louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02837796: Effects of Trans-Obturator Tape outside-in Versus Inside-out Procedure for Stres Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Sexual Dysfunction
Lead sponsor: Istanbul Bakirkoy Maternity and Children Diseases Hospital
Sponsor class: OTHER_GOV
First posted: 2016-07-20
Enrollment: 101
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The investigators think that the two techniques of TOT (inside-out and outside-in) procedures both statistically improve the sexual functions, psychosocial state and quality of life after the surgery. Additionally postoperative physical and behavioral-emotional scores in PISQ-12 were statistically more increase in inside-out group than the outside-in group.


Eligibility criteria: Inclusion Criteria:

* pure urodynamic SUI
* sexual active before and 2 months after the surgery
* married or single
* aged over 20
* have cured after TOT operation

Exclusion Criteria:

* preoperative or postoperative detrusor disfunction
* previous history of malignancy
* prior vaginal surgery
* a partner with sexual incapabilities
* a concomitant gynecologic disorder
* patients with pelvic organ prolapse over stage II
* pelvic radiotherapy and a history of psychological diseases
* participants who had no sexual activity with in the past two months

Primary outcomes:
measure: postoperative differences at emotional-behavioral PISQ-12 score
timeFrame: 1 year
measure: postoperative differences at physical PISQ-12 score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Asoglu MR, Selcuk S, Cam C, Cogendez E, Karateke A. Effects of urinary incontinence subtypes on women's quality of life (including sexual life) and psychosocial state. Eur J Obstet Gynecol Reprod Biol. 2014 May;176:187-90. doi: 10.1016/j.ejogrb.2014.02.008. Epub 2014 Feb 15.
Clinical trial NCT03706196: Comparison of Environmental Factors Between the Areas of Over- and Under-incidence of Crohn's Disease in the Haut de France Region, by the Study of Dental Exposomes
Official title: Comparison of Environmental Factors Between the Areas of Over- and Under-incidence of Crohn's Disease in the Haut de France Region, by the Study of Dental Exposomes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Environmental Exposure
Keywords: dental exposome
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 20
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: adults subjects living in high and low incidence of crohn's disease areas and needing a dental extraction for medical indication.

Brief summary: the aim of this preliminary observational study is to compare external exposomes from 10 teeth issued through 10 subjects living in high incidence of crohn's disease area and 10 teeth issued through 10 subjects living in low incidence of crohn's disease area.


Eligibility criteria: Inclusion Criteria:

* adults subjects living in high and low incidence of crohn's disease areas and needing a dental extraction for medical indication

Exclusion Criteria:

* smokers during 10 last years

Primary outcomes:
measure: comparison of aluminum rate using metabolomic method in teeth between subjects living in high and low incidence crohn's disease areas.
timeFrame: Baseline: one session
Secondary outcomes:
measure: comparison of environmental exposomes using metabolomic method in teeth between subjects living in high and low incidence crohn's disease areas.
timeFrame: Baseline: one session
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU lille
Study officials:
affiliation: University Hospital, Lille
name: Corinne GOWER, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00302796: Antibiotic Treatment to Patients With Low Back Pain
Official title: Antibiotic Treatment to Patients With Low Back Pain Associated With Modic Changes Following Disc Herniation. A Randomized Clinical Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Back Pain
Keywords: Low Back Pain,
Lead sponsor: The Back Research Center, Denmark
Sponsor class: OTHER
First posted: 2006-03-15
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A large proportion of patients with Low Back Pain (LBP) (80 %) are classified as "non-specific", due to the lack of a patho-anatomical diagnosis. This term is not satisfactory, since it implies uncertainty for both the patient and the clinician. Modic changes have recently been identified as a pain giving patho-anatomical diagnosis for a considerable percentage (20-30 %) of LBP patients. The causes of these Modic changes have not been determined conclusively but bacterial infection is among the plausible causes for those following a disc herniation.

Purpose The aim of this study is to assess the clinical effect of antibiotic treatment compared to placebo, in patients with LBP and Modic changes following a lumbar herniated disc.

Design A double blind prospective clinically controlled trial. Patients will be randomized by a blinded observer to either Group A: 1 antibiotic tablet 45 patients Group B: 1 placebo tablet 36 patients Group C: 2 antibiotic tablets 45 patients Group D: 2 placebo tablets 36 patients

The patients will take the drug three times a day for 100 days.


Eligibility criteria: Inclusion Criteria:

* Age between 18-65 years
* Previous lumbar herniated disc confirmed by MRI
* Time since lumbar disc herniation more than 6 months less than 2 years
* LBP in the area of L1 to L5, with an added Low Back Pain Rating Scale of 6 or more
* The present MRI shows Modic changes
* Positive Springing test (SPT) at the level of Modic changes

Exclusion Criteria:

* Allergy against antibiotics
* The Beck Depression Inventory \>7,
* Pregnancy
* Breast feeding
* All Kidney diseases
* Pending workers litigation or pension
* Danish as second language
* Fertile women who do not user safe anti conseption
* Reduced liver functions
* Reduced liver function due to previous treatment wiht amoxicillin/clavulanasid.

Primary outcomes:
measure: Low Back Pain Roland Morris Questionaire
timeFrame: One year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ringe
country: Denmark
facility: The Back Research Center
Study officials:
affiliation: The Back Research Center, University of Southern Denmark
name: Hanne B Albert, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02324296: PEI REGIMEN: A Therapeutic Option in Small Cell Lung Cancer? A Monoinstitutional Experience of 46 Consecutive Cases
Official title: PEI REGIMEN: A THERAPEUTIC OPTION IN SMALL CELL LUNG CANCER? A MONOINSTITUTIONAL EXPERIENCE OF 46 CONSECUTIVE CASES
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small Cell Lung Cancer
Keywords: small cell lung cancer
extended disease
limited disease
chemotherapy
cisplatin
etoposide
ifosfamide
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2014-12-24
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All eligible patients had histologically or cytologically proven SCLC, with measurable disease defined by RECIST criteria, and received at least one cycle of chemotherapy. Patients with central nervous system (CNS) metastases were included in the study.

Brief summary: ABSTRACT Objectives Combination chemotherapy is very active in small cell lung cancer (SCLC), although no improvement in overall survival (OS) has been done in the last 25 years , with Cisplatin-Etoposide (PE) still considered the world-wide standard, with an average median survival of about 7-8 months in patients with extended disease (ED).

In 1995, a randomized trial of the Hoosier Group in 171 ED patients showed a significant advantage in overall survival in patients treated with PEI (Cisplatin, Etoposide and Ifosfamide), compared to PE. Despite that, PEI regimen has not become a commonly used regimen in SCLC.

Materials and Methods Here we present a series of 46 consecutive patients (30 males and 16 females) with SCLC that were treated at our Institution with PEI regimen: Cisplatin 20mg/m2, Etoposide 75mg/m2 and Ifosfamide 1200mg/m2, day 1 to 4, every 3 weeks.

Patients received a total of 219 cycles of chemotherapy, with a mean of 4,7 cycles per patient. Median age was 63 (range 59-70); performance status (PS) was 0 in 29 patients (63%), 1 in 13 patients (28%) and 2 in 4 patients (9%).


Eligibility criteria: Inclusion Criteria:

* histologically or cytologically proven SCLC
* measurable disease defined by RECIST criteria

Exclusion Criteria:

Primary outcomes:
measure: partial response (PR)
timeFrame: 1 year
measure: complete response (CR)
timeFrame: 1 YEAR
Secondary outcomes:
measure: Median time to progression (TTP)
timeFrame: 1 YEAR
measure: overall survival (OS)
timeFrame: 1 YEAR
Other outcomes:
Locations:
Study officials:
References:
citation: Boni C, Pagano M, Baldi L, Gnoni R, Braglia L, Savoldi L, Zanelli F. Pei regimen: a therapeutic option in small cell lung cancer? A retrospective monoinstitutional analysis of 46 consecutive cases. J Transl Med. 2015 Apr 24;13:130. doi: 10.1186/s12967-015-0491-3.
Clinical trial NCT05303896: Investigating Myocardial Remodelling in the Failing Human Heart
Official title: Investigating Myocardial Remodelling in the Failing Human Heart
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Keywords: MRI
Heart transplantation
Heart failure
PET
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients eligible for heart transplantation.

Brief summary: Despite improvements in therapy, heart failure is a disease with high mortality and accelerating prevalence. To improve patient care, it is necessary to better understand the features and underlying mechanisms of myocardial remodeling; how it manifests in vivo and its underlying cellular and extracellular changes. The RELAX study will offer insight into myocardial remodeling, by comprehensively assessing function and structure of failing human hearts, and investigate its underlying cellular and extracellular changes.


Eligibility criteria: Inclusion Criteria:

* Eligible for heart transplantation
* Willingness to participate in the present study and ability to understand and sign the written informed consent

Exclusion Criteria:

* Patients under the age of 18.

Primary outcomes:
measure: MRI functional parameters including Left Ventricular Ejection Fraction and Global Longitudinal Strain
timeFrame: 1 years
measure: MRI morphological parameters including LVEDV and LVESV.
timeFrame: 1 years
measure: Myocardial stiffness measured by MRI and ex-vivo methods.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: University of Oslo, Oslo University Hospital
name: Ivar Sjaastad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00718796: Naturopathic Treatment for the Prevention of Cardiovascular Disease
Official title: Naturopathic Treatment for the Prevention of Cardiovascular Disease: a Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiovascular Disease
Keywords: cardiovascular disease
naturopathic medicine
natural health products
lifestyle intervention
dietary advice
coronary heart disease
Lead sponsor: The Canadian College of Naturopathic Medicine
Sponsor class: OTHER
Collaborators: name: Canada Post Corporation
name: Canadian Union of Postal Workers
First posted: 2008-07-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to test the ability of a comprehensive naturopathic approach to reduce important risk factors for the development of cardiovascular disease. Treatment will take place over the course of one year and the comparator/control group will be followed by their medical doctors and be given conventional care.

Detailed description: Interventions will consist of an individualized treatment approach guided by an expert panel of clinicians who treat patients with cardiovascular disease. These interventions will consist of a combination of dietary, lifestyle and specific recommendations for supplementation. As this is a pragmatic study, blinding will not be attempted nor is appropriate.

Eligibility criteria: Inclusion Criteria:

* 18 to 65 years old
* CUPW worker
* prescreening indicates higher than normal TC/HDL ratio

Exclusion Criteria:

* Experienced an MI or stroke within past 6 months

Primary outcomes:
measure: Metabolic syndrome
timeFrame: 1 year
measure: General Cardiovascular Risk Profile: Framingham Heart Study
timeFrame: 1 year
Secondary outcomes:
measure: Adverse events
timeFrame: 1 year
measure: HbA1C
timeFrame: 1 year
measure: Compliance with naturopathic interventions
timeFrame: 1 year
measure: Quality of Life (Short-form 36)
timeFrame: 1 year
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Canadian College of Naturopathic Medicine
state: Ontario
Study officials:
affiliation: Canadian College of Naturopathic Medicine
name: Dugald Seely, ND
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herman PM, Szczurko O, Cooley K, Seely D. A naturopathic approach to the prevention of cardiovascular disease: cost-effectiveness analysis of a pragmatic multi-worksite randomized clinical trial. J Occup Environ Med. 2014 Feb;56(2):171-6. doi: 10.1097/JOM.0000000000000066.
citation: Seely D, Szczurko O, Cooley K, Fritz H, Aberdour S, Herrington C, Herman P, Rouchotas P, Lescheid D, Bradley R, Gignac T, Bernhardt B, Zhou Q, Guyatt G. Naturopathic medicine for the prevention of cardiovascular disease: a randomized clinical trial. CMAJ. 2013 Jun 11;185(9):E409-16. doi: 10.1503/cmaj.120567. Epub 2013 Apr 29.
Clinical trial NCT02615496: Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept
Official title: Evaluation of Physician and Patient Knowledge of Safety and Safe Use Information for Aflibercept in Europe: An Observational Postauthorisation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration
Keywords: Health Care Surveys
Vascular Endothelial Growth Factor
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: RTI Health Solutions
First posted: 2015-11-26
Enrollment: 716
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Physicians eligible to participate will be ophthalmologists who have administered aflibercept in the past 6 months.

Patients eligible to participate will be those who have already received at least one aflibercept injection and are returning for a subsequent visit. Patients will be aged 18 years or older, and will be able to understand the native language of the country in which the study is conducted.

Brief summary: The study will be an observational, cross-sectional study of knowledge, understanding, and self-reported behavior among a sample of physicians and patients with recent aflibercept experience in a total of up to five European countries.


Eligibility criteria: Inclusion Criteria:

Physicians eligibility:

* Licensed and practicing ophthalmologist
* Prescribed and administered aflibercept to at least one patient in the past 6 months

Patients eligibility:

* Patient has been administered aflibercept at least once within the last 6 months for any indication and is returning for a subsequent visit.
* Patient is aged 18 years or older.
* Patient is able to understand and sign the consent form and patient questionnaire.
* Patient can understand the native language of the country in which the study is being conducted.
* Patient has not participated in a clinical trial for the treatment of an aflibercept indication (e.g., wAMD, CRVO, or DME) in the past 12 months.

Primary outcomes:
measure: The proportion of physicians with accurate knowledge and understanding of key safety information (identified risks and prescribing behaviors) contained in the Eylea educational materials as assessed by a study specific questionnaire.
timeFrame: Up to 2 years
measure: The proportion of patients with accurate knowledge and understanding of key safety information (identified risks and guidelines) contained in the Eylea educational materials as assessed by a study specific interviewer administered questionnaire.
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Many Locations
country: France
city: Many Locations
country: Germany
city: Many Locations
country: Italy
city: Many Locations
country: Spain
city: Many Locations
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06168396: Somatosensation Device Trial
Official title: Testing of the Somatosensation Device (SD) for Device Effectiveness While Enhancing Feedback in Lower Extremities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Neuropathy
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2023-12-13
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This research is being done to test a new device, called the Somatosensation Device, with people who have either a below knee amputation, or neuropathy (i.e. decreased sensation) in their legs. When people have lost sensation in their feet, it may make walking and balance more difficult. The Somatosensation Device is designed to substitute the loss of feeling in a foot by pressing on nerves on the surface of the leg. It presses on the nerves by using a pneumatic balloon to put pressure on your skin. If people receive this extra sensation feedback, it may help improve their walking and balance.


Eligibility criteria: Inclusion Criteria:

* Have a below-knee amputation (either unilateral or bilateral) or neuropathy in their lower limbs.
* Ability to wear the somatosensation device on their lower limbs
* Ability to wear test equipment and heart rate monitors.
* Ability to follow simple directions.

Exclusion Criteria:

* History of severe back pain in the last 3 months.
* History of severe knee pain in the last 3 months.
* Unable to walk for 3 minutes with or without an assistive device
* Poor skin integrity (i.e open wounds, skin breakdown) that could be made worse by wearing the somatosensation device.

Primary outcomes:
measure: Functional Gait Assessment (FGA)
timeFrame: Baseline, during the intervention
Secondary outcomes:
measure: 10 Meter Walk Test
timeFrame: Baseline, during the intervention
measure: Mini-BESTest
timeFrame: Baseline, during the intervention
measure: Activities Specific Balance Confidence Scale (ABC)
timeFrame: Baseline, during the intervention
measure: Vestibular Disorders Activities of Daily Living Scale (VADL)
timeFrame: Baseline, during the intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
References:
Clinical trial NCT05530096: Telo Genomics Technology to Detect & Profile Multiple Myeloma MRD
Official title: Detect and Profile Multiple Myeloma Measurable Residual Disease (MRD )Prognostics for Monitoring Post-transplant Multiple Myeloma (MM) Patients Receiving Maintenance Therapy.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Myeloma
Lead sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 70
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: Participant having confirmed Multiple Myeloma diagnosis will be enrolled in this study.

Brief summary: The purpose :

Detect and profile Multiple myeloma Measurable Residual Disease(MRD) prognostics for monitoring post-transplant Multiple Myeloma (MM) Patients receiving maintenance therapy.


Eligibility criteria: Inclusion Criteria:

* Confirmed MM diagnosis
* Transplant eligible patients in a first remission
* Known MRD level detected by ClonoSeq (other IMWG recognized methodologies can be also employed)
* Availability of deidentified patient's demographic and clinical follow up data
* Receiving standard of care treatment
* Able to provide informed consent

Exclusion Criteria:

* Failure to meet inclusion criteria

Primary outcomes:
measure: To validate the sensitivity of Telo Genomics assay (measurement tool) to detect MRD (measurement expressed in the number of plasma cells per 100000 cells) and establish the clinical utility of TELO - DMRD for MRD enumeration
timeFrame: Approximately 5 years
measure: To assess the utility of TeloView® technology genomic profiling (measurement tool) to stratify post-transplant MM patients into relapse risk groups (dichotomous measure of high or low) by analyzing the residual MRD plasma cells
timeFrame: Approximately 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Sir Mortimer B. Davis - Jewish General Hospital
name: Rayan Kaedbey
role: PRINCIPAL_INVESTIGATOR
References: