bioihbjkbjnl/mcl2 huggingface dataset:
Inducible Regulatory T Cells (iTregs) in Non-Myeloablative Sibling Donor Peripheral Blood Stem Cell Transplantation
Condition: Acute Myelogenous Leukemia; Acute Lymphocytic Leukemia; Chronic Myelogenous Leukemia; Non-Hodgkin Lymphoma; Hodgkin Lymphoma; Chronic Lymphocytic Leukemia; Multiple Myeloma; Myelodysplastic Syndrome
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I single center dose escalation study with an extension at the best available
      dose to determine the tolerability of inducible regulatory T cells (iTregs) when given to
      adult patients undergoing non-myeloablative HLA-identical sibling donor peripheral blood stem
      cell (PBSC) transplantation for the treatment of a high risk malignancy. Up to 5 dose cohorts
      will be tested. Once the tolerable dose is determined for iTregs, enrollment will continue
      with an additional 10 patients using sirolimus/Mycophenolate mofetil (MMF) graft-versus-host
      disease (GVHD) prophylaxis to gain further safety information and to provide pilot data in
      this treatment setting.
    

Detailed description: 
      Co-enrollment in University Of Minnesota protocol MT2001-10 is required and transplantation
      will be according to that protocol with iTregs administered the morning of day 0 followed no
      sooner than 4 hours later by the PBSC transplantation.
    

Intervention name(s): iTreg
Intervention type(s): Biological
Intervention description(s): The iTregs will be infused at the assigned dose without a filter or pump slowly by gravity over 15-60 minutes. The iTregs should be given at least 4 hours before the peripheral blood stem cell (PBSC) infusion (MT2001-10).
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Positive Energy I Through Overfeeding
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this trial is to examine the metabolic and behavioral effects of a positive
      energy balance induced by adding food to the usual level of activity.

      It is hypothesized that: 1) food intake will not differ significantly after 2 days of
      positive energy balance induced by a high carbohydrate vs. high fat diet when both diets are
      low in energy density, and 2) food intake will be higher after a positive energy balance
      induced by a high fat/high energy dense diet vs. a high fat/low energy dense diet.
    

Detailed description: 
      The purpose of this trial is to examine the metabolic and behavioral effects of a positive
      energy balance induced by adding food to the usual level of activity. During this study, we
      will induce a positive energy balance for two days by increasing food intake to 140% of
      baseline energy requirements and keeping energy expenditure constant. The following three
      diets, which vary in dietary fat and energy density (kcal/g), will be used to induce the
      positive energy balance in a within subjects or cross over design: 1) high fat/high energy
      density, 2) high fat/low energy density, and 3) high carbohydrate/low energy density. Food
      intake and activity will be measured for 4 days after each diet to quantify the response to
      positive energy balance and manipulation of dietary fat and energy density.
    

Intervention name(s): Diet A; Diet B; Diet C
Intervention type(s): Other; Other; Other
Intervention description(s): Dietary; Dietary; Dietary
Other intervention name(s): Low Fat High Energy Density (1.6 kcal/g)-50% Fat, 35% Carbohydrate, and 15% Protein; High Fat Low Energy Density (1.05 kcal/g)-50% Fat, 35% Carbohydrate, and 15% Protein; High Carbohydrate Low Energy Density (1.05 kcal/g)-20% Fat, 65% Carbohydrate, 15% Protein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: Appetite; Satiety
Evaluation of the Safety and Efficacy of Carbon Dioxide (CO2) Acupulse Laser Treatment on Urinary Stress Incontinence.
Condition: Exposure Laser
MeSH terms: Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      The study is intended to assess the safety and efficacy of CO2 AcuPulse laser treatment in
      patients with stress urinary incontinence (SUI). Eligible subjects will either receive 3
      laser or sham treatment sessions, 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12
      months following the last treatment.
    

Detailed description: 
      Following a screening visit, eligible subjects will be enrolled into the study. Eligibility
      will be decided depending on the level of SUI the patient has. Each subject will receive
      either 3 laser or sham treatments 4 weeks apart and 4 Follow Up visits, at 1, 3, 6, and 12
      months following the last treatment.

      Further demographic information and patient history will be obtained from the subjects'
      electronical files.
    

Intervention name(s): CO2 AcuPulse Laser; Sham Laser
Intervention type(s): Device; Device
Intervention description(s): Each subject will receive 3 laser treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.; Each subject will receive 3 sham treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of PH3 for the Prevention of Osteoporosis in Postmenopausal Women
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this clinical study is to evaluate the effectiveness and safety of
      PH3 for the prevention of osteoporosis.

      The secondary objectives are to identify the optimal dosage for subsequent studies and to
      provide basis for the next confirmatory study in study design, endpoints, and study
      methodologies.
    


Intervention name(s): PH3
Intervention type(s): Drug
Intervention description(s): Each PH3 tablet, 530 mg/tablet, contains 250 mg of active ingredient. The placebo tablet contains no active ingredient. Three tablets per day will be taken orally before bedtime.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: osteoporosis; postmenopausal women; botanical drug
Effects of Face Masks on Cardiopulmonary Capacity in Healthy Individuals
Condition: Covid-19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The aim of our study is to compare the effects of face masks on cardiopulmonary capacity in
      young healthy individuals. The results of our study will show the effects of face masks
      commonly used during the pandemic period.
    

Detailed description: 
      The aim of our study is to compare the effects of face masks on cardiopulmonary capacity in
      young healthy individuals. The results of our study will show the effects of face masks
      commonly used during the pandemic period.

      The hypotheses we will test for this purpose; H1: face masks affect cardiopulmory capacity in
      healthy individuals H2: face masks affect heart rate in health individuals H3: face masks
      affect oxygen saturation in healthy individuals H4: face masks affect respiratory frequency
      in healthy individuals
    

Intervention name(s): without masks; Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey); FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)
Intervention type(s): Other; Other; Other
Intervention description(s): apply a bicycle ergometer test protocol to individuals without a mask; apply a bicycle ergometer test protocol to individuals with a surgical mask; apply a bicycle ergometer test protocol to individuals with a FFP2\N95 mask
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: individuals will perform cycle ergometer without mask, with surgical mask and FFP2/N95. there will be 48 hours wash-out between tests.
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: covid19; cardiopulmoary; exercise capacity; face masks
Bioavailability Study Comparing Two New Nilotinib Tablet Formulations to an Established Nilotinib Capsule Formulation in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Bioavailability study comparing two new nilotinib tablet formulations to an established
      nilotinib capsule formulation in healthy volunteers
    


Intervention name(s): Nilotinib
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: nilotinib; bioavailability; tablet; capsule; PK; healthy, subject(s),
A Clinical Trial Using Irreversible Electroporation for the Treatment of Liver Cancers
Condition: Hepatocellular Carcinoma; Metastatic Liver Cancers
MeSH terms: Carcinoma, Hepatocellular; Liver Neoplasms
Study type: Interventional

Summary: 
      Liver cancer including primary hepatocellular carcinoma (HCC) and metastatic liver cancers is
      one the most common malignancies in the world. Over 10000 new cases per year are diagnosed in
      Taiwan. Despite the many treatment options, the prognosis of HCC remains dismal. More than
      8000 people died of this cancer every year in Taiwan. A majority (70% to 85%) of patients
      present with advanced or unresectable disease. In contrast, small liver cancers can be cured
      with an appreciable frequency. Five-year disease-free survival exceeding 50% has been
      reported for surgical resection, and for the inoperable patients who do not have vascular
      invasion or extrahepatic spread. Radiofrequency ablation (RFA) is recommended as an
      alternative curative therapy. However, the main drawback of RFA is its limitation to tumor
      size and location. The tumors larger than 5 cm in diameter or located adjacent to vessels,
      could not be ablated completely sometimes.
    

Detailed description: 
      Irreversible electroporation (IRE), developed and manufactured by AngioDynamics US Ltd, can
      ablate tumor by fenestrating the cancer cell membrane by electric pulse. The anti-tumor
      effect does not result from thermotherapy, so is also not diminished by adjacent vessels.
      Several pre-clinical studies have already demonstrated IRE is a safe and effective treatment
      for live cancers. The system has been approved as safe by the European Union (EU) in 2008 and
      received Food and Drug Administration (FDA) approval in 2010. However, there are still few
      experiences in using IRE for tumor ablation in Taiwan. In this study, the investigators will
      perform IRE for 40 inoperable patients with liver cancers adjacent to vessels who are
      suitable to receive radiofrequency ablation (RFA) in the investigators hospital. The
      investigators will evaluate the potential side effect and ablate effect of tumors by
      abdominal computed tomography (CT) or magnetic resonance imaging (MRI), and the investigators
      will also follow-up this patients for 2 years to evaluate the overall survival and local
      recurrence rate. The investigators will appraisal the clinical feasibility and advantage of
      the system by this study.
    

Intervention name(s): Irreversible Electroporation (IRE) System
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatocellular Carcinoma; irreversible electroporation; liver cancer
EZCast-DFU Study With Portal for Application of Topical Medications
Condition: Foot Ulcer; Diabetic Foot
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the ability to modify a contact cast system so that
      topical medications can be applied daily to an underlying wound in patients with diabetic
      plantar ulcers. The modification of the cast will be done by making an opening where the
      wound is located in the contact cast system. A contact cast system is a device that will
      reduce the pressure in the area where the wound is located.
    

Detailed description: 
      The accepted care of a diabetic foot ulcer includes cleaning of the wound of the dead and
      dying tissue around the wound, daily wound care, good nutrition, and adequate relief of
      pressure. Pressure reduction, commonly known as "off-loading," is most often achieved by
      having the patient wear an "off-loading boot". However, using a cast similar to the cast used
      to treat broken bones will result in less activity and better wound healing. The cast is
      considered the best method for off-loading the foot but is not used as often as other methods
      because the cast covers the foot ulcer and it does not allow you to perform daily cleaning
      and examination.

      This study will apply a Total Contact Cast (TCC)System and leave an opening where the ulcer
      can be treated on a daily basis by the investigators. Patients will be asked to apply an
      ointment called Santyl ® to their ulcer on a daily basis. Santyl ® ointment is an FDA
      approved drug that is routinely used on foot ulcers. The Santyl ® ointment cleans wounds to
      promote a better environment for wounds to heal. It helps remove nonliving tissue without
      harming the new healing tissue.

      Trial will last 14 days and it will consist of 4 visits. In the first visits, patients'
      wounds will be cleaned from dead and dying tissue (debridement) and the first modified
      contact cast will be applied. Patients will be provided Santyl to apply daily with
      reapplication of foam dressing. Patients will return at day 3, and then weekly for 2 weeks
      for standard evaluation and debridement and wound measurements and at day 3, and week 1 visit
      for reapplication of the modified contact cast.
    

Intervention name(s): Collagenase ointment; Modified Contact Cast System
Intervention type(s): Drug; Device
Intervention description(s): 250 collagenase units/g; 1 Unit
Other intervention name(s): Santyl; Modified TCC-EZ(R) Total Contact Cast System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetic foot; foot ulcer; foot wound; plantar ulcer; plantar wound; contact cast; collagenase
Nasal Allergen Challenge in Rhinitic Subjects
Condition: Asthma; Allergic Rhinitis
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Study type: Interventional

Summary: 
      Background: Nasal allergen challenge (NAC) is useful to study the pathophysiology of
      rhinitis, and multiple challenges may more adequately approximate natural exposure.

      Objective: To determine the effect of 4 consecutive daily NAC, on clinical and inflammatory
      parameters in rhinitics with or without asthma.
    

Detailed description: 
      The study will be performed outside the pollen season. On a baseline visit, 2 to 7 days prior
      to control challenge, allergy skin prick tests and methacholine inhalation test will be done.
      Prior to first allergen challenge, skin titration will be done using tenfold dilutions of the
      allergen chosen for nasal challenges. Subsequent to baseline visit, a control challenge will
      be done, followed, a week later, by repeated NACs. NACs will be done over 4 consecutive days,
      in the morning. Nasal peak inspiratory flows (NPIF), oral peak expiratory flows (PEF), and
      symptoms will be recorded at baseline and at regular intervals over 7 hours post-challenge on
      each challenge day. Induced sputum and nasal lavage specimen will be obtained 7 hours
      following the control challenge and the first and last NAC.
    

Intervention name(s): Nasal allergen challenge
Intervention type(s): Procedure
Intervention description(s): Allergen sprayed into nostrils. Allergen used will be house dust mite or cat allergen. Allergens will be given in increasing ten-fold dilutions until a positive response occurs.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study Of The Safety And Pharmacokinetics Of CE-326,597 In Patients With Asymptomatic Gallstones
Condition: Obesity
MeSH terms: Gallstones; Cholelithiasis
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to assess whether repeated dosing with CE-326,597 will cause patients
      with asymptomatic gallstones (as detected on screening abdominal ultrasound) to become
      symptomatic. In addition, the study will characterize the pharmacokinetics of CE-326,597.
    


Intervention name(s): CE-326,597; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CE-326,597 administered orally, once daily for 14-days at 1 to 2 doses (25 mg QD, 100 mg QD) with the morning meal.; CE-326,597 matching placebo administered orally, once daily for 14-days with the morning meal.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Safety in patients with Asymptomatic cholelithiasis/gallstones.
A Trial Investigating the Pharmacodynamic Response of Faster Acting Insulin Aspart in Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the
      pharmacodynamic (the effect of the investigated drug on the body) response of Faster acting
      insulin aspart (FIAsp) in subjects with type 1 diabetes.
    


Intervention name(s): Faster-acting insulin aspart; insulin aspart
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®. Single dose of trial products will be administered subcutaneously (s.c. under the skin).; Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®. Single dose of trial products will be administered subcutaneously (s.c. under the skin).
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Multicenter, Randomized, Double-blind, Parallel Group Study to Determine the Optimal Dose of HL301 After 7 Days Oral Administration in Acute Bronchitis or Acute Exacerbations of Chronic Bronchitis Patients (HL301: Mixed Extract of Rehmannia Glutinosa, Schisandra and so on)
Condition: Acute Bronchitis; Acute Exacerbations of Chronic Bronchitis
MeSH terms: Bronchitis; Bronchitis, Chronic; Acute Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the optimal dose of HL301 in patients with acute
      bronchitis or acute exacerbations of chronic bronchitis.

      - BSS(Bronchitis Severity Score), BCSS(Breathlessness, Cough, and Sputum Scale), evaluation
      of symptoms of cough and sputum
    


Intervention name(s): HL301 300mg capsule; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 capsules at once, 3 times a day, for 7 days; 2 capsules at once, 3 times a day, for 7 days
Other intervention name(s): experimental A (0.6g/day) : HL301 300mg 2 capsule; experimental B (1.2g/day) : HL301 300mg 4 capsule; experimental C (1.8g/day) : HL301 300mg 6 capsule; Microcrystalline Cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute bronchitis; acute exacerbations of chronic bronchitis
Nicotine Delivery Rate and Its Abuse Potential: Impact of Menthol
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      A placebo-controlled study to enroll male and female tobacco smokers who will participate in
      five experimental sessions. subjects will be given an IV infusion of either saline or 1 mg
      nicotine at rapid, moderate or slow infusion rates (nicotine at 0.24,0.096, 0.048 and 0.024,
      mcg per kg body weight per sec).
    

Detailed description: 
      A placebo-controlled study that will enroll male and female tobacco smokers' menthol to
      participate in five experimental sessions. During the experimental session, subjects will be
      given an IV infusion of either saline or 1 mg nicotine at rapid, moderate or slow infusion
      rates (nicotine at 0.24,0.096, 0.048 and 0.024, mcg per kg body weight per sec). The infusion
      conditions for each experimental session will be determined in random order. Aim 1 is to
      establish a dose-effect curve for positive subjective effects (drug liking and good drug
      effects) and alleviation of smoking urges, as a function of nicotine delivery rate in menthol
      and non-menthol cigarette preferring smokers Aim 2 is to establish a dose-effect curve
      positive subjective effects and alleviation of smoking urges as a function of nicotine
      delivery rate. Aim 3 is to establish a dose-effect curve for nicotine's effect to alleviate
      symptoms of nicotine withdrawal in abstinent smokers as a function of nicotine delivery rate.
      Aim 4 is to establish a dose-effect curve for nicotine's acute cardiovascular health effects.
      Data from this project will help to establish benchmark values for nicotine's threshold
      effects that will guide policies on the nicotine yield of tobacco products. Presented is the
      time frame at which the peak change was strongest by treatment arm. The possible peak numbers
      could be 1, 3, 5, 7 and 10 minutes."
    

Intervention name(s): Nicotine saline infusion 0.00mcg/kg/s; Nicotine infusion 0.24mcg/kg/s; Nicotine infusion 0.096mcg/kg/s; Nicotine infusion 0.048 mcg/kg/s; Nicotine infusion 0.024mcg/kg/s
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): saline 0.00mcg/kg/s; nicotine 0.24mcg/kg/s; nicotine 0.096mcg/kg/s; nicotine 0.048mcg/kg/s; nicotine 0.024mcg/kg/s
Other intervention name(s): nicotine infusion; nicotine infusion; nicotine infusion; nicotine infusion; nicotine infusion
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single blind, placebo-controlled, mixed-design with nicotine delivery as a within-subjects factor.
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research