bioihbjkbjnl/mcl2 huggingface dataset:
Neuro-ocular Baselines in a Sports Setting
Condition: Wave Form Signals Coming From the Eye in a Healthy Cohort
Study type: Observational

Summary: 
      Rebion (Rebiscan, Inc) has developed a noninvasive, handheld device that uses retinal
      birefringence scanning (RBS) to rapidly assess eye fixation and retinal integrity in adults
      and children. The proprietary technology uses a scanned annulus of polarized laser light to
      create a signature that confirms central fixation within seconds. The project described
      herein aims to provide accurate assessment of brain dysfunction in TBI (Traumatic Brain
      Injury) patients through the use of the developed device, which is called the Head and
      Intraocular Trauma Test (HITT) device.
    


Intervention name(s): HITT device
Intervention type(s): Device
Intervention description(s): Rebion has developed a noninvasive, handheld device that uses retinal polarization scanning (RPS) to rapidly assess eye fixation and retinal integrity in adults and children. RPS can automatically detect the fixation of the human eye with proprietary technology that uses a scanned annulus of polarized laser light to create a signature that confirms central fixation within seconds. RPS requires no calibration or imaging, and eye movement recordings are not required. The HITT device is a repurposed Pediatric Vision Scanner (PVS), Rebion's first commercial product which has passed all applicable safety and performance standards.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cohort study of individuals tested with the Rebion device followed by SCAT3 examination.
        Two data sets will be taken and compared: a cohort with non-contact sport athletes
        (swimmers, tennis, track) and a cohort of contact sport athletes (lacrosse, spring
        football, and spring soccer).
The Addition of Sufentanil Interscalene Block in Shoulder Surgery
Condition: Postoperative Pain; Shoulder Surgery
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the effects and side effects of interscale block
      performed with Naropin 0.1% cum sufentanil or Naropin 0.1% in shoulder surgery.
    

Detailed description: 
      The purpose of this study is to compare the duration of postoperative analgesia and
      supplemental opioid consumption and side effects of interscale block performed with Naropin
      0.1% cum sufentanil or Naropin 0.1% in shoulder surgery
    

Intervention name(s): Naropin 0.1% cum sufentanil
Intervention type(s): Drug
Intervention description(s): 20ml of Naropin 0.1% cum sufentanil 1mikrog per ml
Other intervention name(s): Local analgetic; Ropivacain
Intervention MeSH terms: Sufentanil; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Efficacy, Safety, Tolerability and Pharmacokinetics of KAF156 in Adult Patients With Acute, Uncomplicated Plasmodium Falciparum or Vivax Malaria Mono-infection
Condition: Malaria
MeSH terms: Malaria; Malaria, Vivax
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria
      patients with P. vivax or P. falciparum infection after 3 day dosing with KAF156 at 400
      mg/day (Part 1) and single dosing with KAF156 at 800mg (Part 2)
    


Intervention name(s): KAF156
Intervention type(s): Drug
Intervention description(s): KAF156 was supplied as tablets for oral use.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute malaria, KAF156
A Study of the Safety and Efficacy of Patients With Familial Hypercholesterolaemia Taking Colesevelam as add-on Therapy to Their Existing Medication
Condition: Familial Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to assess whether colesevelam given as third line treatment added to a
      maximal tolerated and stable dose of a statin and ezetimibe is able to further decrease the
      level of LDL cholesterol in a safe and efficient manner in difficult to treat Familial
      Hypercholesterolaemia patients who are not at their target level of LDL cholesterol.
    


Intervention name(s): Colesevelam hydrochloride film-coated tablets; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): tablets; Tablets
Other intervention name(s): Cholestagel
Intervention MeSH terms: Colesevelam Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Meditation for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Major Depressive Disorder (MDD) is a serious, costly and highly prevalent condition. However,
      currently available treatment options have limited efficacy. The aim of this pilot study is
      to determine whether patients suffering from MDD who have not responded to at least one
      antidepressant trial may actively engage in a novel group therapy, Central Meditation and
      Imagery Therapy (CMIT). Preliminary results with individual patients suggest that CMIT
      techniques may have benefit for major depression. The purpose of this trial is to assess the
      feasibility of a group form of CMIT for the treatment of major depression. The trial will
      also seek to identify neurophysiological and cardiovascular predictors of treatment response.

      In this study, 10 subjects with major depressive disorder will receive antidepressant
      treatment augmentation with group meditation and mental imagery therapy for a total of 12
      weeks, as well as daily meditation practice. Group sessions will also involve gentle yogic
      stretches. The subjects will be limited to those who remain depressed despite at least one
      trial of antidepressant medication. Changes in brain activity and heart rate variability will
      be measured at three time points utilizing electroencephalography (EEG) and pulse monitors.
      Depression symptoms will be measured at several time points using questionnaires and
      objective measures. Participation will require a total of 15 visits for weekly therapy and
      the measurements. Two-month follow-up questionnaires will be mailed to the subjects after
      study end to assess durability of any improvements in depressive symptoms.
    


Intervention name(s): Central Meditation and Imagery Therapy
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; Guided Imagery; Psychotherapy; Meditation
A Clinical Study to Evaluate PK, PD, and PG of Rosuvastatin in the Elderly
Condition: Elderly
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical study to evaluate pharmacokinetic, pharmacodynamic, and pharmacogenomic
      characteristics of Rosuvastatin in the elderly after multiple administration of Rosuvastatin
    


Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention description(s): Open-label, one-sequence, multiple administration
Other intervention name(s): Rosuvastatin 20 mg
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 3/4 Study of a Recombinant Protein-Free Factor VIII (rAHF-PFM): Comparison of Continuous Infusion Versus Intermittent Bolus Infusion in Hemophilia A Subjects Undergoing Major Orthopedic Surgery
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the hemostatic efficacy and safety of continuous
      infusion versus intermittent bolus infusion in the peri- and post-operative setting,
      employing rAHF-PFM, a recombinant antihemophilic factor manufactured without added human or
      animal proteins, in previously treated patients with severe or moderately severe hemophilia A
      (baseline factor VIII level <= 2% of normal) who are undergoing unilateral major orthopedic
      surgery that requires drain placement. The total study period per subject (from consent to
      study completion) will vary from approximately 9 to 26 weeks and will involve clinical and
      laboratory assessments.
    


Intervention name(s): Recombinant Protein-Free Factor VIII (rAHF-PFM); Recombinant Protein-Free Factor VIII (rAHF-PFM)
Intervention type(s): Drug; Drug
Intervention description(s): An initial loading dose will be administered intravenously over a period <= 5 minutes (maximum of infusion rate of 10 mL/minute) within 60 minutes prior to surgery dose in order to maintain a minimum target FVIII level of at least 80% of normal.
CI will start prior to surgery as soon as the loading dose has been administered, at a rate calculated according to a formula provided by the sponsor.
All study product must be administered with a syringe pump running at an infusion rate according to the dosing regimen, but always >= 0.4 mL/h.; The treatment schedule for intermittent BI of rAHF-PFM will begin with the administration of the loading dose according to the dose recommendations provided by the sponsor. If required by the hemostatic challenge, additional boluses may be administered after a blood sample for FVIII determination has been drawn. All infusions of rAHF PFM will be given over a period <= 5 minutes (maximum infusion rate, 10 mL/min).
Intervention MeSH terms: Factor VIII
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemophilia A (severe or moderately severe)
Phototoxicity Test of Dapsone Gel in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the potential of dapsone gel and its vehicle to cause a phototoxic
      reaction following irradiation of the skin under controlled conditions.
    


Intervention name(s): dapsone gel; dapsone gel vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Patches containing dapsone gel will be applied to the skin.; Patches containing dapsone gel vehicle will be applied to the skin.
Intervention MeSH terms: Dapsone
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Brentuximab Vedotin Prevention of (GVHD) After Unrelated Allogeneic Stem Cell Transplantation
Condition: Leukemia, Acute Myeloid; Leukemia, Lymphoblastic,Acute; Myelodysplastic Syndromes
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot clinical trial studies the safety and maximum tolerated dose of brentuximab
      vedotin when given with tacrolimus and methotrexate after unrelated allogeneic donor stem
      cell transplant in patients with acute myeloid leukemia, acute lymphoblastic leukemia, or
      myelodysplastic syndromes. The addition of brentuximab vedotin to tacrolimus and methotrexate
      may result in a significant reduction of graft versus host disease in these patients.
    


Intervention name(s): brentuximab vedotin
Intervention type(s): Drug
Other intervention name(s): Adcetris
Intervention MeSH terms: Brentuximab Vedotin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Breakfast Composition on Glycemic and Incretin Responses in Individuals With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study examined the effect of a high protein or high carbohydrate breakfast on the
      glucose and insulin response following the breakfast meal, as well as the subsequent response
      following the lunch meal.
    

Detailed description: 
      Twelve habitual breakfast consumers with type 2 diabetes (T2D) were recruited for the study.
      They completed two, 7-day conditions in random order with a minimum of a 7-day washout period
      between study days. They consumed either a high protein (PRO) or high carbohydrate (CHO)
      breakfast for 6 days of acclimatization, and on the seventh day, they reported to the lab at
      0700 hours following a ~12 hour overnight fast and underwent forearm catheterization before a
      baseline blood draw. The participants consumed the respective breakfast at ~0730 hours. Four
      hours post-breakfast, subjects consumed a standard lunch meal. Blood samples were taken
      continuously throughout the 8-hour test day.
    

Intervention name(s): High protein breakfast; High carb breakfast
Intervention type(s): Other; Other
Intervention description(s): a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat); a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: GLP-1; GIP; second meal phenomena; type 2 diabetes
Pharmacokinetic Study to Investigate Low-dose Combinations of a Cocktail of Seven Drugs for Simultaneous Phenotyping of Cytochromes
Condition: Cytochrome; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess whether a cocktail of seven approved drugs (so-called
      "Basel cocktail") can be used for simultaneous phenotyping of CYP1A2, CYP2B6, CYP2C9,
      CYP2C19, CYP2D6, CYP2E1 and CYP3A4.
    


Intervention name(s): caffeine, efavirenz, losartan, omeprazole, metoprolol, chlorzoxazone and midazolam
Intervention type(s): Drug
Intervention MeSH terms: Efavirenz; Losartan; Metoprolol; Midazolam; Caffeine; Chlorzoxazone; Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Cognitive Therapy in Reducing Depression in Patients With Cancer
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to learn about treatment of depression in people who have any
      type of cancer. Cognitive therapy (CT) helps improve depressive symptoms by targeting
      patient's thoughts and behaviors. People who are depressed tend to have more negative or
      pessimistic thoughts. CT helps people evaluate the accuracy of their thoughts. By encouraging
      patients to develop more balanced views, symptoms of depression begin to improve
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Determine the efficacy of biobehavioral/cognitive therapy for cancer patients/survivors
      with major depression.

      II. Test for the covariation between reduction in depressive symptoms and improvements in
      quality of life.

      OUTLINE:

      Patients undergo cognitive behavioral therapy comprising progressive muscle relaxation
      training, behavioral activation, seeking information as a coping strategy, enhancing social
      support, cognitive reappraisal, assertive communication, changing depressive core beliefs,
      goal setting and planning for maintenance, and maintenance over 1 hour once weekly sessions
      for 12-20 weeks, biweekly sessions for 4-6 weeks, and monthly sessions for 2-3 months for a
      total of 16-26 sessions.

      After completion of study treatment, patients are followed up at 3, 6, and 12 months.
    

Intervention name(s): quality-of-life assessment; questionnaire administration; counseling intervention; behavioral intervention
Intervention type(s): Procedure; Other; Other; Behavioral
Intervention description(s): Ancillary studies; Ancillary studies; Undergo cognitive behavioral therapy; Undergo cognitive behavioral therapy
Other intervention name(s): quality of life assessment; counseling and communications studies; Behavior Conditioning Therapy; Behavior Therapy; Behavioral Modification; Behavioral Therapy; Behavioral Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Depression
Consistency of Questionnaires to Evaluating Sexual Functions in Young Healthy Women
Condition: Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Physical Activity
MeSH terms: Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological
Study type: Interventional

Summary: 
      The sample comprised 31 female undergraduate students attending a private University in João
      Pessoa, northeastern Brazil. The inclusion criteria were: age between 19 and 35 years,
      heterosexual, active sex life, living in a stable relationship for at least 6 months no
      pregnancy or parturition in the last 6 months, clinically healthy and agreeing with the terms
      for participating in the study. All participants gave their informed consent to take part in
      the study.
    

Detailed description: 
      PURPOSE: To compare the consistency of 3 instruments for sexual function evaluation in
      healthy young women before and after a pelvic floor muscle training. Methods: Thirty-one
      healthy young women were enrolled in an 8-week training program, consisting of bipedal
      exercises performed at home. The PERFECT and Peritron methods were used to estimate the
      efficacy of the intervention on pelvic muscles. Three questionnaires (FSFI, SQ-F and GRISS)
      were applied to assess sexual function. Both procedures were performed on three occasions:
      before, 4 and 8 weeks after the start of the training program. ANOVA for repeat measures and
      Tukey's post hoc were applied to analyze PERFECT and Peritron results, as well as individual
      domains and total scores of the questionnaires. The accuracy measured by the area under the
      ROC curve (AUC) for individual domains of each questionnaire and cross-validated pairwise
      comparison of the three instruments were also analyzed.
    

Intervention name(s): Exercise program for pelvic muscle floor
Intervention type(s): Other
Intervention description(s): Pelvic muscles of each participant was evaluated by PERFECT and Peritron methods in terms of strengthening as well as sexual function response using 3 questionnaires, before and after 4 and 8 weeks from the beggining of an exercise program prescribed according to individual ratings obtained in the previous evaluation.
Intervention model: Single Group Assignment
Intervention model description: Perineal floor muscle performance and participants' sexual functions were evaluated in three successive situations: (1) Initial evaluation; (2) after 4 weeks (intermediate evaluation), and (3) 8 weeks (final evaluation) from the start of the training program.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pelvic Floor muscles; Physical Therapy; Sexual function evaluation
A Thorough ECG Study in Subjects With Acne Vulgaris Treated With SB204
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      A Double-Blind, Double-Dummy, Randomized, 4-Period Crossover Study to Define the ECG Effects
      of SB204 Using a Clinical and Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a
      Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study
    

Detailed description: 
      A Double-Blind, Double-Dummy, Randomized, 4-Period, Crossover Study to Define the ECG Effects
      of SB204 Using a Clinical and a Supratherapeutic Dose Compared with Placebo and Moxifloxacin
      (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study
    

Intervention name(s): SB204 4%; SB204 8% or 12%; Vehicle
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Applied topically once; Applied once topically; Applied topically once
Other intervention name(s): NVN1000; NVN1000; Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Gastric Antral Botulinum Toxin Injections in Obese Subjects
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      Obesity is an important public health problem in the United States. The investigators
      hypothesize that stomach injections of botulinum toxin A (BTA), delivered through an
      endoscope using endoscopic ultrasound (EUS), may cause delayed gastric emptying, satiation,
      and reduction in body weight. This protocol is designed to study the effects and safety of
      gastric BTA injections. Subjects are randomized to receive placebo or one of two different
      doses of BTA injected into the stomach during one endoscopy, performed via the mouth. Gastric
      emptying, satiation, symptoms, psychological dimensions of eating behavior, and caloric
      intake are recorded before and after injections, and subjects are seen in follow-up for 24
      weeks.
    

Detailed description: 
      Additional information regarding study interventions can be obtained by contacting study
      staff.
    

Intervention name(s): BTA; Placebo (normal saline)
Intervention type(s): Drug; Drug
Intervention description(s): BTA 100 or 300 U, endoscopic ultrasound (EUS) guided injections into gastric antrum; Placebo (normal saline), gastric injections of normal saline
Other intervention name(s): Botox
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Gastric Emptying; Satiation; Endosonography; Endoscopy; Feeding Behavior
Bed Rest, Inactivity and Early Responses
Condition: Metabolic Responses to Inactivity
Study type: Interventional

Summary: 
      To evaluate the early metabolic responses (whole body and within muscle tissue) to a single
      day of whole body physical inactivity (i.e. bed-rest), and evaluate the contribution of
      inactivity per se vs alterations in diet
    


Intervention name(s): Physical inactivity
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Dose-Response of Exercise on Long-Term Weight Loss
Condition: Obesity; Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose is to examine varying durations and intensities of exercise on long-term weight
      loss.
    


Intervention name(s): behavior weight loss
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment