bioihbjkbjnl/mcl2 huggingface dataset:
Study of Intravenous Administration of Allogeneic Adipose Stem Cells for COVID-19
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed rapidly assess safety and preliminary efficacy in hospitalized
      patients with COVID-19 respiratory distress to provide clinical guidance for possible wider
      use in treating patients in this pandemic environment. This data will be used for FDA IND
      filings and pursuit of a BLA.
    

Detailed description: 
      This study is single arm, non-randomized Phase 1 study of the safety and preliminary efficacy
      of PSC-04, an adipose-derived allogeneic mesenchymal stem cell. The outcome data will be
      compared to contemporaneous non-enrolled patients at the same clinical site(s) as the
      enrolled patients.

      Study Objectives:

      Primary: To evaluate the safety of intravenous infusion of allogeneic adipose stem cells in
      patients with COVID-19 disease and respiratory distress.

      Secondary: To evaluate a set of secondary safety and efficacy outcome variables to give
      guidance in assessing the risk/benefit ratio in patients with COVID-19 respiratory distress.
    

Intervention name(s): PSC-04
Intervention type(s): Biological
Intervention description(s): adipose stem cells derived from screened donor lipoaspirate and culture expanded.
Other intervention name(s): allogeneic, adipose-derived stem cells
Intervention model: Single Group Assignment
Intervention model description: single group comparison with cohort of contemporaneous non-treated patients.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adipose; stem cell; COVID19; COVID-19; pneumonia
Evaluation of Various Doses of Ro 27-2771 (Test Drug) in Asthmatic Patients Not Treated With Inhaled Corticosteroids
Condition: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the appropriate dose of Ro 27-2441 (test drug) to
      be used in future studies, assess the efficacy and safety, and the anti-inflammatory action
      of the test drug in the treatment of asthmatic patients who are not currently receiving
      chronic therapy with corticosteroids. The research is being conducted at up to 80 clinical
      research sites in the US, Mexico, and Canada. Study participants will have a number of visits
      to a research site over approximately a 4-month period.
    


Intervention name(s): Dual Integrin Antagonist
Intervention type(s): Drug
Primary purpose: Treatment
Bioequivalence Study of Ibuprofen D, Oral Suspension, 200 mg/5ml and Nurofen®, Oral Suspension 100 mg/5 ml in Healthy Volunteers Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate bioequivalence of single dose test formulation of Ibuprofen,oral suspension
      200 mg/5 ml (containing ibuprofen 200 mg) of Pharmtechnology LLC, Republic of Belarus with
      reference Nurofen® for Children, oral suspension 100 mg / 5 ml (containing ibuprofen 100 mg)
      of "Reckitt Benckiser Healthcare International Ltd, .", UK in normal, healthy, adult, human
      subjects under fasting conditions.To monitor adverse events and ensure the safety
    

Detailed description: 
      Total 30 normal healthy adult subjects will be enrolled in the study. Subjects will be
      administered either the Test (5 ml of oral suspension containing 200 mg of ibuprofen) or the
      Reference Product (10ml of oral suspension containing 200 mg of ibuprofen) with 200 mL of
      water in each period as per the randomization schedule. Subjects will fast for at least 10
      hours prior to administration of the study drugs and for four (4) hours after administration
      of the study drugs during each study period. Standardized meals will be provided in each
      study period. Water will not be accessible to the subjects 1 hour to administration of the
      study drugs and 2 hours after administration of the study drugs in each period. A total of 20
      blood samples will be withdrawn for pharmacokinetic profiling during each study period. The
      plasma concentrations of R- and S-enantiomers of ibuprofen will be measured by a validated
      LC-MS/MS analytical method. ANOVA will be performed on log transformed pharmacokinetic
      parameters Cmax, AUC0-t and 90% confidence interval will be constructed for the ratio of
      geometric least square mean of the Test and Reference products, obtained from the
      log-transformed data. Bioequivalence will be concluded if the ratio estimate as well as its
      90% confidence interval of S-enantiomers of ibuprofen, both falls within the acceptable range
      of 80.00% to 125.00% for Cmax, AUC0-t.
    

Intervention name(s): Ibuprofen D; Nurofen® for Children
Intervention type(s): Drug; Drug
Intervention description(s): Ibuprofen D, oral suspension, 200 mg / 5ml, manufactured by LLC Pharmtechnology, Belarus; Nurofen® for Children, Oral Suspension, 100 mg / 5 ml, marketed by Reckitt Benckiser Healthcare International Ltd, UK
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence
Integrated Biomarker And Imaging Study - 2
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      IBIS-2 is a study using SB-480848 versus placebo in subjects with angiographically documented
      coronary heart disease. Endpoints include coronary imaging, endothelial function, biomarkers,
      safety and tolerability.
    

Detailed description: 
      Integrated Biomarker and Imaging Study -2 (IBIS-2): An International, Multicenter,
      Randomized, Placebo-controlled, Parallel-group, 1 Year Treatment, Integrated Biomarkers and
      Imaging Study in Subjects with Angiographically Documented Coronary Heart Disease (CHD) to
      Examine the Effects of the Novel Lipoprotein-associated Phospholipase A2 (Lp-PLA2) inhibitor
      SB-480848 on Intermediate Cardiovascular Endpoints, Patient Safety and Tolerability.
    

Intervention name(s): SB-480848; SB-480848 matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): SB-480848 is available as enteric-coated, free-base micronized tablet; Placebo is available as enteric-coated, free-base micronized tablet
Intervention MeSH terms: Darapladib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Coronary artery disease; Lipoprotein-associated Phospholipase A2; palpography; hs-CRP; endothelial function; intravascular ultrasound
Drug-Drug Interaction Study of Esomeprazole (D961H) Capsule and Loxoprofen Tablet After Repeated Oral Administration in Japanese Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic profile of Esomeprazole (D961H)
      during repeated oral administration with and without co-administration of loxoprofen and the
      pharmacokinetic profile of loxoprofen during repeated oral administration with and without
      co-administration of Esomeprazole (D961H).
    


Intervention name(s): Esomeprazole (D961H); Loxoprofen
Intervention type(s): Drug; Drug
Intervention description(s): 20mg; 60mg tablet
Other intervention name(s): Nexium; Loxonin
Intervention MeSH terms: Loxoprofen; Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: male; Japan; Japanese; Healthy volunteers
Efficacy and Safety of BI 1356 BS (Linagliptin) in Combination With Metformin in Patients With type2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the study is to test the efficacy, safety and tolerability of several doses
      of BI 1356 BS (1, 5, or 10 mg taken once daily) compared to placebo given for 12 weeks
      together with metformin in patients with type 2 diabetes mellitus who are not at goal with
      their HbA1c levels. In addition, there will be an unblinded treatment arm with glimepiride as
      add-on therapy to metformin for comparison. The influence of several factors (gender, age,
      weight, race, etc.) on the bioavailability and efficacy of BI 1356 BS will also be tested in
      this study.
    


Intervention name(s): Linagliptin; Linagliptin; Linagliptin; Placebo; Glimepiride
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Linagliptin medium dose tablet once daily; Linagliptin high dose tablet once daily; Linagliptin low dose tablet once daily; Placebo tablets once daily; Glimepiride tablets once daily
Intervention MeSH terms: Glimepiride; Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Preoperative Biliary Drainage in Patients With Operable Malignant Periampulary Tumors
Condition: Periampullary Cancer; Biliary Obstruction; Preoperative Biliary Drainage
Study type: Interventional

Summary: 
      The impact of preoperative biliary drainage (PBD) on morbidity and mortality associated with
      Pancreaticoduodenectomy (PD) in patients with peri-ampulary tumors is still controversial.
      The objective of this study is to evaluate the impact of PBD on surgical and oncologic
      outcomes after PD in jaundiced patients with operable peri-ampulary tumors.
    

Detailed description: 
      150 consecutive jaundiced patients with suspected operable peri-ampullary tumors were
      randomized via concealed envelopes into 2 groups (each included 75 patients), group I managed
      by direct surgery while group II managed by PBD followed by surgery. Both groups were
      compared regarding perioperative mortality, morbidities, tumor recurrence and 2 years
      survival rates.
    

Intervention name(s): Preoperative Biliary Drainage (PBD); Surgery
Intervention type(s): Procedure; Procedure
Intervention description(s): Endoscopic retrograde biliary drainage (ERBD) and stent placement was the first choice for PBD while ultrasound-guided percutaneous transhepatic biliary drainage (PTBD) was done if ERBD was not feasible. Biliary drainage was considered successful if the serum bilirubin level decreased by 50% or more within 2 weeks after the procedure. Patients with failed PBD were referred directly to surgery, while those with successful PBD were referred to surgery 4 to 6 weeks after first drainage procedure according to the latest guidelines; The standard surgical procedure for operable tumors Whipple procedure with triple reconstruction, namely pancreatogastrostomy or pancreatojejunostomy,hepaticojejunostomy and gastrojejunostomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
A Pilot Study Testing 1064nm Q-switch Laser Versus Glycolic Acid Peels for the Treatment of Melasma
Condition: Melanosis
MeSH terms: Melanosis
Study type: Interventional

Summary: 
      The purpose of this study is to find out the safety and effectiveness of 1064 Q-Switch Laser
      Therapy compared to Glycolic Acid Chemical Peels for the treatment of melasma.
    

Detailed description: 
      Participants in this study will be patients at the dermatology clinic who are clinically
      diagnosed with at least a 2X2 cm patch of melasma on each side of their face (forehead or
      cheek). Starting at 2 weeks before treatment (week 2), both sides will be pretreated and
      primed with 4% hydroquinone with, if necessary, 2.5% hydrocortisone cream BID. On the
      treatment day (2-weeks) and 6-weeks one half of the subject's face will receive glycolic acid
      peels and the other half of the face will receive 1064nm Q-switch laser. This study is a
      pilot study designed to determine feasibility of these procedures.
    

Intervention name(s): 1064nm Q-switch Laser; Glycolic Acid Peels
Intervention type(s): Device; Other
Intervention MeSH terms: Glycolic acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Interest of Hypnosis in Virtual Reality on Nociception During Oocyte Retrieval in a Medically Assisted Reproduction Procedure
Condition: Oocyte Retrieval
Study type: Interventional

Summary: 
      Study on the effect of the virtual hypnosis mask in addition to local anaesthesia on anxiety
      and perioperative pain during oocyte puncture
    


Intervention name(s): local anaesthetic injection; hypnosis with Virtual reality mask
Intervention type(s): Drug; Device
Intervention description(s): Infiltration of 40 to 80 ml of a non-adrenalized 0.5% lidocaine solution into the vaginal wall at the level of the vaginal pouches, under ultrasound guidance. (within the limit of the toxic doses, i.e. 5mg/kg); A 20-minute virtual reality hypnosis session is performed from the time the patient is placed on the surgical table until the end of the oocyte poncture
Intervention MeSH terms: Anesthetics; Anesthetics, Local
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-centre, comparative, randomised, parallel group study
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Urinary Biomarkers For Objective Measurement Of InterStim® Response In Over Active Bladder (OAB) Patients.
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Observational

Summary: 
      The goal of this study is to compare protein markers in the urine of patients with and
      without overactive bladder (OAB) and InterStim®.
    

Detailed description: 
      This study will look for changes in protein markers that might reflect bladder symptoms
      before and after InterStim® implant.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with either have OAB and will be undergoing an InterStim® implant (InterStim®
        group) or do not have bladder symptoms or an InterStim® device (Control group)
Clinical Study of TUTI-16 in Asymptomatic HIV-1 Infected Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This protocol represents the first in human study of TUTI-16, and is being conducted to
      establish the safety and human immunogenicity (anti-HIV-1 Tat titers) of subcutaneously
      administered TUTI-16. Activity of TUTI-16 will also be determined in minimizing HIV-1 viral
      loads and sustaining CD4+ T-cell levels.
    

Detailed description: 
      HIV-1 Tat protein, a virally encoded toxin, is secreted by HIV-1 infected cells and acts on
      uninfected cells, rendering them permissive for HIV-1 replication. HIV-1 Tat enhances chronic
      viral replication and induces immune suppression. Antibodies to Tat inhibit this Tat-mediated
      transcellular activation in vitro and minimize chronic plasma viremia. HIV-1 Tat activities
      can be blocked in vitro and in vivo by anti-Tat antibodies.

      The Thymon Universal Tat Immunogen (TUTI-16) is a fully synthetic, self-adjuvanting
      lipopeptide vaccine that is water soluble and administered by subcutaneous injection. In
      preclinical studies, a priming dose and a three week boost in rats induced a high titer
      antibody response to the eight known distinct epitope variants of HIV-1 Tat protein. These
      antibodies block the function of the HIV-1 Tat protein (toxin), which is essential to the
      maintenance of chronic HIV-1 viremia. Therefore, TUTI-16 has potential as a therapeutic
      vaccine for HIV-1 in humans.
    

Intervention name(s): Placebo; TUTI-16 (0.03mg); TUTI-16 (0.1mg); TUTI-16 (0.6mg)
Intervention type(s): Other; Biological; Biological; Biological
Intervention description(s): Subcutaneous injection on Day 0, Day 28, and Day 84; Subcutaneous injection on Day 0, Day 28, and Day 84; Subcutaneous injection on Day 0, Day 28, and Day 84; Subcutaneous injection on Day 0, Day 28, and Day 84
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; vaccine; lipopeptide; Tat; TUTI-16; THYMON; Treatment Naive
Cow Milk Allergy: Evaluation of the Efficacy of a New Thickened Extensively Hydrolyzed Formula in Infants With Confirmed Cow Milk Allergy
Condition: Cow Milk Allergy
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to assess the hypoallergenicity of a new thickened extensively
      hydrolyzed formula.
    


Intervention name(s): Extensively Hydrolyzed formula
Intervention type(s): Dietary Supplement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
Condition: Heart Disease
MeSH terms: Heart Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Ancillary Effects of Dexmedetomidine Sedation After Cardiac Surgery
    

Detailed description: 
      The investigator goal is to evaluate the effects of intraoperative and postoperative
      dexmedetomidine sedation (versus placebo after cardiac surgery.
    

Intervention name(s): Dexmedetomidine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine; Normal saline administration matching dexmedetomidine rate of infusion
Other intervention name(s): Saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Evaluation of the Effects of Heating or Massaging or Vibrating at the Vicinity of the Insulin Delivery Site
Condition: Diabetes
Study type: Interventional

Summary: 
      The aim of this study is to test the pharmacodynamics of insulin analogs and their dependence
      on external and physiological alterations. We plan to compare the pharmacodynamics of insulin
      analog delivery in regular conditions and in the presence of increased perfusion of the
      delivery site, achieved by way of local warming and movement
    


Intervention name(s): with heat and massage
Intervention type(s): Device
Intervention description(s): For the with intervention group a treatment to the injection site is applied after each insulin bolus injection.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: diabetes; post prandial glucose level; insulin; pharmacokinetics; pharmacodynamics
Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers Including Absolute Bioavailability and Food Effect
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of single
      doses of BIIB061 administered to healthy adult volunteers. Secondary objectives in this study
      population are to determine the single-dose pharmacokinetic (PK) profile and the absolute
      bioavailability (Fabs) of BIIB061 and to determine the effects of food intake (high-fat,
      high-calorie meal) on BIIB061 PK and safety.
    


Intervention name(s): BIIB061; Placebo; 14C-BIIB061
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BIIB061 capsules for oral administration; BIIB061 matching placebo capsules; Radiolabeled containing 14C-BIIB061 ≤ 500 nCi.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: BIIB061; Healthy
Effects of Intravenous Clonidine on Ocular Blood Flow and Intraocular Pressure
Condition: Physiology
Study type: Interventional
Phase: Phase 4

Summary: 
      Background Clonidine, a derivate of Imidazol, is an antihypertensive drug. It acts by
      stimulating adrenergic receptors on nerves in the brain and Imidazol-receptors. As a result,
      clonidine slows the heart rate and reduces blood pressure. Clonidine was approved by the FDA
      in 1974 and is registered in Austria with the brand name "Catapresan".

      Alpha2 adrenergic agonists are nowadays used topically as eye drops in glaucoma treatment. In
      addition to their known effect of lowering intraocular pressure, alpha2 adrenoceptor agonists
      are neuroprotective. Brimonidine, which is the most commonly used topical alpha-2 agonist, is
      currently on the market for treatment of glaucoma and is effective in reducing intraocular
      pressure. It has, however, been shown that brimonidine is a very potent vasoconstrictor in
      the ciliary body thus reducing aqueous humor production. Little is, however, known about
      potential vasoconstrictor effects of brimonidine in the posterior pole of the eye. This is of
      clinical importance, because optic nerve head ischemia appears to contribute to glaucoma
      pathophysiology. Direct investigation of the ocular hemodynamic effects of brimonidine is,
      however, difficult, because lowering intraocular pressure with brimonidine may confound the
      results due to the concomitant change in ocular perfusion pressure.

      The aim of the present study is to assess the effect of intravenous clonidine as model drug
      of alpha agonists on ocular blood flow and IOP in healthy humans.

      Study objectives:

      To investigate effects of clonidine on ocular blood flow and intraocular pressure.
    


Intervention name(s): clonidine (drug) intravenously
Intervention type(s): Drug
Intervention MeSH terms: Clonidine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: clonidine; glaucoma
Bronchial Challenge Test of Magnesium-treated Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The present study is part of a project titled 'Magnesium in asthma and chronic obstructive
      pulmonary disease'. The hypothesis of the main project is that a daily magnesium supplement
      will benefit patients with asthma and chronic obstructive pulmonary disease.

      The aim of this part of the project is to study the effect of a daily magnesium supplement on
      the grade of bronchial hyperreactivity in asthmatics.
    


Intervention name(s): Magnesium supplement (magnesium hydroxide/ -oxide); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 3 tablets of Mablet (360 mg per tablet) daily for 12 weeks Produced by: Gunnar Kjems APS; 3 placebo-tablets daily for 12 weeks
Other intervention name(s): Mablet
Intervention MeSH terms: Magnesium Hydroxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bronchial challenge test; Hyperreactivity; PD20 for metacholine; Daily magnesium supplement