louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02567786: Fresh Frozen Plasma and Plasmalyte ® for Priming Cardiopulmonary Bypass in Infants and Children
Official title: Comparison of Fresh Frozen Plasma and Plasmalyte ® for Priming Cardiopulmonary Bypass in Infants and Children Undergoing Open-heart Surgery: A Double-blind Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-10-05
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 70
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Coagulation abnormalities after pediatric open-heart surgery are complex and very often multifactorial. Besides the cardiopulmonary bypass (CPB), the congenital pathology and the coagulation tests during CPB, the younger age has been the most significant risk factor for bleeding and transfusion requirements. In children the volume of pump priming is much higher compared with the patient's circulating blood volume. For this reason the CPB tubing system is primed with packed red blood cells and fresh frozen plasma (FFP) to avoid excessive hemodilution and induced coagulopathy. While this is routinely performed in neonates and small infants, the routine priming of CPB system with FFP has been questioned in several randomized prospective studies in older infants. However, the results of these studies are conflicting. Moreover, they show methodological issues.


Eligibility criteria: Inclusion Criteria:

* Children weighing between 7 and 15 kg and admitted to undergo open-heart surgery with CPB

Exclusion Criteria:

* Patients with preoperative coagulation abnormalities
* Parental refusal
* Emergency surgery
* Patients with preoperative renal or hepatic dysfunction

Primary outcomes:
measure: Postoperative bleeding (mL blood in the chest tubes). Significant postoperative bleeding is defined as a bleeding of > 5ml/kg/h in the first 6hours postoperatively.
timeFrame: The first 6 hours postoperatively
measure: Increased risk of of donor exposure intraoperatively and postoperatively.
timeFrame: The first 6 hours postoperatively
Secondary outcomes:
measure: Volume of transfused allogenic blood products (mL).
timeFrame: The first 6 hours postoperatively
measure: Comparison of Rotem and Multiplate between both groups.
timeFrame: The first 6 hours postoperatively
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Mona Momeni
Study officials:
affiliation: Université Catholique de Louvain; Cliniques Universitaires Saint Luc
name: Mona Momeni, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01824186: Trial Comparing Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
Official title: A Randomized Controlled Trial Comparing Post-operative Pain in Single-incision Laparoscopic Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholelithiasis
Choledocholithiasis
Cholecystolithiasis
Pancreatitis
Cholangitis
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate post-operative pain in single-incision laparoscopic cholecystectomy (SILC) versus the conventional four port technique (LC). The investigators hypothesize that SILC is non-inferior in post-operative pain.

Detailed description: As above

Eligibility criteria: Inclusion Criteria:

* presence of symptomatic gallstones
* American Society of Anesthesiologists (ASA) score 1 or 2
* informed consent

Exclusion Criteria:

* active acute cholecystitis
* previous open upper abdominal surgery
* bleeding disorders

Primary outcomes:
measure: Post-operative pain 4 hours
timeFrame: 4 hours post-operative
measure: Post-operative pain 24 hours
timeFrame: 24 hours post-operative
measure: Post-operative pain 14 days
timeFrame: 14 days post-operative
measure: Post-operative pain 6 months
timeFrame: 6 months post-operative
Secondary outcomes:
measure: Procedural complications
timeFrame: 6 months
measure: Operative duration
timeFrame: following skin closure
measure: Subject satisfaction
timeFrame: 14 days and 6 months
measure: Return to function
timeFrame: 14 days
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: National University Hospital, Singapore
name: Stephen Kin Yong Chang, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chang SK, Wang YL, Shen L, Iyer SG, Madhavan K. A randomized controlled trial comparing post-operative pain in single-incision laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy. World J Surg. 2015 Apr;39(4):897-904. doi: 10.1007/s00268-014-2903-6.
Clinical trial NCT01934686: A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Indonesia
Official title: A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Indonesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-09-04
Enrollment: 1862
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People having been treated for at least a year are eligible for the study. The selection of the patients will be done randomly by the individual physician involved in the study.

Brief summary: This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in Indonesia.


Eligibility criteria: Inclusion Criteria:

* People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months
* Patients willing to sign informed consent form

Exclusion Criteria:

* Previous participation in this study
* Unable to comply with protocol requirements
* Confirmed or suspected pregnancy

Primary outcomes:
measure: Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7%
timeFrame: Evaluated at the first visit (only one study visit)
Secondary outcomes:
measure: Mean Postprandial Plasma Glucose (PPG) of patients
timeFrame: Evaluated at the first visit (only one study visit)
measure: Mean HbA1c of patients
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having dyslipidemia
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having hypertension
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having cardiovascular complications
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having peripheral vascular disease
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having diabetic nephropathy
timeFrame: Evaluated at the first visit (only one study visit)
measure: Proportion of patients having diabetic eye complications
timeFrame: Evaluated at the first visit (only one study visit)
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05158686: Use of Drug-Coated Balloon to Improve Recanalization of a Coronary Chronic Total Occlusion After Failed Angioplasty
Official title: Use of Drug-Coated Balloon to Improve Recanalization of a Coronary Chronic Total Occlusion After Failed Angioplasty: The IMPROVED-RECTO Trial.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Total Occlusion
Keywords: Repeated procedure, Angioplasty, Paclitaxel, drug-coated balloon
Lead sponsor: Hospital Clínico Universitario de Valladolid
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with coronary angiography in which percutaneous coronary intervention results in failure during treatment of a CTO. Indication of the procedures will be clinically driven. Informed consent will be provided after the first failed attempt of CTO recanalization.

Brief summary: Observational retrospective registry to compare effectiveness of paclitaxel-coated vs. non coated balloon angioplasty proximal to a Chronic Total Occlussion (CTO) after failed revascularization. Primary objective is to determine success rate after repeated percutaneous coronary intervention of a CTO 3 to 6 months after paclitaxel-coated balloon angioplasty proximal to the persistent lesion.


Eligibility criteria: Inclusion Criteria:

* Failed recanalization of a CTO in patients with clinical indication for the percutaneous procedure.
* Patient willing to participate in the study providing signed informed consent.
* J-CTO Score ≥2.

Exclusion Criteria:

- Unfeasible recanalization of the CTO according to the interventional cardiologists of the center.

Primary outcomes:
measure: Success of repeated percutaneous coronary intervention of a CTO 3 to 6 months after balloon angioplasty proximal to the persistent lesion.
timeFrame: 6 months
Secondary outcomes:
measure: Mortality after second attempt of CTO recanalization
timeFrame: 6 months
measure: Quality of life assessed by EQ5D questionnaire
timeFrame: 6 months
measure: Procedural duration during second attempt
timeFrame: 6 months
measure: Radiation during second attempt
timeFrame: 6 months
measure: Contrast administration during second attempt
timeFrame: 6 months
measure: Events at 1-year follow-up
timeFrame: 1 year
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
References:
Clinical trial NCT00629486: Genetic Polymorphisms of Interleukin-1B and TNF-A and HBV-Related Hepatocellular Carcinoma
Official title: Genetic Polymorphisms of Interleukin-1B and TNF-A and HBV-Related Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis B
Hepatocellular Carcinoma
Chronic Liver Disease
Keywords: cytokine gene
hepatitis B
hepatocellular carcinoma
chronic liver disease
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
First posted: 2008-03-06
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: By detecting polymorphisms of IL-1β and TNF-α,this study aims to find the effects of cytokine gene polymorphisms(and their interaction) on susceptibility and severity of HBV-related HCC.

Detailed description: Hepatitis B virus (HBV)infection is the major risk factor for chronic liver disease and hepatocellular carcinoma (HCC). Host immunogenetic factors contribute to HBV-associated liver damage and/or carcinogenesis. Variant cytokine alleles, including tumor necrosis factor-α(TNF-α)and interleukin-1β(IL-1β), might contribute to interindividual difference in inflammatory responses and account for heterogeneous disease outcome of infectious disease.

By detecting polymorphisms of IL-1β and TNF-α,this study aims to find the effects of cytokine gene polymorphisms(and their interaction) on susceptibility and severity of HBV-related HCC.

Eligibility criteria: Inclusion Criteria:

* HBsAg-positive patients

Exclusion Criteria:

* HBsAg-negative patients

Primary outcomes:
measure: cytokine polymorphisms increase risk for hepatocellular carcinoma
timeFrame: years
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
Study officials:
affiliation: Professor of Medicine
name: Jung-Fa Tsai, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02149186: Interactive Motor Imagery in Virtual Reality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Stroke
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 79
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This project will build and test the first rehabilitation system employing virtual reality (VR)-based observation, motor imagery and execution to treat lower-limb neuropathic pain and motor dysfunction in participants with an incomplete spinal cord injury or another neurological disorder, eg. stroke: iCTuS-L (Interactive Computer-based Therapy System for legs). Patients using the system will control virtual representations of their legs to engage in entertaining gaming interactions.


Eligibility criteria: Inclusion Criteria:

* Age between 16 and 80
* clinically incomplete spinal cord injury (time since injury: chronic \> 1 year; acute \< 3 months)
* ASI C or D
* neuropathic pain and/or motor deficits
* diagnosed neurological disorder, eg. stroke

Exclusion Criteria:

* any disease limiting training
* epilepsy
* major depression or psychosis

Primary outcomes:
measure: Sensorimotor Assessment
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Curt, Armin, MD
Study officials:
References:
citation: Villiger M, Liviero J, Awai L, Stoop R, Pyk P, Clijsen R, Curt A, Eng K, Bolliger M. Home-Based Virtual Reality-Augmented Training Improves Lower Limb Muscle Strength, Balance, and Functional Mobility following Chronic Incomplete Spinal Cord Injury. Front Neurol. 2017 Nov 28;8:635. doi: 10.3389/fneur.2017.00635. eCollection 2017.
Clinical trial NCT04938986: Interest of the Immunoscore® as a Post-operative Complementary Tool for the Detection of the Risk of Recurrence in Patients With Nonmetastatic Colorectal Cancer
Official title: Interest of the Immunoscore® as a Post-operative Complementary Tool for the Detection of the Risk of Recurrence in Patients With Nonmetastatic Colorectal Cancer : Prospective Cohort Comparing the Recommandation for Patient Care According to the Immunoscore® With the Standard Care Decision.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Metastatic Colorectal Cancer
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluate the patient care recommandation induced by the IMMUNOSCORE® result


Eligibility criteria: Inclusion Criteria:

* age between 18 and 80 inclusive;
* histologically confirmed colon adenocarcinoma;
* having undergone a curative resection of stage I, II or III colorectal cancer;
* diagnosed T1 / T2 / T3 / T4 and N0 / N1 / N2;
* eligible to receive 6 months of adjuvant chemotherapy;
* having given free, informed and written consent;
* agreeing to the use of a tumor sample for research purposes;
* being affiliated to a social security system.

Exclusion Criteria:

* pregnant or breastfeeding women
* legal incapacity or physical, psychological, social or geographical conditions preventing the patient from signing the consent or completing the study.
* history of other solid tumor within 3 years before inclusion, with the exception of in-situ cancer of the cervix and skin cancers (basal or squamous) treated and controlled
* person subject to a safeguard measure.

Primary outcomes:
measure: Number of cases where the recommendations for patient care according to the Immunoscore® are considered beneficial compared to the standard care decision
timeFrame: 5 years
Secondary outcomes:
measure: Replication error (RER) phenotype
timeFrame: 6 and 9 months
measure: KRAS, NRAS and BRAF mutations
timeFrame: 6 and 9 months
measure: Ratio of ciruclating tumor DNA level
timeFrame: 6 and 9 months
measure: Actual survival (patient alive without recurrence, alive with recurrence, dead)
timeFrame: 5 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hôpital Européen
city: Marseille
country: France
facility: Hopital Saint Joseph
Study officials:
affiliation: Hopital Saint Joseph Marseille
name: Hervé PERRIER, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Européen Marseille
name: Yves RINALDI, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06394986: Cardio-fistular Recirculation in Patients With Chronic Heart Failure and Preserved Left Ventricle Ejection Fraction
Official title: Cardio-fistular Recirculation in Patients With Chronic Heart Failure and Preserved Left Ventricle Ejection Fraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease 5D
Heart Failure
Heart Failure NYHA Class I
Heart Failure NYHA Class II
Keywords: arteriovenous fistula
hemodialysis
cardiac output
heart failure
volume blood flow
cardio-fistular recirculation
cardiopulmonary recirculation
ejection fraction
Lead sponsor: Moscow Regional Research and Clinical Institute (MONIKI)
Sponsor class: OTHER_GOV
First posted: 2024-05-01
Enrollment: 20
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: Stable adult patients on maintenance hemodialysis.

Brief summary: This is a single-arm cohort study aimed to evaluate change of arteriovenous fistula volume blood flow / cardiac output ratio in patients with chronic heart failure (NYHA I-II classes) and with preserved ejection fraction as a result of a hemodialysis session after a "long" interdialysis interval.


Eligibility criteria: Inclusion Criteria:

* signed informed consent,
* \> 18 years
* maintenance ("chronic") hemodialysis,
* native arteriovenous fistula,
* arteriovenous fistula volume blood flow ≥1 l/min,
* arteriovenous fistula volume blood flow / cardiac output ratio \< 0.3,
* interdialysis weight gain \<5% of "dry" body weight,
* sufficient hemodialysis dose (eKt/V \> 1.2),
* chronic heart failure (NYHA I-II classes only),
* preserved left ventricular ejection fraction (≥50%),
* absence of arrhythmias (except first-degree atrioventricular block block),
* absence of heart valve disease (except mitral regurgitation grade I-II),
* absence of intradialysis hypo/hypertension
* "long" interdialysis interval (3 days).

Exclusion Criteria:

* hypo/hypertension during or after hemodialysis,
* arrhythmias (except first-degree atrioventricular block) after hemodialysis.

Primary outcomes:
measure: Change in cardio-fistular recirculation
timeFrame: One hour before and two hours after the hemodialysis session.
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Regional Research and Clinical Institute (MONIKI)
Study officials:
affiliation: Moscow Regional Research and Clinical Institute (MONIKI)
name: Alexey B Zulkarnaev, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03856086: Comparing Distress Screening + Consultation With Enhanced Usual Care for Caregivers of Cancer Patients
Official title: The Impact of Caregiver Distress Screening, Targeted Referral and Consultation on MSK Caregiver, Patient and Health System Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer Caregivers
Keywords: Comparing Distress Screening
Consultation With Enhanced Usual Care
Supportive care
18-539
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: University of Virginia
First posted: 2019-02-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized between screening with the CSS-CG + consultation (S+C, and enhanced usual care.
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will help the researchers find out whether the S+C approach is better, the same as, or worse than EUC.


Eligibility criteria: Inclusion Criteria:

* Self-identified caregiver to a patient receiving surgery at JRSC OR self-identified caregiver to a patient at various inpatient surgical floors (i.e., M4, M7, M8) at the Main Hospital OR self-identified caregiver to a patient at the BMT clinic.
* English fluency: Self-report by subject identifying English as the preferred language for healthcare, and self-reported degree of fluency as speaking English "Very well."
* 18 years old or older as per self report
* Agree to fulfill responsibilities as an IC during the perioperative phases as per self report

Exclusion Criteria:

* Cognitive difficulties that preclude participation in the intervention or accurate assessment in the judgment of the PI
* Medical illness that is of sufficient severity to preclude further participation in the study.
* Presenting to JRSC as the IC for a patient undergoing a prophylactic procedure

Primary outcomes:
measure: Number of Informal caregivers with unmet needs
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Allison Applebaum, PhD
role: PRINCIPAL_INVESTIGATOR
References: