louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04486248: Comparison of Magnetic Resonance Techniques for the Measurement of Cerebral Blood Perfusion
Official title: Comparison of Magnetic Resonance Techniques for the Measurement of Cerebral Blood Perfusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Barcelonabeta Brain Research Center, Pasqual Maragall Foundation
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thirty (N=30) healthy individuals older than 18 years old

Brief summary: In this project, we aim at implementing a te-ASL sequence and to compare it to two reference ASL sequences with a fixed PLD on healthy individuals. On the one hand, the te-ASL sequence will be compared against a 3D pCASL with a PLD of 1800 ms, as the current reference according the Consensus of the ISMRM perfusion study group and the European consortium for ASL in dementia. On the other, as the implemented te-ASL sequence will have a 2D readout, it will also be compared to a 2D pCASL ASL sequence with the same PLD, in order to be able to disentangle differences due to the dynamic PLD scheme from those arising from the different read-out schemes.


Eligibility criteria: Inclusion Criteria:

* To sign the study informed consent form approved by the corresponding authorities.
* Healthy men and women (older than 18 years old).

Exclusion Criteria:

* Inability or unwillingness to give written informed consent or communicate with the study staff or illiteracy.
* Any contraindication to perform brain MRI procedure (e.g. pacemaker, MRI-incompatible aneurysm clips).

Primary outcomes:
measure: ASL perfusion MRI data
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: BarcelonaBeta Brain Research Center
Study officials:
References:
Clinical trial NCT00002448: A Study to Compare the Effects of Two Anti-HIV Drug Combinations on the Immune Systems of HIV-Infected Patients
Official title: Evaluation of Immune Reconstitution in HIV Infected Patients Treated With Fortovase (Saquinavir) SGC QD Plus Ritonavir QD Plus 2 NRTIs Vs Efavirenz QD Plus 2 NRTIs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
HIV Protease Inhibitors
Ritonavir
Dosage Forms
Saquinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
efavirenz
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine how the immune systems of HIV-infected patients react to 2 anti-HIV drug combinations.

Detailed description: Patients are randomized to two study arms for at least 48 weeks of treatment. Arm A receives SQV SGC plus RTV plus two NRTIs of choice. Arm B receives EFV plus two NRTIs of choice. NRTIs approved for study use are stavudine (d4T), didanosine (ddI), zidovudine (AZT), lamivudine (3TC), Combivir, and zalcitabine (ddC). Abacavir is excluded. The following immunology variables and HIV-1 viral characteristics will be evaluated during study visits: CD4 and CD8 cell counts; naive and memory T-cells; T-cell activation markers (HLA-DR and CD38); T-cells expressing T helper 1- (TH1-) and T helper 2- (TH2-) associated intracytoplasmic cytokines; anti-CD3 T-cell activation responses; T-cell receptor V Beta repertoire; cytotoxic T-lymphocyte (CTL) activity levels; lymph node histology (optional); HIV-1 qualitative microcultures and viral phenotyping for non-syncytium-inducing (NSI) and syncytium-inducing (SI) viral isolates. Laboratory determinations, adverse effects, neurological exams (including mental status evaluations), and lipodystrophy parameters (including fasting lipid profile and physical parameters) also are evaluated.

Eligibility criteria: Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Have a viral load of at least 5,000 copies/ml and a CD4 cell count greater than 75 cells/mm3.
* Are at least 16 (need consent of parent or guardian if under 18).
* Are able to complete the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have ever taken anti-HIV medications.
* Are pregnant or breast-feeding.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Care Ctr
state: California
city: Palo Alto
country: United States
facility: Palo Alto Veterans Affairs Health Care System
state: California
city: New Brunswick
country: United States
facility: Robert Wood Johnson Med School/UMDNJ
state: New Jersey
Study officials:
name: Mark Holodniy
role: PRINCIPAL_INVESTIGATOR
name: Joseph John
role: STUDY_CHAIR
name: Ronald Mitsuyasu
role: STUDY_CHAIR
References:
Clinical trial NCT02280148: Accessing the Driving Skills After the Endoscopy of Intravenous Anesthesia by Driving Simulator
Official title: Accessing the Driving Skills After the Endoscopy of Intravenous Anesthesia by Driving Simulator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Driving
Keywords: Propofol
gastroscopy and colonoscopy
driving simulator
driving ability
cognitive function
patients
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 22
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to assess the driving and cognitive ability of gastrointestinal endoscopy patients at different time points after intravenous anesthesia (propofol for example), and to explore whether the driving and cognitive ability have a relationship with the blood concentration of propofol or not.

Detailed description: 20-70 year-old volunteers who hold legitimate licenses were recruited to have gastroscopy or colonoscopy under intravenous anesthesia with propofol, and before endoscopy using driving simulator and NCT to measure patients' driving ability and cognitive function as a baseline, in the same way, assessing patients' driving ability and cognitive function after 2h, 4h of the endoscopy , meantime collecting blood samples and separating blood plasma, using HPLC (High Performance Liquid Chromatography) to measure blood concentration of propofol.

Eligibility criteria: Inclusion Criteria:Outpatients who held a valid driver's license,were Aged 20 to 70 years old,had more than 2 years of driving experience, were with endoscopy or colonoscopy indications.

Exclusion Criteria:with gastroscopy or colonoscopy contraindications, long-term use of benzodiazepines or opioids,an American Society of Anesthesiologists physical status score (ASA) of Class IV or V,pregnant women,Emergency and hospitalized patients, allergy to narcotic drugs, with acute and chronic liver injury, have any clinical evidence of hepatic encephalopathy,severe based diseases and mental illness,serious adverse reactions such as dizziness, nausea, and vomiting in simulated driving.

Primary outcomes:
measure: driving ability after of the endoscopy under Intravenous Anesthesia
timeFrame: within the first 4h after endoscopy
Secondary outcomes:
measure: cognitive function after of the endoscopy under Intravenous Anesthesia
timeFrame: within the first 4h after endoscopy
Other outcomes:
measure: measure blood concentration of propofol
timeFrame: within the first 4h after endoscopy
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: peng Li, doctor
role: STUDY_CHAIR
References:
citation: Riphaus A, Gstettenbauer T, Frenz MB, Wehrmann T. Quality of psychomotor recovery after propofol sedation for routine endoscopy: a randomized and controlled study. Endoscopy. 2006 Jul;38(7):677-83. doi: 10.1055/s-2006-925244.
Clinical trial NCT04404348: Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment
Official title: Cognitive Rehabilitation for Opioid Abuse-related Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Substance-Related Disorders
Lead sponsor: Oklahoma State University Center for Health Sciences
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Research has consistently found that cognitive impairment is common in persons with a history of substance abuse. The most commonly identified impairments across all substances are in attentional and working memory functioning and executive functioning; opioid-specific research finds that memory is an additional area of common impairment. Initial research in applying cognitive rehabilitation methods to substance abuse have shown it to be helpful overall.

To develop a cognitive rehabilitation intervention that is effective for opioid abuse, this study will adapt a cognitive training program that has been shown to be effective in other patient groups. Patients in a residential opioid-abuse treatment program will undergo a cognitive evaluation and then be assigned to receive the 4-week cognitive intervention or the 4-week placebo control arm. It is expected that the intervention group will show greater gains on the cognitive post test and will have higher rated treatment adherence and opioid treatment program completion rates.


Eligibility criteria: Inclusion Criteria:

* Has completed the detoxification process
* Has completed at least 8 years of formal education
* Speaks and reads English fluently
* Is beginning residential inpatient treatment for opioid abuse (note: may be receiving treatment for polysubstance abuse but opioid must be one of their regular drugs of abuse)

Exclusion Criteria:

* Unable to self-consent (has a proxy for medical decision-making, legal guardian, or been otherwise determined unable to give consent)
* Past diagnosis or suspected current diagnosis of a neurodevelopmental disorder (e.g., autism, learning disability), attention-deficit disorder, or neurocognitive disorder (e.g., dementia)
* History of major head trauma (defined as loss of consciousness for 30 minutes or longer) or brain surgery. (Note: History of concussion, including brief loss of consciousness, is okay)

Primary outcomes:
measure: Mean Cognitive Change from Baseline to Endpoint
timeFrame: Post-intervention at week 4
measure: Substance Abuse Program Completion Rate
timeFrame: Until treatment program discharge, usually 30-45 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: 12&12, Inc
state: Oklahoma
Study officials:
affiliation: Oklahoma State University Center for Health Sciences
name: Alicia Ford, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05892848: Evaluation of Some Biochemical Markers of Bone Turnover in Childern and Adolescents With Type 1 Diabetes
Official title: Evaluation of Some Biochemical Markers of Bone Turnover in Childern and Adolescents With Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: childern and adolsecents below 16 years of age diagnsed with type 1 diabetes for at least 1 year age and sex-matched control childern and adolsecents will be included

Brief summary: Type 1 diabetes is associated with many longterm complications as retinopathy,neuropathy and nephropathy. Recently, several studies have linked type 1 diabetes to bone fragility.Studies conducted on patients with type 1 diabetes have concluded that bone is negatively affected in type 1 diabetes with impaired bone density,increased fracture risk and impaired bone turnover markers.


Eligibility criteria: Inclusion Criteria:

* childern and adolsecents below 16 years of age diagnsed with type 1 diabetes for at least 1 year age and sex-matched control childern and adolsecents will be included

Exclusion Criteria:

* childern and adolescents with congenital bone disease, those with disorders of the parathyroid gland and those with chronic kidney disease.

Primary outcomes:
measure: level of serum ostecalcin, sclerostin in patients with type 1 diabetes ann d their age and sex matched control
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: Starup-Linde J, Hygum K, Harslof T, Langdahl B. Type 1 Diabetes and Bone Fragility: Links and Risks. Diabetes Metab Syndr Obes. 2019 Dec 3;12:2539-2547. doi: 10.2147/DMSO.S191091. eCollection 2019.
citation: Madsen JOB, Herskin CW, Zerahn B, Jensen AK, Jorgensen NR, Olsen BS, Svensson J, Pociot F, Johannesen J. Bone turnover markers during the remission phase in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2020 Mar;21(2):366-376. doi: 10.1111/pedi.12963. Epub 2019 Dec 27.
citation: El Amrousy D, El-Afify D, Shabana A. Relationship between bone turnover markers and oxidative stress in children with type 1 diabetes mellitus. Pediatr Res. 2021 Mar;89(4):878-881. doi: 10.1038/s41390-020-01197-5. Epub 2020 Oct 10.
citation: Roh JG, Yoon JS, Park KJ, Lim JS, Lee HS, Hwang JS. Evaluation of bone mineral status in prepuberal children with newly diagnosed type 1 diabetes. Ann Pediatr Endocrinol Metab. 2018 Sep;23(3):136-140. doi: 10.6065/apem.2018.23.3.136. Epub 2018 Sep 28.
Clinical trial NCT01452048: Relationship Between Systemic Fatty Acid Availability and Insulin Sensitivity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: insulin sensitivity
fatty acid metabolism
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-10-14
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: UM Health System patients from Dr. Amy Rothberg and colleagues UM Investigational Weight Management Clinic (IWMC) Community Sample

Brief summary: The investigators specific aim is to compare the relationship between systemic fatty acid availability and insulin sensitivity in a relatively homogenous population of obese adults. The investigators anticipate 1) greater systemic fatty acid availability will be associated with lower insulin sensitivity and 2) greater systemic fatty acid availability will be associated with greater accumulation of fatty acid intermediates and pro-inflammatory markers.


Eligibility criteria: Inclusion Criteria:

* Body mass index \[BMI\]: 35-45 kg/m2; All women must be pre-menopausal; Non-exerciser (no regularly planned exercise/physical activity)

Exclusion Criteria:

* Weight instability ≥ ±5 lbs. in past month; medications known to affect lipid and/or glucose metabolism; Pregnancy or actively breast feeding

Primary outcomes:
measure: Insulin Sensitivity
timeFrame: 2-3 hours
Secondary outcomes:
measure: Resting Metabolic Rate
timeFrame: 20-30 min
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Clincal Research Unit
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jeffrey F Horowitz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06350825: Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in mHSPC Patients
Official title: Evaluating the Efficacy and Safety of Cytoreductive Prostatectomy Combined With Triple or Dual Systemic Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Metastatic Prostate Cancer
Therapy, Directly Observed
Keywords: prostate cancer
cytoreductive prostatectomy
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control
Primary purpose: TREATMENT

Brief summary: To evaluate: The radiographic progression-free survival (rPFS) of metastatic hormone-sensitive prostate cancer (mHSPC) patients treated with androgen deprivation therapy (ADT) + second-generation antiandrogens±chemotherapy combined with cytoreductive prostatectomy (CRP)

Detailed description: To investigate the multimodality approaches for mHSPC

Eligibility criteria: Inclusion Criteria:

1. Male aged ≥18 and ≤75;
2. Histologically confirmed prostate adenocarcinoma;
3. Evidence of metastasis confirmed by magnetic resonance imaging (MRI)/computed tomography (CT) scan, bone scan, or histology;
4. Clinical stage M1a (distant lymph node positive), M1b (bone metastasis), or M1c (visceral organ metastasis);
5. Prostate cancer has not received local treatment (e.g., prostate radiotherapy, cryotherapy, etc.);
6. The surgeon believes the prostate can be removed;

Exclusion Criteria:

1. The surgeon believes the disease is unresectable;
2. Life expectancy less than 2 years;
3. Active spinal cord compression;
4. History of prior local treatment for prostate cancer;
5. Difficulty swallowing, chronic diarrhea, intestinal obstruction, and other factors affecting drug intake and absorption;
6. Refusal to sign the informed consent;
7. Investigator believes the individual is not suitable for inclusion.

Primary outcomes:
measure: rPFS
timeFrame: 3 year
Secondary outcomes:
measure: Safety of CRP in mHSPC patients
timeFrame: until one year after the local therapy
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Lixin Hua, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06574425: Long-term, High Blood Flow Hemoadsorption Therapy in Patients Undergoing Maintenance Hemodialysis
Official title: A Multicenter, Prospective, Cohort Study on the Safety and Efficacy of Long-term, High Blood Flow Hemoadsorption Therapy in Patients Undergoing Maintenance Hemodialysis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Chronic Kidney Diseases
Hemodialysis
Keywords: protein-bound uremic toxins
hemoadsorption
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 80
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: Objective：The purpose of the study is to confirm that extending the duration of hemoadsorption (HA) and increasing blood flow during the HA+hemodialysis (HD) treatment process is safe and feasible, and to verify that extending the HP treatment duration can further increase the clearance of protein-bound uremic toxins.

Methods: The study employs a multicenter, prospective, cohort design with a self-controlled before-and-after comparison. The duration of HA+HD treatment for maintenance hemodialysis (MHD) patients is extended to 4 hours, and the extracorporeal blood flow rate is increased to over 250-350 ml/min. The safety of the treatment is assessed by evaluating the safety of the procedure; the levels of relevant toxins in the patients' blood are measured before and after treatment, and the clearance rate of uremic toxins after a single treatment is calculated and compared with the self-controlled before-and-after data to determine whether the modified protocol can remove more uremic toxins.


Eligibility criteria: Inclusion Criteria:

Maintenance Hemodialysis Patients with Uremia receive regular HA+HD treatment

Exclusion Criteria:

Plasma albumin \<30g/L, severe malnutrition or cachectic state; platelet count \<40×10\^9/L or \>300×10\^9/L; hypercoagulable state allergy to the hemoperfusion device; new cardiovascular or cerebrovascular diseases; poor vascular access function, extracorporeal circulation blood flow unable to reach 250ml/min ultrafiltration volume \>4500ml in a single dialysis session use of non-heparin anticoagulants inability to comply with the procedures of this study other conditions deemed unsuitable for participation in this study by the investigator

-

Primary outcomes:
measure: protein-bound toxins
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Nephrology Department of Beijing Jishuitan Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03399825: Optical Coherence Tomography Angiography (OCT-A) in Children (≥ 6 <14 Years of Age)
Official title: Investigation of Vascular Pathology in Eye Diseases Using Optical Coherence Tomography Angiography (OCT-A) in Children (≥ 6 <14 Years of Age)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Retinopathy of Prematurity
Diabetic Retinopathy
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2018-01-16
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a history of clinically diagnosed retinal diseases and healthy individuals undergoing ophthalmic Imaging in Routine clinical practice will be included

Brief summary: Comparison of OCTA to conventional imaging modalities for the diagnosis of eye diseases in children

Detailed description: Optical coherence tomography angiography (OCTA) is a new non-invasive imaging technique that employs motion contrast imaging to high-resolution volumetric blood flow information. OCTA compares the decorrelation signal between sequential OCT b-scans taken at precisely the same cross-section in order to construct a map of blood flow. At present, level 1 evidence of the technology's clinical applications doesn't exist. The investigators plan to compare OCTA as an imaging modality to conventional imaging modalities used in clinical routine.

Eligibility criteria: Inclusion Criteria:

* Patients (children ≥ 6 \<14 years of age) from the Childrens Hospital, University Hospital Bern requiring routine internal medical check-up for the diagnosis of diabetes or children attending routine eye exams at the department of ophthalmology, who are willing to participate in the study, and whos parents are willing to sign informed consent on behalf of their child.
* Patients need to be at least 6 years of age (but younger than 14 years) 6 years of age or younger

Exclusion Criteria:

* Patients (children) who are not willing or able to participate, or potential participant's parents who are not willing to sign informed consent on behalf of their child.
* Patients younger than 6 years of age or 14 years or older.
* Patients (children) with epilepsy

Primary outcomes:
measure: Evaluation of the sensitivity and specificity of OCTA
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: