louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03709238: Pain Processing and Pain Reporting in Patients With Alzheimer's Disease
Official title: Pain Processing and Pain Reporting in Patients With Alzheimer's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Pain
Alzheimers disease
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 47
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Patients with Alzheimers disease
2. Healthy participants

Brief summary: The study investigates pain processing and pain reporting in patients with Alzheimers disease compared to healthy participants.

Employing a within-subject design, the study includes patients with Alzheimers disease and healthy participants that are exposed to thermal stimuli. During the test session the facial expressions of the participant are video recorded.

By repeating this on separate test days, the involvement of pain relief and pain increase is investigated.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate patients with Alzheimers disease (group 1)
* Healthy participants ( group 2)

Exclusion Criteria:

* Chronic pain conditions
* Other medical, psychiatric or neurological disorders
* Use of pain-reliving medication 24 hours prior to testing

Primary outcomes:
measure: Numerical rating scale (NRS)
timeFrame: Participants will be tested on three different days. The numerical rating scale will be applied after each thermal stimulus for each test session.
Secondary outcomes:
measure: Pain Assessment in persons with Impaired Cognition (PAIC)
timeFrame: Participants will be video recorded on each of the three test days during testing.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Psychology and Behavioural Sciences
state: Midtjylland
Study officials:
References:
Clinical trial NCT02328638: Development of a Manual-based, Interdisciplinary Intervention for Youth With ASD and Obesity
Official title: Development of a Manual-based, Interdisciplinary Intervention for Youth With ASD and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Obesity
Keywords: ASD
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 10
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the proposed study is to develop and pilot test a manual-based, interdisciplinary intervention for youth, ages 3 to 10 years, with autism spectrum disorder (ASD) and overweight called the Changing Health in Autism through Nutrition, Getting fit, and Expanding variety (CHANGE) obesity program.

Detailed description: The purpose of the study is to develop and test the feasibility of a structured, innovative approach to treat obesity in 16 children (age 3 to 10 years) with autism spectrum disorder (ASD). This 16-week program integrates behavioral psychology and nutrition science to meet the challenges of obesity in children with autism spectrum disorder (ASD). The PI will apply an evidence-based behavioral intervention to increase food variety,15 use applied behavior analytic strategies to teach physical activities in a developmentally-appropriate manner, employ biometrics to assess progress, utilize dietetic interventions to improve nutritional balance, and train caregivers to use behavior management strategies.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of ASD confirmed by a clinical psychologist using a "gold standard" diagnostic tools
* Overweight status, as evidenced by a BMI percentile \> 85% to 94%, and 4) mild to no food selectivity, as evidenced by either history of consuming some fruits and vegetable, tolerating new foods near their plate, and/or trying new foods

Exclusion Criteria:

* Children being treated with atypical antipsychotics (e.g., olanzapine, aripiprazole, risperidone) or other medications known to cause weight gain will be excluded from the study due to the weight gain associated with these medications
* Children with unstable medical conditions will be excluded for safety concerns
* Children presenting with severe aggression, self injury, or other disruptive behaviors that require intensive behavioral intervention will be excluded and referred to other services as needed

Primary outcomes:
measure: Change in body mass index percentile/ratio
timeFrame: baseline, post treatment (up to 16 weeks)
Secondary outcomes:
measure: Change in intake of healthy food
timeFrame: baseline, post treatment (up to 16 weeks)
measure: Change in physical activity
timeFrame: baseline, post treatment (up to 16 weeks)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Pediatric Feeding Disorders Program at the Marcus Autism Center
state: Georgia
Study officials:
affiliation: Emory University
name: Kristen K Criado, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02623738: A Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-
Official title: A Phase II/III Randomized, Double-masked, Controlled, Parallel Group, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-12-08
Enrollment: 253
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purposes of this study are to determine the optimal concentration of DE-117 ophthalmic solution compared to the placebo ophthalmic solution and to determine if intraocular pressure reduction after 4 weeks of treatment with DE-117 ophthalmic solution is non-inferior to latanoprost ophthalmic solution 0.005%.


Eligibility criteria: Inclusion Criteria:

* Primary open angle glaucoma or ocular hypertension

Exclusion Criteria:

* Patients at risk of progression of visual field loss
* Patients with severe visual field defect
* Patients with any diseases that preclude participation in this study for safety reasons

Primary outcomes:
measure: Intraocular pressure
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo, Osaka
country: Japan
Study officials:
References:
citation: Aihara M, Lu F, Kawata H, Iwata A, Odani-Kawabata N, Shams NK. Omidenepag Isopropyl Versus Latanoprost in Primary Open-Angle Glaucoma and Ocular Hypertension: The Phase 3 AYAME Study. Am J Ophthalmol. 2020 Dec;220:53-63. doi: 10.1016/j.ajo.2020.06.003. Epub 2020 Jun 10.
Clinical trial NCT03948438: Endoscopic Treatment for Zenker's Diverticulum
Official title: Clinical Outcome of Endoscopic Treatment for Zenker's Diverticulum
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Zenker Diverticulum
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 400
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: patients affected by ZD and treated by endoscopic procedures.

Brief summary: Zenker's diverticulum (ZD) is a rare benign condition, due to an acquired sac-like outpouching of the mucosa and submucosa layers originating from the pharyngoesophageal junction. Endoscopic techniques like flexible endoscopic septum division (FESD) or per-oral endoscopic septotomy (POES), represent a minimally invasive alternative to surgery or to rigid endoscopic procedure to treat ZD. The goal of the research will be to evaluate the safety of the procedures and to measure Zenker-symptom severity in all patients treated by endoscopic procedures.


Eligibility criteria: Inclusion Criteria:

* patients with symptomatic ZD treated by endoscopic procedures

Exclusion Criteria:

* pregnancy and breastfeeding

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: 24 hours after the procedure
Secondary outcomes:
measure: symptoms after the procedure
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Humanitas Research Hospital
Study officials:
References:
citation: Repici A, Cappello A, Spadaccini M, Nicoletti R, Carrara S, Fugazza A, Galtieri PA, Lamonaca L, Romana C, Badalamenti M, Di Leo M, Pellegatta G, Ferrara EC, Anderloni A, Maselli R. Cap-Assisted Endoscopic Septotomy of Zenker's Diverticulum: Early and Long-Term Outcomes. Am J Gastroenterol. 2021 Sep 1;116(9):1853-1858. doi: 10.14309/ajg.0000000000001356.
Clinical trial NCT02459938: Safety and Efficacy of ZP-Glucagon to Injectable Glucagon for Hypoglycemia
Official title: A Randomized Open-label Crossover Study to Compare the Safety and Efficacy of ZP-Glucagon to Injectable Glucagon in the Treatment of Insulin-induced Hypoglycemia in Subjects With Type-1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypoglycemia
Lead sponsor: Zosano Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2015-06-02
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether glucagon administered by microneedle patch is comparable to glucagon administered by injection pen in the treatment of insulin-induced hypoglycemia.

Detailed description: The purpose of this study is to compare ZP-Glucagon transdermal patch system at doses of 0.5 mg and 1 mg to glucagon by injection at doses of 0.5 mg and 1 mg by means of a 4 way crossover open label design. Eligible subjects giving informed consent will be randomised to a treatment sequence of each of the four treatments in one week intervals. At each treatment visit, subjects will undergo an insulin induction procedure designed to safely induce hypoglycemia, and then have a treatment applied, either by injection or by patch, and then monitored for return to normoglycemia.

Eligibility criteria: Inclusion Criteria:

* Women or men 18 to 60 years with type-1 diabetes on daily insulin treatment (basal-bolus injection regimen or insulin pump) for at least two years, on a total daily dose that has been stable for the last 3 months preceding enrollment (no more than 20% variation), and with a current level of glycated hemoglobin between 6.5% and 10%

Exclusion Criteria:

* Any history of hypoglycemic coma or hypoglycemic seizures.
* Any episode of severe hypoglycemia (requiring treatment) within one month prior to study start.
* Any history of pheochromocytoma or insulinoma

Primary outcomes:
measure: Percentage of subjects achieving normoglycemia
timeFrame: 30 minutes
Secondary outcomes:
measure: Time at which normoglycemia is first reached
timeFrame: 3 hours
measure: Time at which maximal glucose levels are reached
timeFrame: 3 hours
measure: Increases in blood glucose by 15 minute intervals
timeFrame: 3 hours
measure: Peak Plasma Concentration (Cmax)
timeFrame: 3 hours
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: 3 hours
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network
state: Victoria
Study officials:
affiliation: Baker ID Heart and Diabetes Institute
name: Neale Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01998438: Prospective Trial of Tranexamic Acid in Cardiac Surgery
Official title: A Randomized Double-blinded Trial to Explore the Optimum Dose of Tranexamic Acid in Cardiopulmonary Bypass Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: C.Surgical Procedure; Cardiac
Keywords: tranexamic acid
cardiac surgery
cardiopulmonary bypass
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2013-11-28
Enrollment: 955
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tranexamic acid, an antifibrinolytic drug, is wildly used in cardiac surgeries to decrease perioperative bleeding and allogenic transfusion. But the optimum dose of tranexamic acid is still unknown. We use three different doses to find which is the optimum dose of tranexamic acid in cardiopulmonary bypass cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Noncyanotic congenital heart disease patients requiring cardiac surgeries under cardiopulmonary bypass
* Rheumatic or recessive valvular disease patients requiring valvular repair or replacement under cardiopulmonary bypass
* Coronary artery disease patients requiring coronary artery bypass graft under cardiopulmonary bypass

Exclusion Criteria:

* Non-primary and emergency cardiac surgery
* Disorder in coagulation function before surgery
* Anemia before surgery
* Definite liver and renal dysfunction
* History of stroke
* Pregnancy and lactation
* Disabled in spirit or law
* Fatal conditions such as cancer

Primary outcomes:
measure: Postoperative Blood Loss
timeFrame: 24hrs postoperatively
Secondary outcomes:
measure: Number of Participants Needs Allogenic Transfusion
timeFrame: on the 7th day postoperatively
Other outcomes:
measure: Rate of Reexploration for Bleeding
timeFrame: on the 7th day postoperatively
Locations:
city: Beijing
country: China
facility: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
state: Beijing
Study officials:
affiliation: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
name: Hongwen Ji, MD
role: STUDY_CHAIR
affiliation: Cardiovascular Institute and Fuwai Hospital, CAMS&PUMC
name: Haisong Lu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04580108: Highly Sensitive Serum Cardiac Troponin T and Cardiovascular Events in Patients With Systemic Lupus Erythematosus
Official title: Highly Sensitive Serum Cardiac Troponin T and Cardiovascular Events in Patients With Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic lupus erythematosus
Cardiovascular risk
Biomarkers
Troponin T
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Roche Diagnostics GmbH
First posted: 2020-10-08
Enrollment: 446
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with systemic lupus erythematosus

Brief summary: Identification of biological markers able to better stratify cardiovascular risks in systemic lupus erythematosus patients is needed. We aimed to determine whether serum cardiac troponin T levels measured with a highly sensitive assay (HS-cTnT) may predict cardiovascular events in systemic lupus erythematosus.

Detailed description: Cardiac Troponin (cTnT) is a marker of myocyte necrosis and injury in the early phase of acute myocardial infarction. Measured with high-sensitivity (HS) assays, HS-cTnT has proven predictive value for coronary heart disease, heart failure, and mortality in the general population at apparent low-risk for cardiovascular events. In a previous study, our group showed that HS-cTnT concentration was associated with subclinical atherosclerosis in systemic lupus erythematosus patients. The aim of this study was to determine whether HS-cTnT was associated with incident cardiovascular events in systemic lupus erythematosus

Eligibility criteria: Inclusion Criteria:

* Patient with a systemic lupus erythematosus

Exclusion Criteria:

* Inadequate follow-up period (\< 20 months) -past history of CVE at baseline for inclusion in the TROPOPLUS study

Primary outcomes:
measure: The primary outcome was the occurrence of cardiovascular events over follow-up.
timeFrame: Up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Bichat Hospital
Study officials:
affiliation: GH Bichat-Claude Bernard, Paris, France, 75018
name: Karim Sacré, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06098508: Osteopathic Manual Treatment for Hemiplegic Shoulder Pain and Upper Extremity Function in Stroke Patients
Official title: The Effects of Osteopathic Manual Treatment on Hemiplegic Shoulder Pain and Upper Extremity Function in Stroke Patients: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiplegic Shoulder Pain
Osteopathic Manipulative Treatment
Keywords: stroke
hemiplegic shoulder pain
Osteopathic Manual Treatment
OMT
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2023-10-24
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assesses the feasibility and safety of performing osteopathic manual treatment (OMT) for hemiplegic shoulder pain in stroke patients. This study's participants will be adults with a first-time stroke diagnosis in the past 5 years and shoulder pain on the same side affected by stroke. Eligible participants will be placed on study for approximately 6 weeks and given either OMT or a sham treatment each week.


Eligibility criteria: Inclusion Criteria:

* Patients must be at least 18 years or older to participate in the study
* Presence of shoulder pain on the side of the body affected by stroke
* Patients must have a diagnosis of a first-time stroke within the past 5 years
* Stroke type must be subcortical, brainstem, and/or right-MCA stroke. Participants with multiple stroke types within the first-time diagnosis may be included

Exclusion Criteria:

* Presence of an active systemic or localized infection requiring antibiotic therapy
* Presence of fracture in the area being treated
* Presence of open wound in the area being treated
* Presence of rheumatoid arthritis
* Presence of known active malignancy
* Presence of shoulder pain on the affected side within 3 months prior to stroke
* Patients with left-MCA stroke diagnosis who demonstrate the presence of aphasia based on the Mississippi Aphasia Screening Test (MAST)
* Patients who demonstrate hemispatial visual neglect based on screening motor-free visual perception test (MFVPT)
* Patients already receiving any type of manual therapy by a certified therapist through their standard-of-care treatment
* Patients who do not wish to participate
* Patients who are not fit as judged by the study team
* Patients who lack the capacity to consent for enrollment in the study based on the University of California San Diego Brief Assessment of Capacity to Consent

Primary outcomes:
measure: Feasibility Assessment
timeFrame: From enrollment to the end of treatment at 6 weeks
Secondary outcomes:
measure: Safety Assessment
timeFrame: From enrollment to the end of treatment at 6 weeks
Other outcomes:
Locations:
city: Middleton
country: United States
facility: UW Health University Ave Rehabilitation Clinic
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Ashley Mohan, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05274308: Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples
Official title: Cascadion™ SM Immunosuppressants Panel, Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transplantation Drugs Stability
Lead sponsor: Thermo Fisher Scientific Oy
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2022-03-10
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subject's using following immunosuppressants drugs accordingly with organ transplantation

1. Kidney, liver or heart transplant patient using tacrolimus or cyclosporine A
2. Kidney or liver transplant patient using everolimus
3. Kidney transplant patient using sirolimus

Brief summary: This is a prospective, observational evaluation study to assess the stability of the analytes tacrolimus, cyclosporine A, everolimus and sirolimus measured with Cascadion™ SM Immunosuppressants Panel. Study is pre-market evaluation for the regions where Cascadion™ SM Immunosuppressants Panel is not on the market yet and post-market evaluation where it is.

To assess the stability of tacrolimus, cyclosporine A, everolimus and sirolimus in patient whole blood samples after they are collected, processed and subjected to various storage conditions or freeze-thaw cycles that represent common sample handling conditions in the commercial clinical laboratory setting.

Study subjects will undergo one venous sample collection where 30 mL of blood is drawn.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years
2. Ability to sign informed consent form
3. At least one of the following

   1. Kidney, liver or heart transplant patient using tacrolimus or cyclosporine A
   2. Kidney or liver transplant patient using everolimus
   3. Kidney transplant patient using sirolimus

Exclusion Criteria:

1. Inability to provide informed consent
2. Pregnancy or breastfeeding
3. Likely to believe that the sample collection procedure will pose an unusually high risk for subject's physical or mental health or their comfort

Primary outcomes:
measure: Acceptance criteria for claiming the patient samples storage stability
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza di Torino/S.C Biochimica Clinica
Study officials:
affiliation: Thermo Fisher Scientific, Inc
name: Sanna Anttonen
role: STUDY_DIRECTOR
References: