louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05357807: Extending and Banding the Roux-en-Y Gastric Bypass
Official title: Extending and Banding the Roux-en-Y Gastric Bypass
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Morbid Obesity
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.

Detailed description: The Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for morbid obesity by reducing weight and comorbidities. Extending the pouch may improve weightloss without the increase of complications. Some patients regain weight after initially good weightloss. Placing a minimizer around the pouch may prevent weight regain.

A prospective randomize controlled trial.

Study population: alle patients undergoing RYGB are eligible for the study. inclusion criteria are BMI 35-40 kg/m2 with one or more obesity related comorbidities, or BMI \> 40 kg/m2 without any comorbidities.

Intervention: Standard RYGB versus an extended pouch RYGB vs a banded-extended RYGB.

Eligibility criteria: Inclusion Criteria:

* All patients who are eligible for a primary RYGB

Exclusion Criteria:

* Bariatric surgery in medical history
* Patients with a language barrier which may affect the compliance with medical advice
* Patients with a disease not related to morbid obesity, such as Cushing or drug related.
* Chronic bowel disease for example Crohn's disease or colitis Colitis.
* Renal impairment (MDRD \<30)
* Hepatic dysfunction (liver function twice the normal values)
* Pregnancy during follow-up
* Patients with treatment-resistant reflux symptoms.

Primary outcomes:
measure: Percentage Total Body Weight Loss (%TBWL)
timeFrame: 3 years
Secondary outcomes:
measure: Percentage Excess Weight Loss (%EWL)
timeFrame: 3 years
measure: BODY-Q: Quality of life after bariatric surgery
timeFrame: 3 years
measure: BAROS: Quality of life after bariatric surgery
timeFrame: 3 years
measure: SF-36: Quality of life after bariatric surgery
timeFrame: 3 years
measure: Gastroesophageal reflux disease
timeFrame: 3 years
measure: Change in comorbidities in patients pre- and postoperative
timeFrame: 3 years
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
state: Gelderland
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis
state: Utrecht
city: Den Haag
country: Netherlands
facility: NOK West
Study officials:
References:
Clinical trial NCT01021007: Clinical Research Study Efficacy of a Prototype Oral Rinse
Official title: Clinical Research Study Efficacy of a Prototype Oral Rinse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Plaque
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2009-11-26
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the efficacy of an oral rinse on dental plaque and gingival inflammation


Eligibility criteria: Inclusion Criteria:

1. Male or female volunteers 18-65 years of age
2. Good general health
3. Must sign informed consent form
4. Minimum of 16 natural uncrowned teeth (excluding third molars) must be present.
5. No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.
6. Dental Selection Criteria: Gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a GI score of ≥ 3. Subjects will be stratified according to gingivitis severity. Average full mouth GI score should be in the range of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0

Exclusion Criteria:

1. Subjects unable or unwilling to sign the informed consent form.
2. Medical condition which requires pre-medication prior to dental visits/procedures
3. Moderate or advanced periodontal disease
4. History of allergy to iodine
5. History of thyroid disease
6. History of diabetes
7. 2 or more decayed untreated dental sites at screening.
8. Other disease of the hard or soft oral tissues.
9. Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
10. Use of medications that are currently affect salivary flow.
11. Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
12. Pregnant or nursing women.
13. Participation in any other clinical study within 1 week prior to enrollment into this study.
14. Use of tobacco products
15. Subjects who must receive dental treatment during the study dates.
16. Current use of Antibiotics for any purpose.
17. Presence of an orthodontic appliance.
18. History of allergy to common dentifrice ingredients
19. Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
20. Women of childbearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (Intrauterine device), condoms).
21. Smoker

Primary outcomes:
measure: Gingival Index
timeFrame: 6 weeks
measure: EIBI Bleeding Score: Eastman Indterdental Bleeding Index Scale
timeFrame: 6 weeks
measure: Plaque Index (Quigley-Hein Score)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Northfield
country: United States
facility: New Institutional Service Company
state: New Jersey
Study officials:
name: Matthew Cronin, DMD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05704907: Diagnostic Performance of Dual Energy CT for the Detection of Gallbladder Gallstones
Official title: Diagnostic Performance of Dual Energy CT for the Detection of Gallbladder Gallstones
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gallstone
Keywords: abdominal and pelvic scan
abdominal Ultrasound
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To assess diagnostic performance of Dual Energy CT fo gallblader gallstone detection.

Detailed description: Detection of gallbladder gallstone using Dual Energy CT compare to gallblader ultrasound (gold standard).

All patients who undergo dual-energy CT scans will undergo abdominal ultrasound for gallstones.

Performance of CT to conventionnal KeV will be compare to low Kev monoenergetic reconstruction, and Effective Z.

Expected duration of inclusion 3-6 months. No follow-up.

Eligibility criteria: Inclusion Criteria:

* patient referred to the radiology department for an abdominal CT for abdominal pain, suspicion of cholangitis, cholecystitis, migration of stones, acute pancreatitis, suspicion of perforated ulcer in the emergency setting.
* Non-objection of the subject to participate in the study
* Affiliation to a French social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

* Cholecystectomy
* Legal incapacity or limited legal capacity, legal safeguard
* Pregnant women
* Subject unlikely to cooperate in the study and/or low cooperation anticipated by the investigator
* Subject being in the exclusion period of another study

Primary outcomes:
measure: Gallstone detection using Dual Energy CT
timeFrame: Day 0
Secondary outcomes:
measure: Gallstone detection using reconstruction to conventionnal KeV.
timeFrame: Day 0
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
Study officials:
affiliation: CHU de Besançon
name: Paul CALAME, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02422407: A Longitudinal, Observational Biomarker Study in Participants With Primary Sjogren's Syndrome
Official title: A Biomarker Study to Determine the Gene Expression Signatures of Salivary Gland and Blood in Subjects With Incident Primary Sjögren's Syndrome, Subjects With Sicca, and Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Sicca Syndrome
Sjögren's Syndrome
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-04-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with sicca and healthy volunteers will be recruited from multiple sites

Brief summary: The main objective of the study is to characterize the gene expression in immune and epithelial cells in salivary gland biopsy samples and blood of pSS (primary Sjögren's syndrome) and non-pSS participants including healthy volunteers.


Eligibility criteria: Key Inclusion Criteria:

For Healthy Volunteers:

* In good overall health as determined by the Investigator For Participants With Sicca
* Subjects should present with sicca (i.e., dry eyes and dry mouth) at Baseline
* Must be willing to undergo a minor salivary gland (labial) biopsy

Key Exclusion Criteria:

* A history of any clinically significant medical condition, as determined by the Investigator, that may impact study analyses
* A chronic or persistent infection human immunodeficiency virus (HIV), hepatitis B, hepatitis C, and/or tuberculosis
* Pre-existing connective tissue disease or autoimmune disease, such as systemic lupus erythematosus (SLE), rheumatoid arthritis, systemic sclerosis, or sarcoidosis
* Any known contraindications of sialoscintigraphy

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Gene expression levels in immune cells (innate and adaptive) in salivary gland biopsy samples from participants with and without pSS including healthy volunteers
timeFrame: Up to 12 months
measure: Gene expression levels in immune cells (innate and adaptive) in blood samples from participants with and without pSS including healthy volunteers
timeFrame: Up to 12 months
measure: Gene expression levels in epithelial cells in salivary gland biopsy samples from participants with and without pSS including healthy volunteers
timeFrame: Up to 12 months
measure: Gene expression levels in epithelial cells in blood samples from participants with and without pSS including healthy volunteers
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Research Site
state: Connecticut
city: Boston
country: United States
facility: Research Site
state: Massachusetts
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Dallas
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02841007: Midds Ankle Fracture
Official title: gekoTM Neuromuscular Electrostimulation (NMES) Device, Pilot Feasibility Study Looking at Time to Surgery Study in Patients Requiring Ankle Fixation Following Fracture, Comparison to Matched Retrospective Controls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Fracture Requiring Internal Fixation
Lead sponsor: Firstkind Ltd
Sponsor class: INDUSTRY
First posted: 2016-07-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The geko™ device is indicated for the prevention and treatment of oedema. The aim of this study is to show that recruiting, and performing study assessments in ankle fracture patients requiring surgery to fix their ankle attending the James Cook Hospital is feasible, and to obtain data to support the powering of a larger study to demonstrate the effectiveness of the geko™ device at reducing length of stay for this population of patients. This study will also allow us to assess the acceptability, tolerability and compliance of treatment with the geko device.


Eligibility criteria: Inclusion Criteria:

1. Aged 18-60 years old
2. Clinically and radiologically diagnosed acute ankle fracture that, in the opinion of the treating surgeon, requires operative fixation
3. Able to understand the Patient Information Sheet (PIS) and willing to sign the written Informed Consent Form.
4. Able and willing to follow the protocol requirements.

Exclusion Criteria:

1. Has a pacemaker
2. Morbid Obesity (BMI Index \>40kg/m2).
3. Patients who on presentation to hospital are known to be pregnant.
4. Clinically significant co-morbidities that need to be treated prior to surgical intervention and could therefore impact upon time to theatre
5. History or signs of previous deep or superficial vein thrombosis/pulmonary embolism.
6. Varicosities, ulceration or erosion around the area of the leg where the study device would be fitted
7. Diabetic
8. Already taking part in a clinical study, or has so within the last 8 weeks
9. None responder to geko™ device

Primary outcomes:
measure: Feasibility to recruit n=20 ankle fracture patients in trauma setting within 4 months
timeFrame: 4 months
measure: Time to readiness for surgery
timeFrame: 0-~7days
Secondary outcomes:
measure: Oedema reduction in prospective geko™ subjects prior to surgery, by two circumferential measures using tape measures built into the patients plaster cast
timeFrame: 0-~7days
measure: Adverse events, including the need for secondary surgery or additional treatment, serious adverse events
timeFrame: study duration up to ~14days
Other outcomes:
Locations:
city: Middlesbrough
country: United Kingdom
facility: James Cook Hospital
Study officials:
References:
Clinical trial NCT05621707: Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Locally-advanced Esophageal Squamous Cell Cancer (RICE)
Official title: A Phase 2 Trial of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Esophageal Squamous Cell Carcinomas
Concurrent Chemoradiotherapy
Immunotherapy
Chemotherapy
Keywords: esophageal cancer
chemoradiotherapy
immunotherapy
chemotherapy
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2022-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of non-operative Locally Advanced Esophageal Cancer . The purpose of this study was to evaluate the efficacy and safety of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer.


Eligibility criteria: Inclusion Criteria:

1. Age:18-75 years of age;
2. Histologically confirmed squamous cell carcinoma;
3. locally-advanced ,medical inoperability, technical irresectability, or patient refusal to surgery;
4. Eastern Cooperative Oncology Group (ECOG) performance status:0-2;
5. Able to eat a semi-liquid diet;
6. Less than 20% weight loss within 6 months;
7. Adequate hepatic function, renal function, hematologic function and coagulation function;
8. Documented informed consent.

Exclusion Criteria:

1. Distant metastasis;
2. Known malignancy diagnosed or require active treatment in the last 5 years, except for cancers that can be cured by surgery including cervical cancer in situ, basal or squamous cell skin cancer, breast ductal carcinoma in situ, localized prostate cancer;
3. Prior thoracic irradiation, chemotherapy, or lobectomy
4. Known diseases or conditions that are contraindicated for radiotherapy or surgery;
5. Allergy to the research medications;
6. Pregnant women or women preparing for pregnancy;
7. Diagnosis of autoimmune disease or history of chronic autoimmune disease
8. Absence of informed consent because of psychological, family, social and other factors;
9. Patients with comorbidities (chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, unstable mental disorders requiring therapy).

Primary outcomes:
measure: Overall Survival Rate
timeFrame: 3 years after last patient enrolled
Secondary outcomes:
measure: progression-free Survival (PFS)
timeFrame: 3 years after last patient enrolled
measure: Treatment related complications
timeFrame: During the procedure
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01260207: Using IVR to Maintain ACS Patients on Best Practice Guidelines
Official title: Using Interactive Voice Response to Improve Disease Management and Compliance With Acute Coronary Syndrome Best Practice Guidelines
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Medication Adherence
Keywords: Acute Coronary Syndrome
Interactive Voice Response Technology
Best Practice Guidelines
Compliance
Health Care Utilization
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Ottawa Heart Institute Research Corporation
First posted: 2010-12-15
Enrollment: 654
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether interactive voice response (IVR) technology can be used to bring post discharge care for acute coronary syndrome (ACS) closer to best practice guidelines (BPGs).

The study hypothesis is that ACS patients who are contacted by IVR technology will be more likely to receive care as recommended in the BPGs than those followed by usual care.

Detailed description: Acute coronary syndrome (ACS) is a significant public-health problem in Canada and worldwide with 20,000 Canadians dying of myocardial infarction and 42,000 dying of coronary artery disease in 1999. Large clinical trials have provided evidence for the development of standardized best practice guidelines (BPG) and compliance with these guidelines have significantly improved survival. Despite the development and dissemination of BPG, their application in patients with ACS is suboptimal. This randomized control trial will use 2 groups: IVR and usual care. Patients in the IVR group will receive 5 automated calls at 1,3,6,9 and 12 months consisting of predetermined questions related to medication management, smoking cessation, diet, exercise and education as recommended by the ACC/AHA BPG for ACS. Responses are captured in a database allowing for interventions to maintain patients on BPG as needed.

Eligibility criteria: Inclusion Criteria:

* Patients discharged from LHSC with ACS (acute myocardial infarction, STEMI, NSTEMI or unstable angina)
* Patients who have a land line telephone service at home
* Patients who speak English

Exclusion Criteria:

* Patients discharged to a care facility or transferred to another health care institution
* Patients who cannot provide informed consent

Primary outcomes:
measure: Compliance with BPGs
timeFrame: 1 Year
Secondary outcomes:
measure: Utilization of health care resources: emergency visits, unscheduled physician visits and hospitalization and patient satisfaction
timeFrame: 1 Year
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: University of Western Ontario and London Health Sciences Centre
name: Neville G. Suskin, MBChB, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00623207: Use of Atropine in Tredmill Stress Testing
Official title: Safety and Feasibility of Atropine Added During Treadmill Stress Testing in Patients With Chronotropic Incompetence or Poor Exercise Capacity.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chest Pain
Keywords: Chest Pain Low work Capacity Rate Incompetence
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2008-02-25
Enrollment: 103
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the Safety and feasibility of atropine added during treadmill stress testing in patients with chronotropic incompetence or poor exercise capacity.

Our hypothesis is that we can increase heart rate by using atropin in these patients, so we will achieve more conclusive results.


Eligibility criteria: Inclusion Criteria:

* Patients with chest pain without evidence of ischemia eligible for exercise test.
* Age\> 18 years old

Exclusion Criteria:

Absolute:

* Patients with LBBB
* Unstable Angina
* Recent Myocardial Infarction
* Un controlled Arrythmia
* Congestive heart faliure
* Severe symptomatic valvular heart disease
* Acute Pulmonary Embolism
* Acute perimyocarditis
* Acute aortic dissection

Relative:

* Lt main stenosis
* Severe hypertention (Systolic\> 200 mmHg; Diastolic \> 100 mmHg)
* Cardiomyopathy
* Obstructiove abnormalities
* Psychiatric disorders
* High degree AV Block

Primary outcomes:
measure: 1- To characterize patients who can't achieve target heart rate at treadmill exercise test.2- To evaluate atropine added during treadmill stress testing in order to increase heart rate and achieave conclusive test.
timeFrame: 1 yaer
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Heart Institute, Ha'Emek Medical Center
Study officials:
References: