louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02463201: Obstructive Sleep Apnea in Obese Children and Teenagers - Occurrence and Importance of Intervention
Official title: Obstructive Sleep Apnea in Obese Children and Teenagers - Occurrence and Importance of Intervention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Pediatric Obesity
Keywords: Sleep Apnea, Obstructive
Pediatric Obesity
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: Holbaek Sygehus
First posted: 2015-06-04
Enrollment: 236
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The cohort consists of children attending the Childrens Obesity Clinic in Holbaek.

Brief summary: The prevalence of childhood obesity has increased at an alarming rate over the last decades, both globally and in Denmark. There are a number of serious sequelae related to obesity, such as hypertension, hypercholesterolemia, fatty liver and prediabetes. Obesity is found to be a risk factor for obstructive sleep apnea (OSA). OSA in childhood is known to be associated with cardiovascular complications, neurocognitive problems and reduced quality of life. The correlation between obesity and OSA is still poorly understood. Early detection and intervention is of great importance as the health consequences related to OSA as well as obesity are severe. Adenotonsillectomy is recommended as first-line therapy in children with OSA. However, only around 25% of obese children benefit from this treatment compared to around 75% of normal-weight children suggesting that there might be other structural factors predisposing to OSA in obese children.

In this study the investigators aim to clarify the impact of obesity in the development of OSA. The prevalence of OSA in obese children will be investigated. Furthermore the purpose is to assess the effect of weight loss on OSA.


Eligibility criteria: Inclusion Criteria:

* Age: 7-18 years
* BMI \> 90th percentile for age and gender

Exclusion Criteria:

* Neuromuscular disorders
* Craniofacial syndromes / malformations
* Laryngeal and tracheal malformations

Primary outcomes:
measure: Change in obstructive sleep apnea (OSA)
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Holbaek
country: Denmark
facility: Holbaek Sygehus
state: Danmark
city: Køge
country: Denmark
facility: Zealand University Hospital
state: Danmark
Study officials:
name: Ida Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Orntoft M, Andersen IG, Homoe P. Agreement between manual and automatic analyses of home sleep examinations in pediatric obstructive sleep apnea. J Comp Eff Res. 2019 Jun;8(8):623-631. doi: 10.2217/cer-2018-0093. Epub 2019 May 24.
Clinical trial NCT00162201: An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy
Official title: An Exploratory Study of Changes in Synovial Immune Responses Following BMS-188667 Therapy in Subjects With Active Rheumatoid Arthritis on Background DMARDs Who Have Failed Anti-TNF Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-09-13
Enrollment: 16
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: Study to assess changes in synovial tissue before and after treatment with Abatacept in subjects with RA who remained on their background disease modifying anti-arthritis medications but who have failed previous therapy with anti-TNF (tumor necrosing factor)blocking agents.


Eligibility criteria: Inclusion Criteria:

* RA for at least 1 year
* Clear clinical signs of active RA in 1 knee joint
* Meet ARA (1987) criteria for diagnosis of RA and ACR (1991) criteria for RA functional classes I, II, or III
* Inadequate clinical response to a minimum of 3 months of therapy with anti-TNF-blocking agents
* Taking background DMARDs for a minimum of 3 months and at stable doses for at least 28 days

Exclusion Criteria:

* Serious bacterial infection in last 3 months
* History of TB
* History of cancer within 5 years
* Evidence of latent or active bacterial or viral infection
* Intra-articular corticosteroids within 3 months
* Exposure to live vaccines
* Exposure to CTLA4Ig or BMS-188667
* Treatment with immunoadsorption column(s), mycophenolate mofetil, leflunomide, anakinra, cyclosporine, etanercept, adalimumab, infliximab, azathioprine, oral or parenteral gold, D-penacillamine, calcineurin inhibitors, cyclophosphamide or other alkylating agents

Primary outcomes:
measure: Comparison of each subject's synovial tissue markers
timeFrame: at baseline and after 4 months of treatment with abatacept
Secondary outcomes:
measure: assess baseline & post treatment synovitis by dynamic gadolinium enhanced MRI; determine concentrations of abatacept in synovial fluid & serum
timeFrame: after 4 months of treatment
measure: assess safety & tolerability of abatacept
timeFrame: administered for 4 months
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Local Institution
state: Essex
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Buch MH, Boyle DL, Rosengren S, Saleem B, Reece RJ, Rhodes LA, Radjenovic A, English A, Tang H, Vratsanos G, O'Connor P, Firestein GS, Emery P. Mode of action of abatacept in rheumatoid arthritis patients having failed tumour necrosis factor blockade: a histological, gene expression and dynamic magnetic resonance imaging pilot study. Ann Rheum Dis. 2009 Jul;68(7):1220-7. doi: 10.1136/ard.2008.091876. Epub 2008 Sep 4.
Clinical trial NCT03126201: Predictors of Disease Progression in Primary Focal Segmental Glomerulosclerosis
Official title: Predictors of Disease Progression in Patients With Primary Focal Segmental Glomerulosclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glomerulonephritis
Focal Segmental Glomerulosclerosis
Keywords: focal segmental glomerulosclerosis
disease progression
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with biopsy-proven primary focal segmental glomerulosclerosis.

Brief summary: Focal segmental glomerulosclerosis (FSGS) is one of the most common primary glomerular diseases leading to end stage renal disease. In this study, our aim is to evaluate the effects of histopathological, clinical, and laboratory features of patients with primary FSGS on the disease progression.

Detailed description: Focal segmental glomerulosclerosis (FSGS) is one of the most common primary glomerular diseases leading to end stage renal disease worldwide. Numerous studies have been conducted in order to identify the etiology of this debilitating disease. Beyond the etiological research, however, few studies managed to demonstrate the possible predictors of disease progression in patients. Therefore, we aim to evaluate the effects of histopathological, clinical, and laboratory features of patients with primary FSGS on the disease progression.

Eligibility criteria: Inclusion Criteria:

* Patients with biopsy-proven primary focal segmental glomerulosclerosis.
* Patients who have a renal biopsy available for reviewing including 8 or more glomeruli.
* Patients who have been followed-up for at least 6 months or have progressed to primary outcome regardless the duration of follow-up.

Exclusion Criteria:

* Patients who have secondary focal segmental glomerulosclerosis attributable to any other condition (e.g., obesity, HIV, relevant drug exposure).
* Patients who have a genetic mutation or variation creating a tendency for developing focal segmental glomerulosclerosis.
* Patients who are unwilling or unable to consent.

Primary outcomes:
measure: Reduction in kidney function and/or progression to end stage renal disease
timeFrame: 5-10 years
Secondary outcomes:
measure: Complete remission
timeFrame: 5-10 years
measure: Partial remission
timeFrame: 5-10 years
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
Study officials:
affiliation: Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
name: Yasar Caliskan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: D'Agati VD, Kaskel FJ, Falk RJ. Focal segmental glomerulosclerosis. N Engl J Med. 2011 Dec 22;365(25):2398-411. doi: 10.1056/NEJMra1106556. No abstract available.
Clinical trial NCT03531801: Referred Pain Areas in Subjects With a Recovered Radius Fracture
Official title: Pressure-induced Referred Pain is More Expansive in Individuals With a Recovered Non-painful Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radius Fractures
Keywords: Referred pain
pressure algometry
pain mapping
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
Collaborators: name: Aalborg University
First posted: 2018-05-22
Enrollment: 44
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: NON_PROBABILITY_SAMPLE
Study population: Subjects with a history of distal radius fracture without pain at the moment of the study or any physical sequelae derived from the fracture.

Brief summary: The purpose of the present study is to investigate pressure algometry and pressure-induced referred pain areas in pain free individuals with a history of distal radius fracture (fully recovered) compared with age and gender matched healthy controls without history of fracture. It is hypothesized that individuals with a recovered radius fracture will have a facilitated referred pain patter towards the wrist but normal pressure pain sensitivity.

Detailed description: Musculoskeletal injuries, nociception and pain can increase the sensitivity of the central pain mechanisms, which can be extended even after tissue recovery. However, little is known about the status of these central pain mechanisms once subjects are fully recovered from the tissue injury and pain. This information would help to explain pain conditions in which recurrence of the pain episodes is common (e.g low back pain or shoulder pain).

Pressure-pain thresholds have been widely used in pain research to test the sensitivity of the pain system. Additionally, referred pain has been shown as a valid biomarker for the sensitization of the pain system.

The aim of the present study is to investigate pressure pain sensitivity and referred pain patterns of individuals with a history of recovered fracture, compared with healthy controls.

Eligibility criteria: Inclusion Criteria:

* Subjects with a history of distal radius fracture without pain at the moment of the study.

Exclusion Criteria:

* Subjects with symptoms (e.g pain), functional limitations, history of other fractures in the upper limb or any other pathology.

Primary outcomes:
measure: A change in the area of referred rain
timeFrame: 24 hours (two experimental sessions separated by 24h).
Secondary outcomes:
measure: A change in pressure-pain thresholds
timeFrame: 24 hours (two experimental sessions separated by 24h).
Other outcomes:
Locations:
city: Villanueva de Gállego
country: Spain
facility: Universidad San Jorge
state: Zaragoza
Study officials:
affiliation: Universidad San Jorge
name: Víctor Doménech-García, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01549301: Evaluation of Pharmacokinetic and Pharmacodynamic Parameters of Filgrastim (G-CSF)Produced by Blausiegel Indústria e Comércio Ltda. Compared to Granulokine Produced by Produtos Roche Químicos e Farmacêuticos S/A.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
First posted: 2012-03-09
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to compare the pharmacokinetic and pharmacodynamic effects of two commercial preparations of filgrastim (T and C), after single dose via subcutaneous or intravenous administration at a concentration of 5 mcg/kg or 10 mcg/kg in healthy subjects through the alteration in the pharmacokinetic and pharmacodynamic parameters (measurement of serum levels of G-CSF and absolute neutrophil count - ANC).


Eligibility criteria: Inclusion Criteria:

* Agree with all study procedures, sign and date back by their own free will, the IC;
* Be between 18 and 50 years, of both sexes;
* Present a body mass index (BMI) greater than or equal to 20 and less than or equal to 28;
* are considered healthy, clinical, psychological and laboratory;
* are female, but they have and maintain a safe method of contraception during the study.

Exclusion Criteria:

* Known hypersensitivity to filgrastim;
* Hypersensitivity to products derived from E. coli;
* fever or infectious disease in the 07 days preceding the first administration;
* Positive serology for hepatitis B or C and HIV;
* Prior treatment with CSFs, interleukins and interferons;
* Participation in a clinical study in the last 12 months;
* Donation or loss of blood in the 03 months preceding the study;
* General anesthesia in the 03 months preceding the study;
* Provide a history of alcohol abuse, drug or drugs;
* Have a history of liver disease, renal, pulmonary, gastrointestinal, hematological, psoriasis, gout, acute myocardial infarction, thyroid or psychiatric disease;
* Pregnant or lactating women.

Primary outcomes:
measure: The primary efficacy parameters will be based on the investigation of pharmacokinetics and pharmacodynamics of filgrastim in research subjects after administration of single dose via sc or iv routes at doses of 5 or 10 mcg/kg of the drug.
timeFrame: • PK.: 0, 15 min., 30 min., 45 min., 1h, 1h e 30min., 2h, 3h, 4h, 6h, 8h,10h, 12h, 16h, 24h and 48h. • PD (ANC): 0, 30 min., 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 32h, 48h, 72h, 96h and 120h
Secondary outcomes:
Other outcomes:
Locations:
city: Valinhos
country: Brazil
facility: LAL Clinica Pesquisa e Desenvolvimento Ltda
state: Sao Paulo
Study officials:
References:
Clinical trial NCT03488901: Chemoresistance of Trophoblastic Tumors
Official title: Prediction of Chemoresistance in Patients Treated for Gestational Trophoblastic Tumors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trophoblastic Tumor
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-04-05
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with gestational trophoblastic tumors

Brief summary: Gestational trophoblastic tumors are characterized by their development from placental tissue and their high invasive and metastatic potential. These are rare tumors (1/50 000 pregnancies) affecting young women for whom conservative fertility treatments are preferred. The therapeutic strategy is based on a chemotherapy whose choice of protocol is based on a clinico-biological score, FIGO score, which includes tumor size, gonadotropic chorionic hormone level used as quantitative tumor marker, number and localization. metastases. A FIGO score ≤6 allows the use of monochemotherapy (methotrexate) with a 5-year survival of approximately 99.7%. Scores of 7 to 12 and ≥13 require multidrug therapy (EMA-CO) and are associated with 5-year survival of 95.1% and 61.6%, respectively.

The chemotherapies currently used for the treatment of trophoblastic tumors have been described between the 1950s (methotrexate) and the 1980s (EMA-CO) and have a well documented toxicity regarding the risk of secondary tumors, early menopause or even death by toxicity. .

To date, apart from the FIGO score, there is no predictor of resistance to chemotherapy in gestational trophoblastic tumors. However, among patients with a FIGO score ≤6 and receiving methotrexate in the first line, 9 to 46% will have a resistance and require a second line of treatment. Similarly, if the score is ≥7, 10 to 30% of patients receiving EMA-CO will require at least a second line of multidrug therapy.

The hypothesis of PrediCTTro study is that tissue samples of gestational choriocarcinoma present a transcriptomic profile associated with the risk of further resistance to single or multiagent chemotherapy.

The objective of PrediCTTro is to identify a transcriptomic signature able to predict resistance to single or multiagent chemotherapy.


Eligibility criteria: Inclusion Criteria:

* confirmed gestational trophoblastic tumor histology
* hCG follow-up of at least 12 months after hCG normalization
* registration in the French Reference Center for Trophoblastic Diseases

Exclusion Criteria:

* tissue specimen (block/biopsy) not available
* degraded quality of tissue sample not compatible with transcriptome analysis (\>20% of necrosis)

Primary outcomes:
measure: Transcription profile associated with the resistance to chemotherapy
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pierre-Bénite
country: France
facility: Centre Français de Référence des Maladies Trophoblastiques
Study officials:
References:
Clinical trial NCT06653101: Effect of Akkermansia Muciniphila Akk11 on Metabolic and Gut Health in Overweight and Obese Subjects
Official title: Effect of Akkermansia Muciniphila Akk11 on Metabolic and Gut Health in Overweight and Obese Subjects: a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight or Obesity
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-22
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy and safety of the use of probiotics as a food supplement compared to placebo in regulating body metabolism and gut microbiota in overweight or obese subjects.


Eligibility criteria: Inclusion Criteria:

1. 18-45 years old;
2. BMI ≥ 24 kg/m2 or men with a body fat percentage of ≥ 25% and women with a body fat percentage of ≥ 30%；
3. Normal liver function indexes;
4. Willing to complete study-related questionnaires and diaries and complete all clinical visits.

Exclusion Criteria:

1. Those who have been diagnosed with high uric acid or gout are not recommended to participate in the test;
2. Psychiatric or neurological diseases, celiac disease, lactose intolerance, allergies;
3. Have the following diseases: irritable bowel syndrome, ulcerative colitis, fatty liver, liver cirrhosis, etc.;
4. Recently treated with antibiotics (i.e., \< 3 months prior to the start of the study);
5. Participants who smoked more than 10 cigarettes per day were excluded;
6. It is not recommended to participate in other special circumstances, such as those who are allergic to probiotic products;
7. Pregnant and lactating women are not suitable for experiments.

Primary outcomes:
measure: Changes in serum concentrations of glucagon-like peptide-1 (GLP-1) before and after intervention.
timeFrame: week 0 and week 8
measure: Changes in serum concentrations of leptin before and after intervention.
timeFrame: week 0 and week 8
measure: Changes in serum concentrations of peptide YY before and after intervention.
timeFrame: week 0 and week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Fei Xu
state: None Selected
Study officials:
References:
Clinical trial NCT02789501: Comparison of a TauroLock™ Based Regimen to 4% Citrate as Lock Solution in Tunneled Haemodialysis Catheters for the Prevention of Bacteraemia and Dysfunction
Official title: Prospective Trial for Comparison of a TauroLock™ Based Regimen to 4% Citrate as Lock Solution in Tunneled Haemodialysis Catheters for the Prevention of Bacteraemia and Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Catheter Infections
End-stage Renal Disease
Keywords: Catheter
Dysfunctions
Blood Stream Infections
Haemodialysis
Taurolidine
Tunneled
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2016-06-03
Enrollment: 106
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: Catheter infections and dysfunctions are a major cause of morbidity and mortality in haemodialysis patients. According to the US Renal Data System, infection is the second leading cause of death in dialysis patients and the leading cause of catheter removal and morbidity in patients with end-stage renal disease.

There is evidence that catheter lock solutions containing taurolidine reduce the risk of catheter related infections and improve catheter patency. Lock solutions have a local, but no systemic effect. In this study a taurolidine based lock regimen (TauroLock™-Hep500, Tauropharm, Waldbüttelbrunn, Germany, 2x/week and TauroLock™-U25.000, Tauropharm, Waldbüttelbrunn, Germany, 1x/ week) will be compared to 4% citrate (CitraFlow™ 4%, MedXL, Montreal, Canada, 3x/week) as standard lock solution.

The objective of this study is to evaluate if a TauroLock™ based regimen to lock tunneled haemodialysis catheters has reducing effects on catheter related blood stream infections and catheter dysfunctions.


Eligibility criteria: Inclusion Criteria:

* Adult patients aged greater than 18 years.
* Written informed consent.
* Requirement for haemodialysis using a tunneled dialysis catheter.

Exclusion Criteria:

* Children aged less than 18 years.
* Positive blood culture in previous seven days before catheter insertion.
* Heparin induced thrombocytopenia and any contraindication for anticoagulation (recent or planned surgery, thrombocytopenia \< 70G/l, bleeding disorder).

Primary outcomes:
measure: Number of Catheter Related Blood Stream Infections (CRBSI)
timeFrame: from insertion of the tunneled catheter through study completion, an average of 1 year
Secondary outcomes:
measure: Number of Catheter Dysfunctions (inadequate blood flow during dialysis, necessity of catheter rescue with alteplase)
timeFrame: from insertion of the tunneled catheter through study completion, an average of 1 year
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Department of Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna, Department of Medicine III, Division of Nephrology and Dialysis
name: Guerkan Sengoelge, MD
role: PRINCIPAL_INVESTIGATOR
References: