bioihbjkbjnl/mcl2 huggingface dataset:
Neurobehavioral Effects of Partial Sleep Deprivation
Condition: Control; 1 Night Recovery Sleep; 3 Nights Recovery Sleep; 5 Nights Recovery Sleep
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      This project continues an innovative line of research on how to optimally use sleep as an
      intervention to promote cognitive recovery from, and resistance to, the neurobehavioral risks
      posed by chronic partial sleep deprivation. Chronic insufficient sleep is estimated to affect
      at least 20% of adults. It can result from medical conditions and sleep disorders, as well as
      work demands, and social or domestic responsibilities. It is associated with significant
      clinical morbidity, and directly causes errors and accidents that are due to its adverse
      neurobehavioral effects on alertness, mood, and cognitive functions. In seminal experiments
      conducted under this grant, we showed that the neurobehavioral effects of chronic sleep
      restriction accumulate to severe levels in a few days, without the full awareness of the
      affected individuals, and that recovery from chronic sleep restriction requires more sleep
      than previously assumed. We also discovered that recovery from chronic sleep was illusory,
      because it masked a heightened neurobehavioral vulnerability to even a single post-recovery
      night of sleep restriction. The implications of these findings are that apparent recovery
      from chronic sleep restriction masks a more severe cognitive response to subsequent sleep
      restriction suggesting that there are longer time constants in the brain for neurobehavioral
      recovery from chronic sleep restriction. In light of this finding, we now seek to determine
      whether additional nights of extended recovery sleep will reduce the heightened vulnerability
      induced by prior exposure to sleep restriction. A total of 87 healthy adults (ages 21-50)
      will be studied in the laboratory during a 17-night (N=63) and a 19-night (N=24) protocol
      evaluating cognitive, psychological and physiological responses to varying recovery days
      between two sleep-restriction periods. The results will establish the number of nights of
      recovery sleep needed to prevent accelerated deterioration during a subsequent period of
      sleep restriction. The findings will advance theoretical understanding of sleep homeostasis
      and its relationship to cognitive functions, as well as inform theories of sleep need, and
      have substantial implications for sleep biology, for the treatment of clinical disorders that
      regularly disrupt sleep, and for managing lifestyle factors that frequently restrict sleep.
    


Intervention name(s): Sleep
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Re-exposure of Human Volunteers to a Heterologous Strain of P. Falciparum Sporozoites
Condition: Malaria, Falciparum
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional

Summary: 
      In a previous study (NL33904.091.10) the investigators challenged 24 volunteers after
      Chloroquine Prophylaxis Sporozoites (CPS) immunization with 45, 30 or 15 infected
      mosquito-bites respectively. The availability of this immunized cohort opens the unique
      opportunity to determine protection to a heterologous challenge for both of the protected and
      unprotected volunteers as the previous challenge infection might have served as immunological
      boost to the unprotected volunteers.

      In the current observational, proof of principle study, the investigators aim to investigate
      the protection on an individual basis of these previously immunized and challenged volunteers
      against a heterologous P. falciparum challenge.
    


Intervention name(s): Heterologous challenge; Malarone treatment
Intervention type(s): Biological; Drug
Intervention description(s): challenge by the bites of 5 Plasmodium falciparum infected mosquitoes.; Three days: 4 tablets 250/100mg per day
Other intervention name(s): atovaquon/proguanil
Intervention MeSH terms: Proguanil; Atovaquone, proguanil drug combination
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Plasmodium; falciparum; malaria; heterologous; immunity
A Trial to Learn How a New Liquid Form of Rivaroxaban Behaves and How Safe it is Compared to the Current Tablet Form of Rivaroxaban in Healthy Male Participants
Condition: Thromboembolic Disorders
MeSH terms: Thromboembolism
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers were looking for another way to treat people with a blood clot in their veins.
      Before a treatment can be approved for people to take, researchers do clinical trials to
      better understand its safety and how it behaves.

      In this trial, the researchers learned how a new liquid form of rivaroxaban behaved compared
      to the tablet form in a small number of healthy participants. They also wanted to find out
      how safe it was. The trial included about 30 white men who were between the ages of 18 and
      55. The participants also had a body mass index (BMI) between 18 and 29.9 kilograms per
      square meter (kg/m^2). BMI is a measurement that uses a person's height and weight to learn
      how much body fat they have.

      All the participants in this trial took 10 milliliter of the new form of rivaroxaban
      (containing 1 milligram [mg] of rivaroxaban per milliliter). Later they also took 10 mg of
      the current tablet form of rivaroxaban. They took each form 1 time by mouth.

      This trial was a "crossover" trial. In a crossover trial, all the participants take all of
      the treatments, but in a different order. In between the 2 treatments, there was a "washout
      period" of at least 7 days. This was done so that the first treatment could leave each
      participant's body before they took their next treatment.

      While taking each treatment, the participants stayed at the trial site for 5 days. During
      this time, they did not eat food for at least 10 hours before and at least 4 hours after
      taking each treatment. After taking the last treatment, the participants had a final visit
      about 7 to 14 days later.

      During the trial, the doctors took blood and urine samples. They also did physical
      examinations and checked the participants' heart health using an electrocardiogram (ECG).
      They asked the participants questions about how they were feeling and if they had any medical
      problems.
    


Intervention name(s): Rivaroxaban (Xarelto, BAY59-7939); Rivaroxaban (Xarelto, BAY59-7939)
Intervention type(s): Drug; Drug
Intervention description(s): Granules for oral suspension, 10 mg, oral, single dose; Tablet, 10 mg, oral, single dose
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Thromboembolism
Role of Carnosine as an Adjuvant Therapy for Diabetic Nephropathy in Pediatrics With Type 1 Diabetes
Condition: Type 1 Diabetes; Oxidative Stress; Carnosine; Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      Carnosine, a naturally-occurring dipeptide (β-alanyl-L-histidine) first described in 1900 by
      Gulewitsch and Amiradzibi, is found predominantly in post-mitotic tissues (e.g. brain and
      innervated muscle) of vertebrates . Carnosine is claimed to decrease oxygen free-radical
      mediated damage to cellular macromolecules either by chelating divalent cations or scavenging
      hydroxy radicals with its imidazole moiety. Free-radical damage is not the only process to
      affect the structure of proteins and nucleic acids.

      To the best of our knowledge, no previous study assessed the role of carnosine in diabetes
      associated complications in particular diabetic nephropathy and there is insufficient
      evidence to recommend its supplementation in those patients. Therefore, this study was
      undertaken to investigate the role of carnosine as an adjuvant therapy for diabetic
      nephropathy in children and adolescents with type 1 diabetes and assess its relation to
      microalbuminuria, tubulointerstitial damage marker, glycemic control and oxidative stress.
    


Intervention name(s): Carnosine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Patients in intervention group received carnosine capsules orally daily; Patients in placebo group received placebo that were similar in appearance to carnosine capsules and the administered dose was as the same schedule as carnosine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Investigation of Microbiome-Derived Metabolite Production in Response to a Mediterranean Diet
Condition: Food Habits
Study type: Interventional

Summary: 
      This project proposes to characterise the microbiome-derived metabolites produced upon
      ingestion of bioactive precursor-rich meals by healthy volunteers in order to investigate the
      relationship between gut microbiome composition and the nature of dietary metabolites
      production.
    

Detailed description: 
      There is a large inter-individual variability in gut microbiome-derived metabolites
      production upon ingestion of similar meals. Since many of these microbiome-derived
      metabolites have enteric and systemic biological effects, these variabilities could in part
      account for the different responses to meals and diets.

      This project thus aims to improve the understanding the relationship between gut microbiome
      composition and the nature of dietary metabolites produced from similar bioactive
      precursor-rich meals.

      The investigators therefore propose to characterise the circulating microbiome-derived
      metabolite profiles in healthy individuals fed the same 2-day precursor-rich Mediterranean
      diet prior to and after a 2-week of habitual Canadian diet feeding.
    

Intervention name(s): Mediterranean diet
Intervention type(s): Other
Intervention description(s): During both Mediterranean diet periods, participants will be provided with meals and snacks representative of the Mediterranean nutritional habits. Participants will be required to eat only the meals provided.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Gut Microbiome; Metabolites; Endocannabinoid; Mediterranean diet
Impact of a Booster Course of Antenatal Steroids on Neonatal Outcome in Patients With Premature Rupture of the Membranes
Condition: Premature Birth
MeSH terms: Premature Birth; Rupture
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This trial hopes to prospectively evaluate the impact of one versus two courses of antenatal
      steroids on the incidence of major neonatal morbidity in pregnant women with pre-labor
      premature rupture of the membranes.
    

Detailed description: 
      This is a multicenter randomized double blinded trial that hopes to prospectively evaluate
      the impact of one versus two courses of antenatal steroids on the incidence of major neonatal
      morbidity including respiratory distress syndrome in pregnant women with a singleton
      gestation between 24w0d - 32w6d gestation who have documented premature rupture of the
      membranes.
    

Intervention name(s): Betamethasone - ACTIVE; Normal Saline - PLACEBO
Intervention type(s): Drug; Other
Intervention description(s): antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses.; normal saline of the same quantity as with the experimental drug is to be given by injection 24 hours apart for two doses
Other intervention name(s): antenatal corticosteroid; dexamethasone; NS
Intervention MeSH terms: Dexamethasone; Betamethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Correlation of Reduction of Levodopa and Non-motor Symptoms of Parkinson's Disease After Deep Brain Stimulation
Condition: Parkinson Disease; Visual Impairment
MeSH terms: Parkinson Disease; Vision Disorders; Vision, Low
Study type: Interventional

Summary: 
      Patients with parkinson disease (PD) usually reduced the dose the levodopa after received
      deep brain stimulation (DBS). However, studies seldomly mentioned about the influences on
      non-motors systems after the reduction. Our study focused on the changes after DBS and
      attribute them to the levodopa variety.
    

Detailed description: 
      We calculated that group sample sizes of 126 patients (63 in group 1; 63 in group 2) would
      provide 80% power to reject the null hypothesis of equal means when the mean difference is
      -5(10-15) with standard deviations of 10 for test group and 10 for control group at a
      two-sided alpha of 0.05. Given an anticipated dropout rate of 20%, total sample size required
      is 158 (79 in reduction; 79 in non-reduction group).

      Written informed consent was obtained from all participants. After the baseline measurement,
      we informed the eligible patients the assigned randomization group with sealed opaque
      envelopes marked with the inpatient numbers .

      Within 12 months after STN-DBS, the LEDD of the intervention group was consistent with that
      before operation, and gradually decreased under the guidance of physician according to the
      expert consensus of DBS after 12 months. The compliance problem was solved by determining the
      actual number of antiparkinsonian medications returned by participants.
    

Intervention name(s): Levodopa
Intervention type(s): Drug
Intervention description(s): Some patients did not reduced the dose of levodopa after STN-DBS comparing to some without reducing the dose.
Intervention MeSH terms: Levodopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Deep Brain Stimulation; Levodopa
AXER-204 in Participants With Chronic Spinal Cord Injury
Condition: Chronic Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This two-part trial will assess the safety, tolerability, pharmacokinetics, and efficacy of
      AXER-204 administered by lumbar puncture and slow bolus infusion. Part 1 will evaluate the
      safety, tolerability, and pharmacokinetics of single ascending doses of AXER-204. Part 2 will
      evaluate the safety, tolerability, pharmacokinetics, and efficacy of repeated doses AXER-204
      in comparison to placebo.
    

Detailed description: 
      AXER-204 is a human fusion protein that acts as a soluble decoy/trap for the
      myelin-associated inhibitors of axonal growth known as Nogo-A, MAG, and OMgp. AXER-204 and a
      surrogate protein used in early preclinical studies have been found to promote axon growth
      and recovery of function in animal models of spinal cord injury.

      Part 1 of the trial is a multicenter, open-label, single ascending dose study in participants
      with chronic cervical spinal cord injury. Four cohorts of 6 participants each are planned,
      with participants within each cohort expected to receive the same dose of AXER-204.

      Part 2 is a multicenter, randomized, double-blind, placebo-controlled, repeat dose study in
      chronic cervical spinal cord injury participants. Approximately 32 participants will be
      randomized (ratio 1:1) to receive repeated doses of AXER-204 or placebo (a phosphate buffered
      saline formulation). The dose level and dose frequency will be dependent upon outcomes from
      Part 1.
    

Intervention name(s): AXER-204; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): human NoGo Trap fusion protein; Phosphate buffered saline formulation
Other intervention name(s): human NoGo Trap; human Nogo Receptor decoy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part 1 is open-label single-ascending dose. Part 2 is double-blind, placebo-controlled, repeat dose.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: myelin-associated inhibitor; Nogo-A; MAG; OMgp; Nogo Receptor
TD-1607 MAD Study in Healthy Subjects
Condition: Infections; Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      TD-1607, administered intravenously as multiple ascending doses, will be investigated in
      healthy subjects to assess its tolerability, safety, and pharmacokinetics.
    


Intervention name(s): TD-1607; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gram-positive
Prospective Metabolic Surgery in T2DM Chinese Subjects
Condition: Diabetes; Obesity
Study type: Interventional

Summary: 
      The primary goal of this study is to assess impact of metabolic surgery on glycemic control
      in diabetic patients.
    

Detailed description: 
      The primary objective of this study is to assess the impact of metabolic surgery (Roux-en-Y
      gastric bypass [RYGB] or sleeve gastrectomy [SG]) on composite measure of glycemic control at
      2 years post surgery in a Type 2 Diabetes Mellitus (T2DM) cohort of subjects.
    

Intervention name(s): Roux-en-Y gastric bypass; Sleeve gastrectomy
Intervention type(s): Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Relative Bioavailability of a BI 187004 Tablet Formulation in Comparison With an Oral Solution and the Influence of Food on the Tablet Formulation in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the relative bioavailability of an BI 187004 tablet formulation compared to an
      oral solution of BI 187004 and to assess the influence of food on the bioavailability of the
      tablet formulation.
    


Intervention name(s): BI 187004; BI 187004; BI 187004
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose BI 187004 given as tablet in fed state; single dose BI 187004 given as tablet in fasted state; single dose BI 187004 given as oral solution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pediatric Study to Access Pharmacokinetics and Safety of Oraqix Gel
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      To establish Oraqix is safe when used on adolescent volunteers.
    

Detailed description: 
      This is a single-center, uncontrolled, open-label, single administration patient study. Male
      and female subjects aged 6 through 17 years of age in need of primary tooth extraction will
      be recruited from the Principal Investigator's database and may be supplemented by
      advertising. Subjects who withdraw from the study prematurely will be replaced.

      Subjects will undergo an initial screening visit at which eligibility will be determined.
      After completion of informed consent/assent a physical examination, vitals, 12-lead ECG, and
      dental examination will be conducted. A medical history will be documented and a blood sample
      will be collected for analysis of biochemistry, hematology and as appropriate, serum
      pregnancy assessment for females.

      Subjects will return to the office approximately 1 to 10 days after Visit 1 for Visit 2. At
      Visit 2, study treatment will be administered and PK blood samples will be collected for
      analysis, and monitored for safety parameters. Up to a total of five cartridges of Oraqix®
      will be administered to the oral cavity in the area of the tooth extraction, based on the
      body weight of the subject. No more than five cartridges will be dispensed, since this is the
      maximum dose for this agent. The final sample will be collected 4 hours after administration
      of study material. An abbreviated dental examination will be conducted, any adverse events
      (AEs) will be documented and the subject will be discharged from the clinic.

      All subjects will be contacted by telephone approximately 24 hours after administration of
      study treatment. Study personnel will enquire about the occurrence of any AEs that have
      occurred since leaving the office. If appropriate, further follow-up of AEs will be arranged.
      In the absence of any ongoing AEs requiring follow up the subject will be considered to have
      completed the study at the completion of the telephone call.
    

Intervention name(s): lidocaine and prilocaine
Intervention type(s): Drug
Intervention description(s): Appropriate dose of Oraqix based on weight will be given before tooth extraction
Other intervention name(s): Oraqix periodontal gel
Intervention MeSH terms: Lidocaine; Prilocaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of MEDI-573 Plus Standard Endocrine Therapy for Women With Hormone-sensitive Metastatic Breast Cancer
Condition: Hormone-sensitive, HER-2 Negative Metastatic Breast Cancer
MeSH terms: Breast Neoplasms; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to evaluate the safety, tolerability, antitumor activity, and pharmacology of MEDI-573
      in combination with an aromatase inhibitor (AI) in adult subjects with HR+, HER2-negative
      MBC.
    

Detailed description: 
      This is a Phase 1b/2, multicenter, open-label study to evaluate the safety, tolerability,
      antitumor activity, and pharmacology of MEDI-573 in combination with an AI in adult subjects
      with HR+, HER2-negative MBC. This study has 2 phases: a dose-evaluation phase (Phase 1b) and
      a randomization phase (Phase 2).
    

Intervention name(s): MEDI-573; Aromatase Inhibitor
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion of MEDI-573 (10 or 30 or 45 mg/kg) will be administered on Day 1 of each 21-day cycle until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.; Aromatase inhibitor of the investigator's choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
Intervention MeSH terms: Aromatase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MEDI-573, breast cancer, metastatic, aromatase inhibitor, anti-IGF
Prevalence of Sleep Disordered Breathing in a Lung Cancer Screening Cohort
Condition: Sleep Apnea Hypopnea Syndrome; COPD; Emphysema; Lung Cancer
MeSH terms: Lung Neoplasms; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Emphysema
Study type: Interventional

Summary: 
      Prospective study of sleep disordered breathing in a lung cancer screening cohort.
    

Detailed description: 
      The proposed study is a prospective single arm study evaluating the prevalence of sleep
      disordered breathing in a cohort of lung cancer screening patients.
    

Intervention name(s): poligraphy
Intervention type(s): Other
Intervention description(s): Sleep study
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic