bioihbjkbjnl/mcl2 huggingface dataset:
IMPAACT P1106: Pharmacokinetic Characteristics of Antiretrovirals and Tuberculosis Medicines in Low Birth Weight Infants
Condition: Low-Birth-Weight Infant; Tuberculosis; HIV
MeSH terms: Tuberculosis; Body Weight; Birth Weight
Study type: Observational

Summary: 
      P1106 is Phase IV prospective pharmacokinetic (PK) study of low birth weight infants who are
      receiving or will be receiving as part of clinical care nevirapine (NVP) prophylaxis,
      tuberculosis (TB) prophylaxis or treatment and/or combination antiretroviral (ARV) treatment
      containing lopinavir/ritonavir (LPV/r). The study is designed to describe the
      pharmacokinetics and safety of NVP, INH, RIF, and LPV/r in these infants receiving the
      drug(s) as part of clinical care.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Low birth weight (LBW) infants less than or equal to 2500 grams at birth who are receiving
        or will be receiving as part of clinical care nevirapine (NVP) prophylaxis, tuberculosis
        (TB) prophylaxis or treatment and/or combination antiretroviral (ARV) treatment containing
        lopinavir/ritonavir (LPV/r)
      
Biospecimen description: 
      Cell pellets from PK sampling once will be combined and stored for a DNA extraction,
      amplification, and gel electrophoresis. The genotype analysis will be completed one time per
      study participant. All subjects receiving INH will be genotyped for NAT2. All subjects
      receiving NVP will be genotyped for CYP 2B6. These genotypes will be used as covariates in
      the population PK analyses of NVP and INH to determine their impact on CL/F (clearance
      [apparent]).
Carvedilol + VSL#3 Versus Endoscopic Variceal Ligation for Primary Prophylaxis of Esophageal Variceal Bleeding in Cirrhotic Patients Non Responder to Carvedilol.
Condition: Cirrhosis
MeSH terms: Fibrosis
Study type: Interventional

Summary: 
      Patients of cirrhosis will be enrolled who have large esophageal varices, which have never
      bled. After successful screening baseline hepatic venous pressure gradient (HVPG) will be
      measured. Tablet carvedilol 3.125 mg BD for 1 week will be started. It will be increased to
      6.25 mg BD and continued for next 7 weeks. After completion of 8 weeks the hepatic venous
      pressure gradient (HVPG) will again be measured to find out responders (hepatic venous
      pressure gradient ≥20% reduction from baseline or absolute value of hepatic venous pressure
      gradient <12 mm Hg) and non responders (hepatic venous pressure gradient <20% reduction).The
      responders will be excluded from the study while the non responders will be randomize into
      carvedilol+VSL#3 versus Endoscopic Variceal Ligation.
    


Intervention name(s): Carvedilol+VSL#3; Endoscopic variceal ligation
Intervention type(s): Drug; Procedure
Intervention description(s): Tablet Carvedilol 6.25 mg BD & capsule VSL#3 1 TDS for 2 year; In the Endoscopic Variceal Ligation arm, Endoscopic Variceal Ligation will be performed using multibander devices by senior fully trained endoscopists or under their direct supervision. Varices will be banded starting at the gastroesophageal junction moving proximally upward in a spiral fashion. Patients will undergo Endoscopic Variceal Ligation every 3-4 weeks until eradication. Eradication is defined as the absence of varices or presence of grade I esophageal varices. Following eradication, the interval for the next endoscopy will be every 3 months to look for recurrence of varices. Endoscopic Variceal Ligation sessions would be repeated for the recurrent varices if they are sufficiently large.
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Physical Fitness, Cardiovascular and Brain Health
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The goal of this study is to determine if aerobic exercise or progressive muscle relaxation
      is associated with changes in cardiovascular health, brain function, and cognition.
    

Detailed description: 
      Cognition is the most important determinant of health status, quality of life and functional
      ability in older age. Therefore, early interventions that preserve and enhance cognitive
      function are crucial for ensuring successful aging. The most common treatable risk factor for
      late-life cognitive impairment is midlife hypertension (HTN). One highly promising
      intervention strategy is aerobic exercise as it has been associated cognitive benefits in
      non-demented older adults. However, it is still unclear whether this benefit is due simply to
      prevention of other risk factors (e.g., reductions in blood pressure) or if exercise can
      reverse the negative effects of HTN on the brain. The goals of the current study are to
      employ sensitive measures of neuroimaging and cognition in order to 1).Compare cerebral
      health in endurance trained versus sedentary middle aged adults with normal or borderline to
      stage 1 hypertension, 2). measure the effects of exercise training in previously sedentary
      middle aged adults adults with normal or borderline to stage 1 hypertension, and 3). examine
      if exercise-related differences and changes in neural integrity and cognition are mediated by
      systemic vascular health.
    

Intervention name(s): Aerobic Exercise; Relaxation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12-week moderate-intensity aerobic exercise program designed in accordance with the recommended guidelines established by the American College of Sports Medicine; 12-week progressive muscle relaxation program (active control)
Other intervention name(s): Exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension; aerobic exercise; relaxation; functional magnetic resonance imaging (fMRI); magnetic resonance spectroscopy (MRS); brain health
Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma (PXS-X02)
Condition: Malignant Melanoma
MeSH terms: Coxsackievirus Infections; Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety of an injection of coxsackievirus A21
      into a melanoma tumour, and also to see if there is a tumour response.
    

Detailed description: 
      Coxsackievirus A21, a naturally occurring enterovirus, has shown that in vivo it can infect
      and lyse melanoma. This study is to assess safety of a single intratumoural injection of the
      virus into an accessible subcutaneous melanoma metastasis.
    

Intervention name(s): Coxsackievirus A21
Intervention type(s): Drug
Intervention model: Single Group Assignment
Intervention model description: CAVATAK
Masking: None (Open Label)
Primary purpose: Treatment
A Study of a Novel Multi-Wavelength Laser for Tattoo Removal
Condition: Tattoo Removal
Study type: Interventional

Summary: 
      Single center study to evaluate the safety and efficacy of an investigational version of the
      Cutera enlightenTM laser that offers multiple wavelengths for tattoo removal.
    

Detailed description: 
      A single-center prospective, open-label, uncontrolled pilot study to evaluate the safety and
      efficacy of an investigational version of the Cutera enlightenTM laser that offers multiple
      wavelengths for tattoo removal.
    

Intervention name(s): enLighten Laser
Intervention type(s): Device
Intervention description(s): Laser for tattoo removal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
CKD-828(80/2.5mg) Pharmacokinetic Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic characteristics of CKD-828(Fixed
      Dose Combination Tablet; Telmisartan and S-Amlodipine) in healthy volunteer.
    


Intervention name(s): CKD-828(FDC); Combination Therapy
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Telmisartan 80mg + S-Amlodipine 2.5mg(FDC) Tablet, Oral, Once Daily; Drug: Telmisatan 80mg Tablet, Oral, Once Daily
Drug: S-Amlodipine 2.5mg Tablet, Oral, Once Daily
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: CKD-828; Hypertension; Primary Hypertension; Healthy Volunteer; S-Amlodipine; Telmisartan; Amlodipine; Pharmacokinetic; Phase 1
Bioavailability Study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to One Dutasteride and One Tamsulosin HCl Tablet in Healthy Male Subjects
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to determine the bioavailability of a FDC capsule
      formulation of dutasteride and tamsulosin hydrochloride (0.5 milligram [mg]/0.2 mg) relative
      to coadministration of one dutasteride 0.5 mg capsule and one tamsulosin HCl 0.2 mg tablet in
      healthy male subjects in fed and fasted states. This is an open-label, randomized, single
      dose, two-way crossover study enrolling healthy male subjects, split into fasted (Cohort 1)
      and fed (Cohort 2) conditions. In both cohorts, one FDC capsule formulation of dutasteride
      0.5 mg/tamsulosin HCl 0.2 mg will be administered in one treatment period and the
      coadministration of dutasteride and tamsulosin hydrochloride in a different treatment period.
      Each subject enrolled will be allowed to participate in only one cohort (i.e, will receive
      treatment under fasted or fed conditions) and will participate in both treatment periods. The
      two treatment periods will be separated by a minimum washout period of 28 days. The total
      duration in the study for each subject will be approximately 2.5 months from screening to the
      final follow-up visit.
    


Intervention name(s): FDC capsule of dutasteride and tamsulosin; Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet
Intervention type(s): Drug; Drug
Intervention description(s): Each FDC capsule contains a mixture of dutasteride formulation (equivalent to 0.5 mg dutasteride) and tamsulosin (equivalent to 0.2 mg tamsulosin) and its physical appearance is hard shell capsule.; Coadministration of dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet. Each soft gelatine capsule consist of 0.5 mg of dutasteride and physical appearance is Oblong, size 6, dull yellow capsule. Each oral disintegrating tablet consist of 0.2 mg of tamsulosin and its physical appearance is white, round standard convex.
Intervention MeSH terms: Tamsulosin; Dutasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Dutasteride; Healthy Male Subjects; Fixed Dose Combination
Physical Activity Promotion in Primary Health Care Settings
Condition: Motor Activity
Study type: Interventional

Summary: 
      A quasi experimental study evaluating the effectiveness of a walking program at primary
      health care settings in a low-income area
    

Detailed description: 
      There is a high prevalence of physical inactivity (AF) in the world and in Brazil. Offering
      programs of physical activity becomes a convenient option to increase the physical activity
      level of the population and promote aging process more active and healthy over the life.
      There is need for greater depth in relation to the operation of programs to promote physical
      activity and the effects of these programs on different biopsychosocial aspects, especially
      those offered in primary care settings. This research aims to evaluate a walking program
      geared to adults and seniors on the following aspects:

        1. Characteristics and operation of the intervention,

        2. effects of behavior change to physical activity, and

        3. biopsychosocial effects of physical activity.

      It is a quasi experimental and controlled study, with: 1) intervention group (n = 71), 2) and
      control group (n = 71). The intervention will last for six months, with a subsequent
      follow-up period of six months after the intervention. The program will offer supervised
      exercise twice a week, lasting an hour. The classes will consist of recreational activities,
      walking and educational strategies of behavior change for physical activity. Variables will
      be evaluated for attendance, barriers to physical activity, waiver reasons, physical activity
      level, sociodemographic, socioeconomic and biopsychosocial aspects. Most females, aged over
      40 years, low levels of education, income and varied biopsychosocial characteristics are
      expected. After the intervention, it is expected that the program present characteristics of
      low adhesion and retention, especially because of the barrier "lack of time". Still, the
      promotion of supervised walking increase levels of physical activity beyond the time provided
      by the program and it will improve the biopsychosocial conditions of the participants.
    

Intervention name(s): Walking program
Intervention type(s): Behavioral
Intervention description(s): To encourage people to exercise more through a behavioural and educational intervention during six months and other six months of follow up.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Low income population; Motor Activity; Primary Health Care
To Evaluate Ezetimibe Plus Atorvastatin Versus Atorvastatin in Patients With High Cholesterol Not Controlled on Atorvastatin 20 mg (0653-079)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate and compare the efficacy and safety of ezetimibe
      plus atorvastatin versus atorvastatin in hypercholesterolemic patients at moderately high
      risk for coronary heart disease not adequately controlled on atorvastatin 20 mg.
    


Intervention name(s): Comparator: atorvastatin; Comparator: Placebo; Comparator: ezetimibe; Comparator: Placebo.
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Atorvastatin 40mg tablet po qd (by mouth, once a day) for 6 weeks; Atorvastatin 20mg Pbo and ezetimibe 10mg Pbo tablets po qd (by mouth, once a day). for 6 weeks; Atorvastatin 20mg and ezetimibe 10mg tablets po qd (by mouth, once a day). for 6 weeks.; Atorvastatin 40mg Pbo tablets po qd (by mouth, once a day). for 6 weeks.
Intervention MeSH terms: Atorvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional

Summary: 
      We will estimate the responses of lansoprazole and ecabet sodium combination therapy and
      compare with lansoprazole and placebo therapy in patients who need additional therapy after
      standard proton pump inhibitor treatment for 4week or more in recurrent gastroesophageal
      reflux disease.
    


Intervention name(s): ecabet sodium; lansoprazole; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active comparator group patients will take lansoprazole 15 mg once daily and ecabet sodium 1.0 g three times daily and placebo group patients will take lansoprazole 15 mg once daily and placebo 1.0 g three times daily for total 8 weeks.; Active comparator group patients will take lansoprazole 15 mg once daily and ecabet sodium 1.0 g three times daily and placebo group patients will take lansoprazole 15 mg once daily and placebo 1.0 g three times daily for total 8 weeks.; Active comparator group patients will take lansoprazole 15 mg once daily and ecabet sodium 1.0 g three times daily and placebo group patients will take lansoprazole 15 mg once daily and placebo 1.0 g three times daily for total 8 weeks.
Other intervention name(s): Gastrex ganules
Intervention MeSH terms: Ecabet; Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: gastroesophageal reflux disease; lansoprazole; ecabet sodium
Efficacy and Safety of NicVAX® Co-administered With Varenicline (Champix®)
Condition: Smoking Behavior; Smoking Lapse Behavior; Smoking Relapse Behavior
MeSH terms: Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of NicVAX co-administered
      with varenicline as an aid in smoking cessation over a one-year period in smokers who want to
      quit smoking.
    


Intervention name(s): NicVAX vaccine; Placebo; Varenicline
Intervention type(s): Biological; Biological; Drug
Intervention description(s): NicVAX vaccine given 6 times over 6 months; Phosphate buffered saline and ALhydrogel of identical appearance to NicVAX; IM in 6 doses over 6 months; Days 0-2: 0.5 mg once daily, Days 3-6: 0.5 mg twice daily (morning and evening), Day 7- 84: 1.0 mg twice daily (morning and evening)
Other intervention name(s): Champix; Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking cessation; Smoking lapse behavior; Smoking Relapse behavior; Varenicline; Nicotine conjugate vaccine; Medication effect on smoking lapse behavior
Evaluation of Enamel Demineralization During Clear Aligner Orthodontic Treatment
Condition: White Spot Lesion
Study type: Interventional

Summary: 
      Development of white spot lesions (enamel demineralization) will be evaluated quantitatively
      during clear aligner orthodontic treatment compared to conventional fixed appliances using
      quantitative light induced fluorescence (QLF)
    

Detailed description: 
      White spot lesion (WSL) may develop around fixed orthodontic appliances. With clear aligners,
      however, the issue is not controversial. WSL will be monitored in 2 groups of patients; one
      group using clear aligners and one group wearing fixed orthodontic appliances for 3 months.
      QLF images will be taken before treatment (T0) and 3 months after commencement of the
      treatment (T1). The results will be compared between the two groups
    

Intervention name(s): Orthodontic treatment with clear aligner
Intervention type(s): Device
Intervention description(s): Included orthodontic treatment with clear aligner (eon Aligners)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: White spot lesion; QLF; Clear aligners
A Study of the Effects of Intake of Two Cod Residual Meals on Glucose Regulation in Overweight and Obese Adults
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The investigators have previously shown the intact protein from cod filet improves glucose
      regulation and serum lipid profile in overweight adults. A large amount of trimmings from
      various fish species such as cod is thrown away or sold at very low prices for animal feed,
      and analyses of the amino acid composition reveals that this can be a good protein source for
      humans. Two fractions are normally isolated from intact fish meal, i.e. water soluble and
      non-water soluble proteins. In the present study the investigators will compare these
      fractions, by studying their effects on glucose regulation in overweight/obese adults.
    

Detailed description: 
      Participants receive 6g per day of water soluble on non-water soluble cod protein as tablets
      for 8 weeks.
    

Intervention name(s): Cod protein from presscake; Cod protein from presscake + stickwater; Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 6g protein per day for 8wk; 6 g protein per day for 8 wk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Safety and Efficacy of Estetrol in Healthy Men
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study is designed as a phase Ib multiple dose study to evaluate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of E4 in healthy men after daily oral
      administration for 28 days.
    


Intervention name(s): estetrol; placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: safety; pharmacokinetics; pharmacodynamics; randomized
EFFECTIVENESS AND SAFETY OF CREAM CONTAINING SPENT GRAIN WAX EXTRACT, ARGAN OIL, AND SHEA BUTTER POST-TRICHOLOROACETIC ACID 15% PEEL: RANDOMIZED, CONTROLLED, DOUBLE-BLIND, SPLIT-FACE CLINICAL TRIAL
Condition: Aging Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Chemical peels are resurfacing procedures where chemical agent causes controlled exfoliation
      of the skin, followed by regeneration and remodelling of the epidermis and dermis layers.
      Chemical peels can be used to treat various skin condition, such as skin aging, pigmentary
      disorders, and skin texture disorders. The use of moisturizer after chemical surgery can help
      speed up the wound healing process and repair the skin barrier. TCA chemical peel has more
      side effects than other chemical peel solutions. The risk of complications after TCA chemical
      surgery on Fitzpatrick IV-VI skin types is also higher, especially post-inflammatory
      hyperpigmentation. There is no specific recommendations regarding the type of moisturizer
      that can be used after TCA chemical peels. This study aims to assess the effectiveness of a
      cream containing spent grain wax, argan oil, and shea butter in reducing TCA peel side
      effects.
    


Intervention name(s): Ezerra cream
Intervention type(s): Drug
Intervention description(s): The research subjects were divided into 2 groups: group A (intervention cream on the right side of the face and control cream on the left side of the face) and group B (intervention cream on the left side of the face and control cream on the right side of the face).
The test material consists of a cream containing a mixture of spent grain wax extract, shea butter, and argan oil, along with a vehicle cream. Vehicle cream was prepared by the Pharmacy Department of Faculty of Medicine Universitas Indonesia and has similar consistency, color, and scent as the intervention cream.The creams are applied to the face twice daily (0,5 FTU), immediately after washing, in equal amounts on each side of the face. The creams are applied for 7 days, and participants are instructed to use appropriate sunscreen.
Other intervention name(s): Vehicle cream
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: A randomized, placebo-controlled, double-blinded, split face trial on women undergoing TCA 15% chemical peels.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: aging; skin aging; trichloroacetic acid; chemical peel; anti-inflammation; moisturizer