bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the Effectiveness of Piscean Derived Collagen Dressing on Neuropathic Diabetic Foot Ulcer in T2DM Patients
Condition: Diabetic Foot Ulcer Neuropathic; Diabetic Foot Ulcer
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional

Summary: 
      Diabetic foot ulcers (DFU) are challenging to treat with complicated healing processes and
      require advanced wound care. Piscean collagen has the potential to promote the regenerative
      process while remaining cost-effective and with minimal side effects. In this study, the
      efficacy of a piscean collagen matrix dressing was compared with a standard dressing of
      saline-moistened gauze for wound healing in patients with neuropathic DFU.

      This is a double-blinded, randomised clinical trial.
    

Detailed description: 
      Diabetic foot ulcers (DFU) are challenging to treat with complicated healing processes and
      require advanced wound care. Piscean collagen has the potential to promote the regenerative
      process while remaining cost-effective and with minimal side effects. In this study, the
      efficacy of a piscean collagen matrix dressing was compared with a standard dressing of
      saline-moistened gauze for wound healing in patients with neuropathic DFU.

      This is a double-blinded, randomised clinical trial. After conventional therapy consisting of
      debridement, infection control and offloading, patients were randomly allocated to receive
      either a piscean matrix dressing (the study group) or a saline-moistened gauze dressing
      (control group) for wound care. The reduction in DFU size and the number of patients with
      complete healing were measured throughout the treatment and in follow-up.
    

Intervention name(s): Piscean collagen dressing; Saline infused dressing
Intervention type(s): Device; Device
Intervention description(s): Piscean collagen dressing; Saline infused dressing
Other intervention name(s): Dressing
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blinded, randomized control trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
"Fermented Dairy Beverage on Inflammation/Immune Function in Stressful Exercise"
Condition: Healthy Subjects
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of this pilot study is to determine the effects of a Single and Double Dose of
      Fermented Dairy Beverage on immune health and inflammatory status in healthy adults
      undergoing stressful exercise.
    

Detailed description: 
      This is a "pilot" study. A total of 45 male subjects will be randomized to receive either
      Active product (in 2 doses) or placebo. This is a single-blind design (subjects are unaware
      of product type they are receiving). Randomization is in a 1:1:1 ratio for active test
      product (in different doses) versus placebo. Products will consume the beverages for a 10-day
      period. The subjects will be subjected to a defined strenuous exercise protocol on Days 1 and
      10 of the study. Blood will be collected on the exercise days (pre- and post-exercise) on
      Days 1 and 10.

      Blood will be analyzed for markers of Immunity and Inflammation, to assess the
      immuno-supportive and anti-inflammatory properties of the Active product. Product acceptance
      and tolerability will also be assessed using a VAS scale.

      Outcome analysis will be based upon changes over time (from time-point 0) for within group
      changes as well as between group differences. That is, study will examine differences in
      end-points from baseline to end-of-study; as well as differences among the three groups.
    

Intervention name(s): Placebo comparator; Single Active dose; Double Active dose
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects consume 2 placebo beverages daily for 10 days. The dose-response controls for volume consumed.; Subjects consume 1 placebo + 1 Active beverages daily for 10 days. The dose-response controls for volume consumed.; Subjects consume 2 Active beverages daily for 10 days. The dose-response controls for volume consumed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy adults; three groups: Placebo, vs Single-Dose and Double Dose of Fermented Dairy Beverage consumed for 10 days. Subjected to stressful exercise at beginning and end of study. Primary outcomes: immune/inflammatory markers. Assess changes in treatment vs placebo.
Masking: Single (Investigator)
Primary purpose: Basic Science
The Influence of Thiopurine Methyltransferase Activity on Toxicity After High-dose Methotrexate in Childhood Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      The purpose of this study is to explore the impact of thiopurine methyltransferase (TPMT)
      activity on the risk of HDM-related bone marrow- and hepatotoxicity and treatment
      interruptions during maintenance therapy for children with ALL.

      Hypothesis of the study: Patients with TPMT activity compatible with TPMT low activity
      polymorphisms have an increased risk of toxicity following high-dose methotrexate (HDM)
      compared to children with normal TPMT activity.
    

Detailed description: 
      High-dose methotrexate (HDM) given concurrently with oral 6-mercaptopurine (6MP) may be
      followed by myelotoxicity, which may necessitate treatment interruption and thus interfere
      with the efficacy of the treatment of childhood ALL. Several studies have indicated that MTX
      and 6MP act synergistically. It has previously been reported that the risk of significant
      bone-marrow suppression is increased if oral 6MP is coadministered with HDM during
      maintenance therapy and that reductions of the dose of concurrently given oral 6MP can reduce
      the risk of significant myelotoxicity following HDM. MTX may increase the bioavailability of
      6MP through inhibition of xanthine oxidase, which catabolizes 6MP. In addition, MTX may
      through inhibition of de novo purine synthesis enhance the availability of 6-thioguanine
      nucleotides (6TGN) that primarily exert the cytotoxic effect of 6MP.

      The enzyme TPMT competes with the formation of 6TGN, as it methylates 6MP and thus create
      relatively non-toxic metabolites. TPMT heterozygous patients with one wild type and one
      low-activity allele have a higher risk of myelosuppression and treatment interruption
      compared to patients with TPMT wild type. Furthermore, TPMT heterozygous patients have a
      reduced risk of relapse and a higher risk of secondary malignancy compared to patients with
      TPMT wild type.

      Little has been published on the influence of both TPMT activity and 6MP dosage on myelo- and
      hepatotoxicity following HDM.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The study cohort was based on patients enrolled in the NOPHO ALL92 protocol, where 97% of
        all eligible patients were included.

        Participation in this study was on the basis of TPMT status that was randomly missing.
      
Biospecimen description: 
      whole blood stored for a subset of patients
    
Keywords: acute lymphoblastic leukemia; child; 6-mercaptopurine; methotrexate
Study of CYD Dengue Vaccine in Healthy Children and Adolescents in South America
Condition: Dengue; Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to generate immunogenicity and safety data in preparation for
      efficacy studies in Latin America.

      Primary Objectives:

        -  To describe the immune response to dengue viruses before and after each vaccination with
           CYD dengue vaccine.

        -  To evaluate the safety of each vaccination with CYD dengue vaccine.
    

Detailed description: 
      Participants in the Dengue Vaccine Group will receive 3 vaccinations with CYD Dengue vaccine.
      Participants in the Control Group will receive placebo vaccinations for the first 2
      vaccinations, followed by tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis
      vaccine adsorbed (ADACEL®) (in Venezuela) or Meningococcal A+C vaccine (in Brazil) as a way
      of providing therapeutic benefit to the participants in the control group.
    

Intervention name(s): Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus; NaCl 0.9%; Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed; Meningococcal A+C vaccine
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous (SC); 0.5 mL, Subcutaneous; 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): CYD Dengue Vaccine; ADACEL®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue; Dengue hemorrhagic fever; CYD Dengue Vaccines
Two Dose Levels of DFN-15 vs. Placebo in Patients With Migraine Headaches
Condition: Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      Crossover study of DFN-15 dose A versus DFN-15 dose B versus Placebo in the treatment of
      migraine headaches.
    


Intervention name(s): DFN-15 Dose A (treatment A); DFN-15 Dose B (treatment B); Placebo (treatment C)
Intervention type(s): Drug; Drug; Other
Intervention description(s): DFN-15 Dose A administered; DFN-15 Dose B administered; Placebo administered
Other intervention name(s): DFN-15 120 mg; DFN-15 240 mg; Placebo (no active ingredient)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Treatment of N-methyl-D-aspartate (NMDA) Enhancers for Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Hypofunction of N-methyl-D-aspartate (NMDA) receptor has been implicated in the
      pathophysiology of schizophrenia. To date, several reported trials on adjuvant NMDA-enhancing
      agents, including glycine and sarcosine (a glycine transporter I inhibitor), demonstrated
      clinical benefits for schizophrenia patients. This project aims to compare the efficacy and
      safety of sarcosine and combination of sarcosine and BE, as adjunctive therapy for
      schizophrenia, and to explore the possible synergistic effects of them. Sixty chronic
      schizophrenic inpatients will be enrolled in the 12-week double-blind, placebo-controlled
      trial. The participants receive stable antipsychotic regimens concomitant with sarcosine (2
      g/d) (N=21), sarcosine(2 g/d) + BE(1 g/d ) (N=21), and placebo(N=21). Measures of clinical
      efficacy and side-effects were determined every 3 weeks. Measures of cognitive function were
      determined at the beginning and the end of the study. The efficacies of three groups are
      compared, and the characteristics of better responders are analyzed.
    

Detailed description: 
      We will measure clinical efficacy every 3 weeks during the treatment. At the beginning and
      the end of the trial,We will utilize a battery of tests to assess the effect of the treatment
      on cognitive functions.The side effect assessments are also performed every 3 weeks. Side
      effect assessments include Simpson-Angus Rating Scale for extrapyramidal side-effects,
      Abnormal Involuntary Movement Scale (AIMS) for dyskinesia, and Barnes Akathisia Scale.
      Systemic side effects are reviewed by applying the Udvalg for Kliniske Undersogelser (UKU)
      Side-effects Rating Scale. DAAO level, routine laboratory tests, including CBC, biochemistry
      , urine analysis, and EKG, will be checked at baseline and the end of week 12.

      To compare the metabolic syndrome parameters among groups, body mass index, hip size, waist
      size, blood pressure, fasting blood sugar, triglyceride, and total-cholesterol will be
      checked at baseline and the end of the study.
    

Intervention name(s): sarcosine; sarcosine+ BE; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): sarcosine, 2 g/d , oral, for 12 weeks; sarcosine(2 g/d) + BE (1 g/d ), oral, for 12 weeks; placebo,oral, for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; cognitive function; N-methyl-D-aspartate receptor
A Study Investigating the Safety, Absorption and Elimination of GLPG3312, a New Drug in the Treatment of Inflammatory Diseases
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate how safe 2 different formulations
      (immediate-release (IR) and modified-release (MR) tablets) of the new compound GLPG3312 are
      and how well they are tolerated when they are administered to healthy volunteers.
      Immediate-release and modified-release tablets contain the same active ingredient, but the
      modified-release tablet is covered with a protective layer, so it will dissolve in the
      intestines and not in the stomach. GLPG3312 has not been administered to humans before. Next
      to assessing the safety and tolerability, the purpose of this study is to investigate how
      food affects how quickly and to what extent GLPG3312 in a modified release formulation is
      absorbed and eliminated from the body. In addition, the effect of GLPG3312 on the body will
      be investigated by evaluating the effect of GLPG3312 on markers of the immune response.
    


Intervention name(s): GLPG3312 IR; Placebo; GLPG3312 MR; GLPG3312 FE MR; GLPG3312 MR; GLPG3312 MR; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): GLPG3312 IR tablets, up to 4 single ascending oral doses (A, B, C, D).; Placebo tablets; GLPG3312 MR film-coated tablets, up to 4 single ascending oral doses (H, I, J, K).; GLPG3312 MR film-coated tablets, single oral dose (N) on 2 occasions, i.e. in fed state after a high-fat high-calorie breakfast, and in fasted state.; GLPG3312 MR film-coated tablets, up to 2 multiple ascending oral doses (O, P).; GLPG3312 MR optimized film-coated tablets, up to 3 multiple ascending oral doses (Q, R, S).; Placebo optimized tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part 1 (SAD IR), Part 2 (SAD MR) and Part 4 (MAD MR) are randomized, double-blind, placebo-controlled; Part 3 (FE MR) is open-label.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Bladder Training in Radical Prostatectomy
Condition: Urinary Incontinence; Quality of Life; Lower Urinary Tract Symptoms
MeSH terms: Urinary Incontinence; Lower Urinary Tract Symptoms
Study type: Interventional

Summary: 
      Radical prostatectomy is the gold standard in the treatment of patients with localized
      prostate cancer. Urinary incontinence, which is common after surgery, can affect the quality
      of life of men negatively. There are various attempts to prevent and treat urinary symptoms
      after radical prostatectomy.The aim of this study is to evaluate the effect of the structured
      bladder training program on lower urinary tract symptoms and quality of life in patients
      undergoing radical prostatectomy.
    


Intervention name(s): Bladder Training
Intervention type(s): Behavioral
Intervention description(s): Patients in the structured bladder training group were trained on "lifestyle changes (nutrition, fluid management, exercise), pelvic floor muscle exercises and bladder control techniques".
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
GSK1349572 Drug Interaction With Etravirine and Either Darunavir/Ritonavir or Lopinavir/Ritonavir
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, open label, randomized, three period, one-way, two cohort, adaptive crossover
      study to evaluate the effect of darunavir/ritonavir plus etravirine and lopinavir/ritonavir
      plus etravirine on GSK1349572 pharmacokinetics in healthy adult subjects
    

Detailed description: 
      The study is a three period, randomized, open label study. Approximately 18 healthy subjects
      will receive GSK1349572 50mg q24h for 5 days (Treatment A) in Period 1. Subjects will then be
      administered GSK1349572 50mg q24h in combination with either LPV/RTV 400/100 mg q12h and
      etravirine 200mg q12h (Treatment B, n=9) or DRV/RTV 600/100 mg q12h and etravirine 200mg q12h
      (Treatment C, n=9) for 14 days in Period 2 followed by a washout period. GSK1349572 PK data
      will be obtained from Periods 1 and 2 and used to inform decision making on Period 3. If
      GSK1349572 Cτ is reduced by more than 50% in Period 2 compared to Period 1, subjects will
      return to the clinic and receive GSK1349572 50mg q12h in combination with ETV and either
      DRV/RTV or LPV/RTV in Period 3. Safety evaluations and serial PK samples will be collected
      during each treatment period. A follow-up visit will occur 7-14 days after the last dose of
      study drug. All doses of study drugs will be taken following a moderate fat meal.
    

Intervention name(s): Darunavir; Etravirine; Ritonavir; Lopinavir/ritonavir; GSK1349572
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Darunavir 600 mg every 12 hours for 14 days in Periods 2 and 3. Period 3 may not be done. Darunavir is approved by the FDA as an HIV medication in the protease inhibitor class.; Etravirine 200 mg every 12 hours for 14 days in Periods 2 and 3. Period 3 may not be done. Etravirine is approved by the FDA as an HIV medication in the non-nucleoside reuptake inhibitor class.; Ritonavir 100 mg every 12 hours for 14 days in Periods 2 and 3. Period 3 may not be done. Ritonavir is approved by the FDA as an HIV medication in the protease inhibitor class.; Lopinavir 400 mg and ritonavir 100 mg every 12 hours for 14 days in Periods 2 and 3. Period 3 may not be done. Lopinavir/Ritonavir is approved by the FDA as an HIV medication in the protease inhibitor class.; GSK1349572 50 q24h for 5 days in Period 1 and for 14 days in Period 2. GSK1349572 20 mg q12h for 14 days in Period 3 if Period 3 is done. GSK1349572 is an investigational (not approved by the FDA) HIV medication in the integrase inhibitor class.
Other intervention name(s): Prezista; Intelence; Norvir; Kaletra
Intervention MeSH terms: Ritonavir; Lopinavir; Darunavir; Dolutegravir; Etravirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: ritonavir; GSK1349572; integrase; lopinavir; darunavir; etravirine
Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study will be to determine if a once-weekly prophylaxis regimen of
      BeneFIX in subjects with moderately severe to severe Hemophilia B is safe and effective.
    


Intervention name(s): Nonacog alfa; Nonacog alfa
Intervention type(s): Biological; Biological
Intervention description(s): Period 1: During on-demand period, dosing at the discretion of investigator.; Period 2: During the prophylaxis period, 100 IU/kg once weekly
Other intervention name(s): BeneFIX; BeneFIX
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemophilia B; on-demand; prophylaxis; nonacog alfa; BeneFIX; FIX
Adverse Radiation Effects After Gamma Knife Radio Surgery and Hyperbaric Oxygen Therapy
Condition: Cerebral Necrosis
MeSH terms: Necrosis
Study type: Interventional

Summary: 
      Evaluation of clinical improvement and the reduction of edema lesion documented by magnetic
      resonance imaging (MRI) in patients with cerebral radiation necrosis post gamma knife surgery
      (GKS) by treatment with hyperbaric oxygen therapy (HBO)
    

Detailed description: 
      Patients will be recruited on the basis of the presence of cerebral radionecrosis post gamma
      knife surgery, documented by both clinical examination (Rankin Scale) and instrumental
      imaging (MRI). They will be subjected to hyperbaric oxygen therapy HBO, and during treatment
      the patient performs clinical examination (Rankin Scale) for 24 sessions of HBO. Then they
      will have a break of 10-15 days during which also performs the instrumental survey (Magnetic
      Resonance Imaging). If the radionecrosis has regressed they will suspend the treatment
      otherwise continue up to a maximum of 40 treatment sessions of HBO
    

Intervention name(s): hyperbaric oxygen therapy
Intervention type(s): Other
Intervention description(s): hyperbaric oxygen therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperbaric Oxygen Therapy; Gamma Knife Radiosurgery
Extension Study to Assess Safety and Efficacy of Mylan's Insulin Glargine and Lantus® in Type 1 Diabetes Mellitus (T1DM) Patients
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this extension study is to assess the safety and efficacy of Mylan's insulin
      glargine and Lantus® in T1DM patients.
    

Detailed description: 
      This multi-center, open-label, randomized clinical extension study in patients with T1DM will
      assess safety and efficacy of Mylan's insulin glargine and Lantus®.

      Patients with an established diagnosis of T1DM per American Diabetes Association 2014
      criteria who were randomized to the Lantus® treatment arm of the Mylan Glargine 3001 study,
      and who have completed the 52-week treatment period on Lantus® will be eligible to be
      screened for the MYL-1501D-3003 study.
    

Intervention name(s): Mylan's insulin glargine; Lantus®
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium
Condition: Adverse Events; Pharmacokinetic
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate safety and compare the pharmacokinetic parameters from the fixed dose combination
      ABT-143 relative to that from the co-administration of the two monotherapies.
    


Intervention name(s): ABT-143; ABT-335; Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): once daily for 6 days; once daily for six days; Once daily for 6 days
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment