louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00667238: Chronic Pediatric Pain
Official title: Functional Impact of Chronic Pediatric Pain
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2008-04-28
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children ages 8-18

Brief summary: The purpose will be to study the functional impact of pediatric chronic pain on children, and their families. Focus will be on the impact of pain on school functioning, social functioning, psychological functioning and family functioning of pediatric chronic pain.


Eligibility criteria: Inclusion Criteria:

* All patients who have completed parent surveys before coming to the multidisciplinary pain management clinic evaluations.

Exclusion Criteria:

* If the patient's surveys are missing or incomplete (i.e. more than half of the survey was not completed, they will be excluded from entry into the data base.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Rashmi Parekh Bhandari
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03460938: Remote Ischemic Preconditioning and Postoperative Myocardial Ischemia
Official title: The Effect of Remote Ischemic Preconditioning on Postoperative Myocardial Ischemia in Pancreatic Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischemia
Inflammatory Response
Lead sponsor: St. Antonius Hospital
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: High-risk abdominal surgery is frequently complicated by postoperative complications, such as sepsis, pneumonia or anastomotic dehiscence. Asymptomatic myocardial injury after abdominal surgery (MINS) predicts non-cardiac complications. The etiology of MINS in abdominal surgery patients is unknown. Remote ischemic preconditioning (RIPC) is a physiologic mechanism that exposes tissues to brief periods of non-lethal ischemia and reperfusion, creating resistence for future serious ischemic insults. RIPC in patients after cardiac or aortic surgery is associated with a protective effect on the heart. The effect of RIPC in abdominal surgery patients is unknown.

Objective of the study: To determine the effect of RIPC on MINS in patients after pancreatic sugery.

Study design: Randomised controlled parallel group mono-center pilot study.

Study population: 90 adult patients scheduled for elective pancreaticoduodenectomy in St. Antonius Hospital (45 in the intervention group and 45 in the control group).

Intervention: RIPC: 3 periods of 5 minutes of ischemia followed by 5 minutes of reperfusion are created by inflating a blood pressure cuff on the upper extremity after induction of anesthesia and prior to surgery. In the control group a non-inflated blood pressure cuff is placed on the upper extremity for 30 minutes.

Primary study parameters/outcome of the study: Maximum postoperative concentration of high-sensitive cardiac troponin T.

Secondary study parameters/outcome of the study: Markers of inflammatory, intestinal and renal injury, postoperative complications during 30 days, length of stay and hospital mortality.


Eligibility criteria: Inclusion Criteria:

* Elective pancreaticoduodenectomy
* Age \>18

Exclusion Criteria:

* No informed consent

Primary outcomes:
measure: Postoperative myocardial injury.
timeFrame: 48 hours
Secondary outcomes:
measure: Inflammatory response
timeFrame: 48 hours
measure: Postoperative complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Nieuwegein
country: Netherlands
facility: St Antonius hospital
Study officials:
affiliation: St. Antonius Hospital
name: Peter Noordzij, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Zeggeren L, Visser RA, Vernooij LM, Dijkstra IM, Bosma M, Molenaar Q, van Santvoort HC, Noordzij PG. The effect of remote ischaemic preconditioning on postoperative cardiac and inflammatory biomarkers in pancreatic surgery: a randomized controlled trial. BJS Open. 2021 Mar 5;5(2):zrab015. doi: 10.1093/bjsopen/zrab015.
Clinical trial NCT00416338: Method of Exit Site Care in Chronic Peritoneal Dialysis Patients
Official title: Comparison of Two Exit-Site Care Methods, Film Dressing (F) Method and Simple Gauze Dressing (G) Method, in Chronic Peritoneal Dialysis (CPD) Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Chronic Peritoneal Dialysis
Keywords: renal failure
infection
peritonitis
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2006-12-28
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peritoneal dialysis accounts for more than 70% of the dialysis modality in Hong Kong. Exit site infection (ESI) is one of the causes leading to peritoneal catheter removal. Appropriate exit-site care can prevent ESI. As the presence of a causative organism is essential in ESI, eliminating organism invasion may be useful in preventing ESI. In the present study, an exit site care method aiming at preventing organism invasion is developed to investigate its effectiveness in reducing ESI. It is also hoped the present study can help to develop an exit site care method that can reduce the frequency of exit site dressing so as to reduce the burden of patients and to improve their quality of life.

We'll recruit one hundred new chronic peritoneal dialysis patients into the study. The patients will be divided into two groups. One group of the patients will use film-dressing method (F) and the other group will use simple gauze dressing method (G). F group patients will have the exit site covered with a dressing film and keep it intact for 7 days after having the exit site cleaned with antiseptic solution. G group patients will clean the exit site with antiseptic solution and change the simple gauze dressing daily.

The outcomes of the two groups will be compared. The outcome will be expressed in terms of exit site infection free period, peritonitis free period and exit site condition classification. Patient subjective quality of life will also be compared at first and twelfth month.


Eligibility criteria: Inclusion Criteria:

* chronic renal failure patients with peritoneal catheter newly inserted

Exclusion Criteria:

* Patients have exit-site infection before stitches removal or presence of signs and symptoms of exit-site infection at the time of remove stitches.
* Patients plan to move out of PWH or transplant soon after catheter insertion.
* Patients have known history of allergy to adhesives / tapes.
* Extremely non-compliant patients.

Primary outcomes:
measure: Exit site infection.
Secondary outcomes:
measure: Patient satisfaction / quality of life.
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: Department of Medicine & Therapeutics, Prince of Wales Hospital
Study officials:
affiliation: Renal Unit, Department of Medicine & Therapeutics, Prince of Wales Hospital, Hong Kong
name: Man-Ching Law, BN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02912338: The Effectiveness of Lifestyle Intervention on Body Composition, Physical Performances and Quality of Life Among Elderly People in Long-term Care Facilities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Obesity
Keywords: Sarcopenic obesity
Body composition
Physical function
quality of life
long term care
Lead sponsor: Central Taiwan University of Science and Technology
Sponsor class: OTHER
First posted: 2016-09-23
Enrollment: 123
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: To understand the change in body composition, physical functions and quality of life of elderly residents with sarcopenic obesity in LTC facilities after the implementation of exercise intervention.


Eligibility criteria: Inclusion Criteria:

1. aged and elderly over 60 years old and no exercise restrictions.
2. conscious clear, able to communicate with to the traditional Chinese language or Taiwanese.
3. in the past three months living in long-term care institutions.
4. in the last month the subject biased static life
5. in a stable condition with enough energy: to maintain the support of at least one hour sitting in a wheelchair or bed edge.

Exclusion Criteria:

1. In the past three months have unstable weight (\> ± 4 kg).
2. severe disease states, such as severe heart and lung liver and kidney disease, a serious cancer, severe malnutrition (Mini Nutritional Assessment Scale 0-7 points).
3. limb unable to anti-gravity completely
4. severe dementia (Clinical Dementia Rating (CDR) Scale Clinical Dementia Rating, CDR 3-5 points).

Primary outcomes:
measure: Body Composition
timeFrame: Change gram, kg and percentage from baseline to follow up (12 weeks later)
measure: body weight
timeFrame: Change kg from baseline to follow up (12 weeks later)
measure: BMI
timeFrame: Change from baseline to follow up (12 weeks later)
measure: hand grip
timeFrame: Change from baseline to follow up (12 weeks later)
measure: hand pinch
timeFrame: Change kg from baseline to follow up (12 weeks later)
measure: Activities of daily living
timeFrame: Change score from baseline to follow up (12 weeks later)
measure: Quality of Life
timeFrame: Change score from baseline to follow up (12 weeks later)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Chang SF, Chiu SC. Effect of resistance training on quality of life in older people with sarcopenic obesity living in long-term care institutions: A quasi-experimental study. J Clin Nurs. 2020 Jul;29(13-14):2544-2556. doi: 10.1111/jocn.15277. Epub 2020 Apr 24.
citation: Chiu SC, Yang RS, Yang RJ, Chang SF. Effects of resistance training on body composition and functional capacity among sarcopenic obese residents in long-term care facilities: a preliminary study. BMC Geriatr. 2018 Jan 22;18(1):21. doi: 10.1186/s12877-018-0714-6.
Clinical trial NCT04649138: Fomepizole Dosing During Continuous Renal Replacement Therapy (CRRT)
Official title: Fomepizole Dosing During Continuous Renal Replacement Therapy (CRRT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Toxic Alcohol Poisoning
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Louisiana State University Health Sciences Center Shreveport
First posted: 2020-12-02
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Toxic alcohol poisoning treated with fomepizole and CRRT.

Brief summary: The project is a prospective observation study of patients with suspected or confirmed toxic alcohol poisoning treated with fomepizole and continuous renal replacement therapy (CRRT)


Eligibility criteria: Inclusion Criteria:

* Patients (over 18 year) with suspected or confirmed toxic alcohol poisoning treated with fomepizole and CRRT.

Exclusion Criteria:

* Patients who wish to withdraw from the study

Primary outcomes:
measure: Measure minimum plasma concentration of fomepizole
timeFrame: through study completion, up to 72 hours
Secondary outcomes:
measure: Continuous renal replacement therapy (CRRT) clearance of fomepizole
timeFrame: through study completion, up to 72 hours
measure: Determine saturation/sieving coefficient of fomepizole
timeFrame: through study completion, up to 72 hours
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
References:
Clinical trial NCT01752738: Intestinal Transport of Microbial Metabolites in Chronic Kidney Disease
Official title: The Influence of Chronic Kidney Disease on Intestinal Transport of Gut Microbial Metabolites
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Kidney Disease
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2012-12-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from the nephrology outpatient clinic and dialysis center at University Hospital Leuven, Belgium.

Brief summary: Chronic kidney disease is associated with the accumulation of various metabolites, i.e., uremic retention solutes. Evidence is mounting that the colonic microbiome contributes substantially to these uremic retention solutes. Indoxyl sulfate and p-cresyl sulfate are among the most extensively studied gut microbial metabolites, and are associated with cardiovascular disease, chronic kidney disease progression and overall mortality. Mechanisms governing their intestinal uptake and metabolism, however, are currently unknown. The investigators aim to explore these transport characteristics in depth. Therefore, colonic biopsies will be sampled of patients with chronic kidney disease, analyzed and compared to available data of healthy controls. Insights in the mechanisms controlling intestinal transport and metabolism of indoxyl sulfate and p-cresyl sulfate is certainly relevant as it might lead to novel therapeutic targets in the treatment of chronic kidney disease.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 and ≤ 85 years
* Chronic kidney disease ≤ stage III (KDOQI), i.e., estimated glomerular filtration rate (MDRD) \< 60 ml/min/m² or need of dialysis therapy 27
* Scheduled colonoscopy for diagnostic purposes
* Written informed consent

Exclusion Criteria:

* History of gastro-intestinal disease (e.g., inflammatory bowel disease)
* History of colon surgery
* Recipient of a renal or other solid organ transplant
* Exposure to antibiotics or drug therapy with a known influence on intestinal transporters (e.g., P-gp) or enzymes during 2 weeks before colonoscopy

Primary outcomes:
measure: Percentage change in number of intestinal drug transporters and enzymes
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams Brabant
Study officials:
affiliation: UZ Leuven
name: Bjorn Meijers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Sander Dejongh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02315638: Long-Term Follow-Up Safety Monitoring of Patients Dosed in the First-in-Man Phase I/II Study of TT-034.
Official title: Follow-up to Study Protocol B2801001, A Phase I/II, Open-Label Dose Escalation Study to Evaluate the Safety and Efficacy of Single Doses of TT-034 in Patients With Chronic Hepatitis C [CHC] Infection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis C
Keywords: Adeno-associated viral vectors
Adeno-associated virus
AAV
AAV8
ddRNAi
shRNA
RNAi
Hepatitis
Chronic Hepatitis C
HCV
CHC
Genotype 1
Lead sponsor: Tacere Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-12
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is comprised of subjects that were enrolled in Study B2801001 and who received a dose of TT-034.

Brief summary: This is a long-term safety follow-up protocol for subjects who received TT-034 under the B2801001 protocol and consists of monitoring for at least 4.5 years.

Detailed description: The main purpose of this follow-up study is to detect events suggestive of delayed adverse effects of the study drug by review of clinical histories and discussion with subjects to identify/elicit significant medical events, including but not limited to hematologic, malignant, autoimmune, neurologic, and hepatic events.

Eligibility criteria: Inclusion Criteria:

* Prior enrollment in Study B2801001 and dosing with TT-034
* An informed consent form for this study signed and dated by the subject or a legally acceptable representative

Exclusion Criteria:

* There are no specific exclusion criteria for this follow-up study

Primary outcomes:
measure: Long Term Safety as measured through an assessment of adverse events
timeFrame: 4.5 years
Secondary outcomes:
measure: Long Term Viral Load
timeFrame: 4.5 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Clinical Research Institute
state: North Carolina
Study officials:
affiliation: Tacere Therapeutics, Inc.
name: David Suhy, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06587438: Effect of CGM on Glucose Control in Non-insulin-treated Patients with Type 2 Diabetes Mellitus
Official title: Effects of COntinuous Glucose MoNitoring Versus Usual Care on GlycEmic Control in Non-insulin-tReated Adults with Type 2 Diabetes：a Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Sinocare
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The clinical value of CGM for diabetic patients undergoing insulin therapy has been widely recognized, but the evidence-based support for its use in non-insulin-treated type 2 diabetic patients remains insufficient. The primary objective of this study is to evaluate the effect of real-time continuous glucose monitoring (CGM) compared with self-monitoring of blood glucose on glycemic control in adults with non-insulin treated type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* (1)Subjects aged ≥18 years at screening (based on the day of signing the informed consent form) and of any gender
* (2)Patients diagnosed with type 2 diabetes
* (3)Prior to the screening, glycemic control was suboptimal with diet, exercise control, and oral medication or glucagon-like peptide-1RA (GLP-1RA) therapy maintained for more than 3 months, 7.5%≤HbA1c≤10%
* (4)Subjects voluntarily sign an informed consent form

Exclusion Criteria:

* (1)Patients treated with insulin within 3 months prior to screening
* (2)Currently or have used a CGM device within 3 months prior to enrollment
* (3)Serious skin disease at the sensor placement site, allergy to tape or adhesives
* (4)Pregnant females, those with a positive pregnancy test result at screening, or those who plan to become pregnant during the study
* (5)Those who are participating or will participate in other clinical trials
* (6)Those who, in the opinion of the investigator, should not participate in this clinical trial, such as: ①those who have a history of eye trauma or other diagnosed eye diseases resulting in visual impairment, etc.; ②those who are unwilling or unable to fully understand or cooperate due to speech disorders; ③those who suffer from mental disorders

Primary outcomes:
measure: HbA1c
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00451438: Investigation of Muscle Activity Pattern of Gluteus Medius and Tensor Fascia Lata in Patients With PFPS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patellofemoral Pain Syndrome
Keywords: patellofemoral pain syndrome
electromyography
gluteus medius
tensor fascia lata
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2007-03-23
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: The purpose of this study is to investigate the muscle activity of gluteus medius and tensor fascia lata in health control group and patients with PFPS during submaximal isometric muscle contraction.The research question :Is there any difference of muscle activity of gluteus medius and tensor fascia lata between health control group and patients with PFPS during submaximal isometric muscle contraction ？Null hypothesis:There is no difference of muscle activity of gluteus medius and tensor fascia lata between health control group and patients with PFPS during submaximal isometric muscle contraction.

Detailed description: Basic data

- Name, age, sex, BW, BH, pain VAS scale（VAS-activity）, affected side, dominate leg, symptom duration, activity level

Measurement

* Flexibility of iliotibial band：Ober test
* EMG data collection during 8s submaximal muscle contraction
* Muscle strength measurement of hip abductors

Eligibility criteria: Inclusion Criteria:

* 20-50 years old
* Insidious onset of symptoms
* Pain exist at least 3 month, VAS activity\>4
* Two of the following activities induce pain at anterior or retropatellar site prolonged sitting, stair-climbing, squatting, running, kneeling, and hopping/jumping
* Diagnosed by an orthopedic surgeon

Exclusion Criteria:

* History of lower extremity fracture or operation
* Neurological disease involved
* Observed knee deformity
* Other well-defined musculoskeletal problems in lower extremity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NTU department of physical therapy
name: Mei-Hwa Jan, Master
role: STUDY_CHAIR
References: