bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Opaganib in Coronavirus Disease 2019 Pneumonia
Condition: Coronavirus Infections
MeSH terms: Pneumonia; Coronavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This proof of concept study will take place in the US and other countries in approximately 15
      clinical sites and will enroll about 40 hospitalized patients diagnosed with COVID-19
      infection who have developed pneumonia and require supplemental oxygen. 20 patients will
      receive opaganib in addition to standard of care twice each day for 14 days. 20 will receive
      matching placebo in addition to standard of care unless the patient has been discharged from
      the hospital without requiring supplemental oxygen, in which case study drug will only be
      administered for 10 days. All participants will be followed up for 4 weeks after their last
      dose of study drug.
    

Detailed description: 
      Opaganib, a sphingosine kinase-2 (SphK2) inhibitor, has been broadly tested in Phase I/II
      studies. Extensive nonclinical data indicates both anti-viral and anti-inflammatory activity
      via selective SphK2 inhibition which may prove beneficial for treating COVID-19 infection and
      resulting pneumonia. This proof of concept study will take place in the US and other
      countries and will enroll about 40 hospitalized patients diagnosed with COVID-19 infection
      who have developed pneumonia and require supplemental oxygen. Half of the patients, i.e. 20
      patients, will receive opaganib in addition to standard of care for 14 days. The other 20
      will receive matching placebo (capsules that do not contain the medication) in addition to
      standard of care. Study drug will be administered every day for 14 days, twice each day,
      unless the patient has been discharged from the hospital without requiring supplemental
      oxygen, in which case study drug will only be administered for 10 days. All participants will
      be followed up for 4 weeks after their last dose of study drug.
    

Intervention name(s): Opaganib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study participants received opaganib 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).; Study participants received placebo 2 x 250 mg capsules (500 mg) plus standard of care every 12 hours (pharmacological and/or supportive).
Other intervention name(s): Yeliva; ABC294640
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Relationship Between Tooth Decay and Trabecular Bone
Condition: Dental Caries in Children; Pediatric Patients; Radiology
MeSH terms: Dental Caries
Study type: Observational

Summary: 
      Chewing, a movement that matures with experiences, has effects on the growth and development
      of the stomatognathic system. Tooth decay, which is known to have effects on chewing, can
      affect the jaw bone due to its indirect effect on the mechanical forces transmitted to the
      jaw bone. This study was aimed to evaluate the relationship between dental caries and jaw
      bone trabeculation during the growth and development processes in children by fractal
      dimension analysis method. 40 patients with deep-dentin caries / apical rarefying osteitis on
      the right or left side, 40 patients with deep-dentin caries / apical rarefying osteitis on
      either the right and left sides and 40 patients without deep-dentin caries / apical rarefying
      osteitis between 8-13 ages were randomly selected. Digital panoramic images of the selected
      patients were analyzed with fractal dimension analysis.
    


Intervention name(s): Fractal analysis
Intervention type(s): Diagnostic Test
Intervention description(s): Fractal dimension (FD) analysis, which can be measured in panoramic radiographs, is a technique that can be used to measure mandibular trabecular architecture and to determine early periodontal changes in alveolar bone. Fractal analysis method, which has become more and more popular in recent years; has features such as being easily accessible, not being affected by variables such as projection geometry and radiological density and providing objective data about trabecular structures. It can be measured in the patients' existing panoramic images and does not require extra imaging and material.
Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        -  systemically healthy,

          -  8-13 years-old,

          -  applied to the Clinic between January 2018 and April 2020 patients
      
Keywords: Disturbances in dental development; fractal analysis; pediatric patients; radiology
A Single Arm, Tolerability and Safety Phase IV Study of Fulvestrant(Faslodex® ) as 2nd Line and Later Therapy in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Condition: Locally Advanced or; Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      This single-arm study aims to assess the safety and tolerability profile of
      Fulvestrant(Faslodex®) as 2nd line and later therapy in postmenopausal women with locally
      advanced or metastatic breast cancer. The primary objective is to evaluate the adverse events
      after Fulvestrant (Faslodex®) for about 6 months
    

Detailed description: 
      This study is a Phase 4, single-arm, safety and tolerability study of fulvestrant (Faslodex®)
      as 2nd line therapy in postmenopausal women with locally advanced or metastatic breast
      cancer.

      All of enrolled patients in this study will be injected fulvestrant (Faslodex®). This study
      will be performed for about 3 years and approximately 100 patients(actual target will be 80
      treated patients) will be enrolled in about 10 investigational sites.

      After obtaining the written informed consent from the patients, the information of
      demographic and medical history will be collected and laboratory tests will be performed.

      Patients who meet the inclusion/exclusion criteria will be injected the fulvestrant
      (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after
      the initial dose injection. The information of adverse events will be collected after the 1st
      dose of IP injection. In case that the evaluation of tumor response might be performed in
      regular clinical practice, those data will also be collected as well. The quality of life
      will also be measured.
    

Intervention name(s): Fulvestrant
Intervention type(s): Drug
Intervention description(s): fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection.
Intervention MeSH terms: Fulvestrant
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Hydration to Optimize Metabolism (H2O Metabolism) Pilot Study
Condition: Low Water Intake; High Vasopressin
Study type: Interventional

Summary: 
      This study evaluates increased hydration (1.5 L of water daily during 6 weeks) on top of
      habitual water intake in the lowering of the vasopressin marker copeptin and in the lowering
      of plasma glucose concentration in adults with signs of low water intake at recruitment
      (elevated levels of copeptin, high urine osmolality, low urine volume).
    

Detailed description: 
      High plasma concentration of vasopressin (i.e. antidiuretic hormone) is a novel and
      independent risk factor for type 2 diabetes, the metabolic syndrome, cardiovascular disease
      and premature death. The main physiological role of vasopressin is to maintain constant
      plasma osmolality. Previous studies in rats and a Mendelian randomization study in humans
      suggest causality between elevated vasopressin concentration and elevated plasma glucose
      concentration. As vasopressin can be suppressed by increasing water intake, the investigators
      hypothesize that water supplementation in individuals with high vasopressin can lower plasma
      glucose and prevent diabetes.

      The aim of this pilot study is to test if six weeks of water supplementation of 1.5 Liters of
      extra water per day in low-drinkers with high copeptin can significantly alter hydration
      markers in general and reduce plasma copeptin in particular. Furthermore, the investigators
      also aim at investigating whether this 6-week water intervention can significantly reduce
      fasting plasma glucose concentration.
    

Intervention name(s): Water
Intervention type(s): Dietary Supplement
Intervention description(s): Increased daily water intake with 1.5 Liters of water per day on top of habitual water intake.
Intervention model: Single Group Assignment
Intervention model description: All participants of this pilot intervention study had the intervention of 1.5 Liters of increased daily water intake per day during 6 weeks.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hydration; Water; Vasopressin; Copeptin; Glucose
Clinical Effect Of Cross Titration Of Antipsychotics With Ziprasidone In Schizophrenia Or Schizoaffective Disorder
Condition: Schizophrenia; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to compare effectiveness of ziprasidone treatment to current
      treatments (haloperidol, olanzapine or risperidone) measured by change in Brief Psychiatric
      Rating Scale (BPRS) scores versus baseline
    


Intervention name(s): ziprasidone
Intervention type(s): Drug
Intervention MeSH terms: Ziprasidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sevoflurane Protective Effect on Ischemia Reperfusion Injury in Microvascular Surgery
Condition: Microvascular Breast Flap in Plastic Surgery
Study type: Interventional

Summary: 
      This study aimed to evaluate the possible protective effect of anesthetic technique balanced
      (BAL) compared to total intravenous anesthetic technique (TIVA-TCI) in ischemia reperfusion
      injury in microvascular flap in plastic surgery. The investigators will evaluate the
      viability of the flap using tissue oximetry monitoring and the level of biochemical markers
      in a circle at the end of the intervention.
    


Intervention name(s): Sevoflurane; Diprivan + Remifentanil TCI
Intervention type(s): Drug; Drug
Intervention MeSH terms: Remifentanil; Sevoflurane; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Bioequivalence Study of CT-L01 Compared to Co-administration (ALO 25 mg and MET XR 1,000 mg) in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to
      evaluate bioequivalence after co-administration of ALO and MET XR or administration of CT-L01
      in healthy volunteers.
    


Intervention name(s): CT-L01; Alogliptin Benzoate 25 mg; Metformin HCl XR 1,000 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): FDC tablet, single dose, oral administration; Alogliptin Benzoate 25 mg, oral administration; Metformin HCl XR 1,000 mg, oral administration
Intervention MeSH terms: Metformin; Alogliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose Escalation of Velcade Daily Dose in Patients With Solid Tumors
Condition: Advanced or Metastatic Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      VELCADE has demonstrated marked activity in haematological cancers leading to registration
      (MM, MCL).

      Currently only biweekly or weekly regimens have been explored. Key signalling pathways which
      are aberrant in haematological cancers are also present in solid tumors.

      VELCADE covers a broad spectrum of proteins, which are pivotal in carcinogenesis.VELCADE as a
      single agent & in combination with chemotherapy in solid cancers has shown modest and real
      anti-tumor activity but insufficient for Phase III development.

      VELCADE PK exposure may be inadequate in solid tumors compared to "liquid cancers." VELCADE
      daily low dose administration may allow a greater PK exposure to be achieved, which is
      tolerated

      Hypotheses:

      VELCADE daily dosing (5-days on, 2-days off) is tolerable at biologically active doses
      VELCADE daily dosing (5-days on, 2-days off) results in increased PK (AUC)/PD (20S proteasome
      inhibition) VELCADE daily dosing (5-days on, 2-days off) with increased PK/PD results in
      improved anti-tumor activity (Increased tolerable VELCADE AUC may potentially cross the
      threshold required for clinically significant anti-tumor activity in solid cancers).

      Some preclinical data suggest that: VELCADE daily dosing results in increased proteasome
      inhibition in tumor tissues Combination of VELCADE + XRT/other daily dosing agent may have
      increased anti-tumor activity compared to monotherapy alone.
    


Intervention name(s): Bortezomib
Intervention type(s): Drug
Other intervention name(s): VELCADE
Intervention MeSH terms: Bortezomib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
On the Cyberknife Dose Fraction of Liver Cancer Treatment
Condition: CyberKnife Radiosurgery
MeSH terms: Liver Neoplasms
Study type: Observational

Summary: 
      The research aims to the primary hepatic carcinoma patients whose diameter of the single
      tumor is equal or less than 5cm.By supervising the changes of liver function, Child-Pugh
      score, ICG-R15 value, secondary reaction, incidence rate of RILD during and after the
      radiotherapy, meanwhile combining the outcome of the progression of disease and the condition
      of survival quality, the optimum proposal could be obtained and apply to clinic thus make the
      treatment safe, effective and personalized.
    


Intervention name(s): Dose fraction forms
Intervention type(s): Radiation
Intervention description(s): The investigators divide the participants randomly into 3 groups by SPSS 19.0.Three groups participants receive the different dose fraction(49Gy/7f,54Gy/6f and 55Gy/5f),which also means different Biologic Equivalent Dose.Through the research,the investigators want to find out the optimum dose fraction method,which makes the treatment safe, effective and personalized.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The investigators aim to the hepatocellular participants who receive the radiotherapy
        through different dose fraction by cyberknife.
      
Keywords: CyberKnife; hepatocellular; dose fraction; ICG R15
Effects of the Physical Fitness on Serum Klotho Levels in Healthy Population
Condition: Healthy Population
Study type: Interventional

Summary: 
      Exercise program in serum Klotho levels
    

Detailed description: 
      This study aims to analiyze the effects of acute exercise in serum Klotho levels attending
      physical fitness in healthy population
    

Intervention name(s): plyometric exercise; Aerobic exercise
Intervention type(s): Other; Other
Intervention description(s): acute plyometric exercise; acute aerobic exercise
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Description of the sample
Masking: Single (Participant)
Primary purpose: Other
Keywords: Klotho; Exercise; Physical Fitness
Probiotics for Enhanced Tissue Carotenoid Status in Premenopausal Women
Condition: Carotenoid Status; Gut Microbiome; Skin Health
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Carotenoids are yellow-orange fat soluble plant pigments primarily obtained from the diet
      that serve as an accurate biomarker for fruit and vegetable intake. Carotenoids have
      demonstrated antioxidant, anti-inflammatory, and anti-obesogenic properties among others.
      Excess carotenoids are deposited in the skin for storage where they protect against UV skin
      damage and contribute to improvements in skin health (i.e., decrease the appearance of
      wrinkles). However, carotenoid status is linked to bioavailability and absorption, which has
      a high inter-individual variability. It has been hypothesized that inter-individual
      variations are related to the diversity of gut microbiota.

      The aim of the present study is to determine whether probiotic supplementation can enhance
      carotenoid status and responsiveness to carotenoid-mediated changes in blood and skin from
      intake of a supplement containing mixed forms of carotenoids in pre-menopausal women.
    


Intervention name(s): Probiotic; Placebo; Carotenoid supplement
Intervention type(s): Dietary Supplement; Other; Dietary Supplement
Intervention description(s): Daily intake of 10 x 10^9 CFU of a proprietary strain for a total duration of 10 weeks; 1 capsule daily containing the same carrier material that is similar in size, shape and taste to the probiotic, for a duration of 10 weeks; 1 capsule daily containing ~20 mg of total carotenoids for a total duration of 10 weeks
Intervention MeSH terms: Carotenoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Carotenoid; Microbiome; Skin; Color; Plasma
Copeptin as a Stress Marker During a Written Examination
Condition: Healthy
MeSH terms: Diabetes Insipidus
Study type: Observational

Summary: 
      To investigate whether copeptin levels increase upon a psychological stress (i.e. written
      examination) and whether copeptin levels measured immediately before the written examination
      predict success of the examination.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        42 healthy voluntary medical students studying in the 4th year at Basel University
      
Biospecimen description: 
      Serum, Li-Heparin
    
Keywords: medical students; Basel University
Rapid Opiate Detoxification and Naltrexone Induction Using Buprenorphine - 2
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to develop a clinical protocol to detoxify patients from opiates
      to naltrexone using buprenorphine and to develop pilot data for a grant application for a
      controlled study of the efficacy of the new clinical protocol for outpatients.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Opioid-Related Disorders
Evaluate the Safety, Tolerability and Immunogenicity Study of GLS-5300 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The Middle East Respiratory Syndrome Coronavirus (MERS CoV), is a cause of severe and highly
      fatal lower respiratory tract infection, first identified in 2012. As of August 2018, there
      have been 2229 cases reported with a case fatality rate >35%. In 2015 an individual returning
      to South Korea served as the index case for an outbreak of 186 individuals, of who, >20%
      died. GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein.
      This Phase I/IIa study will evaluate the safety, tolerability and immunogenicity of GLS-5300
      administered intradermally (ID) followed by electroporation at 0.3 and 0.6 mg/dose assessing
      2 and 3-dose regimens.
    

Detailed description: 
      GLS-5300 is a DNA plasmid vaccine that expresses the MERS CoV spike (S) glycoprotein.
    

Intervention name(s): GLS-5300; Cellectra 2000 Electroporation
Intervention type(s): Biological; Device
Intervention description(s): [Part A] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) [Part B] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) GLS-5300 0.6 mg at 0, 4, and 12 weeks (N=25) GLS-5300 0.6 mg at 0 and 8 weeks (N=25); GLS-5300 administered ID followed by Cellectra 2000 Electroporation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: MERS CoV; MERS-CoV; Middle East Respiratory Syndrome; MERS; DNA Vaccine
Exercise Habits: A Survey of Individuals With Parkinson's Disease Living in the Community
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      This study aims to evaluate the exercise regimens of individuals with Parkinson's.
    


Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Participants responded to questions about their exercise habits and perceived levels of intensity as well as demographic information.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals ages 40-90 years old who have been diagnosed with Parkinson's Disease.
      
Keywords: Exercise; Survey
A Study of Ponesimod in Healthy Adult Participants Receiving Propranolol at Steady State
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the effect of the up-titration regimen of
      ponesimod on heart rate (HR) and other electrocardiogram (ECG) parameters when administrated
      to healthy adult participants receiving propranolol at steady state.
    


Intervention name(s): Ponesimod dose range (2 - 20 mg); Placebo Propranolol; Propranolol 80 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive ponesimod oral tablet at a dose of 2 mg in Treatment period 1 and as an up-titrating regimen (dose range: 2mg-20mg) in Treatments period 2.; Participants will be administered placebo propranolol oral capsule from Day 1 to Day 19 in Treatment A of Treatment period 2.; Participants will receive propranolol 80 mg long acting oral capsule from Day 1 to Day 19 in Treatment B of Treatment period 2.
Intervention MeSH terms: Propranolol; Ponesimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Study Comparing Two Different Tablet Formulations Of Bosutinib
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is comparing 2 formulations of bosutinib in healthy subjects.
    


Intervention name(s): SKI-606 (Bosutinib)
Intervention type(s): Drug
Intervention description(s): Arm 1 - Commercial Tablet manufactured by Excella
Arm 2 - Clinical Tablet manufactured by Wyeth Montreal
Other intervention name(s): Bosutinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Subjects