bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Physical Functions in Lower Limb Burn Injury
Condition: Burns; Burn Scar; Lower Limb Injury; Lower Limb Wound
MeSH terms: Wounds and Injuries; Burns; Leg Injuries
Study type: Interventional

Summary: 
      This study evaluates scar tissue, normal range of motion of lowr extremity joints, lower
      extremity functions, functional capacity, functional mobility, kinesiophobia and quality of
      life in lower limb burn injury.
    

Detailed description: 
      Patients with lower extremity burns experience problems with range of motion, muscle
      strength, balance and gait. These problems contribute to prolonged physical disability,
      return to work or deterioration of work capacity and thus lead to a negative impact on
      quality of life.

      In addition to studies showing that quality of life and functions may be affected adversely
      after burn, there are studies showing that burn percentage, health-related quality of life
      and functional outcomes are affected. The aim of this study is to determine the effects of
      burn area (with or without joint), percentage of burns and hypertrophic scar on the patient's
      function in patients with lower extremity burns.
    

Intervention name(s): Physical function assessment
Intervention type(s): Other
Intervention description(s): Physical function assessment is a tool to evaluate mobility levels of patients
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Burn Injury; Balance; Lower extremity function; burn scar
Usage of Dapagliflozin in the Management of Type-2 Diabetes Mellitus: A Real World Evidence Study in Indian Patients
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational [Patient Registry]

Summary: 
      This study is a non-interventional, multicentre, prospective, observational study to be
      conducted at 50 sites in India. The study targets to enrol 2000 patients with 40 patients per
      site. The study will be initiated after obtaining written approval of Independent Ethics
      Committee (IEC) /Institutional Review Board (IRB) and written informed consent of the
      patient.
    

Detailed description: 
      This study is a non-interventional, multicentre, prospective, observational study to be
      conducted at 50 sites in India. The study targets to enrol 2000 patients with 40 patients per
      site. The study would enrol T2DM patients who are/were inadequately controlled (HbA1c >7%)
      with existing anti-diabetic medications and who have been prescribed dapagliflozin 3 months
      prior to study initiation. No study medication will be prescribed or administered as a part
      of study procedure. Patients, who have been treated as per Investigators' routine clinical
      practice and prescribed dapagliflozin 3 months before will be screened for enrolment in
      study. Dosage of dapagliflozin and other medications should be as per the routine clinical
      practice and prescribing information. The study will be initiated after obtaining written
      approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Type 2 diabetes
      
Biospecimen description: 
      no samples retained
    
Keywords: T2D,; Type 2 Diabetes,; T2DM
Validation of the EEG Signal Quality Measured by the URGOnight Device and Comparison With a Clinical Device
Condition: Healthy Volonteers
Study type: Interventional

Summary: 
      The electroencephalogram or EEG is a painless and non-invasive exploratory examination
      routinely performed in clinical and experimental medicine and has various applications. It is
      therefore relevant to develop application-specific EEG measurement devices.

      The clinical development of therapies based on brain control has led to the emergence of
      numerous EEG devices that aim to allow mobile, autonomous, and easy use for users.

      Data from the literature have proven the ability of neurofeedback (a form of biofeedback in
      which subjects respond to a display of their own brainwaves in order to improve their health
      or performance) to improve brain function in healthy or pathological subjects.

      These therapeutic applications are offered in hospital settings with conventional systems and
      in the presence of a therapist.

      The EEG measurement device URGOnight was developed with the aim of offering autonomous
      neurofeedback exercises at home. URGOnight is a portable device. It uses passive electrodes
      (which do not send an electric current) and so-called dry electrodes, i.e. no gel or
      conductive paste is required.

      Therefore, the SIGMA study aims to evaluate the quality of the EEG signal collected by
      URGOnight and compare it with an electroencephalography device commonly used in clinical and
      research settings.

      We will also evaluate the quality of the brain wave measurement usually retained in
      comparative studies of EEG systems.
    


Intervention name(s): URGOnight; Enobio
Intervention type(s): Device; Device
Intervention description(s): EEG dry electrodes portable device; EEG wet electrodes portable device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Venous Air Embolism in Cesarean Delivery, Especially Placental Previa
Condition: Cesarean Delivery With Placental Previa
Study type: Observational

Summary: 
      Effects of placenta previa on incidence and severity of venous air embolism in patients
      during cesarean delivery
    


Intervention name(s): cesarean delivery
Intervention type(s): Procedure
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        cesarean delivery with placental previa
A Phase 3 Comparative Study of TAP-144-SR(6M) in Prostate Cancer Patients Previously Treated With Hormonal Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate hormone dynamics, pharmacokinetics, safety, and
      efficacy of TAP-144-SR(6M) against TAP-144-SR(3M) in prostate cancer patients previously
      treated with hormonal therapy.
    


Intervention name(s): TAP-144-SR(6M); TAP-144-SR(3M)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Leuprolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Placebo Controlled Study of 3 Doses of Rifaximin-EIR Tablet to Treat Moderate, Active Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to determine which of 3 doses of a non-absorbable antibiotic Rifaximin is
      most effective in treating active moderate Crohn's disease. Rifaximin tablets are already
      marketed in some European countries and the USA to treat traveller's diarrhoea. A new
      gastro-resistant form of Rifaximin called Rifaximin-Extended Intestinal Release (EIR) will be
      used in this study. These tablets dissolve in the stomach,releasing gastro-resistant granules
      which pass into the intestines and deliver Rifaximin directly to the site of the disease.
      Rifaximin is not absorbed, making it more effective and greatly reducing the frequency of
      side effects.
    


Intervention name(s): Rifaximin-EIR
Intervention type(s): Drug
Intervention description(s): Comparison of 800 mg, 1600 mg and 2400 mg Rifaximin-EIR versus placebo in the treatment of active moderate Crohn's disease
Other intervention name(s): GRACE
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rifaximin-EIR; Crohn's disease; remission
Interindividual Variation in Excretion of Curcumin
Condition: Metabolites; Gut Microbiota
Study type: Interventional

Summary: 
      The objective of this project is to elucidate the interindividual variations in excretion of
      curcumin and its metabolites.
    


Intervention name(s): curcumin
Intervention type(s): Dietary Supplement
Intervention description(s): subjects will be assigned to consume one capsule of curcumin (330 mg of curcumin per capsule) three times a day (one capsule with each meal).
Intervention MeSH terms: Curcumin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Epiduo and Treatment Adherence of Adolescent Patients With Inflammatory Acne
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Observational

Summary: 
      The purpose of this observational study is to assess the efficacy of Epiduo and patient
      adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years)
      with moderate inflammatory acne using this drug first time in topical monotherapy.
    

Detailed description: 
      The objective of this observational study is to assess the efficacy of Epiduo and patient
      adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years)
      with moderate inflammatory acne using this drug first time in topical monotherapy. This
      non-interventional trial will include a larger population of teenaged acne patients in order
      to establish the practical contribution of a new mini-questionnaire to the evaluation of
      adherence for the physician in the daily clinical practice in general and in young adults
      topically treated with Epiduo in particular. In addition safety and local tolerability
      profile of Epiduo are to be assessed under marketed conditions.
    

Intervention name(s): 0.1% adapalene/ 2.5% benzoyl peroxide
Intervention type(s): Drug
Intervention description(s): topical application, once per day
Other intervention name(s): Epiduo
Intervention MeSH terms: Adapalene; Benzoyl Peroxide
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        About 2.700 patients with moderate inflammatory acne, aged 12 to 20 will be selected from
        about 324 dermatology practices
      
Keywords: acne; Epiduo; adapalene/ benzoyl peroxide
Early Administration of Fibrinogen in Polytraumatized Patients With Hypofibrinogenemia: a Randomized Feasibility Trial
Condition: Trauma; Bleeding Disorder; Fibrinogen; Deficiency, Acquired
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized feasibility trial conducted with severe trauma patients. At admission
      patients presented hypofibrinogenemia, hypotension and tachycardia. The primary outcome was
      feasibility assessed by the proportion of patients receiving the allocated treatment up to 60
      minutes after randomization. The treatments regards to receive or not to receive an early
      replacement of fibrinogen.
    

Detailed description: 
      This is a randomized feasibility trial conducted between December 2015 and January 2017 with
      severe trauma patients (Index of Shock Severity [ISS] ≥ 15) admitted to the emergency room of
      a large trauma center. At admission patients presented qualitative hypofibrinogenemia (FIBTEM
      A5 ≤ 9 mm), hypotension (systolic blood pressure <90 mmHg) and tachycardia (heart rate > 100
      bpm). The primary outcome was feasibility assessed by the proportion of patients receiving
      the allocated treatment up to 60 minutes after randomization meaning receive replacement
      through fibrinogen concentrate (50mg per kg of body weight) by the intervention group and not
      to receive an early replacement of fibrinogen by control group.
    

Intervention name(s): Fibrinogen concentrate
Intervention type(s): Drug
Intervention description(s): Receive fibrinogen concentrate 50mg/kg of body weight after randomization
Other intervention name(s): Haemocomplettan®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Trauma; Coagulopathy; Fibrinogen; Fibrinogen Concentrate; Thromboelastometry; Hypofibrinogenemia; Early Fibrinogen Replacement
Pharmacokinetic Study of Subcutaneous Testosterone Enanthate
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of pharmacokinetics of subcutaneous testosterone enanthate
    

Detailed description: 
      Evaluation of pharmacokinetics and safety profile of testosterone enanthate injected
      subcutaneously via auto-injector in healthy male volunteers
    

Intervention name(s): Testosterone enanthate auto-injector
Intervention type(s): Combination Product
Intervention description(s): Randomization then administration of combination product study medication according to group assignment
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Adult Males
Intravenous Infusions of Ferumoxytol Compared to Oral Ferrous Sulfate for the Treatment of Anemia in Pregnancy
Condition: Iron Deficiency Anemia of Pregnancy
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized controlled trial includes pregnant women with anemia. They are randomized to
      IV iron infusions or to oral iron supplementation. Pregnancy outcomes are assessed.
    

Detailed description: 
      This is a randomized controlled trial aimed at assessing whether IV Iron administration
      (Ferumoxytol x 2 infusions) is superior to oral ferrous sulfate for the treatment of
      iron-deficiency anemia in pregnancy.

      140 patients will be randomized in a 1:1 ratio. Patients in the IV Iron group will receive
      two infusions of Ferumoxytol, one week apart. Patients in the oral Ferrous Sulfate group will
      receive medication to take at home during their pregnancy.

      Patients will have iron studies performed at study entry, and again at presentation for
      delivery. Cord blood will also be sampled for iron studies.
    

Intervention name(s): Ferrous sulfate 325mg; Ferumoxytol
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Oral tablets supplied for home use; Ferumoxytol will be administered in two infusions, one week apart
Intervention MeSH terms: Ferrosoferric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: None (Open Label)
Primary purpose: Treatment
Multiple Ascending Doses of Globalagliatin Hydrochloride in Type 2 Diabetes Mellitus
Condition: Hyperglycaemia (Diabetic); Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I placebo-controlled study to assess safety, tolerability, pharmacokinetics
      and pharmacodynamics of Globalagliatin Hydrochloride (SY-004) after Multiple Ascending Doses
      in patients with Type 2 Diabetes Mellitus (T2DM).
    

Detailed description: 
      Glucokinase is a characteristic hexokinase isoenzyme in hepatocytes that catalyzes the first
      step in glucose metabolism. In addition to its role in glucose metabolism, glucokinase is
      expressed in pancreatic islet beta cells where it acts as a "glucose sensor" for insulin
      release. Activation of glucokinase increases the glucose sensitivity of insulin secretion,
      effectively lowering the glucose threshold for insulin secretion. Because of its potential to
      enhance insulin secretion and affect hepatic glucose metabolism, is being investigated for
      use as a treatment for hyperglycaemia, Globalagliatin( the active ingredient in SY-004
      capsule) is being investigated for use as a treatment for T2DM patients. This is a phase I
      placebo-controlled study to assess safety, tolerability, pharmacokinetics and
      pharmacodynamics of Globalagliatin Hydrochloride (SY-004) after Multiple Ascending Doses in
      patients with Type 2 Diabetes Mellitus.
    

Intervention name(s): Globalagliatin Hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): once daily, oral; once daily, oral
Other intervention name(s): SY-004
Intervention MeSH terms: Globalagliatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Glucokinase Activator
Ability of Late Sodium or Calcium Current Block to Balance the ECG Effects of Potassium Current Block
Condition: Drug-induced QT Prolongation; Pharmacokinetics; Pharmacodynamics
MeSH terms: Long QT Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this research study is to test the hypothesis that late sodium
      current blocking drugs (mexiletine or lidocaine) can attenuate the effect of hERG potassium
      channel blocking drugs (dofetilide) on ventricular repolarization (QTc) by shortening early
      repolarization (J-Tpeakc). The secondary object is to assess the ability of calcium channel
      block (diltiazem) to reduce the QTc prolongation associated with hERG block (moxifloxacin).
    

Detailed description: 
      This is a randomized, double-blind, 5-period crossover study in healthy male and female
      subjects, 18 to 35 years of age, to compare the electrophysiological response of hERG
      potassium channel blocking drugs with and without the addition of late sodium or calcium
      channel blocking drugs. The 5 treatment periods are 1) dofetilide alone, 2) mexiletine with
      and without dofetilide, 3) lidocaine with and without dofetilide, 4) moxifloxacin with and
      without diltiazem and 5) placebo. During each treatment period, 12 blood samples for
      pharmacokinetic measurements are obtained with matched 12-lead ECG recordings.
    

Intervention name(s): Dofetilide; Mexiletine; Lidocaine; Moxifloxacin; Diltiazem; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 8 am: Placebo
12 pm (noon): 250 µg
5:30 pm: 250 µg; 8 am: weight x 4 mg/kg
12 pm (noon): Same as at 8 am
5:30 pm: Same as at 8 am; 9 am : 30 µg/min per kg (loading) for 60 minutes and 10 µg/min per kg (maintenance) for 30 minutes
2 pm: 55 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes
7:30 pm: 52 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes; 9 am: 5.63 mg/h per kg (loading) for 1 hour and 0.26 mg/h per kg (maintenance for 30 minutes)
2 pm: 6.14 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes)
7:30 pm: 2.23 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes); • 7:30 pm: 330 µg/h per kg (loading) for 60 minutes and 61 µg/h per kg (maintenance) for 30 minutes; Placebo (#2 Gelcap or IV saline)
Other intervention name(s): Tikosyn; Mexitil; Lidocaine hydrochloride; Avelox; Diltiazem hydrochloride; #2 Gelcaps or IV saline
Intervention MeSH terms: Moxifloxacin; Lidocaine; Mexiletine; Dofetilide; Diltiazem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy
Condition: Idiopathic Membranous Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, Membranous
Study type: Interventional

Summary: 
      The purpose of this study is:

        -  To explore the potential role of tacrolimus in the treatment of membranous nephropathy.

        -  To investigate the safety and tolerability of tacrolimus vs methylprednisolone plus
           cyclophosphamide.
    

Detailed description: 
      Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults.
      Over the past decade, a number of studies have reported therapeutic efficacy for treatment
      with Cyclosporine-A (CSA) in patients with nephrotic syndrome including patients with
      membranous nephropathy. This study will evaluate the safety and effectiveness of a new
      calcineurin immunosuppressive drug, tacrolimus (FK506), in reducing the amount of protein in
      the urine in patients with membranous nephropathy. Forty patients with biopsy-proven
      membranous nephropathy will be recruited. Candidates must have completed at least six month
      of treatment with a stable dose of angiotensin converting enzyme (ACE) inhibitors or
      angiotensin receptor blockers (ARBs). They will be screened with a medical history, physical
      examination, blood tests, and an examination for infection, cancers, and other conditions
      that can cause membranous nephropathy. The investigators plan to conduct an open-label study
      of the efficacy and safety of tacrolimus in the treatment of membranous nephropathy. They
      will be treated with oral tacrolimus for 6 months, followed by 6 months of maintenance.
      Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour
      urinary protein excretion to less than 0.4 mg/day. This study will explore the potential role
      of tacrolimus in the treatment of membranous nephropathy, which is usually resistant to
      conventional therapy.
    

Intervention name(s): Tacrolimus
Intervention type(s): Drug
Intervention description(s): FK506,0.1mg/kg/d
Other intervention name(s): Tacrolimus,Prograf
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Idiopathic Membranous Nephropathy; Treatment; Tacrolimus; Cyclophosphamide