bioihbjkbjnl/mcl2 huggingface dataset:
Taste Evaluation of Different Liquid Formulations With Eliglustat
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      The purpose of this study is to assess the palatability of eliglustat prototype liquid
      formulations in healthy subjects.
    

Detailed description: 
      The total duration of the study for each subject will be approximately 5 weeks (screening
      period from Day -28 to Day -2, treatment period of 3 days, and follow-up call on Day 5).
    

Intervention name(s): eliglustat
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:liquid formulation
Route of administration: oral without ingestion
Other intervention name(s): GZ385660
Intervention MeSH terms: Eliglustat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Interscanner Variation in Musculoskeletal Computed Tomography (CT) Measures
Condition: Accidental Falls; Loss of Muscle Strength
Study type: Observational

Summary: 
      Maintaining strong muscles is important for the independence and quality of life in our older
      population. Strong muscles provide mobility and reduce the chance of falls that lead to
      injury. Many researchers are carrying out studies to examine different types of exercise and
      drug treatments to prevent loss of muscle strength in older people. Often, these research
      studies use x-ray computed tomography (CT) scans to measure the size and the amount of fat in
      different muscles. These factors are known to reflect muscle health. Large studies can
      involve many research subjects recruited at many different clinics with different CT
      scanners. To ensure that these studies provide reliable results, the investigators must have
      procedures to make sure that different CT scanners measure the same results for the same
      amount of fat or muscle. The goal of our study is to develop these procedures. In this
      project, the investigators will study women because they have the highest risk of bone
      fractures resulting from falls. Thus, the subjects are being asked to volunteer for a study
      where the subjects will be scanned on different scanners.
    


Observational model: Ecologic or Community
Sampling method: Non-Probability Sample
Study population: 
        In this project we will study women 60-70 years old because they have the highest risk of
        bone fractures resulting from falls.
      
Keywords: on two models of CT scanner acquire CT images of the abdomen pelvis and midthigh in 20 Postmenopausal female volunteers
A Study of the Safety and Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a double-blind, randomized, placebo-controlled, 2-period, crossover study to
      evaluate safety and PK of 3 doses of CVT 301 levodopa (l-dopa) in adults with asthma.
    


Intervention name(s): CVT-301 (levodopa inhalation powder); Carbidopa; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Capsules containing l-dopa, designed to deliver ldopa to the lung using the CVT-301 inhaler. CVT-301 will be administered 3 times, 4 hours apart, and 1 hour following the administration of carbidopa.; Administered orally according to the carbidopa dosing schedule.; Placebo of CVT-301 is administered in the same way as the investigational product, except that it does not contain l-dopa.
Other intervention name(s): Lodosyn ®
Intervention MeSH terms: Levodopa; Carbidopa
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Relationship Between Genes Important in Blood Pressure Regulation and Blood Pressure Therapy in Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Whether patients with a functional genotype of a protein important in blood pressure
      regulation respond better to a drug therapy class/combination of therapy classes that target
      that specific pathway using the Geneticure panel for high blood pressure
    

Detailed description: 
      2.1 Study Design and Protocol Overview This is a post-hoc association study of patients who
      have been diagnosed with high blood pressure and have been stable on medication treatment for
      at least 6 months. The purpose of this study is to evaluate the relationship between optimal
      medication therapy (or the therapy that has resulted in the most stable blood pressure for
      that particular patient) and the predicted optimal medication therapy based on a patient's
      genetic profile.

      Chart reviews for the patient's history of antihypertensive therapy will be coupled with
      buccal swabs and blood pressure readings collected from eligible patients who have provided
      informed consent. The swab will be analyzed for fourteen genetic variants that are associated
      with antihypertensive therapy response (efficacy, side-effects).

      2.2 Study Objective To assess the relationship between the drug therapy class/combination of
      therapy classes that resulted in the best blood pressure control for a patient vs. what the
      Geneticure high blood pressure panel would have predicted.

      2.3 Secondary Objectives

        -  To assess the clinical time to achieve optimal blood pressure treatment.

        -  To assess the number of office visits required to achieve optimal blood pressure
           treatment.
    

Intervention name(s): Geneticure Collection Kit for Pharmaocogenetics of Hypertension
Intervention type(s): Device
Intervention description(s): Buccal (cheek) swab kit for DNA collection for analysis of genes for hypertension
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with hypertension
A Pilot Clinical Trial of Varenicline as a Treatment for Alcohol Dependence
Condition: Substance Dependence
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      Purpose: This is an outpatient, randomized, double-blinded, placebo-controlled study in which
      either varenicline (twice daily) or placebo will be administered over a 12 week study period
      to examine genetic influences on treatment response to varenicline for reduction of hazardous
      drinking.
    

Detailed description: 
      Hazardous alcohol use and alcohol use disorders (AUDs) are an area of large unmet medical
      needs. Although there has been some progress with pharmacotherapy for alcohol-dependent
      individuals, a critical need for the development of novel and additional therapeutic
      approaches remains. Pharmacotherapy development for AUDs as a therapeutic area has had
      several recent advancements, where clinically as well as commercially successful additions to
      available treatment options are available and several more are expected in the near future.
      Based on recent preclinical work, we believe that varenicline has potential to become one of
      the first among those newly evolving treatments.

      In this study, participants with nicotine dependence will receive standard varenicline or
      placebo treatment over the recommended course of 12 weeks. Since our research question
      addresses whether alcohol drinking also diminishes with varenicline treatment, we will not
      ask participants to alter alcohol use; we will simply follow their use over time. Study
      visits will take place at the Ernest Gallo Clinic and Research Center. The procedures to be
      completed include vital signs, blood samples at screening and end of study, urine toxicology
      screening and the completion of standard questionnaires. No special facilities are required
      for these procedures. Group therapy (which is not a research procedure, but part of standard
      nicotine dependence treatment) will take place at the Gallo Center.
    

Intervention name(s): varenicline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).; 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Safety of Engensis in Participants With Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety of intramuscular (IM) administration of
      Engensis in Participants with Amyotrophic Lateral Sclerosis (ALS) as compared to Placebo.
      Safety will be assessed by incidences of treatment-emergent adverse events (TEAEs),
      treatment-emergent serious adverse events (TESAEs), injection site reactions (ISRs) and other
      adverse events of special interest (AESIs), and the clinically significant laboratory values
      after injections of Engensis compared to Placebo. Exploratory endpoints include assessment of
      muscle function using the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale
      (ALSFRS-R) and ALSFRS-R subscores for Fine and Gross Motor Function; muscle strength by
      quantitative testing using handheld dynamometry (HHD) and the Accurate Test of Limb Isometric
      Strength (ATLIS) where available; quality of life using the ALS Assessment Questionnaire
      (ALSAQ-40); patient global impression of change (PGIC), clinical global impression of change
      (CGIC), and clinical global impression of severity (CGIS); and evaluation of lung function
      using Slow Vital Capacity (SVC). Muscle biopsies will be performed during the study for
      future biomarker analyses.
    


Intervention name(s): Engensis; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Lyophilized biologic to be reconstituted containing Engensis; Injectable liquid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparative Evaluation of Two Different Radiosurgery
Condition: Metastases to Brain
MeSH terms: Neoplasm Metastasis
Study type: Interventional

Summary: 
      Randomized double arm phase III study to evaluate feasibility and safety of Gamma Knife
      radiosurgery and Linac Based (Edge) radiosurgery in brain metastatic patients
    

Detailed description: 
      This is a prospective double arm phase III study to evaluate cerebral side effects following
      radiosurgery delivered by Gamma Knife Perfexion and Linac Based EDGE. In particular our
      primary objective is to evaluate rate of symptomatic radionecrosis from the two different
      modalities of radiosurgery.
    

Intervention name(s): Radiosurgery with Gamma Knife Perfexion; Linac-based Radiosurgery with EDGE
Intervention type(s): Radiation; Radiation
Intervention description(s): Gamma Knife Radiosurgery is a very precise form of therapeutic radiology. Even though it is called surgery, a Gamma Knife procedure does not involve actual surgery but it uses 192 isocentric beams of highly-focused gamma rays (60-Co) to treat small to medium size lesions. Minimum beam size is 4 mm. This procedure is frame based.; EDGE linear accelerator from Varian (Varian, Palo Alto, USA) is a C-arm machine specifically developed for radiosurgery frameless treatment. The characteristics of this linac are a high level of precision and the possibility to include multiple positioning systems for stereotactical treatments, among which Cone Beam CT (CBCT), the Optical Surface Monitoring System (OSMS), and Calypso.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Radiosurgery, brain, metastases
A Study to Assess the Pharmacokinetics and Food Effect of SR419 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an open-label, single-site, Phase I study to evaluate the PK, safety, and
      tolerability of SR419 in healthy volunteers.
    

Detailed description: 
      This study is a phase 1, open-label study to assess the single dose pharmacokinetics of
      suspension and capsule formulations of SR419 and repeat dose pharmacokinetics of capsule
      formulation of SR419, and to assess the effect of a high-fat meal on the pharmacokinetics of
      SR419 in healthy subjects.The trial will consist of 3 cohorts. Cohort 1 and 2 will follow a
      single sequence, 3-period, 2-formulation, dosing in fasted or fed state design. Cohort 3 will
      be a repeated dose study of SR419 capsule in healthy subjects.
    

Intervention name(s): SR419
Intervention type(s): Drug
Intervention description(s): 2 formulations of SR419, SR419 suspension and SR419 capsule will be used in the study.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Role of Induction Chemotherapy for High-risk Locally Advanced Nasopharyngeal Carcinoma in the Era of IMRT
Condition: Nasopharyngeal Neoplasms
MeSH terms: Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Intensity-modulated radiation therapy
      (IMRT) combined inductive and concurrent chemotherapy with more intensive regimen (cisplatin
      and paclitaxel) is feasible and effective than current standard treatment for high-risk
      locally advanced NPC patients.
    

Detailed description: 
      Meta-analysis showed chemotherapy when combined with conventional radiotherapy in locally
      advanced naso-pharyngeal carcinoma can improve 5-year overall survival with 6%, and beyond
      all concurrent chemotherapy with cisplatin benefits most. However, from Lin's (Lin JC, 2004)
      study, locally advanced NPC with high risk factors can not benefit from conventional
      concurrent chemoradiation. Failure pattern analysis revealed that local and distant failure
      accounted for 50% respectively. Large-scale data has demonstrated that with IMRT, local
      control can achieve 90%. Previous studies showed inductive chemotherapy can decrease distant
      metastasis. We need more effective and stronger chemotherapy, and we still need to testify
      concurrent chemotherapy combined with inductive chemotherapy.

      A prospective trial would thus provide valuable information to help physicians and patients
      more precisely identify the feasibility and effectiveness of inductive + concurrent
      chemotherapy combined with IMRT for high-risk locally advanced NPC.
    

Intervention name(s): Cisplatin; Paclitaxel; IMRT
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): induction: Cisplatin: 80mg/m2, d1 and d22 concurrent: Cisplatin: 100mg/m2, d1, 22, 43 adjuvant: cisplatin: 75mg/m2, d1, d22, d43,d64; induction: paclitaxel 175mg/m2 d1,d22 adjuvant: paclitaxel 175mg/m2 d1,d22, d43,d64; 69.96Gy-73.43Gy to gross tumor volume, 60Gy to high-risk clinincal target volume, 50Gy to lower risk clincial target volume
Other intervention name(s): intensity-modulated radiotherapy
Intervention MeSH terms: Paclitaxel; Cisplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adjuvants; inductive; concurrent; chemoradiotherapy; high-risk; locally advanced; NPC
Efficacy of Pioglitazone and Insulin in Treating Subjects With Type 2 Diabetes Mellitus and Renal Failure.
Condition: Diabetes Mellitus
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the metabolic and cardiovascular effects of
      pioglitazone, once daily (QD), and insulin combination therapy in subjects with Type 2
      Diabetes and Renal Failure.
    

Detailed description: 
      Patients with type 2 diabetes mellitus and clinically significant kidney disease presenting
      with contra-indications for metformin and sulfonylurea drugs are usually treated with insulin
      therapy only. While the prolonged pharmacokinetic insulin profile due to delayed renal
      insulin elimination already is a hurdle for a successful therapy, impaired kidney function
      results in increased oxidative stress and cardiovascular risk, especially in patients
      requiring dialysis. Several potential mechanisms may explain this increased cardiovascular
      risk, and one, frequent finding is coexistence of several other independent cardiovascular
      risk factors including dyslipidemia, hypertension and smoking. In addition, impaired kidney
      function is associated with elevated markers of inflammation and other putative risk factors
      for cardiovascular events.

      The focus of this study is to investigate whether pioglitazone may help improve overall
      metabolic and cardiovascular risks in patients with end stage renal disease, and if
      pioglitazone can potentially exert positive effects on kidney function in patients with renal
      failure requiring dialysis.

      The duration of treatment for patients completing the study is approximately 26 weeks.
    

Intervention name(s): Pioglitazone and insulin; Insulin
Intervention type(s): Drug; Drug
Intervention description(s): Pioglitazone 30 mg, tablets, orally, once daily and variable insulin therapy for up to 24 weeks.; Pioglitazone placebo-matching tablets, orally, once daily and variable insulin therapy for up to 24 weeks.
Other intervention name(s): ACTOS®; AD-4833
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus, Lipoatrophic; Dyslipidemia; Drug Therapy
A Study of the Relative Bioavailability of ASC18 Tablets vs Reference Tablets in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate potential drug interaction between RDV and SOF in
      ASC18 tablets (RDV/SOF compound tablets) and the influence of food effect on the
      pharmacokinetics of ASC18 tablets were evaluated in healthy subjects -and compare the
      pharmacokinetic parameters of ASC18 tablets（ravidasvir and sofosbuvir fixed dose
      combination）with ravidasvir tablets and sofosbuvir tablets in healthy subjects after single
      and multiple oral dosing.
    

Detailed description: 
      This randomized, open-label, crossover study will evaluate the relative bioavailability of
      ASC18 (ravidasvir and sofosbuvir fixed dose combination) tablets as compared to ad hoc
      combination of reference tablets of ravidasvir and sofosbuvir in healthy volunteers. Subjects
      will be randomized to 1 of 2 treatment sequences to receive multiple oral doses of either
      ASC18 tablets (ravidasvir and sofosbuvir fixed Dose Combination) or ravidasvir and sofosbuvir
      as separate tablets. In the crossover design, subjects will participate in 2 study periods
      with at least a 14-day washout between periods.
    

Intervention name(s): ASC18; ravidasvir and sofosbuvir; ASC18
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ASC18：ravidasvir and sofosbuvir fixed Dose Combination 200 mg/400 mg; RDV 200 mg and SOF 400 mg; ASC18：ravidasvir and sofosbuvir fixed Dose Combination 200 mg/400 mg
Intervention MeSH terms: Sofosbuvir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Efficacy of the Alma Hybrid System for a New Approach of Facial Skin Treatment
Condition: Rejuvenation
Study type: Interventional

Summary: 
      The study is aimed to evaluate the efficacy of the Alma Hybrid system for a new approach of
      facial skin treatment, using both ablative and non-ablative wavelengths.

      The study will include 20 subjects with mild-moderate photodamaged skin, that will undergo 2
      facial skin treatments. Follow up visit to evaluate the efficacy of the treatments will take
      place 1 and 3 months after the last treatment.
    


Intervention name(s): Facial skin treatment
Intervention type(s): Device
Intervention description(s): Facial skin treatment using the Alma Hybrid system with a unique pattern that includes both ablative and non-ablative wavelengths
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of the Incidence of Cilioretinal Arteries in the Hungarian Population
Condition: Cilioretinal Arteries
Study type: Observational

Summary: 
      The purpose of this study is to analyze the retinal arteries, to investigate the incidence,
      number, types, distribution and localization of cilioretinal arteries in the Hungarian
      Caucasian population.
    


Intervention name(s): Fundus photography
Intervention type(s): Device
Intervention description(s): Non-mydriatic fundus photographs
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy young population