louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03868592: Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis
Official title: Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obesity, Morbid
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Study insulin action and adipose function before and after weight loss from gastric sleeve surgery
Primary purpose: BASIC_SCIENCE

Brief summary: It is not known how much improvement in insulin regulated lipolysis (the breakdown of triglycerides) occurs following substantial, sustained weight loss. Researchers will test the effects of inflammation and lipolysis regulation in people before and after bariatric surgery (sleeve gastrectomy) to answer these questions.

Detailed description: The purpose of this study is to determine whether the adipose inflammatory cell and cytokine content in Class III obesity is related to lipolysis insulin resistance and, if so, whether sustained, substantial weight loss one year following bariatric surgery reduces inflammation in parallel with improved insulin regulation of lipolysis

Eligibility criteria: Inclusion Criteria:

* BMI 40 - 50 kg/m2.
* Mo active physical illness that would interfere with mobility or weight loss after bariatric surgery

Exclusion Criteria:

* Type 1 or Type 2 Diabetes diagnosis or fasting plasma glucose ≥126 mg/dL
* Active coronary artery disease
* Participation in structured exercise (\>2 times per week for 30 minutes or longer)
* Smoking
* Medications known to affect adipose tissue metabolism (e.g., beta blockers, corticosteroids)
* Renal insufficiency (serum creatinine \> 1.5mg/dl)
* Chronic active liver disease (Bilirubin \> 17mmol/L, AST \> 144 IU/L, or ALT\>165IU/L)
* Pregnancy or breastfeeding.

Primary outcomes:
measure: adipose macrophage content, adipose IL-6 and TNF gene expression
timeFrame: Before bariatric surgery and approximately 1 year after surgery
measure: insulin regulation of lipolysis (IC50)
timeFrame: Before bariatric surgery and approximately 1 year after surgery
Secondary outcomes:
measure: adipocyte perilipin 1 and HSL and ATGL
timeFrame: Before bariatric surgery and approximately 1 year after surgery
Other outcomes:
measure: Long-term, substantial weight loss and insulin regulation of lipolysis
timeFrame: 1 year
measure: Long-term, substantial weight loss and insulin regulation of lipolysis
timeFrame: 1 year
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael D Jensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01992692: Remifentanil Requirement in Patients Receiving Surgical Treatment of Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
remifentanil
deep brain stimulator
cardiovascular response
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement, as well as non-Parkinsonian patients undergoing intracranial surgery

Brief summary: Parkinson's disease (PD) is one the main neurodegenerative disease with an incidence of about 3% in patients older than 65 years. Anesthesia in PD patients has been focused by several studies for concerning the interactive reaction between anesthetics and anti-Parkinsonian medication or Parkinsonian symptoms. However, our previous experience showed that the patients undergoing pulse generator placement were more prone to be involved in delayed emergence in the recovery room, which had been not reported yet. We speculated that PD patients might be a special population with abnormal pharmacodynamic characters of anesthetics, though no related evidence could be found to support this hypothesis. Therefore, in this project we investigated whether remifentanl requirement to inhibit patients' response to trachea intubation and skin insertion in PD patients undergoing DBS and pulse generator placement was different from non-PD patients undergoing intracranial surgery for reasons other than PD.


Eligibility criteria: Inclusion Criteria:

* Adult Parkinsonian patients undergoing deep brain stimulator insertion and pulse generator placement
* Adult non-Parkinsonian patients undergoing intracranial surgery

Exclusion Criteria:

* ASA score higher than Class II
* predicted difficult airway
* alcohol or drug abuser
* informed consent was not provided

Primary outcomes:
measure: Concentrations required to inhibit response to trachea intubation and skin incision
timeFrame: Anesthesia induction to 5min after skin incision
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Anesthesiology, Changhai Hospital
state: Shanghai
Study officials:
References:
citation: Wang JF, Xu XP, Yu XY, Li JB, Wu X, Chen JC, Hu XW, Deng XM. Remifentanil Requirement for Inhibiting Responses to Tracheal Intubation and Skin Incision Is Reduced in Patients With Parkinson's Disease Undergoing Deep Brain Stimulator Implantation. J Neurosurg Anesthesiol. 2016 Oct;28(4):303-8. doi: 10.1097/ANA.0000000000000229.
Clinical trial NCT05041192: The Effects of Synaquell on Brain Function
Official title: The Effect of Synaquell on Objective Brain Function Measures in Ice Hockey Players
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Ice Hockey
Cognitive Function
Cognition
Brain
Supplement
Contact Sport Athletes
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: HealthTech Connex Inc.
name: Thorne HealthTech, Inc
First posted: 2021-09-10
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate the dietary supplement, Synaquell (TM), for effects on brain function.

Detailed description: Ice Hockey players will be administered Synaquell over the course of one season. Each player will be administered Synaquell or a placebo twice, daily. They will be tested during the preseason and the postseason to compare changes in cognitive measures. This is an optimal population, as Synaquell was designed for contact sport athletes and others sustaining frequent head impacts.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or greater.
* Fluent English speakers.
* Medically cleared to play ice hockey.

Exclusion Criteria:

* An allergy to the ingredients of Synaquell or Synaquell+ (Magnesium, beta hydroxybutyrate, Glutathione, N-acetyl-L-cysteine, Riboflavin, Magnesium, Leucine, Isoleucine, Valine, Resveratrol, Curcumin Phytosome, Nicotinamide riboside, Docosahexanoic Acid).
* Clinically documented hearing issues.
* In-ear hearing aid or cochlear implant.
* Implanted pacemaker or defibrillator.
* Metal or plastic implants in skull.
* Lack of verbal fluency in the English language.
* History of seizures.
* Allergy to rubbing alcohol or EEG gel.
* Unhealthy scalp.

Primary outcomes:
measure: Change in brain vital signs
timeFrame: Baseline, Postseason (approximately 6 months)
measure: Change in blood biomarker
timeFrame: Baseline, Postseason (approximately 6 months)
Secondary outcomes:
measure: Change in King-Devick Test (KDT) scores
timeFrame: Baseline, Postseason (approximately 6 months)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael J Stuart, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04012892: Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma
Official title: Study Evaluating the Efficacy and Safety With CD19CAR-T for Relapsed or Refractory Non-Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Relapsed Non-Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Shenzhen University
name: Shenzhen University General Hospital
First posted: 2019-07-09
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a single-arm, open label, phase I clinical trial to evaluate the safety and feasibility of CD19CAR-T in treatment of relapsed / refractory non-hodgkin lymphoma


Eligibility criteria: Inclusion Criteria:

1. Diagnosis with Relapsed or refractory Non Hodgkin Lymphoma with CD19 positive
2. Age 18 to 65 years old, both male and female;
3. Is expected to survive more than 12 weeks;
4. Physical condition is good: 0-1 score ECOG score;
5. No obvious abnormal heart, liver, kidney, no large wounds that haven't healed on the body;
6. Into groups to participate in voluntarily, good adherence, can cooperate test observation, childbearing age women must be 7 days before starting treatment expert pregnancy test and the results were negative, and signed a written informed consent form.

Exclusion Criteria:

1. Organ failure, such as heart: Class III and IV; liver: to Child grading of liver function grade C; kidney: kidney failure and uremia stage; lung: symptoms of severe respiratory failure; brain: disorder of consciousness;
2. Existing serious acute infection, uncontrollable, or have fester sex and chronic infection, wound in delay no more;
3. Pregnancy and lactation women;
4. Patients who have participated in other clinical trials or other clinical trials in the past 30 days;
5. The Investigator believe the patients should not participate in this experiment.

Primary outcomes:
measure: recovery rate of patients being treated with CD19CAR-T
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen University General Hospital
Study officials:
References:
Clinical trial NCT01789892: Methylprednisolone Before Fludeoxyglucose-Labeled Positron Emission Tomography in Patients With Lung Cancer
Official title: FDG PET/CT: Reducing False Positive Mediastinal Uptake by Premedicating With Methylprednisolone
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-02-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine whether giving an anti-inflammatory medication (corticosteroid) prior to a positron emission tomography scan (PET) scan may reduce or eliminate false findings related to inflammation

Detailed description: PRIMARY OBJECTIVES:

I. To assess whether premedication with a corticosteroid may reduce false positive findings on fluorodeoxyglucose (fludeoxyglucose F 18 \[FDG\[) PET/computed tomography (CT) scans in lung cancer patients, by reducing radiotracer uptake in thoracic lymph nodes related to inflammation.

OUTLINE:

Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone intravenously (IV) and then undergo a second FDG PET/CT scan.

After completion of study treatment, patients are followed up for 2 years.

Eligibility criteria: Inclusion Criteria:

* Patient undergoing initial staging of biopsy proven lung cancer (all cancer stages included)
* Undergone clinical FDG PET/CT scan within 14 days of enrollment

Exclusion Criteria:

* Prisoners
* Diabetic patients (on insulin, on oral hypoglycemic, or fasting glucose \> 180 mg/dl)
* Serious infection within 14 days of enrollment
* Known hypersensitivity to methylprednisolone
* Viral skin lesions
* Immunocompromised ANC(absolute neutrophil count \< 1000/microliter)
* Pregnant/nursing
* History of tuberculosis or systemic fungal disease
* History of steroid psychosis
* Current peptic ulcer disease or diverticulitis
* Corticosteroid use within 14 days of enrollment (including inhaled steroids)

Primary outcomes:
measure: Continuous standardized uptake values (SUV)
timeFrame: Within 1-14 days of first scan
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: David Barker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02875392: Fucoidan Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Official title: Fucoidan Improves the Metabolic Profiles of Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease
Lead sponsor: Taipei Medical University WanFang Hospital
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 57
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Studies reveal special function of fucoidan so far include anti-virus, anti-tumor, immunomodulatory, anti-inflammatory, blood fat, anti-oxidation and liver and kidney dysfunction and improve fibrosis. The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.

Detailed description: Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness. The strongest fucoidan among all seaweed for inhibiting cancer cells is in Okinawa Japanese waters. For chemically speaking, the major components for fucoidan consisted of mainly fucose which is a kind of polysaccharide with strong biological activity. However, patients need to take actual fucoidan in order to reach the best effectiveness for inhibiting cancer cell.

Studies reveal special function of fucoidan so far include anti-virus, anti-tumor, immunomodulatory, anti-inflammatory, blood fat, anti-oxidation and liver and kidney dysfunction and improve fibrosis. The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.

Eligibility criteria: Inclusion Criteria:

* Patients who are aged between 20-75 with non alcoholic fatty liver disease (NAFLD).

Exclusion Criteria:

1. Patients were allergic to seafood.
2. Patients who take Vitamin E or Pioglitazone.

Primary outcomes:
measure: Change in ALT Index
timeFrame: 6 months
measure: Change in AST Index
timeFrame: 6 months
measure: Change in HbA1c
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: WanFangH
Study officials:
affiliation: Wanfang Hospital
name: Ming-Shung Wu, Doctor
role: STUDY_DIRECTOR
References:
citation: Yang M, Xuan Z, Wang Q, Yan S, Zhou D, Naman CB, Zhang J, He S, Yan X, Cui W. Fucoxanthin has potential for therapeutic efficacy in neurodegenerative disorders by acting on multiple targets. Nutr Neurosci. 2022 Oct;25(10):2167-2180. doi: 10.1080/1028415X.2021.1926140. Epub 2021 May 15.
Clinical trial NCT03392792: Regisry of the Stroke Patients in Assiut University Hospital
Official title: Regisry of the Stroke Patients in Assiut University Hospital
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: All Patients With Ischemic Cerebrovascular Stroke Aged ≥18 Years of Both Sex
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: • Aim of the work To register all type of acute stroke admitted in Assiut university Hospital and assessment of their risk factor, morbidity and Mortality


Eligibility criteria: Inclusion Criteria:

* All patients with stroke aged ≥18 years of both sex
* Written consent was taken for all patient either from the patient himself of closes relative after explaning to them the type of treatment benefits and possible risks

Exclusion Criteria:

* Stroke due to metabolic causes as hypoglycemia liver, Renal failure and other metabolic causes
* Stroke due to Brain tumors

Primary outcomes:
measure: Registry of the stroke Patients in Assist University Hospital
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06321692: Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications
Official title: Early Identification of Cardiac Involvement in Patients With Carcinoid: Clinical and Prognostic Implications
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuroendocrine Tumors
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-03-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is for patients with neuroendocrine tumours (NET) with or without carcinoid syndrome followed by NET Unit of European Institute of Oncology.

The objective of the trial is to evaluate biochemical markers of myocardial injury (high-sensitive troponins), haemodyinamic markers (pro-brain natriuretic peptide (BNP), N-terminal (NT)-BNP (NT-proBNP)), and markers of fibrosis (Suppression of Tumorigenicity 2 (ST2) in patients with neuroendocrine tumours (NET) with or without carcinoid syndrome.

Detailed description: The main aim of this study is to evaluate blood levels of biomarkers of cardiac damage (ultra-sensitive troponin I), hemodynamic impairment (BNP, NT-proBNP), and cardiac fibrosis (ST2) in patients with diagnosed neuroendocrine tumours (NET) with or without carcinoid syndrome The secondary objective is to correlate the levels of the above markers with the presence/entity of cardiac involvement and its progression over time.

All patients will undergo:

* a baseline assessment including:

  * blood sampling for US-Troponin I, BNP, NT-proBNP, ST2
  * cardiological evaluation including ECG and echocardiogram
* a three-monthly revaluation of these markers
* a six monthly cardiological reassessment with a echocardiogram

Eligibility criteria: Inclusion Criteria:

* patients diagnosed with metastatic NET with or without carcinoid referred to the Unit of Neuroendocrine Tumors of European Institute of Oncology

Exclusion Criteria:

* age \<18 years
* patients diagnosed with heart disease prior to diagnosis of NET

Primary outcomes:
measure: blood levels of biomarkers of cardiac damage
timeFrame: 3 months
measure: blood levels of biomarkers of hemodynamic impairment
timeFrame: 3 months
measure: blood levels of biomarkers of cardiac fibrosis
timeFrame: 3 months
Secondary outcomes:
measure: Correlation between the levels of the biomarkers and the presence/entity of cardiac involvement
timeFrame: 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Daniela Cardinale, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01353092: Pulsating ElectroMagnetive Treatment (PEMF) at Treatment Resistant Depression
Official title: PEMF Treatment in Patients With Treatment Resistant Depression in On-going Antidepressant Drug Therapy. A Randomized, Double-blind, Clinically Controlled, Dose-response PEMF Trial for a Duration of Eight Weeks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Treatment Resistant Depression
Keywords: Randomized Controlled Trial
Major depression
Hamilton
PEMF
Lead sponsor: Hillerod Hospital, Denmark
Sponsor class: OTHER
First posted: 2011-05-12
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study patients with treatment resistant depression, as defined by Harold Sackeim, is subjected to daily sessions, for eight weeks, with Pulsating ElectroMagnetive Treatment (PEMF). Treatment is given two times a day, in the morning and in the afternoon. Patients are randomized into two groups. In group A patients receive active treatment both morning and afternoon. In group B patients receive one sham and one active treatment. The study is double-blind as neither the assessors or patients are aware of treatment allocation. Each session lasts 30 minutes. Patients are psychometrically assessed weekly for depression severity and side effect. After this intervention period patients are followed for further three weeks without PEMF treatment. Patients are on unchanged medication for the whole of the study period.


Eligibility criteria: Inclusion Criteria:

* Treatment resistant Major depression (grade 3 Sackeim criteria)
* Age above 18 and below 85
* Hamilton (17 item version) score above 12
* Unchanged psychopharmacological treatment for last five weeks.

Exclusion Criteria:

* suicidality above 2 on item three on Hamilton scale or,earlier PEMF treatment
* dementia or similar cognitive impairment
* psychotic disorder
* abuse of alcohol or drugs
* pregnant or lactating women
* insufficient birth control measures

Primary outcomes:
measure: Hamilton depression rating scale
timeFrame: Every week for 11 weeks
Secondary outcomes:
measure: UKU
timeFrame: Every week for 11 weeks
Other outcomes:
Locations:
city: Hilleroed
country: Denmark
facility: Psychiatric Research Unit, Mental Health Centre North Zealand
Study officials:
affiliation: Mental Health Centre North Zealand Psychiatric Research Unit
name: Marianne Lunde, Coordinator
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martiny K, Lunde M, Bech P. Transcranial low voltage pulsed electromagnetic fields in patients with treatment-resistant depression. Biol Psychiatry. 2010 Jul 15;68(2):163-9. doi: 10.1016/j.biopsych.2010.02.017. Epub 2010 Apr 10.
citation: Bech P, Timmerby N, Martiny K, Lunde M, Soendergaard S. Psychometric evaluation of the Major Depression Inventory (MDI) as depression severity scale using the LEAD (Longitudinal Expert Assessment of All Data) as index of validity. BMC Psychiatry. 2015 Aug 5;15:190. doi: 10.1186/s12888-015-0529-3.