bioihbjkbjnl/mcl2 huggingface dataset:
Individualized Piano Instruction (IPI) for Improving Cognition in Breast Cancer Survivors.
Condition: Breast Cancer; Chemotherapy-Related Cognitive Impairment
MeSH terms: Breast Neoplasms; Chemotherapy-Related Cognitive Impairment
Study type: Interventional

Summary: 
      The purpose of this study is to test the study method and procedure for individualized piano
      instruction (IPI) and its impact on chemotherapy related cognitive impairment (CRCI)
      symptoms. There have been studies that show the benefits of leaning to play the piano
      keyboard on cognitive skills in children and elderly populations. The information collected
      from the program will be used to examine the feasibility of implementing this program
      permanently
    


Intervention name(s): Individualized Piano Keyboard Instruction
Intervention type(s): Behavioral
Intervention description(s): During weeks two through seven, participants will receive a once a week, hour long, in-person individualized piano keyboard instruction as follows:
Warm-up
Scales and Chords: Consisting of scales on seven major keys (C, D, E, F, G, A and B), chord progressions on I, IV, V, I. Two different keys will be learned every week.
5-finger exercises will be completed four times per week.
Piano Theory and Music
Piano Theory: Playing through Alfred's Basic Adult All-in-One Course, Book 1, to be completed at the ability level of participant, with a least two new pages per lesson.
Chosen Piece: Playing through an instrumental piece chosen by the participant.
Participants will be asked to practice homework from this lesson daily for 20 minutes per day, until their next weekly lesson.
Other intervention name(s): Individual Piano Instruction; IPI
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Study Comparing Two Doses of MG01CI and Placebo in Adults With Predominantly Inattentive Attention Deficit Hyperactivity Disorder
Condition: ADHD Predominantly Inattentive Type
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      study objectives are to compare the efficacy, safety and tolerability of two doses of MG01CI
      (1400 mg and 700 mg) to Placebo for the treatment of symptoms in adults diagnosed with
      PI-ADHD.

      subjects will be randomly assigned in a 1:1:1 ratio to one of three treatment sequences as
      follows:

        1. week 1:1400 mg, week 2:700 mg, week 3:placebo

        2. week 1:700 mg,week 2: placebo,week 3:1400 mg

        3. week 1: placebo, week2:1400 mg, week 3 700 mg

      The study will consist of three periods: a screening period of up to one week, a 3-week
      double-blind treatment period, and a one-week safety follow-up period.
    

Detailed description: 
      The purpose of this dose finding study is to compare two doses of MG01CI (1400 mg and 700 mg)
      to Placebo, in adult subjects with PI-ADHD. A crossover study design will allow evaluation of
      safety/tolerability and efficacy using validated computerized tests.

      subjects will be randomly assigned in a 1:1:1 ratio to one of three treatment sequences as
      follows:

        1. week 1:1400 mg, week 2:700 mg, week 3:placebo

        2. week 1:700 mg,week 2: placebo,week 3:1400 mg

        3. week 1: placebo, week2:1400 mg, week 3 700 mg

      Overview of Study Visits

      Screening Period:

      Visit 1 - Screening/Baseline Visit (up to 7 days prior to dosing)

      Treatment Period:

      Visit 2 - Day 0 (Randomization Visit) Visit 3 - Day 7 ± 3 days Visit 4 - Day 14 ± 3 days
      Visit 5 - Day 21 ± 3 days

      Follow-up period:

      Visit 6 - Day 28 ± 3 days

      Study duration for each subject will be up to 35 days .
    

Intervention name(s): Metadoxine (MG01CI); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MG01CI is an orally administered extended release formulation of metadoxine. Doses: 1400 mg and 700 mg and Placebo; Placebo tablets will be similar in appearance (color and size) to the investigational product
Other intervention name(s): metadoxil
Intervention MeSH terms: Metadoxine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ADHD , Inattention
Clinical Study to Evaluate the 80-Minute Water Resistant Sun Protection Factor (SPF) of Sunscreen Products
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      The purpose of this study is to determine the 80-Minute Water Resistant SPF of three
      sunscreen products (ChapStick Active Performance [CAP] UnScented, CAP Herbal Mint Flavour and
      CAP Mountain Berry Flavour) using the methodology described in the Food and Drug
      Administration (FDA) Final Rule (2011).
    

Detailed description: 
      A single-center, randomized, controlled, intra-individual comparison, evaluator-blind,
      clinical study to determine the 80-minute water resistant SPF of three sunscreen lip balms.
      Each participant will evaluate two of the three test products, an SPF standard and no
      treatment. Study treatments will be randomly assigned to 4 test sites delineated on the skin
      of the participant's back. The two test products will be applied to their allocated test
      sites prior to the 80-minute water immersion procedure (four 20-minute water immersion
      periods, each followed by a 15-minute air-drying period); the SPF standard will be applied to
      its allocated test site on completion of the water immersion procedure. Test sites will be
      exposed to doses of ultraviolet (UV) radiation and erythemal response evaluated 16-24 hours
      later. Minimal erythema dose (MED) will be determined for protected and unprotected sites and
      used to determine the SPF value of each test product.
    

Intervention name(s): CAP UnScented; CAP Herbal Mint Flavour; CAP Mountain Berry Flavour; SPF Standard Sunscreen
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sunscreen lip balm.; Sunscreen lip balm.; Sunscreen lip balm.; SPF Standard (7 percent [%] Padimate-O and 3% Oxybenzone)
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect Of Meal Frequency On Weight Loss And Body Composition Of Obese And Overweight Women
Condition: Overweight and Obesity
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      Studies showing the relationship between meal frequency, weight loss and anthropometric
      measurements are contradictory. This study is planned and conducted to observe the effects of
      meal frequency (3 meals+3 snacks vs 3 meals) on weight loss, anthropometric measurements and
      body composition with 3-month energy restricted Medical Nutrition Therapy program in 19-64
      years old women with a BMI ≥ 27 kg/m2.
    

Detailed description: 
      The study was conducted with 40 female volunteers between the ages of 19-64 years, with a
      Body Mass Index (BMI) ≥27. Energy restricted individualized weight loss programs were applied
      with different meal frequencies (3 meals+3 snacks/day vs 3 meals/day) in a 3 month follow up
      period. 20 participants were randomized in 3 meals+3 snacks and 20 participants were
      randomized in 3 meals group. Food consumption was questioned, and anthropometric measurements
      and body composition were measured before the study and repeated each week till the end of
      the study. Three day food records (2 week days and 1 weekend day) taken before the
      intervention were evaluated and five hundred calorie was subtracted from the average energy
      calculated form the food records to determine the energy of the weight loss plans .
      Breakfast, lunch and dinner are planned as main meals and the beverages and/or food eaten
      between main meals were planned as snacks (50-200 kcal). For both of the groups dietary
      weight loss program was planned by the same dietitian. Macronutrient composition of the
      weight loss plan was designed according to the recommendations of the Turkish Dietary
      Guidelines as 45-60 % carbohydrate, 10-20 % protein and 20-35 % fat for both of the groups.
    

Intervention name(s): 3 meals+3 snacks; 3 meals
Intervention type(s): Behavioral; Behavioral
Intervention description(s): All of the 20 subjects consumed an energy restricted weight loos plan with 3 main meals and 3 snacks for 3 months; All of the 20 subjects consumed an energy restricted weight loos plan with 3 main meals for 3 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Meal Frequency; body composition; BMI; waist circumference
Anxiety Control by Erythrina Mulungu
Condition: Dental Anxiety; Impacted Third Molar Tooth
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluated the effectiveness of the Erythrina mulungu in controlling anxiety in
      patients undergoing bilateral extraction of asymptomatic, impacted mandibular third molars.
    

Detailed description: 
      : In this research, characterized as a randomized, double-blind, crossover study, 30 healthy
      volunteered patients (05 men and 25 women) aged 18 or older who received a capsule of 500mg
      of Mulungu Matusa ® or placebo, orally, one hour before the procedure were selected. The
      level of anxiety was assessed through questionnaires and physical parameters, such as blood
      pressure, heart rate and oxygen concentration. Data were collected, tabulated and analyzed by
      the following statistical tests: chi-square, t-test, ANOVA and Tukey test, Friedman, Fisher's
      exact test with significance level of 5%.
    

Intervention name(s): Mulungu; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg/single dose/1 hour before dental surgery; 500 mg/single dose/1 hour before dental surgery
Other intervention name(s): Mulungu Matusa, Erytrina mulungu
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anxiety; Third molar surgery; Blood pressure; Heart rate; Oxygen saturation
Efficacy Study of RX-10100 to Treat Erectile Dysfunction (ED)
Condition: Erectile Dysfunction (ED)
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this Phase IIa trial is to determine the effective doses and
      treatment period for an upcoming RX-10100 Phase IIb trial in subjects with erectile
      dysfunction (ED). The secondary objectives of this trial are to evaluate the safety and the
      quality of life in subjects with ED receiving RX-10100 treatment.
    


Intervention name(s): Placebo; RX-10100 5mg; RX-10100 10mg; RX-10100 15mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo (w/o API); 5 mg/dose of RX-10100; 10 mg/dose of RX-10100; 15 mg/dose of RX-10100
Other intervention name(s): Zoraxel; Zoraxel; Zoraxel
Intervention MeSH terms: beta-Lactams
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Erectile Dysfunctions; ED
The Effect of Vitamin D Repletion on Small Low Density Lipoprotein (LDL) Particle Number in Subjects at Elevated Cardiovascular Risk
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional

Summary: 
      Vitamin D is a fat-soluble vitamin that is naturally present in very few foods, added to
      others, and available as a dietary supplement. It is also produced in the body when
      ultraviolet rays from sunlight strike the skin and trigger vitamin D synthesis. Vitamin D is
      essential for promoting calcium absorption and maintaining adequate serum calcium and
      phosphate concentrations to enable normal mineralization of bone and bone growth. Without
      sufficient vitamin D, bones can become thin, brittle, or misshapen. Vitamin D sufficiency
      prevents rickets in children and osteomalacia in adults. Together with calcium, vitamin D
      also helps protect older adults from osteoporosis. Many people have low levels of Vitamin D.
      Replacing Vitamin D is thought to help lower the risk of heart disease. Vitamin D may be
      helpful, but it could also be harmful. The investigators are studying the effect of Vitamin D
      on the level of a harmful kind of cholesterol. Participants will have their cholesterol
      levels measured and then receive either Vitamin D or a placebo. After 2 months of treatment,
      the investigators will measure their cholesterol levels again.
    


Intervention name(s): Vitamin D3
Intervention type(s): Dietary Supplement
Intervention description(s): 50,000 units taken orally once a week for 8 weeks
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
A Study of BRT-FC-83C for the Treatment of Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine whether the topical application of BRT-FC-83C is
      effective in the treatment of mild to moderate atopic dermatitis.
    

Detailed description: 
      Atopic dermatitis is a common skin disease. BRT-FC-83C is a skin cream that does not contain
      corticosteroids or other anti-inflammatory components. It represents a novel class of skin
      barrier repair therapy for chronic dermatoses. The objective of this clinical study is to
      determine whether BRT-FC-83C, applied twice a day to the affected area of the skin,
      ameliorates signs and symptoms of mild to moderate atopic dermatitis.
    

Intervention name(s): BRT-FC-83C
Intervention type(s): Device
Intervention description(s): BRT-FC-83C is a topical cream to treat atopic dermatitis. It is applied topically, twice a day, to the atopic dermatitis skin lesion for six weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Efficacy
Femoral Cartilage Thickness In Patients With Lower Limb Amputation
Condition: Amputation; Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational [Patient Registry]

Summary: 
      The aim of the study to investigate any relation with functional parameters and femoral
      cartilage thickness evaluation by ultrasonography in lower extremity amputate individuals.
    

Detailed description: 
      In this prospective observational study, subjects approached Tertiary Rehabilitation Clinics
      for prothesis recipe or long term outpatient follow up was 150 people. Among them 76 subjects
      accepted to enroll study. Informed consent was taken. Subjects firstly performed clinical
      parameters at the first doctor's control. Knee radiography has been performed.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        In this prospective observational study, subjects approached Tertiary Rehabilitation
        Clinics for prothesis recipe or long term outpatient follow up was 150 people. Among them
        76 subjects accepted to enroll study.İnformed consent was taken.1 subject not acceptable
        with inclusion criteria was excluded.
      
Keywords: Amputate; rehabilitation; ultrasonography; osteoarthritis
The Impact of Family CTI on Homeless Children
Condition: Mental Health
Study type: Interventional

Summary: 
      The purpose of this study is to examine how services and housing provided for homeless
      families affect the mental health and behavior of homeless children over time.
    

Detailed description: 
      This study is a supplement to a parent study which concentrates on the outcomes of homeless
      mothers who are provided with services and housing. This study will focus on the effects of
      housing and services on children, who may be the major beneficiaries of such assistance.

      Participants are randomly assigned to either receive services and permanent housing or to
      remain in a homeless shelter without additional assistance. Children and their parents are
      interviewed separately 3, 9, and 15 months after study entry. The teachers of participating
      children are surveyed twice during the study.
    

Intervention name(s): Critical Time Intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Homeless Persons
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZYIL1 in Subjects With Cryopyrin Associated Periodic Syndromes (CAPS)
Condition: Cryopyrin Associated Periodic Syndrome
MeSH terms: Cryopyrin-Associated Periodic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      ZYIL1 is expected to show benefit in patients with CAPS. The present study aims to determine
      the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZYIL1 when administered
      to subjects with CAPS.
    

Detailed description: 
      This is a phase 2a, prospective, open-label study. Primary objective of the study is to
      determine safety and tolerability profile of twice daily oral administration of ZYIL1
      administered for 7 days. The study will be conducted in 3 subjects having CAPS as per
      eligibility criteria. The study will be divided in three periods: Screening Period; Run-in
      Period and Study Period.
    

Intervention name(s): ZYIL1 capsule
Intervention type(s): Drug
Intervention description(s): NLRP3 inflammasome inhibitor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NLRP3; NLPR3 Inflammasone inhibitor
Open Label Clinical Trial of Vitamin D in Children With Autism
Condition: Autism; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency; Autistic Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Primary: to investigate tolerability of interventional high dose Vitamin D3 supplementation,
      titrated to reach serum levels near the high end of the reference range (30-100 ng/ml), in
      vitamin D deficient pediatric Autism Spectrum Disorder (ASD) patients.

      The study will determine if initial safety and effect estimates predict that a double blind
      randomized control trial (RCT) with a larger set of patients will be worthwhile in the
      localization of this treatment aimed at improving the symptoms of ASDs.

      Exploratory: to determine efficacy of high dose D3 replacement for improvement in the core
      symptoms of autism, including sociability, eye contact, anger outbursts, stimming behavior,
      and sleep, as determined by parental and clinical evaluation scales.
    

Detailed description: 
      data is still being collected
    

Intervention name(s): Liquid Vitamin D
Intervention type(s): Drug
Intervention description(s): 300 IU/Kg/day not to exceed 10,000 IU/day.
Other intervention name(s): Ddrops
Intervention MeSH terms: Vitamin D
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Study of Bupropion Hydrochloride Products With Different Release Patterns
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      The objectives of this project are to determine if the bioavailability and release pattern of
      bupropion HCl products differ and if the genotype of the metabolic enzymes affects the
      saturation of intestinal enzymes with different dose strengths within one product line.
      Findings from this project will help the FDA Center for Drug Evaluation and Research's (CDER)
      Office of Generic Drugs improve policy development and review practice in the future for
      similar products, e.g. extended release oral drug products being metabolized in the gut wall
      and having multiple strengths.

      Aim 1: To compare the pharmacokinetics of bupropion and its metabolites in plasma in healthy
      individuals when they ingest different strengths of bupropion (75-300 mg) with variable
      release profiles (IR vs XL vs SR) in GI tract.

      Working hypothesis: Variation in release rate and mechanism of bupropion formulations in
      gastrointestinal (GI) tract will impact metabolism and saturation of bupropion in GI tract,
      which will generate different concentration of bupropion and its metabolites in plasma.

      Aim 2: To investigate pharmacogenomics of CYP 2B6 that influences metabolism, saturation, and
      pharmacokinetics of bupropion

      Working hypothesis: The gain of function of CYP2B6 variants (allele *4 and *22) in patients
      will increase the metabolism of bupropion in the GI tract and liver, reduce both local
      concentration and plasma concentration of bupropion, and thus cause non-bioequivalence when
      bupropion is released earlier in GI tract
    


Intervention name(s): generic bupropion
Intervention type(s): Drug
Intervention description(s): We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.
Other intervention name(s): Wellbutrin
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
I SELECT - Irbesartan In Hypertensive Patients With Left Ventricular Hypertrophy
Condition: Hypertension
MeSH terms: Hypertrophy, Left Ventricular; Hypertrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      -  To evaluate Blood Pressure (BP) reduction to the targeted values (BP ≤ 140/90 mm Hg in
           non-diabetic patients, and ≤ 130/80 mm Hg in diabetic patients).

        -  To emphasize and to evaluate the benefit of Irbesartan in the reduction of left
           ventricular mass index in hypertensive patients with left ventricular hypertrophy.

        -  To demonstrate safety of Irbesartan in this population.
    


Intervention name(s): Irbesartan (Aprovel)
Intervention type(s): Drug
Intervention description(s): Aprovel (150 & 300mg) & CoAprovel (300/12.5mg hydrochlorothiazide one per day per os.
Intervention MeSH terms: Irbesartan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial to Evaluate the Bioavailability and Safety of AGSAV301
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the bioavailability and safety of AGSAV301 tablet in
      healthy male volunteers.
    


Intervention name(s): AGSAV301; Exforge 10/160
Intervention type(s): Drug; Drug
Intervention description(s): tablet, q.d.; Tablet, q.d.
Intervention MeSH terms: Amlodipine, Valsartan Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment