bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Safety, Tolerability, and Immunogenicity of Hantaan and Puumala Virus DNA Vaccines
Condition: Hemorrhagic Fever With Renal Syndrome
MeSH terms: Hemorrhagic Fevers, Viral; Hemorrhagic Fever with Renal Syndrome; Syndrome; Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is:

      • To assess safety and tolerability of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and
      pWRG/PUUV-M(s2), administered intramuscularly using a TDS-IM electroporation device

      Secondary:

      • To evaluate clinical immunogenicity of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and
      pWRG/PUUV-M(s2), including an assessment of the acute procedure tolerability when
      administered with the TDS-IM electroporation.
    

Detailed description: 
      The study will enroll 3 randomized groups of 9 subjects each, along with 3 alternates, for a
      total of 30 subjects. The study will include one group of subjects injected with the HTNV DNA
      vaccine, one group injected with the PUUV DNA vaccine, and one group injected with both HTNV
      and PUUV DNA vaccines (mixed), administered with the Ichor TDS-IM device. Subjects will
      receive one dose of vaccine on Days 0, 28, and 56 and will be followed until Day 240.
      Subjects will complete post-injection memory aids for 14 days after each injection.

      Subjects will be evaluated for safety and immune response throughout the study.
    

Intervention name(s): Vaccine/device combination for prevention of HFRS
Intervention type(s): Biological
Intervention description(s): PUUV DNA Vaccine, 2.0mg/ml TDS-IM injection HTNV DNA Vaccine, 2.0 mg/ml TDS-IM injection HTNV + PUUV Vaccine mixture, 1.0mg/mL + 1.0mg/ml TDS-IM injection
Other intervention name(s): Ichor Tri-Grid Delivery System; Hantavirus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: HFRS
Survey of Inhibitors in Plasma-Product Exposed Toddlers
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to assess the immunogenicity of VWF/FVIII and of rFVIII
      concentrates by determining the frequency of inhibitor development in previously untreated
      patients (PUPs) or minimally blood component-treated (MBCTPs) in the first 50 EDs or in the
      first 3 years from enrollment, whichever occurs first.

      .
    

Detailed description: 
      Patients meeting the enrollment criteria will be consecutively enrolled at each participating
      centre, randomized to be treated exclusively with a single FVIII product either
      plasma-derived or recombinant, and followed up until inhibitor development or until 50
      exposure days (EDs) or 3 years from enrolment have elapsed, whichever comes first. Study
      products, belonging to the class of rFVIII concentrates and to the class of plasma-derived
      VWF/FVIII concentrates, will be provided for free to the patients for all the duration of the
      study
    

Intervention name(s): PLASMA DERIVED Factor VIII; Recombinant FVIII
Intervention type(s): Drug; Drug
Intervention description(s): Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding; Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding
Other intervention name(s): ALPHANATE; ADVATE
Intervention MeSH terms: Factor VIII
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hemophilia A; Factor VIII inhibitors; vWF/FVIII; rFVIII
The Molecular Basis for a Broad Range of Phenotypes Related to hTAS2R38
Condition: Healthy
Study type: Observational

Summary: 
      This single-site, within-subject, experimental study is designed to test the hypothesis that
      individuals express taste receptors differently and have different sensitivities to bitter
      taste samples, which results from uneven expression. Subjects will include 100 racially and
      ethnically diverse, healthy adults. All subjects will provide saliva samples for genetic
      analysis and undergo taste testing with common psychophysical stimuli. From the pool of 100
      subjects, 36 subjects from the common heterozygous group (PAV/AVI) and two from each
      homozygous group (AVI/AVI, nontaster and PAV/PAV, taster) will be invited to return for two
      additional sessions. During both sessions the investigators will 1) measure bitterness
      thresholds for PROP, a common psychophysical stimulus; 2) measure bitterness perception of
      several vegetables; 3) obtain a saliva sample and 4) collect taste papillae. The
      investigators will then isolate DNA and RNA from the taste papillae and isolate DNA from
      saliva to evaluate molecular differences over time and between individuals and how it relates
      to taste psychophysics. All psychophysical and cellular measurements will be done during both
      sessions so that the investigators can determine how much variation is observed over a
      one-week time period in both cellular phenotype and psychophysical phenotype.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults of all races and both genders (N=100) will be involved in the proposed research.
        Typically, our population of subjects is approximately 45% African American, 45% Caucasian,
        6% Hispanic, and 4% Asian. This increased representation of under-represented minorities in
        our subject populations is reflective of the greater Philadelphia region and has been
        achieved, in part, through our outreach efforts advertising in local newspapers throughout
        the city.
      
Biospecimen description: 
      Saliva and taste tissue will be collected from individuals enrolled in the study.
    
Keywords: bitter taste; psychophysics; genetics; epigenetics; bitterness sensitivity
SHR - 1209 Treatment Efficacy and Safety of the Patients With Hypercholesterolemia Ⅲ Period Clinical Research
Condition: Primary Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is ongoing to evaluate the efficacy and safety of SHR-1209 in patients with
      hypercholesterolemia.
    


Intervention name(s): SHR-1209; SHR-1209 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SHR-1209; SHR-1209 Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Background Lipolowering therapy in combination with SHR-1209/ placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Observe the Impacts of Anti-Tumor Necrosis Factor (TNF) Effectiveness on Improvement in Work Place and Household Productivity for Patients With Psoriatic Arthritis (PsA)
Condition: Psoriatic Arthritis; Work Productivity
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Observational

Summary: 
      This post marketing observational study is designed to provide the initial data on work
      impairment of PsA patients in Turkey, as well as changes in work impairment, life quality and
      clinical response during treatment with anti-TNF agents.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients from both genders will be included to this non-interventional epidemiological
        study from selected university or state hospitals or Ministry of Health of Turkey training
        and research hospitals in Turkey.
      
Keywords: Work Productivity; Anti-TNFs; Psoriatic Arthritis
Is it Possible to Screen for Type 2 Diabetes at Day 2 in Gestational Diabetes Mellitus Patients Postpartum?
Condition: Gestational Diabetes Mellitus; Type 2 Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Within 6 months of delivery, women who had gestational diabetes mellitus should be screened
      for type 2 diabetes with a fasting plasma glucose test and/or a 2-h postchallenge glycemia in
      a 75-g oral glucose tolerance test. However, not all women are screened. The objective of
      this study is to compare the screening test for type 2 diabetes done at 48 hours post-partum
      versus 8 weeks post-partum. The investigators want to measure the specificity, sensitivity,
      false and true predictive values of the screening test at 48 hours post-partum compared to
      the gold-standard.
    


Intervention name(s): Oral glucose tolerance test
Intervention type(s): Procedure
Intervention description(s): Subjects will have the Oral glucose tolerance test 48 hours post-partum and the same test 8 weeks post-partum.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with gestational diabetes mellitus who delivered.
      
Keywords: Type 2 diabetes; Post-partum screening
An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing Sites
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate if Xanax sustained release tablets manufactured at two different sites
      provide similar drug levels in the blood.
    


Intervention name(s): Xanax XR tablets 3 mg (sourced from Caugus); Xanax XR tablets 3 mg (sourced from Barceloneta)
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, 3 mg, single dose; Tablets, 3 mg, single dose
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Alprazolam; Xanax; Bioequivalence; Panic disorder with or without agoraphobia.
Open-Label Pilot Study of Guanfacine-Extended Release for the Treatment of Cannabis Dependence
Condition: Cannabis Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether guanfacine represents a tolerable,
      potentially effective pharmacotherapy option for cannabis dependence. Interested in seeing
      whether guanfacine treatment reduces marijuana consumption, withdrawal symptoms, and craving
      as compared to baseline.
    

Detailed description: 
      Cannabis use disorders remain the most common illicit drug use disorder and options for
      treatment remain limited. Compared to other abusable substances, there has been little
      investigation of pharmacotherapies for cannabis dependence and no effective pharmacotherapy
      for cannabis dependence has been developed yet. As such, the development of effective
      cannabis dependence pharmacotherapy is an important unmet public health need. Lofexidine, an
      alpha-2 agonist, is effective in treating opioid withdrawal and shows promise as cannabis use
      disorder pharmacotherapy, though its use may be limited by a cumbersome (thrice daily) dosing
      regimen. An alpha-2-agonist with a longer half-life, such as guanfacine, may have some of the
      same benefits as lofexidine at comparable doses, but its easier (once daily) dosing regimen
      may promote compliance and treatment retention. The purpose of this study is therefore to
      determine whether guanfacine represents a tolerable, potentially effective pharmacotherapy
      option for cannabis dependence. This pilot study can also provide the basis for subsequently
      conducting a larger study aimed at determining efficacy with the appropriate randomized,
      placebo-controlled design.
    

Intervention name(s): Guanfacine
Intervention type(s): Drug
Intervention description(s): Guanfacine, 4mg given once daily
Other intervention name(s): Intuniv
Intervention MeSH terms: Guanfacine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cannabis dependence; marijuana dependence; guanfacine
PF-06372865 in Subjects With Photosensitive Epilepsy
Condition: Reflex Epilepsy, Photosensitive
MeSH terms: Epilepsy; Epilepsy, Reflex
Study type: Interventional
Phase: Phase 2

Summary: 
      PF-06372865 in subjects with photosensitive epilepsy
    


Intervention name(s): PF-06372865; Placebo; Lorazepam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose; Placebo for PF-06372865 and placebo for lorazepam; 2 mg single oral dose
Intervention MeSH terms: Lorazepam; PF-06372865
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Trial Comparing a Paclitaxel Eluting Stent With Biodegradable Polymer Versus a Bare Metal Stent
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The success of stent implantation has led to the increasingly widespread use of them in the
      treatment of coronary artery disease (Sigwart, Serruys, Fischman)and although stent
      restenosis is still a limit for this therapeutic mode (Serruys, Rodriguez) the new generation
      of stents with improved coating materials and the development of polymers that release
      different kinds of drugs that prevent the activation and/or proliferation of smooth muscle
      cells (ultimate cause of restenosis) (Grube, Rodriguez). shows major improvements on this
      matter. The new generation of stents with biodegradable polymers and short time of drug
      release gives new advantages to this therapeutic, multiple studies and registries challenge
      this new devices (Taxus I and II, RAVEL, SIRIUS, ERACI II and III).

      For this reason the present study aims to compare a stainless steel stent with a drug eluting
      stent with coated of biodegradable polymer matrix hemoparin and paclitaxel.
    

Detailed description: 
      Patients with de novo lesions treated in different Institutions in Buenos Aires Argentina
      were randomized to treat with a stainless steel stent ("euca STS Flex") or a drug-eluting
      stent (" euca STS Flex DE") with a coating of a biodegradable polymer matrix of hemoparin and
      paclitaxel.
    

Intervention name(s): Bare Metal Stent; Drug Eluting Stent
Intervention type(s): Device; Device
Intervention description(s): Stainless steel stent; stent coated with the biodegradable polymer matrix hemoparin and paclitaxel
Other intervention name(s): Euca STS Flex; Euca STS Flex DE
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Biodegradable polymer; Drug Eluting Stent; In stent restenosis; stent thrombosis; Bare Metal Stent
Metformin as Adjuvant to Insulin Therapy in Insulin-resistant Diabetes Mellitus With Pregnancy
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      Adding metformin to insulin therapy in pregnant women with diabetes mellitus who show insulin
      resistance may be equivalently effective to further raising the insulin dose
    


Intervention name(s): Metformin; Humulin Insulin Mixtard
Intervention type(s): Drug; Drug
Other intervention name(s): Cidophage
Intervention MeSH terms: Insulin; Metformin; Insulin, Globin Zinc; Insulin, pork; isophane insulin, pork drug combination 30:70
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus; Pregnancy; Insulin; Metformin
The Optimum Omega-3 (003) Diet Study
Condition: Stress, Physiological
Study type: Interventional

Summary: 
      The goal of the Optimum Omega-3 (OO3) Diet Study is to assess whether swapping specific food
      ingredients in diets can significantly change omega-3 blood profiles with 10 weeks of a 7-day
      menu in men and women (18-40 years old). We want to look at the effect on a person's response
      to cognition, satiety and physical fitness. Investigators think that low omega-6 and moderate
      omega-3 fatty acid diets may regulate emotional response and help to return to normal after
      load carrying activities. We plan to test the effects of improving overall fatty acids on
      emotional response, satiety, and physical fitness levels by a diet with an improved omega-3
      to omega-6 diet compared to a control diet.
    

Detailed description: 
      The goal of the Optimum Omega-3 (OO3) Diet Study is to assess whether swapping specific food
      ingredients in components of US Military Garrison diet can significantly change blood
      profiles of n-3 HUFAs (highly unsaturated fatty acids) from baseline with 10 weeks of a 7-day
      menu in men and women (18-40 years old), and its effect on a person's response to cognitive
      measures, satiety and physical fitness (Adjunct Studies). The Department of Defense is
      interested in strategies to improve body composition of n-3 HUFAs and whether such strategies
      help people respond better emotionally. It is felt that low omega-6 and moderate omega-3
      fatty acid diets may improve the regulation of emotional responses, and may accelerate return
      of muscle strength and lower limb range of motion after fatiguing exercise such as walking
      while carrying a heavy load. We plan to test the effects of improving overall fatty acids on
      cognitive response, satiety, and physical fitness levels by substituting all chicken meat,
      eggs, beef, oil and other ingredients in 7 days of 3 meals plus snacks with like products
      that have low omega-6 PUFA (and/or enhanced omega-3 PUFA) in comparison with a control diet
      in which the ingredients have not been replaced.
    

Intervention name(s): The Optimum Omega-3 Fatty Acid Feeding Study
Intervention type(s): Other
Intervention description(s): Assess whether swapping specific food ingredients in the diet can significantly improve polyunsaturated fatty acid blood profiles and improve a person's response to cognitive measures and physical fitness.
Other intervention name(s): Omega-3 Fatty Acids; Omega-3 to Omega-6 Ratios; Physical performance and omega-3
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Omega-3 fatty acids; Omega-3 to omega-6 ratio; Cognitive response; Physical performance
Study to Assess Bioavailability of GLPG1690 Given as Oral Capsule or Tablet
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase I, randomized, open-label, cross-over study with three single-dose
      treatments to compare the bioavailability of an oral tablet relative to an oral capsule of
      GLPG1690 after single dose intake in healthy male subjects and to evaluate the effect of food
      on the bioavailability of the oral tablet.
    


Intervention name(s): GLPG1690
Intervention type(s): Drug
Intervention description(s): Oral administration of GLPG1690 in three different treatment conditions (treatment A through C)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Osteoporosis and Fall Prevention and Posture Correction Interventions in the Metropolitan Area
Condition: Osteoporosis Fracture
MeSH terms: Osteoporosis; Osteoporotic Fractures
Study type: Interventional

Summary: 
      The investigators' previous studies in 2014 and 2015 have demonstrated that among
      community-dwelling older adults with high osteoporotic fracture risks. many sarcopenia
      indices can be improved and bone mineral density (BMD) maintained with different exercise
      programs. In 2016, the investigators aim to determine the effects of 2 exercise interventions
      on posture corrections and further improvement of sarcopenic indices
    

Detailed description: 
      The current study enrolled subjects who already participated in the 2015 study (n=109) at the
      National Taiwan University Hospital Bei-Hu Branch (NTUHBB). Subjects will be maintained in
      their original integrated care group (ICG, target n=50) and muscle training group (MTG,
      target n=50) when possible. If target sample size is not reached, clinic patients are
      screened for high risk of fall, osteoporosis/fracture by standardized questionnaires or FRAX
      for enrollments. New participants are randomized into the ICG and MTG groups. Other than
      assessments provided in 2015, digital photography on posture and low back pain assessments
      are done in 2016. All participants received a CD-ROM and one hour education on osteoporosis,
      sarcopenia, frailty, fall prevention, nutrition, low back pain, good posture, and coping
      strategy and another hour of professional led exercise program with more focus on central
      muscle groups. ICG subjects received once weekly group exercise while MTG subjects received
      twice weekly machine-based resistance training on major muscle groups. Major outcomes were
      muscle mass (measured by bio-impedance analysis), grip strength, walking speed, and lower leg
      extension power, Chinese version of Oswestry Disability Index v 2.1 score (for low back
      pain), and spine curve angle (by photography) at baseline and after 12-weeks of intervention.
    

Intervention name(s): ICG; MTG
Intervention type(s): Behavioral; Behavioral
Intervention description(s): All participants received a CD-ROM and one hour education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, low back pain, good posture, and coping strategy and another hour of professional led exercise program with focus on central muscle groups. ICG subjects received once weekly group exercise.; All participants received a CD-ROM and one hour education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, low back pain, good posture, and coping strategy and another hour of professional led exercise program on central muscle groups. MTG subjects received twice weekly machine-based resistance training on major and central muscle groups.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Spine curve; Posture; Fracture; sarcopenia; Exercise