louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06060002: Role of Prophylactic Biliary Stent in Reducing the Recurrence of Choledocholithiasis
Official title: Role of Prophylactic Biliary Stent in Reducing the Recurrence of Choledocholithiasis and Biliary Complications After Stone Clearance in Patients Awaiting Cholecystectomy-A Multicentric Randomized Controlled Trial (STONE Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Choledocholithiasis
Lead sponsor: Asian Institute of Gastroenterology, India
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: We planned this multicenter randomized controlled trial to study the role of a prophylactic biliary stent in recurrence of stones and biliary complications in patients awaiting cholecystectomy after biliary stone clearance

Detailed description: Patients with cholelithiasis can have presence of concomitant choledocholithiasis (CDL) in upto 30%. These stones may remain asymptomatic or cause obstructive jaundice and complications like cholangitis and pancreatitis. In situations where there is a failure of CDL clearance during endoscopic retrograde cholangiography (ERC), biliary stenting is recommended to prevent complications. However, the role of prophylactic biliary stenting in situations where CDL clearance has been achieved, and the patient is awaiting cholecystectomy is debatable. One retrospective study showed benefit while a small prospective study and a retrospective study did not show benefit of prophylactic biliary stenting. Moreover, a randomized controlled trial addressing this question is lacking. Hence, we planned this multicenter randomized controlled trial to study the role of a prophylactic biliary stent in recurrence of stones and biliary complications in patients awaiting cholecystectomy after biliary stone clearance.

Eligibility criteria: Inclusion Criteria:

* Age between 18-80 years
* Cases of cholelithiasis with concomitant CDL in whom CBD clearance is achieved will be included.

Exclusion Criteria:

* Informed consent not available
* Patients opting for single stage surgery
* Previous hepatobiliary surgery
* Failure to completely clear CDL on ERC
* Concomitant benign biliary strictures (like chronic pancreatitis, portal cavernoma cholangiopathy, post cholecystectomy, primary biliary cholangitis related)
* Previous cholecystectomy patients
* Associated malignancy
* Coagulopathy(INR\>1.5, platlets\<1lac)
* Severe cholangitis

Primary outcomes:
measure: To compare the CDL recurrence rate between the 2 groups
timeFrame: 3 Months
Secondary outcomes:
measure: To compare the pancreatic complications between the 2 groups -To compare the need for repeat ERC between the 2 groups The outcomes will be compared during the time period of 3 months irrespective of the timing of cholecystectomy.
timeFrame: 3 Months
measure: To compare the biliary complications between the 2 groups
timeFrame: 3 Months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04476602: Ambulatory Management of Moderate to High Risk COVID-19 (SARS-CoV-2) Patients - The Coronavirus Related Outpatient Work Navigators (CROWN) Protocol
Official title: Ambulatory Management of Moderate to High Risk COVID-19 (SARS-CoV-2) Patients - The Coronavirus Related Outpatient Work Navigators (CROWN) Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19 (SARS-CoV-2)
Keywords: COVID-19 (SARS-CoV-2)
Homecare
Ambulatory
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2020-07-20
Enrollment: 182
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: General public

Brief summary: Descriptive report of the Northwell CROWN program for ambulatory treatment of COVID-19 (SARS-CoV-2) patients with moderate to high risk features

Detailed description: At the peak of the COVID-19 (SARS-CoV-2) pandemic in New York City, there was a shortage of hospital resources as well as a fear among many New Yorkers of going to the hospital. Emergency Services dead on arrival calls increased by as much as eight-fold.We created the CROWN Program, a pulmonary physician guided home-care protocol to treat ambulatory COVID-19 (SARS-CoV-2) patients with moderate to high risk features. This is a retrospective review of our CROWN program's patient characteristics, results and outcomes.

Eligibility criteria: Inclusion Criteria:

* COVID-19 (SARS-CoV-2) infection Ambulatory

Exclusion Criteria:

* Need for hospital admission

Primary outcomes:
measure: Hospital Admission
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: 410 Lakeville Road, Suite 107
state: New York
Study officials:
affiliation: Northwell Health
name: Gita Lisker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwell Health
name: ramona ramdeo
role: STUDY_DIRECTOR
References:
Clinical trial NCT06544902: Virtual Reality Intervention for Stress, Resilience, and Blood Pressure Management in Black Women - Realist Women Study
Official title: Virtual Reality Intervention for Stress, Resilience, and Blood Pressure Management in Black Women
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stress
Hypertension
Keywords: Intersectional Framework
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-08-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Realist Women Study wants to see if a special program using virtual reality can help Black women deal with stress and improve Black women's heart health. The study team wants to see if using virtual reality (VR) can help with stress of Black women. The investigator will look at things like sleep, stress, and how well the VR works. The investigator also wants to know about any problems Black women might have using virtual reality.


Eligibility criteria: Inclusion Criteria:

* self-identified as a Black woman
* at least 21 years of age
* fluency in English
* International Classification of Diseases (ICD)10 diagnosis of hypertension
* being a South Florida resident
* willing to be audio-recorded

Exclusion Criteria:

* History of psychosis disorders
* absence of vision and cognitive impairment
* absence of epilepsy disorders
* absence of motion sickness.

Primary outcomes:
measure: Change in stress as measured by Perceived Stress Scale (PSS)
timeFrame: Baseline and up to 6 months
measure: Change in discrimination as measured by Intersectional Discrimination Index (InDI)
timeFrame: Baseline and up to 6 months
measure: Change in Traumatic stress as measured by Life Events Checklist
timeFrame: Baseline and up to 6 months
measure: Change in stress as measured by the chronic stress scale
timeFrame: Baseline and up to 6 months
measure: Change in stress as measured by the Stress in Context (SIC) Questionnaire
timeFrame: Baseline and up to 6 months
measure: Change in stress as measured by the Giscombe Superwoman Schema Questionnaire
timeFrame: Baseline and up to 6 months
Secondary outcomes:
measure: Change in resiliency as measured by Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: Baseline and up to 6 months
measure: Change in objective sleep health as measured by Sleep Health Objective
timeFrame: Baseline and up to 6 months
measure: Change in blood pressure
timeFrame: Baseline and up to 3 months after intervention
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Judite Blanc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04740502: Surgical Outcomes in Patients With Primary Hyperparathyroidism and Unclear Preoperative Localisation Studies
Official title: Surgical Approach and Outcomes in Patients With Primary Hyperparathyroidism and Unclear Preoperative Localisation Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Hyperparathyroidism
Lead sponsor: University of Cagliari
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 242
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although some surgeons still consider bilateral neck exploration as the best approach for primary hyperparathyroidism, nowadays most of them perceive the mini-invasive parathyroidectomy (MIP) as the best option for patients with concordant preoperative studies. Nevertheless, the consensus is heterogeneous for patients with unclear localisation studies, with some surgeons deeming BNE as mandatory and others suggesting that a mini-invasive approach is still possible if combined with IOPTH monitoring. In our research, we focused on patients with unclear preoperative localisation studies, to better understand the factors that can determine discordant or negative results between US and MIBI scan, in order to choose the best surgical approach and to evaluate the outcomes in this kind of patients.

Detailed description: This is an unicentric, retrospective study on patients who underwent surgery for PHP from January 2004 to June 2020 at our Department of General and Endocrine surgery, which is a tertiary referral centre for parathyroid disease. Ethical approval was released from our Local Independent Ethical Committee. Patients involved in the study subjects gave informed consent to the work.

In our study, we included only patients who underwent both US and MIBI preoperatively. The exclusion criteria were the association of total or partial thyroidectomy planned preoperatively for thyroid disease, reoperative surgery for persistent or recurrent PHP, and incomplete data or follow-up.

The primary aims of this study were:

* To identify predictive factors of unclear preoperative localisation studies.
* To evaluate if a mini-invasive approach is feasible in this kind of patients, considering the incidence of persistent PHP as the main outcome.

The secondary outcomes were:

* To assess the role of IOPTH assay in patients with unclear localisation studies.
* To evaluate the accuracy of preoperative localisation studies in our series, particularly in patients with discordant or negative US and MIBI scan.

Eligibility criteria: Inclusion Criteria:

* Patients with primary hyperparathyroidism

Exclusion Criteria:

* Patients with concomitant thyroid disease

Primary outcomes:
measure: Surgical failure
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Monserrato
country: Italy
facility: Policlinico di Monserrato
state: Cagliari
city: Monserrato
country: Italy
facility: Policlinico di Monserrato
state: CA
Study officials:
References:
Clinical trial NCT01044602: Metabolic Surgery Versus Medical Management for Resolution of Type II Diabetes
Official title: Metabolic Surgery vs. Medical Management for Resolution of Type II Diabetes: A Prospective Group Match Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Type 2 Diabetes Mellitus
Keywords: Obesity
Type 2 Diabetes Mellitus
Roux-en-Y Gastric Bypass Surgery
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2010-01-08
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Best medical management and gastric bypass surgery is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care).

Detailed description: Best medical management and gastric bypass surgery are ways to treat obesity as part of regular medical care (standard of care). Best medical management is a way to treat diabetes as part of regular medical care (standard of care). However, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care). But, studies suggest that diabetes gets better or goes away after gastric bypass surgery. This study is being done to find out if diabetes gets better or goes away completely after a patient has gastric bypass surgery as part of regular medical care (standard of care).

Eligibility criteria: Inclusion Criteria:

* Age 25 to 70
* BMI 35 or greater
* HbA1c\>6.5%
* Stable weight
* Stable medications

Exclusion Criteria:

* Coagulopathy
* Liver cirrhosis
* C-peptide \<1 ng/ml (off insulin)
* Diagnosis of severe eating disorder
* Untreated endocrine disorder
* Use of medication for weight loss in the past 6 months
* Use of medication for weight loss in the last 6 months (with the exception of orlistat)
* Pregnancy
* Coagulopathy
* Liver cirrhosis
* Incurable, malignant, or debilitating disease
* Severe eating disorder
* Use of weight loss medication in the last 6 months, with the exception of orlistat
* Untreated endocrine disorder
* Pregnant
* Inability to provide informed consent

Primary outcomes:
measure: Resolution of type 2 diabetes mellitus, determined by oral glucose tolerance test.
timeFrame: 2 years
measure: Resolution of obesity co-morbidities including hypertension, OSA, and hyperlipidemia
timeFrame: 2 years
Secondary outcomes:
measure: Improvement in glucose control
timeFrame: 2 years
measure: Improvement in control of chronic co-morbidities
timeFrame: 2 years
measure: Identify predictors of success with regard to improved co-morbidities and velocity of weight loss
timeFrame: 2 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: Asem Ali, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05879302: Shared Decision Making for Kidney Transplant Candidates to Plan for an Organ Offer Decision
Official title: Shared Decision Making for Kidney Transplant Candidates to Plan for an Organ Offer Decision
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: End Stage Renal Disease
End-Stage Kidney Disease
Kidney Transplantation
Esrd
Keywords: Shared Decision Making
SDM
Transplantation
Organ offer
Kidney offer
KDPI
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-05-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this pilot randomized trial is to learn about shared decision making in kidney transplant candidates. The aim of this proposal is to evaluate the Donor Plan Donor Choice tool to promote high-quality Shared Decision Making for providers and kidney transplant candidates at two transplant centers.

Participants will:

* Review an online education tool, Donor Plan Donor Choice.
* Discuss a Kidney Offer Plan with a transplant provider.
* Answer questions about willingness to consider different donor types.

Researchers will compare the Shared Decision Making group to usual care to generate pilot data and implementation outcomes for a larger trial.


Eligibility criteria: Inclusion Criteria:

* Candidate on the kidney transplant waiting list
* Greater than 3 months since listing for transplant
* 18 Years of age or older
* English-speaking

Exclusion Criteria:

* Non-English speaking
* \< 18 years of age
* Patients who choose to opt out of research.
* Unable to provide informed consent

Primary outcomes:
measure: Willingness to accept donor organs at risk of discard
timeFrame: Up to 2 months
Secondary outcomes:
measure: Knowledge
timeFrame: Up to 2 months
measure: Decisional Conflict
timeFrame: Up to 2 months
measure: Distress
timeFrame: Up to 2 months
measure: Shared Decision Making
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin Healthcare
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT05072002: Treatment of Low Back Pain in Pregnant Women : Uses of Drugs and Other Therapies
Official title: Treatment of Low Back Pain in Pregnant Women ; Uses of Drugs and Other Therapies (Acupuncture, Manipulative Medicine, Physical Therapies, Homeopathy) : an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Pregnancy Related
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 370
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women in Lorraine

Brief summary: Low back pain is a frequent clinical condition in pregnancy. Drugs treatments are limited. Other therapies are often used, associated or not with drugs (acupuncture, manipulative medicine, physical therapies, homeopathy). Clinical studies suggest a reduction of low back pain with these therapies.

The primary objective of this study is to determinate how many pregnant women use these alternative therapeutics.

In a second time, we want evaluate efficiency of these therapeutics, especially in pain modification and on quality of life.

Our study is a declarative study on pregnant women in Lorraine.


Eligibility criteria: Inclusion Criteria:

* pregnant women

Exclusion Criteria:

* medical history of : bifida spina, discal hernia, osteoporosis, vertebral compaction, spondylolisthesis, scoliosis ( over 30°)

Primary outcomes:
measure: Percentage of use of other therapies in pregnant women with low back pain ( acunpucture, manipulative medicine, physical therapies, homeopathy)
timeFrame: one day : when each pregnant women submit the questionnaire
Secondary outcomes:
measure: Difference of visual analog scale for pain after and before treatment
timeFrame: one day : when each pregnant women submit the questionnaire
measure: Difference of quality life scale after and before treatment
timeFrame: one day : when each pregnant women submit the questionnaire
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre hospitalier régional universitaire de Nancy
Study officials:
affiliation: Central Hospital, Nancy, France
name: Francis Guillemin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02240602: Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery
Official title: Optimal Dose of i.v Oxycodone for Postoperative Pain After Laparoscopic Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pain
Keywords: acute pain
postoperative
surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Postoperative pain control is required after major abdominal surgery, including laparoscopic colorectal surgery. Intravenous oxycodone is widely used for postoperative acute pain control mainly in Europe. The aim of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean.

Detailed description: Oxycodone is known to be effective in pain control and has less sedative effect than morphine does. It has been described that distribution of cytochrome P450, which is associated with metabolism of oxycodone, differed between the races. Proper dose of intravenous oxycodone after major abdominal surgery has not been well defined in Korean. The purpose of this study is to evaluate the optimal dose of intravenous oxycodone for pain control after laparoscopic colorectal surgery in Korean based on pain score and side effects.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists class 1,2
* Expected surgical time between 2 - 6 hours
* Scheduled for laparoscopic colorectal surgery

Exclusion Criteria:

* Severe dysfunction of liver, heart, kidney, or lung
* Cannot understand numeric rating scale of pain
* Known or suspected allergy to oxycodone
* Previous history of postoperative nausea or vomiting
* Medication of antidepressants
* Postoperative long-term ICU care or prolonged mechanical ventilatory support
* Chronic pain
* Drug abuser
* Hypersensitivity reaction to aspirin or NSAIDs
* Refuse to enroll

Primary outcomes:
measure: resting postoperative pain at 24hr
timeFrame: 24 hr after surgery
Secondary outcomes:
measure: side effects
timeFrame: 24 hr after surgery
Other outcomes:
measure: sedation
timeFrame: 24 hr after surgery
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yunseok Jeon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00610402: Incidence of Ocular Antibodies in Patients With Sturge - Weber Syndrome (SWS)
Official title: Incidence of Ocular Antibodies in Patients With Sturge - Weber Syndrome (SWS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sturge - Weber Syndrome (SWS)
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Mainz University
First posted: 2008-02-08
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

Brief summary: Sturge-Weber Syndrome (SWS) is a neurological disorder characterized at birth by seizures and a large port-wine stain birthmark on the forehead and upper eyelid of one side of the face. SWS is also accompanied by an increased pressure within the eye (glaucoma) which can develop very early in life.

Glaucoma represents a group of ocular disorders that are characterized by the loss of retinal ganglion cells and their axons, damage to the optic nerve, and gradual loss of visual field. Recently, several studies provided evidence that there is a potential role of the immune system in the pathogenesis of glaucoma.

These findings suggest that there might be changes in systemic humoral immunity possibly underlying the optic neuropathy in at least some glaucoma patients.

Detailed description: The ocular antibody profile in patients with SWS is unknown.The researchers want to study on blood and tear drop samples from patients with SWS to determine the incidence of ocular antibodies in patients with this syndrome.

Eligibility criteria: Inclusion Criteria:

* Male and female volunteers with SWS of all ages

Exclusion Criteria:

* Volunteers without SWS

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute Medical clinic
state: California
Study officials:
affiliation: Beckman Laser Institute University of California Irvine
name: John S Nelson, M.D,PhD
role: PRINCIPAL_INVESTIGATOR
References: