louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03864887: Optical Assessment on Brain Death Via a Oxygen Supply Procedure
Official title: Optical Assessment on Brain Death Via a Multiple-phase Protocol at Varied Fraction of Inspired O2
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Brain Death
Keywords: Brain death
Oxygen metabolism
Near infrared spectroscopy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2019-03-06
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult individuals of any gender. Mostly hired in the City of Tianjin, P.R.China

Brief summary: This study aims to evaluate brain death with optical probes. The changes of hemodynamic parameters including oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) were detected by near infrared spectroscopy probes attached on the forehead of patients. A multiple-phase protocol at varied fraction of inspired O2 were utilized during the assessment.

Detailed description: Brain death is an irreversible loss of all brain functions, and the assessment is crucial for organ supply for transplantation. The noninvasive, sensitive, universally available and timely ancillary method to assess brain death has not been established. This study aims to evaluate brain death with optical probes. The changes of hemodynamic parameters including oxyhemoglobin (HbO2) and deoxyhemoglobin (Hb) were detected by near infrared spectroscopy probes attached on the forehead of patients. A multiple-phase protocol at varied fraction of inspired O2 were utilized during the assessment. The concentration changes ratios of oxyhemoglobin to deoxyhemoglobin (Δ\[HbO2\]/Δ\[Hb\]) in the cerebral cortex of brain-dead patients were significantly higher than those of healthy subjects.

Eligibility criteria: Inclusion Criteria:

* Patients who have had brain death or serious brain trauma.
* Healthy people who are interested in optical assessment of hemodynamic parameters

Exclusion Criteria:

* Patients who are in pregnancy or have plan to conception.
* Patients who have vertebra surgery or have plan of surgery.
* Patients who are inappropriate to join this trial judged by the radiologists or specialists.

  * AIDS, Active Hepatitis, Tuberculosis, Syphilis
  * Patients who regularly take anticoagulants, antiplatelet drugs

Primary outcomes:
measure: Δ[HbO2]
timeFrame: 1 day during the whole experiment
measure: Δ[Hb]
timeFrame: 1 day during the whole experiment
Secondary outcomes:
measure: Heart rate
timeFrame: 1 day during the whole experiment
measure: Blood pressure
timeFrame: 1 day during the whole experiment
Other outcomes:
Locations:
city: Tianjin
country: China
facility: NIRS assessment for brain death
state: Tianjin
Study officials:
References:
Clinical trial NCT01163487: Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers
Official title: Phase I Trial of Metabolic Reprogramming Therapy for Treatment of Recurrent Head and Neck Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Head and Neck Cancer
Head and Neck Cancers
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-07-15
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the effect of the drug DCA (dichloroacetate) on recurrent head and neck cancers. Part of this study will also use EF5 PET scan to study tumor hypoxia.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed head and neck squamous cell carcinoma
* Age \> 18 years old
* Patients must have unresectable disease in which there is no accepted potentially curative treatment option
* Patients must have acceptable organ and marrow function as defined below:
* leukocytes \>3,000/uL
* absolute neutrophil count \>1,500/uL
* platelets \>90,000/uL
* total bilirubin \<=1.5X normal institutional limits
* AST(SGOT)/ALT(SGPT) \<=2.5 X normal institutional limits with the following exceptions:

  1. Patients with documented tumors involving the liver who have Grade \<2 elevations in AST, ALT, and/or alkaline phosphatase are eligible if \<5X ULN.
  2. Patients with documented tumors involving bone who have a Grade \<2 elevation in alkaline phosphatase are eligible if \<5X ULN.
* creatinine \<=1.5X normal institutional limits OR creatinine clearance \>50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation
* Patients must have non-cranial gross disease that is greater than 1 cm on CT scan prior to enrollment
* Disease must be FDG-avid on PET scanning
* Creatinine within normal institutional limits
* Eastern Clinical Oncology Group performance status 0, 1 or 2 (Appendix 1)
* Life expectancy \> 12 weeks
* Both men and women and members of all races and ethnic groups are eligible for this trial.

Exclusion Criteria:

* Women who are pregnant
* Administration of any systemic cytotoxic agents within the last 2 weeks of enrollment
* Patients who are unwilling or unable to provide informed consent
* Patients who have potentially curable disease
* Participation in another concurrent treatment protocol

Primary outcomes:
measure: To determine the maximum tolerated dose of DCA in patients with recurrent head and neck cancer who have failed first-line therapy.
timeFrame: Duration of study
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Daniel T Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03348787: Behavioral and Cognitive Therapies for Auditory Hallucination Management
Official title: Behavioral and Cognitive Therapies for Auditory Hallucination Management: Effectiveness and Analysis of Change Processes Involved With Hallucinations in a Population Suffering From Chronic Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Psychosis
Keywords: Behavioral and Cognitive Therapies
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2017-11-21
Enrollment: 55
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 present study wants to evaluate the efficacy of a short psychoeducational type group intervention and Cognitive behavioral therapy (CBT) 3rd wave on the severity of hallucinatory Acoustico-Verbal (HAV) symptomatology in patients with schizophrenia.


Eligibility criteria: Inclusion Criteria:

* Schizophrenic disorders, schizo-affective disorders
* Suffering from persistent HAV
* No change in symptomatology for 3 months.
* No anticipated change in antipsychotic treatment (anti-hallucinatory): olanzapine, risperidone, amisulpride, quetiapine, aripiprazole, loxapine, haloperidol, clopixol, modecate, nozinan, cyamemazine, piportil, clozapine
* Major patient, or major incompetent.

Exclusion Criteria:

* Mental retardation
* Subject participating in another search including an exclusion period still in progress at pre-inclusion

Primary outcomes:
measure: intensity HAV symptoms
timeFrame: Baseline and one week after the last session
Secondary outcomes:
measure: Effect over time
timeFrame: Until 12 months after the last session
Other outcomes:
Locations:
city: Lannemezan
country: France
facility: Lannemezan Hospital
city: Lavaur
country: France
facility: Lavaur Hospital
city: Rodez
country: France
facility: Sainte-Marie de Rodez Hospital
city: Saint-Lizier
country: France
facility: Ariège-Couserans Hospital
city: Toulouse
country: France
facility: Gérard Marchand Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Axel Bourcier, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03781687: Bilateral vs. Unilateral Erector Spinae Plane Block
Official title: Bilateral vs. Unilateral Erector Spinae Plane Block for Laparoscopic Cholecystectomy; A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Cholecystitis; Gallstone
Keywords: erector spinae plane block
postoperative pain
laparoscopic cholecystectomy
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The importance of multimodal analgesia for postoperative pain management is well known and regional anesthesia techniques are commonly prefferred to provide better analgesia. Erector spinae plane block (ESB) is a new defined and effective regional anesthesia technique. But two injections can be unconfortable for some patients. With this study, we aimed to compare the analgesia effect of bilateral and unilateral ESP block for laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* ASA I-II patients
* Pateints undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

* obesity (body mass index \>35 kg/m2)
* infection of the skin at the site of needle puncture area
* patients with known allergies to any of the study drugs
* coagulopathy
* recent use of analgesic drugs

Primary outcomes:
measure: Morphine consumption
timeFrame: preoperative 24th hour
Secondary outcomes:
measure: Numeric Rating Scale
timeFrame: postoperative 24th hour
Other outcomes:
Locations:
city: İzmit
country: Turkey
facility: Kocaeli University Hospital
state: Kocaeli
Study officials:
affiliation: Kocaeli Üniversitesi Tıp Fakültesi
name: Can Aksu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05602987: Comparison Study of the Effect of Enema in Anal Surgery
Official title: The Effect of Enema on Postoperative Recovery and Complications in Anal Surgery: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhoids
Fistula
Lead sponsor: Taipei Medical University Shuang Ho Hospital
Sponsor class: OTHER
First posted: 2022-11-02
Enrollment: 282
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate whether receiving enema before anal surgery or not affects the postoperative recovery and complications.

Detailed description: For patients undergoing anal surgery, some of them receive enema as doctors' preference before the surgery in consider to lower postoperative complications e.g. infection, while others do not. These choices are often determined by surgeons' personal preference according to their experiences due to lack of evidence from researches. Hemorrhoidectomy and fistulotomy are the most common two types of surgery in colon and rectal surgery division in Shuang Ho hospital, where top three quantities of hemorrhoidectomy in Taiwn have been performed.Therefore, we conducted a randomized controlled trial to evaluate the benefits of enema before anal surgery and possible waste of medical resources.

Eligibility criteria: Inclusion Criteria:

* Patients who underwent hemorrhoidectomy, including circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy
* Patients who underwent fistulotomy or fistulectomy

Exclusion Criteria:

* Emergency surgery
* Surgery other than circular stapled hemorrhoidopexy (PPH) and conventional hemorrhoidectomy, e.g., rubber band ligation, injection treatment, and cryosurgery
* Complicated fistulectomy, e.g., requiring surgical drainage and seton placement
* Other types of anal surgery, e.g., anal fissure and colorectal cancer
* Liver cirrhosis
* Coagulation dysfunction
* Bedridden
* Human immunodeficiency virus infection

Primary outcomes:
measure: Pain score
timeFrame: On postoperative day 0 to day 7
measure: Consumption of analgesics
timeFrame: On postoperative day 0 to day 7
Secondary outcomes:
measure: Incidence of surgical site infection
timeFrame: On postoperative day 0-30
measure: Incidence of Urinary retention
timeFrame: On postoperative day 0 to day 7
measure: First defecation after surgery
timeFrame: On postoperative day 0 to day 7
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Taipei Medical University Shuang-Ho Hospital
Study officials:
affiliation: Taipei Medical University Shuang Ho Hospital
name: Tung Cheng Chang, MD, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04176887: Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus
Official title: Levetiracetam Versus Phenytoin in Management of Pediatric Status Epilepticus: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Comparison
the Efficacy of Levetireacetam
Phenytoin
Management of Pediatric Status Epilepticus
Keywords: Levetireacetam
Phenytoin
status epilepticus
children
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be conducted on 60 children suffering from status epilepticus who will be admitted to Pediatric Neurology Unit and Pediatric ICU of Tanta Hospital University.

Detailed description: The aim of this work is to compare the efficacy of Levetireacetam and Phenytoin in management of pediatric status epilepticus.

Eligibility criteria: Inclusion Criteria:

* Children suffering from convulsive generalized tonic clonic status epilepticus at any age.

Exclusion Criteria:

* Non convulsive status epilepticus.
* Children with known contraindication or allergy to levetireacetam or phenytoin.

Primary outcomes:
measure: cessation of convulsion
timeFrame: 30 minutes
Secondary outcomes:
measure: bradycardia
timeFrame: 6 hours
measure: respiratory depression
timeFrame: 6 hours
measure: decreased conscious level
timeFrame: 6 hours
measure: hypotension
timeFrame: 6 hours
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University, Faculty of Medicine
state: Gharbia
Study officials:
affiliation: Tanta University Hospital
name: Amira Darwish, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01721187: Satiety Effects on the Neural Valuation of Food
Official title: Functional Magnetic Resonance Imaging Study of the Valuation of Food as a Function of Satiety
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fasting
Fed
Keywords: fMRI
Satiety
Willingness to Pay
Incentive Delay
Dietary Disinhibition
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
Collaborators: name: Institute for Human Development and Potential (IHDP), Singapore
First posted: 2012-11-04
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: Using fMRI, this study will explore the neural correlates of satiety when individuals make decisions about food. The investigators will also examine individual differences in satiety effects.


Eligibility criteria: Inclusion Criteria:

* Chinese ethnicity
* 21 to 45 years old
* English as first language
* Right-handed
* Have normal eyesight, or have long-sightedness or myopia within +8.0 to -8.0 diopters (unless corrected by contact lenses)
* Weigh less than 100kg with an abdominal circumference of less than 120cm
* Non-smoker, or only smoke occasionally (less than 5 sticks a week)
* Consume less than 2 units (200 mg) of caffeine a day
* Consume less than 21 units of alcohol per week (e.g. 500ml 5% beer = 2.5 units, 250ml 14% wine = 3.5 unit)
* Habitually sleep before 1am and wake before 9am

Exclusion Criteria:

* On a restrictive diet (e.g., vegetarian/vegan diet)
* History of food allergies
* History of psychiatric or neurological disorders
* History of chronic medical illness
* Metal implants in or on the body (e.g. braces, dental retainers, pacemakers)
* Shift worker
* Claustrophobic
* High astigmatism (high = \>2.00 diopters)
* Colour-blind

Primary outcomes:
measure: fMRI - Willingness to Pay task (BDM auction)
timeFrame: Fed and fasted visits (Wks 1 & 2)
measure: fMRI - Monetary and Food Incentive Delay task
timeFrame: Fed and fasted visits (Wks 1 & 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Centre for Cognitive Neuroscience scanner suite
Study officials:
affiliation: Duke-NUS Graduate Medical School
name: Michael WL Chee, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Plassmann H, O'Doherty J, Rangel A. Orbitofrontal cortex encodes willingness to pay in everyday economic transactions. J Neurosci. 2007 Sep 12;27(37):9984-8. doi: 10.1523/JNEUROSCI.2131-07.2007.
citation: Knutson B, Westdorp A, Kaiser E, Hommer D. FMRI visualization of brain activity during a monetary incentive delay task. Neuroimage. 2000 Jul;12(1):20-7. doi: 10.1006/nimg.2000.0593.
Clinical trial NCT02879487: Vaginal Cuff Dehiscence at Total Laparoscopic Hysterectomy
Official title: Vaginal Cuff Dehiscence After Two Different Colpotomy Techniques at Total Laparoscopic Hysterectomy; a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Wound Dehiscence
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to assess a major complication of total laparoscopic hysterectomy, vaginal dehiscence, with two different colpotomy techniques. With this aim patients to be operated for laparoscopic hysterectomy will be randomized to two different techniques. The colpotomy will be undertaken by 'cut mode' in the first group and 'coagulation mode' in the second group. All of the operations will be preformed by the same surgical at a university hospital. Vaginal dehiscence after surgery is the primary outcome measure.


Eligibility criteria: Inclusion Criteria:

* All total laparoscopic hysterectomies performed by a single surgeon
* Both benign and malignant cases
* Completed laparoscopically
* Intracorporeal vaginal cuff suturing

Exclusion Criteria:

* Robotic hysterectomies
* Pelvic infection within 30 days before surgery
* Conversion to laparotomy

Primary outcomes:
measure: Vaginal dehiscence
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Medical Faculty Hospital
Study officials:
affiliation: Ankara University
name: Emre Şükür, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01793987: Coblation in Endoscopic Sinus Surgery
Official title: The Effect of Coblation on Blood Loss in Endoscopic Sinus Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Loss
Keywords: blood loss between two groups
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2013-02-18
Enrollment: 22
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: Chronic Rhinosinusitis (CRS) refers to a pathological condition where the sinonasal mucosa is inflamed for greater than 12 weeks(1). It is associated with a constellation of symptoms, including facial pain, anosmia, and nasal congestion. It has been estimated that CRS affects close to 5% of the Canadian population(2). When medical therapy fails, patients are often referred to Otolaryngology- Head and Neck Surgeons for consideration of surgical management. Endoscopic sinus surgery (ESS) is one of the mainstays of therapy for CRS that has failed medical management(3). Traditionally, the microdebrider has been the go-to tool for performing these surgeries, but recently the Coblator (ArthroCare, Austin, Texas) has begun to define its' role in surgery. By using bipolar radiofrequency energy to ablate tissue (with temperatures up to 60˚ C)(4), theoretically the Coblator will result in less bleeding than so-called "cold" surgical techniques (i.e. the microdebrider). In a retrospective study by Eloy et. al, patients with CRS and nasal polyposis had a statistically significant amount of less intraoperative blood loss when the Coblator was used in their surgery, than those patients who underwent surgery with the microdebrider. The investigators plan to further investigate this in a randomized, controlled fashion


Eligibility criteria: Inclusion Criteria:

* between 18-70 years old, and
* having a diagnosis of CRS.

Exclusion Criteria:

* previous Endoscopic Sinus Surgery,
* coagulopathies,
* being pregnant, or
* being prescribed anti-coagulants or anti-platelet agents

Primary outcomes:
measure: Blood loss
timeFrame: intra-operative
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
Study officials:
References:
Clinical trial NCT03769987: Registry for Advanced Sarcodiosis
Official title: Registry for Advanced Sarcoidosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcoidosis
Keywords: neurosarcoidosis, pulmonary hyeprtension, infliximab, repository corticotropin
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2018-12-10
Enrollment: 800
Sex: ALL
Minimum age (years): 15
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Advanced sarcoidosis is defined by the presence of one or more of the following features:

1. Advanced pulmonary disease as defined by one or more of the following
2. Symptomatic cardiac disease due to sarcoidosis by either MRI or PET scanning and
3. Symptomatic neurologic disease
4. Patients who have received third line therapy (anti-TNF antibodies, rituximab, or RCI)

Brief summary: Registry with evaluation and genetic information of patients with advanced sarcoidosis and matched sarcoidosis


Eligibility criteria: Inclusion criteria

* Patients with diagnosis of sarcoidosis based on ATS/WASOG criteria 22
* Age ≥ 18 years.
* Life expectancy of at least 2 years.
* Pulmonary function tests (spirometry) within one month of entry or willing to under pulmonary function testing on the day of study enrollment
* Sarcoidosis as characterized as either advanced or non-advanced (see protocol for definition of advanced disease)
* Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.

Exclusion criteria

* Subjects with a medical disorder, condition, or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator
* Inability to comply with the protocol and/or not willing or not available for follow-up assessments.
* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.

Primary outcomes:
measure: Death
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Robert Baughman
role: STUDY_CHAIR
References: