louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06012799: Continuous Glucose Monitoring in Peri-operative Period in Kidney Transplant Recipients
Official title: Prospective Observational Study for Efficacy of Perioperative Serum Glucose Level Evaluated by Continuous Glucose Monitoring System in Kidney Transplantation Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: New Onset Diabetes After Transplantation
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kidney transplant patients

Brief summary: his study aims to utilize Continuous Glucose Monitoring (CGM) to observe glucose fluctuations in kidney transplant recipients and predict New-Onset Diabetes After Transplantation (NODAT) based on these patterns. Additionally, it seeks to investigate glucose variability resulting from medications and surgeries such as immunosuppressants and steroid regimens post-kidney transplantation. This prospective observational study anticipates identifying factors influencing blood glucose levels and contributing to future research on blood glucose management using CGM monitoring in kidney transplant patients.


Eligibility criteria: Inclusion Criteria:

* The study will target 100 kidney transplant patients who have provided consent, among those who underwent the procedure at Seoul National University Hospital after March 2021.

Exclusion Criteria:

* multi-organ transplant
* history of previous kidney transplant
* less than 18 years old

Primary outcomes:
measure: Rate of NODAT
timeFrame: 6 months after kidney transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01661699: Oxidative Stress in Obstructive Sleep Apnea: Correlation of Biomarkers and Nasal CPAP Compliance
Official title: Oxidative Stress in Obstructive Sleep Apnea: Correlation of Biomarkers and Nasal CPAP Compliance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Keywords: Obstructive Sleep Apnea
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2012-08-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those over 18 years suspected of having sleep apnea.

Brief summary: The purpose of this study is to check blood and urine levels to further define markers/tests in the blood and urine that would be useful in following patients with obstructive sleep apnea and then to see if by wearing CPAP every night, these markers can be reduced. This research is being done because currently there are no effective blood or urine markers to determine how well CPAP is working.

Detailed description: The goal of this study is to further define biomarkers that would be useful in following patients with obstructive sleep apnea and examining their response to compliance to therapy with CPAP. To date no correlation between biomarkers of oxidative stress and compliance to CPAP has been measured. CPAP is the most effective treatment for obstructive sleep apnea and has been show to reduce blood pressure and decrease oxidative stress.

Eligibility criteria: Inclusion Criteria:

* Men and Women over 18 years suspected of having sleep apnea

Exclusion Criteria:

* Those under 18 years or not suspected of having sleep apnea

Primary outcomes:
measure: Determining biomarkers for polysomnography characteristics before and after CPAP treatment
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
Study officials:
affiliation: Georgetown University
name: Cristina Reichner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05529199: Impact of Preoperative Hypocaloric Hyperproteinic Lipid Restricting Diet on Bariatric Surgery
Official title: Impact of Preoperative Hypocaloric Hyperproteinic Lipid Restricting Diet on Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Abdominal
Keywords: Obesity, Abdominal
Preoperative diets
PSMF diet
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 776
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: Adult patients (≥18 years old) operated on at the HUS between 2010 and 2021 for bariatric surgery

Brief summary: Obesity is one of the greatest pandemics of the 21st century with 30 million new cases each year. In France each year, 60,000 bariatric surgery procedures are performed.

Many preoperative diets have been proposed in the literature with some studies giving positive results. But these diets are often strict and can have adverse effects on metabolism. Very few studies have described the PSMF diet. The hypothesis would be that this diet is associated with a reduction in liver volume with a reduction in steatosis.


Eligibility criteria: Inclusion criteria:

* Adult patient (≥18 years old)
* Man and woman
* Patient operated on at the HUS between 2010 and 2021 for bariatric surgery
* Patient not objecting to the reuse of their data for scientific research purposes.

Exclusion criteria:

- Patient who has expressed his opposition to the reuse of his data for scientific research purposes.

Primary outcomes:
measure: liver volume measurement in cm
timeFrame: Files analysed retrospectively from Ocober 01, 2010 to December 31, 2021 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de chirurgie générale et digestive - CHU de Strasbourg - France
Study officials:
affiliation: Service de chirurgie générale et digestive - CHU de Strasbourg - France
name: Benoit ROMAIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01769599: Comparison of Initial Treatment in With Laser Grid in Diabetic Macular Edema to Intra Vitreal Avastin Injections
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetic Macular Edema
Diabetus Mellitus
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2013-01-16
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic people that suffer from macular edema

Brief summary: there is no yet agreement about the best way to treat Diabetic Macular Edema (DME) the two options up to day are using Grid laser treatment Vs. Avastin injections or a combination of both in this study we want to compare the two attitudes.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients with macular edema
* age 30 to 80 Yrs. old
* no previous ocular treatment
* patiens with macular edema that was shown by OCT or FA
* patients with at least 6 months follow-up after the last treatment

Exclusion Criteria:

* patients with other ocular disease (such as glaucoma etc.)
* patients with previous ocular surgery
* patiens with eye trauma
* patiens with macular edema not from DM

Primary outcomes:
measure: Macular thickness
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Safed
country: Israel
facility: Ziv Medical Center
Study officials:
References:
Clinical trial NCT00617799: Biomarkers That Predict Response to High-Dose Aldesleukin in Metastatic Kidney Cancer or Metastatic Melanoma
Official title: Pilot Study to Identify Biomarkers That May Predict Response to High Dose IL-2
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Cancer
Melanoma (Skin)
Keywords: stage IV renal cell cancer
stage IV melanoma
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-02-18
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be receiving HD IL-2.

Brief summary: RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at biomarkers that predict response to high-dose aldesleukin in patients with metastatic kidney cancer or metastatic melanoma.

Detailed description: OBJECTIVES:

* Determine the relationship of peripheral blood lymphocyte phenotype pattern in patients with metastatic renal cell carcinoma or metastatic melanoma to response to high-dose aldesleukin (IL-2).
* Determine the relationship of peripheral blood mononuclear cells gene microarray patterns in patients with metastatic renal cell carcinoma or metastatic melanoma to response to high-dose IL-2.
* Determine the frequency of mutations on genes encoding for IL-2 receptor A and B.

OUTLINE: Patients receive high-dose aldesleukin (IL-2) as part of standard treatment on days 1 and 8. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients undergo blood collection at baseline, prior to beginning course 2, and 4 weeks after the completion of course 2. Samples are analyzed using peripheral blood cytometry, gene microarray analysis, and IL-2 receptor single-nucleotide polymorphism techniques.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of metastatic renal cell carcinoma or metastatic melanoma
* Must be receiving treatment with high-dose aldesleukin as part of standard therapy

Exclusion Criteria:

none

Primary outcomes:
measure: Relationship of peripheral blood lymphocyte phenotype to response to high-dose aldesleukin (IL-2)
timeFrame: 10 weeks
measure: Relationship of peripheral blood mononuclear cells gene microarray patterns to response to high-dose IL-2
timeFrame: 10 weeks
measure: Frequency of mutations on genes encoding IL-2 receptor A and B
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center, Eppley Cancer Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Ralph Hauke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06934499: Tunisian Lung Cancer Study
Official title: Clinical Observational Study on Tunisian Lung Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Cancer
Keywords: Pulmonary Cancer
Registry
Tunisia
Lead sponsor: Dacima Consulting
Sponsor class: OTHER
Collaborators: name: The Multidisciplinary Consultation Meeting Thoracic Oncology of the Abderrahmen Mami Hospital (ROTHAM)
name: Tunisian Society of Respiratory Diseases and Allergology
name: Tunisian Society of Medical Oncology
First posted: 2025-04-18
Enrollment: 1334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants diagnosed with histologically confirmed lung cancer will be included in the study, regardless of sex, age, stage and histological subtype. Patients will be enrolled in the study consecutively The study will be conducted in different regions of Tunisia, encompassing several sites covering different departments in public hospitals.

Brief summary: This is a prospective, multicenter, observational, national study. Eligible patients will be recruited consecutively among subjects with proven lung cancer, including any disease stage withclinical, therapeutic and evolutive discription.


Eligibility criteria: Inclusion Criteria:

* Age more than 18 years
* Patients receiving health care in the departments of pulmonology, oncology, radiation oncology and thoracic surgery, whose diagnosis is confirmed histologically and/or by cytology, at least 3 months before the inclusion date
* Informed consent

Exclusion Criteria:

* None

Primary outcomes:
measure: Diagnostic delay
timeFrame: Day 1
measure: Survival
timeFrame: 12 months
measure: Relapse
timeFrame: 12 months
Secondary outcomes:
measure: Recommendation Compliance
timeFrame: Day 1
Other outcomes:
measure: Multidisciplinary Consultation Meetings
timeFrame: 12 months
Locations:
city: Ariana
country: Tunisia
facility: Tunisian Society of Medical Oncology
city: Tunis
country: Tunisia
facility: Tunisian Society of Respiratory Diseases and Allergology
Study officials:
affiliation: Multidisciplinary consultation meeting Thoracic of the Abderrahmen Mami ROTHA Hospital
name: Soraya Fenniche, MD
role: STUDY_CHAIR
affiliation: Multidisciplinary consultation meeting Thoracic of the Abderrahmen Mami ROTHA Hospital
name: Nesrine Mejri, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06111599: Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment
Official title: Thermovision-controlled Lumbar Sympathetic Blockade in Chronic Limb-threatening Ischemia Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Limb-Threatening Ischemia
Lead sponsor: Europainclinics z.ú.
Sponsor class: OTHER
Collaborators: name: Slovak Academy of Sciences
First posted: 2023-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with chronic limb-threatening ischemia
Primary purpose: TREATMENT

Brief summary: Thermovision-controlled lumbar sympathetic blockade in chronic limb-threatening ischemia treatment

Detailed description: Chronic limb-threatening ischemia (CLTI), the end-stage of lower extremity artery disease (LEAD), occurs with growing prevalence around the globe and is associated with increased healthcare costs. CLTI is defined by the presence of LEAD in combination with rest pain, gangrene, or lower limb ulceration lasting more than two weeks. Despite unclear results of abdominal surgical lumbar sympathectomy, novel interventional minimally invasive fluoroscopy-guided procedures seem to be promising. A prospective interventional study will be conducted, primarily targeting patients afflicted by critical limb ischemia, with the incorporation of thermal vision control and tissue oxygen monitoring.

Eligibility criteria: Inclusion Criteria:

* Chronic limb-threatening ischemia-Patients with chronic leg pain for at least 6 months with intensity (VAS \>=5)
* those who (only if a signature was obtainable), or whose legal guardian,fully understood the clinical trial -details and signed the informed consent form

Exclusion Criteria:

* Chronic Venous Insufficiency
* women with positive a pregnancy tests before the trial or who planned to become pregnant within the following 3 years
* other patients viewed as inappropriate by the staff
* disagreement with participation in the study

Primary outcomes:
measure: Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 3m
timeFrame: 3 months follow-up
measure: Change From Baseline EuroQoL-5 Dimension (EQ-5D) Value 6m
timeFrame: 6 months follow-up
measure: Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 3m
timeFrame: 3 months follow-up
measure: Change From Baseline Visual Analog Pain Scale (VAS) of Back Pain 6m
timeFrame: 6 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Košice
country: Slovakia
facility: Europainclinics
Study officials:
References:
Clinical trial NCT05678699: The Effects of Medicaid Policy Interventions on Racial Equity in Severe Maternal Morbidity
Official title: The Effects of Medicaid Policy Interventions on Racial Equity in Severe Maternal Morbidity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Maternal Morbidity
Maternal Death
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2023-01-10
Enrollment: 10000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Evaluation of policy interventions at the state level comparing within state and across states over time.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to learn about the effects of structural inventions, such as equity-focused Medicaid polices, on severe maternal morbidity (SMM) and mortality and maternal health. The main questions it aims to answer are:

1. What is the effect of Medicaid healthcare quality interventions on SMM?
2. What is the effect of Medicaid healthcare quality interventions + doula care?
3. What are Medicaid beneficiaries' experiences in receiving services and the potential impact of integration of doula services and equity practices?

Participants will be asked to describe experiences as a result of structural interventions and focused Medicaid policies.


Eligibility criteria: Inclusion Criteria:

* Pregnant and postpartum Medicaid beneficiaries across the US

Qualitative:

* Medicaid beneficiaries who self-identify as Black and/or live in PA Health Equity Zones
* Doulas who provide care to Medicaid beneficiaries in Pennsylvania
* Medicaid Managed Care Organization (MCO) administrators in Pennsylvania. Severe maternal morbidity and mortality outcomes will be assessed in healthcare records and for these quantitative outcomes, patients will not be recruited individually

Exclusion Criteria:

-

Primary outcomes:
measure: Severe maternal morbidity (SMM)
timeFrame: 20 weeks gestation through 42 days postpartum
Secondary outcomes:
measure: All cause mortality
timeFrame: Delivery date through one year after delivery
measure: Follow up for chronic conditions
timeFrame: 43 days through 1 year after delivery
measure: Provision of evidence care in pregnancy and postpartum
timeFrame: During pregnancy and postpartum up to 1 year
measure: Medicaid managed care administrator perspectives on policy interventions
timeFrame: Year 3
Other outcomes:
measure: Assess the changes in effects of the Medicaid healthcare quality interventions on beneficiaries' experiences
timeFrame: Years 2, 3, and 4
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Public Health
state: Pennsylvania
Study officials:
References:
Clinical trial NCT06695299: Kinesthetic and Visual Motor Imagery on Cervical Position Sense and Balance in Mechanical Neck Pain
Official title: Effect of Kinesthetic and Visual Motor Imagery Training on Cervical Position Sense and Balance in Patients With Mechanical Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Neck Pain
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-11-19
Enrollment: 44
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the control group which received the selected exercise program and the study group received the same exercise training program in addition to Kinesthetic and Visual Motor Imagery Training
Primary purpose: TREATMENT

Brief summary: To investigate the Effect of Kinesthetic and Visual Motor Imagery Training on Cervical Position Sense and Balance in Mechanical Neck Pain

Detailed description: Thirty patients with Mechanical Neck Pain will participate in this study. The patients will randomly be divided into two equal groups; the control group which received the selected exercise program and the study group received the same exercise training program in addition to Kinesthetic and Visual Motor Imagery Training, three times per week for four weeks. The evaluation methods are cervical joint position error test, neck disability index, multidirectional reach test and visual analogue scale

Eligibility criteria: Inclusion Criteria:

* thirty patients with mechanical neck pain,
* Age will range as (35:50) years old
* body mass index (18:29)

Exclusion Criteria:

* difficulty to communicate or to understand program instructions
* any other neurological deficits or orthopaedic abnormalities,
* secondary musculoskeletal complication
* Cervical disc prolapses
* Any other cervical problem
* Spinal stenosis
* Previous spinal surgery

Primary outcomes:
measure: cervical joint position error test
timeFrame: four weeks
measure: Neck disability index
timeFrame: four weeks
Secondary outcomes:
measure: Visual analogue scale for pain (VAS-P)
timeFrame: four weeks
measure: multidirectional reach test
timeFrame: four weeks
Other outcomes:
Locations:
city: Al Jīzah
country: Egypt
facility: Lama Saad El-Din Mahmoud
state: Select State
Study officials:
References:
Clinical trial NCT03921099: Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicty
Official title: Evaluation of the Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Kidney Injury
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2019-04-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A Randomized controlled trial aiming to investigate whether ascorbic acid has a role in preventing vancomycin induced nephrotoxicity or not in critically ill patients.

Detailed description: Critically ill patients who have gram positive infection (MRSA) and need vancomycin will be assigned randomly into two groups. The first group will be given vancomycin intravenous only (15-20 mg/kg) every 8-12 hours , while the second group will take vancomycin intravenous (15-20 mg/kg) every 8-12 hours plus ascorbic acid 1 gram twice daily orally just before the vancomycin administration by half an hour. Patients will be monitored for one week where serum creatinine, BUN, urine output, trough level will be measured. Acute kidney injury will be determined according to RIFLE criteria.

Eligibility criteria: Inclusion Criteria:

* Adults who are critically ill and with MRSA infection suspection.

Exclusion Criteria:

1. Pregnancy or breast feeding.
2. Known allergy to either vancomycin or ascorbic acid.
3. Base line serum creatinine ≥2mg/dl.
4. Patients receiving other nephrotoxic drug (e.g., aminoglycosides, amphotericin B, cisplatin or calcinurine inhibitors).
5. Anticepated administration of contrast medium within 7 days.
6. Patients suffering from some underlying diseases (e.g., cancer, HIV infection, systemic lupus erythematoses,or urinary tract stones).
7. Unlikelyhood of receiving the study medications for at least 72 hours

Primary outcomes:
measure: Incidence of nephrotoxicty
timeFrame: one week
Secondary outcomes:
measure: 28 days Mortality
timeFrame: one month
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university hospitals
Study officials:
affiliation: Ain Shams University
name: Nagwa A Sabry, PhD
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Sara M Shaheen, PhD
role: STUDY_DIRECTOR
References:
citation: Hesham El-Sherazy N, Samir Bazan N, Mahmoud Shaheen S, A Sabri N. Impact of ascorbic acid in reducing the incidence of vancomycin associated nephrotoxicity in critically ill patients: A preliminary randomized controlled trial. F1000Res. 2021 Sep 16;10:929. doi: 10.12688/f1000research.55619.1. eCollection 2021.