bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Fufangdanshen Tablets in Mild to Moderate Vascular Dementia
Condition: Vascular Dementia
MeSH terms: Dementia; Dementia, Vascular
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose: The purpose of this study is to examine the efficacy and safety of Fufangdanshen
      Tablets in patients with mild to moderate vascular dementia (VaD).
    

Detailed description: 
      This multicenter, double-blind, placebo-controlled study will evaluate the safety and
      effectiveness of Fufangdanshen Tablets in patients with vascular dementia. All patients will
      initially receive placebo for a 2 weeks period and then will receive Fufangdanshen Tablets or
      placebo for 6 months. The primary measures of effectiveness include the change from baseline
      to the end of treatment in the ADAS-cog/11 score (Alzheimer's Disease Assessment Scale: sum
      of 11 cognitive items) and the CIBIC-plus score (Clinician's Interview Based Impression of
      Change - Plus Caregiver Input). Additional measures of effectiveness include the change from
      baseline to the end of the treatment in the MMSE score (Mini-mental State Examination), the
      ADL (Ability of Daily Living) score. Safety evaluations (incidence of adverse events,
      electrocardiograms (ECGs), physical examinations, laboratory tests) will be performed
      throughout the study. Patients who complete the double-blind portion of the study will be
      followed up 12 weeks. Effectiveness will be assessed at 12 weeks, 24weeks and 36 weeks.
      Safety evaluations (incidence of adverse events, ECGs, physical examinations, laboratory
      tests) will be performed at 12 weeks, 24weeks and 36 weeks of the study. The study hypothesis
      is that Fufangdanshen Tablets will be effective in the treatment of patients with vascular
      dementia and will be well tolerated. Double-blind: Fufangdanshen Tablets: 3 tablets per time,
      3 times per day, and placebo : 3 tablets per time, 3 times per day. The placebo has similar
      smile and appearance as the Fufangdanshen Tablets.
    

Intervention name(s): Fufangdanshen Tablets; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablets contains contains tanshinoneⅡA 0.67mg , salvianolic acid B 8.2mg, Panax Notoginsenosides R1 0.53mg, ginsenoside Rb1 3.03mg, ginsenoside Rg1 2.73mg, 3 tablets per time, 3 times per day for 24 weeks; Placebo for 3 tablets per time, 3 times per day for 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Vascular dementia; Fufangdanshen Tablets; Randomized Controlled trial; Chinese Medicine
Effects of Miglitol on Daily Plasma Glucose in type2 Diabetes Treated With Insulin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study, the effect of miglitol on daily plasma glucose will be evaluated in type 2
      diabetic patients treated with insulin.
    


Intervention name(s): miglitol
Intervention type(s): Drug
Intervention MeSH terms: Miglitol
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: alpha-glucosidase inhibitor,Insulin
Features to Predict Success With Nonoperative Treatment of Patients With Rotator Cuff Tears
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Observational

Summary: 
      The goal of this study is to find which patients will improve with the nonsurgical treatment
      of physical therapy for the treatment of rotator cuff tears.
    

Detailed description: 
      Rotator cuff tears are found in up to 40% of people over the age of 50 with the prevalence
      increasing with age. While most people remain asymptomatic, it is unknown why some develop
      symptoms. In symptomatic patients, surgical repair of a torn rotator cuff fails in 30-50% of
      patients, yet the majority of patients have a significant reduction pain despite failure of
      the repair. Nonoperative treatment has reported successful outcomes in 25-82% of patients yet
      it is not known which patient-related features predict success with nonoperative treatment.
      The general aim of this research effort is to identify patient features (historical
      information, physical examination findings, and MRI-based pathology) that would predict
      success (defined by reduction in visual analog pain scale, and patient satisfaction) with the
      nonoperative treatment of rotator cuff tears. The proposed study design is a prospective
      cohort study of patients with rotator cuff tears who will follow a standard physical therapy
      program derived from an evidence based medicine (EBM) systematic review of Level 1 and Level
      2 studies.

      Study the effect of historical information on predicting success (as determined by pain
      relief and patient satisfaction) of nonoperative treatment using the EBM based physical
      therapy program in treating patients with rotator cuff tears.

      Study the effect of physical examination findings on predicting success of a nonoperative
      treatment using the EBM-based physical therapy program in treating patients with rotator cuff
      tears.

      Study the effect of the severity of the rotator cuff pathology (using standardized magnetic
      resonance imaging protocols) on predicting success of nonoperative treatment for patients
      with rotator cuff tears using the EBM-based physical therapy program.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults between the ages of 18-100 with full thickness rotator cuff tears.
      
Keywords: rotator cuff; rehabilitation
Efficacy and Safety Trial of ALK-depot SQ Mites in Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is performed to assess the efficacy and safety of ALK-depot SQ mites for treatment
      of atopic dermatitis
    


Intervention name(s): subcutaneous immunotherapy
Intervention type(s): Biological
Intervention description(s): Updosing by 16 injections to 100,000 SQ-U
Other intervention name(s): ALK-depot SQ mites
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study on Phenotypic Characterization of Combined Pulmonary Fibrosis and Emphysema
Condition: Pulmonary Fibrosis; Emphysema
MeSH terms: Pulmonary Fibrosis; Pulmonary Emphysema; Fibrosis; Emphysema
Study type: Observational

Summary: 
      This study is to evaluate the expression of biological markers in induced sputum and
      peripheral blood T lymphocytes of patients with combined pulmonary fibrosis and emphysema
      (CPFE). The features of CPFE would be observed, including pulmonary function tests and
      fractional exhaled nitric oxide （FENO）.
    

Detailed description: 
      A new disease including concomitant upper-lobe emphysema and lower-lobe fibrosis in radiology
      has been defined as (combined pulmonary fibrosis and emphysema, CPFE). CPFE has distinct
      clinical characteristics with the emphysema and the pulmonary fibrosis, including gender,
      age, clinical manifestation, pulmonary function tests and prognosis.

      Normally Th1/Th2 is balanced. However, patients with emphysema had a significantly higher
      expression of Th1. On the other hand, higher expression of Th2 is involved in the development
      of pulmonary fibrosis. The expressions of Th1 and Th2 were proved to play a central role in
      pathogenesis of emphysema and pulmonary fibrosis, while are still unknown in patients of
      combined pulmonary fibrosis and emphysema. The study would observe the Th1/Th2 expression,
      pulmonary function tests , fractional exhaled nitric oxide （FENO）and other features in CPFE
      patients.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients with emphysema，pulmonary fibrosis , combined pulmonary fibrosis and emphysema
      
Biospecimen description: 
      whole blood, serum, sputum
    
Keywords: emphysema; pulmonary fibrosis;chemokine;sputum
Predictors of Response to Treatment for Depression
Condition: Adolescent Depression; Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The current study will examine neurophysiological, specifically event-related potential
      (ERP), measures of emotional processing as predictors of response to cognitive behavior
      therapy for adolescent depression.
    

Detailed description: 
      Neurophysiological measures (i.e., event-related potentials) of reward responsiveness and
      regulation of mood-congruent, sad stimuli will be assessed in a sample of adolescents with
      depression prior to group cognitive behavior therapy (CBT). CBT will follow the Adolescent
      Coping with Depression Course, an established 16-session group treatment protocol, and
      consist of behavioral activation, relaxation skills, cognitive therapy, social skills,
      problem solving, and relapse prevention. Changes in symptoms will be monitored through
      biweekly self-report and clinician ratings to examine prediction of change in symptoms across
      CBT. Baseline individual differences in reward responsiveness and emotion regulation will be
      evaluated as predictors of change in self-reported symptoms and clinician-rated improvement
      following CBT.
    

Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Cognitive Behavioral Therapy will follow the Adolescent Coping with Depression Course (CWD; Clarke et al., 1999), an established 16-session group treatment protocol, and consist of behavioral activation, relaxation skills, cognitive therapy, social skills, problem solving, and relapse prevention.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: reward; emotion regulation; electroencephalogram; event-related potentials; cognitive behavior therapy
Efficacy and Safety of Insulin RinGlar® Compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to approve non-inferior efficacy and safety of Insulin RinGlar®
      compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients.
    


Intervention name(s): Lantus Solostar, 100 Units/mL Subcutaneous Solution; Insulin RinGlar, 100 Units/mL Subcutaneous Solution
Intervention type(s): Drug; Drug
Intervention description(s): 4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses; 4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses
Intervention MeSH terms: Insulin Glargine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 1; Insulin; Glargine
Bioequivalence Study of Clopidogrel 75 mg in Two Tablet Formulations Relative to Reference Tablet in Healthy Subjects
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Clopidogrel is a potent anti-thrombotic drug that inhibits adenosine diphosphate
      (ADP)-induced platelet aggregation. This is an open-label, randomized, single dose, three-way
      cross over, six sequence study to investigate the relative bioavailability of two 75
      milligrams (mg) clopidogrel tablet formulations (clopidogrel SB224326 test formulation 1
      [Clop F1] and clopidogrel SB224326 test formulation 2 [Clop F2]) compared with the reference
      product (innovator) in healthy human subjects. A total of 18 healthy human subjects will be
      randomized, such that approximately 14 evaluable subjects complete the study. Total duration
      in the study for each subject will be approximately 8 weeks from screening to the follow-up
      visit.
    


Intervention name(s): Clop F1; Clop F2; Innovator
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state.; A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state.; A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioequivalence; SB224326; clopidogrel; Relative bioavailability
A Study of Whether 3 New Oral Formulations of a Strong Pain Killer Release the Same Amount of Drug Into the Body as the Marketed Medication
Condition: Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine whether three new oral formulations of a strong pain killer release the drug
      into the body in a similar pattern as the already marketed reference capsule formulation with
      or without food
    

Detailed description: 
      Comparisons will be made between three new oral formulations and an existing marketed
      reference capsule formulation to determine whether the release rates of the products are
      similar or equivalent in a fed or fasted state. Determination is by measurement of drug
      concentrations in the blood at serial collection time points pre-dose until 72 hours
      post-dose, following an administration of a single oral dose. Pharmacokinetics parameters of
      AUC and Cmax are the primary endpoints
    

Intervention name(s): MRXXX; MR1XXX; MR2XXX; MR3XXX
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy Volunteer; Pharmacokinetics
Long-term Cancer Risk in the Randomised Oslo Diet and Antismoking Study
Condition: Cancer; Gastrointestinal Cancer; Lung Cancer; Urinary Tract Cancer; Prostate Cancer
MeSH terms: Gastrointestinal Neoplasms; Urologic Neoplasms
Study type: Observational

Summary: 
      This study examines the effect of a five-year multifactorial lifestyle intervention in the
      Oslo diet and antismoking study on long-term cancer risk. In 1972-1973, 1232 men with high
      cardiovascular risk profile were randomised to intervention including cholesterol lowering
      diet, weight loss and antismoking advice, or control (1:1). This study examines the effect of
      the intervention on 43-year cancer incidence and mortality.
    

Detailed description: 
      The Oslo diet and antismoking study showed that a 5-year lifestyle intervention reduced the
      long-term risk of coronary events and mortality. The lifestyle risk factors for cancer are
      partly similar to those for coronary heart disease, e.g. smoking, high body weight,
      unfavourable diet. The investigators therefore expect that the intervention has an effect on
      cancer risk in the long term.

      In this follow-up study, the investigators analyse the association between the intervention,
      and cancer incidence and mortality drawn from the Cancer Registry of Norway and the Norwegian
      Cause of Death Registry from the time of randomisation in 1972/3 until the end of 2015.
    

Intervention name(s): Diet and antismoking advice
Intervention type(s): Behavioral
Intervention description(s): Dietary advice with the aim of reducing participant's serum cholesterol levels, including reduction in the intake of saturated fat and cholesterol, and increased intake of polyunsaturated fat, fish, vegetables and fruit. Weight reduction was recommended for overweight men, as well as reduced consumption of sugar rich foods and drinks, and alcoholic beverages. Smokers were advised to stop smoking. The advice was given both individually and in group sessions during a five-year time period from 1972/3 until 1977/8.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participants selected for this follow-up study (n=1216) are the eligible subjects of
        the 1232 men at high cardiovascular risk profile who participated in the Oslo Diet and
        Antismoking Study (included in 1972-73). Fourteen men were excluded because they did not
        consent to studies other than the main study, and two more because of previous history of
        cancer.
      
Keywords: cancer risk; randomised trial; intervention; smoking cessation; dietary intervention; weight loss
Phase 2 Dose-Ranging Efficacy and Safety Trial of SCH 900271 in Participants With Primary Hypercholesterolemia or Mixed Hyperlipidemia (P05675)
Condition: Primary Hypercholesterolemia; Mixed Hyperlipidemia
MeSH terms: Hyperlipidemia, Familial Combined; Hyperlipoproteinemia Type V; Lipidoses; Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of SCH 900271 compared to placebo on the
      reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 8 weeks of
      treatment in participants with primary hypercholesterolemia (familial and nonfamilial) or
      mixed hyperlipidemia. The study will also evaluate the effect of SCH 900271 on non-high
      density lipoprotein cholesterol (non-HDL-C) and various other lipids and lipoproteins. The
      safety of SCH 900271 in this participant population will also be evaluated.
    


Intervention name(s): SCH 900271 15mg; SCH 900271; SCH 900271; SCH 900271; SCH 900271; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): oral tablets; SCH 900271 - 15 mg taken once daily for 8 weeks; oral tablets; SCH 900271 10 mg taken once daily for 8 weeks; oral tablets; SCH 900271- 5 mg taken once daily for 8 weeks; oral tablets; SCH 900271- 2.5 mg taken once daily for 8 weeks; oral tablets; SCH 900271- 1 mg taken once daily for 8 weeks; oral tablets; placebo administered once daily during the 5-week single-blind placebo run-in and diet stabilization period and during the 8 week double-blind treatment period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Examination of the Anti-inflammatory and Insulin Sensitizing Properties of Doxycycline in Humans
Condition: Type 2 Diabetes; Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      Obesity is a heightened state of inflammation in which production of cytokines and matrix
      metalloproteinases (MMPs) result in loss of function of insulin receptors and insulin
      resistance. Doxycycline (DOX) is a potent MMP inhibitor. We hypothesize that DOX will enhance
      insulin sensitivity and decreases inflammation in obese participants with type 2 diabetes
      (DM2).
    

Detailed description: 
      Design and Setting: 84 day (D84), double-blind, randomized, placebo (PL)-controlled clinical
      trial conducted in an academic tertiary care center.

      Patients: Non-DM2 Controls (n=15); participants with DM2 receiving PL (n=13) or DOX (n=11).

      Interventions: All participants were evaluated at day 1 (D1); those with DM2 were also
      evaluated at D84 after DOX 100mg twice daily or PL.
    

Intervention name(s): Doxycycline; Placebo
Intervention type(s): Drug; Other
Intervention description(s): generic doxycycline 100mg twice daily; Placebo comparator to doxycycline
Other intervention name(s): Vibramycin
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: doxycycline; insulin resistance; obesity; inflammation
Intranasal Dexmedetomidine VS Oral Chloral Hydrate for Rescue Sedation During Magnetic Resonance Imaging
Condition: Administration Related Reaction; Failed Moderate Sedation During Procedure; Chloral Hydrate Adverse Reaction
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this investigation was to test the hypothesis that intranasal dexmedetomidine
      is as effective as second dose of oral chloral hydrate for rescue sedation in infant age
      between 1 and 6 months who were not adequately sedated following initial dose of chloral
      hydrate.
    


Intervention name(s): chloral hydrate Group; low dose dexmedetomidine group; high dose dexmedetomidine group
Intervention type(s): Drug; Drug; Drug
Intervention description(s): chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline); Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup; Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup
Other intervention name(s): AiBeiNing; AiBeiNing
Intervention MeSH terms: Dexmedetomidine; Chloral Hydrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
A Study to Evaluate the Effect of Gastric pH on Acalabrutinib Pharmacokinetics (PK) in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of gastric pH on acalabrutinib pharmacokinetics in
      healthy participants.
    

Detailed description: 
      This is a 2-period study done under fasting conditions. Participants will receive an oral
      wireless motility/pH capsule (SmartPill®) followed immediately by a single 100 mg oral dose
      of acalabrutinib on Day 1 of Period 1 and Period 2 (ie, Day 1 and Day 4, respectively). There
      will be 72 hours of washout between Day 1 dosing of each period. Participants will be
      contacted approximately 14 days after the last dose of study drug for adverse events.
    

Intervention name(s): Acalabrutinib; SmartPill®
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive a single oral dose of acalabrutinib 100 mg capsule on Day 1 (Period 1) and Day 4 (Period 2).; Participnats will receive a single oral dose of wireless motility/pH capsule (SmartPill®) on Day 1 (Period 1) and Day 4 (Period 2).
Other intervention name(s): ACP-196
Intervention MeSH terms: Acalabrutinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acalabrutinib; ACP-196; Gastric pH; Healthy participants; Pharmacokinetics; PK; Safety