louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01365949: Biomarker in Tissue Samples From Patients With Ewing Sarcoma
Official title: INI-1 Deletions in Ewing Sarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Keywords: Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET)
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-06-03
Enrollment: 40
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of Ewing sarcoma.

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in tissue samples from patients with Ewing sarcoma.

Detailed description: OBJECTIVES:

* To determine the frequency of INI-1 protein loss in Ewing Sarcoma.

OUTLINE: Previously collected tissue samples are analyzed for INI-1 protein loss by IHC and tissue microarray.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of Ewing sarcoma
* Prepared tissue microarray with Ewing sarcoma samples available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Frequency of INI1 protein loss in Ewing Sarcoma
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Utah
name: Joshua D. Schiffman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05706649: A Study of Plant-based Diet on Postprandial Sleepiness
Official title: Effect of Plant-based Diet on Postprandial Sleepiness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drowsiness
Keywords: Postprandial Sleepiness
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This research aims to develop a better understanding and clinical knowledge of the effects of a plant-based diet on postprandial sleepiness.


Eligibility criteria: Inclusion Criteria

* Sleepiness after eating lunch.
* ESS score ≥3 for answering the question about these two situations: 'sitting quietly after lunch without alcohol' and 'lying down to rest in the afternoon when circumstances permit'.

Exclusion Criteria

* Diabetes.
* Pregnancy or lactation.
* Current use of a vegan/plant-based diet
* BMI ≤ 22.
* Iron deficiency.
* Vitamin B12 deficiency.

Primary outcomes:
measure: Change in postprandial sleepiness
timeFrame: Baseline, 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Joseph Cheung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04016649: The Mechanical Characterisation of Human Saphenous and Popliteal Vein
Official title: The Mechanical Characterisation of Human Saphenous and Popliteal Vein
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peripheral Vascular Diseases
Lead sponsor: University Hospital of Limerick
Sponsor class: OTHER
Collaborators: name: University of Limerick
First posted: 2019-07-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Study population will consist of individuals under the care of a Vascular Consultant. Patients will be asked to participate if they are going for a procedure in which there will be vein tissue waste that would usually be discarded in the operating theatre. The procedures of interest are Varicose Vein Procedures, Lower Limb Amputation and Lower Limb Bypass Surgery.

Brief summary: Non-interventional study aiming to ascertain the mechanical properties of human saphenous and popliteal vein tissue.

Detailed description: The aim of this study is to mechanically characterise saphenous and popliteal vein segments that have been deemed waste following varicose vein procedures, lower limb amputation and lower limb bypass surgery.

By characterising the stress-stretch relationship of the vein vessel wall, treatment techniques can be better understood. Mechanical device design can be bteer informed and the the suitability of vein as a conduit for bypass and AVF procedures can be assessed.

Eligibility criteria: Inclusion Criteria:

* Male or Female patients aged 18 years or older
* Patients undergoing varicose vein procedures or;
* Patients undergoing lower limb amputation or;
* Patients undergoing lower limb bypass surgery

Exclusion Criteria:

* Patients unable to give informed consent
* Seriously ill/unconscious patients

Primary outcomes:
measure: The identification of vein tissue mechanical distension and stretching properties.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Limerick
country: Ireland
facility: University Hospital Limerick
Study officials:
affiliation: University Hospital of Limerick
name: Eamon Kavanagh, MD FRCSI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04311749: Expanded NIPT for Pregnancy Complications
Official title: The Role of Expanded Panel Non-Invasive Prenatal Testing in Identifying Rare Autosomal Trisomies in Pregnancies With Placentally-Mediated Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fetal Growth Restriction
Preeclampsia Severe
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes pregnant women diagnosed with severe, early onset, unexplained fetal growth restriction.

Brief summary: This study evaluates the utility of expanded panel non-invasive prenatal testing (NIPT) in detecting confined placental mosaicism of rare autosomal trisomies among pregnancies with placentally-mediated complications, including fetal growth restriction and severe preeclampsia.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of early onset (\< 34 weeks) severe fetal growth restriction, defined as estimated fetal weight less than 10th percentile with abnormal umbilical artery Dopplers OR estimated fetal weight less than 5th percentile alone OR biometric size at least 14 days behind expected dates

Exclusion Criteria:

* Maternal age \< 18 years
* Multifetal gestation
* Chronic hypertension require use of pharmacotherapy
* Tobacco or drug use
* Major congenital malformations

Primary outcomes:
measure: Composite adverse pregnancy outcome
timeFrame: Through study completion, an average of 2 years
Secondary outcomes:
measure: Preterm birth < 34 weeks
timeFrame: Through study completion, an average of 2 years
measure: Neonatal intensive care unit admission
timeFrame: Through study completion, an average of 2 years
measure: Intrauterine fetal demise
timeFrame: Through study completion, an average of 2 years
measure: Neonatal demise
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Nasim Sobhani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03720249: Effects of Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia
Official title: Supplementation of Compound Nutrients on Plasma Homocysteine in Chinese Adults With Hyperhomocysteinemia: a Randomized Double-blind Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperhomocysteinemia
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether supplementation of compound nutrients,including folic acid, vitamin B6, vitamin B12, betaine and zinc, will decrease the level of plasma homocysteine in Chinese adults with hyperhomocysteinemia.


Eligibility criteria: Inclusion Criteria:

1. People aged 18-65 years.
2. The level of plasma homocysteine is 15-100μmol/L.
3. Free from products which could decrease plasma homocysteine for at least one month.
4. Willing to participate in the study, consume the test product and perform all measurements.

Exclusion Criteria:

1. pregnant or lactating women.
2. severe diseases need to control.
3. people who unconsciousness and can not complete questionnaire.
4. long-term regular use of vitamin or mineral supplements.

Primary outcomes:
measure: levels of homocysteine
timeFrame: 12 weeks
Secondary outcomes:
measure: levels of 5-methyltetrahydrofolic acid, vitamin B6, vitamin B12 and betaine
timeFrame: 12 weeks
measure: levels of s-adenosyl-methionine and s-adenosyl-homocysteine
timeFrame: 12 weeks
measure: anthropomorphic measurements and blood biochemical markers
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: SunYat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Huilian Zhu, professor
role: STUDY_CHAIR
References:
Clinical trial NCT06393049: Microdialysis and Jugular Bulb Glucose Profiles During Hyperglycaemic Clamping in Patients with Severe Acute Brain Injury
Official title: Microdialysis and Jugular Bulb Glucose Profiles During Hyperglycaemic Clamping in Patients with Severe Acute Brain Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Brain Injury
Keywords: Acute brain injury
Intensive care
Neurointensive care
Anaesthesiology
Multimodal neuromonitoring
Glucose
Hyperglycaemic clamp
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-05-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 14 patients, all will have an hyperglycaemic clamp performed during admission while measuring cerebral microdialysis
Primary purpose: TREATMENT

Brief summary: Acute brain injury is a serious condition that often results in admission to an intensive care unit. Some of the most seriously ill patients are fitted with multimodal neuromonitoring, a newer monitoring modality that can, among other things, measure oxygen tension and sugar levels in brain tissue. It is common clinical practice, but the interaction between the body's sugar levels and the brain's sugar levels is not sufficiently elucidated.

The study will investigate the relationship between the body's sugar levels, measured in arterial and venous blood, and the brain's sugar level, measured by microdialysis, in patients with severe acute brain injury.

Furthermore, we hope to be able to use our measurements to set up a mathematical model for the brain's sugar uptake.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Admission to the neuro-ICU at Rigshospitalet.
* Multimodal neuromonitoring

Exclusion Criteria:

* Closest relative does not understand written and spoken Danish or English.
* Patients with known diabetes mellitus upon admission.

Primary outcomes:
measure: (Change in) MD-glucose (mmol/L)
timeFrame: Throughout the intervention, approximately five hours
Secondary outcomes:
measure: Jugular vein glucose (mmol/L) over time as a function of arterial blood glucose.
timeFrame: Throughout the intervention, approximately five hours
measure: Lactate-pyruvate-ratio (LP-ratio) as a function of arterial blood glucose.
timeFrame: Throughout the intervention, approximately five hours.
Other outcomes:
measure: Mathematic model of transport of glucose over the blood brain barrier.
timeFrame: Throughout the intervention, approximately five hours.
Locations:
city: Copenhagen
country: Denmark
facility: Department of Neuroanaesthesiology, Rigshospitalet
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT01428349: Matching Cognitive Remediation to Cognitive Deficits in Substance-Abusing Inmates
Official title: Matching Cognitive Remediation to Cognitive Deficits in Substance-Abusing Inmates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychopathy
Personality Disorders
Keywords: Incarcerated offenders
emotionally reactive
emotionally stable
psychopathy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2011-09-05
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a 2 -year NIDA funded grant (Co-PIs: Joseph P. Newman, John Curtin, and Carl Lejuez) that examines whether recent progress in characterizing the cognitive deficits associated with psychopathic and externalizing offenders may be used to develop better therapeutic interventions to treat their substance abuse and other self-control problems. Inmates with externalizing or psychopathy will receive one of two computer-based interventions to remediate the core cognitive skills that have been linked to self-regulation deficits in the two groups. One intervention (ACC) targets the affective cognitive control deficits associated with externalizing offenders whereas the other intervention (ATC) targets the attention to context deficits associated with psychopathic offenders. The specific components of the project include: selection and randomization of inmates; pre- and post-treatment behavioral and brain-related (ERP and Startle) measures to evaluate the impact and specificity of the ACC and ATC treatments; and 6 sessions of behavioral (e.g. computerized) and verbal training in ACC or ATC.


Eligibility criteria: Inclusion Criteria:

* Male,
* ages 18-45 years,
* elevated scores of psychopathy or externalizing measures

Exclusion Criteria:

* currently taking psychotropic medication,
* below a 4th grade reading level,
* history or current learning disability,
* history of head trauma with lasting effects,
* current diagnosis of PTSD,
* Bipolar, or
* psychosis

Primary outcomes:
measure: Psychophysiological change from pre-treatment to post-treatment
timeFrame: 6 weeks after pre-testing
Secondary outcomes:
measure: Frequency of Conduct Reports
timeFrame: within 3 months of participation
Other outcomes:
Locations:
city: Fox Lake
country: United States
facility: Fox Lake Correctional Institution
state: Wisconsin
city: Oshkosh
country: United States
facility: Oshkosh Correctional Institution
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Joseph P Newman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baskin-Sommers AR, Curtin JJ, Newman JP. Altering the Cognitive-Affective Dysfunctions of Psychopathic and Externalizing Offender Subtypes with Cognitive Remediation. Clin Psychol Sci. 2015 Jan 1;3(1):45-57. doi: 10.1177/2167702614560744.
Clinical trial NCT00362349: Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients
Official title: A Single-arm, Open Label, Multi-centre Study Evaluating the Efficacy and Safety of Ig NexGen 10% in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Thrombocytopenic Purpura (ITP)
Keywords: ITP
IVIg
Platelet count
Bleeding
Lead sponsor: CSL Limited
Sponsor class: INDUSTRY
First posted: 2006-08-10
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Idiopathic Thrombocytopenic Purpura (ITP) is an autoimmune bleeding disorder characterised by isolated low platelet counts. The aim of treating patients with ITP is to increase the platelet concentration and reduce the risk of bleeding. A number of controlled multi-centre studies have demonstrated that Intravenous Immunoglobulin (IVIg) therapy produces a rapid rise in platelet counts within a 24 to 72 hour period. This study will evaluate the efficacy and safety of Ig NextGen 10% in adult patients with ITP.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of ITP
* platelet count of \<50 X 10\^9

Exclusion Criteria:

* planned splenectomy
* previous non-responders to IVIg treatment
* known or suspected hypersensitivity or previous evidence of severe side effects to immunoglobulin therapy
* patients who have received treatment with:

  1. IVIg or anti-D immunoglobulin
  2. immunosuppressive, any other immunomodulatory drug(s) or other active treatment(s)for ITP within three weeks prior to first day of study drug administration
  3. patients who have received IV administration of steroids OR have had a change of oral corticosteroid treatment OR danazol within 15 days prior to first day of study drug administration.

Primary outcomes:
measure: Efficacy
timeFrame: 90 days
Secondary outcomes:
measure: Safety
timeFrame: 97 days
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St George Hospital
state: New South Wales
city: Brisbane
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Redcliffe Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
Study officials:
affiliation: The St George Hospital (NSW, Australia)
name: Beng N/A Chong, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01256749: A Comparative Study of Global 12 Lead Electroencephalogram to Frontal SedlineTM Electroencephalogram
Official title: A Comparative Study of Global 12 Lead Electroencephalogram to Frontal SedlineTM Electroencephalogram Monitoring for the Evaluation of Intraoperative Burst Suppression During Elective Craniotomy or Transphenoidal Pituitary Resection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Craniotomy
Transphenoidal Pituitary Resection
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2010-12-09
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients scheduled for elective craniotomy or transphenoidal pituitary resection at LLUMC University Hospital in which the surgeon has requested intraoperative burst suppression therapy regardless of the inciting etiology will be eligible to participate in this study.

Brief summary: The fundamental reason for comparing the ability of the Frontal Sedline TM Electroencephalogram (PSA EEG) to standard Global 12 Lead Electroencephalogram (EEG) for burst suppression detection is to determine if a less expensive, less invasive and possibly more convenient bifrontal EEG monitor can be effective for evaluation of anesthesia-induced intraoperative burst suppression therapy (IBST) for cerebral protection.


Eligibility criteria: Inclusion Criteria:

1. Adult ASA class 1-3 male or female 18-90 years of age;
2. scheduled for elective craniotomy in the LLUMC University Hospital, for which the surgeon has requested intraoperative burst suppression therapy;
3. capable of understanding and signing informed consent;
4. willing to have dual EEG monitoring.

Exclusion Criteria:

1. Age under 18 years;
2. emergency or trauma situation requiring craniotomy;
3. surgical approach that prohibits placing the SEDLineTM array on the forehead;
4. known sensitivity to the adhesives on the SEDLineTM array;
5. lack of availability of standard EEG monitoring;
6. patients with seizure disorders and refusal of consent.

Primary outcomes:
measure: Correlation between 4 channel PSA EEG and a global 12 lead EEG
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
Study officials:
affiliation: Loma Linda University
name: Deborah W McIvor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02680249: Food Effect Study of CTP-656 in Healthy Male Volunteers
Official title: A Phase 1 Single Center, Open-Label, Randomized, Three-Way Crossover Study of the Relative Bioavailability of a Single Dose of CTP-656 in a Fasted, Fed Low-Fat and Fed Moderate-Fat Condition in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety, Bioavailability and Pharmacokinetics
Lead sponsor: Concert Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2016-02-11
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Three way crossover study to assess the bioavailability of 656 under fed and fasted conditions.

Detailed description: This study will assess in healthy male subjects a solid oral dose formulation of CTP-656 under fasted and fed conditions.

Primary:

• To characterize the relative bioavailability and pharmacokinetic profile of a single 150 mg solid oral dose of CTP-656 in healthy volunteers under fasted, fed low-fat and fed moderate-fat conditions.

Secondary:

* To characterize the pharmacokinetic profile of metabolites of CTP-656 following a single 150 mg solid oral dose of CTP-656 in healthy volunteers under fasted, fed low-fat and fed moderate-fat conditions.
* To assess the safety and tolerability following a single 150 mg solid oral dose of CTP-656 in healthy volunteers under fasted, fed low-fat and fed moderate-fat conditions.

Eligibility criteria: Inclusion Criteria:

* Healthy adults between 18 and 50 years of age, inclusive
* Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive, at screening

Exclusion Criteria:

* History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal (including nephrolithiasis), hepatic, including history of Gilbert's syndrome or gastrointestinal (GI) conditions
* PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcF interval \> 450 msec obtained at screening visit or prior to the first dose of study drug
* Liver function tests greater than the upper limit of normal.
* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening
* Urinalysis positive for greater than trace blood, protein or glucose
* A positive screen for alcohol, drugs of abuse, or tobacco use.
* Inability to comply with dietary restrictions during study participation.
* Donation or blood collection or acute loss of blood prior to screening.

Primary outcomes:
measure: Measurement of CTP-656 in plasma under fed and fasted conditions
timeFrame: 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: CMAX
state: South Australia
Study officials:
affiliation: Concert Pharmaceuticals, Inc.
name: Lana Pilja
role: STUDY_DIRECTOR
References: