bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Feasibility of an Endotoxemia Model
Condition: Cardiovascular Disease; Inflammation
MeSH terms: Endotoxemia; Cardiovascular Diseases; Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish the safety and feasibility of low dose LPS
      administration to a small subset of humans in preparation for a larger USDA funded study
      examining what is the lowest effective dose of EPA + DHA (300, 600, 900 and 1,800 mg/day
      delivered as fish oil supplements) that significantly attenuates the inflammatory response
      the investigators wish to examine the effects of an endotoxemia model for inducing
      inflammation. Based on previous research, low dose LPS administration affects metabolism in
      humans with only minimal clinical effects (such as "flu" like illness). Therefore, each of
      the six subjects included in this small pilot study will receive a low dose of LPS and
      placebo in order to learn more about the metabolic changes that occur during administration
      and inflammation. The investigators hypothesis that LPS administration will elicit only
      minimal clinical effects (such as "flu" like illness) when compared to placebo (saline--water
      with the same amount of salt as in your blood).
    


Intervention name(s): LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP)
Intervention type(s): Drug
Intervention description(s): LPS or placebo (saline-salt water) will be injected (at approximately 7:30 am) in this catheter by a trained GCRC staff member involved with this study. Participants will not be told if they have received the drug or placebo. The LPS is a sterile solution of protein-free endotoxin which will be injected at a dose of 0.6 ng/kg body weight. Blood samples will be collected from a venous catheter for the first 12 hours and by venipuncture thereafter. Subjects will be continuously monitored by trained nursing staff for blood pressure (q 15 minutes) and body temperature (q 30 minutes), and the study will have physician oversight.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Cardiovascular disease; Inflammation; LPS; Endotoxin
Decreased EEG Complexity in Schizophrenia
Condition: Electrophysiological Randomness; Entropy
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      Aim was to detect EEG complexity in a specific group of patients to contribute to the
      discussion whether schizophrenia is associated with increased or decreased complexity. We
      included the EEG recordings of patients with a diagnosis of schizophrenia. We hypothesized
      that chronic residual schizophrenia is characterized by decreased complexity in EEG.
    

Detailed description: 
      Twenty right-handed patients diagnosed with schizophrenia, residual subtype, by two senior
      psychiatrists according to the Diagnostic Statistical Manual of Mental Disorders 4th Edition
      (DSM-IV)were recruited from Neuropsychiatry Istanbul Hospital. Only patients scoring 4 or
      higher on the Clinical Global Impression Scale for Severity (CGI-S) were included. They were
      assessed with the Turkish version of the Positive and Negative Syndrome Scale. Data was
      collected with a 16-channel Neuroscan Synamps II (Neuroscan Products, Compumedics, Charlotte,
      NC, USA), silver-silver chloride electrodes were applied to the scalp surface according to
      the international 10-20 system
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        diagnosed with schizophrenia,
      
Keywords: complexity; electroencephalogram; entropy; negative symptoms; schizophrenia.
Study to Evaluate ATP-induced Pain and ATP-induced Dermal Vasodilation by Iontophoresis (0000-118)(COMPLETED)
Condition: Osteoarthritis Pain
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate ATP-induced Pain (AIP) and ATP-induced dermal vasodilation (AIDV) as
      target engagement tools for future development of analgesics.
    


Intervention name(s): Comparator: Iontophoresis and Laser Doppler with ATP; Comparator: Iontophoresis and Laser Doppler with Saline
Intervention type(s): Procedure; Procedure
Intervention description(s): Iontophoresis treatments with 10 mM ATP (adenosine triphosphate) solution and a current of 0.8 or 1.2 mA. Iontophoresis treatments will last 4 minutes. Laser doppler will be used during the iontophoresis treatments to measure dermal blood flow.; Iontophoresis treatments with 20 mM saline solution and a current of 0.8 or 1.2 mA. Iontophoresis treatments will last 4 minutes. Laser doppler will be used during the iontophoresis treatments to measure dermal blood flow.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivixx Tab. 5/160mg in Healthy Male Subjects (N=60)
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the pharmacokinetic characteristics of valsartan and S-amlodipine after single oral
      administration of Exforge tab. 10/160mg, a combination formulation of valsartan and
      amlodipine as reference drug and Lodivixx tab
    

Detailed description: 
      The purpose of this study is to assess the pharmacokinetic characteristics of valsartan and
      S-amlodipine after single oral administration of Exforge tab. 10/160mg, a combination
      formulation of valsartan and amlodipine as reference drug and Lodivixx tab. 5/160mg, a
      combination formulation of valsartan and S-amlodipine as test drug in healthy male adults.
      Additionally the safety and tolerability of two drugs will be evaluated.
    

Intervention name(s): Exforge tab. 10/160mg; Lodivixx tab. 5/160mg
Intervention type(s): Drug; Drug
Other intervention name(s): - amlodipine besylate; - valsartan; - S-amlodipine; - valsartan
Intervention MeSH terms: Amlodipine; Valsartan; Amlodipine, Valsartan Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]
Condition: Autosomal Dominant Polycystic Kidney Disease （ADPKD)
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 3

Summary: 
      ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of
      tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).
    


Intervention name(s): tolvaptan
Intervention type(s): Drug
Intervention description(s): Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.
Intervention MeSH terms: Tolvaptan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Whole Body Periodic Acceleration on Activity and Sleep In Parkinson's Disease
Condition: Sleep Disorders; Physical Activity
MeSH terms: Parkinson Disease; Sleep Wake Disorders
Study type: Interventional

Summary: 
      Whole-body periodic acceleration (WBPA) is a new, non-invasive, and promising therapy for a
      diverse and growing list of disorders including cardiovascular disease. During WBPA, patients
      lie in the supine position on a bed that is capable of translating back and forth parallel to
      the ground, along the head-to-foot axis of the patient. Thus, this treatment is best
      described as a form of "passive exercise." The frequency of the translation (up to 180
      cycles/minute; cpm) as well as the distance traveled (2-24mm) by the bed can be adjusted by
      the patient or health care professional.

      The science behind the therapeutic effects of WBPA still remains largely unknown.

      The investigators are observing how WBPA may impact on sleep and activity in individuals with
      Parkinson's disease.
    

Detailed description: 
      Sleep disturbances are common in individuals with Parkinson's Disease. Whole-body periodic
      acceleration (WBPA) is a new, non-invasive, and promising therapy for a diverse and growing
      list of disorders. During WBPA, patients lie in the supine position on a bed that is capable
      of translating back and forth parallel to the ground, along the head-to-foot axis of the
      patient. Thus, this treatment is best described as a form of "passive exercise." WBPA has
      been shown in previous studies to increase nitric oxide. Increased levels of nitric oxide
      have been shown to improve sleep patterns in other populations. The current pilot study will
      investigate how WBPA will impact upon sleep disturbances in subjects with Parkinson's disease
      who suffer from abnormal sleep patterns. The investigators will record sleep patterns and
      activity levels using a Jawbone U3® activity monitor.
    

Intervention name(s): Whole Body Periodic Acceleration
Intervention type(s): Device
Intervention description(s): oscillating bed that the subject will lie on 3 days a week for 45 minutes at 140 cycles per minute.
Other intervention name(s): WBPA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
RC2S+: Remediation of Social Cognitive Impairments
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Background:

      Difficulties in social interactions are a central characteristic of people with
      schizophrenia, and can be partly explained by impairments of social cognitive processes.
      According to renown researchers, three to five social cognitive processes are usually altered
      in schizophrenia: (1) emotional processing; (2) theory of mind (ToM); (3) attributional
      style; and (4 and 5) social perception and knowledge. The components of social cognition
      appear to be related to both symptomatology and functioning in everyday life.

      New strategies of cognitive remediation have been recently developed to target these deficits
      and few meta analyses have assessed the extent to which social cognitive remediation programs
      have led to multiple improvements for schizophrenia patients. Overall, it seems that such
      therapies showed encouraging results in both patient interest and motivation, and social
      cognitive processes.

      The RC2S therapy is the first individualized and partly computerized program through which
      patients practice social interactions and develop social cognitive abilities with simulation
      techniques in a realistic environment.
    

Detailed description: 
      Methods:

      This is a randomized controlled trial to establish the validity of the RC2S+ program in
      schizophrenia.

      The project's main objective is to assess the impact of RC2S+ on social cognitive impairments
      in schizophrenia compared with a cognitive remediation program (control therapy) focusing on
      neurocognition, equivalent in terms of number, duration and rhythm of sessions.

      The study has four other objectives:

        1. To assess the influence of the RC2S+ therapy versus control therapy on neurocognitive
           processes

        2. To assess the impact of the RC2S+ therapy versus control therapy on social functioning

        3. To assess the impact of the RC2S+ therapy versus control therapy on both positive and
           negative symptoms

        4. To study the maintenance of benefits 3 months forward

      Outcomes:

      To treat social cognitive impairments in people with schizophrenia.
    

Intervention name(s): RC2S+; active comparator
Intervention type(s): Behavioral; Behavioral
Intervention description(s): new cognitive remediation program; cognitive remediation program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: social cognition; cognitive remediation; emotions; theory of mind; attributions; social perception
Novel Device for Screening Patients With Symptoms of OSA
Condition: Sleep Apnea Syndromes
MeSH terms: Sleep Apnea Syndromes
Study type: Observational

Summary: 
      An innovative ring type oxymetry will be wore by patient undergoing sleep study to validate
      it's accuracy and usefulness as a screening device for patients with symptoms of OSA
    


Intervention name(s): Ring oxymetry
Intervention type(s): Diagnostic Test
Intervention description(s): a new type oxymetry wear on index finger like a ring
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients with symptoms of OSA who will be undergoing sleep study for establishing a
        diagnosis
Mass Balance of Oral [14C]TPN171H in Healthy Male Subjects
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is objective to evaluate the in vivo absorption, excretion and biotransformation
      pathways of [14C]-TPN171H in Chinese male healthy volunteers, and to reveal the overall
      pharmacokinetic characteristics of TPN171H in human body, so as to provide basis for rational
      use of the drug.
    

Detailed description: 
      This will be an open-label, single-center study to evaluate the mass-balance and
      pharmacokinetics of TPN171H in approximately 6 healthy male subjects receiving a single oral
      10 mg dose of TPN171H containing approximately 100 microcuries of [14C]-TPN171H. Subjects
      will be checked in to the research unit from approximately 24 hours prior to dosing and
      remain in house until greater than 80% of the administered radioactivity is collected from
      bodily excreta or until less than 1% of the administered radioactivity is recovered from
      excreta in two consecutive time intervals, and blood sample radioactivity concentration at
      two consecutive time points less than 3 times the plasma background value. This study will
      investigate the main biotransformation and elimination pathways of TPN171H in the human body
      and will seek to identify compound's major metabolites.
    

Intervention name(s): [14C]TPN171H
Intervention type(s): Drug
Intervention description(s): A single 10 mg oral dose of [14C]TPN171H containing approximately 100 microcurie of [14C]-TPN171H.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Mass balance; TPN171H; Simmerafil
Simultaneous Integrated Boost Preoperative Radiotherapy for Rectum Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators propose a randomized non-inferiority trial that compares preoperative
      Fluoro Uracil (FU)-based chemoradiotherapy to radiotherapy with a simultaneous integrated
      boost. In patients with T3-4 rectal cancer, the latter approach is considered preferential
      with regard to toxicity and cost. The metabolic response of the tumor, as assessed by
      18F-2-Fluoro-2-Deoxyglucose-Positron Emission tomography (18F-FDG PET) or PET-CT, will be
      used as a surrogate marker of cause specific outcome
    


Intervention name(s): Chemoradiotherapy; Radiotherapy with boost
Intervention type(s): Other; Radiation
Intervention description(s): Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends; Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor
Other intervention name(s): Xeloda (capecitabine); Preoperative radiotherapy
Intervention MeSH terms: Capecitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colorectal cancer; colorectal neoplasms; radiotherapy; chemoradiotherapy; T3-4 rectal cancer
Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term safety of SPD489 administered as a
      daily morning dose (5, 10, 15, 20, and 30 mg/day) in preschool children diagnosed with
      Attention-deficit/Hyperactivity Disorder (ADHD).
    

Detailed description: 
      This study is a long-term, open-label study where participants who participated in an
      antecedent SPD489 study (SPD489-211 [NCT02402166] or SPD489-347 [NCT03260205]) or through
      direct enrollment. Participants entering into this study will be classified as either a
      roll-over participants or a direct-enrolled participants.
    

Intervention name(s): SPD489
Intervention type(s): Drug
Intervention description(s): Participants will receive 5 mg of SPD489 capsule orally once daily in the morning and titrated in a step-wise fashion up to either 10 mg, 15 mg, 20 mg, or 30 mg until an optimal dose was reached.
Other intervention name(s): Lisdexamfetamine dimesylate
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The PreNAPS Study: FI, Nutrition, and Psychosocial Health Outcomes at Gulu Regional Referral Hospital
Condition: HIV; Pregnancy
Study type: Observational

Summary: 
      The Prenatal Nutrition and Psychosocial Health Outcomes (PreNAPS) study was a two year
      collaboration between Gulu, Makarere, Cornell, and Tufts Universities. The PreNAPs study's
      primary goals were: a) to determine the differential impacts of food insecurity on
      gestational weight gain and prenatal depression, and b) to elucidate the mechanisms
      underlying the relationship between food insecurity and weight gain and/depression among HIV
      infected and HIV uninfected pregnant women in Gulu, Northern Uganda.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women were enrolled during pregnancy at Gulu Regional Referral Hospital antenatal
        clinic in Gulu, Uganda
      
Keywords: Food Insecurity; Nutrition
MRI Imaging in Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Observational

Summary: 
      MRI Study for females ages 18-45 with Borderline Personality Disorder(BPD): This study is a
      non-treatment study that involves 2 visits. Study Hypothesis:

        1. To refine and pilot test functional neuroimaging paradigms to assess the amygdala
           response to neutral facial expressions across positive and negative emotional contexts.

        2. To assess whether patients with borderline personality disorder show a heightened
           amygdala response to neutral facial expressions relative to healthy controls (20 female
           healthy controls, 20 females with borderline personality disorder).

        3. To assess the relationship between individual differences in clinical ratings of
           personality and affective regulation, and the amygdala response to facial expressions.
    

Detailed description: 
      The first visit will be an interview assessment and will take place at the Ambulatory
      Research Center (ARC), Fairview University-Riverside Campus. In addition to the interview
      assessment, we will ask you to complete a set of questionnaires about your behavior and mood.
      This first visit will last approximately 2.5-3 hours. Following the interview assessment, if
      you are eligible for the MRI study we will contact you to schedule an MRI scan on a separate
      visit. This visit will last approximately 2 hours. At this visit you will have an MRI scan of
      your brain. Prior to the MRI scan, you will have a practice session in an MRI simulator.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        20 Female subjects ages 18-45 whom meet criteria for BPD will be included in the study. 20
        healthy controls will also be females between the ages 18-45.
      
Keywords: Borderline Personality Disorder; BPD; amygdala; facial expression response; MRI
Impact of Probiotic Supplementation on Cognition and Related Health Outcomes Among Video Gamers
Condition: Stress; Attention Disturbances
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the current study is to investigate the effect of two probiotic
      formulations on task-switching following acute stress in healthy, adult action video gamers.
      It is hypothesized that the participants that consume the probiotic formulations will have
      improved task-switching performance following acute stress compared to those who consume a
      placebo.
    

Detailed description: 
      Participants who are action gamers will be recruited to participate in this randomized,
      placebo-controlled, 2-arm, parallel trial. Eligible participants will be enrolled in this
      study for 8 weeks.

      The study will consist of 2 laboratory visits: Baseline Visit and Post-Treatment Visit.
    

Intervention name(s): Probiotic; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants will be asked to take 1 capsule (3 billion CFU) daily for 8 weeks in the morning with their first meal.; Participants will be asked to take 1 capsule daily for 8 weeks in the morning with their first meal.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled, double-blinded.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Attention; Cognition; Acute Stress; Task-switching; Probiotics; HPA-axis
GRINCH: Groningen Initiative on Reference Intervals in Children
Condition: Inflammatory Bowel Disease
MeSH terms: Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      The purpose of this study is to establish reliable reference intervals for fecal S100A12 in
      healthy children.
    

Detailed description: 
      RATIONALE S100A12 (calgranulin C) is a cytoplasmic protein secreted exclusively by activated
      neutrophils. It can be measured in stools and elevated levels are observed in children with
      inflammatory bowel disease. The protein is stable in stool samples for up to seven days at
      room temperature, which allows collection at home and potential delays in transport to the
      laboratory. S100A12 could be used as a marker to discriminate between pediatric inflammatory
      and functional gastro-intestinal conditions, and prevent children with a low probability of
      inflammation from unnecessary endoscopic procedures. Until now a reliable reference interval
      for healthy children is lacking.

      OBJECTIVE To establish reliable reference intervals for fecal S100A12 in healthy children.

      TIME FRAME Healthy children will be asked to send in one feces sample anonymously during the
      inclusion period. The investigators expect that the required 120 samples will be collected
      before December 2015. There will be no follow up of patients.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy children, aged 6-18 years old
      
Biospecimen description: 
      feces samples