bioihbjkbjnl/mcl2 huggingface dataset:
Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma
Condition: Medulloblastoma
MeSH terms: Medulloblastoma
Study type: Observational

Summary: 
      Survivors of pediatric medulloblastoma (MB) are at-risk for neurocognitive and social
      deficits, including specific skills such as facial affect recognition which is the ability to
      recognize the emotional expressions of another person. Because the underlying mechanisms of
      these deficits are poorly understood, the investigators propose to examine social-cognitive
      skills (i.e. facial affect recognition) and indices of brain integrity, including an
      established core neural network of face perception in MB survivors and healthy controls. By
      comparing these outcomes between survivors of MB and healthy controls, investigators seek to
      identify the areas of the brain that help individuals recognize emotions.

      Primary Objective:

        -  To evaluate social cognition in adolescent and young adult survivors of pediatric
           medulloblastoma.

      Secondary Objective:

        -  To examine indices of brain integrity and function and their association with facial
           affect recognition in survivors of pediatric medulloblastoma.
    

Detailed description: 
      Comprehensive social-cognitive and behavioral data will be collected and structural and
      functional brain imaging will be completed in an attempt to determine if disruptions to brain
      integrity and function caused by prior treatment of medulloblastoma directly influence
      social-cognition and behavior in survivors. These outcomes will be compared between survivors
      and age-, gender-, and race-matched healthy community controls.

      Participants who meet eligibility criteria and consent will undergo neurocognitive
      (intelligence, attention, memory, processing speed, motor, executive function, and
      visuospatial) and social cognitive evaluations (affect recognition, prosody, social memory,
      withdrawal/isolation, loneliness, social anxiety, visuospatial, and executive function).
      Functional magnetic resonance imaging (fMRI) will be completed during affect identification
      tasks to assess activation of the core face perception network. Magnetic resonance with
      diffusion tensor imaging (DTI) will be obtained to quantify water diffusion within white
      matter tracts to assess white matter integrity and its association with functional outcomes.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Medulloblastoma survivors enrolled in the St Jude Lifetime Cohort parent protocol will be
        recruited to complete comprehensive social-cognitive and neurocognitive evaluations as well
        as structural and functional brain imaging. Investigators will also recruit a comparison
        sample of healthy individuals matched on age, sex and race.
      
Keywords: Childhood Cancer Survivor; Social-cognition; Healthy Volunteers
A Phase 1 Antiretroviral Drug-Drug Interaction Study in Healthy Volunteers (DDI)
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single sequence, 2-cohort, drug-drug interaction study in healthy male
      and female subjects. There is no formal hypothesis, however, it is expected that the
      coadministration of BMS-663068 with darunavir (DRV)/cobicistat (COBI) or COBI will increase
      the systemic exposure of BMS-626529.
    


Intervention name(s): BMS-663068; Darunavir; Cobicistat
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BMS-663068; Darunavir; Cobicistat
Intervention MeSH terms: Darunavir; Cobicistat; Fostemsavir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study]
Condition: Tobacco Use; Tobacco Smoking; Cigarette Smoking; Smokeless Tobacco Cessation
Study type: Interventional

Summary: 
      To pilot test the appeal of non-tobacco oral nicotine products in cigarette smokers,
      smokeless tobacco users, and oral nicotine users.
    

Detailed description: 
      This study will assess the use, nicotine delivery, subjective response, and sensory appeal of
      an oral nicotine product (ZYN) compared to electronic nicotine delivery systems (ENDS, Vuse
      Alto) in cigarette smokers, smokeless tobacco users and oral nicotine users.
    

Intervention name(s): Electronic Cigarette; Oral Nicotine Pouch
Intervention type(s): Other; Other
Intervention description(s): Participants engage in 30 minutes of an oral nicotine product. In those 30 minutes the product can be used as much or as little as preferred.; Participants will be instructed to place a 6mg nicotine pouch in their mouth between gum and lip for up to 30 minutes.
Other intervention name(s): Vuse Alto; ZYN
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Phase III Study With FE 999169 Versus Niflec for Colon Cleansing
Condition: Colon Cleansing in Preparation for Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate non inferiority of a) "FE 999169 Split Dosing Schedule" (one dose on the day
      before and the second dose on the day of colonoscopy) and b) "FE 999169 Day Before Dosing
      Schedule" (two doses on the day before colonoscopy) to " Niflec On the Day Dosing Schedule"
      in subjects requiring colonoscopy.
    

Detailed description: 
      This was a phase III, randomized, assessor-blinded, parallel-arm, multicenter, study in
      Japanese patients. Patients, who signed an informed consent and fulfilled all screening
      criteria, were randomized in a 1:1:1 ratio to one of the following 3 treatment groups: "FE
      999169 Split Dosing Schedule", "FE 999169 Day Before Dosing Schedule" and " Niflec On the Day
      Dosing Schedule" in subjects requiring colonoscopy.
    

Intervention name(s): FE 999169; Niflec
Intervention type(s): Drug; Drug
Intervention description(s): FE 999169 is a white crystalline powder for oral solution. Each sachet (16.1 g) contains sodium picosulfate hydrate 10 mg, magnesium oxide 3.5 g and anhydrous citric acid 12 g as well as orange flavour, potassium bicarbonate and sodium saccharin as excipients. FE 999916 is dissolved by mixing the contents of the sachet with approximately 150mL of cold water in a cup before administration.; Niflec is a white-yellowish powder for oral solution. Each plastic sachet (137.155 g) contains sodium chloride 2.93 g, potassium chloride 1.485 g, sodium bicarbonate 3.37 g and sodium sulfate anhydrous 11.37 g, as well as macrogol 4000, saccharin sodium hydrate, flavour as excipients. Niflec is dissolved in water to make approximately 2 L of solution before administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Premeal Protein-bar on Food Intake
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The aim of this study is to explore premeal protein-enriched bar effect in food intake in
      healthy subjects.
    

Detailed description: 
      Twenty healthy subjects will be recruited. Every subject will be randomized in 6 groups and
      studied on 3 separate days in random order with 1 week intervals. These participants will
      consume protein enriched bar, commercial cereal bar, or water followed by a standardized diet
      (gimbap). For study outcomes, food intake, appetite and satiety (visual analog scale), plasma
      glucose, and satiety related hormone will be measured. Blood sampling will be done before 15
      min of breakeast, at the moment of start of breakfast (0 min), and then 30, 60, 90, 120 min.
      Plasma glucose levels, total/active GLP-1, ghrelin, total PYY will be measured.
    

Intervention name(s): Protein-enriched bar, commercial cereal bar, or water
Intervention type(s): Dietary Supplement
Intervention description(s): Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: protein-enriched bar; food intake; appetite; satiety related hormones
Platelet-rich Plasma for Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      Stress urinary incontinence (SUI) is defined by the International Continence Society (ICS) as
      "the complaint of any involuntary loss of urine on effort or physical exertion or on sneezing
      or coughing. The treatment varies from Kegel exercise, bulking agents, vaginal LASER, to
      surgery. Platelet-rich plasma (PRP) stimulates angiogenesis, promoting vascular in-growth and
      fibroblast proliferation, enhancing wound-healing in both soft and hard tissue. PRP regulates
      tissue reconstruction and has been previously used in orthopedics and plastic surgery. The
      previous study revealed some promising results for PRP use in pelvic floor dysfunction,
      including SUI. We aim to evaluate the effect of PRP on female SUI.
    

Detailed description: 
      Women with SUI were enrolled. Pre-treatment evaluation included Overactive Bladder Symptom
      Score (OABSS), International Consultation on Incontinence Questionnaire-Urinary Incontinence
      Short Form (ICIQ-UI), Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6), Female Sexual
      Function Index (FSFI), Urinary Distress Inventory Short Form (UDI-6), Incontinence Impact
      Questionnaire, Short Form (IIQ-7), pelvic examination, and urodynamic study (UDS) (including
      pad test).

      10 milliliter blood was taken from each participant. The RegenKit-THT (RegenLab SA,
      Switzerland) was used to separation of plasma and blood cells. 3 milliliter PRP was extracted
      from the bottom of the plasma. PRP was injected into anterior vaginal wall, near external
      urethral sphincter, and into endopelvic fascia. The participants received one treatment per
      month for three times. Follow-up schedule is as below: 1st month (transperineal ultrasound
      and questionnaires), 3rd month (UDS and questionnaires), 6th month (questionnaires), and 12th
      month (questionnaires).
    

Intervention name(s): Platelet-rich plasma
Intervention type(s): Device
Intervention description(s): The RegenKit-THT (RegenLab SA, Switzerland) was used to separation of plasma and blood cells. 3mL PRP was extracted from the bottom of the plasma. PRP was injected into anterior vaginal wall, near external urethral sphincter, and into endopelvic fascia.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stress urinary incontinence; Platelet-rich plasma
Safety and PK of HM10460A (HNK460) in Healthy Adult Japanese and Caucasian Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study Design

        -  Randomized, double-blind, placebo-controlled, escalating single-dose design.

        -  Six ascending dose cohorts

        -  In each cohorts, subjects will be randomized to receive a single dose of HM10460A,
           placebo (negative control), or Neulasta® (positive control).

        -  Primary Objective

        -  to assess the safety and tolerability of single escalating subcutaneous doses of
           HM10460A in healthy adult Japanese and Caucasian subjects.
    

Detailed description: 
      Secondary objectives:

        -  to assess the pharmacokinetics (PK) of a single subcutaneous dose of HM10460A.

        -  to compare the PK of HM10460A in Japanese and Caucasian subjects.

        -  to assess the relationship between the serum concentration of HM10460A and absolute
           neutrophil count (ANC).

        -  to assess the relationship between the serum concentration of HM10460A and CD34+ cell
           counts in the blood.

        -  To assess the immunogenicity potential of HM10460A by measuring binding antibodies (bAb)
           and neutralizing antibodies (nAb) to HM10460A and native G-CSF following a single
           subcutaneous dose of HM10460A.
    

Intervention name(s): HM10460A or placebo or Neulasta
Intervention type(s): Drug
Intervention description(s): Single SC injection of the appropriate dose of drug ranging from 1.1 mcg/kg to 270 mcg/kg.
Other intervention name(s): LAPS-G-CSF
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Multiple Oritavancin Doses on Safety, Tolerability, and Pharmacokinetics in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This protocol describes a double-blind study to evaluate the safety and pharmacokinetics of
      multiple IV doses of 1200 mg ORBACTIV (oritavancin) in healthy subjects.
    

Detailed description: 
      Oritavancin has been approved in the United States for the treatment of adult patients with
      acute bacterial skin and skin structure infections (ABSSSIs) caused or suspected to be caused
      by susceptible isolates of designated Gram-positive microorganisms. The purpose of this study
      is to determine the (a) safety and tolerability and (b) pharmacokinetic profile of multiple
      doses of Oritavancin given over a 7-8 week period.

      Cohort 1 will consist of 14 subjects, randomized to receive a total of four doses of either
      oritavancin or placebo, given once every two weeks in a double-blind fashion.

      After completion of cohort 1, a Data Safety Monitoring Board will review the blinded safety
      data and pharmacokinetics (PK) for cohort 1 and determine whether to continue with cohort 2,
      modify cohort 2 or end the study. The cohorts for this study are sequential.

      Cohort 2 will consist of 14 subjects, randomized to receive a total of eight doses of either
      oritavancin or placebo (4 subjects) given once every week in a double-blind fashion.
    

Intervention name(s): Oritavancin; Placebo (D5W)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oritavancin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Volunteers
AME Study of [14C]-PC14586 in Healthy Male Participants
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the PK and rates of elimination and mass balance of total
      radioactivity from [14C]-PC14586
    

Detailed description: 
      PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the
      TP53 Y220C mutation. The study will assess the PK, absorption, metabolism, and excretion of
      [14C]-PC14586 following a single dose in healthy male participants.

      The aim is to recruit approximately 8 participants with a minimum number of 6 evaluable
      participants.

      Each participant will be admitted to the study site pre-dose on Day -1 and will remain at the
      study site until at least Day 14. Participants will receive a single administration of
      [14C]-PC14586 as oral capsules on Day 1. During this study, whole blood, plasma, urine,
      feces, and vomit samples (if presented) will be collected at various timepoints to
      characterize the absorption, metabolism, excretion, and PK of [14C]-PC14586.

      The duration of the residential period will be evaluated following the administration of
      [14C]-PC14586 and may be extended to ensure recovery of at least 90% of the total
      radioactivity, or until less than 1% of dose is recovered in urine and/or feces.
    

Intervention name(s): [14C]-PC14586
Intervention type(s): Drug
Intervention description(s): Single, oral dose of [14C]-PC14586
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Y220C; PC14586; PMV Pharma; PMV; AME
Neuropsychological Rehabilitation of Spontaneous Confabulation: a Replica Study
Condition: Memory Disorders
MeSH terms: Memory Disorders
Study type: Interventional

Summary: 
      Confabulators consistently generate false memories without intention to deceive and with
      great feeling of rightness. However, there is currently no known effective treatment for
      them. In order to fill this gap, we performed a neuropsychological treatment in two groups of
      confabulators: experimental vs. control (ClinicalTrials.gov ID: NCT02540772).

      Now, we intend to replicate the treatment with a larger sample of confabulators and with
      other two control groups: non-confabulator patients with brain injury and healthy individuals
    

Detailed description: 
      The treatment consisted of some brief material that patients had to learn and recall at both
      immediate and delayed moments. After both recollections, patients were given feedback about
      their performance (errors and correct responses). Pre-treatment and post-treatment
      measurements were administered.

      Non-confabulator patients and healthy participants performed only the pre-treatment
      measurement.
    

Intervention name(s): Neuropsychological treatment
Intervention type(s): Behavioral
Intervention description(s): Participants had to learn some brief material (words, faces, pictures, news), after which they were asked for an immediate and a delayed recall. After both recalls, participants were confronted with feedback about correct responses, non-responses and errors (i.e., confabulations and errors of attribution). This type of feedback worked on: 1) selective attention during the learning phase, training patients to focus on the relevant details of the stimuli; 2) monitoring processes during the retrieval phase, reinforcing the strategic search and training patients to inhibit traces that were irrelevant; and 3) memory control processes after the retrieval phase. The treatment consisted of 9 sessions and lasted for 3 weeks and the participants performed a baseline before and after treatment.
Other intervention name(s): Confabulations treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Confabulations; Neuropsychological rehabilitation; Memory
Decoding Chronic Pain With fMRI
Condition: Chronic Back Pain
MeSH terms: Back Pain
Study type: Observational

Summary: 
      Recent evidence suggests that chronic pain is associated with abnormal connectivity between
      brain regions associated with the processing of pain. We aim to test the diagnostic power of
      resting state functional magnetic resonance imaging (MRI) to diagnose patients with chronic
      back pain. Using new methods of image acquisition and analysis we aim to develop a
      computational method to correctly classify patients and matched control subjects.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with >6 months of mechanical lower back pain, not sue to any major systemic disease
A Study of Tirzepatide in Participants With Impaired Liver Function
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess how fast tirzepatide gets into the blood stream and
      how long it takes the body to remove it in participants with impaired liver function compared
      to healthy participants. The study will last about two months and will include five visits to
      the study center.
    


Intervention name(s): Tirzepatide
Intervention type(s): Drug
Intervention description(s): Administered SC
Other intervention name(s): LY3298176
Intervention MeSH terms: Tirzepatide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of Xeloda (Capecitabine) in Combination With XELOX (Oxaliplatin) in Patients With Metastatic Nasopharyngeal Cancer.
Condition: Nasopharyngeal Cancer
MeSH terms: Nasopharyngeal Neoplasms; Nasopharyngeal Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      This single arm study will assess the efficacy and safety of Xeloda + oxaliplatin when given
      as first line treatment for patients with metastatic nasopharyngeal cancer. Patients will
      receive Xeloda (1000mg/m2 bid orally from day 1 to day 14, followed by a rest period of 7
      days) plus oxaliplatin (130mg/m2 iv infusion on day 1 of each 21 day cycle) for 6-8 cycles.
      The anticipated time on study treatment is until disease progression, and the target sample
      size is <100 individuals.
    


Intervention name(s): Oxaliplatin; capecitabine [Xeloda]
Intervention type(s): Drug; Drug
Intervention description(s): 130mg/m2 iv on day 1 of each 3 week cycle; 1000mg/m2 po bid on days 1-14 of each 3 week cycle
Intervention MeSH terms: Capecitabine; Oxaliplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Glutathione on Immunity in Individuals Training for a Marathon
Condition: Healthy
Study type: Interventional

Summary: 
      The aim of this study is to determine the effects of glutathione supplement on the immune
      cell response and symptomatology of upper respiratory health, and antioxidant capacity in
      healthy people in exercise-induced model.
    

Detailed description: 
      A minimum of 60 individuals will be recruited and enrolled to complete the entire protocol in
      a randomized, double-blinded, 18 week placebo-controlled trial. Subjects will receive either
      a placebo or glutathione while participating in a stepwise exercise approach that mixes
      periods of high and low training volume to train subjects and improve running efficiency.
      Upper Respiratory Tract Infection-related health conditions will be monitored and assessed
      throughout the study period. Blood and saliva samples will be collected at baseline, and
      before and after timed 15k and half marathon runs at 12 and 16 weeks respectively.
    

Intervention name(s): Glutathione Supplement; Placebo Supplement
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1000 mg/day Glutathione; Crystalline cellulose
Other intervention name(s): L-Glutathione reduced; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science