bioihbjkbjnl/mcl2 huggingface dataset:
An Open Trial of Duloxetine on Comorbid Major Depression and Chronic Headache
Condition: Major Depression; Chronic Primary Headache
MeSH terms: Headache Disorders; Headache; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Although major depression and chronic headache are strongly associated, there is
      insufficient evidence on the use of antidepressants for this specific comorbidity. This trial
      aimed to investigate the efficiency and tolerability of duloxetine for this indication.

      Methods: Thirty outpatients of our clinic, with DSM-IV major depression and concurrent
      primary chronic headache (chronic migraine, chronic tension-type headache or both), 18-55
      years, were recruited from April 2006 to March 2007, if they scored >21 on the
      Montgomery-Äsberg Depression Scale (MADRS) and had no other significant clinical condition.
      Subjects received duloxetine 60 mg/day for 8 weeks. MADRS scores and a visual analog pain
      scale (VAS) were the co-primary outcome measures. WHO quality of life scale (WHOQoL BREF)
      scores and headache days/week were secondary outcome measures.Conclusion: In this preliminary
      open trial, duloxetine 60 mg/day was effective, fast acting and well tolerated for the
      treatment of comorbid major depression and chronic headache.
    


Intervention name(s): duloxetine
Intervention type(s): Drug
Intervention description(s): duloxetine 60 mg/d
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: major depression; chronic headache; antidepressant; duloxetine
Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations
Condition: Caloric Restriction; Exercise; Sleep
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to determine the effects of a single dose of testosterone
      undecanoate during and in recovery from simulated operational stress.
    

Detailed description: 
      This is a double-blind, randomized, placebo controlled trial in 32 physically active men
      exposed to 20 complete days (days 8-27) of simulated operational stress followed by 20
      complete days of recovery (days 29-48). After completing baseline testing (Phase 1),
      participants will be randomized to receive either a single intramuscular injection of
      testosterone undecanoate or an isovolumetric placebo (Day 8). The 20-day simulated
      operational stress (Phase 2) will be highly controlled (live-in study) and consist of 4
      successive cycles of undulating stress, starting with 2 consecutive days of low stress
      followed by 3 consecutive days of high stress. Low- and high-stress days will result from low
      and high militarily-relevant exercise-induced energy expenditures, adequate and restricted
      sleep (8 hours vs. 4 hours daily), and diet restriction to produce energy deficits. After
      completing Phase 2, participants will be released to resume their habitual physical activity
      routines and will be provided a controlled diet to consume (Phase 3), to assess recovery from
      sustained, severe operational stress.
    

Intervention name(s): Testosterone Undecanoate; Sesame Oil
Intervention type(s): Drug; Drug
Intervention description(s): single intramuscular injection of 750 mg testosterone undecanoate; single intramuscular injection of 750 mg sesame oil solution
Other intervention name(s): Aveed
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: testosterone; anabolism; muscle mass; military operational stress
Dysfunctional Hemoglobin CO-ox
Condition: Elevated Levels of Carboxyhemoglobin
Study type: Observational

Summary: 
      The study verifies accuracy of a new pulse co-oximeter in the presence of elevated
      carboxyhemoglobin levels.
    


Intervention name(s): Pulse Co-Ox
Intervention type(s): Device
Intervention description(s): Comparison of pulse co-oximeter to blood gas analyzer.
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adult volunteers
A Drug-Drug Interaction Study of GK Activator (2) and Simvastatin in Patients With Type 2 Diabetes.
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the potential pharmacokinetic interaction between GK Activator (2) and
      simvastatin, and the potential effect of simvastatin on the glucose-lowering effect of GK
      Activator (2) in patients with type 2 diabetes. Patients will be randomized to one of 6
      treatment sequences to receive single doses of a)GK Activator (2) 100mg po, b)simvastatin
      80mg po and c)GK Activator (2) 100mg + simvastatin 80mg po. Dosing will take place on study
      days 1, 8 and 15, and there will be a 7-14 day follow-up period after the last dose. The
      anticipated time on study treatment is <3 months, and the target sample size is <100
      individuals.
    


Intervention name(s): GK Activator (2); Simvastatin
Intervention type(s): Drug; Drug
Intervention description(s): 100mg po; 80mg po
Intervention MeSH terms: Simvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Performance Study Using the OptiScanner on Healthy Diabetics
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to demonstrate the accuracy of the OptiScanner glucose measurement.
      The accuracy of the test device will be determined using plasma samples collected directly
      from Type 1 and Type 2 Diabetics using the OptiScanner. Blood samples will simultaneously be
      collected and measured on YSI 2300 STAT PLUS (YSI) made by YSI Incorporated. These results
      will be compared to the OptiScanner's glucose measurement.
    


Intervention name(s): glucose and insulin IV to alter blood glucose
Intervention type(s): Other
Intervention MeSH terms: Insulin
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: glucose monitoring; diabetes; glucose monitoring in patients with diabetes
Single Rising Dose Study of BI 655066 in Patients With Moderate and Severe Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety, tolerability and efficacy of BI 655066 in male and female patients with moderate to
      severe psoriasis.
    


Intervention name(s): BI 655066 (very high i.v. dose); Placebo, i.v.; BI 655066 (high s.c. dose); BI 655066 (low i.v. dose); BI 655066 (high medium i.v. dose); BI 655066 (very low i.v. dose); BI 655066 (low s.c. dose); BI 655066 (high i.v. dose); Placebo, s.c.; BI 655066 (low medium i.v. dose)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single very high i.v. dose BI 655066; Single i.v. administration of placebo; Single high s.c. dose BI 655066; Single low i.v. dose BI 655066; Single high medium i.v. dose BI 655066; Single very low i.v. dose BI 655066; Single low s.c. dose BI 655066; Single high i.v. dose BI 655066; Single s.c. administration of placebo; Single low medium i.v. dose BI 655066
Other intervention name(s): ABBV-066; risankizumab; ABBV-066; risankizumab; ABBV-066; risankizumab; ABBV-066; risankizumab; ABBV-066; risankizumab; ABBV-066; risankizumab; ABBV-066; risankizumab; ABBV-066; risankizumab; ABBV-066; risankizumab
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ABBV-066; BI 655066; risankizumab
Pharmacokinetics and Safety of ASC16 Tablets in Healthy Volunteers in China
Condition: HCV
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the Pharmacokinetics and Safety of single dose of
      Ravidasvir and Danoprevir/r and repeated doses of Ravidasvir in combination with Danoprevir/r
      in healthy volunteers.
    


Intervention name(s): Danoprevir; Ritonavir; Ravidasvir; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23; Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23; Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23; Placebo
Other intervention name(s): ASC16(RDV)
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia
Condition: Androgenetic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      In this proof-of-concept study, the safety and efficacy of a solution formulation will be
      investigated in male subjects with androgenetic alopecia (AGA) after twice daily application
      for up to 26 weeks.
    


Intervention name(s): CB-03-01 solution; Minoxidil Solution 5%; Placebo solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Investigational drug solution; FDA approved marketed product; Vehicle solution
Other intervention name(s): cortexolone 17α-propionate
Intervention MeSH terms: Minoxidil; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: androgen; alopecia; CB-03-01; solution; topical
Effect Of Biomechanical Stimulation On Skeletal Health In Adolescent And Young Women With Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      This study will evaluate the effects of a novel, non-pharmacologic intervention for the
      prevention of deleterious changes in bone density and strength in adolescents with anorexia
      nervosa (AN), a disease commonly treated with extended periods of bed rest and
      immobilization. The primary focus of the trial is to conduct a prospective short-term
      intervention to prevent an uncoupling of bone turnover in inpatients hospitalized for AN, and
      to determine the long-term effects of a biomechanical intervention on skeletal health in
      ambulatory adolescents with AN.
    


Intervention name(s): Low-magnitude mechanical stimulation platform
Intervention type(s): Device
Intervention description(s): Low-magnitude mechanical stimulation platform
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: skeletal health; bone turnover; bone geometry; malnutrition
Evaluate the Effects of a Marine Lipid Oil Concentrate Formulation on Inflammation/Discomfort
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of the study is to assess the efficacy and safety of a Marine Lipid Oil
      Concentrate formulation on inflammation/discomfort and overall well-being in male and female
      subjects who are generally healthy
    

Detailed description: 
      This is an open-label, single-arm remote study to evaluate the effects of a Marine Lipid Oil
      Concentrate formulation on inflammation/discomfort and overall well-being in individuals who
      are generally healthy. Each subject will receive a specific dose of the study products to be
      taken once daily for a total of 60 days.

      Participants complete assessments and questionnaires.

      The primary objective is the evaluation of the change in the responses to the SF-36
      (Short-Form-36) Health Survey, Medical Symptoms questionnaire, Pain questionnaire and
      responses on an assessment form relative to baseline.

      Safety and tolerability will be evaluated through receipt of documentation and responses from
      the telephone contacts/emails as per protocol.
    

Intervention name(s): Marine Lipid Oil Concentrate Formulation; Dietary Supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Marine Lipid Oil Concentrate softgels; Dietary Supplement capsules
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: inflammation; Pain; Discomfort; Soreness
Clinical Performance of CAD/CAM Splint Materials
Condition: TMD
Study type: Interventional

Summary: 
      The goal of this clinical study is to compare the performance of computer aided designed and
      computer aided manufactured (CAD/CAM) occlusal splints with splints produced with
      conventional methods. The main questions this clinical study aims to answer are:

        -  Do CAD/CAM splints have the same therapeutic effect as the traditional splints ?

        -  Do CAD/CAM splints demonstrate better surface wear and fit and lower wear in opposing
           jaw than traditional splints ?

        -  Is objective pain evaluation of the patient better with CAD/CAM splints ?

      Participants were asked to use the splints for 6 months, 8 hours a day and come for follow-up
      appointments 3 times during this 6 month period:

        -  Delivery appointment

        -  First appointment: one week later after delivery appointment

        -  Last appointment: 6 months after delivery appointment Researchers compared CAD/CAM
           groups with traditional group to see the clinical performance of the CAD/CAM groups.
    

Detailed description: 
      24 patients applying to Istanbul University Faculty of Dentistry Department of Prosthodontics
      and diagnosed with Diagnostic Criteria/ Temporomandibular Disorders (DC/TMD) protocol were
      included in the study. The patients were randomly divided into 3 groups (n=8); PEEK group
      (PEEKG), PMMA group (PMMAG), and control group (CG). Dental stone casts of the upper and the
      lower jaws of the patients were obtained by condensation type silicone impression material
      and occlusal splints were fabricated in study groups with digital method (designed and
      milled, manufactured with CAD/CAM) either from PEEK blocks or PMMA blocks and in control
      group with traditional vacuum pressing machine and adapted by the clinician at chairside. The
      patients wore the splints for 6 months. Surface roughness, surface wear, fit of the splints
      and patient satisfaction as well as therapeutic effect of the splints were examined.
    

Intervention name(s): PEEK; PMMA; Traditional
Intervention type(s): Device; Device; Device
Intervention description(s): Participants receiving splints produced with CAD/CAM from PEEK blocks,; Participants receiving splints produced with CAD/CAM from PMMA blocks,; Participants receiving splints from vacuum forming system
Other intervention name(s): bite splints; PMMA splints; traditional splints
Intervention MeSH terms: Polymethyl Methacrylate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study is designed as a prospective, randomized, double-blind in-vivo study
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: occlusal splint; CAD/CAM splint; clinical performance
Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS)
Condition: ADHD NOS
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label study with daily doses up to 144 mg/day Strattera (atomoxetine) in the
      treatment of adults with attention deficit hyperactivity disorder not otherwise specified.
      The researchers hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to
      Strattera treatment and Strattera treatment (in doses of up to 120 mg/day or 1.5 mg/kg/day,
      whichever is less) in adults with ADHD NOS will be safe and well tolerated.
    

Detailed description: 
      Strattera (atomoxetine) is a non-stimulant specific norepinephrine reuptake inhibitor
      recently approved by the Food and Drug Administration for the treatment of child, adolescent
      and adult patients with ADHD. It is possible Strattera could be a viable alternative
      treatment for ADHD individuals. The purpose of this study is to assess the effectiveness,
      safety and tolerability of Strattera in adults with ADHD NOS. If this initial study shows
      promise, we will follow-up with a randomized clinical trial.

      The study includes:

        1. use of a six-week design to document the response rate,

        2. weekly assessments to document the impact of Strattera NOS on functional capacities,

        3. careful assessment of safety and tolerability.

      Primary outcomes measure symptom reduction.
    

Intervention name(s): Strattera (atomoxetine)
Intervention type(s): Drug
Intervention description(s): Up to maximum of 1.2mg atomoxetine/kg PO QD, or 120 mg atomoxetine PO QD (whichever is less).
Other intervention name(s): Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD NOS; Adults; Strattera (atomoxetine); Open-Label
Safety and Tolerability of 4 Different Dosage Strengths of BIBW 2992 Tablets to Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess pharmacokinetics incl. dose proportionality, safety and tolerability of 4
      different dosage strengths of BIBW 2992 tablets (final formulation of 20 mg, 30 mg, 40 mg, 50
      mg) administered as single doses to healthy male volunteers
    


Intervention name(s): BIBW 2992 MA2 - single rising dose
Intervention type(s): Drug
Intervention MeSH terms: Afatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Incidence of the Intravascular Injection During S1 Transforaminal Epidural Steroid Injection in Two Approaches: Anteroposterior Versus Oblique
Condition: Lumbosacral Radicular Pain
Study type: Interventional

Summary: 
      Lumbosacral transforaminal epidural steroid injection (TFESI) is helpful for the treatment of
      lumbosacral radicular pain, but in case of intravascular injection, infrequently serious
      complication can be developed. Against this backdrop, if there is any difference of frequency
      of intravascular injection incidence during S1 TFESI between method in anteroposterior view
      and method in oblique view using Scotty dog, the result can be crucial factor in selecting
      the approach. In addition, appropriate volume of injection will be checked in each approach.
    


Intervention name(s): anteroposterior approach group; oblique approach group
Intervention type(s): Procedure; Procedure
Intervention description(s): anteroposterior approach group (n=104): check intravascular injection while performing S1 transforaminal epidural steroid injection in anteroposterior view under fluoroscopy; oblique approach group (n=104): same as anteroposterior approach group except using oblique view
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Keywords: epidural injections, intravascular injection
Postural Effects of Being Rotated in a Whole Body Gyroscope
Condition: Falls; Balance; Movement Disorders
MeSH terms: Movement Disorders
Study type: Observational

Summary: 
      Subjects will be secured and rotated in a whole body gyroscope, similar to a flight trainer
      for astronauts. The rotations will be in many directions and the speed will be at 90 deg/sec.
      The effects of this rotation on the ability to stand upright will be measured.
    

Detailed description: 
      Computerized dynamic posturography (CDP) testing will be obtained after practice sessions on
      all subjects using a CAPS Pro system (Vestibular Technologies, Cheyenne WY, USA). All tests
      will be conducted with the subject standing on a perturbing foam cushion. Six different
      conditions will be tested in sequence without the subjects stepping away from the
      foam/platform in order to assess if the center of sway position changed with the changing
      test conditions: (1) Eyes Open Head Neutral, (2) Eyes Closed Head Neutral, (3) Eyes Closed
      Head Right, (4) Eyes Closed Head Left, (5) Eyes Closed Head Flexed, (6) Eyes Closed Head
      Extended. Subjects will be continuously rotated in a computer-controlled multi-axis chair
      (Gyrostim by UltraThera Technologies, Inc.) in combinations of whole body Pitch and Yaw
      simultaneously over a 40 second profile at 90 deg/sec (15 RPM). The acceleration rates to 90
      degrees per second as well as deceleration rates will be linear and occur in 1 second. We
      will utilize rotations that will represent all combinations of pitch and yaw with Pitch
      direction changing two times and Yaw direction four times (Backward Pitch -20 seconds with
      right Yaw-10 seconds to left Yaw-10 seconds, to Forward Pitch- 20 seconds with right Yaw-10
      seconds to left Yaw 10 seconds). Post rotational CDP testing will be compared to the Pre
      Rotational CDP,
    

Intervention name(s): Rotating Chair
Intervention type(s): Device
Intervention description(s): Subjects will be spun in rotating chair
Other intervention name(s): gyrostim
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Normal healthy volunteers without a history of vertigo or dizziness
      
Keywords: Posturography; Balance; Falls; Gyroscope; Rotational Chair; Vestibular; Movement Disorders
Swallowing Exercises for Nasopharyngeal Cancer After Radiation Therapy
Condition: Nasopharyngeal Cancer; Dysphagia
MeSH terms: Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma
Study type: Interventional

Summary: 
      This study is designed to investigate the treatment efficacy of 8 weeks swallowing exercise
      programs for patients with NPC after radiation therapy. This study also compares two
      different swallowing exercise: effortful swallow and Mendelsohn's maneuver, to see which one
      can bring more benefits to patients after a certain period of exercise training. Three
      assessment tools are selected to evaluate the study result: Mann Assessment of Swallowing
      Ability (MASA), videofluoroscopic swallowing study (VFSS), and Chinese version Swallowing
      Quality-of-Life Questionnaire (CSWAL-QOL). The hypothesis of this study is that the effortful
      swallowing exercise would have better treatment efficacy.
    


Intervention name(s): effortful swallowing exercise; Mendelsohn swallowing exercise
Intervention type(s): Other; Other
Intervention description(s): voluntarily increases the posterior tongue base pushing effort while swallowing; voluntarily increase the extent and duration of laryngeal elevation while swallowing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: radiation; speech-language pathology