louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06596200: Spinal Cord Stimulation for Chemotherapy Induced Peripheral Neuropathy
Official title: Pilot Study for the Use of Spinal Cord Stimulation to Alleviate Pain from Chemotherapy Induced Peripheral Neuropathy Due to Taxane or Platinum Based Agents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Chemotherapy-induced Peripheral Neuropathy
Lead sponsor: University of Maryland St. Joseph Medical Center
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Spinal Cord Stimulation using 10 kHz stimulation to the thoracic spinal cord will be a safe and effective treatment for CIPN, reducing pain in the lower extremities by at least 50%.


Eligibility criteria: Inclusion Criteria:

* CIPN as diagnosed by Oncology and/or neurology
* Receipt of a platinum-based or taxane chemotherapy prior to development of CIPN
* Pain severity greater than 4 out of 10 on a numeric rating scale of pain
* Pain chronicity greater than 6 months after the cessation of chemotherapy
* Failure of medical therapy, which must have included duloxetine
* Age 18 or greater

Exclusion Criteria:

* Platelet count less than 100k/mm3
* Spinal anatomy precluding placement of the SCS leads between T6 and T11
* Active infection
* Estimated Lifespan less than 1 year
* Receipt of vincristine, thalidomide, bortezomib, or eribulin within the prior 12 months

Primary outcomes:
measure: -- Measure response of CIPN pain to HF10 treatment using the numeric scale of pain (NRS) at SCS trial for all subjects and at 3, 6 and 12 months after implant for subjects who qualify for permanent implant.
timeFrame: 1 year
Secondary outcomes:
measure: - - Neuropathy symptoms will be quantified using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CIPN twenty-item scale (CIPN20). CIPN20 is a 20-item patient questionnaire with items scored 1 to 4.
timeFrame: 1 year
measure: - Pain interference in daily life will be quantified via the brief pain inventory (BPI).
timeFrame: 1 year
measure: - Neuropathy findings will be quantified with the modified Toronto clinical neuropathy score (mTCNS).
timeFrame: 1 year
measure: - The subject's impression of SCS efficacy will be measured using the patient global impression of change (PGIC).
timeFrame: 1 year
measure: - Health related quality of life will be assessed using the EuroQOL5D-5L questionnaire.
timeFrame: 1 year
measure: - Any treatment related adverse events observed during the trial will be documented using the Common Terminology Criteria for Adverse Events (CTCAE) ver 5.0.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03728400: Follow-up of Malnutrition Screening in USINV
Official title: Follow-up of Malnutrition Screening in Neurovascular Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 66
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in Neurovascular Intensive care Unit following a stroke

Brief summary: This aim of the study is to set up a procedure for screening for undernutrition in the neurovascular intensive care unit. This screening procedure follows a specific work concerning undernutrition in thrombolyzed patients (NCT03303820). This work was motivated by the fact that, despite a high frequency of undernutrition in the hospital (at least 30% of patients), undernutrition in neurovascular unit is studied very little. A cohort of thrombolysed patients in 2014 was studied retrospectively. Patients malnourished at the entrance had a non-significant, less good recovery of their stroke (+ 1 Rankin score point at 3 months in malnourished patients at the entrance).

Detailed description: The main objective of this project is to assess, prospectively, the frequency of undernutrition at the entrance to the neurovascular intensive care unit and to evaluate the implementation of the undernutrition screening procedure.

Eligibility criteria: Inclusion Criteria:

* Patient whose age ≥ 70 years
* Patient hospitalized in Neurovascular Intensive care Unit following a stroke (infarction or cerebral hematoma)
* Francophone patient

Exclusion Criteria:

* Patient hospitalized in Neurovascular Intensive care Unit following a transient ischemic attack
* Patient whose age ≤ 70 years
* Patient hospitalized in Neurovascular Intensive care Unit for another reason than neurovascular disease
* Patient opposing the use of his data

Primary outcomes:
measure: frequency of undernutrition at the entrance
timeFrame: Day 1
Secondary outcomes:
measure: Modified Rankin scale
timeFrame: 3 months
measure: Recurrence rate of ischemic or haemorrhagic stroke
timeFrame: 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Marie P BRUANDET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01654900: Mid-term Survival and Quality of Life of Elderly Patients Undergoing Open Heart Surgery
Official title: Mid -Term Survival and Quality of Life of Elderly Patients Undergoing Open Heart Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Quality of Life
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-08-01
Enrollment: 207
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients age \>75 y who underwent open heart surgery between 2008-2011 at hadassah medical center.

Brief summary: The purposes of the investigators study is to examine the overall survival and quality of life in elderly patients (\> 75 years) undergoing open heart surgery at Hadassah medical center between 2008-2011. All alive patients will be phone interviewed using the 36-item short form health survey. Results will be compared to similar health survey results (36-SF)obtained from a group of Israeli adults who had no open heart surgery (controlled group). The investigators hypothesize that elderly patients achieve improvement in quality of life after open heart surgery with acceptable operative morbidity and mortality.


Eligibility criteria: Inclusion Criteria:

* all patients age \> 75 years who discharged alive after surgery

Exclusion Criteria:

* death

Primary outcomes:
measure: Quality of life
timeFrame: 2-4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
state: Ein Kerem
Study officials:
affiliation: Hadassah Medical Organization
name: Oz Shapira, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000200: Cocaine Effects in Humans: Physiology and Behavior - 1
Official title: Cocaine Effects in Humans: Physiology and Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: self-administration
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Columbia University
First posted: 1999-09-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of buprenorphine or methadone maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving, in opiate-dependent cocaine users.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Interaction of cocaine and meds on cardio
timeFrame: 3 hr
measure: Interaction of cocaine & meds on coc's subjective
timeFrame: 3 hr
measure: Effects of medication on cocaine craving
timeFrame: 3 hr
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Marian Fischman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foltin RW, Fischman MW. Effects of methadone or buprenorphine maintenance on the subjective and reinforcing effects of intravenous cocaine in humans. J Pharmacol Exp Ther. 1996 Sep;278(3):1153-64.
Clinical trial NCT04180800: Studying the Association Between Folic Acid Deficiency and Social Isolation for Elderly Patients
Official title: Studying the Association Between Folic Acid Deficiency and Social Isolation for Elderly Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Folic Acid Deficiency
Social Isolation
Elderly Patients
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-11-29
Enrollment: 61
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over 75 years old, hospitalized in geriatric rehabilitation care in Strasbourg University Hospital

Brief summary: Social isolation among elderly people is a frequent and major determinant for health.

The risk of premature death is 2 to 5 time higher for socially isolated people, similarly for morbidity, duration of healing and complications rate.

Denutrition is also frequent for elderly people with potentially serious consequences. Vitamin deficiency, especially in B9 and B12 vitamins, are often associated with denutrition among elderly people.

Folic acid (vitamin B9) is not influenced by inflammation and folic acid income are necessarily exogene. Vitamin B9 is provided by fresh fruits and vegetables, and giblets.

The investigators observed a high prevalence in folic acid deficiency for socially isolated elderly patients. The investigators made the hypothesis that a folic acid defiency is associated with social isolation for elderly people.

The primary purpose is the study of the association between folic acid deficiency (measured by dosing of plasma concentration of vitamin B9) and social isolation evaluated by Lubben Social Network Scale in 6 questions.

The secondary purposes are the study of the correlation between folic acid deficiency and social conditions, nutritional status, biological data, poly pharmacy, cognitive functions, dependency and length of stay at hospital.


Eligibility criteria: Inclusion criteria :

* Patients hospitalized in geriatric rehabilitation care in Strasbourg University Hospital
* Age \> 75 years
* Patient has given his consent

Exclusion criteria :

* Digestive malabsorption disorder : gastrectomy, extended intestinal resection, Crohn disease, celiac disease, parenteral nutrition
* Chronic alcoholism
* Treatment with sulfamids, methotrexate, anti epileptic treatment (hydantoin)
* Hemodialysis
* Patients under protection measure (curatorship, guardianship, judicial protection)
* Patient refuses to participate

Primary outcomes:
measure: Measure of plasma concentration on vitamin B9 by blood test taken in regular hospital admission
timeFrame: 10 weeks
measure: Measure of social isolation by Lubben Social Network Scale in 6 questions
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Catherine JEHL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05629000: Optimization Strategy of Carotid Artery Stenosis
Official title: Cohort of Optimized Assessment Strategy of Carotid Artery Stenosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carotid Artery Stenosis
Keywords: carotid artery stenosis
Perfusion
plaque
MRI
CT
PET/MRI
Ultrasound
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mild to severe carotid stenosis or near-occlusion patients receiving carotid revascularization treatment.

Brief summary: The goal of this observational study is to learn about how to utilize multiple evaluation techniques in carotid artery stenosis patients for optimizing assessment of diagnosis and treatment strategy.

The main questions it aims to answer are:

* Identify best strategy that use multi-modal MRI and CT to assess patients' cerebral lesions and perfusion.
* Identify best strategy that use multi-modal MRI, PET-MRI ultrasound and CT to assess components and characters of patients' carotid plaques.

Participants will accept imaging examination before and after surgery. And doctors will collect basic characteristics, imaging results and biological samples of patients for analysis.


Eligibility criteria: Inclusion Criteria:

1. patients with severe stenosis (≥50%) or near-occlusion diagnosed by computed tomographic angiogram;
2. patients received carotid endarterectomy at Peking Union Medical College Hospital

Exclusion Criteria:

(1) Any contraindication to image examination; (3) refuse to sign the Informed consent.

Primary outcomes:
measure: stroke
timeFrame: During hospital stay, usually 7-30 days post operation
measure: cardiac infarction
timeFrame: During hospital stay, usually 7-30 days post operation
measure: transient ischemic attack
timeFrame: During hospital stay, usually 7-30 days post operation
measure: cerebral hyperperfusion syndrome
timeFrame: During hospital stay, usually 7-30 days post operation
measure: death
timeFrame: During hospital stay, usually 7-30 days post operation
Secondary outcomes:
measure: Image characters of MRI
timeFrame: half year after operation
measure: Image characters of PET/MRI
timeFrame: half year after operation
measure: Image characters of ultrasound
timeFrame: half year after operation
measure: Carotid plaque characters
timeFrame: half year after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: vascular surgery department of PUMCH
state: Beijing
Study officials:
References:
Clinical trial NCT03500900: Vildagliptin on Gastric Accommodation
Official title: Effect of the DPP-4 Inhibitor, Vildagliptin, on Gastric Accommodation and Food Intake in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: gastric accommodation
food intake
gastrointestinal hormones
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Dipeptidyl peptidase-4 (DPP-4) inactivates glucagon-like peptide-1 (GLP-1). Whether DPP-4 inhibition affects GLP-1 metabolism in vivo and/or food intake remains unknown.

The aim of this study is to evaluate the effect of vildagliptin (DPP-4 inhibitor) on gastric accommodation and ad libitum food intake in healthy volunteers (HVs).These effects will be evaluated in two randomized, placebo-controlled, single-blinded trials. Each protocol will include ten volunteers.

Protocol 1: Sixty minutes after treatment a nutrient drink (270 kcal) will be intragastrically infused and intragastric pressure (IGP) will be measured for one hour.

Protocol 2: 60 min after treatment the participants consume one nutrient drink (300 kcal). Thirty minutes hereafter, the participant will eat ad libitum from a free-choice buffet for 30 minutes. Blood will be collected at several time points to measure active GLP-1 plasma levels.


Eligibility criteria: Inclusion Criteria:

- Aged between 18 to 65 years old

Exclusion Criteria:

* presence of symptoms or a history of gastrointestinal diseases
* diabetes
* drug allergies
* psychological disorders
* major gastrointestinal surgery

Primary outcomes:
measure: Change in intragastric pressure measured by high resolution manometry
timeFrame: Until 2 hours after administration of study drug or placebo
Secondary outcomes:
measure: Change in subjective gastrointestinal symptom scores measured by visual analogue scale of 100 mm
timeFrame: assessment by questionnaire (100 mm Visual Analogue Scale) every 5 minutes, up to 2 hours after administration
measure: Change in GLP-1 plasma concentrations
timeFrame: Blood samples to assess active GLP-1 plasma levels were collected immediately before medication or placebo administration, 55 minutes, 75 minutes and 120 minutes after medication or placebo administration.
measure: Ad libitum food intake in grams
timeFrame: Buffet was served 1,5 hour after intake of study medication or placebo. Participants had 30 minutes to eat ad libitum until maximal satiation.
measure: Ad libitum food intake in kcal
timeFrame: Buffet was served 1,5 hour after intake of study medication or placebo. Participants had 30 minutes to eat ad libitum until maximal satiation.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05223400: Drug Use Evaluation of Clindamycin in Critical Care Units in Alexandria Main University Hospital
Official title: Drug Use Evaluation Study of Clindamycin in Critical Care Units in Alexandria Main University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection, Bacterial
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients admitted to critical care units and on clindamycin emperical therapy .

Brief summary: Irrational use of antibiotics is a one of the main health system problems,it leads to antibiotic resistance,increasing antibiotics side effects and the total cost. This study is a medication use evaluation study aims to evaluate intravenous clindamycin prescribing practice in critical care units in Alexandria Main University Hospital.


Eligibility criteria: Inclusion Criteria:

* Adults 18 years old or more .
* Patients on clindamycin as an empirical treatment.
* Patients started clindamycin as an emperical treatment in other departments but the physician approved to continue it in critical care.

Exclusion Criteria:

* Children (less than 18 years old)
* Patients started clindamycin as a defenitive treatment (based on microbiological culture results).

Primary outcomes:
measure: the number of prescriptions with appropriate indications of clindamycin will be counted during the retrospective observation of all prescriptions
timeFrame: 1 month
Secondary outcomes:
measure: the number of prescriptions with duplication of therapy with clindamycin will be counted during the retrospective observation of all prescriptions
timeFrame: 1 month
measure: the number of patients who had diarrhea as a main side effect of clindamycin
timeFrame: 1 month
measure: the number of patients who had severe drug interactions with clindamycin
timeFrame: 1 month
measure: Total clindamycin DDD defined daily doses and clindamycin defined daily doses per 1000 patients days.
timeFrame: 1 month
measure: to calculate the total cost of clindamycin.
timeFrame: 1 month
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Mdicine
Study officials:
References:
Clinical trial NCT03114800: Monitoring Movement for Pressure Ulcer Prevention
Official title: Monitoring Movement for Pressure Ulcer Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pressure Ulcer
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-04-14
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this work is to develop and test an automated movement detection monitoring tool that could lead to reduced burden on clinicians and in-turn reduce pressure ulcer incidence rates. Ten healthy participants will perform video-recorded bed movements while weight distribution and interface pressures at bony prominences on the pelvis are recorded.

Detailed description: The incidence rate and subsequent costs of preventable pressure ulcers is astounding. Although pressure ulcer risk assessment tools and prevention approaches have been a topic of research and for many years, the incidence rate has remained relatively consistent. One reason that progress has not been made to lower the incidence rate is that there is no objective monitoring tool to determine how much a person is moving or is being moved in their bed. Current practices are time-intensive and have not yet leveraged intelligent monitoring technology that could reduce clinical burden and increase accuracy of the risk assessment and efficacy of prevention protocols. The goal of this work is to develop and test an automated movement detection monitoring tool that could lead to reduced burden on clinicians and in-turn reduce pressure ulcer incidence rates. This monitoring tool will be an extension of our intelligent bed sensor we developed named the Embedded Scale, or E-Scale. The E-Scale currently has software modules that detect bed exit, individual weight, and multi-person weight. The project described here would develop a movement module for the E- Scale to monitor people's movements in bed in an attempt to eventually reduce incidence of pressure ulcers in clinical care.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older

Exclusion Criteria:

* Not able to independently get onto a bed and reposition themselves
* Skin lesions in the area where sensors will be placed

Primary outcomes:
measure: Weight change
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Bakery Square
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Jonathan Pearlman, PhD
role: PRINCIPAL_INVESTIGATOR
References: