bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability of Dienogest and Ethinyl Estradiol Tablets 2.0 mg/0.03 mg With Regards to Reference Product
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This Pilot study will investigate the bioavailability in fasting women of 2 tablet
      formulations containing Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg.

      The Pilot study will be performed at a single site with 10 subjects. Participants will take 2
      tablets of the test product and reference product in 2 periods and 2 sequences (either test
      after reference or reference after test). There will be a washout of at least 14 days between
      each study period.
    

Detailed description: 
      The primary objective of the study is to investigate the relative bioavailability of
      Dienogest and Ethinyl estradiol of 2 tablet formulations with Dienogest 2.0 mg and Ethinyl
      estradiol 0.03 mg and to demonstrate bioequivalence of both formulations in terms of rate and
      extent of absorption:

        -  Test Product: Product manufactured by Laboratorios Andrómaco S.A.

        -  Reference Product: Valette [Trademark], product of Jenapharm, Germany.

      The 90% confidence intervals for the intra-subject coefficient of variation (Test versus
      Reference Product) for the main pharmacokinetic parameters area under the plasma
      concentration-time curve from time zero to time t (AUC0-t) and from time zero to 72 hours
      (AUC0-72), and maximum plasma concentration (Cmax) for total Dienogest and Ethinyl estradiol
      will be determined.

      Participants will be confined in the study site for approximately 36 hours during each study
      period (for 12 hours pre-dosing and for 24 hours post dosing) during which pharmacokinetic
      (PK) blood samples will be obtained. 16 blood samples will be taken up to 24 hours after the
      administration in each period. Participants will return to the site to provide additional
      blood samples at 48 h, and 72 h post-dose.

      The washout period between the two study periods will be at least 14 days. The samples from
      each participant will be analyzed with 2 methods of high-performance liquid
      chromatography-tandem mass spectrometry bioanalytical assays to quantify total Dienogest and
      Ethinyl estradiol in plasma.

      The safety objective is to evaluate the tolerability of both formulations in women by
      collecting adverse events.
    

Intervention name(s): Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg Test Drug; Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg Reference Product
Intervention type(s): Drug; Drug
Intervention description(s): Coated Tablets; Coated Tablets
Other intervention name(s): Investigational Medicinal Product; Valette (Trademark)
Intervention MeSH terms: Dienogest; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Estradiol; Polyestradiol phosphate; Nandrolone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Hybrid Training and Middle Age
Condition: Women's Health; Hybrid Training; Middle Aged; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome
Study type: Interventional

Summary: 
      Modern living and physical inactivity results in many ailments, including obesity,
      non-alcoholic fatty liver disease (NAFLD), and inflammatory issues.

      Though there are a lot of studies on physical training, there is little detail on hybrid
      training or electrical and voluntary contractions of the musculature. This study investigated
      the efficiency of hybrid training in biochemistry, ultrasound, and proinflammatory outcomes
      in middle-aged sedentary and obese women with NAFLD.
    


Intervention name(s): hybrid training
Intervention type(s): Other
Intervention description(s): The experimental group trained two to three sessions of 45 to 50 minutes a week with a recovery of 24 to 48 hours between each session to burn 500 kcal. The first three weeks held hybrid training with a metabolic program and the other three weeks held a strength training program.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Phase I Study of E7050 in Subjects With Solid Tumors
Condition: Solid Tumor; Gastric Cancer
MeSH terms: Neoplasms; Stomach Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the tolerability, safety, pharmacokinetics (PK),
      pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally once daily to
      patients with advanced solid tumor and gastric cancer.
    


Intervention name(s): E7050
Intervention type(s): Drug
Intervention description(s): Drug: E7050 The starting dose of E7050 will be 400 mg given orally, once-daily, in patients with advanced tumor that have progressed following effective therapy. The study consists of 2 parts: a Tolerability Confirmation Component to confirm the tolerable dose in subjects with solid tumor and an Expansion Component to confirm the safety and to preliminarily assess the anti-tumor activity in subjects with gastric cancer.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cancer; Gastrointestinal Cancer
Pharmacokinetics of Telavancin in Normal and Obese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize plasma and urinary concentrations of telavancin
      following intravenous administration of a single dose of telavancin in healthy subjects who
      are normal weight, overweight, and obese.
    

Detailed description: 
      This study is a Phase I, open-label, single-dose pharmacokinetic study in healthy adult male
      and female subjects. Eligible subjects will be assigned to one of four groups based on their
      body mass index and total body weight. Subjects will receive a single dose of telavancin
      depending on subject's group as a 1-hour intravenous infusion. Serial blood and urine samples
      will be collected over 12 hours to determine serum and urinary pharmacokinetics of
      telavancin. Subjects will return for blood and urine sample collection at 24 and 48 hours.
      Safety evaluations will be assessed throughout the study and will include physical
      examination, vital sign monitoring, clinical laboratory tests, monitoring of adverse events,
      and markers of kidney injury.
    

Intervention name(s): Telavancin
Intervention type(s): Drug
Intervention description(s): A single dose of telavancin as a 1-hour intravenous infusion
Other intervention name(s): Vibativ
Intervention MeSH terms: Telavancin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Physiotherapy and Osteopathy on Infant Colic
Condition: Infantile Colic; Manual Therapy
MeSH terms: Colic
Study type: Interventional

Summary: 
      This study compares the effectiveness of manual therapy (osteopathy) on infant colic versus
      education to the family, and a third group with no specific intervention.
    

Detailed description: 
      Infant colic is a problem that affects 10-30% of babies in their first months of life. This
      research project aims to verify the effectiveness of manual therapy on infant colic. The
      sample is divided in three groups, performing in the firts one osteopathy manual therapy; in
      the second one, measures to support and education to the family; and in the third, there is
      no specific intervention.
    

Intervention name(s): Osteopathy manual therapy; Measures to support and education to the family
Intervention type(s): Other; Behavioral
Intervention description(s): Technique for the treatment of parasympathetic innervation, Techniques for the treatment of sympathetic innervation of the digestive system, Functional visceral techniques.; Pedagogical intervention in parents and health education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infant Colic; Osteopathy; Stress; Physiotherapy
Fycompa Titration Intervals and Effects on Retention Rate
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will aim to improve retention and tolerability by slowing the initial titration
      rate of perampanel from a standard up-titration rate of 2 week intervals to a slower
      up-titration rate consisting of 3 week intervals. Subjects will be randomized to either
      perampanel, standard titration interval rate (Group A) or perampanel, slower titration
      interval rate (Group B).
    

Detailed description: 
      A total of 60 subjects with a confirmed diagnosis of either partial onset or primary
      generalized epilepsy will be recruited into the trial. 30 subjects will initiate perampanel
      at a dose of 2 mg/day and titrate upwards every 2 weeks to a target dose of 6 mg/day.
      Subjects in this group will be designated Group A. The remaining 30 subjects will also begin
      perampanel at a dose of 2 mg/day but will titrate upwards every 3 weeks to a target dose of 6
      mg/day and will be designated Group B.
    

Intervention name(s): Perampanel Oral Tablet
Intervention type(s): Drug
Intervention description(s): Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
Other intervention name(s): Fycompa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Epilepsy, partial onset; Epilepsy, generalized onset; Fycompa; perampanel
Evaluating of New Screening Tool for Arthritis* in Psoriasis
Condition: Psoriasis; Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic; Psoriasis
Study type: Observational

Summary: 
      This study evaluates a new screening tool for arthritis in psoriasis and compares its
      reliability with well-known screening tool (TOPAS 2).
    

Detailed description: 
      Early diagnosis and treatment of PsA may prevent destruction in joints.Our aim is to create a
      simple and user friendly screening tool that can be used by dermatologists in out patient
      clinics.

      A question pool will be created from a review of the literature and expert opinions from a
      physicians experienced in rheumatology and dermatologists .Psoriasis patients will answer
      these newly created questions. All patients will be examined by dermatology and also physical
      therapy and rehabilitation-rheumatology experts. The diagnosis of psoriatic arthritis (PsA)
      will be made by CASPAR (Classification criteria for psoriatic arthritis) criteria and ASAS
      (Assessment of Spondyloarthritis International Society) criteria for spondyloarthritis.
      Synchronously patients will be asked for to reply Turkish version of well known questionary
      named TOPAS 2. According to the results of collected data, statistically best matched
      questions will be selected for Turkish population. Also, the reliability of TUPAST (Turkish
      PsA Screening Tool) and TOPAS 2 (Toronto Psoriatic Arthritis Screen II) will be compared
      statistically.
    

Intervention name(s): Questionary
Intervention type(s): Diagnostic Test
Intervention description(s): All patients will answer two different questionary (TUPAST, TOPAS 2)
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients over 18 years with psoriasis
      
Keywords: psoriasis; psoriatic arthritis; screening tool
TMS Stimulation and Cognitive Training in Alzheimer Patients
Condition: Alzheimer Disease; Mild to Moderate
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to examine if combined treatment with TMS and cognitive training
      (CoTra) for several weeks can produce a sustained improvement in cognitive and behavioral
      symptomatology of mild to moderate Alzheimer's disease (AD) patients.
    

Detailed description: 
      The current available pharmaceutical treatment for Alzheimer Disease (AD) is only partially
      and temporary effective. Therefore, new approaches are needed. rTMS is a non-invasive
      technique which generates a small electric current that induces a modulation in cortical
      excitability. In addition, cognitive training was suggested to improve cognitive functions in
      Alzheimer patients.

      In this study we intend to treat mild to moderate AD patients with rTMS interlaced with
      cognitive training (rTMS- COG).

      Patients with probable AD will be treated with rTMS-COG daily for 6 weeks followed by
      maintenance sessions for additional 3 months.
    

Intervention name(s): Sham-NICE-System; NICE-System
Intervention type(s): Device; Device
Intervention description(s): sham TMS and sham cognitive training; TMS combined with cognitive training
Other intervention name(s): NICE-System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Disease; Cognitive Training; Cortical Reorganization; Brain Plasticity
A SAD/MAD to Assess the Safety, PK/PD of FT-4202 in Healthy Volunteers and Sickle Cell Disease Patients
Condition: Healthy Volunteers; Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      FT-4202 is an oral small-molecule agonist of pyruvate kinase red blood cell isozyme (PKR)
      being developed for the treatment of hemolytic anemias. This initial study will characterize
      the safety, tolerability and the pharmacokinetics/pharmacodynamics (PK/PD) of a single
      ascending dose and multiple ascending doses of FT-4202 in the context of Phase 1 studies in
      healthy volunteers and sickle cell disease patients. The effects of food on the absorption of
      FT-4202 will also be evaluated in healthy volunteers.
    

Detailed description: 
      This is a first-in-human (FIH), Phase 1 study of FT-4202 that will characterize the safety,
      PK and PD of FT-4202 after a single dose and after repeated dosing first in healthy adult
      volunteers and then in adolescents or adults with sickle cell disease (SCD). Initially, a
      dose range of FT-4202 in single ascending dose (SAD) escalation cohorts will be explored in
      healthy subjects. Enrollment of healthy subjects into 2-week multiple ascending dose (MAD)
      escalation cohorts will be initiated once the safety and PK from at least two SAD cohorts is
      available to inform the doses for the 2-week MAD portion of the study. The MAD cohorts will
      then run in parallel to the single dose cohorts. A single dose cohort of healthy subjects is
      planned to understand food effects (FE) on the PK of FT-4202. After the SAD and FE studies in
      healthy subjects are completed, the safety, PK, and PD of a single dose of FT-4202 that was
      found to be safe in healthy subjects will then be evaluated in SCD subjects. Multiple dose
      studies in SCD subjects will then be initiated upon completion of MAD studies in healthy
      volunteers.
    

Intervention name(s): FT-4202/Placebo; FT-4202; FT-4202/Placebo; FT-4202
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Healthy volunteer subjects will receive FT-4202/placebo and monitored for side effects while undergoing pharmacokinetics and pharmacodynamic studies; Healthy volunteer subjects will receive FT-4202 with or without food and undergo pharmacokinetic studies; SCD subjects will receive FT-4202/placebo and monitored for side effects while undergoing pharmacokinetics and pharmacodynamic studies; SCD subjects will receive FT-4202 and monitored for side effects while undergoing pharmacokinetics and pharmacodynamic studies
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single ascending dose escalation and multiple ascending dose escalation study followed by an evaluation of food effects on absorption
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A New Approach for Controlling Hemostasis During Canal Treatment: a Pilot Study
Condition: Blood Contamination of Root Canal During Endodontic Therapy
Study type: Interventional

Summary: 
      Blood contamination, such as apical microleakage, of root canal during preparation can be a
      major problem in endodontics. The purpose of this investigation was to evaluate the
      hemostatic properties of sulfonic/sulfuric acid solution used during root canal therapy in
      teeth with irreversible pulpitis.
    

Detailed description: 
      A new device (HYBENX®) has been developed with the purpose of destroying dental biofilm. The
      material contains a concentrated aqueous mixture of hydroxybenzenesulfonic acid (37%) and
      hydroxymethoxybenzene acids (23%), sulfuric acid (28%), and water (12%).

      The investigators planned a clinical and microbiological study using the decontaminant device
      in order to destroy the dental biofilm of root canals in cases of irreversible pulpitis. The
      ability of the decontaminant device to immediately stop bleeding during canal instrumentation
      was found out accidentally during the procedures of this still unpublished trial.

      Due to this fact, the investigators were interested in evaluating the coagulation property of
      the material. Therefore, the aim of this prospective study is to describe a new approach to
      obtain hemostasis during root canal therapy using a sulfonic/sulfuric acid solution.

      A total of 15 teeth with irreversible and acute pulpitis were included in the study. After
      manual and mechanical instrumentation of the root canal, a sterile paper point was introduced
      in the canal, and a first score was given based on the blood quantity.

      The solution was used to irrigate the bleeding root canal; then a second sterile paper point
      was introduced, and the same score was assessed. The null hypothesis was that there is no
      difference in root canal bleeding before and after the use of the solution (⎧=0)
    

Intervention name(s): HYBENX®
Intervention type(s): Device
Intervention description(s): The mixture was then introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement.
Finally, the canal was rinsed with sterile saline water using a syringe with a side-vented 30 G needle.
Intervention MeSH terms: Hybenx
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Confirm the Safety of High Frequency DRG Stimulator in Patients With Chronic Lower Limb Pain
Condition: Failed Back Surgery Syndrome; Complex Regional Pain Syndrome (CRPS)
MeSH terms: Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Syndrome; Failed Back Surgery Syndrome
Study type: Interventional

Summary: 
      This study is a prospective, single-arm, open label, single center pilot study to confirm the
      safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The
      actual trial length is 5 days. Pts will be given ultrahigh frequency pulse stimulation, and
      VAS will be obtained after 3-4 hours of each stimulation.
    

Detailed description: 
      This study is a prospective, single-arm, open label, single center pilot study to confirm the
      safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The
      actual trial length is 5 days. An initial eligibility screening within Day -14. Pt admitted
      to hospital on Day 1. The lead implantation is conducted on Day 2, and the 1st treatment
      starts after anesthesia recovery (Day 2 T1). If VAS >4 at 4 hours after the 1st treatment,
      the 2nd treatment will be conducted. VAS will be acquired 4 hours after the 2nd treatment. On
      Day 3, physical examination and vital signs will be collected. If VAS >4, the 3rd treatment
      will be provided. One hour after the 3rd treatment, the device will be removed and an X-ray
      will be taken. Three hours after the removal, VAS will be collected and then the patient will
      be discharged. VAS will be estimated by phone call on Day 4, and the patient will return to
      OPD for follow up examination on Day 5. The trial is completed on Day 5 visit.
    

Intervention name(s): GiMer Medical MN 1000 External Stimulator
Intervention type(s): Device
Intervention description(s): Trial stimulator to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Initial Treatment With Golimumab in Early PsA
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators will perform a 22-week randomized, double-blind, placebo-controlled trial
      of golimumab + methotrexate (MTX) versus methotrexate alone in methotrexate-naïve patients
      with Psoriatic Arthritis (PsA). Afterwards, a 28 week open label phase with methotrexate
      alone is started. Golimumab will be discontinued.

      Hypotheses:

      First, the investigators hypothesize that initiation of a combination therapy with golimumab
      + MTX will be safe and superior to MTX alone in MTX-naïve PsA patients, as assessed by the
      percentage of patients achieving Disease Activity Score (the investigators hypothesize that
      more patients with the early combination treatment will respond (according to Disease
      Activity Score (DAS), American college of Rheumatology (ACR), or Psoriatic Arthritis Response
      Criteria (PsARC) responses) and achieve a state of Low Disease Activity (LDA) or Minimal
      Disease Activity (MDA) than patients on MTX alone.

      Third, the investigators hypothesize that a significant proportion of the patients will
      continue to benefit from this early aggressive treatment initiation even after stopping
      golimumab treatment.
    


Intervention name(s): golimumab; methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): golimumab 50mg subcutaneous injections (in combination with methotrexate), once a month, for a period of 22 weeks; Methotrexate will be started at a dosage of 15 mg/week orally and, if well tolerated, increased to 20mg/week at week 4 and 25mg/week at week 8 of the trial. If well tolerated, the maximum dose of 25 mg/week will be sustained until end of study (week 50). Folic acid 5 mg/week will be administered orally one day after the MTX intake.
Other intervention name(s): simponi
Intervention MeSH terms: Golimumab; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: psoriatic arthritis; golimumab; methotrexate; minimal disease activity; safety; withdrawal