bioihbjkbjnl/mcl2 huggingface dataset:
AT9283 in Children and Adolescents With Relapsed and Refractory Solid Tumors
Condition: Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: AT9283 may stop the growth of tumor cells by blocking some of the enzymes needed
      for cell growth.

      PURPOSE: This phase I trial is studying the side effects and best dose of AT9283 in children
      and adolescents with relapsed and refractory solid tumors.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To evaluate the safety and tolerability of Aurora kinase inhibitor AT9283 by
           characterizing the dose-limiting toxicities in children and adolescents with relapsed
           and refractory solid tumors.

        -  To determine the maximum-tolerated dose of this regimen in these patients.

      Secondary

        -  To determine the pharmacokinetic parameters of this regimen in these patients.

        -  To demonstrate the pharmacodynamic (PD) activity of this regimen in these patients by
           studying its effects in surrogate tissue.

        -  To assess preliminary evidence of activity of this regimen by using appropriate
           objective tumor measurements in these patients.

      Tertiary

        -  To demonstrate the PD activity of this regimen in these patients by studying its effects
           in both surrogate and tumor tissue (skin punch, bone marrow, and tumor biopsies).

      OUTLINE: This is a multicenter, dose-escalation study.

      Patients receive Aurora kinase inhibitor AT9283 IV over 72 hours on days 1-3. Treatment
      repeats every 21 days for up to 6 courses in the absence of disease progression or
      unacceptable toxicity.If a patient is benefiting from treatment with AT9283 (i.e. has stable
      or responding disease as measured by RECIST) and the benefit risk balance is considered
      acceptable then further treatment may be given.

      Blood and skin tissue samples are collected at baseline and periodically during treatment for
      pharmacokinetic studies and pharmacodynamic and biomarker (M30, M65, pHH53, p53, PCNA and
      Ki67) analysis by IHC and ELISA assays.

      After completion of study therapy, patients are followed up periodically.

      Peer Reviewed and Funded or Endorsed by Cancer Research UK.
    

Intervention name(s): multikinase inhibitor AT9283; enzyme-linked immunosorbent assay; immunohistochemistry staining method; laboratory biomarker analysis; pharmacological study
Intervention type(s): Drug; Other; Other; Other; Other
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified childhood solid tumor, protocol specific
Fourth-generation Immucillin Derivative DI4G Associated Therapy in Cutaneous Leishmaniasis
Condition: Leishmaniasis; Leishmaniasis, Cutaneous; Leishmaniasis; American
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      A clinical trial to asses efficacy and safety of Transition-state Analog Inhibitor of Human
      Purine Nucleoside Phosphorylase for topical use associated standard antimonial in the
      treatment of Cutaneous Leishmaniasis in Bahia, Brazil.
    

Detailed description: 
      The treatment of cutaneous leishmaniasis caused by L. braziliensis in Brazil with pentavalent
      antimony is associated with a high rate of failure, reaching up to 45% of cases.
      Additionally, pentavalent antimony is only administered by parenteral route with important
      toxicity and ulcer lesion healing takes a long time, from 2 to 3 months.

      So, this randomized and controlled clinical trial was designed to compare the efficacy and
      safety of standard antimonial (20mg/day /kg for 20 days) associated with Transition-state
      Analog Inhibitor of Human Purine Nucleoside Phosphorylase for topical use versus standard
      antimonial (20mg/kg/day for 20 days) associated with placebo for topical use in the treatment
      of Cutaneous Leishmaniasis and Early Cutaneous Leishmaniasis caused by L. braziliensis in the
      endemic area of Corte de Pedra, Bahia, Brazil.
    

Intervention name(s): Immucillin DI4G; Meglumine antimoniate
Intervention type(s): Drug; Drug
Intervention description(s): Immucillin DI4G was administered by topical use at 2% concentration once a day for 20 days associated with Meglumine antimoniate administered by intravenous route at a dosage of 20mg/kg/day, during 20 days.; Placebo for topical use once a day at the ulcer for 20 days associated with Meglumine antimoniate administered as the standard treatment for cutaneous leishmaniasis by intravenous route at a dosage of 20mg/kg/day, during 20 days.
Other intervention name(s): Fourth-generation Immucillin Derivative; Glucantime
Intervention MeSH terms: Meglumine Antimoniate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Meglumine antimoniate; L.Braziliensis; Immunotherapy; Immucillin
Heartbeat Sensitivity Calibration Using the ECG Accessory
Condition: ECG Comparisons in Normal Healthy Subject
Study type: Observational

Summary: 
      This is an observational, un-blinded, non-significant risk, non-interventional study designed
      to collect ECG data on at least one subject out of a pool of up to three (3) healthy male
      subjects at one clinical site (Clinical Trials of Texas). Cyberonics will be collecting ECG
      recordings collected by an investigational device for comparison with conventional ECG
      recordings. This data will be used to validate a new device under development.
    

Detailed description: 
      This is an observational, un-blinded, non-significant risk, non-interventional study designed
      to collect ECG data on at least one subject out of a pool of up to three (3) healthy male
      subjects at one clinical site (Clinical Trials of Texas). If acceptable data is acquired from
      one (1) subject the remaining subjects will not be entered into the study. Three (3) to six
      (6) researchers will record data, but all direct contact with the subject will be done by the
      study coordinator or principal investigator (PI).

      The purpose of this study is to validate a Heartbeat Sensitivity calibration process
      utilizing the Cyberonics ECG Accessory. The non-invasive, passive collection of ECG signals
      from a resting healthy subject will be used to validate the use of the ECG Accessory with the
      Model 201 Programming Wand, Model 250 VNS Programming Software Version 9.0, Model 106
      Generator, and ECG monitor (DRE True ECG-12), as well as the associated Instructions for Use.
      The data generated from this exercise will be used in future clinical trials utilizing this
      device.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Normal Healthy male
An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption
Condition: Cystic Fibrosis; Steatorrhea
MeSH terms: Cystic Fibrosis; Malabsorption Syndromes; Steatorrhea; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of PANCREASE MT
      (pancrelipase microtablets) to improve steatorrhea (excessive excretion of fat in feces) in
      infants and toddlers with cystic fibrosis who have pancreatic insufficiency, and to assess
      whether the consistency of the microtablets is acceptable for swallowing in infants and
      toddlers
    

Detailed description: 
      The objective of this randomized, Investigator-blinded, parallel group, multicenter, pilot
      study is to evaluate the preliminary safety, palatability and effectiveness of pancrelipase
      microtablets to improve fat absorption. The hypothesis is that PANCREASE MT will provide
      effective, safe and palatable pancreatic enzyme supplementation to be used for the treatment
      of fat malabsorption in a cohort of infants with cystic fibrosis-related pancreatic
      insufficiency. On Day 1 of the study, parents will be instructed to administer 500 units
      lipase/kg/meal for a full five days. Stool will be collected and analyzed during the last 72
      hours of this baseline period. On Day 6 of the study, subjects will be randomly assigned to
      one of four treatment groups. Parents will be instructed to administer the appropriate dose
      for a full five days and stool will be collected and analyzed during the last 72 hours of
      this randomized treatment period. Patients will receive PANCREASE MT 500 units lipase/kg/meal
      by mouth for a maximum of five doses per day for the first 120 hours. Patients will receive
      PANCREASE MT 500, 1000, 1500 or 2000 units lipase/kg/meal by mouth, for a maximum of five
      meals per day for the next 120 hours.
    

Intervention name(s): Pancrelipase microtablets
Intervention type(s): Drug
Intervention MeSH terms: Pancrelipase; Pancreatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Cystic fibrosis; Pancreatic insufficiency; Steatorrhea; Fat malabsorption; Pancrelipase
Hearing Aid Quality and Reliability Study
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Quality and reliability study of hearing aid. Adults with mild to severe hearing loss will
      wear hearing aids daily for approximately 3 months.
    


Intervention name(s): Phonak Audeo hearing aid
Intervention type(s): Device
Intervention description(s): Rechargeable hearing aid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Sitagliptin (REMIT-Sita)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine whether in patients with early type 2 diabetes,a
      short-term intensive metabolic intervention comprising of sitagliptin, metformin, basal
      insulin glargine and lifestyle approaches will be superior to standard diabetes therapy in
      achieving sustained diabetes remission.
    

Detailed description: 
      This is a multicentre, open-label, randomized controlled trial in 100 patients with
      recently-diagnosed T2DM. Participants will be randomized to 2 treatment groups: (a) a 12-week
      course of treatment with sitagliptin, metformin, insulin glargine and lifestyle therapy, or
      (b) standard diabetes therapy, and followed for a total of 64 weeks (1 year and 3 months). In
      all participants with HbA1C < 7.3% at the 12 week visit, glucose-lowering medications will be
      discontinued and participants will be encouraged to continue with lifestyle modifications and
      regular glucose monitoring. Participants with HbA1C ≥ 7.3% at this visit or who meet criteria
      for hyperglycemic relapse after stopping drugs will receive standard glycemic management as
      informed by the current Canadian Diabetes Association clinical practice guidelines
    

Intervention name(s): insulin glargine; sitagliptin/metformin; lifestyle therapy
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Dose is titrated to achieve fasting normoglycemia; Dose is titrated to 50/1000 mg bid or maximal tolerated dose; Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
Other intervention name(s): Lantus; Janumet; diet and exercise
Intervention MeSH terms: Metformin; Insulin Glargine; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Insulin; Glargine; Metformin; Sitagliptin; Diet; Excercise; Lifestyle
Human Urinary Biomarker for Orange Juice Consumption
Condition: Healthy
Study type: Interventional

Summary: 
      Human urinary metabolic profiling showed to be very successful to elucidate biomarkers linked
      to geographic origin and specific food consumption patterns (Holmes and Loo et al.: Human
      metabolic phenotype diversity and its association with diet and blood pressure. Nature
      2008:1-6). It was possible to identify urinary metabolites directly linked to animal vs.
      vegetable protein intake. This is very valuable for future population studies, where diet is
      an important lifestyle factor but food questionnaires are time-consuming and expensive.
      Moreover, miss-reporting is a very common problem.

      Our hypothesis is to find the same biochemical marker for orange juice as we already found in
      a preceding nutritional studies where participants recorded orange consumption.
    

Detailed description: 
      To elucidate the citrus fruit biomarker it needs to be ensured that all volunteers do not
      consume citrus fruits and foods potentially containing similar ingredients. Therefore it is
      necessary to ask volunteers to refrain from these foods by giving them dietary restrictions.
      Extensive literature research showed that some foods (such as grain legumes and brie cheese)
      may contain the same compound, but in much smaller amounts.

      Days 1-3 will be on open diet but with dietary restrictions (no alcohol, cheese, fruits,
      ethnic foods such as Chinese and Indian food, grain legumes such as beans, lentils, peas and
      peanuts, and all kinds of sprouts (such as cress or alfalfa)). On day 2 a glass of orange
      juice (200ml) will be consumed in addition to the open diet. Urine collection will continue
      and stop on day 4 at 10 am.

      During the study to minimise variation in biomarker excretion due to other beverages the
      participants beverage intake will be restricted to water and coffee.

      All urine samples will then be analysed using high resolution NMR spectroscopy and mass
      spectrometry. Mathematical data analyses as well as the visual examinations of the NMR
      spectra will also be carried out to validate the presence of citrus fruit biomarkers.
    

Intervention name(s): orange juice
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Cutaneous DNA Damage Caused by UV-A Irradiation
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The DIMUVA study aims to evaluate the correlation between cutaneous phototype and the nature
      and quantity of damage caused to cutaneous DNA after exposure to UV-A radiation.
    

Detailed description: 
      Due to their capacity to damage Deoxyribonucleic acid (DNA), Ultra-Violet (UV) radiation is
      one of the causes of skin cancers.

      Until recently, the genotoxic effects of UV-A radiation, were poorly identified, in
      particular their capacity to lead to the dimerization of pyrimidine bases .

      It is well known that the response to UV-A and UV-B radiations is different depending on the
      cutaneous phototype.

      Thus, the aim of this study is to determine the correlation between cutaneous phototype and
      the quantity and nature (CPD or oxidative lesions) of damage caused to cutaneous DNA after an
      ex-vivo exposure to UV-A and UV-B radiations.
    

Intervention name(s): UVA and UVB irradiation
Intervention type(s): Radiation
Intervention description(s): 4 cutaneous biopsies for Ex-vivo irradiation
Determination of the minimal erythemic dose of UVA and UVB for each volunteer
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: UV-A irradiation; Cyclobutane-Pyrimidine Dimer; Oxidative lesions; cutaneous phototype; UV-B irradiation; DNA damages
Study to Assess Safety and Clinical Activity of Local MBN-101 in Treatment of Infected Bone Sites
Condition: Bacterial Infection
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the safety and clinical benefit of MBN-101 administered intraoperatively
      to osteosynthesis or osteomyelitis sites for patients diagnosed with an orthopedic infection,
      with or without orthopaedic hardware. Three quarters of the patients will receive MBN-101,
      while the other one quarter will receive placebo.
    

Detailed description: 
      Postoperative orthopaedic infections, particularly antibiotic-resistant infections, present a
      serious clinical challenge to surgeons and other treating physicians. These infections
      frequently involve implanted foreign materials (stabilizing orthopaedic hardware), making
      infection of these sites much more likely than if foreign materials were not involved.
      MBN-101 has broad spectrum antimicrobial activity against orthopaedic wound pathogens.

      This is a randomized, single-blind, placebo-controlled, multi-center study to assess the
      safety and tolerability of escalating doses of MBN-101 to treat orthopaedic infections during
      revision surgery, (a) with or without orthopaedic hardware, and (b) with or without removal
      and replacement of orthopaedic hardware.
    

Intervention name(s): MBN-101; Placebo
Intervention type(s): Drug; Other
Intervention description(s): MBN-101 is a locally administered, anti-infective drug product; The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient
Other intervention name(s): MBN-101 Drug Product; Diluent; Vehicle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Osteosynthesis; Complications; Infection or Inflammation; Orthopedic; Device; Fracture; Osteomyelitis
Study to Determine Tolerability After Intravenous Administration of BIBN 4096 BS in Healthy Male and Female Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the present study is to obtain information about the safety, tolerability
      and pharmacokinetics of BIBN 4096 BS after single intravenous administration of increasing
      doses in healthy male and female volunteers
    


Intervention name(s): BIBN 4096 BS - in single rising doses; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olcegepant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Feasibility of Kanasina Gulabi, a Pilot Peer Support Intervention for Young Adults With Type 2 Diabetes in Mysore District, South India
Condition: Type 2 Diabetes; Quality of Life; Depression; Stigma, Social; Behavior, Health
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate a pilot peer support intervention, entitled
      "Kanasina Gulabi" (Translation "My Dream Rose" in Kannada), designed to improve quality of
      life and diabetes management among young adults living with type 2 diabetes. The
      intervention, delivered by non-specialist providers - trained young adult peer navigators who
      are also managing type 2 diabetes - is expected to improve physical and mental health
      outcomes among participants. The sample includes young adults aged 18-40 with a diagnosis of
      type 2 diabetes in Mysore district, South India. Participants were quasi-randomly allocated
      to the intervention or control group. With the support of their peer navigators, intervention
      participants will develop action plans to improve their physical and mental health outcomes.
      This study plans to assess the feasibility, acceptability, and preliminary effectiveness of
      the intervention.
    


Intervention name(s): Kanasina Gulabi
Intervention type(s): Behavioral
Intervention description(s): Kanasina Gulabi is a theory-driven, educational-behavioral intervention designed to improve the quality of life and diabetes management among young adults living with type 2 diabetes in Mysore district, South India. In this intervention, young adults with type 2 diabetes were matched to non-specialist peer navigators -- trained young adult peers who were also managing type 2 diabetes -- and developed action plans to improve their physical and mental health outcomes. Intervention components included group education, mindfulness activities, self care activity tracking, and phone follow-ups to address knowledge gaps and misinformation about type 2 diabetes, build self-efficacy for type 2 diabetes-related self care activities, and provide emotional support for diabetes management.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a Hybrid Type 2 Effectiveness-Implementation Trial of a pilot, 2-arm, parallel-group, quasi-randomized trial.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Young Adult; India
Using Peer Mentors to Support PACT Team Efforts to Improve Diabetes Control
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to test the effectiveness of a peer mentor model in a mixed race
      population of poorly controlled diabetic Veterans. Also, the study aims to assess the effects
      of becoming a mentor on those who originally were mentees. It is expected that participants
      in the peer mentoring arms (Arm 2 and 3) will have improved glucose control regardless of
      race or ethnicity at the end of the intervention.
    

Detailed description: 
      The primary objectives of this study are: (1) test the long-term effectiveness of a peer
      mentor model on improving glucose control, blood pressure, LDL levels, diabetes mellitus
      quality of life, and depression scores in a mixed race population of poorly controlled
      diabetic Veterans; (2) test the effectiveness of using former peer mentees as peer mentors as
      a means of creating a self-sustaining program; and (3) and test the effects of becoming a
      mentor on those who were originally mentees given a growing literature that being a mentor is
      good for your health. Secondary objectives include: (1) in those randomized to being a
      mentee, explore mentor characteristics associated with improved HbA1c.

      This study will be a prospective randomized controlled trial. Outcomes to be measured include
      glycosylated hemoglobin, blood pressure, direct LDL, diabetes quality of life and depression.

      The trial has two phases. In phase one, patients with poorly controlled diabetes are
      randomized to usual care or receiving peer mentoring. In phase two, poorly controlled
      diabetics are randomized to usual care or receiving peer mentoring from former mentees.
      Former mentees from phase 1 are also randomized such that they will have a 50% chance of
      becoming a mentor.
    

Intervention name(s): Peer Mentoring
Intervention type(s): Behavioral
Intervention description(s): Patients will receive peer mentoring.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Mentors; Glucose control; Hemoglobin A, Glycosylated; Randomized Controlled Trial; Veterans