bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Acute Ketone Monoester Supplementation on Exercise Efficiency and the Influence of Dose and Intensity
Condition: Exercise; Ketosis
MeSH terms: Ketosis
Study type: Interventional

Summary: 
      Diet can alter blood ketone levels and this in turn may affect exercise capacity. This study
      will determine if the acute ingestion of a ketone supplement alters cycling exercise
      efficiency. Participants will perform three trials in a randomized order. Each trial will
      involve an incremental exercise protocol on a stationary cycle ergometer to volitional
      fatigue. Participants will ingest either a high or low dose of a ketone supplement or a
      taste-matched placebo drink prior to exercise. Blood samples will be obtained to assess
      selected metabolic responses. This study will provide information regarding the effect of
      ketone supplementation on exercise efficiency.
    

Detailed description: 
      This study will determine if the acute ingestion of a ketone supplement alters cycling
      exercise efficiency. Trained participants with cycling experience will be recruited.
      Participants will perform three trials in a randomized order. Each trial will involve a
      3-minute warm-up followed by an incremental ramp test. The ramp will initially consist of
      three, 5-minute stages performed at relative workloads corresponding to 75%, 100%, and 125%
      of individual ventilatory threshold intensity. This will be followed by a further incremental
      ramp test to volitional fatigue. Participants will ingest either a high or low dose of a
      ketone supplement or a taste-matched placebo drink prior to exercise using a randomized,
      double-blind crossover design. Diet prior to exercise will be standardized between trials for
      a given participant. Blood samples will be obtained to assess selected metabolic responses.
      This study will provide information regarding the effect of ketone supplementation on
      exercise efficiency.
    

Intervention name(s): Ketone monoester; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): A commercial liquid ketone monoester supplement.; A liquid placebo that is taste-matched to the ketone monoester supplement.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Efficiency
Chronic Obstructive Pulmonary Disease Patient Preferences Survey
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The purpose of this study is to distribute a questionnaire created for individuals living
      with chronic obstructive pulmonary disease (COPD) to assess their activities, participation,
      and healthcare and COPD-related research priorities. The data collected will be compared
      across diagnosed COPD stages and disease severity to determine the extent to which adults
      with COPD participate in the listed activities and identify their primary research and
      healthcare related priorities. The questionnaire was originally developed based on past
      research then verified by a panel of COPD and participation experts; as well as, individuals
      living with COPD in the form of focus groups. The questionnaire will now be administered to
      200 individuals living COPD (50 in each GOLD stage) at three sites across Montreal where
      clinical data for each participant will be available. This phase will help establish the
      reliability of the questionnaire.
    


Intervention name(s): Patient Survey
Intervention type(s): Other
Intervention description(s): Participants will answer an online survey and their medical chart information will be gathered to compare responses across disease severity.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults living with chronic obstructive pulmonary disease (COPD).
      
Keywords: Survey; Priorities; Activities; Participation
A Study to Assess the Efficacy and Safety of TC-5214 as an Adjunct Therapy in Patients With Major Depressive Disorder.
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if TC-5214 or placebo (a tablet that looks like a
      medicine tablet or capsule, but contains no active medicine) is safe and effective when taken
      together with another antidepressant.
    

Detailed description: 
      A Multicenter, Randomized, Double-Blind Parallel Group Placebo-Controlled Phase III, Efficacy
      and Safety Study of 3 Fixed Dose Groups of TC-5214 (S-mecamylamine) as an Adjunct to an
      Antidepressants in Patients with Major Depressive Disorder Who Exhibit an Inadequate Response
      to Antidepressant Therapy
    

Intervention name(s): TC-5214; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Twice daily for 8 weeks.; Twice daily for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder, MDD, Depression
Cut-off Values of 6-min Walk Test and Sit-to-stand Test for Determining Symptom Burden and Functional Impairment in Atrial Fibrillation
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      Cut-off values indicating higher symptom burden and impairment in health status in 6-min walk
      test and 30-second sit-to-stand test in patients with atrial fibrillation will be determined
      in the study.
    

Detailed description: 
      The 6-min walk test (6MWT) is the most used field test for measuring functional impairment in
      cardiopulmonary patients. However, to be able to objectively interpret 6MWT of a patient with
      specific chronic condition, the distance walked in 6MWT should be compared to either a
      healthy control group or a cut-off value that was specifically determined for that
      population. Such cut-off values are present for 6MWT in several cardiopulmonary diseases
      including COPD (350 m), heart failure (200 m) and pulmonary hypertension (400 m) for
      identifying patients with high mortality, poor prognosis and/or poor health status, but there
      is no cut-off value determined for atrial fibrillation (AF). The European Heart Rhythm
      Association (EHRA) score is a practical measure for assessing symptom burden and functional
      impairment caused by AF-related symptoms. While EHRA class 1 indicates asymptomatic patients,
      EHRA class 2, 3 and 4 indicates higher severities of symptom burden and functional
      impairment. Primary aim of this study is to determine a cut-off value in 6MWT for
      discriminating between the asymptomatic and symptomatic AF patients according to EHRA
      classification. In addition, a cut-off value for 30-second sit-to-stand test will be
      determined in these patients as well, since sit-to-stand tests have gained a lot of interest
      in the recent literature for practically evaluating functional status in various
      cardiopulmonary conditions.
    

Intervention name(s): Evaluation of functional impairment; Evaluation of pulmonary function; Evaluation of quality of life; Evaluation of physical activity level
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Symptom burden and functional impairment will be evaluated with EHRA Score, 6-min walk test and 30-second sit-to-stand test; Pulmonary function will be evaluated using basic spirometry and respiratory pressure meter.; Quality of life will be evaluated using Short Form-36 Questionnaire.; Physical activity level will be evaluated using International Physical Activity Questionnaire Short Form
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients diagnosed with atrial fibrillation
      
Keywords: Symptomatology; Functional impairment; Exercise capacity; 6-min walk test; Sit-to-stand test; Cut-off value
The Significance of Blood-tryptase and c-Kit Mutation in Insect Venom Immunotherapy
Condition: Hypersensitivity, Immediate; Insect Bites and Stings; Mastocytosis
MeSH terms: Mastocytosis; Hypersensitivity; Hypersensitivity, Immediate; Insect Bites and Stings; Bites and Stings
Study type: Observational

Summary: 
      The investigators wish to evaluate the association between tryptase values as well as c-Kit
      mutation and adverse effects in the course of immunotherapy. The investigators also intend to
      assess the effect of immunotherapy on tryptase levels.
    

Detailed description: 
      According to the presently available reports there is an association between systemic
      allergic responses to hymenoptera venom and elevated tryptase levels or c-Kit mutation. The
      presence of these findings may imply the existence of mast cell activation syndrome or
      mastocytosis. Therefore, baseline tryptase evaluation has become standard evaluation in
      patients with systemic responses. Meir Medical Center is the only hospital in Israel in which
      tryptase can be measured. Consequently, the Meir Clinic has accumulated considerable data
      with regards to tryptase levels in subjects with allergy to hymenoptera venom. The
      investigators wish to evaluate the association between tryptase values as well as c-Kit
      mutation and adverse effects in the course of immunotherapy. The investigators also intend to
      assess the effect of immunotherapy on tryptase levels.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population will include all the subjects undergoing venom immunotherapy at the Clinic
        of Allergy and Clinical Immunology, Meir Medical Center.
      
Biospecimen description: 
      Biospecimen will include 5 ml of venous whole blood drawn for measurement of serum tryptase
      and leukocyte c-Kit mutation.
False Safety Behavior Elimination Therapy: A Randomized Study of a Brief Individual Transdiagnostic Treatment for Anxiety Disorders
Condition: Panic Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Panic Disorder; Phobia, Social
Study type: Interventional

Summary: 
      The aim of the current study was to test the efficacy of an individually administered, brief
      (5-session) transdiagnostic treatment for anxiety disorders. The current treatment (called
      F-SET) focuses chiefly on the elimination of anxiety maintaining behaviors and cognitive
      strategies (so-called "safety" aids) among individuals suffering from a range of anxiety
      disorders including generalized anxiety disorder (GAD), social anxiety disorder (SAD) and
      panic disorder (PD). We hypothesized that the F-SET protocol would produce better overall
      outcome relative to a waitlist control.
    

Detailed description: 
      The aim of the current study was to test the efficacy of an individually administered, brief
      (5-session) transdiagnostic treatment for anxiety disorders. The current treatment (called
      F-SET) focuses chiefly on the elimination of anxiety maintaining behaviors and cognitive
      strategies (so-called "safety" aids) among individuals suffering from a range of anxiety
      disorders including generalized anxiety disorder (GAD), social anxiety disorder (SAD) and
      panic disorder (PD).

      Four primary hypotheses were evaluated in the current study: (1) the F-SET protocol would
      produce better overall outcome relative to a waitlist control, (2) the F-SET protocol would
      yield clinically significant improvement of primary diagnosis symptoms as well as secondary
      diagnosis symptoms, (3) the F-SET protocol would create treatment improvement that is
      maintained during a 1 month follow-up interval and (4) given that reduction of safety aid use
      is the key mechanism of change in the F-SET treatment, a reduction in safety aid use will
      mediate the relationship between pre and post treatment.
    

Intervention name(s): Transdiagnostic Treatment (F-SET)
Intervention type(s): Behavioral
Intervention description(s): F-SET treatment consisted of five weekly individual sessions (approximately 50 minutes each). The participants learn to techniques and skills to help them reduce their anxiety. F-SET protocol is consistent with current CBT protocols for anxiety disorders.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: transdiagnostic treatment; cognitive behavior therapy; anxiety; panic disorder; generalized anxiety disorder; social anxiety disorder
Safety Study of Subcutaneously-Injected Prandial INSULIN-PH20 NP Compared to Insulin Lispro Injection in Participants With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Insulin lispro is approved by the Food and Drug Administration (FDA) for the treatment of
      diabetes mellitus. Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid
      to the absorption and dispersion of other injectable drugs. In this study, rHuPH20 combined
      with a non-preserved (NP) formulation of regular human insulin (INSULIN-PH20 NP) will be
      compared to insulin lispro with respect to absorption and action of insulin.
    

Detailed description: 
      The purpose of this study is to compare the safety and tolerability of INSULIN-PH20 NP versus
      insulin lispro alone.
    

Intervention name(s): Insulin Lispro; regular human insulin; recombinant human hyaluronidase PH20; Insulin glargine
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): Humalog; Humulin R; Hylenex; rHuPH20; PH20; Lantus
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: recombinant human hyaluronidase (rHuPH20); Insulin lispro; regular human insulin
16w Interventional Study on Titration and Dose/Efficacy Assessment of Exelon in Chinese Alzheimer's Disease Patients
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the efficacy of Exelon capsule at maximal tolerated dose in mild to moderate
      Chinese AD patients via dosage titration from 3mg/d to 12mg/d in a 16 weeks duration
    


Intervention name(s): ENA713
Intervention type(s): Drug
Intervention description(s): The following strengths of Rivastigmine capsules were provided: Rivastigmine capsule strengths: 1.5mg, 3mg, 4.5mg. The 6mg dose was administered as one 1.5mg capsule and one 4.5mg capsule, and when necessary, the 3mg dose could also be administered as two 1.5mg capsules. Rivastigmine was administered from 3mg/d at baseline. Then dose escalation was made in 3mg/d increments, at a minimun of 4 weeks between dose increases to a maximum dose of 12mg/d or the individual's best tolerated dose.
Other intervention name(s): Rivastigmine
Intervention MeSH terms: Rivastigmine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alzheimer's disease; ENA713; Chinese patients; INSTINCT
Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs
Condition: HIV-1-infection; Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is open label, phase 1 clinical study to evaluate the safety, tolerability and
      pharmacokinetics of Elpida® in healthy subjects and patients with hepatic impairment (Child -
      Pugh Class А and B), as well as to assess the impact of food intake and drug-drug
      interactions in case of Co-administration with other antiviral drugs in healthy subjects.
    

Detailed description: 
      In medical practice HIV infection is often found associated with viral hepatitis, especially
      chronic hepatitis C virus (HCV). This, as well as a possible change in PK parameters in case
      of co-administration of Elpida® and HIV integrase inhibitors, necessitates the study of PK
      and safety of co-administration of Elpida® with a combination of Sofosbuvir + Daclatasvir and
      Dolutegravir in healthy subjects. Thus, the study to evaluates safety and pharmacokinetics of
      Elpida® in healthy subjects and patients with hepatic impairment, as well as assesses the
      impact of food intake and drug-drug interactions in case of co-administration with other
      antiviral drugs in healthy subjects.
    

Intervention name(s): Elpida®; Dolutegravir; Sofosbuvir; Daclatasvir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Elpida® capsules, 20mg; Dolutegravir, film-coated tablets, 50mg; Sofosbuvir, film-coated tablets, 400mg; Daclatasvir, film-coated tablets, 60mg
Other intervention name(s): Elsulfavirine; VM1500; VM-1500; TIVICAY®; Sovaldi; Daklinza®
Intervention MeSH terms: Sofosbuvir; Dolutegravir; Elsulfavirine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treatment of Psoriasis With Parathyroid Hormone
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a clinical study in two phases. The first phase compares the effect of an ointment
      containing parathyroid hormone (PTH) with the effect of a placebo ointment (inactive ointment
      without PTH) on psoriasis lesions. Neither the study participants nor the researchers will
      know who is receiving PTH ointment and who is receiving placebo until the end of this first
      study phase. The second phase is a study of the PTH ointment on large areas of psoriasis to
      find out how long the effects last.
    

Detailed description: 
      Patients with active plaque psoriasis will be withdrawn from systemic and topical
      medications. After washout, we will select active psoriatic lesions of at least 25 square cm
      in size to receive either placebo ointment or a proprietary ointment containing PTH for 8
      weeks. We will see the patients every 2 weeks. We will evaluate the lesions by examination
      and digital photography at each visit and measure parameters of calcium metabolism
      periodically during the 8 weeks.

      At the conclusion of the 8 weeks, we will obtain punch biopsies from the treated lesions and
      from one lesion without treatment. If the patients elect, we will transition them into an
      open label trial with the PTH ointment including up to 1000 square cm of psoriatic lesions
      and monitor them for duration of effect and changes in parameters of calcium metabolism.
    

Intervention name(s): Parathyroid hormone ointment
Intervention type(s): Drug
Intervention MeSH terms: Hormones; Parathyroid Hormone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Parathyroid hormone; Psoriasis; Lesions; Topical medications; Ointment; Calcium metabolism; Skin biopsy
Study to Learn About Relapse Prevention of Hypericumextract (a Drug Based on the Plant St. John Wort) in Outpatients Suffering From Moderate Depressive Episodes
Condition: Moderate Depressive Episodes (Major Depression)
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The researchers in this trial want to learn more about the drug Laif® 900 in preventing the
      return of signs and symptoms of depressions (also called relapse) in patients suffering from
      moderate depression episodes. The study drug Laif® 900 is based on Hypericumextract made from
      the plant St. John wort. Patients will be accepted to take part in the study if they have
      20-24 points on the Hamilton Depression Rating Scale (HAM-D) which is a questionnaire helping
      the doctor to rate the severity of the depression and includes questions on patient's mood,
      sleep difficulties, agitation, anxiety and weight loss. About 400 patients will be enrolled
      into the first part of the study and will be treated for 12 weeks with Laif® 900 capsule once
      daily. Only patients with an improved HAM-D score by 50% will stay in the study and continue
      with the second part of the study which will last for 24 weeks.

      In this second part of the study patients will receive either Laif® 900 capsule once daily or
      an inactive tablet (placebo). Neither the treating doctor nor the patient will know which
      patient receives the Laif® 900 or placebo. At the end of the study the researcher will assess
      the effectiveness of the study drug in prevention relapse of depression episodes and will
      also have more information on the safety of the study drug.
    


Intervention name(s): Laif® 900, BAY98-7108; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 x daily, 1 tablet, 900 mg; 1 x daily, 1 tablet, 900 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Serving Size and Addition of Sugar on the Glycemic Response Elicited by Oatmeal
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study was to determine the impact of serving size and the addition of
      sugar on the glycemic response elicited by oatmeal compared to that elicited by cream of rice
      cereal.
    


Intervention name(s): Classic Quaker Quick Oats; Cream of Rice Cereal
Intervention type(s): Other; Other
Intervention description(s): Various doses of oats without or with sugar; Various doses of cereal without sugar
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Blood glucose; Humans; Postprandial; Sugar; Carbohydrate; Oat beta-glucan