louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06815107: Risk Factors for Poor Tolerance of Ureteral Double-J Stent
Official title: Risk Factors for Poor Tolerance of Ureteral Double-J Stent
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tolerance
Ureteral Double-J Stent
Urinary Symptoms
Keywords: Ureteral Double-J Stent
tolerance
urinary symptom
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier d'Abbeville
name: centre hospitalier de Compiegne
name: University Hospital, Caen
First posted: 2025-02-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The placement of a Ureteral Double-J Stent as an emergency treatment or preparation for endoscopy after Colic nephritis is very frequent. It is often poorly supported, most often by young patients. A rich symptomatology is related to the probe responsible for a limitation of activities that can have a strong socio-economic impact. The objective of this study is the identification of the predictive factors of poor tolerance.


Eligibility criteria: Inclusion Criteria:

* patient over 18 years old
* patient who need Ureteral Double-J Stenting

Exclusion Criteria:

* patient under 18 years old,
* Iterative change,
* understanding disorder,
* inability to answer the questionnaire,
* refusal of the patient,
* long-term Ureteral Double-J Stenting (more than 6 month),
* active cancer.

Primary outcomes:
measure: tolerance score of Ureteral Double-J Stent
timeFrame: day 15
measure: tolerance score of Ureteral Double-J Stent
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
Study officials:
References:
Clinical trial NCT02297607: Routine Post-Operative Supplemental Nutrition
Official title: Routine Post-Operative Supplemental Nutrition: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Esophageal Cancer
Keywords: Esophageal Cancer
Esophagectomy
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-11-21
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Patients undergoing an esophagectomy will be randomized to receive either (1) routine post-operative tube feeding for 1 month post-operative or (2) usual practice, which is tube feeding to continue in the hospital until the patient is taking adequate nutrition by mouth at POD#8, or upon discharge.

Specific Aim 1 is to determine the occurrence of common complications and readmissions post-operatively between the two patient groups. The investigators hypothesize that routine use of tube feeding may reduce the occurrence of post-operative complications.

Specific Aim 2 is to determine if routine dietary supplementation with enteral tube affects recovery and QOL after esophagectomy. The investigators hypothesize that routine post-operative supplementation will enhance patients recovery and QOL.

For esophagectomy specifically, there is very limited literature evaluating the complication rate and QOL associated with the length of post-operative tube feeding and adequate nutritional requirements. Small randomized studies have not shown a benefit to routine tube feeding, although the numbers were very small, ranging from 12-70 per group. The investigators will randomize 200 patients for the purpose of this study.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing an elective esophagectomy
* Jejunal feeding tube placed at the time of surgery

Exclusion Criteria:

* Emergent esophagectomy procedure
* Inability to provide informed consent or to complete testing or data collection
* Unwillingness to be randomized
* Tube feeding dependent on discharge

Primary outcomes:
measure: Quality of Life after surgery
timeFrame: 6-months post-operatively
Secondary outcomes:
measure: Jejunostomy tube-specific complications
timeFrame: 2-weeks, 1-month, 3-months and 6-months post-operatively
Other outcomes:
measure: Other post-operative complications
timeFrame: 30-days post-operative
measure: Costs
timeFrame: 6-months post-operative
measure: Length of hospital stay
timeFrame: 2-weeks post-operative
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Philip W Carrott, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01131507: PR-018: An Open-Label, Safety Extension of Study PR-011
Official title: A Multicenter, Open-Label, Safety Extension of Study PR-011 Titled: A Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystic Fibrosis
Exocrine Pancreatic Insufficiency
Keywords: Exocrine Pancreatic Insufficiency
Infants with CF
Lead sponsor: Forest Laboratories
Sponsor class: INDUSTRY
First posted: 2010-05-27
Enrollment: 15
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A study to evaluate long term safety and effect on ability to thrive of EUR-1008 (APT-1008) 3,000 lipase units (Zenpep® \[pancrelipase\] delayed release capsules) in infants with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF).

Detailed description: This is a multi-center, open-label, safety extension of Aptalis (formerly Eurand) study PR-011 (NCT01100606) in pediatric participants with EPI due to CF. The study will be carried out in participants who completed the PR-011 study.

The study is comprised of 5 visits: an enrollment visit, treatment visit 1 (3 months), treatment visit 2 (6 months), treatment visit 3 (9 months) and treatment visit 4 (12 months). Once determined eligible for participation, participants will be enrolled into the study.

Eligibility criteria: Inclusion Criteria:

* Participant's parent or guardian signed informed consent form (ICF)
* Participants who have completed study PR-011 (NCT01100606)

Exclusion Criteria:

* Participant having any condition that would, in the investigator's opinion, limit the participant's ability to complete the study or will result in excess risk to the participant that is above the standard of care

Primary outcomes:
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Month 12 or early termination
Secondary outcomes:
measure: Change From Baseline in Growth Percentiles at Month 3, 6, 9 and 12
timeFrame: Baseline, Month 3, 6, 9 and 12
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Las Vegas
country: United States
facility: Children's Lung Specialists Ltd.
state: Nevada
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Cystic Fibrosis Care Center
state: Texas
Study officials:
affiliation: Forest Laboratories
name: Aptalis Medical Information
role: STUDY_DIRECTOR
References:
Clinical trial NCT00796107: A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer
Official title: An Open Label Study to Evaluate the Safety, Tolerability and Effect on Tumor Response of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-11-24
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aim was to determine the safety and efficacy of R1507 in combination with letrozole in patients with advanced breast cancer. In the first part of the study a cohort of patients with advanced breast cancer received letrozole 2.5mg po daily in combination with R1507 16mg/kg every 3 weeks.


Eligibility criteria: Inclusion Criteria:

* postmenopausal female patients;
* stage IV or locally advanced breast cancer;
* measurable disease;
* letrozole failure (Part 2);
* Eastern Cooperative Oncology Group (ECOG) performance status \<=2.

Exclusion Criteria:

* previous chemotherapy for metastatic breast cancer;
* concurrent antibody or immunotherapy for advanced disease, within 4 weeks prior to receipt of study drug;
* history of primary malignancy in 5 years prior to study, excluding adequately treated basal or squamous cell cancer of skin, or cancer in situ of cervix;
* concurrent radiotherapy, or radiotherapy within 28 days prior to receipt of study drug.

Primary outcomes:
measure: Objective Tumor Response (Part 2)
timeFrame: Up to 14 months
Secondary outcomes:
measure: Pharmacokinetics (PK) Profile (Part 2)
timeFrame: Up to 14 months
measure: Progression-free Survival (Part 2)
timeFrame: Up to 14 months
measure: Number of Participants With Adverse Events (Part 2)
timeFrame: Up to 14 months
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Washington
country: United States
state: District of Columbia
city: Miami
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Saint Louis
country: United States
state: Missouri
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04570007: Vitreous Fragments Length After Pars Plana Vitrectomy
Official title: Vitreous Fragments Length After Pars Plana Vitrectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vitreous Disorder
Vitreous Anomalies
Lead sponsor: Ospedale Policlinico San Martino
Sponsor class: OTHER
First posted: 2020-09-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients over 18 undergoing pars plana vitrectomy for macular surgery or retinal detachment

Brief summary: To measure vitreous collagen fragments length after pars plana vitrectomy performed at different cut rates

Detailed description: Pars plana vitrectomy consists in the removal of vitreous obtained with a vitreous cutter. The instruments attracts vitreous in its port through active suction and cuts with a blade at different cut rates. There is no consensus as to which cut rate would be ideal in order to minimize traction, neither there is agreement on whether increasing cut rates generate shorter collagen fragments or the fluid turbulence creates unpredictable flows at the port generating fragments of different length.

The investigators plan to gather vitreous cut at 1,000, 2,000, 4,000, 8,000 and 16,000 cuts per minute and measure vitreous collagen average length

Eligibility criteria: Inclusion Criteria:

* patient undergoing pars plana vitrectomy for:
* macular pucker
* macular hole-
* retinal detachment
* age \>18

Exclusion Criteria:

* unwilling to participate
* previous trauma
* vitreous haemorrhage

Primary outcomes:
measure: collagen fragment molecular weigth
timeFrame: at time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Genova
country: Italy
facility: IRCCS Policlinico San Martino
state: RM
Study officials:
affiliation: IRCCS Policlinico San MArtino
name: Tommaso Rossi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06055907: Influence of Vasopressors on Anti-Xa Activity in Critically Ill Patients
Official title: Anti-Xa Activity in Patients Receiving Different Vasopressors.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Thrombosis
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort study will be conducted on a population of 50 adult patients of both sexes treated in the Intensive Care Unit at the University Clinical Center in Gdansk, Poland.

Brief summary: Critically ill patients require antithrombotic prophylaxis. At the same time, majority of them is receiving various vasopressors. The aim of the study is to determine whether there is a difference in anti-Xa activity, which is a marker of anti thrombotic activity of low molecular weight heparins, between the patients receiving norepinephrine with argipressin, compared to those receiving norepinephrine alone.


Eligibility criteria: Inclusion Criteria:

* Circulatory failure
* Supported by continuous infusion of noradrenaline or noradrenaline and argipressin
* Receiving subcutaneous dalteparin for the prevention of venous thromboembolism.

Exclusion Criteria:

* Contraindications for dalteparin
* Severe coagulopathy
* Acute or subacute bacterial endocarditis
* Pregnant women
* BMI (body mass index) \> 30kg/m2
* Chronic kidney disease with eGFR (estimated glomerular filtration rate) \< 30 ml/min/1.73 m2
* Renal replacement therapy
* The patient died within 52 hours of starting VTE (venous thromboembolism) prophylaxis with dalteparin

Primary outcomes:
measure: Anti-Xa activity
timeFrame: 4 hours after third dose
Secondary outcomes:
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care
Study officials:
affiliation: Medical University of Gdansk
name: Radosław Owczuk, MD., PhD., Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03615209: Effect of Vagus Stimulation on Peripheral Glucose Metabolism
Official title: Effekte Der Transkutanen Aurikularen Vagus-Nervenstimulation (tVNS) Auf Die Postprandiale Stoffwechselregulation im Menschen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Glucose Intolerance
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Two important mechanisms play a major role in the pathogenesis of type 2 diabetes: insulin resistance of the target tissues and the impaired insulin secretion from pancreatic β-cells. Postprandial factors (such as insulin) are perceived by the human brain and induce signals that regulate glucose metabolism via the parasympathetic nervous system.

Transcutaneous auricular vagus nerve stimulation (tVNS) can be used on the outer ear to stimulate the auricular branch of the vagus nerve in humans. Heart rate variability (HRV) in healthy people can be significantly increased via tVNS, indicating a shift from sympathetic activity to parasympathetic activity.

The hypothesis is that this postprandial shift results in a change in peripheral glucose metabolism. In turn, the increased parasympathetic activity could potentially result in a change in postprandial insulin sensitivity or secretion.

To test this hypothesis, this study investigates the effect of vagal stimulation versus sham stimulation on insulin sensitivity, on insulin secretion, glucose tolerance, resting energy expenditure, and on parasympathetic tone (analysis of heart rate variability).


Eligibility criteria: Inclusion Criteria:

* HbA1c \<6.5%
* Must be able to understand the explanations of the study and the instructions

Exclusion Criteria:

* Any relevant (according to investigator's judgment) cardiovascular disease
* Neurological and psychiatric disorders
* Diabetes mellitus
* Active implants (e.g. pacemaker, cochlear implant, cerebral shunt)
* asthma
* skin diseases on the ear

Primary outcomes:
measure: Whole body insulin sensitivity
timeFrame: 0-120 min
Secondary outcomes:
measure: Insulin secretion
timeFrame: 0-120 min
measure: Glucose tolerance
timeFrame: 0-120 min
measure: Resting energy expenditure
timeFrame: 140-160 min. after start of stimulation
measure: Heart rate variability
timeFrame: -30 - 120 min
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University of Tuebingen, Department of Internal Medicine IV
Study officials:
affiliation: University Hospital Tuebingen
name: Martin Heni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06070909: Selective Activation of the Infraspinatus During External Rotation Exercises in Participants With Rounded Shoulder Posture
Official title: Selective Activation of the Infraspinatus During External Rotation Exercises in Participants With Rounded Shoulder Posture: Comparison of 3 Common Exercises and Muscle Architecture-Based Exercise
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Disease
Keywords: Infraspinatus
Muscle architecture
Rounded Shoulder Posture
Superficial EMG
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Fifteen (7 males and 8 females) participants without shoulder pain, totally able to perform overhead activities with no pain or discomfort, without a history of shoulder injuries, and with rounded shoulder posture were recruited for this study.

Brief summary: The purpose of this prospective, cross-sectional study was to evaluate the selective activation of the infraspinatus during external rotation exercises in participants with rounded shoulder postures and compare the different exercise positions. The fifteen (7 males and 8 females) participants with rounded shoulder posture were recruited for this study. The EMG activations of the middle trapezius, posterior deltoid and infraspinatus muscles in the dominant limb were recorded during exercises in standing external rotation (SER), side-lying position (SDER), scapular plane (SPER) and muscle architecture-based (MABER) positions.


Eligibility criteria: Inclusion Criteria:

* without shoulder pain,
* totally able to perform overhead activities with no pain or discomfort,
* without a history of shoulder injuries
* with rounded shoulder posture

Exclusion Criteria:

* a history of shoulder muscle injury
* bone fractures in shoulder region
* luxation or subluxation
* cervical dysfunction radiating to upper limbs
* neurologic or musculoskeletal disorders that would prevent shoulder external rotation in the testing postures.

Primary outcomes:
measure: The EMG activations of the middle trapezius, posterior deltoid and infraspinatus muscles in the dominant limb
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation
state: Etlik
Study officials:
References:
Clinical trial NCT04990609: EUS-RFA PANCARDINAL-1 Trial
Official title: A Single-arm Phase II Study to Evaluate the Safety and Efficacy of Combination Systematic Chemotherapy and Multiple Rounds of Endoscopic Ultrasound-guided Radiofrequency Ablation in Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Pancreatic Ductal Adenocarcinoma (PDAC)
Keywords: Endoscopic Ultrasound Radiofrequency ablation (EUS-RFA)
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-08-04
Enrollment: 60
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 objectives of this study are to determine the feasibility, tolerability, and treatment effect of endoscopic ultrasound (EUS) radiofrequency ablation (RFA) plus standard-of-care neoadjuvant chemotherapy (NAC) in the treatment of pancreatic ductal adenocarcinoma (PDAC). Endoscopic ultrasound (EUS) radiofrequency ablation (RFA) and neoadjuvant chemotherapy (NAC) will be performed before tumor resection surgery, with the goal of shrinking a tumor or stopping the spread of cancer so that surgery might be less invasive and more effective.


Eligibility criteria: Inclusion Criteria:

* Diagnosed and histologically-confirmed PDAC by biopsy
* Permanent street address
* Consent to study participation
* Axial CT scan consistent with PDAC
* No prior chemotherapy or less than 2 months of pre-operative chemotherapy for PDAC
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria:

* Male or female patients \< 18 years of age
* No permanent street address or telephone number
* Pregnant patients
* Inmates or prisoners
* Unable to provide informed consent

Primary outcomes:
measure: Number of participants who are able to complete neoadjuvant chemotherapy plus EUS-RFA and later undergo surgical tumor resection
timeFrame: From the time of EUS-RFA NAC intervention to the time of surgical tumor resection (about 5-6 months)
Secondary outcomes:
measure: Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria
timeFrame: 2 months after the initiation of chemotherapy
measure: Radiographic treatment response as assessed by standard Response evaluation criteria in solid tumors (RECIST) criteria
timeFrame: 4 months after the initiation of chemotherapy
measure: Number of participants with post-operative complications
timeFrame: from the time of surgical tumor resection to 90 days following surgical tumor resection
measure: Disease-free survival time
timeFrame: from the time of diagnosis to time of recurrence (or up to 5 years after diagnosis, whichever occurs first)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Nirav Thosani, MD
role: PRINCIPAL_INVESTIGATOR
References: