louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04422197: This Randomized Controlled Study Aims to Investigate the Effect of Botox Injection in Abdominal Wall Muscle Post Major Abdominal Surgery in Terms of Postoperative Pain, Incidence of Incisional Hernia.
Official title: Effect of Botox Injection on Lateral Abdominal Wall Muscles After Major Open Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Abdominal
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 30
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: PREVENTION

Brief summary: Aim of the work This randomized controlled study aims to investigate the effect of botox injection in abdominal wall muscle post major abdominal surgery in terms of postoperative pain, incidence of incisional hernia Study design and setting This is a double-blind prospective randomized controlled trial that will be conducted in the general surgery department and colorectal surgery unit of Mansoura University hospital in the period from June 2019 to June2020. The patient's recruitment process will be started and continued for one year after getting the approval from the local Institutional Review Board in Mansoura University in concordance with the Helsinki Declaration Principals. The data will be collected and analyzed prospectively. A signed informed consent will be obtained from every patient before enrollment highlighting the possible future publication. On request, patients can be excluded from the study at any time if they do not want to continue.


Eligibility criteria: Inclusion Criteria:

-Patients with major abdominal surgery including trauma and elective exploration surgery, damage control surgery.

Exclusion Criteria:

* pregnancy
* patients with myopathies
* motor polyneuropathies, impaired neuromuscular transmission (Myasthenia Gravis)
* complicated Chronic Obstructive Pulmonary Disease (COPD),
* necrotizing fasciitis of the trunk
* unfit for general anesthesia
* patients with psychiatric disorders
* patients with drug abuse or history of opioid intake
* chronic pain disorder
* coagulopathy

Primary outcomes:
measure: incidence of incisional hernia.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlia
Study officials:
References:
Clinical trial NCT03752697: Metacognition in Neurological Injury
Official title: Longitudinal Examination of Metacognition in Neurological Samples
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Injuries
Keywords: metacognition
self-assessment
Lead sponsor: University of Nebraska Lincoln
Sponsor class: OTHER
Collaborators: name: Quality Living, Inc.
First posted: 2018-11-26
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participants in rehabilitation facility and community-dwelling individuals

Brief summary: The purpose of this study is to investigate the trajectory of metacognitive functioning throughout phases of recovery from neurological insult, and to determine its relationship to rehabilitation compliance and functional outcome. It is hypothesized that metacognitive accuracy improves over time, and is a significant predictor of engagement in rehabilitation activities.

Detailed description: This study will examine the trajectory of metacognitive functioning through different phases of recovery from neurological insult, and document its relationship to rehabilitation compliance. Individuals currently completing rehabilitation programs and individuals from the community who meet study criteria are invited to participate. After consenting and enrolling in the study, participants complete 2 study sessions: a baseline session, and a follow-up session either at time of completion of rehabilitation program or 3 months later if not in a rehabilitation program. During the study sessions, participants will complete paper-and-pencil and computerized tests of cognition (including metacognitive tasks).

Eligibility criteria: Inclusion Criteria:

* history of brain and/or spinal cord injury
* no history of brain or neurological injury/insult (for healthy control group)
* fluent in spoken and written English
* adequate gross motor abilities to provide a button push on a keyboard

Exclusion Criteria:

* exclusion criteria for healthy controls include:
* current/past history of psychiatric illness
* learning disorder
* developmental disorder
* diagnosis of Attention Deficit Disorder/Attention Deficit Hyperactive Disorder

Primary outcomes:
measure: Change from baseline metamemory performance to completion of rehabilitation
timeFrame: At baseline and at end of length of stay in rehabilitative setting (on average 3 months)
Secondary outcomes:
measure: Change in rehabilitative engagement
timeFrame: At baseline and at end of length of stay in rehabilitative setting (on average 3 months)
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: University of Nebraska-Lincoln
state: Nebraska
Study officials:
affiliation: University of Nebraska Lincoln
name: Kathy Chiou, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05905497: The Study of Bemnifosbuvir in Healthy Japanese Subjects
Official title: A Phase 1, Open-Label, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Bemnifosbuvir in Healthy Adult Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-15
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability and pharmacokinetics (PK) of Bemnifosbuvir in healthy adult Japanese subjects


Eligibility criteria: Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/m2
* Willing to comply with the study requirements and to provide written informed consent
* The subject must have been born in Japan and have both parents and 4 grandparents of Japanese descent
* The subject must have lived outside of Japan for no more than 10 years

Exclusion Criteria:

* Pregnant or breastfeeding
* Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Other clinically significant medical conditions or laboratory abnormalities

Primary outcomes:
measure: Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax)
timeFrame: Day 1, Day 5
measure: Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC)
timeFrame: Day 1, Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Atea Study Site
state: California
Study officials:
References:
Clinical trial NCT02965105: Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers
Official title: Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incontinence, Urinary
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2016-11-16
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to test the performance and safety of a newly developed intermittent catheter


Eligibility criteria: Inclusion Criteria:

* 1. Have given written informed consent and signed letter of authority 2. Be at least 18 years of age and have full legal capacity 3. Be a male 4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits 5. Have a negative urine multistix - erythrocytes (Microscopic haematuria) 6. Have a negative urine multistix:

  * Leukocytes
  * Nitrite Or if positive, subsequent negative for bacterial growth in urine culture

Exclusion Criteria:

1. Abnormalities, diseases or surgical procedures performed in the lower urinary tract
2. Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
3. Participating in other clinical investigations related to urinary tracts system during this investigation (inclusion to termination) or have previously participated in this investigation
4. Known hypersensitivity toward any of the test products -

Primary outcomes:
measure: Pain
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshopsitalet
state: København Ø
Study officials:
affiliation: MD at the clinic for urology at Rigshospitalet
name: Per Bagi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05878405: Methylene Blue Mouthwash for the Treatment of Oral Mucositis Pain in Patients With Cancer
Official title: Methylene Blue Mouthwash for Oral Mucositis Pain in Cancer: An Open-Label, Non-Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Stomatitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This phase III trial compares the effect of methylene blue mouthwash to standard of care mouthwash for the treatment of oral mucositis pain in patients with cancer. Using methlylene blue mouthwash may improve oral pain in patients with oral mucositis related to cancer and/or cancer treatments compared to usual standard of care.


Eligibility criteria: Inclusion Criteria:

* Active cancer diagnosis
* Admitted to the inpatient setting
* Pain related to oral mucositis
* Experiencing oropharyngeal pain
* Able to provide informed consent

Exclusion Criteria:

* Pediatric age (under 18 years old)
* Pregnant or nursing women
* Any contraindication to methylene blue including severe hypersensitivity to methylene blue and patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of hemolytic anemia

Primary outcomes:
measure: Change in oral pain
timeFrame: Baseline, 3 days
Secondary outcomes:
measure: Change in the amount of oral intake
timeFrame: Baseline, 3 days
measure: Change in the amount of daily requirements of oral morphine equivalents
timeFrame: Baseline, 3 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Regina M Mackey, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04747405: Evaluation of Psychological Impact of Group Therapy for Patients Who Have Been Hospitalized in Intensive Care During COVID-19 Pandemic: Exploratory Study
Official title: Evaluation of Psychological Impact of Group Therapy for Patients Who Have Been Hospitalized in Intensive Care During COVID-19 Pandemic: Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intensive Care Unit Syndrome
Covid19
Anxiety
Depression
Lead sponsor: Centre Hospitalier Metropole Savoie
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Psychological impact of intensive care hospitalization for patients has been demonstrated during the last few years: anxiety, depression and post traumatic stress disorder. Hospitalizations during COVID-19 pandemic have been marked by factors such as confinement forbidding family members visits, stress on intensive care unit ...Those factors may have a psychological impact added to factors of long hospitalization and prolonged mechanical ventilation.

For all these reasons the investigators fear that patients hospitalized in intensive care during COVID-19 pandemic develop psychological trouble with an increased risk for those who experienced COVID-19 infection. The hypothesis therapy group added to standard care might have a positive impact on psychological troubles such as anxiety, depression and post traumatic stress disorder for patients who have been hospitalized in intensive care during COVID-19 pandemic.

The investigators will compare two groups:

* group receiving standard of care
* group receiving standard of care and therapy group


Eligibility criteria: Inclusion Criteria:

* 18 years old and older
* hospitalized at least 72h in intensive care during COVID-19 pandemic crisis
* out of intensive care for at least 2 months and maximum 6 months
* psychological evaluation done according to local practice and standard of care
* speaking french
* patient coming alone to the therapy group
* patient agree to respect confidentiality rules and demonstrating goodwill with others participants
* patient comite to respecting barriers rules against COVID-19
* affiliated to social security system
* no juridic protection engaged

Exclusion Criteria:

* presenting psychological disease
* drug addiction
* participation to other interventional clinical trial

Primary outcomes:
measure: prevalence of post traumatic stress syndrome
timeFrame: 12 months after intensive care hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Chambéry
country: France
facility: CH Métropole Savoie
Study officials:
affiliation: Cebtre Hospitalier Metropole Savoie
name: Romain PERCOT
role: STUDY_DIRECTOR
References:
Clinical trial NCT02927405: Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain
Official title: Combination of Preoperative Gabapentin and TAP Blocks in Decreasing Postoperative Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: gabapentin
TAP block
Lead sponsor: State University of New York - Downstate Medical Center
Sponsor class: OTHER
First posted: 2016-10-07
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is an increasing trend on decreasing narcotic use and maximizing efficiency in the perioperative care. There are no studies that have compared a TAP block versus a TAP block plus gabapentin for laparoscopic procures.This study will investigate if taking gabapentin and receiving a TAP block decrease post-operative morphine consumption. It will be a randomized controlled, double blind study, with 130 patients between 18-60 years; that will undergo laparoscopic GYN procedures. Secondary outcomes will look at the incidence of nausea, vomiting, and VAS (verbal analog scale) scores. This combination may be helpful because gabapentin will be used to decrease visceral and central pain, and TAP block will decrease somatic pain. Performing a multimodal approach may decrease narcotic consumption, adverse effects and improve pain management.


Eligibility criteria: Inclusion Criteria:

* female
* receiving laparoscopic GYN procedure
* between 18-60

Exclusion Criteria:

* are already taking gabapentin
* have diabetic neuropathy
* have a chronic pain syndrome
* take opioids at home
* are pregnant
* have kidney disease
* have an allergy to morphine

Primary outcomes:
measure: Post-operative morphine consumption
timeFrame: 24 hours after surgery.
Secondary outcomes:
measure: VAS Scores
timeFrame: 24 hours after surgery
Other outcomes:
measure: Incidence of nausea and vomiting
timeFrame: 24 hours after surgery
Locations:
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
Study officials:
References:
Clinical trial NCT00288405: The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System
Official title: Cordis Neurovascular Feasibility Study of the Enterprise Self-Expanding Stent System to Facilitate Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Aneurysms
Keywords: Intracranial
Wide-neck
Saccular
Aneurysms
Lead sponsor: Codman & Shurtleff
Sponsor class: INDUSTRY
First posted: 2006-02-08
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and feasibility of the Cordis Neurovascular Self-Expanding Stent System to facilitate endovascular coil embolization of wide neck saccular intracranial aneurysms.

Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel

Detailed description: This is a multi-center, prospective, non-randomized feasibility study including 30 subjects. Subjects will receive a safety follow-up evaluation at 30 days (+ two weeks) and an efficacy follow-up evaluation at 6 months (+ four weeks).

Eligibility criteria: Inclusion Criteria:

* Patients with intracranial, wide-neck, saccular aneurysms

Exclusion Criteria:

* Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage

Primary outcomes:
measure: Successful stent placement with satisfactory coil mass position angiographically.
timeFrame: immediately after post procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Azienda Ospedaliera
Study officials:
affiliation: Azienda Ospedaliera
name: Edoardo Boccardi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Higashida RT, Halbach VV, Dowd CF, Juravsky L, Meagher S. Initial clinical experience with a new self-expanding nitinol stent for the treatment of intracranial cerebral aneurysms: the Cordis Enterprise stent. AJNR Am J Neuroradiol. 2005 Aug;26(7):1751-6.
citation: Weber W, Bendszus M, Kis B, Boulanger T, Solymosi L, Kuhne D. A new self-expanding nitinol stent (Enterprise) for the treatment of wide-necked intracranial aneurysms: initial clinical and angiographic results in 31 aneurysms. Neuroradiology. 2007 Jul;49(7):555-61. doi: 10.1007/s00234-007-0232-2. Epub 2007 May 3.
Clinical trial NCT06614205: Tumor Absorbed Dose-Response Relationship in Patients Treated With 177Lu-DOTATATE for Meningioma
Official title: Tumor Absorbed Dose-Response Relationship in Patients Treated With 177Lu-DOTATATE for Meningioma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meningioma of Brain
Keywords: meningioma
theragnostic
dosimetry
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-09-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients treated with 177Lu-DOTATATE for meningioma at Nancy University Hospital

Brief summary: The hypothesis for this study is that there is a dose-response relationship in patients treated with 177Lu-DOTATATE for meningiomas.

Detailed description: Dosimetry is essential for Peptide Receptor Radionuclide Therapy (PRRT) of meningiomas, to predict efficacy and dose-effect relationships at the individual level, and to move towards personalized medicine. Due to the increasing therapeutic applications of Lutathera, the European Association of Nuclear Medicine (EANM) recently issued recommendations on the dosimetry of 177Lu-labeled somatostatin analogues. Nevertheless, despite these recommendations, the evaluation of meningioma tumor dosimetry in Peptide Receptor Radionuclide Therapy studies is not systematic, which has not enabled us to clearly determine the dose delivered to the meningioma lesion in these treatments and the possible dose-response relationship in this type of treatment.

Eligibility criteria: Inclusion Criteria:

* patients treated for menigioma at nancy hospital
* patients who performed 3 scintigraphics exams during there treatment

Exclusion Criteria:

* patients deprived of liberty
* patient who refused to collect data retrospectively

Primary outcomes:
measure: Diagnostic accuracy for progression free survival
timeFrame: Day 1
Secondary outcomes:
measure: Diagnostic accuracy for overal survival
timeFrame: Day 1
Other outcomes:
Locations:
city: Vandoeuvre les Nancy cedex
country: France
facility: CHRU de NANCY
city: Vandoeuvre les Nancy cedex
country: France
facility: Nuclear medicine Department CHRU de NANCY
Study officials:
References: