bioihbjkbjnl/mcl2 huggingface dataset:
Study of Escitalopram in Adult Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Escitalopram is the S-enantiomer of citalopram. Both escitalopram and citalopram are
      selective serotonin reuptake inhibitors (SSRIs) and are used to treat depression in adults.
      This study is designed to evaluate the efficacy, safety, and pharmacoeconomics of
      escitalopram and an active comparator in patients with major depressive disorder.
    


Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Depression; Major Depressive Disorder; Escitalopram
Multiple Ascending Dose Study of TD-1439 in Healthy Adult and Elderly Subjects
Condition: Healthy Adults, Elderly Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of TD-1439 in healthy adult and elderly subjects
    


Intervention name(s): TD-1439; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Multiple ascending dose (MAD)
Differential Metabolic Effects of Fenofibrate and Fatty Acid
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesize that fenofibrate and fatty acid may have different metabolic
      effects in hypertriglyceridemic patients
    


Intervention name(s): fenofibrate, fatty acid, placebo
Intervention type(s): Drug
Intervention description(s): fenofibrate 160 mg, fatty acids 2 gm, placeob 8 weeks of treatment
Intervention MeSH terms: Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Insulin resistance
Effectiveness of Silver Diamine Fluoride in Arresting Dental Caries
Condition: Dental Caries in Children
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The present study aims to evaluate, through a controlled clinical randomized study,the
      effectiveness of silver diamine fluoride in arresting dentin caries lesions in primary molars
      when compared to atraumatic restorative treatment.
    

Detailed description: 
      The present controlled clinical randomized study aiming at evaluating the effectiveness of
      silver diamine fluoride (SDF) in arresting dentin caries lesions on the occlusal surface of
      primary molars when compared to atraumatic restorative treatment (ART). For this, 118 healthy
      children aged 2-5 years with at least one active dentin carious lesion, with no signs of pain
      or pulp involvement. The participants will be allocated randomly to one of two treatment
      groups: (1) Test Group - SDF and (2) Control Group - ART. The International Caries Detection
      and Assessment System (ICDAS) will be used to determine caries diagnosis and activity. In
      both groups, the guardians and children will receive oral hygiene instructions and will be
      advised about eating habits and fluoride dentifrice use.The clinical success will be verified
      through examinations performed by a blinded operator, after 3, 6 and 12 months, with clinical
      evaluations to detect caries arresting, representing the primary outcome of the study.
    

Intervention name(s): Atraumatic Restorative Treatment; Silver Diamine Fluoride
Intervention type(s): Procedure; Other
Other intervention name(s): ART; Glass Ionomer Cements; Ketac Molar Easymix; SDF; SDF 30%; Cariostop 30% Biodinâmica
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tooth, Deciduous; Dental Caries; Glass Ionomer Cements; Dental Atraumatic Restorative Treatment; Cariostatic Agents; Fluorides
Effects of Concomitant Administration of BMS-986195 on Methotrexate, Caffeine, Montelukast, Flurbiprofen, Omeprazole, Midazolam, Digoxin, and Pravastatin
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      Drug-drug interaction study in healthy men and women not of childbearing potential. Assess
      the effect of BMS-986195 on the pharmacokinetics of methotrexate, caffeine, montelukast,
      flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on safety of
      BMS-986195 and methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam,
      digoxin, and pravastatin. Collect data on multiple-dose pharmacodynamics of BMS-986195.
    


Intervention name(s): BMS-986195; Methotrexate; Leucovorin; Caffeine; Montelukast; Flurbiprofen; Omeprazole; Midazolam; Digoxin; Pravastatin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Leucovorin; Flurbiprofen; Methotrexate; Digoxin; Midazolam; Caffeine; Omeprazole; Pravastatin; Montelukast; Branebrutinib
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacity of Cognitive Remediation Treatment Compared to a Controlled Group in Young Patient With Anorexia Nervosa
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      The aim of research is to test in a randomized clinical trial with active sessions, the
      efficacy of cognitive remediation therapy in children anorexia nervosa compared to a
      controlled group. The investigators want to confirm the efficacy of cognitive remediation
      treatment in children's flexibility problems.
    

Detailed description: 
      In this research, the investigators want to evaluate remediation cognitive therapy in
      anorexia nervosa compared to a controlled group (relaxation) based on different factors that
      testified the cognitive improvement of patients: one week after therapy, six months after and
      one year after.

      Those factors are:

      Weight, perfectionism and food symptomatology, temperament, therapeutic alliance and change
      motivation, clinical evolution of anorexia nervosa, self esteem, executive functions,
      neuropsychological performance (flexibility and central coherence).
    

Intervention name(s): Cognitive remediation therapy; relaxation therapy
Intervention type(s): Behavioral; Other
Intervention description(s): Our scheme comprises 10 biweekly sessions ( 5 in group and 5 single) . Each session last about 45 minutes.
Individual sessions will be held with the patient and a therapist trained in the CRT; group sessions will be led by two therapists trained in CRT and regroup the maximum 5 patients.; Our scheme comprises 10 biweekly sessions. Each session last about 45 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Anorexia nervosa; Cognitive remediation therapy
Gingival Crevicular Fluid and Placental Tissue Levels of Interleukin-17 as a Possible Marker for Preterm Labor in Patients With Chronic Periodontitis
Condition: Chronic Periodontitis; Preterm Labor
MeSH terms: Periodontitis; Chronic Periodontitis; Premature Birth; Obstetric Labor, Premature
Study type: Observational

Summary: 
      This case control-study measures the levels of Interleukin-17 in gingival crevicular fluid
      and placental tissue samples of pregnant females as a possible marker in determining whether
      or not an association exists between chronic periodontitis and preterm labor. Interleukin-17
      is a pro-inflammatory cytokine whose levels have been proven to increase in periodontal
      disease.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Conducted in Cairo, Egypt at the Maternal-Fetal Medical Clinic at the Department of
        Obstetrics and Gynecology, Faculty of Medicine, Ain Shams University.
      
Biospecimen description: 
      Gingival crevicular fluid and placental tissue samples
    
Keywords: Chronic Periodontitis; Preterm Labor; Preterm Birth; Interleukin-17; IL-17; Periodontal Disease; Periodontitis; Periodontal risk factors; Medical risk factors
Biomarkers for the Progression of IgA Nephropathy
Condition: IgA Nephropathy; Glomerular Diseases
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Study type: Observational [Patient Registry]

Summary: 
      IgA nephropathy (IgAN) is the most prevalent primary glomerular disease worldwide and an
      important cause of end stage renal disease. IgAN has an incidence of 8-25 new cases/year/per
      million age-related population in adults and 3-5/new cases/year/per million age-related
      population in children and progresses to need of renal replacement treatment in 5-15% at 10
      years and in about 20% at 20 years. The variability of the clinical course anticipates
      different treatment options. There is an absolute need of validated biomarkers to predict
      risk of progression and indication for treatment at early stages, when lesions can be
      reversible. This study aimed to evaluate IgAN progression and its histological and clinical
      correlates.
    

Detailed description: 
      IgA nephropathy is the most prevalent primary glomerular disease worldwide and an important
      cause of end stage renal disease. Clinical course varies from long term stable renal
      functions with minimal proteinuria and microscopic hematuria to rapidly progressive
      glomerulonephritis with crescents on renal biopsy which progresses to end stage renal disease
      in a very short time.

      In current practice the diagnosis is made with renal biopsy. A less invasive procedure for
      diagnosis is not present and no serum biomarkers for clinical follow-up, treatment response
      and prognosis are available. For that reason follow-up of the disease is enabled with
      indirect markers of renal function like proteinuria, serum creatinine and glomerular
      filtration rate. These markers are not specific for IgA nephropathy. The lack of disease
      specific markers hinders the standardization of patient follow-up and treatment. Development
      of specific and sensitive, repeatable, histopathological and clinical markers for diagnosis,
      follow up and treatment response in IgA nephropathy the most prevalent primary glomerular
      disease affecting many patients worldwide will offer prospects of diagnosis and improved
      prognostication.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with the diagnosis of biopsy confirmed IgA nephropathy
A Bioavailability Study Comparing 3 Different AZD1981 Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to study the relative bioavailability of AZD1981 when using a
      new tablet compared to the current tablet.
    


Intervention name(s): AZD1981, current small-particle tablet; AZD1981, new small-particle tablet; AZD1981, new large-particle table
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3x100 mg per oral, single dose in fasted state; 3x100 mg per oral, single dose; 3x100 mg per oral, single dose in fasted state
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; bioavailability study; AZD1981; tablets; To study the relative bioavailability of single dose AZD1981 via three different tablets; To compare the bioavailability between three different AZD1981 tablets
To Evaluate Effects of GSK2256294 on Pulmonary Artery Pressure in Healthy Volunteers Under Normoxic and Hypoxic Conditions
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The study evaluates the effect of GSK2256294 exposure at steady state on pulmonary artery
      systolic pressure (PASP) in healthy volunteers, under hypoxic conditions, after 7 days of
      dosing. It is single centre, double blind, randomized, placebo-controlled study to be
      conducted in approximately 30 healthy volunteers. Subjects will be screened no more than 30
      days. Subject will be admitted in clinical unit on Day -1. Subject will be dosed for 7 days
      in unit in morning on all days except for dosing on Days 3 -6. Dosing on Days 3 -6 will occur
      at home. Subjects will return to the unit on the evening of Day 6 and remain there until Day
      8. Subjects will undergo echocardiography under normoxic and hypoxic on Day 1 pre-dose and on
      Day 7 post-dose. Subject will be followed up for 28- 32 days after discharge. The maximum
      estimated time that a subject will be enrolled in the study is 62 days from the screening
      visit to follow up.
    


Intervention name(s): GSK2256294; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK2256294 will be supplied as gelatin capsule to be administered orally with the unit dose 5 mg / dose level 15 mg; Matched Placebo will be supplied as gelatin capsule to be administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: GSK2256294; normoxic; hypoxic; Pulmonary artery systolic pressure (PASP)
An Open Label Study in Adults to Test the Efficacy of Mitoquinone/Mitoquinol Mesylate to Prevent Severe Viral Illness
Condition: Respiratory Viral Infection; Antiviral Treatment; COVID-19
MeSH terms: COVID-19; Virus Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Open label clinical trial of persons (adults) that will determine the safety and efficacy of
      the diet supplement oral mitoquinone/mitoquinol mesylate (Mito-MES) to prevent the
      development and progression of severe viral infections like COVID-19 after high-risk exposure
      to a person with possible respiratory viral infection such as SARS-CoV-2 infection in persons
      who will receive Mito-MES compared to persons who will not receive Mito-MES (controls).
    

Detailed description: 
      Overview of study design Open label clinical trial of persons (adults) that will determine
      the safety and efficacy of the diet supplement oral mitoquinone/mitoquinol mesylate
      (Mito-MES) to prevent the development and progression of severe viral infections like
      COVID-19 after high-risk exposure to a person with possible respiratory viral infection such
      as SARS-CoV-2 infection in persons who will receive Mito-MES compared to persons who will not
      receive Mito-MES (controls). A study participant will have the option to enroll either in the
      treatment arm or the control arm (no intervention but will complete relevant questionnaires
      and study procedures).

      Efficacy: To determine the efficacy of the treatment with mito-MES 20 mg daily for up to 14
      days compared to no treatment with mito-MES to prevent development of severe clinical
      symptoms of any viral infection in high-risk close household contacts of cases with viral
      infection. Viral infection will be defined clinically based on history obtained by the
      investigator who is an infectious diseases physician and stringent criteria will be followed.
      Viral infection will be defined as presence of at least two new onset independent symptoms or
      signs (fever) of respiratory disease that cannot be attributed to bacterial cause (for
      example the combination of runny nose and sore throat is very characteristic of a viral
      illness). The combination of fever and cough is not specific enough presentation since it can
      be attributed also to bacterial bronchitis or pneumonia. A study participant with chronic
      allergies or chronic sinusitis or asthma will not be included in the study.
    

Intervention name(s): Mitoquinone/mitoquinol mesylate
Intervention type(s): Drug
Intervention description(s): Mitoquinone/mitoquinol mesylate
Other intervention name(s): MitoQ
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Respiratory Viral Infection; Antiviral treatment; COVID-19; Prophylaxis COVID-19
Effects of Atorvastatin on Blood Pressure and Urinary Albumin Excretion
Condition: Hypertension; Hypercholesterolemia
MeSH terms: Hypertension; Essential Hypertension; Hypercholesterolemia
Study type: Interventional

Summary: 
      To evaluate the possible effects of atorvastatin on ambulatory blood pressure, urinary
      albumin excretion, insulin resistance and arterial stiffness in hypertensive patients, beyond
      those on lipid profile. Glycemic parameters, "novel" cardiovascular risk factors and safety
      parameters will be also evaluated.
    


Intervention name(s): Atorvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg of atorvastatin once daily for six months; placebo once daily for six months
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: essential hypertension
Fast Track Total Knee Arthroplasty: Local Infiltration Analgesia vs Femoral Nerve Block
Condition: Arthroplasty, Replacement, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to determine whether either a femoral nerve block (FNB) or
      local infiltration analgesia (LIA) is a better anesthetic technique to achieve optimal
      functional outcome after one year in patients receiving a total knee arthroplasty and
      following a fast track rehabilitation protocol.
    

Detailed description: 
      For an optimal and fast recovery after total knee arthroplasty (TKA), a fast track
      rehabilitation protocol has been developed. The literature is not yet conclusive about the
      optimal anesthestic technique. The optimal technique should support fast mobilization by
      giving good pain relieve with minimal side effects such as nausea, drowsiness and muscle
      weakness. If pain relieve is optimal, the patient mobilizes fast and length of stay is
      shortened. But does fast recovery lead to better functional outcome? The objective of this
      study is to determine whether either a femoral nerve block (FNB) or local infiltration
      analgesia (LIA) is a better anesthetic technique to achieve optimal functional outcome after
      one year in patients receiving a total knee arthroplasty and following a fast track
      rehabilitation protocol.
    

Intervention name(s): LIA of the posterior capsule of the knee; LIA of the anterior capsule of the knee; LIA of the subcutaneous tissue of the knee; FNB with catheter
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.; the surgeon infiltrates the anterior capsule of the knee using 50 mL ropivacaine 0.2% with 0.25 mg epinephrine.; the surgeon infiltrates the subcutaneous tissue of the knee using 50 mL ropivacaine 0.2% before wound closure.; pre-operatively the anesthesiologist will ultrasound guided place a catheter close to the femoral nerve using sodium chloride (NaCl 0.9%) (no local anesthetic). During surgery, when the LIA of the posterior capsule is performed, 20 mL ropivacaine 0.2% will be administered through the catheter to create a femoral nerve block (FNB). Postoperatively patients will receive 20 mL ropivacaine 0.2% through the catheter 6 times daily for 24 hours
Other intervention name(s): Naropin 0.2%; Adrenalin 1mg/mL; local infiltration analgesia; Naropin 0.2%; Adrenalin 1mg/mL; local infiltration analgesia; Naropin 0.2%; local infiltration analgesia; Naropin 0.2%; normal saline; femoral nerve block; continuous femoral nerve block; femoral catheter
Intervention MeSH terms: Epinephrine; Racepinephrine; Ropivacaine; Epinephryl borate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: total knee arthroplasty; femoral nerve block; local infiltration analgesia; fast track
Painted Playgrounds: Aim 2: Assessments
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The Painted Playgrounds Aim 2 (Assessment) project will examine the effects of a stenciling
      intervention aimed at increasing physical activity and improving fundamental motor skill
      functioning of preschool aged children. 72 children from local licensed childcare centers
      will participate in individual assessments at baseline and follow-up 6-8 weeks later.
      Assessments include height/weight, surveys and wearing a physical activity monitor
      (accelerometer) for 7 days. A parent/legal guardian will provide consent for their child to
      participate and will also complete a brief survey about their child's lifestyle and habits.
    


Intervention name(s): Playground Stencils
Intervention type(s): Other
Intervention description(s): The stencils (hopscotch, agility trail, foursquare, bullseye, etc.) will be painted on the playgrounds at each childcare center. A toolkit and training video will be distributed to staff at each center to aid in instructing the children on how to perform the tasks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Other
Evaluate the Effect of Omega-3 vs Soy Isoflavones in Postmenopausal Women With Moderate to Severe Vasomotor Symptoms
Condition: Menopause; Hot Flashes
MeSH terms: Hot Flashes
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is aiming to evaluate changes in vasomotor symptoms in postmenopausal women
      treated for 4 months with Omega-3 vs Soy Isoflavones.
    

Detailed description: 
      This is a non-inferiority study of Omega 3 versus Soy Isoflavones, being each patient its own
      control from the baseline.

      In order to determine the difference observed in the evolution of intensity, frequency and
      the total number of hot flashes in 4 months in patients treated with Omega-3 vs Soy
      Isoflavones, is planned to include at least 100 patients, 50 per treatment arm.

      It si estimated a standar deviation of 0.5%, and a 10% lost follow-up rate.
    

Intervention name(s): Omega-3; Soy Isoflavones
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 600 mg oral twice a day; 54.4 mg oral twice a day
Other intervention name(s): Om3gafort; Flavia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Vasomotor Symptoms Associated With Menopause; Menopause; Hot Flashes; Postmenopausal Women