bioihbjkbjnl/mcl2 huggingface dataset:
Effect of KNO3 Compared to KCl on Oxygen UpTake in Heart Failure With Preserved Ejection Fraction (KNO3CK OUT HFPEF)
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial seeks to assess if potassium nitrate (KNO3) therapy improves exercise capacity and
      oxygen uptake in heart failure patients with preserved ejection fraction (HFpEF).
    

Detailed description: 
      Approximately 50% of heart failure patients exhibit preserved left ventricular (LV) ejection
      fraction (EF), and therefore have HF with preserved EF (HFpEF). There are currently no proven
      effective pharmacologic interventions. Exercise intolerance with reduced aerobic capacity is
      the hallmark of HFpEF and greatly impairs quality of life (QOL). During exercise, blood
      vessels within active muscle vasodilator, increasing perfusion to the muscle bed. Nitric
      oxide is a chief mediator of this process. Inorganic nitrate can ultimately be converted to
      nitric oxide. This conversion occurs preferentially at the site of exercising muscle,
      allowing for vasodilation to occur, hence increasing blood flow to the working muscle.
      Preliminary data suggest that inorganic nitrate improves exercise tolerance in HFpEF. The
      investigator will aim to test this hypothesis in a larger group.
    

Intervention name(s): Potassium Nitrate (KNO3); Potassium Chloride (KCl)
Intervention type(s): Drug; Drug
Intervention description(s): The effect of potassium nitrate (KNO3) supplementation on exercise capacity and peak oxygen consumption in HFpEF will be assessed.; Potassium Chloride (KCl) is the matching placebo control drug in this trial.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Failure; Exercise Intolerance; Ejection Fraction
Alimta and Gemcitabine in Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer; Stage IIIB or IV
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The aims of this study are: (1) to assess the safety and activity of gemcitabine plus Alimta
      (pemetrexed) regimen (GA regimen) in patients with advanced NSCLC patients in the context of
      a randomized trial, and (2) to compare the GA with the paclitaxel plus gemcitabine (PG
      regimen) in terms of toxicity and QoL
    

Detailed description: 
      Patients with stage IIIB or IV non-small cell lung cancer will be randomly allocated to
      receive: (a)PG regimen: paclitaxel 120 mg/sqm followed by gemcitabine 1,000 mg/sqm i.v. on
      days 1 & 8 q 3 weeks; (b)GA regimen: gemcitabine 1,250 mg/sqm i.v. on day 1 (plus folinic
      acid 350 μg daily orally and vitamin B12 1,000 μg i.m. q 9 weeks), pemetrexed (Alimta®) 500
      mg/sqm i.v. on day 8 followed by gemcitabine 1,250 mg/sqm, q 3 weeks.
    

Intervention name(s): gemcitabine plus pemetrexed, paclitaxel plus gemcitabine
Intervention type(s): Drug
Intervention description(s): gemcitabine 1,250 mg/sqm days 1&8 + pemetrexed 500 mg/sqm day 8 paclitaxel 120 mg/sqm + gemcitabine 1,000 mg/sqm days 1&8
Intervention MeSH terms: Paclitaxel; Gemcitabine; Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gemcitabine; pemetrexed; non-small cell lung cancer
Brain Imaging of Cocaine Craving in Recreational Cocaine Users
Condition: Cocaine Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Observational

Summary: 
      The purpose of this study is to compare individuals with cocaine dependence to recreational
      users of cocaine in terms of their brain reactivity to cocaine cues, in hopes that this
      comparison may help us better understand the transition from recreational to compulsive
      cocaine use.
    

Detailed description: 
      Chronic cocaine exposure is associated with an intensified and broadened pattern of neural
      reactivity to cocaine and cocaine cues; prolonged use is also associated with prefrontal
      abnormalities during response inhibition. Limited research suggests that recreational cocaine
      use has similar, but attenuated, effects on neural functioning. Unfortunately, very little
      research has directly compared cocaine dependent individuals and recreational cocaine users
      in terms of their neural reactivity to cocaine cues and response inhibition. Such comparisons
      could help to elucidate the pathological neuroplasticity associated with the transition from
      cocaine use to dependence. The proposed study will assess neural reactivity to cocaine cues
      and response inhibition in recreational cocaine users using fMRI. These data will be compared
      to data from the baseline visit of an ongoing IRB approved investigation (NCT00759473) in
      cocaine dependent individuals that is using the same experimental procedures as the proposed
      study.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        community sample
      
Keywords: Recreational; cocaine; fMRI; neuroimaging; craving; impulsivity
Manual Therapy in Postoperative Breast Cancer
Condition: Breast Cancer; Axillary Lymph Node Dissection; Shoulder Joint Limitation
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      To evaluate the effectiveness of manual therapy (joint mobilization and massage) combined
      with kinesiotherapy in women with impaired range of motion after axillary lymph node
      dissection due to breast cancer regarding the recovery of shoulder range of motion and
      functionality of the upper limb.
    


Intervention name(s): manual therapy, kinesiotherapy
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Combination Chemotherapy Followed by Radiation Therapy Before Surgery in Treating Patients With Stage IIIB NSCLC
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high energy x-rays to damage tumor cells.
      Combining chemotherapy with radiation therapy before surgery may shrink the tumor so that it
      can be removed during surgery.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by
      radiation therapy before surgery in treating patients who have stage IIIB non-small cell lung
      cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the feasibility and efficacy of sequential neoadjuvant docetaxel, cisplatin,
           and radiotherapy followed by surgery in patients with operable stage IIIB non-small cell
           lung cancer.

        -  Determine the rate of event-free survival at 1 year in patients treated with this
           regimen.

        -  Determine the operability and complete resection rate in patients treated with this
           regimen.

        -  Determine the postoperative 30-day mortality in patients treated with this regimen.

        -  Determine the response rate, failure pattern, and overall survival in patients treated
           with this regimen.

        -  Determine the toxicity of this regimen in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1. Treatment
      repeats every 3 weeks for 3 courses in the absence of unacceptable toxicity.

      Beginning 3 weeks after the last chemotherapy dose, patients without progressive disease
      receive radiotherapy 1-2 times daily on days 1-5, 8-12, and 15-19.

      Patients undergo surgery within 3-4 weeks after completion of radiotherapy.

      Patients are followed at 1 month and then every 3 months thereafter.

      PROJECTED ACCRUAL: A total of 15-46 patients will be accrued for this study.
    

Intervention name(s): Hyperfractionated; Taxotere/Cisplatin; conventional surgery
Intervention type(s): Radiation; Drug; Procedure
Intervention description(s): Hyperfractionated radiotherapy; Taxotere/Cisplatin; conventional surgery
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: squamous cell lung cancer; large cell lung cancer; stage IIIB non-small cell lung cancer; adenosquamous cell lung cancer
Early Detection of Postoperative Anastomotic Leak by CT
Condition: Anastomotic Leak
MeSH terms: Anastomotic Leak
Study type: Observational

Summary: 
      Postoperative anastomotic leak is rare but life threatening complication after gastric cancer
      surgery. Early diagnosis is key to minimize other hazards which are caused by anastomotic
      leak. Investigators introduced a novel method to detect early diagnosis of anastomotic leak
      after gastric cancer surgery.
    

Detailed description: 
      Postoperative anastomotic leak is rare but life threatening complication after gastric cancer
      surgery. Early diagnosis is key to minimize other hazards which are caused by anastomotic
      leak. Investigators introduced a novel method to detect early diagnosis of anastomotic leak
      after gastric cancer surgery. Oral contrast agent is used for CT. Investigators carefully
      collected all the data prospectively and standard definition of anastomotic leak was applied.
    

Intervention name(s): computed tomography
Intervention type(s): Diagnostic Test
Intervention description(s): computed tomography
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who underwent gastric cancer surgery.
      
Keywords: gastric cancer; postoperative complication; anastomotic leak; oral contrast agent; computed tomography
The Move Well Study
Condition: Effects of Meditative Movement on Body Composition
Study type: Interventional

Summary: 
      This study will explore the effects of meditative movement on body composition in a group of
      60 midlife women. Women will participate in 30-minute meditative movement (MM) classes for an
      eight-week period. Participants will be encouraged to practice MM at home for at least 30
      minutes most days per week. Participants will be asked to complete a log of their time spent
      doing meditative movement outside of classes.
    

Detailed description: 
      A growing body of published evidence indicates that meditative movement (MM) practices may be
      helpful for body composition improvement. Less strenuous forms of exercise that include a
      focus on the breath and meditative state (i.e., "meditative movement" such as Yoga, Qigong,
      or Tai Chi) may be easier to adopt for unfit, sedentary, overweight or obese women, which
      characterizes a large percentage of the general population. Despite this preliminary
      evidence, no studies have proposed a model for how or why weight loss might occur in MM
      interventions where the goals are not designated as weight loss, nutritional counseling is
      not included, and energy expenditure is not at the level assumed to be required to achieve
      weight loss. The proposed intervention is designed to refine and gather preliminary evidence
      for a novel "mindful-body-wisdom" model of intervening on improving body composition and to
      examine the contribution of model factors (psychological and behavioral) of how such a
      non-diet/non-vigorous exercise intervention might work, in 60 midlife women.

      TCE is a simple TC/QG form that was developed by Dr. Roger Jahnke and developed into a
      standardized research intervention protocol by a team of researchers. It has been used in
      several prior projects and one recently completed NIH/NCCAM-funded randomized controlled
      trial (RCT) with breast cancer survivors showing reduction in fatigue and depression, and
      improved sleep and physical function.
    

Intervention name(s): Meditative Movement
Intervention type(s): Behavioral
Intervention description(s): Intervention will be taught by a certified Tai Chi Easy (TCE) group practice leader. The TCE movements will be repeated in differing sequences and time-frames during the course of the study. The variety and combination of the exercises will begin easy and progress to more advanced movements and/or intensities as the study progresses and participants become more experienced and comfortable with the routine. Participants spend one hour in class each week for a total of eight weeks.
Other intervention name(s): Tai Chi Easy (TCE)
Intervention model: Single Group Assignment
Intervention model description: Clinical trial with single arm
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Midlife Women; Body Composition; Meditative Movement; Emotional Eating; Sleep Quality; Body Fat Percentage; Tai Chi Easy
Effect of Gum Arabic on Gastrointestinal Transit and Permeability
Condition: Diverticulitis
MeSH terms: Diverticulitis
Study type: Interventional

Summary: 
      The study aims to determine the effect of gum arabic on gut bacteria and GI function.
    

Detailed description: 
      To compare the effect of placebo, low-dose prebiotic, or high-dose prebiotic on gut
      microbiota composition and function, GI transit and permeability, and assess development of
      symptoms or a change in pre-existing symptoms present, in patients with recent history of
      clinically diagnosed diverticulitis which has been successfully treated.
    

Intervention name(s): High-dose prebiotic; Low-dose prebiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): This is a spray-dried powder, yellowish-white in color, that is dissolvable.; This is a spray-dried powder, yellowish-white in color, that is dissolvable.; Powder fiber supplement, yellowish-white in color, that is dissolvable.
Other intervention name(s): Acacia, gum acacia, acacia gum, gum arabic, arabic gum; Acacia, gum acacia, acacia gum, gum arabic, arabic gum; Dextrin fiber powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Pilot Study Efficacy and Tolerance Fish Oil Emulsion Daunorubicin and Cytarabine Treatment of AML Younger Patients
Condition: Acute Myeloid Leukemia (AML)
MeSH terms: Leukemia; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      Pilot study of the efficacy and tolerance of the adjunction of a Fish oil emulsion to
      daunorubicin and cytarabine chemotherapy for the treatment of Acute MYeloblastic Leukemia of
      Younger patients (under 61 years) with high-risk cytogenetics.
    

Detailed description: 
      Adjunction of a Fish oil emulsion OMEGAVEN to daunorubicin and cytarabine chemotherapy for
      the treatment of Acute MYeloblastic Leukemia of Younger patients.
    

Intervention name(s): OMEGAVEN; Daunorubicin; Cytarabine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AML Study treatment induction phase; AML Study treatment induction phase; AML Study treatment induction phase
Other intervention name(s): Cerubidine; Aracytine
Intervention MeSH terms: Cytarabine; Daunorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML; high-risk cytogenetics; younger patients; Induction treatment; OMEGAVEN
Phase III Clinical Trial of NPB-01maintenance Therapy in Patients With Chronic Inflammatory Demyelinating Polyneuropathy.
Condition: Chronic Inflammatory Demyelinating Polyneuropathy
MeSH terms: Polyneuropathies; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy were confirmed
      based on the European Federation of Neurological Societies/ Peripheral. Nerve Society
      Guideline. Patients who meet all inclusion criteria and do not conflict with the exclusion
      criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive
      days. Subsequently, patients receive NPB-01 1g/kg every 3weeks and evaluate the Inflammatory
      Neuropathy Cause and Treatment（INCAT） score and INCAT sensory sumscore（ISS） et al.

      As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse
      events by one year after the start of the study treatment.
    


Intervention name(s): NPB-01
Intervention type(s): Drug
Other intervention name(s): Intravenous immunoglobulin
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; gamma-Globulins; Rho(D) Immune Globulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IVIG in Chronic Inflammatory Demyelinating Polyneuropathy; Patients with Chronic Inflammatory Demyelinating Polyneuropathy
Diabetic Macular Edema Treated With Ozurdex (DMEO)
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      To measure various pro-permeability factors in the aqueous humor of patients with
      persistent/recurrent diabetic macular edema
    

Detailed description: 
      Patients with Diabetic Macular Edema (DME) are increasingly being treated with molecules
      targeting vascular endothelial factor (VEGF). One potential advantage of a dexamethasone
      implant over specific VEGF antagonists is that steroids suppress production of multiple
      pro-permeability factors.

      Our primary objective is to measure the pro-permeability factors in the aqueous humor of
      patients with persistent/recurrent macular edema despite prior treatment with anti-VEGF
      agents at baseline and at 1, 2, 3, and 4 months after intraocular injection of a
      dexamethasone implant.
    

Intervention name(s): Dexamethasone Implant; Anti-VEGF injection
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive a single injection of a dexmethasone implant; Patients will receive PRN injections of an anti-VEGF agent
Intervention MeSH terms: Dexamethasone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Bone Structure and Strength Evaluated by Extreme-CT Scan Before and After Treatment of Hyper- and Hypothyroidism
Condition: Hyperthyroidism; Hypothyroidism
MeSH terms: Hypothyroidism; Hyperthyroidism
Study type: Observational

Summary: 
      The aim to evaluate the bone structure by Dexa-scan, extreme CT and bone markers before and
      one year after treatment for a thyroid functional disorder
    

Detailed description: 
      The aim to evaluate the bone structure by Dexa-scan, extreme CT and bone markers before and
      one year after treatment for a thyroid functional disorder. Women with hyper- og
      hypothyroidism are included and undergo usual treatment. Patients are stratified into 10
      different groups.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women with untreated hyper- or hypothyroidism
      
Biospecimen description: 
      blood, urine
    
Keywords: osteoporosis; hyperthyroidism; hypothyroidism
A Study to Evaluate the Efficacy and Safety of Sirukumab in Confirmed Severe or Critical Confirmed Coronavirus Disease (COVID)-19
Condition: Critical Confirmed Coronavirus Disease (COVID)-19
MeSH terms: Coronavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the clinical response of sirukumab (administered as
      a single intravenous dose) plus standard of care (SOC) compared to placebo plus SOC in
      COVID-19.
    

Detailed description: 
      Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), the causative agent of
      coronavirus disease 2019 (COVID-19), is an enveloped, positive-sense, single-stranded
      ribonucleic acid (RNA) betacoronavirus. Symptoms of COVID-19 infection may appear from 2 to
      14 days following exposure, with the spectrum of illnesses ranging from mild symptoms to
      severe illness or death. The identification of SARS-CoV-2 follows the emergence of 2 other
      novel betacoronaviruses: SARS-CoV and Middle East respiratory syndrome coronavirus
      (MERS-CoV). Current management of COVID-19 is supportive, and respiratory failure from acute
      respiratory distress syndrome (ARDS) is the leading cause of mortality. While an
      understanding of the epidemiology and clinical spectrum of COVID-19 is still evolving during
      the ongoing pandemic, the current knowledge of the disease burden highlights the urgent
      medical need to develop a treatment. Sirukumab (also known as CNTO136) is a human
      anti-interleukin (IL)-6 immunoglobulin G1 kappa (IgG1k) monoclonal antibody (mAb). Sirukumab
      binds with high affinity and specificity to human IL-6 and as a result inhibits IL-6-mediated
      signaling and the biological effects of IL-6. The study will include a Screening Phase (up to
      1 Day), a Treatment Phase (Day 1 to Day 28) and a Follow-up Phase (post Day 28, follow-up
      phone calls on Week 8, Week 12 and Week 16). Safety evaluations will include monitoring of
      adverse events and serious adverse events, physical examinations, vital sign measurements,
      electrocardiograms, clinical laboratory tests, pregnancy testing, and checking of vital
      status. The entire study duration for each participant will be 16 weeks.
    

Intervention name(s): Sirukumab; Placebo; Standard of Care (SOC)
Intervention type(s): Drug; Drug; Other
Intervention description(s): Participants will receive single dose infusion of sirukumab on Day 1.; Participants will receive placebo IV single dose infusion on Day 1.; SOC treatment will be determined by the investigator based on local practice and consists of supportive care.
Other intervention name(s): CNTO136
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment