bioihbjkbjnl/mcl2 huggingface dataset:
A Study Assessing the Tolerable Upper Intake Level and Safety of Sugars From Fiber
Condition: Gastrointestinal Tolerance
Study type: Interventional

Summary: 
      The purpose of this study is to determine the upper tolerable limit of Sugars from Fiber
    


Intervention name(s): Sugars from Fiber; Resistant Maltodextrin
Intervention type(s): Other; Other
Intervention description(s): Proprietary blend of Sugars from Fiber baked into 50 g flapjack; Resistant Maltodextrin baked into 50 g flapjack
Other intervention name(s): SFF; RM
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Open Label, Sequential Dosing , Single Ascending Dose and Multiple Dose Safety Tolerability and Pharmacokinetic Study
Condition: Metastatic Breast Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial is to learn the comparative pharmacokinetic parameters
      between the test product and the Reference listed drug in healthy female volunteers

      The main question[s] it aims to answer are:

        -  To assess the sequential dose exposure safety and tolerability of KSHN001034 injection
           in healthy female subjects after single ascending doses from 25 mg to 500 mg and
           multiple doses of maximum tolerable dose from single ascending dose

        -  To assess dose showing comparative bioavailability of KSHN001034 injection in comparison
           with Faslodex®.
    

Detailed description: 
      Single ascending dose (SAD) of four cohorts (01, 02, 03, and 04) for the test product (25,
      100, 250, and 500 mg, respectively).

      Subjects who will participate in cohort no. 01 (N= 18 subjects) will be randomized to receive
      a single dose of the test product 25 mg (N= 10 subjects) or a single dose of the reference
      product 500 mg (N= 08 subjects). The randomization ratio will be 5:4 for T: R Study Part II:
      Multiple doses of three treatment arms will be administered in one cohort (N= 32, parallel
      design).

      • Two treatment arms of the test product: T1: the dose lower than maximum tolerated dose
      (MTD-1) determined in Study Part I, N=12 subjects.

      T2: maximum tolerated dose determined in Study Part I, N=12 subjects.

      • One treatment arm of the reference product: R: 500 mg, N= 08 subjects The randomization
      ratio will be 3:3:2 for T1:T2: R]
    

Intervention name(s): Fulvestrant injection
Intervention type(s): Drug
Intervention description(s): phosphate ester of fulvestrant for test arm
Other intervention name(s): faslodex
Intervention MeSH terms: Fulvestrant
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: open label, sequential dosing , single ascending dose and multiple dose pharmacokinetic , safety , tolerability study
Masking: None (Open Label)
Primary purpose: Treatment
Chlorhydrate of Ropivacaine and Breast Cancer Surgery
Condition: Breast Neoplasms; Pain,Postoperative
MeSH terms: Breast Neoplasms; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study is to evaluate the effect of local anesthetic (chlorhydrate of
      ropivacaine) to prevent chronic pain after breast surgery for cancer.
    

Detailed description: 
      An estimated 20-65% of women treated with breast surgery for breast cancer experience chronic
      pain in the treated breast. Patients will be randomize between: infiltration with
      chlorhydrate of ropivacaine at the time of breast surgery for cancer versus
      placebo.Intra-operative analgesia will be standardized as well as peri-operative pain
      management.
    

Intervention name(s): Chlorhydrate de Ropivacaine; placebo
Intervention type(s): Drug; Other
Intervention description(s): The Ropivacaïne group received 3mg/kg of 0.375% ropivacaïne(0.75% ropivacaïne, Astra, mixed with saline); The PCB group received saline solution in equal volume.
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Female; Anesthetics,local
High Risk Screening Breast MR Using a Rapid Imaging Exam
Condition: Breast Cancer
Study type: Observational

Summary: 
      This study is being done to find out if breast cancer detection will be improved using a
      short MRI (magnetic resonance imaging) scan, in addition to mammography, in patients who are
      at an increased risk of developing breast cancer.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        breast clinic patients
A Phase 2 Study of Brivanib in Chinese Patients With Previously Treated Advanced HCC
Condition: Hepatocellular Carcinoma (HCC)
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, Open-label, Randomized, Multicenter Study to Investigate the Efficacy,
      Safety, and Pharmacokinetics of Brivanib in Patients with Previously Treated Advanced
      Hepatocellular Carcinoma.
    


Intervention name(s): Brivanib 800 mg, QD; Brivanib 400 mg, BID
Intervention type(s): Drug; Drug
Intervention description(s): Brivanib Alaninate 800 mg QD, PO; Brivanib Alaninate 400 mg BID, PO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular Carcinoma; HCC; Brivanib
Intraperitoneal Ropivacaine Nebulization for Pain Control After Laparoscopic Surgery
Condition: Laparoscopic Cholecystectomy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess if intraperitoneal nebulization of Ropivacaine 50 mg,
      100 mg or 150 mg may prevent the use of morphine during the first day after laparoscopic
      cholecystectomy.
    

Detailed description: 
      Intraperitoneal aerosolization of Bupivacaine 50 mg after laparoscopic cholecystectomy has
      been proved to significantly reduce postoperative pain, morphine consumption and incidence of
      postoperative nausea and vomiting in comparison with patients receiving direct instillation
      of Bupivacaine 50 mg or placebo.

      Ropivacaine can be effectively administrated with non-heating nebulizers (AeronebPro®). In a
      recent study our group found that nebulization of Ropivacaine 30 mg with the AeronebPro®
      before or after laparoscopic cholecystectomy significantly reduced postoperative pain and
      morphine consumption. Nonetheless, most patients still need strong opioid based analgesia
      after surgery.

      We hypothesize that intraperitoneal nebulization of Ropivacaine 100 mg and 150 mg (maximum
      recommended dose in adults 300 mg or up to 3 mg/kg) may prevent the use of morphine during
      the first day after surgery maintaining ropivacaine plasma levels below toxic concentration.
    

Intervention name(s): Ropivacaine 50 mg; Ropivacaine 100 mg; Ropivacaine 150 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Preoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity; Preoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity; Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity
Other intervention name(s): Nebulization; Ropivacaine; Nebulization; Ropivacaine; Nebulization; Ropivacaine
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laparoscopic Cholecystectomy; Nebulization; Ropivacaine
Detection and Cytotoxic T Lymphocyte Therapy of Post-Transplant Lymphoproliferative Disorder After Liver Transplant
Condition: Liver Disease; Lymphoproliferative Disorders
MeSH terms: Liver Diseases; Lymphoproliferative Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      Despite advances in medical and gene therapy, orthotopic liver transplantation remains the
      only definitive therapeutic option for children with end-stage liver disease. Recent advances
      in pre-, intra-, and early post-transplant care have resulted in a dramatic improvement in
      survival of the pediatric liver transplant patient. The broad long-range goal of our research
      program is directed at enhancing the patient's long-term survival. Our primary focus relates
      to obligate life-long immunosuppression, with its inherent complications including severe
      infection and development of cancer. These two complications come together in a single
      disease, Epstein-Barr Virus (EBV)- associated post-transplant lymphoproliferative disorder
      (PTLD). EBV, a latent human lymphotrophic herpes virus infects and immortalizes B cells.
      Primary infection usually occurs via salivary exchange and results in a mild, self-limited
      illness followed by life-long EBV-specific T cell controlled EBV latency. T cell-based
      immunosuppression prevents allograft rejection, however, it also suppresses cytotoxic T
      lymphocyte (CTL) function, generating an environment in which EBV-infected cells can
      proliferate. Patients receiving life-long T cell-based immunosuppression have an increased
      risk of developing PTLD due to their inability to produce normal immunoregulatory responses.
      This disease is particularly devastating to the pediatric patient as its incidence is at
      least 4-fold greater than in the adult liver transplant patient population. In fact, PTLD is
      the number one cause of death following pediatric liver transplantation. At this time, there
      is no definitive method of prospectively detecting, diagnosing, or treating PTLD, and current
      treatment protocols place the liver allograft and patient at risk. Therefore, a diagnostic
      tool that is both sensitive and specific, and a treatment strategy with low toxicity are
      greatly needed to decrease the morbidity and mortality suffered by the pediatric liver
      transplant patient with PTLD. Our proposed studies will support our hypothesis that the
      combination of a persistently elevated EBV load in the setting of a diminished immune
      response to EBV will be an early risk indicator associated with PTLD development, and that
      pre-emptive treatment utilizing autologous adoptive EBV-specific CTL immunotherapy will
      provide a low toxicity treatment option.
    


Intervention name(s): EBV-specific autologous CTL
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PTLD; CTL Therapy; Post-transplant lymphoproliferative disorder
Inhibiting Dietary Iron Absorption in Subjects With Hereditary Hemochromatosis by a Natural Polyphenol Supplement
Condition: Iron Metabolism Disorders; Iron Overload; Polyphenols
MeSH terms: Hemochromatosis; Metabolic Diseases; Iron Overload; Hemosiderosis; Iron Metabolism Disorders
Study type: Interventional

Summary: 
      Polyphenolic compounds are very strong Inhibitors of non-heme iron absorption, as they form
      insoluble complexes with ferrous iron. Patients with hereditary hemochromatosis (HH) have an
      increased intestinal non-heme iron absorption due to a genetic mutation in the regulatory
      pathway, leading to excess iron in the body. This study investigates the inhibitory effect of
      a natural polyphenol Supplement in participants with HH.
    


Intervention name(s): meal matrix & NPPS; meal matrix & CS; no-matrix & NPPS; no-matrix & CS
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Test meal consumed with the natural polyphenol supplement; Test meal consumed with the control supplement; Test drink consumed with the natural polyphenol supplement; Test drink consumed with the control supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
The Effect of Mindfulness on Psychophysiological Stress in a Population With Elevated Stress Symptoms
Condition: Psychological Stress; Physiological Stress
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      Stress-related disorders have over the last decade increased and contributed to a worldwide
      disease burden. At the same time there is limited treatment access for mental health
      disorders, which has left many people without necessary care. However, in recent years there
      has been a rise in digital mindfulness interventions. Specifically, these interventions have
      focused on smartphone-based applications as an effective format for mindfulness training
      programs. Thus, the goal of this randomized controlled trial is to test the effects of three
      types of mindfulness programs in a population with elevated stress. The three formats of
      mindfulness interventions are identical in total training duration but varies in content and
      intervention length. Specifically, the first intervention consists of programmatic
      mindfulness content that progress over the course of 30 sessions with a duration of 10 min
      per session. The second intervention consists of single succinct breathing exercises with no
      programmatic content over the course of 30 sessions with a duration of 10 min per session.
      The third intervention consists of mindfulness-based content specifically targeted to people
      with elevated stress that progress over the course of 20 sessions with a duration of 15 min
      per session. An active control group listening to an audiobook over the course of 30 sessions
      with a duration of 10 min per session will be employed and a passive control group.

      The study will evaluate outcomes related to subjective stress, sleep quality, mindfulness and
      physiological effects of stress using HRV.
    


Intervention name(s): Headspace Basics Program; Headspace Breathing Exercises; Headspace Stress Program; Active Control (Audiobook)
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): 30-day smartphone-based mindfulness intervention consisting of 10 minutes per day. The program consist of generic mindfulness techniques such as breath awareness, body scans, mindful noting of thoughts and emotions.; 30-day smartphone-based breathing exercises. Each exercise consists of box breathing for 1 minute and participants are instructed to complete 10 sessions corresponding to 10 minutes per day.; 20-day smartphone-based mindfulness intervention consisting of 15 minutes per day. The Stress program content is based on well-established concepts and practices within stress management, and mindfulness, and is targeted to people with elevated stress.; 30-day smartphone-based Audiobook book consisting of 10 minutes per day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Stress; Mindfulness; HRV
The Efficacy and Safety of Oral Oxcarbazepine 300-1200 mg/Day as Adjuvant Therapy in the Treatment of Adolescents With Impulsivity and Aggressive Behavior in Conduct Disorder This Study is Not Being Conducted in the United States.
Condition: Conduct Disorder
MeSH terms: Aggression; Impulsive Behavior; Conduct Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      Conduct disorder is a group of psychiatric symptoms that can include clinical characteristics
      of impulsivity and aggressive behavior. This study will investigate the efficacy a safety of
      oxcarbazepine in the treatment of adolescents with conduct disorder.
    


Intervention name(s): Oxcarbazepine
Intervention type(s): Drug
Intervention MeSH terms: Oxcarbazepine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Oxcarbazepine, conduct disorder, adolescents
Pilot Study of Stellate Ganglion Injection to Provide Relief From Hot Flushes
Condition: Hot Flashes; Menopause
MeSH terms: Hot Flashes
Study type: Interventional

Summary: 
      This study is being done to determine whether stellate ganglion injection with local
      anesthetic (the study procedure) can reduce the number and severity of hot flashes in women
      who have hot flashes.

      Hot flashes can have a significant impact on daily living, disrupt sleep, and lead to fatigue
      and irritability during the day. Hot flashes are the most common reason that women seek
      hormonal therapy. However, for many women, including breast cancer survivors, this is rarely
      an option, and these women seek alternatives to hormonal therapy to treat hot flashes.

      The study procedure has been in clinical use for more than fifty years in treating certain
      disease states and chronic pain. The study procedure has not been used to relieve hot flashes
      and the use of the study procedure with local anesthetic for the reduction of hot flushes is
      considered experimental.
    


Intervention name(s): Sympathetic nerve block with 1% lidocaine 1-2 ml; Superficial subcutaneous injection
Intervention type(s): Procedure; Procedure
Intervention description(s): Stellate Ganglion Injection; Superficial subcutaneous injection with saline
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Hot flushes (vasomotor symptoms)
Nitrate and Hypertension in Heart Transplanted Patients
Condition: Hypertension; Heart Transplantation
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of the study was to evaluate the acute effect of nitroglycerine infusion on blood
      pressure and heart rate in heart-transplanted patients with cyclosporine-induced
      hypertension.
    

Detailed description: 
      Background: Cyclosporine represents a milestone in immunosuppression after organ
      transplantation. Its use, however, comes at the cost of significant side effects, such as
      arterial hypertension. Our aim was to investigate the effect of acute administration of
      nitroglycerin in heart-transplanted patients with cyclosporine-induced hypertension.

      Methods: We included 18 hypertensive patients (HT) scheduled for elective cardiac
      catheterization after heart transplantation and treated with cyclosporine, as well as
      6-matched HT. Simultaneous measurements of BP in the aorta and pulmonary artery before and
      after administration of nitroglycerin were done.

      Results: After injection of 50μg and 100μg nitroglycerin a significant BP decrease was
      observed both in heart-transplanted patients (sBP p=0.0001; dBP p=0.0001) and in controls
      (sBP p=0.006; dBP p=0.05). This reduction was more pronounced in heart-transplanted patients
      (sBP p=0.022; dBP 0.018 for group comparison). 8±3 minutes after the last nitrate infusion BP
      remained significantly reduced vs baseline in heart-transplanted patients (p<0.001) while it
      comes back to baseline in controls. The reduction in sBP (p=0.04 after 50μg nitroglycerin;
      p=0.05 after 100μg nitroglycerin) but not dBP correlated to cyclosporinemia.

      Conclusions: This study indicates that nitroglycerin reduces sBP in heart-transplanted
      patients with cyclosporine-induced hypertension. Further studies are needed to evaluate the
      long-term effect of nitrates in these patients.
    

Intervention name(s): acute infusion of nitroglycerine into the pulmonary artery
Intervention type(s): Drug
Intervention MeSH terms: Nitroglycerin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: heart transplantation; cyclosporine; hypertension; nitroglycerin
Pharmacokinetics and Safety Study of PT010 and PT003 in Healthy Chinese Adult Subjects
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the pharmacokinetics and safety of two doses of PT010 and a single dose of
      PT003 in healthy Chinese adult subjects
    

Detailed description: 
      A Phase I, Randomized, Double-Blind, Parallel Group, Study to Assess the Pharmacokinetics and
      Safety of Two Doses of PT010 and a Single Dose of PT003 in Healthy Chinese Adult Subjects
      Following a Single Administration and After Chronic Administration for 7 Days
    

Intervention name(s): PT010 (BGF MDI) 320/14.4/9.6 µg; PT010 (BGF MDI) 160/14.4/9.6 µg; PT003 (GFF MDI) 14.4/9.6 µg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.; A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.; A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.
Other intervention name(s): Budesonide, Glycopyrronium, Formoterol Metered Dose Inhaler; Budesonide, Glycopyrronium, Formoterol Metered Dose Inhaler; Glycopyrronium and Formoterol Fumurate Metered Dose Inhaler
Intervention MeSH terms: Budesonide; Glycopyrrolate; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Patient Satisfaction With the Cancer Clinical Trial Experience
Condition: Cancer
Study type: Observational

Summary: 
      The primary objective of this study is to evaluate the quality of the clinical trial
      experience of cancer patients participating in cancer research studies through Summa Health
      System Hospitals Cancer Research Program by evaluating patient satisfaction regarding reasons
      for participating, facility, consent and treatment, personal issues and overall assessment.

      The secondary objective of this study is to determine areas for improvement to make the
      patient's clinical trial experience a satisfying and positive journey.
    


Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participant must have participated in a clinical trial conducted by the Summa Health System
        Hospitals Cancer Research Program.
      
Keywords: Participant must have participated in a clinical trial conducted by the Summa Health System Hospitals Cancer Research Program.; Participant should have been registered for clinical trial participation three months prior to receiving the satisfaction survey.