bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Green Tea in Obese Pre-hypertensive Women
Condition: Obese; Hypertension
MeSH terms: Hypertension; Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of green tea on body weight, waist
      circumference, metabolic profile, inflammation, blood pressure and endothelial function in
      obese pre-hypertensive women.
    

Detailed description: 
      Crossover randomized controlled double-blinded trial. Twenty women with obesity and
      pre-hypertension, aged 28-59 years, with stable body weight were randomized to receive a
      daily supplement of 3 capsules that contained either 500mg of green tea extract (GTE) or a
      matching placebo for 4 weeks, with a washout period of 2 weeks between the treatments.
      Endothelial function was evaluated by peripheral arterial tonometry method, using Endo-PAT
      2000®.
    

Intervention name(s): Green Tea
Intervention type(s): Dietary Supplement
Intervention description(s): Twenty women with obesity and pre-hypertension, aged 28-59 years, with stable body weight were randomized to receive a daily supplement of 3 capsules that contained either 500mg of green tea extract (GTE) or a matching placebo for 4 weeks, with a washout period of 2 weeks between the treatments.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Repetitive Transcranial Magnetic Stimulation (rTMS) for Dystonia and Tremor
Condition: Dystonia; Tremor
MeSH terms: Tremor; Dystonia; Dystonic Disorders
Study type: Interventional

Summary: 
      The study will include subjects diagnosed with Dystonic Tremor (DT), Essential Tremor (ET),
      and healthy controls in the age range of 21-80 years. Electroencephalography (EEG) will be
      used as the primary outcome measure. Transcranial Magnetic Stimulation (TMS) will be used
      over the motor cortices or cerebellar cortices as an intervention that is expected to have
      short-term (less than an hour) electrophysiological effects.
    

Detailed description: 
      The primary goal of this study is to compare differences in cortical activity of patients
      with tremor before and after applying a session of rTMS. Specifically, the investigators will
      apply rTMS to the primary motor cortex (M1) as our group and others have shown abnormal
      function of the region. Moreover, a study shows that targeting of M1 and the dorsal premotor
      cortex (dPMC) with rTMS results in a trend towards improved clinical outcome in patients with
      focal hand dystonia and cervical dystonia. The central hypothesis of this study is that rTMS
      can modify cortical oscillations in patient populations with tremor and that the
      investigators will be able to detect these changes with the use of Electroencephalography
      (EEG). By applying inhibitory rTMS to the motor cortices, the investigators may expect a
      shift in cortical oscillations towards normal activity.
    

Intervention name(s): repetitive Transcranial Magnetic Stimulation (rTMS); Control group
Intervention type(s): Device; Other
Intervention description(s): Repetitive transcranial magnetic stimulation (rTMS) is a form of brain stimulation therapy using a magnet to target and stimulate certain areas of the brain.; No application of rTMS
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Brain Imaging and Pain in Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      This study examines the mechanisms, including brain imaging of placebo analgesia
    


Intervention name(s): placebo
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Keywords: Placebo; Analgesia; Pain; Brain mechanism; Expectation
Leader Partner Interactions
Condition: Socioeconomic Status; Food Intake
Study type: Interventional

Summary: 
      Obesity is often cited as being inversely related with socioeconomic status (SES), although
      the mechanisms linking social status with obesity are not well understood. Dietary restraint,
      physical activity, and social mobility have been proposed as possible mechanisms. Although
      there is some evidence of SES variation in the proposed mechanisms, evidence is mixed and
      mostly observational. The purpose of this research is to determine if one's social position
      influences eating behaviors. This study will attempt to determine this using a randomized, 2
      parallel arm trial to determine the effects that social hierarchy positioning has on energy
      intake. To prevent compromise in the integrity of data, the investigators will detail the
      exact treatment condition (i.e., social positioning) after the data collection period.

      Based on findings from previous animal and large clinical observational studies, there are
      two complementary hypotheses tested in this study. First, it is hypothesized that being in a
      lower social position affects one's perception of food availability by making the future
      availability of food seem less certain. This uncertainty will lead to increased food
      consumption. Second, it is hypothesized that being in a position of power will lower one's
      food consumption, as previous research has found that individuals in power tend to east less
      in groups. Understanding how social position influences food intake could help improve weight
      loss/maintenance interventions by identifying unexpected factors that could limit the
      intervention's effectiveness.
    


Intervention name(s): Designation of Social Positioning
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls
Condition: Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, open-label, single-dose study in adults with moderate hepatic impairment
      (defined as Child-Pugh B cirrhosis) and matched healthy control participants with normal
      hepatic function. All participants in both cohorts (moderate hepatic impairment and matched
      healthy controls) will receive a single dose of the study drug, linerixibat. The purpose of
      this study is to assess the effect of hepatic impairment on the pharmacokinetics (PK) and
      safety of linerixibat.
    


Intervention name(s): Linerixibat
Intervention type(s): Drug
Intervention description(s): Linerixibat dose and administration as per study intervention.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This phase 1 study is an open-label, non-randomized, single-dose linerixibat study with 2 cohorts (moderate hepatic impairment and matched healthy control participants).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Linerixibat; Pruritus; GSK2330672; Pharmacokinetics; Primary biliary cholangitis; Hepatic impairment; Liver Cirrhosis
Impact of Aerobic Exercise Training on Sympathetic Vasoconstriction and Vascular Function in Essential Hypertension
Condition: Hypertension,Essential
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional

Summary: 
      Sympathetic nervous activity plays an important role in the development of hypertension and
      studies have shown that the pannexin-1 channel is involved in the signalling of the
      sympathetic activity to the vascular bed. The main project aim is to investigate the effects
      of 10 weeks of high intensity training on the effect of the sympathetic nervous activity on
      vascular function in individuals with essential hypertension. A secondary aim is to assess
      the role of essential hypertension and physical activity on vascular endothelial function,
    


Intervention name(s): Training
Intervention type(s): Other
Intervention description(s): 10 weeks of high intensity exercise training. 2-3 trainings per week of approx. 40 min.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized double blinded case-control interventional study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Pannexin-1 channel
A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet® (Levodopa/Carbidopa)
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A Single Period Investigation to Assess the Tolerability of Healthy Subjects to Oral Sinemet®
      (Levodopa/Carbidopa) Doses Administered Using a Divided Dose Approach
    

Detailed description: 
      This is a single centre, open-label, single period study in healthy subjects. Each subject
      will receive the following regimen:

      On Day -2, 10 mg domperidone administered every 8 hours 3 times a day (for illustrative
      purposes, dosing at 07:30, 15:30 and 23:30) On Day -1, 3 doses of 100 mg Sinemet® (every 8
      hours) administered as 2 × Sinemet® 12.5 mg/50 mg tablets containing 13.5 mg carbidopa
      (equivalent to 12.5 mg anhydrous carbidopa) and 50 mg levodopa. Subjects will receive
      concomitant 10 mg domperidone 30 minutes before every Sinemet® dose.

      On Day 1, Sinemet® 12.5 mg/50 mg containing 13.5 mg carbidopa (equivalent to 12.5 mg of
      anhydrous carbidopa) and 50 mg levodopa administered every hour for 16 consecutive doses
      (total dose of 800 mg). Subjects will also receive concomitant domperidone up to 20 mg 30
      minutes before the first Sinemet® 50 mg dose and every 8 hours (total of 3 doses) after
      treatment initiation.

      It is planned to enrol 6 subjects to ensure there are 6 evaluable subjects. A subject is
      considered to be evaluable if they have received all 16 Sinemet® 50 mg doses.
    

Intervention name(s): Levodopa/Carbidopa (Sinemet)
Intervention type(s): Drug
Intervention description(s): Oral administration of 2 × 12.5 mg/50 mg Sinemet® tablet containing 13.5 mg carbidopa (equivalent to 12.5 mg anhydrous carbidopa) and 50 mg levodopa three times a day on Day -1 with 240 mL water Oral administration of 1 × 12.5 mg/50 mg Sinemet® tablets containing 13.5 mg carbidopa (equivalent to 12.5 mg of anhydrous carbidopa) and 50 mg levodopa administered with 100 mL water every hour for 16 hours on Day 1
Other intervention name(s): Sinemet
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Beneficial Effects of Long Term Menaquinone-7
Condition: Bone Loss; Arteriosclerosis
MeSH terms: Arteriosclerosis
Study type: Interventional

Summary: 
      From all K-vitamins, menaquinone-7 (MK-7) has been identified now as the most effective
      cofactor for the carboxylation reaction of Gla-proteins such as osteocalcin (in bone) and
      matrix-Gla protein (in the arterial vessel wall). The question remains whether
      supplementation with MK-7 also leads to measurable improvements of bone and vascular health.
      The purpose of the study is to demonstrate that MK-7 has a health benefit in apparently
      healthy postmenopausal women. In a placebo-controlled randomized clinical trial the effect of
      an MK-7- supplement will be monitored during three years on bone quantity and quality and on
      vascular characteristics and function.
    


Intervention name(s): menaquinone-7; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 180 µg menaquinone-7 daily for three years; 1 placebo capsule daily for three years
Intervention MeSH terms: Vitamin K 2; Vitamin K; Menaquinone 7
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: vitamin K2; menaquinone-7; bone health; vascular health
A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study seeks to evaluate the efficacy and safety of ABBV-8E12 in participants with early
      Alzheimer's disease (AD).
    


Intervention name(s): ABBV-8E12; placebo for ABBV-8E12
Intervention type(s): Drug; Drug
Intervention description(s): ABBV-8E12 solution for IV infusion; placebo solution for intravenous (IV) infusion
Other intervention name(s): Tilavonemab
Intervention MeSH terms: Tilavonemab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Early Alzheimer's Disease (AD); Mild Cognitive Impairment (MCI); Mild Alzheimer's Disease (AD); Tau; Early dementia; Tauopathies; AD; Neurodegenerative diseases; Memory loss; Nervous system diseases
Safety, Tolerability and Efficacy of DEXDOR in Pediatric Patients in ICU
Condition: ICU Sedation
Study type: Interventional
Phase: Phase 4

Summary: 
      Open clinical trial to evaluate safety, tolerability, and efficacy of Dexdor for sedation in
      paediatric patients in intensive care settings. Multi-centre trial in Russia for marketing
      registration of Dexdor
    

Detailed description: 
      Dexmedetomidine is in Russian currently approved for sedation only in adults; paediatric
      experiences in the literature are in the form of small studies and case reports.

      Dexmedetomidine may be useful in paediatric patients for sedation in a variety of clinical
      situations. Based on literature analysis, dexmedetomidine may be potentially used in the
      intensive care unit in pediatric patients who require sedation, either breath spontaneously
      or require mechanical ventilation.

      Dexmedetomidine is a newer sedative with little safety data in paediatrics, particularly for
      therapy lasting longer than 48 h. Additional studies in paediatric patients are warranted to
      further evaluate its safety and efficacy in all age ranges.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): infusion
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physical Therapy for Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      Background: The aim of this study to compare the effect of moderate exercises versus light
      exercises on patients with type 2 diabetes mellitus.

      Methods: This 3-month, 2-arm cluster randomized controlled trial involved 60 patients aged
      between 35and 60 years divided randomly into two groups. Group 1 received 30 minutes of
      aerobic exercise at 40-60% of maximum heart rate. Group 2,Treated by walking30 minutes daily
      divided into 5minutes every 2 hours to break sedentary position for 12 hours daily.

      Results: At the base line no significant difference were found in both groups in all
      parameters. After three months of treatment, there is no significant difference in all
      parameters BMI, p=0.111, waist to hip ratio, p=0.245, 6 minutes' walk, p=0.614, blood
      glucose, p=0.105 and sf-36, p=0.106. The study approved by ethical committee of faculty of
      physical therapy, Cairo University REC/012/002607.

      Conclusion: Light exercise has the same effect on blood glucose as moderate exercise, so just
      walking for 5 minutes every 2 hours can be useful for patients with type 2 diabetes mellitus.
    

Detailed description: 
      78 patients have been chosen from department of internal medicine, Cairo university
      hospitals, Egypt. 8 patients were excluded because 3 have chronic renal failure, 3 have
      cardiopulmonary diseases and 2 have severe osteoarthritis of knees.

      They were divided randomly into two groups, group one will be treated by moderate exercises
      and group and group 2 will be treated by light exercises.

      after division all the procedures were explained to patients.5 patients refused to sign
      informed consent and excluded from the study.33 patients in group1 and 32 patients in
      group2.3patients dropped in group1 and excluded from the study and two patients didn't
      continued the programmed treatment in group 2 and their data removed.

      Thirty patients in each group signed an informed consent and complete the treatment program.
    

Intervention name(s): Moderate exercises
Intervention type(s): Other
Intervention description(s): Group 1 received 30 minutes of aerobic exercise at 40-60% of maximum heart rate. Group 2,Treated by walking30 minutes daily divided into 5minutes every 2 hours to break sedentary position for 12 hours daily.
Other intervention name(s): Light exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2-arm cluster randomized controlled trial involved 60 patients aged between 35and 60 years divided randomly into two groups. Group 1 received 30 minutes of aerobic exercise at 40-60% of maximum heart rate. Group 2,Treated by walking30 minutes daily divided into 5minutes every 2 hours to break sedentary position for 12 hours daily.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: moderate exercises; light exercises; obesity; sedentary behavior
Impact of Chemotherapy Followed by Aromatase Inhibitors on Bone Health of Women With ER-positive Early Breast Cancer
Condition: Breast Cancer; Other Disorders of Bone Density and Structure
MeSH terms: Breast Neoplasms; Bone Diseases
Study type: Observational

Summary: 
      The purpose of this study is to identify the combined impact on bone loss as well as the
      incidence of bone fractures in women with estrogen receptor (ER)-positive, early breast
      cancer treated with an aromatase inhibitor (AI) either as first line therapy or as
      maintenance therapy after initial treatment with chemotherapy, in real life clinical settings
      in Greece.
    

Detailed description: 
      Subjects with ER-positive early breast cancer will be treated with AIs either as first line
      therapy or as maintenance therapy after initial treatment with chemotherapy. The total study
      duration will be 24 months comprising of a recruitment period of 12 months and a follow-up
      period of 12 months for each participating subject. The primary outcome variable is the mean
      percentage variation in lumbar spine (LS) bone mineral density (BMD) during the 12 month
      follow - up period. Measurements will be taken before and after chemotherapy and at the end
      of the 12 month follow - up period.
    

Intervention name(s): Aromatase Inhibitors; Chemotherapy
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aromatase Inhibitors
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Post-menopausal female patients with ER-positive early breast cancer, who receive therapy
        with a third generation AI either as first line hormonal treatment or as maintenance
        therapy after first-line anthracycline- and/or taxane-based chemotherapy for a period no
        longer than 1 month (4 weeks) prior to inclusion in the study
Childhood Obesity Treatment - Telephone Coaching vc Usual Care
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      This study evaluates if usual physical care visits to an outpatient pediatric clinic can be
      replaced with more frequent and shorter Telephone coaching Contacts during 18 months.
    

Detailed description: 
      In this randomized controlled study, patients at age 5 to 14 and enrolled in obesity
      treatment, were randomized to either usual care according to regular routine or to telephone
      consultation.The randomization was done at the start of individual treatment and lasted for
      18 months. We also studied working time required for the Health care, and the families'
      experience of the Telephone coaching.
    

Intervention name(s): Usual care, individual visits; Telephone coaching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Randomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity.; Randomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Behavioral treatment; Telephone coaching; Outpatient clinic
A Study To Evaluate An NK-1 Antiemetic For The Prevention Of Post Operative Nausea And Vomiting
Condition: Postoperative Nausea and Vomiting; Nausea and Vomiting, Postoperative
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is looking at a range of doses of this NK-1 receptor antagonist drug, for both
      safety and effectiveness in prevention PONV
    

Detailed description: 
      A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group
      Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of the Oral
      Neurokinin-1 Receptor Antagonist, GW67969, When Administered With Intravenous Ondansetron
      Hydrochloride for the Prevention of Post-Operative Nausea and Vomiting (PONV) and
      Post-Discharge Nausea and Vomiting (PDNV) in Female Subjects With Known Risk Factors for PONV
      Who Are Undergoing Surgical Procedures Associated With an Increased Emetogenic Risk
    

Intervention name(s): intravenous ondansetron
Intervention type(s): Drug
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: emesis; nausea; post operative nausea and vomiting; vomiting; PONV
Treatment for Obesity and Binge Eating Disorder
Condition: Binge Eating Disorder; Obesity
MeSH terms: Obesity; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional

Summary: 
      This study is a test of cognitive behavioral therapy(CBT) and behavioral weight loss (BWL)
      treatments for obese patients with binge eating disorder (BED). The study involves a
      comparison of three treatment conditions: (1) CBT; (2) BWL, and (3) a sequential (two-part)
      treatment consisting of CBT followed by BWL.
    


Intervention name(s): Cognitive Behavior Therapy; CBT and BWL; Behavioral Weight Loss Treatment
Intervention type(s): Behavioral; Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: binge eating disorder; cognitive behavior therapy; combination therapy; obesity; weight loss; body weight; clinical trial; dietary restriction; overeating; weight control