louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00304252: Safety and Efficacy of Treatment With Interferon Beta-1a Rebif® in Patients With Crohn's Disease
Official title: A Phase II, Multicenter, Randomised, Double-blind, Placebo Controlled, Dose Finding Study of Subcutaneously Administered Interferon Beta-1a for Maintenance of Remission in Patients With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Crohn's Disease
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2006-03-17
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and efficacy of interferon beta-1a in maintaining remission in patients with Crohn's disease.


Eligibility criteria: Inclusion Criteria:

* Patients with an established diagnosis of Crohn's disease who went into remission using corticosteroids within 4 weeks before the study

Exclusion Criteria:

* Any other treatment for the maintenance of remission of Crohn's disease

Primary outcomes:
measure: The primary efficacy endpoint was the proportion of patients who maintained remission (relapse-free) and did not receive any additional treatment for the management of Crohn's disease by week 26.
Secondary outcomes:
measure: The secondary efficacy endpoints assessed the effect of treatment with IFN beta 1a on the following measures:
measure: The proportion of patients who maintained remission (relapse-free) and did not receive any additional treatment for the management of Crohn's disease by week 52
measure: Time to relapse
measure: Change from baseline to end of treatment in Quality of Life (IBDQ) score, CDAI score, biological markers of inflammation (CRP and ESR), number of fistulas (including new fistulas and closure of existing ones), and antibodies to interferon beta-1a.
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Medical Information Office
city: Roma
country: Italy
facility: Medical Information Office
city: Solna
country: Sweden
facility: Medical Information Office
city: Zug
country: Switzerland
facility: Medical Information Office
city: Feltham
country: United Kingdom
facility: Medical Information Office
Study officials:
affiliation: EMD Serono
name: Claudia Pena Rossi, M.D.
role: STUDY_DIRECTOR
References:
citation: Pena Rossi C, Hanauer SB, Tomasevic R, Hunter JO, Shafran I, Graffner H. Interferon beta-1a for the maintenance of remission in patients with Crohn's disease: results of a phase II dose-finding study. BMC Gastroenterol. 2009 Mar 20;9:22. doi: 10.1186/1471-230X-9-22.
Clinical trial NCT02887352: French Adaptation of the California Card Sorting Task (CCST) in Multiple Sclerosis
Official title: French Adaptation of the CCST (California Card Sorting Task). Comparison of 3 Packages to CCST With Multiple Sclerosis (MS) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-02
Enrollment: 48
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: multiple sclerosis patients

Brief summary: Cognitive impairment affects up to 65% of multiple sclerosis (MS) subjects, especially executive functions. The California Card Sorting Task (CCST) assesses specific components of problem-solving ability. There is currently no French version of this test. Reims neurological department in collaboration with Rothschild Foundation has developed a French adaptation of CCST. This version includes three cards packages with two alternate forms to control practice effects (test-retest). In order to assess "test-retest reliability" we have to verify the comparability of the three cards packages within one session in MS patients.


Eligibility criteria: Inclusion Criteria:

* Multiple Sclerosis patients
* age \> 18 years old

Exclusion Criteria:

* Montreal Cognitive Assessment (MOCA) ≤20
* psychiatric disease
* no proficiency in the French language
* opposition to participate in the study
* no medical insurance coverage

Primary outcomes:
measure: CCST Test score
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Anne-Claire VIRET
role: STUDY_DIRECTOR
affiliation: Fondation OPH A de Rothschild
name: Olivier GOUT, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01045252: Study of Hemodynamics of Neonates by Echocardiography and USCOM
Official title: Study of Hemodynamics of Healthy Neonates and Those With Congenital Heart Diseases and Sepsis by Echocardiography and USCOM
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Congenital Heart Disease
Keywords: hemodynamics
neonatal
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2010-01-11
Enrollment: 60
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients enrolled in the NICU of Guangdong General Hospital

Brief summary: The purpose of this study is to evaluate the hemodynamic values of neonates that are healthy and those with various congenital heart diseases and sepsis by using echocardiography and USCOM.

Detailed description: Echocardiography is a diagnostic tool for congenital heart disease.However,it requires skilled specialists to perform it and is a little expensive.Besides,it is too big to move to the bedside easily.USCOM is another newly choice to evaluate hemodynamic values in recent years.This study will compare the hemodynamic values of neonates that are healthy and those with congenital heart diseases and sepsis by using echocardiography and USCOM.

Eligibility criteria: Inclusion Criteria:

* neonatal
* congenital heart disease
* sepsis

Exclusion Criteria:

* aged more than thirty days

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong General Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Shaoru He
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02813252: Long-Term Follow-up Study for Patients Previously Treated With JCAR015
Official title: Long-Term Follow-up Protocol for Subjects Treated With JCAR015
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lymphoblastic Leukemia
Keywords: long-term follow-up
chimeric antigen receptor (CAR) T cells
JCAR015
Lead sponsor: Juno Therapeutics, a Subsidiary of Celgene
Sponsor class: INDUSTRY
First posted: 2016-06-24
Enrollment: 15
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 previously treated with JCAR015 in a prior clinical trial

Brief summary: This study will provide long-term follow-up for patients who have received treatment with JCAR015 in a previous clinical trial. In this study, patients will be followed for up to 15 years after their last dose of JCAR015 for evaluation of delayed adverse events, presence of persisting JCAR015 vector sequences, and survival.


Eligibility criteria: Inclusion criteria:

* Patients who have received at least one dose of JCAR015 in a previous treatment protocol.
* Patients who have provided informed consent for the long-term follow-up study prior to study participation.

Exclusion criteria:

* None. All patients who have previously received JCAR015 treatment are eligible for this long-term follow-up study.

Primary outcomes:
measure: Proportion of patients with adverse events
timeFrame: Every year for up to 15 years post-treatment
measure: Proportion of patients with detectable JCAR015 vector sequences during first 5 years post-treatment
timeFrame: Every 6 months for the first 5 years post-treatment
measure: Proportion of patients with detectable JCAR015 vector sequences between 5 and 15 years post-treatment
timeFrame: Every year from 5 years post-treatment to up to 15 years post-treatment
measure: Survival
timeFrame: Up to 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00120952: A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty
Official title: A Comparison Between Titanium Femoral Stem and Cobalt-Chromium Femoral Stem in Cemented Hip Arthroplasty. A Randomized Prospective Roentgen Stereogrammetric Analysis.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Osteoarthritis
Keywords: RSA
Osteoarthritis
Hip arthroplasty
DEXA
Titanium
Cobalt chromium
Bone cement
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2005-07-19
Enrollment: 0
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this randomised study, the migration of a specific cemented titanium femoral stem will be compared with a similar cemented cobalt-chromium stem using Roentgen stereogrammetric analysis (RSA). In addition, the periprosthetic bone mineral density (BMD) will be evaluated to point out any interference from the modulus of the stem investigated.


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis of the hip
* Spinal anesthesia
* Informed written consent

Exclusion Criteria:

* Neuromuscular disease in the affected leg
* Vascular disease in the affected leg
* Fracture sequelae in the affected hip
* Weight over 100 kg
* Regular non-steroid anti-inflammatory drug (NSAID) intake in the postoperative period

Primary outcomes:
measure: Migration of femoral components evaluated by RSA
Secondary outcomes:
measure: Periprosthetic BMD changes evaluated by DEXA
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Orthopaedic Department, Ribe County Hospital
Study officials:
affiliation: Orthopaedic Center, Aarhus University Hospital, Aarhus, Denmark
name: Kjeld Søballe, MD, DMSc
role: STUDY_CHAIR
References:
Clinical trial NCT00470652: Management of Acute Pain in the Emergency Department
Official title: Management of Acute Pain in the Emergency Department:Impact of a Computer-Assisted Support
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: pain
Pain Measurement
Decision Making, Computer-Assisted
Informatics
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
Collaborators: name: Societe Française de Medecine d'urgence
First posted: 2007-05-08
Enrollment: 631
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients discharged from our ED who either had pain on admission or suffered of a new pain while in our ED

Brief summary: Oligoanalgesia1 has been widely recognized as an issue in emergency department.The purpose of our study is to assess the impact of the implementation of a computer-assisted support program to improve pain management in our ED.

Detailed description: Inadequate pain management remains a major challenge for health care providers. Despite extensive research on the mechanisms of acute pain, identification of factors leading to poor pain management and development of evidence-based strategies, the transfer of this knowledge into effective clinical practices has been surprisingly slow. Oligoanalgesia1 has been widely recognized as an issue in emergency department (ED) patients. Acute pain is reported by 60-80% of ED inpatients but is frequently undertreated. Overall, an insufficient proportion of patients with acute pain receive any type of analgesia, and pain relief remains unsatisfactory. We showed that the implementation of guidelines improved pain management. However, rotation of the medical \& nursing staff leads to the forgetting of guidelines. The purpose of our study is to assess the impact of the implementation of a computer-assisted support program to improve pain management in our ED.

Eligibility criteria: Inclusion Criteria:

Any patient admitted to our Emergency Department who is

* age \> 16 years
* pain lasting =\< 1 week or
* no pain on admission but pain during the ED stay

Exclusion Criteria:

* life-threatening condition requiring immediate admission in the OR or ICU
* no pain or pain lasting \>1 week
* inability to give informed consent (intoxicated, psychiatric disorder, language problem, prisoner)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universiataire Vaudois
name: Olivier W Hugli, MD,MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Decosterd I, Hugli O, Tamches E, Blanc C, Mouhsine E, Givel JC, Yersin B, Buclin T. Oligoanalgesia in the emergency department: short-term beneficial effects of an education program on acute pain. Ann Emerg Med. 2007 Oct;50(4):462-71. doi: 10.1016/j.annemergmed.2007.01.019. Epub 2007 Apr 18.
Clinical trial NCT05790252: Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy (Patch BRIDGE)
Official title: Using the Transdermal Patch for BupRenorphine Induction DurinG PrEgnancy: A Randomized Controlled Trial (The Patch BRIDGE Trial)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Opioid Use Disorder
Pregnancy Related
Pregnancy, High Risk
Pregnancy Complications
Buprenorphine Withdrawal
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2023-03-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare buprenorphine patch for induction (starting) of buprenorphine in pregnant patients with opioid use disorder. The main questions it aims to answer are:

1. Is there a buprenorphine induction method that results in the least moderate-to-severe opioid withdrawal symptoms in pregnant patients with opioid use disorder?
2. Is there a buprenorphine induction method that results in a higher treatment success rate? Under normal circumstances, patients who are planning to start sublingual (under the tongue) buprenorphine for opioid use disorder must first go into withdrawal to start the medication safely. Study participants will be given a buprenorphine patch during the required withdrawal period before starting sublingual treatment, and be surveyed daily by phone to assess their withdrawal symptoms. They will also be followed at prenatal appointments to evaluate treatment success based on urine drug screen results. Researchers will compare patients receiving no buprenorphine patch according to the current standard care protocol.


Eligibility criteria: Inclusion Criteria:

* Viable pregnancy
* Meet diagnostic criteria for opioid use disorder
* Receive prenatal care through opioid use disorder specific clinic at our institution
* Opioid use within 24 hours prior to presentation
* Desire treatment with buprenorphine

Exclusion Criteria:

* Patients already receiving treatment for opioid use disorder
* History of prior induction attempt with buprenorphine
* Active withdrawal at time of presentation
* Medical contraindication to buprenorphine
* Requiring immediate hospitalization

Primary outcomes:
measure: Induction withdrawal severity
timeFrame: Days 0 through 4
Secondary outcomes:
measure: Induction success
timeFrame: Days 0 through 7
measure: Treatment adherence
timeFrame: Days 0 through delivery
measure: Recovery success
timeFrame: Days 0 through delivery
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jeannie C Kelly, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02286752: Comparison of the Effects of Neostigmine With Sugammadex on Postoperative Nausea and Vomiting.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Incidence of Postoperative Nausea and Vomiting
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2014-11-10
Enrollment: 98
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: Postoperative nausea and vomiting is one of most common complications after general anesthesia. Female sex, history of postoperative nausea and vomiting, motion sickness, non smoker status, opioid administration are known as risk factors for developing postoperative nausea and vomiting.

It has been suggest that antagonism of residual neuromuscular block with a mixture of neostigmine and atropine at the end of the surgery increases the risk of postoperative nausea and vomiting.

Sugammadex is a very safe drug with almost no serious adverse effects. The known adverse effects include slight coughing, movement, an altered taste sensation in the mouth, transient prolongation of the QT interval, hypersensitivity, and a short term prolongation of the activated partial thromboplastin time.

The aim of this study was to compare the sugammadex versus neostigmine plus atropine for reversal of rocuronium induced neuromuscular blockade in terms of incidence of postoperative nausea and vomiting.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1 and 2
* endotracheal intubation and general anesthesia scheduled for elective surgery

Exclusion Criteria:

* age \< 18 years, \> 65 years
* pregnancy
* refusal to participate and patients already participating in another study
* allergy to study drugs
* communication difficulty
* psychiatric and neurological disorders
* use of analgesics or sedative or antiemetic drugs within 24 hours before surgery.
* emergency surgery
* history of drug or alcohol abuse
* ASA 3 and above
* patients with vertigo
* Laparoscopic surgery, oncologic surgery, strabismus and mid ear surgery neurosurgery, gynecologic surgery, breast surgery

Primary outcomes:
measure: Verbal Descriptive Scale
timeFrame: within postoperative 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Altınordu
country: Turkey
facility: Anesthesiology and Reanimation Dept. Ordu University Training and Research Hospital
state: Ordu
Study officials:
References:
Clinical trial NCT03880552: Perineal Body Length and Perineal Lacerations
Official title: Perineal Body Length and Perineal Lacerations During Delivery in Primigravid Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perineal Laceration Involving Skin
Delivery; Trauma
Keywords: perineal laceration
obstetric trauma
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Meet the criteria of inclusion in our hospital for birth,The study was planned for women with singleton pregnancies of 35 weeks or more.

Brief summary: The aim of this study was to evaluate the relationship between perineal body length and perineal laceration risk in primigravid patients.

Primigravid women with singleton pregnancies in the first stage of labor at the 35th week of gestation were included in the study. The peineal body length of the patients was measured by the same physician.

Detailed description: After 35 weeks of gestation, nulliparous women with single gestation were included in the study and genital hiatus and perineal body measurements were taken.

The presence and degree of perineal laceration after birth were determined. Correlation of genital hiatus and perineal body measurements with perineal laceration risk were evaluated.

After birth, vaginal laceration, oxytocin use, fetal birth weight, the presence of episiotomy were recorded.

Eligibility criteria: Inclusion Criteria:

-Primigravid women with singleton pregnancy at over 35th week

Exclusion Criteria:

* the story of operative vaginal birth;
* caesarean section;
* breech presentation;
* those with a history of anorectal surgery or trauma

Primary outcomes:
measure: Perineal body length
timeFrame: during delivery
measure: perineal laceration
timeFrame: during delivery
Secondary outcomes:
measure: genital hiatus length
timeFrame: during delivery
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT00751452: Citrulline Allo. Evaluation of Citrullinemia as a Marker of Bowel Damage After Allogeneic Bone Marrow Transplantation in Children
Official title: Evaluation of Citrullinemia as a Marker of Bowel Damage After Allogeneic Bone Marrow Transplantation in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Benign Disease
Keywords: Children
Allogeneic bone marrow transplantation
Intestinal damage
Citrulline
Graft versus Host Disease
0 to 18 years old
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2008-09-12
Enrollment: 30
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: screening

Brief summary: determine the interest of the dosage of citrullinemia to monitor the bowel damage after allogeneic bone marrow transplantation in children.

Detailed description: 30 children included. Dosage of citrullinemia on day -7, day 0 and every week up to 100 days after BMT. Histological examination and extensive infectious screening in case of persistent digestive symptoms (more than 3 days).

Two groups of patients regarding on digestive involvement. Comparison of the values of citrullinemia between these two groups.

Eligibility criteria: Inclusion Criteria:

* 0 to 18 years
* allogeneic bone marrow transplantation for malignant or benign disease
* affiliation to French sécurité sociale
* parent's consent

Exclusion Criteria:

* severe gastro-intestinal involvement before transplant
* previous digestive surgery

Primary outcomes:
measure: Citrullinemia (weekly)
timeFrame: weekly
Secondary outcomes:
measure: Gastro-intestinal complications in children following allogeneic bone marrow transplantation
timeFrame: following allogenic bone marrow transplantation
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: Etienne MERLIN
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Merlin Etienne, Dr
role: PRINCIPAL_INVESTIGATOR
References: