bioihbjkbjnl/mcl2 huggingface dataset:
Imatinib Treatment in Recent Onset Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type I; Diabetes Mellitus, Insulin-Dependent, 1; Type 1 Diabetes Mellitus; Insulin-Dependent Diabetes Mellitus 1; IDDM
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      Type 1 diabetes mellitus (T1DM) results from the autoimmune destruction of insulin-producing
      ß cells. Although exogenous insulin is widely available, it is not possible for affected
      individuals to consistently achieve euglycemia with current technology, and thus they are at
      risk for devastating long-term complications. This phase II study is designed to evaluate the
      safety and efficacy of imatinib mesylate as a novel therapy for new-onset T1DM. Imatinib is a
      first-in-class tyrosine kinase inhibitor.

      This study will explore the potential role of short-term therapy with imatinib to induce
      tolerance and possibly lead to a durable long-term remission of T1DM.
    

Detailed description: 
      Eligible participants will be randomized to receive either imatinib mesylate or placebo
      daily.

      All participants randomized into this study will be seen at a study site for a follow-up
      evaluation, 2 weeks and 4 weeks after randomization, and every month month thereafter for the
      first year. Participants will come in for a visit ever 6 months for the second year.

      At the study visits, participants will undergo assessments of their insulin production,
      immunologic status, and overall health. Subjects will be followed until the conclusion of the
      study. The trial is expected to last approximately 2-4 years or until the required amount of
      information is gathered.
    

Intervention name(s): Imatinib Mesylate; Placebo (For imatinib mesylate)
Intervention type(s): Drug; Drug
Other intervention name(s): GLEEVEC; Glivec
Intervention MeSH terms: Imatinib Mesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pharmacodynamics of Injection of Cisatracurium Base on Lean Body Mass Pattern to Maintain Deep Neuromuscular Blockade in Obese Patients
Condition: Obese Patients; Laparoscopic Colorectal Surgery
MeSH terms: Obesity
Study type: Interventional

Summary: 
      To observe the pharmacodynamics of intravenous injection of cisatracurium to maintain deep
      neuromuscular blockade in obese patients with lean body mass in laparoscopic colorectal
      surgery
    

Detailed description: 
      According to the random number table method, one hundred and twenty patients who underwent
      elective laparoscopic colorectal surgery were divided into four groups (n=30): Normal weight
      patients according to lean body weight group(NL group), normal weight patients according to
      real weight group (NR group), obese patients according to lean body weight group(OL group),
      and obese patients according to real weight group(OR group).Intraoperative deep neuromuscular
      blockade (PTC≤2)was maintained in all four groups.The dosage of cisatracurium, the number of
      injections,time to effect,time to recovery from TOFr,time to recover TOFr（train-of-four rate）
      to 0.7 and 0.9,and time to stay in PCAU were recorded.The surgeon's satisfaction with the
      operative field and the average intraoperative pneumoperitoneum pressure were recorded at the
      time of pneumoperitoneum establishment,1 hour and 2 hours after pneumoperitoneum
      establishment.
    

Intervention name(s): base on Lean Body Mass Pattern; base on Actual Body Weight; obese patients; normal patients
Intervention type(s): Behavioral; Behavioral; Genetic; Genetic
Intervention description(s): PTC(post-tetanic count) was measured every 6min during the operation, and single injection of 0.05 (1ED95) mg/kg cisatracurium that was calculated based on lean body weight mass pattern once when PTC > 2.; PTC was measured every 6min during the operation, and single injection of 0.05 (1ED95) mg/kg cisatracurium that was calculated based on actual body weight once when PTC > 2.; obese patients with elective laparoscopic colorectal surgery were selected，and the inclusion criteria were as follows: age 18-65, body mass index (BMI) 30-35, waist circumference (WC) : female ≥80cm, male ≥90cm, and American Society of Anesthesiologists (ASA) grade Ⅰ ~ Ⅲ.; normal patients with elective laparoscopic colorectal surgery whose body mass index (BMI) 18-24 were selected,and American Society of Anesthesiologists (ASA) grade Ⅰ ~ Ⅲ.
Other intervention name(s): general anesthesia; base on Actual Body Mass Pattern; laparoscopic colorectal surgery; laparoscopic colorectal surgery
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Laparoscopy; Cisatracurium; Obesity; Neuromuscular Blockade; Pneumoperitoneum; Pharmacology
Pharmacodynamic/Pharmacokinetic Interactions Between Oral Roflumilast and Inhaled Formoterol
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I, open, randomized controlled, multiple-dose, parallel-group study investigated
      the potential pharmacodynamic and pharmacokinetic interactions between multiple doses of oral
      roflumilast and inhaled formoterol. Healthy male subjects were assigned to treatment A or
      treatment B. Subjects in treatment A received 500 μg/d roflumilast from day 2 to day 18 and
      48 μg/d formoterol from day 12 to day 18. Subjects in treatment B received 48 μg/d formoterol
      from day 2 to day 18 and 500 μg/d roflumilast from day 9 to day 18. Impedance cardiography,
      ECG, serum potassium and glucose concentrations and effects on blood eosinophils assessed
      potential pharmacodynamic interactions. In addition, the safety and tolerability were
      evaluated. Pharmacokinetic parameters were assessed for roflumilast, roflumilast N-oxide, and
      formoterol.
    


Intervention name(s): Roflumilast; Roflumilast
Intervention type(s): Drug; Drug
Intervention description(s): Treatment A (500 μg/d roflumilast from day 2 to day 18 and 48 μg/d formoterol from day 12 to day 18); Treatment B (48 μg/d formoterol from day 2 to day 18 and 500 μg/d roflumilast from day 9 to day 18)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug interactions; Pharmacodynamic interactions; Pharmacokinetic interactions; Formoterol; Healthy subjects; Phase I study; Roflumilast
Breast Study to Learn More About the Application of Optical Transillumination Measurements to Assess Breast Cancer Risk and to Potentially Detect the Presence of Breast Cancer.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This study aims to evaluate if a light based technique, called Transillumination Breast
      Spectroscopy (TIBS), can be used to construct a non-invasive breast cancer risk predictor
      which provides a better odds ratio than mammographic parenchymal density.
    

Detailed description: 
      In a previous cross sectional study in a group of women without breast cancer and with
      varying degrees of parenchymal density patterns, a strong association was demonstrated
      between Transillumination Breast Spectroscopy (TIBS) and x-ray derived mammographic density.
      From this, we expect that TIBS should also provide a comparable odds ratio (4-6) as
      mammographic density for breast cancer risk shown in other independent epidemiological
      studies. It is possible that TIBS may provide complementary information and a higher odds
      ratio if compared to the incidence of breast cancer. In contrast to mammography derived
      parenchymal density pattern, no historical TIBS data is available for a retrospective
      analysis and hence a cross sectional study within a group of screened women is proposed. We
      hypothesize that TIBS provides physical information about the breast tissue which can be used
      to construct a breast cancer risk predictor with an odd ratio > 6.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Cases and controls recruited from the Breast Imaging Clinic at Princess Margaret Hospital
        or the Marvelle Koffler Centre at Mount Sinai Hospital (Toronto, Ontario, Canada)
      
Keywords: Breast Cancer Risk; Optical Transillumination Spectroscopy; Transillumination Breast Spectroscopy
Development of a Space Exploration Assessment for Children With Spinal Muscular Atrophy
Condition: Spinal Muscular Atrophy; Assessment, Self
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Interventional

Summary: 
      The aim of this randomized study is to develop a new motor assessment of space exploration in
      a 2D environment with upper limbs for children with spinal muscular atrophy 1 and 2 from 3
      until 16 years old.
    

Detailed description: 
      Thirty children are included in the prospective randomized study. They are evaluated with the
      new test, Space Exploration Test (TES), and with the Motor Function Measure (MFM), a gold
      standard scale. The objective is to compare the results and to demonstrate the
      complementarity of the two tools.
    

Intervention name(s): Motor assessment
Intervention type(s): Other
Intervention description(s): An occupational therapist install the patient sitting in front of the test board and tell him the instructions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Spinal Muscular Atrophy; Children; Motor assessment; Space exploration; Upper limbs
Antimicrobial Activity of IV Clear™ Dressing - Prevention of Antimicrobial Regrowth
Condition: Skin Flora Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the surface cutaneous antimicrobial activity of IV
      Clear™ Dressing, Tegaderm CHG™ Dressing and a Silicone Vehicle Control Dressing.
    

Detailed description: 
      A single center, within-subject randomized study design in healthy adult subjects with a
      history of high bacteria counts on their upper back, meeting the inclusion criteria.

      Antimicrobial efficacy will be measured by determining the mean number of Colony Forming
      Units (CFUs) per square centimetre (cm²) of skin prior to treatment (baseline measurement),
      following preparation with 70% isopropyl alcohol, and following post treatment samples.

      The goal of this study is to demonstrate that IV Clear™ is as effective as or better than
      Tegaderm™ CHG dressing in preventing regrowth of cutaneous microbial flora on test subjects.
    

Intervention name(s): IV Clear™ Dressing; Tegaderm CHG™; Silicone Vehicle Control Dressing
Intervention type(s): Device; Device; Device
Intervention description(s): Polyurethane film, silicone adhesive dressing with chlorhexidine and silver; Polyurethane film, polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate; Polyurethane film with silicone adhesive dressing, without antimicrobials
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Evaluation of the Anti-aging Efficacy of a Novel Skin Health Product
Condition: Skin Aging
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effect of cosmetic products with two different
      concentrations of the active on skin aging and in acting on the mitochondrial health of skin
      in comparison to a placebo product.
    


Intervention name(s): Topical Placebo Cream; Topical Cream with 0.5% Active; Topical Cream with 1% Active
Intervention type(s): Other; Other; Other
Intervention description(s): cosmetic cream to be applied topically on face and forearms twice/daily using split/face design; cosmetic cream to be applied topically on face and forearms twice/daily using split/face design; cosmetic cream to be applied topically on face and forearms twice/daily using split/face design
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split face/arm design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Mitochondria, Aging
Aprepitant Effects in Intravenous Heroin Dependence
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders; Heroin Dependence
Study type: Interventional
Phase: Phase 1

Summary: 
      Current treatments for opioid addiction would benefit by the addition of a non-opioid based
      treatment medication. Recent behavioral studies have shown that the neurokinin-1 (NK1)
      receptor is involved in opioid reward and withdrawal. This study proposes to study a
      potential non-opioid treatment, the clinically available, FDA approved, NK1 antagonist
      aprepitant, in opioid addicted patients. Based on the unique behavioral and pharmacological
      characteristics of opioid addiction, and what is known of the currently employed treatments,
      the investigators propose that the therapeutic mechanism of any potential opioid addiction
      treatment medication must include the ability to reduce opioid withdrawal. This is of
      particular importance during treatment initiation (eg. detoxification). In addition, for
      long-term treatment and relapse prevention, it is important to manage drug craving and
      inhibit the rewarding effects of opioids if patients do experience a slip. Therefore, the
      investigators propose to study aprepitant using human models of opioid withdrawal, craving
      and acute opioid reward and reinforcement. The investigators will also include a
      neuro-economics choice procedure paradigm.
    


Intervention name(s): Aprepitant; Placebo pill
Intervention type(s): Drug; Drug
Intervention description(s): Aprepitant 125 mg oral tablets; Placebo oral pill- inactive compound
Other intervention name(s): Brand name: Emend
Intervention MeSH terms: Aprepitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Aprepitant; Intravenous heroin dependence
Influence of Sevoflurane and Propofol on Maximum Muscular Strength, Speed of Contraction and Relaxation
Condition: Anesthesia, General; Neuromuscular Transmission Disorders
MeSH terms: Neuromuscular Junction Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      Many drugs have an influence on neuromuscular transmission. In clinical practice,
      neuromuscular blocking agents are commonly used, but even in the absence of neuromuscular
      blocking agents, anesthetic drugs can influence neuromuscular transmission. Especially
      volatile anesthetic agents have a clinical impact on neuromuscular transmission, they have
      been shown to prolong and deepen the effect of neuromuscular blocking agents. But even in the
      absence of neuromuscular blocking agents, volatile anesthetics can impair neuromuscular
      transmission. One mechanism of action is the desensitization of the acetylcholine receptors
      by shifting them from a normal to a desensitized state. This effect can weaken neuromuscular
      transmission by reducing the margin of safety that normally exists at the neuromuscular
      junction, or can cause an apparent increase in the capacity of neuromuscular blocking agents
      to block transmission.

      In this study, the influence of sevoflurane and propofol on the maximum force, maximum speed
      of contraction and relaxation will be measured at the adductor pollicis in patients having
      general anesthesia without the use of neuromuscular blocking agents. Maximum force and speed
      of contraction and relaxation will be measured before and after anesthesia by either
      sevoflurane or propofol. Primary outcome is the influence of either anesthetic agent on
      maximum muscular force and speed of contraction - relaxation, and if this influence is
      greater for volatile anesthetic agents than for intravenous anesthetic agents.
    


Intervention name(s): Sevoflurane; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): Anesthesia will be maintained by sevoflurane.; Anesthesia will be maintained by propofol.
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effects of Playing Video Games on Energy Balance
Condition: Obesity
Study type: Interventional

Summary: 
      The aim of this study is to examine the effects of playing video games on various components
      of energy balance and substrate metabolism as well as on glucose homeostasis and relevant
      hormonal systems that might be involved in the underlying mechanisms.
    


Intervention name(s): 1-hour video game play
Intervention type(s): Other
Intervention description(s): FIFA 2009, a football video game played on Xbox 360
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Video games; Energy balance; Metabolism; Appetite control
Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status
Condition: Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a non-randomized, open-label study to assess olaparib tablets as a treatment for
      subjects with different homologous recombination deficiency (HRD) tumor status and with
      platinum-sensitive, relapsed, high-grade serous or high-grade endometrioid ovarian cancer.
      Subjects should have received at least 1 prior line of platinum-based chemotherapy.
    

Detailed description: 
      This is a Phase II, open-label, non-randomized, multi-center study assessing the efficacy and
      safety of olaparib tablets 300 mg (two 150 mg tablets) given orally twice daily (bid) in
      subjects with platinum-sensitive or partially platinum-sensitive, relapsed, high-grade serous
      or high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer,
      who have received at least 1 prior line of platinum-based chemotherapy.

      The study will assess the effectiveness of olaparib tablets as measured by the objective
      response rate (ORR) as determined by Response Evaluation Criteria in Solid Tumors (RECIST)
      v1.1, in subjects with germline BRCA mutations (gBRCAm), somatic BRCA mutations (sBRCAm), or
      potential aberrations in homologous recombination deficiency (HRD) as determined by myChoice®
      HRD, as well as in subjects without identifiable HRD. This study will utilize Myriad
      BRACAnalysis CDx® for germline BRCA analysis and a tumor test (myChoice® HRD) for tumor BRCA
      analysis and HRD status. Four cohorts will be identified based upon the genetic testing
      described above:

        -  Cohort 1: gBRCAm,

        -  Cohort 2: sBRCAm and germline BRCA wild type,

        -  Cohort 3: myChoice® HRD positive (genomic instability positive) and BRCA wild type
           (BRCAwt) (no BRCA mutation),

        -  Cohort 4: myChoice® HRD negative (genomic instability negative) and BRCAwt (no BRCA
           mutation).
    

Intervention name(s): OLAPARIB
Intervention type(s): Drug
Intervention description(s): 300 mg olaparib tablets taken orally twice daily
Intervention MeSH terms: Olaparib
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BRCA, ovarian, platinum, chemotherapy
Evaluation of Intestinal Vascolarization With Indocianine Green Angiography During Rectal Resection or Left Colectomy
Condition: Rectal Disease; Sigmoid Disease
MeSH terms: Rectal Diseases; Sigmoid Diseases
Study type: Interventional

Summary: 
      A randomized controlled multicenter trial on the usefulness of intraoperative angiography
      with indocyanine green to assess anastomosis perfusion in patients who undergo laparoscopic
      rectal resection or left colectomy.
    

Detailed description: 
      Anastomotic leakage after colorectal surgery is a severe complication. One possible cause of
      anastomotic leakage is insufficient vascular supply. The aim of this study is to evaluate the
      usefulness of intraoperative assessment of vascular anastomotic perfusion in laparoscopic
      colorectal surgery using indocyanine green (ICG)-enhanced fluorescence, in order to assess if
      the information of the ICG angiography could lead to change the site of resection and
      improving the anastomotic leak rate. Two-hundred and eight patients, undergoing rectal
      resection or left colectomy, for benign or malignant disease, with high vessels ligation,
      will be randomized intro 2 arms: ICH angiography (colonic perfusion is intraoperatively assed
      with ICG angiography and level of resection is selected based on the fluorescence) and
      Control (resection is performed with subjective judgment). The rate of postoperative leak in
      the two groups will be recorded.
    

Intervention name(s): ICG- angiography; No angiography
Intervention type(s): Procedure; Procedure
Intervention description(s): Angiography with ICG prior to and after anastomosis. Extension of colon resection based on ICG angiography results; Extension of resection based on subjective measures
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention