louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00193505: Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in Relapsed/Refractory Intermediate Grade B-Cell Lymphoma
Official title: Phase II Trial of Ifosfamide/Carboplatin/Etoposide/Rituxan Followed by Zevalin in the Treatment of Patients With Relapsed/Refractory Intermediate Grade B-Cell Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Hodgkins Lymphoma
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Biogen
First posted: 2005-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this Multicenter trial, we will evaluate the feasibility, toxicity, and efficacy of treatment with 90Y Zevalin following a short course of salvage chemotherapy in patients with relapsed/refractory intermediate grade B-cell non-Hodgkin's lymphoma.

Detailed description: Upon determination of eligibility, patients will receive:

* Ifosfamide + Carboplatin + Etoposide + Rituximab

Patients showing no response to this combination regimen will receive 90Y Zevalin after two cycles or when progression is clearly documented. In responding patients, four cycles will be administered, followed by 90Y Zevalin.

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Intermediate grade CD20-positive B-cell non-Hodgkin's lymphoma
* Persistent lymphoma after one or two previous chemotherapy regimens
* Patients should not be considered candidates for high-dose chemotherapy
* Ability to perform activities of daily living with assistance
* Measurable or evaluable disease
* Age \> 18 years
* Adequate bone marrow, liver and kidney function

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Patients with impaired bone marrow reserve
* Female patients who are pregnant or lactating
* Serious active infection at the time of treatment
* Any other serious underlying condition
* Brain or meningeal) with lymphoma
* HIV or AIDS-related lymphoma
* Received external beam radiation therapy to \> 25% of active bone marrow.
* History of other cancers, either active or treated

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: complete response rate
Secondary outcomes:
measure: progression-free survival
measure: overall survival
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01620905: Development of a Clinical Prediction Rulefor Neck Manipulation
Official title: Development of a Clinical Prediction Rule to Identify Patients With Neck Pain Likely to Benefit From Cervical Spine Manipulation and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Neck Pain
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
Collaborators: name: Franklin Pierce University
name: University of Colorado, Denver
name: International Spine Pain Institute
name: Universidad Rey Juan Carlos
First posted: 2012-06-15
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Cervical spine manipulation has been shown to be helpful for some patients with neck pain. This study sought to determine factors which were predictive of which patients with neck pain would benefit from manipulation.


Eligibility criteria: Inclusion Criteria:

* age 18 to 60 years
* primary report of neck pain with or without unilateral upper extremity symptoms
* baseline neck disability index score of 10 points (out of 50) or greater

Exclusion Criteria:

* any medical red flags suggesting that the etiology of symptoms might be nonmusculoskeletal
* diagnosis of cervical spinal stenosis (as identified in the patients' medical intake form)
* bilateral upper extremity symptoms
* evidence of central nervous system involvement
* history of whiplash injury within 6 weeks of the examination
* pending legal action regarding their neck pain
* 2 or more positive neurologic signs consistent with nerve root compression (changes in sensation, myotomal weakness, or decreased deep tendon reflexes)
* any history of cervical spine surgery, rheumatoid arthritis, osteoporosis, osteopenia, or ankylosing spondylitis.

Primary outcomes:
measure: Global Rating of Change Scale
timeFrame: 48 hours post intervention
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 48 hours and 96 hours post intervention
measure: Neck Disability Index
timeFrame: 48 hours and 96 hours post intervention
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: UNLV PT Department
state: Nevada
Study officials:
References:
Clinical trial NCT03690505: Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place
Official title: Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Age-related Macular Degeneration (AMD)
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2018-10-01
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Age-related macular degeneration (AMD) is a disease that blurs the sharp, central vision you need for "straight-ahead" activities such as reading, sewing, and driving. AMD affects the macula, the part of the eye that allows you to see fine detail

The purpose of the study is to describe in patients with AMD and depending on the nature of their pathology (neovascular or atrophic):

(i) knowledge about their pathology (risk factors, symptoms, treatments, self-monitoring tool), (ii) their needs and (iii) impact on their daily lives

This study is to make an inventory of the knowledge of patients with AMD about their disease and risk factors using a questionnaire (Appendix 1) and to identify their needs, the impact of the disease on their daily lives during individual interviews by raising the recurrent data and confronting them during the focus group. The information gathered will enable the construction of a therapeutic education program for better patient care and to strengthen the patient's capacities so that he becomes an actor in his change throughout his care project.

This a 3 steps study:

1. 200 patients will be enrolled and answer a questionnaire on knowledge of the disease
2. Two groups of 20 patients will be selected to participate to a semi-structured individual interviews
3. Two focus groups of 10 patients will be organized to assess needs, expectations, satisfactions or to better understand opinions, motivations or behaviors.


Eligibility criteria: Inclusion Criteria:

* Patient with AMD (neovascular and atrophic) whatever the stage of the disease
* Patient over 50
* Patient affiliated to a social security scheme
* Written informed consent of the patient

Exclusion Criteria:

* Patient unable to understand the information, fill out the questionnaires
* Patient with diabetic retinopathy

Primary outcomes:
measure: Knowledge of AMD
timeFrame: throughout the study, 2 years at maximum
measure: Social vulnerability
timeFrame: throughout the study, 2 years at maximum
Secondary outcomes:
measure: Health literacy.
timeFrame: throughout the study, 2 years at maximum
Other outcomes:
Locations:
city: Limoges
country: France
facility: Service d'Ophtalmologie
Study officials:
References:
Clinical trial NCT03248505: Cryotherapy and TENS on Low Back Pain
Official title: Immediate Effects of Conventional TENS and Burst TENS Combined With Cryotherapy in the Non-specific Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Back Pain, Mechanical
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3x6
Primary purpose: TREATMENT

Brief summary: This study aim analyze the immediate effects of conventional transcutaneous electrical nerve stimulation (TENS) and Burst TENS combined or not with cryotherapy in patients with non-specific low back pain.

All subjects will be submitted to an evaluation of the painful sensation, through the numerical rating scale, and pain threshold, through algometry, before, immediately after the intervention and 25 minutes after.


Eligibility criteria: Inclusion Criteria:

* Aged between 18 and 50 years;
* Have chronic non-specific low back pain.

Exclusion Criteria:

* Serious spinal pathologies (fractures, tumors, and inflammatory pathologies such as ankylosing spondylitis);
* Nerve root compromise (disc herniation and spondylolisthesis with neurological compromise, spinal stenosis, and others);
* Fibromyalgia
* Corticosteroid treatment in the previous two weeks;
* Antiinflammatory treatment in the previous 24 hours;
* Contraindications to the use of Kinesio Taping (allergy or intolerance);
* Score of three or less on Visual Analogue Scale of the first day;
* Pregnancy;
* Ice allergy.

Primary outcomes:
measure: Painful sensation
timeFrame: Evaluation of pain sensation 25 minutes after the application of the intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Natal
country: Brazil
facility: Federal University of Rio Grande do Norte
state: RN
Study officials:
References:
Clinical trial NCT00460005: Clinical Study Of Migraine Evolution
Official title: A Multicenter Study to Determine the Clinical Characteristics of the Temporal Aspects of Migraine in a Canadian Population: Clinical Study Of Migraine Evolution (C-SOME)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Headache
Keywords: Migraine
headache
observational
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-04-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Understanding the speed at which migraine headaches develop is of importance to patients. Determining the proportions in which different headache pain build-up occurs, may provide health care practitioners with valuable information with which to prescribe the most appropriate treatment. Patients who experience a slow pain build-up may gain more benefit from medications which have a slow onset of effect, high tolerability and long action. Conversely, medications with a rapid onset of effect may be of greater benefit to patients who experience rapid onset of migraine pain.


Eligibility criteria: Inclusion Criteria:

* Subject is outpatient.
* Subject has a diagnosis of migraine with/without aura according to IHS criteria, of at least 1 years duration.
* Subject is able to comprehend the study procedures and to comply with study requirements.

Exclusion Criteria:

* Subject has other chronic pain condition(s) not associated with migraine
* Subject is unable to understand the schedule/questionnaire.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: GSK Clinical Trials Call Centre
state: Alberta
city: Richmond
country: Canada
facility: GSK Clinical Trials Call Centre
state: British Columbia
city: Vancouver
country: Canada
facility: GSK Clinical Trials Call Centre
state: British Columbia
city: Saint John
country: Canada
facility: GSK Clinical Trials Call Centre
state: New Brunswick
city: Halifax
country: Canada
facility: GSK Clinical Trials Call Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: GSK Clinical Trials Call Centre
state: Ontario
city: Toronto
country: Canada
facility: GSK Clinical Trials Call Centre
state: Ontario
city: Unionville
country: Canada
facility: GSK Clinical Trials Call Centre
state: Ontario
city: Longueuil
country: Canada
facility: GSK Clinical Trials Call Centre
state: Quebec
city: Montreal
country: Canada
facility: GSK Clinical Trials Call Centre
state: Quebec
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02922205: Stapler Post-market Observational Study
Official title: Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler in Laparoscopic Gastric Bypass Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Observational
Lead sponsor: Duomed
Sponsor class: INDUSTRY
First posted: 2016-10-04
Enrollment: 100
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: Obese patients eligible for laparoscopic Roux-en-Y gastric bypass surgery.

Brief summary: The purpose of this observational study is to evaluate the safety and performance of the Endoscopic Linear Cutter Stapler and reloads from Fengh Medical used in laparoscopic Roux-en-Y gastric bypass surgery to create anastomoses. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.


Eligibility criteria: Inclusion Criteria:

* Age at study entry is at least 18 years.
* Patient must sign and date the informed consent form prior to the index-procedure.
* Patient has a BMI ≥ 35 kg/m with one or more related co-morbidity.
* Patient has a BMI ≥ 40 kg/m.

Exclusion Criteria:

* Patient is pregnant.
* History of bariatric surgery.
* Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits.

Primary outcomes:
measure: Number of patients with adverse events related to the index-procedure.
timeFrame: 1 month follow-up
measure: Number of patients with adverse events related to the index-procedure.
timeFrame: 6 months follow-up
Secondary outcomes:
measure: Number of adverse device effects.
timeFrame: 1, 6, 12 and 24 month follow-up
measure: Number of patients with bariatric surgery related re-interventions.
timeFrame: 1, 6, 12 and 24 month follow-up
measure: Percentage of excess weight loss.
timeFrame: 1, 6, 12 and month follow-up
measure: Questionnaire on food tolerance.
timeFrame: 1, 6, 12 and 24 month follow-up
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: ZOL, Genk
name: Hans Verhelst, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02759705: Bladder Exstrophy (FIVES FertIlity Vesical Exstrophy Sexuality)
Official title: Male Bladder Exstrophy in Adulthood : What Sexuality and Fertility Prospects ?
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Fertility
Keywords: fertility
sexuality
male
exstrophy-epispadias complex
bladder exstrophy
epispadias
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 0
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: Adult male patients born with classic bladder exstrophy or epipadias

Brief summary: This analytical descriptive study aims to describe the fertility and sexuality male adult subjects carrying classic bladder exstrophy or epispadias and to highlight infertility risk factors. A questionnaire on paternity, urinary status, erections, ejaculations and sexual self-esteem and a semen analysis will be realized at first consultation, semen analysis results wil be explained at second consultation. It is assumed that fertility and sexuality exstrophic men are impaired.


Eligibility criteria: Inclusion Criteria:

* Patients followed the Hospices Civils de Lyon
* Consultant spontaneously in adult or pediatric Urology, or neuroperineal rehabilitation and sexology
* Aged over 18 years
* Born with classic bladder exstrophy or epispadias.

Exclusion Criteria:

* Refusal of participation
* Refusal to sign consent
* minor Patients or protected major, under guardianship
* Patients unable to understand the course of the study
* cloacal exstrophy

Primary outcomes:
measure: paternity rate
timeFrame: Baseline (at first consultation)
measure: Sperm quality
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Urology Department, Centre Hospitalier Lyon Sud, Hospices Civils de Lyon, France
name: Jean-Etienne TERRIER, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06369805: EVALUATION OF BLOOD BIOMARKER-BASED DIAGNOSTIC AID IN OUTPATIENTS SUFFERING FROM DEPRESSION
Official title: EVALUATION DE L'AIDE AU DIAGNOSTIC PAR BIOMARQUEURS SANGINS CHEZ DES PATIENTS SOUFFRANT DE DEPRESSION SUIVIS EN AMBULATOIRE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder
Bipolar Disorder
Bipolar Depression
Lead sponsor: Les Toises - Psychiatry and Psychotherapy Center
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult outpatients suffering from depression and/or bipolar disorders

Brief summary: This is an observational (non-interventional) study, carried out in an outpatient setting, which involves a blood sampling. The primary objective of this study is to confirm the association between the EDIT-B® editing signature and early unipolar or bipolar differentiation. Results of this research may provide an aid to early diagnosis and guide clinical practice towards individualized treatment.


Eligibility criteria: Inclusion Criteria:

Adult outpatients suffering from depression and/or bipolar disorders who gave their written informed consent to participate in the present study

Exclusion Criteria:

Any patient without capacity of discernment or with harmful use of psychoactive substances

Primary outcomes:
measure: Psychiatric symptomatology
timeFrame: Once
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Les Toises - Psychiatry and Psychotherapy Center
Study officials:
References:
Clinical trial NCT01636505: The Results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of Embryos Obtained From GnRH-agonist Long and GnRH-antagonist Ovarian Stimulation Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Embryo's Genetic and Chromosomal Quality
Lead sponsor: European Hospital
Sponsor class: OTHER
First posted: 2012-07-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The aim of this study is to performed a randomized controlled trial to evaluate the rate of genetic and chromosomal abnormalities in embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocols.

Patients will be prospectively randomized in two groups: the first undergoing controlled ovarian stimulation in GnRH-agonist long protocol and the second following GnRH-antagonist ovarian stimulation regimen.

The end-points of the study include the number of genetically and chromosomally abnormal embryos, the pregnancy, the implantation and the healthy baby birth rate.

The patients included in PGS program were selected on the base of advanced maternal age, repeated pregnancy lost and implantation failure whereas the patients who were know to carry sex-linked or monogenic disorders were considered for PGD strategy.

The uterine abnormalities, endometriosis and endocrinal diseases were considered to be the exclusion factors.


Eligibility criteria: Inclusion Criteria:

* patients carrier genetic disease
* advanced maternal Age
* repeated IVF failure
* recurrent pregnancy loss

Exclusion Criteria:

* uterine abnormalities
* endometriosis
* endocrinal diseases

Primary outcomes:
measure: The results of Preimplantation Genetic Diagnosis and Preimplantation Genetic Screening of embryos obtained from GnRH-agonist long and GnRH-antagonist ovarian stimulation protocol
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: European Hospital
Study officials:
References:
Clinical trial NCT04219605: Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions
Official title: Evaluation of a Rapid Microscopic Diagnostic System for Different Vaginitis Conditions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Vaginosis
Candida Albicans Vulvovaginitis
Candida Vulvovaginitis
Trichomonas Vaginitis
Atrophic Vaginitis
Desquamative Inflammatory Vaginitis
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 226
Sex: FEMALE
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: Patients with vulvovaginal symptoms

Brief summary: Evaluate the diagnostic performance of the Gyni™ device to detect different vaginitis conditions by comparison to microscopic diagnosis and related lab tests.

Detailed description: During gynecological exams, vaginal discharge samples will be are taken for testing the pH level, microscopic examination and laboratory examinations (vaginal cultures and sexually transmitted infections).

One additional sample will be taken intended for the Gyni™ system diagnosis. This additional examination will be performed in the clinic by pulling the cytobrush through a dedicated cartridge and scanning it in the Gyni table-top scanner. The result diagnosis will be anonymously kept in the cloud.

The diagnosis suggested by the Gyni system will not be visible to the physician in order to prevent any bias. Results from the physician, from the device and from the lab will be summarized and compared by the chief investigator

Eligibility criteria: Inclusion Criteria:

* Women with vaginal complaints: Discharge, Malodor, Itching, Irritation, Dyspareunia, Pain
* Age \>= 18y

Exclusion Criteria:

* Age \< 18y
* Not eligible to sign an informed consent
* Vaginal discharge samples found microscopically not interpret-able by the investigator due to patient using vaginal creams, ointments, lubricants or sperm presence.
* During menstruation

Primary outcomes:
measure: Diagnostic performance
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Clalit HMO
Study officials:
affiliation: Clalit HMO
name: Avraham Ben Chetrit, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lev-Sagie A, Strauss D, Ben Chetrit A. Diagnostic performance of an automated microscopy and pH test for diagnosis of vaginitis. NPJ Digit Med. 2023 Apr 13;6(1):66. doi: 10.1038/s41746-023-00815-w.