bioihbjkbjnl/mcl2 huggingface dataset:
The Sleepless Brain: Neuroimaging Support for a Differential Diagnosis of Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      One-tenth of the population suffers from insomnia, increasing their risk on other health
      problems such as depression. Self-reported sleep quality only was historically leading for
      insomnia diagnosis, but more recently a state of 24-hour hyperarousal has been associated
      with insomnia, either physiological (increased heart rate, higher frequency EEG) or
      predominant cognitive-emotional hyperarousal (worry, rumination, repetitive thoughts). Strong
      evidence shows that those suffering from insomnia with physiological hyperarousal are at
      higher risk of short and long term severe health problems such as inflammation and
      hypertension than the group without physiological hyperarousal. The neurophysiological basis
      of these insomnia phenotypes has however barely been investigated, although its results can
      have major consequences for how this limiting condition will be treated.

      To support the development of a differential diagnosis of insomnia, structural and functional
      brain connectivity in insomnia patients with different levels of hyperarousal will be
      investigated and related to sleep variables. Investigators will compare the insomnia group to
      a normal sleeping control group. Investigators expect that the emotion processing circuit
      (amygdala-ventromedial prefrontal cortex) is a) more affected in insomniacs compared to
      normal sleeping controls and b) the directionality of this effect to depend on the level and
      type of hyperarousal in insomniacs. Further, investigators expect c) amygdala activity to be
      positive correlated with physiological hyperarousal level and d) prefrontal activity to be
      positively correlated with cognitive-emotional hyperarousal level. Investigators expect a
      higher physiological hyperarousal level to be reflected in affected afferent pathways of the
      amygdala towards the ventromedial prefrontal cortex and investigators expect higher
      cognitive-emotional hyperarousal to be related to affected efferent pathways from the
      ventromedial prefrontal cortex to the amygdala. Investigators expect sleep quality to play a
      mediating role in both types of hyperarousal and their brain activation patterns in insomnia
      patients and normal sleeping controls.

      These data can lead to the definition of new insomnia phenotypes and to new customized and
      effective insomnia treatment, focused not only on improving sleep but also on changing
      dysfunctional hyperarousal levels that currently put insomniacs at risk of numerous severe
      health problems.
    


Intervention name(s): MRI
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Insomnia; Hyperarousal
A Comprehensive Smoking Cessation Intervention Duration Radiation for Upper Aerodigestive Cancers
Condition: Tobacco Use Disorder; Head and Neck Neoplasms; Thoracic Neoplasms; Radiation
MeSH terms: Neoplasms; Head and Neck Neoplasms; Thoracic Neoplasms; Tobacco Use Disorder
Study type: Interventional

Summary: 
      Smoking is the greatest risk factor for upper aerodigestive cancers (thoracic or head and
      neck) and negatively impacts survival and other outcomes, but many patients have difficulty
      quitting after their diagnosis. Smoking cessation interventions for cancer patients thus far
      have had limited success. This is a pilot randomized controlled trial designed to determine
      if a new comprehensive, evidence-based smoking cessation intervention can improve quit rates
      for cancer patients who smoke.
    


Intervention name(s): Comprehensive smoking cessation intervention; Enhanced usual care
Intervention type(s): Other; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking cessation; Head and neck neoplasms; Lung neoplasms; Thoracic neoplasms; Radiation
Study to Evaluate Pharmacokinetics and Tolerability of Multiple Doses of Eslicarbazepine Acetate and Oxcarbazepine
Condition: Partial Epilepsy
MeSH terms: Epilepsy; Epilepsies, Partial
Study type: Interventional
Phase: Phase 1

Summary: 
      This purpose of this study is to measure the concentrations of two anti-epileptic drugs
      (Eslicarbazepine acetate and oxcarbazepine) and their metabolites in the cerebrospinal fluid
      and blood plasma of healthy subjects and also to assess how these drugs are tolerated.
    


Intervention name(s): Eslicarbazepine acetate; Oxcarbazepine
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9; Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)
Other intervention name(s): BIA 2-093; Trileptal; Trexapin; 10,11-Dihydro-10-oxo-5 H -dibenz(b,f)azepine-5-carboxamide
Intervention MeSH terms: Eslicarbazepine acetate; Oxcarbazepine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Partial; Epilepsy; Eslicarbazepine acetate; Pharmacokinetics; Tolerability
Clearblue Home Pregnancy Test Consumer Study
Condition: Pregnancy
Study type: Observational

Summary: 
      Approximately 120 female volunteers requesting a pregnancy test will be recruited locally to
      the UK trial centre.

      Volunteers will be required to use the Clearblue Pregnancy Test according to the product
      instructions, and provide a urine sample from the same void.

      Trained technicians will conduct a second test from the urine sample.
    

Detailed description: 
      Approximately 120 female volunteers attending the study site requesting a pregnancy test will
      be recruited locally to the UK trial centre.

      Volunteers will be required to use the Clearblue Pregnancy Test according to the product
      instructions, and provide a urine sample from the same void.

      Trained technicians will conduct a second test from the urine sample to evaluate performance
      between consumer and technician testing.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Volunteers requesting a pregnancy test
      
Biospecimen description: 
      Urine samples
    
Keywords: Pregnancy,
Carotid Ultrasound Study
Condition: Resistant Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      To use carotid ultrasound to screen 20-30 patients with longstanding or resistant
      hypertension for carotid atherosclerotic disease and bifurcation anatomy. This will establish
      a screening protocol for Cibiem's eventual endovascular carotid body modulation trial and
      will give insight into the prevalence and specific location of carotid plaque at the
      bifurcation in this patient population.
    


Intervention name(s): Ultrasonography
Intervention type(s): Other
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        30 patients with longstanding or resistant hypertension
Study to Evaluate the Safety and Efficacy of IV Infusion Treatment With Omecamtiv Mecarbil in Subjects With Left Ventricular Systolic Dysfunction Hospitalized for Acute Heart Failure (ATOMIC-AHF)
Condition: Heart Failure
MeSH terms: Heart Failure; Ventricular Dysfunction, Left; Systolic Murmurs
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to evaluate the effect of 48 hours of intravenous (IV)
      omecamtiv mecarbil compared with placebo on dyspnea in subjects with left ventricular
      systolic dysfunction hospitalized for acute heart failure. This is a multicenter, randomized,
      double-blind, placebo-controlled study with 3 dose cohorts enrolled sequentially in order of
      ascending dose strength of omecamtiv mecarbil. In each cohort, subjects are randomized 1:1 to
      omecamtiv mecarbil or placebo.
    

Detailed description: 
      This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due
      to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021
      and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics,
      Cytokinetics is now listed as the sponsor.
    

Intervention name(s): Placebo; Omecamtiv mecarbil
Intervention type(s): Drug; Drug
Intervention description(s): 48-hour infusion of placebo; 48-hour infusion of omecamtiv mecarbil; dose strength will depend on cohort assignment.
Other intervention name(s): CK-1827452; AMG 423
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intravenous; IV; Left Ventricular Systolic Dysfunction; Hospitalized; Acute heart failure; Heart failure; Left ventricular ejection fraction; pharmacokinetics; Pharmacodynamics; Dyspnea; hospitalization; In-patient; Omecamtiv mecarbil; Double-blind; Randomized; Placebo-controlled
Optical Imaging and User Perception Study of Vaginal Gel
Condition: Characterize Gel Distribution in the Vagina; Study Women's Sensory Perceptions and Preferences of Gel
Study type: Interventional

Summary: 
      This study will compare two investigational techniques for measuring how vaginal gels spread
      and coat the vagina. This study will also explore the experiences and opinions of women using
      this vaginal gel. We want to understand how the characteristics of a gel, such as a gel's
      thickness or consistency, affect how the gel spreads and feels in the body. We hope to use
      the information we learn from this study to develop future vaginal gels that could be
      combined with medications and used to slow down or stop the spread of sexually transmitted
      infections.
    

Detailed description: 
      The pharmacokinetics of a microbicide gel, i.e. the time- and space-dependent distribution of
      its active microbicidal ingredient(s) (APIs) throughout the body, derives from the time- and
      space-dependent distribution of the gel itself within the vaginal canal. That distribution
      may also serve as a physical barrier that retards migration of semen-borne HIV virions to
      epithelial surfaces. Within the vagina, the gel creates local physical forces ("stresses")
      against the epithelial surfaces; and its distribution along the canal might be so extensive
      that gel leaks out from the introitus. A woman may have sensations of those stresses and also
      feel gel leakage. Thus, intravaginal microbicide gel distribution is central to both its
      biological functioning (to deliver APIs and also to slow HIV transport) and the behavioral
      perception of it by users (i.e. how it "feels" and whether that experience is pleasurable or
      not). The latter, in turn, can govern acceptability of the gel and adherence to designated
      gel use in clinical trials. This study will characterize and correlate gel distribution and
      women's sensory perceptions and preferences of that distribution, for two relevant volumes (2
      mL and 4 mL) of a current microbicide placebo gel. An optical vaginal imaging device will
      measure gel distribution in the vagina. A computer-assisted self-interview (CASI) survey will
      capture women's perceptions and preferences.
    

Intervention name(s): vaginal gel imaging; computer aided self interview
Intervention type(s): Other; Behavioral
Intervention description(s): Imaging of vaginal gel distribution using two investigational techniques (low coherence interferometry and fluorimetry).; Questionnaire to gather the perceptions and preferences of the subject with respect to the vaginal gel.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: vaginal gel; vaginal coating; sensory perceptions
Overnight Switch From Rasagiline To Safinamide
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Rasagiline label report the indication to wait at least 14 days between discontinuation of
      rasagiline and initiation of another MAO inhibitor. This results in a major inconvenience for
      Parkinsonian patients (PD) due to their clinical worsening. Safinamide is a reversible MAO-B
      inhibitor, characterized by a good safety profile. In clinical practice safinamide is often
      introduced instead of rasagiline following an overnight switch. The aim of this study is to
      explore the safety and tolerability of the immediate switch from rasagiline (irreversible
      MAO-B inhibitor) to safinamide, with the expectation that there will be no adverse events or
      increased risk of hypertensive crisis for patients with PD or signs of serotonin syndrome
    

Detailed description: 
      Objective: The aim of this study is to verify safety and tolerability of the immediate switch
      from rasagiline to safinamide trough monitoring of BP by 24-hour Holter recording. The
      primary objective of the study will be achieved if the mean BP will not increase by >10 mmHg
      in the studied population.

      Methods: This is an open-label, single-centre study conducted at IRCCS San Raffaele Pisana.
      Study population included patients with idiopathic PD in the mid-late stage of the disease,
      suffering from motor fluctuation, on stable treatment with rasagiline and Levodopa (alone or
      in combination with other anti-parkinsonian medication). The protocol contemplates five
      visits during six weeks, with two 24-hour Holter recording (first in rasagiline and second in
      first-day of safinamide therapy), monitoring typical symptoms of the serotonin syndrome.
    

Intervention name(s): Safinamide
Intervention type(s): Drug
Intervention description(s): Overnight switch from rasagiline 1 mg OD to safinamide 50 mg OD
Other intervention name(s): Xadago
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: IMAO-B; Safinamide; Rasagiline
Natural History, Genetic Bases and Phenotype-genotype Correlations in Autosomal Dominant Spinocerebellar Degenerations
Condition: Spinocerebellar Ataxias; Spastic Paraplegias
MeSH terms: Spinocerebellar Ataxias; Spinocerebellar Degenerations; Paraplegia
Study type: Observational

Summary: 
      The autosomal dominant spinocerebellar degenerations are a highly heterogeneous, clinically
      and genetically, group of rare diseases and of severe evolution. So far, the responsible
      genes for less than 50% of the cases are known and because of their rarity, there are no
      phenotype-genotype correlations and well-defined disease history.

      The aims of the project are to develop and validate quantitative tools of the cerebellar
      syndrome and of the spasticity, to establish links between the phenotype and the result of
      the molecular analysis, to identify new loci/genes responsible for these disorders, and to
      establish the natural history of the disease according to the genotype.

      To this end, a prospective and multicentric study is proposed for recruiting and evaluating,
      clinically, a cohort of 225 patients; 150 of them are already followed-up in the centers
      involved. A DNA collection will be set up in order to search for the implication of new loci
      and genes. A clinico-genetic database will be set up combining data from successive clinical
      evaluations and those of genotyping.

      This strategy will allow access to genetic counselling and molecular diagnosis (positive,
      presymptomatic or prenatal diagnoses), based on a rational strategy from phenotype-genotype
      correlations and the information concerning the relative frequency of the genes. The detailed
      description, with the help of new evaluation tools and of the follow-up of the natural
      history of the disease according to the genotype, constitutes a crucial step in the design of
      therapeutical trials in these orphan disorders. Furthermore, the regular follow-up by
      specialized centers will allow better care of the patients.
    


Observational model: Family-Based
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        French population
      
Keywords: dominant spinocerebellar degenerations; new rate scales; natural history; molecular biology; candidate genes
Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eye
Condition: Dry Eye Syndrome; Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional
Phase: Phase 2

Summary: 
      Thymosin Beta 4 (Tβ4) is a synthetic copy of the naturally-occurring 43-amino acid peptide
      that is found in a variety of tissues. Tβ4 promotes/accelerates wound repair in dermal,
      ocular, and cardiac animal models. Two recent pre-clinical evaluations have demonstrated that
      Tβ4 promotes corneal ocular surface defects healing in animal models of dry eye. RGN-259
      (formulation of Tβ4 ophthalmic solution) mechanism of action offers potential to be a product
      that meets a major unmet medical need in patients with dry eye.
    

Detailed description: 
      Tβ4 promotes wound repair and regeneration in various tissues. In the eye, it promotes
      corneal epithelial cell migration, decreases inflammation and has anti-apoptotic activities.
      It up-regulates the gene expression of laminin-5, a major subepithelial adhesion protein,
      located in the basement membrane region of the cornea, conjunctiva, and important in wound
      healing. In compassionate-use cases, Tβ4 has demonstrated efficacy in repairing non-healing
      neurotrophic corneal ulcers and other corneal epithelial wounds. In twenty-four nonclinical
      toxicology and safety pharmacology studies, the safety of Tβ4 has been demonstrated for its
      current and planned uses in man. The results of the two recent dry eye murine mouse model
      studies show that Tβ4 reduced corneal staining more than positive controls and demonstrated
      statistically significant reduction in staining compared to vehicle control. The results of
      these studies, in addition to data from compassionate use studies in patients with
      non-healing corneal surface defects, suggests that Tβ4 has a significant potential to be an
      important new safe and effective therapeutic in the treatment of dry eye syndrome.
    

Intervention name(s): Thymosin beta 4; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.; A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
Other intervention name(s): Tβ4; RGN-259 (eye drop formulation of Tβ4); Vehicle Control
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thymosin beta 4; Dry eye syndrome; Dry eye
A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma
Condition: Hodgkin Lymphoma; Anaplastic Large-cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Hodgkin Disease; Lymphoma, Large-Cell, Anaplastic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label trial to estimate the concentrations of brentuximab vedotin in
      relapsed/refractory Hodgkin lymphoma (HL) or relapsed/refractory systemic anaplastic large
      cell lymphoma (sALCL) participants treated with either brentuximab vedotin or brentuximab
      vedotin + rifampicin.
    


Intervention name(s): brentuximab vedotin; Brentuximab vedotin and rifampicin
Intervention type(s): Drug; Drug
Intervention description(s): Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg.; Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg beginning on Cycle 1, Day 1; daily rifampicin (600 mg PO) will be administered during Cycles 0 through 3 only, beginning on Cycle 0, Day 1 (7 days before the Cycle 1, Day 1 dose of brentuximab vedotin) and continuing through Cycle 3, Day 21.
Other intervention name(s): SGN-35; SGN-35
Intervention MeSH terms: Rifampin; Brentuximab Vedotin; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphoma; Hodgkin; Anaplastic Large-cell; Relapsed; Refractory; Antigens, CD30; Antibody-Drug Conjugate; Antibodies, Monoclonal; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Anaplastic; Monomethyl auristatin E; Drug Therapy; Immunotherapy; Hematologic Diseases
Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months (V419-008)
Condition: Bacterial Infections; Virus Diseases
MeSH terms: Bacterial Infections; Virus Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12
      months of age have an acceptable response to the vaccine. This study will also determine
      whether the immune response to V419 is similar to that of participants who received a
      licensed vaccine control. The primary hypothesis is that participants who receive PR5I at 2,
      4, and 11 to 12 months have an acceptable response rate to all PR5I-contained antigens at one
      month after the Toddler dose of PR5I.
    


Intervention name(s): PR5I; Rotavirus vaccine; Prevenar 13™; INFANRIX™ hexa
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): DTaP-HB-IPV-Hib (Diphtheria, tetanus, pertussis [acellular, component], hepatitis B [recombinant DNA], polio virus [inactivated], and Haemophilus influenza type b conjugate vaccine [adsorbed]) Vaccine 0.5 mL intramuscular injection at 2, 4, and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine. PR5I is a liquid suspension hexavalent vaccine.; Rotarix™ 1.5 mL oral dose at 2 and 4 months of age (subset 1, Italy and Sweden) or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age (subset 2, Finland); Prevenar 13™ 0.5 mL intramuscular injection at 2, 4, and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine.; Combined Diphtheria-Tetanus-acellular Pertussis [DTaP], Hepatitis B [HepB], Poliovirus [IPV] and Haemophilus influenzae type b [Hib] Vaccine 0.5 mL intramuscular injection at 2, 4 and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine. INFANRIX™ hexa is provided as 2 components (lyophilized Hib and liquid DTaP, IPV, and HepB). Prior to administration, the vaccine must be reconstituted by adding the liquid DTaP-HepB-IPV component to the vial containing the Hib pellet.
Other intervention name(s): V419; Vaxelis®
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: combination vaccine; diphtheria; pertussis; tetanus; hepatitis B; Hep B; Haemophilus influenzae b; Hib; polio; poliovirus