louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01148693: Gentamicin in Preventing Post Endoscopic Retrograde Cholangiopancreatography (ERCP) Cholangitis in Non-calculus Stenting
Official title: Comparing Addition of Gentamicin vs. Placebo in Preventing Post ERCP Cholangitis in Non-calculus Stenting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholangitis
Keywords: Cholangitis; Cholangiopancreatography, Endoscopic Retrograde; stents; cholestasis
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2010-06-22
Enrollment: 114
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Cholangitis is the most prevalent infectious complication of ERCP. Stenting of biliary strictures and stenosis is one of important risk factors for post-ERCP cholangitis. Adding antibiotics to contrast media has proposed in some studies for prevention of cholangitis but remains controversial. In this study we compare effect of adding gentamicin versus placebo in preventing cholangitis in patients who undergone endoscopic stenting for non-calculus strictures and stenosis.


Eligibility criteria: Inclusion Criteria:

* Patients with non-calculus biliary obstruction who need palliative treatment

Exclusion Criteria:

* Fever (\> 37.8 Celsius)
* Leukocytosis (WBC \> 10,000 /mm3)
* Not candidate for surgical cure of obstruction

Primary outcomes:
measure: Number of Participants With Cholangitis
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: TUMS Digestive Disease Research Center
Study officials:
affiliation: Tehran Medical University of Medical Science associate professor
name: Rasoul Sotudemanesh, MD
role: STUDY_CHAIR
References:
citation: Norouzi A, Khatibian M, Afroogh R, Chaharmahali M, Sotoudehmanesh R. The effect of adding gentamicin to contrast media for prevention of cholangitis after biliary stenting for non-calculous biliary obstruction, a randomized controlled trial. Indian J Gastroenterol. 2013 Jan;32(1):18-21. doi: 10.1007/s12664-012-0208-y. Epub 2012 Oct 19.
Clinical trial NCT03655093: Validation of a Self-questionnaire in French on the Use of the Upper Limbs in Patients With Multiple Sclerosis
Official title: Validation of a Self-questionnaire in French on the Use of the Upper Limbs in Patients With Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Self-questionnaire
Measurement tools
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 200
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 with MS according to the diagnostic criteria of 2010

Brief summary: Multiple sclerosis (MS) is an inflammatory and demyelinating disease of the central nervous system that causes disability in young adults. This disability can take many forms depending on the neurological systems affected: disability walking, cognitive impairment or disability in the upper limbs. The development of validated measurement tools for these different disabilities is essential for the follow-up of patients in clinical routine and for the evaluation of new therapies.

Detailed description: A specific self-questionnaire for patients with MS has recently been developed and validated in English and Dutch: "The Arm Function in Multiple Sclerosis Questionnaire (AMSQ)". The questionnaire groups 31 items and was created from questionnaires developed for other pathologies. The Dutch team that developed this questionnaire combines biostatisticians and neurologists, experts in the development and validation of disability measurement tools.

This study aims to validate the French version of AMSQ questionnaire. This study is carried out in collaboration with the Amsterdam team, which has carried out the methodology and will conduct the statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Patient with MS according to the diagnostic criteria of 2010
* Age ≥18 years
* Patients seen in consultation at the SEP reference center in Rennes

Exclusion Criteria:

* Other neurological or rheumatological pathology hindering the use of the upper limbs
* Inability to understand
* Minors
* Major persons subject to legal protection (legal safeguards, guardianship)
* Persons deprived of their liberty

Primary outcomes:
measure: Validate the French version of the AMSQ self-questionnaire in a population of MS patients
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: Rennes University Hospital
name: Anne Kerbrat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Samejima F. Estimation of latent ability using a response pattern of graded scores. Richmond, VA: The Psychometric Society, 1969.
Clinical trial NCT01818193: Neurological Complications - Pulmonary Transplant
Official title: Neurological Complications - Pulmonary Transplant
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cognitive Dysfunctions
Keywords: Pulmonary transplant
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients enregistered in the waiting list for lung transplant

Brief summary: A monocentric prospective open study to evaluate the frequency and nature of cognitive complications in the 3rd month post pulmonary transplant.


Eligibility criteria: Inclusion Criteria:

* Patients more than 18 years of age.
* Enregistered in lung transplant waiting list
* Have given their agreement to be enrolled in the study

Exclusion Criteria:

* Patients had a previous lung transplant
* patients with insufficient level of french language that may affect the comprehension and answering the psychometric test

Primary outcomes:
measure: Rey auditory verbal learning test
timeFrame: 3 months
measure: Rey complex figure test
timeFrame: 3 months
measure: Boston naming test of 30 figures
timeFrame: 3 months
measure: Visual construction skills
timeFrame: 3 months
measure: Grooved Pegboard test
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital FOCH
state: Ile de France
Study officials:
References:
Clinical trial NCT04073693: Characterization of the Nutritional Status in the Patient With Liver Cirrhosis
Official title: Characterization of the Nutritional Status in the Patient With Liver Cirrhosis and Impact of a Nutritional Intervention With Nutritional Supplements With BRCA vs. Standard Treatment in the Subgroup of Patients With Sarcopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcopenia
Lead sponsor: Puerta de Hierro University Hospital
Sponsor class: OTHER
First posted: 2019-08-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the subgroup of patients with sarcopenia, regardless of their body mass index, we want to verify the real impact of nutritional supplements with branched chain amino acids on the standard treatment based on nutritional intervention and physical exercise.


Eligibility criteria: Inclusion Criteria:

* Cirrhotic patients with sarcopenia in abdominal CT.

Exclusion Criteria:

* chronic renal failure or being on hemodialysis
* active hepatitis B or C virus infection
* active alcohol abuse
* coinfection with human immunodeficiency virus
* renal or previous liver transplantation
* history of neoplasia requiring chemotherapy or radiotherapy
* hepatocellular carcinoma outside of Milan criteria
* TIPs
* unwillingness to participate in the study.

Primary outcomes:
measure: Change of muscle mass in patients with sarcopenia
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Majadahonda
country: Spain
facility: Jose Luis Calleja
state: Madrid
Study officials:
References:
citation: Hernandez-Conde M, Llop E, Gomez-Pimpollo L, Fernandez Carrillo C, Rodriguez L, Van Den Brule E, Perello C, Lopez-Gomez M, Abad J, Martinez-Porras JL, Fernandez-Puga N, Ferre C, Trapero M, Fraga E, Calleja JL. Adding Branched-Chain Amino Acids to an Enhanced Standard-of-Care Treatment Improves Muscle Mass of Cirrhotic Patients With Sarcopenia: A Placebo-Controlled Trial. Am J Gastroenterol. 2021 Nov 1;116(11):2241-2249. doi: 10.14309/ajg.0000000000001301.
Clinical trial NCT04002193: Pleth Variability Index in Modified Prone Position or Knee-chest Position (Concord Position)
Official title: Pleth Variability Index as Predictors of Fluid Responsiveness in Modified Prone Position(Concord Position) or Knee-chest Position
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Responsiveness
Modified Prone Position
Keywords: Pleth variability index
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 44
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients received cervical operation at modified prone position (concord position)

Brief summary: To investigate whether PVI predicts the fluid responsiveness in modified prone position undergoing posterior approach cervical operation. Furthermore, modified prone position could influence on dynamic variables including stroke volume variation(SVV), pulse pressure variation(PPV) and PVI.

Detailed description: Objective :

To compare measurements of pleth variability index (PVI), pulse pressure variation (PPV) and stroke volume variation (SVV) to predict fluid responsiveness in modified prone position or knee-chest position (concord position) for cervical operation.

To identify Influence of the modified prone position (concord position) on these variables.

Method

1. To assess influence of the position change on PVI and other variables(PPV, SVV)
2. To assess PVI to predict fluid responsiveness at modified prone position

Eligibility criteria: Inclusion Criteria:

* American Society of Anaesthesiologists'(ASA) physical status 1-3
* patients who received cervical operation in modified prone position or knee-chest position

Exclusion Criteria:

* Valvular heart disease
* Congestive heart failure, reduced left ventricular function ( Ejection fraction \< 40%)
* Moderate grade of pulmonary disease
* Arrhythmia (atrial fibrillation, atrial flutter.. etc.)
* body mass index \> 30 or \< 15 kg/m2

Primary outcomes:
measure: To assess influence of the position change on PVI and other variables(PPV, SVV)
timeFrame: 1.supine position : 5 minute after anesthesia induction with arterial-line insertion 2. 5 min after crystalloid 4 ml/kg loading / 3. modified prone position (baseline)
Secondary outcomes:
measure: To measure dynamic variables (pulse pressure variation, stroke volume variation and pleth variability index) in modified prone position
timeFrame: 1. Supine position : 5 minute after anesthesia induction with arterial-line insertion 2. 5 minute after a position change to prone 3. before and after fluid loading
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-gu
Study officials:
References:
Clinical trial NCT04819893: Study of the Involvement of Fatty Acids in Retinopathy of Prematurity: Relationship Between Retinopathy of Prematurity and the Rate of Expression of Transplacental Fatty Acid Receptors.
Official title: Study of the Involvement of Fatty Acids in Retinopathy of Prematurity: Relationship Between Retinopathy of Prematurity and the Rate of Expression of Transplacental Fatty Acid Receptors.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prematurity
Retinopathy
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2021-03-29
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women giving birth at term or prematurely

Brief summary: The development of the retinal vascular network is completed during the third trimester of pregnancy and and the first 15 days of life of the newborn. This late maturation can be problematic in cases of preterm births and result in immature retinal vascularization, known as retinopathy of prematurity (ROP). Among the various factors influencing retinal vascular development, the tissue content of omega-3 polyunsaturated fatty acids (PUFAs) appears to be a crucial element. In a previous project, OMEGA-ROP, we showed a difference in the blood bioavailability of omega-3 PUFAs in infants born at less than 28 weeks of amenorrhea who develop ROP compared to healthy newborns with no retinopathy. This study also showed that mothers experienced variations in the blood levels of omega-3 PUFAs that were contrary to the types of variations observed in their children. This suggests a sequestration of omega-3 PUFAs in the mothers of children who will develop ROP. This new project aims to better understand the underlying molecular mechanisms by studying the expression levels of placental fatty acid receptors in relation to the development of ROP in newborns.


Eligibility criteria: Inclusion Criteria:

1. Mothers giving birth to premature babies less than 29 weeks of amenorrhea (WA), after obtaining their non-opposition.
2. Mothers giving birth at term between 39 and 41WA+6 days, after obtaining their non-opposition.
3. ≥18 years
4. Mothers not under legal protection

Exclusion Criteria:

1. Mothers giving birth between 29WA and 38WA+6 days
2. Mothers in critical condition.
3. Person not affiliated to national health insurance
4. For full-term mothers: patient presenting or having presented a health condition that affected a previous pregnancy (vascular such as pregnant hypertension, preeclampsia; gestational diabetes; intrauterine growth retardation, maternal infection during pregnancy such as toxoplasmosis, cytomegalovirus, rubella, measles, chickenpox).

Primary outcomes:
measure: Estimation of the linear correlation coefficient between placental fatty acid receptor expression rate and term of delivery
timeFrame: 16 weeks maximum after birth
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT01203293: Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector
Official title: CBT for Latinos With Generalized Anxiety Disorder in the General Medical Sector
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Generalized Anxiety Disorder
Lead sponsor: University of Puerto Rico
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2010-09-16
Enrollment: 90
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: TREATMENT

Brief summary: The purpose of this project is to implement culturally adapted Cognitive Behavioral Therapy (CBT) based interventions in general health settings that are delivered to reduce Generalized Anxiety Disorder (GAD) symptoms, increase levels of functioning, and improve health-related quality of life.

Detailed description: This project seeks to lay the foundation for an effectiveness trial that will lead to the advancement of CBT based treatments for GAD among Spanish-speaking Latinos, particularly Puerto Ricans. This area of research is important in light of the limited treatment options currently available for Spanish-speakers with GAD and the long-term negative consequences of this condition. Participants in this study are recruited in general health settings. Patients meeting criteria for enrollment will be randomly assigned to receive either cognitive behavior based therapy or treatment as usual. Assessments for all participants will be collected at baseline, post-treatment, and at two months follow-up visits.

Eligibility criteria: Inclusion Criteria:

* diagnosis of GAD
* 18 to 65 years
* Spanish speaker
* able to read and write
* plan to continue receiving services in the health care setting during the next six months

Exclusion Criteria:

* severe cognitive impairment, psychoses, history of bipolar disease, alcohol or drug abuse or dependence
* clinically judged to have a high acute suicide risk
* life-threatening medical condition
* currently receiving psychotherapy

Primary outcomes:
measure: Penn State Worry Questionnaire
timeFrame: Baseline
measure: Penn State Worry Questionnaire
timeFrame: Week 20
measure: Penn State Worry Questionnaire
timeFrame: Week 28.
Secondary outcomes:
measure: SF-36 Social Functioning Scale
timeFrame: Baseline
measure: SF-36 Social Functioning Scale
timeFrame: Week 20
measure: SF-36 Social Functioning Scale
timeFrame: Week 28
measure: Quality of Life Inventory
timeFrame: Baseline
measure: Quality of Life Inventory
timeFrame: Week 20
measure: Quality of Life Inventory
timeFrame: Week 28
Other outcomes:
Locations:
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico, Medical Sciences Campus
Study officials:
References:
Clinical trial NCT00618293: Haemate HS in Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis
Official title: Phase 2 Study in Evaluation of the Efficacy and Safety of Haemate HS in This Clinical Setting (Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Blood Loss, Surgical
Keywords: intraoperative bleeding
aortic-valve replacement
aortic stenosis
Von Willebrand
HEAMATE
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: CSL Behring
First posted: 2008-02-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation of efficacy by determination of transfusion requirements and safety by determination of adverse events in administration of Von Willebrand factor concentrate F VIII (Haemate).


Eligibility criteria: Inclusion Criteria:

* patients with isolated valvular aortic stenosis or combined aortic-valve defect with prevailing stenosis with severe bleeding during aortic-valve replacement
* Caucasian
* written informed consent (Classification of bleeding as "normal", "moderate" or "excessive" by the surgeon.Classification as excessive leads to recruitment)

Exclusion Criteria:

* active endocarditis
* history suggestive for inherited oe acquired bleeding disorder
* concomitant coronary heart disease
* agents impairing platelet function up to 14 days before surgery
* Pregnancy
* inherited platelet function
* known intolerance against HAEMATE HS
* previous thromboembolic complications
* Hepatitis B, C or HIV infection
* previous chemotherapy
* emergency surgery within the last 7 days
* weight \< 50 kg and \> 100 kg

Primary outcomes:
measure: intra- and postoperative transfusion requirements of packed red cells, platelet concentrates and fresh frozen plasma according to defined transfusion thresholds
timeFrame: begin of surgery and 48h after administration of medication
Secondary outcomes:
measure: Assessment of adverse events and viral safety
timeFrame: 1.perioperative 2. during hospital admission 3. within 90 days after surgery
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Klinik für Kardiovaskuläre Chirurgie
Study officials:
affiliation: Klinik für Kardiovaskuläre Chirurgie
name: Peter Feindt, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05724693: Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function
Official title: A Phase 1, Multicenter, Open-Label, Parallel-Group, Pharmacokinetic Single Dose Study of Bemnifosbuvir (AT-527) in Adult Subjects With Normal and Impaired Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Hepatic Impairment
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-02-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Bemnifosbuvir After a Single Dose


Eligibility criteria: Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* BMI of 18.5 to 42.0 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Subjects with Normal Hepatic Function (Groups 3 and 5):

* Medically healthy, in the opinion of an Investigator
* Must match by gender, age (± 10 years), and BMI (± 20%) to the pooled mean values of subjects with hepatic impairment

Hepatic Impaired Subjects (Groups 1, 2, and 4):

* Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator
* When applicable, presence of mild hepatic impairment (Child-Pugh Class A: score of 5 to 6), moderate hepatic impairment (Child-Pugh Class B: score of 7 to 9) or severe hepatic impairment (Child-Pugh Class C: score of 10 to 15). Hepatic impairment should be stable for at least 1 month prior to Screening

Exclusion Criteria:

* Pregnant or breastfeeding
* Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities

Hepatic Impaired Subjects (Groups 1, 2, and 4):

* Currently undergoing any method of dialysis
* History of liver transplant
* Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c (HbA1c) \> 10%
* Evidence of hepatic carcinoma presence at Screening

Primary outcomes:
measure: Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax)
timeFrame: Day 1
measure: Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC)
timeFrame: Day 1
measure: Pharmacokinetics (PK) of BEM AUC
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Atea Study Site Orlando Clinical Research Center
state: Florida
Study officials:
References: