bioihbjkbjnl/mcl2 huggingface dataset:
Vertistop® D and Vertistop® L in Preventing Recurrence of High-recurrence BPPV
Condition: Benign Paroxysmal Positional Vertigo (BPPV)
MeSH terms: Vertigo; Benign Paroxysmal Positional Vertigo; Recurrence; Dizziness
Study type: Interventional

Summary: 
      Randomized, 3-arm controlled clinical study, to evaluate the effectiveness of supplementation
      with Vertistop® D (food supplement containing alpha-lipoic acid at modified release,
      Carnosine and Zinc, Vitamin D and Vitamins B) and Vertistop® L (food supplement containing
      fast releasing alpha-lipoic acid, Carnosine, Zinc and Curcumin) in preventing recurrence of
      high-recurrence BPPV (Benign Paroxysmal Positional Vertigo)
    

Detailed description: 
      Benign paroxysmal positional vertigo (BPPV) is the most common type of vertigo detectable in
      otoneurological clinical practice. It is characterized by violent, short and relapsing
      vertiginous crises that arise when the patient assumes certain positions of the head in the
      space and is accompanied by a usually "typical" paroxysmal positional nystagmus. In most
      cases we cannot trace the exact causal agent, so we mainly identify two forms: primitive
      forms and secondary forms. BPPV therapy is essentially physical, and it is based on specific
      maneuvers which make the otoconial mass come out of the semicircular canal. Recent studies
      showed the existence of a seasonal trend of BPPV related to fluctuations in Vitamin D levels.
      Based on these considerations this clinical trial was designed in order to evaluate the
      possible efficacy of the administration of Vitamin D (Vertistop® D) in preventing recurrence
      of BPPV.
    

Intervention name(s): Vertistop D; Vertistop L
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Food supplement containing alpha-lipoic acid, carnosine, zinc, vitamin D3 and vitamins of group B, 1 tablet/day before meals; Food supplement containing alpha-lipoic acid, carnosine, zinc and curcumin, 2 tablets/day (morning and evening)
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: BPPV; Vertistop; Vitamin D; Alpha-lipoic acid; Zinc
Safety of Nasal Influenza Immunisation in Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently been
      approved by a number of licensing boards and is given by a spray into the nose. In the United
      Kingdom (UK), the vaccine has been demonstrated to be highly effective against influenza
      infection. Further, despite concerns that LAIV can cause wheezing in children under age 2
      years, the previous SNIFFLE studies have demonstrated it to be safe in children over 2 years
      with mild-moderate asthma.

      The objective of this multicentre study is to further assess the safety of intranasal LAIV in
      children with asthma and recurrent wheeze, including those with severe symptoms.
    


Intervention name(s): Administration of Live attenuated influenza vaccine (LAIV)
Intervention type(s): Drug
Other intervention name(s): Flumist; Fluenz
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Antibiotic Prophylaxis Before Percutaneous Gastrostomy
Condition: Infection
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the use of antibiotics (i.e. Kefzol) before
      percutaneous gastrostomy performed in interventional radiology. Patient will be randomized to
      receive antibiotics or placebo before the procedure, and the rates of skin infection after
      the procedure will be determined between the two groups. This has never been studied in our
      population of patients undergoing the procedure. However, antibiotics are routinely given
      despite the lack of evidence. The investigators hypothesize that patient receiving
      prophylactic antibiotics will have a decreased number of infections compared to placebo.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Anyone referred to Interventional Radiology for percutaneous gastrostomy is in the study
        population (with inclusion and exclusion criteria below).
Meaning of Life in HIV-infected Youths
Condition: Meaning of Life
Study type: Interventional

Summary: 
      Logotherapy has never been evaluated in HIV-infected teenagers. In this study, we will
      evaluate the meaning of life by using The Purpose in Life Test and the affect of logotherapy
      in HIV infected youth at HIV-NAT, Thai Red Cross AIDS Research Centre and King Chulalongkorn
      Memorial Hospital.
    

Detailed description: 
      In the HAART era, HIV infected children can live longer and will grow up to become teenagers.
      However, some may develop psychosocial problems because they have lost family members,
      experienced poverty, social discrimination etc. Being a normal teenager is tough and is the
      most complex period of his/her life. This is the period when most teenagers will find their
      identity and reasons for living. Therefore it is believed that interventions may help
      HIV-infected teenagers better deal with life. For this study, logotherapy, a therapy that
      will help a person to discover his/her purpose in life, live meaningful life, and attain
      self-esteem was used. The success of the intervention was evaluated by using The Purpose in
      Life Test.
    

Intervention name(s): logotherapy
Intervention type(s): Behavioral
Intervention description(s): Logotherapy is therapy during which the interaction between the therapist and the client centres on the topic of meaning. The problems that the clients experience are presented to the client as inseparable parts of his everyday life. The client is then challenged to discover his/her meaning and to take responsibility in facing up to his/her problem. This approach is aimed at helping the client to deal and understand what his /her existences entail.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: meaning of life; logotherapy; HIV-infected teenagers; adherence
Prediction of Drug Interactions With CYP2C9 Substrates
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      CYP2C9, is one of the major drug metabolism enzymes accounting for about 20% of the hepatic
      cytochrome P450 content and being second only to CYP3A4.

      The proposed study will explore different possible drug interactions with CYP2C9 substrates
      by evaluating the effect of prototype inducers and inhibitors on the phenotypic trait
      measurement. It is expected that the identification of drugs that might interact with CYP2C9
      substrates will be used to rationalize future drug interaction studies designed to evaluate
      the actual magnitude of effect and its clinical implications. This approach should be
      particularly useful when applied to those CYP2C9 drugs characterized by a narrow therapeutic
      index (i.e. warfarin).

      This study will consist of three study periods separated from each other by a two weeks
      washout period. In the course of the study the subjects will receive in a double blind,
      crossover fashion, rifampin 300 mg. twice daily, diclofenac 50 mg twice daily. and
      fluconazole 200 mg. twice daily, each for one week. All drugs will be administered as
      identical looking tablets that will be prepared at the pharmacy of the Hadassah University
      Hospital and their order of administration will be randomized.On the day prior to, on day 6
      of and 7 days following each drug period, the activity of CYP2C9 will be evaluated by the
      administration of a single phenytoin 300 mg. dose. The subjects will be requested to collect
      their urine for 24 hours and a single blood sample will be obtained 12 hours post phenytoin
      intake.
    


Intervention name(s): Phenytoin; Rifampicin; Diclophenac; Fluconazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Rifampin; Fluconazole; Diclofenac; Phenytoin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
"First-in-human" Study To Assess the Safety and Tolerability of PBF-677 in Healthy Volunteers
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The proposed trial a "Randomized, Double Blind, Placebo Controlled "first in-human" Study to
      Assess the Safety and Tolerability of Single Ascending Oral Doses of PBF-677 in Male Healthy
      Volunteers" (Protocol Code No:CUNFI-1509 EudraCT No:2015-003546-57) will be a single-centre,
      randomized, double-blind, dose escalation study without therapeutic benefit, in which PBF-677
      will be administered as single, oral, ascending-dose to volunteers.

      Up to four different rising doses (100 mg, 200 mg, 400 mg and 600 mg) will be tested in
      groups of 8 participants; in each dose level participants will be randomized to active drug
      or placebo in a 6:2 fashion. As this will be the first time that PBF-677 in going to be
      administered to humans, as a safety measure a stepwise drug administration will be performed
      in each cohort. The volunteers of each cohort will be divided in 3 blocks/subgroups:
      Initially, one volunteer will receive active drug (subgroup 1). After 48h of safety and
      tolerability assessment, a second subgroup of 3 volunteers will receive 2 active drug and 1
      placebo and after further 48h of safety and tolerability assessments a third subgroup of 4
      volunteers will receive 3 active drug and 1 placebo. After evaluation of safety, parameters
      of corresponding dose level the process will replicate one week afterwards in the following
      dosages.

      The principal variable safety and tolerability of PBF-677 will be evaluated with physical
      records (Electrocardiogram (ECG), vital signs, blood chemistry and haematology, conducted
      before, during and after study course). Assessment of the pharmacokinetic profile (Maximum
      plasma concentration of the drug (peak) after single dose (Cmax),Time necessary to reach Cmax
      (tmax), Area under the time-concentration curve to "zero" to time "t" (AUC0t), and
      Elimination half-life (t1/2) of PBF-677 will be included as secondary variable.
    


Intervention name(s): PBF-677; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): once daily oral administration; once daily oral administration
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Adenosine A3 receptor antagonist
Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the study drug, BMS-986142, is safe and
      effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate
      response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors.
      Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in
      1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the
      course of the study.
    


Intervention name(s): BMS-986142; Placebo; Methotrexate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BMS986142 specific dose on specific days; Placebo of BMS-986142 specific dose on specific days; Methotrexate specific dose on specific days
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Targeting Diet-Microbiome Interactions in the Pathogenesis of Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the microbiome of medicated and non-medicated
      subjects diagnosed with Parkinson's disease. Where available, in comparison to the microbiome
      of a healthy spouse or 1st degree relative.
    

Detailed description: 
      First, a cross sectional study where the investigators will compare microbiome composition in
      subsets of PD and Multiple System Atrophy (MSA) patients whose household control agree to
      provide stool samples as well. Each household control subject will be evaluated to ensure
      there is no clinical evidence of neurological disorders including PD. Also, these subjects
      will complete a 24 hour diet recall questionnaire before stool collection and validated 3
      month food frequency questionnaire to collect dietary information similar to PD patients.
      Each subject (including PD subjects) will complete a smell questionnaire and a sleep
      questionnaire to determine whether these "control" subjects have loss of smell or have REM
      sleep disorders because these conditions increase the risk of PD. For assessing smell,
      investigators will use the UPSIT questionnaire. For assessing REM sleep disorder,
      investigators will use RBD1Q which consists of a single question, answered "yes" or "no," as
      follows: "Has the subject ever been told, or suspected themselves that they seem to 'act out
      their dreams' while asleep (for example, punching, flailing their arms in the air, making
      running movements, etc.)?"

      Second, in the longitudinal study, the investigators will collect stool every 3 months with 3
      day diet questionnaire prior to each collection over 12 months and determine microbiome
      composition over time. Investigators will correlate the microbiome data with PD symptoms,
      diet and response to treatment and progression of disease. These studies will determine
      whether disease progression and factors such as PD medications and diet significantly impact
      microbiome composition. Furthermore, the investigators will determine whether changes in
      SCFA-producing bacteria and/or abnormal SCFA profiles correlate with severity of PD symptoms.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Population will be selected from the neurology clinic, as well as a self-referrals.
      
Biospecimen description: 
      Stool samples
    
Keywords: PD; Parkinson's; Parkinson's Disease; Microbiome
Safety and Pharmacodynamcis of SELA-070 Nicotine Vaccine in Smokers
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and pharmacodynamics of SELA-070.
      Increasing subcutaneous doses of SELA-070 will be administered to healthy smoker volunteers.
      The resulting safety profile and anti-nicotine antibody levels will be evaluated.
    


Intervention name(s): SELA-070; Saline
Intervention type(s): Biological; Biological
Intervention description(s): Sub-cutaneous injection, multiple dose; Sub-cutaneous injection, multiple dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: nicotine vaccine; smoking vaccine; smoking cessation; SELA-070
Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to understand efficacy and safety of investigational agent (PF-04937319)
      compared to approved agent (glimepiride) in patients with diabetes on metformin
    


Intervention name(s): Placebo; PF-04937319 10 mg; PF-04937319 50 mg; PF-04937319 100 mg; Glimepiride
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Combination of tablets and capsules, a total of 3 pills/dose, administered once daily for 84-days; Combination of tablets and capsules, dose of 10 mg, a total of 3 pills/dose, administered once daily for 84-days; Combination of tablets and capsules, dose of 50 mg, a total of 3 pills/dose, administered once daily for 84-days; Combination of tablets and capsules, dose of 100 mg, a total of 3 pills/dose, administered once daily for 84-days; Combination of tablets and capsules, dose of up to 6 mg, a total of 3 pills/dose, administered once daily for 84-days
Intervention MeSH terms: Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: T2DM; PF-04937319; Phase 2
Effect of Lipid Modifying Drugs on HDL Function in Patients With Hyperlipidemia
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional

Summary: 
      1) to test HDL function comprehensively in healthy and diseased individuals; 2) to evaluate
      if this test correlates with cardiovascular risk, independent of traditional risk factors; 3)
      and to differentiate effects of lipid-modifying or antiatherosclerotic drugs on HDL function
      and composition
    


Intervention name(s): Atorvastatin 20 mg; Cholestyramine 8 g; Omega-3 2g; Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mg; Lifestyle modification
Intervention type(s): Drug; Drug; Drug; Drug; Behavioral
Intervention description(s): The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.; The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.; The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.; The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.; The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.
Intervention MeSH terms: Atorvastatin; Ezetimibe; Cholestyramine Resin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pharmacokinetics, Efficacy, and Safety Study of RI-002 (IGIV) in Subjects With Primary Immunodeficiency Diseases (PIDD)
Condition: Primary Immune Deficiency Disorder
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase III, multicenter, open-label study of RI-002 administered as an intravenous
      infusion of RI-002 (IGIV) every 21 or 28 days in approximately 60 subjects with Primary
      Immunodeficiency Diseases (PIDD).
    

Detailed description: 
      Primary immunodeficiency diseases (PIDDs) are genetically determined disorders of the immune
      system resulting in greatly enhanced susceptibility to infectious disease, autoimmunity and
      malignancy. As most subjects with PIDDs present with infections, the differential diagnosis
      and initial investigations for an underlying immune defect are typically guided by the
      clinical presentation. In subjects with PIDDs, individual infections are not necessarily more
      severe than those that occur in a normal host. Rather, the clinical features suggestive of an
      immune defect may be the recurring and/or chronic nature of infections with common pathogens
      that may result in end organ damage, such as bronchiectasis. Several immune globulin products
      have already been approved by the FDA.
    

Intervention name(s): RI-002
Intervention type(s): Biological
Intervention description(s): Immune Globulin Intravenous (IGIV)
Other intervention name(s): Immune Globulin (Human)
Intervention MeSH terms: Immunoglobulins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PIDD, PID, humoral immunity, antibody deficiency
Drug-drug Interaction Study Using Rosuvastatin as a Breast Cancer Resistant Protein (Efflux Transporter), Organic Anion-transporting Polypeptide (OATP)1B1, and OATP1B3 (Uptake Transporters) Probe Substrate
Condition: Healthy Volunteers; Pharmacokinetics; Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of the potential perpetrator effect of BAY1841788 (ODM-201) on rosuvastatin
      pharmacokinetics.

      PK of BAY1841788 (ODM-201) after single and repeated administration in male and female
      subjects.
    


Intervention name(s): Rosuvastatin; BAY1841788 (ODM-201)
Intervention type(s): Drug; Drug
Intervention description(s): 5 mg tablet single dose on Day 01 in Period 1 and on Day 08 in Period 2.; 600 mg single dose, administered as 2 x 300 mg tablets on Day 01 in Period 2; 600 mg BID multiple dose, administered as 2 x 300 mg tablets on Day 04 to Day 08 in Period 2.
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
The Short Form-36: Pre- Versus Post-Surgical Administration in Cardiac Surgery Patients
Condition: Coronary Artery Bypass Grafting; Heart Diseases; Heart Valve Diseases
MeSH terms: Heart Diseases; Heart Valve Diseases
Study type: Observational

Summary: 
      The purpose of this study is to determine whether the SF-36 can be administered reliably to
      cardiac surgery patients (two to three days) post-surgery, with the patient answering the
      questions of this survey from a pre-surgical perspective.
    

Detailed description: 
      The purpose of this study, is to determine whether the SF-36 can be administered reliably to
      cardiac surgery patients (two to three days) post-surgery, with the patient answering the
      questions of this survey from a pre-surgical perspective.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cardiac Surgery Patients at New York Presbyterian Hospital-Weill Cornell Medical College
      
Keywords: Cardiac surgery patients; Quality of Life; Recall bias; Aortic valve replacement; Mitral valve replacement; Tricuspid valve replacement; Coronary artery bypass graft surgery