bioihbjkbjnl/mcl2 huggingface dataset:
Cosmetic Fat Transplantation Using Expanded ASC Enriched Fat Grafts
Condition: Breast Hypoplasia and Facial Ageing
MeSH terms: Facies
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the present study is to examine whether enrichment of a fat graft with
      autologous ex vivo expanded ASC injected into the breast tissue or face, both for cosmetic
      use, will significantly improve the results of conventional lipofilling and synthetic facial
      fillers, thereby being able to offer a safer, more natural and long-lasting alternative to
      current artificial solutions for cosmetic patients.
    

Detailed description: 
      The cosmetic breast augmentation design is a double-blind (surgeon and data assessor)
      randomized, prospective clinical study on healthy subjects.

      The cosmetic facial filling design is a data assessor-blinded, randomized, prospective
      clinical study on healthy subjects.
    

Intervention name(s): ASC enriched lipofilling; Standard Lipofilling
Intervention type(s): Biological; Biological
Intervention description(s): Fat grafts enriched with ex vivo expanded ASC; Non-ASC enriched fat grafts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of the Second Generation Dutasteride and Tamsulosin Hydrochloride (HCL) Combination Capsule in Fasted State
Condition: Urologic Diseases
MeSH terms: Urologic Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of the second generation
      dutasteride and tamsulosin hydrochloride (HCL) combination capsule versus currently available
      commercial combination of dutasteride 0.5 milligram (mg) and tamsulosin HCL 0.4 mg capsule in
      healthy adult male subjects. Subjects in this study will receive either a single oral dose of
      the second generation dutasteride 0.5 mg and tamsulosin 0.4 mg combination capsule or a
      single dose of commercially available combination of dutasteride 0.5 mg and tamsulosin HCL
      0.4 mg followed by a 28-day washout period both in fasted state. The study will enroll
      approximately 92 healthy adult male subjects in order to complete approximately 76 evaluable
      subjects. The total duration of a subject's involvement in this study is anticipated to be
      approximately 12 weeks.
    


Intervention name(s): Commercially available combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg; Second generation dutasteride 0.5 mg and tamsulosin HCL 0.4 mg combination capsule
Intervention type(s): Drug; Drug
Intervention description(s): Commercially available, orange and brown, hard shell capsule, administered orally as a single dose on Day 1 under fasted condition.; Orange and brown, hard shell capsule, administered orally, as a single-dose on Day 1 under fasted condition.
Intervention MeSH terms: Tamsulosin; Dutasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: dutasteride; tamsulosin; healthy subject; dutasteride and tamsulosin combination; combination capsule of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg
Health-Related Quality of Life in Patients With Systemic Lupus Erythematosus:Focusing on Fibromyalgia
Condition: Quality of Life
Study type: Observational

Summary: 
      Systemic lupus erythematosus (SLE) patients show a high prevalence of fibromyalgia though
      rates vary considerably from one study to another (from 8.2% to 45%). Although fibromyalgia
      can bring out the disability in daily life, the majority of previous reports only ascertained
      no significant association between the presence of fibromyalgia and the severity of SLE.

      It is necessary to make unremitting effort to reduce the mortality and life-threatening
      disease flare-up due to SLE disease itself. Additionally, we think that physicians need to
      pay more attention to improve health-related quality of life (HRQoL) in the patients with
      SLE. HRQoL could be influenced by various factors such as depression, fibromyalgia, disease
      duration, disease activity and etc. To improve the HRQoL in SLE patients, it might be the
      clinically important and constructive theme to investigate that which is the most important
      factor among the fibromyalgia, depression, sleep quality, SLE activity and SLE duration.

      The objective of this study is to evaluate the degree of contribution of fibromyalgia for
      reduced HRQoL and to identify the status of managing fibromyalgia in Korean patients with
      SLE.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        -  Patients : 150 women age 30 to 60 years with SLE

          -  Control subjects : age, sex matched control subject (150 subjects)

          -  Patients : First visit and second visit after an interval of six months

          -  Control subjects : baseline only
      
Keywords: systemic lupus erythematosus, disease activity, sleep, quality of life
Evaluation of Subchondroplasty™ for Defects Associated With Bone Marrow Lesions
Condition: Bone Marrow Edema
MeSH terms: Edema
Study type: Observational

Summary: 
      Studying long-term changes in a sub-set of patients who undergo the Subchondroplasty
      procedure including changes in pain, function, and overall health.
    

Detailed description: 
      This study is designed as a prospective, consecutive series outcomes study. Patients
      presenting with knee pain associated with bone marrow lesions that meet the inclusion
      criteria will be eligible to undergo Subchondroplasty procedure. The subjects will be
      followed for twenty-four (24) months after surgery via office visits and will be contacted
      once per year for up to 5 years post-operatively and asked questions regarding their pain and
      functioning to further understand long-term outcomes.. Seventy (70), a ( minimum of sixty-two
      (62)) patients who meet the inclusion/exclusion criteria will be enrolled in the study. Up to
      5 sites will participate in this study. The study is intended to provide an estimate of
      one-year and two-year clinical success with minimum bias and with sufficient statistical
      precision to permit meaningful comparison to commonly accepted two-year clinical success
      rates for currently available treatment alternatives. An improvement of 10 points on the Knee
      Injury and Osteoarthritis Outcome Score (KOOS) Pain Subscore on the KOOS Scoring System from
      baseline to 1-year post-operative is considered minimal perceptible clinical improvement and
      will be used to define the primary clinical success criterion for this study.
    

Intervention name(s): Subchondroplasty
Intervention type(s): Procedure
Other intervention name(s): Calcium Phosphate Bone substitute filling of micro fractures
Intervention MeSH terms: Calcium
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with single bone marrow edema of the tibia, single bone marrow lesion of the femur
        or adjoining bone marrow lesions of the tibia and femur (kissing lesions).
      
Keywords: bone marrow edema; bone marrow defects
Home-Based Functional Exercise Program in Patients With Patellar Femoral Syndrome Over a 10-Week Period
Condition: Patellar Femoral Syndrome
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a 10 week exercise rehabilitation program
      decreases anterior knee oain (PFPS) and improves function in patients with patellofemoral
      pain syndrome (PFPS). Individuals (age 18-50) with PFPS will be recruited to participate in
      this study to see if a 10 week exercise program focusing in core and hip strengthening, lower
      extremity strengthening foot intrinsic strengthening can decrease pain and increase function.
    

Detailed description: 
      Patellofemoral pain syndrome (PFPS) is a very prevalent condition that presents in great
      number to patients in physician's offices and has a high recurrence rate. Physical therapy
      and exercise therapy to strengthen the quadriceps is often prescribed, however recurrence is
      common. It is hypothesized that PFPS patients have core weakness, hip strength abnormalities
      and neuromuscular control deficits.
    

Intervention name(s): 10 Week Exercise Program; DVD Program After 10 Weeks
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will complete a 10 week exercise program using DVD with instructions provided. Participants will have to do one session of exercise on 5 different days each week for a total of 5 sessions per week, for 10 weeks.; If the DVD program shows to help participants in Group 1, the program and DVD will be provided to Group 2 participants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency
Condition: Congenital Bleeding Disorder; Congenital FXIII Deficiency
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial will be conducted in Asia, Europe and the United States of America (USA).

      The aim of this clinical trial is to investigate long-term safety of rFXIII when administered
      for prevention of bleeding episodes in children aged between 1 and 6 years with congenital
      FXIII A-subunit deficiency. This trial is an extension to trial F13CD-3760 (mentor™4,
      NCT01230021). If applicable the trial will be extended up to maximum 3 years dependent on
      when recombinant factor XIII will be commercially available in subject's respective country
      for use in children of 1-6 years of age.
    


Intervention name(s): catridecacog
Intervention type(s): Drug
Intervention description(s): Intravenous injection of a single dose of recombinant factor XIII, 35 IU/kg body weight every 4th week
Other intervention name(s): recombinant factor XIII
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Approved Drug to Study a New Indication for Seasonal Allergic Rhinitis in Patients With Asthma (0476-269)
Condition: Rhinitis, Allergic, Seasonal; Asthma, Bronchial
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effect of an approved medication on the
      symptoms of seasonal allergic rhinitis (a seasonal variety of inflammation of the mucous
      membrane of the nose) in patients who are experiencing symptoms of seasonal allergic rhinitis
      and asthma.
    

Detailed description: 
      The duration of treatment is 2 weeks.
    

Intervention name(s): MK0476, montelukast sodium; Comparator: placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Determine the Effect of Food on the Pharmacokinetics of Oral AZD8931 Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I, randomised, open label, 3-period crossover study in healthy male subjects to
      investigate the effect of food on the pharmacokinetics of AZD8931 and to investigate the
      safety and tolerability of AZD8931.
    


Intervention name(s): AZD8931
Intervention type(s): Drug
Intervention description(s): 160mg oral single dose (4 x 40mg tablets)
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteers; ADME; Healthy male volunteers
Amlodipine VaLsartan Efficacy in Hypertensive Patients.A Real World Trial
Condition: Essential Hypertension
MeSH terms: Essential Hypertension
Study type: Observational

Summary: 
      To determine the efficacy of valsartan/amlodipine 80/5 mg once daily dose is reducing mean
      sitting systolic blood pressure (MSSBP) and mean sitting diastolic blood pressure (MSDBP)
      after 8 weeks of therapy.
    

Detailed description: 
      Avsar in tablet form which contains two antihypertensive compounds with complementary
      mechanisms to control blood pressure in patients with essential hypertension: amlodipine
      belongs to the calcium antagonist class and valsartan to the angiotensin II antagonist class
      of medicines Amlodipine is a dihydropyridine calcium channel blocker that inhibits the
      transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle.
      Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle
      to cause a reduction in peripheral vascular resistance and reduction in blood
      pressure.Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of
      angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor in
      many tissues, such as vascular smooth muscle and the adrenal gland International studies are
      available concerning the single pill combination therapy used in Blood pressure reduction. To
      determine the clinical significance of single pill combination, conducted multi center real
      life study i.e.; "ALERT Trial" in our local population. Through this study, observed the
      effect of single pill combination on BP reduction and adverse events in health care settings.
      Antihypertensive drugs use in a single pill combination may further enhance BP control by
      reducing pill burden and improve patient compliance.
    

Intervention name(s): Valsartan, Amlodipine -
Intervention type(s): Drug
Intervention description(s): Valsartan is a non-peptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype used as an antihypertensive agent.
Amlodipine besylate is a dihydropyridine long-acting calcium channel blocker.
Other intervention name(s): AVSAR
Intervention MeSH terms: Amlodipine; Valsartan
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ages Eligible for Study: 18 years - 70 Years Genders Eligible for Study: Both
      
Keywords: ALERT, MSSBP, MSDBP
A Comparative Evaluation of the Extent of Neointima Formation at 1 Month and 2 Months After Implantation Using OCT
Condition: Coronary Artery Disease; Stable Angina Pectoris; Unstable Angina Pectoris
MeSH terms: Coronary Artery Disease; Angina Pectoris; Angina, Stable; Angina, Unstable
Study type: Interventional

Summary: 
      The objective of this study is a comparative evaluation of BuMA Supreme™ stent and of Xience
      V/Prime stent in terms of the extent of neointima formation at 1 or 2 months after implanting
      in relatively high bleeding risk patients with coronary artery disease using OCT.
    

Detailed description: 
      This is a prospective, multicenter, randomized, non-inferiority study, which will enroll a
      total of 80 subjects from approximately 8 centers. All subjects will be firstly randomly
      assigned to 1st month OCT (40 pts) or 2nd month OCT group(40 pts). Then both two groups will
      be randomly assigned to undergoing implantation of BuMA Supreme™ stent (20 pts) or Xience
      V/Prime stent (20 pts). If non-inferiority was met, superiority test will be planned.

      All of the patients be followed up to 2 years. The follow-up visits will be conducted at 1 or
      2 months (including QCA/OCT investigation), 3 months, 6 months, 1 and 2 years post
      percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and
      Secondary Endpoints.
    

Intervention name(s): BuMA Supreme™ stent; Xience V/Prime stent
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: BuMA Supreme; Xience V/Prime; OCT; neointima formation; HT Supreme
Cyberknife® Partial Breast Irradiation (PBI) for Early Stage Breast Cancer
Condition: Early Stage Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      By using stereotactic body radiation therapy (SBRT) delivered with the Cyberknife system®,
      the current protocol attempts to mimic or improve the excellent local control rates seen in
      treatment of early stage breast cancer while attempting to increase convenience, limit
      invasiveness, decrease toxicity, and improve cosmesis compared to other methods of radiation
      treatment.
    


Intervention name(s): Stereotactic Body Radiation Therapy
Intervention type(s): Radiation
Intervention description(s): 3 dose cohorts. Patients in each dose cohort will all be treated as a single group for dose escalation. The starting dose for the dose escalation portion will be 6 Gy per fraction for 5 fractions (total dose = 30 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation).
Other intervention name(s): SBRT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Topical Therapy for Prevention of Infections in Preterm Infants
Condition: Skin Diseases
MeSH terms: Infections; Skin Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine how to best take care of the skin of preterm
      infants in order to prevent infections through the skin.
    

Detailed description: 
      The skin of babies who are born too early is not mature, which means they are at risk for
      infections of the skin or in the body. Their skin also become very dry, leading to cracking
      and breakdown, and this may feel painful or uncomfortable for the infant.
    

Intervention name(s): Aquaphor; Sunflower Seed Oil
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pre-term infants; skin infections; infant skin; Aquaphor; sunflower seed oil; nutrition; skin care
Effect of Combination of Mitiglinide and Metformin on Glycemic Control in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      We performed a prospective, randomized, multicenter trial to assess the efficacy and safety
      of combined treatment with mitiglinide and metformin for patients with type 2 diabetes who
      show inadequate glycemic control with metformin monotherapy. Subjects with HbA1c >7.0% after
      an 8-week metformin run-in phase were randomized to a 16-week trial phase with metformin plus
      mitiglinide (Met+Mit) or metformin plus placebo (Met).
    

Detailed description: 
      This was a 16-week, randomized, double-blind study for comparing metformin plus mitiglinide
      (Met+Mit) versus metformin plus placebo (Met+Pcb). An 8-week metformin run-in phase (500 mg
      twice a day for the first 4 weeks and 500 mg three times a day for the following 4 weeks) was
      followed by a 16-week trial phase (mitiglinide 10 mg or placebo three times a day added to
      metformin 500 mg three times a day). The subjects with an HbA1c >7.0% at the end of the
      metformin run-in phase were randomized to a Met+Mit group or a Met+Pcb group of the trial
      phase.
    

Intervention name(s): Mitiglinide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): mitiglinide 10 mg three times a day added to metformin 500 mg three times a day
for 16 weeks; placebo three times a day added to metformin 500 mg three times a day for 16 weeks
Intervention MeSH terms: Mitiglinide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
The Effect of Multiple Oral Doses of BI 1356 BS on Pharmacokinetics, Safety and Tolerability of Multiple Oral Doses of Simvastatin and on the Pharmacokinetics of Its Metabolite Simvastatin Acid in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigation of the multiple dose pharmacokinetics, safety and tolerability of simvastatin
      and simvastatin acid with and without concomitant administration of BI 1356 BS
    


Intervention name(s): Simvastatin; 10 mg BI 1356 BS
Intervention type(s): Drug; Drug
Intervention MeSH terms: Linagliptin; Simvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Food Effect Study on the Bioavailability and PK of PA-824 Tablets in Healthy Adult Subjects
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center, randomized, balanced, single-dose, two-treatment,
      two-period, two-sequence, crossover, open-label study to evaluate the effect of food on the
      pharmacokinetics of PA-824. This study was designed to understand the possible effects of a
      high-calorie, high-fat meal on PA-824 absorption and pharmacokinetics. The hypothesis to be
      tested in this study is that the rate and extent of absorption of PA-824, as measured by
      Tmax, Cmax, AUC(0-t), and AUC(0 inf), are the same after a high-calorie, high-fat meal as
      compared with after a minimum 10-hour fast.
    


Intervention name(s): PA-824 1000 mg
Intervention type(s): Drug
Intervention description(s): Two single administrations of 1000mg each administered by 5 tablets of 200mg, one administered in the fed state and one administered in the fasted state.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tuberculosis; PK; PA-824; food effect,; bioavailability; pretomanid; CL-003