bioihbjkbjnl/mcl2 huggingface dataset:
Conditioning Regimen and the Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematologic Malignancies.
Condition: Leukemia; Myelodysplastic Syndrome; Non-Hodgkins Lymphoma; Chronic Myelogenous Leukemia; Hodgkins Lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Hematologic Neoplasms; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The traditional way of doing a donor transplant is to give high doses of chemotherapy and
      radiation before giving the stem cells. However, high doses of chemotherapy and radiation can
      have serious side-effects. The doctors think that the transplant will be safer and more
      likely to be successful with reduced doses of chemotherapy and radiation. The purpose of this
      study is to find out how good a combination of chemotherapy and radiation at reduced doses
      followed by a cord blood transplant are at treating cancer.

      The stem cells chosen for the transplant are from umbilical cord blood. Umbilical cord blood
      is collected from healthy newborn babies and frozen. One cord blood collection is called a
      "cord blood unit." On transplant day, the cord blood will be given through the catheter just
      like a blood transfusion. Transplants done this way have been successful. However, this type
      of transplant is fairly new. Therefore, it is important to study it so the doctors can better
      understand how it works.

      Most blood or bone marrow transplants using donor stem cells are done as part of a study.
      When patients are on a study we test new ways of treating them which we think may be better
      than the old ways. We collect information about the result of this treatment so we can
      understand how well the treatment works. This is so we can learn better ways to treat our
      patients.
    


Intervention name(s): fludarabine, cyclophosphamide, thiotepa, radiation therapy, unrelated donor umbilical cord blood graft
Intervention type(s): Drug
Intervention description(s): Cyclophosphamide 50 mg/kg/dose x 1 IV day -6 (1 dose) Fludarabine 30 mg/m2/dose x 5 IV days -6 to -2 (5 doses) Thiotepa 5 mg/kg/dose x 2 IV days -5 to -4 (2 doses) TBI 200 cGy/dose x 2 days -2 to -1 (2 doses). On transplant day, the cord blood cells will be given through your catheter. The immune suppressing drugs you will receive are called cyclosporine-A (CSA) and mycophenolate mofetil (MMF). These will be started 3 days before the transplant and will be given through your catheter. Later they can be given as tablets.
Intervention MeSH terms: Cyclophosphamide; Thiotepa; Fludarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CYCLOPHOSPHAMIDE (CYTOXAN); CYCLOSPORINE A; FLUDARABINE; G-CSF; MYCOPHENOLATE MOFETIL (MMF); THI0TEPA; UMBILICAL CORD BLOOD (UCB); 08-087
Resistant Starch Blend Gastrointestinal Impact
Condition: Quality of Life; Health, Subjective
Study type: Interventional

Summary: 
      This study aims to test the hypothesis that a unique blend of resistant starches and fiber
      will promote gastrointestinal health, as measured by an increase in short-chain fatty acids
      and improvement in quality of life measures in conjunction with microbial community changes.
      This study specifically evaluates the impact on short-chain fatty acids and gut microbiota
      and the impact on quality of life from a resistant starch blend in healthy adult humans with
      occasional gastrointestinal distress.
    

Detailed description: 
      Low microbial diversity in the intestine correlates with chronic diseases such as
      Inflammatory Bowel diseases, colorectal cancer, obesity, Type 1 and Type 2 diabetes and more.
      The incidence of chronic diseases is greater in the industrialized society consuming a diet
      low in microbiota-accessible-carbohydrates. Thus, research is growing to seek prebiotics,
      which are substrates that host microbes selectively use, providing a health benefit.

      Better-tolerated prebiotics may be desirable, particularly for those avoiding FODMAPs
      (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) due to
      gastrointestinal distress. Additionally, the intestinal microbiome may benefit from a
      diversity of prebiotics that may affect different types of bacteria to contribute to overall
      microbial diversity as well as provide stronger effects on positive outcomes. Resistant
      starch type 2, also called RS2, so named due to its ability to resist digestion in the upper
      gastrointestinal tract, is a candidate prebiotic, growing in popularity for increasing
      beneficial intestinal bacteria and improving gastrointestinal symptoms and reducing glycemic
      responses.

      This study aims to test the hypothesis that a unique blend of resistant starches and fiber
      will promote gastrointestinal health, as measured by an increase in short-chain fatty acids
      and improvement in quality of life measures in conjunction with microbial community changes.
      This study specifically evaluates the impact on short-chain fatty acids and gut microbiota
      and the impact on quality of life from a resistant starch blend in healthy adult humans with
      occasional gastrointestinal distress.
    

Intervention name(s): RS blend; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The intervention is a proprietary resistant starch blend.; The placebo is starch.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Prebiotics; Resistant starch; Gut microbiota; Microbial diversity; Dietary fiber; Short-chain fatty acid; Gastrointestinal symptom; Dose-ramping design; Resistant starch blend; Fecal consistency; Fecal frequency; PROMIS; Microbiome analysis; Virtual; Remote access
Safety of Zostavax Vaccination in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis; Varicella Zoster
MeSH terms: Herpes Zoster; Chickenpox; Varicella Zoster Virus Infection; Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      Herpes Zoster (shingles) is caused by reactivation of latent varicella zoster virus (VZV)
      that usually occurs decades following initial exposure. The risk of developing shingles
      increases with age. Shingles presents as a painful, itchy blistering rash that usually
      involves a single portion of the skin and lasts about 7-10 days. The risk of developing
      shingles increases with age in healthy people, and has been shown in some studies to be
      increased in people with rheumatoid arthritis and other autoimmune diseases.

      Zostavax, a live-attenuated vaccine against the varicella zoster virus, was first approved by
      the FDA for the prevention of Shingles among people 60 years and older, and is now approved
      for use in people aged 50 years and older. Because rheumatoid arthritis and some of the
      medications used to treat rheumatoid arthritis can impair the body's immune system, it is not
      known how much of an immune response can be generated in people with rheumatoid arthritis.

      The goals of this study are to measure the immune response after standard vaccination with
      Zostavax in people with rheumatoid arthritis in comparison to people with healthy immune
      systems. All participants will be 50 years old or older, and subjects with rheumatoid
      arthritis will not be eligible if they are taking certain biologic medications, including TNF
      inhibitors (Etanercept or Adalimumab). Ten healthy subjects and 10 subjects with rheumatoid
      arthritis will all receive a single vaccination with Zostavax, then will be followed for 12
      weeks to assess the immune response and for the development of local rash or other potential
      side effects.
    


Intervention name(s): Zostavax (varicella zoster virus) vaccine
Intervention type(s): Drug
Intervention description(s): Standard vaccination protocol for Zostavax will be utilized. 0.65 ml (19,400 plaque forming units) Zostavax will be administered subcutaneously once at the baseline visit
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot study
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Rheumatoid arthritis; vaccination; immune response; varicella zoster
Gastric pH in Intubated Children - Part Two
Condition: Preoperative Fasting
Study type: Interventional

Summary: 
      Fasting (according to ASA, ESA or institutional guidelines) is an important strategy to
      minimize the risk of regurgitation, vomiting and pulmonary aspiration during general
      anaesthesia; the effect of fasting time for clear fluid on gastric pH in children is goal of
      this study and can be investigated in children undergoing elective procedures in general
      anaesthesia and intubation without inconvenience or additional invasive procedure and hence
      without additional risk

      Hypotheses: Gastric pH is higher in children that drink clear fluids until premedication
      before anaesthesia induction than in those that drink until 2 hours before anaesthesia
      induction
    


Intervention name(s): clear fluid ingestion
Intervention type(s): Procedure
Intervention description(s): drinking of clear fluid in preoperative period
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
A Crossover Study to Evaluate the Safety, Tolerability and Efficacy of XPF-002 in Subjects With Postherpetic Neuralgia (PHN)
Condition: Postherpetic Neuralgia
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to determine if XPF-002 is safe and effective for the treatment
      of pain in subjects with Postherpetic Neuralgia
    


Intervention name(s): XPF-002; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Twice daily application of XPF-002 ointment which contains 8% of the XPF-002 active ingredient; Twice daily application of Placebo ointment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain from Shingles, PHN, Postherpetic Neuralgia
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of JNJ-64991524 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety and tolerability of JNJ-64991524 compared
      with placebo after administration of single ascending oral doses of JNJ-64991524 (Part 1) and
      multiple ascending oral doses of JNJ-64991524 (Part 2) in healthy participants.
    


Intervention name(s): JNJ-64991524 Dose Level 1; JNJ-64991524 Dose Level 2; JNJ-64991524 Dose Level 3; JNJ-64991524 Dose Level 4; JNJ-64991524 Dose Level 5; JNJ-64991524 Dose Level 6; Placebo; JNJ-64991524 Dose Level 7; JNJ-64991524 Dose Level 8; JNJ-64991524 Dose Level 9
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study.; Participants will receive JNJ-64991524 at a Dose Level 2 in SAD Part 1 of study.; Participants will receive JNJ-64991524 at a Dose Level 3 in SAD Part 1 of study.; Participants will receive JNJ-64991524 at a Dose Level 4 in SAD Part 1 of study.; Participants will receive JNJ-64991524 at a dose of Dose Level 5 in SAD Part 1 of study.; Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.; Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.; Participants will receive JNJ-64991524 at a dose of Dose Level 7 in MAD Part 2 of study for 14 days.; Participants will receive JNJ-64991524 at a Dose Level 8 in MAD Part 2 of study for 14 days.; Participants will receive JNJ-64991524 at a Dose Level 9 in MAD Part 2 of study for 14 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Understanding Liver Fat Metabolism: Studies to Understand the Role of Dietary Sugars on Liver Fat Metabolism
Condition: Hypertriglyceridaemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional

Summary: 
      High levels of fatty substances in the blood increase the risk of developing coronary heart
      disease and having a heart attack. The investigators know a lot about one of these fatty
      substances, cholesterol. However, there is another fatty substance in the blood called
      triglyceride. The investigators do not understand much about what regulates the rate at which
      the liver produces triglyceride and liberates it into the bloodstream after eating a meal(s).
      The investigators are developing new techniques to measure these processes in healthy people.
      Ultimately a deeper understanding of the regulation of this process might lead to the
      development of new treatments for fat accumulation in the liver and high blood fat levels and
      related disorders. The present study is an investigation of how these processes relate to
      various bodily characteristics such as thinness and fatness and the distribution of fat in
      the body.
    

Detailed description: 
      The investigators will recruit men and women with no medical condition or relevant drug
      therapy that affects lipid, glucose or liver metabolism.

      Purpose and design:

      The investigators are asking the research question: "How does the amount and type of sugars
      consumed, such as those found in soft drinks, influence postprandial fatty acid and liver fat
      metabolism?"

      It is known that consuming fructose by itself or with glucose can increase plasma
      triglyceride concentrations and liver fat amounts but it remains unclear how this happens.

      To address this research question investigators want to undertake detail physiological
      studies, in a randomised cross-over study where individuals will be studied twice after the
      consumption of a single test meal that will contain different amounts of glucose and fructose
      with the same amount of dietary fat.
    

Intervention name(s): Sugar study
Intervention type(s): Other
Intervention description(s): Subjects are given a single test meal on two study days that has a sugary drink that varies in the amount of fructose and glucose it contains. They consume the same amount of fat on both study days.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: triglycerides; glucose; fructose; fatty acids
Image Guidance for Improved Vessel Cannulation in Pediatric Patients
Condition: Central Vein Cannulation
Study type: Interventional

Summary: 
      Feasibility Study This will be performed by an expert operator in Interventional Radiology
      who routinely performs CVC catheter placement, using appropriate pediatric human anatomy and
      vessel size, as well as real patient care scenarios.
    

Detailed description: 
      Phase I Feasibility Study This will be performed by an expert operator in Interventional
      Radiology who routinely performs CVC catheter placement, using appropriate pediatric human
      anatomy and vessel size, as well as real patient care scenarios. n=5 patients will be
      enrolled, and success would be 4 children (80%) successfully cannulated with a single pass
      using the P-SCENERGY.
    

Intervention name(s): central vein cannulation
Intervention type(s): Device
Intervention description(s): central vein cannulation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Transobturator Urethral Sling Placement With an Autologous Rectus Facia
Condition: Stress Urinary Incontinence; Surgery--Complications
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      The investigators aimed to evaluate outcomes of transobturator urethral sling placement using
      autologous rectus fascia for female stress urinary incontinence at perioperatively and at
      2-year follow-up.
    

Detailed description: 
      Stress urinary incontinence (SUI) is very common condition in middle-aged women, and can
      affect quality of life. Some clinical trials reported that the lifetime risk of a woman
      undergoing surgery for SUI is increase in up to 15%. The midurethral synthetic sling is the
      most common surgery performed for female SUI. This procedure has high efficacy and low
      perioperative morbidity.

      Although many clinical trials have demonstrated that synthetic mid-urethral slings are safe,
      effective and recommended by several guidelines (e.g. Society of Urodynamics, Female Pelvic
      Medicine and Urogenital Reconstruction/American Urogynecologic Society and American Urologic
      Association), the safety and efficacy of surgery for SUI using mesh devices has been
      questioned by a community of patients and clinicians. After Food and Drug Administration
      notification on mesh use in pelvic surgery, many patients and providers begin to search of
      different surgery without synthetic mesh alternatives in SUI. Recently, female patients in
      England formed the campaign group "Sling the Mesh" to protest the synthetic mesh.

      Several options such as the autologous pubovaginal sling, biologic grafts, or urethral
      bulking agent injection have some problems related to morbidity or efficacy. The autologous
      pubovaginal urethral sling is associated with a higher risk of postoperative voiding
      dysfunction.

      The investigators aimed to demonstrate the feasibility of an autologous transobturator
      urethral sling to avoid the related problems of synthetic mesh placement and the increased
      rate of voiding dysfunction with pubovaginal sling placement.
    

Intervention name(s): Mid-urethral sling placement using autologous rectus fascia; Mid-urethral sling placement using synthetic mesh
Intervention type(s): Procedure; Procedure
Intervention description(s): Mid-urethral sling placement using autologous rectus fascia; Mid-urethral sling placement using synthetic mesh
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients who undergo a transobturator sling placement using autologous rectus fascia
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: midurethral sling placement; synthetic mesh; autologous rectus fascia; transobturator approach
A Single-blind Pilot Study to Investigate Safety and Tolerability of the Chymase Inhibitor BAY1142524 in Clinically Stable Patients With Left-ventricular Dysfunction
Condition: Heart Failure
MeSH terms: Ventricular Dysfunction; Ventricular Dysfunction, Left
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the trial is the analysis of safety and tolerability of the chymase inhibitor
      BAY1142524 in comparison to placebo using a 2 weeks treatment period in clinically stable
      patients with left-ventricular dysfunction after myocardial infarction. BAY1142524 or placebo
      will be given on top of evidence-based standard of care for left-ventricular dysfunction
      after myocardial infarction. Primary objectives are the analysis of safety and tolerability
      as evidenced by the incidence and severity of adverse events. BAY1142524 will be administered
      in a parallel group design using four doses (5, 10, 25 mg twice daily, and 50 mg once daily).
      Each dose group consists of 9 patients treated with verum and 3 patients treated with
      placebo.
    


Intervention name(s): BAY1142524; BAY1142524; BAY1142524; BAY1142524; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 mg BAY1142524 or placebo given as 5 mg IR tablet twice daily for 2 weeks; 10 mg BAY1142524 or placebo given as 2 x 5 mg IR tablets twice daily as for 2 weeks; 25 mg BAY1142524 or placebo given as 5 x 5 mg IR tablets twice daily for 2 weeks; 50 mg BAY1142524 or placebo given 1 x 50 mg IR tablet once daily for 2 weeks; The patients will be treated orally with combinations of IR tablets containing placebo to achieve the indicated dosages.
Intervention MeSH terms: Fulacimstat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
A Study of the Combination of Oxaliplatin, Capecitabine, and Trastuzumab With Chemoradiotherapy in the Adjuvant Setting in Operated Participants With Human Epidermal Growth Factor Receptor-2 Positive (HER2+) Gastric or Gastroesophageal Junction Cancer
Condition: Gastric Cancer; Gastroesophageal Junction Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This single-arm, open-label study will evaluate the safety and efficacy of the combination
      oxaliplatin, capecitabine, and trastuzumab with chemoradiotherapy in the adjuvant setting in
      participants with curatively resected HER2+ gastric or gastroesophageal junction cancer.
      Participants will receive trastuzumab 8 milligrams per kilogram (mg/kg) intravenously (IV) on
      Day 1 of Cycle 1 and 6 mg/kg IV on Day 1 of every following 3-week cycle, with oxaliplatin
      100 milligrams per square meter (mg/m^2) IV on Day 1 of Cycles 1-3, and capecitabine 850
      mg/m^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during
      chemoradiotherapy. Radiotherapy will be given at a total dose of 45 gray (Gy) divided into 25
      doses on 5 treatment days each week for 5 weeks starting Day 22 of Cycle 3. Anticipated time
      on study treatment is 1 year plus a 1-year follow-up period.
    


Intervention name(s): Oxaliplatin; Radiation; Capecitabine; Trastuzumab
Intervention type(s): Drug; Radiation; Drug; Drug
Intervention description(s): Participants will receive oxaliplatin 100 mg/m^2 IV on Day 1 of Cycles 1-3.; Participants will receive radiotherapy at total dose of 45 Gy divided into 25 doses, 5 treatments per week for 5 weeks starting on Day 1 of Cycle 4.; Participants will receive capecitabine 850 mg/m^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy.; Participants will receive trastuzumab 8 mg/kg IV on Day 1 Cycle 1, 6 mg/kg IV on Day 1 of each following 3-week cycle for 12 months (a total of 17 doses).
Intervention MeSH terms: Capecitabine; Oxaliplatin; Trastuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment