louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02407743: TEMporal PostOperative Pain Signatures
Official title: Finding Good TEMporal PostOperative Pain Signatures (TEMPOS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Keywords: postoperative pain
surgery
pain resolution
pain intensity
persistent postsurgical pain
pain-related genes
analgesic
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2015-04-03
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for surgery will be invited to participate in this study.

Brief summary: The purpose of this research study is to determine what causes pain after surgery to increase or decrease over time.

Detailed description: Before surgery, study participants will be asked questions about age, gender, race/ethnicity, annual income, and education level. Study participants will also be questioned regarding prior pain experiences, their mood and how they think about pain. A small test tube of blood, a cheek swab or a saliva sample will be taken to see what genetic differences may influence individuals pain after surgery.

After surgery, study participants will be asked questions about their pain intensity while in the hospital. Additional information will be collected about the effects of pain medicine, and their recovery from surgery.

Following discharge from the hospital, study participants will be contacted monthly to confirm continued communication. Study participants will also be contacted six months after surgery, and asked to complete a final survey about their pain after surgery.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* anticipated length of hospital stay of 72 hours or greater
* expected post-operative survival greater than 6 months

Exclusion Criteria:

* \< 18 years of age
* anticipated need for prolonged post-operative intubation (greater than 24 hours)
* urgent or emergent surgical procedure
* inability to understand or participate in questionnaires, surveys or data collection

Primary outcomes:
measure: Measure postoperative pain scores change with respect to time
timeFrame: up to 7 days
Secondary outcomes:
measure: Measure variables that contribute to postoperative pain scores
timeFrame: up to 6 months
measure: Measure timing patterns that may influence development of persistent postsurgical pain (PPP)
timeFrame: up to 6 months
measure: Genetic testing
timeFrame: up to 1 day
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: Assistant Professor of Anesthesiology and Program Director, Perioperative Analytics Group Joint Assistant Professor of Orthopedics
name: Patrick J Tighe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04682743: Prevention of Post-Operative Shivering
Official title: Efficacy of Ondansetron Versus Paracetamol for Prevention of Post-Operative Shivering
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Post-Operative Shivering
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Shivering and vasoconstriction are thermoregulatory mechanisms that are required to increase core body temperature (BT) in patients with core hypothermia.

paracetamol is an antipyretic drug that has been in clinical use for a long time.

It can lower the BT of febrile and nonfebrile patients. A previous study demonstrated that orally administered paracetamol can suppress in a dose-dependent manner the increase in the BT of patients with acute ischemic stroke. However, few studies have evaluated the effects of paracetamol on postoperative shivering.


Eligibility criteria: Inclusion Criteria:

* Adult patients between 18-40 years.
* ASA physical status I and II
* Both genders
* Patients scheduled for elective mega-liposuction surgery under combined general epidural anesthesia

Exclusion criteria

* Patients who refused to participate in the study,
* ASA physical status more than II,
* any contraindications to regional anesthesia,
* surgical duration less than two hours or exceeding six hours,
* giving history of any of the following; allergy to the study medications used, system impairment, alcohol abuse, any endocrine disease affecting body temperature such as thyroid disorders,
* any psychiatric or neurological disorders, convulsions, patient receiving vasodilators or medications likely to alter thermoregulation,
* Finally if their body temperature was recorded to surpass 37.5ºC or \<36.5°C before enrolment.

Primary outcomes:
measure: Incidence of shivering
timeFrame: UP TO 1 HOURE
Secondary outcomes:
measure: The assessment the core temperatures
timeFrame: UP TO 24 HOURE
measure: postoperative shivering scores
timeFrame: up to 2 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT00551343: Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome
Official title: Contribution of a GLP-1 Agonist to Appetite Regulation, Metabolism and Body Composition in Subjects With Prader-Willi Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prader-Willi Syndrome
Lead sponsor: Garvan Institute of Medical Research
Sponsor class: OTHER
First posted: 2007-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of a GLP-1 agonist on satiety hormones in patients with Prader-Willi Syndrome (genetic defect causing obesity).

Detailed description: Prader-Willi Syndrome (PWS) is the most frequent known genetic disorder of obesity. Hyperphagia is the main barrier to independent living in adults with PWS, and hitherto behavioural restraints and environmental modification are the only effective management measure. The emerging costs for professional care are immense. Thus, there is an urgent need for treatment which reduce appetite and food intake in this patient group. Agonists of the gut derived hormone GLP-1 which reduces food intake and causes weight loss due to slowed gastric emptying and through direct central effects. The aim of this pilot drug trial is to analyse the effect of a GLP-1 agonist on appetite regulating hormones, insulin secretion and energy expenditure before and after a meal.

Eligibility criteria: Inclusion Criteria:

* see below

Exclusion Criteria:

* Diabetes mellitus, acute infections

Primary outcomes:
measure: satiety hormones
timeFrame: 1 day
Secondary outcomes:
measure: appetite (visual analogue scale) insulin secretion
timeFrame: 1 day
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Garvan Institute of Medical Research
state: New South Wales
Study officials:
affiliation: Garvan Institute of Medical Research
name: Lesley V Campbell, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05132543: Neural Basis of Cognition
Official title: Studying Human Cognition and Neurological Disorders Using ÂµECoG Electrodes
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 38
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The overall purpose of this study is to better understand human cognition and human epilepsy by working with patients undergoing clinical treatment for pharmacologically resistant epilepsy. The investigators will investigate human cognition by conducting controlled experiments that focus on sensory, motor, and cognitive phenomena such as sensory processing, memory, and language. The investigators will also examine the neural underpinnings of epilepsy during both sleep and wakefulness to better understand both the foundations of epilepsy and how epilepsy affects cognition. The investigators hope to use these data to have a better understanding of cognition, epilepsy, and how the two interact. This will potentially lead to better markers for seizure onsets as well as epilepsy more generally. For this research, the investigators will use μECoG arrays manufactured by commercial partners. These arrays have passed all major ISO 10993 bio-compatibility tests. Based on this characterization and use in the intraoperative setting (limited duration and supervised usage), these devices pose a minimal risk to participants. Data will be analyzed and protected using the Duke SSRI protected research data network.


Eligibility criteria: Inclusion Criteria:

* Potential subjects will come from adult and pediatric patients (between the ages of 12 and 18) undergoing surgery for the treatment of pharmacologically resistant epilepsy, brain tumor resection, brain mass resection, or deep brain stimulation (DBS) for the first time
* Proficient English speakers
* No Major cognitive impairment

Exclusion Criteria:

* Previous DBS procedure
* Subject unable to consent to study

Primary outcomes:
measure: Evoked signal-to-noise analysis human brain.
timeFrame: Intraoperative data collection period, 20 minutes
measure: Percentage of phoneme decoding accuracy as measured by linear decoding model
timeFrame: Intraoperative data collection period, 20 minutes
measure: Number of HG power modulation as measured by signal power.
timeFrame: Intraoperative data collection period, 20 minutes
measure: Number of kriging resolution as measured by signal power.
timeFrame: Intraoperative data collection period, 20 minutes
Secondary outcomes:
measure: Number of serious adverse events as measured by medical record review
timeFrame: Implantation to Three-months follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Gregory B Cogan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02175043: Clinical Benefits of Additional Complex Fractionated Atrial Electrogram Targeted Catheter Ablation for Longstanding Persistent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation, catheter ablation, recurrence
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Purpose of the study

1) To compare clinical outcome, procedure time, complication rate of persistent atrial fibrillation patients between conventional additional linear ablation and additional complex fractionated atrial electrogram targeted catheter ablation.

2. Scientific evidence of the study

1. In atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality.
2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed.
3. catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy.
4. However, there are no consensus for proper ablation strategy in longstanding persistent atrial fibrillation.
5. additional ablation make extent of myocardial injury and paradoxically increase recurrence rate, thus still controversial.
6. Therefore, we will compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation.

3. Methods

1. Treatment of All patients with atrial fibrillation is performed according to the standard treatment guideline of atrial fibrillation.
2. there is no additional blood sampling, imaging study, or any other invasive procedure according to the inclusion of the study.

4. study contents

1. to evaluate superior ablation strategy in longstanding persistent atrial fibrillation

   * compare conventional linear ablation with additional complex fractionated atrial electrogram targeted catheter ablation. both strategies are conventional ablation strategies being performed world-wide.
2. compare complex fractionated atrial electrogram before and after linear ablation.


Eligibility criteria: Inclusion Criteria:

1) patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation

Exclusion Criteria:

1. patients who do not agree with study inclusion
2. permanent AF refractory to electrical cardioversion
3. AF with valvular disease ≥ grade 2
4. Patients with left atrial diameter greater than 60mm
5. patients with age less than 19

Primary outcomes:
measure: number of Clinical recurrence of atrial fibrillation (AF) after catheter ablation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Cardiovascular Hospital, Yonsei University Health System
Study officials:
References:
Clinical trial NCT01739543: A Reduction in C-section Rates Using the Hem-Avert Perianal Stabilizer
Official title: A Reduction in C-section Rates Using the Hem-Avert Perianal Stabilizer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complications; Cesarean Section
Lead sponsor: Stetrix, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-03
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A REDUCTION IN C-SECTION RATES USING THE HEM-AVERT® PERIANAL STABILIZER.

Detailed description: This study is being conducted to evaluate an existing FDA approved device called the HEM-AVERT® Perianal Stabilizer for its efficacy in reducing Cesarean births and/or reducing the second stage of labor.

Eligibility criteria: Inclusion Criteria:

* Subject is scheduled for vaginal delivery.
* Subject is willing and able to comply with the study plan as indicated by understanding and signing the Subject Informed Consent Form.
* Subjects' pre-natal examination indicates that this is to be a single birth delivery.

Exclusion Criteria:

* Subject's scheduled for vaginal delivery with anticipated complications.
* Subject is unable to understand and sign the informed consent form.
* Subject does not deliver at study facility (hospital).

Primary outcomes:
measure: Reduce C-section Rate
timeFrame: 24 hours
Secondary outcomes:
measure: Reduce duration of 2nd stage of labor.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Niagara Falls
country: United States
facility: Niagara Falls Memorial Medical Center
state: New York
Study officials:
affiliation: Unafilliated
name: Dan Burns, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burns DA. Effectiveness of a novel device in the reduction of cesarean deliveries. ISRN Obstet Gynecol. 2013 Sep 1;2013:173278. doi: 10.1155/2013/173278. eCollection 2013.
Clinical trial NCT06331143: Analgesic Efficacy of Mid-Transverse Process to Pleura (MTP) Block and Intrathecal Morphine in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion
Official title: Comparison of Analgesic Efficacy of Mid-Transverse Process to Pleura (MTP) Block and Intrathecal Morphine in Idiopathic Scoliosis Patients Undergoing Posterior Spinal Fusion: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mid-Transverse Process Block
Intrathecal Morphine
Idiopathic Scoliosis
Posterior Spinal Fusion
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the analgesic efficacy of mid-transverse process to pleura (MTP) block and intrathecal morphine in idiopathic scoliosis patients undergoing posterior spinal fusion surgery.

Detailed description: The postoperative period for idiopathic scoliosis patients undergoing posterior spinal fusion (PSF) is fraught with challenges, including adequate postoperative pain control and prolonged hospitalization.

Intrathecal opioids have been used to manage postoperative pain in pediatric patients for a wide variety of surgeries , including adolescent and adult PSF. Multimodal analgesic (MMA) regimens using several drugs and techniques are considered to be necessary for postoperative pain relief.

The mid-transverse process to pleura (MTP) block was first described as a modified paravertebral block in 2017. The local anesthetics (LAs) are administered between the transverse process and the pleura. This results in a LA spread to the dorsal and ventral rami in the paravertebral space through the fenestrations in the superior costotransverse ligament at the level of injection, and frequently to adjacent levels.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Idiopathic scoliosis patients undergoing posterior spinal fusion surgery.

Exclusion Criteria:

* Patient with morbid obesity (body mass index \>40 kg/m2).
* Patients with pre-existing infection at block site.
* Known allergy to study drugs.
* Coagulation disorder.
* History of psychiatric illness.
* Pre-existing neurological deficits.
* Presence of any pre-operative pain or history of chronic pain.
* History of regular analgesic.

Primary outcomes:
measure: Degree of pain
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: Heart rate
timeFrame: Till the end of surgery.
measure: Mean arterial pressure
timeFrame: Till the end of surgery.
measure: Patient satisfaction
timeFrame: 24 hours postoperative.
measure: Complications
timeFrame: 24 hours postoperative.
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: ElGharbia
Study officials:
affiliation: Faculty of Medicine, Tanta University, Tanta, Egypt.
name: Mohammed S ElSharkawy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06433843: FKBP5 Methylation and Childhood Emotional Abuse in Complex Posttraumatic Stress Disorder: Investigating the Relationship and Its Predictive Role in Therapy Outcome
Official title: FKBP5 Methylation and Childhood Emotional Abuse in Complex Posttraumatic Stress Disorder: Investigating the Relationship and Its Predictive Role in Therapy Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Posttraumatic Stress Disorder
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the role FKBP5 DNA methylation levels in patients suffering from complex posttraumatic stress disorder, who participated in a 12-weeks disorder-specific DBT-PTSD inpatient treatment. DNA methylation levels were measured before and after completing DBT-PTSD.

Detailed description: Epigenetic modifications in the FKBP5 gene, which is involved in regulating the stress response, have been found to be associated with trauma-related mental disorders like posttraumatic stress disorder (PTSD). Previous research has suggested that FKBP5 may also be a predictor of therapy outcomes. However, there is limited evidence regarding its relationship with complex PTSD (cPTSD). This pilot study aimed to investigate the association between cPTSD and FKBP5 DNA methylation, as well as its predictive role in therapy outcomes among patients undergoing Dialectical Behavior Therapy for PTSD (DBT-PTSD), a 12-week trauma-focused inpatient treatment program.

29 patients with cPTSD who participated in the DBT-PTSD program were enrolled. FKBP5 DNA methylation levels were measured at two CpG sites before treatment (n=25) and after completing DBT-PTSD (n=15). To assess the predictive value of FKBP5 DNA methylation, we categorized the sample into responders and non-responders based on therapy outcome.

Eligibility criteria: Inclusion Criteria:

complex posttraumatic stress disorder with or wothout comorbid borderline personality disorder Age between 18 and 65 Years Participiation in 12 weeks DBT-PTSD inpatient treatment

Exclusion Criteria:

Acute suicidality

Primary outcomes:
measure: DNA methylation levels of FKBP5 before and following DBT-PTSD
timeFrame: After 12 weeks of DBT-PTSD treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
state: Baden Württemberg
Study officials:
References:
Clinical trial NCT05604443: Keratoconus Detection Using MS39 and Pentacam
Official title: Keratoconus Detection Using MS39 and Pentacam - a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus
Keywords: Keratoconus
Pentacam
MS39
Lead sponsor: Johannes Kepler University of Linz
Sponsor class: OTHER
First posted: 2022-11-03
Enrollment: 173
Sex: ALL
Minimum age (years): 14
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients between 14 and 100 years who consult Keratokonus specialst.

Brief summary: This retrospective study aims to investigate whether the MS39 and Pentacam are delivering comparable results in the diagnosis of keratoconus.

In the future, these measurement devices could be interchangeable in usage.

Detailed description: Keratoconus is a degenerative pathology of the cornea, which tends to progress. It comes along with central and paracentral thinning of the cornea as well as with an apical protrusion of the cornea. Keratoconus leads to vision loss. This pathology is diagnosed by using CE certified OCT technology in order to map the topography of the cornea. This process constitutes a really important step in the line of management of the keratoconus. MS39 and Pentacam are used for detection. Retrospectively, data will be investigated, in order to see if these measurement devices deliver comparable results. In the future, these measurement devices could be interchangeable in usage.

Eligibility criteria: Inclusion Criteria:

* age older than 14 years
* patients who show up at Keratokonus consultation hours

Exclusion Criteria:

* age younger than 14 years
* age older than 100 years

Primary outcomes:
measure: topography of the cornea
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Department for Ophthalmology and Optometry, Kepler University Hospital GmbH, Johannes Kepler University Linz, Altenberger Strasse 69, 4040 Linz, Austria
state: Oberösterreich
Study officials:
affiliation: JKU Linz
name: Matthias Bolz, MD
role: PRINCIPAL_INVESTIGATOR
References: