bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, and Pharmacokinetics of a Single Oral Dose of SKI-O-703 in Healthy Volunteers
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This double-blind, placebo-controlled, single ascending dose study is designed to demonstrate
      safety, tolerability and pharmacokinetics of SKI-O-703 in healthy volunteers. The results of
      this study will guide selection of dose levels for future multiple dose studies in healthy
      volunteers and adult patients with moderately to severely active rheumatoid arthritis.
    

Detailed description: 
      This is a double-blind, placebo-controlled study in healthy adult volunteers that will be
      conducted to evaluate the safety, tolerability, and pharmacokinetics of ascending single
      doses of SKI-O-703. A total of 48 subjects are planned to participate in 6 cohorts (8
      subjects each). In each cohort, 6 subjects will be randomly assigned to receive SKI-O-703 and
      2 subjects will be randomly assigned to matching placebo. Dosing will be initiated in the 50
      mg dose cohort and sequentially escalated to the 100 mg, 200 mg, 400 mg, 600 mg, and 800 mg
      cohorts.
    

Intervention name(s): SKI-O-703 capsule; Placebo capsule
Intervention type(s): Drug; Drug
Intervention description(s): SKI-O-703 25 mg capsule or 200 mg capsule without excipient; Placebo 180 mg capsule filled with microcrystalline cellulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: rheumatoid arthritis; healthy volunteers; moderately to severely active
Investigation of Changes in Bone Scan Imaging Before and After Intravenous Bisphosphonate Therapy for Osseous Metastases From Breast Cancer
Condition: Osseous Lesions From Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine for changes in the bone scan after treating with
      zoledronic acid (Zometa™). This study is designed to show if intravenous (IV)
      bisphosphonates, which are infused by vein, such as pamidronate (Aredia™) or zoledronic acid
      (Zometa™), cause changes in the result of bone scans in women with metastatic breast cancer.
      Both bone scans and the IV bisphosphonates are components of routine care of women with
      breast cancer that has spread to the bone.
    

Detailed description: 
      Presently, intravenous bisphosphonates are routinely used every 3 to 4 weeks in patients with
      osseous metastases from breast cancer. However, there is no data addressing the effects of
      intravenous bisphosphonate therapy on the results of bone scan imaging. Therefore, the first
      step in the collaboration between MSKCC Breast Cancer Medicine Service and Nuclear Medicine
      Service is to define whether or not intravenous bisphosphonate therapy affects the results of
      bone imaging with the standard technetium, Tc-99m MDP. Women receiving intravenous
      bisphosphonate therapy for breast cancer metastases involving bone at MSKCC are eligible for
      this diagnostic clinical is no therapeutic intent in this study.

      Bone Scan performed before intravenous bisphosphonate therapy (baseline as clinically
      indicated). Ideally, the bone scan will be performed immediately before to, bisphosphonate
      therapy.

      Zoledronic acid, intravenous bisphosphonate therapy (as clinically indicated)

      Bone Scan performed within 1 day after intravenous bisphosphonate therapy (study test).

      Number of lesions seen in the baseline and study test will be counted and compared for
      changes in imaging results induced by intravenous bisphosphonate therapy.

      The number of lesions detected by bone scan pre and post therapy will be recorded and the
      difference will be calculated.
    

Intervention name(s): Zometa™
Intervention type(s): Radiation
Intervention description(s): Patients who will be receiving zoledronic acid therapy and are scheduled for an extent of disease evaluation with bone scan would undergo a second bone scan within 1 day of zoledronic acid therapy to assess changes in imaging.
Other intervention name(s): Zoledronic acid
Intervention MeSH terms: Zoledronic Acid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: osseous lesions; breast cancer; metastatic breast cancer
Evaluation of a Smartphone Based Diagnostic Tool to Assess Neonatal Jaundice in a Mexican Population
Condition: Jaundice, Neonatal
MeSH terms: Jaundice, Neonatal; Jaundice
Study type: Interventional

Summary: 
      This corss-sectional study aims to test the performance and accuracy of the Picterus JP
      screening device in newborns with different skin types.
    

Detailed description: 
      A descriptive cross-sectional study among 174 newborns was carried out at Hospital
      Materno-Infantil de Irapuato in Mexico during July and August 2018.

      The Picterus Calibration Card will be placed on the chest of the newborn with the hole in the
      card placed over the infant's sternum. A validated smartphone with Picterus JP will be used
      to collect digital images..
    

Intervention name(s): Picterus Jaundice Pro
Intervention type(s): Device
Intervention description(s): Use Picterus Jaundice Pro, a smartphone app that is used to take photo of the newborns skin, where the Picterus calibration card is place.
Other intervention name(s): Picterus JP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Naltrexone for Relapse Prevention
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to evaluate the safety and effectiveness of an injectable slow releasing
      preparation of naltrexone to reduce alcohol consumption and risk of relapse in
      alcohol-dependent subjects. Individuals will receive either naltrexone or a placebo injection
      for a total of three months, with two subsequent followup visits spanning a 6- month period.
    


Intervention name(s): naltrexone (Revia)
Intervention type(s): Drug
Intervention MeSH terms: Naltrexone
Intervention model: Parallel Assignment
Primary purpose: Treatment
Interaction of Melatonin With MTNR1B Genotype on Glucose Control - Study 2
Condition: Glucose; Circadian Rhythm; Melatonin; Genes; Light
Study type: Interventional

Summary: 
      This project aims to test the impact of melatonin and MTNR1B variation on regulation glucose
      regulation in a highly controlled in-laboratory setting and ex vivo in pancreatic islets.
    

Detailed description: 
      The investigators' recent GWAS discovery of MTNR1B as a novel type 2 diabetes gene has
      sparked great interest into the role of melatonin in glycemic control, for which the
      mechanism is largely unknown. This research will determine the effect of melatonin and MTNR1B
      on glycemic control under highly-controlled, in-laboratory protocols while manipulating
      circulating melatonin concentrations (both up and down) and assessing glycemic control by
      frequently-sampled intravenous glucose tolerance tests, as well as in ex vivo human
      pancreatic islets. This research will provide mechanistic insights into the metabolic effects
      of melatonin and the MTNR1B risk variant and may help in evidence-based approaches and
      personalized recommendations to improve glycemic control in night shift workers and
      late-night eaters.
    

Intervention name(s): placebo; melatonin; bright light; dim light
Intervention type(s): Drug; Dietary Supplement; Other; Other
Intervention description(s): Capsules containing microcrystalline cellulose; 5 mg of melatonin per os.; room light will be bright; room light will be dim
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Pharmacokinetic Study: Effect of 25(OH)D and Vitamin D3 on Serum 25(OH)D
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      We compare the effect of HyD (25-hydroxyvitamin D) and vitamin D3 in their effect on
      25-hydroxyvitamin D plasma levels over a course of 4 month. This is a pharmacokinetic study
      including 35 postmenopausal women.

        -  Trial with medicinal product
    

Detailed description: 
      We include postmenopausal women age 50 to 75, race/ethnicity: Caucasian, serum 25(OH)D at
      baseline between 20 to 60 nmol/l, body mass index: < 30 kg/m2

      to compare 25(OH)D and vitamin D3 in equimolar doses over a 4 month pharmacokinetic trial.
      The dosing arms are daily, weekly, and bolus
    

Intervention name(s): 25(OH)D; vitamin D3
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): daily (20ug), weekly (140 ug), Bolus (140 ug); daily (800 IU), weekly (5600 IU), Bolus (5600 Iu)
Other intervention name(s): HyD; Cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy postmenopausal women
VR Mind and VR Mind+ Intervention
Condition: Social Phobia
MeSH terms: Phobia, Social
Study type: Interventional

Summary: 
      The aim of the study is to assess the safety and efficacy of VR Mind and VR Mind +
      interventions.
    

Detailed description: 
      In this study, investigators will test the software developed by Tomorrow Sp. z o. o., named
      VR Mind and VR Mind+. The software utilizes the concept of virtual reality exposure therapy
      to treat social anxiety disorder. The aim of the study is to assess the safety and efficacy
      of VR Mind and VR Mind + interventions.

      The research consists of fourteen sessions. The first and the last session will be dedicated
      to participant assessment. Subsequent sessions 2-13 will be performed according to the
      therapy protocol for each arm. Control group of participants (active comparative arm) will
      receive standard treatment for social anxiety disorder - cognitive behavioral therapy based
      on the protocol developed by the Principal Investigator [protocol adapted from the approach
      of Clark and Wells (Mayo-Wilson, Dias, Mavranezouli, 2014)]. Experimental group 1 will
      receive cognitive behavioral therapy with exposure in virtual environment. Experimental group
      1 and control group were designed to be as similar as possible, with the exception of the
      modality for the delivery of exposure. All treatment session will be led by licensed
      therapist.

      Participants of the experimental group 2 will independently conducts the self-therapy
      process. The intervention will consist of 12 therapeutic sessions. At each of the 12
      sessions, the participant will selects a specific scenario of social situations that arouse
      fear (e.g. public speaking, job interview or other situations from everyday life).

      Because of the risk of simulator sickness (e.g., headaches, nausea), exposure trials will
      last no longer than 20 minutes for each session.
    

Intervention name(s): Virtual Reality Exposure Therapy VR Mind+; Virtual Reality Exposure Therapy VR Mind; Cognitive Behavioral Therapy
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Virtual Reality Exposure Self-Therapy led by a participant; Treatment with Virtual Reality Exposure Therapy led by a therapist; Standard treatment for social phobia led by a therapist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: virtual reality; social phobia; vret; virtual reality exposure therapy
Safety of and Immune Response to a Dengue Virus Vaccine (rDEN3delta30/31-7164) in Healthy Adults
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Dengue fever, which is caused by dengue viruses, is a major health problem in tropical and
      subtropical regions of the world. The purpose of this study is to test the safety of and
      immune response to a new dengue virus vaccine in healthy adults.
    

Detailed description: 
      More than 2 billion people living in tropical and subtropical regions of the world are at
      risk of dengue virus infection. Dengue viruses cause dengue fever, as well as the more severe
      dengue hemorrhagic fever/shock syndrome, and dengue virus infection is the leading cause of
      hospitalization and death in children in several tropical Asian countries. This study will
      evaluate the safety and immunogenicity of a live, attenuated dengue virus called
      rDEN3delta30/31-7164.

      This study will consist of two groups, with Group 1 enrolling first. Group 1 participants
      will be randomly assigned to receive either 10^3 PFU of rDEN3delta30/31-7164 or placebo
      subcutaneously in their deltoid. Participants will be monitored at the clinic for 30 minutes
      after receiving the immunization to monitor for adverse effects. After that, participants
      will be asked to return to the clinic approximately every other day for the next 16 days, and
      then on Day 21, 28, 42, and 180. At each visit participants will have physical and clinical
      exams, vital signs, measures, blood drawn, and will be asked about any adverse events they
      may have experience. Female participants will be given a pregnancy test. In addition,
      participants will be asked to measure their temperature 3 times a day and record it in a
      temperature diary for the first 16 days after immunization.

      If less than 90% of the participants in Group 1 seroconvert to DEN3 then Group 2A will be
      enrolled. Group 2A will follow the same procedures as Group 1, but will receive a 10^5 PFU
      dose of rDEN3delta30/31-7164.

      If more than 90% of the participants in Group 1 seroconvert to DEN3 then Group 2B will be
      enrolled. Group 2A will follow the same procedures as Group 1, but will receive a 10^1 PFU
      dose of rDEN3delta30/31-7164.
    

Intervention name(s): rDEN3delta30/31-7164
Intervention type(s): Biological
Intervention description(s): A live attenuated, recombinant DEN3 candidate vaccine virus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Dengue Vaccine; Dengue Virus; Dengue Hemorrhagic Fever; Dengue Shock Syndrome
Immunogenicity and Safety of a DTPa-HBV-IPV/Hib Vaccine Given at 2, 3 and 4 Months of Age
Condition: Acellular Pertussis; Tetanus; Diphtheria; Hepatitis B; Poliomyelitis; Haemophilus Influenzae Type b
MeSH terms: Hepatitis B; Tetanus; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to show that the immunogenicity of newly formulated
      DTPa-HBV-IPV/Hib vaccine is as good as the immunogenicity of the currently licensed
      formulation of the vaccine. The vaccine will be administered as a primary vaccination course
      to healthy infants at 2, 3 and 4 months of age and its safety and reactogenicity will also be
      assessed.
    


Intervention name(s): Infanrix hexa Vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Haemophilus influenzae type b; Double-blind; Finland; randomized; phase 2; GSK Biologicals; DTPa-HBV-IPV/Hib
"Cataract Surgery in Eyes With Epiretinal Membrane"
Condition: Epiretinal Membrane; Pseudophakic Cystoid Macular Edema; Irvine-Gass Syndrome; Cataract
MeSH terms: Cataract; Macular Edema; Epiretinal Membrane
Study type: Observational

Summary: 
      The purpose of the study is to evaluate retinal thickness change and the occurrence of
      central structural retinal changes after uneventful small-incision cataract surgery in eyes
      with asymptomatic early stages of epiretinal membrane.
    

Detailed description: 
      Optical coherence tomography (OCT) is nowadays used in daily clinical practice and has become
      a helpful tool for detection of macular changes also in presence of opacification of the lens
      before cataract surgery. Using recent high-resolution OCT technology, early stages of
      epiretinal membranes can easily be detected and analysed. Since cataract surgery is one of
      the most frequently performed operations worldwide, this study was aimed to investigate the
      influence of uncomplicated cataract surgery on central retinal thickness and the incidence of
      structural and morphological macular changes after surgery in eyes with asymptomatic
      epiretinal membrane.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Thirty patients with visually compromising cataract and asymptomatic epiretinal membrane
        (ERM group) and 15 consecutive eyes with senile cataract with a healthy macula (control
        group) were included.
      
Keywords: central retinal thickness; epiretinal membrane; cataract surgery; pseudophakic cystoid macular edema
COVID-19 Sequelae: Treatment and Monitoring. A Dietary Supplement Based on Sea Urchin Eggs With Echinochroma A
Condition: Long COVID
MeSH terms: COVID-19; Post-Acute COVID-19 Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to assess the efficacy and efficiency of a nutraceutical from sea
      urchin eggs with Echinochrome A in the inflammation of tissues in subjects with long Corona
      Virus (COVID) syndome
    

Detailed description: 
      This is a double-blind placebo-controlled study in approximately 60 subjects with long COVID
      syndrome. After being informed about the study and potential risks, all subjects giving
      written informed consent will be screened to assess initial respiratory, cardiological
      inflammatory, neurological and emotional conditions. Prior to the first administration of the
      treatment, subjetcs will be randomized to receive three vials of the Dietary Supplement with
      sea urchin eggs extract with presence of the antioxidant Echinochrome A or placebo. According
      with the ACRO suggestions this study is focus on the patients. Subjects will be monitor by a
      Telemedicine platform called SkyMed developed for this study to assess their health daily and
      will have a weekly virtual meeting with a counselors to assess emotional state. Subjects will
      attend tp the Hospital, at the beggining of the study, and after finishing the vials of the
      Dietary Supplement (30, 60 and 90 days). Clinical, cardiological, neumonological and
      neurological studies will carried out to asses the systemic health as well as the quality of
      life indicators. Inflammation, trombolotic and inmune indicators will be assess in blood
      samples (basal, 30, 60 and 90 days).

      The main objetivec behind this clinical trial is to diminish ROS in the cells, enhance
      gluthation pathways and diminish cellular inflammation. Echinochrome A is a powerfull marine
      poliphenol with known antioxidant activity found in the eggs, shells and spines of sea
      urchins, that had been use in eastern medicien for a long time. Powder of sea urchin eggs are
      mention in Materia Medica back far 1647 as a powerfull anti inflamation agent.
    

Intervention name(s): Echinochrome A; Control
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Dietary Supplement with Echinochroma A Simple randomized design, in this arm patients will take 6ml of a 0.025% Echinochroma A solution twice a day for 90 days. 3 mg of Echinochroma A will be consumed per day.; Simple randomized design, in this arm patients will take 6ml of an fructose aqueous solution twice a day for 90 days with the same flavor as the treatment
Other intervention name(s): EchA Marine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Ramdomized Control
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Covid-19; sequalae; long covid; lung; telemedicine; brain; biomarker
Adjunctive Mixed Salts Amphetamine for Depressed Adults With Incomplete Response to Current Antidepressant Therapy
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      In this Phase 4 trial we will study the safety, tolerability and efficacy of mixed salts
      amphetamine (MSA), trade name Adderall, augmentation of antidepressant therapy for Major
      Depressive Disorder (MDD) in depressed outpatient adults who are taking an antidepressant but
      have not had complete resolution of their symptoms.
    

Detailed description: 
      Forty adult outpatients with MDD who failed at least one adequate trial of antidepressant
      monotherapy will be consented in a 63-day, cross-sequential, multicenter study comprising two
      treatment phases of 21 days each. The time frame from consent to baseline is 7 days. Patients
      will receive placebo or MSA in Phase 1, and in Phase 2, participants will receive MSA. There
      will also be a two-week follow up visit after the completion of Phase 2.

      We hypothesize that MSA will be safe and well tolerated, and will improve the patient's
      response to their antidepressant and provide superior symptom relief to antidepressant alone.
      The primary outcome measure is the Massachusetts General Hospital Cognitive-Physical Function
      Questionnaire (MGH-CPFQ).
    

Intervention name(s): mixed salts amphetamine
Intervention type(s): Drug
Intervention description(s): adjunctive to ADT
Other intervention name(s): Adderall
Intervention MeSH terms: Amphetamine; Adderall
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment