louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05987566: Chronobiology of Meal Timing: Effects on Vascular and Renal Function
Official title: Chronobiology of Meal Timing: Effects on Vascular and Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The purpose of this study us to investigate the effects of mistimed eating on blood pressure, kidney function and vascular function.

Detailed description: Despite advancements in pharmacologic antihypertensives, hypertension currently affects 1 in 3 Americans and accounts for more than $50 billion of health care spending. Importantly, hypertension is the leading cause of cardiovascular (CVD) and kidney diseases (CKD). As a result, the AHA/ACC lowered the diagnostic criteria for hypertension to encourage earlier preventative lifestyle intervention. There is a critical need to identify and implement novel lifestyle interventions in individuals with early-stage hypertension to prevent the subsequent development of CVD and CKD. Chronotherapy that aligns behavioral cues (such as time of eating) with the body's internal biological clocks, has gained much attention as a potential strategy to prevent and manage hypertension, however, the underlying mechanisms are not yet fully understood. The purpose of this study is to investigate the effects of mistimed eating on blood pressure, kidney function and vascular function.

Eligibility criteria: Inclusion Criteria:

* Men and Women aged 18-45 years
* Elevated (SBP 120-129; DBP \<80 mmHg) or stage 1 hypertension (SBP 130-139; DBP 80-89 mmHg)

Exclusion Criteria:

* History of chronic disease (CV, lung, cancer, renal, sleep apnea, diabetes, autoimmune)
* Anti-hypertensive medication use
* Currently pregnant or lactating
* Current shift worker
* Travel \>3 time zones four weeks before the start of the study or during the study
* Insomnia
* Practiced intermittent fasting in past six months
* Current nicotine use
* Current hormone replacement therapy
* Current melatonin use
* Current use of antioxidants and unwilling to stop taking them for the duration of the study
* Unable to provide informed consent

Primary outcomes:
measure: Urinary sodium excretion and markers of kidney injury
timeFrame: 24 hours
Secondary outcomes:
measure: 24hr ambulatory blood pressure
timeFrame: 24 Hours
measure: Macrovascular function
timeFrame: At baseline and after each 24hour experimental arm
measure: Microvascular function
timeFrame: At baseline and after each 24hour experimental arm
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth Univesity
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Danielle Kirkman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00266266: Human Papilloma Virus DNA Self-Test
Official title: Human Papilloma Virus DNA Self-Test
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Papilloma Virus, Human
Keywords: Human Papilloma Virus
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
First posted: 2005-12-16
Enrollment: 171
Sex: FEMALE
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: Abnormal pap smear ASCUS or higher

Age 18-postmenopausal

Brief summary: HPV DNA testing by a clinician has been shown to be highly sensitive in detecting cervical disease. Can we prove that HPV self-testing will be sufficiently sensitive to detect disease in high risk population who for various reasons would not have routine pap smear screening?

Detailed description: Women between the ages of 18 years to post-menopausal with documented abnormal pap smear atypical squamous cells of undetermined significance and higher will be enrolled into the study. Patients will be taught how to collect vaginal samples with dacron swab and vaginal tampons by means of instructional video and manufacturer's instruction guide respectively. Physicians will perform pap smear and colposcopy. All samples will be sent to the University of Louisville lab for processing for HPV DNA detection by Hybrid capture 2 method.

Eligibility criteria: Inclusion Criteria:

Abnormal pap smear ASCUS or higher

Age 18-postmenopausal

Exclusion Criteria:

Less than 18 years old

Prior hysterectomy

Pregnancy

Use of corticosteroids

HIV positive

Primary outcomes:
measure: HPV DNA self-testing device to detect disease in patients with abnormal Pap smear
timeFrame: Patient will self-test immediately prior to their standard physician papsmear
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
Study officials:
affiliation: University of Louisville,James Graham Brown Cancer Center
name: Robert Edwards, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01988766: Risk of Central Venous Stenosis in Patients With Chronic Renal Failure After IJ Line Placement
Official title: Risk of Central Venous Stenosis in Patients With Chronic Renal Failure After IJ Line Placement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombosis
Keywords: Thrombosis
Central Venosis Catheter
Renal Disease
Vascular Access
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 1424
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who had a PICC line placed at the University of Chicago by the procedure service between September 1, 2010 and December 31, 2011

Brief summary: The purpose of this study is to compare the difference in thrombosis as a result of internal jugular (IJ) catheters versus peripherally inserted central catheter (PICC) lines. It is hypothesized that there will be a decreased rate of thrombosis in patients as a result of IJ catheters verses PICC lines.

Detailed description: In a cohort of patients from Sept 1, 2010 until December 31, 2011 with chronic kidney disease (CKD) has shown that the incidence of IJ thrombosis after short term catheter access occurred in only 1/26 subjects or 4%. The current study is being done to compare this experience with the incidence of thrombosis from PICC lines. A secondary aim will be to determine if variables such as level of renal function, prior history of thrombosis or atherosclerosis contribute to the risk of thrombosis when PICC lines are placed. This data will provide the first comparison of the incidence of thrombotic complications from short term IJ catheter access versus PICC lines.

Eligibility criteria: Inclusion Criteria:

* subjects who had a PICC line placed at the University of Chicago between September 1, 2010 and December 31, 2011

Exclusion Criteria:

* subjects under the age of 18

Primary outcomes:
measure: Incidence of Thrombosis
timeFrame: 15 months
Secondary outcomes:
measure: Demographic Risk Factor Association with Risk of Thrombosis from PICC or IJ access
timeFrame: 15 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Mary Hammes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05743166: Bariatric Surgery Observation Study Part 2
Official title: Bariatric Surgery Observation Study Part 2 An Observational Study of Patients Who Underwent Bartiatric Surgery in Public Hospitals in Central Norway 2010-2015.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery Candidate
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Helse Nord-Trøndelag HF
name: Helse Møre og Romsdal HF
First posted: 2023-02-24
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1400 patients who had baratric surgery at three public hospitals in Central Norway from 2010 to 2015 are invited to a follow up in 2023-2025

Brief summary: The goal of this observational study is to explore the longterm effects of two bariatric surgical procedures by inviting patients from three public hospitals who had Roux-en-Y gastric bypass or Sleeve gastrectomy to a follow-up after10-15 years

The main question\[s\] it aims to answer are:

* The duration of the surgical method on weight reduction and remission of comorbidities
* Theprevalence of complications and new morbidities after the surgical procedures Participants will be asked be asked to

  * fill inn questionnaires,
  * have a clinical examinition
  * have an interview with nurse and doctor
  * have blood samples taken
  * undergo other investigations

Detailed description: The BAROBS project is a collaberation between three public hospitals in Norway exploring the concequeces ten years or more after undergoing gastric bypass or sleeve gastrectomy for severe obesity.

1400 patients who underwent bariatric surgery at the three hospitals will be invited to a follow up including antrophometric, meassurment of bodily composition by bioimpedance and DXA, blood samples, questionnaires on sosioeconomic topics, symptoms and quality of life, continous glucose monitoring, dental examination, and other clinical evaluation.

Eligibility criteria: Inclusion Criteria:

* Bariatric surgery at Namsos Hospital, St. Olavs hospital or Ålesund Hospital from 01.01.2010 to 31.12.2015

Exclusion Criteria:

* Not able to consent for participation
* Includable participants not longer living in Norway

Primary outcomes:
measure: Long-term weight loss
timeFrame: 10-15 years after surgery
Secondary outcomes:
measure: Remission of comorbidities after bariatric surgery
timeFrame: 10-15 years after surgery
measure: Quality of life after bariatric surgery
timeFrame: 10-15 years after surgery
Other outcomes:
Locations:
city: Namsos
country: Norway
facility: Helse Nord-Trondelag
city: Trondheim
country: Norway
facility: St. Olavs Univeristy Hospital
city: Ålesund
country: Norway
facility: Helse Møre og Romsdal
Study officials:
affiliation: St. Olavs Hospital
name: Jorunn Sandvik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03916666: Chronic Low Back Pain - Epiduroscopy Treatment
Official title: Chronic Low Back Pain - Epiduroscopy Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Low Back Pain
Lead sponsor: Pavol Jozef Safarik University
Sponsor class: OTHER
Collaborators: name: Europainclinics z.ú.
First posted: 2019-04-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: After epiduroscopy, FBSS Y/N

Brief summary: Retrospective analysis of patients with low back pain after epiduroscopic procedure

Detailed description: Retrospective analysis of patients with low back pain after epiduroscopic procedure Retrospective analysis of ambulatory data and next phone survey

Eligibility criteria: Inclusion Criteria:

* all patients after epiduroscopy

Exclusion Criteria:

* patients disagreement

Primary outcomes:
measure: Incidence of back pain after epiduroscopic procedure
timeFrame: 1 year
measure: Incidence of leg pain after epiduroscopic procedure
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Praha
country: Czechia
facility: EuroPainClinics .z.ú
state: Smetanovo Nábřeží 327/14
city: Kosice
country: Slovakia
facility: East Slovak Institute for Cardiovascular Diseases
Study officials:
References:
Clinical trial NCT02908126: Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility
Official title: Compare Efficacy of Oxytocin Administrations on Postpartum Uterine Contractility
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Post Partum Haemorrhage
Lead sponsor: Oxytone Bioscience BV
Sponsor class: INDUSTRY
First posted: 2016-09-20
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a Phase I open-label, parallel-group clinical study in healthy term pregnant females undergoing a caesarean section. Two administrations of oxytocin will be tested, after which uterine contractility will be assessed.


Eligibility criteria: Inclusion Criteria:

* Healthy, term pregnant female with a gestational age of 37-42 weeks (singleton)
* Undergoing a planned primary and uncomplicated caesarean section (CS) for their first born under regional anaesthesia
* Aged between 18 and 40 years (both inclusive)
* Ability to communicate well with the Investigator and to comply with the requirements of the entire study
* Willing to give informed consent in writing.

Exclusion Criteria:

* Being obese with BMI ≥35 before pregnancy
* History of, or existing thromboembolic, cardiovascular or cerebrovascular disorder
* History of cervical cancer
* History of severe infection of the uterus
* Previous surgery of the cervix or uterus or any other (previous) condition that could interfere with the measurement of uterine contractility
* Any clinically significant abnormality following review of medical history, laboratory result and physical examination at screening as judged by the Investigator
* Conditions or disorders that might affect the absorption, distribution, metabolism or excretion of any of the study medication
* Contraindications for oxytocin use
* Hypersensitivity to the active substances or to any of the excipients of the investigational product (test product or comparator drug)
* Present use or use within 30 days before the start of the study medication of one or more of the following medications: antihypertensive drugs, anti-coagulant therapy, medication that could affect myometrial contractility, sex steroids, prostaglandins and its analogues, inhalation anaesthetics, vasoconstrictors/sympathomimetics and caudal anaesthetics, vasopressin-like drugs
* Administration of any other investigational drug within 3 months before first dosing
* Tobacco use (smoking or snuffing), currently or within the last 6 months before screening

Primary outcomes:
measure: Uterine contractility: area under the curve (AUC)
timeFrame: 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institute, Danderyd hospital,Dept of Obstetrics and Gynecology
Study officials:
References:
Clinical trial NCT01778426: Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy (French SCS Registry)
Official title: Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain Syndrome
Keywords: Chronic neuropathic pain syndrome
Spinal Cord Stimulation
Painstim devices
Efficacy
Safety
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
Collaborators: name: Medtronic Cardiac Rhythm and Heart Failure
First posted: 2013-01-29
Enrollment: 414
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients implanted (first implant or replacements) with a Medtronic neurostimulator in selected French sites .

Brief summary: Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over 2 years following SCS implant.

This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for SCS in approved indication in France.


Eligibility criteria: Inclusion Criteria:

* Patient indicated for Spinal Cord Stimulation (pain therapy)
* Patient implanted for less than 3 months or hospitalized for the implant of a Medtronic neurostimulator including:
* primary implant with Spinal Cord Stimulation indication and positive test of stimulation or
* device replacement of a Medtronic neurostimulator used for Pain Therapy
* Evaluation of usual pain in the back, upper and lower limbs using a visual analogic scale must be available for the 3 days preceding implant.
* Treatments must also be available
* Patient read and signed the data release form

Exclusion Criteria:

* Patient declined participation
* Patient is not available for follow up
* Stimulation of other body part than spinal

Primary outcomes:
measure: Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years
timeFrame: 2 years
Secondary outcomes:
measure: Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain
timeFrame: 1 year and 2 years
measure: Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 1 Year
timeFrame: 1 year
measure: Concomitant Pain Relief Medication
timeFrame: Baseline, 1 and 2 years
measure: Dose of Analgesics Level 3 (Morphinics)
timeFrame: Baseline, 1 and 2 years
measure: Patient Satisfaction
timeFrame: 1 and 2 years
measure: Return to Work
timeFrame: 1 and 2 years
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch - 40 rue Worth
Study officials:
affiliation: Hôpital Saint Anne, Paris
name: Marie-Christine DJIAN, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02784626: Intraoperative Sedatives and Postoperative Pain
Official title: The Influence of Intraoperative Sedative on Postoperative Pain in Total Knee Arthroplasty Under Spinal Anesthesia: Comparison Between Dexmedetomidine and Propofol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthritis, Degenerative
Keywords: Dexmedetomidine
Propofol
Pain, Postoperative
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2016-05-27
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this study, based on the hypothesis that dexmedetomidine administered intraoperatively for sedation can reduce postoperative pain than that of propofol, the investigators examined the ability of dexmedetomidine to reduce postoperative pain in in patients undergoing the total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing total knee arthroplasty
* Age: 20 - 80 yrs

Exclusion Criteria:

* ASA classification ≥ 3
* Patient who do not want sedation during the surgery
* Patient who wants general anesthesia
* Cardiovascular disease
* Liver dysfunction
* Renal dysfunction

Primary outcomes:
measure: Visual analogue scale
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Rescue analgesics
timeFrame: Postoperative 24 hours
measure: Rescue analgesics
timeFrame: Postoperative 48 hours
measure: Visual analogue scale
timeFrame: Postoperative 48 hours
Other outcomes:
measure: Nausea and vomiting
timeFrame: Postoperative 24 hours
measure: Nausea and vomiting
timeFrame: Postoperative 48 hours
measure: Antiemetics
timeFrame: Postoperative 24 hours
measure: Antiemetics
timeFrame: Postoperative 48 hours
measure: Patient's satisfaction
timeFrame: Postoperative 48 hours
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT06193226: Is Cryotherapy Effective as a Therapeutic Option for Oral Lesion
Official title: Is Cryotherapy Effective as a Therapeutic Option for Oral Lesion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cryotherapy
Oral Lesions
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effectiveness of cryotherapy as a therapeutic option for oral lesions.

Detailed description: Low-temperature applications were originally employed by the Egyptians to treat pain, and subsequently during the Franco-Prussian War for severed limbs. Hippocrates advocated the application of cold to lessen bruising, bleeding, and discomfort, while John Hunter wrote in 1777 that "the local tissue response to freezing includes local tissue necrosis, vascular stasis, and excellent healing." Using a solution of salt and ice, James Arnott (1851) was the first to describe and demonstrate this freezing technique for malignant breast tumors.

The term "cryotherapy" was used in 1908 to describe the use of extremely low temperatures to cure skin lesions. Currently, cryotherapy involves cooling the body's surface without destroying tissue, whereas in cryosurgery, sick tissues are frozen to death.

In the technique, several cryogens include: liquid nitroglycerine (-196 °C), Nitrous oxide (0°C), Solid CO2 (-78o C), Chlorodifluoromethane (-41°C), Dimethyl ether (-24 °C) and propane (-42 °C).

The intralesional technique, open method, or closed method can all be used to apply cryogens. The best application approach for big superficial cutaneous lesions is an open spray technique, in which the spray's nozzle is situated 1 cm away from the skin's surface, and the lesion is destroyed using either a paintbrush technique or a spiral technique.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* Patients who had benign intraoral epithelial lesions free of infection.

Exclusion Criteria:

* Patients with Reynaud's illness.
* Cold sensitivity.
* History of diabetes.
* Severe infections.
* Patients who had cryoglobulinemia.
* Cold urticaria.
* Patients who was receiving hemodialysis.
* Patients who was receiving immunosuppressive medication.

Primary outcomes:
measure: The degree of pain
timeFrame: 21st days postoperatively
Secondary outcomes:
measure: Epithelization of the lesion
timeFrame: 1st month postoperatively
measure: The incidence of recurrence of the lesion
timeFrame: 2nd month postoperatively
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: October 6 University
Study officials:
References: