louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06269575: Evaluation Of The Effectiveness Of Safe Nutrition Program Applied To Acute Stroke Patients With Dysphagia
Official title: Evaluation Of The Effectiveness Of Safe Nutrition Program Applied To Acute Stroke Patients With Dysphagia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: DYSPHAGIA
Keywords: DYSPHAGIA
STROKE
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: non-randomized controlled
Primary purpose: SUPPORTIVE_CARE

Brief summary: It was planned in a quasi-experimental design with a non-randomized control group. The study was planned to be completed in three stages: control, preparation and intervention periods.

Question 1: Does a safe nutrition program prevent aspiration pneumonia, dehydration and malnutrition in acute stroke patients with dysphagia? Question 2: Is the safe nutrition program effective on addiction level, quality of life and depression in acute stroke patients with dysphagia? Question 3: Does a safe nutrition program shorten the hospital stay and NG tube duration in acute stroke patients with dysphagia?

Detailed description: Introduction: Dysphagia is a common complication in acute stroke patients. Although there are treatment options, healing takes time. Managing this process in the safest way is important for the physical and mental health of the patient.

Purpose: This study aimed to evaluate the effectiveness of a safe nutrition program applied to acute stroke patients with dysphagia.

Eligibility criteria: Inclusion Criteria:

* acute stroke patients
* 18 years and over

Exclusion Criteria:

* those who do not want to be involved in the study

Primary outcomes:
measure: Complications of dysphagia
timeFrame: 3 months
measure: Complications of dysphagia
timeFrame: 3 months
measure: Complications of dysphagia
timeFrame: 3 months
Secondary outcomes:
measure: Stroke-Specific Quality of Life Scale (SS-QOL)
timeFrame: 3 months
measure: Swallowing Anxiety Scale (YKÖ)
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Universitesi-Cerrahpasa
Study officials:
affiliation: Istanbul Universitesi-Cerrahpasa
name: Aysel Cavusoglu
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Universitesi-Cerrahpasa
name: Zeliha Tulek
role: STUDY_DIRECTOR
References:
Clinical trial NCT00114075: Effects of Walking Analysis on Surgical Outcomes
Official title: Impact of Gait Analysis on Surgical Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cerebral Palsy
Keywords: gait
walking
orthopedic surgery
orthopaedic surgery
Lead sponsor: Agency for Healthcare Research and Quality (AHRQ)
Sponsor class: FED
First posted: 2005-06-14
Enrollment: 186
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of pre-operative gait analysis testing on surgical outcomes in children with cerebral palsy who have problems walking.

Detailed description: Gait analysis testing has been used to assist orthopaedic surgeons in developing treatment plans for children with gait abnormalities, particularly children with cerebral palsy. Previous studies have shown that gait analysis testing significantly impacts surgical decision-making for these patients. However, no controlled studies have been done to determine whether gait analysis and the subsequent changes in surgical decision-making affect clinical outcomes. Consequently, the use of gait analysis in clinical practice remains controversial. The purpose of this study is to conduct a randomized controlled trial to assess the effects of preoperative gait analysis on surgical outcomes in ambulatory children with cerebral palsy.

Comparison: Surgery with information from gait analysis testing compared with surgery without information from gait analysis testing.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of cerebral palsy
* Able to walk
* Under evaluation for orthopedic surgery to correct walking problem(s)

Exclusion Criteria:

* Orthopaedic surgery in past 1 year
* Injection of botulinum toxin in past 6 months

Primary outcomes:
measure: Change in walking ability at 1 year
timeFrame: 1 year
measure: Change in walking efficiency at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Change in gross motor function at 1 year
timeFrame: 1 year
measure: Change in quality of life at 1 year
timeFrame: 1 year
measure: Additional treatment needed at 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Shriners Hospital for Children, Los Angeles
state: California
city: Los Angeles
country: United States
facility: Childrens Hospital Los Angeles
state: California
Study officials:
affiliation: Children's Hospital Los Angeles
name: Tishya AL Wren, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kay RM, Dennis S, Rethlefsen S, Reynolds RA, Skaggs DL, Tolo VT. The effect of preoperative gait analysis on orthopaedic decision making. Clin Orthop Relat Res. 2000 Mar;(372):217-22. doi: 10.1097/00003086-200003000-00023.
Clinical trial NCT01388075: Genetic Variability in the Response to Warfarin at Baseline and During Induction of CYP2C9
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Subjects
Keywords: induction
CYP2C9
Genetic variability
Expression
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2011-07-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The genetic factors associated with variability in CYP2C9 induction have not been elucidated. The hypothesis underlying this study is that following 7 days treatment with rifampicin, a known CYP450 inducer, the genetic variability in regulatory elements controlling CYP2C9 expression will be associated with the magnitude of change in INR response to warfarin and in CYP2C9-mediated warfarin metabolism.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects

Exclusion Criteria:

* Consumption of any medication during 30 days
* Smoking
* Alcohol consumption

Primary outcomes:
measure: International Normalized Ratio (INR)
timeFrame: 6 weeks
Secondary outcomes:
measure: Warfarin concentration
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Hebrew University Medical Center
Study officials:
References:
Clinical trial NCT01511575: Studying Biomarker Expression in Samples From Patients With Down Syndrome and Acute Myeloid Leukemia or Other Transient Myeloproliferative Disorder
Official title: Analysis of MicroRNA Expression in Down Syndrome Acute Myeloid Leukemia and the Transient Myeloproliferative Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: childhood acute myeloid leukemia in remission
childhood acute myeloid leukemia/other myeloid malignancies
childhood acute megakaryocytic leukemia (M7)
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-01-18
Enrollment: 60
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Down syndrome (DS) diagnosed with acute myeloid leukemia or transient myeloproliferative disorder.

Brief summary: RATIONALE: Studying samples of blood, tissue, and bone marrow from patients with cancer in the laboratory may help doctors learn about changes that occur in RNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies RNA samples from patients with Down syndrome and acute myeloid leukemia or other transient myeloproliferative disorder.

Detailed description: OBJECTIVES:

* To compare miRNA expression in distinctive diagnostic groups: transient myeloproliferative disorder (TMD), Down syndrome (DS) acute megakaryocytic leukemia (AMkL), non-DS AMkL, and in remission DS samples (representing germline, non-malignant samples).

OUTLINE: Archived RNA samples are analyzed for mature micro (mi)RNA expression by real-time RT-PCR. Results are then compared with miRNA expression of non-Down syndrome patients with acute megakaryocytic leukemia.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Patients with Down syndrome (DS) diagnosed with acute myeloid leukemia or transient myeloproliferative disorder
* Clinical samples obtained from patients enrolled on the COG AAML0431 and COG AAML08B1

PATIENT CHARACTERISTICS:

* Previously consented to biologic studies

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Gene expression levels between DS AMKL and non-DS AMKL patients
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's Hospital of Michigan
name: Jeffrey Taub, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000175: The Effects of Sex Hormones on Cognition and Mood in Older Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cognition Disorders
Mood Disorders
Keywords: Emotions
Cognition
Aging
Memory
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
First posted: 1999-11-01
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is investigating the effects of hormone replacement therapy on memory, mental abilities and mood in older adults aged 65-90. During the nine month long study, men will take testosterone for three months and women will take estrogen for three months. At four points during the study (once every three months), participants will complete a test battery and have blood drawn.

Detailed description: Double-blind, placebo-controlled, crossover study investigating the effects of estrogen replacement and testosterone replacement on cognition and mood in older adults. Women who have not had a hysterectomy will be given Prempro (estrogen with progesterone to protect the uterine lining), and hysterectomized women will be given Premarin (estrogen only).

Eligibility criteria: Inclusion Criteria:

* Women and men aged 65-90 who have not received hormone replacement for the last three months.

Exclusion Criteria:

* Previous head injury with loss of consciousness for more than one hour.
* Men with a history of prostate cancer.
* Men on testosterone replacement within the past three months.
* Women with a history of breast or uterine cancer.
* Women on estrogen replacement within the past three months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Gerontology Research Center
state: Maryland
Study officials:
affiliation: National Institute on Aging, Gerontology Research Center
name: Dr. Pauline Maki
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henderson VW. The epidemiology of estrogen replacement therapy and Alzheimer's disease. Neurology. 1997 May;48(5 Suppl 7):S27-35. doi: 10.1212/wnl.48.5_suppl_7.27s.
citation: Janowsky JS, Oviatt SK, Orwoll ES. Testosterone influences spatial cognition in older men. Behav Neurosci. 1994 Apr;108(2):325-32. doi: 10.1037//0735-7044.108.2.325.
citation: Sherwin BB. Estrogen effects on cognition in menopausal women. Neurology. 1997 May;48(5 Suppl 7):S21-6. doi: 10.1212/wnl.48.5_suppl_7.21s.
Clinical trial NCT01269775: Comparison of Face to Face Lecture, Interactive Internet Based and Computer Based Teaching
Official title: Comparison of Face to Face Lecture Based, Interactive Internet Based and Computer Based Teaching Regarding Students' Knowledge Achievement and Satisfaction: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: 3rd Year Medical School's Students
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators carried out a randomized controlled trial comparing three methods of teaching. These three instructional methods consist of face to face lecture, interactive internet based teaching and computer based teaching (lecture synchronized with presentation).

The hypotheses tested were: a) whether there is a difference between these three methods in knowledge achievement and b) whether there is a difference between Students satisfaction in three groups.


Eligibility criteria: Inclusion Criteria:

* 3rd year medical school's students

Exclusion Criteria:

* It must be their first experience of the course and they must have no previous elective or obligatory study about teaching topic (multiple myeloma).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
affiliation: Tehran University of Medical Sciences
name: Aeen Mohammadi, Instructor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05537675: Semi-automated Segmentation Methods of SSTR PET for Dosimetry Prediction
Official title: Semi-automated Segmentation Methods of SSTR PET for Dosimetry Prediction in Refractory Meningiomas Treated by SSTR-targeted Peptide Receptor Radionuclide Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractory Meningioma
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 patients with meningioma will be included in this study, and 10 patients of 20 will have been treated with Lutathera®.

Brief summary: Tumor dosimetry with somatostatin receptor-targeted peptide receptor radionuclide therapy (SSTR-targeted PRRT) by 177Lutetium-DOTATATE might contribute to improve follow-up and treatment response of refractory meningiomas. This study aims to evaluate Standard Uptake Value mean (SUVmean) as a tumoral absorbed dose predictive predictive factor and propose semi-automated segmentation method to determine metabolic tumor volume with pretherapeutic 68-Gallium-DOTATOC PET.


Eligibility criteria: Inclusion Criteria:

* Patients with meningioma

Exclusion Criteria:

- PET scan not available

Primary outcomes:
measure: To evaluate the SUVmean (Standard Uptake Value)as a predictive factor of the tumor absorbed dose compared to the SUVmax
timeFrame: 2 months
measure: To propose a semi-automated segmentation
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Vandoeuvre les Nancy cedex
country: France
facility: Nuclear medicine Department CHRU de NANCY
Study officials:
affiliation: CHRU Nancy
name: Anne-Sophie HUE, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT02113475: Venous Thrombectomy/Thrombolysis Outcome Registry
Official title: A Patient Outcome Study After Pharmacomechanical Catheter-directed Thrombolysis and Standard Treatment for Venous Thrombosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Deep Venous Thrombosis
Post Thrombotic Syndrome
Keywords: CDT
PCDT
DVT
PTS
Quality of Life
Lead sponsor: Heart and Vascular Outcomes Research Institute
Sponsor class: OTHER
First posted: 2014-04-14
Enrollment: 1800
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participating study centers will enroll patients and enter data in the web-based registry that include demographics, clinical features,

Brief summary: Deep Venous Thrombosis affects more than 350,000 individuals each year in the U.S.The Registry will track patient outcome and quality of life over 60 months for treatment with anticoagulation and elastic compression stockings and catheter-directed thrombolysis (CDT) in accordance with current treatment guidelines .


Eligibility criteria: Inclusion Criteria:

•Data obtained in line with good clinical practice, applicable laws and regulation

Exclusion Criteria:

-

Primary outcomes:
measure: Quality of Life,
timeFrame: 60 months
Secondary outcomes:
measure: Rate of Post-Thrombotic Syndrome
timeFrame: 60 Months
Other outcomes:
Locations:
city: Beverly
country: United States
facility: Heart & Vascular Outcomes Research Institute
state: Massachusetts
Study officials:
affiliation: Heart and Vascular Outcomes Research Institute
name: Uchenna N Onyeachom
role: STUDY_DIRECTOR
References:
Clinical trial NCT05975775: Outpatient Laparoscopic Radical Prostatectomy
Official title: Study of Postoperative Complications After Laparoscopic Outpatient Radical Prostatectomy in Patients With Localized Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2023-08-04
Enrollment: 64
Sex: MALE
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: This study is aimed at patients with prostate cancer for whom an ambulatory laparoscopic radical prostatectomy has been validated at a multidisciplinary consultation meeting. Ambulatory management is at the surgeon's discretion, according to well-defined medical procedure criteria.

Brief summary: The purpose of the study is to evaluate the incidence of surgery-related complications between Day 0 and Day 30.

Detailed description: This is an observational, prospective, open, non-comparative (single arm), bicentric study.

This study is aimed at patients with prostate cancer for whom an ambulatory laparoscopic radical prostatectomy has been validated at a multidisciplinary consultation meeting. The possibility of performing this procedure on an outpatient basis is left to the surgeon's discretion, according to well-defined medical procedure criteria.

This cohort is part of the usual care. The study will observe the incidence and describe the type, number, severity, duration and frequency of procedure-related complications that may arise in the first month post-op of ambulatory Laparoscopic Radical Prostatectomy. For this reason, patient follow-up will stop at 1 month after surgery, during a routine follow-up visit.

Eligibility criteria: Inclusion Criteria:

* Male, age ≥ 18 years;
* Localized prostate cancer;
* Validation in a multidisciplinary consultation meeting of curative treatment;
* Scheduled laparoscopic radical prostatectomy;
* Patient able to understand the information related to the study, to read the information leaflet and to signify his/her non-opposition or opposition to participating in the study;
* Membership of a social security scheme;
* Patient having been informed and having given oral non-opposition.

Exclusion Criteria:

* Surgical emergency;
* Patient not eligible for ambulatory care;
* Long-term curative anti-coagulant treatment;
* Resident more than 100km from the clinic;
* Home alone the first night;
* Patient under guardianship, curatorship or deprivation of liberty.

Primary outcomes:
measure: Incidence of complications
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Clinique de la Sauvegarde
Study officials:
References:
Clinical trial NCT00929175: Antihypertensive Effect of Continuous Positive Airway Pressure in Resistant Hypertensive Patients With Sleep Apnea
Official title: Antihypertensive Effect of Continuous Positive Airway Pressure (CPAP) in Resistant Hypertensive Patients With Sleep Apnea: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
Resistant Hypertension
Sleep apnea syndrome
Treatment
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2009-06-26
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obstructive sleep apnea syndrome (OSAS) has been linked to resistant hypertension, but the effect of treatment of OSAS on the resistant hypertension have no been established. In a double-blind randomized clinical trial patients with resistant hypertension with at least moderate sleep apnea will be randomized to receive therapeutic CPAP or Placebo CPAP for eight weeks in an ambulatory set. The investigators want to determine any difference on hypertension control between the 2 management strategies.

Detailed description: This is a double blind, randomized, placebo controlled trial. Participants were consecutive patients with resistant hypertension, defined as uncontrolled BP, despite the concurrent use of 3 or more antihypertensive agents, including a diuretic, with adherence to treatment and without white coat phenomenon. All participants should have a diagnosis of at least moderate OSAS, defined by AHI \> 15 in a portable monitoring sleep exam. Participants were assigned to active CPAP or sham-CPAP. The main outcome was change in 24-hour ambulatory blood pressure (ABP) monitoring values from baseline to two months of active CPAP or sham CPAP

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of resistant hypertension
* Apnea/hypopnea index \> 15

Exclusion Criteria:

* Cardiac surgery on last 3 months
* Serious arrhythmias
* Insulin dependent diabetes
* Debilitating neurological disease
* severe COPD

Primary outcomes:
measure: Blood pressure evaluated with ambulatory 24-hour blood pressure monitoring
timeFrame: 8 weeks after treatment
Secondary outcomes:
measure: aldosterone, renin, activated protein C
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio grande do sul
Study officials:
affiliation: Hospital de Clínicas de Porto Alegre
name: Flavio D Fuchs
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Oliveira AC, Martinez D, Massierer D, Gus M, Goncalves SC, Ghizzoni F, Steinhorst AM, Moreira LB, Fuchs SC, Fuchs FD. The antihypertensive effect of positive airway pressure on resistant hypertension of patients with obstructive sleep apnea: a randomized, double-blind, clinical trial. Am J Respir Crit Care Med. 2014 Aug 1;190(3):345-7. doi: 10.1164/rccm.201403-0479LE. No abstract available.