louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00673400: Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM
Official title: Morbidity and Functional Outcome of Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM in Obstructed Defecation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructed Defecation Syndrome
Rectocele
Intussusception
SNS
Keywords: Obstructed defecation syndrome
ODS
Rectocele
Intussusception
STARR
Lead sponsor: Cantonal Hospital of St. Gallen
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The stapled transanal rectal resection (STARR procedure) is an effective treatment for obstructed defecation syndrome (ODS) caused by intussusception and rectocele. Recently a new technique has been developed using the new Contour® TranstarTM stapler, which was specifically designed to facilitate the STARR procedure. The investigators would like to evaluate the morbidity and quality of life.


Eligibility criteria: Inclusion Criteria:

* Rectocele
* Intussusception

Exclusion Criteria:

* Non operability
* inflammatory bowel disease

Primary outcomes:
measure: Quality of Life
timeFrame: 6 months after intervention
Secondary outcomes:
measure: Morbidity
timeFrame: 1 year
measure: Hospitalization
timeFrame: 1 day to 1 year (until release from hospital)
Other outcomes:
measure: Severity of Symptoms Score
timeFrame: before surgery - 6 weeks - 3 months - 6 months
measure: Obstructive Defecation Syndrome Score
timeFrame: before surgery - 6 weeks -3 months - 6 months
measure: SF36 Component Summary Scores
timeFrame: Before surgery - 6 months
Locations:
city: St. Gallen
country: Switzerland
facility: Department of Surgery, Cantonal Hospital St. Gallen
Study officials:
affiliation: Cantonal Hospital St. Gallen, Department of Surgery
name: Franc Hetzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolff K, Marti L, Beutner U, Steffen T, Lange J, Hetzer FH. Functional outcome and quality of life after stapled transanal rectal resection for obstructed defecation syndrome. Dis Colon Rectum. 2010 Jun;53(6):881-8. doi: 10.1007/DCR.0b013e3181cdb445.
Clinical trial NCT01367600: Open-Label Treatment Extension of Protocol MNTX 301
Official title: A Three-Month Open-Label Treatment Extension of Protocol MNTX 301
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Terminal Illness
Keywords: Advanced medical illness
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 27
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: This study is an open-label extension allowing patients who have completed Protocol MNTX 301 to continue to receive SC MNTX.


Eligibility criteria: Inclusion Criteria:

1. Completion of protocol MNTX 301; Double-Blind Treatment and Open-Label Treatment
2. Negative pregnancy test

Exclusion Criteria:

1. Women who are pregnant and/or nursing
2. Any concurrent experimental drug therapy
3. Evidence of fecal impaction
4. Clinically significant active diverticular disease

Primary outcomes:
measure: Number of patients with adverse events
timeFrame: 3 months
Secondary outcomes:
measure: Change from baseline in pain scores
timeFrame: 3 months
measure: Number of patients with opioid withdrawal symptoms
timeFrame: 3 months
Other outcomes:
Locations:
city: Tarrytown
country: United States
facility: Progenics Pharmaceuticals
state: New York
Study officials:
affiliation: Progenics Pharmaceuticals, Inc.
name: Tage Ramakrishna, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00483600: Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction
Official title: Studies of Fondaparinux in Patients With Renal Dysfunction: PK Study of Fondaparinux in Outpatients With Renal Dysfunction
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Kidney Diseases
Keywords: Fondaparinux
Pharmacokinetic
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2007-06-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To determine the appropriate dose and safety of a preventative dose of fondaparinux, an anticoagulant medication (blood thinner) in patients with kidney disease.

Detailed description: This study will evaluate the PK of fondaparinux in patients who have renal insufficiency. Fondaparinux is cleared from the body mainly by the kidneys. Therefore in patients with kidney diseases, full doses of fondaparinux could cause bleeding problems. The correct dose of fondaparinux that should be used in patients with kidney disease is not known. The purpose of this research is to determine the PK and safety of a preventative dose (2.5mg subcutaneously every other day) of fondaparinux for patients with kidney disease.

Eligibility criteria: Inclusion Criteria:

* Outpatients in the Medicine and Nephrology clinics who are 18 years or older,
* Outpatients in the Medicine and Nephrology clinics who have an estimated creatinine clearances between 20-30ml/min,
* Outpatients in the Medicine and Nephrology clinics who are able to give consent will be included.

Exclusion Criteria:

* anticoagulation therapy for thrombosis or other indication
* pregnant or breast-feeding
* hypersensitivity to fondaparinux
* subjects also will be excluded if there is concern for an increased risk of bleeding which includes the following:

  * known bleeding disorder (see Section 8. Hemostatic Assessment)
  * blood transfusion in the past 3 months
  * acute ulcer disease with past 3 months
  * platelet count \< 120,000 mm3
  * prolonged baseline prothrombin time (PT) or activated partial thromboplastin time (aPTT) above upper limit of normal laboratory range
  * major trauma or surgery within two weeks prior to enrollment
  * history of intracranial hemorrhage

Primary outcomes:
measure: PK parameters (half-life, area-under-the curve, and peak serum concentration)
timeFrame: after day 7 and after day 27
Secondary outcomes:
measure: Anti-factor Xa levels and assessment for bleeding(complete blood count)
timeFrame: days 3, 13 and 19
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Thomas L Ortel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01111500: Immobilization After an Anterior Glenohumeral Joint Dislocation With a Bankart Lesion
Official title: First Time Anterior Glenohumeral Joint Dislocation With a Bankart Lesion in Young Patients: Which Type of Immobilization Should be Chosen? A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glenohumeral Joint Dislocation
Lead sponsor: Hopital de l'Enfant-Jesus
Sponsor class: OTHER
First posted: 2010-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Glenohumeral joint dislocation is the most frequent joint dislocation with a prevalence of 1.7/100000 citizens/year. It is treated by reduction, under sedation or anaesthesia, followed by an immobilization of the arm.

The purpose of the study is to evaluate the healing of the labrum in first time anterior glenohumeral joint dislocation with a Bankart lesion in young patients by comparing an external rotation brace to an internal rotation brace to immobilize the injured arm.


Eligibility criteria: Inclusion Criteria:

* \> 18 years old
* \< 40 years old
* anterior glenohumeral joint dislocation proved by radiography
* dislocation needing a reduction manoeuvre
* home close to evaluation site for 24 months follow-up visits
* signed consent form

Exclusion Criteria:

* associated fracture
* Hill-Sachs lesion = or \> than 30%
* neurovascular deficit
* hypermobility
* pre-existing instability of the injured shoulder
* systemic neurological disease
* allergy to gadolinium
* functional sequel to the shoulder due to previous injury
* incapacitated adult patient
* minor patient
* home far from evaluation site
* refusal to sign the consent form

Primary outcomes:
measure: Anatomical healing of the labrum
timeFrame: 3 months after dislocation
Secondary outcomes:
measure: Decrease in relapse rate
timeFrame: 3 months after dislocation
measure: Decrease in relapse rate
timeFrame: 12 months after dislocation
measure: Decrease in relapse rate
timeFrame: 24 months after dislocation
Other outcomes:
Locations:
city: Québec
country: Canada
facility: CHA-Pavillon Enfant-Jésus
state: Quebec
Study officials:
affiliation: Hôpital Enfant-Jésus
name: Stéphane Pelet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00015600: Community-Based Environmental Health Intervention
Official title: Community-Based Environmental Health Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poisoning
Keywords: Pesticide
Farmworker
Occupational health
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-04-25
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This community-based project, called the Together for Agricultural Safety project, was developed to help farmworkers reduce their exposure to dangerous agricultural chemicals (such as pesticides) through education and social marketing. The project is a partnership of university researchers and the Farmworkers Association of Florida. After collecting extensive data from farmworkers, health providers and farm owners about primary means of pesticide exposure we are collaboratively developing an intervention that will reduce pesticide exposure by educating workers and owners about: the need to have adequate washing facilities; to wash hands frequently; to obey reentry intervals; to change work clothes after work to prevent child exposure and more.


Eligibility criteria: Must be an agricultural worker in the fernery or nursery industries in Central Florida.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
References:
Clinical trial NCT05158400: Diagnostic Value of Hand Ultrasound in Assessment of Rheumatoid Arthritis
Official title: Diagnostic Value of Hand Ultrasound in Assessment of Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient's With Rheumatoid Arthritis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Rheumatoid arthritis (RA) is one of the most common autoimmune rheumatic diseases, affecting one in 100 individuals worldwide. It is considered a complex systemic multifactorial inflammatory process in which the immune system targets synovial joints and causes mild to severe joint destruction with extra-articular manifestations.

If left untreated, RA leads to deformity, considerable disability, and major comorbid conditions, including cardiovascular disease and increased mortality.

Early treatment with targeted therapies can alter long-term outcomes by minimizing disease activity, preventing joint damage and disability, and improving patients' quality of life.


Eligibility criteria: Inclusion Criteria:

1. Adult-onset disease.
2. Patients who fulfill the 2010 American College of Rheumatology/European League Against Rheumatism classification criteria for rheumatoid arthritis.

Exclusion Criteria:

1. Any patient with any collagen disease rather than Rheumatoid arthritis.
2. Patients with joints deformities.

Primary outcomes:
measure: Diagnostic performance of Ultrasound in Rheumatoid Arthritis of the hand
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Kaeley GS, Bakewell C, Deodhar A. The importance of ultrasound in identifying and differentiating patients with early inflammatory arthritis: a narrative review. Arthritis Res Ther. 2020 Jan 2;22(1):1. doi: 10.1186/s13075-019-2050-4.
citation: Tan YK, Ostergaard M, Conaghan PG. Imaging tools in rheumatoid arthritis: ultrasound vs magnetic resonance imaging. Rheumatology (Oxford). 2012 Dec;51 Suppl 7:vii36-42. doi: 10.1093/rheumatology/kes329.
citation: Rowbotham EL, Grainger AJ. Rheumatoid arthritis: ultrasound versus MRI. AJR Am J Roentgenol. 2011 Sep;197(3):541-6. doi: 10.2214/ajr.11.6798.
Clinical trial NCT06890000: Effectiveness of Scapular Exercises Compared To Conventional Treatment in Shoulder Pain
Official title: Effectiveness of Scapular Exercises Compared To Conventional Treatment in People With Shoulder Pain: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Pain
Scapular Dyskinesis
Keywords: Shoulder pain
obvious scapular dyskinesis
Conventional Treatment
Scapular Exercises
Effectiveness
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
Collaborators: name: Gulhane School of Medicine
First posted: 2025-03-21
Enrollment: 48
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: The contribution of the scapula to shoulder joint movement is great. The contribution of the scapula bone is more prominent, especially in overhead activities. Therefore, the position and movement of the scapula are generally examined in people with shoulder disease. Scapula-focused exercises are used in patients with shoulder problems. However, some studies focused on the effectiveness of scapula-focused exercises on shoulder problems. Thes studies fundings are controversial. Scapular dyskinesis has not been evaluated in these studies. No study has set the condition of having scapular dyskinesis as an inclusion criterion. Scapular-focused exercises are expected to have a greater effect especially on patients with scapular dyskinesis. Therefore, the aim of this study is to examine the effectiveness of scapula-focused exercises on patients with shoulder pain and obvious scapular dyskinesis.


Eligibility criteria: Inclusion Criteria:

* Having shoulder pain for at least 1 month
* Having obvious scapular dyskinesia
* Having a shoulder ROM (range of motion) at least 120º
* Being 18 years of age or older

Exclusion Criteria:

* Having received any shoulder treatment in the last 6 months
* Having an acromioclavicular joint problem
* Having a diagnosis of frozen shoulder
* Having a fracture in the shoulder area
* Having a major rotator cuff muscle tear
* Having a diagnosis of calcific rotator cuff tendinopathy
* Having a neurological or rheumatological disease

Primary outcomes:
measure: shoulder pain and disability index (SPADI)
timeFrame: Baseline and at 6 week
Secondary outcomes:
measure: Global Rate of Change
timeFrame: Baseline and at 6 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Universtiy of Health Sciences - Gülhane Faculty of Physiotherapy and Rehabilitation
Study officials:
References:
citation: Bury J, West M, Chamorro-Moriana G, Littlewood C. Effectiveness of scapula-focused approaches in patients with rotator cuff related shoulder pain: A systematic review and meta-analysis. Man Ther. 2016 Sep;25:35-42. doi: 10.1016/j.math.2016.05.337. Epub 2016 Jun 4.
Clinical trial NCT01963000: Standardized Emergency Care for Community Acquired Pneumonia (CAP)
Official title: Reduction of Mortality in Community-Acquired Pneumonia After Implementing Standardized Care Bundles in the Emergency Department
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Community Acquired Pneumonia
Pneumonia
Infection
Keywords: Community Acquired Pneumonia
Emergency Department
Standardized Care
Reduced Mortality
CRB-65 Risk Classes
Antibiotic Therapy
Lead sponsor: Klinikum Nürnberg
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 2819
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Emergency department patients

Brief summary: Community acquired pneumonia (CAP) is associated with a high in-hospital mortality. Standardization of diagnostics and adherence to sepsis bundles in the emergency department (ED) are associated with reduced mortality in patients with sepsis. Investigators examined whether the introduction of standardized care bundles and check lists in the ED are associated with a reduced mortality rate in patients hospitalized for CAP.

This is an observational trial. The investigators retrospectively analyzed performance indicators of 2819 consecutive patients with CAP admitted to the Nuremberg Hospital, Germany, from 2008 to 2009. At the turn of the year, implementation of CAP care bundles took place including interprofessional education, checklists and institutionalized feedback. Primary endpoint was in-hospital mortality of CAP patients. After the implementation of CAP care bundles in the ED, mortality of affected patients was significantly lower in 2009 compared to 2008. This study should demonstrate that the implementation of a standardized CAP care bundle in the ED is associated with a risk reduction in affected patients. Standardization of diagnostic and therapeutic processes in the ED therefore improves the outcome of patients hospitalized for CAP.


Eligibility criteria: Inclusion Criteria:

* all patients with community acquired pneumonia

Exclusion Criteria:

* exacerbation of chronic obstructive pulmonary disease
* malignancy
* immunosuppression
* neutropenia

Primary outcomes:
measure: mortality of CAP patients
timeFrame: up to 14days
Secondary outcomes:
measure: mortality up to 14days in subgroups
timeFrame: up to 14 days
Other outcomes:
Locations:
city: Nuremberg
country: Germany
facility: City Hospital Nuremberg
state: Bavaria
Study officials:
References:
Clinical trial NCT06986200: MultiCPR: The Influence of Firefighter's PPE on Chest Compressions (MultiCPR3)
Official title: MultiCPR: The Influence of Firefighter's PPE on Chest Compressions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiac Arrest (CA)
Occupational Health
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this clinical study is to evaluate the impact of wearing firefighters' personal protective equipment (PPE) on the quality of chest compressions during simulated resuscitation scenarios. The study compares the effects of one-minute versus two-minute intervals for switching the individual performing compressions.

How does the clinical trial work? This randomized cross over trial will be conducted in several locations and will involve a total of 38 fire-fighters. The study will be conducted by the Department of Anesthesiology of the Medical University of Vienna.

Participation in this clinical study is expected to last 30 minutes in total. Participants are randomized to either one or two minute intervalls of performing chest compressions in teams of two. After a cooling-of phase of at least 24 hours, they will be switched to the other group.

Chest compressions will be performed for 12 minutes in full firefighter's PPE. Primary outcome will be chest compression depth.


Eligibility criteria: Inclusion:

* Healthy fire-fighters trained in CPR
* CPR Training in the last four years
* Fit and rested

Exclusion:

- Pregnant participants

Primary outcomes:
measure: Chest Compressions depth
timeFrame: during 12 minutes of chest compressions. 2x12 = 24minutes in total per participant
Secondary outcomes:
measure: Chest compression rate
timeFrame: during 12 minutes of chest compressions. 2x12 = 24minutes in total per participant
measure: Incomplete recoil (leaning) during chest compressions
timeFrame: during 12 minutes of chest compressions. 2x12 = 24minutes in total per participant
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Academic Simulation Center
Study officials:
References:
Clinical trial NCT04287400: Prospective Trial for the Evaluation of Radiogenomics in Advanced Rectal Cancer
Official title: Prospective Clinical Trial for the Evaluation of Radiogenomics: Correlation, Treatment Response and Prognosis in Patients With Advanced Rectal Cancer, Who Undergo Preoperative Chemoradiation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2020-02-27
Enrollment: 210
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with mid-lower rectal cancer and expected to receive chemoradiotherapy before surgery

Brief summary: In patients with advanced rectal cancer, molecular subtypes will be identified by preoperative biopsy, CT, MRI / PET radiomics analysis, clinical features, and clinical features will be confirmed and compared.

Also, we want to confirm the relationship between these factors and the treatment response after chemoradiotherapy before surgery. The prognosis will be then assessed through 5-year overall survival and 3-year disease free survival.

A prospective clinical trial, recruiting 210 persons (approximately 53 per year) that meet the selection criteria for approximately four years from the IRB approval date in 2019 (about 53 per year) We will analyze the data and then collect and analyze the data and report the results.


Eligibility criteria: Inclusion Criteria:

* Age: 20-80 years
* Patients diagnosed with mid-lower rectal cancer and expected to receive chemoradiotherapy before surgery

Exclusion Criteria:

* Patients with distal metastases confirmed at diagnosis
* Patients with other bowel diseases such as IBD, ischemic colitis and TB colitis in addition to colorectal cancer
* If patients do not agree with this study

Primary outcomes:
measure: K-RAS Mutation
timeFrame: 4 weeks
Secondary outcomes:
measure: Radiomics - MR image findings
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
References: