louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03826251: Small Bowel Obstruction and Surgery
Official title: Nasogastric Tube After Small Bowel Obstruction Surgery is Not Mandatory: a Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Small Intestine Obstruction
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2019-02-01
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing surgery for adhesive small bowel obstruction in the CHU of Angers between January 1, 2014 and December 31, 2017

Brief summary: Postoperative management after small bowel obstruction (SBO) surgery is not consensual and better knowledge of risk factors for postoperative morbidity could help to add evidence of the feasibility of enhanced recovery programs (ERPs).

In elective surgery, ERPs have shown a significant benefit for the patient but this is not performed routinely in emergency surgery due to the difficulty to avoid postoperative nasogastric tube.

The aim was to identify risk factors for postoperative morbidity and for nasogastric tube (NGT) replacement after SBO surgery.


Eligibility criteria: Inclusion Criteria:

* Surgical management of Small bowel obstruction due to adhesions

Exclusion Criteria:

* obstruction not caused by single band adhesion
* matted adhesions, or if they were less than 18 years old

Primary outcomes:
measure: postoperative morbidity
timeFrame: within 30 days
Secondary outcomes:
measure: Nasogastric tube replacement
timeFrame: within 30 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02930551: Neuromas as the Cause of Pain
Official title: Infiltration of Neuromas With Local Anesthetics to Eliminate Pain: A Double-blinded Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuropathic Pain
Neuroma
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2016-10-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Neuromas are frequent after trauma and surgery, including amputation and can be identified by high-resolution ultrasound. The role of neuromas as the cause of neuropathic pain is uncertain. The investigators therefore wish to explore if spontaneous and evoked pain will be relieved by injection of local anesthetics near painful neuromas in subjects with peripheral nerve injury.


Eligibility criteria: Inclusion Criteria:

* Subjects with peripheral nerve injury 3 months prior to participation

Exclusion Criteria:

* Severe somatic or psychiatric diseases
* Other peripheral neuropathy
* Lack of ability to cooperate to the clinical examination
* Allergy to Lidocaine or similar analgetics

Primary outcomes:
measure: Spontaneous pain on numerical rating scale (NRS 0-10)
timeFrame: 15 minutes after injection
measure: Evoked pain on numerical rating scale (NRS 0-10)
timeFrame: 15 minutes after injection
Secondary outcomes:
measure: Brush allodynia
timeFrame: 15 minutes after injection
measure: Pinprick hyperalgesia
timeFrame: 15 minutes after injection
measure: Cold allodynia
timeFrame: 15 minutes after injection
measure: Heat allodynia
timeFrame: 15 minutes after injection
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Center, Aarhus University Hospital
Study officials:
References:
Clinical trial NCT05568251: TDCS Combined With CT In Opioid Use Disorder
Official title: Transcranial Direct Current Stimulation Combined With Cognitive Training In Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Keywords: brain stimulation
cognitive functions
neuropsychological evaluation
opioid use disorder
transcranial direct current stimulation
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Research, Treatment and Training Center for Alcohol and Substance Dependence (AMATEM)
First posted: 2022-10-05
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to investigate the effect of prefrontal transcranial Direct Current Stimulation (tDCS) combined with cognitive training on cognitive functions in individuals with Opioid Use Disorder (OUD). The participants will be allocated into active/sham groups (1:1) and will receive a single session of prefrontal tDCS combined with cognitive training. Outcomes of the active and sham groups will be compared.


Eligibility criteria: Inclusion Criteria:

* Being aged between 18-65 years
* being in the maintenance phase of the OUD treatment
* naivety to tDCS
* at least 5 years of education

Exclusion Criteria:

* current diagnosis of major depressive disorder
* current diagnosis or history of bipolar disorders, psychotic disorders, neurocognitive disorders, pervasive developmental disorders, mental retardation, severe neurological disorders,
* common tDCS contraindications

Primary outcomes:
measure: Changes in the Iowa Gambling Task net score
timeFrame: Before and immediately after the intervention
measure: Changes in the Adjusted Number of Pumps in the Balloon Analogue Risk Task
timeFrame: Before and immediately after the intervention
Secondary outcomes:
measure: Changes in Interference Time in the Stroop Test
timeFrame: Before and immediately after the intervention
measure: Changes in the Stop Signal Reaction time in the Stop Signal Test
timeFrame: Before and immediately after the intervention
measure: Changes in the verbal fluency performance
timeFrame: Before and immediately after the intervention
measure: Changes in the digit span performance
timeFrame: Before and immediately after the intervention
measure: Changes in the Trail Making Test A Time
timeFrame: Before and immediately after the intervention
measure: Changes in the Trail Making Test B Time
timeFrame: Before and immediately after the intervention
measure: Changes in the Letter Number Sequencing (LNS) Test performance
timeFrame: Before and immediately after the intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
city: Istanbul
country: Turkey
facility: Research, Treatment and Training Center for Alcohol and Substance Dependence (AMATEM)
Study officials:
affiliation: Istanbul University
name: Serkan Aksu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01754051: A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System
Official title: VOLCAN: A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysms
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-21
Enrollment: 100
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: Up to 200 patients with intracranial aneurysms treated by the PC 400 System at up to 20 centers will be enrolled.

Brief summary: This study is a prospective, multi-center registry of patients with intracranial aneurysms who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3 months post-procedure for the study.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years
* Intracranial aneurysms \>2mm, ruptured or unruptured

Exclusion Criteria:

* Fusiform aneurysms
* Dissecting aneurysms
* Aneurysms associated with brain AVMs
* Multiple aneurysms
* Re-treated aneurysms
* Patients in whom endovascular embolization therapies other than PC 400 System are used will be excluded from this study. However, adjunctive use of balloon and stent are acceptable.

Primary outcomes:
measure: Packing density with the number of coils implanted
timeFrame: During the procedure
measure: Time of fluoroscopic exposure
timeFrame: During the procedure
measure: Procedural device-related serious adverse events at immediate post-procedure
timeFrame: During the procedure
measure: Quality of aneurysm occlusion post-operatively and at 12±3 months post-procedure based on the Raymond Scale
timeFrame: At 1 year post-procedure
Secondary outcomes:
measure: Acute occlusion of the aneurysm sac at immediate post-procedure
timeFrame: At immediate post-procedure
measure: Adverse events occurring during the procedure and in the 30±7 days following the treatment.
timeFrame: During and at 30 days post-procedure
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Pellegrin
Study officials:
affiliation: CHU Pellegrin - Bordeaux
name: Dr. Jérôme Berge, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01690351: A Study Comparing PF-05089771 TS Capsule To PF-05089771 TS Oral Dispersion In The Fasted State
Official title: A Phase 1, Open Label, Single Dose, Bioavailability Study In Healthy Volunteers Comparing PF-05089771 TS Oral Dispersion To PF-05089771 TS Capsule
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-09-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to estimate the relative bioavailability and food effect of a PF-05089771 capsule.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or non-childbearing potential female subjects between the ages of 18 and 55 years

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal,endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* A positive urine drug screen.
* History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening.
* Treatment with an investigational drug within 60 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.
* Screening supine blood pressure ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest 7. Single 12-lead ECG demonstrating QTc \>450 msec or a QRS interval \>120 mseca at screening. If QTc exceeds 450 msec, or QRS exceeds \>120 mseca the ECG should be repeated two more times and the average of the three QTc or QRS values should be used to determine the subject's eligibility.

Primary outcomes:
measure: Maximum concentration (Cmax) for PF-05089771 in plasma (measured in ng/mL)
timeFrame: days 1-2
measure: AUClast = Area under the curve from the time of dosing to the last data point taken (ng.hr/mL)
timeFrame: days 1-2
measure: AUCinf = Area under the curve from the time of dosing extrapolated to infinity (ng.hr/mL)
timeFrame: days 1-2
measure: Tmax = Time of maximum concentration of PF-05089771 in plasma (hr)
timeFrame: days 1-2
measure: t½ = Elimination half life of PF-05089771 (hr)
timeFrame: days 1-2
Secondary outcomes:
measure: evaluation of safety clinical laboratory tests, vital signs, ECGs, physical examinations and adverse event monitoring.
timeFrame: days 1-2
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00524654: The Effects of Cervical Spine Manipulation On Postural Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Posture
Keywords: To determine the effects of cervical spine manipulation on postural control.
Lead sponsor: Logan College of Chiropractic
Sponsor class: OTHER
First posted: 2007-09-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to test the effect of high velocity low amplitude (HVLA) chiropractic cervical manipulation on the patient's postural control as measured by a force plate.


Eligibility criteria: Inclusion Criteria:

* Students
* Normal healthy adults

Exclusion Criteria:

* Previous or ongoing foot, ankle, or hip problems
* Experiencing vertigo, visual difficulties and other disorders that would make it difficult to balance for a set period of time.
* Anyone with high risk for injury due to cervical manipulation
* Anyone with training in areas of activity that require superior balance
* Body mass index over 30

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chesterfield
country: United States
facility: Logan College
state: Missouri
Study officials:
affiliation: Logan College
name: Rodger Tepe, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03982654: Investigating the Physiology of Labour and Labour Onset Through Longitudinal Measurements Performed With a Wearable Sensor
Official title: Investigating the Physiology of Labour, Labour Onset and Pregnancy Outcomes in Pregnant Women, Through Longitudinal Measurements Performed With a Wearable Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labour Onset
Lead sponsor: Bloom Technologies
Sponsor class: INDUSTRY
First posted: 2019-06-11
Enrollment: 145
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of the study is to collect data to support the development and validation of a machine learning model for the automatic detection, prediction and monitoring of labour, through the use of a wearable sensor (Bloomlife sensor) that can be easily used at home.

Women participating in the study will be asked to regularly record data with the Bloomlife sensor, from inclusion in the study until delivery. In addition, clinical information related to their pregnancy and delivery will be collected.


Eligibility criteria: Inclusion Criteria:

* Pregnant
* Gestational age between 20 weeks and 0 days and 30 weeks and 0 days
* Willingness to participate in the study

Exclusion Criteria:

* Implanted pacemaker or any other implanted electrical device
* History of allergies to silicone-based adhesives
* Any health condition resulting in higher chance of C-section (meeting one of these criteria is sufficient to be excluded): previous history of C-section, placental abnormality, being primipara and older than 40

Primary outcomes:
measure: Accuracy
timeFrame: At delivery
Secondary outcomes:
measure: Labour probability
timeFrame: At delivery
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Liège
country: Belgium
facility: CHR de la Citadelle
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Wilfried Gyselaers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHR de la Citadelle
name: Frederic Chantraine, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01671254: Effect of Citrus Bioflavonoids/Vitamin E in Conjunction With Fish Oil Supplementation
Official title: A Double-blind, Placebo-controlled Trial of a Dietary Supplement Containing Citrus Bioflavonoids and Vitamin E at 2 Doses in Conjunction With Fish Oil Supplementation in Hyperlipidemic Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemia
Lead sponsor: MetaProteomics LLC
Sponsor class: INDUSTRY
First posted: 2012-08-23
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this 8-week intervention trial is to investigate the effect of a dietary supplement (containing citrus bioflavonoids and vitamin E) plus fish oil supplementation in healthy hyperlipidemic subjects


Eligibility criteria: Inclusion Criteria:

* men and women ≥ 18 and ≤ 72 years old
* generally healthy
* BMI \> 18 and \< 38
* LDL cholesterol ≥ 130 mg/dl and \< 270 mg/dl
* triglycerides ≥ 150 mg/dl and \< 400 mg/dl
* ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* use of nutritional supplements and medical foods for dyslipidemia within 30 days prior to the study
* use of omega-3 fatty acid dietary supplements within 30 days prior to the study
* use of prescription HMG-CoA reductase inhibitors, bile acid sequestrants, fibrates, cholesterol absorption blocking agents, or niacin
* use of prescription medications and/or nonprescription medications for acute and semi-acute medical conditions
* history of cardiovascular disease, type i diabetes, autoimmune disease, liver or kidney disease, malignancy, and serious mental illness.
* known infection with HIB, TB, hepatitis B or hepatitis C
* history of allergy or intolerance to study products
* smoking, use of nicotine-containing products, or use of drugs of abuse 30 days prior to the study
* history of regular intake of \> 14 alcoholic drinks per week for females and \> 21 drinks per week for males

Primary outcomes:
measure: LDL cholesterol
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Triglyceride
timeFrame: Baseline, 8 weeks
measure: oxLDL
timeFrame: Baseline, 8 weeks
measure: Total cholesterol
timeFrame: Baseline, 8 weeks
measure: HDL cholesterol
timeFrame: Baseline, 8 weeks
Other outcomes:
Locations:
city: Gig Harbor
country: United States
facility: Functional Medicine Research Center
state: Washington
Study officials:
affiliation: MetaProteomics / Metagenics / FMRC
name: Joseph J Lamb, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02151253: Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
Official title: A Double-Blind, Placebo-Controlled, Cross-over Study of Armodafinil Treatment of Daytime Sleepiness Associated With Treated Nocturia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Nocturia
Daytime Sleepiness
Keywords: Nocturia
Daytime sleepiness
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-05-30
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate armodafinil as a wakefulness-promoting therapy as a means of improving residual daytime sleepiness in patients with treated nocturia.


Eligibility criteria: Inclusion Criteria:

1. Receiving standard-of-care therapy for nocturia based on assessment by study physician
2. Evaluation by study physician indicates that the patient meets criteria for either overactive bladder diagnosis, or nocturnal polyuria diagnosis.
3. Mean number of nocturia episodes at least 2 per night based on day sleep/bladder diary
4. Epworth Sleepiness Scale Score of at least 10
5. Clinical Global Impression of Sleepiness at least Moderate
6. Age 18-90 years inclusive

Exclusion Criteria:

1. Medications affecting urinary or sleep-wake function other than therapy for OAB o or NP within 5 half-lives of baseline assessment
2. Sleep disorders other than nocturia based on history and screening assessment
3. Unstable medical or psychiatry conditions
4. Medical or psychiatric conditions affecting sleep/wake or urologic function
5. Apnea-Hypopnea Index (AHI) ≥ 15 on screening polysomnogram
6. Periodic Leg Movement Arousal Index (PLMAI) ≥ 15 on screening polysomnogram
7. History of substance abuse or dependence in the last year
8. Regular consumption of over 800 mg of caffeine use
9. Shift-work in the 3 months prior to or during the study

Primary outcomes:
measure: Change From Baseline in Epworth Sleepiness Scale [ESS]
timeFrame: Baseline, Week 4 of each phase
Secondary outcomes:
measure: Clinical Global Impressions, Change in Severity of Excessive Daytime Sleepiness (EDS)
timeFrame: week 4, of each phase
measure: Mean Number of Naps/Day
timeFrame: week 4 of each phase.
measure: Mean Number of Minutes Napped Per Day Based on Sleep Diary
timeFrame: week 4 of each phase.
measure: Mean Number of Nocturic Events (Episode of Urination Preceded and Followed by Sleep)
timeFrame: week 4 of each phase.
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Andrew Krystal, MD
role: PRINCIPAL_INVESTIGATOR
References: