louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06974617: Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine
Official title: Sphenopalatine Block Versus BOTOX in Management of Chronic Migraine: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sphenopalatine Block
BOTOX
Chronic Migraine
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-05-16
Enrollment: 64
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: This trial compares the efficacy and safety of sphenopalatine ganglion block (SPGB) and intramuscular BOTOX injection in chronic migraine.

Detailed description: The International Headache Society's Headache Classification Committee recognizes three broad categories of headaches: primary headaches, secondary headaches, and a third catchall category called "painful cranial neuropathies, other facial pain, and other headaches." Migraines fall into the primary headache category.

Sphenopalatine ganglion (SPG), or the pterygopalatine ganglion (PPG), is a large extracranial parasympathetic ganglion with multiple neural connections, including autonomic and motor.

The botulinum toxin (BOTOX®), which can exert a paralytic effect by binding to presynaptic cholinergic nerve terminals at the neuromuscular junction, is produced by the Gram-positive, rod-shaped, spore-forming, anaerobic bacterium Clostridium botulinum. It internalizes and inhibits the exocytosis of the neurotransmitter acetylcholine by decreasing the frequency of acetylcholine release

Eligibility criteria: Inclusion Criteria:

* Age 18 and 65 years.
* Both sexes.
* Chronic migraine. Chronic migraine, defined as headaches on ≥15 days per month for ≥3 months, of which ≥8 days meet criteria for migraine without aura or respond to migraine-specific treatment according to International Classification of Headache Disorders-3 Beta.

Exclusion Criteria:

* Patients with medication over use headache.
* Bleeding disorders.
* Abnormal neurological examination.
* History of allergy to local anesthetics or BOTOX.

Primary outcomes:
measure: Degree of pain
timeFrame: 12 weeks post-procedure
Secondary outcomes:
measure: Percentage of patients free of headache
timeFrame: 12 weeks post-procedure
measure: Headache relief rate
timeFrame: 12 weeks post-procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT00483717: Efficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Analgesic Efficacy of Ketorolac Tromethamine Administered Intranasally for the Acute Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Keywords: Migraine
Ketorolac
Lead sponsor: Egalet Ltd
Sponsor class: INDUSTRY
First posted: 2007-06-07
Enrollment: 173
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 study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.

Detailed description: Evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of migraine with or without aura (IHS criteria 1.1 and 1.2.1);
* Onset of migraine prior to age 50;
* 2-8 moderate to severe migraine headaches per month

Exclusion Criteria:

* Subjects receiving any investigational drug within 30 days before study entry;
* More than 15 headache days per month;
* Known allergy or hypersensitivity to ketorolac and/or excipients;
* Allergy to aspirin or other NSAIDs;
* Currently receiving other NSAIDs or aspirin;
* Medical history that would preclude NSAID use

Primary outcomes:
measure: The Number of Treated Subjects Who Became Pain-free (International Headache Society Grade of 0 = no Pain) by Observation Time Point.
timeFrame: 2 hours after dosing
Secondary outcomes:
measure: The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
timeFrame: 0.5 hours post-dosing
measure: The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
timeFrame: 1 hour post-dosing
measure: The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
timeFrame: 1.5 hours post-dosing
measure: The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
timeFrame: 3 hours post-dosing
measure: The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
timeFrame: 4 hours post-dosing
measure: The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
timeFrame: 24 hours post-dosing
measure: The Number of Treated Subjects Who Became Pain-free (IHS Grade 0) by Observation Time Point
timeFrame: 48 hours post-dosing
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Volker Pfaffenrath
state: Bavaria
Study officials:
affiliation: American Regent, Inc.
name: Roger Whiting, Ph D
role: STUDY_CHAIR
References:
Clinical trial NCT01270217: Behavior and Driving Safety Study II
Official title: Behavior and Driving Safety Study II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcoholic Intoxication
Keywords: Automobile driving
Driving under the influence
Interview, psychological
Brief intervention
Brief motivational interview
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Sacramento Police Department
name: California Office of Traffic Safety
First posted: 2011-01-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether brief motivational interviews reduce problematic drinking behavior among individuals arrested for the first time for driving under the influence of alcohol (DUI).

Detailed description: Despite extensive legislative, law enforcement, and public awareness efforts, driving under the influence of alcohol (DUI) remains a major cause of mortality and loss of years of productive life. A brief motivational interview (BI) is a non-confrontational, patient-centered discussion during which the individual's motivation and confidence to change health-related behaviors are explored. Previous studies of BIs in health care settings suggest that BIs administered after hospitalization for alcohol-related injury reduce the likelihood of repeat injury hospitalization and arrest for DUI. This study will evaluate whether brief motivational interviews reduce problematic drinking behavior among individuals arrested for the first time for driving under the influence of alcohol (DUI).

Eligibility criteria: Inclusion Criteria:

* First arrest for driving under the influence of alcohol
* Arrest involved operation of a motor vehicle
* At least 18 years of age
* English-speaking

Exclusion Criteria:

* Arrest involved injury to another person

Primary outcomes:
measure: Alcohol Use Disorders Identification Test score
timeFrame: 3 months
Secondary outcomes:
measure: Time to repeat arrest for driving under the influence of alcohol
timeFrame: Up until one year after the conclusion of enrollment
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Sacramento County Main Jail
state: California
Study officials:
affiliation: University of California, Davis
name: Garth H Utter, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Utter GH, Young JB, Theard LA, Cropp DM, Mohar CJ, Eisenberg D, Schermer CR, Owens LJ. The effect on problematic drinking behavior of a brief motivational interview shortly after a first arrest for driving under the influence of alcohol: a randomized trial. J Trauma Acute Care Surg. 2014 Mar;76(3):661-70; discussion 670-1. doi: 10.1097/TA.0000000000000144.
Clinical trial NCT03720717: Baclofen as a Perioperative Analgesic Adjuvant
Official title: Baclofen as a Perioperative Analgesic Adjuvant
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 34
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Coded envelopes with study drug/placebo had been generated and randomized. Patients were enrolled and given drug in next envelope. After completion of study patients assigned into opioid-naive or daily opioid-tolerant groups based on history given by patient
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a single, oral dose of baclofen alters postoperative opioid requirements.

Detailed description: Postoperative pain continues to be a significant clinical problem. Use of perioperative adjuvants has improved postoperative pain control. The GABA-B receptor agonist, baclofen, is an appropriate drug to trial as such an analgesic adjuvant. Therefore, the investigators will conduct a study designed to determine whether or not a single, oral dose of baclofen given to patients undergoing kidney stone surgery will reduce postoperative opioid requirements measured in the first 24 hours following surgery.

Eligibility criteria: Inclusion Criteria:

* Adult patients (age \>= 19 y.o.) scheduled for kidney stone-related surgery

Exclusion Criteria: (note - there were no patients requiring exclusion)

* History of allergy to baclofen
* Any condition which might limit appropriate report and treatment of postoperative pain (e.g., non-English speaking; severe psychiatric disease)
* Active history of cancer
* Potential for difficult airway as judged by attending anesthesiologist due to concerns there could be muscle weakness from the drug with consequent respiratory depression

Primary outcomes:
measure: Postoperative Opioid Requirements
timeFrame: From 0 hours post-operatively to 24 hours post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Mark Mandabach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05042817: Effect of Intrathecal Morphine on Urinary Bladder Function and Recovery in Patients Having a Cesarean Delivery
Official title: Effect of Intrathecal Morphine on Urinary Bladder Function and Recovery in Patients Having a Cesarean Delivery - A Double-blind Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Keywords: Obstretics
Regional anesthesia
Injections
Spinal
Analgesics
Opioid
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2021-09-13
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The enhanced recovery anesthesia concept has been widely adopted, including cesarean delivery. Modern obstetrical anesthesia aims to offer an experience to a patient undergoing a cesarean delivery similar to normal vaginal delivery in order to maximize postoperative comfort and facilitate bonding between the mother and her newborn. Therefore, early removal of the bladder catheter has been recommended. However, this is challenged by the administration of intrathecal morphine recommended to provide long-lasting postoperative analgesia after cesarean delivery.

Detailed description: This double-blind, randomized trial investigates the effects of intrathecal morphine on urinary dynamics in women undergoing CD under spinal anesthesia. The hypothesis is that the addition of intrathecal morphine (ITM) will delay micturition in women undergoing cesarean delivery. The primary outcome is the effect of ITM on urodynamics the difference in time to micturition. The secondary outcome is the need for bladder re-catheterization.

Eligibility criteria: Inclusion Criteria:

* ASA physical status I and II
* Term singleton pregnancies
* Elective cesarean delivery under spinal anesthesia
* Between October 2021 and March 2022

Exclusion Criteria:

* Pre-existing or gestational hypertension
* Diabetes
* Cardiovascular disease
* Cerebrovascular disease
* Known fetal abnormalities
* Extremes of weight (\<40 kg or \> 100 kg)
* Contraindications to neuraxial anesthesia
* Twin pregnancies
* Excessive intraoperative bleeding (blood loss exceeding \> 1000 mL or requiring a blood transfusion)

Primary outcomes:
measure: First micturition (hours)
timeFrame: until the end of the study, an average of 6 months
measure: Bladder volume (mL)
timeFrame: until the end of the study, an average of 6 months
measure: Debimetry
timeFrame: until the end of the study, an average of 6 months
Secondary outcomes:
measure: Bladder re-catherization
timeFrame: until the end of the study, an average of 6 months
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University of Liege, University Hospital
Study officials:
References:
Clinical trial NCT00275717: A Study That Will Look at the Impact of Immunosuppression on Antibody Production in Kidney Transplant Recipients.
Official title: The Effects of Thymoglobulin on Antibody Screening Cells.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2006-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Three groups will be studied:

1. Non-sensitized renal allograft candidates prior to any therapy;
2. High DSA recipients--Recipients with a positive T or B cell cytotoxicity crossmatch or a B cell flow cytometric crossmatch assay with a channel shift \>350 at baseline against their living donor at baseline and
3. Low DSA recipients-recipients with a negative T and B cell cytotoxicity assay, but a positive T or B cell flow cytometric crossmatch with a B cell channel shift \<350.

Brief summary: This study is being done to collect blood and bone marrow samples for biologic studies of antibody producing cells. Donor specific antibodies can cause damage to the kidneys after they are transplanted. The study will look at the impact of immunosuppression on antibody production by antibody producing cells.

Detailed description: Bone marrow and blood samples from both non-sensitized kidney transplant recipients and sensitized kidney transplant recipients will be collected. The samples will be used to compare the effect immunosuppression has on the antibody producing cells from both of these kinds of transplant recipients. Bone marrow will be collected from sensitized kidney transplant recipients before desensitization therapy prior to transplantation and at the time of kidney transplant surgery. Non-sensitized patients will have bone marrow collected only at the time of kidney transplant surgery. Blood will be collected at the same time point that the marrow is collected in both kinds of patients.

Eligibility criteria: Participants must be between the ages of 18 and 70 years of age and undergoing a kidney transplant.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark D. Stegall, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06748417: FITLIGHT Reliability and Acute Training Effects
Official title: Reliability of the FITLIGHT System and Acute Effects of Cognitive Training on Dual-task Performance in Hopping and Cutting Assessments
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Athletic Injuries
Keywords: Reaction time
neurocognitive performance
Agility training
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The purpose of this study is to assess the reliability of outcomes collected using a speed and cognitive light training system. This study will also be used to understand the effects of brain training on athletic performance using the FITLIGHT System.


Eligibility criteria: Inclusion Criteria:

* Healthy as determined by a Physical Activity Readiness Questionnaire
* BMI under 30

Exclusion Criteria:

* Color-blindness
* Fractures within the past year
* Musculoskeletal injury limiting sports activity within the past 6 months
* Anterior cruciate ligament (ACL) injuries within the past 5 years
* Medical conditions that do not have physician clearance to participate in exercise
* History of concussion
* Diagnosed cognitive impairments
* Untreated attention deficit/hyperactivity disorder (ADHD) or attention deficit disorder (ADD)
* Prisoners
* Pregnant women
* Smokers

Primary outcomes:
measure: Change in Reaction Time
timeFrame: Up to 5 minutes before and up to 5 minutes after intervention
measure: Change in Percentage of Correct Responses in Cognitive-Motor Running T-test
timeFrame: Up to 5 minutes before and up to 5 minutes after intervention
measure: Change in Completion Time
timeFrame: Up to 5 minutes before and up to 5 minutes after intervention
measure: Change in Hop distance
timeFrame: Up to 10 minutes before and up to 10 minutes after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Zachary A Ripic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06465017: ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer
Official title: ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer and Compared With 18F-FDG and 68Ga-FAPI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tumor
Solid Tumor
Thyroid Cancer
Positron-Emission Tomography
Keywords: Tumor
Solid
Positron-Emission Tomography
Trop-2
Diagnosis
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of the study is to construct a noninvasive approach 68Ga-THP-Trop2 VHH PET/CT to detect the Trop-2 expression of tumor lesions in patients with thyroid cancer and to identify patients benefiting from Trop-2 targeting antibody-drug conjugate treatment.

Detailed description: As a new trophoblast cell-surface antigen 2 (Trop-2) targeting PET radiotracer, 68Ga-THP-Trop2 VHH is promising as an excellent imaging agent applicable to various cancers. In this research, subjects with thyroid cancer or highly suspected recurrence detection underwent contemporaneous 68Ga-THP-Trop2 VHH and standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT) either for an initial assessment or for metastases or highly suspected recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of standard-of-care imaging and 68Ga-THP-Trop2 VHH PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-THP-Trop2 VHH was calculated and compared to standard-of-care imaging.

Eligibility criteria: Inclusion Criteria:

* Adult patients (aged 18 years or older);
* Patients with newly diagnosed, highly suspected recurrence or previously treated metastases of thyroid cancer (supporting evidence may include MRI, CT, tumor markers, and pathology report);
* Patients who had scheduled both standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT) and 68Ga-THP-Trop2 VHH PET/CT scans;
* Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* Patients with pregnancy;
* The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Primary outcomes:
measure: Diagnostic efficacy
timeFrame: 2 years
Secondary outcomes:
measure: Number of lesions
timeFrame: 2 years
measure: SUV
timeFrame: 2 years
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
Study officials:
References:
Clinical trial NCT02822417: Clinical and Genetic Factors on the Postoperative Recovery Time of General Anaesthesia
Official title: Clinical and Genetic Factors on the Postoperative Recovery Time of General Anaesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: General Anesthesia
Keywords: Recover time
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 1453
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Laparoscopic surgery, orthopedics surgery or open surgery patients in Chinese

Brief summary: To evaluate the effect of clinical factors on the recovery time of postoperative anesthesia and the effect of genetic variation in gDNA on the recovery time of postoperative anesthesia.

Detailed description: Recovery time of postoperative anesthesia is an important index to reflect patient's postoperative health status. The investigators want to collect patients' clinical dates and their blood samples, then extract DNA from blood samples, acquire every patients' genetic variation information. Finally, acquiring the mathematical model of the influence of clinical factors and genetic factors on the recovery time after operation, predicting the recovery time of anesthesia.

Eligibility criteria: Inclusion Criteria:

1. Aged more than 18 years;
2. General anesthesia for all patients;
3. Patients underwent surgery for laparoscopic surgery, orthopedics surgery or open surgery;
4. Patients were not delivered allogeneic blood in three months;
5. Having the ability to understand and sign the informed consent.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Having an immune deficiency, as a patient with HIV infection;
3. Patients with infectious diseases, such as syphilis;
4. Patients delivered allogeneic blood in three months;
5. Researchers believe that may increasing the risk of subjects or interfering clinical trial;
6. Don't have the ability to understand or sign the informed consent.

Primary outcomes:
measure: Recover time of anesthesia
timeFrame: within 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Yijing He, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: