bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study for Perceived Effectiveness Evaluation of Moisturizing Action of Intimate Use Product in Postmenopausal Women
Condition: Female Dry Genital Mucosa
Study type: Interventional

Summary: 
      The purpose of this study is to verify the effectiveness of the investigational product
      through Subjective Assessment and answered by volunteers.
    


Intervention name(s): KL029 Intimate Lubricant Gel
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: Single (Participant)
MapTrek for Sedentary Workers
Condition: Sedentary Lifestyle
Study type: Interventional

Summary: 
      The aim of this study is to determine if participants randomized to our mHealth MapTrek game
      increases daily physical activity (average steps/day, active minutes/day) compared to a
      control group among sedentary office workers over 10 weeks. The investigators hypothesize the
      MapTrek intervention group will significantly increase their daily steps and active minutes
      compared to the control group over 10 weeks.
    


Intervention name(s): Fitbit + Maptrek; Fitbit only
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Users receive a Fitbit Zip to wear daily. Users aslo receive the mHealth MapTrek game that places users in weekly walking races and sends automated text messages to users on a daily basis for the purpose of increasing daily physical activity.; Users receive a Fitbit Zip to wear daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the safety and efficacy profiles of Watson
      Laboratories, Inc.'s Pimecrolimus Cream, 1% to those of Valeant Pharmaceuticals North America
      LLC's Elidel® (pimecrolimus) Cream, 1%, and to demonstrate the superior efficacy of the two
      active creams over that of the placebo (Vehicle of test product), in the treatment of mild to
      moderate atopic dermatitis.
    

Detailed description: 
      Pimecrolimus cream, 1% is a calcineurin inhibitor immunosuppressant. Pimecrolimus inhibits T
      cell activation by blocking the transcription of early cytokines. Pimecrolimus cream, 1% is
      indicated as second-line therapy for the short-term and non-continuous chronic treatment of
      mild-to-moderate atopic dermatitis in non-immunocompromised adults and children 2 years of
      age and older who have failed to respond adequately to other topical prescription treatments,
      or when those treatments are not advisable. This study is being conducted to evaluate the
      clinical bioequivalence of sponsor's formulation of Pimecrolimus Cream, 1%, the Test product,
      and Elidel Cream, 1%, the Reference product. A vehicle control arm is included to demonstrate
      that the Test and Reference products are active and to establish that the study is
      sufficiently sensitive to detect differences between products.
    

Intervention name(s): Pimecrolimus Cream 1% (Valeant); Vehicle cream; Pimecrolimus Cream, 1%
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Elidel® (pimecrolimus) Cream, 1% (Valeant); Vehicle of test product (Actavis); Pimecrolimus Cream, 1% (Actavis)
Intervention MeSH terms: Pimecrolimus; Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy Subjects
Condition: Effect of Ketoconazole on the PK of NBI-98854 in Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to: learn about the safety of the study drug (NBI-98854);
      learn how subjects tolerate the study drug; and evaluate and compare the pharmacokinetics (PK
      testing, the study of how the body absorbs, distributes, breaks down and eliminates a drug)
      of the investigational study drug after taking it alone and with ketoconazole. Ketoconazole
      is known to affect the PK of many drugs and is studied to more safely prescribe medications.
    


Intervention name(s): NBI-98854 50 mg capsule once daily; Ketoconazole 400 mg (200 mg twice daily)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ketoconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Rosiglitazone (Avandia®) Treatment in HIV: Its Effect on Blood Vessels
Condition: Atherosclerosis; HIV Infections
MeSH terms: Atherosclerosis
Study type: Interventional

Summary: 
      This trial will study the effect of rosiglitazone on the progression of atherosclerosis
      (hardening of blood vessels) through improvements of the sugar and fat metabolism (body
      buildup, breakdown and excretion of sugar and fat).

      Participants will be randomly assigned to one of two groups: the first group will receive 8
      mg of the study drug and the second group will be given a placebo, though neither group will
      know which formulation they are receiving. The study will follow both groups for one year,
      during which it will measure changes in blood vessel composition and activity, sugar
      metabolism, concentration of blood fat, and body fat distribution. This single-site study
      aims to enroll 50 participants.
    


Intervention name(s): Rosiglitazone maleate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): See Detailed Description.; See detailed description.
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Treatment Experienced; HIV Metabolic Syndrome; Atherosclerosis in HIV
Study on the Efficacy and Safety of Oral Probucol Tablets in Patients With Hyperlipidemia - Post-Marketing Surveillance
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Observational

Summary: 
      The primary objective of this post marketing surveillance (PMS) is to determine the safety
      and efficacy of probucol in lowering the level of serum cholesterol in the blood.
    

Detailed description: 
      This nationwide post marketing surveillance targets to recruit a total of 3,000 patients with
      hyperlipidemia. Duration of treatment is 60 days. The usual starting dose for Lorelco is 500
      mg administered daily, divided into two (2) doses (250mg BID) and given after meals. The dose
      may be adjusted according to the patient's age and condition. Lipid serum test will be
      obtained at Day 0 (Baseline). In subjects requiring antihyperlipidemics that fulfill the
      inclusion criteria, Lorelco 250 BID will be started. There will be 2 follow-up visits after
      baseline on Day 30 and Day 60. Both lipid serum tests and ECG will be done on these 2
      follow-up visits. During each visit the investigator will assess the subject's vital signs
      and symptoms and check for any adverse events.

      The primary outcome of measure is the percentage reduction or increase in total cholesterol
      and triglycerides from baseline values at Week 0 to Week 4 and Week 8 using the following
      scale:

      Total Cholesterol Triglycerides

        1. Markedly reduced

        2. Moderately reduced

        3. Slightly reduced

        4. Unchanged

        5. Increased Reduction of ≥ 15% Reduction of ≥ 10% but < 15% Reduction of ≥ 5% but < 10%
           Change of < 5% Increase of ≥ 5% Reduction of ≥ 30% Reduction of ≥ 20% but < 30%
           Reduction of ≥ 10% but < 20% Change of < 10% Increase of ≥ 10% The percentage change on
           the last week of treatment will be the final evaluation.

      The secondary outcome is measured by the changes in symptoms and vital signs. Using the
      following scale:

        1. Markedly Improved

        2. Improved

        3. Slightly Improved

        4. Unchanged

        5. Aggravated

        6. Unknown (not assessable)

      Safety will be measured by the incidence of adverse events to be collected.

      Overall efficacy and safety will be evaluated to assess the usefulness of Lorelco using the
      following scale:

        1. Very useful

        2. Useful

        3. Somewhat useful

        4. Not useful

        5. Unfavorable

        6. Unknown (not assessable)
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 3,000 patients in the Philippines with hyperlipidemia (including familial
        hypercholesterolemia and xanthoma).
Assessment of Near Vision Capacity in Different Light Intensities
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Observational

Summary: 
      Patients who underwent presbyopic correction with bilateral bifocal intraocular lenses
      implantation are supposed to have sufficient uncorrected vision capacity for activities of
      daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is
      known that light intensity and temperature has a great impact on near vision capacity.
      Primary objective of this study is to identify the optimal task lighting conditions (in terms
      of light intensity and temperature) for ADLs that demand near vision acuity for a sample oa
      patients who underwent presbyopic correction with bilateral bifocal intraocular lenses
      implantation
    


Intervention name(s): BB-Phaco
Intervention type(s): Procedure
Intervention description(s): Phacoemulsification with bilateral bifocal lenses implantation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Presbyopic patients that underwent pseudophakic presbyopic correction with bilateral
        bifocal intraocular lenses implantation
Improve SCA Bridge Study
Condition: Sudden Cardiac Arrest; Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Heart Arrest; Death, Sudden, Cardiac; Infarction
Study type: Observational

Summary: 
      The purpose of the Improve SCA Bridge study is to characterize the care pathway flow of
      post-acute myocardial infarction (MI) patients as a result of standard assessments of left
      ventricular ejection fraction (LVEF) in the acute phase (≤14 days post- acute MI) and chronic
      phase (≥40-90 days post-acute MI).
    

Detailed description: 
      To determine how many patients are referred for sudden cardiac death (SCD) risk
      stratification and management, indicated for implantable cardioverter defibrillator (ICD), or
      cardiac resynchronization therapy- defibrillator (CRT-D) implant, and how many receive such
      devices within 12 months of experiencing an MI.
    

Intervention name(s): EP referred group; Non-Referred group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Referred for sudden cardiac death (SCD) risk stratification and management; Not referred for sudden cardiac death (SCD) risk stratification and management.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who have an acute Myocardial Infarction (MI) (STEMI or Non-STEMI).
Same-Day Mifepristone-Misoprostol Compared to Misoprostol Only for Surgical Abortion Cervical Preparation
Condition: Induced Abortion
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized double---blinded comparison of same---day mifepristone and misoprostol with
      misoprostol only for cervical preparation in second---trimester surgical abortion in 100
      women at 14 0/7---19 6/7 weeks gestation.
    

Detailed description: 
      Women desiring abortion at gestational ages between 14 weeks 0 days and 19 weeks 6 days were
      randomized to 200-mg mifepristone or identical placebo with 400-mcg misoprostol vaginally 4-6
      hours prior to D&E. Primary outcome was cervical dilation assessed by the largest Hegar
      dilator accepted without resistance. Secondary outcomes included total procedure time, and
      patient and provider perceptions. The study was powered to detect a 2-mm difference in
      cervical dilatation with 48 participants in each arm.
    

Intervention name(s): Mifepristone; Misoprostol; Placebo
Intervention type(s): Drug; Drug; Dietary Supplement
Intervention description(s): Progesterone antagonist; Prostaglandin E1; Tasteless, odorless, sugar based pill
Other intervention name(s): Mifeprex; Cytotec
Intervention MeSH terms: Misoprostol; Mifepristone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Platelet Rich Fibrin+1% Alendronate in Treatment of Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The present study is designed to evaluate the combined efficacy of Platelet Rich Fibrin (PRF)
      and 1% Alendronate (ALN) with open flap debridement (OFD) in treatment of intrabony defects
      in chronic periodontitis patients.
    

Detailed description: 
      Background: Platelet-rich fibrin (PRF) is a second-generation platelet concentrate, act as
      reservoirs of growth factors and cytokines which are the key factors for regeneration of the
      bone and maturation of the soft tissue. Alendronate (ALN), a potent member of bisphosphonate
      group is known to promote tissue regeneration by inhibiting osteoclastic bone resorption and
      promoting osteoblastogenesis. The present study was designed to evaluate the combined
      efficacy of PRF and 1% ALN with open flap debridement (OFD) in treatment of intrabony defects
      in chronic periodontitis patients.

      Methods: Ninety patients with single defects were categorized into three groups: OFD alone,
      OFD with PRF,OFD with PRF+1% ALN. Clinical parameters; site specific plaque index (PI),
      modified sulcus bleeding index (mSBI), probing depth (PD), clinical attachment level (CAL)
      and gingival marginal level (GML) were recorded at baseline before surgery and 9 months
      post-operatively. Percentage radiographic intra-bony defect depth reduction (IBD) was
      evaluated at baseline and 9 months.
    

Intervention name(s): Open flap debridement (OFD); OFD with Platelet rich fibrin (PRF); OFD with Platelet rich fibrin (PRF)+1% Alendronate
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Oral prophylaxis followed by Open flap debridement (OFD); Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect; Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate placement into the bone defect
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Immune Reconstitution in HIV Disease (IREHIV)
Condition: HIV Infection
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim with this study is to provide immunotherapy with vitamin D and phenylbutyrate to
      treatment-naive HIV infected patients to induce important antimicrobial defence mechanisms
      and decreased inflammation.
    


Intervention name(s): vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate); Placebo tablets
Intervention type(s): Drug; Drug
Intervention description(s): Dose of interventions: 5,000 IU of vitamin D (cholecalciferol tablets) once daily and 500 mg PBA (sodium phenylbutyrate tablets) twice daily for 16 weeks.; Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.
Intervention MeSH terms: Vitamin D; Cholecalciferol; 4-phenylbutyric acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; cholecalciferol; sodium phenylbutyrate; antimicrobial peptides; immune response; inflammation
Intima Media Thickness Regression in Dyslipidemic Teenagers
Condition: Obesity; Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized controlled trial of statin intervention in dyslipidemic obese teenagers. Primary
      outcome is intima media thickness before and after intervention.
    

Detailed description: 
      Obese teenagers with abnormal lipid profiles were randomized to either low dose statin or
      placebo and had their carotid intima media thickness compared before and after intervention.
    

Intervention name(s): Atorvastatin; sugar pill
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg Atorvastatin vs placebo daily in a randomized controlled trial for one year; placebo controlled arm receives similarly looking placebo.
Other intervention name(s): Statin; Lipitor; placebo
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Dyslipidemia; Cholesterol; Intima media thickness
Qigong for Pre-frail and Frail Older Cancer Survivors
Condition: Cancer; Frailty
MeSH terms: Frailty
Study type: Interventional

Summary: 
      To-date, there is no evidence on qigong's effects for improving well-being of pre-frail and
      frail older cancer survivors. Our aim is to conduct a pilot study for testing out the
      feasibility and acceptability of a qigong intervention to the elderly cancer survivors.
    

Detailed description: 
      Frailty is an emerging concept in geriatric research and practice. It is defined as a state
      of increased vulnerability to adverse outcomes including death. A cohort study has found that
      respondents with cancer were significantly more frail compared to those without cancer. A
      plausible explanation is both cancer itself and the therapies used to treat it add additional
      stressors that challenge a patient's physiologic reserve. A systematic review has revealed a
      high prevalence of frailty and pre-frailty in older cancer patients, with the median
      estimates of 42% and 43%, respectively. Cancer treatment can hasten survivors' aging process
      and increase their risk of developing frailty, thus placing cancer survivors at heightened
      risk of such poor health outcomes as falls, fractures, and disability. This calls for
      effective interventions that would improve frailty in older cancer survivors.

      Qigong, a type of mind-body intervention, is particularly suitable for older adults, as it is
      implemented without aerobic and musculoskeletal strain. This equipment-free form of exercise
      is ideal for settings with limited resources, as well as for the frail elderly, because it
      can be performed at home at any time, reducing such barriers as weather, transportation, and
      cost. Meta-analysis suggests that Baduanjin is beneficial in the general population in terms
      of improved quality of life, balance, handgrip strength, and trunk flexibility. To our
      knowledge, there is no evidence on qigong's effects for improving well-being of pre-frail and
      frail older cancer survivors. Our aim is therefore to conduct a pilot study for testing out
      the feasibility and acceptability of a qigong intervention to the elderly cancer survivors.
    

Intervention name(s): Qigong; Light flexibility exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Qigong Baduanjin, comprising eight standardized movements, will be adopted in the study. It is practiced as a combination of body movements, breath control, and mindful meditation.; The supervised sessions will include seated and standing stretches that target upper (neck, arms, upper back, shoulders, and chest) and lower body (quadriceps, hamstrings, calves, and hips), as well as trunk rotations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Frailty; Cancer survivors; Qigong; Feasibility
Diabetic Macular Edema Severity at Diagnosis
Condition: Diabetes Mellitus; Diabetic Retinopathy; Macular Edema
MeSH terms: Macular Edema; Retinal Diseases; Diabetic Retinopathy; Edema
Study type: Observational

Summary: 
      The purpose of this study is to identify the severity level distribution at the moment of
      diagnosis, in diabetic patients with macular edema from a Mexico City sample, and to identify
      the rate with severe macular edema that needed immediate treatment.
    

Detailed description: 
      The international severity scale grades macular edema as mild, moderate or severe, according
      to the distance of the thickening from the center of the fovea; However, this scale does not
      define the distances which fulfill the criteria of "distant from" or "approaching" the center
      of the macula; a quantitative and reproducible tool, such as optical coherence tomography
      (OCT), could be more accurate to grade severity, by localizing thickening in a standardized
      way.

      As far as we know, distribution of clinically significant macular edema at the moment of
      diagnosis, according to the international scale has not been described. A study was conducted
      to identify the rate of eyes that had severe macular edema at the moment of diagnosis, whose
      risk of visual loss could be higher and required immediate treatment.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Target population were type 2 diabetic patients with CSME who attended general hospitals of
        Mexico City and its metropolitan area; available population were patients with CSME
        evaluated at a general hospital
      
Keywords: Clinically Significant Macular Edema; Diabetic Macular Edema; Optical Coherence Tomography; Diabetic Retinopathy; Severity