louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00758355: Data Collection on ReCap/Magnum in Total Hip Replacement and Resurfacing
Official title: A Prospective, Multicentre Study Evaluating the Clinical Performance of the ReCap/Magnum in Total Hip Replacement and Resurfacing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Total Hip Resurfacing
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
Collaborators: name: Biomet France SARL
First posted: 2008-09-25
Enrollment: 150
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: Consecutive series of patients received Total Hip Replacement or Resurfacing with ReCap/Magnum for Their Respective Indications for Use/Intended Uses

Brief summary: Observational study on ReCap/Magnum in Total Hip Replacement and Resurfacing.

Detailed description: This observational study intends to collect efficacy and safety data on ReCap/Magnum in Total Hip Replacement and Resurfacing.

Eligibility criteria: Inclusion Criteria:

Consecutive series of patients received Total Hip Replacement or Resurfacing with ReCap/Magnum for Its Respective Indications for Use/Intended Uses

Primary outcomes:
measure: Postel-Merle d'Aubigné (PMA), Harris Hip Score
timeFrame: 1yr and 2yr
Secondary outcomes:
measure: Complication
timeFrame: Any time
measure: Survival
timeFrame: 1yr and 2yr
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Bordeaux
country: France
facility: CHU Pellegrin Tripode
city: Grenoble
country: France
facility: CHU Hôpital Sud
city: Henin-beaumont
country: France
facility: Polyclinique de Hénin Beaumont
city: Lievin
country: France
facility: Polyclinique de Riaumont
city: Reims
country: France
facility: Clinique Saint Andre
Study officials:
affiliation: Hopital Sud - Echirolles
name: Dominique Saragaglia, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01609855: Does the Hyoscine N-Butylbromide Administered During Colonoscopy Increase the Adenoma Detection Rate?
Official title: Does Hyoscine N-butylbromide Administered During Colonoscopy Increase the Polyp Detection Rate? a Randomized, Single Center, Double Blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Colonic Adenomas
Keywords: Adenoma Detection Rate
Anti-spasmotic drug
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary aim of the study was to test if the administration of Hyoscine Butyl Bromide, at time of caecal intubation, increases the adenoma detection rate.

Detailed description: Outpatients referred for colonoscopy were screened for possible enrollment. Exclusion criteria included: glaucoma, benign prostatic hyperplasia or urinary obstruction, previous intestinal resection, ongoing therapy with tricyclic antidepressants, chronic renal failure and history of IBD. Eligible patients were randomized to receive either 20 mg/2ml of HBB i.v. or 2ml of saline i.v.; both the endoscopist and the patient were blind to the administered drug. The endoscopist was asked to inspect the right, transverse and left colon for at least 2 min for each segment. The number, size and location of polyps were recorded as well as the occurrence episodes of tachycardia (defined as bpm\>140). As indirect estimation of the amount of air retained in the abdomen at the end of the procedure, the DAC (difference in the abdominal circumference measured before and after colonoscopy) was also calculated. At discharge (at least 1 hour after colonoscopy) the bloating perceived by the patient was measured by means of a VA scale (range 0-100).

Eligibility criteria: Inclusion Criteria:

* outpatients referred for colonoscopy

Exclusion Criteria:

* glaucoma
* benign prostatic hyperplasia or urinary obstruction
* previous intestinal resection,
* ongoing therapy with tricyclic antidepressants
* chronic renal failure
* history of IBD
* participation other studies
* unsedated colonoscopy

Primary outcomes:
measure: Effect of Hyoscine Butyl Bromide on Adenoma Detection Rate (ADR)
timeFrame: 5 months
Secondary outcomes:
measure: Tolerability of HBB
timeFrame: this outcome will be evaluated at the end of colonoscopy
Other outcomes:
Locations:
city: Como
country: Italy
facility: Ospedale Valduce
city: Como
country: Italy
facility: Ospedale Valduce
Study officials:
affiliation: Gastroenterology Unit, Ospedale Valduce, Como, Italy.
name: Spinzi Giancarlo, MD
role: STUDY_DIRECTOR
affiliation: Gastroenterology Unit, Ospedale Valduce, Como. Italy.
name: Franco Radaelli, MD
role: STUDY_CHAIR
affiliation: Gastroenterology Unit, Ospedale Valduvce, Como. Italy.
name: Emanuele Rondonotti, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01205555: Combining LHu With Ultrasound Monitoring in IUI
Official title: Combining Urinary Luteinizing Hormone Testing With Ultrasound Monitoring in Intrauterine Insemination Cycles
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Keywords: intra uterine insemination
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2010-09-20
Enrollment: 367
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Intra-uterine insemination (IUI), generally in combination with ovarian stimulation, is one of the most commonly used treatments for infertility. Accurate timing of insemination, in order to coincide with ovulation, has an important impact on the success rate. Optimal timing of insemination is achieved either by monitoring follicular growth through serial ultrasound measurements followed by the administration of human chorionic gonadotropin (hCG) or by the detection of urinary luteinizing hormone (LH). However in cycles where follicular growth is monitored there is a possibility of premature LH rise before the administration of hCG, which may affect the outcome of the treatment. The goal of the study is to determine if adding the testing of urine LH in conjunction with ultrasound monitoring leads to an increase in pregnancy rates in IUI cycles when compared to ultrasound monitoring alone.


Eligibility criteria: Inclusion Criteria:

* Undergoing IUI treatments for:

  * Unexplained infertility (including endometriosis stage 1-2)
  * Mild male factor (\>5x106/ml motile sperm as determined by total sperm concentration x % A+B motility in the latest spermogram)
  * Donor insemination
* Natural or stimulated cycles with clomiphene citrate or letrozole
* At least 1 patent tube on hysterosalpingogram, hysterosonogram or laparoscopy within the last two years
* Antral follicular count ≥10 and FSH\<10

Exclusion Criteria:

* Polycystic ovarian syndrome or any cause of oligo or anovulation
* Patients taking other infertility medication (metformin, 17B estradiol, progesterone or gonadotropins)
* Presence of an ovarian cyst or a follicle \>20 mm on the first ultrasound or any reason for immediate HCG administration
* A previous sperm washing result with less than 5x106/ml motile sperm
* Previous inconclusive uLH test or inability to perform uLH testing

Primary outcomes:
measure: pregnancy rate
timeFrame: 14 days post IUI
Secondary outcomes:
measure: rate of positive LH testing
timeFrame: before hCG administration
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Ovo Fertilité
state: Quebec
Study officials:
affiliation: ovo fertilité
name: Roland Antaki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ovo fertilité
name: Louise Lapensee, MD
role: STUDY_DIRECTOR
affiliation: ovo fertilité
name: Isaac Jacques Kadoch, MD
role: STUDY_DIRECTOR
affiliation: ovo fertilité
name: Nicola Dean, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00429455: Survey of the Need for Information on Fertility and Menopause-Related Treatment Effects Among HSCT Patients
Official title: Survey of the Need for Information on Fertility and Menopause-Related Treatment Effects Among Young Women Who Underwent Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stem Cell Transplantation
Keywords: Fertility
Menopause
Hematopoietic Stem Cell Transplantation
Questionnaire
Survey
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2007-01-31
Enrollment: 196
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients who had a hematopoietic stem cell transplantation between January 1987 and September 2004 at M. D. Anderson Cancer Center.

Brief summary: Primary Objective:

- To understand the importance of receiving information on fertility- and menopause-related treatment effects for female patients undergoing hematopoietic stem cell transplantation.

Detailed description: Researchers are currently conducting a survey on how important it is to women who are having a stem cell transplant to have information about the effects of the treatment on their fertility (their ability to have children) and on the risk of early menopause. Researchers know that some women who had transplants think that the information that they received may have been lacking or was not appropriate for their needs. Therefore, researchers would like to ask women who have had stem cell transplants at M. D. Anderson Cancer Center to report what kind of information they got and would like to have gotten before or during their treatment.

Eligibility criteria: Inclusion Criteria:

* Female patients who had a hematopoietic stem cell transplantation between January 1987 and September 2004 at M. D. Anderson Cancer Center.
* Age 16 to 50 years at the time of the transplant.

Exclusion Criteria:

* History of ovarian cancer.
* History of hysterectomy/oophorectomy
* Non-English speaking patients

Primary outcomes:
measure: Number of Survey Responders
timeFrame: 2 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: U.T. M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Naoto Ueno, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01834755: Physical and Psychological Profiles Associated With Patient's Preference for ESRD Treatment
Official title: Physical and Psychological Evaluation of Patients Reaching End Stage Renal Disease : Effects on the Choice of Renal Replacement Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Failure
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2013-04-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Highlighting the relationship between psychological and physical profiles and patient's preference to better understand the patient's treatment preference and improve the information provided.

Detailed description: CKD is a Public Health Problem with a prevalence of 10% in general population. For patients reaching The making decision to treat ESRD with renal replacement therapy is a complex process and needs to be shared between patients, family, physician and nephrologist.

Systematic Information delivery about several treatments of ESRD is recommended for patients and his family (Hemodialysis, Peritoneal Dialysis, Kidney Transplantation and Conservative treatment). Some studies on the preference of patients for renal replacement therapy reported a choice for PD about 50% while the registers report a low diffusion of PD (around 10%). Since 2009 we propose a systematic information about the different therapeutic options for ESRD and identified some clinical characteristics associated to patient's preference. However we want to know if psychological or physical phenotype is associated to patient's preference.

The objective of the study is to highlight the relationship between psychological and physical profiles and patient's preference to better understand the patient's treatment preference and improve the information provided.

Eligibility criteria: Inclusion Criteria:

* More than 18 years
* CKD with estimated GFR below 20 ml/min/1.73m2 without dialysis treatment
* Patient who accepts information delivery about treatments of ESRF
* Patient who accepted and signed the informed consent
* Subject beneficiary of a social security system

Exclusion Criteria:

* Inability to achieve psychological tests
* Inability to achieve physical tests

Primary outcomes:
measure: Comparison of different psychological and physical characteristics according to patients preference
timeFrame: one day
Secondary outcomes:
measure: Clinical characteristics and laboratory values
timeFrame: one day
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice - Service de Néphrologie
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Olivier MORANNE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01442155: An Observational Study of Adjuvant Treatment With Capecitabine (Xeloda) in Combination With Oxaliplatin in Participants With Stage III Colon Cancer
Official title: An Open Label Study of the Effect of Adjuvant Treatment With Capecitabine in Combination With Oxaliplatin on Disease-Free Survival in Patients With Stage III Colon Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Adjuvant setting
Capecitabine
Oxaliplatin
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-09-28
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with Stage III colon cancer

Brief summary: This observational study evaluates the efficacy and safety of capecitabine in combination with oxaliplatin in the adjuvant setting in participants with Stage III colon cancer. Data were collected from each participant for up to 36 months or until disease recurrence.


Eligibility criteria: Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Treatment in line with the currently approved indication in the Summary of Product Characteristics

Exclusion Criteria:

* Contraindications according to the current Summary of Product Characteristics

Primary outcomes:
measure: Disease-Free Survival (Time to Event)
timeFrame: Up to 3 years
Secondary outcomes:
measure: Safety: Percentage of Participants With Adverse Events
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Banska Bystrica
country: Slovakia
city: Bratislava
country: Slovakia
city: Bratislava
country: Slovakia
city: Kosice
country: Slovakia
city: Martin
country: Slovakia
city: Nitra
country: Slovakia
city: Poprad
country: Slovakia
city: Presov
country: Slovakia
city: Ruzomberok
country: Slovakia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03262155: Study of Immunity Dysfunction Induced by Extracorporeal Assistance (ECMO / ECLS)
Official title: Study of Immunity Dysfunction Induced by Extracorporeal Assistance (ECMO / ECLS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Cardiogenic Shock
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 18
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: Patients hospitalized for ARDS or Cardiogenic shock with or without ECMO / ECLS

Brief summary: Study of immunosuppression biomarkers in patients with ARDS or cardiogenic shock with ECMO / ECLS, compared to patients with ARDS or cardiogenic shock without ECMO / ECLS


Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years old
* Patient hospitalized in an intensive care unit
* Patient whose initial ARDS or Cardiogenic shock began less than 5 days before admission
* Patients hospitalized for ARDS or Cardiogenic shock with ECMO / ECLS or - Patients hospitalized for ARDS or Cardiogenic shock without ECMO / ECLS

Exclusion Criteria:

* Opposition of patient, relative or legal representative for participation in the study
* Pregnant woman
* Pre-immunodepression
* Implementation of immunosuppressive therapy such as chemotherapy, cyclophosphamide, high-dose corticosteroids (\> 0.5mg / kg / day).

Primary outcomes:
measure: Prevalence of immunosuppression in patients with ARDS or cardiogenic shock under ECMO / ECLS hospitalized in intensive care unit
timeFrame: Hour 24
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU de Rennes
Study officials:
References:
Clinical trial NCT01232855: Biomarkers in Tissue Samples From Patients With Acute Promyelocytic Leukemia
Official title: Regulation of S100A10 by the PML-RAR-alpha Oncoprotein
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leukemia
Keywords: adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute promyelocytic leukemia (M3)
childhood acute promyelocytic leukemia (M3)
adult acute myeloid leukemia in remission
untreated adult acute myeloid leukemia
childhood acute myeloid leukemia in remission
untreated childhood acute myeloid leukemia and other myeloid malignancies
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-11-02
Enrollment: 10
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With Acute Promyelocytic Leukemia

Brief summary: RATIONALE: Studying samples fo tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from patients with acute promyelocytic leukemia.

Detailed description: OBJECTIVES:

* Demonstrate that S100A10 is expressed on APL cells and that levels of S100A10 correspond to the amount of fibrinolytic activity.
* Evaluate the impact of ATRA on S100A10 level and fibrinolytic activity in vitro.
* Evaluate the impact of S100A10 knockdown on fibrinolytic activity.
* Correlate in vitro findings in cell culture to primary patient samples both pre- and post-ATRA therapy.

OUTLINE: This is a multicenter study.

Previously collected samples are analyzed via flow cytometry and western blot analysis. Cell surface levels of S100A10 and annexin A2 are correlated to the promyelocyte population and total protein levels are examined to determine total annexin A2 and S100A10 in acute promyelocytic leukemia cells.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of acute promyelocytic leukemia
* Available cryopreserved cells from diagnosis or cryopreserved cells from remission (germline)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Demonstration that S100A10 is expressed on acute promyelocytic leukemia cells and that levels of S100A10 correspond to the amount of fibrinolytic activity
measure: Evaluation of the impact of all-trans retinoic acid (ATRA) on S100A10 level and fibrinolytic activity in vitro
measure: Evaluation of the impact of S100A10 knockdown on fibrinolytic activity
measure: Correlation of in vitro findings in cell culture to primary patient samples both pre- and post-ATRA therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: IWK Health Centre
name: Jason N. Berman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000355: Effects of Buprenorphine and Naloxone in Opiate Addicts - 4
Official title: Effects of Buprenophine and Naloxone in Opiate Addicts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: opiate dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Pennsylvania
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the behavioral and physiological effects of buprenorphine and naloxone, both alone and in combination.


Eligibility criteria: Please contact site for information.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: PDVAMC Treatment Research Center
name: Charles O'Brien, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03350555: Clinical Trials to Validate the Use of Additioned Endoscopy in Endoscopic Retrograde Cholangiopancreatography
Official title: Validation of Clinical Use of Additioned Endoscopy in Endoscopic Retrograde Cholangiopancreatography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ERCP
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One arm includes participants who will receive additioned endoscopy assisted ERCP, and the other arm includes participants who will not receive additioned endoscopy assisted ERCP.
Primary purpose: OTHER

Brief summary: Validation of clinical use of additioned endoscopy in Endoscopic Retrograde Cholangiopancreatography(ERCP) treatment.

Detailed description: Investigators recently developed a device named additioned Endoscopy. The purpose of current clinical trial is to evaluate the use of additioned endoscopy in ERCP treatment, specifically in shortening the duration of ERCP operation and lowering incidence of complications.

Eligibility criteria: Inclusion Criteria:

* People who are indicated to ERCP treatment.

Exclusion Criteria:

* People who are not suitable for ERCP treatment.

Primary outcomes:
measure: Duration of ERCP treatment
timeFrame: Duration of operation in each patient, ie. from beginning to the end of ERCP operation in each patient
Secondary outcomes:
measure: complications of ERCP treatment
timeFrame: up to 1 month after ERCP completion
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, MD
role: STUDY_CHAIR
References: