bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Coffee Roasting on Blood Sugar Levels in Healthy Humans
Condition: Hyperglycemia
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      The present study determined the effects light, medium, and dark roasted, brewed coffees on
      blood glucose responses in normal (n = 19) subjects.
    

Detailed description: 
      This is a single-blinded, randomized partial block design conducted over 6 weeks in two
      parts.

      In part 1 (3 weeks), participants were randomly assigned to consume four beverages: a placebo
      containing water and caramel color, light, medium, or dark roast coffee before, during, or
      after consumption of a beverage containing 50 g of glucose.

      In part 2 (3 weeks), participants were randomly assigned to consume four beverages: a placebo
      containing water and caramel color, light, medium, or dark roast coffee before, during, or
      after consumption of a standardized breakfast (corn flakes cereal + skim milk) containing 50
      g of glucose.

      In each part, fasting and postprandial glucose profiles were determined.
    

Intervention name(s): Placebo Comparator; Light Roasted Coffee; Medium Roasted Coffee; Dark Roasted Coffee
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Placebo designed to mimic coffee color.; 12 oz light roast coffee; 12 oz medium roast coffee; 12 oz dark roast coffee
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, single-blinded, partial block, crossover design
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: coffee; glucose challenge; blood glucose levels
Performance Equivalence of Rainbow Acoustic Monitoring (RAM) Small Sensor and RAM Revision D Sensor
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study was to conduct a side by side comparison of the accuracy of
      respiratory rate (RR) between our investigational Rainbow Acoustic Monitoring (RAM) small
      sensor and the FDA-cleared RAM Revision D sensor in healthy volunteers under controlled
      conditions.
    


Intervention name(s): RAM sensors
Intervention type(s): Device
Intervention description(s): Noninvasive acoustic monitoring device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers and in Participants With Sickle Cell Disease
Condition: Healthy Volunteers; Anemia, Sickle Cell
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety and tolerability of AG-946 in healthy
      volunteers after oral administration of single ascending doses (SAD) and multiple ascending
      doses (MAD) of AG-946 over 14 or up to 28 days of dosing, and to identify a range of doses
      that are safe and pharmacologically active in participants with sickle cell disease. The SAD
      and MAD parts of the study will be randomized and double-blinded, and will assess the safety,
      pharmacokinetics (PK), and pharmacodynamics (PD) of AG-946 as well as the effect of food (SAD
      only) on the pharmacokinetics (PK) of AG-946. The sickle cell disease (SCD) part of the study
      will be non-randomized and open-label, and is designed to identify 1 or more safe and
      tolerable dose(s) of AG-946 with potential activity in the treatment of participants with
      sickle cell disease (SCD).
    


Intervention name(s): AG-946; AG-946 Matched Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AG-946, oral encapsulated coated-granules or tablets.; AG-946 matched-placebo, oral encapsulated sugar spheres or tablets.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sickle Cell Disease; Healthy
Tepotinib Hepatic Impairment Trial
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will investigate the effect of various degrees of hepatic impairment on the
      pharmacokinetics (PK), safety and tolerability of tepotinib.
    


Intervention name(s): Tepotinib
Intervention type(s): Drug
Intervention description(s): Participants will receive a single oral dose of tepotinib in Part 1.
Intervention MeSH terms: Tepotinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hepatic Impairment; Tepotinib; Pharmacokinetics
Exercise Training and Testosterone Replacement in Heart Failure Patients
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if exercise training with or without testosterone
      replacement can improve cardiopathy in heart failure patients
    

Detailed description: 
      In this study, we are evaluating:

        -  hospital length of stay and readmission

        -  muscle sympathetic nerve activity

        -  functional capacity

        -  body composition
    

Intervention name(s): Testosterone replacement; Exercise training
Intervention type(s): Drug; Other
Intervention description(s): Application quarterly of Testosterone Undecylate; Aerobic and strength exercise training
Other intervention name(s): Testosterone Undecylate (Nebido)
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
The Effect of Telephone Consulting on HbA1 and Self-Management
Condition: Type 2 Diabetes; Self-management
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of this study was to investigate the effect of telephone counseling (12 weeks) based
      on the Information, Motivation, Behavioral Skills (IMB) Model in patients with type 2
      diabetes mellitus (T2DM) on self-management and HbA1c.
    

Detailed description: 
      The aim of this study was to investigate the effect of telephone counseling based on the
      Information, Motivation, Behavioral Skills (IMB) Model in patients with type 2 diabetes
      mellitus (T2DM) on self-management and HbA1c. This study was conducted with a randomized
      controlled trial. This study, between January 2019 and September 2019 were conducted in
      endocrine clinic. A total of 63 patients (31 interventions, 32 controls) diagnosed with T2DM
      were included. The intervention group received 45-60 minutes of patient training based on the
      Information, Motivation and Behavioral Skill Model (IMB). A weekly short reminder message and
      a two-weekly phone call were made and a total of 12 weeks of follow-up was conducted. As a
      result, there was a statistically significant difference between pre-test HbA1c, weight and
      systolic blood pressure (p<0.05). Also, after three months of follow-up, self-efficacy,
      self-management and self-management perceptions were significantly higher in the intervention
      group (p<0.05).
    

Intervention name(s): Intervention group (telephone counseling)
Intervention type(s): Behavioral
Intervention description(s): Then, each patient was given 45-60 minutes of individual instruction. The patient training content was prepared based on the Knowledge, Motivation and Behavioral Skills Model (IMB). A total of 12 weeks of follow-up was performed with a weekly short reminder message and a two-weekly phone call. The research data were collected again at the end of 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Randomized Controlled Trial
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Type 2 diabetes; Telephone counseling; IMB; Self-management; HbA1c
Bioequivalence Study of Carbidopa/Levodopa/Entacapone Combination vs. Carbidopa/Levodopa Combination Plus Entacapone in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and bioequivalence of a single oral dose of
      carbidopa+levodopa+entacapone combination versus a single oral dose of carbidopa+levodopa
      combination plus a single oral dose of entacapone under fed conditions in healthy volunteers.
    


Intervention name(s): ELC200 (carbidopa+levodopa+entacapone)
Intervention type(s): Drug
Intervention MeSH terms: Levodopa; Carbidopa; Entacapone; Carbidopa, levodopa drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; bioavailability; carbidopa; levodopa; entacapone; fed condition; Healthy volunteers study
PiCCO Guided Therapy in Liver Cirrhosis
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      Prospective comparison of standard therapy in liver cirrhosis versus standard therapy plus
      intensified hemodynamic monitoring using the PiCCO system.
    

Detailed description: 
      Patients presenting with advanced liver cirrhosis will receive either standard treatment or
      standard treatment plus hemodynamic monitoring with the PiCCO device. Fluids and vasoacitve
      drugs will be administered according to the measurements over a period of 5 days.
    

Intervention name(s): Hemodynamic monitoring system PiCCO
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Liver cirrhosis; Hemodynamics; Fluid balance
Combining rTMS and Video Game-based Dexterity Training to Improve Dexterity in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      We investigate the effectiveness of a combined repetitive transcranial magnetic stimulation
      (rTMS) - video game-based training (VBT) dexterity intervention in Parkinson's diseases. The
      short and long-term benefits of this training program will be evaluated. For these purposes,
      a blinded sham controlled randomized controlled trial will be performed.
    

Detailed description: 
      Patients with Parkinson's disease (PD) often exhibit dexterous difficulties during the
      performance of activities of daily living (ADL) such as tying shoe laces, hand-writing, using
      remote controls, smartphone or tablet. These difficulties further add to the burden of the
      disease, leading to reduced quality of life (QoL). A relatively new, but rapidly growing
      aspect of training in PD neurorehabilitation is exergaming. To enhance training effects a
      combination of repetitive transcranial magnetic stimulation (rTMS) with exergaming will be
      tested.
    

Intervention name(s): Transcranial magnetic stimulation; Sham transcranial magnetic stimulation
Intervention type(s): Other; Other
Intervention description(s): Non-invasive brain stimulation; Non-invasive brain stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: blinded randomised clinical trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: transcranial magnetic stimulation; dexterity; video game-based training
Comparing Efficacy and Safety Between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Multi-center Study to Compare Efficacy and Safety between Eperisone a BID and a TID Regimen
      in Acute Low Back Pain Patients during 7 days.
    


Intervention name(s): Epirisone 50mg or placebo TID
Intervention type(s): Drug
Intervention description(s): 3 times a day after meals for 1 week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Zonegran for the Treatment of Weight Gain Associated With Psychotropic Medication Use: A Placebo-Controlled Trial
Condition: Obesity
MeSH terms: Weight Gain
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to compare the efficacy of zonisamide (Zonegran; 100mg
      - 400mg/day) and placebo as an adjunctive agent on lowering weight in subjects who have a
      body mass index (BMI) of >25 and are on a psychotropic medication with a known side effect of
      weight gain.
    

Detailed description: 
      After the screening period, patients fulfilling entrance criteria will be randomized to 100mg
      of zonisamide or placebo in a 2:1 ratio respectively. Patients will be assessed at baseline
      and on Weeks 2, 4, 8, 12, and 16-post randomization for weight, side effects, and symptoms.
      Symptoms will be assessed by the Young Mania Rating Scale (YMRS), Brief Psychiatric Rating
      Scale (BPRS), Hamilton Depression Rating Scale (HAMD), Hamilton Rating Scale for Anxiety
      (HARS), and Self-report measures of general health and mental status at baseline, weeks 2, 4,
      8, 12,and 16. At the conclusion of the study, patients will be tapered from the study
      medication and will return to their primary provider for continued treatment of their
      psychiatric condition.
    

Intervention name(s): Zonegran; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): zonisamide; Placebo pill
Other intervention name(s): zonisamide; placebo pill
Intervention MeSH terms: Zonisamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; zonisamide; zonegran; psychotropic weight gain; psychotropic
Bioequivalence of a Fixed Dose Combination Tablet of Empagliflozin/Metformin Extended Release Compared With Mono Compound Tablets in Healthy Male and Female
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to investigate bioequivalence of a newly developed fixed dose
      combination (FDC) tablet containing empagliflozin and metformin extended release compared to
      the free combination of empagliflozin and metformin extended release under fed conditions.
    


Intervention name(s): metformin; empagliflozin/metformin; empagliflozin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose of metformin given as tablets; Single dose empagliflozin/metformin given as fixed-dose combination tablet; single dose of empagliflozin given as tablet
Intervention MeSH terms: Metformin; Empagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Control of Trichomoniasis
Condition: Trichomoniasis
MeSH terms: Trichomonas Infections
Study type: Interventional

Summary: 
      This study is designed to try to find the best method of partner notification and treatment
      for partners of women with trichomonas
    

Detailed description: 
      To carry out a randomized trial to compare the effectiveness of three methods of partner
      notification and treatment for sexual partners of women with vaginal trichomoniasis - patient
      self-referral of partners (the current practice standard), delivery of curative therapy to
      partners by patients themselves, or public health style Disease Intervention carried out by a
      specially trained Disease Intervention Specialists (DIS) locating the partners and delivering
      the medication in the field. Reinfection rates with trichomonas at three months of follow-up
      among the index women will be the measure of effectiveness.
    

Intervention name(s): different methods of partner notification; partner delivered meds; field intervention
Intervention type(s): Other; Other; Other
Intervention description(s): comparing patient referral, partner delivered medications and field intervention to treat sex partners; patient given meds to give to her partner; health worker finds partners
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: trichomoniasis; partner notification
Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Muscle and Cardiometabolic Health
Condition: Aging; Sarcopenia; Disability Physical; Cardiovascular Diseases; Insulin Resistance; Diabetes Mellitus
MeSH terms: Sarcopenia; Cardiovascular Diseases; Insulin Resistance
Study type: Interventional

Summary: 
      What are the effects of resistance exercise (RE) alone or RE plus low intensity physical
      activity (LPA) breaks in sedentary time (ST) on skeletal muscle health in older adults?

      What are the effects of resistance exercise (RE) alone or RE plus low intensity physical
      activity (LPA) breaks in sedentary time (ST) on skeletal cardiometabolic health in older
      adults?
    

Detailed description: 
      Although awareness of the detrimental impact that sedentary behavior has on skeletal muscle
      and cardiometabolic health has increased over the last 20 years, more than 60% of older
      adults remain sedentary for greater than 8 hours per day. Moreover, 80% to 90% of adults 60
      years of age or older do not meet the current public health guidelines for aerobic exercise
      (AE) or resistance exercise (RE) based physical activity (PA). Collectively, these adverse
      health behaviors contribute to the development of multiple chronic medical conditions
      commonly afflicting older adults, including type 2 diabetes, cardiovascular disease,
      sarco/dynapenia, frailty, and premature mortality. Emerging evidence suggests that breaking
      up sedentary time with light intensity PA (LPA) improves muscle and cardiometabolic health.
      Recent data also suggest that RE combined with moderate intensity AE effectively improves
      muscle and cardiometabolic health in older adults. However, the impact that RE combined with
      LPA breaks in sedentary time has on muscle and cardiometabolic health in older adults remains
      unknown. The overall objective of this pilot study is to determine the effect of 16 weeks of
      RE alone or RE combined with LPA breaks in sedentary time on muscle and cardiometabolic
      health.
    

Intervention name(s): Exercise Intervention
Intervention type(s): Behavioral
Intervention description(s): The use of exercise to improve muscle and cardiometabolic health in older adults.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
To Demonstrate the Relative Bioavailability of Cyclobenzaprine HCl Tablets
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the relative bioavailability of Cyclobenzaprine HCl tablets.
    


Intervention name(s): Cyclobenzaprine HCl Tablets 10 mg, Cord Laboratories; Cyclobenzaprine HCl Tablets 10 mg, Merck Sharp & Dohme
Intervention type(s): Drug; Drug
Intervention MeSH terms: Amitriptyline; Cyclobenzaprine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antidepressant
Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      Study the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab
      SAR236553 (REGN727).

      Secondary Objectives:

        -  Assess the safety and tolerability of alirocumab SAR236553 (REGN727) in patients with
           mild and moderate hepatic impairment and in matched subjects with normal hepatic
           function.

        -  Assess the pharmacodynamic profile of alirocumab SAR236553 (REGN727) in patients with
           hepatic impairment and in matched subjects with normal hepatic function.
    

Detailed description: 
      Total duration of the study per subject (excluding screening) is about 12 weeks.
    

Intervention name(s): alirocumab SAR236553 (REGN727)
Intervention type(s): Drug
Intervention description(s): alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)
Pharmaceutical form:Solution for injection Route of administration: subcutaneous
Intervention MeSH terms: Alirocumab
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
African-American Diabetes Intervention Project
Condition: Insulin-Dependent Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      A controlled trial to assess the potential benefit of a home based worker in improving
      control in African-American children with insulin dependent diabetes.
    


Intervention name(s): home based worker
Intervention type(s): Behavioral
Allocation: Randomized
Primary purpose: Treatment
The Effect of Phonophoresis in Subacromial Impingement Syndrome.
Condition: Subacromial Impingement Syndrome
MeSH terms: Shoulder Impingement Syndrome; Syndrome; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Subacromial impingement syndrome (SIS) is a dysfunction caused by an impingement of the
      rotator cuff tendon between the head of the humerus and the acromion as a result of changes
      in the subacromial space. The patients' symptoms, such as pain, limited joint mobility and
      reduced strength, may lead to a diagnosis of SIS. The conservative treatment of individuals
      with SIS is includes analgesics and non-steroidal anti-inflammatory drugs (NSAIDs), steroid
      injections and physiotherapy. Ultrasound therapy is one of the common physiotherapy
      applications for SIS, but its effectiveness is controversial. Phonophoresis is a combination
      of ultrasound therapy and medical therapy. In phonophoresis, a medicine in gel form is used
      as a transmitter with ultrasound instead of the aquatic conductor gel. It was hypothesized
      that ultrasound waves favoring the penetration of an anti-inflammatory drug would lead to an
      improved response to the treatment of SIS. However, the effectiveness of ultrasound modes
      (pulsed or continuous) can be used in phonophoresis is debatable. The purpose of this study
      is to determine the effect of ultrasound therapy, pulsed mode ultrasound and continuous mode
      ultrasound phonophoresis in patients with SIS.
    


Intervention name(s): phonophoresis therapy with pulsed mode ultrasound; phonophoresis therapy with continuous mode ultrasound; sham ultrasound
Intervention type(s): Device; Device; Device
Intervention description(s): phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks; phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks; sham ultrasound therapy, five days a week for three weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: subacromial pain; ultrasound therapy; phonophoresis