louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00534534: Decrease of Recurrent Pancreatitis
Official title: Randomized Clinical Trial of the Effect of Standard Versus Intensive Intervention Protocol in Attempting to Reduce Recurrent Episodes of Acute Alcoholic Pancreatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatitis
Keywords: Pancreatitis
acute
alcoholic
recurrence
alcoholism
treatment
Acute alcoholic pancreatitis
Lead sponsor: Tampere University
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Retrospective studies have shown, that about half of the patients will have a recurrent episode after the first acute alcoholic pancreatitis. Of the patients in hospital, more than half annually are treated for recurrent acute pancreatitis. Because alcohol has been shown an important factor in the development of recurrent pancreatitis, it was hypothesized, that by attempting intensively to diminish the individual alcohol consumption the number of recurrent pancreatitis could be decreased. Two protocols will be compared: A) initial intervention against alcohol abuse and B) repeated interventions at 6 month intervals.


Eligibility criteria: Inclusion Criteria:

* Patients who recovered from their first acute alcoholic pancreatitis and start to be ready to be discharged from hospital

Exclusion Criteria:

* Other etiologies of pancreatitis besides alcohol
* Uncertain diagnosis
* Recurrent disease
* Refusal

Primary outcomes:
measure: The number of recurrent pancreatitis during the study period
timeFrame: 2 years
Secondary outcomes:
measure: Decrease of alcohol consumption
timeFrame: 2 years
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Isto H Nordback, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04602234: Diagnostic of Lower Respiratory Tract Infection by Lung Ultrasonography in General Practice
Official title: Diagnosis of Lower Respiratory Tract Infection by Lung Ultrasonography in General Practice : a Prospective, Interventional and Multicentric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Resp Tract Infection
Ultrasound Therapy; Complications
Keywords: Lung ultrasonography
Lower Respiratory Tract Infection
General Practice
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2020-10-26
Enrollment: 151
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Among the 151 patients included, 111 LUS were performed (LUS group)
Primary purpose: DIAGNOSTIC

Brief summary: Lower Respiratory Tract Infection (LRTI) is a frequent motive of consultation in General Practice. Cost, irradiation and availability of traditional imagery make it difficult to perform in every patient with suspected LRTI.

The objective is to evaluate the performance of LUS realized by family physicians into the usual LRTI diagnostic pathway.

This study is a prospective, interventional, multi-centric and open study conducted in 3 different centers by 15 General Practitioners (GP) in France. Patient complaining of dyspnea or cough were recruited from December 2019 to March 2020. GP received a training course by LUS expert before the study.

The primary outcome measure was diagnosis modification after LUS. Secondary measures were therapeutic modification after LUS, decision of imagery prescription after LUS, decision of hospitalization or not after LUS, medical evolution and result of imagery initially prescribed by GP.

Detailed description: After an initial medical report, GP's concluded to an initial diagnosis and make initial prescription and finally decided or not to perform a standardized eight-points LUS. GP were free to perform or not LUS. If GP decided to perform LUS, GP were allowed to change their diagnosis and prescriptions (LUS group). However, therapeutic changes after LUS could not "downgrade" patient care.

Eligibility criteria: Inclusion Criteria:

* Age \> 3 months
* Dyspnea or cough complaint

Exclusion Criteria:

* Age \< 3 months
* Rejection to participate to the study

Primary outcomes:
measure: Diagnosis modification
timeFrame: 3 months
Secondary outcomes:
measure: Therapeutic modification
timeFrame: 3 months
measure: Imagery prescription
timeFrame: 3 months
measure: Decision of hospitalization
timeFrame: 3 months
measure: Medical evolution
timeFrame: 3 months
measure: Imagery result
timeFrame: 3 months
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital, Caen
state: Calvados
Study officials:
References:
Clinical trial NCT06680934: CABP2 Patient Registry and Natural History Study
Official title: Patient Registry for Individuals With CABP2-Associated Hearing Loss
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: CABP2-related Auditory Synaptopathy
Hearing Impairment
Keywords: CABP2 patient registry
Patient registry
DFNB93
Lead sponsor: University Medical Center Goettingen
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with hearing impairment who have a molecular genetic diagnosis involving CABP2

Brief summary: This registry is designed to collect comprehensive information about the molecular genetic diagnoses and clinical information of individuals with CABP2-associated hearing impairment to support a natural history study.

Detailed description: A patient registry, in both German and English languages, has been established for patients with hereditary hearing impairment due to variants in CABP2. The study is conducted in accordance with the current version of the Declaration of Helsinki. The study protocol and database structure have been approved by the Ethics Committee of the University Medical Center Goettingen.

Eligibility criteria: Inclusion Criteria:

* A molecular genetic diagnosis involving biallelic variants in CAPB2 and audiometry

Exclusion Criteria:

* Patients with evidence of non-CABP2 molecular genetic diagnoses

Primary outcomes:
measure: Pure-tone audiometry
timeFrame: 1 year, year 1, according to participant consent
measure: Speech audiometry
timeFrame: 1 year, year 1, according to participant consent
Secondary outcomes:
measure: Otoacoustic emission thresholds
timeFrame: 1 year, year 1, according to participant consent
measure: Auditory brainstem response
timeFrame: 1 year, year 1, according to participant consent
Other outcomes:
Locations:
city: Göttingen
country: Germany
facility: University Medical Center Goettingen
Study officials:
affiliation: University Medical Center Goettingen
name: Tobias Moser, MD
role: STUDY_DIRECTOR
affiliation: University Medical Center Goettingen
name: Bernd Wollnik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Goettingen
name: Nicola Strenzke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Goettingen
name: Barbara Vona, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00173134: The Prevalence of Erectile Dysfunction (ED) and ED Related Quality of Life of Diabetic Men
Official title: Investigating the Prevalence of Erectile Dysfunction and Erectile Dysfunction Related Quality of Life of Diabetic Men in Taiwan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Erectile Dysfunction
Keywords: diabetes
erectile dysfunction
erectile dysfunction related quality of life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 300
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: OTHER

Brief summary: Adult diabetic patients aged above 20 attending the diabetic clinic of National Taiwan University Hospital are invited to attend a face to face screening and interview. After obtaining the informed consent, questionnaires including IIEF, DAN-PSS-SEX and erectile dysfunction effect on quality of lie are filled.Personal data, status of diabetes control and complications of diabetes are recorded.The results will be used to investigate the prevalence of erectile dysfunction of diabetic men in Taiwan and erectile dysfunction related quality of life change.

Detailed description: Adult diabetic patients aged above 20 attending the diabetic clinic of National Taiwan University Hospital are invited to attend a face to face screening and interview. After obtaining the informed consent, questionnaires including IIEF, DAN-PSS-SEX and erectile dysfunction effect on quality of lie are filled.Personal data, status of diabetes control and complications of diabetes are recorded.The results will be used to investigate the prevalence of erectile dysfunction of diabetic men in Taiwan and erectile dysfunction related quality of life change.

Eligibility criteria: Inclusion Criteria:

diabetic male age above 20

Exclusion Criteria:

men using any form of erectile dysfunction treatment-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shih-Ping Liu
Study officials:
affiliation: Department of Urology, National Taiwan University Hospital, Taipei, Taiwan
name: Shih-Ping Liu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03489434: Technology-Based Prevention for Adolescents in Primary Care
Official title: Technology-Based Prevention for Adolescents in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Keywords: adolescents
primary care
sexual assault
substance use
sexual risk behavior
Lead sponsor: Georgia State University
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 123
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Adolescent substance use, sexual assault, and sexual risk behaviors pose a great public health concern, and subsequently there is also a great need to prevent these behaviors and experiences. This project involves the adaptation and integration of evidence-based prevention content aimed at preventing and reducing substance use, sexual assault, and sexual risk behaviors. This project uses innovative technology within primary care visits to conduct a feasibility trial of an integrated prevention program.

Detailed description: Pilot feasibility trial in preparation for RCT. Adolescents aged 14-18 will be recruited for screening from community-based primary care clinics to ensure ease of dissemination and representation of community-based primary care settings. The primary goal is to develop feasibility to apply for an R01 to conduct an RCT. Power analyses indicate that 280 participants would be needed for an RCT after accounting for attrition. Given that the RCT would be conducted over a 3-year period, a recruitment rate of 8 adolescents per month would indicate feasibility for a larger RCT.

Eligibility criteria: Inclusion Criteria:

* Aged 14-18
* Recent visit to primary care doctor

Exclusion Criteria:

* Inability to comprehend English independently due to disability or language

Primary outcomes:
measure: Enrollment and Recruitment Rate
timeFrame: within 2 year recruitment period
measure: Retention Rate: Number of Participants Who Completed at Least 1 Follow-Up Study
timeFrame: within 6 months of baseline participation
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia State University
state: Georgia
Study officials:
affiliation: Georgia State University
name: Amanda K Gilmore, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02526134: Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum
Official title: Placing Trust in Endoscopic Ultrasonography: Impact on Planning Conformal Radiotherapy of Cancer of the Esophagus and Rectum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oesophageal Cancer
Rectal Cancer
Keywords: Laying of medical devices (radio opaque markers)
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
Collaborators: name: Cook medical laboratory
First posted: 2015-08-18
Enrollment: 29
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: The purpose of this study is to estimate the rate of patients in whom a significant change in the area to be irradiated will be observed between the assessment before and after laying the evaluation of Trustees.

Detailed description: The centering of radiotherapy is done with the pre-radiation scanner for tracking the implementation of target skin markers. On this scanner, it is often difficult for the radiation therapist to pinpoint the target volume. To improve the definition of the target volume, image fusion techniques with other imaging tests were developed.

To improve the pre-radiotherapy identification, setting up markers echo-endoscopy has been described without major complications. The impact on targeting radiotherapy was mainly described for the prostate.

The marking of digestive tumors was described by the establishment of Trustees, radiopaque markers in the lymph nodes, esophagus, stomach, pancreas, and bile ducts.

Eligibility criteria: Inclusion Criteria:

* Male or female over the age of 18
* Rectal cancer diagnosis or esophagus
* Radiotherapy indication
* Signed consent to participate
* Patient affiliated to a social security system or benefiting from such a system

Exclusion Criteria:

* Pregnant women, of child-bearing potential, or lactating women
* Patient deprived of liberty or under supervision of a guardian
* Impossibility to undergo medical examinations of the study for geographical, social or psychological reasons
* Contra-indication for procedure study (infeasible EUS)
* Contra-indication for general anesthesia
* Patient (e) with disorders of hemostasis
* Patient (e) with portal hypertension

Primary outcomes:
measure: Patients rate in which a significant variation in the area to be irradiated will be observed between before evaluation and evaluation after laying the trustees.
timeFrame: From inclusion to 12 months follow up
Secondary outcomes:
measure: Number of trustees (2 up 6 maximum) and set up their positions estimated success rate of implementation and the evaluation of the safety and toxicity (complications) associated with the establishment trustees (composite measure)
timeFrame: From inclusion to 12 months follow up
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
Study officials:
References:
Clinical trial NCT00921934: Intravenous Vitamin C in the Treatment of Viral Infection, Especially in the Treatment of Shingles
Official title: PASCORBIN 7.5g in the Treatment of Viral Infection, Especially Varicella Zoster Infection: An Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Virus Diseases
Herpes Zoster
Keywords: Herpes
Shingles
virus disease
vitamin C
ascorbic acid
antioxidant
oxidative stress
Lead sponsor: Pascoe Pharmazeutische Praeparate GmbH
Sponsor class: INDUSTRY
Collaborators: name: Dr. Loges & Co. GmbH
First posted: 2009-06-17
Enrollment: 68
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: Cohort of adult patients suffering from acute viral infections, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany.

Brief summary: Chronic viral infections induce oxidative stress that can cause a number of concomitant diseases, e.g. cardio-vascular diseases or metabolic disorders. Therefore, a sufficient treatment of oxidative stress may be of benefit for the patient to prevent further diseases.

Shingles (herpes zoster infection) have been successfully treated with antioxidative substances like high-dose vitamin C for ages. Not only the acute symptoms can be diminished by high-dose vitamin C. Even long-term sequelae, like painful post-herpetic neuropathy, may be mitigated or even fully avoided.


Eligibility criteria: Due to the design of an Observational Cohort Study, no inclusion or exclusion criteria are named. The included patient group is described under "Cohort / Group".

Observational Criteria:

* adult patients
* acute viral infection (especially herpes zoster)
* Primary Care patient
* eligible for add-on therapy with vitamin C
* willingness to provide pseudonymized data to the Sponsor

Primary outcomes:
measure: Change of Pain Measured by VAS
timeFrame: visit 1 - 3
Secondary outcomes:
Other outcomes:
Locations:
city: Ransbach-Baumbach
country: Germany
facility: Praxis Dr. Schencking, Rheinstr. 77a
state: Rheinland-Pfalz
Study officials:
affiliation: Rheinstr. 77a, D-56235 Ransbach-Baumbach
name: Martin Schencking, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pascoe Pharmazeutische Praeparate GmbH
name: Bianka Krick
role: STUDY_DIRECTOR
References:
Clinical trial NCT01127334: Pilot Study Using Echocardiography to Evaluate Patients With Heart Failure and Dyssynchrony Who Have a CRT-D Device
Official title: Validation of a Robust Method for Kinematic Analysis of Ventricular Mechanical Dyssynchrony by Two Dimensional Echocardiography in Patients With Cardiac Resynchronization Devices for Chronic Systolic Heart Failure and Conduction System Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Systolic Heart Failure
Keywords: Dyssynchrony
Cardiac resynchronization therapy
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
First posted: 2010-05-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiology and electrophysiology clinics

Brief summary: Out of all the patients that receive a CRT-D ( a dual chamber pacemaker with defibrillator ) for cardiac resynchronization therapy there is approximately one-third that do not respond. We believe that by using a simple technique that includes routine echocardiography that are normally performed in these patients could help us better understand how to program their device to reach better optimization.


Eligibility criteria: Inclusion Criteria:

1. Adults age 18-110 years
2. Must have a CRT-D (A biventricular pacemaker with defibrillator)
3. Last optimization of their device (CRT-D) must not have been done in the past 3 months
4. Must be optimal heart failure medical regimen. This includes target dose of beta-blocker and angiotensin converting enzyme inhibitor (ACE-I) (or equivalent; i.e angiotensin receptor blocker (ARB); or balanced preload and afterload reducers with hydralazine and nitrates.)

Exclusion Criteria:

1. Less than 18 years of age or greater than 110 years old.
2. Does not have a CRT-D
3. Optimization of their device has occurred in the past 3 months
4. Not on optimal medical therapy for heart failure as listed in the inclusion criteria.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: University of Mississippi Medical Center
name: Donny R. Stokes, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Mississippi Medical Center
name: John P. Payne, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02780934: Comparing Pressure Versus Simple Adhesive Dressing After Mohs Reconstruction
Official title: Comparing Pressure Versus Simple Adhesive Dressing After Mohs Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-melanoma Skin Cancer
Keywords: Pressure Dressing
Post-operative Care
Simple Adhesive Dressing
Mohs
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
First posted: 2016-05-24
Enrollment: 81
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether using a pressure- vs. simple adhesive dressing affects the postoperative course and wound healing outcomes following Mohs surgery.

Detailed description: The investigators will randomize patients undergoing Mohs surgery to receive either a pressure or a simple adhesive dressing following their procedure. The hypothesis is that patients with the simple adhesive dressings will be more satisfied and comfortable with their wound care on follow-up. These patients are also expected to cite greater convenience managing the simple dressing at home. Finally, the investigators anticipate no difference in the number of postoperative complications between the two groups and expect that there will be a lower cost associated with the simple adhesive dressing as compared to the pressure dressing.

Eligibility criteria: Inclusion Criteria:

* Patients will be considered for enrollment if they have been referred to a Mohs surgeon for consideration of Mohs surgery for non-melanoma skin cancer.

Exclusion Criteria:

* Lack of indication for Mohs
* Significant comorbidities
* Case of a high-risk location or tumor size which necessitates consultation with other specialties in advance.

Primary outcomes:
measure: Patient Satisfaction
timeFrame: Assessed at the first clinical follow-up visit, 1-2 weeks following Mohs procedure
measure: Complications
timeFrame: Assessed at the first clinical follow-up visit, 1-2 weeks following Mohs procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: