louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04439812: Influence of Positive Margins on Tumour Recurrence and Overall Survival After Gastrectomy for Gastric Cancer
Official title: Influence of Positive Margins on Tumour Recurrence and Overall Survival After Gastrectomy for Gastric Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stomach Neoplasms
Keywords: Gastric cancer
gastrectomy
R1
positive margins
recurrence
overall survival
prognosis
Lead sponsor: Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 267
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all consecutive patients who underwent an oncological gastrectomy due to gastric cancer, between January 2010 and December 2018 at Ramon y Cajal University Hospital.

Brief summary: Incidence of positive surgical margins after curative gastrectomy ranges from 1% to 20%. It has been suggested that positive surgical margins is an adverse prognosis factor, with a higher local recurrence and worse overall survival (OS). However, the management of these patients remains unclear.


Eligibility criteria: Inclusion Criteria:

* all consecutive patients who underwent an oncological gastrectomy due to gastric cancer, between January 2010 and December 2018 at Ramon y Cajal University Hospital.

Exclusion Criteria:

* distant disease (including patients with positive cytology), early postoperative mortality (within 30 days after surgery) and follow-up data not available. Resections in patients with palliative intent were also excluded.

Primary outcomes:
measure: evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC
timeFrame: 8 years
Secondary outcomes:
measure: The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy.
timeFrame: 8 years
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario Ramón y Cajal
name: Pablo Priego, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03853512: A Study to Gain Information How Well Dexpanthenol Dermal Spray Helps the Skin to Recover After a Peeling in the External Genital Area of Women
Official title: Safety Assessment, Instrumental and Perceived Efficacy 21 Days of Use at Home - Bepantol Derma Spray® Dermal and Gynecological Acceptability Assessment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Skin Recovery
Keywords: Dermal spray
Peeling
Skin hydration
Consumer satisfaction
Sensorial perception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-02-25
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, researchers want to learn more about the effect of dexpanthenol dermal spray on skin recovery after a dermatological procedure (peeling) in the intimate area of women.

After the peeling, participants will return within 3 weeks for 4 visits to the study center to investigate the skin conditions such redness, irritation, softness and possible side effects. In addition, study participants will be asked about their general acceptance of dexpanthenol dermal spray.

Detailed description: The primary objective is to evaluate the efficacy of the test product to aid skin recovery after peeling in the female intima and inguinal region.

Secondary objectives comprise clinical efficacy with respect to skin hydration, softness, vitality, appearance etc. and skin recovery, consumer judgement of product performance and acceptability, and safety.

Eligibility criteria: Inclusion Criteria:

* Phototypes I and II according to the Fitzpatrick scale;
* Participants willing to have peeling in the genital area to improve the general appearance of the skin and bleaching of spots.

Exclusion Criteria:

* Pathologies and/or skin injuries, such as psoriasis, sensitive skin, skin cancer, atopic dermatitis or other medical criteria to be considered at the time of evaluation
* Hyperpigmentation in the test area that interfere with the evaluation of possible reactions (vascular malformations, scars, increase of pilosity and large amount of nevi)
* Pathologies and/or active skin injuries (local and/or disseminated) in the evaluation area

Primary outcomes:
measure: Transepidermal water loss by TEWL probe
timeFrame: Up to 23 days
Secondary outcomes:
measure: Skin properties of the participants
timeFrame: Up to 23 days
measure: Treatment satisfaction
timeFrame: Up to 23 days
measure: Product evaluation
timeFrame: Up to 23 days
measure: Number of adverse events by dermatological evaluation
timeFrame: Up to 23 days
measure: Number of adverse events by gynecological evaluation
timeFrame: Up to 23 days
measure: Severity of adverse events by dermatological evaluation
timeFrame: Up to 23 days
measure: Severity of adverse events by gynecological evaluation
timeFrame: Up to 23 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Medcin Instituto da Pele
Study officials:
References:
Clinical trial NCT04173312: Efficacy of Local Anesthetic Through Continuous Infusion
Official title: Efficacy of Local Anesthetic Through Continuous Infusion Following Laparotomy Procedures.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain Control
Keywords: local anesthetic
continuous infusion
pain control
Lead sponsor: Ascension Health
Sponsor class: INDUSTRY
First posted: 2019-11-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: TREATMENT

Brief summary: Efficacy of using continuous infusion of local anesthetic for post operative pain control following laparotomy.

Detailed description: This study will evaluate the benefits of placing an analgesic pain pump in laparotomy incisions with the addition of intravenous/oral pain medications as needed versus using solely intravenous and oral pain medications as needed for post-operative pain management. The goal of this study will be to decrease the usage of narcotics in post-operative laparotomy patients by providing local incision pain relief. This will be a double blinded randomized control study with placebo with two groups of patients: One with a local anesthetic infusion pump filled with Bupivacaine, a local anesthetic, after laparotomy and the other group with an infusion pump filled with normal saline. The pain pumps will be placed in the OR. Post-operatively, all patients will have the standard pain regimen available to them during their stay. Surgeons will monitor the patient for 4 days post-operatively and the infusion pain pump will be removed on post-operative day 4. Investigator will then look back through each patient's records and gather the amount of pain medications that they requested during their stay. Both groups will then have their data collected in the same manner and placed for data analysis. - The standard pain regimen will include a morphine IV 4mg every 4 hours and Hydrocodone-acetominophen 5/325 Q6H PRN. If a patient controlled analgesia infusion pump is needed this will be considered a need for increase in pain management. Every patient will be started on this pain regimen post operatively. During their stay, If the patient requires an increase in their pain medication, the supervising attending will determine which drug will be added in improve their pain. At the end of the patients stay, the amount of narcotic usage will be compiled and turned into morphine equivalents in order to compare them with the control group.

Eligibility criteria: Inclusion Criteria:

- Patients scheduled for elective laparotomy

Exclusion Criteria:

* Emergency laparotomy
* Pregnancy
* Patients on chronic pain medication

Primary outcomes:
measure: Self Reported Pain
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Blanc
country: United States
facility: Ascension Genesys Hospital
state: Michigan
Study officials:
affiliation: Ascension Health
name: Tarik Wasfie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02903212: Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis
Official title: Tolerance and Effectiveness of Cell Therapy by Autologous Apoptotic Cells in the Treatment of Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Arthritis, Rheumatoid
Keywords: Apoptotic cells
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to determine the tolerance of apoptotic autologous cells injection in subjects with active rheumatoid arthritis.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of Rheumatoid arthritis
* Therapy failure with at least one biological agent from anti-TNF-alpha (etanercept, infliximab, adalimumab, certolizumab and golimumab; 3 months at optimal dose), anti-IL6 (tocilizumab; 3 months); T-cell costimulatory pathway inhibitor (abatacept; 3 months); anti-CD20 (rituximab; 6 months at optimal dose); Anti IL-1 (anakinra; 3 months)
* Disease Activity Score (DAS) DAS28 ≥ 3.2
* Subject has provided written informed consent

Exclusion Criteria:

* Pregnant or lactating women
* Inflammatory arthritis other than rheumatoid arthritis
* History of invasive cancer
* Immunodeficiency (HIV infection, Immunosuppressive therapy)
* Active bacterial or viral infections, in particular HCV or HBV.
* Surgery not older than 4 weeks.
* Unstable comorbidities: uncontrolled diabetes, heart disease, advanced renal or hepatic impairment.
* Contraindication to an apheresis

Primary outcomes:
measure: Tolerance of apoptotic cells injection
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rhumatology - CHU Besançon
name: Eric Toussirot, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05236712: Mobile Health Intervention to Support Healthful Diet
Official title: Pilot Clinical Trial for a Mobile Health Intervention to Support Healthful Dietary Choices in Older Person
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-02-11
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This will be a pilot clinical trial to evaluate preliminary efficacy of a newly designed mobile intervention designed to support healthy eating in old people. The main scientific premise of this project is that mobile approaches are feasible for behavioral and metabolic improvements in the population of people 65+ with mild-to-moderate frailty. Specific Aim of this project is to describe feasibility, acceptability and initial efficacy of the newly designed mobile intervention in a pilot RCT. The pilot RCT, comparing usual care to usual care plus mobile intervention, will provide data on the sensitivity of outcome measures and estimated effect size to inform a larger RCT. Primary outcomes for the pilot RCT will include change in adherence to Mediterranean diet (MedD) score, change in insulin sensitivity measures, feasibility and acceptability. Secondary outcomes include MedD knowledge, self-efficacy, outcome expectation, self-regulation, social support, platform use and anthropometric and functional measures.


Eligibility criteria: Inclusion Criteria:

Age 65+

Mild to moderate frailty

Suboptimal diet

-

Exclusion Criteria:

1. Dependence in activities of daily living
2. Memory Impairment
3. Hearing or visual impairment
4. Unusual dietary restrictions

Primary outcomes:
measure: Change From Baseline Mediterranean Diet (MED) Adherence Score at 3 Months
timeFrame: baseline, 3 month
measure: Change From Baseline HOMA-IR Score at 3 Months
timeFrame: baseline, 3 month
Secondary outcomes:
measure: Change From Baseline Mediterranean Diet Knowledge Score at 3 Months
timeFrame: baseline, 3 month
measure: Change From Baseline Positive Outcome Expectations Score at 3 Months
timeFrame: baseline, 3 month
measure: Change From Baseline Negative Outcome Expectations Score at 3 Months
timeFrame: baseline, 3 month
measure: Change From Baseline Self-regulation Score at 3 Months
timeFrame: baseline, 3 month
measure: Change From Baseline Self-Efficacy Score at 3 Months
timeFrame: baseline, 3 month
measure: Change From Baseline Social Support Score at 3 Months
timeFrame: baseline, 3 month
measure: Change From Baseline Physical Performance Measure at 3 Months
timeFrame: baseline, 3 month
measure: Change From Baseline BMI at 3 Months
timeFrame: baseline, 3 month
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Univeristy of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Oleg Zaslavsky, PhD, MHA, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02014012: PWV for Cardiovascular Complication After Cardiac Surgery
Official title: Evaluation of Pulse Wave Velocity as a Predictive Factor for Postoperative Cardiovascular Complication After Cardiac Surgery: a Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: C.Surgical Procedure; Cardiac
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2013-12-17
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cardiac surgery

Brief summary: Arterial stiffness has been suggested as an independent risk factor for the development of coronary artery disease and stroke. Pulse wave velocity (PWV) is an noninvasive established index to quantify arterial stiffness. Therefore, we try to investigate the correlation between PWV values and cardiovascular complications like stroke, acute renal failure, or perioperative myocardial infarction after cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Cardiac surgery patients who sign the informed consent

Exclusion Criteria:

* Chronic renal failure (Cr\>1.5mg/dL), Dialysis patients
* Previous stroke
* Left ventricular dysfunction (EF \<50%)
* ASO with claudication
* \< 40 years

Primary outcomes:
measure: Postoperative cardiovascular complication and parameters
timeFrame: within the first 7 days after surgery
Secondary outcomes:
measure: E/e' and e' measured by transthoracic echocardiography with color-coded tissue dopper imaging in patients undergoing non-valvular cardiac surgery
timeFrame: baseline and within the first 14 days after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
References:
Clinical trial NCT02726412: PACU Stay After Lower Limb Revascularisation
Official title: Perioperative Mechanisms for Postoperative Function - Case of Lower Extremities Revascularisation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative, Enhanced Recovery
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study includes every patients who undergo revascularisation surgery of one or both of lower extremeties to regain blood perfusion and relieve symptoms. The surgeries in question are for instance bypass, thrombectomy/embolectomy and thromboendarterectomy. The patients preoperative physical state for surgery will be registrered in detailed such as comorbidities, height, weight, bloodpressure and blood test results.

Brief summary: This study aims to describe the postoperative functions of patients with ischaemic lower extremities after undergoing revascularisation surgery . Primary endpoints will focus on complications in the post-anaesthesia care unit (PACU) which prevent discharge from PACU to the general ward. This include Aldrete scores and other complications that can be registrered descriptively. Furthermore, the study seeks to compare the complications outcomes between acute and elective revascularisation surgery.

Detailed description: As above

Eligibility criteria: Inclusion Criteria:

* Patients with symptoms of ischaemic lower extremities for instance intermittent claudication, resting leg pain, non-healing/gangrenouswounds and acute cold leg.
* Patients who underwent one or more of the following surgical procedure: PTA + TEA, TEA, bypass, thrombectomy, embolectomy, femoral-femoral crossover bypass, axillary-femoral bypass.

Exclusion Criteria:

* Only PTA intervention
* Only thrombolysis intervention

Primary outcomes:
measure: Complications assessed by aldrete score
timeFrame: up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet, abdominal center
Study officials:
affiliation: Rigshospitalet, Denmark
name: Eske K Aasvang, DMSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02761512: Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer
Official title: A Double Blind, Randomized, Active-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Ulcer
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2016-05-04
Enrollment: 306
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate non-inferiority of CJ-12420 to lansoprazole 30 mg capsule in terms of therapeutic efficacy, and to confirm safety of CJ-12420, after once daily oral administration of CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg capsule in gastric ulcer patients.

Detailed description: This is a double blind, randomized, placebo-controlled, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg).

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of 1 or more active gastric ulcers (≥3 mm \~ ≤30 mm using open biopsy forceps) according to the Sakita-Miwa classification (A1 or A2 stage) from upper GI endoscopy at the same institution within 14 days prior to initiation of the investigational product administration.

Exclusion Criteria:

1. Finding of gastrointestinal bleeding, esophageal stricture, ulcer stenosis, pyloric stenosis, esophageal gastric varices, Barrett's esophageal of \>3 cm (long segment Barrett esophagus, LSBE), duodenal ulcer, intractable ulcer, digestive ulcer perforation or malignancy on upper GI endoscopy.
2. Ulcer caused by an endoscopic surgery (e.g., ulcer after EMR/ESD)
3. Requirement of persistent daily use of drugs that may cause an ulcer such as nonsteroidal anti-inflammatory drugs(NSAIDs) or aspirin during the course of the study
4. Scheduled surgery requiring hospitalization or requirement of surgical treatment during study participation
5. Subjects who participated in the other clinical trial within 4 weeks prior to randomization

Primary outcomes:
measure: Cumulative healing rate of gastric ulcer at 8-week
timeFrame: 8 weeks
Secondary outcomes:
measure: Healing rate of gastric ulcer at 4-week
timeFrame: 4 weeks
measure: Week 8 healing rates by H. pylori infection
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Catholic Univ. Seoul St. Mary Hospita
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
Study officials:
affiliation: Catholic Univ. Seoul St. Mary Hospital
name: Myung Gyu Choi, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02354612: Open Label Continuation Study of TRC105 for Patients Who Have Completed a Prior TRC105 Trial
Official title: An Open Label Continuation Study of TRC105 Therapy for Patients Who Have Completed a Prior TRC105 Trial and Are Judged by the Investigator to Have the Potential to Benefit From Continued TRC105 Therapy
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Solid Tumors
Lead sponsor: Tracon Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2015-02-03
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Open-label, continuation study

Detailed description: This is a multicenter, open-label, non-randomized, study of TRC105 in patients that have completed a previous TRC105 study and are judged by the investigator to have the potential to benefit from continued TRC105 therapy.

Eligibility criteria: Inclusion Criteria:

* Participation in a TRACON Pharmaceuticals sponsored parent TRC105 study and, thought to have potential to derive clinical benefit from continued treatment with TRC105 in the opinion of the parent study investigator.
* Willing and able to consent for self to participate in study
* Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* 18 years of age or older
* ability to begin TRC105 dosing on this protocol within 6 weeks from the subjects last dose of TRC105 in the parent TRC105 study

Exclusion Criteria:

* Any clinical event that would make TRC105 therapy inappropriate under the parent protocol
* Current treatment in another clinical study
* Pregnant or breastfeeding
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator, would make the subject inappropriate for entry into the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: UCLA
state: California
Study officials:
affiliation: Tracon Pharmaceuticals Inc.
name: Charles Theuer, MD
role: STUDY_DIRECTOR
References: