of stimulus and sham sessions
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Closed loop auditory stimulus; sleep; memory
Study of Tai Chi Exercise and Balance in Persons With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients practicing Tai Chi will exhibit significant improvements in primary outcome measures
      of balance, and secondary outcomes of gait, physical performance, Unified Parkinson's Disease
      Rating Scale, Falls, muscle strength.
    

Detailed description: 
      The study is designed to determine the effects of Tai Chi training on balance and other
      functional outcomes in persons with Parkinson's disease.
    

Intervention name(s): Tai Chi; Strength training; Low-Impact Exercise Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): a set of pre-designed Tai Chi Movements; Lower-extremity strength training exercises; a set of chair-based low-impact exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 1 Clinical Study in Healthy Volunteers to Investigate the Drug-drug Interaction Between Multiple Doses of RO7033877 and Multiple Doses of Colistin Methanesulfonate Sodium (CMS)
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This single center, open-label, randomized study will investigate the drug-drug interaction
      potential between multiple doses of RO7033877 and multiple doses of colistin methanesulfonate
      sodium (CMS).
    


Intervention name(s): CMS; RO7033877; RO7033877 + CMS
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Multiple doses of CMS over 2.5 days; Multiple doses of RO7033877 over 2.5 days; Multiple doses of RO7033877 and CMS over 2.5 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
SSRI Effects on Depression and Immunity in HIV/AIDS
Condition: Depression; HIV; AIDS
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 10 week, double-blind, placebo controlled trial to evaluate SSRI (Selective
      Serotonin Reuptake Inhibitor) effects for treatment of depression in HIV/AIDS with a focus on
      innate immunity and inflammation. Depressed population is HIV + on cART (Combination
      Antiretroviral Therapy), not currently on pharmacotherapy for depression. Subjects will
      complete computerized cognitive behavior therapy, CCBT for their depression. Blood samples
      collected for virologic, neuroendocrine, and immunologic evaluation. Our overarching
      hypothesis is that SSRI treatment of depression and improvement of depressive symptoms leads
      to increased innate immunity and decreased inflammation, resulting in better control of HIV
      disease and decreased morbidity.
    

Detailed description: 
      To pursue our long-term objective of successfully treating co-morbid mental and medical
      disorders in HIV/AIDS, this study aims to determine whether: 1) SSRI treatment significantly
      increases innate immunity and decreases chronic inflammation and immune activation, and 2)
      changes in depressive symptoms correlate with changes in immunity in HIV/AIDS.

      HIV-seropositive, depressed subjects will be randomized to 10 weeks of double blind therapy
      with either escitalopram or placebo. All participants will concurrently begin CCBT
      (Computerized Cognitive Behavioral Therapy) using the program Good Days Ahead.

      Subject visits will occur weekly for the first 6 weeks and then at weeks 8 and 10. The
      treating clinician will assess side effects, review symptomatic progress, and adjust the
      study medication as clinically appropriate. An independent clinical evaluator will assess
      patients at baseline, and weeks 1-6, 8 and 10. Blood samples collected at baseline and weeks
      2, 4, and 10 will be used to assay markers of innate immune suppression (lytic units of NK
      cells, LUNK, and intracellular IFN gamma in NK cells) and markers of inflammation (IL-6 and
      C-Reactive Protein). At the end of the 10-week treatment phase, all participants will be
      referred for appropriate clinical treatment of their depression.
    

Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 10 week trial; 10 week trial
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; AIDS; Depression; SSRI; Escitalopram; Immunity
A Study of Octreotide Depot vs Saline Control in Pediatric Hypothalamic Obesity Patients
Condition: Hypothalamic Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      The extension protocol is designed to allow those patients randomized to placebo in the core
      portion of the protocol to receive a 6 month treatment of open label octreotide and allow
      those patients randomized to octreotide who appeared to benefit from treatment, to continue
      to receive octreotide.
    


Intervention name(s): Octreotide
Intervention type(s): Drug
Intervention MeSH terms: Octreotide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity