bioihbjkbjnl/mcl2 huggingface dataset:
Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of a Ebola Virus Vaccine
Condition: Ebola Viruses
MeSH terms: Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      Ebola virus has infected and killed people, mostly in Africa. In 2014, the Ebola virus has
      affected several thousand people. There is no approved effective way to treat or prevent
      Ebola. Researchers are trying to develop a vaccine for it.

      Objectives:

      To study the anti-Ebola vaccine VSV ZEBOV (BPSC1001) to see if it is safe. Also, to see how
      it affects people's immune system.

      Eligibility:

      - Healthy men and women ages 18-65. They must not have a chronic medical condition that
      requires medicine. They must not be a healthcare worker, an animal care worker, or a
      childcare worker, and they must not have a household contact that has a compromised immune
      system, is pregnant, or is under the age of 5 years.

      Design:

        -  Participants will be screened with medical history, physical exam, and blood tests.

        -  Participants will be randomly assigned to get the vaccine or the placebo.

        -  At visit 1 (vaccination), vital signs will be taken and blood will be drawn. The vaccine
           or placebo will be injected into the upper arm muscle.

        -  Participants will return to the clinic 11 times over the next 6 months. Participants
           will have blood drawn at every study visit. Their mouth will be swabbed and urine tested
           at least four times after vaccination.

        -  For 14 days after vaccination, participants will write down their temperature, any
           symptoms, and any redness at the injection site. They will bring the booklet to each
           study visit.

      All visits take place at the Canadian Center for Vaccinology, Dalhousie University/IWK Health
      Centre, Halifax, NS.
    


Intervention name(s): BPSC-1001 (VSVΔG-ZEBOV); Placebo
Intervention type(s): Biological; Other
Intervention description(s): Ebola vaccine candidate; Normal saline
Other intervention name(s): BPSC-1001
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of Brexpiprazole Plus Ketamine in Treatment-Resistant Depression (TRD)
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-site, double-blind, placebo-controlled study of the acute efficacy of
      brexpiprazole or placebo in combination with intranasal ketamine added to ongoing, stable,
      and adequate antidepressant therapy (ADT) in the treatment of adults with Major Depressive
      Disorder with Treatment Resistant Depression.
    

Detailed description: 
      This is a five-site, double-blind, placebo-controlled study of the acute efficacy of oral
      brexpiprazole or placebo combined with intranasal ketamine added to ongoing, stable, and
      adequate antidepressant therapy (ADT) in the treatment of adults with MDD with TRD. Adequate
      ADT is defined as a therapeutically sufficient dose for a sufficient treatment period, which
      would be expected to be effective as listed in the MGH ATRQ.
    

Intervention name(s): Brexpiprazole; Ketamine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administration of up to 3mg brexpiprazole; administration 6 times over two weeks of inhaled ketamine; Administration of placebo which matches brexpiprazole in size and number of tablets per dose
Other intervention name(s): rexulti; Inhaled ketamine
Intervention MeSH terms: Ketamine; Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: treatment resistant; inadequate response
Determination of the RANKL/Osteoprotegerin Ratio in Patients With Systemic Lupus Erythematosus. Role in Osteoporosis and Cardiovascular Calcification
Condition: Osteoporosis; Lupus Erythematosus, Systemic
MeSH terms: Osteoporosis; Lupus Erythematosus, Systemic; Calcinosis
Study type: Interventional

Summary: 
      Patients with Systemic lupus erythematosus (SLE) are known to present an increased risk of
      osteoporosis and cardiovascular calcification. It has also been suggested that bone
      remodelling and cardiovascular calcification are regulated by the same mechanisms, but
      inversely in terms of calcium deposition, as osteoporosis is often associated with
      cardiovascular calcification. Inflammatory and immune factors have been implicated in these
      two processes.

      The role of the RANKL/OPG system in osteoclast differentiation has been elucidated over the
      last ten years. RANKL induces differentiation of monocytes-macrophages into osteoclasts,
      while, inversely, OPG exerts an inhibitory role by inactivating RANKL. Differentiation of
      smooth muscle cells into osteoblasts in the vessel wall induces calcification, and this
      phenomenon is counterbalanced by differentiation of monocytes into osteoclasts. Although the
      role of the RANKL/OPG ratio in the pathogenesis of osteoporosis has now been clearly
      established, its role in vascular calcification is only hypothetical at the present time.

      This study will focus on patients with SLE diagnosed and followed in the Amiens University
      Hospital Internal Medicine and Nephrology departments
    


Intervention name(s): RANKL/OPG ratio; bone densitometry; fan beam CT scan; Doppler ultrasound
Intervention type(s): Biological; Device; Device; Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: cardiovascular calcification; RANK: Receptor Activator of Nuclear Factor kappa B; RANKL: Receptor Activator of Nuclear Factor kappa B Ligand; OPG: Osteoprotegerin; SLE: Systemic lupus erythematosus
Management of Lower Limb Apophysitis: A Cross-sectional Study on Long-term Impact on Health Status
Condition: Lower Limb Apophysitis (Severs, Osgood Schlatter, Sinding-Larsen Johansson)
MeSH terms: Osteitis
Study type: Observational [Patient Registry]

Summary: 
      Lower limb apophysitis cause long-term pain, decrease in function, and can reduce or
      completely hinder participation in sports and physical activity, yet there is little
      knowledge on the long-term consequences for health. Our objective with this investigation is
      to capture self-reported health-status for all adults having been diagnosed with lower limb
      apophysitis in the period of 1977 to 2020 and compared these data with normative values for
      the background population. We are therefore conducting a national cross-sectional study based
      on data from the Danish National Patient Registry. In this protocol we describe, as detailed
      as possible, the planned methods.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Sample size will be of convenience with no pre-determined cut-off for smallest or largest
        sample of interest, rather, the final sample of respondents will be based on however many
        have been designated the diagnostic codes and responds to the survey.
A Multiple Oral Doses Study Of PF-06427878 In Healthy Adult Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary
      purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      multiple oral doses of PF-06427878 in healthy adult subjects.
    


Intervention name(s): PF-06427878; Placebo; PF-06427878; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).; Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).; PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).; Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Multiple Ascending Dose; Healthy Subjects; Hyperlipidemia; Lipid Metabolism Disorders; Metabolic Diseases
Acute Intermittent Hypoxia in Persons With Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis; Hypoxia
Study type: Interventional

Summary: 
      The overall objective of this project is to investigate the effectiveness of Acute
      Intermittent Hypoxia (AIH), to improve muscle strength and activity level in individuals with
      relapsing-remitting MS.
    


Intervention name(s): Intermittent Hypoxia; Sham Hypoxia
Intervention type(s): Other; Other
Intervention description(s): 1 minute of 9% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 iterations/episodes.; 1 minute of 21% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 iterations/episodes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of HTD1801 in Healthy Subjects
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double blind, single center, ascending single dose study to evaluate
      the safety, tolerability, and PK of HTD1801.
    


Intervention name(s): HTD1801
Intervention type(s): Drug
Intervention description(s): A small molecular compound for the treatment of primary sclerosing cholangitis
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Investigation of Brain Oxygenation and Blood Flow in Smokers
Condition: Cerebral Oxygenation and Blood Flow in Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Observational

Summary: 
      Cerebral oxygenation and blood flow in tobacco use disorder and their relation to smoking
      abstinence will be measured with MRI" ändern in "Cerebral oxygenation and blood flow in
      tobacco use disorder
    

Detailed description: 
      In this study, cerebral oxygenation and tobacco-related attentional bias in smokers and
      non-smokers will be measured with magnetic resonance imaging (MRI).

      In this study, the oxygen extraction fraction (OEF), the cerebral blood flow (CBF) and the
      cerebral metabolic rate of oxygen (CMRO2) are to be measured in smokers and non-smokers using
      MRI. On the one hand, the influence of chronic smoking (i.e. smokers versus non-smokers) and
      on the other hand the effect of acute nicotine administration (in smokers) on these
      parameters will be examined. Furthermore, the influence of these parameters on fMRI results
      is to be investigated using the example of a stimulus-reaction task. It can be assumed that
      the OEF does not change through nicotine administration, but differs in smokers and
      non-smokers and is associated with the strength of tobacco addiction in smokers. CBF and
      CMRO2 are expected to be reduced in abstinent smokers, but can be normalized by nicotine
      administration. In this study, 20 smokers and 10 never-smokers will be investigated.
      Never-smokers will be examined once with MRI and questionnaires, whereas smokers will be
      examined twice: before and after a smoking break.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): observational study
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        residents from Mannheim/Heidelberg Germany and other.
A Study of the Absorption, Metabolism, and Excretion of Tucatinib in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will look at how a drug (tucatinib) leaves the body and what happens to tucatinib
      while it is still in the body. Healthy participants will get one dose of tucatinib by mouth.
      Patients will be monitored for 8-14 days after they take the dose of tucatinib.
    

Detailed description: 
      This study will examine the absorption, metabolism, and excretion of tucatinib in healthy
      individuals. Participants will receive one oral dose of tucatinib and will be followed for
      8-14 days after the dose is received.
    

Intervention name(s): tucatinib
Intervention type(s): Drug
Intervention description(s): Single dose of 300 mg of [¹⁴C]-tucatinib containing approximately 150 μCi of [¹⁴C] radioactivity
Intervention MeSH terms: Tucatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of V503 Given Concomitantly With Menactra™ and Adacel™ in 11 to 15 Year Olds (V503-005)
Condition: Human Papillomavirus Infection
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the tolerability and immunogenicity of administration of the first
      dose of V503 at the same time as Menactra™ and Adacel™ versus administration of V503 one
      month prior to administration of Menactra™ and Adacel™.
    


Intervention name(s): V503; Comparator: Menactra™ (Concomitant); Comparator: Adacel™ (Concomitant); Comparator: Menactra™ (Non-Concomitant); Comparator: Adacel™ (Non-concomitant)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6; Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.; Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1.; Menactra™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.; Adacel™ given as a single 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa
Condition: Vaccines, Pneumococcal; Infant; Fever, Chemically Induced; Drug Therapy, Combination
MeSH terms: Fever
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine whether prophylactic antipyretic treatment after
      vaccination with Prevenar and a concomitant hexavalent DTPa combination vaccine reduces the
      rate of febrile reactions.
    


Intervention name(s): Prevenar; Infanrix hexa
Intervention type(s): Biological; Biological
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine; infant
Imaging the Vesicular Acetylcholine Transporter Using 18F-FEOBV PET in Parkinsons Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      Patients with Parkinson's disease (PD) often display symptoms, such as constipation, due to
      denervation of the cholinergic nerves in the gut. It has been hypothesized that PD initiates
      in the gut years prior to diagnosis. To gain a detailed understanding of the early stages of
      PD, techniques for quantification of cholinergic nerves are needed. The PET tracer 18F-FEOBV
      binds specifically to the vesicular acetylcholine transporter, situated in presynaptic
      cholinergic nerve terminals. The investigators will investigate 18F-FEOBV uptake in the brain
      and internal organs of 15 patients with moderate-stage PD and compare to 15 healthy controls.
      Furthermore, findings are correlated to validated clinical tests of the autonomic nervous
      system. The aim is to validate 18F-FEOBV PET/CT as a clinical imaging modality to diagnose
      parasympathetic denervation in PD.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Parkinson patients are moderate stage disease. Healthy subjects have to meet the criteria
        below.
      
Keywords: Parasympathetic
Different Types of Suture for Sacral Colpopexy
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      This randomized controlled study is designed to test absorbable suture compared to non
      absorbable suture in laparoscopic sacral colpopexy in terms of anatomical correction of the
      prolapse, post-operative and long term morbidity, rate of recurrence, subjective satisfaction
      of the patient and rate of mesh erosion.
    


Intervention name(s): laparoscopic sacral colpopexy with absorbable suture; laparoscopic sacral colpopexy with non absorbable suture
Intervention type(s): Procedure; Procedure
Intervention description(s): laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with absorbable suture; laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with non absorbable suture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Nocturnal Breathing Pattern in Lowlanders
Condition: Effect of High Altitude
MeSH terms: Altitude Sickness
Study type: Interventional

Summary: 
      Prospective interventional trial in lowlanders evaluating the effect of acute exposure,
      acclimatization and re-exposure of high altitude on nocturnal breathing pattern.
    

Detailed description: 
      Respiratory polygraphies will be performed in Santiago de Chile, 520 m, over the course of 3
      days. Participants will then travel by commercial airline (5 h flight) and by bus (3 h ride)
      to the ALMA base camp located at 2900 m near San Pedro de Atacama, northern Chile.
      Participants will stay there for the next 7 nights and respiratory polygraphies will be
      performed on night 1 and 6. They will be spend the days (6-8 h daily) at the telescope
      station at 5050 m while undergoing physiological testing. Daily transports from 2900 to 5050
      m will be by car (1 h ride, one way). After the first 8 day altitude sojourn participants
      will return to the Santiago area (520 m) for a 6 day recovery period.

      A second altitude sojourn with an identical schedule as the one described above and a final
      low altitude stay of 3 days will follow.
    

Intervention name(s): Altitude exposure
Intervention type(s): Other
Intervention description(s): Altitude exposure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Altitude; Nocturnal breathing pattern
Clinical Trial on the Effects and Side Effects of ProOxy in the Treatment of Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was conducted to determine the effects and side effects of ProOxy facial spray in
      the treatment of acne.
    

Detailed description: 
      A study on the effects and side effects of ProOxy facial spray was done. Sixty people were
      selected and approved to participate in this study. Pictures of the face (frontal,left side
      and right side) were taken upon acceptance, during and after treatment at 4,8 and 12 weeks
      intervals.
    

Intervention name(s): ProOxy
Intervention type(s): Drug
Intervention description(s): Clean the face with ProOxy facial wash before spraying ProOxy on the face enough to wet it twice daily, upon waking up and before bedtime.
Other intervention name(s): 15% Oxygen solution spray
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: moderate; facial acne; acne vulgaris
Balance in Children With Cochlear Implants
Condition: Severe, Profound Deafness
MeSH terms: Deafness; Hearing Loss
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose is to test the balance of children with unilateral,bilateral cochlear implants
      and patients having unilateral implants before,bilateral implants after surgery,using the
      Bruininks-Oseretsky Test 2nd ed. to find out if the cochlear implants have an effect.
    

Detailed description: 
      Hearing impairment has a significant impact on individual quality of life and stresses
      community resources. In the last two decades cochlear implantation has developed into the new
      standard of care for severe to profound haring loss. Recent studies have shown bilateral
      implantation improves sound localization and understanding of speech in noise. For children,
      this is seen as a significant benefit. As we begin to offer bilateral cochlear implants to a
      growing number of children it would be in our patient's best interest to evaluate whether or
      not this may cause balance impairment. We will evaluate the balance scores of children with
      bilateral cochlear implants, and compare their results to unilaterally implanted children and
      a hearing impaired population, with the Bruininks-Oseretsky Test 2nd ed (BOT2). In addition
      we will take a small group of unilaterally implanted patients and test them before and after
      a contralateral cochlear implant as a prospective study group.
    

Intervention name(s): Evaluation of motor proficiency skills.; Evaluation of motor proficiency; Evaluation of motor proficiency; Evaluation of motor proficiency.
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.; The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.; The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.; The balance subtest of the Bruininks-Oseretsky Test 2nd Ed. will be administered and scored.
Other intervention name(s): deaf children, balance, unilateral cochlear implants,; bilateral cochlear implants; balance,unilateral/bilateral cochlear implants,; deaf children; balance, unilateral/bilateral cochlear implants,; deaf children; deaf children, unilateral/bilateral cochlear implants,; balance
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Balance; Severe, Profound deafness; Children; unilateral/bilateral cochlear implants; unilateral cochlear implant; bilateral cochlear implants