bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Pharmacokinetics of Three Dosages of Niagen in Healthy Subjects
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study in to analyse the way in which the body processes Niagen
      (nicotinamide riboside) in healthy people. Blood and urine samples from subjects who are
      given a dose of Niagen will be analyzed for metabolites over the 24 hours after taking the
      dose.
    


Intervention name(s): Niagen 100mg; Niagen 300mg; Niagen 1000mg
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Pharmacokinetics; Niagen; Nicotinamide riboside
Study to Assess the Safety and Pharmacokinetics of WP1122 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study in healthy human volunteers will investigate the effects of a single dose (SAD)
      and multiple days of dosing (MAD) of WP1122 administered as an oral (PO) solution. Dose
      escalation will take place in sequential SAD cohorts, and MAD will start as soon as SAD has
      completed at least 3 dosing cohorts in which WP1122 is found to be safe and well-tolerated.
      This study in healthy volunteers will explore safety and PK, and subsequent clinical
      development will be in patients infected with SARS CoV-2 in the setting of continued safety
      and favorable risk/benefit.
    


Intervention name(s): WP1122; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution; Oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Usefulness of Non-invasive Radiofrequency Therapy for Facial Contouring
Condition: Subcutaneous Fat
Study type: Interventional

Summary: 
      To evaluate the efficacy of novel noninvasive RF technology for reduction of submental fat.
    

Detailed description: 
      Recently, Novel radiofrequency (RF) technology was introduced as a promising tool for
      non-invasive body and face contouring, which can heats subcutaneous fat up to 45℃
      continuously without surface damage and induces adipocytes apoptosis.

      Subjects with an excessive subcutaneous fat on the submental area received twice treatments
      at 1-month intervals. Clinical outcomes including the thickness of the submental fat
      (measured by ultrasound) and the submental circumference (measured by a tape measure), and
      clinical photographs were obtained at baseline, and 1-month and 6-month after last treatment.
    

Intervention name(s): Noninvasive Radiofrequency TruSculpt
Intervention type(s): Procedure
Intervention description(s): Heating subcutaneous fat up to 45℃ continuously at least 3 minutes without surface damage and induces adipocytes apoptosis.
Other intervention name(s): TruSculpt
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: radiofrequency; submental fat; fat reduction; body contouring
Factor Xa Inhibitor Versus Standard of Care Heparin in Hospitalized Patients With COVID-19 (XACT)
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a multicenter, randomized trial to study the potential benefit of treatments
      with a direct FXa inhibitor (rivaroxaban) versus standard of care dose subcutaneous low
      molecular weight heparin (LMWH) (Lovenox) in hospitalized subjects with COVID-19.
    

Detailed description: 
      As clinicians learn how to better care for hospitalized COVID-19 patients, the clinical
      picture of a hypercoagulable state with abnormal blood clotting has emerged. Fulminant heart,
      lung, kidney, and liver failure are hallmarks of COVID-19 non-survivors and have been
      associated with abnormal blood coagulation parameters, such as elevated D-Dimer levels. The
      current standard of care using prophylactic levels of subcutaneous heparin has not
      significantly mitigated the risk of patients entering a hypercoagulable state, however the
      dysregulated thrombotic and inflammatory events that drive poor outcomes in many COVID-19
      patients may be amenable to early treatment with a factor Xa (FXa) inhibitor. The purpose of
      this study is to study the potential benefit of treatments with a direct FXa inhibitor
      (rivaroxaban) versus standard of care dose subcutaneous LMWH (Lovenox) in hospitalized
      subjects with COVID-19.
    

Intervention name(s): Enoxaparin; Rivaroxaban
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous enoxaparin While hospitalized only.; Oral rivaroxaban While hospitalized and through discharge for a total of 28 days.
Intervention MeSH terms: Enoxaparin; Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Open-label Multicenter Prospective Randomized Trial in hospitalized patients with severe acute respiratory syndrome (SARS)-CoV-2 infection. Patients will be randomized 1:1 to subcutaneous enoxaparin (Lovenox) versus rivaroxaban after hospitalization, with the exact dosing is based on an adaptive strategy.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronavirus; Enoxaparin; Rivaroxaban; Anticoagulants; Anti-inflammatory; Anti-viral; ARDS
Skin Sensitisation (Modified Draize-95 Test)
Condition: Skin Sensitisation
Study type: Interventional

Summary: 
      Skin Sensitization Test (Modified Draize-95) to Support a Low Dermatitis Potential Claim for
      a Powder Free Polychloroprene Surgical Gloves, Sterile. To evaluate whether residual chemical
      additives at a level on the gloves that may induce type IV allergy to the unsensitized
      general user population when using polychloroprene based surgical gloves
    

Detailed description: 
      1. To evaluate whether residual chemical additives at a level that may induce Type IV
           allergy in the unsensitized general user population are present in a finished
           Polychloroprene Rubber Containing Medical Device, Powder Free Polychloroprene Surgical
           Gloves, Sterile. (CR-SG-140-AF-WH)

        2. To meet requirements for claim: This product demonstrated reduced potential for
           sensitizing users to chemical additives as described in Guidance for Industry and FDA
           Staff- Medical Glove Guidance Manual. Supporting Test Data: A negative skin
           sensitization test (Modified Draize-95 Test) on a minimum of 200 non-sensitized human
           subjects.
    

Intervention name(s): Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs.
Intervention type(s): Device
Intervention description(s): Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.
Intervention model: Single Group Assignment
Intervention model description: Powder Free Polychloroprene Surgical Glove, Sterile. Low Dermatitis Potential, tested for use with chemotherapy drugs
Masking: None (Open Label)
Primary purpose: Treatment
Study to Compare How the Body Distributes and Excretes the Drugs Jivi (BAY 94-9027) and Adynovi in Patients With Severe Hemophilia A (Bleeding Disorder Resulting From a Lack of Blood Clotting Factor VIII)
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to compare how the body distributes and excretes the drugs Jivi
      (BAY 94-9027) and Adynovi. Jivi is a recently approved blood clotting Factor VIII (FVIII)
      medication for the treatment of hemophilia A (bleeding disorder resulting from a lack of
      FVIII). Both drugs are FVIII products which have been manufactured via recombinant technology
      and have an extended half-live, i.e. they will stay longer in the body than other FVIII
      products. Therefore these products act longer in the body which reduces the frequency of drug
      injections. To compare the two drugs, a cross-over design was chosen, i.e. each patient will
      receive both products one after another.

      Patients participating in this study will receive one dose of Jivi and one dose of Adynovi.
      Both drugs are injected into a vein. Observation will last for about 10 weeks, and blood
      samples will be taken from the participants to measure the blood levels of FVIII. Generic
      name of Jivi is Damoctocog-alfa-pegol, generic name of Adynovi is Rurioctocog alfa pegol.
    


Intervention name(s): Damoctocog-alfa-pegol (BAY94-9027, Jivi); Rurioctocog alfa pegol (Adynovi)
Intervention type(s): Biological; Biological
Intervention description(s): Single dose, 50 IU/kg BAY94-9027 (IU: international Units); Single dose, 50 IU/kg Adynovi
Intervention MeSH terms: Factor VIII; BAX 855
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Food Effect Study of Single Dose of Fruquintinib (HMPL-013) in Healthy Subjects
Condition: Food Effect of Fruquintinib in Health Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the effect of food on the pharmacokinetics (PK) of a single dose of
      4mg fruquintinib in normal healthy subjects.
    

Detailed description: 
      This study will be an open-label, randomized, two-period, crossover PK food effect study of
      fruquintinib administered orally at 4mg. Subjects will be screened for eligibility up to 14
      days prior to entry into the study.

      For each of 2 study periods, subjects will be admitted to the clinical research unit (CRU) on
      the day before dosing and fast overnight (approximately 10 hours). On the morning of dosing
      for each of the 2 study periods, subjects will receive a single oral dose of 4 mg
      fruquintinib in either the fasted or fed state. Subjects will remain at the CRU for at least
      120 hours after administration of study drug for collection of serial blood samples for
      pharmacokinetic (PK) analysis and safety monitoring. Subjects will return to the CRU for
      safety assessment for up to 336 hours postdose.
    

Intervention name(s): fruquintinib
Intervention type(s): Drug
Intervention description(s): Fruquintinib 4 mg capsule, 2 discrete single doses separated by 2-weeks
Other intervention name(s): HMPL-013
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Post Approval Pharmacokinetic Study of Loratadine in Japanese Pediatric and Adult Patients (Study P05539)
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a post marketing study to confirm the appropriate dose of loratadine in children by
      obtaining drug concentration data at multiple time points per child and adult patient, after
      the patient receives repeated administrations of the approved dose of loratadine.
    


Intervention name(s): loratadine; loratadine; loratadine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Loratadine (SCH 29851) dry syrup 1% 5 mg/day for 4 weeks; loratadine 10 mg tablet once daily for 4 weeks; loratadine 10 mg tablet once daily for 4 weeks
Other intervention name(s): Claritin; SCH 29851; Claritin; SCH 29851; Claritin; SCH 29851
Intervention MeSH terms: Loratadine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Facilitating Anemia Treatment Risk Communication for Patients With Kidney Disease: Decision Aid Trial
Condition: Chronic Kidney Disease; End Stage Renal Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Anemia is a common complication of chronic kidney disease (CKD). In anemia of chronic kidney
      disease, patients suffer from low hemoglobin levels, which contribute to feelings of malaise
      and fatigue. The current accepted practice is often to administer erythropoietin-stimulating
      agents (ESAs), which act like the body's natural hormones to stimulate the production of red
      blood cells from bone marrow. Although ESAs are widely used in CKD, recent evidence suggests
      that they are not as safe as previously thought. In this study, we seek to test a decision
      aid to be used when a patient visits his or her nephrologist at Vanderbilt. The objective of
      the decision aid is to reduce patient confusion, improve their satisfaction with their care,
      improve their knowledge of kidney disease, and ultimately bring more clarity to patients
      about a controversial but ubiquitous drug.

      The decision aid will be about 1 page long and will include questions and information that
      might help the patient be more active and informed regarding the choice of a course of ESA
      therapy. We will ask patients to answer questions before and after their clinic visits
      regarding their satisfaction and confidence in their treatment and their knowledge of kidney
      disease; we will ask some of the same questions 3 months after the clinic visit. We will
      compare patients who are counseled using the decision aid to patients who are not. We
      anticipate total experiment running time to be approximately 5 months to recruit and follow
      up on all patients.
    


Intervention name(s): interactive educational intervention
Intervention type(s): Behavioral
Intervention description(s): Use of a concise, literacy-sensitive, physician-led, educational interaction with the patient.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: health literacy; health numeracy
Bioavailability Investigations of Thyronajod Mite Tablets of Dosage Strengths 50 μg Levothyrox-ine/75 μg Iodine, and 100 μg Levothyroxine/75 μg Iodine vs. a Levothyroxine Drinking-Solution: A Randomised Cross Over Study in Healthy Male Individuals. Currently: 50 μg/ 75 μg Tablets
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure the area under the curve (AUC0-48h; extent of
      systemic availability) and the maxi-mum concentrations (Cmax) of total serum levothyroxine
      (TT4, bound and free fraction) after a single pharmacological dose of 600 μg administered as
      tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered
      as a reference solution without iodine.
    


Intervention name(s): levothyroxine; levothyroxine
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioavailability; levothyroxine
Hyperbaric Oxygen Treatment Ameliorates Insulin Resistance
Condition: Obesity; Type 2 Diabetes
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      Obesity is an epidemic in Western society and is the biggest risk factor for insulin
      resistance and type 2 diabetes. The investigators have preliminary evidence showing that
      hyperbaric oxygen therapy rapidly increases insulin sensitivity in humans. This requires
      confirmation in a larger population, and with this study the investigators will also test for
      mechanisms how this occurs. The investigators suspect that modulation of hypoxia and stress
      response proteins following changes in tissue oxygenation may contribute to these
      improvements. This study has the potential to yield new and important insights into the
      insulin resistance in obesity.
    


Intervention name(s): Hyperbaric Oxygen Treatment
Intervention type(s): Procedure
Intervention description(s): Participants will undergo 4 treatments of hyperbaric oxygen. Each treatment consists of 90 minutes compression at 2 atmospheres of pressure, with 30 minutes decompression back to 1 atmosphere, during this time, patients will be treated with 100% Oxygen delivered via a hood system.
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Insulin resistance; Inflammation; Hypoxia
Asthma and Allergy Screening AA2000 (Cross Sectional)
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Asthma screening of 493 asthma patients
    

Detailed description: 
      Questionnaire, and testing
    

Intervention name(s): Usual care versus primary care
Intervention type(s): Drug
Intervention description(s): RCT study
Other intervention name(s): RCT study, usuar care in specialist setting (GINA and ARIA)
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Population based asthma study
      
Keywords: asthma; airway hyperresponsiveness; asthma management
Baclofen for the Treatment of Alcohol Drinkers
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The main objective of this study is to show the effectiveness to a year of baclofen compared
      to placebo, on the proportion of patients with a low risk alcohol consumption or no,
      according to the WHO standards.
    

Detailed description: 
      Baclofen, a gamma-aminobutyric acid 'B-receptor' agonist, has long been used to treat
      spasticity from neurological diseases, at a dose of 30-90 mg/day. It appears today to be a
      promising but controversial candidate for treating alcoholic patients (Enserick, 2011) by
      reducing or even suppressing their craving to drink. A few case reports (Ameisen, 2005;
      Bucknam, 2007; Dore et al., 2011) and a retrospective study (Rigal et al, 2012) suggest that
      some patients might respond favorably to baclofen at higher doses than 90 mg/day. This is a
      randomized controlled trial versus placebo testing such doses.

      An extraction of patients DNA and a genetic analysis will be done after the end of the trial.
      In a gene candidate approach, the association of several genes with the efficiency of the
      treatment and its side effects, based on the literature, will be investigated using
      micro-array technology.
    

Intervention name(s): Baclofen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Baclofen will be administered orally for a maximum of 52 consecutive weeks. For the first 3 days, patients will receive baclofen in a dose of 5 milligrams three times a day; then the dose of baclofen will be increased to a maximum of 300 milligrams a day. In case of intolerance, dosage can be decreased.; Sugar pill will be administered orally for a maximum of 52 consecutive weeks. For the first 3 days, patients will receive sugar pill in a dose of 5 milligrams three times a day; then the dose of sugar pill will be increased to a maximum of 300 milligrams a day. In case of intolerance, dosage can be decreased.
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: High dose baclofen; Alcoholism; Abstinence; Low risk consumption; Craving
Nationwide Long-term Outcome Surveillance of Physiomesh® vs. Other Meshes in Laparoscopic Incisional Hernia Repair
Condition: Hernia, Abdominal; Recurrence; Postoperative Complications
MeSH terms: Hernia; Recurrence; Postoperative Complications; Incisional Hernia; Hernia, Abdominal; Internal Hernia
Study type: Interventional

Summary: 
      The primary aim of the present study was to show how a national clinical register combined
      with other nationwide administrative registers may serve as a tool for pre- and
      post-marketing evaluation of new mesh and mesh fixation products for hernia surgery, using
      Physiomesh® versus other meshes designed for laparoscopic hernia repair as an example.
    

Detailed description: 
      All adult (≥18 yrs) patients registered in the Danish Hernia Database (DHB) who underwent
      elective primary laparoscopic incisional hernia repair between January 1st 2010 and December
      31st 2016.

      To obtain 100% follow-up data from DHB will be combined with administrative data from the
      Danish National Patient register.

      Patients will be followed from initial hernia repair until reoperation for recurrence, death,
      emigration outside Denmark or end of follow-up (november 2017).

      Physiomesh and other mesh repairs will be propensity score matched. Each patient in the
      Physiomesh® group will be matched with two patients treated with one of the other synthetic
      meshes. The Propensity score includes age, sex, year of surgery, diagnosis of chronic
      obstructive pulmonary disease, diagnosis of diabetes, diagnosis of obesity, Charlson
      comorbidity index and size of hernia defect

      The primary outcome: Difference in risk for a reoperation for recurrence between patients
      operated with Physiomesh® and patients operated with another synthetic mesh designed for
      laparoscopic repair.

      The secondary outcome will be rates of 30-day readmission, 30-day reoperation for
      complications (excluding hernia recurrence) as well as 30- and 90-day mortality.
    

Intervention name(s): Physiomesh
Intervention type(s): Device
Intervention description(s): difference in risk for recurrence and postoperative complication
Other intervention name(s): other mesh
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Register study
Masking: None (Open Label)
Primary purpose: Treatment
Single Dose Safety Study for Compound to Treat Anemia in Patients With Renal Impairment
Condition: Kidney Disease
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the safety and tolerability of single doses of
      compound 1278863A in subjects with renal impairment.
    

Detailed description: 
      Compound 1278863A is a novel small molecule agent, which stimulates erythropoiesis through
      inhibition of hypoxia-inducible factor (HIF)-prolyl hydroxylases (EGLNs). This compound is
      being developed for the treatment of anemia. This study, PHI112843, will be the first
      administration of 1278863A to investigate the safety, tolerability, pharmacokinetics and/or
      pharmacodynamics of single oral doses of 50 mg and 150 mg in pre-dialysis subjects with
      moderate or severe renal impairment and 150 mg in hemodialysis-dependent subjects. Four to
      eight subjects will complete each dose cohort. Multiple blood samples for pharmacokinetic
      and/or pharmacodynamic analyses will be obtained post-dose in each cohort. Safety will be
      assessed by measurement of vital signs, cardiac monitoring, collection of adverse event
      assessments and laboratory safety tests.
    

Intervention name(s): GSK1278863A; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50mg, 150mg; matching placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Tolerability; Safety; Pharmacokinetics; Pharmacodynamics