bioihbjkbjnl/mcl2 huggingface dataset:
Topical Interferon Alfa 2b and Mitomycin C in Conjunctival-Corneal Intraepithelial Neoplasia
Condition: Conjunctival Intraepithelial Neoplasia; Corneal Intraepithelial Neoplasia
MeSH terms: Neoplasms; Carcinoma in Situ
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the therapeutic efficacy of interferon alfa 2b and
      topical mitomycin C in patients with diagnosis of conjunctival-corneal intraepithelial
      neoplasia.
    

Detailed description: 
      The corneal and conjunctival intraepithelial neoplasia is the most common malignant tumor of
      the ocular surface. Classic treatment is complete excision with safety margins, however,
      usually the edges are not sharp and difficult clinical differentiation between healthy areas
      that are not; to this treatment has joined him carrying out cryotherapy bedding and borders .
      Despite this treatment the recurrence rate ranges from 9-52 %. Antineoplastic drugs have been
      used either as adjuvant or primary treatment . Among the drugs used the investigators have
      mitomycin C (MMC) and interferon alpha 2b (INFα 2b).

      Controlled clinical trial , single-blind , randomized . Non-probability sampling of
      consecutive cases. Patients will be assigned to treatment with MMC or INFα2b Periodic
      clinical evaluations and photos will be made. Time of resolution, resistance and adverse
      effects will be determined.

      Patients treated with mitomycin will be handled by cycles until resolution of the lesion,
      which according to previous studies is expected between 3 and 6 cycles (between half months
      and 3 months).

      Patients managed with interferon will be treated for a period ranging from one month to 12
      months according to clinical resolution of the lesion. Both groups will be evaluated by at
      least one year after the resolution of the lesion to determine the presence of recurrences.
    

Intervention name(s): Mitomycin C; Interferon Alfa-2b
Intervention type(s): Drug; Drug
Intervention description(s): Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months).; Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences
Other intervention name(s): Mutamycin; Mitomycin; Urifron; Intron A
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Mitomycins; Mitomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Conjunctival-corneal intraepithelial neoplasia; Mitomycin C; Interferon alfa 2b
Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics of ACT-389949
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a prospective, single-center, double-blind, randomized, placebo-controlled, ascending
      single oral dose and food interaction Phase 1 study. It will evaluate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of ascending single oral doses of
      ACT-389949 in healthy male subjects. It will also investigate the effect of food on the
      pharmacokinetics, safety, and tolerability of a single dose of ACT-389949.
    


Intervention name(s): ACT-389949 1 mg; ACT-389949 5 mg; ACT-389949 20 mg; ACT-389949 50 mg; ACT-389949 100 mg; ACT-389949 200 mg; ACT-389949 500 mg; ACT-389949 1000 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: ACT-389949
A Study of BMS-986171 in Healthy People to Assess Safety, to Measure Blood Levels of Drug, and to Find Out What the Drug Does to the Body
Condition: Liver Fibrosis/NASH
MeSH terms: Liver Cirrhosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety, to measure blood levels of drug, and to find
      out what the drug does to the body.
    


Intervention name(s): BMS-986171; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Continuous Positive Airway Pressure (CPAP), Oral Appliance and Physical Exercise in the Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Introduction: It is unclear whether exercise training with or without Continuous Positive
      Airway Pressure (CPAP) and Oral Appliance (OA) is more effective in reducing symptoms of
      Obstructive Sleep Apnea (OSA) than treatment solely with CPAP or OA.

      Objective: In patients with moderate OSA, the investigators will evaluate the effect on the
      subjective and objective measures of sleep, quality of life and mood of different forms of
      treatment: exercise training of 4 months; exercise training of 4 months associated with CPAP
      and OA; treatment with CPAP and treatment with OA.

      Material and Methods: Sixty male patients (25-65 years, sedentary lifestyle, Body Mass Index
      (BMI) < 35kg/m2, Apnea-Hypopnea Index (AHI) between 15-30/h, Epworth sleepiness scale > 9)
      will be divided into three groups: CPAP+exercise group (CE; n=20), OA+exercise group (AE;
      n=20), and Exercise training group (E; n=20). The patients in groups CE and AE will complete
      two months of treatment with CPAP or OA to examine the separate effects of these devices. As
      the patients of the E group did not use the CPAP but will undergo four months of exercise
      training. After this initial step, patients in CE and AE groups will undergo four months of
      exercise training associated with CPAP or OA. The investigators will evaluate the subjective
      sleep parameters (sleep disorders questionnaire, the Epworth Sleepiness Scale, sleep diaries)
      and objective (polysomnography), Short Form Health Survey (SF-36), Questionnaire Profile of
      Mood States (POMS) and anthropometric measurements (neck circumference and body composition),
      the incremental exercise test (ergospirometry) and the one Repetition Maximum test (1RM).
    


Intervention name(s): Continuous Positive Airway Pressure (CPAP); Oral Appliance (OA); Physical Exercise
Intervention type(s): Device; Device; Behavioral
Intervention description(s): Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise; Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise; aerobic and resistance Physical exercise, three times a week, for four months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea; CPAP; Oral appliance; Aerobic exercise; Resistance training
A Trial Investigating the Pharmacokinetic Properties of Insulin Degludec/Insulin Aspart in Healthy Chinese Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Asia. The aim of this trial is to investigate the pharmacokinetic
      (the exposure of the trial drug in the body) properties of insulin degludec/insulin aspart in
      healthy Chinese subjects.
    


Intervention name(s): insulin degludec/insulin aspart
Intervention type(s): Drug
Intervention description(s): A single dose of IDegAsp will be administered subcutaneously (s.c., under the skin).
Intervention MeSH terms: Insulin; Insulin Aspart
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Evaluating Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR) In The Treatment Of Child and Adolescent Outpatients With Major Depressive Disorder
Condition: Depressive Disorder, Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to evaluate the long-term safety and tolerability of
      Desvenlafaxine Succinate Sustained-Release (DVS SR) in child and adolescent outpatients with
      major depressive disorder. A secondary aim is to evaluate the efficacy of DVS SR in the
      treatment of child and adolescent outpatients with major depressive disorder in an
      exploratory manner.
    


Intervention name(s): Desvenlafaxine Succinate Sustained-Release Tablets (DVS SR)
Intervention type(s): Drug
Intervention description(s): tablet
subjects randomly assigned to 10-200 mg/day by age group
6 month treatment period(~182 days)
Intervention MeSH terms: Desvenlafaxine Succinate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MDD; Depression; Pediatrics; Major Depressive Disorder
A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)
Condition: Erythropoietic Protoporphyria
MeSH terms: Protoporphyria, Erythropoietic
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objectives of the study were to evaluate the safety and tolerability of
      afamelanotide by measuring treatment emergent adverse events (AEs) and to determine whether
      afamelanotide can improve the quality of life of EPP patients.
    


Intervention name(s): Afamelanotide
Intervention type(s): Drug
Intervention MeSH terms: Afamelanotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Calcium on Postprandial Lipid Profile and Appetite
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of calcium on postprandial lipid
      profile and appetite.
    

Detailed description: 
      Several reports have found inverse associations between calcium intake and body weight.
      Intervention studies have shown that a high calcium diet resulted in a greater body weight
      loss than a low calcium diet. In addition, it seems that calcium from dairy products have a
      more profound effect than calcium from supplements. The mechanism of this additional dairy
      effect is not yet clear, but one possible explanation could be reduced absorption of fat in
      the gut. The increase in fecal fat excretion on a high calcium diet could be due to the
      formation of calcium-fatty acid soaps in the gut.

      The long term effect of a high calcium intake have been under intense investigation, but as
      far as we know the acute effect of a high calcium intake have not yet been examined. A study
      concerning the acute effects could help us understand the effect of calcium on the absorption
      of fat. After a meal triglyceride (TG) is packaged with cholesterol, lipoproteins and other
      lipids into particles called chylomicrons. Earlier studies have shown that the fatty acid
      pattern of chylomicron lipids postprandial was very similar to that of the ingested fat. If
      we assume that calcium inhibits the absorption of fat, we would expect a reduced total plasma
      triglyceride concentration after a calcium-rich meal.

      Appetite involves many different sensations among which hunger and satiety are the most
      investigated. Several different hormones are involved in the regulation of appetite. Some of
      these hormones are known to respond to the intake or absorption of fat. If the absorption of
      fat is inhibited the regulation of appetite most likely will be affected. In the long term
      this could be important because an increased appetite probably would increase energy intake
      and thereby reducing the weight loss we otherwise might have accomplished by the reduced
      absorption of fat.
    

Intervention name(s): high calcium intake
Intervention type(s): Behavioral
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Obesity; Calcium; Fat absorption; Postprandial lipid profile; appetite
2-Week Study In People With Nonalcoholic Fatty Liver Disease
Condition: Non-alcoholic Steatohepatitis; Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      2-week study in people with nonalcoholic fatty liver disease. Study drug at 1 of 2 doses, or
      placebo, will be given for 14 days. Blood samples, heart monitoring, vital signs, and imaging
      procedures will be performed.
    


Intervention name(s): Placebo; PF-06865571; PF-06865571
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablet, 0 mg, 14 days, every 12 hours; tablet, 50 mg, 14 days, every 12 hours; tablet, 300 mg, 14 days, every 12 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
The Safety and Effectiveness of Two Forms of Saquinavir Combined With Other Anti-HIV Drugs in HIV-Infected Infants and Children
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the pharmacokinetic properties, tolerance and safety of 2 formulations of
      saquinavir, given in combination with 2 nucleoside antiretroviral drugs (part 1) or in
      combination with nelfinavir and nucleoside antiretroviral drugs (part 2), in HIV-infected
      infants and children.
    

Detailed description: 
      This Phase I/II study will be conducted in 2 parts each lasting at least 24 weeks.
      Pharmacokinetics and safety data for part 1, a treatment regimen containing saquinavir and
      nucleoside antiretrovirals, will be collected for 8 weeks before proceeding to part 2. During
      the first 8 weeks, pharmacokinetic data will be analyzed to allow dose adjustments for
      individual patients and to confirm the starting dose estimates for part 2. In addition,
      safety data will be reviewed to ensure that saquinavir is well tolerated with nucleoside
      antiretrovirals before it is combined with a second protease inhibitor. In part 2, saquinavir
      will be combined with nelfinavir, a protease inhibitor recently approved for use in children.
      The pharmacokinetics and safety profile of these drugs in combination will be determined.
    

Intervention name(s): Nelfinavir mesylate; Saquinavir
Intervention type(s): Drug; Drug
Intervention MeSH terms: Nelfinavir; Saquinavir
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Therapy, Combination; HIV Protease Inhibitors; Dosage Forms; Saquinavir; Nelfinavir; Anti-HIV Agents
Study to Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S in Participants With Staphylococcus Aureus Bacteremia Receiving Standard-of-Care (SOC) Antibiotics
Condition: Bacteremia
MeSH terms: Bacteremia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase Ib, randomized double-blind, placebo-controlled multiple-ascending dose study
      to investigate the safety, tolerability, and pharmacokinetics of multiple doses of DSTA4637S
      when given in addition to anti-staphylococcal SOC antibiotics to participants with
      methicillin-resistant staphylococcus aureus (MRSA) and methicillin-sensitive staphylococcus
      aureus (MSSA) bacteremia requiring at least 4 weeks of anti-staphylococcal SOC antibiotics.
    


Intervention name(s): DSTA4637S; Placebo; SOC
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DSTA4637S will be administered as an IV infusion at 3 dose levels.; Placebo matched to DSTA4637S IV infusion will be administered as specified.; Anti-staphylococcal SOC antibiotics dosage and duration of therapy will be based on relevant health-authority approved indications and local and national treatment guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Biologic Joint Replacement Strategy to Treat Patients With Severe Knee Trauma and Post-Traumatic Knee Osteoarthritis
Condition: Post-traumatic Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      With IRB approval and informed consent, patients (n=10) (18-50 years old) with post-traumatic
      knee OA and requiring a tibial plateau and meniscus arthroplasty plus a femoral condyle
      arthroplasty will be enrolled in the study. Primary criteria for inclusion will be Grade IV
      changes in the articular cartilage of the femoral condyle and tibial plateau and meniscal
      pathology in the medial or lateral femorotibial joint as determined by physical examination,
      diagnostic imaging and knee arthroscopy by the PI. Exclusion criteria include Grade III or IV
      changes in any other compartment of the knee, acute injury to any other part of the affected
      lower extremity, or inability to comply with the protocol.

      After enrollment, patients will undergo standardized knee radiography, and complete
      assessments (described below). Size-matched (standard clinical methodology) proximal tibia
      with meniscus and distal femur allografts from the same donor will be obtained from a tissue
      bank (Musculoskeletal Transplant Foundation, Edison, NJ) who has licensed the MOPS
      technology. The medial or lateral femoral condyle will be replaced using our novel
      instrumentation and technique described above. Tibial plateau-meniscus grafts will be trimmed
      and used to replace the entire medial or lateral tibial condyle while sparing the attachments
      of ACL, PCL and respective collateral ligament. The tibial plateau graft will be fixated
      using commercial available implants used for bone fixation. In the event that the meniscus
      has been detached from the tibial plateau during graft harvest, the periphery of the meniscus
      will be sutured to the capsule following standard meniscus transplant procedure.

      Patients will undergo controlled post-operative rehabilitation according to standard
      protocols for osteochondral with concurrent meniscus allografts.

      Range of motion, VAS pain score, SF-12, Tegner score, International Knee Documentation
      Committee (IKDC) subjective and objective scores, PROMIS Bank v1.2 - Physical
      Function-Mobility, PROMIS v1.1 - Global Health, PROMIS Bank v1.1- Pain Interference, PROMIS
      Bank v1.2 - Physical Function and Marx score as well as complete radiographs of the affected
      knee will be obtained prior to surgery and at 6 weeks, 3 months, 6 months, and 12 months
      after surgery to evaluate healing, function and evidence for arthrosis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients (n=10) (18-50 years old) with post-traumatic knee OA and requiring a tibial
        plateau and meniscus arthroplasty plus a femoral condyle arthroplasty
Screw Retained Arch Bar Versus Conventional Erich's Arch Bar in Maxillomandibular Fixation
Condition: Mandibular Fractures
MeSH terms: Mandibular Fractures
Study type: Interventional

Summary: 
      A randomized prospective clinical study to compare screw Retained Arch Bar and Conventional
      Erich's Arch Bar in Maxillomandibular Fixation
    

Detailed description: 
      2) Patients with non-pathological favorable or non-favorable fracture of mandible or maxilla
      that can be treated by MMF when acceptable occlusion can be obtained via bimanual reduction
      will be divided randomly into two equal groups: Group I: 10 patients will receive
      conventional Erich's arch bar. Group II: 10 patients will receive modified screw retained
      arch bar.
    

Intervention name(s): screw retained arch bar; conventional Erich's Arch Bar
Intervention type(s): Procedure; Procedure
Intervention description(s): maxillomandibular fixation with bone screwed arch bar; maxillomandibular fixation with conventional arch bar fixed to the teeth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Aflibercept in Treating Young Patients With Relapsed or Refractory Solid Tumors
Condition: Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial is studying the side effects and best dose of aflibercept in treating
      young patients with relapsed or refractory solid tumors. Aflibercept may stop the growth of
      tumor cells by blocking blood flow to the tumor.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To estimate the maximum tolerated dose (MTD) or recommended phase II dose (RPTD) of
      aflibercept administered intravenously every 14 days in children with relapsed or refractory
      solid tumors.

      II. To estimate the MTD or RPTD of aflibercept administered intravenously every 21 days in
      these patients.

      III. To define and describe the toxicities of intravenous aflibercept administered on a
      14-day and 21-day schedule, respectively.

      IV. To characterize the pharmacokinetics of intravenous aflibercept in these patients.

      SECONDARY OBJECTIVES:

      I. To define, preliminarily, the antitumor activity of intravenous aflibercept within the
      confines of a phase I study.

      OUTLINE: This is a multicenter study.

      PART 1: Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days
      for 2 years in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6
      patients receive aflibercept until the maximum tolerated dose (MTD) is determined.

      PART 2: Patients receive aflibercept as in part 1 at 150% of the MTD determined in part 1.
      Treatment repeats every 21 days for 2 years in the absence of disease progression or
      unacceptable toxicity.

      Blood samples are collected prior to treatment on day 1 of courses 1, 2, and 5 or 6 for
      pharmacokinetic studies.

      After completion of study treatment, patients are followed for at least 30 days.
    

Intervention name(s): ziv-aflibercept
Intervention type(s): Biological
Intervention description(s): Given IV
Other intervention name(s): aflibercept; vascular endothelial growth factor trap; VEGF Trap; Zaltrap
Intervention MeSH terms: Aflibercept; Endothelial Growth Factors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment