bioihbjkbjnl/mcl2 huggingface dataset:
Ghrelin, Growth Hormone and Growth Factors at High Altitude
Condition: Healthy; Growth Hormone
Study type: Observational

Summary: 
      Regulation of ghrelin, growth hormone and growth factors at high altitude and their change
      during ascent to high altitude has not been studied in depth yet. The study includes 33
      volunteers (12f) investigated at sea level, 4 days after ascent to 3440m and 14 days after
      ascent to 5400-5900m.

      The investigators hypothesized that during ascent growth hormone levels would increase to
      compensate for the higher energy needs at high altitude.
    


Intervention name(s): exposure to high altitude
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Caucasians from an Alpinist association
      
Keywords: mountain medicine; ghrelin; growth hormone; hypoxia; physiology of hormonal adaptation to high altitude
Combination Chemotherapy Plus Rituximab in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells
      and either kill them or deliver cancer-killing substances to them without harming normal
      cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy combined with
      rituximab in treating patients who have recurrent or refractory non-Hodgkin's lymphoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the chemosensitivity rate in patients with recurrent or refractory
           non-Hodgkin's lymphoma treated with ifosfamide, carboplatin, and etoposide (ICE) in
           combination with rituximab.

        -  Determine whether the addition of rituximab changes the toxicity profile of the ICE
           chemotherapy regimen in these patients.

      OUTLINE: Patients receive rituximab IV on days 1, 8, and 15 and ifosfamide IV over 1 hour,
      etoposide IV over 2 hours, and carboplatin IV on days 2-4. Treatment continues every 21 days
      for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who
      are not candidates for autologous stem cell transplantation may receive 1-4 more courses of
      chemotherapy without rituximab.

      Patients are followed at 1 month.

      PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 2 years.
    

Intervention name(s): rituximab; carboplatin; etoposide; ifosfamide
Intervention type(s): Biological; Drug; Drug; Drug
Other intervention name(s): Rituxan; Paraplatin; Etopophos, Toposar; Ifex
Intervention MeSH terms: Rituximab; Carboplatin; Etoposide; Ifosfamide
Primary purpose: Treatment
Keywords: recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult Burkitt lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent small lymphocytic lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; nodal marginal zone B-cell lymphoma; splenic marginal zone lymphoma
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of TNP-2198 Capsules After Single Oral Dose in Healthy Participants
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a single-center, randomized, double-blind, placebo-controlled phase 1 study to
      evaluate the safety, tolerability, pharmacokinetics of single ascending dose and the food
      effect on the pharmacokinetics of TNP-2198 capsules after single dose oral administration in
      healthy subjects.
    


Intervention name(s): TNP-2198; TNP-2198 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; The placebo for TNP-2198 active drug
Other intervention name(s): Rifasutenizol
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effectiveness of PEMF in Patients With Chronic Radicular Pain Due to Lomber Disc Herniation
Condition: Lumbar Disc Herniation
MeSH terms: Intervertebral Disc Displacement; Hernia
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effectiveness of pulse magnetic field therapy on
      pain, functional status, and quality of life in patients with chronic radicular pain due to
      lumbar disc herniation.
    

Detailed description: 
      Pulsed Electromagnetic Field Therapy (PEMF) is a non-invasive, painless treatment for various
      injuries, bone related conditions and pains. However, further studies on PEMF effects on low
      back and radicular pain is needed due to lack of studies in this area.
    

Intervention name(s): PEMF; Hot pack; TENS; Sham PEMF
Intervention type(s): Device; Device; Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of LASIK on the Calibration of IOL Formula Calculation: a Comparative Study
Condition: Cataract Senile
MeSH terms: Cataract
Study type: Observational

Summary: 
      Direct comparison study between previous LASIK or non-LASIK cataract eyes, the performance
      between non-LASIK and LASIK patients were (i) Ophthalmic examinations: UDVA, CDVA and
      uncorrected near visual acuity (UNVA) (40cm) and (ii) Refractive prediction error: defined as
      difference between postoperative sphere and target refraction.
    


Intervention name(s): routine cataract surgery and intraocular lens implantation
Intervention type(s): Device
Intervention description(s): routine cataract surgery and intraocular lens implantation
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Clear corneal phacoemulsification and IOL implantation were performed by single surgeon
        Chao-Kai Chang. The surgical process involved topical anesthesia, a 3-step clear corneal
        incision (2.75 mm) at 180° (temporal in both eyes), a 5.0-mm continuous curvilinear
        capsulorhexis, phacoemulsification using the stop-and-chop technique, IOL implantation with
        an injector, IOL centration, and a sutureless incision. The study IOL models include only
        EDOF Symfony IOL (Johnson and Johnson, Santa Ana, CA, USA).
An Anti-inflammatory Diet Effect on Metabolic, Inflammatory and Immune Status of Obese Younger Adults
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Diet has a major role in the etiology of obesity, and there is a growing body of evidence
      suggesting that a variety of dietary factors can modulate obesity-induced chronic low-grade
      inflammation and thus the course of obesity-related chronic non-communicable diseases. The
      present intervention study aims to evaluate the effect of an anti-inflammatory diet on weight
      loss, body composition, cardiometabolic risk factors and immune system response among young
      adults of the obese younger adults.
    

Detailed description: 
      Obesity pandemic presents a major challenge to chronic disease prevention worldwide. A
      low-grade chronic inflammation is associated with obesity and related cardiometabolic
      disorders, such as cardiovascular diseases, type 2 diabetes and some type of cancers. Diet
      has a major role in the etiology of obesity, and there is a growing body of evidence
      suggesting that a variety of dietary factors can modulate obesity-induced chronic low-grade
      inflammation and thus the course of obesity-related chronic non-communicable diseases. The
      present intervention study aims to evaluate the effect of an anti-Inflammatory diet on weight
      loss, body composition, cardiometabolic risk factors and immune system response among younger
      adults. A nutritional intervention based on an energy-restricted anti-inflammatory diet will
      be compared with an isocaloric standard diet (55-60% carbohydrates, 25% fat, 15-20% protein).
      The inflammatory potential of the diet will be assessed with the Dietary Inflammatory Index®.
    

Intervention name(s): Anti-inflammatory energy-restricted diet; Control energy-restricted diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): During 6 months the participants will we asked to use recommended energy-reduced diet with anti-inflammatory properties, based on colorful vegetables and fruits, legumes, nuts, seeds, marine fish, whole-grain products, and daily use of olive oil, green/black tea, multiple spices and herbs.; During 6 months the participants of control group will be asked to use recommended energy-reduced diet based on standard obesity management (55-60% carbohydrates, 25% fat, 15-20% protein)
Intervention MeSH terms: Anti-Inflammatory Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The randomized controlled intervention study. A nutritional intervention will be based on an energy-restricted anti-inflammatory diet that will be compared with an isocaloric standard diet (55-60% carbohydrates, 25% fat, 15-20% protein).
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: anti-inflammatory diet; obesity; low-grade inflammation; cardiometabolic; immunity
Monitoring the Efficacy of a Probiotic Dietary Supplement SmartProbio C in Patients With Severe COVID-19 Infection
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The aim of the study is to test the efficacy of the probiotic SmartProbio C in patients with
      a severe course of COVID-19 infection. Patients were randomly divided into two arms between
      the probiotic group and the placebo group. They were further divided into four groups
      according to 1) BMI (Body mass index; <=30/>30), 2) age (<=65/>65), 3) CRP (C-reactive
      protein; <=100/>100), 4) chronic lung disease (yes/no). Gut microbiome analysis and its
      changes in selected parameters (amount of lactobacilli, bifidobacteria, Akkermansia,
      Proteobacteria, Firmicutes/Bacteroidetes ratio) were chosen as the primary endpoint. Other
      assessed indicators include:

        -  Tracking of time to clinical improvement by two points on a seven-point ordinal scale
           for clinical improvement according to R&D Blueprint: COVID-19 Therapeutic Trial Synopsis
           (WHO, 2020) or time to hospital discharge (whichever comes first)

        -  Monitoring the length of oxygen dependence

        -  Monitoring of laboratory markers of inflammation - serum peripheral blood CRP levels

        -  Monitoring of mortality
    


Intervention name(s): SmartProbio C; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Probiotic supplement consisting of 19 strains (Lactobacillus acidophilus NCFM, Bifidobacterium lactis, subsp. Infantis Bi-07, Lactobacillus rhamnosus LR22, Lactobacillus acidophilus LA14, Lactobacillus rhamnosus LGG, Bifidobacterium lactis HN019, Bifidobacterium lactis Bl-04, Lactobacillus acidophilus LA 11 ONLLY, Lactobacillus rhamnosus HN001, Lactobacillus plantarum LP ONLLY, Lactobacillus casei LC18, Bifidobacterium breve BB8, Lactobacillus reuteri LE16, Bifidobacterium lactis BI516, Streptococcus thermophilus ST6, Bifidobacterium animalis BA77, Bifidobacterium bifidum BB47, Bifidobacterium longum BL88 ONLLY, Bifidobacterium infantis BI211) in different ratios. Probiotic mixture enclosed in HPMC (hydroxypropylmethylcelulose) capsule, 25 billion CFU (colony-forming units) in each capsule. As a filling agent mix of inulin and maltodextrin was used. Dosage twice a day.; Placebo. HPMC (hydroxypropylmethylcelulose) capsule filled with maltodextrin. Dosage twice a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: COVID-19; probiotics; probiotic supplementation
Autologous Endothelial Progenitor Cells Transplantation for Chronic Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Stroke is a frequently occurring and common diseases in nervous system,and most of the
      survivors will remain disorders of motor,sensory and cognition function.Stem cell
      transplantation provides a promising approach for rehabilitation. The main objective of this
      study is to evaluate the efficacy and safy of the transplantation of autologous endothelial
      progenitor cells in patients with chronic stroke.
    

Detailed description: 
      Stroke is a frequently occurring and common diseases in nervous system,and most of the
      survivors will remain disorders of motor,sensory and cognition function.It will brought heavy
      burden to patients themselves,their family and society.Drugs,rehabilitation excise and
      hyperbaric oxygen will improve functions after acute stroke.However,in the chronic ischemic
      stroke,there was few methods to improve the functions.In recently research,stem cell will be
      a new methods to improve the neural function after through differentiate to nervous cells and
      secrete some neurotrophic factors to repair the damage. In this study, the investigators will
      assess the safety and feasibility of intracerebral transplantation of autologous endothelial
      progenitor cells in patients with chronic ischemic stroke. The neurological outcome will be
      determined after transplantation.
    

Intervention name(s): Intravenous stem cell transplantation
Intervention type(s): Drug
Intervention description(s): Intravenous injection of autologous endothelial progenitor cells transplantation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endothelial Progenitor Cells; Transplantation; Stroke
A Clinical Trial to Verify the Accuracy of Seers Technology's Pulse Oximeter (mobiCARE +Pulse, MP100W) in Healthy Volunteers
Condition: Oxygen Saturation
Study type: Interventional

Summary: 
      It is important to evaluate the accuracy of the pulse oximeter, which is commonly used in
      clinical practice. The US FDA only allows the use of devices that meet the ISO
      80601-2-61:2017 standard in the United States. According to the ISO 80601-2-61:2017 standard,
      the accuracy of the oxygen saturation (SpO2) of the pulse oximeter should have an error range
      of less than 4.0% compared to the actual arterial blood oxygen saturation (SaO2) in the range
      of 70-100%. To prove compliance with this requirement, it is necessary to conduct a clinical
      trial that induces hypoxemia in healthy adults and compares and evaluates the arterial blood
      oxygen saturation values of the pulse oximeter's SpO2 and the arterial blood oxygen
      saturation values of the carbon monoxide-oxygen meter (CO-oximeter).
    


Intervention name(s): mobiCARE +Pulse (MP100W)
Intervention type(s): Device
Intervention description(s): Volunteers were monitored using end-tidal carbon dioxide partial pressure and fraction of inspired oxygen. Each volunteer was placed in a semi-Fowler's position and connected to a breathing circuit to administer the nitrogen-air-carbon dioxide mixtures. A nose clip was applied to prevent breathing of room air. For frequent blood sampling, an arterial cannula was placed in the radial artery of each volunteer. Pulse oximeter probes were simultaneously attached to each volunteer's fingers. Each volunteer was exposed to various levels of induced hypoxia from 70~100% of SaO2. Each plateau of oxygen saturation was maintained for at least 30 s until stabilization, after which 1 ml of arterial blood was drawn into a heparinized syringe. The study period consisted of two rounds of hypoxia, and the volunteers were maintained on room air between each round. SaO2 measurements using a CO-oximeter were used as a reference for the SpO2 accuracy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Oxygen Saturation
Relative Contributions of Red Cell Catabolism and Dietary Absorption to Fetal Iron Accretion During Pregnancy
Condition: Iron Deficiency
MeSH terms: Iron Deficiencies
Study type: Observational

Summary: 
      The two specific aims of this study are 1) to assess the relative contributions of two major
      maternal iron sources (i.e. dietary iron intake and red cell catabolism) at supplying iron to
      the fetus, and 2) to determine the impact of maternal and fetal iron status on placental
      transfer of these two iron sources in pregnant women and adolescents during the last
      trimester of pregnancy.
    

Detailed description: 
      Pregnant women and adolescents (n=24) will be recruited when entering prenatal care. They
      will be invited to participate in a longitudinal study comparing the relative contribution of
      the two major maternal iron sources, i.e. maternal dietary iron intake and maternal red blood
      cell iron recycling, to fetal iron accretion during pregnancy. At about 15 weeks of
      gestation, participants will consume an oral dose of a stable iron isotope (57Fe as ferrous
      sulfate) to enrich their red blood cells (RBCs) with 57Fe. Maternal blood samples will be
      collected at 4 times during pregnancy to monitor changes in blood 57Fe concentrations. In the
      third trimester of pregnancy, women will consume a dose of a different iron isotope (58Fe as
      ferrous sulfate) as dietary nonheme iron. Cord blood samples and placental tissue will be
      obtained at delivery to determine how much of the dietary iron (58Fe) and RBC iron (57Fe) was
      transferred to the fetus and how much of each isotope was retained in the placenta. Placenta
      tissue samples will also be used to assess placental expression of iron transporters in
      relation to the amount of each iron isotopes transferred to the fetus. Circulating iron
      status indicators and regulators will be measured in all maternal and cord blood samples to
      examine the effect of iron status on placental transfer of iron derived from the diet vs. RBC
      during pregnancy.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women and pregnant adolescents from Rochester, NY (n=24)
      
Biospecimen description: 
      -  A total of 45 mL maternal blood sample is collected at five study visits during
           pregnancy

        -  At delivery, an additional 10 mL maternal blood sample, a 30 mL cord blood, and the
           placenta are collected
    
Keywords: pregnancy; stable isotopes; red blood cell catabolism
Effect of SRT2104 on Endotoxin-induced Inflammation
Condition: Sepsis
Study type: Interventional
Phase: Phase 1

Summary: 
      SRT2104 is a potent small molecule activator of SIRT1 that has been found to inhibit systemic
      inflammation induced by intravenous injection of lipopolysaccharide (LPS) in mice. The
      objective of this study is to test if SRT2104 may be a novel compound for the treatment of
      inflammatory disorders in man.
    


Intervention name(s): Placebo; SRT2104
Intervention type(s): Drug; Drug
Intervention description(s): Matching placebo will be supplied as hard gelatin capsules, with each containing an appropriate amount of placebo.; SRT2104 will be supplied as hard gelatin capsules, with each containing 250mg of SRT2104.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Email Campaign to Increase Uptake of myGeisinger
Condition: Telehealth; Health Behavior
Study type: Observational

Summary: 
      The purpose of the current study is to test different email messages to determine the most
      effect way of promoting enrollment in Geisinger's patient portal, called myGeisinger.
    

Detailed description: 
      Online patient portals are convenient tools that improve patient access to healthcare
      services while often reducing burden to both patients and providers. However, fewer than half
      of patients have enrolled in Geisinger's patient portal, myGeisinger.

      The purpose of the current study is to assess what kind of messaging improves the
      effectiveness of an email campaign targeted at enrolling patients into Geisinger's online
      patient portal, called myGeisinger. Currently, Geisinger sends an email every month to
      patients who have started but not completed the enrollment process (they have had an
      activation code generated but have not yet used that code to enroll). This study will A/B
      test 5 email messages to assess if they perform better than the current standard email
      message.

      Performance will be assessed based on whether patients open the email, click on the
      myGeisinger enrollment link, and enroll in myGeisinger. Statistical analyses will employ
      generalized linear models with a binary distribution and log-link function.
    

Intervention name(s): Less-is-better; Social proof; Endowment / decision staging; Standard email
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Email; Email; Email; Email
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The population consists of Geisinger patients whose myGeisinger status is "Pending" and who
        have an email address on file.
      
Keywords: Behavioral Economics; Patient Portal; Social Proof; Endowment Effect; Less-is-better
fMRI Cholinergic Mechanisms in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      This study aims to determine how clozapine treatment improves neuronal measures of sensory
      gating in subjects with schizophrenia.
    

Detailed description: 
      This study will use functional magnetic resonance imaging (fMRI) to study patients treated
      with risperidone, a commonly used neuroleptic that does not improves sensory gating, to those
      treated with clozapine to determine which brain areas are involved in clozapine's
      normalization of sensory gating in schizophrenia.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects with schizophrenia
A Study to Investigate the Effects of Rifampicin on the Pharmacokinetics of Aleglitazar in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, fixed-sequence, three-period, single group study will evaluate the effects
      of rifampicin on the pharmacokinetics of aleglitazar in healthy volunteers. Volunteers will
      receive single doses of aleglitazar in all three periods and single doses of rifampicin in
      periods 1 and 2, and multiple doses in period 3. The anticipated time on study treatment is
      up to 14 weeks.
    


Intervention name(s): aleglitazar; rifampicin
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of aleglitazar in Periods 1, 2, 3; Single dose in Periods 1 and 2; multiple doses in Period 3
Intervention MeSH terms: Rifampin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)