bioihbjkbjnl/mcl2 huggingface dataset:
Interest of Branched Chain Amino Acids Associated With a Respiratory Rehabilitation Program in Patients Broncho Chronic Obstructive Pulmonary Disease
Condition: Broncho Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Respiratory rehabilitation is one of the main treatments for COPD in the early stages of the
      disease (Stage 2 of GOLD) with a recognized effect on improving the capacity of the patients
      to exert effort by fighting against deconditioning. the effort. This treatment also improves
      the quality of life of patients and reduces the risk of respiratory exacerbations. The
      patients are very often malnourished and various studies have proposed the addition of oral
      supplementation such as hormone therapy (testosterone) to improve the exercise performance of
      these atrophied muscles. The use of branched-chain amino acids (AARs) such as valine,
      leucine, isoleucine in this indication can be fully justified because they stimulate protein
      synthesis and promote muscle maintenance and repair.
    


Intervention name(s): Amino Acids; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Sweet taste cocoa flavored drink; Sweet taste cocoa flavored drink
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Tolerability of Nebicapone in Parkinson's Disease Patients With "Wearingoff" Phenomenon
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to investigate the effect on the "wearing-off" phenomenon of 3
      different doses of nebicapone (NEB 50 mg, 100 mg and 150 mg), compared with entacapone and
      placebo when dministered concomitantly with existing treatment with levodopa plus a dopa
      decarboxylase inhibitor (DDCI: carbidopa or benserazide).
    

Detailed description: 
      The study was conducted in 40 sites in Europe and South America: Argentina (6); Austria (2);
      Brazil (5); France (1); Hungary (4); Poland (7); Portugal (2); Romania (7); and Ukraine (6).

      Multicentre study with a screening visit (Visit V1), a single-blind placebo run-in period of
      1 or 2 weeks (Period 1, Visits V2 to V3), and an 8-week randomised, double-blind, activeand
      placebo-controlled, parallel-group (5 groups) treatment period (Period 2, Visits V3 to V7).
      In Hungary only: a 1-week tapering-off period was added by amendment #1HU. The dosage of
      nebicapone was to be tapered off stepwise during 6 days. This period was to end with a
      follow-up Visit V8.
    

Intervention name(s): Comtan®; Nebicapone; Levodopa/DDCI; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 200 mg entacapone were to be taken concomitantly with each levodopa/DDCI dose.; 50 mg, 100 mg and 150 mg doses of nebicapone were to be taken concomitantly with each levodopa/DDCI dose.; Prior to the study, all patients were to have been receiving levodopa/DDCI therapy for at least 1 year with clear clinical improvement. At entry to the study, patients were to be receiving levodopa/DDCI therapy of at least 4 but not more than 8 (inclusive) standard daily doses.
All patients were to continue receiving levodopa/DDCI during the study. Levodopa and DDCI were prescribed by the investigators and purchased locally by patients.; Administered orally as encapsulated tablets, which were identical in appearance to the study drugs
Other intervention name(s): entacapone; BIA 3-202; Levodopa plus a dopa decarboxylase inhibitor (DDCI: carbidopa or benserazide); placebo tablets
Intervention MeSH terms: Levodopa; Carbidopa; Entacapone; Benserazide; Dopa Decarboxylase; Aromatic Amino Acid Decarboxylase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioavailability of Duloxetine 60 mg With Regards to Reference Product in Feeding Conditions
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      This Study will investigate the bioavailability in fasting subjects of 1 capsule formulation
      containing Duloxetine 60 mg. The Study will be performed at a single site with 36
      subjects.Participants will take 1 capsule 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
      Duloxetine of 1 capsule formulation with Duloxetine 60 mg under feeding conditions 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: Cymbalta[Trademark], product of Eli Lilly, Puerto Rico.

      The 90% confidence intervals for the intra-subject coefficient of variation (Test versus
      Reference Product) for the main pharmacokinetic parameters area under the plasma
      concentrationtime 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 Duloxetine will be determined.

      Participants will be confined in the study site for approximately 25,5 hours during each
      study period (for 10 hours pre-dosing and for 15,5 hours post dosing) during which
      pharmacokinetic (PK) blood samples will be obtained. 17 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 postdose.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 Duloxetine in
      plasma.

      The safety objective is to evaluate the tolerability of both formulations in subjects by
      collecting adverse events.
    

Intervention name(s): Duloxetine 60mg Test Drug Enteric Coated Granules; Duloxetine 60mg Reference Product Enteric Coated Granules
Intervention type(s): Drug; Drug
Intervention description(s): Investigational Medicinal Product; Cymbalta (Eli Lilly)
Other intervention name(s): Test Drug; Reference Product
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
CSE v. Epidural for Postpartum Depression
Condition: Depression, Postpartum; Labor Pain
MeSH terms: Depression, Postpartum; Labor Pain; Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this pilot prospective randomized control trial is to compare the initiation
      of labor epidural analgesia by combined spinal epidural vs. epidural for the influence on
      risk for postpartum depression symptoms. Investigators will randomize women to the receipt of
      CSE or E during labor, after measuring baseline psychological, psychosocial, and
      psychophysical factors related to pain and depression. The immediate research goals are to
      understand whether the association between labor pain and PPD is modifiable through the use
      of tailored anesthetic techniques.
    


Intervention name(s): CSE; Epidural; Bupivacaine / fentaNYL
Intervention type(s): Procedure; Procedure; Drug
Intervention MeSH terms: Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pregnant; Analgesia; Labor analgesia; Epidural; Combined spinal epidural
Clinical Evaluation of Teeth Prepared With Vertical Preparation Versus Deep Chamfer
Condition: Single Posterior Crowns; Endodontically Treated Teeth; Decayed Teeth
MeSH terms: Tooth, Nonvital; Dental Caries
Study type: Interventional

Summary: 
      It has been demonstrated that a great amount of tooth structure is lost during the prosthetic
      preparations of abutments for full-coverage FDPs with tooth substance removal of 63% of 73%,
      this aggressive loss of tooth structure usually accompanied with pain and post-operative
      sensitivity. In comparison with the vertical preparation technique, there is less amount of
      tooth substance loss. this clinical study will provide benefits for practitioners and
      clinicians by guiding them to choose a more conservative treatment plan with the better
      marginal fit, clinical performance and satisfaction for the patients on the long term. rather
      than other benefits like less chair time, less risk for pulp injury, less time and cost
    

Detailed description: 
      A healthy relationship between dental restorations and the periodontium is of prime
      importance for the clinical longevity and esthetic harmony of full coverage restorations .
      One of the Most Common complications, derived from fixed prostheses is gingival recession,
      which constitutes an important clinical concern. This problem is largely associated with
      iatrogenic effects produced during dental preparation or as a result of poor prosthetic fit
      which can cause chronic inflammation leading to gingival margin recession around the
      restoration .
    

Intervention name(s): monolithic zirconia single posterior crowns with deep chamfer finish line; monolithic zirconia single posterior crowns with vertical finish line
Intervention type(s): Other; Other
Intervention description(s): deep chamfer of 1 mm average thickness for cervical finish line, a convergence angle of 6-12° on each side and up to 20° total, in some studies, is acceptable and occlusal reduction of 1,5-2 mm; using special round-ended 2 degrees tapered diamond burs a non-working tip (batt bur). It has coronal diameter of 1.2 mm, apical diameter of 0.7 mm, and non- cutting end of 1 mm, which reduces or avoids damage to the connective attachment and allows a tooth-guided preparation procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB PRP~T Combined Vaccine in Filipino Infants
Condition: Diphtheria; Tetanus; Pertussis; Hepatitis B; Influenza
MeSH terms: Hepatitis A; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs
      for immunization in infancy, while offering the benefit of a reduced number of injections,
      and potentially of an increased acceptance.

      Primary Objectives:

        -  To describe the antibody persistence at 12 to 18 months following a three-dose primary
           series vaccination of either DTaP-HB-PRP~T or Tritanrix-Hep B/Hib™ given at 6, 10 and 14
           weeks of age, and one dose of Hepatitis B (Hep B) vaccine given at birth.

        -  To describe the effect of a booster dose of DTaP-HB-PRP~T on immunogenicity at 12 to 18
           months following a three-dose primary series vaccination of either DTaP-HB-PRP~T or
           Tritanrix HepB/Hib™ given at 6, 10 and 14 weeks of age, and one dose of Hep B vaccine
           given at birth.

      Secondary Objective:

        -  To describe the safety profile of the booster dose of the DTaP-HB-PRP~T vaccine when
           administered concomitantly with Oral Polio Vaccine (OPV).
    

Detailed description: 
      This study will assess the immunogenicity and reactogenicity of the investigational
      DTaP-HB-PRP~T combined vaccine when given as a booster dose, concomitantly with OPV, in
      Filipino children previously primed at 6, 10, and 14 weeks with the investigational
      DTaP-HB-PRP~T combined vaccine or Tritanrix-Hep B/Hib™ vaccine and having received a first
      dose of Hep B vaccine (Recomvax B™) at birth in a previous study, AL201 (NCT00348881).
    

Intervention name(s): DTaP-HB PRP~T Combined Vaccine; DTaP-HB-PRP~T vaccine; Oral Polio Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular (IM); 0.5 mL, IM; Oral co-administered with study vaccine.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphtheria; Tetanus; Pertussis; Hepatitis B Hansenula (HB); Haemophilus influenzae type b
A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I multicenter study that will be conducted in the United States and Europe.
    


Intervention name(s): placebo; PRO283698
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous and subcutaneous ascending dose; Intravenous and subcutaneous ascending dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: RA
A Phase Ⅱ Clinical Study of Sanhuangjingshimingwan in Wet( Neovascular)Age-related Macular Degeneration(wAMD) Subjects
Condition: Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is to evaluate the efficacy and safety of Sanhuangjingshimingwan in Wet AMD.
    

Detailed description: 
      The study is to evaluate the efficacy and safety of Sanhuangjingshimingwan,give two times a
      day versus placebo in wAMD .The clinical phase of the study comprises a 6-months double-blind
      treatment period, resulting in 6.5-months overall duration of the study for each patient.
    

Intervention name(s): Sanhuangjingshimingwan; Sanhuangjingshimingwan Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sanhuangjingshimingwan,12g,Bid,6 months.Anti VEGF injection will be injected monthly if needed.; Sanhuangjingshimingwan Placebo,12g,Bid,6 months.Anti VEGF injection will be injected monthly if needed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: wAMD
A Study of huMAb OX40L in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
Condition: Asthma
MeSH terms: Asthma; Airway Obstruction
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II, double-blind, placebo-controlled, randomized, parallel-group study is designed
      to evaluate the efficacy, safety, and tolerability of huMAb OX40L administered to patients by
      IV infusion for the treatment of allergen-induced asthma.
    


Intervention name(s): huMAb OX40L; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous repeating dose; Intravenous repeating dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anti-OX40L; Mild Allergic Asthma; Allergies; Allergic Asthma; Adult Asthma
24-hour IOP Pattern With SENSIMED Triggerfish® in a Healthy Population
Condition: Healthy Subject
Study type: Interventional

Summary: 
      A database (Snapfish) has been generated at Sensimed compiling all data acquired up to now on
      healthy volunteers and patients with glaucoma. However, healthy subjects were much younger
      than glaucoma patients. Additionally, the number of glaucoma patients in Snapfish database
      was almost twice higher than the number of healthy subjects. As it is generally accepted that
      intra ocular pressure (IOP) in the aging population is higher than IOP in young adults it is
      of interest to evaluate the 24-hour IOP pattern of older healthy subjects. Furthermore,
      improving our knowledge of the "healthy" 24-hour IOP pattern in comparison to glaucoma
      profiles would be beneficial for management of glaucoma.
    


Intervention name(s): Sensimed Triggerfish
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Casodex/Zoladex Biomarkers in Localised Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate anti-androgen (bicalutamide) induced biological and molecular changes in prostate
      comparison to chemical castration induced (goserelin) ones
    


Intervention name(s): bicalutamide (Casodex), goserelin (Zoladex)
Intervention type(s): Drug
Intervention MeSH terms: Goserelin; Bicalutamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: biomarker study; Patients with clinically localised prostate cancer
Error Enhancement of the Velocity Component
Condition: Stroke; Hemiparesis
MeSH terms: Paresis
Study type: Interventional

Summary: 
      The purpose of this pilot study was to explore the impact of enhancement of the velocity
      component error in the course of reaching movements of the impaired/hemiparetic limb in an
      acute stroke subject. We hypothesized that the method would shift velocity profiles toward
      the optimal, resulting in a reduction in error. A prototype robot. This robotic device system
      has a two-dimensional motor, basic measurement capacities, and a robotic arm which is engaged
      to the subject's upper-limb in a sitting position.

      The enhancement of the velocity component error would shift velocity profiles toward the
      optimal, resulting in a reduction in error.
    

Detailed description: 
      The wrist of the subject is connected to the robotic arm by a strip which supports the arm
      but allows free movements of the wrist. This configuration allows subjects with impaired
      grasping ability to use the system. A bio-feedback system enables the subject to perform
      various functional motor tasks that are presented on the screen in front of him. The system's
      sensors detect motor errors or deviations from an optimal/proper movement trajectory or
      velocity profile. Any deviation in direction, velocity, acceleration or necessary force from
      the optimal trajectory results in applied robotic forces that enhance such errors/deviations.
      The sensors and the applied forces all work and compute in real time, so that the force
      measurements and the applied force are updated to the executed movement.
    

Intervention name(s): Error Enhancement; control treatment
Intervention type(s): Device; Device
Intervention description(s): Patients underwent upper extremity robotic training with the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions.; Patients underwent upper extremity robotic training without the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions.
Other intervention name(s): Experimental: Error Enhancement of the Velocity Component
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: CVA, rehabilitation
Effects of GSK1278863A on Pulmonary Artery Pressure in Healthy Volunteers
Condition: Anaemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This protocol is designed to explore whether short-term therapy with GSK1278863 affects PASP
      under normoxic and hypoxic conditions in healthy volunteers. Healthy subjects will be
      evaluated using echocardiography to estimate PASP based on the velocity of the tricuspid
      regurgitant jet. Resting PASP will be assessed under normoxic (room air) conditions, as well
      as after 30 minutes' exposure to 15% O2 before, during, and after short-term treatment with
      GSK1278863.
    

Detailed description: 
      This is a single-center, randomized, placebo-controlled, single-blinded (subjects and
      investigators will be blinded, GSK internal personnel will not be blinded) study designed to
      test whether short-term administration (5 days) of GSK1278863 affects PASP under normoxic and
      hypoxic conditions in healthy volunteers. Approximately 45 healthy subjects with
      mild-moderate baseline tricuspid regurgitation (sufficient to allow reliable assessment of
      PASP) will be enrolled into this study and will provide ~15 evaluable subjects in each arm
      [Placebo, 5 mg, and 100 mg GSK 1278863].
    

Intervention name(s): GSK1278863; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK1278863; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: GSK1278863; Pulmonary artery pressure
Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis
Condition: Skin Alterations Associated With Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      Investigation aimed to explore the efficacy of a topical Sertaconazole cream 2% in patients
      with skin alterations associated with atopic dermatitis
    


Intervention name(s): Sertaconazole 2% cream; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Sertaconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Skin alterations; Atopic Dermatitis
Study to Evaluate the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of this study are to evaluate the safety, tolerability, and efficacy
      of vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are
      currently not being treated.
    


Intervention name(s): TDF; Vesatolimod; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 300 mg tablets administered orally once daily; Tablets administered orally once a week (every 7 days) for 12 doses; Placebo administered orally once a week (every 7 days) for 12 doses
Other intervention name(s): Viread®; GS-9620
Intervention MeSH terms: Vesatolimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HBV; Hepatitis; Liver Disease