bioihbjkbjnl/mcl2 huggingface dataset:
A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor
Condition: Related Donors Donating Peripheral Blood Stem Cells (PBSC) to a Family Member; Acute Myelogenous Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome; Chronic Myelogenous Leukemia; Non-Hodgkin's Lymphoma; Hodgkin's Disease; Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Hodgkin Disease; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II, open-label, two strata, multicenter, prospective study of
      plerixafor-mobilized HLA-identical sibling allografts in recipients with hematological
      malignancies. This study will establish the safety and efficacy of subcutaneous plerixafor
      for this purpose.
    

Detailed description: 
      The primary objective is to determine the proportion of donors whose cells can be
      successfully mobilized and collected with a sufficient CD34+ cell dose using plerixafor as
      the mobilizing agent, using an intention-to-treat analysis. Donor mobilization following
      plerixafor will be considered successful if ≥ 2.0x10e6 CD34+ cells/kg recipient weight are
      collected in no more than two leukapheresis collections.

      All donors receiving plerixafor will be included in the analysis of the primary objective
      based on the intention-to-treat principle.Recipients will be classified into one of the two
      strata, myeloablative or reduced intensity, according to his/her conditioning regimen. The
      target enrollment is 64 donor/recipient pairs, 32 pairs per stratum.
    

Intervention name(s): Plerixafor
Intervention type(s): Drug
Other intervention name(s): Mozobil; AMD3000
Intervention MeSH terms: Plerixafor
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence of Two Different Capsule Types of Dabigatran
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this Phase I trial is to demonstrate the bioequivalence of two capsules of
      dabigatran etexilate made from two different drug product batches.

      The reference batch is dabigatran etexilate hard capsules 150 mg using the currently approved
      capsule shell (Qualicaps). The test batch is dabigatran etexilate 150 mg hard capsules using
      a new capsule shell (Capsugel). The test batch is the drug product intended for future
      commercial use.
    


Intervention name(s): Dabigatran etexilate; Dabigatran etexilate
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg Capsugel (T); 150 mg Qualicaps (R)
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Type One Diabetes and Low Carb Study
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      The investigators have identified a support group on social media with ~1500 members
      (children and adults), the majority of whom have T1DM and follow a carbohydrate-restricted
      diet. Many participants report exceptionally low HbA1C and insulin requirements. If these
      anecdotal reports are reflective of a large group of people with type 1 diabetes, a clinical
      trial would be warranted.

      The investigators propose to survey the above-mentioned group and their professional diabetes
      care providers to characterize glycemic control and explore associated dietary and diabetes
      care factors.
    

Detailed description: 
      The surveys will address questions in the following domains: 1) Diabetes diagnosis and
      treatment; 2) Carbohydrate-restricted diet; 3) Insulin regimen; 4) Other diabetes related
      care; 5) Diabetes complications; 6) Other related health and healthcare; 7) Patient provider
      interactions; 8) Socio-demographics. Drafts of these surveys are included in the appendix of
      this protocol.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The social media group on Facebook, TYPEONEGRIT, includes approximately 1500 members, the
        majority of whom reportedly have type 1 diabetes and follow a carbohydrate-restricted diet.
      
Keywords: low carbohydrate diet
A Phase 1 Study to Evaluate the Effect of Food on Pharmacokinetics of ASTX029
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Open-label, single dose, randomized, three-period, crossover design study to evaluate the
      effect of food on the bioavailability of a single oral dose of ASTX029 in healthy adult male
      and female participants.

      Following a screening period of up to 28 days, eligible participants will be enrolled and
      randomized to receive a single treatment (A, B, C) in a random order, with each treatment
      separated by an approximate 5-day washout period. The duration of the study is expected to be
      approximately 42 days.
    


Intervention name(s): ASTX029
Intervention type(s): Drug
Intervention description(s): Form: tablet; Route of Administration: oral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Smoking, Abstention and Nicotine Replacement Therapy on Wound Healing
Condition: Wound Healing
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The aim was to determine the wound healing capacity in healthy never smokers and smokers who
      continue to smoke, or quit smoking using transdermal nicotine patch versus placebo patch.
    

Detailed description: 
      Two wound healing models were applied: the excisional skin biopsy model to study wound
      histology and the suction blister model to study epidermal regeneration and skin transudate.
      In addition blood sampling was made to validate compliance to the study arms and to study
      systemic markers of collagen metabolism and oxidative stress. In addition, wound infections
      and wound ruptures were recorded post hoc as complications to the excisional skin biopsy
      model were not expected to occur.
    

Intervention name(s): Transdermal nicotine patch; Placebo patch; Smoking cessation; Continuous smoking
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): 15mg/16h + 10mg/16h to be used 24h; subjects smoke 20 cigarettes per day
Other intervention name(s): Nicorette patch
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Topical Use of Corticosteroid to Prevent Epiretinal Membrane Following Retinal Tear
Condition: Epiretinal Membrane
MeSH terms: Epiretinal Membrane; Retinal Perforations
Study type: Interventional

Summary: 
      In this prospective randomized controlled double blind pilot clinical study, we aim to assess
      whether administration of a topical corticosteroid would attenuate epiretinal membrane
      formation following development of retinal tears treated with laser retionpexy.
    

Detailed description: 
      Epiretinal membrane (ERM) is a frequent, sight-threatening eye condition occurring in 1.02% -
      28.9% of eyes in persons aged 40 years or older. [1] While often idiopathic in nature, ERM
      formation has been associated with retinal tears, possibly due to a breakdown of the
      blood-retinal barrier [1-3]. Pathological analysis of ERM content shows inflammatory
      mediators such as cytokines, growth factors and interleukins, which can promote fibroblast
      remodelling that leads to a contractile scar formation on the retinal surface. [1, 4-8] For
      this reason, ERM formation has been suggested to be an aberrant tissue repair or
      wound-healing process driven by inflammatory reactions. Since corticosteroids inhibit the
      inflammatory cascade and fibroblast transdifferentiation, administration of a corticosteroid
      following retinal tears should theoretically reduce the risk of ERM formation. [9-10] In this
      study, we aim to assess whether administration of a topical corticosteroid would attenuate
      ERM formation following laser retinopexy of retinal tears.
    

Intervention name(s): Prednisolone acetate
Intervention type(s): Drug
Other intervention name(s): Pred Forte
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
A Study to Evaluate Safety and Tolerability of JNJ-61178104 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and
      immunogenicity of JNJ-61178104 following a single ascending Intravenous (IV) dose
      administration and a single Subcutaneous (SC) dose administration in healthy participants.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, single ascending dose, single site,
      interventional study. There will be 5 single ascending dose (SAD) IV cohorts and 1 SC cohort.
      Nine participants will be enrolled into each of 5 IV cohorts and 1 SC cohort and participants
      will be randomized at a ratio of 2:1 to receive JNJ-61178104 or placebo. The total duration
      of participants participation will be approximately 21 weeks including a Screening Visit up
      to 4 weeks prior to study drug administration. Participants will have an inpatient period
      consisting of 6 days/5 nights and will return to the study-site at Weeks 2, 3, 4, 5, 7, 9,
      13, and 17. Participants will be evaluated for safety throughout the study.
    

Intervention name(s): JNJ-61178104 Intravenous; JNJ-61178104 Subcutaneous; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive JNJ-61178104 Intravenously on Day 1.; Participants will receive JNJ-61178104 Subcutaneously on Day 1.; Participants will receive placebo on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy; JNJ-61178104; Placebo; Safety
Use of MigraineBoxTM Head and Neck Cooling Bath for Treatment of Primary Headache in the Emergency Department
Condition: Primary Headache
MeSH terms: Emergencies; Headache
Study type: Observational

Summary: 
      MigraineBoxTM is a simple, contoured cooling bath for the head and neck. Effectiveness of
      MigraineBoxTM will be studied in primary headaches in the emergency department. The user
      simply reclines his/her head and neck into this device that has contours that support the
      head and neck. Luke warm water is filled into the MigraineBoxTM before use and then a frozen
      insert is placed inside. This will gradually cool the water surrounding the patient's head
      and theoretically provide headache relief.
    


Intervention name(s): MigraineBoxTM
Intervention type(s): Device
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting to the emergency department at an urban county hospital.
      
Keywords: Primary headache; Headache; MigraineBox
Early Risk of Asthma in Children Exposed to In-utero Maternal Obesity
Condition: Asthma; Children; Obesity; Maternal
MeSH terms: Asthma; Obesity, Maternal; Obesity
Study type: Observational

Summary: 
      This study seeks a better understanding of the pathogenesis of asthma in early life. The aim
      of this project is to determine whether the offspring of obese mothers at 3 years of life
      have increased the risk of asthma compared to children whose mothers were not obese and
      whether this increased risk is associated with a programming altered immune reactivity at
      birth.
    

Detailed description: 
      The general objectives of this study are:

        1. To determine whether the increased risk of asthma in children born from a pre-pregnant
           obese mother can be observed at 3 years of life and whether this increased risk
           associated with altered plasma levels of immune mediators at birth.

        2. To explore in children born from pre-pregnant obese mother whether monocyte physiology
           and M1-M2 polarization present an altered response and expression of asthma-related
           immune-modulations at birth.

        3. To study in neonates born from pre-pregnant obese mother whether the in vitro expression
           of TNFα, IL12, IL-10 and IL-4Rα in monocytes associates with changes in the DNA
           methylation status in the promoter regions of those genes.

      The study is performed in accordance with the Helsinki Declaration, and the study protocol
      was accepted by Institutional Review Boards at School of Medicine of the Pontificia
      Universidad Católica de Chile.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The recruitment of participants was performed in the Sotero del Rio Hospital at Santiago.
        Women that were obese (BMI>30) or normal weight (BMI<25) at their first antenatal visit
        were invited to participate in the study at the moment of delivery.

        Questionnaires: Information regarding birth outcomes, maternal and paternal history of
        asthma and allergy, as well as environmental conditions at home (pet ownership, indoor
        smoking, heating system, and so on) was collected using a questionnaire at the moment of
        recruitment.

        Follow-up questionnaires by phone are completed every 6 months. These questionnaires
        collect information regarding diagnosis of asthma/allergy and acute respiratory illness,
        environmental conditions, and relevant confounding variables
      
Biospecimen description: 
      Maternal blood sample, cord blood sample and skin prick test.
RCT on Ketorolac and Tramadol in Bone Fractures Pain of Child
Condition: Fracture; Pain
MeSH terms: Fractures, Bone
Study type: Interventional
Phase: Phase 4

Summary: 
      Randomized double blind Trial with the aim to estimate effectiveness of two therapeutic
      regimes per os on pain due to not compound bone fractures in child 4-17 years old:

        -  ketorolac 0,5 mg/kg (1 drop every 2 Kg)

        -  tramadol 2,5 mg/Kh (1 drop every 2 Kg)

      Intensity of pain will be estimated with linear 1 to 10 or analogic McGrath type scale every
      20 min.

      The main objectives are the evaluation of pain decreasing in every group, the time of
      decreasing, the intensity of pain during procedures (ex. Xray) and the occurrence of side
      effects Secondary outcomes are comparison between the two groups on effectiveness on pain and
      on side effects
    


Intervention name(s): ketorolac; tramadol
Intervention type(s): Drug; Drug
Intervention description(s): 0,5 mg/kg per os one time; 2,5 mg/ kg per os in one dose
Intervention MeSH terms: Ketorolac; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bone fracture; ketorolac; tramadol
Reliability of Dosing With NovoLog® Mix 70/30 FlexPen® Compared With Vial and Syringe
Condition: Diabetes; Diabetes Mellitus, Type 2; Delivery Systems
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America (USA). The aim of this trial is to
      compare desired (target) with actual target amounts of insulin dispensed using NovoLog® Mix
      70/30 FlexPen® and vial and syringe in subjects with type 2 diabetes mellitus. No insulin is
      administered in this trial - insulin is dispensed into an empty vial.
    


Intervention name(s): FlexPen®; vial and syringe
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Vaccination of Melanoma Patients With Dendritic Cells Loaded With Allogeneic Apoptotic-Necrotic Melanoma Cells
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Background: Sixteen melanoma patients (1 stage IIC, 8 stage III, and 7 stage IV) were treated
      in a Phase I study to evaluate safety and immune responses, with a vaccine (DC/Apo-Nec)
      composed of autologous dendritic cells (DCs) loaded with a mixture of apoptotic/necrotic
      melanoma cell lines (Apo-Nec).

      Methods: PBMC were obtained from leukapheresis and DCs were generated from monocytes cultured
      in the presence of GM-CSF and IL-4 in serum-free medium. Immature DCs (iDCs) were loaded with
      gamma-irradiated Apo-Nec cells and injected id without adjuvant. Cohorts of four patients
      were given four vaccines with 5, 10, 15, or 20 x106 DC/Apo-Nec per vaccine, two weeks apart.

      Results: The vaccine was well tolerated in all patients. Toxicity to vaccine was mild, and
      the toxicity-limiting dose has not been reached. We found that 42.3 ±13.7 % melanoma
      patients´ iDCs were able to phagocyte Apo-Nec cells wich induced DCs maturation, as evidenced
      by increased expression of CD83, CD80, CD86, HLA class I and II compared to iDCs. Also, after
      phagocytosis, a 75.2 ±16 % reduction in Dextran-FITC endocytosis was observed compared to
      iDCs. CCR7 was upregulated upon Apo-Nec phagocytosis in DCs from all patients and accordingly
      in vitro DC/Apo-Nec cells were able to migrate towards MIP-3 beta. The DTH score increased
      significatively in the patients after the first vaccination and slightly decreased by the
      fourth vaccine (Mann-Whitney Test, p<0.05). For patient #1 a positive DTH reaction was
      detected to her own tumor irradiated cells. The presence of CD8+ T lymphocytes specific to
      gp100 and Melan A/MART-1 Ags were studied by tetramers binding in HLA-A*0201 patients (7 /15
      patients) before and after vaccination. Two patients who remain NED increased Ags their
      specific T lymphocytes after vaccination. No humoral responses to Apo-Nec cells were
      detected. With a mean follow-up of 44.5 months post-surgery, the stage IIC pt is NED, 7/8
      stage III pts are NED and 7/7 stage IV patients have progressed.

      Conclussions: We conclude that DC/Apo-Nec vaccine is well tolerated, it induces specific
      immunity against melanoma Ags and in stage III patients it may prolong disease-free survival,
      affording protection from relapse in an adjuvant setting.
    


Intervention name(s): DC/Apo-Nec
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: melanoma; dendritic cells; apoptotic/necrotic cells; therapeutic vaccine
A Study of Tirzepatide in Overweight and Very Overweight Participants
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to measure the effect of tirzepatide on food intake in
      participants who are overweight or very overweight. The study will also use imaging to learn
      more about how tirzepatide affects specific parts of the brain. The effect of tirzepatide on
      appetite will also be studied. The study will last up to about four months and will include
      up to 14 visits to the study center.
    


Intervention name(s): Tirzepatide; Placebo; Liraglutide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered SC.; Administered SC.; Administered SC.
Other intervention name(s): LY3298176
Intervention MeSH terms: Liraglutide; Tirzepatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effects of Fasting-Mimicking Diet on Central and Peripheral Components of Fatigue, Muscular Resistance
Condition: Fatigue; Muscle, Heart; Fasting; Diet, Healthy; Fatigue, Mental
MeSH terms: Fatigue; Mental Fatigue
Study type: Interventional

Summary: 
      The aim of the study is to test a Fasting Mimicking Diet (FMD) for its efficacy on improving
      muscular resistance and endurance. The investigators will perform a randomized clinical trial
      to test the efficacy of the FMD on improving muscular strength, muscular resistance and
      endurance in physically active young adults (18-40 years of age). The study will include two
      arms: Placebo (Placebo diet) and FMD (3 cycles of 5-day fasting-mimicking diet within two
      months). Study endpoints will include muscular strength evaluation of lower limbs,
      cardio-pulmonary responses, neuromuscular function and muscle architecture. Subjects will be
      evaluated 4 times within 3 months: at baseline (T1), after the 1st cycle of diet (T2), 7 to
      15 days after the 3rd cycle of diet maintaining baseline intensity (T3) and with
      re-assessment of Peak Power Output (T4).
    


Intervention name(s): Fasting-Mimicking Diet (ProLon®); Placebo bars
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary restriction: Fasting-Mimicking Diet (ProLon®). 5-days cycles spaced at 1-month intervals for 3 months (3 cycles in total).; Dietary supplementation: Low-energy bars (L-Nutra®) to integrate the daily nutritional habits - one bar per day.
5-days cycles spaced at 1-month intervals for 3 months (3 cycles in total).
Other intervention name(s): Dieta Mima Digiuno® (italian name)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: fatigue; fasting-mimicking diet; healthy; young adults; exercise
A Study to Assess Selected Biomarkers in Subjects Requiring Daily Inhaled Corticosteroids for Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The rationale for conducting this study is to explore potential clinical and peripheral
      biomarkers in subjects requiring daily medium to high dose inhaled corticosteroids for
      persistent asthma
    


Intervention name(s): No drug will be used; No drug will be used
Intervention type(s): Other; Other
Intervention description(s): Biomarker; Biomarker
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with asthma on stable medium- to high-dose inhaled corticosteroids.
      
Biospecimen description: 
      Blood and Sputum