louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00374400: The Paired Donation Consortium Paired Donation Program
Official title: The Paired Donation Consortium Paired Donation Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant
Keywords: Kidney
Transplant
Paired donation
Living donor
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: The Paired Donation Consortium
First posted: 2006-09-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: The purpose of the protocol is to increase the number of living donor transplants by eliminating immune incompatibilities between donors and recipients through paired donation.

Detailed description: The purpose of the protocol is to increase the number of living donor transplants by eliminating immune incompatibilities between donors and recipients through paired donation.

To increase the number of patients transplanted by paired donation by establishment of regional paired donation programs.

To develop educational programs for potential living donors and their recipient, as well as the opportunity for transplant professionals to increase acceptance of the PDC to maximize the opportunity for organ donation.

To identify and evaluate ethical and psychological factors that may influence the effects of paired donation on living kidney donation.

Eligibility criteria: Inclusion Criteria:

* Persons capable of providing written informed consent.
* Each recipient must have one or more medically suitable donors who are either ABO-incompatible or HLA-incompatible.

Exclusion Criteria:

* Persons with eligible, compatible donor.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Steve Woodle, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03866200: Resveratrol Trial for Relief of Pain in Pseudoachondroplasia
Official title: Resveratrol Trial for Relief of Pain in Pseudoachondroplasia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pseudoachondroplasia
Keywords: resveratrol
joint pain
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-03-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if self-administered oral resveratrol can dampen joint pain for individuals with pseudoachondroplasia compared to placebo. Another goal of this study is to evaluate side effects in this population.


Eligibility criteria: Inclusion Criteria:

* The diagnosis of pseudoachondroplasia is based on clinical assessment either in person or by photographic review by skeletal dysplasia specialist (JTH),
* Healthy beyond pseudoachondroplasia associated complications,

Exclusion Criteria:

* Current use of resveratrol
* Current use of blood thinners, lovastatin, ketoconazole, itraconazole, fexofenadine and triazolam.
* Other non-pseudoachondroplasia related health conditions, e.g. cancers.
* Pregnancy or breastfeeding. Women must use adequate contraception during the study.
* Participation in another clinical study and/or using investigational agents.
* Use of Non-steroid anti-inflammatory (NSAIDs) or aspirin.
* Current use of Alfentanil, Cyclosporine, Dihydroergotamine, Dofetilide, Ergotamine, Fentanyl, Flibanserin, Oxycodone, Pimavanserin, Pimozide, Quinidine, Saquinavir, Sirolimus, Tacrolimus, Temsirolimus, Theophylline, Tizanidine, Thioridazine, Fosphenytoin, Phenytoin or Warfarin.
* Baseline level of pain of 2 or higher on 10 point scale.
* Platelet count below 50,000 per ul on baseline complete blood count (CBC).

Primary outcomes:
measure: Pain as Assessed by Numeric Pain Rating Scale
timeFrame: baseline, 30 days, 60 days, 90 days
Secondary outcomes:
measure: Health Related Quality of Life Score (HRQoL) Assessed by 36-item Short Form Health Survey Short Form-36 (SF-36)
timeFrame: baseline, 30 days, 60 days, 90 days
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
Study officials:
affiliation: University of Texas
name: Karen Posey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03190200: MRI Findings of Epiphyseal Growth Plate in Healthy Children
Official title: MRI Findings of Epiphyseal Growth Plate in Healthy Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: OCD - Osteochondritis Dissecans
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 7
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 6-10-year-old children with a sibling with known OCD and 6-10-year-old children with a known OCD in the contralateral knee

Brief summary: The purpose of the study is to determine if by using MRI changes can be identified changes early on in the knees of young children that may be at risk for developing osteochondritis dissecans. If MRI can identify changes then better council can be offered about the risks of future activity and treatment options.

Detailed description: Each subject will be asked to undergo an MRI at enrollment, six,12, and 18 months. Subjects will be monitored for evidence of osteochondritis dissecans in order to determine if we can identify it and then create a treatment program to allow these children to avoid developing definitive disease

Eligibility criteria: Inclusion Criteria:

6-10-year-old children with a sibling with known OCD and 6-10-year-old children with a known OCD in the contralateral knee

Exclusion Criteria:

Unable to undergo an MRI

Primary outcomes:
measure: OCD
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT06171100: Low-dose Tolvaptan for Inpatient Hyponatraemia.
Official title: Efficacy and Safety of Low-dose Tolvaptan in Treatment of Inpatient Hyponatraemia.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hyponatremia
SIADH
Keywords: Tolvaptan
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to hospital through Accident \& Emergency department or those who developed inpatient moderate to severe refractory hyponatraemia associated with SIADH and needed treatment with Tolvaptan.

Brief summary: This is a retrospective cohort study to assess the safety and efficacy of low first dose of Tolvaptan and low or standard second dose of Tolvaptan in patients with moderate to severe hyponatraemia associated with SIADH not responding to conservative means of hyponatraemia management.

Patients are treated as part of standard clinical care. There is growing evidence that treating patients with SAIDH induced hyponatraemia using a low dose of Tolvaptan with 7.5mg (below licensed lowest 15mg daily dose). This is the largest study to date and seeks to validate the efficacy and safety or this lower than approved dose of Tolvaptan in patietns who only need a first dose but also in patients who need a second low or srandard dose of Tolvaptan.


Eligibility criteria: Inclusion Criteria:

* All patients presenting to Accident \& Emergency department or seen as inpatients with moderate to severe hyponatraemia (sNa: \<125mmol) associated with SIADH and not responding to conservative measures of hyponatraemia management.
* Patients of all genders aged 18-90 y.o

Exclusion Criteria:

* Pregnant women and patients aged \< 18y.o
* Hyponatraemia not associated with SIADH

Primary outcomes:
measure: Response to low dose tolvaptan
timeFrame: Within 30 hours from tolvaptan intake
measure: Safety of low dose tolvaptan
timeFrame: Within 30 hours from tolvaptan intake
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
Study officials:
References:
Clinical trial NCT01877200: A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Bangladesh
Official title: A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Bangladesh
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-06-13
Enrollment: 2092
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People treated for at least a year are eligible for the study. The selection of the patients will be done randomly by the individual physician involved in the study.

Brief summary: This study is conducted in Asia. The aim of this non-interventional study is to evaluate the the current status of diabetes management, control, and complications in diabetic subjects with type 2 diabetes in Bangladesh.


Eligibility criteria: Inclusion Criteria:

* People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months
* Patients willing to sign informed consent form

Exclusion Criteria:

* Previous participation in this study
* Unable to comply with protocol requirements
* Confirmed or suspected pregnancy

Primary outcomes:
measure: Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7%
timeFrame: Evaluated at the first visit (only one study visit)
Secondary outcomes:
measure: Mean Fasting Plasma Glucose (FPG) of patients
timeFrame: Evaluated at the first visit (only one study visit)
measure: Mean Postprandial Plasma Glucose (PPG) of patients
timeFrame: Evaluated at the first visit (only one study visit)
measure: Mean HbA1c of patients
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having dyslipidemia and hypertension
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having cardiovascular complications
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having peripheral vascular disease
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having diabetic nephropathy
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having diabetic eye complications
timeFrame: Evaluated at the first visit (only one study visit)
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02037100: Sleep Disordered Breathing and Impaired Glucose Homeostasis in Obese Children
Official title: Sleep Disordered Breathing and Impaired Glucose Homeostasis in Obese Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SDB
T2DM
Obesity
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Schneider Children's Hospital
First posted: 2014-01-15
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children 6-20 years old

Brief summary: SDB has been identified as an important risk factor for insulin resistance and the metabolic syndrome.

In a recent study in patients with SDB and T2DM it was shown that CPAP therapy can lead to improvements in postprandial glucose levels and in glycosylated hemoglobin levels (HbA1c).

In children, there are only 3 studies that have examined the relations between SDB, obesity and the metabolic syndrome.

In order to further understand the relative contribution of SDB to the development of impaired glucose homeostasis and metabolic abnormalities we aim to investigate the prevalence and severity of SDB in children with T2DM compared to obese children without T2DM. The investigators hypothesize that SDB will be more prevalent and more severe among obese children with T2DM compared with the general obese pediatric population.


Eligibility criteria: Inclusion Criteria:

* diagnosed with T2DM
* obese

Exclusion Criteria:

-

Primary outcomes:
measure: Investigate the prevalence and severity of SDB among children with T2DM compared to its prevalence in non-diabetic obese children.
timeFrame: In 6 months
measure: To measure markers of inflammation and oxidative stress known to be associated with cardiovascular morbidity in children with T2DM and SDB compared to non-diabetic obese children.
timeFrame: In 6 months
measure: To examine changes in metabolic measures and markers of inflammation and oxidative stress in response to treatment for SDB (adenotonsillectomy) in children with T2DM compared to obese children without T2DM.
timeFrame: In 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
References:
Clinical trial NCT01220700: Antimicrobial Coated Sutures in Paediatric Surgery
Official title: Antimicrobial Coated Sutures in Paediatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Infections
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2010-10-14
Enrollment: 1635
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if suture material coated by antimicrobial agent triclosan would decrease the incidence of surgical site infections (SSIs) in paediatric surgery compared to ordinary sutures.

1500 children (age form 4 weeks to 18 years) coming for general pediatric surgery to the Oulu University Hospital are randomised to have sutures coated with triclosan (Vicryl Plus, Monocryl Plus) or ordinary sutures. The occurrence of SSIs is monitored by email questionnaires to the parents on days 10 and 30. The diagnosis of SSIs are made along CDC criteria.

Detailed description: We have now (spring 2014) recruited almost 1500 patients to the study. When reviewing the recruited material, we found out that the study suture material has been used in 83% of the recruited patients. The reasons for this have been clinical issue during the operation where melting suture material may not have been needed at all.

We have decided to prolong recruiting so that we would gather the calculated sample size of 1500 of patient with study suture material. This will take 12-18 months (probably till autumn 2015).

Eligibility criteria: Inclusion Criteria:

* any general surgery during childhood where melting sutures will be used

Exclusion Criteria:

* wound infection as a cause for surgery

Primary outcomes:
measure: occurrence of surgical site infections
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital/ Paediatric Surgery
Study officials:
affiliation: University of Oulu, Department of Paediatrics
name: Marjo Renko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oulu, Deparment of Paediatrics
name: Terhi Tapiainen, MD, PhD
role: STUDY_CHAIR
affiliation: University of Oulu, Deparment of Peadiatric Surgery
name: Willy Serlo, prof
role: STUDY_CHAIR
affiliation: University of Oulu, Department of Paediatrics
name: Matti Uhari, prof
role: STUDY_DIRECTOR
affiliation: University of Oulu, Department of Paediatric Surgery
name: Juha-Jaakko Sinikumpu, MD
role: STUDY_CHAIR
References:
citation: Renko M, Paalanne N, Tapiainen T, Hinkkainen M, Pokka T, Kinnula S, Sinikumpu JJ, Uhari M, Serlo W. Triclosan-containing sutures versus ordinary sutures for reducing surgical site infections in children: a double-blind, randomised controlled trial. Lancet Infect Dis. 2017 Jan;17(1):50-57. doi: 10.1016/S1473-3099(16)30373-5. Epub 2016 Sep 19.
Clinical trial NCT06336200: Knee Osteoarthritis and Kinesiophobia
Official title: Kinesiophobia in Patients With Total Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Kinesiophobia
Lead sponsor: Karabuk University
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals who have undergone total knee arthroplasty surgery will be included in the study. Patients will be divided into two groups, high and low kinesiophobia levels, according to the Tampa Kinesiophobia Scale.

Brief summary: Kinesiophobia after total knee arthroplasty is an important parameter affecting recovery. However, the relationship between kinesiophobia and the factors it may cause is not clear. Therefore, this study aimed to examine the relationship between kinesiophobia, pain, fear of falling, mobility and proprioception in the early period after total knee arthroplasty.

Detailed description: Various biopsychosocial factors affect the recovery process and quality of life after total knee arthroplasty. This situation reaches a level that can affect the daily life activities of patients, especially in the long term. Especially kinesiophobia is one of these factors. This condition also affects the proprioceptive sense in the knee, the capacity to move and the fear of falling. However, studies have generally examined long-term effects after total knee arthroplasty. Early studies are limited in number. More studies are needed to better understand the relationship between kinesiophobia and biopsychosocial factors. Additionally, the lack of relationship between the patients' kinesiophobia level, fear of falling, and proprioception in the early period after TKA draws attention. Therefore, this study aimed to examine the relationship between kinesiophobia, pain, fear of falling, mobility and proprioception in the early period after TKA.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-80
* Total knee arthroplasty surgery due to knee osteoarthritis
* Volunteering to participate in the study

Exclusion Criteria:

* Previously had knee surgery or fracture
* Diagnosed with rheumatoid arthritis
* Those with severe obesity (BMI \> 40 kg/m2)
* Those with sensory and motor impairments
* Revision knee arthroplasty planned
* Venous thromboembolism
* Neurological diseases (MS, Parkinson, etc.)
* Early post-surgical complications

Primary outcomes:
measure: Kinesiophobia
timeFrame: Baseline
measure: Severity of pain
timeFrame: Baseline
measure: Functional mobility
timeFrame: Baseline
measure: Proprioception
timeFrame: Baseline
measure: Fear of falling
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Pursaklar Public Hospital
Study officials:
References:
Clinical trial NCT02012400: Effects of Regular Exercise on Adult Asthma
Official title: Effects of Regular Exercise on Physical Fitness, Asthma Control and Quality of Life of Adult Asthmatics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Exercise
Asthma control
Physical fitness
Quality of life
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
name: Foundation of the Finnish Anti-Tuberculosis Association
name: Research Foundation of the Pulmonary Diseases
name: Jalmari and Rauha Ahokas Foundation
name: Vaino and Laina Kivi Foundation
name: Ida Montini Foundation
name: Oulu University Hospital
First posted: 2013-12-16
Enrollment: 131
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effects of regular exercise on physical fitness, asthma control, and quality of life among adult asthmatics.


Eligibility criteria: Inclusion Criteria:

* diagnosis of asthma made by physician, or reimbursement for asthma medication from the National Social Insurance Institution of Finland (code 203), or patient fulfills the diagnostic criteria for asthma as outlined in the Finnish Guidelines for Asthma Management (Käypä hoito -suositus 2006 and 2012)

Exclusion Criteria:

* FEV1 \< 60 % of predicted in spirometry
* PEF variability \> 30 % at least 2 times during a 1-week monitoring period
* use of bronchodilating medication at least 4 times daily
* permanent, daily steroid tablet treatment
* patients who exercise regularly already at baseline at least 3 times a week at least 30 min at a time
* serious coronary heart disease
* severe hypotension
* severe heart failure
* severe musculoskeletal disorder
* dementia
* physician-diagnosed chronic obstructive lung disease

Primary outcomes:
measure: Asthma control
timeFrame: 6-month period
Secondary outcomes:
measure: Physical fitness
timeFrame: Baseline and 6 months
Other outcomes:
measure: Lung function
timeFrame: Baseline and 6 months
measure: Quality of Life
timeFrame: Baseline and 6 months
measure: Step test
timeFrame: Baseline and 6 months
measure: Muscle strength and flexibility
timeFrame: Baseline and 6 months
Locations:
city: Oulu
country: Finland
facility: Center for Environmental and Respiratory Health Research, University of Oulu
Study officials:
References: