louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00831805: Screening of Psycho-cognitive Troubles in Elderly Patients
Official title: Impact of a Geriatric Mobile Unit on the Screening of Psycho-cognitive Troubles in Internal Medicine Departments and Circumstances of Calling in This Unit.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psycho-cognitive Troubles
Keywords: geriatrics
psycho-cognitive troubles
elderly
mobile unit
elderly patients
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2009-01-29
Enrollment: 200
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: elderly patients hospitalised in the internal medicine department of a suburban Parisian hopital

Brief summary: The main objective of the study is to assess the rate of patients with psycho-cognitive troubles among hospitalised elderly patients.

Detailed description: It also aims to assess this rate among patients 1) when the geriatrics mobile unit is involved in the screening of these troubles and 2) when it is not.

All the patients (75 and older) hospitalised in the internal medicine department of a suburban Parisian hospital are included in the study and their psycho-cognitive functions assessed by a geriatrics physician, using 3 validated tests.

The result of this screening provides the rate of psycho-cognitive troubles among patients that would not have been tested by a geriatrics physician in usual care. It assesses the interest of a systematic evaluation of elderly patients by the geriatric mobile unit.

Eligibility criteria: Inclusion Criteria:

* patients aged 75 years old or more
* hospitalised in internal medicine

Exclusion Criteria:

* patient confused (interference with the assessment of psycho-cognitive functions)
* diagnosis of dementia at admission
* refusal of the patient or close relative for participating in the study
* poor understanding of French language
* hospitalisation for less than 3 nights

Primary outcomes:
measure: rate of patients with psycho-cognitive troubles among hospitalised elderly patients
timeFrame: 1 day
Secondary outcomes:
measure: rates of patients with psycho-cognitive troubles 1) when the geriatrics mobile unit is involved in the screening of these troubles and 2) when it is not; and comparison of these rates
timeFrame: 1 day
measure: comparison of the rates of diagnosed dementia among 300 hospitalised patients, between 2006 and 2008 (before and after the creation of the geriatric mobile unit)
timeFrame: 2 years
Other outcomes:
Locations:
city: Colombes
country: France
facility: Hopital Louis Mourier, Assistance Publique Hopitaux de Paris
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Philippe Charru, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00394797: Surgical Correction of Moderate Ischemic Mitral Regurgitation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate Ischemic Mitral Regurgitation
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2006-11-01
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing coronary bypass surgery who have moderate degree of ischemic MR

Brief summary: The purpose of this study is to try and determine whether repair of moderate ischemic mitral regurgitation at the time of coronary bypass graft surgery (CABG) has an impact on survival.We will compare patients undergoing CABG + mitral repair or CABG only groups. Primary endpoints include late survival. Secondary endpoints include event free survival, symptoms, and echocardiographic outcomes.


Eligibility criteria: Inclusion Criteria:

* patients undergoing coronary bypass surgery who have moderate degree of ischemic MR

Exclusion Criteria:

* etiology of mitral regurgitation other than ischemic, degree of regurgitation other than moderate.

Primary outcomes:
measure: survival at 1,5 and 10 years
Secondary outcomes:
measure: event free survival
measure: symptoms
measure: echocardiographic parameters
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
Study officials:
affiliation: Shaare Zedek Medical Center
name: Shuli Silberman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00943397: Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)
Official title: A Multicenter, Open-Label, Controlled, Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2009-07-22
Enrollment: 190
Sex: ALL
Minimum age (years): 6
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study. Additionally, patients with asthma who were 6 to 11 months of age and who had not participated in Protocol MK0476-176-01, could also enroll.


Eligibility criteria: Inclusion Criteria:

* Patient successfully completed visit 5 of MK0476 Protocol 176 (NCT00943683)

OR:

* Patient is in good, stable health
* Patient has been fed solid foods for at least 1 month
* Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit
* Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines

Exclusion Criteria:

* Patient was hospitalized at the start of the study or had any major surgery 4 weeks prior
* Patient had an allergy to apples or applesauce

Primary outcomes:
measure: Number of Clinical Adverse Experiences (CAEs) Reported by Patients With up to 52 Weeks of Treatment
timeFrame: Up to 52 weeks of treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Bisgaard H, Skoner D, Boza ML, Tozzi CA, Newcomb K, Reiss TF, Knorr B, Noonan G. Safety and tolerability of montelukast in placebo-controlled pediatric studies and their open-label extensions. Pediatr Pulmonol. 2009 Jun;44(6):568-79. doi: 10.1002/ppul.21018.
Clinical trial NCT01953497: Phase 1 Study of URC102 in Healthy Subjects
Official title: A Phase I, Placebo-controlled, Randomized, Double Blind, Single or Multiple Dose Study of URC102 in Healthy Male Volunteers of Korean and Caucasian to Assess Safety, Pharmacokinetics and Pharmacodynamics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2013-10-01
Enrollment: 81
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety, tolerability, PK and PD of URC102 in healthy subjects. To evaluate the food effect on PK.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers

Exclusion Criteria:

* Received other investigational drug within 12 weeks prior to the first dose of study drug

Primary outcomes:
measure: Number of participants with AE
timeFrame: 1 week
Secondary outcomes:
measure: Plasma URC102 concentration
timeFrame: 1 week
measure: Blood uric acid
timeFrame: 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Kyung-Sang Yu, MD, PhD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee HA, Yu KS, Park SI, Yoon S, Onohara M, Ahn Y, Lee H. URC102, a potent and selective inhibitor of hURAT1, reduced serum uric acid in healthy volunteers. Rheumatology (Oxford). 2019 Nov 1;58(11):1976-1984. doi: 10.1093/rheumatology/kez140.
Clinical trial NCT03536897: IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
Official title: Intraoperative Radiation Therapy (IORT) Following Breast Conserving Surgery for Early Stage Breast Cancer Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: breast cancer
invasive ductal carcinoma
intraoperative radiation therapy
iort
Lead sponsor: Mount Carmel Health System
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 168
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women aged 65 and above with early stage breast cancer, ER+, low to intermediate grade invasive ductal carcinoma of the breast amenable to breast conserving surgery and radiation therapy.

Brief summary: This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival.


Eligibility criteria: Inclusion Criteria:

* Female
* ECOG performance status 0-1
* Age 65 years or older
* cT1 or cT2 (≤3.0 cm)
* Invasive ductal carcinoma histology
* Estrogen receptor positive (ER+)
* Grade 1 or Grade 2
* Clinically negative lymph nodes (cN0) by examination, imaging and/or nodal sampling
* Suitable for breast conserving surgery and radiation therapy
* Patient must be able to provide study-specific informed consent

Exclusion Criteria:

* Multi-centric cancer not amenable to single lumpectomy
* Prior ipsilateral whole breast radiation
* Known BRCA 1 or BRCA 2 mutation
* Status post neoadjuvant hormonal or chemotherapy
* Invasive lobular histology
* Pure ductal carcinoma in situ (DCIS)
* Grade 3
* Diffuse suspicious microcalcifications

Primary outcomes:
measure: In-Breast Tumor Recurrence (IBTR)
timeFrame: 5 years
Secondary outcomes:
measure: Late Toxicity
timeFrame: 5 years
measure: Acute Toxicity
timeFrame: 3 months
measure: Disease Free Survival
timeFrame: 5 yeras
measure: Overall Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Mount Carmel West Hospital
state: Ohio
Study officials:
affiliation: Mount Carmel Health System
name: Malolan Rajagopalan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02873897: Acceptability of Products and Eating Pleasure in Elderly People Living at Home or in Establishment Hosting For the Dependant Elderly (EHPAD) (Old-people's Home)
Official title: Acceptability of Products and Eating Pleasure in Elderly People Living at Home or in an EHPAD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nutrition
Keywords: elderly
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-22
Enrollment: 520
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: In independent elderly people, the aim is to test recipes for different types of food from different countries (starter, main course with culinary aids, carrot purees, desserts and smoothies) likely to improve sensory acceptability of foods for elderly people who are dependent for their meals (persons for whom at least one meal per day is provided by a catering service - meals at home, old people's home). All of the recipes were developed thanks to the first two parts of the OPTIFEL project so as to take into account the needs of elderly people and recommendations in each country. The interest is to increase the sapidity/ attractiveness of meals by optimizing sensory properties and the nutritional content of the foods, to meet the nutritional needs of this specific population with enriched recipes (with leguminous proteins and/or vitamins and minerals and/or fibre) suitable for different cultures. This ongoing research is being conducted on 2-4 different variants of each type of product: the starter (a soup of legumes), the main dish (diced chicken with culinary aids) and garnished (carrot puree), an apple-based dessert and fruit smoothies.

For each product family, two products will be selected for each country: the preferred product (highest hedonic value of recipes enriched with leguminous proteins and/or vitamins and minerals) and the standard product without enrichment.

Finally, at the end of this study, nine products will have been chosen: 2 soups, 2 culinary aids, 2 carrot purees, 2 desserts and 1 smoothie


Eligibility criteria: Inclusion Criteria:

* people older than 65 years
* persons living in EHPAD-type old people's homes or living at home and using a meals-on-wheels service
* persons without known heart disease or arterial hypertension
* persons who have given oral consent

Exclusion Criteria:

* Persons suffering from a serious illness during the trial
* Persons with life expectancy of less than 6 months
* Persons with proven anosmia (total loss of olfaction), from birth or because of physical trauma (head injury) or disease (acute rhinitis)
* Persons with an allergy or an aversion for any of the foods used
* Persons with a strict prescribed diet

Primary outcomes:
measure: Measuring new product satisfaction
timeFrame: throughout the study; completion up to 13 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT01295697: Study of EZN-2208 Pediatric Patients With Solid Tumors
Official title: A Phase 1/2 Study of EZN-2208 in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Keywords: Patients with non-CNS or CNS tumors
Pediatric patients with Relapsed/Refractory Solid Tumors
Lead sponsor: Enzon Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-14
Enrollment: 32
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this clinical research study is to find the highest tolerable dose of EZN-2208 that can be given to pediatric patients with Relapsed or Refractory Solid Tumors. The safety of the study drug and its effect on the disease will also be studied.

Detailed description: Pharmacokinetic (PK) testing of EZN-2208, will be performed for patients who volunteer. PK testing measures the amount of a drug in the body at different time points.

Eligibility criteria: Inclusion Criteria:

* Patients with histologic verification of malignancy at original diagnosis or relapse.
* Measurable or evaluable disease
* Karnofsky score more or equal to 50 for patients \>16 years of age and Lansky score more or equal to 50 for patients \<16 years of age
* Patients previously treated with irinotecan will be eligible for this study if they have not had documented progressive disease during treatment with an irinotecan-containing regimen.
* Adequate hematologic, hepatic, coagulation, renal, and metabolic function

Exclusion Criteria:

* Pregnant or breast feeding patients will not be enrolled in this study
* Patients who are currently receiving other anticancer agents
* Patients who have an uncontrolled infection
* Patients requiring cytochrome P450 3A4 enzyme inducing or inhibiting agents

Primary outcomes:
measure: Determine the MTD and recommended phase 2 dose of i.v. EZN-2208 administered q3wk.
timeFrame: 2 years
Secondary outcomes:
measure: Assess evidence of tumor response activity of EZN-2208
timeFrame: 2 years
measure: Evaluate the safety and tolerability of EZN-2208
timeFrame: 2 years
measure: Assess the PK profile of EZN-2208
timeFrame: 2 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Lia Gore, MD
state: Colorado
city: Boston
country: United States
facility: Suzanne Shusterman, MD
state: Massachusetts
city: Philadelphia
country: United States
facility: Rochelle Bagatell, MD (Principal Investigator)
state: Pennsylvania
city: Houston
country: United States
facility: Jodi Muscal, MD
state: Texas
Study officials:
affiliation: Developmental Therapeutics Program, The Children's Hospital of Philadelphia, CTRB 4022; 3501 Civic Center Blvd. Philadelphia, PA 19104
name: Rochelle Bagatell, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03012997: Effects of Hyperoxia on Open Heart Surgery
Official title: Effects of Hyperoxia on Oxidative Stress in Patients Undergoing Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Valve Disease
Coronary (Artery) Disease
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Koşuyolu Kartal Heart Training and Research Hospital
First posted: 2017-01-06
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Patients undergoing Open Cardiac Surgery will be randomized into two groups. Group I will be ventilated with 40% Fio2 during induction, surgery and in Postoperative care unit. Group II will be ventilated with 100% Fio2 during induction and with 60-70% ( determined according to the arterial blood gas sample results) during surgery and in Postoperative care unit.

Hemodynamic parameters ( systolic arterial pressure, diastolic arterial pressure, heart rate ), Arterial blood gas samples ( PaO2, PaCO2, pH, Oxygen saturation, Lactate), and pre and post cardiopulmonary bypass Superoxide dismutase and malonyl aldehyde levels.


Eligibility criteria: Inclusion Criteria:

* ASA II-III
* Patients with EF higher than 50%.
* patients undergoing elective open heart surgery on pump ( CABG, Valve Replacement)

Exclusion Criteria:

* patients with Diabetes Mellitus
* patients with COPD
* Patients with Cerebral Vascular Disease
* Patients with hypoxia in Arterial blood gas samples ( PaO2 lower than 80 mmHg) and hypercarbia (PaCO2 higher than 45 mmHg)

Primary outcomes:
measure: change in Malondialdehyde (MDA) (nmol/mg pr) levels (as a biomarker for oxidative stress ) and Superoxide dismutase (SOD) (nmol/mg pr) levels as a biomarker for antioxidant response in the plasma between "before" and "after" cardiopulmonary bypass
timeFrame: 72 hours
Secondary outcomes:
measure: Partial pressure of oxygen(mmHg),
timeFrame: 72 hours
measure: Partial pressure of carbondioxide(mm Hg)
timeFrame: 72 hours
measure: lactate (mmol/l)
timeFrame: 72 hours
measure: ph values
timeFrame: 72 hours
measure: systolic arterial pressure (mmHg),
timeFrame: 72 hours
measure: diastolic arterial pressure (mmHg)
timeFrame: 72 hours
measure: Oxygen saturation (%)
timeFrame: 72 hours
measure: heart rate (beat/min)
timeFrame: 72 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kartal Kosuyolu Training and Research Hospital
state: Marmara
city: Istanbul
country: Turkey
facility: Kartal Kosuyolu Training and Research Hospital
Study officials:
affiliation: Istanbul University
name: Guniz Koksal, Professor
role: STUDY_DIRECTOR
References:
citation: Koksal GM, Dikmen Y, Erbabacan E, Aydin S, Cakatay U, Sitar ME, Altindas F. Hyperoxic oxidative stress during abdominal surgery: a randomized trial. J Anesth. 2016 Aug;30(4):610-9. doi: 10.1007/s00540-016-2164-7. Epub 2016 Mar 21.
Clinical trial NCT03243097: CROS Application in CI
Official title: Contralateral Routing of Signal in Unilateral Cochlear Implant Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Bilateral profound sensorineural hearing loss (PSNHL) is often treated with Cochlear Implants. The majority of bilaterally deafened patients, however, often only receive a unilateral cochlear implant (CI), with resultant limitations related to monaural listening. For unilateral CI users, the deficits inherently associated with monaural listening remain despite the considerable benefits achieved through implantation. Providing bilateral input to monaural listeners (MLs) overcomes some of these disadvantages. Treatment by contralateral routing of signal (CROS) hearing aids, where the signal of interest is routed from the impaired (deaf) ear to the normal cochlea for processing is a promising alternative in unilateral CI recipients who cannot benefit from bilateral CIs. Utilizing CROS technology provides a less invasive alternative for patients who are unable or unwilling to undergo a second CI surgery and offers an innovative approach to resolving the auditory deficits associated with monaural listening. CROS technology has been used to treat traditional monaural listeners since 1965. When applied to unilateral CI users, this novel approach can overcome a key limitation of current treatment by restoring access to sound from the non-implanted ear and improving speech perception in noise.


Eligibility criteria: Inclusion Criteria:

* Unilateral Advanced Bionics CI recipient
* ≥ 6 months CI-listening experience and/or better than 50%-word recognition on Consonant-Nucleus-Consonant (CNC) word testing
* English speaking

Exclusion Criteria:

* Subjects who do not meet one or more of the above mentioned inclusion criteria are excluded from the study

Primary outcomes:
measure: Speech perception in noise
timeFrame: 8 weeks
Secondary outcomes:
measure: Subjective Benefit
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Department of Otolaryngology
state: Florida
Study officials:
affiliation: University of Miami
name: Hillary Snapp, AuD
role: PRINCIPAL_INVESTIGATOR
References: