louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01701921: The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery
Official title: The Effects of Pregabalin on Acute and Chronic Postoperative Pain After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain
Keywords: cardiac surgery
pregabalin
postoperative pain
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2012-10-05
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether pregabalin is effective in the treatment of acute postoperative pain after cardiac surgery if administered before the surgery.

Detailed description: Pregabalin was introduced as an antiepileptic drug with analgesic anti-hyperalgesic and anxiolytic properties and was also used to treat neuropathic pain. In recent years it has been used as part of a multimodal management of acute postoperative pain after various types of surgery. We study the effect of pregabalin administered before cardiac surgery on acute and chronic postoperative pain. Post CABG syndrome is well known since 1980 and various analgesic methods have been used from time to time (opioids, regional analgesia, non-steroidal anti-inflammatory drugs). In our research patients will be divided into three groups. The control group will receive a placebo capsule before surgery. The second group will receive 75mg of pregabalin per os before surgery while the third will receive 150mg of pregabalin. After the surgery all patients will be connected to an intravenous PCA morphine pump for 48 hours. The postoperative pain will be assessed with the Visual Analogue Scale (0-10) every day. Total morphine consumption by the patients as well as any other pain medications administered supplementary will be registered and compared between the different groups. Remaining postoperative pain will be assessed after 3 months. The results will be statistically analyzed in order to determine whether there is significant difference in pain management between the groups.

Eligibility criteria: Inclusion Criteria:

* Patients' age 18-85years who are undergoing cardiac surgery

Exclusion Criteria:

* Chronic pain syndromes
* Renal failure
* Age \>85
* Allergy to Pregabalin
* Patients already taking pregabalin

Primary outcomes:
measure: opioid consumption and other analgesics after surgery
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Remaining surgery related pain and analgesics consumption
timeFrame: 3 months after surgery
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Univercity Hospital of Larissa
state: Thessaly
Study officials:
affiliation: PhD candidate, School of Medicine, Univercity of Larissa
name: Aikaterini A Bouzia, Medicine
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Anaesthesiology, Schooll of Medicine, University of Larissa
name: Georgios Vretzakis, Medicine
role: STUDY_DIRECTOR
References:
Clinical trial NCT01252121: Residence Time Evaluation of Systane Ultra Lubricant Eye Drops vs. Hialid and Saline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Syndrome
Keywords: Dry Eye
Ocular Retention Time
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-12-02
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the ocular retention time of Systane Ultra compared to Hialid and saline.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with mild to moderate dry eye as defined in the protocol.
* Able and willing to follow instructions.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any medical condition that may affect the results of the study.
* History or evidence of ocular or intraocular surgery within the past six months.
* History of intolerance or hypersensitivity to any component of the study medications.
* Use of concomitant topical ocular medications during the study period.
* Ocular conditions that may preclude safe administration of the test article.
* Unwilling to discontinue contact lens wear during the study period.
* Participation in an investigational drug or device study within 30 days of enrollment.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Ocular surface residence time
timeFrame: Time to event
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05942521: Effects of Subconscious Memory Extinction in Patients With Alcohol Dependence and Its Mechanism
Official title: Effects of Subconscious Memory Extinction in Patients With Alcohol Dependence and Its Mechanism
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Alcohol
Craving
Extinction training
Subconscious
Lead sponsor: Shenzhen Kangning Hospital
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the subconscious memory extinction therapy based on very brief exposure is used to intervene to reduce the alcohol craving of alcohol-dependent patients, prevent relapse, and observe the psychological craving, heart rate, skin conductance, and pupil diameter changes of the patients during the brief exposure extinction. The main questions it aims to answer are:

1. Whether subconscious extinction intervention would reduce psychological craving and alcohol relapse?
2. What is the mechanism of subconscious extinction intervention in alcohol dependence?

Detailed description: After being informed about the study and potential risks, all patients giving written informed consent will undergo a screening period to determine eligibility for study entry. patients who meet the eligibility requirements will be randomized in very brief extinction, clearly visible extinction, or very brief neutral extinction. This study will recruit alcohol-dependent participants aged 18-60 in the ward, observe reported subjective scores during the extinction, and record the heart rate, skin conductance, pupil diameter, and ERP changes.

Eligibility criteria: Inclusion Criteria:

1. Adopt DSM-IV alcohol dependence diagnostic criteria;
2. Complete detoxification treatment without obvious withdrawal symptoms;
3. Informed consent, voluntary participation.

Exclusion criteria:

1. Acute alcohol dependence withdrawal period;
2. Patients who meet the DSM-Ⅳ diagnosis of psychoactive substances or non-psychoactive substances other than alcohol (except nicotine);
3. Previous acceptance experienced similar exposure therapy;

Primary outcomes:
measure: Change from baseline in alcohol craving by using Visual Analog Scale of Alcohol Craving at week 1.
timeFrame: baseline and week 1
measure: Relapse rate
timeFrame: Four week after intervention
Secondary outcomes:
measure: Skin conductance level (SCL)
timeFrame: During the intervention period
measure: Pupil diameter
timeFrame: During the intervention period
measure: Event-relatred potential (ERP)
timeFrame: During the intervention period
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen Kangning Hospital
state: Guangdong
Study officials:
affiliation: Shenzhen Kangning Hospita
name: Xiaojian Jia
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06027021: Assessment of Hypoxia Before Radioembolization Treatment With 18F-FMISO PET
Official title: Assessment of Hypoxia Before Radioembolization Treatment With 18F-FMISO PET
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radioembolization
Radiotherapy
Cancer
Positron Emission Tomography
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients with hepatocellular carcinoma or colorectal carcinoma with liver metastasis who are referred for transarterial radioembolization to Ankara University School of Medicine Department of Nuclear Medicine will be enrolled for the trial.

Brief summary: Hypoxia is a known factor for resistance to radiotherapy in tumors. Response to transarterial radioembolization is known to be variable between different patients even if the same dose of radiation was delivered. In this study the investigators aim to quantify the hypoxia in the primary and secondary tumors of liver with 18F-FMISO PET before radioembolization and to prove any effect of the hypoxia, if present, on the dose that should be delivered to tumor to ensure treatment response.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with colorectal carcinoma with liver metastasis or hepatocellular carcinoma.
* Is not eligible for surgery
* Above 18 years old
* The patients who are referred for transarterial radioembolization treatment to Ankara University School of Medicine Department of Nuclear Medicine.

Exclusion Criteria:

* Patients with ECOG performance score \>1
* Claustrophobia
* Life expectancy shorter than 3 months
* Pregnant or breast-feeding patients

Primary outcomes:
measure: Demonstrate the effect of the hypoxia in the success of the radioembolization treatment
timeFrame: 08/2024
measure: The effect of the hypoxia on the dose-response relationships and required doses to achieve treatment response in the hypoxic and non-hypoxic group.
timeFrame: 08/2024
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
affiliation: Ankara University
name: Cigdem Soydal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04255121: Bicarbonate Epidural Injection in Emergency Caesarian
Official title: Interest of the Alkalinization of the Adrenaline Lidocaine Solution for Conversion of Epidural Analgesia Into Epidural Anesthesia During an Emergency Caesarean
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Emergency Caesarean
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During labor, pain is systematic. In France, epidural analgesia is the gold standard to fight pain.

Sometimes, emergency situations involve the maternal or fetal prognosis and require an emergency fetal extraction by caesarean. When an effective epidural analgesia is in place, an injection of adrenaline lidocaine converts this epidural analgesia into an epidural anesthesia allowing a surgical procedure. Sometimes, the time required to set up the anesthesia cannot be expected and a general anesthesia is performed.

Local anesthetics used during epidural analgesia have Pka between 7.8 and 8.1. In solution, local anesthetics exist in two forms: an un-ionized form and an ionized form. The non-ionized form is liposoluble and crosses the lipid membranes to reach the site of intracellular action. The non-ionized form conditions the time taken to install anesthesia.

When the pH of the solution is equal to Pka, un-ionized and ionized form are present in equal quantity. Commercial local anesthetic solutions have acidic pH and so contained a majority of ionized form. Alkalinization of local anesthetics solution should bring the pH closer to pKa and therefore to favor a greater proportion of non-ionized form.

Detailed description: The aim of this study is to evaluate impact of an alkalinization of adrenaline lidocaine solution for conversion of epidural analgesia into epidural anesthesia during an emergency caesarean.

Eligibility criteria: Inclusion Criteria:

* pregnant women followed up in the Reims University Hospital
* women whose birth is expected by vaginal delivery in the Reims University Hospital
* women wishing to benefit from epidural analgesia
* women agreeing to participate in the research and having signed informed consent
* women aged 18 years old and more
* women affiliated to a social security system

Exclusion Criteria:

* women who don't benefit from emergency caesarian (vaginal delivery or scheduled caesarian)
* women for whom epidural analgesia cannot be used
* women for whom epidural analgesia is not effective

Primary outcomes:
measure: delay in obtaining a T6 anesthetic level
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT03970421: Severity Factors and Needed Observation Time at ED of Patients Wih Head Injury
Official title: Demographic and Clinical Data Associated to Head Injury Severity on Adults Patients (Older Than 16yo), and Follow up for 90 Days to Check the Development of Associated Complications, Deciding the Optimal Observation Lapse at ED
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head Injury Other
Length of Stay
Delayed Complications
Lead sponsor: Hospital El Escorial
Sponsor class: OTHER
First posted: 2019-05-31
Enrollment: 300
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated by HI in the Emergency Department (ED) and to whom an imaging test is performed (cranial CT scan)

Brief summary: We know precisely which patients and when they should have an imaging test to evaluate a Head Injury (HI). But in those patients on anticoagulant and / or antiaggregant treatment we do not know the exact incidence of early and late hemorrhagic lesions, and there is no specific recommendation on how long they should remain under observation in the emergency department if no initial lesions are evident. Our goal is to try to answer these two questions.

Detailed description: MATERIAL: Prospective study of patients treated of HI in the Emergency Department (ED) and to whom an image test is performed (cranial CT scan). Collection of demographic, clinical, analytical, image tests, and observation time in the emergency department (from admission to medical discharge)

METHODS: Separation of subjects included in the study in 4 cohorts: patients without anticoagulant and / or antiaggregant treatment; patients with antiplatelet therapy (ASA and / or clopidogrel); patients with anticoagulant treatment with acenocoumarol and INR \<2; and patients on anticoagulant therapy with acenocoumarol and INR\> = 2 or patients on treatment with direct thrombin inhibitors (dabigatran), or inhibitors of factor Xa (rivaroxaban, apixaban, edoxaban) or patients on treatment with low molecular weight heparins (LMWH) ) Follow-up through analysis of clinical history and telephone interview at 2, 7, 15, 30, 60 and 90 days.

Statistical analysis of the results.

Eligibility criteria: Inclusion Criteria:

* HI attended at ED
* Head CT performed as recommended by clinical guides
* Contact data available (phone number)

Exclusion Criteria:

* Patients not able for follow up (foreigners or tourists or whatsoever whom are not going to stay on the country for at least 3 months)

Primary outcomes:
measure: Severity factors associated to head injury
timeFrame: 24 hours
measure: Development of haemorragical complications during observation time
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Lorenzo de El Escorial
country: Spain
facility: Hospital EL Escorial
state: Madrid
Study officials:
affiliation: Hospital El Escorial
name: Francisco J Favá, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00374621: Trial of Cervical Ripening and Labor Induction Using Misoprostol With or Without Intravaginal Isosorbide Mononitrate
Official title: Randomized Clinical Trial of Cervical Ripening and Labor Induction Using Stepwise Oral Misoprostol With or Without Intravaginal Isosorbide Mononitrate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Ripening
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2006-09-11
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of the addition of intravaginal isosorbide mononitrate to an established protocol of oral misoprostol for cervical ripening and labor induction.


Eligibility criteria: Inclusion Criteria::

* Pregnant women
* 18 years of age or greater
* Singleton pregnancy between 32-42 weeks gestation requiring labor induction
* Membranes must be intact

Exclusion Criteria:

* Ruptured membranes
* Gestational age less than 32 weeks
* Non-reassuring fetal heart rate tracing

Primary outcomes:
measure: Time to vaginal delivery
timeFrame: First dose of study medication to delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Yasser Yehia El-Sayed
role: PRINCIPAL_INVESTIGATOR
References:
citation: Collingham JP, Fuh KC, Caughey AB, Pullen KM, Lyell DJ, El-Sayed YY. Oral misoprostol and vaginal isosorbide mononitrate for labor induction: a randomized controlled trial. Obstet Gynecol. 2010 Jul;116(1):121-126. doi: 10.1097/AOG.0b013e3181e408f2.
Clinical trial NCT06345521: Etablishment of Follow-up System and End-Stage Heart Registration Platform for Pediatric Heart Failure
Official title: A Comprehensive Research of Pediatric Heart Failure-- Etablishment of Follow-up System and End-Stage Heart Registration Platform for Pediatric Heart Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Congenital
End-stage Heart Failure
Keywords: Congenital Heart Failure
Registry
End-stage Heart Failure
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Peking University First Hospital
name: Beijing Children's Hospital
First posted: 2024-04-03
Enrollment: 100
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with end-stage heart failure

Brief summary: Establish a follow-up management system for pediatric heart failure and a registration platform for end-stage heart failure


Eligibility criteria: Inclusion Criteria:

* Patients younger than 14 years of age
* refractory heart failure

Exclusion Criteria:

-

Primary outcomes:
measure: the recurrence rate of heart failure
timeFrame: 6 months
Secondary outcomes:
measure: NT-proBNP level
timeFrame: 6 months
measure: Incidence rate of drug adverse reactions
timeFrame: 6 months
measure: Readmission rate for heart failure
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Shoujun Li
role: STUDY_CHAIR
References:
Clinical trial NCT02141321: Sub Lingual Misoprostol Before IUD Insertion in Women With Only Previous Cesarean Section
Official title: SUB LINGUAL MISOPROSTOL PRIOR TO IUD INSERTION IN WOMEN WITH ONLY PREVIOUS CESARIAN SECTION: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: IUD Insertion
Keywords: IUD
Misoprostol
Rectal administration
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2014-05-19
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The aim of the work is to evaluate the efficacy of the sub lingual prostaglandin E1 synthetic analogue (misoprostol) before IUD insertion to facilitate the procedure in patients delivered before only by cesarean section.

Detailed description: The study will be conducted at Ain Shams University Maternity Hospital. 124 women candidate for Cu T 380A IUD insertion will be enrolled in the study. Half of them will receive 400 micro gram of misoprostol (Sigma) sub lingually and the other half will receive the placebo two hours before IUD insertion.

Eligibility criteria: Inclusion Criteria:

* Normal size uterus.
* Willing to participate.
* Candidate for IUD insertion.
* Delivered only by cesarean section.
* Last delivery is more than 40 days before participating in the study.

Exclusion Criteria:

* Previous vaginal delivery
* Signs of genital infection.
* Menopause.
* Body mass index (BMI) \> 35 kg/m2.
* Contraindication to misoprostol.
* Copper allergy.
* Positive pregnancy test.
* Had a prior attempt for IUD insertion.
* Uterine anomalies.
* Uterine fibroid.

Primary outcomes:
measure: Pain
timeFrame: During the procedure
Secondary outcomes:
measure: Difficulty of Procedure
timeFrame: During the procedure
measure: Complications
timeFrame: During the procedure and the following 24 hours.
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
Study officials:
affiliation: Ain Shams University
name: Mohamed S. Sweed, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ain Shams University
name: Hassan A. Bayoumy, Professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Mohamed Y. Mohamed, M.B., B.Ch.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02073721: The Importance of Electrical Stimulation as a Treatment for Urinary Incontinence in Patients Prostatectomy
Official title: The Importance of Electrical Stimulation as a Treatment for Urinary Incontinence in Patients Undergoing Prostatectomy to Exercise the Pelvic Floor Muscles (MAPs): Randomised Controlled Trial, Double Blind
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Universidade Gama Filho
Sponsor class: OTHER
First posted: 2014-02-27
Enrollment: 34
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of electrical stimulation to reduce urinary incontinence in men undergoing prostatectomy exercises of the pelvic floor muscles (MAPs)

Detailed description: The study will be an experiment with active control, randomized, double-blind, parallel intervention. After met the eligibility criteria of the patients will be randomly allocated into two groups: Group exercises MAPs (GEX), which is the active control group and electrostimulation + exercises MAPs (GEEX).

Eligibility criteria: Inclusion Criteria:

* patients with urinary sphincter deficiency resulting from a radical prostatectomy surgery
* sent by urologists the same hospital where the experiment will take place
* having the maximum time six months after surgery
* to use 2 to 5 disposable protective per day

Exclusion Criteria:

* Symptoms of urinary tract infection
* symptoms of lower urinary tract obstruction
* anal fistula
* metallic implant in the body
* transurethral resection of prostate
* radiation therapy
* non-enforcement of the proposed treatment.

Primary outcomes:
measure: urinary incontinence
timeFrame: august/2013 to December/2013 (4 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Federal Hospital Servants of the State of Rio de Janeiro
state: RJ/Rio de Janeiro
Study officials:
affiliation: Gama Filho University
name: Patrícia Z Barros, expert
role: PRINCIPAL_INVESTIGATOR
References: