bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Metformin on Reducing Lupus Flares
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicenter, randomised, double-blind placebo controlled trial on the efficacy and
      safety of add-on metformin to conventional immunosuppressants in systemic lupus erythematosus
      (SLE).

      The purpose of this study is to evaluate: 1) the effect of metformin on reducing disease
      flares; 2) the influence of metformin on corticosteroid sparing effect; 3) the influence of
      metformin on body mass index (BMI); 4) the safety of metformin.
    


Intervention name(s): metformin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg metformin three times daily; 500 mg placebo three times daily
Other intervention name(s): Metformin Hydrochloride Tablets
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: metformin; systemic lupus erythematosus
A Healthy Volunteer Study Evaluating the the Safety, Tolerability, and Pharmacokinetics of RT234
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this two part study was to demonstrate safety, tolerability, and
      pharmacokinetics of RT234 in healthy volunteers.

      This study is also known as Vardenafil Inhaled for Pulmonary Arterial Hypertension PRN Phase
      1 (VIPAH-PRN 1) study
    

Detailed description: 
      This study was designed to evaluate safety and tolerability and to characterize the PK
      profiles of single and repeated doses of inhaled vardenafil as RT234. In addition, vardenafil
      PK after single 0.6 mg doses of RT234 was compared to that following administration of a
      single 20 mg dose of oral vardenafil tablets.
    

Intervention name(s): Drug: RT234 - vardenafil inhalation powder; Device: RS01 dry powder inhaler (RS01 DPI); Vardenafil Oral Tablet
Intervention type(s): Combination Product; Drug
Intervention description(s): RT234 is a drug/device combination product composed of vardenafil hydrochloride as the drug constituent and will utilize RS01 DPI device.; 20 mg oral vardenafil tablet.
Other intervention name(s): vardenafil inhalation powder; Levitra
Intervention MeSH terms: Vardenafil Dihydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Vascular Diseases; Cardiovascular Diseases; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Vardenafil Dihydrochloride; Inhaled Vardenafil; Vasodilator Agents; Phosphodiesterase 5 Inhibitors; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action
Ibuprofen Suspension Bioequivalence Study
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to determine the rate and extent of absorption of Ibuprofen
      suspension formulations.
    


Intervention name(s): Nurofen for Children®; Algifor Dolo Junior®
Intervention type(s): Drug; Drug
Other intervention name(s): Ibuprofen orange oral suspension; Ibuprofen oral suspension
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Ibuprofen
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - 2019_04
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Participants will take part in both a passive and active emotion recognition task: (1)
      passively listening to semantically-neutral sentences with emotional prosody, and (2)
      actively listening and subsequently categorizing emotional sentences and sounds. Participants
      are seated and instructed to stare at a fixation cross while the stimulus is played. During
      this study, non-invasive physiological measurements of pupil dilation will be recorded from
      the participants. Using this paradigm we will be assessing the effect of frequency lowering
      on emotion recognition. The study takes the form of a partly three factorial design (passive
      task x frequency lowering x acclimatization). Participants also perform a two factor design
      (active task x frequency lowering). Each participant performs two passive tests (20 minutes
      long each) with frequency lowering on and off, and a four week acclimatization period
      in-between. Participants perform one active listening task after the acclimatization period
      with frequency lowering on and off.
    


Intervention name(s): Hearing Aid without frequency lowering enabled; Hearing Aid with frequency lowering enabled
Intervention type(s): Device; Device
Intervention description(s): Each participant will be fitted with frequency lowering disabled. Disabled means standard hearing loss compensation without lowering higher frequencies in lower frequency areas. The input frequency is mapped to the same frequency in output.; Each participant will be fitted with frequency lowering enabled. The principle of the frequency lowering algorithm is to lower high frequencies to a lower frequency region with the aim of ensuring high frequency audibility to improve auditory emotion recognition.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Safety, Tolerability, and Pharmacokinetics Study of MK-8189 in Participants With Schizophrenia and in Healthy Participants (MK-8189-007)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This 4-panel study will evaluate the safety, tolerability, pharmacokinetics (PK) and
      corrected QT interval (QTc) effect of MK-8189 versus placebo, as monotherapy in healthy
      participants (Panel A) including those of Japanese descent, as monotherapy in participants
      with schizophrenia (Panel B), as add-on therapy in participants with schizophrenia (Panel C),
      and under an alternative dosing regimen as monotherapy in participants with schizophrenia
      (Panel D). Analysis of QTc effect will be exploratory. There will be no hypothesis testing in
      this study.
    

Detailed description: 
      As specified by Phase 1 protocol-flexible language in the protocol, modifications to the dose
      or dosing regimen can be made to achieve the scientific goals of the study objectives and/or
      to ensure appropriate safety of the study participants. The proposed doses for each Panel may
      be adjusted downward based on evaluation of observed safety, tolerability, and PK data.
    

Intervention name(s): MK-8189; Placebo; Background AAP Therapy
Intervention type(s): Drug; Drug; Drug
Intervention description(s): MK-8189 4 mg tablet(s) will be administered orally QD for a total daily dose of 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 36 mg or 48 mg.; MK-8189 dose-matching placebo tablets will be administered orally QD.; Participants with schizophrenia in Panel C will be on background therapy with an AAP medication (e.g., olanzapine, quetiapine, paliperidone, asenapine, iloperidone, aripirprazole, lurasidone, risperidone [not to exceed daily dose of 6 mg], or ziprasidone) throughout the study. Participants should be on a stable and well tolerated treatment regimen for at least 2 months prior to screening. NOTE: clozapine is not allowed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Single Puncture Arthrocentesis vs Double Puncture Arthrocentesis
Condition: Arthrocentesis
Study type: Interventional

Summary: 
      The aim of the present study was to compare the treatment efficacy of single puncture
      arthrocentesis (SPA) and double puncture arthrocentesis (DPA) techniques in Temporomandibular
      joint (TMJ) disc displacement without reduction (DDwoR).
    

Detailed description: 
      Study sample consisted of 36 patients with DDwoR. 18 patients received SPA procedure and
      included in SPA group. The other 18 patients received DPA procedure and included in DPA
      group.

      Double puncture arthrocentesis technique:

      Posterior puncture method was used as described by Alkan and Etoz. for DPA. A straight line
      was drawn with a marker pen along the skin from the middle portion of the auricular tragus to
      the lateral chantus. The first puncture point was marked 10 mm anterior and 2 mm inferior to
      the tragus and the second 7 mm anterior and 2 mm inferior to the tragus. After local
      anesthesia, upper joint cavity was irrigated with 200 mL of Lactated Ringer's (RL) solution
      by inserting two 21- gauge needle. At the end of the procedure, after withdrawn of one of the
      needles, 1 mL of sodium hyaluronate (SH) was injected into the upper TMJ compartment through
      the other needle.

      Single Puncture Arthrocentesis Technique:

      SPA was performed with one needle (SPA Type-1 according to Senturk and Cambazoglu). The first
      reference point in DPA was used as the needle entry point fort he SPA. With this technique,
      the inflow and outflow of solution were provided through the same cannula and lumen of one
      21-gauge needle as described by Guarda-Nardini et al. The joint was irrigated with 200 mL of
      RL solution under high pressure. At the end of the procedure1 mL of SH was injected through
      the needle.
    

Intervention name(s): TMJ Arthrocentesis
Intervention type(s): Procedure
Intervention description(s): Temporomandibular joint arthrocentesis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Temporomandibular Joint
Effectiveness of Fluoride Varnish in the Prevention of Early Childhood Caries: A Randomized Controlled Trial
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Triple-blind randomized controlled trial with two parallel arms conducted between 2012 and
      2014. Children 2-3 years old, from 28 rural public preschools, located in low socioeconomic
      areas of Chile were invited to participate. Oral health education component was given to
      children, parents and educators, twice yearly. A new toothbrush and toothpaste for each child
      was delivered to the parents at baseline and in each of the follow-up visits. The
      experimental group was treated with fluoride varnish every six months while the control group
      received placebo applications. 277 preschoolers (2 to 3 years) Main outcome: Number of Caries
      Incident Cases, increment dmft index
    

Detailed description: 
      Triple-blind randomized controlled trial with two parallel arms conducted between 2012 and
      2014. Children 2-3 years old, from 28 rural public preschools, located in low socioeconomic
      areas of Chile were invited to participate. Oral health education component was given to
      children, parents and educators, twice yearly. A new toothbrush and toothpaste for each child
      was delivered to the parents at baseline and in each of the follow-up visits. The
      experimental group was treated with fluoride varnish every six months while the control group
      received placebo applications. A trained, calibrated dentists blinded to treatment arm
      performed a visual-tactile dental assessment at 6, 12, 18 and 24 months. The number of
      incidents children with caries were recollected as the number of caries during the follow-up
      visits.

      Nº of participant/ centres: 277 preschoolers (2 to 3 years) of 28 public preschools in
      non-fluoridated areas.

      Main outcome: Number of Caries Incident Cases, increment dmft index
    

Intervention name(s): Fluoride varnish plus education
Intervention type(s): Other
Intervention description(s): Biannual varnish every 6 month/ 24 months plus educational component
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety Study to Determine the Maximum Tolerated Dose, Pharmacokinetics and Pharmacodynamics of Oral MP470, a Multitargeted Tyrosine Kinase Inhibitor, in Patients With Solid Malignancies
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Multicenter, open-label, dose-ranging study in two parts: maximum tolerated dose (MTD)
      segment (the first 28-day course of MP 470) followed by long-term safety segment.

      MTD segment: follows standard oncology phase-I design; within-patient dose level adjustments
      prohibited; each patient participates in one of three stages:

        1. Accelerated Titration Stage

        2. Dose Escalation/De-Escalation Stage

        3. Dose Confirmation Stage
    

Detailed description: 
      Multicenter, open-label, dose-ranging study in two parts: MTD Segment (the first 28-day
      course of MP 470) followed by Long-Term Safety Segment

      MTD Segment: follows standard oncology phase-I design; within-patient dose level adjustments
      prohibited; each patient participates in one of three stages:

      Accelerated Titration Stage: 1 patient per dose level; first patient receives MP 470 at 100
      mg/day; subsequent patients assigned higher dose levels based on modified Fibonacci sequence;
      stage stops when any first-course DLT is observed or when grade-2 or greater MP 470-related
      toxicity is observed at 2 dose levels; dosing next patient prohibited until previous
      patient's MTD-Segment result is confirmed Dose Escalation/De-Escalation Stage: 3 patients per
      cohort; two additional patients enrolled to receive last dose level studied during
      Accelerated Titration Stage (first 3-patient cohort); subsequent 3-patient cohorts assigned
      dose level conditional on number of patients with first-course DLT in previous cohort; new
      cohorts enrolled until MTD is defined; dosing next cohort prohibited until previous cohort's
      MTD-Segment results are confirmed Dose Confirmation Stage: an additional 6-10 patients
      enrolled to receive MP 470 at the established MTD; patient accrual stops following Dose
      Confirmation Long-Term Safety Segment: patients continue receiving 28-day courses of MP 470
      until experiencing unmanageable toxicity or disease progression; within-patient dose level
      adjustments based on toxicity; DLT during preceding 28-day course mandates one-level dose
      reduction; one-level dose increase possible in absence of grade-3 or greater MP 470-related
      AEs during preceding 28-day course
    

Intervention name(s): MP-470; amuvatinib (MP-470)
Intervention type(s): Drug; Drug
Intervention description(s): escalating daily doses of amuvatinib; escalating doses of daily amuvatinib
Other intervention name(s): amuvatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MP470; MP-470; SuperGen; Tyrosine; Kinase; Inhibitor; Solid Malignancies; Oncology
Cognitive/Cerebrovascular Consequences of HTN Treatment
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Randomized trial of two antihypertensive drugs of known efficacy to investigate whether one
      has more favorable effects on brain blood flow and cognitive function.
    

Detailed description: 
      The project examines the neuropsychological status, peripheral blood flow, and structural
      cortical (magnetic resonance imaging, MRI) and functional cortical blood flow (quantitative
      positron emission tomography, PET) status of previously unmedicated hypertensives. These
      individuals are then medicated for one year with one of two effective blood pressure
      medications. Our hypothesis is that the angiotensin-converting enzyme inhibitor, but not the
      beta-blocker will normalize cerebral blood flow and possibly, cognitive function. This
      hypothesis is tested by a repetition of our initial examinations at the completion of one
      year of treatment.
    

Intervention name(s): Atenolol (drug), Lisinopril (drug)
Intervention type(s): Drug
Intervention MeSH terms: Atenolol; Lisinopril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cerebral blood flow, positron emission tomography, magnetic resonance imaging, neuropsychology
Human Papilloma Virus Vaccine Safety and Immunogenicity Trial in Young Adolescent Women With GSK Bio HPV-16/18.
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      Human Papilloma virus (HPV) are viruses that cause a common infection of the skin and
      genitals in men and women. Several types of HPV infection are transmitted by sexual activity
      and, in women, can infect the cervix (part of the uterus or womb). This infection often goes
      away by itself, but if it does not go away (this is called persistent infection), it can lead
      in women over a long period of time to cancer of the cervix. If a woman is not infected by
      HPV, it is very unlikely that she will get cervical cancer. This study will evaluate the
      safety and immunogenicity of GSK Biologicals HPV-16/18 vaccine over 12 months, in pre-teen
      and adolescent women of 10-14 years of age at study start. Approximately 2000 study subjects
      will receive the HPV vaccine or a control vaccine (hepatitis A vaccine) administered
      intramuscularly according to a 0-1-6 month schedule.
    


Intervention name(s): HPV-16/18 L1/AS04
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Drug Interaction Study of Simvastatin and Albiglutide
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label study evaluates the pharmacokinetics of simvastatin when coadministered with
      albiglutide in healthy adult subjects. The primary objective is to assess the effect of
      albiglutide doses on the pharmacokinetics of simvastatin.
    

Detailed description: 
      This Phase I open-label study evaluates the pharmacokinetics of simvastatin when
      coadministered with albiglutide in healthy adult subjects. The primary objective is to assess
      the effect of albiglutide doses on the pharmacokinetics of simvastatin.
    

Intervention name(s): simvastatin plus albiglutide
Intervention type(s): Biological
Intervention description(s): A single dose of 80mg simvastatin on Day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 80mg simvastatin on Day 38.
Intervention MeSH terms: Simvastatin; rGLP-1 protein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: albiglutide; simvastatin; healthy volunteers; pharmacokinetics
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis; Rotator Cuff Tendinosis; Tendinopathy
MeSH terms: Arthritis; Arthritis, Rheumatoid; Tendinopathy; Rotator Cuff Injuries
Study type: Interventional

Summary: 
      Study aiming at determining the efficacy of eccentric versus concentric exercises for
      improving tendon biological characteristics, pain, and shoulder overall function for rotator
      cuff tendinopathy in patients with Rheumatoid arthritis (RA).

      Moreover, investigation the relationship between RA activity and the severity of rotator cuff
      tendinopathy.

      Patients will be randomly assigned into either concentric or eccentric exercise group.
      Randomizations will be done using computer random generated numbers.
    

Detailed description: 
      Study aiming at determining the efficacy of eccentric versus concentric exercises for
      improving tendon biological characteristics, pain, and shoulder overall function for rotator
      cuff tendinopathy in patients with RA. Moreover, investigation the relationship between RA
      activity and the severity of rotator cuff tendinopathy.

      Patients will be randomizations using computer random generated numbers. patients will
      receive either eccentric or concentric exercises for internal, external rotators and
      abductors muscles All patient will do stretching for posterior capsule and pectoralis minor
      Tendon biological changes and subacromial space will be assessed using musculoskeletal
      ultrasonography Shoulder function will be assessed using SPADI (shoulder pain and disability
      index Pain will be assessed using Visual Analogue Scale (VAS) Rheumatoid arthritis disease
      activity will be assessed using Disease Activity Score-28 for Rheumatoid Arthritis with
      erythrocyte sedimentation rate (DAS 28 ESR) patient will be assessed at base-line and after
      finishing of the study
    

Intervention name(s): concentric exercises; eccentric exercises; Stretching
Intervention type(s): Other; Other; Other
Intervention description(s): concentric exercises for rotator cuff. internal rotators, external rotators and abductors Patient will do 3 sets of 10 repetitions resistance will be personalized to each patients; Eccentric exercises exercises for rotator cuff internal rotators, external rotators and abductors Patient will do 3 sets of 10 repetitions resistance will be personalized to each patients; stretching exercise for posterior capsule and pectoralis minor each stretch will be done for 30 seconds and repeated 3 times
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Lispro Mix 25 vs. Glargine in Type 2 Diabetics
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      In patients with type 2 diabetes who have not been on insulin therapy before the study will
      achieve better glycemic control by the treatment regiment consisting of two times daily
      insulin lispro mix 25 than by the treatment regiment with consisting of one time daily
      injection of insulin glargine. Improved glycemic control will be compared by the fasting
      plasma glucose and blood glucose excursions 2 hours after breakfast.
    

Detailed description: 
      The objective of this study is to investigate which type of insulin regimen is the best way
      to achieve best glycemic control in early type 2 diabetes. Patients with diabetes mellitus
      type 2 with a duration of diabetes between 1 and 10 years without previous insulin therapy
      will be randomized on insulin lispro mix 25 or insulin glargine therapy. Glycemic control
      will be compared by the between treatment difference in fasting plasma glucose and 2h
      postprandial blood glucose excursions (preprandial -postprandial excursions) after breakfast.
    

Intervention name(s): Insulin lispro mix 25; Glargine
Intervention type(s): Drug; Drug
Intervention description(s): Insulin lispro mix 25 given SC twice-daily in conjunction with oral antidiabetic medications.; Insulin glargine given SC once-daily in conjunction with oral antidiabetic medications.
Other intervention name(s): Humalog Mix25; Lantus
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Diabetic; Insulin; Humalog; Lantus; Glargine; Lispro