bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Safety, Tolerability, Pharmacokinetics of E2027 in Healthy Adult and Elderly Subjects, and the Pharmacodynamics in Healthy Adult Subjects
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This first-in-human study, designed to assess the safety, tolerability, and pharmacokinetics
      (PK) of single oral ascending doses of E2027, will be administered to healthy adult
      participants to determine the maximum tolerated dose (MTD). Thereafter, the pharmacodynamic
      (PD) effects of single doses of E2027 on elevation of cerebrospinal fluid (CSF) cyclic
      guanidine monophosphate (cGMP) in healthy adult participants will be evaluated across a broad
      dose range, to establish the PK/PD relationship.
    

Detailed description: 
      The study will consist of 4 parts, Parts A, B, C, and D. Part A is a single ascending dose
      (SAD) clinical pharmacology for evaluation of safety, tolerability, and PK characteristics up
      to the MTD in healthy adult (greater than or equal to 18 years and less than or equal to 50
      years old). In Part B, the PK and PD effects of E2027 on CSF cGMP are evaluated in healthy
      adult (greater than or equal to 18 years and less than or equal to 50 years old).
      Participants in 2nd cohort of Part B will participate in the evaluation of food effect in
      Treatment Period 2. In Part C, the design is similar to Part A. This healthy elderly cohort
      (greater than or equal to 65 years and less than or equal to 85 years old) will provide
      bridging PK, safety, and tolerability data on E2027 compared to younger healthy participants
      in Part A and Part B. Part D will be conducted in healthy Japanese adult participants
      (greater than or equal to 20 years and less than or equal to 50 years old) and is designed to
      bridge the PK, safety, and tolerability data of E2027 between Japanese and non-Japanese
      participants. All parts of the study will have 2 phases: the Prerandomization Phase and the
      Randomization Phase. The Prerandomization Phase will consist of a Screening Period and a
      Baseline Period during which each participant's study eligibility will be determined and
      baseline assessments will be conducted. The Randomization Phase will consist of the Treatment
      Period and a Follow-Up Period. During the Treatment Period, participants will be randomized
      to receive a single oral dose of either E2027 or placebo matching E2027.
    

Intervention name(s): E2027; E2027 matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part A: E2027 capsules will be administered orally in doses of 10 mg to 1200 mg in Part A and in Part B, C, and D at doses not exceeding the highest dose achieved in Part A.; E2027 matching placebo capsule will be administered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: E2027; Healthy Adult and Elderly Subjects; Pharmacokinetics/Pharmacodynamics
Clomiphene Citrate (CC) Co-treatment With HP Urinary FSH vs HP Urinary FSH in CC-resistant PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome
Study type: Interventional

Summary: 
      To test whether adding small doses of HP urinary FSH to standard regimen of clomiphene
      citrate in clomiphene resistant PCOS well yield better results in terms of better ovulation
      rate,lower follicle number, less consumption of HP urinary FSH,lower treatment cost , better
      pregnancy rate, lower multiple pregnancy rates compared with the exclusive use of HP urinary
      FSH in these cases.
    

Detailed description: 
      To test whether CC co- treatment with chronic low dose HP uFSH vs chronic low dose HP uFSH in
      CC resistant PCOS will yield better results in terms of ,ovulation rate, lower follicle
      number,lower HP uFSH dose ,better outcome in terms of pregnancy rates, better
      cost-effectiveness ratio, lower multiple pregnancy rates,lower cycle cancellation.
    

Intervention name(s): Step-up HP u FSH; Clomiphine citrate plus low dose uFSH
Intervention type(s): Drug; Drug
Intervention description(s): HP u FSH (Fostimone 75 IU ,IBSA Institut Biochimique SA-CH 6903 Lugano) in doses of 37.5 IU (half ampole) im /day statrted from second day of the cycle for 7 days ,then increased to 75 IU for another 7 days ,then to 112.5 IU (one and half ampoule) untilleading follicle mean diameter reaches 18 mm; Clomiphene citrate 50 mg tab oral tablets(Clomid 50 mg tablets Global Napi , Egypt) two tablets(100 mg) /day are started from the 2nd day of cycle for 5 days togeteher with 37.5 IU HP uFSH (Fostimone 75 IU IBSA)/day for 8 days and may be extended to 10-12 days until leading follicle diameter reaches 18 mm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS; Clomiphene resistance; ovulation induction; low dose uFSH; uFSH step-up protocol
IRIS : Use of Implantable Defibrillator in High-risk Patients Early After Acute Myocardial Infarction
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      Of the patients who survive hospitalization after an acute myocardial infarction, ca. 10% die
      of sudden cardiac death in the following 2 years. The prognosis appears not improved by
      medication with antiarrhythmics (class I/III). A positive effect of beta-blockers (Metoprolol
      CR/Zok) on total mortality after myocardial infarction in patients with heart failure is well
      established. On the other hand, an implantable defibrillator (ICD) proved to be superior to
      medication when used for secondary prevention in patients after cardiac arrest. The question
      arises whether ICD therapy is also effective in primary prevention in high risk patients
      after acute myocardial infarction. This study determines if patients, who were defined as
      high risk patients in the early post infarction phase by means of noninvasive methods,
      benefit from primary prevention by means of an ICD. Special emphasis is put on an individual
      optimization of the infarction therapy, including beta-blockers.
    


Intervention name(s): Implantable cardioverter defibrillator
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Acute myocardial infarction; Non-sustained ventricular tachycardia; Left ventricular dysfunction; Implantable cardioverter defibrillator; ICD; Risk-stratification
A Two-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-7684 in Healthy Adult Volunteers
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first in human study to determine the safety, tolerability, pharmacokinetics and
      pharmacodynamics of ONO-7684 in healthy adult volunteers. This study will be conducted in 2
      parts: Part A is a single-ascending dose and Part B is a multiple-ascending dose.
    

Detailed description: 
      This study aims to obtain safety, tolerability, pharmacokinetic and pharmacodynamic data when
      ONO-7684 is administered orally as single doses and as multiple doses to healthy subjects.
      The study will consist of 2 parts: A single ascending dose (SAD) phase (Part A); a multiple
      ascending dose (MAD) phase (Part B). One cohort of Part A will receive ONO-7684 under both
      fasted and fed conditions to investigate the effect of food.
    

Intervention name(s): ONO-7684; ONO-7684 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single ascending doses for cohorts A1-A8 and multiple ascending doses cohorts B1-3; Placebo comparator
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Chromium's Effect on Insulin Resistance in Obesity
Condition: Insulin Resistance; Obesity
MeSH terms: Obesity; Insulin Resistance
Study type: Interventional

Summary: 
      This research is to investigate the nutritional supplement chromium picolinate. A large
      number of people use chromium picolinate from health food stores to improve the function of
      the hormone insulin. The investigators are testing how effective this supplement is and are
      also monitoring its safety. In patients with diabetes, chromium has been shown to increase
      sensitivity to the hormone insulin. Since obesity can cause insensitivity or resistance to
      insulin, the investigators are studying obese individuals with documented insulin resistance.
      The investigators would like to know if chromium is also effective in treating the insulin
      resistance associated with obesity.
    


Intervention name(s): chromium picolinate
Intervention type(s): Dietary Supplement
Intervention description(s): 1000 mg per day
Intervention MeSH terms: Chromium; Picolinic acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: chromium picolinate; insulin resistance; obesity
Atorvastatin in the Treatment of Mandibular Degree II Furcation Defects
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Furcation Defects
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      ABSTARCT Background: Atorvastatin is an inhibitor of 3-hydroxy-2-methyl-glutaryl coenzyme A
      reductase. Lately, it has shown to have anti-inflammatory and bone stimulatory effects. The
      aim of the current study is to explore the effectiveness of 1.2% atorvastatin (ATV) as an
      adjunct to scaling and root planning (SRP) in the treatment of mandibular degree II furcation
      defects.

      Method: A total of sixty subjects were randomly assigned to two treatment groups. 1. SRP plus
      placebo gel 2. SRP plus 1.2% ATV gel. Clinical parameters like probing depth (PD), relative
      vertical clinical attachment level (RVCAL) , relative horizontal clinical attachment level
      (RHCAL), modified sulcus bleeding index (mSBI) and site specific plaque index were recorded
      at baseline and then at 3, 6 and 9 months. The radiological assessment of bone defect fill
      was done at 6 and 9 months, using a computer-aided software.
    

Detailed description: 
      Two groups were made. One was delivered with ATV after SRP, the other was delivered with
      placebo gel after SRP.
    

Intervention name(s): Atorvastatin (ATV); Placebo Gel
Intervention type(s): Drug; Drug
Intervention description(s): After SRP, ATV gel was delivered subgingivally into the pocket; After SRP, placebo gel was delivered subgingivally into the pocket
Other intervention name(s): ATV gel
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Evaluate the Safety, PK, and Pharmacodynamics of LIB003
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, double-blind, placebo-controlled, single ascending dose study in nine (9)
      separate and sequential dose cohorts (7 SC and 2 IV cohorts) to assess the safety and
      tolerability, pharmacokinetics and pharmacodynamics of LIB003 in subjects with moderately
      elevated LDL-C levels.
    

Detailed description: 
      After meeting eligibility criteria within each cohort subjects will be randomized to receive
      a single dose of LIB003. Seven (7) cohorts will receive LIB003 escalating doses of LIB003, or
      placebo, by SC injection and 2 cohorts LIB003 or placebo by IV infusion. Dose escalation will
      be based on the assessment of safety and tolerability data. All cohorts will each first
      enroll a sentinel group of subjects who will receive LIB003 or placebo in a double-blind
      fashion with the remaining subjects in that cohort only to be dosed after the safety data on
      day 4 from the sentinel subjects has been assessed and deemed safe.
    

Intervention name(s): LIB003
Intervention type(s): Biological
Intervention description(s): LIB003 or placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: single ascending dose with placebo controll
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Isokinetic Parameters and the Amputee Mobility Predictor Scale
Condition: Amputation, Traumatic
MeSH terms: Amputation, Traumatic
Study type: Observational

Summary: 
      There is very limited research examining isokinetic parameters and activity level in patients
      with amputation.. Therefore, the aims of this study were to illustrate isokinetic
      measurements including strength and proprioception and to analyze the correlation between
      those isokinetic parameters and activity level and to predict amputee mobility score. It is
      hypothesized that muscle strength and proprioception were associated with activity level and
      could be used to estimate amputee mobility scale score in patients with amputation.
    

Detailed description: 
      Isokinetic measurements are used in the rehabilitation of amputee patients and to evaluate
      the effectiveness of rehabilitation. The parameters that are frequently looked at in these
      measurements are isokinetic muscle strength and proprioception. There is very limited
      research examining isokinetic parameters and activity level in patients with amputation..
      Therefore, the aims of this study were to illustrate isokinetic measurements including
      strength and proprioception and to analyze the correlation between those isokinetic
      parameters and activity level and to predict amputee mobility score. We hypothesized that
      muscle strength and proprioception were associated with activity level and could be used to
      estimate amputee mobility scale score in patients with amputation
    

Intervention name(s): İsokinetic assessment
Intervention type(s): Diagnostic Test
Intervention description(s): Isokinetic assessments of hip flexor and extensor muscle strength and proprioception wiill be performed
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A total of 43 patients with lower limb amputations
Minimally Invasive Ridge Augmentation
Condition: Alveolar Bone Loss; Bone Density Increased
MeSH terms: Alveolar Bone Loss; Osteosclerosis
Study type: Interventional

Summary: 
      The present study is a human, prospective, randomised controlled clinical trial conducted to
      explore the outcome of a minimally invasive ridge augmentation technique with and without low
      level laser therapy. The trial is in accordance with the Consolidated Standards of Reporting
      Trials (CONSORT) criteria, 2010.
    

Detailed description: 
      Twenty healthy individuals satisfying the inclusion and exclusion criteria were recruited for
      the study. A detailed, thorough medical and dental history was obtained and each patient was
      subjected to comprehensive clinical and radiological examination. All patients were informed
      about the nature of the study, the surgical procedure involved, potential benefits and risks
      associated with the surgical procedure and written informed consent were obtained from all
      patients.

      All the patients were treated with subperiosteal minimally invasive aesthetic ridge
      augmentation technique. the test group of ten were given low level laser therapy as an
      adjunct. The clinical and radiographic parameters were recorded at baseline and six months
      postoperatively.
    

Intervention name(s): Low Level Laser Therapy
Intervention type(s): Device
Intervention description(s): Hydroxyapatite bone graft with collagen
Other intervention name(s): G- Bone (Bone Graft)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups were made one test and control. The control group were treated with MINIMALLY INVASIVE RIDGE AUGMENTATION technique alone and the test group were treated with adjunctive low-level laser therapy for bone regeneration.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Study of Antimicrobial Activity of Omiganan 1% Gel vs. Chlorhexidine 2% for Topical Skin Antisepsis in Healthy Adult Subjects
Condition: Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to determine if omiganan 1% gel (the investigational
      medication in this research study) is effective and safe when compared to chlorhexidine 2%
      (an FDA approved medication) for killing bacteria (germs) that live on the surface of the
      skin. Both of the study medications are applied topically (on the surface of the skin).
    

Detailed description: 
      The study is comprised of 2 parts with approximately 20 subjects participating in each part.

      Subjects eligible for Part 1 will have omiganan 1 % gel applied to 6 sites across the chest
      and/or abdomen and chlorhexidine 2% solution will be applied to 6 matching sites on the
      contralateral side.

      Subjects eligible for Part 2 will each have omiganan 1% gel applied to 6 sites across the
      upper chest or abdomen.In addition,subjects in Part 2 will have 2 peripheral catheters
      inserted, one in each arm.One catheter insertion site will be treated with omiganan 1% gel
      (following treatment with isopropyl alcohol) and the other site will be treated with
      chlorhexidine 2%/isopropyl alcohol.
    

Intervention name(s): omiganan 1% gel; chlorhexidine 2% solution
Intervention type(s): Drug; Drug
Intervention description(s): Omiganan 1% gel will be applied to 6 sites on the chest and/or abdomen.Swab cultures will be obtained at specified timepoints over a period of 3 days (Part1) or 7 days (Part 2).
In addition, subjects in Part 2 will have omiganan 1% gel applied to one intravenous (IV) catheter site.; Part 1- chlorhexidine 2% solution will be applied to 6 sites on the chest and/or abdomen. All application sites will be covered with semi-transparent dressings.Swab cultures will be obtained at specific timepoints over a period of 3 days.
Part 2: Subjects in Part 2 will have chlorhexidine 2% solution applied to one intravenous (IV) catheter site only.
Intervention MeSH terms: Chlorhexidine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Skin colonization; Catheter colonization; Catheter site infection
Basic Life Support Cardiopulmonary Resuscitation Refresher in MS2 at St George's University
Condition: Cardiopulmonary Resuscitation Skill Retention in Medical Students
Study type: Interventional

Summary: 
      175 second year medical students were assessed on their BLS CPR skill retention after an
      approximate one year after taking the initial certification class, and the investigators
      assessed which type of refresher course would be most effective in improving the students'
      CPR skills. Group 2 had no refresher, Group 3 had a multimedia refresher, and Group 4 had the
      same multimedia refresher plus hands on practice on a Laerdal BLS manikin. The investigators
      hypothesized that Group 4 would perform CPR skills with the highest competency compared to
      the other two groups.
    


Intervention name(s): Multimedia; Hands-on practice
Intervention type(s): Other; Other
Intervention description(s): AHA specific BLS refresher video, 7 minutes in length.; Hands-on BLS CPR practice on a Laerdal BLS manikin.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Eliciting which type of refresher provides the greatest improvement in BLS CPR skills.
Drug-Drug Interaction Study of Vadadustat With Cyclosporine, Probenecid and Rifampin
Condition: Drug Interaction Potentiation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, two-part, open-label study to evaluate the interaction of cyclosporine,
      probenecid, and rifampin as perpetrators with vadadustat (victim) in healthy male and female
      subjects.
    

Detailed description: 
      This is a Phase 1, two-part, open-label study to evaluate the interaction of cyclosporine,
      probenecid, and rifampin as perpetrators with vadadustat (victim) in healthy male and female
      subjects. Part 1 consists of 2 arms (cyclosporine and probenecid) and Part 2 consists of 1
      arm (rifampin). Twenty (20) unique subjects will be enrolled into each study arm. The PK and
      safety/tolerability data from Part 1 Arm 1 (cyclosporine) will determine if Part 2 (rifampin)
      will proceed. Subjects will be on study for up to 72 days, including a 28-day screening
      period, 6-10 day clinic period, and a 30-day follow-up period post last dose. Blood and/or
      urine samples for PK analysis will be collected at pre-defined timepoints throughout the
      study.
    

Intervention name(s): vadadustat; Rifampin; Probenecid; Cyclosporins
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral dose 300 mg; IV Rifampin; Oral Probenecid; Oral Cyclosporine
Other intervention name(s): AKB 6548
Intervention MeSH terms: Cyclosporine; Rifampin; Probenecid; Cyclosporins
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: This is a 2 part study. Part 1 Arm 1 is a cross over design to assess the drug-drug interactions of cyclosporine with vadadustat. Part 1 Arm 2 is a fixed sequence design to assess the drug-drug interactions of probenecid with vadadustat. Part 2 is a crossover design to assess the drug-drug interaction of rifampin with vadadustat
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteers; vadadustat; drug interactions
Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b, randomized, double blind, vehicle controlled, parallel group, multicenter
      study in participants with mild to moderate plaque psoriasis. The duration of study
      participation will be approximately 22 weeks, including up to a 6 week screening period, 12
      week treatment period, and approximately 4 week follow up period. Approximately 280
      participants are planned to be randomized into the study.
    


Intervention name(s): PF-06700841; Vehicle (Placebo)
Intervention type(s): Drug; Drug
Intervention description(s): PF-06700841 topical cream; Vehicle topical cream
Intervention MeSH terms: PF-06700841
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: psoriasis; topical