bioihbjkbjnl/mcl2 huggingface dataset:
Rollover Trial for Placebo Subjects Previously Enrolled Into GEN-003-002 Study
Condition: Genital Herpes Simplex Type 2
MeSH terms: Herpes Simplex; Herpes Genitalis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a voluntary study to allow subjects who received placebo while on GEN-003-002 to be
      randomized, in a blinded manner, to 1 of 6 active combinations of GEN-003 and Matrix-M2.

      Objectives:

        -  To compare the impact on clinical Herpes Simplex Virus type-2 (HSV-2) disease among 6
           different combinations of GEN-003 antigens and Matrix-M2 adjuvant measured by:

             -  Time to first clinical and/or virologic recurrence after Dose 3 (Day 43)

             -  Proportion of subjects who are recurrence free at 6 and 12 months after the last
                dose of vaccine

             -  Lesion rate (percent of days with genital lesions present) during the
                post-vaccination follow-up period

             -  Antiviral use.

        -  To evaluate the safety and tolerability of GEN-003 in combination with Matrix-M2.
    


Intervention name(s): GEN-003 Vaccine (30μg of each antigen); GEN-003 Vaccine (60μg of each antigen); Matrix-M2 Adjuvant (25μg); Matrix-M2 Adjuvant (50μg); Matrix-M2 Adjuvant (75μg)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D; HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D; Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.; Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.; Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
Other intervention name(s): HSV Vaccine; HSV Vaccine; MM2; Adjuvant; MM2; Adjuvant; MM2; Adjuvant
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HSV; Herpes; genital infection; vaccine
RISE Adult Medication Study
Condition: Prediabetes; Type 2 Diabetes
MeSH terms: Prediabetic State
Study type: Interventional
Phase: Phase 3

Summary: 
      The RISE Adult Medication Study is a 4-arm, 3-center, clinical trial of adults with
      prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose
      lowering will lead to recovery of beta-cell function that will be sustained after withdrawal
      of treatment. Adult participants (ages 20-65) will be randomized to one of the following
      treatment regimens: (1) blinded placebo, (2) blinded metformin alone, (3) early intensive
      insulin treatment with basal insulin glargine followed by open-label metformin, (4) the
      glucagon-like peptide-1 receptor agonist (GLP-1RA) liraglutide plus open-label metformin.

      The primary clinical question RISE will address is: Are improvements in ß-cell function
      following 12 months of active treatment maintained for 3 months following the withdrawal of
      therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal
      of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell
      function, insulin sensitivity and glucose tolerance and the response to an intervention.
    


Intervention name(s): Metformin; Liraglutide; Glargine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Titrated to 1000 mg BID; Titrated to 1.8 mg/day; Titrated to target fasting glucose <90 mg/dl; Matching to metformin 1000 mg BI
Other intervention name(s): Glucophage; Victoza; Insulin glargine, Lantus
Intervention MeSH terms: Metformin; Insulin Glargine; Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Metabolic Dynamics During Physical Activity
Condition: Healthy Men and Women
Study type: Interventional

Summary: 
      The aim of this study is to systematically Analyse the metabolome in capillary blood of
      healthy men and women at rest and during defined standardized physical activity under
      normobaric normoxia or hypoxia with a specific focus on metabolites and metabolic pattern
      related to energy metabolism. The metabolome analyses in capillary blood could give us also
      or more detailed insight into erythrocyte metabolic physiology because it is known for a
      longer time that the primary metabolism of the erythrocyte reflects its Oxygen Saturation via
      the glycolytic metabolites / intermediates pattern.
    


Intervention name(s): running on a treadmill under normoxia or hypoxia
Intervention type(s): Other
Intervention description(s): 30 min running (60% VO2max) on a treadmill under hypoxia (O2: 14%)
30 min running (60% VO2max) on a treadmill under normoxia (O2: 20%)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: metabolism; metabolome; physical activity; hypoxia
Impact of a Nutritional Intervention on Type1 Diabetes Adult With Metabolic Syndrome
Condition: Type 1 Diabetes; Metabolic Syndrome
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Recent studies have found that up to 45 % of patients with type 1 diabetes have metabolic
      syndrome, a cluster of conditions (abdominal obesity, hypertension, dyslipidemia, insulin
      resistance) that increase the cardiovascular risk. The investigators have observed in
      previous studies a strong association between the adherence to a Mediterranean diet and the
      prevalence of metabolic syndrome on patients with metabolic syndrome. However, no
      intervention has been realized on this population and the current recommendations (low fat
      diet) differ from the Mediterranean diet. A nutritional intervention on the principles of the
      Mediterranean diet could therefore play a role in the treatment of the metabolic syndrome in
      Type 1 diabetes patients. The main objective of this study is to examine the impact of a
      nutritional intervention on the waist circumference after 6 months of an intervention group
      (Mediterranean diet) versus a control group (low fat diet).
    


Intervention name(s): Nutritional Counseling
Intervention type(s): Behavioral
Intervention description(s): Carbohydrate counting will be reviewed, as well as hypoglycemia management. The 9 following visits will focus on different aspects of each diets: types of fats, meat and alternatives, grain products, milk and alternatives, fruits and vegetables, salt intake, energy density and restaurants.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physical Activity in Patients With Severe Mental Illness
Condition: Mental Disorders
MeSH terms: Mental Disorders
Study type: Observational

Summary: 
      The aim of the study was to evaluate the applicability of the Physical Activity Scale (PAS)
      in relation to patients with severe mental illness. The study hypothesised that physical
      activity levels among patients with severe mental illness was significantly lower than
      healthy controls. The physical activity level of patients with severe mental illness
      attending Aarhus University Hospital, Risskov in comparisons with healthy controls matched on
      gender and age was assessed with PAS.
    

Detailed description: 
      The study population of interest was psychiatric in- or outpatients from Aarhus University
      Hospital , Risskov, some of whom were referred for physiotherapeutic treatment. The patients
      were compared with healthy controls matched on gender and age, recruited from hospital staff
      including administrative employees.Patients and controls were included in the study after
      giving informed consent, according to the Declaration of Helsinki 2008. All participants
      assessed their physical activity level by completing the PAS questionnaire twice within a
      time period of 5-7 days for evaluation of the test-retest reliability of PAS. For patients,
      PAS was administered as an interview, and for controls as a self-questionnaire. Several
      physiotherapists (PTs) were involved in interviewing the patients.

      In total, 47 hospitalized patients or outpatients and 28 controls were included in the study.
      In comparison with controls, the physical activity level of daily life of the patients was
      statistically significantly lower, even though the average physical activity level of the
      healthy controls was just above 'moderate physical activity'.

      There was a satisfactory test-retest reliability of PAS when applied to both mentally ill
      patients and healthy controls. PAS was found to be an applicable method for evaluating
      physical activity levels in patients with severe mental illness, and also useful in measuring
      changes in physical activity levels.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Psychiatric in- and outpatients admitted to Aarhus University Hospital, Risskov, Denmark
      
Keywords: Severe mental illness; physical activity; evaluation
The Effect of Electronic Cigarette Liquid Characteristics in Smokers.
Condition: Electronic Cigarettes
Study type: Interventional

Summary: 
      The purpose of this study is to determine differences in nicotine delivery, user behaviors,
      subjective effects, and physiological effects, when cigarette smokers use an electronic
      cigarette with different nicotine (and sweetener) concentrations relative to using their own
      brand of cigarettes.
    


Intervention name(s): Own Brand Cigarette; ECIG 15 mg nicotine, sweetened; ECIG 15 mg nicotine, unsweet; ECIG 0 mg nicotine, sweetened; ECIG 0 mg nicotine, unsweet
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Effects of own brand cigarette use.; Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid; Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid; Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid; Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid
Intervention MeSH terms: Nicotine
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Impact of Personalized Feedback Alone on Substance Use Behaviors
Condition: Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The investigators seek to develop a more efficient and effective approach to providing brief
      behavioral health interventions for risky substance use behaviors by comparing a brief coach
      directed intervention to a tailored report only group.
    

Detailed description: 
      Screening and brief intervention (SBIRT) generally involves universal screening for risky
      substance use behaviors in medical settings and the immediate provision of a 3-15 minute
      intervention to those found to be at risk. In this pilot study, the investigators seek to
      develop a more efficient and effective approach to providing brief behavioral health
      interventions in the field by comparing a brief coach directed intervention to a tailored
      report only group. The goal is to create a cost-effective and sustainable system that
      provides consumers with tailored information that will help them both initiate and sustain
      the lifestyle changes necessary for improving their overall health.

      Hypothesis 1: In a medical setting, personalized feedback alone will be associated with a
      reduction in risky substance use behaviors.

      Hypothesis 2: In a medical setting, personalized feedback alone will have the same impact on
      behavior as that information plus a brief coach education session on risky substance use
      behaviors..
    

Intervention name(s): Personalized feedback report; Personalized feedback report plus education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants receive the personalized feedback report but no additional education.; Participants receive the personalized feedback report plus education. This is the currently implemented service approach.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: SBIRT; brief intervention; alcohol; drug abuse
An Exploratory Maintenance Trial of BI 655064 in Patients With Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The main objectives of this trial are to evaluate the long term efficacy and safety of
      different doses of BI 655064 versus placebo as add-on therapy to Standard of Care (SOC)
      during maintenance therapy for lupus nephritis.
    

Detailed description: 
      Initially planned participating countries:

      Argentina, Australia, Canada, Colombia, Czech Republic, France, Germany, Greece, Hong Kong,
      Italy, Japan, Republic of Korea, Malaysia, Mexico, Philippines, Poland, Portugal, Serbia,
      Spain, Taiwan, Thailand, United Kingdom, United States
    

Intervention name(s): BI 655064; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection; subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2, randomized, open-label study comparing the safety, antiviral activity, and
      pharmacokinetics of HCV-796 administered in combination with peginterferon alfa 2B
      (Peg-Intron) plus concomitant Rebetol vs. Peg-Intron plus Rebetol in Hepatitis C Virus (HCV)
      genotype

      1-infected subjects who are either naive to treatment or who have previously failed treatment
      (non-responders).
    


Intervention name(s): Peg-Intron; REBETOL; HCV 796; Peg-Intron; REBETOL; HCV 796; Peg-Intron; REBETOL
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): SC injection, weight based dosing, weekly, 48 weeks; Capsules, weight based dosing, Q12 hrs daily, 48weeks; Capsules, 500 mg, Q 12 hrs. daily, 48 weeks; SC injection, weight based dosing, weekly, 48 weeks; Capsules, weight based dosing, Q12 hrs daily, 48weeks; Capsules, 500 mg, Q 12 hrs. daily, 48 weeks; SC injection, weight based dosing, weekly, 48 weeks; Capsules, weight based dosing, Q12 hrs daily, 48weeks
Intervention MeSH terms: Ribavirin; Interferon alpha-2; Peginterferon alfa-2b; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C
Intravitreal Injections of Ranibizumab With Deferred Laser Grid Laser Photocoagulation for Treatment of Diabetic Macular Edema With Visual Impairment
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      In the prospective monocentric open label trial patients with diabetic macular edema will be
      treated with intravitreal injections of ranibizumab given for 3 months then with laser grid
      at month 4. During follow-up a ranibizumab injection will be performed every 2 months in case
      of best-corrected visual acuity decreased more than 5 letters.
    


Intervention name(s): ranibizumab
Intervention type(s): Drug
Intervention MeSH terms: Ranibizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Investigate the Effect of Rosuvastatin (CRESTOR®) on High Density Lipoprotein Kinetics in Patients With the Metabolic Syndrome
Condition: Metabolic Syndrome; Dyslipidemia
MeSH terms: Metabolic Syndrome; Dyslipidemias; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the dose-related effect of treatment with
      rosuvastatin on production and fractional catabolism of apolipoprotein A-I (apoA-I) and
      apolipoprotein A-II (apoA-II), and on the plasma apoA-I, apoA-II and high-density lipoprotein
      cholesterol (HDL-C) concentration.
    


Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Metabolic Syndrome; Dyslipidaemia
Efficacy Study of Yi-Zhi-An-Shen Granules For Older Adults With Amnestic Mild Cognitive Impairment
Condition: Cognitive Dysfunction
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The main purpose of this study is to investigate the safety and efficacy of Yi-Zhi-An-Shen
      Granules in participants with amnestic mild cognitive impairment (aMCI).
    

Detailed description: 
      The investigators performed a randomized, placebo-controlled, double-blind study on
      evaluating effect of Yi-Zhi-An-Shen Granules on cognition, sleep quality, and gut microbiome
      of older adults with amnestic mild cognitive impairment (aMCI). The investigators plan to
      involve 80 cases for observation in 2 years (40 cases for each group), expecting that
      cognition and sleep quality of aMCI patients can be improved by Yi-Zhi-An-Shen Granules
      versus placebo, and discussing the differences between individuals with aMCI and ones with
      normal cognition, also investigating whether this Chinese medicine compound can regulate gut
      microbiome of older individuals with aMCI.
    

Intervention name(s): Yi-Zhi-An-Shen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Yi-Zhi-An-Shen Granules 5g given three times a day for up to 16 weeks.; Placebo granules 5g given three times a day for up to 16 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomized, double-blind, placebo-controlled study.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: amnestic
Low-level Laser Therapy Versus Formocresol in Primary Molar Pulpotomies
Condition: Pulpotomy
Study type: Interventional

Summary: 
      This study aimed to assess and compare the clinical and radiographic success rates of LLLT
      and FC for pulpotomy in human primary teeth. One hundred and six primary molars from 36
      children aging five to eight years were included and randomly assigned into two equal groups;
      LLLT group and FC group. Teeth were evaluated clinically and radiographically at 3, 6 and 12
      months.
    

Detailed description: 
      Background: Various agents are available to dress the remaining pulp tissue after pulpotomy
      procedure with the formocresol (FC) being the gold standard for the last 60 years. Nowadays,
      low-level laser therapy (LLLT) becomes a technique of interest, due to its many
      characteristics. However, the literature available on its success in pulpotomy is limited and
      reported conflicting results.

      Aim of the study: To assess and compare the clinical and radiographic success rates of LLLT
      and FC for pulpotomy in human primary teeth.

      Materials and methods: Utilizing split-mouth technique, the sample consisted of 106 primary
      molars from 36 children aging five to eight years. The teeth were selected based on specific
      clinical and radiographic inclusion criteria and randomly assigned into two equal groups;
      LLLT group and FC group. All the 106 primary molars were indicated for pulpotomy, where 53
      teeth were treated using FC and 53 teeth were treated with LLLT. Teeth were evaluated
      clinically and radiographically at 3, 6 and 12 months.
    

Intervention name(s): Low-level laser therapy
Intervention type(s): Device
Intervention description(s): It is a diode laser device that has laser set at low level, used for pain relief and inflammation reduction to induce healing
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It is a split-mouth randomized controlled clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low-level laser therapy, pulpotomy, formocresol
Obstructive Sleep Apnea and Bronchoscopy
Condition: Obstructive Sleep Apnea of Adult
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      The prevalence of sleep-disordered breathing in Republic of Korea is 27% and 16% in men and
      women aged 40-69 years. Up to 93% of women and 82% of men with obstructive sleep apnea (OSA)
      remain undiagnosed. Polysomnography, the gold standard, is time consuming and costly.
      Patients with undiagnosed OSA may experience obstructive episodes during procedures with
      conscious sedation.

      STOP-Bang questionnaire is the validated questionnaire to screen patients for undiagnosed OSA
      in the preoperative setting. It has high sensitivity (92.9%) for predicting patients with
      moderate to severe OSA.

      Previous studies reported that STOP-Bang questionnaire predicted cardiopulmonary events
      during advanced endoscopic procedures such as endoscopic retrograde cholangiopancreatography
      (ERCP) and endoscopic ultrasound. However, there have been no studies regarding the risk for
      sedation-related cardiopulmonary events in patients with undiagnosed OSA undergoing
      bronchoscopy. Thus, we aimed to evaluate the prevalence of high-risk patients for OSA by a
      screening questionnaire, and to determine whether the questionnaire could predict patients
      who are at risk for cardiopulmonary events during bronchoscopy with conscious sedation.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Tertiary referral hospital
      
Keywords: Obstructive Sleep Apnea; Bronchoscopy; STOP-Bang questionnaire; Cardiopulmonary events