bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Positive Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objectives of this study are to compare the efficacy, safety, and tolerability of
      tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of
      HBeAg-positive chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks
      (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to
      480 weeks.
    


Intervention name(s): TDF; ADV; TDF placebo; ADV placebo; FTC/TDF
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 300 mg tablet administered orally once daily; 10 mg tablet administered orally once daily; Tablet administered orally once daily; Tablet administered orally once daily; 200/300 mg fixed-dose combination (FDC) tablet administered orally once daily
Other intervention name(s): Viread®; Hepsera®; Truvada®
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Adefovir dipivoxil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tenofovir; adefovir; hepatitis B; HBeAg Positive
Safety, Tolerability, and Efficacy of RLS103 in Subjects With Acute Anxiety Within Social Anxiety Disorder (SAD)
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b/2a clinical trial to evaluate the safety, tolerability, and efficacy of
      RLS103 (cannabidiol [CBD] inhaled dry powder) to relieve the anxiety induced by a public
      speaking challenge in adults with social anxiety disorder (SAD).

      Subject participation will last 4 - 6 weeks. Upon signing an informed consent, all subjects
      will enter a screening phase lasting up to 3 weeks and including history, physical
      examination, laboratory tests, ECG, spirometry, and psychological tests. Subjects will
      undergo a public speaking test after screening tests are performed and eligibility is
      confirmed. One week after the completion of the public speaking test, subjects will come back
      for a follow-up visit that will involve a repeat of the safety and psychiatric assessments
      conducted during screening.
    


Intervention name(s): Low dose RLS103; High dose RLS103; placebo inhaled dry powder
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3 mg CBD inhaled powder administered before public speaking challenge; 6 mg CBD inhaled powder administered before public speaking challenge; placebo inhaled powder administered before public speaking challenge
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study in Healthy Men to Find Out How BI 1015550 is Taken up and Handled by the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the basic pharmacokinetics of BI 1015550
      and its metabolite BI 764333 (M480), [14C]-radioactivity, including mass balance, excretion
      pathways and metabolism following a single oral dose BI 1015550 (C-14) administered to
      healthy male subjects.

      The primary objective is:

      - To assess the mass balance recovery of [14C]-radioactivity from urine and faeces as well as
      vomit in case of occurrence after a single oral dose of BI 1015550 (C-14) administered to
      healthy male subjects

      The secondary objectives are:

        -  To assess the pharmacokinetics of [C-14]-BI 1015550 and BI 1015550 as well as its
           metabolite BI 764333 in plasma following a single oral dose of BI 1015550 (C-14)

        -  To assess the safety and tolerability of BI 1015550
    


Intervention name(s): BI 1015550 (C-14)
Intervention type(s): Drug
Intervention description(s): BI 1015550 (C-14)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pentriox - Induction of Oxidative Stress
Condition: Oxidative Stress
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to investigate phenoxymethylpenicillin (the v-penicillin) and
      trimethoprim's possible induction of oxidative stress in human cells. The induction is
      examined by comparing changes in oxidative stress in the treatment group with the change in a
      placebo group. The study is a randomized-based placebo-controlled study. Each treatment group
      consists of 30 healthy male volunteers who consume either v-penicillins, trimethoprim or
      placebo over 7 days. The induction of oxidative stress is measured by 8-oxoguanosine and
      8-oxodeoxoguanosine, isolated from urine. A t-test will be performed to compare drug
      treatment with placebo. The results will be published.
    


Intervention name(s): Penicillin V; Trimethoprim; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Penicillin V: 2 x 330mg tablets should be taken twice daily; Trimopan: 2 x 100mg tablets should be taken twice daily; Placebo: 2 tablets should be taken twice daily
Other intervention name(s): Penicillin V, Pancillin; Trimethoprim, Trimopan
Intervention MeSH terms: Trimethoprim; Penicillins; Penicillin V
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Oxidative Stress; antibiotics
Effect of Intake of Glycin Max (L.) Merr. Peel Extract on Body Fat and Body Weight
Condition: Obesity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators performed a 8-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of Glycin max (L.) Merr. peel extract on decrement
      of body fat. The investigators measured decrement of body fat parameters , including Body Fat
      Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure.
    


Intervention name(s): Glycin max(L.) Merr. peel extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Glycin max(L.) Merr. peel extract (2.5g/day); Placebo (2.5g/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Safety and Efficacy of Self Administered Injections of Pegvaliase (>40mg/Day Dose) in Adults With PKU
Condition: Phenylketonuria (PKU)
MeSH terms: Phenylketonurias
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3 open-label extension study enrolling adult patients with PKU who were
      previously treated with pegvaliase in Studies PAL-003 (NCT00924703) or 165-302 (NCT02468570).
      The study is designed to evaluate the long-term safety and efficacy of pegvaliase
      administered at doses > 40 mg/day to 60 mg/day.
    

Detailed description: 
      Pegvaliase dosing will continue without interruption from Parent Study 165-302 (NCT02468570)
      or Parent Study PAL-003 (NCT00924703). Beginning on Day 1, subjects will receive the same
      dose and regimen of pegvaliase they were receiving in either 165-302 or PAL-003. A subject
      who reduces to a dose of 40 mg/day or lower for 32 consecutive weeks will be discontinued
      from study drug and withdrawn from the study as they will have the option to transition to
      commercial drug. Dose reductions may be performed if warranted due to AEs or
      hypophenylalaninemia. Dose increases to up to 60 mg/day may be performed per investigator
      discretion in consultation with the sponsor's medical monitor. Dosing will continue for
      approximately 121 weeks.
    

Intervention name(s): Pegvaliase
Intervention type(s): Drug
Intervention description(s): 40-60mg/day
Other intervention name(s): rAvPAL-PEG
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PHARM-S.A.V.E.S: Suicide Prevention Training
Condition: Suicide
MeSH terms: Suicide; Suicide Prevention
Study type: Interventional

Summary: 
      This is a pilot Randomized Controlled Trial (RCT) in which 150 pharmacy staff members will be
      randomized to an experimental or control group and data on suicide prevention communication
      and secondary outcomes will be collected over the course of the RCT.
    

Detailed description: 
      This is a prospective pilot RCT that will evaluate the impact of suicide prevention
      gatekeeper training (Pharm-SAVES) on 150 pharmacy staff member communication behaviors
      (primary outcome). Data will be collected at baseline, immediately after training is
      completed, and at 1-month follow up. Data sources include simulated patient observations (to
      rate quality of communication) and survey data (for self-reports of knowledge, self-efficacy,
      and referral behaviors).
    

Intervention name(s): Pharm-SAVES; Interactive video cases
Intervention type(s): Behavioral; Behavioral
Intervention description(s): A 30 minute long online module with videos and didactic content that covers the following topics: warning signs of suicide, how to ask a patient if they are contemplating suicide, and how to refer a patient to the Crisis Line. Three videos model patient scenarios of suicidal behavior in pharmacy settings including the pharmacy drive through, over the phone, and in person. Participants will receive continuing education credits (CEUs) (0.1 CEUs) for completing the course.; Two video interactive cases (approximately 10-minutes combined total) ask participants to complete open and close-ended questions about patients who exhibit suicidal behavior at the pharmacy. Participants will receive continuing education credits (0.1 CEUs) for completing the course.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: community pharmacy; communication; gatekeeper training; suicide prevention; pharmacy
Quantitative Study of New Limbal Ring Prototypes
Condition: Cosmetic Effect
Study type: Interventional

Summary: 
      The study is designed to test five new soft contact lens color pattern variants to determine
      whether the test lens makes the wearers eyes look bigger, more defined or enhances their
      overall appearance.
    


Intervention name(s): etafilcon test contact lens Variant AP; etafilcon test contact lens Variant JG; etafilcon test contact lens Variant CS; etafilcon test contact lens Variant VC; etafilcon test contact lens Variant LA
Intervention type(s): Device; Device; Device; Device; Device
Intervention description(s): Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.; Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.; Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.; Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.; Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Live Validation of the Lower Eyelid Steatoblepharon Severity (LESS) Scale
Condition: Steatoblepharon
Study type: Observational

Summary: 
      This observational study will test the inter-rater and test-retest reliability of the LESS
      scale in a live context.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Eligible adults with varying degrees of lower eyelid steatoblepharon
Objective Structured Assessment of Technical Skills (OSATS) Evaluation of Delivery by Vacuum Extraction
Condition: Surgery
Study type: Interventional

Summary: 
      In a prospective, randomized Trial, the investigators compare Hands-on teaching and frontal
      teaching using a Training Video for learning how to perform an assisted delivery by vacuum
      extraction on a pelvic Training model. Objective Structured Assessment of Technical Skills
      (OSATS) scores are the primary outcome. The investigators hypothesize that Hands-on Training
      is superior to a video-teaching with regard to the OSATS scores achieved by the Trainees.
    

Detailed description: 
      The optimal mode of Training surgical novices how to perform an assisted delivery by means of
      vacuum extraction is unknown. We prospectively randomize probands to a 30 min hands-on (group
      1) and a 30 min demonstration (group 2) training session teaching a standardized vacuum
      Extraction (VE) algorithm scheme on a pelvic training model. Probands are tested with a 24
      item Objective Structured Assessment of Technical Skills (OSATS) scoring system after
      training and 48 hours, and 72 hours thereafter. OSATS scores are the primary outcome.
      Performance time (PT), self assessment (SA), confidence (CON), and global rating scale (GRS)
      are the secondary outcomes. Statistics will beperformed using Mann-Whitney U-test, chi-square
      test, and multivariable logistic regression analysis.
    

Intervention name(s): hands-on teaching; Frontal teaching
Intervention type(s): Other; Other
Intervention description(s): Training session of 30 minutes duration with every proband performing a vacuum extraction on a pelvic training model.; Training session of 30 minutes duration consisting of a video which demonstrates how to perform a vacuum extraction on a pelvic training model.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Children and Parents With ADHD and Related Disorders
Condition: General Population; TDAH; Children Aged 5 to 18 Years
Study type: Observational

Summary: 
      Almost all rating scales for Attention-Deficit/Hyperactivity Disorder (ADHD) are not
      validated in France. This clearly hampers the development of the diagnosis and the monitoring
      of patients but also research in this domain. This study is conceived to collect data in the
      general population of children aged from 4 to 18 years in public schools in the city of Nice.

      Children are pseudo-randomly selected from classes of randomly selected schools in the city
      of Nice (France). Teachers fill out questionnaires using a dedicated secured website, and ask
      parents to fill out a similar set of questionnaires regarding their child's behaviour at
      home. Since ADHD has a strong genetic components, parents are also asked to fill out
      questionnaires regarding their own behaviour at adulthood and in childhood retrospectively.

      Additionally, known factors related to ADHD and other disorders as well as other putative
      factors are tested in the epidemiologic study.
    


Intervention name(s): questionnaire; Questionnaire
Intervention type(s): Other; Other
Intervention description(s): The teachers or the professors complete questionnaires on the child on their behavior in classes; The parents complete a questionnaire on the behavior of their child and on their own behavior
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Two non-independant study groups: children aged 5 to 18, and at least one of their parents
Urdu Translation, Validity and Reliability of Dyspnea 12 (D-12)
Condition: COPD
MeSH terms: Dyspnea
Study type: Observational

Summary: 
      Dyspnea is a distressing symptom with pain like perception. The object of study is to
      translate a tool that measure overall dyspnea severity. Although many scales are available to
      assess dyspnea but D12 is a clear reliable scale and is use full in clinical practice to
      assess dyspnea in terms of intensity, quality and emotional response.
    

Detailed description: 
      Aim of study is to translate a clinical validate of Urdu version of D-12 in COPDs patients.
      The study will measure reliability & validity of dyspnea in Urdu version. No study has been
      conducted in our region to translate D-12 follow the proper cross culture adaptation.
      Therefor the instrument will translate in our language adapting proper cross culture
      guidelines.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COPD
      
Keywords: Body mass index (BMI); Rate of perceived exertion (RPE); 6 minute walk test (^MWT)
Pharmacokinetic Comparison of XS003 and Tasigna
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will assess bioavailability of XS003 given as a single oral dose compared to
      Tasigna® given as a single oral dose in healthy male subjects.
    

Detailed description: 
      The study consists of two parts, the first part is composed as a pilot part and compares the
      bioavailability of single oral doses of XS003 compared to Tasigna® given as single oral dose
      in healthy male subjects. The second part is a food-effect part which assesses the food
      effect of a single oral dose of XS003 in healthy male subjects either fed or fasted. The
      study will also evaluate safety and tolerability of XS003 as secondary objectives.
    

Intervention name(s): XS003; Tasigna
Intervention type(s): Drug; Drug
Other intervention name(s): RightSize Nilotinib; Nilotinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Relative Bioavailability Between Two ASP015K Tablets and the Food Effect of a New Tablet in Healthy Adult Subjects
Condition: Bioavailability of ASP015K; Healthy Subjects; Pharmacokinetics of ASP015K; Food Effect of ASP015K
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the relative bioavailability of ASP015K under
      fasting conditions after single-dose administration between a test-tablet formulation and a
      reference-tablet formulation. This study will also evaluate the food effect on
      bioavailability of the test formulation, and evaluate the safety and tolerability after
      single-dose administration of the test- and reference-tablet formulations.
    


Intervention name(s): ASP015K
Intervention type(s): Drug
Intervention description(s): oral tablet
Intervention MeSH terms: Peficitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: ASP015K; healthy subjects
Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia
Condition: Nocturia
MeSH terms: Nocturia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years
      or older nocturic patients.
    

Detailed description: 
      Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration
      or Level 2 SER120 nasal spray concentration
    

Intervention name(s): SER120 Nasal Spray 500 ng/day; SER120 nasal spray 750 ng/day
Intervention type(s): Drug; Drug
Intervention description(s): SER120 Level 1; SER120 (750 ng/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport
Condition: Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI)
      study in healthy subjects.
    

Detailed description: 
      Following a Screening period, eligible subjects will be enrolled sequentially to one of three
      cohorts to receive a single dose of probe substrate(s), followed by repeated titrated doses
      of ecopipam twice daily (BID) (with subjects in Cohort 3 also receiving a single dose of
      ecopipam and probe substrates on Day 4 prior to titration). After steady-state ecopipam
      dosing is reached, ecopipam will be co-administered with a single dose of probe substrate(s)
      (with continuation of ecopipam BID (every 12 h) dosing during the blood sampling period for
      the respective probe substrates), followed by an ecopipam tapering period and clinic
      discharge assessments.
    

Intervention name(s): Ecopipam; Cohort 1 Probe Substrate Cocktail; Cohort 2 Probe Substrate; Cohort 3 Probe Substrate Cocktail
Intervention type(s): Drug; Combination Product; Drug; Combination Product
Intervention description(s): ecopipam HCl ~2mg/kg/day; dextromethorphan, caffeine, omeprazole, and midazolam; bupropion; dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam
Intervention MeSH terms: Ecopipam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 44847 in Female and Male Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI
      44847 following administration of multiple rising oral doses over 8 days in patients with
      type 2 diabetes.
    


Intervention name(s): BI 44847; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Integrative Ayurveda Healing Relieves Minor Sports Injury Pain
Condition: Acute Pain; Sports Injury
MeSH terms: Acute Pain; Wounds and Injuries; Athletic Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      Sports-related soft tissue injuries, such as sprains, strains, and contusions, are a common
      painful condition. Current treatment includes oral nonsteroidal anti-inflammatory drugs
      (NSAIDs), which have a high incidence of intolerable gastrointestinal side effects.

      Ancient Indian healing system, Ayurveda addresses the need of sports medicine up to certain
      extent. In practice, there are different treatment modalities for injuries, uses of drugs &
      dietetics as well as practices of rehabilitation. Although, previous evidences support the
      efficacy of ayurveda practices with significant reduction in pain, joint tenderness, joint
      swelling, mobility restriction and early morning joint stiffness. But there is no treatment
      studies have been performed to evaluate the clinical outcome for specific sports injuries.

      This study assessed the efficacy and safety of ayurveda gel and patches applied to the
      painful injury site for the treatment of acute minor sports injury pain.
    


Intervention name(s): Ayurveda; Placebo
Intervention type(s): Device; Device
Intervention description(s): Ayurveda combinations in the form of gel and patches were applied on acute pain site.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ayurveda; Acute pain; Sports Injury