louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00501501: The Association Between Delivery Method and Maternal Rehospitalization
Official title: The Association Between Delivery Method and Maternal Rehospitalization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hospitalization
Keywords: Rehospitalization
Cesarean
Vaginal delivery
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2007-07-16
Enrollment: 92
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: Hypothesis: The rates of rehospitalization after cesarean section are significantly higher than those following spontaneous vaginal delivery and are due mainly to late bleeding and less to infection.

Detailed description: To determine if there is an association between delivery method and maternal rehospitalization rate, the type of association and the reasons for rehospitalization.

The study population will consist women who were rehospitalized in the Western Galilee Hospital following cesarean section and after a vaginal delivery. Demographic data and hospitalization characteristics will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Parturients rehospitalized after delivery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Western Galilee Hospital
Study officials:
affiliation: Western Galilee Hospital
name: ido Solt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01811901: Reduction of In-hospital Delays in Stroke Thrombolysis: SITS-WATCH
Official title: Reduction of In-hospital Delays in Stroke Thrombolysis: SITS-WATCH
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: inhospital delays, door-to-needle time, thrombolysis, acute ischemic stroke, SITS, SITS-WATCH, stroke registry
Lead sponsor: SITS International
Sponsor class: NETWORK
First posted: 2013-03-15
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In patients with acute ischemic stroke: the sooner the thrombolysis treatment is administered after symptom onset - the better the outcome. This delay can be dissected into onset-to-door time and door-to-needle time (DNT). SITS-WATCH aims to reduce median DNT in participating centres.

Detailed description: In patients with acute ischemic stroke: the sooner the thrombolysis treatment is administered after symptom onset - the better the outcome. This delay can be dissected into onset-to-door time and door-to-needle time (DNT). Of the two, DNT can be directly influenced within the hospital by stream-lining of acute stroke care. The aim of our study is to reduce in-hospital delays (DNT) in self-selecting centers recruiting patients into the the Safe Implementation of Treatments in Stroke-International Stroke Thrombolysis Register (SITS-ISTR) , comprising currently more than 80 000 patients from 1338 centers. Current median of DNT in all SITS centers is 65 minutes (compared with 20 minutes in Helsinki Univer-sity Central Hospital). An itemized detailed questionnaire, including all factors known to influence DNT, has been sent to all SITS centers to identify the reasons for long in-hospital delays. Based on the replies, we have prepared a list of interventions that can be considered by individual SITS centers in order to reduce DNT with interventions that are in line with national legislation.

Eligibility criteria: Inclusion Criteria:

* All consecutive patients with acute ischemic stroke registered in SITS registry.

Exclusion Criteria:

* Centers not inputing patient data into SITS registry. Patients with missing DNT data.

Primary outcomes:
measure: Absolute DNT reduction of at least 20 minutes or at least 20% change in SITS-WATCH centers that completed the whole study period
timeFrame: January 2013-December 2014
Secondary outcomes:
measure: Significantly larger reduction of DNT in SITS-WATCH centers compared with non-SITS-WATCH centers in SITS.
timeFrame: 2014-2015
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: SITS International / Karolinska Hospital
Study officials:
References:
Clinical trial NCT02478801: Protein Requirements in Endurance-trained Athlete
Official title: Evaluation of Protein Requirements in Male Endurance Athletes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Increased Metabolic Requirement
Healthy
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Ajinomoto Co., Inc.
First posted: 2015-06-23
Enrollment: 9
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Protein requirements in individuals who participate in endurance-based exercise training have been suggested to be greater than the current recommended dietary allowance (RDA).

Nutritional requirements for dietary amino acids in adults have traditionally been determined utilizing the nitrogen balance technique, which is prone to underestimating protein requirements. As a result, there is a need to re-evaluate recommendations in order to characterize how dietary amino acid needs may be modulated by physical activity.

Recent studies using the minimally invasive indicator amino acid oxidation (IAAO) technique have suggested that protein requirements in young men are at least 50% higher than RDA based on nitrogen balance data.

Therefore, the purpose of this study is to measure the protein requirement in endurance trained adults using the IAAO technique.


Eligibility criteria: Inclusion Criteria:

* Healthy, male, endurance-trained participants who regularly more than 40 km/week
* Ability to perform the exercise stimulus (20 km run) on metabolic trial.

Exclusion Criteria:

* Inability to meet health and physical activity guidelines according to the physical activity readiness questionnaire (PAR-Q+)
* Inability to adhere to any of the protocol guidelines (i.e. alcohol, caffeine consumption)
* Regular tobacco use
* Illicit drug use

Primary outcomes:
measure: 13CO2 (carbon dioxide) excretion (μmol/kg/h)
timeFrame: 4 hours / study day
Secondary outcomes:
measure: [13C]phenylalanine oxidation (μmol/kg/h)
timeFrame: 4 hours/study day
Other outcomes:
Locations:
Study officials:
References:
citation: Kato H, Suzuki K, Bannai M, Moore DR. Protein Requirements Are Elevated in Endurance Athletes after Exercise as Determined by the Indicator Amino Acid Oxidation Method. PLoS One. 2016 Jun 20;11(6):e0157406. doi: 10.1371/journal.pone.0157406. eCollection 2016.
Clinical trial NCT03985501: DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry
Official title: DREPAMASSE Study - Evaluation of a Newborn Screening for Sickle Cell Disease by Tandem Mass Spectrometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sickle Cell Disease
Infant, Newborn, Disease
Drepanocytosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-06-13
Enrollment: 1431
Sex: ALL
Minimum age (years): 1
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants with SCD newborn screening conducted in the hospital center of Lyon

Brief summary: Three methods are actually used in newborn screening for sickle cell disease (SCD) in France: isoelectric focusing, high performance liquid chromatography and capillary electrophoresis. New technologies are currently under development such as Matrix Assisted Laser Desorption Ionisation - Time of Flight (MALDI-TOF) and tandem mass spectrometry (MS/MS) using the SpOtOn Diagnostics Reagent Kit available in United Kingdom only.

Zentech company (Liège, Belgium) is developing a package for SCD newborn screening using MS/MS technology. The main objective of the present study will be to compare this new technique with the technique actually used in the hospital center of Lille (sub-contractor for SCD newborn screening of Lyon) and the haemoglobin analysis to test its accuracy (sensitivity and specificity).


Eligibility criteria: Inclusion Criteria:

* Infants with SCD newborn screening conducted in the hospital center of Lyon

Exclusion Criteria:

* Insufficient quantity of sampling
* Parents' opposition to their newborn's participation in the study

Primary outcomes:
measure: Percent agreement between the two techniques
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Groupement Hospitalier Est - Hospices Civils de Lyon
city: Lyon
country: France
facility: Hopital de la Croix Rousse
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
Study officials:
References:
Clinical trial NCT05098301: Data Therapy Collection to Evaluate Performances of an Automated Insulin Titration Algorithm Compared to Standard Method of Titration
Official title: Data Therapy Collection to Evaluate Performances of an Automated Insulin Titration Algorithm Compared to Standard Method of Titration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: Diabetes
Functional insulin therapy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 diabetic patients

Brief summary: A data collection of blood glucose values, insulin, meal composition will be performed for a period of two months, to evaluate the performances of an automated insulin titration algorithm


Eligibility criteria: Inclusion criteria:

* Person with Type 1 diabetes
* Treated by basal-bolus therapy with MDI or pump
* Patient with social security or beneficiary of medical coverage
* Patient using functional insulin therapy or starting and education course
* Patient able to read and understand the procedure, and able to express consent for study protocol

Exclusion criteria:

* Patient abusing substances
* Patient deprived of liberty by judicial or administrative decision, person subject to a legal protection measure, patient having a psychological condition making him unable to follow and understand study protocol

Primary outcomes:
measure: evaluate the performances of an insulin titration algorithm
timeFrame: day 1
Secondary outcomes:
measure: measure time-in-range evolution adjustment of insulin therapy parameters
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Eric RENARD, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04963101: RNA-seq Analysis of PBMC in Patients With OPLL
Official title: Characteristics of Transcriptome Expression Profile of PBMCs in Patients With Ossification of the Posterior Longitudinal Ligament
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: OPLL
PBMCs
Transcriptome
Bioinformatics
Lead sponsor: Fifth Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 30 peripheral blood samples were enrolled in this study, including 15 cases in the OPLL disease group and 15 cases in the non-OPLL control group.

Brief summary: In this study, we planned to identify transcriptome expression profiles (circRNAs, lncRNAs, and mRNAs) from peripheral blood mononuclear cells (PBMCs) of 30 patients with OPLL and 30 other non-OPLL patients by high-throughput sequencing.Sequence analysis was used to predict miRNAs that might bind circRNAs and lncRNAs.Through bioinformatics analysis, competitive endogenous RNAs (cerRNAs), as well as coexpression networks among circRNAs, lncRNAs, miRNAs, and mRNAs, were constructed to provide key molecules and signaling pathways associated with OPLL.


Eligibility criteria: Inclusion Criteria:

1. Voluntarily participate in the clinical study and sign the informed consent;
2. All OPLL patients meet the diagnostic criteria set out in the JOA Clinical Practice Guidelines for Spinal Ligament Osification 2019;
3. Age ≥18, gender unlimited;
4. All non-OPLL patients and healthy volunteers have no serious diseases of the heart, lung, brain, liver, kidney and blood system, such as autoimmune diseases, tumors, psychosis, infectious diseases, etc., and have no bad habits or recent history of taking special drugs.

Exclusion Criteria:

1. Unable to sign the informed consent;
2. Patients who do not meet the inclusion criteria or diagnostic criteria;
3. \<18 years old;
4. Women planning to become pregnant/lactating/pregnant;
5. Complicated with serious heart, lung, brain, liver, kidney, blood system diseases, such as autoimmune diseases, tumors, mental illness, infectious diseases, drug addiction and other bad addicts;Those who have recently taken special drugs;
6. Individuals who do not agree to donate peripheral blood or who are obviously uncomfortable with drawing blood.

Primary outcomes:
measure: circRNA, lncRNA, mRNA
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: Facility
state: Guangdong
Study officials:
References:
Clinical trial NCT01481701: A Trial Evaluating Efficacy and Safety of Oxaliplatin With 5-Fluorouracil in Patients With Recurrent Ovarian Carcinoma
Official title: A Non Randomized Stratified Phase II Trial Evaluating Efficacy and Safety of Oxaliplatin in Combination With 5-Fluorouracil in Patients With Platinum-sensitive and Platinum-resistant Recurrent Ovarian Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Carcinoma
Relapse
Keywords: ovarian carcinoma
Bordet
relapse
Lead sponsor: Jules Bordet Institute
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase II study for recurrent ovarian carcinoma platinum-sensitive and resistant tumors Folfox regimen.

Detailed description: Evaluation of the safety and the efficacy of a combination of oxaliplatin and 5FU (Folfox) in patients with ovarian carcinoma relapsing either after platinum-combined regimen.

The Folfox regimen is administered every 14 days. Evaluation of the toxicity is performed at each cycle and evaluation of the efficacy every 4 cycles of chemotherapy.

Eligibility criteria: Inclusion Criteria:

* ovarian carcinoma relapse

Exclusion Criteria:

* neurotoxicity grade III renal clearance \< 60 ml/min

Primary outcomes:
measure: Objective response rate
timeFrame: at 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Institut Jules Bordet
Study officials:
affiliation: Jules Bordet Institute
name: Veronique D'Hondt, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03852446: Single Ascending Dose PK, Oral Bioavailability and Food Effect Study in Healthy Male Volunteers
Official title: A Phase 1, Randomized Trial to Evaluate the Pharmacokinetics and Safety of Single Ascending Doses of Indoximod HCl (F2) Tablets (Part 1) and to Compare the Oral Bioavailability of Indoximod Cl (F2) Tablets and Indoximod Free Base Capsule Formulations and the Effect of Food (Part 2) in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: Indoximod
Lead sponsor: Lumos Pharma
Sponsor class: INDUSTRY
First posted: 2019-02-25
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This 2-part study will assess the effect of formulation and food on the pharmacokinetics of Indoximod in healthy volunteers. Part 1 is a randomized single ascending dose study of indoximod salt formulation to characterize the PK profile and determine the safety and tolerability of each dose in healthy male volunteers. Part 2 is an open-label, randomized, 3-period, 3-way crossover study. Participants will receive single doses of Indoximod base or salt formulation, in the fasted or fed state.


Eligibility criteria: Inclusion Criteria:

* Non-smoker for at least 3 months
* BMI within 18 to 30 kg/m2
* Able to speak, read, and understand English or Spanish

Exclusion Criteria:

* Clinically significant cardiac, pulmonary, hepatic or renal disease
* History of substance abuse or alcohol dependence within past 2 years
* Inability to fast for a minimum of 14 hours
* Inability to swallow large capsules/tablets
* Pending legal charges or is on probation

Primary outcomes:
measure: Area Under the Plasma Concentration-Time Curve
timeFrame: up to 20 Days
measure: Pharmacokinetics: Serum concentrations (Cmax/Steady State)
timeFrame: up to 20 Days
measure: Pharmacokinetics: Serum concentrations (Cmax/Steady State)
timeFrame: up to 4 Days
Secondary outcomes:
measure: Percentage of patients with adverse events
timeFrame: up to 18 Days
measure: Percentage of patients with adverse events
timeFrame: up to 36 Days
Other outcomes:
Locations:
city: Secaucus
country: United States
facility: Frontage Clinical Services, Inc.
state: New Jersey
Study officials:
affiliation: NewLink Genetics Inc
name: Eugene Kennedy, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04772846: Chloroquine for Glioblastoma.
Official title: Adjuvant Chloroquine to the Conventional Treatment for Glioblastoma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Glioblastoma
Lead sponsor: Egyptian Medical Syndicate
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adjuvant chloroquine to the conventional treatment for glioblastoma; A randomized, single-blind, placebo-controlled, phase I/II trial.


Eligibility criteria: Inclusion Criteria:

Histologically confirmed glioblastoma Adequate hematologic, hepatic, and renal function Karnofsky performance status score ≥ 70% Life expectancy ≥ six weeks

Exclusion Criteria:

Abnormal severe un-controlled medical conditions

Primary outcomes:
measure: Survival duration after surgery
timeFrame: Three years
Secondary outcomes:
measure: End-point evaluation, survival at three years
timeFrame: Three years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Private clinics
Study officials:
References:
Clinical trial NCT01073046: Gastric Decompression After Sub-total Gastrectomy
Official title: Naso-gastric/Jejunal Tube Placement After Sub-total Gastrectomy. A Multicenter Prospective Randomized Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: Naso-Gastric/Jejunal Tube
Sub-total Gastrectomy
Gastric Cancer
Decompression
Discomfort
Complications
Lead sponsor: Catholic University, Italy
Sponsor class: OTHER
Collaborators: name: Italian Research Group For Gastric Cancer - IRGGC
First posted: 2010-02-23
Enrollment: 276
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be included, using a randomization list provided to each center, in one of two groups:

1. placement of a polyurethane nasogastric/jejunal tube, preferentially 12-14 Fr;
2. no feeding tube placement.

Brief summary: The purpose of this study is to test the utility of the nasogastric tube, which is used to decompress and as "guardian" of gastro-jejunal anastomosis, in patients undergoing distal subtotal gastrectomy for gastric cancer with reconstruction according to Billroth II or according Roux.

Detailed description: A silastic naso-gastric tube (Rusch® distributed by Teleflex Medical Srl) is used in the naso-gastric/jejunal tube group

Eligibility criteria: Inclusion Criteria:

* All people subjected to subtotal gastrectomy for distal gastric adenocarcinoma.

Exclusion Criteria:

* People undergoing enteral nutrition through naso-jejunal tube

Primary outcomes:
measure: Influence of Naso-Gastric/Jejunal Tube on Postoperative complications
timeFrame: 2 years
Secondary outcomes:
measure: Influence of Naso-Gastric/Jejunal Tube on Postoperative Patient's Comfort
timeFrame: 2 years
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Digestive Surgery, Catholic University
Study officials:
References:
citation: Pacelli F, Rosa F, Marrelli D, Morgagni P, Framarini M, Cristadoro L, Pedrazzani C, Casadei R, Cozzaglio L, Covino M, Donini A, Roviello F, de Manzoni G, Doglietto GB. Naso-gastric or naso-jejunal decompression after partial distal gastrectomy for gastric cancer. Final results of a multicenter prospective randomized trial. Gastric Cancer. 2014 Oct;17(4):725-32. doi: 10.1007/s10120-013-0319-x. Epub 2013 Nov 30.
Clinical trial NCT02217046: Decrease Implantation Site INFECTION : a Randomized Controlled Trial
Official title: Phase 1 Study of Prevention of Cardiac Device Replacement Site Infection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infection
Keywords: Infection
prevention
cardiac devices
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2014-08-15
Enrollment: 352
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: Cardiovascular implantable electronic device (CIED) infections have been increasing out of proportion to the number of devices implanted the investigators investigated recent trends and possible causes of the increasing numbers of Cardiovascular implantable electronic device infections.

Detailed description: There are many studies on the preventive use of Antibiotics or povidone iodine to Cardiovascular implantable electronic device (CIED) infections.

But, studies of posterior pocket capsule removal is still limited.

The investigators had planned research on effects of posterior pocket capsule removal before cardiac devices replacement.

Eligibility criteria: Inclusion Criteria:

* scheduled for cardiac devices replacement

Exclusion Criteria:

* under the age of 18
* take an antibiotic
* history of infection within 30 days

Primary outcomes:
measure: freedom of cardiac device-related infection
timeFrame: 1 year after precedure
Secondary outcomes:
measure: freedom of endocarditis
timeFrame: 1 year after precedure
Other outcomes:
measure: freedom of general infection
timeFrame: 1 year after procedure
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
state: Seo Ch-gu
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Yong Seog Oh, Ph.D
role: STUDY_CHAIR
References: