bioihbjkbjnl/mcl2 huggingface dataset:
Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat-Dialysis (ASCEND-D)
Condition: Anaemia; Aspergillosis, Allergic Bronchopulmonary
MeSH terms: Aspergillosis; Aspergillosis, Allergic Bronchopulmonary; Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this multi-center event-driven study in participants with anemia associated
      with chronic kidney disease (CKD) to evaluate the safety and efficacy of daprodustat.
    


Intervention name(s): Daprodustat; rhEPO; Placebo; Iron therapy
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Daprodustat dose is based on prior ESA dose, the dose is adjusted thereafter in order to achieve the target range.; The initial ESA dose is based on converting the prior ESA dose to the nearest available study rhEPO dose and is administered IV. The dose is adjusted thereafter in order to achieve the target range.; Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).; Participants will receive supplemental iron therapy if ferritin is <=100 ng/mL or TSAT is <=20%. The investigator will choose the route of administration and dose of iron.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: erythropoiesis stimulating agents; GSK1278863; daprodustat; anemia; chronic kidney disease; hemoglobin; recombinant human erythropoietin
Population Study of the Prevalence of Celiac Disease and Other Gluten-dependent Disorders in Children and Adolescents
Condition: Celiac Disease in Children
MeSH terms: Celiac Disease
Study type: Observational [Patient Registry]

Summary: 
      To study the prevalence and clinical features of celiac disease in children to develop new
      treatment approaches and rehabilitation strategies.
    

Detailed description: 
      The purpose of this screening program is to identify people at high risk for developing
      celiac disease, which is due to the genetic intolerance of gluten - a protein found in wheat,
      rye and barley. When a person with celiac disease consumes gluten-containing foods, his
      immune system damages the mucous membrane of the small intestine. Inflammation develops and,
      as a result, the absorption of vitamins, minerals and other vital nutrients is disrupted.
      Studies have shown that timely diagnosis of celiac disease is important for the treatment or
      prevention of its complications. Left untreated, the disease can lead to impaired growth and
      development, diabetes, cancer, or other diseases. In Europe and the USA, celiac disease is a
      chronic disease that occurs in approximately one in 100 and one in 22 who have risk factors.
      There are frequent cases of an erased or low-symptom course of celiac disease. Unfortunately,
      ninety-seven percent of cases remain undiagnosed and, accordingly, do not receive proper
      treatment. A screening program will increase knowledge about the disease and contribute to
      the early detection of the disease.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Schoolchildren of the city of Moscow
Safety and Immunogenicity Study of a Dengue Virus DNA Vaccine
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to exame the safety of a DNA vaccine against dengue-1.
    

Detailed description: 
      Dengue is a desease that affects 100 million people throughout the world mainly in tropical
      countries in the South Pacific, Asia, the Caribbean, and Africa. The disease often presents
      with high fever, severe headache, and joint/muscle pain that usually goes away on its own,
      but it can also present as a sometimes deadly hemorrhagic (bleeding) disease. Humans catch
      this disease by being bitten by mosquitoes that have been infected with dengue virus.
      Scientists at the Naval Medical Research Center have been working on vaccines to prevent
      dengue disease. This vaccine, referred to as D1ME, is an experimental DNA vaccine that
      contains genes from the dengue-1 virus. The purpose of this study is to test the safety of a
      new experimental vaccine against dengue and to see if the vaccine can stimulate the immune
      system.
    

Intervention name(s): D1ME100 (dengue-1 premembrane/envelope DNA vaccine)
Intervention type(s): Biological
Intervention description(s): IM injection delivered by Biojector
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dengue; DNA vaccine
Multi-center Study of Myeloablative Allo Stem Cell Transplant for Non-remission AML Using CloBu4 Regimen
Condition: Acute Myeloblastic Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 2

Summary: 
      Although transplant results for AML in complete remission (CR) at the time of transplant have
      improved, transplant results for non-remission AML have been quite poor. Most multi-center
      studies have focused on standard risk AML patients and not many studies have been done in
      this population of patients with non-remission AML. There are a large number of older
      patients with non-remission AML because the complete remission rate with induction
      chemotherapy decreases with age. Such older patients do not tolerate conventional full
      intensity conditioning regimens. Thus, an effective and tolerable conditioning regimen for
      non-remission AML is a great unmet need for current transplant practice.

      From the investigators earlier study, it is suggested that replacing Fludarabine of standard
      FluBu4 regimen by Clofarabine (a related drug with much more potent anti-leukemia effect) in
      the transplant conditioning regimen may potentiate the anti-tumor activity of the
      conditioning regimen without adding significant toxicity, a goal of new conditioning regimen
      development.

      The investigators expect to enroll a total of 75 patients from about fifteen sites. The
      investigators main objective is to confirm both the safety and efficacy as measured by
      one-year overall survival, of the CloBu4 combination as full intensity conditioning for
      non-remission acute myelogenous leukemia.
    


Intervention name(s): Clofarabine/Busulfan x 4; Peripheral blood stem cell transplant
Intervention type(s): Drug; Procedure
Intervention description(s): Clofarabine IV dose level: 40 mg/m2/day x 5 days
Busulfan IV dose level: 3.2 mg/kg daily x 4 days; Peripheral blood stem cell transplant, after pre-conditioning drug treatment
Intervention MeSH terms: Busulfan; Clofarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AML
The Efficacy of Cranial Electrostimulating Therapy for Depression and Anxiety Among Homeless Adults
Condition: Depression; Anxiety
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      This is a trial of the use of cranial electrostimulating therapy for depression and anxiety
      among homeless adults.
    

Detailed description: 
      Cranial Electrostimulating (CES) Therapy is a Food and Drug Administration (FDA) approved
      treatment for depression and anxiety. However, there are no known studies on the use of this
      device with homeless adults. The objectives of this study are as follows: 1) to evaluate the
      acceptability and feasibility of CES as a treatment for homeless adults; and 2) to evaluate
      the efficacy of CES for the treatment of anxiety and depressive symptoms among homeless
      adults. Participants will be randomly assigned to one of two treatments: sham (n=10) or CES
      (n=10). Changes in anxiety and depressive symptoms will be evaluated over time.
    

Intervention name(s): Alpha Stim device; Sham device
Intervention type(s): Device; Device
Intervention description(s): cranial electrotherapy stimulation device; Sham device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Validation of a Portable Medical Device for Diagnostic in Vitro
Condition: Healthy Volunteer; Patients Under Vitamin K Antagonist (VKA)
Study type: Interventional

Summary: 
      This clinical trial is about a new technology, named HEMOPTIC. It enables to mesure time of
      blood coagulation for monitoring of patients under Vitamin K antagonist (VKA).

      This device was created as an alternative to blood sample, that have to be done in a medical
      laboratory.

      The main goal is to evaluate the accuracy of the International Normalized Ratio (INR)
      measurement of this new portable device for diagnostic in vitro, among healthy patients and
      patients under anti-vitamin K treatment.
    


Intervention name(s): HEMOPTIC
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Medical device; Hemoptic; Vitamin K antagonist; Diagnostic in vitro
Safety of DTPa-IPV/Hib & DTPa-HBV-IPV/Hib, Followed by DTPa-IPV/Hib Vaccine in Infants Who Received Hepatitis B Vaccine
Condition: Haemophilus Influenzae Type b; Diphtheria; Tetanus; Poliomyelitis; Acellular Pertussis
MeSH terms: Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the safety and reactogenicity of the DTPa-HBV-IPV/Hib vaccine and DTPa-IPV/Hib
      vaccine. This DTPa-IPV/Hib vaccine given at 3 and 4 months of age is co-administered with GSK
      Biologicals' rotavirus vaccine or Placebo. The Protocol Posting has been updated in order to
      comply with the FDA Amendment Act, Sep 2007.
    

Detailed description: 
      Single group study. Subjects in GSK Biologicals' rotavirus study (Rota-028) in Singapore will
      be enrolled in this study.
    

Intervention name(s): DTPa-HBV-IPV/Hib; DTPa-IPV/Hib vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 1 intramuscular injection (3rd study vaccine dose); 3 intramuscular injections (1st, 2nd and 4th vaccine dose)
Other intervention name(s): INFANRIX HEXA™
Intervention MeSH terms: Edetic Acid; Pentetic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Characterization of Skeletal Muscle Using Magnetic Resonance Elastography (MRE)
Condition: Stroke; Immobilization; Myofacial Pain; Hyperthyroid Myopathy
MeSH terms: Muscular Diseases; Hyperthyroidism; Facial Pain
Study type: Observational

Summary: 
      The goal of this proposal is two-fold: (1) to further develop and validate a technology,
      magnetic resonance elastography (MRE), for quantitatively imaging mechanical properties and
      tension distribution in muscle and (2) to apply the technique for in vivo evaluation of
      patients with four common, and clinically significant muscle disorders (spasticity, disuse
      atrophy, myofascial pain and a metabolic myopathy). These studies will employ a magnetic
      resonance imaging sequence with synchronous motion-sensitizing gradients to map propagating
      shear waves in the muscle. The technique will assess the mechanical properties of the muscle
      and its tension distribution. Specifically, the study can be divided into three specific
      aims. Aim 1: Optimize MRE methods of acquisition and analysis for the assessment of muscle,
      including electromechanical drivers, data acquisition techniques, and methods for image
      analysis. Advanced techniques for very rapid MRE assessment of muscle will continue to be
      developed. Aim 2: Validate the MRE assessment of muscle properties and tension with phantom,
      ex-vivo muscle, and Finite Element Modeling (FEM) techniques. Finite Element Analysis will be
      performed by using both phantom and bovine muscles to better correlate MRE wave-length
      findings as function of muscle properties, tension and fiber architecture. Aim 3: Study In
      Vivo Normal and Abnormal Muscle. The MRE technique will be applied in vivo to provide
      elastographic images of abnormal muscle with known disorders. The patient groups chosen for
      study are each important in their own right, and furnish unique information across the
      spectrum of muscular disease and dysfunction. Groups to be studied include individuals with
      new onset of spasticity following an ischemic, hemispheric stroke, disuse atrophy as a result
      of immobilization, metabolic (hyperthyroid) myopathy and myofascial pain for trigger point
      identification. The overall hypothesis of this work is that will bring benefits to both basic
      research and clinical care.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Residents of the community and patients of the study investigators.
      
Keywords: Stroke; Immobilization; Myofacial Pain; Hyperthyroid Myopathy
Validation of the Doubly Labelled Water Method in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The present study is an exploratory trial to establish a feasible DLW (doubly labelled water)
      protocol for implementation in clinical trials conducted at Profil Institut für
      Stoffwechselforschung, investigating treatment options for overweight and obesity in
      populations with and without diabetic comorbidity. The study aims at the practical validation
      of a 1-2-week DLW protocol in overweight and obese type 2 diabetic subjects.

      Total Energy Expenditure (TEE) values as assessed by DLW will then be compared to (1) TEE as
      calculated based on individual anthropometric measurements (including body composition) using
      the Müller formula and the AEE (activity related energy expenditure) based on reported work
      place and leisure time activities and (2) TEE as calculated from measured REE (resting energy
      expenditure) as assessed by indirect calorimetry and the AEE based on information recorded by
      the subjects in a physical activity diary and corresponding pedometer counts. Moreover, TEE
      assessments will be repeated once (separated by 2-4 weeks) to determine intra-subject
      variability / re-test reliability of the measurement.
    


Intervention name(s): Doubly labelled water method
Intervention type(s): Procedure
Intervention description(s): DLW (doubly labeled water) method measures isotope dilution spaces and elimination rates to assess total energy expenditure (TEE). After enriching the body water of a subject with DLW (2H and 18O), it is only necessary to collect urine samples at defined time points, usually over a period of 1-2 weeks, so that the measurement can be done in individuals able to engage in their typical habits without restrictions. The resulting TEE measurement represents an integral value over the measurement period.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Cesarean Section Study
Condition: Diarrhea; Atopic Dermatitis
MeSH terms: Dermatitis; Diarrhea
Study type: Interventional

Summary: 
      Effect, tolerance and safety of a supplementation with a probiotic on the risk of
      gastrointestinal infections, on growth, and on gut microbiota in healthy newborn term infants
      born by Cesarean section. Exploratory comparison between a probiotic vs. placebo in the
      formula-fed and in the breastfed feeding groups.
    


Intervention name(s): Probiotic
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Cesarean section, probiotic, formula fed, gut microbiota
Epinephrine Inhalation Aerosol USP, CLINICAL STUDY-B3 FOR ASSESSMENT OF PHARMACOKINETICS
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine
      Inhalation Aerosol USP, an HFA134a propelled Metered Dose Inhaler (MDI) (E004), using a
      stable isotope deuterium-labeled epinephrine (epinephrine-d3) to differentiate the
      administered drug from the endogenous epinephrine, in healthy male and female adult
      volunteers.
    

Detailed description: 
      The current study is designed to complement and expand the previous PK studies, API-E004-CL-B
      and API-E004-CL-B2, with emphasis on lower E004 dose strengths (at 90 and 100 mcg per
      inhalation), for a more thorough evaluation of the E004 PK profiles. Safety of E004 will also
      be evaluated, under augmented dose conditions.
    

Intervention name(s): Arm T1: Primatene Mist HFA; Arm T2: Primatene Mist HFA; Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes; epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes; epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes
Other intervention name(s): epinephrine inhalation aerosol; epinephrine inhalation aerosol; epinephrine inhalation aerosol
Intervention MeSH terms: Epinephrine; Racepinephrine; Epinephryl borate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Asthma; shortness of breath; wheezing
Evaluation of Graft Material in Coronary Artery Bypass Grafting (CABG)
Condition: Angina Pectoris
MeSH terms: Angina Pectoris
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the patency in different kinds of vessels used as graft
      material in coronary artery bypass grafting.

      The hypothesis is that vein grafts harvested with a pedicle of surrounding tissue have the
      same, or better, patency compared to radial grafts and that skeletonisation of the left
      internal mammary artery does not effect the patency for this graft.
    

Detailed description: 
      Patients undergoing coronary artery bypass grafting are included in the study.

      Each patient receive a radial artery graft and a vein graft harvested with a pedicle of
      surrounding tissue to the right and left side of the heart respectively. The left internal
      mammary artery is used for the left anterior descending artery in a skeletonised or
      non-skeletonised fashion.

      The evaluation is made with angiography up to 5 years after surgery.
    

Intervention name(s): Coronary artery bypass grafting
Intervention type(s): Procedure
Intervention description(s): Bypass of stenoses in coronary arteries using different types os vessels as conduit.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: CABG; LIMA; saphenous vein; radial artery
Bioequivalence Study Comparing Clindamycin Phosphate (1.2%) and Tretinoin (0.025%) Topical Gel to Ziana and Placebo
Condition: MILD TO SEVERE ACNE VULGARIS
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      ZIANA® (clindamycin phosphate 1.2% and tretinoin 0.025%) gel, marketed by Medicis, The
      Dermatology Company®, is a safe and effective topical therapy used for the treatment of acne
      vulgaris. Actavis Mid-Atlantic LLC has developed a generic formulation of clindamycin
      phosphate (1.2%) and tretinoin (0.025%) topical gel and the current study is designed to
      evaluate the bioequivalence of this formulation to ZIANA®.
    


Intervention name(s): CLIND PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL; ZIANA®; Vehicle Control
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Topical Gel applied in the evening for 84 days; Topical Gel applied in the evening for 84 days; Topical Gel applied in the evening for 84 days.
Intervention MeSH terms: Tretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acne; Ziana; clindamycin; tretinoin
Sensitivity and Specificity of the Roth Test in Patients With COVID-19 Positive
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      The presence of the described silent hypoxia in subjects diagnosed with COVID19 highlights
      the need for valid tools to assess respiratory capacity. The Roth test has been associated
      with acceptable sensitivity and specificity criteria in patients with previous respiratory
      pathology; however, its validity in this type of patient has not been proven.
    


Intervention name(s): Roth´s Test
Intervention type(s): Diagnostic Test
Intervention description(s): Subjets must count from 1 to 30 in their languages, and health professional will count seconds that last in take breath during the count.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects aged 18 to 90 years were recruited by non-probabilistic convenience sampling in
        Primary Health Care Centres of the Primary Health Care Management of SERMAS and the
        Intensive Care Unit of the University Hospital of Gran Canaria Doctor Negrín of the Canary
        Health Service