louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02155686: Elderly Chronic Diseases Online Biometric Analysis Home Living Technology
Official title: Etude de l'Impact Clinique de la télésurveillance à Domicile Par télémédecine de paramètres biométriques de la Personne âgée Polypathologique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Elderly
Keywords: Elderly
Prevention
Multiple chronic disease
Telemonitoring
Geriatric teleexpertise
Home heath care
Medico-economics
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2014-06-04
Enrollment: 536
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The elderly or people with disabilities want to remain in their homes even when their health condition has been getting worse.

This project aims to demonstrate that home automation and telemonitoring can lead to develop a home safety environment that could help the elderly and individual with disability live independently in their own home.

In this study, the automation sensors containing devices follow up chronic disease clinical factors to monitor their biometrical parameters and detect any abnormal prodromal disease decompensation via telemonitoring and geriatric expertise.

The purpose of this study is:

* to provide clinical evidence of the effectiveness of automation tools and telemonitoring/expertise for the home support for people at risk of loss of autonomy
* to demonstrate the clinical benefit of combining the automation and telemonitoring and geriatric teleexpertise


Eligibility criteria: Inclusion Criteria:

* Aged 65 or more.
* House equipped with home automation
* Having been hospitalized in the year prior to the inclusion for the following conditions : heart failure, chronic obstructive pulmonary disease (COPD ), diabetes, high blood pressure ( hypertension ) , repetitive falls, chronic renal failure , stroke, neurodegenerative diseases , malnutrition (according to criteria HAS)
* Multiple chronic diseases (at least 2 comorbidities) .
* Having given free and informed consent

Exclusion Criteria:

* Life expectancy less than 12 months
* Enrolled in another clinical trial

Primary outcomes:
measure: Number of unplanned hospitalization for decompensation
timeFrame: at 12 months
Secondary outcomes:
measure: Impact on global health
timeFrame: at 12 months
measure: Cost/effectivness preventive care
timeFrame: at 12 months
Other outcomes:
Locations:
city: Limoges
country: France
facility: Service de Gériatrie - CHU de LImoges
Study officials:
affiliation: CHU Limoges
name: Thierry DANTOINE, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02973386: Prognostic Analysis of Concurrent Chemoradiotherapy With/Without Adjuvant Chemotherapy for Locally Advanced NPC Patients
Official title: Randomized Trial of Concurrent Cisplatin Chemoradiotherapy Plus Capecitabine Adjuvant Chemotherapy vs Concurrent Cisplatin Chemoradiotherapy Alone for Patients With Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Local Advanced High Risk Nasopharyngeal Carcinoma
Keywords: Local advanced
High Risk
Nasopharyngeal Carcinoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-11-25
Enrollment: 278
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: This is a randomized,controlled,prospective phase III clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.Exploring an Individualized comprehensive treatment plan which is reasonable,effective,low toxicity and fitting with Modern radiotherapy techniques for Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.


Eligibility criteria: Inclusion Criteria:

* Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
* Clinical stage III\~IVb(UICC/AJCC 7th)
* No distant metastasis
* Karnofsky Performance Status Scale≥70
* WBC count ≥ 4×109/L, neutrophil differential count≥ 1.5×109/L, Hemoglobin ≥ 90g/L, platelet count ≥ 100×109/L
* ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN, Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min
* Sign the informed consent.

Exclusion Criteria:

* Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas
* Younger than 18 years old or older than 70 years old
* Are receiving other drugs treanment
* kidney disease
* Have suffered from other tumor or now suffering from other tumor
* Have recieved chemotherapy or radiotherapy
* Pregnancy or lactation
* unstable heart disease need timely treatment
* Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes

Primary outcomes:
measure: Distant metastasis-free survival
timeFrame: Five year
Secondary outcomes:
measure: Failure-free survival
timeFrame: Five year
measure: Locoregional relapse-free survival
timeFrame: Five year
measure: Overall survival
timeFrame: Five year
measure: Acute toxicity
timeFrame: three months after corresponding treatment
measure: Late toxicity
timeFrame: Five year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Cancer Center, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: zhao chong, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01215786: Safety and Pharmacodynamics Study of AGN-207281 Ophthalmic Solutions Compared With Timolol Ophthalmic Solution or Placebo in Patients With Ocular Hypertension or Primary Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2010-10-07
Enrollment: 50
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 is an exploratory study that will evaluate the safety and pharmacodynamics of up to 3 doses of AGN-207281 based on an ongoing review of data during the study period compared with timolol ophthalmic solution or placebo in patients with ocular hypertension or primary open-angle glaucoma.


Eligibility criteria: Inclusion Criteria:

* Ocular hypertension or primary open-angle glaucoma in each eye
* Requires IOP-lowering therapy in both eyes
* Visual acuity score of 20/100 or better in each eye

Exclusion Criteria:

* Experienced significant weight change (over 10 pounds) within 60 days
* History of alcohol or drug addiction
* History of migraines or frequent headaches
* Anticipated wearing of contact lenses during the study
* Required chronic use of ocular medications during study
* Eye surgery within 6 months
* Use of systemic beta blockers (eg, atenolol, propranolol) within 2 months
* Use of oral, intramuscular, intravenous corticosteroids within 21 days
* Use of ophthalmic corticosteroids within 2 months

Primary outcomes:
measure: Change From Baseline in Worse Eye Intraocular Pressure (IOP) at Day 14
timeFrame: Baseline, Day 14
Secondary outcomes:
measure: Mean Concentration of AGN-207281 in Plasma at Day 7
timeFrame: Day 7
measure: Mean Concentration of AGN-207281 in Plasma at Day 14
timeFrame: Day 14
Other outcomes:
Locations:
city: Newport Beach
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01484886: Restrictive Versus Liberal Transfusion Protocol in Infants Undergoing Cardiac Surgery
Official title: Prospective Randomized Controlled Clinical Trial Comparing a Restrictive Versus Liberal Transfusion Strategy in Neonates and Infants Undergoing Surgery for Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Oxygen Delivery
Congenital Heart Disease
Keywords: Hemoglobin
Congenital heart disease
Cardiac surgery
Red blood cell transfusion
Number of red blood cell transfusions
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2011-12-02
Enrollment: 162
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In neonates and infants \</= 10 kg following cardiac surgery for congenital heart disease a more restrictive red blood cell (RBC) transfusion strategy will be as effective as, and possibly superior to, a liberal RBC strategy. Allowing lower hemoglobin concentration will not affect the cardiac or pulmonary status of the patient.


Eligibility criteria: Inclusion Criteria:

* children \</= 6 months of age with congenital cardiac disease undergoing cardiac surgery with cardiopulmonary bypass.

Exclusion Criteria:

* presence of a known bleeding disorder or coagulopathy.
* age \> 6 months,
* lack of informed consent.

Primary outcomes:
measure: oxygen utilization derived from the arterio-venous oxygen difference.
timeFrame: 3 days
Secondary outcomes:
measure: volume of RBC transfused
timeFrame: 7 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT06496386: Robotic Assisted Major Lung Resection in Elderly Patients
Official title: Robotic Assisted Major Lung Resection in Elderly Patients: Results From a Retrospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: robot-assisted thoracoscopic surgery
lung resection
Lead sponsor: Scientific Institute San Raffaele
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 386
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the study will focus on the population of subjects undergoing lung resection with the DaVinci surgical platform from May 2015 to December 2022.

The anatomical resections considered will be segmentectomy, lobectomy, bilobectomy or pneumonectomy using robotic system.

Brief summary: The study is a retrospective observational study. The study is designed to be multicentric and it will analyze medical records from selected patients that underwent major lung resection using DaVinci surgical platform performed in the participating centers.

There are no risks for the patients, as this is a retrospective data collection.

Detailed description: The investigators will recruit all patients who underwent major lung resection (segmentectomy, lobectomy, bilobectomy, or pneumonectomy using a robotic system) from May 2015 to December 2022.

Patients are divided into two groups: older than 80 years (case- very elderly patients) and younger than 80 years (control- elderly).

the aim: Minimally invasive techniques such as robot-assisted thoracoscopic surgery (RATS) can potentially reduce surgical trauma and therefore prove particularly beneficial for elderly patients.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years at the moment of surgery
* Suspected or confirmed diagnosis of lung cancer
* The patient can be candidate in terms of cardiac, kidney, liver and respiratory function the primary pathology is under control or controllable
* Absence of extrapulmonary metastases that are not controlled or controllable
* All procedures included use of DaVinci robot system

Exclusion Criteria:

* Age \< 18 years at the moment of surgery
* Patients who cannot undergo surgery, as they do not meet the conditions outlined above

Primary outcomes:
measure: The perioperative complications
timeFrame: from the surgery at 30-90 days after
measure: spirometry tests
timeFrame: from hospitalizzation to the discharge date at maximum one week
measure: Postoperative hospital stay
timeFrame: from hospitalizzation to the discharge date at maximum one week
Secondary outcomes:
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milan
city: Milan
country: Italy
facility: Scientific Institute Ospedale San Raffaele
Study officials:
References:
Clinical trial NCT01355263: Effect of Vitamin A Supplementation on Iron Metabolic Homeostasis of Preschool Children in Sichuan,China
Official title: Effect of Vitamin A Supplementation on Iron Metabolic Homeostasis of Preschool Children in Sichuan,China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Iron Metabolic Homeostasis
Keywords: vitamin a
preschool children
iron metabolic homeostasis
supplementation effect
Lead sponsor: Chengdu Maternal and Children's Health Care Hospital
Sponsor class: OTHER
First posted: 2011-05-18
Enrollment: 450
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The investigators plan to perform a randomized, mutual-control and double-blinded cohort study to further exploit the vitamin A supplementation on iron metabolic homeostasis (including iron reserve, mobilization and absorption status in the same population) compared with solely iron and vitamin A plus iron.


Eligibility criteria: Inclusion Criteria:

* apparent health;
* Hb concentration\>60 g/L;
* C-reaction protein (CRP)\<10 mg/L;
* parental or guardian approval of participation in all aspects of the study; and
* parental/guardian agreement to avoid the additional use of vitamin and mineral supplements during the investigation.

Exclusion Criteria:

* does not match the inclusion criteria

Primary outcomes:
measure: hemoglobin
timeFrame: 6 months
measure: hemoglobin
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05331963: Effects of Functional Kinesio Taping on Subacromial Space in Athletes With Rotator Cuff Tendinopathy
Official title: The Effects of Functional Kinesio Taping on Subacromial Space in Athletes With Rotator Cuff Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sports Physical Therapy
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-04-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the effects of functional kinesio taping on subacromial space in athletes with rotator cuff tendinopathy.

Detailed description: Subacromial impingement is a condition among athletes those involved in overhead sports activities such as swimming and volleyball. According to Neer there are two main categories of shoulder impingement, these are structural and functional. Structural: caused by reduction of the subacromial space (SAS) due to bony growth, calcification or soft tissue inflammation whereas functional is caused by or superior migration of the humeral head due to muscular weakness imbalance. In some cases subacromial impingement can be result from a combination of both structural and functional factors.Maintenance of the SAS during arm elevation is thus essential for the prevention of Rotator cuff tendinopathy.

The aim of this randomized controlled trial (RCT) is to evaluate the long-term effects of scapular KT, added to a 6-week rehabilitation program, on the subacromial space at different arm positions in athletes with Rotator cuff tendinopathy. To better understand the underlying mechanisms of KT, our secondary objective addressed the effects of KT on reliving pain-free and full ROM of shoulder joint.

Eligibility criteria: Inclusion Criteria:

* Age between 18 to 35 years
* Both gender
* Athletes participating in volley ball, tennis, badminton and golf.
* Presence of shoulder pain in abduction and external rotation during training for more than three months
* Three out of five positive results for the following: painful arc, pain or weakness with resisted external rotation, abduction, Neer test, Hawkins Kennedy test, empty can test/Jobe test

Exclusion Criteria:

* H/O shoulder fractures,
* Instability or dislocation (positive apprehension and relocation tests)
* Frozen shoulder (All stages)
* Recent shoulder surgery for a shoulder injury

Primary outcomes:
measure: Subacrimial space measurement by Ultrasonography
timeFrame: Six weeks
measure: Visual Analogue Scale
timeFrame: Six weeks
measure: The Disabilities of Arm, Shoulder and Hand Questionnaire
timeFrame: Six weeks
measure: The Western Ontario Rotator Cuff Index
timeFrame: Six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Pain and Spine Clinic
state: Federal
Study officials:
affiliation: Riphah International University
name: Aadil Omer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02188563: A Comprehensive Smoking Cessation Intervention Duration Radiation for Upper Aerodigestive Cancers
Official title: Efficacy and Impact of a Comprehensive Smoking Cessation Intervention During Radiation for Upper Aerodigestive Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Head and Neck Neoplasms
Thoracic Neoplasms
Radiation
Keywords: Smoking cessation
Head and neck neoplasms
Lung neoplasms
Thoracic neoplasms
Radiation
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2014-07-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Smoking is the greatest risk factor for upper aerodigestive cancers (thoracic or head and neck) and negatively impacts survival and other outcomes, but many patients have difficulty quitting after their diagnosis. Smoking cessation interventions for cancer patients thus far have had limited success. This is a pilot randomized controlled trial designed to determine if a new comprehensive, evidence-based smoking cessation intervention can improve quit rates for cancer patients who smoke.


Eligibility criteria: Inclusion Criteria:

* New diagnosis of head and neck or thoracic (including lung) cancer
* Undergoing radiation at Johns Hopkins Radiation Oncology for 5 or more weeks
* English-speaking and able to provide informed consent
* Smoked any cigarettes in previous 14 days

Exclusion Criteria:

* Palliative radiation
* Undergoing stereotactic radiosurgery
* Pregnant or breastfeeding

Primary outcomes:
measure: Smoking cessation
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology
name: Gypsyamber D'Souza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
Clinical trial NCT05357963: Incidence of Chronic Pain After Sternotomy
Official title: Incidence of Chronic Pain After Sternotomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Pain
Postoperative Pain, Acute
Postoperative Pain, Chronic
Sternotomy
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients between the ages of 18-80 years, in the ASA I-II-III-IV risk group, with a BMI between 18-35 kg/m2 and undergoing sternotomy will be included in the study.

Patients under the age of 18 years and over the age of 80 years, with an ASA score of V and above, with a BMI below 18 kg/m2 and above 35 kg/m2, who were operated under emergency conditions, and who received chronic pain treatment will be excluded from the study.

Brief summary: Chronic postoperative pain is a well-known problem. Chronic postoperative pain is defined as pain that begins following a surgical procedure and persists for more than 2 months without other obvious causes such as infection or underlying disease. Sternotomy causes significant postoperative pain, and patients with chronic pain after sternotomy are often referred to pain clinics. The incidence of chronic pain after sternotomy ranges from 17% to 56%; In approximately one-third of these patients, chronic pain after sternotomy can compromise their quality of life by affecting their sleep patterns and impairing their ability to work. However, epidemiological studies on chronic pain after sternotomy are scarce. The aim of this study is to examine the incidence and possible risk factors of chronic pain following sternotomy operations. In this study, it was aimed to analyze the chronic pain findings of the patients who underwent sternotomy in the postoperative 3rd month.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years
* American Society of Anesthesiologists' physical status I-II-III-IV
* Body mass index (BMI) between 18-35 kg/m2
* Patients undergoing elective sternotomy

Exclusion Criteria:

* History of chronic analgesic therapy
* Patients with previous sternotomy surgery
* Patients who were operated under emergency conditions

Primary outcomes:
measure: Chronic pain symptoms at 3rd months.
timeFrame: Chronic pain symptoms at 3rd month
measure: Quality of life at 3rd months.
timeFrame: Quality of life at 3rd months.
Secondary outcomes:
measure: Acute pain score
timeFrame: At the 24th hour after surgery
Other outcomes:
Locations:
city: Çankaya
country: Turkey
facility: Ankara City Hospital
state: Ankara
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Nilgün ZENGİN, MD
role: PRINCIPAL_INVESTIGATOR
References: