louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06808269: Prospective Comparative Multicenter Study of the Care Pathway After Shoulder Surgery
Official title: Prospective Comparative Multicenter Study of the Care Pathway After Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shoulder Injury
Keywords: shoulder surgery
pain
comfort
Lead sponsor: Clinique Victor Hugo
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Post-operative management of shoulder surgery patients, particularly in terms of pain management and follow-up, can vary from one center to another, influencing clinical outcomes and patient satisfaction. The aim of this study is to compare two approaches to post-operative follow-up in two distinct centers: structured follow-up using the Vivalto-Dom protocol in Paris, and autonomous follow-up through contact with a nurse in Saint-Grégoire. The hypothesis is that these differences in the care pathway will affect pain management, comfort and patient satisfaction. By controlling for operative variability (a single surgeon operating in both centers), the study will identify the most effective follow-up practices for improving post-operative management, with the ultimate aim of optimizing quality of care and reducing post-operative complications.


Eligibility criteria: Inclusion Criteria:

* Patient eligible for one of the following 4 types of surgery: Simple non-repair arthroscopic surgery (acromion, calcification), arthroscopic repair surgery (cuff, DAS, bankart), open surgery without prosthesis (ligamentoplasty, bone block), open surgery with prosthesis (inverted prosthesis, anatomic prosthesis, etc.).

Exclusion Criteria:

* Patients with one or more communication disorders.
* Pregnant or breast-feeding patients
* Patients not covered by a social security scheme
* Refusal to participate in research
* Patients unable to understand or give informed consent
* Patients under guardianship, deprived of liberty or under court protection
* Patients with past or present drug addiction
* Patients with neuropathy
* Patients with cognitive disorders
* Patients with chronic illnesses or inflammatory pathologies leading to chronic pain.

Primary outcomes:
measure: Pain intensity (VAS)
timeFrame: 3 days, 6 weeks, 3 months and 6 months after surgery
Secondary outcomes:
measure: Patient comfort (Likert scale)
timeFrame: 3 days, 6 weeks, 3 months and 6 months after surgery
measure: Postoperative complications
timeFrame: 3 days, 6 weeks, 3 months and 6 months after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06868069: Study on Blood Pressure Variability and Frailty in the Older People
Official title: Study on Blood Pressure Variability and Frailty in the Older People: the HypoPHrail Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Old Age
Keywords: Blood pressure variability
Frailty
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 220
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly hypertensive patients who are enrolled at the Hypertension Centre of Istituto Auxologico italiano IRCCS

Brief summary: Observational prospective single-center, non-profit study. Primary objective of the study: To determine if the hypotensive phenotype, defined as one episode of daytime systolic blood pressure (SBP) \<90 mmHg (or two episodes of daytime SBP \<90 mmHg, if mean 24 h SBP is \<125 mmHg) detected at Ambulatory Blood Pressure Monitoring (ABPM) is associated with adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events)

Detailed description: Observational prospective single-center, non-profit study. Primary objective of the study: To determine if the hypotensive phenotype, defined as one episode of daytime systolic blood pressure (SBP) \<90 mmHg (or two episodes of daytime SBP \<90 mmHg, if mean 24 h SBP is \<125 mmHg) detected at Ambulatory Blood Pressure Monitoring (ABPM) is associated with adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events)

Secondary objectives of the study:

* To examine the association between home Blood Pressure Variability (BPV) and frailty, assessed using various tools for assessing frailty
* To examine the association between short term BPV and adverse events at follow up (death, hospitalization, falls, emergency room admission for uncontrolled hypertension, major cardiovascular events)
* To determine the prevalence of hypotensive phenotype according to frailty status in hypertensive individuals.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 75 years
* Diagnosis of hypertension according to the criteria of the European Society of Cardiology guidelines \[Williams 2018\]
* Consent of the patient (or legal representative) to participate in the study

Exclusion Criteria:

* Refusal of the patient or his/her legal representative
* Life expectancy of less than 6 months

Primary outcomes:
measure: Incidence of adverse events
timeFrame: At 24 months of follow-up
measure: Prevalence of hypotensive phenotype
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Auxologico Italiano IRCCS
Study officials:
References:
Clinical trial NCT04214769: Effect of Radiation Therapy Among Head and Neck Cancer Patients on the Inner Ear Function
Official title: Evaluation of the Effect of Radiation Therapy Among Head and Neck Cancer Patients on the Inner Ear Function Using Novel Techniques
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer Patients Treated With Radiotherapy
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-01-02
Enrollment: 17
Sex: ALL
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: Patients diagnosed Head and Neck cancers, not treated previously, and planned for radiation therapy in which the inner ear will be radiated

Brief summary: Aims: 1. To evaluate the effects of radiation therapy on the inner ear, among patients treated with radiation therapy for head and neck cancers using a wide battery of tests (Audiometry and tympanometry, vHIT, VEMP, ENG) ; 2. To correlate the mean total radiation dose to the cochlea with the effects on audiological and vestibular function


Eligibility criteria: Inclusion Criteria:

* Females and males, Age: ≥ 18 years old
* Patients diagnosed Head and Neck cancers, not treated previously
* Planned for radiation therapy in which the inner ear will be radiated

Exclusion Criteria:

* Patients who were previously diagnosed with a vestibular disorder
* Previous middle or inner ear anomaly
* Failure to complete the whole course of radiation therapy
* More than one course of radiation therapy
* Patients treated with concurrent ototoxic chemotherapy
* Pregnant women
* Patients who will not sign an informed consent form
* Helpless or incompetent patients

Primary outcomes:
measure: Audiometry
timeFrame: 1.5 Year
measure: ENG test
timeFrame: 1.5 Year
measure: VEMP test
timeFrame: 1.5 Year
measure: vHIT test
timeFrame: 1.5 Year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01560169: Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients
Official title: Clinical Evaluation of Three Celiac Disease-Specific Patient Reported Outcome Instruments in Established and Newly Diagnosed Celiac Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Celiac Disease
Keywords: Celiac Disease
Coeliac Disease
Celiac Sprue
Keilakia Disease
Lead sponsor: Alvine Pharmaceuticals Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-22
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Biopsy proven celiac disease patients

Brief summary: This is an evaluation of celiac-specific patient reported outcome instruments in celiac disease patients.


Eligibility criteria: Inclusion Criteria:

* History of biopsy proven celiac disease
* Adherence to a gluten-free diet (established patients only)
* TG2 negative (established patients only)
* TG2 positive (newly diagnosed patients only)
* Signed informed consent

Exclusion Criteria:

* History of IgE-mediated reactions to gluten
* Significant laboratory abnormalities
* History of untreated or GI disease
* Positive pregnancy test
* Any medical condition which could adversely affect study participation

Primary outcomes:
measure: Change in symptoms using patient reported outcome instruments
timeFrame: 8 and 12 weeks
Secondary outcomes:
measure: Safety - incidence of adverse events
timeFrame: 8 and 12 weeks
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Southern California, Allergy Department
state: California
city: Aurora
country: United States
facility: University of Colorado, Denver
state: Colorado
city: Chicago
country: United States
facility: University of Chicago Celiac Disease Center
state: Illinois
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York City
country: United States
facility: Columbia University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: Alvine Pharmaceuticals Inc.
name: Daniel Adelman, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05895669: Cardiovascular Outcomes in Orthotopic Liver Transplanted Patients (COLT Study)
Official title: Evaluation of Cardiovascular Outcomes in Patients Undergoing Orthotopic Liver Transplantation: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Transplant; Complications
Cardiovascular Complication
Cardiovascular; Attack
Cardiovascular Stroke
Death
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with ortothopic liver transplantation

Brief summary: All patients with orthotopic liver transplantation who are evaluated and followed at each participating centers will be recorded in this study. Within this register a characterization of patients and therapy will be done. Prognostic factors of defined clinical relevant endpoints will be evaluated.


Eligibility criteria: Inclusion Criteria:

* All patients with ortothopic liver transplantation and at least 2 year follow-up at the referral center

Exclusion Criteria:

* Missing Informed Consent Form
* Missing Contact Informations for Follow up

Primary outcomes:
measure: Cardiovascular death
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
measure: cardiovascular complication
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
Secondary outcomes:
Other outcomes:
Locations:
city: Gragnano
country: Italy
facility: Gragnano Hospital
state: SA
city: Napoli
country: Italy
facility: University of Campania Luigi Vanvitelli
Study officials:
References:
Clinical trial NCT06328569: Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome
Official title: Effect of Virtual Reality Therapy on Dysphagia in Wallenberg Syndrome: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Wallenberg Syndrome
Lead sponsor: Chao Phya Abhaibhubejhr Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:

the efficacy of Virtual Reality Therapy in the rehabilitation of patients with dysphagia in Wallenberg syndrome.

Participants received conventional dysphagia treatment and Virtual Reality Therapy once a day for 14 days. Researchers compared the control group to see the effect and mechanism of Virtual Reality Therapy.

Detailed description: Virtual Reality technology has revolutionized various fields, and its application in rehabilitation medicine is particularly noteworthy. Virtual Reality provides immersive environments that simulate real-life situations, making it an invaluable tool in the rehabilitation process.

The goal of this clinical trial is to learn about on dysphagia in wallenberg syndrome. The main questions it aims to answer are:

the efficacy of Virtual Reality Therapy in the rehabilitation of patients with dysphagia in Wallenberg syndrome.

Participants received conventional dysphagia treatment and Virtual Reality Therapy once a day for 14 days. Researchers compared the control group to see the effect and mechanism of Virtual Reality Therapy.

Eligibility criteria: Inclusion Criteria:

* age more than 18, and right-handed;
* first onset, vital signs stable and conscious;
* the dysphagia confirmed by videofluoroscopic swallowing study;
* no cognitive impairment, the mini-mental state examination score: \>17 for those with an illiterate education, \>20 for those with an elementary education, and \>24 for those with a secondary education and above;
* cranial integrity without craniotomy and/or craniectomy;
* patient and/or his/her relative agrees and signs written informed consent.

Exclusion Criteria:

* combined ischemic foci at other sites;
* presence of organic swallowing dysfunction or pre-existing dysphagia due to Parkinson's disease, dementia, and others;
* severe cardiac, pulmonary, hepatic, and renal insufficiency and vital organ failure;
* infected or broken skin on the head;
* poorly controlled epilepsy;
* poor patient compliance.

Primary outcomes:
measure: standardized swallowing assessment
timeFrame: day 1 and day 14
Secondary outcomes:
measure: Murray secretion scale
timeFrame: day 1 and day 14
measure: penetration-aspiration scale
timeFrame: day 1 and day 14
measure: swallowing-quality of life
timeFrame: day 1 and day 14
Other outcomes:
Locations:
Study officials:
affiliation: Site Coordinator of United Medical Group
name: Nieto Luis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01077869: A Feasibility Study on the Use of F-18-FDG-PET and Optical Imaging in Evaluation of Radiation-induced Oral Mucositis
Official title: A Feasibility Study on the Use of F-18-FDG-PET and Optical Imaging in Evaluation of Radiation-induced Oral Mucositis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Squamous Cell Carcinoma of the Oral Cavity
Oropharynx Metastases
Lymph Metastases
Keywords: oropharynx and lymph node metastases from an unknown primary tumor
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2010-03-01
Enrollment: 10
Sex: ALL
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: Squamous cell carcinoma of the oral cavity, oropharynx and lymph node metastases from unknown primary tumor.

Brief summary: In this study, the feasibility of optical imaging and FDG-PET in the evaluation of radiation-induced mucositis will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Non-operated histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx (except the posterior wall) and lymph node metastases from the unknown primary tumor (CUP)
* Stage T1-4; Tx N+ for the CUP
* Multidisciplinary Group of Head and Neck Tumors at Ghent University Hospital decision of radical radiotherapy (±concurrent chemotherapy)
* Informed consent obtained, signed and dated before specific protocol procedures.

Exclusion Criteria:

* Age \< 18 years
* Pregnant or lactating women
* Active infection or fistula in the oral/oropharyngeal mucosa
* Previous cancer of the oral cavity and the oropharynx
* Prior head-and-neck radiotherapy
* Expectation of non-compliance with the study protocol
* Known allergy for topical anesthetics (Xylocaïne)

Primary outcomes:
measure: Feasibility of optical imaging in the evaluation of radiation-induced mucositis.
timeFrame: weekly assessment during 7 weeks
measure: Feasibility of FDG-PET in the evaluation of radiation-induced mucositis.
timeFrame: 2 weeks after radiotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: wilfried De Neve, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01080768: Assessment of Aliskiren/Amlodipine and Amlodipine on Ankle Foot Volume (AFV) in Patients With Hypertension
Official title: A Double Blind, Randomized, Parallel Study to Assess the Effects of Aliskiren/Amlodipine and Amlodipine Monotherapy on Ankle Foot Volume (AFV) in Patients naïve to Trial Drugs With Mild to Moderate Hypertension
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypertension
Ankle Edema
Keywords: Pedal edema
hypertension
aliskiren
amlodipine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-03-04
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can attenuate ankle edema formation in hypertensive patients.


Eligibility criteria: Inclusion Criteria:

* Patients (male or female) with hypertension aged between 18-75 yrs.
* Patients not treated with amlodipine or no amlodipine in previous 1 year.
* Post-menopausal females

Exclusion Criteria:

* Patients unable to switch from prior hypertensive medication.
* Severe hypertension.
* Pregnant or nursing females.
* Patients with Type 1 or Type 2 diabetes mellitus
* History of immunodeficiency diseases, including a positive Human immunodeficiency virus (HIV) (Enzyme-linked immunosorbent assay \[ELISA\] and Western blot) test result.
* A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.

Other protocol-defined inclusion/exclusion criteria are applied

Primary outcomes:
measure: Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method
timeFrame: Baseline, 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Beek en Donk
country: Netherlands
facility: Novartis Investigative Site
city: Bosch
country: Netherlands
facility: Novartis Investigative Site
city: Den Haag
country: Netherlands
facility: Novartis Investigative Site
city: Hoogwoud
country: Netherlands
facility: Novartis Investigative Site
city: Lichtenvoorde
country: Netherlands
facility: Novartis Investigative Site
city: Lieshout
country: Netherlands
facility: Novartis Investigative Site
city: Poortvliet
country: Netherlands
facility: Novartis Investigative Site
city: Utrecht
country: Netherlands
facility: Novartis Investigative Site
city: Wildervank
country: Netherlands
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02298868: Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study
Official title: Safety and Efficacy of Baclofen for Treatment of Muscle Spasms in Patients With Cirrhosis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Muscle Cramps
Cirrhosis
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 10
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 determine the safety and efficacy of the medication Baclofen for treatment of muscle cramps in patients with cirrhosis.


Eligibility criteria: Inclusion Criteria:

* Cirrhosis
* Presence of muscle cramps on a regular basis

Exclusion Criteria:

* Allergy or hypersensitivity to Baclofen
* Active or untreated Portosystemic encephalopathy
* Active alcohol or substance abuse
* Age less than 18
* Pregnancy
* Concomitant use of narcotic pain medication, other muscle relaxer, or other anti-spastic agent
* Concomitant use of Tricyclic Antidepressant due to drug interaction
* History of chronic kidney disease defined by GFR \< 30 (using MDRD equation)
* Subject is institutionalized or a prisoner
* Inability or unwillingness to give informed consent
* Expected lifespan less than 3 months
* Severe or poorly controlled coexisting medical conditions or other significant issues as determined by the principal investigator to hinder the ability to adhere to study protocols

Primary outcomes:
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Headache)
timeFrame: 4 weeks of active therapy
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Nausea)
timeFrame: 4 weeks of active therapy
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Dizziness)
timeFrame: 4 weeks of active therapy
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Encephalopathy)
timeFrame: 4 weeks of active therapy
measure: Number of Participants With Adverse Events as a Measure of Safety and Tolerability (Somnolence)
timeFrame: 4 weeks of active therapy
Secondary outcomes:
measure: Efficacy of Baclofen to Change Frequency of Muscle Cramps in Patients With Cirrhosis at the End of 4 Weeks of Therapy
timeFrame: Baseline to 4 weeks of therapy
measure: Efficacy of Baclofen to Change Severity of Muscle Cramps in Patients With Cirrhosis After 4 Weeks of Therapy
timeFrame: Baseline to end of 4 weeks of therapy
measure: Change in Frequency of Muscle Cramps After Washout Period
timeFrame: End of treatment (week 4) to end of washout (week 7)
measure: Change in Severity of Muscle Cramps After Washout Period
timeFrame: End of treatment (week 4) to end of washout (week 7)
Other outcomes:
Locations:
Study officials:
affiliation: University of Virginia
name: Zachary Henry, M.D.
role: PRINCIPAL_INVESTIGATOR
References: