bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of DBT Compared to Drug Counseling for Opiate Addicts
Condition: Opiate Addiction; Borderline Personality Disorder
MeSH terms: Opioid-Related Disorders; Personality Disorders; Borderline Personality Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to compare a one year treatment program of Dialectical Behavior
      Therapy (DBT) + suboxone for opiate addicted individuals meeting criteria for borderline
      personality disorder (BPD) to a one year program of standard drug counseling (I/GDC) +
      suboxone.
    

Detailed description: 
      The purpose of this study is to compare a one year treatment program of Dialectical Behavior
      Therapy (DBT) + suboxone for opiate addicted individuals meeting criteria for borderline
      personality disorder (BPD) to a one year program of standard drug counseling (I/GDC) +
      suboxone. Drug counseling consists of manualized individual sessions + group therapy. This
      trial is being completed at two sites, at the University of Washington and at Duke
      University. One hundred and seventy-two individuals (86 per condition) with opiate dependence
      and meeting criteria for BPD will be enrolled in a one-year treatment and a one-year
      follow-up assessment. Each site (University of Washington, Duke) will enroll 86 clients with
      both treatment conditions being conducted at each site. Assessments measuring drug use,
      suicidal behaviors, retention and other treatment-related behaviors, general psychopathology
      and functioning, and increases in behavioral skills will be given at four month intervals for
      the entire two years.
    

Intervention name(s): Dialectical Behavior Therapy; Drug Counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weekly individual DBT, DBT group skills training, as needed phone calls for coaching, team meeting for psychotherapists, suboxone; Weekly individual counseling and weekly group therapy following guidelines of drug counseling treatment manual,
Other intervention name(s): DBT; Individual and Group Drug Counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Opiate Dependence; DBT; Dialectical Behavior Therapy; Drug Counseling; Therapy, Cognitive Behavior
The Effect of an Exercise Program on the Health-quality of Life (HQL) in Older Adults
Condition: Healthy
Study type: Interventional

Summary: 
      The present study aimed to investigate the effect of exercise program on health-quality of
      life (HQL) in older adults.
    

Detailed description: 
      The questionnaire consisted of demographic data (such as age, gender, educational level, and
      employment) and the LEIPAD questionnaire used to measure HQL.
    

Intervention name(s): An exercise program
Intervention type(s): Other
Intervention description(s): The study subjects were recruited among those who responded to advertisements in outpatient clinics
Allocation: Randomized
Primary purpose: Health Services Research
Keywords: Exercise
The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients
Condition: Mastocytosis
MeSH terms: Mastocytosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Patients with mastocytosis often suffer from associated symptoms such as nausea, vertigo,
      fatigue, urticaria, abdominal cramps, diarrhea or hypotension due to release of mediators by
      mast cells. These patients have also an increased frequency of anaphylactic/anaphylactoid
      reactions due to allergens such as hymenoptera or nonspecific stimuli such as contrast media,
      local anesthetics or analgesics. In addition, there is increased osteoporosis in mastocytosis
      patients due to the activity of mast cell mediators on osteoblasts and osteoclasts. Symptoms
      of mastocytosis respond poorly to treatment with antihistamines or other antiallergic drugs.
      There is currently no specific treatment for this disease with the exception of rare cases.
      There are, however, some case reports suggesting that omalizumab might decrease symptoms
      including hypotensive events.

      The aim of the study is to investigate whether patients suffering from mastocytosis benefit
      from a 6 month course of omalizumab with regard to symptoms and quality of life and whether
      the applied in vitro and in vivo monitoring tools represent useful surrogate markers for the
      efficacy of omalizumab in patients with mastocytosis.

        -  Trial with medicinal product
    

Detailed description: 
      The study will take place as double-blind placebo controlled study. After a first a
      run-period of 2 months for all participants randomization (1:1) in two group will take place:

      Group A: With omalizumab treatment for 6 months; dosage and administration schedule according
      to body weight and total IgE level (1/2 of the patients). Group B: Placebo (1/2 of the
      patients). After 4 months of treatment in both groups patients are encouraged to stop all
      drugs given to reduce mast cell related effects, mainly antihistaminics . In case that
      disturbing symptoms are reoccurring patients are allowed to restart these drugs. The
      evaluation will take place after 5 months of treatment.

      Finally, a follow up visit 1 and 4 months after the study will take place.
    

Intervention name(s): injections
Intervention type(s): Drug
Intervention description(s): subcutaneous injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: mastocytosis; omalizumab
A Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a double-blind, prospective, randomized study in which patients will be randomized to
      1 of 4 treatment arms (3 active and 1 placebo).

      Each patient will receive two doses of active medication or placebo, with study drug
      administered intravenously (IV). The primary goal of the study is to assess the safety and
      tolerability of repeat administrations of REGN475 compared to placebo in patients with
      osteoarthritis (OA) of the knee.
    


Intervention name(s): REGN475; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 2 Administrations of REGN475 within 24 weeks.; Placebo to match REGN475 doses
Intervention MeSH terms: Fasinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cluster Analysis to Identify Metabolic Syndrome Components and Physical Fitness in Patients With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Observational [Patient Registry]

Summary: 
      The components of MetS (abdominal obesity, high blood pressure, high serum glucose, high
      triglyceride level and low HDL-C) differ according to demographic characteristics such as
      age, gender and comorbidities. Low physical activity level, genetic makeup, nutritional
      disorders, decreased muscle strength and low cardiorespiratory fitness can be counted among
      the risk factors associated with MetS. In our study, it was aimed to examine the relationship
      between the components of the MetS and muscle strength, physical activity, functional
      capacity and quality of life. Our secondary aim is to investigate the independent effects of
      different components of MetS on each parameter.
    

Detailed description: 
      The participants' sociodemographic characteristics such as age, height, weight, body mass
      index, waist circumference, marital status and education level, and anthropometric
      measurements, body fat percentage distributions, fasting blood glucose, HbA1c and lipid
      profiles will be recorded from previous analysis reports. Lower extremity quadriceps muscle
      strength Hand-held dynamometer, grip strength hand dynamometer, physical activity level
      International Physical Activity Questionnaire-Short Form-IPAQ-SF, number of steps pedometer,
      functional capacity 6 minute walking test and quality of life will be evaluated with the
      European Quality of Life Scale-5 Dimension.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Volunteers between the ages of 40-65, who have been diagnosed with MetS on the basis of
        type 2 diabetes for at least one year by an Internal Medicine Specialist, applying to the
        Department of Endocrinology and Metabolism Diseases, Department of Internal Medicine,
        Istanbul University, Istanbul Medical Faculty, will be included in the study.
      
Keywords: MetS, physical fitness, physical activity, cluster analysis
Safety and Efficacy of AIV001 on Low Risk Basal Cell Carcinoma
Condition: Superficial Basal Cell Carcinoma; Nodular Basal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Basal Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To evaluate safety and efficacy of AIV001 treatment on low-risk basal cell carcinoma.
    


Intervention name(s): AIV001
Intervention type(s): Drug
Intervention description(s): Intradermal/intratumoral
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nonmelanoma Skin Cancer; Keratinocyte Carcinoma; NMSC; BCC
Trial to Compare the Effects of Either Telmisartan (40-80 mg PO Once Daily) or Ramipril (5-10 mg PO Once Daily) on Renal Endothelial Dysfunction in Hypertensive Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Hypertension
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to evaluate the effect of 9 weeks treatment with either telmisartan
      or ramipril on NO bioavailability in the renal vasculature, measured as renal plasma flow
      (RPF) in response to NG-monomethyl-L-arginine (LNMMA) infusion.
    

Detailed description: 
      This study was designed as a randomised, double-blind, double-dummy, parallel group in
      hypertensive patients with type 2 diabetes and normo- or microalbuminuria over a treatment
      period of 9 weeks.

      After a 4 week Run-in period, patients will be randomised to one of the treatment groups and
      receive either Telmisartan 40 - 80 mg or Ramipril 5 - 10 mg. The treatment regimen is a
      forced titration with the lower dose given for 3 weeks and the higher dose given for the rest
      of the treatment period summing up to 9 weeks of treatment. During the treatment period, 3
      visits to the investigator will be scheduled in order to control blood pressure, renal
      function parameters and safety. In addition, parameters of endothelial function in the renal
      vasculature, based on a nephrological clearance investigation and a provocation with L-NMMA
      will be measured at baseline and after 9 weeks of treatment.

      Study Hypothesis:

      Due to the exploratory nature of the trial, the primary objective to evaluate the effect on
      RPF in response to L-NMMA infusion at baseline and after 9 weeks of therapy with either
      telmisartan 80 mg or ramipril 10 mg was not planned to be addressed by a test of prespecified
      hypotheses.

      Comparison(s):

      The change in RPF from baseline (Visit 4) to the end of treatment (Visit 7) in response to
      L-NMMA infusion was to be calculated as the change from the pre L-NMMA infusion (S1) to the
      end of the L-NMMA infusion (S2). A comparison of treatment groups was to be made using an
      analysis of covariance (ANCOVA) with pooled centre and treatment included as main effects and
      RPF (in response to L NMMA infusion) at baseline as a covariate. The treatment group
      difference, adjusted for the other factors in the model, was to be presented with a
      corresponding 95% confidence interval (CI) and a test of statistical significance. The model
      was also to be used to provide analysis results for the within treatment group changes.
    

Intervention name(s): Telmisartan; Ramipril
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan; Ramipril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Dose Finding Study Depigoid Phleum: 4 Doses in Patients With Allergic Rhinitis/Rhinoconjunctivitis +-Asthma
Condition: Allergic Rhinitis/Rhinoconjunctivitis +- Intermittent Asthma; Sensitization Against Phleum Pratense Pollen; Dose-Finding Study
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Conjunctivitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Specific immunotherapy for IgE mediated sensitization to grass pollen

      4 concentrations of a modified pollen extract of Phleum pratense are applied to find out the
      optimum dose.
    

Detailed description: 
      This is a dose finding study and no therapeutic study. Patients will receive in 4-weekly
      intervals 6x 0,5mL of one of 4 different concentrations of Depigoid Phleum. The study is
      performed outside the pollen season. Thus the aim of the study is not the therapeutic effect
      of the specific immunotherapy (effect on allergy specific symptoms during the pollen season)
      but the effect on the Conjunctival provocation test (CPT). According to the EMA "Guideline on
      clinical development of products for specific immunotherapy for the treatment of allergic
      diseases" provocation tests are accepted as primary outcomes for dose-finding studies.

      For the CPT increasing doses of Phleum pollen solutions are applied to the eye and
      characteristic symptoms (eye redness, weeping, itching or burning, and nose
      dripping/blockage) are assessed at each concentration: 0=absent, 1=mild, 2=moderate,
      3=severe. At a score value of >=5/concentration the test is considered positive and finished.

      It is expected that at the end of the study higher doses are necessary to provoke a positive
      CPT.

      Furthermore comparative evaluation of the safety data (AEs) in the different dosage groups is
      a very important parameter for the evaluation of the outcome of the study.
    

Intervention name(s): Depigoid Phleum
Intervention type(s): Biological
Intervention description(s): Suspension for subcutaneous injection Build-up phase (day 1): 0,1mL + 0,2mL + 0,2mL s.c.injections in intervals of 30 minutes Maintenance phase: 5x single s.c. injection of 0,5mL every 4 weeks
Other intervention name(s): Depigoid (R) Phleum; Depigmented and glutaraldehyde polymerized extract of 100% phleum pratense pollen adsorbed onto aluminium hydroxide)
Intervention MeSH terms: Aluminum Hydroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Allergic Rhinitis; Hayfever; Immunotherapy; Dose-Finding-Study
Telmisartan With or Without Hydrochlorothiazide in Patients With Mild-to-moderate Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to demonstrate that a fixed dose combination of telmisartan 80 mg plus
      hydrochlorothiazide (HCTZ) 12.5 mg (FDC 80/12.5) is superior to telmisartan 80 mg (Telm 80)
      alone in patients who failed to respond adequately to Telm 80 monotherapy in lowering seated
      trough diastolic blood pressure (DBP) after eight weeks of treatment.
    


Intervention name(s): Telmisartan; Telmisartan/Hydrochlorothiazide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Hydrochlorothiazide; Telmisartan; Telmisartan, hydrochlorothiazide drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Acute Effects of Dairy and Meat Proteins on Bone Metabolism and Metabolic Profile
Condition: Obesity; Bone Metabolism
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this randomized, controlled, cross over single meal study is to investigate
      the metabolic effects of a breakfast rich in dairy proteins and to determine biomarkers for
      their intake. The results from this project will increase our knowledge about nutritional
      value of dairy proteins, which is necessary to decide whether dairy products can be
      recommended for prevention of weight related bone loss.
    


Intervention name(s): Dietary meal intervention
Intervention type(s): Other
Intervention description(s): Test meals with different protein types (dairy versus meat)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Obesity; Adults; Bone metabolism; Metabolic profile; Dairy protein; Meat protein
Early Identification of Subclinical Atherosclerosis Using Non-Invasive Imaging Research (EISNER)
Condition: Atherosclerosis; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis
Study type: Interventional

Summary: 
      Early Identification of Subclinical Atherosclerosis by Noninvasive Imaging Research (EISNER)
      is a multi-study research program being conducted at Cedars-Sinai Medical Center.

      The principal objective of this randomized trial (referred to as "Study 1") is to assess
      whether coronary artery calcium (CAC) scanning provides clinical benefit thus improving
      patient outcomes in asymptomatic subjects with intermediate coronary artery disease (CAD)
      risk. Additionally, the study is designed to assess the value of combining the CAC scan with
      the Framingham risk score (FRS) and measurements of serum or plasma biomarkers to predict
      outcomes.
    

Detailed description: 
      At baseline eligible subjects underwent a clinic visit where they were randomized 2:1 to a
      "scan group" which had complete cardiac risk assessment and CAC scanning or a "no scan group"
      which had only complete cardiac risk assessment. Both groups underwent a private counseling
      session with a trained nurse practitioner to review their results and receive customized
      health behavior suggestions based on current American Heart Association guidelines for
      primary prevention of heart disease.

      Subjects were followed up for changes in clinical status, medication use and specific health
      behaviors at one year after baseline. Annually for four years, subjects were followed up for
      subsequent diagnostic testing, therapy, and outcomes related to their cardiac health.

      At four years after baseline, all subjects (from both groups) returned for a repeat clinic
      visit to have a complete cardiac risk assessment and CAC scanning. Year 4 CAC scanning was
      performed in both the "scan group" and "no scan group".

      Additional long-term followup is being conducted under a separate protocol.
    

Intervention name(s): Coronary Artery Calcium (CAC) Scan
Intervention type(s): Other
Intervention description(s): A coronary artery calcium (CAC) scan is performed during the baseline clinic visit. The results including the actual images from the scan are viewed by the subject during the risk factor consultation with the nurse practitioner. Results are available for the subjects' physicians upon request.
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Atherosclerosis; Coronary Artery Disease; Cardiac Risk Factors; Coronary Calcium Scan; Prevention
Efficacy and Safety Study of E2007 in Migraine Prophylaxis
Condition: Migraine Prophylaxis
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a 22-week, prospective, randomized, double-blind, placebo-controlled, multicenter,
      parallel-group study that included a 4-week Baseline Phase at the beginning and a 4-week
      single-blind placebo Safety Phase at the end of the study.
    


Intervention name(s): E2007; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Rifaximin in Minimal Hepatic Encephalopathy
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether alteration of gut flora with rifaximin can
      lead to improvement in driving performance, psychometric test performance, and quality of
      life in patients with minimal hepatic encephalopathy (MHE) and cirrhosis in a randomized,
      blinded, placebo-controlled trial.
    


Intervention name(s): Rifaximin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 550mg BID rifaximin for 8 weeks; same as the experimental arm
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Minimal hepatic encephalopathy
Vascular Effects of a Single Bout of Electronic Cigarette Use
Condition: Arterial Stiffness
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigating the acute effects of a single use E-Cigarette upon vascular health.
    

Detailed description: 
      Subjects will inhale e-cigarettes of 5.4%, 0%, and sham menthol inhaler to determine the
      effects upon to measures of vascular health. These measures will include Cardio-Ankle
      Vascular Index and Flow Mediated Dilation.
    

Intervention name(s): E-cigarette; Nicotine 0%; Menthol Inhalant Product
Intervention type(s): Drug; Drug; Drug
Intervention description(s): E-Cigarette containing 5.4% nicotine will be administered to determine the effects on vascular function.; E-Cigarette containing 0% nicotine will be administered to determine the effects on vascular function.; Menthol inhaler will be administered to determine the effects on vascular function.
Other intervention name(s): Nicotine 5.4%; Placebo; Placebo
Intervention MeSH terms: Menthol; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will be asked to inhale one of three mediums; 5.4% NBV e-ciggarette, 0% NBV cigarette, and sham menthol inhaler (no vapor). Baseline measurements will be conducted upon arrival and followed immediately post inhalation, 1-hour post, and finally 2-hours post. All trials will require a minimum of 48 hours washout.
Masking: Single (Participant)
Primary purpose: Other
Keywords: vascular function
A Study to Test How Healthy Men Tolerate Different Doses of BI 1595043
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this trial are to investigate safety and tolerability of BI 1595043
      in healthy male subjects following administration of multiple rising doses over 14 days.

      Secondary objectives are the exploration of pharmacokinetics (PK) of BI 1595043 after single
      and multiple dosing.
    


Intervention name(s): BI 1595043; Placebo; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BI 1595043; Placebo; Midazolam
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment