bioihbjkbjnl/mcl2 huggingface dataset:
Study of a Novel Laser for Skin Rejuvenation
Condition: Rejuvenation
Study type: Interventional

Summary: 
      Single-center study to evaluate the safety and efficacy of an investigational version of the
      enlighten™ 670nm laser for photo-rejuvenation.
    

Detailed description: 
      A single-center prospective, open-label uncontrolled exploratory study to evaluate the safety
      and efficacy of an investigational version of the enlighten™ 670nm laser for
      photo-rejuvenation.

      Subjects will receive laser treatments, and will be followed at 12 weeks post-final
      treatment. In addition, after each treatment, subjects will complete a 3 day post treatment
      phone follow-up.
    

Intervention name(s): enLighten Laser
Intervention type(s): Device
Intervention description(s): Dual-pulse duration laser for the treatment of skin rejuvenation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Topical Liposomal Form of Drugs in Cutaneous Leishmaniasis
Condition: Cutaneous Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Leishmaniasis with diverse clinical manifestations is caused by different species of
      Leishmania and is endemic in many countries. Although Cutaneous Leishmaniasis (CL) is a
      self-healing disease, but it takes a long time to heal. Pentavalent antimonials are still the
      first-line treatment of CL which needs multiple injections, are painful and as such not
      tolerated by most of the patients, in addition available treatments are not always effective
      and resistance is reported. Paromomycin sulfate (PM) reported to show anti-Leishmania
      activity against both CL and visceral leishmaniasis (VL) since 1960s. Therapeutic strategy
      with high efficacy is urgently needed especially for Anthroponotic Cutaneous Leishmaniasis
      (ACL). Liposomes are lipid bilayer molecules which entrap water-soluble molecules in their
      internal water compartment and water-insoluble ones into their lipid bilayers. Liposomes, in
      proper formulations and sizes, deliver drugs to the skin based on the similarity of the
      bilayers structure of lipid vesicles to that of natural membrane and target the macrophages
      within dermis. Several lipid-based formulations have been developed to treat experimental
      leishmaniasis. Recently different doses of liposomal formulation of PM and liposomal
      formulation of Glucantime were prepared and showed high efficacy in vivo against L. major
      infection in BALB/c mice.

      In this study the efficacy of liposomal formulation of PM or liposomal formulation of
      Glucantime in combination with systemic Glucantime in the treatment of ACL parasitologically
      proven patients will be evaluated. The clinical trial will be carried out according to the
      International approved GCP (Good Clinical Practice) guide lines.
    


Intervention name(s): Liposomal meglumine antimoniate (Glucantime); Liposomal meglumine antimoniate; Liposomal Paromomycin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Liposomes containing meglumine antimoniate; Liposomal form of meglumine antimoniate; Liposomal form of 10% Paromomycin; Placebo
Intervention MeSH terms: Paromomycin; Meglumine Antimoniate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Cutaneous Leishmaniasis caused by l. tropica
Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety
Condition: Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase III, multicentric, double blind, randomized study, controlled by Valeriana officinalis
      for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L
      and Salix alba L. on mild and moderate anxiety. The treatment period will last 6 weeks and be
      followed by a post treatment visit.

      Hamilton anxiety scale will be used to assess anxiety.
    

Detailed description: 
      Passiflora incarnata L; Crataegus Oxyacantha L are plant-derived treatment widely used to
      treat anxiety disorders. This study will compare the association of Passiflora incarnata L;
      Crataegus Oxyacantha L and Salix alba L for the treatment of mild and moderate anxiety. 150
      participants will be randomly assigned to receive the association of Passiflora incarnata L;
      Crataegus Oxyacantha L and Salix alba L. or Valeriana officinalis for 6 weeks. A post
      treatment visit will be done 2 weeks for safety evaluation.

      Primary outcome: Hamilton anxiety (HAM-A) scale Secondary outcome: Insomnia quality index,
      Global clinical impression and patients global evaluation scales.

      Side effects will be monitorized throughout the study.
    

Intervention name(s): Passiflora ; Crataegus and Salix; Valeriana
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet PO twice a day; 1 tablet PO twice a day
Other intervention name(s): Pasalix; Valeriana officinalis 50 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Passiflora; Crataegus; Herbal; Valeriana; anxiety
A Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, randomized, double-blind, parallel-group, placebo-controlled study to
      evaluate the effects of MABT5102A on brain amyloid burden (as assessed by amyloid PET
      imaging) and other biomarkers in patients with mild to moderate Alzheimer's disease.
    


Intervention name(s): MABT5102A; MABT5102A; placebo; placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Repeating subcutaneous injection; Repeating intravenous infusion; Repeating subcutaneous injection; Repeating intravenous infusion
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Food on the Pharmacokinetics of Single Oral Dose Administration of a Fixed-Dose Combination of SYR-322 and Metformin Hydrochloride in Healthy Adult Male Subjects
Condition: Clinical Pharmacology
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, open-label, crossover study to determine the effect of food when a
      combination tablet of SYR-322 and metformin hydrochloride ( hereinafter referred to as
      SYR-322-MET tablet) is orally administered under fasting conditions in the morning or after
      breakfast in Japanese healthy adult male subjects.
    

Detailed description: 
      The primary objective of this clinical trial is to determine the effect of food on the
      pharmacokinetics of single oral dose administration of SYR-322-MET tablets in Japanese
      healthy adult male subjects
    

Intervention name(s): SYR-322-MET
Intervention type(s): Drug
Intervention description(s): Oral administration of SYR-322-MET
Intervention MeSH terms: Alogliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Subcutaneous Immunotherapy With Dermatophagoides Pteronyssinus in Local Allergic Rhinitis
Condition: Local Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy of an extract of Dermatophagoides pteronyssinus versus placebo in
      the treatment of local allergic rhinitis. The primary efficacy endpoint is the reduction in
      symptom scores and medication use in the active group compared to placebo.

      The influence of treatment in "in vitro" and "in vivo" objective parameters was also
      assessed.
    


Intervention name(s): Pangramin Plus D. pteronyssinus; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Subcutaneous immunotherapy with Dermatophagoides pteronyssinus; Placebo for subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: local allergic rhinitis; subcutaneous immunotherapy; house dust mite allergy; Dermatophagoides pteronyssinus allergy
Effects of Non-nutritive Sweeteners on the Composition of the Gut Microbiome
Condition: Obesity; Diabetes
Study type: Interventional

Summary: 
      This pilot study is being conducted to evaluate whether consumption of diet soda sweetened
      with sucralose and acesulfame-potassium leads to changes in the gut microbiota. Following a
      one week run-in period, healthy, young adults are randomized to consume either diet soda or
      carbonated water (control) three times per day for one week. Stool and urine samples are
      collected at baseline, following the run-in, and after the one-week intervention.
    


Intervention name(s): commercially-available diet soda; carbonated water (control)
Intervention type(s): Other; Other
Intervention description(s): Subjects are asked to consume diet soda three times daily for one week.; Subjects are asked to consume carbonated water three times daily for one week.
Other intervention name(s): seltzer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Effects of Massage Between Sets of an Intense Isokinetic Exercise- Protocol of Knee Extensors in Tae Kwon Do Athletes
Condition: Athletic Performance
Study type: Interventional

Summary: 
      26 Tae Kwon Do athletes performed a vigorous exercise program on the isokinetic dynamometer
      twice in a period of 10 days, each time on a different extremity. In this way two groups of
      26 individuals each were created, with the same individuals alternating. In the massage group
      (MG) a sport massage was applied between the sets while in the control group (NMG) the break
      was passive.
    

Detailed description: 
      Objective: Τo investigate the effects of massage in athletic performance when applied during
      intervals of an intense isokinetic exercise protocol for knee extensor muscles.

      Design: Randomized Controlled Trial. Participants: 26 Tae Kwon Do athletes performed a
      vigorous exercise program on the isokinetic dynamometer twice in a period of 10 days, each
      time on a different extremity. In this way two groups of 26 individuals each were created,
      with the same individuals alternating. In the massage group (MG) a sport massage was applied
      between the sets while in the control group (CG) the break was passive.

      Main Outcome Measures: knee flexion and extension ROM, thigh circumference, and creatine
      kinase (CK) levels in blood plasma were measured before and after each test while L-DOMS was
      measured 24, 48, 72 and 96 hours after the exercise.
    

Intervention name(s): Isokinetic intense exercise protocol; Massage treatment
Intervention type(s): Other; Other
Intervention description(s): The isokinetic protocol included 6 sets of 10 maximum efforts at 60 °/s of one leg with a 2-minute break between the sets.; Massage consisted of stroking (30") and petrissage (50") for muscle relaxation, then friction (10"), pincement and clapping (30") to prepare muscles for the next set.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 26 Tae Kwon Do athletes performed a vigorous exercise program on the isokinetic dynamometer twice in a period of 10 days, each time on a different extremity. In this way two groups of 26 individuals each were created, with the same individuals alternating. In the massage group (ME) a sport massage was applied between the sets while in the control group (NME) the break was passive. knee flexion and extension ROM, thigh circumference, and creatine kinase (CK) levels in blood plasma were measured before and after each test while L-DOMS was measured 24, 48, 72 and 96 hours after the exercise.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: sport massage; delayed onset muscle soreness; muscles recovery; continuous concentric eccentric exercise
Study on the Effects of Botulinum Toxin Type A on Back Muscle in Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to analyse the changes in back muscle size and strength
      following use of Dysport®, and to establish whether there is any association between pain
      reduction and change in strength, in patients suffering from chronic low back pain.
    


Intervention name(s): Botulinum toxin type A
Intervention type(s): Biological
Other intervention name(s): AbobotulinumtoxinA (Dysport®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic; muscular
Pharmacokinetic Study With Levodopa-carbidopa Fixed-dose Products in Healthy Subjects After Oral Administration
Condition: Fasted State
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is carried-out to describe and compare the plasma pharmacokinetics of levodopa and
      carbidopa after oral single-dose administration of 100 mg levodopa plus 25 mg carbidopa by
      means two fixed combination products (test: Isicom® 100/25 mg; reference: Nacom® 100/25 mg).

      Additionally, to describe and compare the safety and tolerability of the two investigational
      treatments administered to healthy subjects.
    

Detailed description: 
      Isicom® 100/25 mg and Sinemet® (Trade name in Germany: Nacom®) 100/25 mg are authorised
      fixed-combination products containing 100 mg levodopa plus 25 mg carbidopa. These two
      formulations were tested for bioequivalence in 1997 (DESITIN trial № LCD-010/K); based on the
      regulatory provisions in place at that time (CPMP/EWP/QWP/1401/98), the two formulations
      could be accepted to be bioequivalent.

      The present study is proposed to be conducted in order to verify and confirm the
      bioequivalence of Isicom® 100/25 mg (test formulation) and Nacom® 100/25 mg (reference
      formulation) in agreement with the pertinent regulatory guidance that came in place 2010
      (CHMP Guideline On The Investigation Of Bioequivalence - CPMP/EWP/QWP/1401/98- Rev. 1/ Corr -
      Jan.2010).
    

Intervention name(s): Levodopa Carbidopa immediate release tablets
Intervention type(s): Drug
Intervention description(s): oral administration
Other intervention name(s): isicom 100/25 mg; Nacom 100/25 mg
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Effect of a Bolus of 10 µg/kg of Alfentanil on the Pupillary Pain Index
Condition: Pain; Anesthesia
Study type: Interventional

Summary: 
      This study aims to assess the Pupillary Pain Index before and after a bolus of alfentanil in
      children under general anesthesia, before skin incision.
    


Intervention name(s): Alfentanil; sevoflurane or propofol
Intervention type(s): Drug; Drug
Intervention description(s): Bolus of alfentanil 10 µg/kg 5 minutes before skin incision
Intervention MeSH terms: Alfentanil; Propofol; Sevoflurane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
EEG Profiles During General Anesthesia : a Comparative Study Between Sevoflurane and Propofol
Condition: Anesthesia
Study type: Interventional

Summary: 
      A cerebral pharmacodynamic feedback may help the anesthesiologist to adjust anesthetics
      administration. The BIS, which provides a single number resulting from an algorithm
      calculated from cortical EEG parameters, may play this role.Moreover, halogenated agents and
      propofol may have different EEG effects, which might interfere on measured BIS values.

      The aim of this prospective randomized study was to compare, in steady state conditions, the
      EEG profiles in children anesthetized with sevoflurane (S) or propofol (P) : for both
      anesthetics, the BIS-concentration relationship and raw EEG were analysed at different levels
      of general anesthesia.
    

Detailed description: 
      Children will be prospectively included and randomly assigned in two groups : Propofol (P)
      Group or Sevoflurane (S) Group.

      Steady state periods will be performed at a fixed randomized concentration between 2, 3, 4, 5
      and 6 mcg/ml of stable Ct P concentration in the P group and between 1,2,3,4,5 % of FeS in
      the S group.

      At the end of each steady-state period the BIS value was noted and the relationship between
      BIS and anesthetic concentrations will be studied using non linear regression. For all steady
      state periods, EEG traces will be reviewed to determine the presence of epileptiform signs
      (ES) and spectral EEG signal analysis with fast Fourier transformation (FFT) will be
      performed.
    

Intervention name(s): EEG monitoring; Target Controlled Infusion
Intervention type(s): Device; Device
Intervention description(s): Steady state concentrations periods of Propofol for EEG data analyzes. Remifentanil was administrated at constant rate in all patients.; Steady state effect site concentrations of remifentanil administrated to all patients.
Other intervention name(s): TCI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Propofol; Sevoflurane; Bispectral Index; Children; Electroencephalographic signs
Efficacy and Safety of AP Collagen Peptide on the Skin
Condition: Dry Skin
Study type: Interventional

Summary: 
      This double-blinded, randomized, placebo-controlled study aimed to evaluate the efficacy and
      safety of AP collagen peptides (APCP) containing 3% Glycine-Proline-Hydroxyproline (GPH) on
      improving skin health. Subjects with dried skin were randomly assigned to receive placebo or
      APCP once daily for 12 weeks.
    


Intervention name(s): AP collagen peptide; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Health functional food; placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
The Phase I Clinical Study to Evaluate the Pharmacokinetics of Dw1029M in Healthy Male Volunteer
Condition: Diabetic Kidney Disease
MeSH terms: Kidney Diseases; Diabetic Nephropathies
Study type: Interventional
Phase: Phase 1

Summary: 
      1. Objective After single dose in healthy adults the capacity of the Group for DW1029M
           evaluate the pharmacokinetic characteristics.

        2. Indication Diabetic kidney disease

        3. Efficacy

             1. Primary

                  -  AUClast, AUCinf, AUClast/D, AUCinf/D

                  -  Cmax, Cmax/D

             2. Secondary

                  -  Tmax, t1/2, CL/F, Vz/F

        4. Safety

             1. Adverse Event Monitoring

             2. V/S, EKG, Laboratory Test, P/E
    

Detailed description: 
      Healthy volunteers for clinical trials targeting drug administration date (1d) within 3 weeks
      from the (-21d ~-1d) in the interview, physical examination and laboratory tests , including
      through the screening is performed.

      Through screening deems appropriate in this clinical trial is intended for the final subjects
      randomized to three groups to order .

      The first phase one clinical trial subjects performed one day before (the -1 ) 18:00 Chonbuk
      National University Hospital, convened as a physical examination and perform hwalryeong signs
      .

      One person to dinner , except for the drinking water should be fasting . One clinical trials
      (the first day) 20:00 subjects randomly assigned to groups according to the order in which
      the test is administered in a single oral medication .

      The subjects for clinical trials with 240 mL water, medicines and swallow whole , chew before
      swallowing drugs should .

      Blood according to the schedule after the clinical trial , including vital signs and physical
      examination is performed. The subjects that had a fixed schedule and is discharged on the
      morning of the second .

      Is at least one week washout period . Since the two groups according to the order group and
      three creeping dose , except for the one the same tiles to proceed.

      After a period of three clinical trials, three day period from taking drugs for clinical
      trials after 3-5 days to perform the post-study visit .
    

Intervention name(s): DW1029M300mg; DW1029M600mg; DW1029M1200mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DW1029M300mg PO Once; DW1029M300mg 2 tablets Once; DW1029M300mg 4 tablets PO Once
Other intervention name(s): DW1029M300mg 1 tablet; DW1029M300mg 2 tablets; DW1029M300mg 4 tablets
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise)
Condition: Intracranial Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and short-term effectiveness of
      implantation of 'Flowise Cerebral Flow Diverter' for the treatment of unruptured wide-necked
      cerebral aneurysm in the internal carotid artery.
    

Detailed description: 
      Flowise is indicated for use in patients with unruptured wide-necked aneurysm in the internal
      carotid artery. Consecutive subject data should be collected at discharge, 1, 3, and 6 month
      post Flowise implantation.
    

Intervention name(s): Flowise Cerebral Flow Diverter
Intervention type(s): Device
Intervention description(s): Flowise Cerebral Flow Diverter Placement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Paricalcitol Injection Phase II Trial
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The PK and tolerability of paricalcitol after repeated intravenous administration for 2 weeks
      (total 6 doses at every HD session) are studied in subjects with 2°HPT who are receiving HD 3
      times a week for stable chronic renal failure.
    

Detailed description: 
      The purpose of this study is pharmacokinetic & tolerability.
    

Intervention name(s): paricalcitol; paricalcitol; paricalcitol; paricalcitol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): paricalcitol 0.04 mcg/kg three times a week; paricalcitol 0.08 mcg/kg three times a week; paricalcitol 0.16 mcg/kg three times a week; paricalcitol 0.24 mcg/kg three times a week
Other intervention name(s): ABT-358; Zemplar; ABT-358; Zemplar; ABT-358; Zemplar; ABT-358; Zemplar
Intervention MeSH terms: Ergocalciferols
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)