louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00874276: Pharmacotoxicology of Trichloroethylene Metabolites
Official title: Pharmacotoxicology of Trichloroethylene Metabolites
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Lactic Acidosis
Keywords: DCA
Dichloroacetate
Trichloroacetate
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: To establish the relationship between human MAAI haplotype and DCA and tyrosine metabolism. This aim test the postulates that MAAI haplotype determines, and thus can predict,1) dose-dependent DCA kinetics and biotransformation.

Detailed description: The arms of the study involves determining the haplotype of individuals enrolled. Then participants were divided into two groups based on their genotype. The groups include a genotype with an EGT alle and a group of genotype without an EGT alle. All subjects first took a low dose of DCA 2.5ug/kg for 5 days then wait 30 days and take a therapeutic dose of DCA 25mg/kg for 5 days On the first day and on the 5th day of taking DCA kinetics were be done. A total of 16 blood samples were obtained through an intravenous catheter. Urine collection will also occur.

Population pharmacogenetic analysis of MAI allelic frequencies and the GC or LC-MS/MS techniques for blood or urinary metabolites were used in this investigation. Pharmacokinetic data was used to determine metabolism rate of DCA for each allele

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Pregnancy
* Other medications
* Psychiatric illness on meds
* Abnormal labs

Primary outcomes:
measure: Hypothesize That Subject's Genotype Will Determine How DCA is Metabolized.
timeFrame: 24 hours for analysis on Day 5, Clinical dose
Secondary outcomes:
measure: Terminal Half-life (the Amount of Time Needed to Clear One-half of the Dose of Drug)for Environmental Dose 2.5 ug/kg/Day.
timeFrame: 24 hours for analysis on Day 5, Environmental dose
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Shands Hospital
state: Florida
Study officials:
affiliation: University of Florida
name: Peter W Stacpoole, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00113776: Evaluating ABX-EGF Extended Therapy in Subjects With MetastaticColorectal Cancer
Official title: A Multicenter, Open-label, Single Arm Clinical Trial to Determine the Safety of ABX-EGF Extended Therapy in Subjects With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: Metastatic Colorectal Cancer, Colon
Colorectal, Rectal Cancer, EGFr
Metastatic, Cancer, ABX-EGF
Panitumumab, Clinical Trial
Immunex, Abgenix, Amgen
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2005-06-13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the safety of ABX-EGF administered as monotherapy in subjects with metastatic colorectal cancer who were previously randomized to best supportive care (BSC) in protocol 20020408 and subsequently determined to have progressive disease.


Eligibility criteria: Inclusion Criteria: - Subject previously randomized to BSC in protocol 20020408 and subsequently determined to have progressive disease - ECOG performance status of 0, 1 or 2 - Adequate hematologic, renal and hepatic function Exclusion Criteria: - Myocardial infarction in time interval between completing 20020408 and enrollment in study - History or evidence of interstitial pneumonitis or pulmonary fibrosis - Prior anti-tumor therapies including prior experimental agents or approved anti-tumor small molecules and biologics during the time interval between completing 20020408 protocol and enrollment in this study - Use of systemic chemotherapy or radiotherapy during the time interval between completing 20020408 protocol and enrollment in this study

Primary outcomes:
measure: Incidence of Adverse events
measure: Changes in Lab values
measure: Incidence of HAHA formation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Van Cutsem E, Siena S, Humblet Y, Canon JL, Maurel J, Bajetta E, Neyns B, Kotasek D, Santoro A, Scheithauer W, Spadafora S, Amado RG, Hogan N, Peeters M. An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy. Ann Oncol. 2008 Jan;19(1):92-8. doi: 10.1093/annonc/mdm399. Epub 2007 Sep 4.
citation: Amado RG, Wolf M, Peeters M, Van Cutsem E, Siena S, Freeman DJ, Juan T, Sikorski R, Suggs S, Radinsky R, Patterson SD, Chang DD. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol. 2008 Apr 1;26(10):1626-34. doi: 10.1200/JCO.2007.14.7116. Epub 2008 Mar 3.
Clinical trial NCT03866876: Eucapnic pH Compared With Arterial pH and Base Deficit
Official title: Umbilical Cord Arterial Eucapnic pH Compared With Arterial pH and Base Deficit as Predictor of Severe Adverse Outcomes Among Term Neonates
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurologic Complication
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 36435
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All birth more than 37 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant from 1st of january 2000 to 31 december 2016

Brief summary: Neonatal asphyxia per partum can be complicated by severe neurologic sequelae and can lead to neonatal death. Of the 0.2% of live births to cerebral palsy, 10 to 28% would be secondary to neonatal acidosis. Only metabolic acidosis plays a neurotoxic role, explaining the recent interest of Racinet et al. in the development of a new biochemical marker, more specific than pH or base deficit, of neonatal asphyxia per partum at risk of anoxo-ischemic encephalopathy. This eucapnic neonatal pH raises the hope of a biochemical marker of situations at risk of poor prognosis, with high diagnostic value, prognostic and forensic.

Our hypothesis is that eucapnic pH is more efficient than cord blood arterial pH and base deficit in the prediction of adverse neurologic outcomes.


Eligibility criteria: Inclusion Criteria:

* All birth more than 37 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant
* from 1st of january 2000 to 31 december 2016

Exclusion Criteria:

* Infants born out of the hospital and secondarily hospitalized in the hospital Femme-Mère-Enfant
* Children with congenital anomalies or without valid arterial and venous umbilical cord samples

Primary outcomes:
measure: Number of patients with at least one of these criteria including neonatal seizure, neonatal hypotonia requiring intensive care unit admission, neonatal encephalopathy, and/or neonatal death.
timeFrame: Between 2000 and 2016
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
Study officials:
affiliation: Hospices Civils de Lyon
name: Muriel DORET, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02527382: Peritoneal Bacterial Contamination Following Resection With Closed or Open Rectal Stump for Left-sided Cancer
Official title: Peritoneal Bacterial Contamination With Closed or Open Rectal Stump
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterium-Related Malignant Neoplasm
Lead sponsor: Bucharest Emergency Hospital
Sponsor class: OTHER
First posted: 2015-08-19
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to check if there is a difference in peritoneal contamination in patients undergoing rectal resection with closed and open rectal stump prior to anastomosing.

Detailed description: There is not much information regarding the peritoneal bacterial contamination during colorectal surgery. The null hypothesis is that there is no difference in peritoneal contamination following resection with closed or open rectal stump for left-sided cancer. Patients scheduled for elective resection are allocated for open resection with the distal stump closed or open. Anastomosis is performed while a clamp is placed on the rectal stump in one arm of the study while in the other arm, the stump remains open until the anastomosis is completed. A second bacterial sample will be obtained at the completion of the anastomosis from the same place (pelvic pouch) as the first one. After sampling an air leak test will be performed. A quantitative assessment of the number of Colony Forming Units (CFU/ml) of aerobic and anaerobic bacteria will be done for each patient. Operative time and time interval between samples will be measured. Postoperatively, possible complications (surgical site infections, leakage) will be monitored. The primary objective will be to determine the differences in peritoneal contamination between closed and open rectal stump during colorectal surgery.

Eligibility criteria: Inclusion Criteria:

* Consecutive adult patients scheduled for a left colectomy, sigmoidectomy or rectal resection with a proposed anastomosis at the level of the rectum agreeing to participate in the study.

Exclusion Criteria:

* Patients without informed consent
* Class V patients on American Society of Anesthesiologists (ASA) of Physical Health Score
* Patient with prior peritonitis
* Patients with acute inflammatory bowel disease
* Recent antibiotic treatment

Primary outcomes:
measure: The number of Colony-Forming Units (CFU)/ml from the peritoneal samples
timeFrame: within the first 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Bucharest Emergency Hospital
name: Florin M Iordache, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01681082: Psychological Effects of Tai Chi Training
Official title: Psychological Effects of Tai Chi Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-09-07
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 23
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The general purpose of this study is to examine the effect of tai chi training on cognitive function in young adults. The investigators will test subjects enrolled in a semester-long tai chi course along with control subjects. The specific aims are to measure duration of practice, cognitive function, physical balance, and Attention Deficit Hyperactivity Disorder (ADHD) indicators. The investigators primary hypotheses are that, compared to controls, subjects in the tai chi course will show improvements in (1a) spatial working memory and (1b) response inhibition. The investigators secondary hypotheses are that, among the subjects participating in the tai chi course, these cognitive improvements will correlate with (2a) improvements in balance and (2b) duration of tai chi practice, and that, among all participants, (2c) ADHD indications will correlate with cognitive measures.


Eligibility criteria: Inclusion Criteria:

* Able to perform balance and cognitive tests

Exclusion Criteria:

Primary outcomes:
measure: Change in working memory
timeFrame: Baseline and 14 weeks
Secondary outcomes:
measure: Change in physical balance
timeFrame: Baseline and 14 weeks
measure: Change in impulsivity
timeFrame: Baseline and 14 weeks
measure: Change in affective processing
timeFrame: Baseline and 14 weeks
measure: Change in attention deficit hyperactivity disorder (ADHD) scale
timeFrame: Baseline and 14 weeks
measure: Duration of practice
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin-Madison, Waisman Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Alexander K. Converse
role: PRINCIPAL_INVESTIGATOR
References:
citation: Converse AK, Ahlers EO, Travers BG, Davidson RJ. Tai chi training reduces self-report of inattention in healthy young adults. Front Hum Neurosci. 2014 Jan 27;8:13. doi: 10.3389/fnhum.2014.00013. eCollection 2014.
Clinical trial NCT06271382: The Effect Of Acupressure and Foot Exercise on Ankle Brachial Index in Individuals With Type 2 Diabetes
Official title: The Effect Of Acupressure and Foot Exercise on Ankle Brachial Index in Individuals With Type 2 Diabetes: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Acupressure
Ankle Brachial Index
Exercise
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with Type 2 diabetes.

Detailed description: Diabetes Mellitus (DM) is a health problem that affects many lifelong systems and organs throughout the world, increases the risk of premature death, affects the individual, family, society and the world, has a serious spiritual and financial care burden, and has important and vital consequences.

Diabetes can cause damage to nerves as well as small and large vessels. Patients who have had DM for a long time will experience circulatory disorders in the upper and lower extremities.

Ankle-Brachial Index (ABI) is a non-invasive examination of blood vessels that functions to detect clinical signs and symptoms of ischemia, reduced peripheral perfusion that can lead to angiopathy and diabetic neuropathy.

Studies indicate that foot exercise and acupressure application can be used as an alternative intervention to increase the value of the ankle-brachial index in patients with type 2 diabetes.

When the literature was examined, no comprehensive study could be found comparing the effect of foot exercise and acupressure application on the Ankle Brachial Index in diabetic patients in our country. It is thought that acupressure application and ankle exercises will accelerate peripheral circulation and may be effective on the ankle brachial index.

This study was planned with a randomized controlled experimental design to examine the effects of acupressure and ankle exercises on ankle brachial index in individuals with Type 2 diabetes.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with type 2 diabetes
* Be 18 years or older
* Ability to speak Turkish
* Ability to establish verbal communication
* Volunteering to participate in the research

Exclusion Criteria:

* Presence of any psychiatric disease diagnosed by a physician
* Presence of diabetic ulcers on both feet and legs
* Presence of any amputation in the foot or leg
* Having myalgia in the foot,
* Foot fracture
* Edema in the feet

Primary outcomes:
measure: Ankle Brachial Index
timeFrame: 2 week
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Beşkavaklar Aile Sağlığı Merkezi
Study officials:
affiliation: http://www.ibu.edu.tr/tr
name: Saadet CAN ÇİÇEK
role: STUDY_DIRECTOR
References:
Clinical trial NCT05652582: Seroprevalence of Covid-19 in the Staff of the University Hospitals of Strasbourg
Official title: Seroprevalence of SARS-CoV 2 in the Staff of the University Hospitals of Strasbourg
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: COVID-19
SARS-COV-2
Prevalence of SARS-CoV-2
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 5694
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospital staff practicing at HUS who performed SARS-CoV 2 serology in the period from 06/22/2020 to 11/1/2020

Brief summary: The Grand Est region is one of the most affected regions in France during the first wave of the COVID-19 epidemic. A significant increase in the number of patients hospitalized for SARS-CoV 2 infection at the University Hospitals of Strasbourg (HUS) led to a sudden saturation of their capacities. Hospital workers appear to be a population at particular risk for this new infectious agent. The percentage of hospital workers who have been in contact with the virus or have contracted COVID-19 is unknown.

The objective of this work is to determine the prevalence of SARS-CoV-2 positive serologies among hospital staff screened from June 22, 2020 to November 1, 2020 following a screening campaign offering serological testing to all volunteer HUS professionals.


Eligibility criteria: Inclusion criteria:

* Adult subject (≥ 18 years of age)
* Hospital staff practicing at HUS who performed SARS-CoV 2 serology in the period from 06/22/2020 to 11/1/2020

Exclusion criteria:

- Subject not meeting inclusion criteria

Primary outcomes:
measure: To determine the positive seroprevalence of SARS-CoV-2 among hospital staff screened from June 22, 2020 to November 1, 2020
timeFrame: Files analysed retrospectively from June 22, 2020 to November 1, 2020 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Laboratoire de Virologie - PTM - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT04439682: The Effects of Exercise on Some Biochemical Parameters in Patients With Rheumatoid Arthritis
Official title: The Effects of Exercise on Some Biochemical Parameters in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Biochemical Parameters
exercise
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: RA may progress with articular and non-articular involvement.Depression prevelance is found to increase for RA patients according to healthy population and to be correlated with pain, decreased quality of life, fatigue and physical disability.BDNF level was found significantly lower in RA patients with depression. Aim of this study is to investigate the variation of BDNF, VEGF, TNF- α, IL-6, IL-1β, irisin and α- Klotho levels following acute exercise.

Methods: This study included 45 RA patients and 45 age and sex matched healthy controls. Blood samples from all subjects were taken and centrifuged before and immediately after the exercise intervention.


Eligibility criteria: Inclusion Criteria:

* Patients who were aged between 18-65 years,
* Patients who got diagnosed according to American College of Rheumatology criteria
* Patients who were being followed at Firat University Department of Rheumatology

Exclusion Criteria:

* Patients who had regular exercise habits, malignancy, pregnancy, incorporation,
* Patients who took anti-TNF treatment
* Patients who had changes of medical treatment in last 3 months
* Patients who diagnosed with Fibromyalgia Syndrome and Osteoarthritis for lower extremity
* Patients who had cardiac symptoms according to New York Heart Association
* Patients who had dysfunction that can prevent physical activity

Primary outcomes:
measure: Irisin
timeFrame: 1 minute
Secondary outcomes:
measure: BDNF, VEGF, TNF- α, IL-6, IL-1β and α- Klotho
timeFrame: 1 minute
Other outcomes:
Locations:
city: Elazığ
country: Turkey
facility: Songul Baglan Yentur
Study officials:
References:
citation: Grimsholm O, Rantapaa-Dahlqvist S, Dalen T, Forsgren S. BDNF in RA: downregulated in plasma following anti-TNF treatment but no correlation with inflammatory parameters. Clin Rheumatol. 2008 Oct;27(10):1289-97. doi: 10.1007/s10067-008-0910-4. Epub 2008 May 17.
citation: Szuhany KL, Bugatti M, Otto MW. A meta-analytic review of the effects of exercise on brain-derived neurotrophic factor. J Psychiatr Res. 2015 Jan;60:56-64. doi: 10.1016/j.jpsychires.2014.10.003. Epub 2014 Oct 12.
citation: Ercan Z, Deniz G, Yentur SB, Arikan FB, Karatas A, Alkan G, Koca SS. Effects of acute aerobic exercise on cytokines, klotho, irisin, and vascular endothelial growth factor responses in rheumatoid arthritis patients. Ir J Med Sci. 2023 Feb;192(1):491-497. doi: 10.1007/s11845-022-02970-7. Epub 2022 Mar 16.