louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01510314: Inflammatory Markers After COloRectal Surgery)
Official title: Comparison of C-reactive Protein and Procalcitonin to Detect Infectious Complications After Elective Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infectious Complications After Colorectal Surgery
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2012-01-16
Enrollment: 552
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The clinical symptoms of septic complications (SC) (responsible for the majority of morbidity in colorectal surgery) become apparent only 5-7 days after the operation, whereas the efficacy of treatment depends on early diagnosis. By detecting such complications early it could be possible to reduce their severity, the length of hospitalisation, repeat colostomy and the number of readmissions. Our team has shown that C-reactive protein (CRP) \> 125 mg/L at postoperative day 4 (D4) was a predictor of SC in this context. Procalcitonin (PCT) is a marker of sepsis currently used in intensive care, but its use in the follow-up of elective surgery, particularly colorectal surgery, has not been fully evaluated.

The aim of this study is to compare the ability of CRP and PCT to detect SC as early as postoperative day 2 (D2) (intra-abdominal or systemic SC, such as those defined by the CDC) after elective colorectal surgery.

Adult patients about to undergo elective colorectal surgery with anastomosis will be included once they have given their written informed consent. Levels of CRP and PCT will be measured the day before the surgery, then at D1, D2, D3 and D4. The clinical data (temperature, recovery of bowel movement, pain, pain on palpation) will be recorded daily. Imaging examinations will be performed at the discretion of the surgeon; the only obligation will be to perform a contrast-enhanced abdominopelvic CT-scan if CRP at D4 \> 125 mg/L with no other clinical anomalies. The discriminating ability (measured by the area under the ROC curve) of CRP at D2 was 0.653 in our previous study. An improvement of at least 0.1 will be necessary to show the superiority of PCT over CRP in clinical terms and with regard to the cost.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective colorectal surgery with anastomosis for benign or malignant disease
* \> 18 years old
* Giving written informed consent
* Included in the national health insurance

Exclusion Criteria:

* Emergent surgery
* Previous infection
* Patients undergoing Hyperthermic Intraperitoneal Chemotherapy
* Pregnancy

Primary outcomes:
measure: Intraabdominal infection
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
city: Dijon
country: France
facility: CGFL
city: Dijon
country: France
facility: CHU Dijon
Study officials:
affiliation: Centre Hospitalier Universitaire Dijon
name: Pablo Ortega-Deballon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04210414: Cleave-stage Transfer on Day 3 Versus Day 5 Transfer When Only One Embryo Available
Official title: Transfer of Single Embryo on Day 3 or 5 When Only One Embryo Transfer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
First posted: 2019-12-24
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: When only one embryo is available after in vitro fertilization, the option is to transfer either day 3 or day 5. There is no randomized trial compared the day 3 to day 5 for this subgroup.

Detailed description: Recruitment is very slow. The TSC will discuss termination next meeting with the DMC.

Eligibility criteria: Inclusion Criteria:

* Infertile couple with only one embryo available for transfer

Exclusion Criteria:

* ineligible for study

Primary outcomes:
measure: Ongoing pregnancy rate
timeFrame: within 20 weeks of gestation
Secondary outcomes:
measure: Biochemical pregnancy rate
timeFrame: One month
measure: clinical pregnancy
timeFrame: 7 weeks of gestation
measure: Embryo development after In vitro fertilization cycle
timeFrame: 6 days after in vitro fertilization
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon Assiut
city: Qena
country: Egypt
facility: Qena Fertility Center
city: Sohag
country: Egypt
facility: IbnSina IVF Center, IbnSina Hospital
Study officials:
References:
Clinical trial NCT04656314: Renal Functional Magnetic Resonance Imaging in Healthy Persons - Reproducibility and Impact of Stress
Official title: Renal Functional Magnetic Resonance Imaging in Healthy Persons - Reproducibility and Impact of Stress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2020-12-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy participants

Brief summary: The main purpose of the study is to describe the applicability and reproducibility of functional MRI scans of the kidneys in healthy participants. Furthermore, the study examines to what extent physiological stress caused by lying in a scanner affects the renal perfusion and thus the reproducibility

Detailed description: 2 groups of 10 healthy participants each are included. 1 group aged 18 to 40 and a group of participants above 60 years of age.

The functional MRI sequences are performed consecutively in a protocol set up on a 1,5 T MRI scanner.

In totl, 3 identical scans are being performed. 2 scans on day 1 followed by another scan 1-2 weeks later. Before and after each scan, cortisol and copeptin is controlled in a blood sample to quantify the level of physiological stress.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 40
* Age of 60 or above

Exclusion Criteria:

* Known kidney or cardiovascular disease
* Medicine of any kind, that must be taken on days of scanning
* MRi incompatible implants or other contraindications to MRi
* Claustrophobia
* Not being able to lie still in an hour
* Body weight above 110 kg or waist circumference above 95 cm
* Pregnancy

Primary outcomes:
measure: Reproducibility
timeFrame: Results from scans performed with an interval of 1 to 2 weeks are compared
measure: Physiological stress
timeFrame: Results from scans performed with an interval of 1 to 2 weeks are compared
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
state: Region Midt
Study officials:
References:
Clinical trial NCT04998214: Hepatic Manifestations and Effect of Long COVID-19 on Patients With Chronic Liver Disease
Official title: Hepatic Manifestations and Effect of Long COVID-19 on Patients With Chronic Liver Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years old, 1 month post COVID 19 infection.

Brief summary: To measure the frequency of persistent liver dysfunction (raised liver enzymes, serum albumin, prothrombin time, etc) in recovered COVID -19 patients.

To compare the hepatic manifestations in post COVID -19 patients with and without liver disease

Detailed description: The digestive tract, particularly the liver, has recently been reported to be affected by SARS-CoV-2. Although abnormal liver enzymes were regularly described as an extra-pulmonary clinical feature, and almost one half of patients experienced grades of hepatic injury. liver damage in patients with SARS infections was primarily manifested in the mild and moderate elevation of alanine and/or aspartate aminotransferases (ALT and AST) with some degree of hypoalbuminemia and hyperbilirubinemia during the early stage of the illness.

Eligibility criteria: Inclusion Criteria:

* Patients previously diagnosed by COVID 19 eg : PCR and / or HRCT chest, lab of more than 1 month duration.

Exclusion Criteria:

* Patients less than 18 y.
* Patients with acute COVID 19.

Primary outcomes:
measure: to evaluate the long term effect of COVID 19 on the liver
timeFrame: 1 month
Secondary outcomes:
measure: : Effect of COVID 19 on diseased liver
timeFrame: 1 month
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Assiut University
name: Khaled Abu Bakr
role: STUDY_DIRECTOR
References:
citation: Ye ZW, Yuan S, Yuen KS, Fung SY, Chan CP, Jin DY. Zoonotic origins of human coronaviruses. Int J Biol Sci. 2020 Mar 15;16(10):1686-1697. doi: 10.7150/ijbs.45472. eCollection 2020.
citation: Fung SY, Yuen KS, Ye ZW, Chan CP, Jin DY. A tug-of-war between severe acute respiratory syndrome coronavirus 2 and host antiviral defence: lessons from other pathogenic viruses. Emerg Microbes Infect. 2020 Mar 14;9(1):558-570. doi: 10.1080/22221751.2020.1736644. eCollection 2020.
citation: Sultan S, Lim JK, Altayar O, Davitkov P, Feuerstein JD, Siddique SM, Falck-Ytter Y, El-Serag HB; AGA Institute. Electronic address: ewilson@gastro.org. AGA Rapid Recommendations for Gastrointestinal Procedures During the COVID-19 Pandemic. Gastroenterology. 2020 Aug;159(2):739-758.e4. doi: 10.1053/j.gastro.2020.03.072. Epub 2020 Apr 1. No abstract available.
Clinical trial NCT05099614: Naloxone Auto-injection in Healthy Volunteers
Official title: Naloxone Administration Via Auto-injection in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Overdose Antidote
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: U.S. National Science Foundation
First posted: 2021-10-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study continues the work to develop a mobile breathing monitoring system to detect slowed breathing and overdose events caused by opioid use. This is a single-site feasibility study designed to test the mobile application with a commercially available drug delivery device called the SmartDose by West Pharmaceuticals, Inc. The SmartDose is a wearable self-injection device that can deliver a drug under the skin with a push of a button. Naloxone is a drug used to reverse the effects of opioid drugs in the body. This study will evaluate if the mobile application can wireless trigger the delivery of a small dose of naloxone to a healthy adult volunteer.


Eligibility criteria: Inclusion Criteria:

* Healthy male/female volunteers
* \>18 years
* No allergy to naloxone or ingredients in its formulation
* Ability to read and understand English
* Written informed consent obtained from subject
* Ability to comply with study requirements

Exclusion Criteria:

* History of alcohol or substance abuse
* History of unusual pain sensitivity, lack of sensitivity
* History of chronic myofascial, inflammatory, neuropathic pain
* Chronic use of medication known to interfere with naloxone
* Pregnant women and nursing mothers
* Presence of a condition or abnormality that in the opinion of the Principal Investigator would compromise subject safety or the quality of the data (e.g., persons with liver disease, renal insufficiency/failure)
* Alcohol on the breath

Primary outcomes:
measure: Detection of slowed breathing that triggers the successful actuation of the auto-injector
timeFrame: The participant breathes to 8 breaths per minute and the breath hold (15 - 30 seconds) triggers the auto-injector. This will take place over 1 -3 minutes.
measure: Plasma concentration of naloxone in blood samples
timeFrame: Blood sampling at 3 and 8 minutes after the auto injector is triggered
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Jacob Sunshine, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04522414: PremCry Study : Study of Ontogeny of Crying in Preterm Infants.
Official title: PremCry Study : Study of Ontogeny of Crying in Preterm Infants.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preterm Birth
Keywords: Newborn
ontogeny of crying
preterm infants
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infant born between 26 and 33 amenorrhea week will be included.

Brief summary: Crying is a survival mechanism for babies and their almost exclusive means of expression until the age of 4 months. Babies 'cry is mostly related to pain, a feeling of hunger, discomfort or separation following the departure of a parent around. Crying is a complex but essential means of communication and information between a baby and his parents that raises the question of their meaning.

Very few longitudinal studies have been produced on preterm's crying. As the term approaches, the characteristics of preterm babies' crying are similar to those of term infants. But these studies date back more than 30 years and are obsolete in terms of the quality and performance of sound recording equipment and signal processing.

No study has looked at the genesis of the cry itself and the varieties of the cry of the preterm baby, depending on whether it was in a situation of hunger, pain, discomfort (bath).

Detailed description: This longitudinal study recordings of crying babies from 26 amenorrhea week to 33 amenorrhea week, 24 hours per week, each week until the return home. In the same time, parents will be asked to know the situation of the baby (hunger, pain, bath).

Eligibility criteria: Inclusion Criteria:

* Infant born between 26 and 33 amenorrhea week
* Live infant at birth
* Parent affiliated or entitled to a social security scheme
* Parent who received informed written information about the study

Exclusion Criteria:

- Intubated infant

Primary outcomes:
measure: Analysis fundamental frequency (f0)
timeFrame: at the end of hospitalization (on average 2 months)
Secondary outcomes:
measure: Analysis roughness of the cry (PC1)
timeFrame: at the end of hospitalization (on average 2 months)
measure: Analysis pitch of the cry (PC2)
timeFrame: at the end of hospitalization (on average 2 months)
measure: Analysis NIP∑ (neonatal index of parasympathetic activity) index
timeFrame: at the end of hospitalization (on average 2 months)
measure: Correlation between crying acoustic structures and parent's responses
timeFrame: at the end of hospitalization (on average 2 months)
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Hugues PATURAL, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01531114: PraSugrel vs TicagrElor in ST-Elevation Myocardial Infarction paTients With Diabetes Mellitus
Official title: Prasugrel Or Ticagrelor In ST-Elevation Myocardial Infarction Patients With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: ST-Elevation Myocardial Infarction
Keywords: Diabetes mellitus
antiplatelet effect
prasugrel
ticagrelor
STEMI
Insulin
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dual antiplatelet therapy is essential in patients following ST-Elevation myocardial infarction (STEMI) with percutaneous coronary intervention (PCI) and drug eluting stent implantation. Current guidelines recommend prasugrel and ticagrelor in patients with STEMI undergoing primary PPCI. We sought to investigate the superiority antiplatelet effect in terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg) in diabetic patients with STEMI undergoing primary PCI at 1 and 2 hours post drug administration. Secondary end-points will be: PR level measured at 6 and 12 hours post study drugs administrationin hospital. All consecutive diabetic patients with STEMI undergoing PPCI with stent implantation will be considered for PR assessment at 1-2-6-12 h after the drug LD administration. All patients must will be naïve for platelet P2Y12 receptor inhibition therapy. A subanalysis will be performed between two study groups according to insulin treatment.


Eligibility criteria: Inclusion Criteria:

* Diabetic patients
* acute coronary syndrome
* patients underwent to primary PCI
* naïve for platelet P2Y12 receptor inhibition therapy

Exclusion Criteria:

* history of bleeding diathesis
* chronic oral anticoagulation treatment
* contraindications to antiplatelet therapy
* PCI or coronary artery bypass grafting (CABG) \< 3 months
* hemodynamic instability
* platelet count \< 100,000/μl
* hematocrit \< 30%
* creatinine clearance \< 25 ml/min
* Patients with a history of stroke
* contraindication for prasugrel administration
* patients weighing \< 60 kg
* patients treated with morphine
* \> 75 years of age.

Primary outcomes:
measure: the superiority antiplatelet effect in terms of PR level of loading dose (LD) of Prasugrel (60 mg) versus LD of Ticagrelor (180 mg) in diabetic patients with STEMI undergoing primary PCI at 2 hours post drug administration.
timeFrame: 1 and 2 hours
Secondary outcomes:
measure: PR level measured at 6 and 12 hours post study drugs administration.
timeFrame: in hospital
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Dept.of Cardiovascular Sciences,Policlinico Umberto I
Study officials:
References:
Clinical trial NCT03299114: WHIRLPOOL FOR OSTEOARHRITIS
Official title: THE EFFECTIVENESS OF WHIRLPOOL FOR PATIENTS WITH NEUROPATHIC PAIN DUE TO KNEE OSTEOARTHRITIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Osteo Arthritis Knee
Sleep Disorder
Keywords: Neuropathic Pain
Whirlpool
Osteoarthritis
Sleep
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2017-10-02
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Both neuropathic and nociceptive mechanisms may contribute to the OA pain experience. Aims: The aim of this study was to determine the efficacy of warm whirlpool on pain, disability, quality of life (QoL) and sleep for patients with neuropathic pain.

Detailed description: Whirlpool treatment method is used for medical and surgical conditions. In literature there are studies which recommend whirlpool therapy as a treatment for reducing pain in patients with osteoarthritis. The aim of this study was to determine the efficacy of warm whirlpool on pain, disability, quality of life (QoL) and sleep for patients with neuropathic pain.

Eligibility criteria: Inclusion Criteria:

* suffering from knee pain at least 3 months
* radiological manifestations considering were consistent with grade 3 and 4 knee OA due to Kellgren and Lawrence criteria had DN4 scores ≥4.

Exclusion Criteria:

* lower extremity surgery history, knee infection inflammatory disease like rheumatoid arthritis back or pelvic pain related with knee pain another cause of polyneuropathy (diabetes mellitus, vitamin B 12 deficiency, toxic or neurological disease like stroke, spinal cord injury) lumbar disc herniation malignancy or active systemic disease.

Primary outcomes:
measure: visual analogue scale
timeFrame: one month
Secondary outcomes:
measure: Short Form-36 Health Survey
timeFrame: one month
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: one month
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: one month
measure: DN4
timeFrame: one month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University
Study officials:
References:
Clinical trial NCT00441714: Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise
Official title: Effect of Ischemic Postconditioning on Targeting of Annexin A5 After Forearm Exercise
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cardiovascular Disease
Ischemia-reperfusion Injury
Postconditioning
Keywords: cardiovascular disease
ischemia-reperfusion injury
postconditioning
annexin targeting
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2007-03-01
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: To adjust our forearm model for ischemia reperfusion injury, in order to used it for assessment of ischemia reperfusion damage in elderly and patients.

To test the effect of ischemic postconditioning on ischemia reperfusion injury in healthy volunteers, using Annexin binding after repetitive handgripping.

Detailed description: Recently, ischemic postconditioning has been identified as a protective intervention against ischemia-reperfusion injury. In animal studies, the signalling pathway of this (impressive) protective phenomenon is very similar to ischemic preconditioning. It opens a new avenue of post-reperfusion interventions with drugs that have been shown to mimic ischemic preconditioning. Before we can study this phenomenon in our forearm ischemia-reperfusion model, we need additional validating experiments. The purpose of this study proposal is to provide these data.

Eligibility criteria: Inclusion Criteria:

* Age 18-50 years
* No physical limitation to perform ischemic exercise
* Informed consent

Exclusion Criteria:

* Diabetes (fasting glucose \> 7,0mmol/l, or random glucose \>11,0mmol/l)
* hyperlipidemia (random total cholesterol \> 6.5 mmol/l)
* Hypertension (supine SBP/DBP \> 140/90 mmHg at screening)
* Any cardiovascular disease
* Drug abuse
* Concomitant chronic use of medication
* Administration of radioactivity in research setting during the last 5 years
* Participation to any drug-investigation during the previous month as checked with VIP check according to CRCN standard procedures.

Primary outcomes:
measure: Annexin A 5 targeting in the non dominant thenar muscle after (ischemic exercise), as a indicator for ischemia reperfusion injury.
Secondary outcomes:
measure: Workload during (ischemic) exercise.
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: RUMCN
name: Gerard Rongen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rongen GA, Oyen WJ, Ramakers BP, Riksen NP, Boerman OC, Steinmetz N, Smits P. Annexin A5 scintigraphy of forearm as a novel in vivo model of skeletal muscle preconditioning in humans. Circulation. 2005 Jan 18;111(2):173-8. doi: 10.1161/01.CIR.0000151612.02223.F2. Epub 2004 Dec 27.