bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Safety, Tolerability, and Immunogenicity of Candidate Human Cytomegalovirus Vaccine in Healthy Adults
Condition: Cytomegalovirus Infections
MeSH terms: Infections; Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and effectiveness of four different doses
      of cytomegalovirus vaccines in healthy adults.
    

Detailed description: 
      This study is designed to assess safety and immunogenicity of four dose formulations of
      cytomegalovirus (CMV) vaccine (0.5 μg gB content with aluminum phosphate (alum), 1.0 μg
      glycoprotein B (gB) content with alum, 2.0 μg gB content with alum, or 1.0 μg gB content
      (without alum) as compared with placebo in approximately 125 healthy CMV-seronegative
      volunteer participants between 18 and 40 years of age.
    

Intervention name(s): VBI-1501A 0.5 μg; VBI-1501A 1.0 μg; VBI-1501A 2.0 μg; VBI-1501 1.0 μg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): VBI-1501A: 0.5 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168; VBI-1501A: 1.0 μg with alum with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168; VBI-1501A: 2.0 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168; VBI-1501: 1.0 μg without alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168; buffer/sucrose used for VBI-1501 suspension- administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: VBI-1501A; VBI-1501; prophylactic vaccine; virus diseases; cytomegalovirus (CMV); cytomegalovirus infections; cytomegalovirus vaccines; Herpesviridae Infections; Phase 1; Human Herpesvirus 5 (HHV5); Vaccines, virus-like particle (VLP); enveloped virus-like particle (eVLP)
Sofosbuvir/Ledipasvir and Nitazoxanide for Treatment of COVID-19
Condition: COVID
Study type: Interventional
Phase: Phase 4

Summary: 
      The efficacy of treating COVID-19 infection by using Sofosbuvir/Ledipasvir and Nitazoxanide
      will be examined. Included patients will be into 3 groups. The 1st group will receive
      Sofosbuvir/Ledipasvir plus the standard care treatment (SCT). The 2nd group will take
      Nitazoxanide and SCT, while the 3rd group will receive only SCT. Then the clinical
      improvement and the rate of PCR change from positive to negative will be evaluated in each
      group.
    

Detailed description: 
      This study is an open-label, randomized, controlled trial. A total of 240 patients who are
      recruited in 2 quarantine hospitals (15th of May hospital, Cairo, and Al Rajhi hospital,
      Assiut), will be randomly assigned in a 1:1:1 ratio (80 patient in each treatment arm), to
      receive either the fixed combination of Sofosbuvir/Ledipasvir (400 mg and 90 mg, orally) once
      daily for 14 days, plus the standard care treatment regimen (SCT) for COVID-19 patients
      according to the Egyptian Ministry of Health (MOH) protocol (Group 1), or nitazoxanide (500
      mg, orally) four times per day for 14 days, plus STC (Group 2), or SCT alone (Group 3). All
      treatment groups will be followed up by laboratory investigations and PCR for SARS-CoV-2
      virus at the time of enrollment, days 5, 8, 11, and 14. Supportive care comprised, as
      necessary, supplemental oxygen, noninvasive and invasive ventilation, antibiotic agents,
      vasopressor support, renal-replacement therapy, and extracorporeal membrane oxygenation
      (ECMO). To ensure a balanced distribution of case severities in all study groups,
      randomization will be stratified based on the case severity index issued by WHO
      (https://www.who.int/docs/default-source/coronaviruse/clinical-management-of-novel-cov.pdf).

      Written informed consent will be obtained from all patients or the patient's legal
      representative if the patient is too unwell to provide consent. The trial will be conducted
      in accordance with the principles of the Declaration of Helsinki and the Good Clinical
      Practice guidelines of the International Conference on Harmonisation. The authors are
      responsible for designing the trial and for compiling and analyzing the data. The authors
      vouch for data completeness and accuracy and adherence to the trial protocol.
    

Intervention name(s): Sofosbuvir and Ledipasvir; Nitazoxanide
Intervention type(s): Drug; Drug
Intervention description(s): Evaluate the efficacy of Sofosbuvir/Ledipasvir in treatment of COVID-19; Evaluate the efficacy of Nitazoxanide in treatment of COVID-19
Other intervention name(s): Treatment; Treatment
Intervention MeSH terms: Sofosbuvir; Ledipasvir; Ledipasvir, sofosbuvir drug combination; Nitazoxanide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Galcanezumab (LY2951742) in Participants With Episodic Migraine
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The reason for this study is to see if the drug galcanezumab is safe and effective in
      participants with episodic migraine. The study will last about 53 weeks and may include up to
      12 visits.
    


Intervention name(s): Galcanezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Administered SC
Other intervention name(s): LY2951742
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: prevention; prophylactic
Hypertension and Retinal Microvascular Dysfunction
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Hypertension is a worldwide health care burden that affects the structure and function of the
      macro- and microcirculation. Non-invasive vascular biomarkers are essential to timely
      diagnose end organ damage to improve cardiovascular (CV) risk stratification and medical
      decision making. The "Hypertension and retinal microvascular dysfunction" (HyperVasc) trial
      will investigate macro- and microvascular impairments in hypertensive patients and healthy
      controls to investigate hypertension-induced end organ damage by using gold-standard methods
      as well as newly developed and unique retinal microvascular biomarkers. Additionally, this
      trial will investigate the reversible effects of an eight weeks supervised and walking based
      high-intensity exercise intervention on blood pressure as well as macro- and microvascular
      health, compared to a control group with standard physical activity recommendations.
      Secondary outcomes will be cardiorespiratory fitness, physical activity, microalbuminuria,
      hypertensive retinopathy, and classical cardiovascular risk marker. The results of the
      HyperVasc trial will improve the understanding of hypertension-induced vascular impairments
      and will push the development of non-invasive vascular biomarker to screen end organ damage
      in general CV risk stratification.
    


Intervention name(s): HIIT exercise intervention; Physical activity recommendations
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The exercise intervention will be eight weeks of high-intensity interval training (HIIT) started by one warm-up week with an intensity of 75% maximum heart rate (HRmax). In the following seven weeks, the participants will perform a HIIT based on the following protocol and with a total duration of 45 minutes per session: warm-up for 10 minutes at 60-70% HRmax followed by a high-intensity interval consisting of 4x4 minutes at 80-90% HRmax with 3 minutes of active recovery at 60-70% HRmax and a 10 minutes cool-down at 60-70% HRmax. HR will be monitored during training by Polar® H7 heart rate sensors combined with Polar® M400 watches.; The control group will get physical activity recommendations based on actual guidelines from the European Association of Preventive Cardiology.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Use of a Novel Synbiotic to Change Human Gut Bacteria and Improve Health in Obese Adults
Condition: Intestinal Microbiota and Barrier Function
Study type: Interventional

Summary: 
      This study evaluates the effect of a dietary supplement to improve gut health. The
      participants will take one of six dietary treatments for three weeks, and the gut bacteria
      and the gut intestinal barrier will be assessed to determine if these dietary treatments
      beneficially change these markers of gut health.
    

Detailed description: 
      In this study, we intend to test the ecological and therapeutic functionality of a synbiotic
      combination of a Bifidobacterium adolescentis strain and the prebiotic galactooligosaccharide
      (GOS) in a human clinical trial. The synbiotic combination was selected based on a novel in
      vivo selection; specifically, the strain (BD1) is an human autochthonous gut organism that
      was enriched in an individual by GOS. Our experiments will test the efficacy of this
      synbiotic compared to a conventional synbiotic. We hypothesize this rationally selected
      synbiotic will improve intestinal barrier function in obese adult subjects, thereby
      preventing endotoxemia and metabolic inflammation, physiologically relevant functions that
      are increased in obese individuals. Our objectives are to: (1) compare the ability of the
      test and control synbiotic preparations to alter the gut microbiota in obese individuals; (2)
      test if GOS supports colonization and metabolic activity of test and control strains in the
      human gut; (3) compare the ability of the two synbiotic preparations to improve intestinal
      permeability and endotoxemia in obese subjects; and (4) assess associations between the gut
      microbiota and the test strain with biomarkers for translocation and endotoxemia.
    

Intervention name(s): Bifidobacteria adolescentis BD1; Bifidobacteria animalis subsp. lactis BB-12; Bifidobacteria adolescentis BD1 and galactooligosaccharide; Bifidobacteria animalis subsp. lactis BB-12 and galactooligosaccharide; galactooligosaccharide; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): packet containing 10^9 cells of Bifidobacteria adolescentis BD1; packet containing 10^9 cells of Bifidobacteria animalis subsp. lactis BB-12; packet containing 10^9 cells Bifidobacteria adolescentis BD1 and 5 g galactooligosaccharide; packet containing 10^9 cells B animalis subsp. lactis BB-12 and 5 g galactooligosaccharide; 5 g galactooligosaccharide; lactose powder, 5 grams
Intervention MeSH terms: DEFB1 protein, human
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assess Safety and Efficacy of Vilaprisan in Patients With Uterine Fibroids
Condition: Leiomyoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is performed to assess the efficacy of Vilaprisan (BAY1002670) in patients with
      uterine fibroids compared to placebo and ulipristal. It is also aimed to evaluate the safety
      of vilaprisan in subjects with uterine fibroids. Further, data on population pharmacokinetic
      (PK)/ pharmacodynamic (PD) relationship for vilaprisan in subjects with uterine fibroids will
      be supplemented.
    


Intervention name(s): Vilaprisan (BAY1002670); Vilaprisan (BAY1002670; Vilaprisan (BAY1002670; Vilaprisan (BAY1002670); Ulipristal; Ulipristal; Ulipristal
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Vilaprisan 2 mg (12 weeks), Vilaprisan 2 mg (12 weeks); Placebo (12 weeks),Vilaprisan (12 weeks); Vilaprisan 2 mg (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks); Placebo (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks); Ulipristal 5 mg (12 weeks), treatment break, Ulipristal 5 mg (12 weeks); Placebo (12 weeks), treatment break, Ulipristal 5 mg (12 weeks); Ulipristal (12 weeks), treatment break, Placebo (12 weeks)
Intervention MeSH terms: Ulipristal acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Uterine fibroids; Heavy Menstrual Bleeding
Study of ISA247 (Voclosporin) in De Novo Renal Transplantation
Condition: Kidney Diseases
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will see if voclosporin is safe and effective in preventing kidney transplant
      rejection.
    

Detailed description: 
      Prograf® (tacrolimus) is associated with numerous side effects, including neurotoxicity,
      nephrotoxicity, polyoma nephropathy, QT prolongation, and New Onset Diabetes Mellitus After
      Transplant (NODAT). Voclosporin is a novel calcineurin inhibitor intended for use in the
      prevention of organ graft rejection.

      Comparison(s): Voclosporin at 3 dose levels (0.4, 0.6, and 0.8 mg/kg twice a day) compared to
      tacrolimus
    

Intervention name(s): Voclosporin; tacrolimus
Intervention type(s): Drug; Drug
Intervention description(s): voclosporin 0.4, 0.6, 0.8 mg/kg po BID; tacrolimus 0.05 mg/kg po BID
Other intervention name(s): ISA247
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Randomized Controlled Trials; Immunosuppression; Adult; Kidney Transplantation; Treatment Outcome
Effect of BrainPhyt, a Microalgae Based Ingredient on Cognitive Function in Healthy Older Subjects
Condition: Healthy Aging; Dietary Supplement; Fucoxanthin; Cognitive Impairment; Neuroprotection; Mood; Stress; Sleep
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      In developed countries, the acceleration of the general population ageing has been widely
      described for decades, involving changes in public health policies. Among the health issues
      arising from this demographic change, the maintenance of cognitive function will be a major
      challenge in the next years, both in societal and economic terms. In this regard, some
      pharmacological and behavioural (e.g. physical activity, social involvement, intellectually
      demanding activities) preventive approaches have been evaluated to improve cognitive function
      with ageing. Among them, dietary interventions showed a potential interest to prevent
      cognitive decline during ageing. In this sense, there is a growing interest to find
      ecological solutions and to meet major societal challenge the use of microalgae as molecule
      of interest sources is a recent promising approach. Marine environments harbour a huge
      biological diversity of microalgae that represents a large source of almost untapped
      bioactive compounds. This biodiversity comprises 200,000 to 2 million species with about
      35,000 which are described and 15,000 maintained in culture collections. Microalgae are able
      to produce bioactive molecules, such as pigments, fatty acids, peptides and sterols. Some of
      these compounds are unique and specifically found in the marine environment and they could be
      increasingly used as natural bioactive products for targeted applications. Fucoxanthin is one
      of the major carotenoid found in microalgae well known for its neuroprotective effect but to
      our knowledge no human studies were realized.

      Thus the objective is to evaluate, in healthy older adults, the effect of a 24-week period of
      daily supplementation of high and low BrainPhyt, doses on cognitive function parameters
      (Spatial Working Memory scores, Attention and vigilance, episodic memory, executive
      function), stress, mood, sleep quality and biomarkers.
    


Intervention name(s): BrainPhyt; 100 % Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): BrainPhyt low dose supplementation during 6 months; 100 % Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study to Assess the Relative Bioavailability of 7 Test Tablet Formulations of JNJ-56021927 With Respect to the Capsule Formulation of JNJ-56021927 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (what the body does to the
      medication) and relative bioavailability (the extent to which a medication or other substance
      becomes available to the body) of JNJ-56021927 when administered as 7 test tablet
      formulations of JNJ-56021927 compared with the softgel capsule formulation of JNJ-56021927 in
      healthy male participants under fasted conditions at a single dose of 240 mg.
    

Detailed description: 
      This is a randomized (the study medication is assigned by chance), open-label (all people
      know the identity of the intervention), single-center, 8-treatment, parallel-group (each
      group of participants will be treated at the same time) study. Approximately 120 participants
      (15 participants in each treatment group) will participate in this study. All participants
      will be randomly assigned to 1 of 8 possible treatments (A, B, C, D, E, F, G, and H). The
      study will consist of a screening phase (within 21 days before the first administration of
      the study medication), a treatment phase with 8 parallel single-dose treatments (8 days); a
      follow up phase (42 days) and an end-of-study or early withdrawal assessments (Day 57).
      Safety will be evaluated by the assessment of adverse events, clinical laboratory tests,
      vital signs, and physical examination which will be monitored throughout the study. The
      duration of participation in the study for an individual participant will be approximately 78
      days.
    

Intervention name(s): JNJ-56021927 capsule; JNJ-56021927 tablet
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive oral soft gel capsules providing a total dose of 240 mg JNJ-56021927 on Day 1.; Participants will receive oral tablets providing a total dose of 240 mg JNJ-56021927 on Day 1.
Other intervention name(s): ARN-509
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; JNJ-56021927; ARN-509; Bioavailability
Autologous Mesenchymal Stromal Cells for Multiple Sclerosis
Condition: Relapsing-Remitting Multiple Sclerosis; Secondary Progressive Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study evaluates the effect of cryopreserved autologous adult bone-marrow mesenchymal
      stromal cells (BM-MSC) in patients with active multiple sclerosis, compared to placebo.

      Patients will be allocated to one of the 2 treatment arms (BM-MSC or placebo)and at month 6,
      the treatment will be crossed to receive the other product. The objective is to assess the
      safety of a single infusion BM-MSC, and to explore its efficacy in these patients.

      Patients will be evaluated at month 12 and will be followed-up for a total of 3 years.
    

Detailed description: 
      To date, there is no effective therapy to cure multiple sclerosis (MS). Immunomodulatory
      therapies are useful in reducing the frequency of inflammatory processes (relapses) but don't
      delay significantly the progression of the disease, prevent long term disability or induce
      the repair of damaged tissue. This proposal contemplates the use of adult autologous bone
      marrow mesenchymal stromal cells (BM-MSC) as an alternative therapeutic strategy to treat
      patients with active MS. This is a randomized, double blind, crossover clinical trial in
      which 8 patients with active forms of MS and moderate disability will enter the trial with
      the primary objective of assessing the safety and tolerability of a single intravenous
      infusion of BM-MSC. Secondary objectives are to assess the efficacy by gadolinium enhancing
      lesions though magnetic resonance imaging, neurophysiological effects and immunological
      effects. Once randomized, patients will undergo BM extraction and once confirmed the
      availability of the needed dose, they will be randomized to one of the 2 treatment arms
      (BM-MSC named XCEL-MC-ALPHA, or placebo). XCEL-MC-ALPHA will be cryopreserved for all
      patients regardless the allocated arm. At month 6, the treatment will be crossed. Patients
      will be evaluated at month 12 and will be followed-up for a total of 3 years.
    

Intervention name(s): XCEL-MC-ALPHA; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single infusion; Single infusion
Other intervention name(s): Bone-marrow mesenchymal stromal cells
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple sclerosis; Bone marrow mesenchymal stromal cells; Stem cells; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases
Persisting Effects of Psilocybin
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The proposed pilot study will assess whether ingestion of a classic hallucinogen (psilocybin)
      leads to changes in emotion processing and neural circuitry that may predict repeated
      self-administration of this drug and underlie an atypical mechanism of abuse liability, which
      may vitally contribute to the understanding of the potential for abuse and the underlying
      mechanisms supporting abuse of classic hallucinogens.
    


Intervention name(s): Psilocybin
Intervention type(s): Drug
Intervention description(s): 25 mg/70 kg Psilocybin
Intervention MeSH terms: Psilocybin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science