louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03698656: Effect on Patient Quality of Life of Taking Into Account the Spiritual Dimension in Nurse's Care for Haematologic Cancers.
Official title: Effect on Patient Quality of Life of Taking Into Account the Spiritual Dimension in Nurse's Care for Haematologic Cancers : a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Leukemia
Lymphoma
Keywords: Spiritual dimension
Hematologic cancer
Acute leukemia
Lymphoma
Nurse interview
Quality of life
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute leukaemia or lymphoma during the first month after diagnosis or after first relapse hospitalised in Toulouse Cancer University Hospital

Brief summary: Pilot study on feasibility of taking into account spiritual dimension in nurse's care of patients with haematologic cancer

Detailed description: Patients with acute leukaemia or lymphoma will be invited to have three interviews centered on spiritual issues on a six-eight months period.

The intervention consist on 3 intervention interviews conducted at the beginning of the study and approximatively 2 and 4 months later (according to the program of medical care). Quality of life (FACT-G) and spiritual well-being (FACIT-SP12) scales will be completed at the beginning (before the first intervention interview) and at the end of the study (approximately 2 month after the third intervention interview, i.e. 6 to 8 month after the first interview).

This pilot study will assess the proportion of patients who will accept to enter in the study and to complete it.

Eligibility criteria: Inclusion Criteria:

* Patients with acute leukaemia or lymphoma, in the first month of hospitalisation after primary diagnosis or firs relapse
* More than 17 years old
* French language
* Having signed informed consent

Exclusion Criteria:

* Patients requiring palliative care
* Important psychic vulnerability or severe psychiatric disorders

Primary outcomes:
measure: Rate of patients accepting to enter the study and to complete it on the 6 - 8 month period
timeFrame: 6-8 months
Secondary outcomes:
measure: Rate of entire completion of quality of life scales
timeFrame: 6-8 months
measure: Number of contacted patients with regards to the number of eligible hospitalized patients
timeFrame: 6-8 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Valérie FLOUCAUD, IDE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02869256: Regional Central Database Recording of Chronic Myeloid Leukemia
Official title: Regional Central Database Recording of Chronic Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Myeloid Leukemia
Keywords: chronic myeloid leukemia
practices evaluation
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2016-08-16
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with chronic myeloid leukemia diagnosis in chronic phase

Brief summary: It will be a centralized database , multicentre (6 centers) , regional, chronic myelogenous leukemia cases of registration (CML) prospectively and retrospectively.

Detailed description: Given the complexity and evolution of recommendations and to harmonize these, it appears necessary to establish a central database for recording , monitoring patients with CML supported by the participating centers the region and evaluation of care practices in use .

Indeed , the main purpose of this database is to provide diagnostic and therapeutic management of reported cases of chronic myeloid leukemia and to study the prognostic factors . The main objective is to improve significantly the percentage of patients treated adequately load in the region, in the initial stages of the disease and during its evolution.

Eligibility criteria: Inclusion Criteria:

* chronic myeloid leukemia Diagnosis (CML) in chronic phase , accelerated or blast
* male or female patient aged 18 years or more
* Cases transmitted by referring hematologist , one of the 6 participating centers after patient's oral information
* Clinical record presented Concertation Meeting LMC Multidisciplinary coordinated by the Institute Bergonié

Exclusion Criteria:

* none

Primary outcomes:
measure: compliance of the management of patients with chronic myeloid leukemia compared to the guidelines
timeFrame: 10 years
Secondary outcomes:
measure: overall survival
timeFrame: 10 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
city: Bordeaux
country: France
facility: Institut Bergonié
city: Dax
country: France
facility: Centre Hospitalier Universitaire de Dax
city: Libourne
country: France
facility: Centre hospitalier Libourne
city: Pau
country: France
facility: Centre Hospitalier Universitaire de Pau
Study officials:
References:
Clinical trial NCT00295256: Randomized Trial to Evaluate the Effectiveness of Nurse Case Management
Official title: Randomized Trial to Evaluate the Effectiveness of Nurse Case Management on High-Risk Pregnancy Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Gestational Diabetes
Hypertension
Preterm Delivery
Keywords: randomized trial
diabetes
pregnancy
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2006-02-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The management of high-risk pregnancies require substantial use of medical resources. Our goal is to determine the effectiveness of a nurse case management program in which case managers are assigned to patients with high-risk conditions.

Our hypothesis is that women with diabetes in pregnancy or hypertension who are assigned a nurse case manager will have lower glucose levels and lower blood pressure levels

Detailed description: We will recruit 50 women for each arm of the study. We we conduct a stratified randomization (by disease) in which women are randomized to a nurse case manager who provides on-going face-to-face contact compared to women who are assigned to a case manager with telephone contact only.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes, gestational diabetes, preterm labor, hypertensive disease

Exclusion Criteria:

* No telephone; ability to provide consent; english-speaking

Primary outcomes:
measure: Outcomes measures are mean fasting glucose levels, mean systolic pressure and mean diastolic pressure
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Medical Institutions
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Wanda Nicholson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00534456: An Exploratory Sub-study for the RED-HF™ (Reduction of Events With Darbepoetin Alfa in Heart Failure) Trial
Official title: Double-Blind, Placebo Controlled, Multicenter Study to Assess the Effect of Darbepoetin Alfa Treatment on Cardiac Function and Disease Specific Biomarkers in Subjects With Symptomatic Left Ventricular Systolic Dysfunction and Anemia: An Exploratory Sub-study for the RED-HF™ Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Anemia
Cardiovascular Disease
Congestive Heart Failure
Heart Failure
Ventricular Dysfunction
Keywords: exploratory study
anemia
pharmacogenetics testing
biomarkers
echocardiography
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-09-24
Enrollment: 12
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: The purpose of Study 20060172 was to measure echocardiographic parameters and biomarkers in a subgroup of study subjects enrolled in Study 20050222 (the RED-HF Trial). This substudy 20060172 was terminated early due to feasibility constraints. All subjects enrolled in 20060172 were also enrolled in Study 20050222, which is ongoing. Study data will be analyzed when Study 20050222 ends, since unblinding before then would adversely affect Study 20050222.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent for Study 20060172
* Randomized into Study 20050222

Exclusion Criteria:

* Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, render the subject unsuitable for accurate echocardiography, may confound the study results, or may interfere significantly with the subject's participation in Study 20060172 or in Study 20050222.

Primary outcomes:
measure: To determine whether treatment of anemia with darbepoetin alfa, in patients with heart failure and anemia, results in changes in cardiac structure and function.
timeFrame: 12 months
Secondary outcomes:
measure: Explore correlations among measures of cardiac systolic and diastolic function, surrogate markers of cardiac injury and function, and clinical outcomes in heart failure subjects treated with darbepoetin alfa or placebo.
timeFrame: 12 months
measure: Investigate the effect of treatment of anemia with darbepoetin alfa on novel biomarkers relevant to the pathophysiology and progression of heart failure
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00872456: Associations Between Diabetes Care and Haptoglobin Genotype On outComes
Official title: The ADHOC Project: Associations Between Diabetes Care and Haptoglobin Genotype On outComes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Cardiovascular Disease
Myocardial Infarction
Stroke
Keywords: Diabetes Mellitus
Cardiovascular Disease
Haptoglobin
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2009-03-31
Enrollment: 3054
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients recruited from primary care clinics. All are diabetic patients 55 years old or older at the time of ICARE initiation (2005).

Brief summary: The ADHOC Cohort comprised 3044 DM individuals, treated in 47 CHS primary care clinics, that underwent haptoglobin genotyping between 2 march, 2005 and 26 September 2006. Individuals were eligible for inclusion if they had DM and were 55 years of age or older. All treatment decisions, regarding all aspects of care and follow-up of the study participants, remained at the discretion of the individual's primary care physician, who was blinded to the individual's Hp type. Hp distribution was: Hp 1-1 285 (9.4%); Hp 2-1 1248 (41.0%); Hp 2-2 1511 (49.6%).

Hypothesis: strict glucose control (HbA1c\<7%) reduces the rate of cardiovascular events only to diabetic patients with the Hp 2-2 phenotype. We also postulated that, since Hp 2-2 DM individuals are at an increased genetic susceptibility for cardiovascular disease (CVD), this unique cohort merits an investigation on the associations between various CVD risk variables and CVD events and establish whether any evident association was dependent of the individual's Hp type.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients
* 55 years old or older at the time of ICARE initiation.
* Known haptoglobin genotype
* Signed informed consent for ICARE study and registry

Primary outcomes:
measure: Composite of major CVD events (non fatal MI, Stroke and CVD death)
timeFrame: Data retrived continuously till end of 2015
Secondary outcomes:
measure: Non cardiovascular death
timeFrame: Data retrived continuously till end of 2015
measure: Revascularization procedures
timeFrame: Data retrived continuously till end of 2015
Other outcomes:
Locations:
Study officials:
affiliation: Clalit Health Services, Haifa and Western Galilee District, Haifa, Israel.
name: Uzi Milman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carmel Medical Center, Clalit Health Services
name: Chen Shapira, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02346656: a BavaRiAn eValuatiOn of Dorsal Root Ganglion (DRG) Stimulation for the Treatment for Chronic Post Surgical Pain of the Groin
Official title: BRAVO: a BavaRiAn eValuatiOn of DRG Stimulation for the Treatment for Chronic Post Surgical Pain of the Groin
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Post Surgical Groin Pain
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2015-01-27
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post Surgical Groin Pain Patients

Brief summary: 15-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic post surgical groin pain


Eligibility criteria: Inclusion Criteria:

1. The patient is at least 18 years old
2. The patient is willing and able to comply with the examination schedule and the trial schedule.
3. The patient has suffered from chronic post-surgical neuropathic groin pain for at least 6 months
4. Conservative treatments of the chronic pain including medication, physiotherapy and interventions have been exhausted
5. The pain level at the time of the baseline examination is at least 60mm on the visual analogue scale (VAS) in the primary pain area (groin pain)
6. The patient is able to give consent in writing

Exclusion Criteria:

1. Pregnant or breastfeeding patients or those who plan to become pregnant during the study
2. It has been established in an examination by the tester that the pain has significantly worsened or changed its characteristics in the course of the previous month.
3. In the last 30 days, the patient has been treated with corticosteroids on an area scheduled for the stimulation.
4. In the last 3 months, the patient has been treated with radio frequency therapy on an area scheduled for the stimulation.
5. The patient has already been treated with an active implantable device, including an implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or an intrathecal medication pump.
6. The patient is not able to operate the stimulation device
7. The patient is currently suffering from an infection
8. The patient has participated in another clinical study in the last 30 days
9. The patient has a coagulation disorder or is taking anti-coagulants, which would make participation impossible, as per the study doctor
10. The patient has been diagnosed with a malignancy in the past 2 years

Primary outcomes:
measure: Pain Relief - Assessed by Change in Pain Intensity Assessed using a Visual Analogue Scale (VAS) from Pre-Treatment Baseline
timeFrame: Post treatment at; 1 week and 1, 3, 6 and12 months
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Algesiologikum Zentrum für Schmerzmedizin
Study officials:
References:
Clinical trial NCT00537056: Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI
Official title: Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Neoplasms
Carcinoma, Renal Cell
Kidney (Renal Cell) Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
First posted: 2007-09-28
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To learn whether Flourine-18 Fluoro-deoxi-glucose positron emission tomography / computed tomography (F-18 FDG PET/CT) and dynamic contrast enhanced magnetic resonance imaging (DCE MRI) are better predictors of response to therapy than the current standard of care (CT or MRI).

Detailed description: This is a single arm prospective trial in patients with newly-diagnosed advanced renal cell cancer (RCC) who were scheduled for sunitinib therapy and utilized an extensive panel of quantitative metrics on baseline and interim FDG PET/CT to evaluate the predictive utility of each of these measurements.

The objectives were to evaluate the FDG PET/CT measurement parameters for prediction of prognosis after sunitinib therapy in patients with RCC using histopathologic (post-therapy nephrectomy) or clinical follow-up for validation.

Eligibility criteria: Inclusion Criteria:- Measurable disease by RECIST criteria

* Pathologic diagnosis of renal cell cancer
* Advanced (stage IV) renal cell cancer
* Karnofsky performance status of (KPS\>70)
* Consent to participate in the clinical trial Exclusion Criteria:- Patients who cannot complete a PET/CT scan.
* Pregnant women.
* Healthy volunteers.
* Patients participating in other research protocols will be excluded from this study.
* Metallic implants (prosthesis, ICD, pacemakers), since these are contraindications for MRI.

Primary outcomes:
measure: F-18 FDG Tumor Uptake (SUV Max)
timeFrame: 12 weeks minus baseline
Secondary outcomes:
measure: Histopathology
timeFrame: 1 day
measure: Initial Comprehensive Metabolic Panel
timeFrame: Prior to baseline DCE MRI
measure: Adverse Events
timeFrame: up to 12 months
measure: Tumor Necrosis
timeFrame: 12 weeks
measure: Tumor Size by Computed Tomography (CT) Scan
timeFrame: 12 weeks
measure: Tumor Size by DCE Magnetic Resonance Imaging (MRI) Scan
timeFrame: 12 weeks
measure: DCE MRI AUC Peak Flow
timeFrame: 12 weeks
measure: Initial Tumor Size
timeFrame: pre-sunitinib therapy
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr Andrew Quon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04322656: Stability of Biometry in Meibomian Gland Dysfunction
Official title: Stability of Biometry in Patients With Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meibomian Gland Dysfunction
Keywords: Lipiflow
Meibomian gland dysfunction
Biometry
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 31
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Accurate biometry is an essential and indispensable tool in preoperative cataract surgery setting to yield optimal postoperative refractive outcome. However, some recent studies indicate that preoperative biometry is influenced by dry eye disease (DED). Hence, the investigator's study aims to investigate the effect of the therapy of MGD using the Lipiflow® device on the stability of biometry and selection of IOL.

Detailed description: Accurate biometry is an essential and indispensable tool in preoperative cataract surgery setting to yield optimal postoperative refractive outcome. 31 Patients suffering from DED caused by MGD will be selected and allocated randomly to therapy. Patients with pre-existing DED therapy other than lubricants will be excluded. After completing prestudy-screening and baseline visit, Lipiflow® therapy is applied to the study eye. Follow-up visits will be scheduled two weeks and three months after baseline visit. Each visit includes dry eye investigations and IOL calculation by IOLmaster 700 and CSO MS-39. After each study visit an IOL will be theoretically selected.

Eligibility criteria: Inclusion Criteria:

* Age older than 18 years
* Evidence of meibomian gland dysfunction
* Meibomian gland secretion score equal or less than 15 (for 15 glands of the lower eye lid) using the meibomian gland evaluator (see below)

Exclusion Criteria:

* Usage of eye drops other than lubricants (e.g. antibiotics, steroids, cyclosporin-A)
* Usage of systemic antibiotic therapy
* Any pathology of the ocular surface except dry eye disease (e.g. corneal scarring, cornea ectasia)
* Ocular surgery within prior 3 months
* Ocular injury within prior 3 months
* Ocular herpes of eye or eyelid within prior 3 months
* Active ocular infection
* Active ocular inflammation or history of chronic, recurrent ocular inflammation within prior 3 months
* Eyelid abnormalities that affect lid function
* Ocular surface abnormality that may compromise corneal integrity
* Pregnancy

Primary outcomes:
measure: Spherical and toric IOL power selected at baseline and at 3 months visit
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery
Study officials:
References: