louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04783961: Cold Snare Endoscopic Resection for Duodenal Adenomas
Official title: Cold Snare Endoscopic Resection for Duodenal Adenomas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duodenal Adenomas
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2021-03-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diagnosed large duodenal adenomas (\>20 mm)

Brief summary: Non-ampullary sporadic duodenal adenomas (SDA) are rare lesions, incidentally discovered in up to only 5% of patients during routine endoscopy. In any case, these lesions require treatment due to their potential malignant transformation because of the adenoma-carcinoma sequence, occurring in 30-85% of cases. Endoscopic resection (ER) of SDA represents an attractive alternative to surgical resection in appropriately selected patients, with lower morbidity and mortality rates.

However, most endoscopists are not keen to resect larger lesions due to the risk of complications. Indeed, endoscopic resection in the duodenum has unique challenges: thin wall, high vascularity, very limited space and harmful effects of bile and acid both acting on the ER defect.

Cold snare endoscopic resection has been shown to be a viable method for removing colorectal lesions with comparable efficacy outcomes compared to conventional polypectomy/endoscopic mucosal resection (EMR) and a promising safety profile. As a matter of fact, adverse events associated with hot snare resection technique such as delayed bleeding, post-polypectomy syndrome, and perforation are all related to electrocautery-induced injury.

Performing cold snare piece-meal resection and avoiding the need of thermal therapy, may have a major impact in the duodenum where the risk of delayed bleeding and perforation is consistent.

The aim of this pilot study is to prospectively evaluate the feasibility and the efficacy in term of safety and efficacy of cold snare endoscopic resection.


Eligibility criteria: Inclusion Criteria:

• Patients able to give informed consent to involvement in trial.

Exclusion Criteria:

* Patient's with known strictures/stenosis
* Pregnancy
* Patients who did not consent to study
* Bleeding diathesis
* Anticoagulants

Primary outcomes:
measure: Number of patints that will have serious and non-serious adverse events
timeFrame: 3 Months
measure: Number of residual adenomas
timeFrame: 3 Months
Secondary outcomes:
measure: Duration of endoscopic procedure
timeFrame: 3 Months
measure: Hospital stay
timeFrame: 3 Months
measure: Hospital readmission
timeFrame: 3 Months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Endoscopy Unit, Humanitas Research Hospital
state: Milano
Study officials:
References:
Clinical trial NCT00405561: Study to Evaluate Progression Free Survival in Cancer Patients With Advanced Colorectal Carcinoma With AMT2003
Official title: A Prospective, Open, Single-Arm, Multicenter Phase II Clinical Trial to Evaluate the Progression Free Survival and Safety in Patients With Advanced Colorectal Carcinoma Treated With AMT2003
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Colorectal Carcinoma
Keywords: Advanced Colorectal Carcinoma
Lead sponsor: Auron Healthcare GmbH
Sponsor class: INDUSTRY
First posted: 2006-11-30
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate efficacy and safety of AMT2003 in cancer patients with advanced colorectal carcinoma.

The primary endpoint is progression free survival rate at 18 weeks after registration

Detailed description: The study will include patients with advanced colorectal carcinoma that is refractory to standard therapy or for which no effective standard therapy exists. Eligible patients must have had at least second-line chemotherapy.

Eligibility criteria: Inclusion Criteria:

* Cancer confirmed by histology or cytology
* At least one measurable lesion
* Advanced disease refractory to standard therapy or for which no standard therapy exists
* Life expectancy of at least 3 months

Exclusion Criteria:

* Known secondary neoplasia or central nervous system (CNS) metastases; acute or chronic leukemia, lymphoma or multiple myeloma
* Body weight below 45 kg
* Female patients who are pregnant or breast feeding or adults of reproductive potential not employing effective method of birth control
* Confirmed diagnosis of HIV
* Insulin dependent diabetes mellitus / abnormal glucose tolerance test (GTT) / latent diabetes mellitus type I or II
* Chemotherapy or radiotherapy less than 4 weeks prior to entry
* Surgery less than 2 weeks prior to entry (or not recovered from effects of surgery)
* Participation in a clinical trial less than 30 days prior to entry in the study

Primary outcomes:
measure: Progression free survival;at 18 weeks after registration
timeFrame: 2010
Secondary outcomes:
measure: Best overall response rate (ORR, CR and PR) within 18 weeks after registration
timeFrame: 2010
measure: Progression Free survival time (PFS), over complete observation period
timeFrame: 2010
measure: Overall Survival (OS) time
timeFrame: 2010
measure: Quality of Life (EORTC QLQ-C30) and Performance Status (Karnofsky Index)
timeFrame: 2010
measure: Safety and Tolerability
timeFrame: 2010
Other outcomes:
Locations:
city: Freiburg im Breisgau
country: Germany
facility: Clinic SanaFontis
Study officials:
affiliation: Clinic Sanafontis, Freiburg
name: Joachim Drevs, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03285061: Excess Opioid Disposal Following Orthopedic Foot and Ankle Surgery
Official title: Excess Opioid Disposal Following Orthopedic Foot and Ankle Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Disposal
Behavior
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2017-09-15
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study aims to survey the drug disposal methods of orthopedic foot and ankle patients with excess pain medication following and operation. The study is a randomized control trial comparing the use of FDA approved at home disposal methods to current clinical methods of recommending disposal at medication drop off locations.


Eligibility criteria: Inclusion Criteria:

* This study will include foot and ankle orthopedic patients at Brigham and Women's Hospital undergoing a surgical procedure.

Exclusion Criteria:

* Those under age 18 will be excluded from this study, as their variation in care could affect the data. We will also exclude adults with impaired decision-making capacity and adults who take methadone or have a history of prior opioid dependence.

Primary outcomes:
measure: Number of Participants Who Safely Disposed The Excess Medication
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Christopher Chiodo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06243861: Attachment Bonding and Neonatal Hospitalization: the Impact of Hospitalization in a Kangaroo Unit
Official title: Attachment Bonding and Neonatal Hospitalization: the Impact of Hospitalization in a Kangaroo Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postnatal Care
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2024-02-06
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient hospitalized in a Kangaroo Unit or in a post-natal unit

Brief summary: The Kangaroo Unit (UK) takes care of newborns requiring special care or monitoring for a pathology whose clinical situation is stable and whose prognosis is favorable. In order to avoid separating mother and child, these units were created with a care pathway somewhere between that requiring hospitalization in a neonatal unit and that of pathology-free newborns in post-natal care. Theoretically, the mother-child bond created in the UK is as good as that created in conventional post-natal care. However, studies show that there are limits to the quality of the bond in the UK. This study aims to assess whether the mother-child bond is degraded in the UK, in comparison with that of mothers in post-natal care.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years of age, hospitalized in a Kangaroo Unit or in a post-natal unit,
* Affiliated to a social security scheme,
* fluent in French
* no objection of participation

Exclusion Criteria:

* Patient who :

  * given birth to a child who was stillborn or died at birth
  * difficulty understanding written French
  * psychological incapacity (psychiatric disorder, too great a vulnerability) or physical incapacity (physical/motor disability) to answer questionnaires,
* Patient under court protection, guardianship or curatorship.

Primary outcomes:
measure: Mother-infant bonding
timeFrame: Up to 3 days after delivery
Secondary outcomes:
measure: Assessment of mothers' state and trait anxiety levels
timeFrame: Up to 3 days after delivery
measure: Assessment of perceived parenting competence
timeFrame: Up to 3 days after delivery
measure: Assessment of patients' quality of life
timeFrame: Up to 3 days after delivery
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville/Hopital Mercy
Study officials:
affiliation: CHR Metz Thionville
name: Marie-Laure BOYE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01459861: Early Ambulation After Adductor Canal Block for Total Knee Arthroplasty
Official title: Assessment of Early Ambulation in Patients Receiving Continuous Adductor Canal Block With Ultrasound Guided Posterior Capsular Knee Injection vs. Femoral Nerve Block With Tibial Nerve Block Following Total Knee Replacement
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Osteoarthritis
Keywords: early ambulation
knee arthroplasty
Lead sponsor: Trinity Health Of New England
Sponsor class: OTHER
First posted: 2011-10-26
Enrollment: 11
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: TREATMENT

Brief summary: The purpose of this study is to assess early ambulation following total knee replacement in patients receiving continuous adductor canal block with posterior capsular injection compared to continuous femoral nerve block with tibial nerve block.


Eligibility criteria: Inclusion Criteria:

* knee arthroplasty
* ages 18-80

Exclusion Criteria:

* history of neurological disease
* diabetes
* pregnancy
* neuropathy
* chronic narcotic use
* allergy to local anesthetic solution or NSAIDS
* inability to give consent or cooperate with the study protocol

Primary outcomes:
measure: Ability to ambulate post operatively.
timeFrame: Up to 3 days (72 hours) post surgery.
Secondary outcomes:
measure: Pain scores at rest and with knee flexion.
timeFrame: Up to 3 days ( 72 hours) after surgery
measure: Pain Medication Consumption
timeFrame: Up to 3 days (72 hours) post surgery
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Saint Francis Hospital and Medical Center
state: Connecticut
Study officials:
affiliation: Saint Francis Hospital
name: Sanjay Sinha, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00207961: The Threshold Value of Regional Cerebral Oxygenation in Detecting Cerebral Ischemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Ischemia
Regional Cerebral Oxygenation
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2005-09-21
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Using patients receiving spinal anesthesia as a model to evaluate the treshold value of cerebral oximeter to detect the symptoms of cerebral ischemia

Detailed description: 56 patients has been recruited for the analysis of relationship between the symptoms of cerebral ischemia and the value of cerebral oximeter. All patients were recieved spinal anesthesia for the procedure of Ceserean section.

Eligibility criteria: Inclusion Criteria: patients who are going to undergo Cesarean section under spinal anesthesia

Exclusion Criteria: conditons contraindicated for regional anesthesia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Anesthetic Department
Study officials:
affiliation: Anesthetic Department
name: Hung C Cheng, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00824161: Phase II Study of TAS-109 to Treat Advanced Colorectal Cancer
Official title: A Phase II Study of TAS-109 Given by Continuous Intravenous 14-day Infusion in Patients With Chemotherapy-refractory Advanced Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Advanced Colorectal Cancer
Lead sponsor: Taiho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-01-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate progression free survival primarily. The secondary objectives are to evaluate the antitumor activity, as assessed by objective tumor response, duration of clinical benefit, overall survival, and the safety profile of TAS-109


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed colorectal adenocarcinoma
* Received prior therapy, at least two regimens, containing a fluoropyrimidine, oxaliplatin, and irinotecan
* Have at least one measurable tumor, as defined by RECIST
* Must be capable of maintaining a central venous line access

Exclusion Criteria:

* Had previous anti-tumor therapy in the 3 weeks prior to study entry
* Have not recovered from all toxicities (excluding alopecia) from prior therapy to baseline or ≤grade 1 prior to study entry
* Have another malignancy in the past 3 years except curatively treated non-melanoma skin cancer or carcinoma in situ of the cervix

Primary outcomes:
measure: Percentage of Progression Free Survival
timeFrame: From date of randomization until date of the first documented progressive disease (PD) or death from any cause, whichever came first, assessed up to 3 months.
Secondary outcomes:
measure: Antitumor Activity
timeFrame: From the date of initial treatment until the date of the first objective documentation of PD or death from any cause.
measure: Overall Survival
timeFrame: From the initial treatment until 12 months after enrollment of the last patient.
Other outcomes:
Locations:
city: East 34th Street, New York
country: United States
facility: NYU Cancer Institute
state: New York
city: Holcombe Boulevard, Houston
country: United States
facility: The University of Texas M.D. Anderson Cancer Center
state: Texas
city: West Magnolia Avenue, Fort Worth
country: United States
facility: The Center for Cancer and Blood Disorders
state: Texas
Study officials:
affiliation: The Center for Cancer and Blood Disorders
name: Henry Xiong, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06080061: Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer
Official title: Phase I Trial of Personalized Accelerated ChEmoRadiation (PACER) for Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Lung Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: LUNGevity Foundation
First posted: 2023-10-12
Enrollment: 45
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 purpose of this study is to examine the use of hypofractionated accelerated radiation therapy (HART) to treat locally advanced lung cancer. Depending on the location and size of the tumor.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically documented malignancy of the lung including non-small cell lung cancer or small cell lung cancer planned for definitive therapy with fractionated radiation (60-66 Gy) and concurrent systemic therapy
* ECOG performance status of 0-2
* Age \> 18 years old
* Ability to understand and the willingness to personally sign the written IRB approved informed consent document
* Estimated life expectancy of 12 weeks or longer

Exclusion Criteria:

* Contraindication to receiving radiotherapy or systemic therapy as determined by treating radiation and medical oncologist
* Age \< 18 years old
* Tumor directly invading the major pulmonary arteries, aorta, heart or proximal bronchial tree
* Diagnosis of interstitial pulmonary fibrosis
* Previous radiation therapy to the thorax that would result in overlapping high dose radiation fields

Primary outcomes:
measure: Dose limiting pulmonary and esophageal toxicity
timeFrame: 9 months
Secondary outcomes:
measure: Acute and Late Toxicities
timeFrame: 36 months
measure: Integrated adaptive dosing regimen with an automated planning system
timeFrame: 36 months
measure: Progression free survival
timeFrame: 36 months
measure: Overall survival
timeFrame: 36 months
measure: Local control
timeFrame: 36 months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Lucas K Vitzthum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03248661: Assessing Repeat Fit Testing for CRC
Official title: Assessing Repeat Annual FIT Screening for Colo-Rectal Cancer (CRC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colo-rectal Cancer
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2017-08-14
Enrollment: 220
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study will randomly assign 220 men and women to either a social media intervention or a standard reminder system to have a repeat screening test for colo-rectal cancer.

Detailed description: Only persons initially screening by FIT (through a Rural Cancer Prevention Center service program) will be eligible for study participation. The objective is to test a social media-based intervention designed to promote annual repeat colo-rectal cancer screening using the Fecal Immunochemical Test (FIT) among person who have taken the FIT test once before. 220 men and women (50 to 75 years of age) will be recruited and randomly assigned to either the intervention condition (monthly social media contact) or a control condition (standard of care reminder for repeat testing one month before the annual test is due). The dependent variable will be whether volunteers requested and retuned a FIT kit with 60 days of the annual due date (one year from their initial screening).

Eligibility criteria: Inclusion Criteria:

* must have completed and returned an initial FIT kit to us as part of a Rural Cancer Prevention Center service program to the community

Exclusion Criteria:

* visible blood in stool or prior diagnosis of cool-rectal cancer

Primary outcomes:
measure: Primary endpoint is a received completed FIT kit within 15 months after the participant received results from the original FIT test
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
References:
Clinical trial NCT03226561: Assessment of Near Vision Capacity in Different Light Conditions Following Bilateral Trifocal Intraocular Implantation
Official title: Assessment of Near Vision Capacity in Different Light Conditions Following Bilateral Trifocal Intraocular Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2017-07-24
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is known that light intensity and temperature has a great impact on near vision capacity. Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for ADLs that demand near vision acuity for a sample of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation

Detailed description: Patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation are supposed to have sufficient uncorrected vision capacity for activities of daily living (ADLs) that require near vision acuity (NV), (ie. book reading). However, it is known that light intensity and temperature has a great impact on near vision capacity. Primary objective of this study is to identify the optimal task lighting conditions (in terms of light intensity and temperature) for ADLs that demand near vision acuity for a sample of patients who underwent presbyopic correction with bilateral trifocal intraocular lenses implantation. The following light intensities will be evaluated: 25, 50, and 75 foot candles. Moreover, the following light temperatures will be evaluated: 3000, 4000, and 6000 Kelvins.

Eligibility criteria: Inclusion Criteria:

Presbyopia

Exclusion Criteria:

Glaucoma Corneal pathology Fundus pathology Severe neurological/mental diseases that interfere with visual acuity

Primary outcomes:
measure: uNVC (3000K)
timeFrame: 6 months
measure: uNVC (4000K)
timeFrame: 6 months
measure: uNVC (6000K)
timeFrame: 6 months
measure: uNVC (25FC)
timeFrame: 6 months
measure: uNVC (50FC)
timeFrame: 6 months
measure: uNVC (75FC)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroúpoli
country: Greece
facility: Democritus University of Thrace
state: Evros
Study officials:
affiliation: Associate Professor
name: Georgios Labiris, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Labiris G, Ntonti P, Panagiotopoulou EK, Konstantinidis A, Gkika M, Dardabounis D, Perente I, Sideroudi H. Impact of light conditions on reading ability following multifocal pseudophakic corrections. Clin Ophthalmol. 2018 Dec 14;12:2639-2646. doi: 10.2147/OPTH.S180766. eCollection 2018.