louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00759265: Improving Mobility in Diabetic Patients Through Resistance Training
Official title: Improving Mobility in Diabetic Patients Through Resistance Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Patients With Polyneuropathy
Keywords: Muscle strength
Physical activity
Mobility
Gait analysis
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2008-09-25
Enrollment: 160
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Impaired mobility is a major health problem affecting many subjects with diabetes mellitus. It is associated with loss of quality of life and it is a strong predictor for poor health outcomes. Reduced lower extremity muscle function, as a consequence of diabetic polyneuropathy, is a major cause of impaired mobility. We hypothesize that a programme of resistance training will counterbalance the effects of polyneuropathy on muscle wasting, and will improve mobility and associated quality of life.

The objective of this study is to develop a resistance training intervention that improves mobility and quality of life in diabetic patients. It is also our intension to achieve a better understanding of the relation between diabetic neuropathy and muscle weakness, limited mobility and quality of life. Moreover, insight will be gained in optimizing training programmes for neuropathic patients.


Eligibility criteria: Inclusion Criteria:

* diabetic patients with polyneuropathy:
* valkscore \>5;
* diabetic type 2;
* age \>50 years

Exclusion Criteria:

* muscular related diseases;
* ischemia;
* amputation (except for toe amputation)

Primary outcomes:
measure: Mobility
timeFrame: 0 month, 3 months, 6 months, 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Academic Hospital Maastricht
state: Limburg
Study officials:
affiliation: Maastricht UMC
name: Teunis H IJzerman, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Melai T, Schaper NC, Ijzerman TH, de Lange TL, Willems PJ, Lima Passos V, Lieverse AG, Meijer K, Savelberg HH. Lower leg muscle strengthening does not redistribute plantar load in diabetic polyneuropathy: a randomised controlled trial. J Foot Ankle Res. 2013 Oct 18;6(1):41. doi: 10.1186/1757-1146-6-41.
Clinical trial NCT04439565: Study on Susceptibility Genes and Pathogenic Mechanism of Non-syndromic Familial Aortic Dissection
Official title: Study on Susceptibility Genes and Pathogenic Mechanism of Non-syndromic Familial Aortic Dissection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aortic Dissection
Family Research
Aortic Dissection, Familial, With or Without Aortic Aneurysm
Keywords: aortic dissection
pathogenesis
familial inheritance
susceptibility gene
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2020-06-19
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1, family members have no traumatic aortic dissection; 2, no pregnancy or tumor.

Brief summary: Aortic dissection is dangerous and difficult to predict, so it is particularly important to carry out early prevention, diagnosis and rational treatment for high-risk groups. The related genes found in previous studies can not be detected in all patients with dissection; at present, the pathogenesis of non-syndromic aortic dissection is not clear, of which about 20% of patients have family aggregation and have the general representative characteristics of non-syndromic dissection. In this project, the peripheral blood samples of core family subjects were detected by sequencing technique. analyze disease-related susceptibility genes; 2 determine the effect of susceptibility genes on the incidence of dissection in mice through animal experiments; and 3 explore the effect of susceptibility genes on cell function at the cellular level.


Eligibility criteria: Inclusion Criteria:

* Family inclusion criteria: 1 at least one person in each generation of a family has aortic dissection, and at least two generations of members can be included;

Exclusion Criteria:

* Pedigree exclusion criteria: pedigree members have marfan syndrome, Loeys-Dietz syndrome, Ehler-Danlos syndrome, aneurysm-Osteoarthritis syndrome and other syndroms

Primary outcomes:
measure: gege
timeFrame: 2023
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhaihospital
state: Shanghai
Study officials:
References:
Clinical trial NCT01102465: Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide 100 mg /25 mg Tablet Under Fed Conditions
Official title: A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Losartan Potassium/Hydrochlorothiazide Tablets 100 mg/25 mg Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-04-13
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of losartan potassium/hydrochlorothiazide 100/25 mg tablet under fed conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to losartan potassium hydrochlorothiazide or any comparable or similar product.

Primary outcomes:
measure: Bioequivalence determined by statistical comparison Cmax
timeFrame: 25 days
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: CEDRA Clinical Research, LLC
state: Texas
Study officials:
affiliation: CEDRA Clinical Research, LLC
name: Daniel V Freeland, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02912065: Tube Feeding Tolerance After Switch to Peptide Based Formula in Children With Developmental Delay
Official title: Tube Feeding Tolerance After Switch to Peptide Based Formula in Children With Developmental Delay: A Retrospective Assessment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Disabilities
Feeding Disorder
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2016-09-23
Enrollment: 13
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population studied retrospectively will be pediatric patients with developmental delays dependent on enteral nutrition for 90% or more of their nutritional needs and meeting the inclusion/ exclusion criteria.

Brief summary: A retrospective chart review to assess feeding tolerance in children who had been switched from an intact protein formula to a Peptide based formula due to feeding intolerance in a pediatric facility for the developmentally delayed.

Detailed description: Medical records of pediatric patients with enteral feeding intolerance on standard polymeric formulas that were switched to a peptide based formula will be retrospectively analyzed. Data will be collected on caloric intake, ability to meet enteral nutrition goals, incidence of intolerance, and the use of medications to control gastrointestinal symptoms.

Eligibility criteria: Inclusion Criteria:

* 13 months to \< 18 years of age on admission to facility
* Required enteral nutrition to meet 90% or more of their energy needs prior to switch to a Peptide based formula
* Received enteral nutrition with an intact protein formula for a minimum of two weeks prior to a switch to a Peptide based formula
* Have documentation of intolerance to an intact protein formula, followed by a switch in formula received to a Peptide based formula
* Have documentation of an assessment of feeding tolerance following the switch to a Peptide based formula
* Formulas received must be indicated for use in children or adults (not infant formulas).

Exclusion Criteria:

* Recent abdominal surgery, change in tube position/placement (within past 30 days)
* Cow's milk protein allergy
* Any current infections including upper respiratory, viral, gastroenteritis, wound infection.

Primary outcomes:
measure: Feeding tolerance after switching to Peptide based formula
timeFrame: up to 30 days post formula switch
Secondary outcomes:
measure: Intake of target feeding volume
timeFrame: up to 30 days post formula switch
measure: Feeding intolerance parameter(s) identified before switch to Peptide based formula and feeding tolerance parameter(s) improved by switch.
timeFrame: up to 30 days post formula switch
Other outcomes:
Locations:
city: Hollywood
country: United States
facility: Childrens Center for Gastroenterology
state: Florida
Study officials:
affiliation: Childrens Center for Gastroenterology
name: Gerard Minor, PA-C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05748665: Effect of Remimazolam on the Recovery Quality After Day Surgery
Official title: Effect of Remimazolam Induction on the Recovery Quality After Day Surgery in Elderly Patients: a Comparison Study With Etomidate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly Patients
Ambulatory Surgery
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 118
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare remimazolam and etomidate in inducing quality of recovery after day surgery for laryngeal mask general anesthesia in elderly patients. The main question it aims to answer is:

• The quality of postoperative recovery induced by remimazolam for laryngeal mask general anesthesia in elderly patients undergoing day surgery is not inferior to that induced by etomidate Participants will be given remimazolam to induce anesthesia。 Researchers will compare etomidate to see if the quality of postoperative recovery.


Eligibility criteria: Inclusion Criteria:

* undergoing day surgery under laryngeal mask anesthesia
* American society of anesthesiologists (ASA) grade 1-3
* BMI\<30kg/m2

Exclusion Criteria:

* have benzodiazepines drugs in the latest month cognitive dysfunction
* Cognitive dysfunction and neuropsychiatric disorders
* It was estimated as a difficult airway
* There was a history of adrenal insufficiency, porphyria, or chronic corticosteroid therapy
* There is a contraindication or allergy to benzodiazepines, opioids, etomidate and its components

Primary outcomes:
measure: The quality of recovery 15
timeFrame: postoperative day 1
Secondary outcomes:
measure: The time of loss of consciousness
timeFrame: within 3 minutes after the end of the intravenous anesthetic
measure: Adverse events
timeFrame: During stay of post anesthesia care unit (up to 30minutes）
measure: the mean blood pressure，the systolic blood pressure ，the diastolic pressure
timeFrame: From 5 minutes before anesthesia induction to the time point surgery start
measure: heart rate
timeFrame: From 5 minutes before anesthesia induction to the time point surgery start
measure: pulse oxygen saturation
timeFrame: From 5 minutes before anesthesia induction to the time point surgery start
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The Fourth military medical university, Xijing Hospital
state: Shannxi
city: Xi'an
country: China
facility: Xi 'an International Medical Center Hospital
state: Shannxi
city: Yanan
country: China
facility: Yan 'an University Affiliated Hospital
state: Shannxi
Study officials:
References:
Clinical trial NCT01301365: Autonomic Response During Cystodistension in Patients Suspected of Having Interstitial Cystitis
Official title: Autonomic Response During Cystodistension in Patients Suspected of Having Interstitial Cystitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Interstitial Cystitis
Keywords: autonomic response
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients having cystodistension suspected of painful bladder syndrome

Brief summary: The aim of this study is to check whether patients with cystoscopic findings supporting the diagnosis of Interstitial Cystitis (IC) have a higher autonomic response (change in blood pressure / pulse)than patients without cystoscopic findings.

Detailed description: checking the changes in blood pressure and pulse rate during the initiation of the anesthesia and at the completion of the cystodistension in patient with cystoscopic finding supporting IC

Eligibility criteria: Inclusion Criteria:

* All patients having cystodistension suspected of painful bladder syndrome
* symptoms lasting for at least six months
* symptoms suspect of the syndrome: super pubic pain, urinary urgency and frequency
* lack of urinary infection or any other pathology of the urinary tract

Exclusion Criteria:

* Refusal of the patient to participate

Primary outcomes:
measure: changes in blood pressure and pulse
timeFrame: measuring blood pressure and pulse at the beginning of the anasthesia and at the end of the cystodistension
Secondary outcomes:
Other outcomes:
Locations:
city: Zerifin
country: Israel
facility: Assaf-HarofehMC
Study officials:
affiliation: Assaf-Harofeh Medical Center
name: kobi stav, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06834165: Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients with Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy
Official title: A Phase IV Study Evaluating the Safety and Efficacy of Neffy or Intramuscular Adrenalin in Patients with Allergic Reactions After Oral Food Challenge or Allergen Immunotherapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Allergic Reactions
Lead sponsor: ARS Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-19
Enrollment: 600
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is to assess the safety of neffy or IM Adrenalin in patients who are experiencing allergic reactions after an OFC, allergen Immunotherapy (AIT), or other allergy challenge that may require epinephrine intervention.


Eligibility criteria: Inclusion Criteria:

* Is a patient 4 years old or greater, inclusive, who are scheduled to undergo OFC, AIT, or other relevant allergy challenge.
* Has body weight 15 kg or greater at the time of allergy challenge.
* Is willing and able to provide written informed consent prior to participating in the study. In the case of minors (\<18 years old), assent can be obtained from his/her legal representative, and as much possible from the patient himself/herself.
* Patient experiences an allergic reaction that, in the opinion of the Investigator, requires treatment with epinephrine via neffy or IM Adrenalin.

Exclusion Criteria:

- Has any clinically significant medical condition that precludes treatment with epinephrine as assessed by the Investigator.

Primary outcomes:
measure: AEs after epinephrine treatment within 2 hours
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT07003165: Research on a New Intelligent Mobile Screening and Diagnosis Pattern for Ocular Diseases
Official title: Research on a New Intelligent Mobile Screening and Diagnosis Pattern for Ocular Diseases
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ophthalmic Diseases (Specific Types Not Restricted)
Cataract
Refraction Error
Diabetic Retinopathy (DR)
Age Related Macular Degeneration (ARMD)
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 15000
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample or primary care clinic

Brief summary: The global distribution of primary ophthalmic medical resources is uneven, and the traditional eye disease screening model has problems such as low efficiency, high cost and limited coverage. With the development of artificial intelligence and other technologies, it provides technical support for the construction of intelligent mobile screening model for eye diseases. The investigator's team has developed the 5G intelligent ophthalmic vehicle and served tens of thousands of people in 108 cities nationwide, initially verifying the feasibility of the new intelligent mobile screening model. However, the application effect, acceptance and influencing factors of this model in different regions are not clear, and there is a lack of economic benefit analysis based on real-world data. In this study, the investigators will conduct a cross-sectional study of large-scale population screening for blinding eye diseases in grassroots areas through the smart mobile screening model, focusing on the screening effectiveness and cost-effectiveness of the smart mobile screening model, integrating real-world multimodal eye health data, developing multiple smart screening analysis models, and exploring its adaptability and direction of improvement in grassroots areas.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 7 years
* Voluntary informed consent

Exclusion Criteria:

-Inability to complete the required examinations with the help of others due to old age, infirmity, poor general condition, etc.

Primary outcomes:
measure: Cost-effectiveness
timeFrame: Baseline,6months,12months
Secondary outcomes:
measure: Eye disease detection rate
timeFrame: Baseline,6months,12months
measure: Accuracy of multiple intelligent screening analysis models
timeFrame: Baseline
measure: Screening participation rate
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05532865: Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital With Biobanking
Official title: Prospective Cohort of Patients With Systemic Sclerosis at Brest University Hospital and Constitution of a Biobank
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Sclerosis
Keywords: Systemic Sclerosis
Patient library
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 100
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: Major patient with systemic sclerosis defined according to the EULAR 2013 criteria

Brief summary: This study corresponds to a monocentric prospective cohort of adult patients with systemic sclerosis.

It will allow the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood samples, as well as stool sample and skin swab for microbiota analysis.


Eligibility criteria: Inclusion Criteria:

* Major patient with systemic sclerosis defined according to the EULAR 2013 criteria (see Appendix 1)
* Patient evaluated within the framework of the reference center for rare autoimmune diseases of the CHU of Brest.
* Patient affiliated to the social security system
* Patient having signed a written informed consent.

Exclusion Criteria:

* Minor
* Patient under legal protection (guardianship, curatorship)
* Refusal to participate
* Patient unable to consent
* Pregnant or breastfeeding woman
* Hemoglobin (Hb) level \< 7g/dl

Primary outcomes:
measure: Age
timeFrame: 5 years
measure: Sex
timeFrame: 5 years
measure: Weight
timeFrame: 5 years
measure: Medical history
timeFrame: 5 years
measure: Family history
timeFrame: 5 years
measure: Rodnan score
timeFrame: 5 years
measure: active digital ulcers
timeFrame: 5 years
measure: dyspnea
timeFrame: 5 years
measure: Free Carbon Monoxide Diffusion (DLCO)
timeFrame: 5 years
measure: 6-minute walk test
timeFrame: 5 years
measure: systemic pulmonary arterial pressures
timeFrame: 5 years
Secondary outcomes:
measure: SF-36 (Short-Form 36)
timeFrame: 5 years
measure: BPI : Pain scale
timeFrame: 5 years
measure: HAQ- Health Assessment Questionnaire - Disability Index
timeFrame: 5 years
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT03889665: Effects of Suspension Training on the Balance of Healthy Young Adults
Official title: Influencia Del Entrenamiento en suspensión en el Equilibrio de Adultos jóvenes Sanos
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Valencia
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Non-specific training through the use of devices in which the subject can be suspended is a technique that has aroused a growing interest in recent years. One of its advantages may be to enhance the balance, since it induces a high level of neuromuscular stimulation. Indeed, a suspension training suppose a high demand of the core musculature, require a high degree of postural control, precise response strategies , anticipatory capacity and muscular conditioning. However, current literature targeting healthy young adults and appraising the specifics effects of suspension training on balance is scarce or non-existent to the best of our knowledge. For this reason this interventional study will primarily assess the effects of suspension training on different balance components.


Eligibility criteria: Inclusion Criteria:

* Healthy young adults aged between 18 and 30

Exclusion Criteria:

* Professional athlete
* Musculoskeletal injury in the last 6 months (i.e. sprain, bone fracture)
* Known balance disorders including vertigo, central or vestibular limitations

Primary outcomes:
measure: Y-Balance test
timeFrame: Change from baseline to four weeks
Secondary outcomes:
measure: Emery test
timeFrame: Change from baseline to four weeks
measure: Posturography measures
timeFrame: Change from baseline to four weeks
measure: Jumping sideways test
timeFrame: Change from baseline to four weeks
Other outcomes:
measure: Five times sit-to-stand test
timeFrame: Change from baseline to four weeks
measure: Stabilizer pressure biofeedback
timeFrame: Change from baseline to four weeks
Locations:
city: València
country: Spain
facility: Universitat de València
state: Valencia
Study officials:
References: