louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01100515: Hyperbaric Oxygen Therapy for Acute Domestic Carbon Monoxide (CO) Poisoning
Official title: Phase 3 Study of Hyperbaric Oxygen Therapy in Non-Comatose Patients With Acute Domestic Carbon Monoxide Poisoning
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carbon Monoxide Poisoning
Keywords: intoxication
carbon monoxide
adults
domestic accident
acute domestic carbon monoxide poisoning
Lead sponsor: University of Versailles
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2010-04-09
Enrollment: 179
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Carbon monoxide poisoning still places a burden on the healthcare system worldwide. While oxygen therapy is the cornerstone treatment, the role and practical modalities of hyperbaric oxygen therapy (HBO) remain controversial. This study aimed at comparing one session of HBO at 2 absolute atmosphere followed by 4 hours of normobaric oxygen therapy to 6 hours of normobaric oxygen therapy in adult victims of acute domestic carbon monoxide poisoning and without coma.


Eligibility criteria: Inclusion Criteria:

* patients older than 15 years of age
* admitted for domestic CO poisoning within 12 hours after the end of CO exposure.
* had transient loss of consciousness (syncope, malaise)
* carboxyhemoglobin level at presentation \>10% or 5%, in smokers and non-smokers, respectively.

Exclusion Criteria:

* poisoning by more than one compound (e.g., CO plus a drug or CO plus other toxic gases such as those found in fire smoke
* suicide attempt
* pregnancy
* coma
* contraindications to HBO (circulatory collapse or pneumothorax)
* technical obstacles to HBO
* non domestic CO poisoning
* difficulty in determining whether the patient experienced initial loss of consciousness or initial coma
* consent refusal.

Primary outcomes:
measure: full recovery
timeFrame: at one month
Secondary outcomes:
measure: persistent neurological sequels
timeFrame: at one month
measure: delayed neurological sequels
timeFrame: at one month
measure: variations in carboxyhemoglobin levels
timeFrame: at 12 hours from randomization
measure: serious adverse events
timeFrame: at one month
Other outcomes:
Locations:
city: Garches
country: France
facility: Raymond Poincaré Hospital
Study officials:
References:
Clinical trial NCT01837615: Assessment of Photopill Capsule Treatment for Safety and Feasibility in Ulcerative Proctitis
Official title: Assessment of the Photopill Capsule Treatment for Safety and Feasibility in Patients With Ulcerative Proctitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Proctitis
Keywords: Ulcerative Colitis
Ulcerative Proctitis
Low Level Light Therapy
Safety
Efficacy
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Photopill Medical Ltd
First posted: 2013-04-23
Enrollment: 8
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: Low Level Light therapy (LLLT) has been used for tissue healing in many mucosal diseases that involve wounds, ulcers and inflammation, oral chemotherapy-induced mucositis in particular. Likewise IBD is characterized by chronic tissue inflammation, tissue damage and ulcerations in various extents. Therefore we hypothesize that LLLT might be effective in treating IBD and the Photopill capsule was developed for this purpose.

An open-label, interventional, clinical trial was designed for assessment of the safety and feasibilty of the Photopill capsule treatment in patients with mild to moderate Ulcerative Proctitis.

Primary endpoints being: safety reflected by the number and severity of adverse events and mucosal appearance at sigmoidoscopies day 14, day 28, day 42 compared to baseline condition.

Furthermore clinical and biochemical parameters are monitored during the study.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Ulcerative Proctitis (Mayo grade 1/2)

Exclusion Criteria:

* Symptomatic hemorrhoids
* Pregnant or lactating females
* Patients that have used any experimental treatment within 8 weeks prior to Day 0
* Patient that have used any biologics therapies or immunomodulation agents and/or steroids 4 weeks prior to Day 0
* Rectal therapy 2 weeks prior to Day 0

Primary outcomes:
measure: Adverse events
timeFrame: day 0-42
Secondary outcomes:
measure: Inflammatory markers
timeFrame: day 0,14,28,42
measure: Clinical Questionnaires
timeFrame: day 0,14,28,42
measure: Mucosal appearance at sigmoidoscopy
timeFrame: week 0,14,28.42
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: North Holland
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Geert R D'Haens, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01530815: Bupivicaine to Reduce Postoperative Pain in Laparoscopic Ventral Hernia Repair
Official title: Intraoperative Local Anesthesia for Management of Postoperative Pain Following Laparoscopic Ventral Hernia Repair: a Prospective Double-blind Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Lead sponsor: Chang, Steve S., M.D.
Sponsor class: INDIV
First posted: 2012-02-10
Enrollment: 80
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 investigators are testing to see if infusion of bupivicaine between the mesh and abdominal wall can reduce postoperative pain and decrease use of narcotics in the postoperative setting.

Detailed description: The primary objective of this study is to test different methods for pain management following laparoscopic ventral hernia repair. We hypothesize that local analgesic injection between the abdominal wall and mesh intraoperatively during laparoscopic ventral hernia repair will result in a 20% decrease in the use of post-surgery pain medication in the first four hours after surgery.

Eligibility criteria: Inclusion Criteria:

1. Patient must be scheduled for a laparoscopic ventral hernia repair at SBCH. If any additional procedure is performed, the subject will be excluded from the study
2. Age 18 or older
3. Patient must agree to complete pain journal postoperatively
4. Informed consent signed and dated by patient. Consenting through a legally authorized guardian will not be accepted due to the necessity of completing a subjective pain journal

Exclusion Criteria:

1. Any surgical procedure occurring besides the study procedure
2. Any allergy or sensitivity to bupivicaine or its derivatives
3. Less than 18 years of age
4. Patient unable to self report in pain journal due to cognitive disabilities
5. Discharged less than 4 hours post-surgery

Primary outcomes:
measure: Pain
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Santa Barbara Cottage Hospital
state: California
Study officials:
affiliation: Santa Barbara Cottage Hospital
name: Steve S Chang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gough AE, Chang S, Reddy S, Ferrigno L, Zerey M, Grotts J, Yim S, Thoman DS. Periprosthetic Anesthetic for Postoperative Pain After Laparoscopic Ventral Hernia Repair: A Randomized Clinical Trial. JAMA Surg. 2015 Sep;150(9):835-40. doi: 10.1001/jamasurg.2015.1530.
Clinical trial NCT03124615: Effect of Enzalutamide Dose Reduction on Fatigue, Cognition, and Drug Trough Levels in Patients With Prostate Cancer
Official title: Effect of Enzalutamide Dose Reduction on Fatigue, Cognition, and Drug Trough Levels in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Macquarie University, Australia
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 47
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients will have commenced standard dose enzalutamide (160mg) daily and dose will be reduced if Grade 3 fatigue or cognition change has occurred and if toxicity is attributed to enzalutamide
Primary purpose: TREATMENT

Brief summary: The primary purpose of this trial is to determine whether dose reduction of enzalutamide in patients with grade 3 fatigue and/or cognition change will lead to an improvement in symptoms while maintaining active drug levels.

Patients within 3 months of starting enzalutamide will be assessed by their oncologist as being potentially eligible for dose reduction due to the onset of moderate to severe fatigue and/or cognition change, which is assessed as being due to enzalutamide


Eligibility criteria: Inclusion Criteria:

1. Patients with prostate cancer who have commenced enzalutamide within 3 months
2. Patient must have concomitant LHRH agonist or antagonist (no single agent enzalutamide)
3. Receiving enzalutamide before or after docetaxel
4. Patients may have hormone-sensitive or castrate resistant disease
5. Patients may have metastatic (M1) or non-metastatic (M0) disease
6. Onset of grade 3 or more cognition change and/or fatigue after commencement of enzalutamide considered to be due to enzalutamide

Exclusion Criteria:

1. Clinical dementia
2. Concomitant use of drugs known to impair cognition such as benzodiazepines or antihistamines.
3. Concomitant use of strong CYP3A4 and/ or CYP2C8 inducers or inhibitors.
4. Patient expected to have a change in opioid dose during the study period or have had a change 4 weeks before study entry.
5. Diagnosed with sleep apnoea
6. Brain metastases, prior seizures, drugs that significantly reduce seizure threshold.
7. Active infection or other intercurrent illness that may contribute to fatigue or cognition change within 4 weeks of study entry.

Primary outcomes:
measure: The proportion of patients who have an improvement in cognition/ fatigue symptoms
timeFrame: 1 year post enrolment
Secondary outcomes:
Other outcomes:
Locations:
city: North Ryde
country: Australia
facility: Macquarie University
state: New South Wales
Study officials:
affiliation: Medical Oncologist
name: Howard Gurney
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01292915: Survey of Non-Variceal Upper Gastro Intestinal Bleeding in Vietnamese Patients
Official title: Survey of Non-Variceal Upper Gastro Intestinal Bleeding in Vietnamese Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Re-bleeding in NVUGIB
Keywords: Re-bleeding, NVUGIB
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-02-10
Enrollment: 1044
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: NVUGIB patients in 13 hospitals in Hanoi, HCMC, Danang

Brief summary: The main aim of the study is to describes the outcomes of patients with Upper Gastrointestinal Bleed (UGIB) in a real-life setting. Additionally analyse assessed predictors of outcome, including the impact of hemostatic endoscopic and pharmacologic therapies.

Detailed description: MSD

Eligibility criteria: Inclusion Criteria:

* Adult patients (\>=18yrs) admitted to the hospital, or inpatients admitted for another reason, presenting with overt non-variceal upper GI bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia...
* Evidence that an upper GI endoscopy was performed

Exclusion Criteria:

* GI bleeding not from NVUGIB

Primary outcomes:
measure: Rebleeding (within 7 days from the Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB) episode)
timeFrame: 7 days
Secondary outcomes:
measure: Surgery due to re-bleeding
timeFrame: 7 days
measure: Mortality due to bleeding
timeFrame: 7 days
measure: Rebleeding in high risk peptic ulcer patients
timeFrame: 7 days
Other outcomes:
Locations:
city: Danang
country: Vietnam
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: HoChiMinh City
country: Vietnam
facility: Research Site
Study officials:
affiliation: Hanoi Medical University
name: Dao Van Long, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00254215: Glycemic Load, Weight Loss and Cardiovascular Disease Risk
Official title: The Effect of 4 Diets Varying in Glycemic Index, Glycemic Load, Carbohydrate and Protein, on Weight, Body Composition and Cardio-Vascular Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Overweight
Obesity
Keywords: overweight
obesity
glycemic index
glycemic load
high protein diet
blood cholesterol
Lead sponsor: University of Sydney
Sponsor class: OTHER
Collaborators: name: Meat & Livestock Australia
name: National Heart Foundation, Australia
First posted: 2005-11-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the hypothesis that reducing the glycemic load of the diet will improve changes in body composition and cardio-vascular risk factors. The study compares a conventional reduced-fat, high carbohydrate diet with 3 means of reducing glycemic load: changing the carbohydrates to low-GI choices, replacing some of the carbohydrate with protein, or combining both effects to produce the lowest glycemic load.

Detailed description: Conventional low fat diets produce modest wegiht loss at best and the results are not well maintained. More recently there has been interest in low glycemic index and high protien diets wiht some evidence that these produce better fat loss and improvement in cardiovascular risk factors. This trial aims to evaluate these different approaches and compare the outcomes over 12 weeks. Major outcomes are weigth loss, body composition change, blood lipids change, measures of glucose homeostasis, insulin resistance, leptin and CRP.

Eligibility criteria: Inclusion Criteria:

* 18-40 years of age BMI \>=25 stable weight for 3 months non-vegetarian good understanding of English

Exclusion Criteria:

medications other than the contraceptive pill weight \>150kg (weight limit of DEXA machine) vegetarian (diets included red meat) specific diets diabetes or impaired glucose tolerance pregnancy

-

Primary outcomes:
measure: weight loss at 12 weeks
measure: Fat loss at 12 weeks
measure: Lean mass change at 12 weeks
Secondary outcomes:
measure: Total cholesterol, LDL and HDL cholesterol change at 12 weeks
measure: glucose, insulin & measures of insulin sensitivity change at 12 weeks
measure: TG change at 12 weeks
measure: Leptin change at 12 weeks
measure: CRP change at 12 weeks
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: University of Sydney
state: New South Wales
Study officials:
affiliation: University of Sydney
name: Jennie C Brand-Miller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: McMillan-Price J, Petocz P, Atkinson F, O'neill K, Samman S, Steinbeck K, Caterson I, Brand-Miller J. Comparison of 4 diets of varying glycemic load on weight loss and cardiovascular risk reduction in overweight and obese young adults: a randomized controlled trial. Arch Intern Med. 2006 Jul 24;166(14):1466-75. doi: 10.1001/archinte.166.14.1466.
Clinical trial NCT02997215: Intravenous Lidocaine and Postoperative Pain Management
Official title: Effect of Intravenous Lidocaine on Postoperative Pain Management After Laparoscopy Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Pain Management
Keywords: intravenous lidocaine
postoperative pain management
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 80
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: This study was to evaluate the effect of intraoperative intravenous lidocaine on postoperative pain management after laparoscopic cholecystectomy. Half of patients will receive intravenous lidocaine during procedure, the rest half of patients will receive regular anesthesia care and placebo treatment.

Detailed description: Postoperative pain and ileus are primary reasons for delayed patient recovery and longer hospital stays after abdominal surgery. Opioids have been widely used to treat pain in this patient population. However, opioid administration can exacerbate postoperative ileus and further delay patient recovery. Multimodal approaches and adjunctive therapies are therefore recommended for pain control after abdominal surgery to reduce opioid consumption and opioid-related adverse effects.

Studies have reported that systemically administered lidocaine has analgesic, anti-inflammatory, and anti-hyperalgesic effects. Several clinical trials have been published that evaluated systemically administered lidocaine for postoperative pain management and recovery after surgery. However, the evidence for beneficial effects of systemic lidocaine for postoperative recovery remains controversial. Therefore, the investigators performed this study to evaluate the efficacy of systemic administration of lidocaine for postoperative analgesia and gastrointestinal recovery after laparoscopic cholecystectomy. The investigators primary hypothesis is that systemic lidocaine administration reduces pain intensity following surgery.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist (ASA) status I-II adult patients undergoing elective laparoscopic cholecystectomy.

Exclusion Criteria:

* Open surgery;
* Patients allergic to lidocaine or other local anesthetics;
* Drug abuser.

Primary outcomes:
measure: postoperative pain score
timeFrame: 6 hours after surgery
measure: postoperative pain score
timeFrame: 24 hours after surgery
measure: postoperative pain score
timeFrame: 72 hours after surgery
measure: total postoperative opioid consumption
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: incidence of postoperative complication
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Anesthesiology; Beijing Tongren Hospital
Study officials:
References:
Clinical trial NCT06707415: Compare the Accuracy of MindTension Blink Eye Reflex Measuring Device to DANTAC Keypoint Electromyography (EMG) System.
Official title: A Clinical Study to Compare the Accuracy and Precision of the MindTension Blink Eye Reflex Measuring (Evoked Response)Device to DANTAC Keypoint EMG System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Electromyography
Auditory Event-related Potential (AERP)
Keywords: MT1
Electromyography
Auditory evoked potentials
Lead sponsor: MindTension
Sponsor class: INDUSTRY
Collaborators: name: Carmel Medical Center
First posted: 2024-11-27
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: A clinical study aimed to compare the accuracy and precision of the MindTension MT1 auditory evoked response parallel to an FDA cleared device (Natus DANTEC Keypoint).

Detailed description: Mindtension device measures the orbicularis muscle response to auditory stimuli, the device is backed up by an algorithm that calculates several parameters of startle reflex and startle related indices. In the present study we aim to test the validity, accuracy and precision of MT1 system compared to an FDA cleared device, the Natus DANTEC Keypoint EMG system (K944547).

The aim of this clinical trial is to demonstrate the accuracy and precision of the MT1 device to the FDA cleared Natus DANTEC Keypoint EMG system that is used in the EMG unit.

Participants (n=38) will be evaluated for eligibility of inclusion. As this is paired-group design study, patients will be randomized in a 1:1 ratio to group 1 (Right facial side with MT1 device), or group 2 (Right facial side Natus keypoint device), each patient will be tested using both devices at the same time. The test is 6 minutes in duration. The results will be compared within and between subject analysis.

Safety will be assessed through collection and analysis of adverse events.

Eligibility criteria: Inclusion Criteria:

* Subject's informed consent.
* Healthy subjects, with no known chronic disease.
* Both genders, age between 18-45.

Exclusion Criteria:

* Any current co-morbid Chronic illness.
* Hearing loss.
* Pregnancy.
* Substance abuse during the last 3 months.
* Lack of cooperation.

Primary outcomes:
measure: Average maximal peak levels
timeFrame: Day 1
measure: Average peak index
timeFrame: Day 1
measure: Average eye blink width
timeFrame: Day 1
measure: Average inhibition
timeFrame: Day 1
Secondary outcomes:
measure: Average eye blink sum
timeFrame: Day 1
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: MindTension
name: Hadas Shatz Azoulay, PhD
role: STUDY_DIRECTOR
References: