louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05962385: State Dependence of Prefrontal Transcranial Magnetic Stimulation
Official title: State Dependence of Prefrontal Transcranial Magnetic Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Healthy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Repeated measures design - across two separate sessions (one week apart, counterbalanced between participants), participants will receive transcranial magnetic stimulation (TMS) whilst engaging in either a cognitive control or a perceptual task.
Primary purpose: BASIC_SCIENCE

Brief summary: The study will examine whether the benefits of brain stimulation on mental functioning can be enhanced if an individual is actively engaging the target brain networks while receiving brain stimulation. The study includes two separate sessions and people will complete either a cognitive task or a perceptual task while receiving transcranial magnetic stimulation. The study will measure change in brain function with EEG.


Eligibility criteria: Inclusion Criteria:

* Age 18 - 65,
* healthy controls

Exclusion Criteria:

* Diagnosed psychiatric disorder
* Potential contraindications to EEG (e.g. visible scalp abrasions, non-removable hair extensions and/or hair styling that would impede proper EEG recording)
* Potential contraindication to TMS (as identified by the TMS safety screener)
* Any previous adverse reaction to TMS or MRI
* Diagnosed epilepsy or previously experienced a seizure
* Diagnosed neurological condition, such as stroke or tinnitus
* Experienced a head trauma that was diagnosed as concussion
* Current use of, or recent withdrawal from, medications that can increase the risk of seizure
* Currently pregnant
* Any metal in the head (excluding mouth)
* Any implanted medical device

Primary outcomes:
measure: Theta-gamma cross frequency coupling
timeFrame: 0-500 ms after each TMS stimulus
measure: Cortical excitability
timeFrame: 60-300 ms after each TMS stimulus
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Alik Widge
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02686385: Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury
Official title: Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Drug Induced Liver Injury
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2016-02-19
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Intervention - Subjects will be randomized to 2 groups

Group A - subjects will receive Prednisolone for 20 days with NAC (N-Acetylcysteine)

Group B - will receive NAC (N-Acetylcysteine) only NAC (N-acetylcysteine) dosing

Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 hour

Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h

Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h

* Monitoring and assessment-Liver Biopsy at baseline and at 3 months, Liver Function Test at regular intervals.
* Stopping rule-Development of sepsis, worsening of Liver functions.


Eligibility criteria: Inclusion Criteria:

* All patients with severe DILI (Drug Induced Liver Injury)
* Age more than or equal to 18 years

Exclusion Criteria:

* Patients with HAV (Hepatitis A Virus), HBV (Hepatitis B Virus), HCV (Hepatitis C Virus), HEV (Hepatitis E Virus) Positive
* Patients with sepsis
* AMA positive
* Low Ceruloplasmin
* Transferrin saturation \>45%
* Patients with Cirrhosis
* Patients with h/o jaundice prior to the intake of drug

Primary outcomes:
measure: Proportion of patients with normalization of LFT (Liver Function Test) in both groups.
timeFrame: 20 days
Secondary outcomes:
measure: Improvement in of Histology.
timeFrame: 20 days
measure: Improvement in CBC profile
timeFrame: 20 days
measure: Improvement in coagulation profile
timeFrame: 20 days
measure: Improvement in KFT profile
timeFrame: 20 days
measure: Proportion of patients develop adverse effects in both groups.
timeFrame: 20 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Anand Kulkarni V, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05746585: The TALK for Black Male Adolescent Sexual Health
Official title: The TALK; A Novel Nurse-led, Family-based Web-based Application Marketed in Barbershops and Beauty Salons for Black Fathers and Mothers to Promote Sexual Health Among Black Male Adolescents and Young Adults in the United States
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexuality Education
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 118
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to construct the first nurse-led web-based intervention, The TALK, a parent-centered, adolescent-involved health promotion intervention for Black male adolescents and young adults (AYA). Through the use of entertainment videos and educational modules, investigators will provide parents with resources and tools for communicating with their adolescents about sexual health and experiences of racial discrimination, and how these experiences impact sexual health.


Eligibility criteria: Inclusion Criteria:

Self-identified as a parent, parent figure, or caregiver of a Black or African American male adolescent between the ages of 13-17 years, able to speak and read English. Adolescents of these parents will also be recruited along with their parents. Adolescents recruited will be required to sign additional consent forms.

Exclusion Criteria:

-

Primary outcomes:
measure: Usability
timeFrame: 6 months
measure: Acceptability
timeFrame: 6 months
measure: Communication Frequency
timeFrame: 6 months
measure: Communication Quality
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Schenita Randolph, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03773185: A Comparative Study of Brain Structure and Amyloid Load in MCI Patients
Official title: A Comparative Study of Brain Structure and Amyloid Load Between Cognitively Impaired Older People With or Without Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Mild Cognitive Impairment
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: MCI patients with DM or without DM

Brief summary: Older people with DM are at greater risk of cognitive decline than their counterparts with DM. Cognitive impairment in older people with DM may be associated with non-AD related brain atrophy and white matter disease. The investigators therefore propose to compare DM and non-DM older people with amnesic MCI in brian volumes, white matter disease and amyloid load.

30 older people with aMCI, 30 older people with aMCI and DM, age 65-85 will be recruited. They all will have amyloid PET scan and MRI brain scan.


Eligibility criteria: Inclusion Criteria:

* MCI patients

Exclusion Criteria:

* Patients with depression

Primary outcomes:
measure: Amyloid load
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Timothy Kwok, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06581185: Pseudotumor Cerebri Headache Ten Years Outcome
Official title: Headache Long Term Follow-up in Patients Who Suffered From PTCS During Their Childhood
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Pseudotumor Cerebri
Keywords: Headache
outcome
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2024-09-03
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults who were diagnosed with Ptc at their childhood .

Brief summary: Telephone interview on patient who suffered from PTC ten years ago regarding their headache status

Detailed description: The study will followup using existing medical data from patients previously diagnosed with Pseudotumor cerebri (PTC) using a telephone contact with patients diagnosed more than 10 years ago. After obtaining verbal consent, conducted interviews to collect information on their headaches and quality of life. Data related to PTC was be obtained from medical records. Demographic information was be collected using a questionnaire, the HIT-6 questionnaire will assess headache severity, and a quality of life questionnaire was be used.

Eligibility criteria: Inclusion Criteria:

Patients who were diagnosed with PTC as children

-

Exclusion Criteria:

Patients has other headache types other than PTC

-

Primary outcomes:
measure: headache outcome HIT-6
timeFrame: 5-10 years
Secondary outcomes:
measure: Quality of life (QOL)
timeFrame: 5-10 years
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bani Zion
Study officials:
affiliation: Bnai Zion Medical Center
name: jacob Genizi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith JL. Whence pseudotumor cerebri? J Clin Neuroophthalmol. 1985 Mar;5(1):55-6. No abstract available.
citation: Kesler A, Bassan H. Pseudotumor cerebri - idiopathic intracranial hypertension in the pediatric population. Pediatr Endocrinol Rev. 2006 Jun;3(4):387-92.
citation: Buchheit WA, Burton C, Haag B, Shaw D. Papilledema and idiopathic intracranial hypertension. N Engl J Med. 1969 Apr 24;280(17):938-42. doi: 10.1056/NEJM196904242801707. No abstract available.
citation: Friedman DI, Jacobson DM. Diagnostic criteria for idiopathic intracranial hypertension. Neurology. 2002 Nov 26;59(10):1492-5. doi: 10.1212/01.wnl.0000029570.69134.1b.
citation: Baker RS, Baumann RJ, Buncic JR. Idiopathic intracranial hypertension (pseudotumor cerebri) in pediatric patients. Pediatr Neurol. 1989 Jan-Feb;5(1):5-11. doi: 10.1016/0887-8994(89)90002-7.
citation: Couch R, Camfield PR, Tibbles JA. The changing picture of pseudotumor cerebri in children. Can J Neurol Sci. 1985 Feb;12(1):48-50. doi: 10.1017/s0317167100046588.
citation: Dhiravibulya K, Ouvrier R, Johnston I, Procopis P, Antony J. Benign intracranial hypertension in childhood: a review of 23 patients. J Paediatr Child Health. 1991 Oct;27(5):304-7. doi: 10.1111/j.1440-1754.1991.tb02544.x.
Clinical trial NCT06159985: Effect of Left Posterior Pericardiotomy for the Prevention of POAF
Official title: Effect of Left Posterior Pericardiotomy for the Prevention of Postoperative Atrial Fibrillation in Coronary Artery Bypass Grafting: A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Atrial Fibrillation New Onset
Pericardial Effusion
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 270
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is planned to evaluate the effect of left posterior pericardiotomy for the prevention of postoperative atrial fibrillation after coronary artery bypass grafting. Eligible patients will be randomized to be created or not to be created the left posterior pericardiotomy at the end of the operation, and the incidence of postoperative atrial fibrillation will be compared.

Detailed description: Postoperative atrial fibrillation (POAF) is a common complication after cardiac surgery, particularly after coronary artery bypass grafting (CABG), and is associated with prolonged in-hospital stay and increased adverse outcomes, including death and stroke. There is evidence that pericardial effusion can trigger the occurence of POAF. Therefore, this study is aimed to evaluate the effect of left posterior pericardiotomy for the prevention of POAF after CABG.

Patients who are planned to undergo off-pump CABG will be randomized to be created or not to be created the left posterior pericardiotomy at the end of the operation, and the incidence of postoperative atrial fibrillation will be compared as the primary outcome. Secondary outcomes will include early clinical outcomes and hospital stay.

Eligibility criteria: Inclusion Criteria:

* patients who are planned to undergo coronary artery bypass grafting
* patients aged ≥19 years

Exclusion Criteria:

* patients who are planned to undergo other concomitant cardiac procedures (e.g. valve procedures, aorta procedures)
* patients who undergo coronary artery bypass grafting using cardiopulmonary bypass
* patients who are documented with paroxysmal, persistent, or permanent atrial fibrillation before operation
* patients who have a history of cardiac surgery
* patients who have a history of pericardial disease
* patients who have severe adhesion at left pleural cavity which precludes effective left posterior pericardiostomy
* patients who refuse to participate in this study

Primary outcomes:
measure: occurence rate of postoperative atrial fibrillation
timeFrame: From date of operation until postoperative day 7
Secondary outcomes:
measure: operative mortality
timeFrame: at 30 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT05933785: the Value of Transanal Endoscopic ISR
Official title: The Value of Transanal Endoscopic Intersphincteric Resection (taE-ISR) in Extreme Anal Preservation in Ultra-low Rectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Cancer
Lead sponsor: Shanghai Minimally Invasive Surgery Center
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patient with low and ultra-low rectal cancer

Brief summary: The Intersphincteric resection (ISR) technique is an alternative for anal preservation in ultra-low rectal cancer. The transanal total mesorectal excision (TaTME) technique might compensate for the deficiencies of ISR in terms of tumor spillage and poor surgical field exposure. Thus, the investigators perform ISR through a transanal endoscopic approach (taE-ISR), seeking to evaluate the value of this innovative technique in anal preservation in ultra-low rectal cancer.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 75 years
* American Society of Anesthesiologists (ASA) score I to III
* A biopsy proven histological diagnosis of rectal carcinoma
* preoperative stage as (y) cT1-3N0-2M0
* lower margin of the tumor less than 5cm from the anus
* tumor diameter ≤5cm

Exclusion Criteria:

* Pregnant or lactating women
* Synchronous rectal carcinoma
* History of colorectal cancer or other malignant tumors
* Clinical evidence of metastasis
* Emergency procedure

Primary outcomes:
measure: anal preservation rate
timeFrame: 1 year after sugery
Secondary outcomes:
measure: incidence of Defecation disorders
timeFrame: 6 months after surgery
measure: incidence of positive distal resection margin
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
city: Shanghai
country: China
facility: Shanghai Minimally Invasive Surgery Center
Study officials:
References:
Clinical trial NCT01114685: A Comparison of Changes in Bone Density With the Same Bone-health Plan, But With Different Bone-health Supplements
Official title: Bone Mineral Density (BMD) Changes in a Bone Health Plan Using Two Versions of a Bone Health Supplement: A Comparative Effectiveness Research (CER) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteopenia
Lead sponsor: Integrative Health Technologies, Inc.
Sponsor class: NETWORK
Collaborators: name: AlgaeCal Inc.
First posted: 2010-05-03
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A comparison of changes in bone density following the same bone-health plan, but with a different bone-health supplement.

Detailed description: The US Surgeon General's Report on Bone Health suggests America's bone-health is in jeopardy and issued a "call to action" to develop bone-health plans that:

1. improve nutrition,
2. increase health literacy and,
3. increase physical activity.

The purpose of this study was to use a comparative effective research model to compare 6-month changes in bone mineral density (BMD)in two study groups. Both followed the same bone health plan that contained the three components listed above with the same plant-source calcium supplement, but enhanced with different levels of calcium, vitamin D3, vitamin K and magnesium.

Eligibility criteria: Inclusion Criteria:

* All subjects were required to contact the physicians to ensure they had no medical issues that would preclude their participation.

Exclusion Criteria:

* Younger the 18 years of age, and
* Recommendations not to participate from their physicians.

Primary outcomes:
measure: Changes in Bone Mineral Density (BMD)
timeFrame: baseline and 6 months
Secondary outcomes:
measure: A comparison of changes from baseline in 43-blood chemistry panel and a self-reported quality of life inventory in both study groups
timeFrame: six months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Integrative Health Technologies
state: Texas
Study officials:
affiliation: Integrative Health Technologies
name: Gilbert R Kaats, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgetown University
name: Harry G Preuss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Michalek JE, Preuss HG, Croft HA, Keith PL, Keith SC, Dapilmoto M, Perricone NV, Leckie RB, Kaats GR. Changes in total body bone mineral density following a common bone health plan with two versions of a unique bone health supplement: a comparative effectiveness research study. Nutr J. 2011 Apr 14;10:32. doi: 10.1186/1475-2891-10-32.
Clinical trial NCT06729385: Blood Proteome Profiling Identifies Biomarkers in Ischemic Stroke
Official title: The Blood Proteome Profiling Identifies Biomarkers Associated with Prognosis in Ischemic Stroke Due to Large Artery Atherosclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Capital Medical University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with large artery atherosclerotic ischemic stroke, presenting 7 to 30 days after onset, and who have not received reperfusion therapy.

Brief summary: Endovascular thrombectomy and intravenous thrombolysis have become key therapeutic approaches for acute ischemic stroke. However, due to time window limitations, many patients are unable to receive reperfusion therapy, and the majority only receive supportive treatment. Ischemic stroke-related complications, including edema and infection, gradually subside after 7 days post-stroke, with the patient's condition generally stabilizing. Endogenous repair mechanisms will play a critical role in the coming months. This study aims to predict prognostic biomarkers for ischemic stroke patients who have not undergone reperfusion therapy, using blood proteomics data. All samples in our study are derived from this experiment. Our goal is to elucidate the molecular mechanisms underlying post-reperfusion prognosis and to provide insights for optimizing stroke treatment strategies.


Eligibility criteria: Inclusion Criteria:

* Age ≥18.
* Clinical signs consistent with acute ischemic stroke (TOAST classification: large artery atherosclerosis)
* 7 to 30 days from symptom onset.

Exclusion Criteria:

* Severe infection or multiple organ failure.
* Untreated moderate or severe coronary artery stenosis, or a history of coronary artery bypass surgery.
* Ongoing hemodialysis or peritoneal dialysis, or severe renal insufficiency characterized by a glomerular filtration rate (GFR) of less than 30 ml/min or serum creatinine levels exceeding 220 mmol/L (2.5 mg/dl).
* Known intracranial aneurysm or cerebral arteriovenous malformation.
* Malignant brain tumor or central nervous system (CNS) infection.
* Pre-existing neurological or psychiatric conditions that could confound the neurological or functional assessments.
* Baseline platelet count \<50 × 109/L.
* Pregnancy or lactation at the time of admission.

Primary outcomes:
measure: Primary Outcome Measures:
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital
state: Beijing
city: Chongqing
country: China
facility: People's hospital of Xiushan Country
state: Chongqing
city: Nanyang
country: China
facility: Nanyang Nanshi Hospital
state: Henan
city: Changsha
country: China
facility: Liuyang Jili Hospital, Hunan, China
state: Hunan
Study officials:
References: