bioihbjkbjnl/mcl2 huggingface dataset:
A Multicenter, Investigative Study of the Safety and Efficacy of Extended Administration of Aripiprazole in Combination With Mood Stabilizer for the Treatment of Patients With Bipolar Disorder Experiencing a Manic or Mixed Episode
Condition: Bipolar I Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the safety and efficacy of long-term administration of aripiprazole by performing
      extended administration of aripiprazole in combination with mood stabilizer (lithium or
      valproate) in an unblinded manner to those patients who completed the preceding multicenter,
      double-blind, placebo-controlled, parallel group-comparison trial of aripiprazole in patients
      with bipolar disorder experiencing a manic or mixed episode (Study 031-06-003, hereafter
      "Study 003") but whose condition worsened or remained unchanged or who discontinued Study 003
      between Day 14 and Day 21 due to lack of drug efficacy.
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): oral, 24mg(4 tablets)/day
Other intervention name(s): OPC-14597
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Bausch & Lomb PureVision Under Nighttime Driving Conditions
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Observational

Summary: 
      The objective of this study is to quantify differences in nighttime driving performance
      between the Bausch & Lomb PureVision™ aspheric contact lenses and a conventional spherical
      contact lens.

      The primary aims of this study are to determine the differences between B&L PureVision™
      aspheric contact lenses and a conventional spherical contact lens in visual performance
      measures associated with driving, such as number of objects seen.

      The secondary aims of this study are to determine differences between B&L PureVision™
      aspheric contact lenses and a conventional spherical contact lens in driving performance
      measures such as number of objects hit.
    

Detailed description: 
      Contact lenses have the potential to affect visual performance in various driving situations,
      including low-visibility situations such as driving at night. This study will assess the
      effect on typical nighttime driving tasks such as reading signs and avoiding road hazards.

      This is a single-site study. Individuals who are currently spherical contact lens wearers,
      who believe they have little or no astigmatism, and who are licensed drivers will be invited
      to partipate in this study. Twenty-four completed subjects are required. This study will
      involve a 2x2 within-subject comparison.

      The first independent variable is the contact lens. Each subject will wear both PureVision
      (TM0 aspheric contact lenses and conventional spherical contact lenses on separate visits.
      The second independent variable is visibility condition. Subjects will complete the study
      drive both in clear nighttime conditions and at night under glare conditions. In both cases,
      the driver will experience oncoming traffic; however, in the glare condition, the simulator
      will be equipped with a point light source sufficient to provide glare similar to that
      provided by oncoming traffic in the real world.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects who currently wear spherical contact lenses and believe they have little or no
        astigmatism and are licensed drivers.
Effect of Food on Bioavailability of a Modified Release Formulation of Imatinib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, four-treatment, four period, crossover study to evaluate the effect
      of food on the relative bioavailability of a single dose of imatinib (STI571) given as a 800
      mg modified release tablet, MR2 compared to twice-daily doses of 400 mg film-coated imatinib
      tablets. There will be a 10 day wash out phase between treatments and a 1 week safety period
      at the end of the study. Each participant will receive all four treatments
    


Intervention name(s): imatinib
Intervention type(s): Drug
Intervention MeSH terms: Imatinib Mesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Food effect; bioavailability; pharmacokinetic; imatinib; STI571; modified release formulation of STI571; CML; Chronic Myeloid Leukemia; Philadelphia Chromosome
LDL-Cholesterol Lowering Effect of KB2115 as Add on to Ezetimibe
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in
      the liver, while an euthyroid state is preserved in the extrahepatic tissue. Eprotirome has
      in clinical trials demonstrated pronounced reduction of several independent risk factors for
      the development of atherosclerotic cardiovascular diseases.

      The purpose of the study is to assess the efficacy and safety of KB2115 as add on therapy to
      ezetimibe following 10 weeks of exposure compared to placebo. The aim of the study is to
      assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115 and to define a
      clinically relevant dose or dose range for future studies.
    


Intervention name(s): Ezetimibe and placebo; Eprotirome and ezetimibe
Intervention type(s): Drug; Drug
Intervention description(s): Placebo or three different doses of eprotirome added to ezetimibe treatment; Placebo or three different doses of eprotirome added to ezetimibe treatment
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Eprotirome; KB2115; dyslipidemia; hypercholesterolemia; hypertriglyceridemia
Piezoelectric Vibrations and Tissue, Cellular and Molecular Mechanisms of Oral Wound Healing After Third Molar Surgery
Condition: Tooth, Impacted
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      The aim of this clinical trial is to investigate and compare the effect of piezoelectric
      surgery on tissue, cellular and molecular level of oral surgical wound healing and
      postoperative outcomes (pain, swelling, trismus) after lower third molar surgery in healthy
      patients
    


Intervention name(s): piezo surgery; conventional surgery
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: piezolectric surgery; conventional surgery; lower third molars
First-in-Man Trial of NNC114-0005 in Healthy Subjects and Subjects With Rheumatoid Arthritis
Condition: Inflammation; Rheumatoid Arthritis; Healthy
MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the safety,
      tolerability, pharmacokinetic (the effect of the body on the investigated drug),
      pharmacodynamic biomarkers (biomarkers related to anti-IL-21 expected mode of action) and
      signs of clinical efficacy of increasing single doses, at 9 i.v. (into the vein) dose levels
      in Healthy Subjects , at 3 i.v. dose levels in subjects with rheumatoid arthritis (RA) and at
      3 s.c. dose levels in Healthy Subjects.
    


Intervention name(s): NNC0114-0000-0005; NNC0114-0000-0005; NNC0114-0000-0005; NNC0114-0000-0005; NNC0114-0000-0005; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects.; A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA. In addition a single dose of NNC0114-0000-0005 administered s.c. (under the skin) in healthy subjects.; A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. In addition a single dose of NNC0114-0000-0005 may be administered s.c. (under the skin) in healthy subjects based on safety data.; A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA. In addition a single dose of NNC0114-0000-0005 may be administered s.c. (under the skin) in healthy subjects based on safety data.; A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA.; A single dose of NNC0114-0000-0005 placebo.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Ureteral Stent Size Measurement Study
Condition: Quality of Life
Study type: Observational

Summary: 
      To examine a patient's quality of life using three methods for measuring stent size: (a)
      direct measurement, (b) patient height, and (c) a standardized formula. The intent of the
      study is to show if there is a difference in a patient's quality of life, postoperative
      symptoms, pain medication and anticholinergic use by using one of these specific methods for
      stent size determination. No method is interventional in this study.
    

Detailed description: 
      Ureteral stent placement is common in Urologic practice and many studies have been done
      looking at factors to improve stent related symptoms, but few have used a validated
      questionnaire to assess these symptoms affect on quality of life.We plan to prospectively
      randomize patients to three separate techniques such as (a) direct measurement,(b) patient
      height, and (c) a standardized formula for the determination of stent size. Using a validated
      questionnaire, the Ureteral Stent Symptoms Questionnaire (USSQ), we will assess whether there
      is a difference in outcome measures such as patient quality of life, need for pain
      medications and anticholinergics, and in postoperative symptoms based on one of these
      techniques. The USSQ was developed by Joshi et al to assess the impact of health-related
      quality of life issues related to ureteral stents. Data from USSQ questionnaire will be
      collected 7-10 days post-operatively as well as 4 weeks post-op and then this will be
      aggregated for our outcome measures to determine which method of stent size give better
      outcomes.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Community patients who present to Charleston area Medical Center (CAMC) or the private
        urology clinics of Drs. Davalos,Martinez,Tierney with the requirement of ureteral stent
        would be screened for possible enrillment in the study.
      
Keywords: Ureteric Measurement
Evaluation Of The Pan-microbiome and Host Immune Response in CF
Condition: Cystic Fibrosis (CF)
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Investigators will examine temporal and regional dynamic changes in the microbiome of Cystic
      Fibrosis patients to explore microbiome features that are associated with an inflammatory
      phenotype. Investigators hypothesize that temporal and spatial differences in lung microbiome
      are associated with host inflammatory responses.

      While chronic and polymicrobial airway colonization are commonly recognized in cystic
      fibrosis (CF), it is unclear what factors of the microbial environment lead to infection with
      pathogenic microorganism. This is a multi center, longitudinal cohort of adult Cystic
      Fibrosis subjects recruit4ed from NYU and Columbia to understand how changes in the airway
      microbiome may affect the host inflammatory responses in Cystic Fibrosis (CF). There will be
      three approaches to understanding inflammatory responses; 1) a longitudinal assessment of
      temporal changes in the microbiome over a 6-month period of clinical stability; 2) comparison
      of the regional differences in airway microbiome between lung segments with more versus less
      disease; 3) evaluation of functional aspects of the lung microbiome.
    


Intervention name(s): Two-Bronchoscope Technique
Intervention type(s): Procedure
Intervention description(s): Used to validate the use of sputum to sample the lower airway microbiome
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Multicenter study to create a longitudinal cohort of adult CF subjects recruited from NYU
        and Columbia. A subgroup of subjects will be selected for a more invasive assessment of the
        lung microbiome with research bronchoscopy.
      
Keywords: Cystic Fibrosis (CF)
Cold Water Immersion Modulates Reinforcing Effects of Nitrous Oxide - 2
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to conduct experiments to examine subjective and reinforcing
      effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug
      abusers and preference procedures will be used to assess reinforcing effects. To evaluate:
      cold water immersion modulates the reinforcing effects of nitrous oxide in healthy
      volunteers.
    


Intervention name(s): 0% N2O; 40% N2O
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will inhale 100% oxygen with no N2O for 25 min then immerse forearm in warm water and cold water; Subjects will inhale 40% N2O then immerse forearm in warm water and cold water
Intervention MeSH terms: Nitrous Oxide
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: nitrous oxide; choice; subjective effects; pain; analgesia; reinforcer; healthy volunteer
Comparison of Different Inspiratory to Expiratory Ratios on Respiratory Mechanics and Oxygenation in Robot-assisted Laparoscopic Radical Prostatectomy With Steep Trendelenburg Position and Pneumoperitoneum
Condition: General Anesthesia Using Endotracheal Intubation
Study type: Interventional

Summary: 
      The steep trendelenburg position and pneumoperitoneum during laparoscopic surgery have the
      potential to cause an adverse effects on respiratory mechanics and gas exchange. Previous
      studies have proposed that a prolonged I:E ratio ventilation improved respiratory mechanics
      and gas exchange. Therefore, the aim of this study is to evaluate whether a prolonged I:E
      ratio ventilation improves gas exchange and respiratory mechanics in patients undergoing
      robot-assisted laparoscopic radical prostatectomy.
    


Intervention name(s): prolonged inspiratory to expiratory (I:E) ratio (1:1); conventional I:E ratio (1:2)
Intervention type(s): Other; Other
Intervention description(s): 80 patients are randomly allocated into two groups : prolonged I:E ratio (1:1) (n=40) and conventional I:E ratio (1:2) group (n=40). In the prolonged I:E ratio (1:1), mechanical ventilation is maintained with during I:E ratio 1:1 during steep trendelenburg with pneumoperitoneum.; 80 patients are randomly allocated into two groups : prolonged I:E ratio (1:1) (n=40) and conventional I:E ratio (1:2) group (n=40). In the conventional I:E ratio (1:2) group (n=40), mechanical ventilation is maintained with during I:E ratio 1:2 during steep trendelenburg with pneumoperitoneum.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
A Study to Test How Well Empagliflozin Works in Chinese Patients With Type 2 Diabetes Who Already Take Insulin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study in Chinese adults with type 2 diabetes. The study is open to people who take
      insulin but still have too high blood sugar levels. Participants may additionally be taking
      up to 2 other medicines for their diabetes. The purpose of this study is to find out whether
      empagliflozin taken together with insulin helps people with type 2 diabetes to better control
      their blood sugar.

      The participants are in the study for about 7 months. During this time, they visit the study
      site about 8 times, 1 additional visit may be either a visit to the study site or a phone
      call. At the start of the study, participants are put into 3 groups by chance. Participants
      get either 10 mg empagliflozin tablets, or 25 mg empagliflozin tablets, or placebo tablets
      once a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine.

      The doctors regularly take blood samples from the participants. The changes in blood sugar
      levels are compared between the groups. The doctors also check the general health of the
      participants.
    


Intervention name(s): Empagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Empagliflozin; Placebo
Intervention MeSH terms: Empagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Breastfeeding Training Program and System (BMUM) for Mothers
Condition: Breastfeeding
Study type: Interventional

Summary: 
      The goal of the study was to investigate effect of breastfeeding training program and
      nurse-led breastfeeding online counselling system (BMUM) on mothers' breastfeeding
      self-efficacy, breastfeeding attitudes, breastfeeding problems and postpartum depression we
      hypothesized that there would be differences between BG and CG groups in terms of
      breastfeeding self-efficacy, breastfeeding problems, postpartum depression and breastfeeding
      frequency. This was a randomized controlled trial. Participants were randomly assigned to the
      breastfeeding group (BG; n = 36), or control group (CG; n = 36). Control group will receive
      only standart care breastfeeding group will receive standart care and web based breastfeeding
      support. Breastfeeding attitudes, infant feeding attitude breastfeeding problems and
      postpartum depression will assessment. The assesment point will be 32-37 gestational week,
      postpartum 1st day, 1st week, 3 months, and 6 months.
    


Intervention name(s): Bmum supportive system
Intervention type(s): Behavioral
Intervention description(s): Bmum is a web-based online tracking system that aims to improve positive attitude about breastfeeding
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Surgical Sympathetic Blockade in Heart Failure
Condition: Systolic Heart Failure; Beta-blockers Intolerance; Beta-blockers Resistance
MeSH terms: Heart Failure; Heart Failure, Systolic; Systolic Murmurs
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators sought to evaluate the feasibility and safety of surgical sympathetic
      blockade in systolic heart failure patients and secondary to assess its cardiovascular
      consequences.
    


Intervention name(s): Left cervico-thoracic sympathetic blockade
Intervention type(s): Procedure
Intervention description(s): Left cervico-thoracic sympathetic blockade by videothoracoscopic clipping under general anesthesia and single-lumen orotracheal intubation in semi-sitting position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart Failure; Sympathetic Nervous System; Sympathectomy; Adrenergic beta-Antagonists; Ventricular Dysfunction, Left
Feasibility, Acceptability, and Preliminary Efficacy of a Mobile App (nOCD) for OCD
Condition: Obsessive Compulsive Disorder (OCD)
MeSH terms: Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the feasibility, acceptability, and potential
      usefulness of using a mobile application (nOCD) for treatment of obsessive compulsive
      disorder (OCD) in a sample of 25 adults (ages 18-65) in an 8 week trial. nOCD is a free
      iOS/Android application that provides treatment strategies. The study team will evaluate the
      effect of the application using gold-standard clinician-administered and self-report
      measures. Prior to downloading the application, participants will receive 4 (up to 5)
      in-person visit (orientation to the app and psychoeducation) and receive brief weekly phone
      check-ins. The long-term goal of this study is to use this information to develop new
      treatments for patients with OCD. All study procedures will be conducted on site at the New
      York State Psychiatric Institute.
    

Detailed description: 
      The purpose of this study is to evaluate the feasibility, acceptability, and potential
      usefulness of using a mobile app (nOCD) for treatment of OCD in a sample of 25 adults (ages
      18-65). nOCD is a free iOS/Android app that provides EX/RP-consistent treatment strategies.
      The study team will evaluate the effect of the app using gold-standard clinician-administered
      and self-report measures. Prior to downloading the app, participants will receive 4 (up to 5)
      in-person visits and receive brief weekly phone check-in. The long term goal of this line of
      research is to increase access to evidence-based treatment and to ultimately reach more
      patients giving them access to tools to reduce their OCD symptoms and improve their quality
      of life.
    

Intervention name(s): Therapist assisted mobile intervention
Intervention type(s): Behavioral
Intervention description(s): Individuals will receive 4 introductory sessions with a therapist followed by weekly phone calls. Participants will utilize nOCD application to assist with treatment protocol adherence.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OCD; Mobile; Technology; CBT; Cognitive-Behavioral Therapy