louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06902597: Association Between Sarcopenia And Diabetic Neuropathy In Adults With Type 1 Diabetes, A Pilot Study
Official title: Association Between Sarcopenia And Diabetic Neuropathy In Adults With Type 1 Diabetes, A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-30
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Monocentric interventional prospective study to evaluate the prevalence of sarcopenia in adults with type 1 diabetes (T1DM) and to evaluate the association between diabetic neuropathy and sarcopenia in subjects with T1DM; to evaluate the prevalence of dynapenia in adults with T1DM and its association with diabetic neuropathy.


Eligibility criteria: Inclusion Criteria:

1. Age 50-80 years, both sexes
2. Diagnosis of T1DM for at least 10 years, in both multiple daily injections of insulin (MDI) and continuous subcutaneous insulin infusion (CSII)
3. Informed consent before any study activity
4. Ability to fully perform all protocol activities

Exclusion Criteria:

1. Previous diagnosis of T2DM
2. Previous diagnosis of dementia
3. Presence of heart failure (NYHA class III and IV)
4. Presence of muscular disease
5. Diagnosis of neurodegenerative disease (e.g. multiple sclerosis, Parkinson's disease)
6. eGFR evaluated through CKD-EPI formula \<20 ml/min /1.73m2 , estimated on previous creatinine dosage
7. Previous history of stroke or cerebrovascular disease
8. Diagnosis of coeliac disease
9. Diagnosis of chronic inflammatory bowel disease
10. Untreated hypothyroidism or hyperthyroidism or not well controlled hypothyroidism or hyperthyroidism with current therapy (TSH \>5 or TSH \<0.15)
11. Alcohol abuse or consumption of more than 14 alcoholic units weekly
12. Active cancer or therapy
13. Pregnancy
14. Primary hyperparathyroidism
15. Corticosteroid and/or estrogen-progestogen therapy for at least 12 months in medical history
16. On going treatment with antiretroviral therapy
17. On going treatment with immunosuppressive therapy, e.g. cyclosporine, tacrolimus
18. On going treatment with anti-epileptic drugs

Primary outcomes:
measure: Prevalence of sarcopenia
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Prevalence of microvascular complications in subjects with T1DM and sarcopenia
timeFrame: through study completion, an average of 1 year
measure: Prevalence of dynapenia
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS; UOC Diabetologia
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Dario Pitocco
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00653497: Effectiveness and Cost-Efficiency of Aquatic Exercise for Management of Osteoarthritis
Official title: Effectiveness and Cost-Efficiency of Aquatic Exercise for Management of Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2008-04-07
Enrollment: 249
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study was to estimate the cost and outcomes of the Arthritis Foundation aquatic exercise classes.

* DESIGN. Randomized trial of 20-week aquatic classes.
* SUBJECTS AND METHODS. Recruited 249 adults from Washington State aged 55 to 75 with a doctor-confirmed diagnosis of osteoarthritis
* MEAURES. The Quality of Well-Being Scale (QWB), Current Health Desirability Rating (CHDR), Health Assessment Questionnaire(HAQ), Center for Epidemiologic Studies-Depression Scale (CES-D), Perceived Quality of Life Scale (PQOL)


Eligibility criteria: Inclusion Criteria:

* Clinically confirmed diagnosis of osteoarthritis from a physician
* Aged 55 to 75
* Not currently exercising, defined as engaging in an average of less than 60 minutes of exercise/week during the last month
* Permission of the subject's primary physician to participate in the aquatic class
* Not currently enrolled in another medical study
* Not scheduled for joint replacement surgery during the study period
* Living in an area where Arthritis Foundation aquatic programs were offered
* Willingness to be randomized and to commit to the 5-month study period

Primary outcomes:
measure: Quality of Well-Being Scale
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Washington
name: Donald L Patrick, PhD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03154697: Development of Clinical Database of Individuals With Smith-Magenis Syndrome and Sleep Disturbances
Official title: Development of Clinical Database of Individuals With Smith-Magenis Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sleep Disturbances in Smith-Magenis Syndrome
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2017-05-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with SMS

Brief summary: This database will be used to better understand the sleep problems of people with SMS. This clinical database will be a part of a larger Smith-Magenis Patient Registry used to create an awareness campaign around SMS and the sleep disturbances that are characteristic of the disorder.


Eligibility criteria: Inclusion Criteria:

* Parent or legal guardian of individual with Smith-Magenis Syndrome

Exclusion Criteria:

* Not legal guardian of individual with SMS

Primary outcomes:
measure: Number of individuals with Smith- Magenis syndrome
timeFrame: 5 years
Secondary outcomes:
measure: Sleep Disturbances
timeFrame: Up to 100 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: Vanda Pharmaceuticals
state: District of Columbia
Study officials:
References:
Clinical trial NCT05304897: PRP Efficacy and Safety in BPF
Official title: Efficacy and Safety of Platelet-rich Plasma on Bronchopleural Fistula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchopleural Fistula
Keywords: Bronchopleural Fistula
Platelet-rich plasma
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Platelet-rich plasma(PRP), is a concentrate of platelet-rich plasma protein derived from whole blood. The main components of it are platelets, leukocytes and fibrin. Autologous PRP treatment can avoid the immune rejection caused by exogenous growth factor and the spread of disease. Evidence of the efficacy and safety of PRP has been proven in many studies. Bronchopleural fistula (BPF) represents a challenging clinical entity characterized by abnormal communication between the bronchial tree and the pleural space. Respiratory intervention has become one of the most common treatments to fight the disease. Although the short-term occlusion effect of conventional treatment methods of respiratory intervention is relatively easy to achieve, there is great uncertainty in the long-term treatment effect, and long-term large fistulas have little chance of healing. PRP has shown significant efficacy for hyperplastic scar of skin. Correspondingly, PRP will be applied as treatment of BPF to cure fistula.


Eligibility criteria: Inclusion Criteria:

* Subjects with aged between 18 to 75
* Subjects diagnosed with bronchopleural fistula (the sizes of the fistulas less than 4mm)
* Subjects willing to accept PRP treatment

Exclusion Criteria:

* Subjects with fistulas larger than 4mm
* Subjects who cannot tolerate bronchoscopy due to severe cardiac disease or other major comorbidities
* Pregnant or breastfeeding women

Primary outcomes:
measure: Cure rate for bronchopleural fistula
timeFrame: within 4-6 weeks after administration
Secondary outcomes:
measure: the modified Medical Research Council dyspnea scale (mMRC scale)
timeFrame: within 4-6 weeks after administration
measure: COPD Assessment Test (CAT)
timeFrame: within 4-6 weeks after administration
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT05195697: ACUTE-Acute Surgical Care- Risk Factors and Outcomes for Patients in Need of Acute Surgical Care
Official title: ACUTE-Acute Surgical Care- Risk Factors and Outcomes for Patients in Need of Acute Surgical Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Risk Factors
Complication of Surgical Procedure
Complication of Treatment
Complication of Anesthesia
Long Term Effects After Emergency Surgery
Long Term Effects After GI Bleeding
Keywords: Emergency surgery
Acute surgery
Complications
Risk factors
Frailty
Ageing
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2022-01-19
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to to Skåne University hospital in need of acute surgical care between 2009-2019

Brief summary: Observational retrospective study of patients in need of acute surgical care admitted to Skåne University Hospital between 2009 and 2019.

Detailed description: At Skåne University Hospital approximately 6000 individuals are treated for acute abdominal diseases each year. Given the high number of patients, there is an urgent need to optimize acute surgical care. Lower complication rates would decrease hospital stay, health care costs as well as personal suffering.

Assessment instruments for risks and frailty are not validated for the acute setting and the investigators hypothesize there is room for improvement in prophylactic interventions and risk assessment. The investigators will study cohorts of patients with three different surgical diagnosis: acute pancreatitis, gastrointestinal bleeding and perforated ulcer aiming to identify risk factors for complications or death and to investigate assessment tools in this population. Using propensity score analysis, the investigators will try to identify treatment options associated with better outcome for subcohorts defined by frailty, comorbidity, age or gender. Specific factors of interest include: time to- and kind of treatment, handling of ongoing pharmacological therapy (anticoagulants, corticosteroids) and need for further treatments on a long time basis. The results from this project will be used in a future prospective study where prophylactic treatments and specific treatment options are studied.

Eligibility criteria: Inclusion Criteria: Patients admitted to Skåne University hospital in need of acute surgical care -

Exclusion Criteria: Below 18 years old

-

Primary outcomes:
measure: Mortality
timeFrame: 5 years
measure: Reintervention
timeFrame: 5 years
measure: Recurrent disease
timeFrame: 5 years
Secondary outcomes:
measure: Lengths of hospital stay
timeFrame: 5 years
measure: Number of interventions
timeFrame: 5 years
measure: complications
timeFrame: 5 years
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skåne University Hospital
state: Skåne
Study officials:
affiliation: Region Skåne
name: Sara Regnér, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02004197: Quadruple and Phytomedicine-based Therapies in H. Pylori Infection
Official title: Phytomedicine-based and Quadruple Therapies in Helicobacter Pylori Infection. A Comparative Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Helicobacter Pylori [H. Pylori] as the Cause of Diseases
Lead sponsor: Shifa Ul Mulk Memorial Hospital
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Helicobacter pylori is strongly associated to the development of gastrointestinal disorders. Emerging antibiotic resistance and poor patient compliance of modern therapies has resulted in significant eradication failure. Clinical trial was conducted to see the efficacy of current quadruple and phytomedicine-based therapies for the eradication of H. pylori infection and relief in its associated symptoms in Pakistan.


Eligibility criteria: Inclusion Criteria:

1. The patients suffering from H. pylori infection
2. Patients having no previous record of treatment against H. pylori infection
3. Patients living in Karachi, Rawalpindi and Bahawalpur
4. Patients having no pathological complications on routine examination
5. All socioeconomic classes were included in the study
6. Male and female patients between 15 to 45 years of age

Exclusion Criteria:

1. there was peptic ulceration, gastrointestinal bleeding or gastric carcinoma
2. if history of use of antibiotics, proton-pump inhibitors or bismuth compound in the last one month before test
3. any patient found to be allergic or intolerant to therapeutic regimens
4. they failed to report for follow-up

Primary outcomes:
measure: H. pylori eradication rate was the primary endpoint, which was considered to be achieved on the basis of a negative urea breath and stool antigen test four weeks after the end of treatment
timeFrame: 1 month
Secondary outcomes:
measure: The secondary endpoint was the improvement in the clinical features as assessed by an improvement in dyspepsia scores
timeFrame: 1 month
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: clinical trial was conducted in high risk areas of Pakistan such as Karachi, Bahawalpur, Islamabad and Rawalpindi at Shifa-Ul-Mulk Memorial Hospital, Hamdrad University Karachi, Bahawalpur Victoria Hospital and Nawaz Salik Hospital respectively
city: Karachi
country: Pakistan
facility: Shifa Ul MUlk Memorial Hospital
Study officials:
affiliation: Hamdard University Karachi
name: Khan Usman Ghani, Ph. D
role: STUDY_DIRECTOR
References:
Clinical trial NCT06864897: The 10-year Follow-up of the Delta-TT Trial.
Official title: The 10-year Follow-up of the Delta-TT Trial: Stability of the Delta-TT Cup with Polyethylene Insert Compared to the Delta-TT Cup with Ceramic Insert.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hip Dislocation
Lead sponsor: JointResearch
Sponsor class: OTHER
First posted: 2025-03-07
Enrollment: 51
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients enrolled in the initial Delta-TT trial are eligible for inclusion. These patients recieved a hip prothesis including a Delta-TT cup, a H-MAX S Stem and either a polyethylene or a ceramic Liner.

Brief summary: This 10-year follow-up study aims to further investigate long-term migration patterns of the uncemented Delta-TT cup and H-MAX S stem, comparing outcomes between ceramic and polyethylene liners. Given the predictive value of early RSA migration patterns at the 2-year mark for identifying implants at risk of aseptic loosening, we hypothesize that the Delta-TT cup will demonstrate good stability at the 10-year postoperative mark. Besides, it is hypothesized that migration of Delta TT-cups is comparable between ceramic and polyethylene liners.

The primary objective of this study is to measure the long-term stability of the Delta TT cup, combined with either a ceramic or cross-linked polyethylene liner, by means of RSA at 10-years postoperatively.

Secondary objectives are to measure long-term stability of the H-MAX S stem, by means of RSA at 10-year postoperatively. Furthermore the study aims to measure implant survival rates and patient-reported outcomes for both the Delta-TT cup and H-MAX S stem, comparing outcomes between the ceramic and polyethylene group.


Eligibility criteria: Inclusion Criteria:

* Enrolled in the initial Delta-TT trial

Exclusion Criteria:

* Patient is unable or unwilling to sign the Informed Consent specific to this study.
* Patient is unsuitable for participation in the study based on the investigator's judgement.

Primary outcomes:
measure: Long-term (10-year) migration pattern of the Delta-TT cup compared between a ceramic and polyethylene liner.
timeFrame: 10 Years
Secondary outcomes:
measure: Long-term (10-year) migration pattern of the H-MAX S Stem compared between a ceramic and polyethylene liner.
timeFrame: 10 years
measure: Implant survival of the Delta TT cup and H-MAX S stem.
timeFrame: 10 years
measure: Radiographic signs of osteolysis around the Delta-TT cup.
timeFrame: 10 years
measure: Radiographic signs of osteolysis around the H-Max S stem.
timeFrame: 10 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: OLVG Hospital
state: Noord Holland
Study officials:
affiliation: Orthopedic Surgeon
name: Rudolf Poolman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04403997: Virtual Chromoendoscopy With Second Generation NBI (HQ190) vs Chromoendoscopy in Inflammatory Bowel Disease
Official title: Virtual Chromoendoscopy With Second Generation NBI (HQ190) vs Chromoendoscopy in Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chromoendoscopy
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Study to compare the detection of neoplastic lesions between chromoendoscopy and NBI

Detailed description: Single-blind (patient) randomized study to compare detection of neoplastic lesions between chromoendoscopy and NBI.

Patients with Inflammatory Bowel Disease who are to undergo chromoendoscopy according to usual clinical criteria will be included. The endoscopic procedure is similar to the one usually performed. All patients will undergo colonoscopy according to the usual procedure, with Olympus HQ190 series endoscopes, with the same bowel preparation. During intubation, the faecal remains will be thoroughly washed.

Patients will be randomly assigned to one of the two techniques: Chromoendoscopy with 0.1% methylene blue or New generation NBI with Near focus.

Biopsies will be taken of all those lesions detected, instead of random biopsies.

Eligibility criteria: Inclusion Criteria:

* Patients with an established diagnosis of Inflammatory Bowel Disease with indication to undergo chromoendoscopy

Exclusion Criteria:

* Patients who are not trained to understand the nature of the study, the procedures to be followed or are not able to sign an informed consent
* Known allergy or intolerance to methylene blue
* Pregnant or lactating women
* Personal history of colorectal cancer
* Ulcerative colitis active more than 20 cm from the anal verge
* Patients with known G6PD deficiency
* Severe kidney failure

Primary outcomes:
measure: Lesions detected
timeFrame: Baseline
Secondary outcomes:
measure: Detection rate of dysplastic lesions
timeFrame: Baseline
measure: Non-dysplastic lesions
timeFrame: Baseline
measure: Ratio of neoplastic lesions/total lesions
timeFrame: Baseline
measure: Total endoscopy time
timeFrame: Baseline
measure: Removal time
timeFrame: Baseline
measure: Near Focus ability
timeFrame: Baseline
measure: Number of biopsies
timeFrame: Baseline
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Universitario La Paz
name: Eduardo Martín Arranz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05091697: Cost-utility of VIRTUAL FIBROWALK
Official title: Cost-utility of the Multicomponent Program VIRTUAL FIBROWALK in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fibromyoma;Cervix
Keywords: Cost-utility
Fibromyalgia
multicomponent treatment
randomized controlled trial
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Universitat Autonoma de Barcelona
First posted: 2021-10-25
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study is to assess the effectiveness and cost-utility of the VIRTUAL FIBROWALK multicomponent treatment program as coadjuvant of treatment-as- usual (TAU) compared to TAU alone.

Detailed description: This is a two-arm RCT focused on the effectiveness and cost-utility of the multicomponent program VIRTUAL FIBROWALK as coadjuvant of treatment-as- usual (TAU) vs. TAU alone (in a 3-month follow-up RCT) VIRTUAL FIBROWALK combines multicomponent approach based on Pain Neuroscience Education (PNE), therapeutic exercise, Cognitive Behavioural Therapy (CBT) and Mindfulness training.

Eligibility criteria: Inclusion Criteria:

* Adults from 18 to 75 years-old.
* 1990 American College of Rheumatology (ACR) classification criteria + the 2011 modified ACR diagnostic criteria for fibromyalgia
* Able to understand Spanish and accept to participate in the study.

Exclusion Criteria:

* Participating in concurrent or past RCTs (previous year).
* Comorbidity with severe mental disorders (i.e. psychosis) or neurodegenerative diseases (i.e. Alzheimer) that that would limit the ability of the patient to participate in the RCT.

Primary outcomes:
measure: Revised Fibromyalgia Impact Questionnaire (FIQR)
timeFrame: Change from baseline values at 6 months
measure: Client Service Receipt Inventory (CSRI)
timeFrame: Change from baseline values at 6 months
measure: EuroQoL questionnaire (EQ-5D-5L)
timeFrame: Change from baseline values at 6 months
Secondary outcomes:
measure: Tampa Scale for Kinesiophobia (TSK-11)
timeFrame: Change from baseline values at 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change from baseline values at 6 months
measure: Physical Function of the 36-Item Short Form Survey (SF-36)
timeFrame: Change from baseline values at 6 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Mayte Serrat
Study officials:
References: