bioihbjkbjnl/mcl2 huggingface dataset:
Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride (HCL) 1% Cream for Erythematotelangiectatic Rosacea
Condition: Erythematotelangiectatic Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare treatment outcome with pulsed dye laser, when used used as an
      adjunctive treatment to oxymetazoline HCl 1% cream, compared to oxymetazoline HCL 1% cream
      alone, for patients with moderate or severe erythematotelangiectatic rosacea.
    

Detailed description: 
      This is a prospective, two-arm randomized, baseline-controlled, pilot study to evaluate
      treatment outcome of 3 Vbeam® Prima PDL treatments in subjects applying once-daily RHOFADE®
      topical oxymetazoline HCL 1.0% cream for improvement in erythematotelangiectatic rosacea.
      Treatment outcome will be compared to oxymetazoline HCL 1% cream alone.

      Subjects with moderate or severe (Grade 3 or 4) erythematotelangiectatic rosacea on the
      validated Clinical Erythema Assessment (CEA) Scale and Subject Self-Assessment (SSA) Scale
      will be enrolled and randomized to one of two study arms:

      Arm 1- 3 monthly treatments with Vbeam® PDL with daily RHOFADE® topical oxymetazoline HCL
      1.0% cream.

      Arm 2 -Treatment with daily RHOFADE® topical oxymetazoline HCL 1.0% cream only.

      All subjects will apply RHOFADE® cream daily during the 6-month study. After 1-month of
      RHOFADE® cream, subjects in the combined treatment Arm 1 will receive the first of three
      monthly Vbeam® PDL treatments (at 4-week intervals) with a 3-day washout of cream before each
      treatment.

      Investigators will assess erythema severity, global aesthetic improvement and vessel size
      improvement with treatment at 1, 2, 3 and 6-months' post-baseline. Subject satisfaction will
      be assessed. Safety assessments will be conducted at each study visit, and subjects in Arm 1
      will also be assessed for treatment-associated discomfort and post-treatment response
      following PDL treatments.
    

Intervention name(s): The Vbeam® Prima System; Oxymetazoline HCL 1% Cream
Intervention type(s): Device; Drug
Intervention description(s): 3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment.; Daily application of Oxymetazoline HCL 1% cream for the 6-month study.
Other intervention name(s): Vbeam® Prima Pulsed Dye Laser Treatment; Pulsed Dye Laser Treatment; PDL Treatment; RHOFADE®
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects randomized at baseline to either 3 monthly treatments with PDL and daily oxymetazoline 1.0% cream (Arm 1) or oxymetazoline cream alone (Arm 2).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Erythema; Rosacea; Telangiectasia; pulsed dye laser; oxymetazoline hydrochloride 1% cream
Bioequivalence Study of Tacrolimus 5 mg Capsule Under Fasting Condition
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The objective of the study is to demonstrate bioequivalence between Test Product (A):
      Tacrolimus Capsules 5 mg, manufactured by Panacea Biotec Limited, India and the corresponding
      Reference Product (B): Prograf (Tacrolimus) Capsules 5 mg, manufactured by Astellas Pharma,
      Inc., USA in 36 normal, healthy, adult, male subjects under fasting condition.
    

Detailed description: 
      Total 36 normal healthy adult male subjects will be enrolled in the study. Subjects will be
      administered either the Test or the Reference Product with 240 mL of water in each period as
      per the randomization schedule. Subjects will fast for at least 10 hours prior to dose
      administration and for at least 4 hours post dose. Standardized meals will be provided in
      each study period. Water will not be accessible to the subjects 1 hour Predose and 2 hours
      Post dose in each period. A total of 23 blood samples will be withdrawn for pharmacokinetic
      profiling. The whole blood concentrations of Tacrolimus will be measured by a validated
      LC/MS/MS analytical method. Ratio analysis will be performed for untransformed and log
      transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0 inf. ANOVA will be performed on
      log transformed pharmacokinetic parameters Cmax, AUC0-72, AUC0-inf and 90% confidence
      interval will be constructed for the ratio of geometric least square mean of the Test and
      Reference products, obtained from the log-transformed data. Bioequivalence will be concluded
      if the ratio estimate as well as its 90% confidence interval, both falls within the
      acceptable range of 80.00% to 125.00% for Cmax, AUC0-72 and AUC0-inf.
    

Intervention name(s): Tacrolimus 5 mg Capsule
Intervention type(s): Drug
Intervention description(s): Subjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule
Other intervention name(s): Tacrolimus Capsule
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence study in healthy volunteers
Effects of Metformin on Hepatic FFA Metabolism
Condition: Type 2 Diabetes; Dyslipidemia
MeSH terms: Diabetes Mellitus, Type 2; Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Metformin treatment has beneficial effects on both glucose and lipid metabolism.
      Whereas there is general agreement that the blood glucose lowering effect of metformin
      results from inhibition of hepatic gluconeogenesis, it is less clear exactly how the drug
      lowers blood triglyceride concentration. There are indications that it enhances hepatic free
      fatty acid (FFA) oxidation thus diminishing substrate for reesterification and resecretion as
      very-low-density-lipoprotein (VLDL) triglycerides (TG). However, the liver is not easily
      accessible for sampling in humans and data on the clinical effects of metformin in the liver
      are therefore lacking. This may change due to the increasing use of the positron emission
      tomography (PET) technique. Using PET isotopes (11C or 18F) coupled to either palmitate or a
      fatty acid analogue, it is possible to non-invasively measure hepatic fatty acid handling.

      Aim: To determine how 3 months metformin treatment (1000 mg twice daily) affects hepatic
      lipid and glucose metabolism in patients with newly diagnosed type 2 diabetes.

      Design: Randomized, placebo controlled, double-blind parallel study with patients receiving
      either metformin or placebo. A control group of BMI and age-matched non-diabetic individuals
      will receive metformin for 3 months.

      Hypothesis: Metformin lowers VLDL-TG secretion and circulating triglycerides by increasing
      hepatic fatty acid oxidation
    


Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1000 mg metformin twice daily in 3 months; 2 tablets twice daily in 3 months
Other intervention name(s): Metformin "Sandoz" 500 mg
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Type 2 diabetes; Hepatic fatty acid oxidation; Dyslipidemia; Metformin
Study In Airway Physiology In Children SERETIDE DISKUS ® Inhlaer and FLIXOTIDE® Inhaler Are Trademarks of GSK Group of Companies.
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of two asthma treatments by lung function measures.
    


Intervention name(s): Salmeterol/fluticasone propionate; Fluticasone propionate
Intervention type(s): Drug; Drug
Other intervention name(s): Salmeterol/fluticasone propionate
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma; inhaled corticosteroids
The Role of ITGAM in Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Observational

Summary: 
      Study to examine the role of ITGAM molecule in normal control subjects with known genetic
      variation in the ITGAM gene.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Normal Control Subjects with genotype of interest registered in the Genotype and Phenotype
        Registry
      
Biospecimen description: 
      Blood and DNA will be collected and retained
Single Dose Escalation Study of GSK2838232 in Healthy Subjects
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      GSK2838232 is a novel human immune virus (HIV) maturation inhibitor being developed for the
      treatment of chronic HIV infection. This study is the first administration of GSK2838232 in
      humans to establish the initial safety, tolerability, and pharmacokinetic profile following
      single doses of GSK2838232 and to evaluate the effect of food and ritonavir (RTV) on
      GSK2838232 in healthy subjects. There will be 2 cohorts in this study. In Cohort 1,
      approximately 8 healthy subjects will be enrolled (6 active and 2 placebo) at each dose
      visit. There will be four dosing sessions for each subject with subjects randomized to
      receive placebo in a random sequence. In Cohort 2, approximately 8 healthy subjects will be
      enrolled (6 active doses and 2 placebo doses at each dose visit). Cohort 2 will have four
      dosing sessions for each subject with subjects randomized to receive placebo in a random
      sequence.
    


Intervention name(s): GSK2838232; Placebo; Ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Bottled powder with 5, 10 and 20mg unit dose strength per single dose for re-constituted oral suspension given once daily; Visually matching GSK2838232; 100mg tablets once daily for 12 days
Intervention MeSH terms: Ritonavir; GSK-2838232
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: single dose; HIV; maturation inhibitor; GSK2838232; FTIH; healthy subjects
Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To characterize the steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered
      twice daily with meals to healthy subjects
    


Intervention name(s): Saxagliptin
Intervention type(s): Drug
Intervention description(s): Tablets, oral, 2.5 mg, twice daily, 7 days
Other intervention name(s): Onglyza™
Intervention MeSH terms: Saxagliptin
Intervention model: Single Group Assignment
Masking: None (Open Label)
To Investigate Effects GSK561679 on Part of the Body's System That Controls the Balance of Many of the Hormones.
Condition: Depressive Disorder and Anxiety Disorders
MeSH terms: Depressive Disorder; Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to investigate the effects GSK561679 on part of the body's system that controls the
      balance of many of the hormones (including cortisol).
    


Intervention name(s): metyrapone; alprazolam; placebo; GSK561679
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Metyrapone will be available as 250 mg dose capsule.; Alprazolam capsules will be available with dose strength of 0.25mg; GSK561679 placebo tablets visually match the active GSK561679 tablets. Placebo to match Alprazolam is a hard gelatine capsule that visually matches active Alprazolam capsules.; GSK561679 tablets will be available with dose strength of 50, 10 and 200 mg.
Other intervention name(s): Single dose of GSK561679; Single dose of metyrapone; Single dose of placebo; Single dose of alprazolam
Intervention MeSH terms: Alprazolam; Metyrapone
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Diagnostic
Keywords: HPA axis,; Healthy volunteers; hormones,; GSK561679,; cortisol,
Evaluation of Decisional Conflict and Needs Assessment in Asthma Management
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Many patients suffering from asthma are not compliant to their treatment and consequently,
      are not well controlled. Shared decision making intervention has shown an improvement in the
      outcome of patients with chronic disease. The aim of this study is to evaluate decisional
      conflict and to assess decisional needs of adults with asthma.
    

Detailed description: 
      Asthmatic patients will be recruited and asked to fill a decisional conflict scale.

      Patients, asthma educators and physicians will also be recruited to fill a needs assessment
      questionnaire about decisions taken by asthmatics.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults with mild to moderate asthma controlled or slightly controlled
An Observational Clinical Feasibility Study of the Magnetic Esophageal Sphincter
Condition: Gastroesophageal Reflux Disease
MeSH terms: Gastroesophageal Reflux
Study type: Interventional

Summary: 
      Magnetic Esophageal Sphincter implant is intended to reinforce Esophageal Sphincter function
      in the treatment of Gastroesophageal Reflux Disease (GERD)
    

Detailed description: 
      The purpose of this feasibility study is to collect preliminary performance and safety
      information and develop procedural optimization for the Torax Medical Inc. Magnetic
      Esophageal Sphincter device (MES) in reinforcement of Esophageal Sphincter function to treat
      Gastroesophageal Reflux Disease (GERD). The information from this study will be used to
      support the design and conduct of an expanded clinical trial.
    

Intervention name(s): Torax Medical, Inc. LINX Reflux Management System
Intervention type(s): Device
Intervention description(s): Implantable device, Magnetic Esophageal Sphincter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GERD
Clinical Assessment of Pharmacokinetics, Efficacy, and Safety of 10% IVIg in PID Patients
Condition: Primary Immunodeficiency Disease
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to assess efficacy and safety of Kedrion Immunoglobulin 10%
      (KIg10) in participants with Primary Immunodeficiency (PID).
    


Intervention name(s): Kedrion IVIG 10%
Intervention type(s): Biological
Intervention description(s): Kedrion intravenous immunoglobulin (IVIg) 10%
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immunoglobulin; Kedrion IVIg10%; IgG antibodies; Agammaglobulinemia; Hypogammaglobulinemia
The Eye Patch and Headset on Sleep Quality, Anxiety, Fear and Vital Signs
Condition: Intensive Care Unit Syndrome
Study type: Interventional

Summary: 
      This study was planned to investigate the effects of eye patch and headphones on sleep
      quality, anxiety, fear and vital signs in coronary intensive care unit patients.
    

Detailed description: 
      In intensive care units, it can be much easier to change the environment perception of
      patients with simple tools such as headphones and sleep bands, rather than changing the
      environment of the patients. The use of sleep bands and headphones, which are
      non-pharmacological methods, can reduce sleep deprivation by changing the environmental
      perception of the patients.
    

Intervention name(s): Eye patch and headphones
Intervention type(s): Other
Intervention description(s): Patients in the experimental group will be asked to use an eye mask and earplugs from 22:30 to 6:30 in the morning on the 1st, 2nd and 3rd nights.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This research is a single-blind study with a pretest-posttest randomized control group.
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Intensive Care Unit; Headphones; Sleep bands; Sleep
Safety and Effectiveness of BM-MSC vs AT-MSC in the Treatment of SCI Patients.
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Spinal Cord Injury (SCI) is a devastating condition that leads to permanent functional and
      neurological deficits in injured individuals. The limited ability of the Central Nervous
      System (CNS) to spontaneously regenerate impairs axonal regeneration and functional recovery
      of the spinal cord. The leading causes are motor-vehicle crashes, sports-associated
      accidents, falls, and violence-related injuries.

      Unfortunately, there is still no effective clinical treatment for SCI. In recent years,
      tissue engineering and regenerative medicine based approaches have been proposed as
      alternatives for SCI repair/regeneration. Mesnchymal stem cells (MSC) use in SCI showed
      promising results in several studies. Our aim is to assess and compare the safety and
      effectiveness of autologous BM-MSC vs autologous AT-MSC in these patients.
    

Detailed description: 
      The study will be conducted at Cell Therapy Center (CTC) in Jordan, where 14 SCI patients
      meeting the inclusion criteria will be recruited and blindly divided into 2 groups of equal
      numbers. The first groups will be treated with autologous BM-MSC, while the second group will
      be treated with autologous AT-MSC. The outcomes and improvements will be assessed using the
      American Spinal Injury Association (ASIA) Impairment Scale (AIS). Magnetic Resonance Imaging
      (MRI) will be performed at base line and after 12 months of the stem cell transplantation.
    

Intervention name(s): Autologous Mesenchymal Stem Cells
Intervention type(s): Biological
Intervention description(s): Autologous Mesenchymal Stem Cells will be collected from patients, prepared in the lab and then injected intrathecally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Cord Injury; Mesenchymal Stem Cells
The Efficacy and Safety of Fang yi Qing Feng Shi Granules in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the efficacy and safety of Fang yi qing Feng shi
      granules in subjects with Rheumatoid Arthritis.
    

Detailed description: 
      Fang yi qing feng shi granules is the chinese patent medicine, which contains 8 kinds of
      chinese medicine .

      Fang yi qing feng shi granules was approved by China Food and Drug Administration (CFDA) in
      2005, produced by means of modern technology by Maoxiang Group Jilin Pharmaceutical Co.,
      Ltd.The study is a multi-center, double -blind, placebo -controlled, randomized in Chinese
      subjects with Rheumatoid Arthritis to assess treatment effect and safety in the subjects
      treated with Fang yi qing feng shi granules versus subjects treated with placebo.
    

Intervention name(s): Fang yi qing feng shi granule; placebo; Methotrexate; Acetaminophen tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 10g, Oral,Three each time, 3 times a day,for 3 months;; 10g, Oral,Three each time, 3 times a day,for 3 months; 7.5-15mg per week，All patients should be used; Oral,0.5g, 1~2 times a day, when vas=10
Intervention MeSH terms: Acetaminophen; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Theta Burst Stimulation to Promote Motor Re-education in Tetraplegia
Condition: Quadriplegia/Tetraplegia
MeSH terms: Quadriplegia
Study type: Interventional

Summary: 
      A repetitive, non-invasive brain stimulation technique referred to as theta burst stimulation
      can modulate corticomotor excitability and therefore has great rehabilitative potential for
      individuals with neurologic deficits, including individuals with spinal cord injury (SCI). In
      particular, intermittent theta burst stimulation (iTBS) can increase corticomotor
      excitability and may be a useful adjunct to physical rehabilitation to promote motor
      re-education after upper limb reconstruction in individuals with tetraplegia. Upper limb
      reconstruction involves surgical transfer of a non-paralyzed tendon or nerve with a redundant
      or less important function to perform a more critical function. Upper limb reconstruction is
      intended to help individuals achieve their goals related to activities of daily living and
      independence in the community. Outcomes after reconstruction are variable and depend largely
      on the efficacy of motor re-education of the transferred muscle to perform a new function.
      The long-term goal of our research is to determine whether iTBS combined with physical
      rehabilitation can improve motor re-education after reconstruction. As a first step, the
      purpose of this proposal is to determine the effect of iTBS on corticomotor excitability of
      proximal muscles in nonimpaired individuals and two groups of individuals with tetraplegia:
      individuals with and without upper limb reconstruction.
    


Intervention name(s): Intermittent theta burst stimulation
Intervention type(s): Other
Intervention description(s): Intermittent theta burst stimulation (iTBS) is a non-invasive brain stimulation technique that can increase corticomotor excitability.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science