louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01391975: Surveillance and Proactive Intervention for Dialysis Access
Official title: A Multi Centre Randomized Controlled Trial of the Clinical and Cost Effectiveness of Duplex Ultrasound Surveillance With Proactive Intervention Versus no Surveillance and Reactive Intervention for the Management of Stenosis in Arterio-venous Fistulae for Dialysis Vascular Access.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Renal Failure
Arteriovenous Fistula
Keywords: arteriovenous fistula
surveillance
arterial stenosis
venous stenosis
Lead sponsor: University of Hull
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Newly formed dialysis fistulae can often fail, and failure is usually due to narrowing of the blood vessels. Methods of detecting narrowing are available and, more importantly, can detect narrowings before a fistula fails. It is not known whether treating these narrowings will actually improve fistula survival or if the majority can be left alone. we wish to see if we can detect such narrowings with ultrasound scanning and if early detection and treatment improves patient outcomes.


Eligibility criteria: Inclusion Criteria:

1. Incident patients referred to vascular or transplant surgery departments for primary AV fistula formation for haemodialysis access.
2. Ability to give informed written consent
3. Aged over 18 at time of referral

Exclusion Criteria:

1. Inability to give informed written consent
2. Aged under 18 at time of referral
3. Inability to attend follow-up appointments

Specific exclusion;

1. Previous arteriovenous access procedures in target limb
2. Unsuitable for upper limb radiocephalic or brachiocephalic AVF formation
3. Known thrombophilic or thrombotic pathology

Primary outcomes:
measure: Cumulative or secondary patency
timeFrame: within 6 months of fistula formation
Secondary outcomes:
measure: Number of thrombosis events
timeFrame: within 6 months of fistula formation
measure: Number of fistula failures
timeFrame: within 6 months of fistula formation
measure: Number, type and technical success rate for elective interventions
timeFrame: within 6 months of fistula formation
measure: Number, type and technical success rate of acute interventions
timeFrame: within 6 months of fistula formation
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
Study officials:
References:
Clinical trial NCT05642975: Comparing Suprainguinal Fascia Iliaca Block With Erector Spinae Plane Block in Hip and Proximal Femur Surgery
Official title: Comparing Ultrasound-Guided Suprainguinal Fascia Iliaca Block With Lumbar Erector Spinae Plane Block in Hip and Proximal Femur Fracture Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Femur Fracture
Regional Anesthesia
Keywords: Postoperative Pain
Lumbar Erector Spinae Plane Block
Fascia Iliaca Block
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Most hip fractures occur in the elderly population. Opioid-related respiratory depression is more common in the elderly population but can cause severe brain damage or death. Reducing the amount of opioids administered before, during and after surgery by adding a regional block may increase the postoperative quality of recovery, reduce chronic pain syndromes, and may potentially facilitate the participation of patients in rehabilitation.

Despite their potential advantages, peripheral nerve blocks are still not widely used in people with hip fractures.

The primary objective of this study is to compare patients' postoperative pain scores and opioid consumption.


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years old, undergoing hip fracture surgery

Exclusion Criteria:

* Patients with solid organ dysfunction, chronic opioid or corticosteroid use, bleeding diathesis, patients receiving inpatient medication, patients with psychiatric disorders and patients who cannot be contacted after surgery.

Primary outcomes:
measure: Opioid Consumption
timeFrame: 48 hours
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 48 hours
measure: Complications Related to Pain Management
timeFrame: 48 hours
measure: Postoperative Pain Scores
timeFrame: 48 hours
measure: The lengths of ICU and hospital stays
timeFrame: 7 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University Hospital
Study officials:
References:
Clinical trial NCT04246775: Low Anterior Resection Syndrome and Rectal Irrigation Study
Official title: Low Anterior Resection Syndrome and Rectal Irrigation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Resection Syndrome
Lead sponsor: Cardiff and Vale University Health Board
Sponsor class: OTHER_GOV
Collaborators: name: South East Wales Trials Unit (SEWTU)
name: Tenovus
First posted: 2020-01-29
Enrollment: 22
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: Prospective study assessing treatment acceptability and the impact of rectal irrigation on patients with low anterior resection syndrome (LARS) in terms of quality of life and bowel function.

Detailed description: Aims: To assess if rectal irrigation improves patient symptoms and quality of life in patients with LARS and to see if the treatment is acceptable to patients.

Methods: This is a mixed methods evaluation study on functional outcomes in patients who have undergone anterior resection for rectal neoplasia and who have had bowel continuity restored between Jan 2009 and Jan 2014. Those patients deemed to have LARS who consent to participation in the study will be offered rectal irrigation.

Eligibility criteria: Inclusion Criteria:

* patients who have undergone anterior resection for rectal neoplasia, patients who have had restored bowel continuity
* LARS score of \>20 (defined LARS syndrome)
* patients \> 18 years of age.

Exclusion Criteria:

* previous use of rectal irrigation
* patients who are unable to give informed consent
* patients who are not physically capable of performing the treatment in their home

Primary outcomes:
measure: SF12
timeFrame: pre intervention and 6 months post
Secondary outcomes:
measure: EORTC
timeFrame: pre intervention and 6 months post
measure: Low anterior resection score
timeFrame: pre intervention and 6 months post
measure: St Marks Faecal incontinence score
timeFrame: pre intervention and 6 months post
measure: treatment acceptability questionnaire
timeFrame: post training for treatment and 6 months post treatment
Other outcomes:
measure: qualitative interviews
timeFrame: after 6 months treatment or drop out from treatment group
Locations:
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
Study officials:
References:
Clinical trial NCT03527875: Process Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice
Official title: Process Optimization of Preoperative Biliary Drainage in Patients With Malignant Obstructive Jaundice of Extrahepatic Bile Duct: A Multi-center, Prospective, Open-labeled, Real World Study Based on Electronic Data Capture System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Jaundice, Obstructive
Klatskin Tumor
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-05-17
Enrollment: 564
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of different methods of preoperative biliary drainage in patients with extrahepatic bile duct neoplasms with obstructive jaundice (hilar cholangiocarcinoma, distal bile duct cancer, and periampullary carcinoma), including PTBD (Percutaneous Transhepatic Biliary Drainage), ENBD (Endoscopic Nasobiliary Drainage) and EBS (Endoscopic Biliary Stenting).


Eligibility criteria: Inclusion Criteria:

* Patients who meet the following four criteria are included into the study:

  1. Preoperative clinical diagnosis of hilar cholangiocarcinoma, distal bile duct cancer, periampullary cancer without distant metastasis or peripheral vascular invasion, and plan for radical surgery;
  2. Serum total bilirubin is higher than 51 umol/l;
  3. Age is older than 18 and younger than 80 years old;
  4. Sign in informed consent to receive preoperative PTBD, ENBD, EBS or without PBD.

Exclusion Criteria:

* If any of the following items are met, the subject cannot enter the study.

  1. Incorporate severe mental illness, severe heart, lungs and kidneys disease, etc., and be unable to tolerate surgery;
  2. Malignant obstructive jaundice caused by metastatic tumors;
  3. Pregnancy or lactation women.

Primary outcomes:
measure: Complication rate after drainage
timeFrame: From PBD to completion of radical surgery, an average of 1 month
measure: Complication rate after radical surgery
timeFrame: 1 month post operatively
measure: Success rate of PBD
timeFrame: Day 1
Secondary outcomes:
measure: operative time
timeFrame: Day 1
measure: Hepatoduodenal edema
timeFrame: at time of radical surgery
measure: Perioperative mortality
timeFrame: from PBD to 4 weeks after surgery, an average of 2 month
measure: implantation metastasis
timeFrame: Day 1
measure: Rate of change in Total bilirubin
timeFrame: 2 weeks after PBD
measure: Rate of change in alanine aminotransferase
timeFrame: 2 weeks after PBD
measure: Rate of change in aspartate aminotransferase
timeFrame: 2 weeks after PBD
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04831775: Cognitive Training for Diabetes Self-Management
Official title: Cognitive Training for Diabetes Self-Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: cognitive function
glucose variability
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2021-04-05
Enrollment: 95
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to determine the effects of a comprehensive cognitive rehabilitation intervention on biological, cognitive, and diabetes self-management outcomes.

Detailed description: Aim 1: Test the efficacy of the MAPSS-DM intervention for improving cognitive function, A1C, and DM-SM. Based on preliminary data, the working hypothesis is that compared with the control group, persons who receive the intervention will have improved memory, executive function, and perceived cognitive function, greater use of cognitive strategies, and improved DM-SM immediately post-intervention and at three and six-months post-intervention.

Aim 2: To explore changes in glycemic variability and their association with changes in cognitive function. The working hypothesis here is that MAPSS-DM participants will exhibit less glycemic variability post-intervention as compared with baseline and glycemic variability will mediate improvements in cognitive test performance.

Eligibility criteria: Inclusion Criteria:

* age 50 years old or greater
* T2DM diagnosis for 2 years
* access to phone and Internet
* Score of ≥10 on the Perceived Deficits Questionnaire (PDQ)
* A1C of \>7%.

Exclusion Criteria:

* a diagnosis of dementia/head injury
* score of \>5 on the Mini-Cog
* inability to speak English, and T1DM diagnosis

Primary outcomes:
measure: Change in A1C at Week 22
timeFrame: Baseline and week 22
measure: Change in Diabetes Self-management Adherence at Week 22
timeFrame: Baseline and week 22
measure: Change in Glucose Variability at Week 22
timeFrame: Baseline and week 22
measure: Change From Baseline to Week 22 in the Number of Correct Responses in 90 Seconds on the Symbol Digit Modalities Test
timeFrame: Baseline and week 22
Secondary outcomes:
measure: Change in Perceived Cognitive Function at Week 22
timeFrame: Baseline and week 22
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: Heather E Cuevas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02829775: A Study of Continued Treatment Among Participants Who Have Responded to Peginterferon Alfa-2a (Pegasys®) or Recombinant Interferon Alfa-2a (Roferon-A®) in Prior Clinical Studies
Official title: Extension Protocol for Patients With Chronic Myelogenous Leukemia, Malignant Melanoma or Renal Cell Carcinoma That Have Responded to Treatment With Pegylated-Interferon α-2a or Roferon-A® in Prior Clinical Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Myelogenous Leukemia
Malignant Melanoma
Renal Cell Carcinoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-07-12
Enrollment: 9
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: This open label extension study will give an opportunity to the participants that have responded to the treatment with Pegylated-Interferon Alfa-2a (Pegasys) or Recombinant Interferon Alfa-2a (Roferon-A®) in prior clinical studies NO15753 (NCT00003542) for Renal Cell Carcinoma (RCC), NO15764 (NCT number not available) and NO16006 (NCT02736721) for Chronic Myelogenous Leukemia (CML), and NO16007 (NCT number not available) for Malignant Melanoma (MM).


Eligibility criteria: Inclusion Criteria:

* Participants must have completed protocol NO15753, NO15764, NO16006 or NO16007 and responded to treatment at the end of the trial as defined in the parent protocol
* CML participants must have a confirmed cytogenetic complete response within 2 months of entering the extension study. MM and RCC participants must have tumour assessments verifying stable or better response within 2 months of entering the extension study

Exclusion Criteria:

* Pregnant or lactating women
* Refusal to use adequate contraceptive measures among men and women of childbearing potential

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: Baseline up to approximately 3 years
Secondary outcomes:
measure: Number of Participants With Overall Tumor Response
timeFrame: Baseline until disease progression, withdrawal or death, whichever occurred earlier (assessed every 6 months up to approximately 3 years)
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
city: Halifax
country: Canada
state: Nova Scotia
city: Lucknow
country: India
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Kosice
country: Slovakia
city: Durban
country: South Africa
city: Valencia
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT00757575: Disease Burden of Pneumonia, Meningitis and Bacteremia Among Children in Japan: Pneumonet Japan
Official title: Epidemiological Surveillance Network Study To Assess the Disease of Pneumonia in Infants and Children in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Disease
Keywords: PNEUMONET JAPAN STUDY
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-23
Enrollment: 28511
Sex: ALL
Minimum age (years): 28
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants and children less than 5 years of age living in Okinawa and Eastern Hokkaido.

Brief summary: Streptococcus pneumoniae is a major cause of pneumonia, among infants and children in Japan and worldwideThis study plans to investigate the rate of invasive pneumococcal disease "IPD " and the rate of hospitalizations due to pneumonia in Okinawa and the Eastern half of Hokkaido Currently, only a limited information about pneumococcal disease burden is available in Japan.


Eligibility criteria: Eligibility Criteria

- Children residing in the surveillance area(s) aged 28 days to \<60 months with clinical suspicion of pneumonia, meningitis and bacteremia who were admitted to the hospital.

Primary outcomes:
measure: 1.Describe the distribution of causal pathogen of meningitis and bacteremia 2.Estimate the hospital admission rate of pneumonia patients 3.Estimate the incidence rate of IPD 4.Describe the serotype distribution of S. pneumoniae
timeFrame: 2 years
Secondary outcomes:
measure: 1.CFRof patients admitted with IPD and/or pneumonia. 2.Antibiotic resistance rate of S. pneumoniae 3.Risk factor distribution 4.Average duration of the hospitalization of patients with IPD, meningitis, and/or pneumonia.
timeFrame: 2-3 years
Other outcomes:
Locations:
city: Kushiro
country: Japan
state: Hokkaido
city: Naha City
country: Japan
state: Okinawa
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03577275: A Study to Evaluate the Effects of NST-4016 on QT/Corrected QT (QTc) Interval
Official title: A Randomised, Partially Double Blind, Placebo and Positive Controlled, 4 Way Crossover Study to Evaluate the Effect of Icosabutate (NST 4016) on the QT/QTc Interval in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemias
Lead sponsor: NorthSea Therapeutics B.V.
Sponsor class: INDUSTRY
First posted: 2018-07-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, single centre, randomised, double blind (except for moxifloxacin), placebo and positive controlled, 4 way crossover study assessing the ECG effects of therapeutic and supratherapeutic doses of icosabutate in healthy male and female subjects.


Eligibility criteria: Inclusion Criteria:

* 1. Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening.
* 2. Body mass index (BMI) between 18.0 and 33.0 kg/m2, inclusive, at Screening
* 3. In good health

Exclusion Criteria:

* 1. An uninterpretable or abnormal ECG at Screening and/or Check in
* 2. History of risk factors for Torsades de Pointes
* 3. sustained supine systolic blood pressure \>140 mmHg or \<90 mmHg
* 4. Unstable cardiovascular disease, including recent myocardial infarction or cardiac arrhythmia.
* 5. Female subjects who are pregnant (or planning to become pregnant within 90 days after the final dose administration) or are currently lactating
* 6. Subjects who, in the opinion of the Investigator (or designee), should not participate in this study

Primary outcomes:
measure: Change From Baseline in Fridericia's Correction for QT Interval (QTcF)
timeFrame: 24 hours
Secondary outcomes:
measure: Change From Baseline in Heart Rate (HR)
timeFrame: 24 hours
measure: Change From Baseline in Fridericia's Correction for QT Interval (QTcF)
timeFrame: 24 hours
measure: Change From Baseline in PR Interval (PR)
timeFrame: 24 hours
measure: Change From Baseline in QRS Interval (QRS)
timeFrame: 2 hours
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Covance Clinical Research Unit (CRU) Ltd
Study officials:
References:
Clinical trial NCT03900975: Vulvar Paget Disease
Official title: Analyses of the Outcome of a Treatment of Vulvar Paget Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vulvar Paget's Disease
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2019-04-03
Enrollment: 8
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with vulvar paget disease

Brief summary: In this study only women with vulvar paget disease will be included and will be analysed retrospectively. Vulvar paget disease patients are frequently treated with surgical resection of the affected tissue. During a surgical treatment surgical margins are frequently positive. Recidives are seen frequently after surgical treatment or the development of other pathologies such as vulvar carcinoma. In this study the outcome of the vulvar paget disease will be analysed and compared between the participants. It's primary goal is to create a better view on the outcome and the prognosis to prevent e.g. complications in the future.

Detailed description: In this study only women with vulvar paget disease will be included and will be analysed retrospectively. Vulvar paget disease patients are frequently treated with surgical resection of the affected tissue. During a surgical treatment surgical margins are frequently positive. Recidives are seen frequently after surgical treatment or the development of other pathologies such as vulvar carcinoma. In this study the outcome of the vulvar paget disease will be analysed and compared between the participants. It's primary goal is to create a better view on the outcome and the prognosis to prevent e.g. complications in the future.

All the information of the patients will be gathered retrospectively from their medical file , after they gave their consent.

Eligibility criteria: Inclusion Criteria:

* Vulvar Paget disease

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Number of complications after the treatment of vulvar Paget disease
timeFrame: Max. 10 years after treatment
measure: Type of complications after the treatment of vulvar Paget disease
timeFrame: Max. 10 years after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
state: East Flanders
Study officials:
References: