bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Tailored Cognitive-Behavioral Therapy for Chronic Back Pain
Condition: Back Pain
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      This clinical trial compares two psychological treatments for back pain.
    

Detailed description: 
      The primary objective is to examine the incremental efficacy of a patient-centered and
      tailored self-management treatment approach, Tailored Cognitive-Behavior Therapy (TCBT), for
      persons with chronic musculoskeletal pain. TCBT will be compared with a Standard Cognitive-
      Behavior Therapy (SCBT) condition. The hypothesis is that TCBT will be associated with
      improved outcomes following treatment. Outcome will be assessed by multiple standardized
      measures of key domains of the chronic pain experience. Secondary objectives are to examine
      the process of successful self-management treatment.
    

Intervention name(s): tailored cognitive behavior therapy; standard care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): tailored psychological treatment; standard psychological treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chronic back pain; cognitive-behavioral; pain; stages of change
Efficacy/Safety of Vildagliptin and Metformin Combination Therapy in Patients With Type 2 Diabetes Not Well Controlled With Metformin Alone
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the efficacy and safety of vildagliptin in combination
      with metformin 500 mg bid compared to metformin 1000 mg bid in patients with type 2 diabetes.
    


Intervention name(s): Vildagliptin; metformin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Type 2 diabetes; vildagliptin; hemoglobin A1c; metformin
Bioequivalence Study of Favipiravir From Flupirava 200 mg Tablet (European Egyptian Pharmaceutical Industries , Egypt) Versus Avigan 200 mg Tablets (Man. by Toyama Chemical Co., Ltd Japan)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label randomized, single dose, two-way crossover bioequivalence study to determine
      the bioequivalence of Favipiravir from Flupirava 200 mg tablet (European Egyptian
      Pharmaceutical Industries, Egypt) versus Avigan 200 mg Tablets (Man. by Toyama Chemical Co.,
      Ltd Japan) in Healthy Human Volunteers Under Fasting Condition.
    

Detailed description: 
      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Flupirava; Avigan
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet contains 200 mg Favipiravir; 1 tablet contains 200 mg Favipiravir
Other intervention name(s): Avigan
Intervention MeSH terms: Favipiravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of Lasmiditan and Propranolol in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the effects on heart rate and blood pressure when a single dose of
      lasmiditan is administered with a daily dose of propranolol. This study will also measure how
      much lasmiditan gets into the bloodstream after taking lasmiditan alone and after taking it
      together with propranolol. The study will also look at how well both drugs are tolerated.
      Information about any side effects that may occur will be collected.

      This study will last approximately 45 days including screening. This study will require 13
      days/12 nights in a Clinical Research Unit (CRU) followed by 1 follow-up appointment
      approximately 7 days after the last dose. Screening is required within 28 days prior to the
      start of the study.

      This study is for research purposes only and is not intended to treat any medical condition.
    


Intervention name(s): Lasmiditan; Propranolol
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY573144
Intervention MeSH terms: Propranolol; Lasmiditan
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluating Vitamin D Content in Mushrooms
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      This study will evaluate how much vitamin D is present in a mushroom supplement. This
      supplement contains an extract from mushrooms that have been exposed to sunlight. The
      mushroom supplement will be compared to non-commercially available vitamin D supplements
      produced in a Goo Manufacturing Practices (GMP)-licensed facility.
    

Detailed description: 
      Mushrooms have the capability to produce vitamin D in a similar way to human skin. When
      exposed to ultraviolet light, mushrooms will convert a precursor to vitamin D. This reaction
      produces large amounts of vitamin D. This study is comparing a natural source of vitamin D to
      a synthetic source of vitamin D and will help determine if mushrooms are a novel source for
      this essential nutrient.
    

Intervention name(s): Mushroom Vitamin D2; Cholecalciferol; Vitamin D2 - Ergocalciferol; Mushroom Extract
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 2000 IU vitamin D2 in a mushroom extract, once/day for 12 weeks; 2000 IU crystalline cholecalciferol once/day for 12 weeks; 2000 IU vitamin D2, ergocalciferol once/day for 12 weeks; Same quantity of mushroom extract in a capsule
Other intervention name(s): Ergocalciferol; Ercocalciferol
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Treatment of Post Traumatic Stress Disorder in Patients With Other Mental Illnesses
Condition: Stress Disorders, Post-Traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to develop an effective treatment for people with Post Traumatic
      Stress Disorder (PTSD) along with other mental illnesses.
    

Detailed description: 
      Despite the progress in treating PTSD in the general population and the elevated prevalence
      of PTSD in people with severe mental illness (SMI), there are no empirically validated
      treatments designed for patients with comorbid PTSD. The cognitive behavioral treatment
      provided in this study may improve knowledge of PTSD, decrease distorted beliefs, reduce PTSD
      symptoms, and improve quality of life.

      Participants are randomly assigned to receive either a cognitive behavioral treatment plus
      standard care for SMI or standard care alone. The cognitive behavioral treatment incorporates
      several common features, including psychoeducation, relaxation training, and cognitive
      restructuring. Standard care for SMI includes medication, case management, and psychosocial
      treatment. PTSD, psychiatric symptoms, health, quality of life, and substance abuse outcomes
      are measured. Participants' knowledge of PTSD and beliefs about the world are also measured.
      Participants are assessed at baseline, post-treatment (16 weeks), and at 3- and 6-month
      follow-ups.

      For information on a related study, please follow this link:

      http://clinicaltrials.gov/show/NCT00494650
    

Intervention name(s): Cognitive Behavior Treatment
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Comorbidity; Schizophrenia; Bipolar Disorder; Depression
A Comparison Between Child-Pugh and Albumin-Bilirubin Scores
Condition: Rupture, Spontaneous; Rupture Liver; Hepatocellular Carcinoma; Hepatic Impairment
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Rupture, Spontaneous; Rupture
Study type: Observational

Summary: 
      To compare Child-Pugh and Albumin-Bilirubin scores in patients with spontaneous rupture of
      hepatocellular carcinoma
    

Detailed description: 
      To compare Child-Pugh and Albumin-Bilirubin scores in patients with spontaneous rupture of
      hepatocellular carcinoma. And to determine which is better in predicting long-term survival
      and short-term survival.
    

Intervention name(s): Liver resection; Transcatheter arterial embolization
Intervention type(s): Procedure; Other
Intervention description(s): Liver resection was comprised of single or multiple liver resections aiming to excise all macroscopic tumors.; Transcatheter arterial embolization or transcatheter arterial chemoembolization can localize the bleeding point and provide interventional embolization.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From January 2005 to August 2015, all patients complied with the criteria mentioned above
        who received surgical treatment or non-surgical treatment at the investigator's center were
        included in this study.
      
Keywords: Spontaneous rupture; survival; hepatocellular carcinoma; Child-Pugh; Albumin-bilirubin
Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder
Condition: Depression; Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER
      relative to placebo in the prevention of depression relapse in patients with major depressive
      disorder (MDD).
    

Detailed description: 
      Patients who demonstrate improvement in depressive symptoms at the end of the initial 12-week
      open-label treatment period with Levomilnacipran ER are randomized to continue
      Levomilnacipran ER or switch to placebo under double-blind conditions for up to 24 weeks of
      additional treatment.
    

Intervention name(s): Levomilnacipran ER; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.; Matching placebo to be given orally, in capsule form, once daily.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate Nicotine Uptake and Biomarkers in Adult Smokers Using mybluTM Electronic Cigarettes
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This study evaluates the overall performance of the currently-marketed MybluTM e-cigarette
      device and pods, as assessed by nicotine uptake, exposure to smoke constituents, safety and
      consumer satisfaction, over 8 days. The study is designed as an open-label, randomized study
      in adult smokers.

      Subjects are invited to participate to a second part of the study, for 5 additional days, to
      compare the use of MybluTM to the use of subject's usual brand combustible cigarettes.
    


Intervention name(s): Myblu flavor A_2.4; Myblu flavor B_2.4; Myblu flavor C_2.4; Myblu flavor D_2.4; Myblu flavor E_1.2; Myblu flavor F_1.2; Myblu flavor G_2.4; Myblu flavor H_2.4
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine; Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine; Use of Myblu e-cigarette with flavor C at 2.4% nicotine; Use of Myblu e-cigarette with flavor D at 2.4% nicotine; Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine; Fse of Myblu e-cigarette with flavor F at 1.2% nicotine; Use of Myblu e-cigarette with flavor G at 2.4% nicotine; Use of Myblu e-cigarette with flavor H at 2.4% nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Determine the Bioavailability and Food Effect of a Single TAK-935 Dose in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the relative bioavailability (BA) of 300 milligram
      (mg) TAK-935 tablets compared to 300 mg of TAK-935 solution and to determine the effect of
      food on the BA of TAK-935 300 mg tablets in healthy adult participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-935. The study will look at the relative BA
      of TAK-935 300 mg tablets compared to a TAK-935 300 mg oral solution and will assess the
      effect of food on the BA of TAK-935 300 mg tablets in healthy adult participants.

      The study will enroll approximately 9 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to one of the 3 treatment sequences:

        -  TAK-935 (300 mg Tablets Fed + 300 mg Tablets Fasted + 300 mg Solution Fasted)

        -  TAK-935 (300 mg Tablets Fasted + 300 mg Solution Fasted + 300 mg Tablets Fed)

        -  TAK-935 (300 mg Solution Fasted + 300 mg Tablets Fed + 300 mg Tablets Fasted)

      Administration of each dose will be separated by a washout period of at least 3 days.
      Participants will be asked to take single dose of TAK-935 tablet or oral solution on Day 1 of
      each Intervention Period.

      This single center trial will be conducted in the United States. The overall time to
      participate in this study is 39 days. Participants will remain confined to the clinic from
      Day 1 of Intervention Period 1 to Day 3 of Intervention Period 3 and will be contacted by
      telephone 30 days after last dose of TAK-935 for a follow-up assessment.
    

Intervention name(s): TAK-935 Tablets; TAK-935 Oral Solution
Intervention type(s): Drug; Drug
Intervention description(s): Tablets; Oral solution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
Effect of Exercise on the Disease Activity of Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional

Summary: 
      This study will evaluate the effect of exercise on the number of swollen and tender joints
      associated with rheumatoid arthritis after a 12 week exercise program of treadmill walking
      and weightlifting.
    

Detailed description: 
      The goal of this study was to evaluate the effect of exercise on the number of swollen and
      tender joints associated with rheumatoid arthritis. It was hypothesized that persons would
      have less inflammation associated with rheumatoid arthritis after a 12 week exercise program
      of treadmill walking and weighlifting. Immune parameters were measured to determine potential
      mechanisms responsible for changes in inflammation with exercise.
    

Intervention name(s): Aerobic and resistance exercise training
Intervention type(s): Other
Intervention description(s): Exercise was performed 3 times per week. It consisted of 30 minutes of treadmill exercise at approximately 85% of heartrate max and 2 sets of 6 resistance weight lifting exercises resulting in volitional fatigue at 12 to 15 repetitions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise; disease activity; inflammation; resistance training; rehabilitation
Carboplatin With or Without Gemcitabine in Treating Patients With Advanced Ovarian Epithelial Cancer That Has Not Responded to Previous Chemotherapy
Condition: Ovarian Cancer
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
      yet known if carboplatin is more effective with or without gemcitabine for ovarian epithelial
      cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin with or
      without gemcitabine in treating patients who have advanced ovarian epithelial cancer that has
      not responded to previous chemotherapy.
    

Detailed description: 
      OBJECTIVES:

        -  Compare time to progression in patients with advanced ovarian epithelial carcinoma who
           failed prior first-line platinum-based therapy when treated with carboplatin with or
           without gemcitabine.

        -  Compare response rate, duration of response, and survival time of patients treated with
           these regimens.

        -  Compare the toxicity of these treatment regimens in these patients.

        -  Compare quality of life of patients treated with these regimens.

      OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
      according to progression-free time (6-12 months vs more than 12 months), type of prior
      first-line therapy, and bidimensionally measurable disease (yes vs no). Patients are
      randomized to one of two treatment arms.

        -  Arm I: Patients receive carboplatin IV over 30-60 minutes on day 1 and gemcitabine IV
           over 30-60 minutes on days 1 and 8.

        -  Arm II: Patients receive carboplatin IV as in arm I. Treatment in both arms repeats
           every 3 weeks for up to 6-8 courses in the absence of disease progression or
           unacceptable toxicity.

      Quality of life is assessed at baseline, before each subsequent chemotherapy course, and at
      50 days after study.

      Patients are followed at 50 days, every 2 months for 1 year, and then every 3 months for 1
      year.

      PROJECTED ACCRUAL: A total of 350 patients will be accrued for this study.
    

Intervention name(s): carboplatin; gemcitabine hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Carboplatin; Gemcitabine
Allocation: Randomized
Primary purpose: Treatment
Keywords: recurrent ovarian epithelial cancer
A Case-Control Study to Verify Diagnostic Performance of AminoIndex™ Technology
Condition: Lung Cancer
Study type: Observational

Summary: 
      This is a prospective, multi-center study to evaluate the diagnostic performance
      characteristics of the AminoIndex™ technology among patients at high risk for developing lung
      cancer as compared with standard lung cancer screening and diagnostic procedures including
      low-dose CT, high-dose CT, biopsy and histopathology.
    

Detailed description: 
      This is a prospective, multi-center study to evaluate the diagnostic performance
      characteristics of the AminoIndex™ technology among patients at high risk for developing lung
      cancer as compared with standard lung cancer screening and diagnostic procedures including
      low-dose CT, high-dose CT, biopsy and histopathology.

      The study will enroll patients into one of three arms:

        1. patients with lung nodule(s) ≥ 6 mm but ≤ 35 mm that have been biopsied and diagnosed
           with primary lung cancer who have not yet initiated treatment of any kind for their lung
           cancer;

        2. patients with lung nodule(s) ≥ 6 mm but ≤ 35 mm that have been biopsied and determined
           to not be cancerous OR that have demonstrated no nodule growth for > 2 years by repeat
           CT imaging; and

        3. patients at high-risk for lung cancer (per NLST guidelines) with no evidence or history
           of lung cancer (negative LDCT/CT/X-ray).
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study will enroll sufficient subjects to yield a minimum of 60 subjects in Study Group 1,
        30 subjects in Study Group 2 and 60 subjects in Study Group 3 - a total of 150 evaluable
        study subjects who meet all inclusion and exclusion criteria. Eligible subjects will be men
        and women age ≥ 18 years for Group 1 and 2 and 55 - 79 years inclusive for Group 3. Group 3
        study subjects must also meet NLST guidelines of being at high risk for lung cancer:
        greater than or equal to a 30 pack year smoking history (equivalent of 1 pack per day for
        30 or more years) and a current smoker or quit less than 15 years ago.
      
Biospecimen description: 
      Subjects will consent to archiving and future analysis of their blood samples for up to
      twenty (20) years.
    
Keywords: Neoplasms, Lung; Pulmonary Neoplasms; Pulmonary Cancer
Histologic Evaluation of Healing Following Tooth Extraction With Ridge Preservation Using NuOss XC and NuOss Particulate
Condition: Oral Ridge Preservation
Study type: Observational

Summary: 
      This study histologically evaluates sites grafted with NuOss XC using ridge preservation
      techniques prior to placement of dental implants. Sites grafted with NuOss XC (bovine bone
      mineral with self-expanding collagen) will be compared to sites grafted with NuOss
      particulate (bovine bone mineral).
    

Detailed description: 
      Patients presenting to the University of Oklahoma College of Dentistry Graduate Periodontics
      Clinic who are treatment planned for tooth extraction and placement of dental implant(s) will
      be interviewed for possible participation in the study. Forty extraction sites will be
      included in this study to provide statistical significance.

      The ridge preservation sites, using either NuOss XC or NuOss particulate, will be selected
      randomly. The first site will be selected using the flip of a coin. Thereafter, every other
      site will be grafted using NuOs XC. The ridge preservation procedure will involve tooth
      extraction with as little trauma as possible to preserve all four bony socket walls,
      curettage of the socket to remove all periodontal ligament fibers and granulation tissue,
      placement of the graft material into the socket and coverings the graft material with
      long-lasting collagen membrane. Facial and lingual mucoperiosteal flaps will be elevated to
      facilitate securing of the membrane with long-lasting absorbable sutures. Patient will be
      given prescriptions for analgesics and antibiotics as necessary.
    

Intervention name(s): NuOss XC
Intervention type(s): Device
Intervention description(s): NuOss XC is a bone grafting material that will be placed in extraction socket site.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Periodontal Clinic Population at the University of Oklahoma College of Dentistry
      
Biospecimen description: 
      Hard tissue histological evaluation
    
Keywords: Ridge Preservation; Dental Implant; Histology