louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06334289: A Predictive Study of Peripheral Blood Biomarkers on Postoperative Neurocognitive Dysfunction in Elderly Frail and Non-frail Patients Undergoing Gastrointestinal Surgery
Official title: A Predictive Study of Peripheral Blood Biomarkers on Postoperative Neurocognitive Dysfunction in Elderly Frail and Non-frail Patients Undergoing Gastrointestinal Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Perioperative Neurocognitive Disorders
Frail Elderly
Keywords: Peripheral blood biomarkers
inflammatory markers
Alanine aminotransferase
blood lipids
vitamin D
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 338
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Elderly patients undergoing gastrointestinal surgery under general anesthesia.

Brief summary: Perioperative neurocognitive impairment (PND) mainly includes acute postoperative delirium (POD) and persistent postoperative cognitive impairment (POCD), which are common postoperative complications in elderly patients. Perioperative neurocognitive impairment (PND) is attracting increasing attention, but its exact mechanism is still unclear. The diagnosis of PND lacks the gold standard, so it is difficult to determine the incidence rate. At present, the diagnosis is mainly conducted through the scale. Therefore, this study aims to explore the correlation between peripheral blood biomarkers and PND in elderly frail patients undergoing gastrointestinal surgery.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 65 years old
* American Society of Anesthesiologists (ASA) classification: grades I-IV
* Hospitalization time ≥ 3 days

Exclusion Criteria:

* The revised version of the Cognitive Function Telephone Questionnaire (TICS-M) was used before surgery to determine cognitive impairment (TICS-M score ≤ 27 points)
* Refuse to participate
* Emergency surgical patients
* Central nervous system diseases (dementia, depression, etc.)
* Severe renal insufficiency (requiring dialysis)
* Long term use of psychotropic drugs (such as clozapine, risperidone, olanzapine, haloperidol, chlorpromazine, etc.)
* History of alcohol abuse or use of acetylcholine drugs
* The same patient can only be included once, regardless of whether the reason for the second surgery is related to the first cause

Primary outcomes:
measure: Postoperative 7-day incidence of PND
timeFrame: 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01645189: Safety and Efficacy of Hunterase
Official title: To Evaluate the Safety and Efficacy of Hunterase(Idursulfase-beta) in Hunter Syndrome Patients < 6 Years of Age Receiving Idursulfase Enzyme Replacement Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hunter Syndrome
Keywords: Hunter syndrome
idursulfase-beta
Hunterase
GC1111
Lead sponsor: GC Biopharma Corp
Sponsor class: INDUSTRY
First posted: 2012-07-20
Enrollment: 6
Sex: MALE
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the safety and efficacy of once weekly dosing of idursulfase-beta 0.5mg/kg administered by intravenous(IV) infusion for Hunter syndrome patients \< 6 years old.


Eligibility criteria: Inclusion Criteria:

1. The patient has a diagnosis of Hunter syndrome based upon biochemical criteria:

   * as measured in plasma, leukocytes, or fibroblasts,

     * a deficiency in iduronate-2-sulfatase (I2S) enzyme activity of ≤ 10 % of the lower limit of the normal range
   * That corresponds to one or more of the following:

     * a normal enzyme activity level of one other sulfatase
     * Confirmed as MPS2 by genetic test results
     * shows clinical symptoms/ visible signs of MPS2
2. \< 6 years old and male
3. Patients who are able to comply with the study requirements
4. The patient's parent(s), or patient's legal guardian must have given voluntary written consent to participate in the study

Exclusion Criteria:

1. The patient has had a tracheostomy
2. The patient has known severe hypersensitivity or shock to any of the components of idursulfase
3. The patient has received treatment with another investigational therapy within 30 days prior to enrollment
4. History of a stem cell transplant
5. The patient has known severe hypersensitivity or shock to any of the components of test drug(excipient etc)

Primary outcomes:
measure: Incidence of adverse events
timeFrame: One year
Secondary outcomes:
measure: change of anti-idursulfase-beta antibody status
timeFrame: baseline and one year
measure: Percent Change of Urine GAG
timeFrame: baseline to 53 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsug Medical Center
Study officials:
affiliation: Samsung medical center, Seoul, Republic of Korea
name: Dong-Kyu Jin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03094689: Cold Water Immersion in the Recovery of Markers of Muscle Damage of 10km Street Runners
Official title: Cold Water Immersion in the Recovery of Clinical, Biochemical, Functional and Neuromuscular Markers of Muscle Damage of 10km Street Runners: Clinical, Randomized and Blinded Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Behavior
Keywords: Physical activity
Muscle pain
Cryotherapy
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2017-03-29
Enrollment: 30
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To analyze the effect of cold water immersion (CWI) on the recovery of clinical, biochemical, functional and neuromuscular markers of muscle damage in 10 km street runners.

Materials and Methods: This is a randomized, blinded trial in which 30 subjects, 10 km street runners, were randomly divided into three groups: control (gC), immersion (gI) and CWI (gCWI). The runners will be evaluated for clinical (subjective perception of exertion), biochemical (serum CK), functional (unipodal triple hop distance and shuttle test time) and neuromuscular variables by means of isokinetic variables (peak torque, total work and fatigue index). Volunteers will perform pre-assessment, immediately post-race and post-intervention, and 24-hour post-intervention. The data will be expressed by mean and standard deviation, analyzed in the statistical package SPSS 20.0. A significance level of 5% and a 95% confidence interval will be considered for all measures.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index between 18.5 and 30 kg/m2;
* Street runners for at least 6 months;
* Week frequency of at least 3 times;
* Do not present cardiopathies, muscles and neurological diseases;

Exclusion Criteria:

* Hypersensitivity or allergies to cryotherapy;
* Unable to complete the 10 km event on the day of the evaluation;
* Do not complete or perform any of the study procedures for any reason (phobias, do not withstand the exposure time).

Primary outcomes:
measure: Subjective perception of pain.
timeFrame: Up to 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00943189: Fetal Anomalies Scan at the Time of Nuchal Translucency Study
Official title: Fetal Anomalies Scan at the Time of Nuchal Translucency Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Anomalies
Keywords: Fetal anomalies scan at the time of NT study
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-07-22
Enrollment: 600
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All pregnant women at 12-14 weeks of gestation that are coming for nuchal translucency examination and willing to participate in the study.

Brief summary: Purpose: Fetal anomalies scan at the time of Nuchal Translucency (NT) study.

Detailed description: Prospective study of patients at 12-14 weeks gestation that are coming for NT examination is conducted. Meticulous ultrasound examination will be done to the fetuses using trans vaginal and transabdominal techniques. The patients will receive only the NT information. Only in cases of detection of severe fetal anomalies the patient will get the information of the examination and counseling according to the findings. All patients will be asked to provide information of the 15 weeks early comprehensive ultrasound examination. The NT examination will be compared to the 15 weeks ultrasound. All patients will be asked to give information after delivery of the baby's health condition.

Eligibility criteria: Inclusion Criteria:

* pregnant women at 12-14 weeks

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References:
Clinical trial NCT06624189: Active Choice Clinical Decision Support (CDS): Hepatocellular Carcinoma (HCC) Screening in Patients With Cirrhosis
Official title: Active Choice Clinical Decision Support: Hepatocellular Carcinoma Screening in Patients With Cirrhosis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hepatocellular Carcinoma
Cirrhosis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 600
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 presenting with a cirrhosis diagnosis, and at the date of their appointment had been 6 months or more after their most recent imaging.

Brief summary: The research team will evaluate the effectiveness of an auto-pended bot liver ultrasound order that will prompt providers at the time of encounter to place appropriate imaging orders for hepatocellular carcinoma (HCC) screening in patients with cirrhosis.


Eligibility criteria: Inclusion Criteria:

* cirrhosis diagnosis,
* 6 months or more after since most recent imaging.

Exclusion Criteria:

* previous liver transplant,
* HCC diagnosis,
* receiving hospice care,
* completed external imaging in the past 6 months.

Primary outcomes:
measure: Percentage of Participants for whom the Physician Completed Ordering of the Pending Liver Ultrasound
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of Participants with Completed Liver Ultrasound Imaging
timeFrame: Day 1
measure: HCC Diagnosis Rate from Completed Liver Ultrasound Imaging
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Saul Blecker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00767689: Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Capecitabine Chemotherapy
Official title: A Randomized Trial to Determine if Vitamin B6 Can Prevent Hand and Foot Syndrome in Cancer Patients Treated With Capecitabine Chemotherapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hand and Foot Syndrome
Lead sponsor: Cook County Health
Sponsor class: OTHER_GOV
First posted: 2008-10-07
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Capecitabine (Xeloda) a drug in cancer therapy. Its use is limited often by its toxicities. This study is asking if vitamin B6 can prevent one of the common toxicities of xeloda which is numbness and/or rash of the hands and feet, a condition called Hand and Foot syndrome. patients , starting capecitabine chemotherapy for their cancer, will participate in this study at John H. Stroger Jr. Hospital of Cook County. They will be randomized to receive either vitamin B6 or a placebo. investigators and patients will be blinded to the intervention.

Detailed description: Double-blind, placebo-controlled trial, with randomly assignment of eligible patients who were treated with capecitabine to receive either daily pyridoxine 100 mg or placebo along with their capecitabine-containing chemotherapy regimen. Patients were observed during the first 4 cycles of capecitabine treatment. The primary endpoint was the incidence and grade of Hand-Foot Syndrome (HFS) that occurred in both study arms.

Eligibility criteria: Inclusion Criteria:

* Any adult patient starting capecitabine-containing chemotherapy
* Has never had capecitabine before
* Performance status 0-2 using the ECOG classification
* Life expectancy more than 6 months
* Agreed to stop any vitamin supplements, apart from vitamin D.
* Liver function studies including AST/ALT within 3x upper limit of normal
* Signed informed consent must be obtained from participating individuals

Primary outcomes:
measure: Incidence of Hand-Foot Syndrome (HFS)
timeFrame: 1 year
Secondary outcomes:
measure: Grade of Hand-Foot Syndrome (HFS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Chicago
country: United States
facility: John H stroger Jr hospital of cook county
state: Illinois
Study officials:
affiliation: Cook County Health Oncology NCORP
name: Thomas Lad, MD
role: STUDY_DIRECTOR
affiliation: Cook County Health
name: Susan McDunn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03131089: Young Breast Cancer Cohort Study
Official title: Prospective Cohort Study for Development of Personalized Treatment Strategy Based on Biologic Tumor Behavior and Clinical Characteristics in Young Breast Cancer (YBC) Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 2000
Sex: FEMALE
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Diagnosis with breast cancer
2. Age under 40 year-old or diagnosis with breast cancer at pregnancy or within 1year after delivery

Brief summary: This study is prospective cohort study to investigate and identify comprehensively the clinicopathological features and long-term outcome of young breast cancer (YBC).

We have enrolled Breast cancer patients under 40 year-old and collected their baseline characteristics including tumor character, familiar history and other background information. Moreover, we have collected breast cancer tissue/blood sample for analyzing genetic characteristics, if patient agree to genetic analysis.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis with breast cancer
2. Age under 40 year-old or diagnosis with breast cancer at pregnancy or within 1year after delivery
3. Obtained informed consent form

Exclusion Criteria:

1) Cannot understand or disagree to informed consent form

Primary outcomes:
measure: Progression free survival
timeFrame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
Clinical trial NCT02217189: Study of the Effect of Oral Zinc Supplementation on Superoxide Radical Scavengers
Official title: Study of the Effect of Oral Zinc Supplementation on Superoxide Radical Scavengers in Spermatozoa of Patients With Asthenospermia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthenozoospermia
Keywords: Zinc supplementation.
Oxidative stress.
Superoxide radical scavengers.
Asthenospermia.
Oxido-sensitive index.
Lead sponsor: Babylon University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Iraq
First posted: 2014-08-15
Enrollment: 120
Sex: MALE
Minimum age (years): 26
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although several studies have considered the relationship between infertility and semen super oxide radical scavengers levels, no study on the effects of asthenospermia treatments such as oral zinc supplementation on superoxide radical scavengers activity which are important in fertility of the individual has been reported.

Detailed description: The present study was conducted to study the effect of zinc supplementation on the quantitative and qualitative characteristics of semen along with superoxide radical scavengers activity in the seminal plasma of asthenospermic patients.

Eligibility criteria: Inclusion Criteria:

* the presence of asthenozoospermia in the semen sample.

Exclusion Criteria:

* the absence of endocrinopathy, varicocele, and female factor infertility. Smokers and alcoholic men were excluded from the study because of their recognized high seminal ROS levels and decreased antioxidant levels.

Primary outcomes:
measure: Oxido-sensitive index level in spermatozoa and seminal plasma.
timeFrame: up to three months.
Secondary outcomes:
measure: Volume of semen.
timeFrame: up to three months.
measure: Xanthine oxidase activity in spermatozoa and seminal plasma.
timeFrame: up to three months.
measure: Catalase like activity in spermatozoa and seminal plasma.
timeFrame: up to three months.
measure: Superoxide dismutase activity in spermatozoa and seminal plasma.
timeFrame: up to three months.
measure: Progressive sperm motility percentage.
timeFrame: up to three months
measure: Total normal sperm count.
timeFrame: up to three months.
Other outcomes:
Locations:
city: Hilla
country: Iraq
facility: Babylon University
state: Babylon
Study officials:
affiliation: Babylon University/ Iraq
name: Mahmoud H. Hadwan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Babylon University/ Iraq
name: Lamia A. Almashhedy, PhD
role: STUDY_DIRECTOR
affiliation: Babylon University/ Iraq
name: Abdulrrazaq S. Alsalman, PhD
role: STUDY_CHAIR
References:
citation: Hadwan MH, Almashhedy LA, Alsalman AR. Oral Zinc Supplementation Restores Superoxide Radical Scavengers to Normal Levels in Spermatozoa of Iraqi Asthenospermic Patients. Int J Vitam Nutr Res. 2015;85(3-4):165-73. doi: 10.1024/0300-9831/a000235.
Clinical trial NCT03340389: Dysfunctional Lens Index Serves as a Novel Surgery Decision Maker for Age-related Cataracts
Official title: Dysfunctional Lens Index Serves as a Novel Surgery Decision Maker for Age-related Cataracts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Age-related Cataract
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: To study the correlations among the dysfunctional lens index (DLI), Lens Opacities Classification System III (LOCS III) nuclear opalescence grading score, preoperative corrected distance visual acuity (CDVA), the objective scatter index (OSI) and Scheimpflug based average lens density in age-related cataracts. To investigate the potential of the DLI as a novel surgery decision maker via the Operating Characteristic (ROC) curve analysis.

Detailed description: Each patient received a comprehensive eye examination, including corrected distance visual acuity (CDVA) preoperatively and the day after surgery, subjective refraction, slit-lamp evaluation, noncontact tonometry (TX-F; Cannon, Tokyo, Japan), and dilated fundus examination. According to the surgery decision made by the three surgeons based on the slit lamp biomicroscopy and CDVA, patients were divided into two groups: Surgical and Non-Surgical. The results of the DLI, OSI and average lens density (ALD) were masked to the surgeons. The DLI, OSI, average lens density, LOCS III nuclear opalescence grading, and preoperative CDVA were obtained. Correlations among these parameters were analyzed. ROC curves were used to analyze DLI values to determine a value to separate between surgical and non-surgical cataracts.

Eligibility criteria: Inclusion Criteria:

* patients with age-related cataracts

Exclusion Criteria:

* any corneal opacity, corneal dystrophies, retinal anomalies, a history of ocular surgery or laser treatment, a LOCS III grade of cortical opacity ≥ 3.0 or posterior subcapsular cataract ≥ 2.0.

Primary outcomes:
measure: Dysfunctional lens index
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical College
state: Zhejiang
Study officials:
References:
Clinical trial NCT01808989: Clinical Interest of the TcPO2 Technique
Official title: Multicentric Study of the Clinical Interest of the TcPO2 Technique
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Claudication
Keywords: peripheral artery disease
tcpo2
treadmill walking test
intermittent claudication
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2013-03-12
Enrollment: 952
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with buttock pain and referred for an oximetry exercise test

Brief summary: The measurement of the transcutaneous oxygen pressure records simultaneously the tcpO2 at the buttocks and chest level during walking. Before and after exercise the diagnosis, investigations and treatments ongoing or to be performed are recorded.

The present study focuses on the clinical interest of the transcutaneous oxygen pressure during exercise in the diagnosis of claudication in patient referred for an oximetry exercise test.

Detailed description: Pre-test diagnostic hypothesis with probability will be completed by the physician.

Pre-test and post test ongoing or scheduled treatments will be completed by the physician.After the test, the same post test items will be evaluated.

Analysis will be done on differences of pre and post test results.

Eligibility criteria: Inclusion Criteria:

* referred for an oximetry exercise test
* Patient able to walk on a treadmill
* Patient covered by the French health insurance
* Patient able to understand the protocol
* Patient agrees to be involve in the protocol and sign the consent form

Exclusion Criteria:

* any heart issues during the last 3 months
* pregnancy

Primary outcomes:
measure: The percentage of patients for whom results tcpO2 effort led to changes in diagnosis measured by the questionnaire filled by the doctor in charge of the patient before and after the test
timeFrame: up to 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
city: Lille
country: France
facility: University Hospital
city: Lomme
country: France
facility: University Hospital
city: Marseille
country: France
facility: University Hospital
city: Nantes
country: France
facility: University Hospital
city: Rennes
country: France
facility: University Hospital
city: Toulouse
country: France
facility: University Hospital
city: Tours
country: France
facility: Hospital
Study officials:
affiliation: University hospital, Angers, FRANCE
name: Pierre Abraham, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: