louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05620108: Intubating Conditions of Neuromuscular Blockade
Official title: Intubating Conditions At Various Levels of Neuromuscular Blockade
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Endotracheal Intubation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to learn about the difference in the endotracheal intubation condition (ease of using a device to view vocal cords, position of vocal cords, and patient's reaction to endotracheal tube insertion) and determining the appropriate time to perform the intubation.


Eligibility criteria: Inclusion Criteria:

* Patients willing to participate and provide an informed consent.
* Patients undergoing elective surgical procedures that require use of NMBA agents (rocuronium) administered intraoperatively.

Exclusion Criteria:

* Patients with disorders, such as stroke, carpal tunnel syndrome, broken wrist with nerve damage, Dupuytren contracture, or any similar wrist injury.
* Patients with systemic neuromuscular diseases such as myasthenia gravis.
* Patients with significant organ dysfunction that can significantly affect pharmacokinetics of neuromuscular blocking and reversal agents; i.e., severe renal impairment or end-stage liver disease.
* Patients having surgery that would involve prepping the arm into the sterile field.
* Patients receiving a rapid sequence induction.

Primary outcomes:
measure: Assessment of the intubating conditions
timeFrame: Approximately 15 minutes after intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: J. Ross Renew, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02060708: Determining the Specificity of High Definition Electrical Brain Stimulation Using Simultaneous Magnetoencephalography
Official title: Measuring the Stimulated Brain: Determining the Specificity of High Definition Electrical Brain Stimulation Using Simultaneous Magnetoencephalography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Real HD-tDCS
Sham HD-tDCS
Visual Task
Motor Task
Auditory Task
Working Memory Task
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2014-02-12
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Non-invasive human brain stimulation using weak transcranial direct-current stimulation (tDCS) has been thousands of times in research studies over the past fifteen years as a therapy to help improve the effectiveness of repeated training sessions (e.g., hand exercises in the context of daily physiotherapy), due to its safety, tolerability, convenience and cost-effectiveness. tDCS works by temporarily enhancing brain activity during performance of a specific task, helping with learning and training.

The investigators will use magnetoencephalography (MEG) brain imaging to view the real-time effects of high definition (HD) tDCS on several brain areas involved in vision, hearing, movement, and memory. The investigators hypothesize that changing the task (auditory, visual or memory task) but keeping the position of the electrodes over the motor cortex will result in modulation of brain activity in only the central target motor area, and not on non-target temporal, occipital or pre-frontal areas.


Eligibility criteria: Inclusion Criteria:

* Normal hearing and vision

Exclusion Criteria:

* Current pregnancy
* Presence of metallic implants in the head
* Use of any medications
* Any history of mental health or neurological conditions
* Inability to perform any of the tasks for any reason

Primary outcomes:
measure: Change from baseline in brain activity
timeFrame: Immediate (20 minutes)
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
References:
Clinical trial NCT03597308: Prospective Pain Study Comparing Different Treatments After Hand Surgery
Official title: PROSPECTIVE RANDOMIZED CONTROLLED TRIAL COMPARING OXYCODONE, IBUPROFEN AND ACETAMINOPHEN AFTER WIDE AWAKE HAND SURGERY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-operative Pain
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the efficacy of three different types of pain medication (Oxycodone - an opioid, Ibuprofen - a non-steroidal anti-inflammatory, and Acetaminophen - a non-opioid analgesic) in the management of postoperative pain following single soft tissue procedures of the hand and wrist performed exclusively under local anesthesia without sedation. The results of this study will help define optimal prescribing guidelines following the two most common hand surgeries while also potentially validating the use of opioid alternatives post-operatively in order to help mitigate excessive or unnecessary dispensal of opioid analgesics.


Eligibility criteria: Inclusion Criteria

1. Patients indicated to undergo primary, unilateral carpal tunnel release or trigger finger release surgery under local anesthesia alone.
2. Age eligibility is \> 18 years of age.
3. Local anesthesia with 1% lidocaine with 1:100,000 epinephrine and Bicarbonate.

Exclusion Criteria

1. Bilateral procedures.
2. Additional soft tissue or boney procedures performed simultaneously.
3. The use of sedation and/or general anesthesia.
4. Pediatric patients (age \< 18 years).
5. Pregnant female patients.
6. Non-English speaking patients.
7. Known allergies or medical contraindications to Oxycodone, Ibuprofen, Acetaminophen.
8. History of chronic pain and/or narcotic use preoperatively.

Primary outcomes:
measure: Numeric rating Scale for Pain
timeFrame: 2 weeks post-op
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03789708: Effects of Gum Arabic Supplementation in Hemodialysis Patients
Official title: Study of Some Pharmacological and Biochemical Effects of Gum Arabic Supplementation to Hemodilaysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Kidney Failure, Chronic
Lead sponsor: University of Khartoum
Sponsor class: OTHER
Collaborators: name: National Center for Kidney Diseases and Surgery
name: Almughtaribeen University
First posted: 2018-12-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized and controlled clinical trial with parallel design
Primary purpose: TREATMENT

Brief summary: Gum Arabic is a naturally produced gummy exudate from Acacia Senegal tree. It's a complex polysaccharide with proven prebiotic properties. Through its effect on intestinal bacteria, it's expected to reduce systemic levels of toxic bacterial metabolites and reduce inflammatory markers.By increasing fecal bacteria mass it's also expected to reduce blood urea level. These changes are potentially beneficial to hemodialysis patients who suffer from disturbed intestinal flora and a chronic inflammatory status. The investigators hypothesize that supplementing the diet of hemodialysis patients with Gum Arabic for four weeks would reduce inflammatory markers, increase total anti-oxidant capacity and reduce blood urea concentration.


Eligibility criteria: Inclusion Criteria:

* Adult end-stage renal disease patients maintained on regular hemodialysis

Exclusion Criteria:

* Chronic liver disease
* Malignant condition
* Inflammatory bowel disease
* History of bowel resection
* Long term antibiotic therapy
* Pregnancy or lactation
* Current use of immunosuppressive medication

Primary outcomes:
measure: Highly sensitive C-reactive protein (hs CRP) level
timeFrame: 4 weeks
measure: Total anti-oxidant capacity
timeFrame: 4 weeks
measure: Blood urea level
timeFrame: 4 weeks
Secondary outcomes:
measure: Serum calcium
timeFrame: 4 weeks
measure: Serum phosphorus
timeFrame: 4 weeks
measure: Serum uric acid
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: Doctor Salma Center for Kidney Diseases
Study officials:
affiliation: Consultant Nephrologist
name: Sarra Elamin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01636908: Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies.
Official title: Pilot Study on the Determination of Intratumoral Concentrations of Kinase Inhibitors in Patients With Advanced Solid Malignancies.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Advanced Solid Tumors
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2012-07-10
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine intratumoral concentration of kinase inhibitors upon 2 weeks of treatment in tumor tissue of patients.

Detailed description: Patients will be cohort-wise treated with clinically available kinase inhibitors for 2 weeks prior to standard palliative treatment. Five patients will be included in each of eight drug cohorts. Biopsies will be performed to determine intratumoral drug concentrations and to compare tissue (phospho)proteomic and kinase activity profiles before and during therapy.

Eligibility criteria: Inclusion Criteria:

* Advanced solid malignancy
* minimum age 18 years
* indication for palliative treatment
* measurable disease with at least one lesion accessable for biopsy

Exclusion Criteria:

* Cardiovascular conditions including congestive heartfailure NYHA class \>2
* recent myocardial infarction or uncontrolled coronary artery disease
* cardiac arrhythmias requiring anti-arrhythmic therapy
* uncontrolled hypertension
* uncontrolled infections
* serious non-healing wound, ulcer or bone fracture
* pregnant or breast feeding

Primary outcomes:
measure: concentrations of intratumoral kinase inhibitors upon 2 weeks of treatment
timeFrame: 2 weeks
Secondary outcomes:
measure: kinase inhibitor concentrations in plasma, serum and PBMC's upon 2 weeks of treatment
timeFrame: 2 weeks
measure: intra-dermal kinase inhibitor concentrations upon 2 weeks of treatment
timeFrame: 2 weeks
measure: To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of phosphoproteomic profiles in tumor tissue
timeFrame: 2 weeks
measure: To determine per patient whether 2 weeks of treatment with kinase inhibitors induces significant change of kinase activity in tumor tissue
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VUMedical Center
Study officials:
affiliation: VU Medical Center Amsterdam
name: H.M.W. Verheul, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04446208: Endoscopy for Post-operative Fistula
Official title: Endoscopic Treatment of Post-operative Fistula of the Upper Digestive Tract
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post-operative Fistula
Keywords: Fistula
Upper digestive tract
Cancer
Lead sponsor: French Society of Digestive Endoscopy
Sponsor class: OTHER
First posted: 2020-06-24
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: Patients with post-operative fistula of the upper digestive tract, in the setting of a cancerous underlying condition.

Brief summary: Endoscopic treatment of early post-operative fistula in patients with underlying esophageal or gastric cancer has now become the standard of care. However, data regarding the yield of this type of treatment is lacking. This study aims to evaluate endoscopic management of this post-operative complication. The main outcome of this prospective observational study conducted in tertiary centers in France is fistula healing defined as the absence of collection on CT scan (with opacification) in a patient on PO diet, 3 months after the end of the endoscopic treatment.


Eligibility criteria: Inclusion Criteria:

* Patient over 18 years
* Early fistula (\< 30 days)
* Post surgery: Lewis Santy, Akiyama, partial or total gastrectomy
* Indication of endoscopic management: metal stents and/or plastic stents

Exclusion Criteria:

* Pregnancy
* Incapable of decision making and informed consent
* Life expectancy \< 1 month
* General anesthesia contra-indication
* Late fistula (\> 30 days)
* Prior endoscopic treatment
* Wall ischemia
* Duodenum or small bowel fistula
* Post bariatric surgery

Primary outcomes:
measure: fistula healing
timeFrame: 3 months after the end of the endoscopic
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Saint Antoine Hospital
Study officials:
References:
Clinical trial NCT02128308: Clinical Trial to Investigate the Pharmacokinetics of Second-Line Anti-Tuberculosis Agents
Official title: A Open-label, Single Sequence Clinical Trial to Investigate the Pharmacokinetic Characteristics of Second-Line Anti-Tuberculosis Agents After Multiple Oral/Intramuscular Administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Antituberculosis agents
Pharmacokinetics
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-05-01
Enrollment: 16
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the pharmacokinetic characteristics of second-line anti-tuberculosis agents after oral/intramuscular administration in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* healthy male subject aged 20 to 50 at screening
* a body weight in the range of 55 kg (inclusive) to 90 kg (inclusive) with ideal body weight range of 19.0 to 26.0 subjects who decide to participate voluntarily and write a informed consent form

Exclusion Criteria:

* subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor
* subject judged not eligible for study participation by investigator.

Primary outcomes:
measure: AUC (area under the plasma concentration-time curve)
timeFrame: Predose and 2d 0h, 3d 0h, 4d 0h, and 5d 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24h postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
References:
citation: Park SI, Oh J, Jang K, Yoon J, Moon SJ, Park JS, Lee JH, Song J, Jang IJ, Yu KS, Chung JY. Pharmacokinetics of Second-Line Antituberculosis Drugs after Multiple Administrations in Healthy Volunteers. Antimicrob Agents Chemother. 2015 Aug;59(8):4429-35. doi: 10.1128/AAC.00354-15. Epub 2015 May 18.
Clinical trial NCT03134508: Population Based Evaluation of the Use of TNFα Antagonists in Pregnant Women With Inflammatory Bowel Diseases
Official title: Evaluation of Adherence to Guidelines, and of the Risk to Benefit Ratio, in the Use of TNFα Antagonists in Pregnant Women With Inflammatory Bowel Diseases. Study on the French National PMSI Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 8726
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All pregnant women with a diagnosis of IBD

Brief summary: : Inflammatory bowel diseases (IBD), such as Crohn's disease (CD) and ulcerative colitis (UC) need long term treatments which can conflict with a desire of pregnancy in women. Uncontrolled IBD increases the risk of poor pregnancy outcomes \[1\]. Antitumor Necrosis Factor α (antiTNFα) are commonly used, off-label, in pregnancy but with the risk of treatment-related complications. Existing recommendations on the use of antiTNFα during pregnancy are conflicting and only rely on expert opinions. This study was aimed to assess appropriateness and risk to benefit ratio of antiTNFα treatment during pregnancy in women with IBD, for both the mother and the baby until the end of the first year.


Eligibility criteria: Inclusion Criteria:

* pregnancy between 01/01/2011 and 31/12/2014
* Diagnosis of IBD (Crohn's disease or Ulcerative Colitis)

Exclusion Criteria:

* Non IBD indication of antiTNFα treatment

Primary outcomes:
measure: Overall complications
timeFrame: 9 months
Secondary outcomes:
measure: Infectious Complications in the children born from IBD mothers
timeFrame: The first year of life
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu de Dijon
Study officials:
References:
Clinical trial NCT05624008: Clinical Performance of Bioceramic vs High Viscosity GIC for Cervical Restorations of Geriatric Patients
Official title: Clinical Performance of Bioactive Bioceramic Glass Ionomer Restorations vs Conventional High Viscous Glass Ionomer Restorations in Geriatric Patients With Carious Cervical Lesions: A One Year Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Caries
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 28
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to clinically evaluate the performance of the bioceramic glass ionomer compared to conventional high viscosity glass ionomer for restoration of carious cervical lesions in geriatric patients over 12 months follow up.


Eligibility criteria: Inclusion Criteria:

* Geriatric patients aged above 55 years
* Patients with untreated carious lesions
* Patients who have at least 20 teeth under occlusion
* Patients with normal occlusion
* Vital teeth with carious cervical lesion with asymptomatic vital pulp.
* Teeth with no or minimum mobility.
* Teeth with normal occlusion.
* Teeth with surrounding healthy gingiva and supporting-structures.

Exclusion Criteria:

* Patients who are unable to return for recall appointments
* Presence of abnormal oral, medical or mental conditions.
* Patients with severe medical diseases.
* Patients with xerostomia
* Patients with parafunctional habits.
* Non vital teeth.
* Teeth with signs or symptoms of pulpitis.
* Teeth with non carious lesions.

Primary outcomes:
measure: Change in Marginal adaptation score
timeFrame: Baseline, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Change in Retention score
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in Color match score
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in Marginal discoloration score
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in Secondary caries score
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in Wear score
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in Postoperative hypersensitivity score
timeFrame: Baseline, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
state: ElManial
Study officials:
References:
Clinical trial NCT00704808: Post Marketing Surveillance: Newly Diagnosed Glioblastoma Multiforme Treated With Radiotherapy/Temozolomide and Adjuvant Temozolomide (Study P04739)
Official title: Post Marketing Surveillance of Radiotherapy With Concomitant and Adjuvant Chemotherapy With Temozolomide for Patients With Newly Diagnosed and Operated Glioblastoma Multiforme
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioblastoma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-25
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed glioblastoma multiforme.

Brief summary: The purpose of this surveillance is to collect more safety and efficacy data in "non-study" patients during concomitant and adjuvant temozolomide therapy.


Eligibility criteria: Inclusion Criteria:

* Patients must have newly diagnosed and operated glioblastoma multiforme with postoperative residual tumor \<=1.5 cm by magnetic resonance imaging (MRI).
* Age \>=18 years.
* Hemoglobin \>=10 g/dL.
* White blood cell count \>=1.5x10\^9/L.
* Platelet count \>=100x10\^9/L.
* Blood urea \<=1.5 x upper limit of normal values (ULN).
* Creatinine \<=1.5 x ULN.
* Bilirubin \<=1.5 x ULN.
* Aspartate aminotransferase \<=3 x ULN.
* Alanine aminotransferase \<=3 x ULN.
* Alkaline phosphatase \<=2 x ULN.

Exclusion Criteria:

* Tumor-specific pretreatment.
* Contraindication against radiotherapy and/or chemotherapy.
* Malignomas other than basaliomas.
* Existing or planned pregnancy or lactation or inadequate contraception.
* Psychiatric disease.
* Simultaneous participation in another clinical trail or participation in another clinical trail in the last 30 days before recruitment.

Primary outcomes:
measure: Median Progression Free Survival After Primary Surgical Treatment, Concomitant and Adjuvant Chemotherapy With Temozolomide, for Patients With Newly Diagnosed Glioblastoma Multiforme
timeFrame: After primary surgical treatment and concomitant and adjuvant chemotherapy with temozolomide
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: