louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02090998: Sphenopalatine Ganglion Nerve Block vs. Elavil for Treatment of Transformed Migraines
Official title: A Comparison of the Efficacy of 5% Lidocaine Anesthetic to Provide SPGB Vs. Elavil for the Treatment of Transformed Migraine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Transformed Migraine
Chronic Daily Headache
Keywords: Migraine Headache
Menstrual Migraine
Vascular Headache
Temporal Lobe Seizure
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2014-03-19
Enrollment: 10
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: This study will compare a local anesthetic technique that has been used to treat subjects suffering from transformed migraines (chronic migraines) versus medical management with traditional antidepressant Amitriptyline / Elavil.

Subjects will be randomized into one of two treatment groups to compare the safety and efficacy of the therapies. Subjects will recieve either sphenopalatine ganglion nerve block with 5% lidocaine gel into the nasopharynx or medical management with traditional antidepressants, Elavil, to produce a reduction in the frequency and severity of the headache.

We propose that there will be a difference in the outcomes when comparing the two methods of treating transformed migraines and that one research arm will result in more patient satisfaction and greater efficacy in the treatment of subjects

Detailed description: Arm one will receive Sphenopalatine Ganglion Nerve Block weekly for 4 weeks

Arm two will receive Amitriptyline / Elavil daily for 30 Days

Eligibility criteria: Inclusion Criteria:

1. Male and female age 18-90
2. Subject have formal medical diagnosis of migraine headache
3. Subjects currently require treatment for headache
4. Subjects who have received optimal medical management from migraines including triptans (Imitrex, Amerge and Relpax)
5. Subjects who have recieved optimal medical management for migraines including anticonvulsants (Depakote, Lamictal, klonopin

Exclusion Criteria:

1. Less than 18 years of age
2. Subjects will be excluded if they are already being treated with lidocaine (patch or other vehicle) for chronic pain
3. Untreated Heart Failure
4. Pregnancy
5. Individuals unwilling to comply with study procedures and follow-up

Primary outcomes:
measure: Number of Daily Headaches
timeFrame: Study Day 1 through Study Day 30
Secondary outcomes:
Other outcomes:
measure: Duration of Inactivity Associated With Headaches
timeFrame: Study Day 1 thorugh Study Day 30
Locations:
city: New Brunswick
country: United States
facility: Rutgers, Robert Wood Johnson Medical School , Pain Center of NJ
state: New Jersey
Study officials:
References:
Clinical trial NCT05291598: Meloxicam for Pain Management After Total Joint Arthroplasty (TJA)
Official title: IV Meloxicam for Pain Management Post TJA: Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Total Knee Replacement
Total Hip Replacement
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 223
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 project is to determine if a change in patient reported pain, nausea and vomiting after total knee and hip arthroplasty could be observed with the substitution of Intravenous meloxicam for ketorolac in the current established peri-operative pain protocol and if these changes lead to a decrease in opioid consumption (in morphine equivalents).


Eligibility criteria: Inclusion Criteria:

1. Patients over the age of 18,
2. Patients undergoing primary total knee or primary total hip replacement at the University of Miami Hospital,
3. Patients that have capacity to provide medical consent

Exclusion Criteria:

1. All patients under the age of 18
2. Prisoners, diabetics, increased risk of bleeding, and pregnant women.
3. Patients with prior surgery or history of infection on the joint of interest.
4. Patients with an estimated glomerular filtration rate (eGFR) \<50 ml/min
5. Patients on dialysis or renal transplant.
6. Patients on steroid preoperatively.
7. Allergy to sulfas
8. Inability to provide medical consent.
9. Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements will exclude the participant.

Primary outcomes:
measure: Pain Measured by the Numeric Rating Scale
timeFrame: 2 hours postoperatively
measure: Pain Measured by the Numeric Rating Scale
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Nausea Score as Measured by a Likert Scale
timeFrame: 2 hours postoperatively
measure: Nausea Score as Measured by a Likert Scale
timeFrame: 24 hours postoperatively
measure: Length of Stay as Measured by Hours in the Hospital
timeFrame: Until patient discharged from the hospital
measure: Length of Stay as Measured by Hospital Nights
timeFrame: From surgery until discharge
measure: Length of Stay as Measured by Same Day Discharges
timeFrame: From surgery until discharge
measure: Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)
timeFrame: Within 2 hours postoperatively
measure: Opioid Consumption as Measured by Morphine Milligram Equivalents (MME)
timeFrame: Within 24 hours postoperatively
measure: Renal Injury as Measured by the Change in Creatinine Levels
timeFrame: From preoperative baseline labs while hospitalized, up to 1 week
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Victor H Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03400098: ATTR Expanded Access Program (EAP) by Ionis
Official title: Expanded Access Program for Inotersen (ISIS 420915) in Patients With Hereditary Transthyretin Amyloidosis (hATTR)
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Amyloidosis, Hereditary
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2018-01-17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The purpose of this program is to provide expanded access to Inotersen for up to 100 Patients with Hereditary Transthyretin Amyloidosis (hTTR).

Detailed description: The Program is intended to provided expanded access to Inotersen for eligible patients with hATTR who have limited or no available treatment options.

Eligibility criteria: Inclusion Criteria:

* Male or female at least 18 years of age with a diagnosis of hATTR
* Symptoms consistent with polyneuropathy
* Meet Polyneuropathy Disability (PND) Stage I-III requirements

Exclusion Criteria:

* Known Primary Amyloidosis, Leptomeningeal Amyloidosis or Monoclonal Gammopathy of Undetermined Significance or Multiple Myeloma
* Have inadequate cardiac function
* Have low platelet counts
* Have inadequate renal function

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06555198: Promotion of Nurses' Lower Extremity Health by Foot(at)Work Intervention
Official title: Promotion of Nurses' Lower Extremity Health by Foot(at)Work Intervention to Support Work Wellbeing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lower Extremity Problem
Foot Deformities
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: The Hospital District of Satakunta
name: Finnish Work Environment Fund
First posted: 2024-08-15
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The quasiexperimental study aims to analyse the effecs of Foot(at)Work intervention on nurses' lower extremity health. The Foot(at)Work intervention is in electronic format consisting of 5 themes. The idea is that the participants familiarizes with the foot health -related content. The primary outcome is knowledge about lower extremity self-care. Secondary outcomes are work well-being, lower extremity health and musculoskeletal health. The outcomes are measured before the intervention (M0), after the intervention (M1), one month after the intervention (M2), six months after the intervention (M3) and 12 months after the intervention (M4).

The purpose of the Foot(at)Work intervention is to support nurses ability to self-care their lower extremities. The intervention consists of text, videos, and pictures that educate nurses to self-care their lower extremities and to select proper footwear.


Eligibility criteria: Inclusion Criteria:

* Registered nurse
* Working in the specialized health care in surgical or internal medicine wards of one certain hospital

Exclusion Criteria:

* Nursing students

Primary outcomes:
measure: Knowledge of lower extremity self-care
timeFrame: before intervenion, right after the intervention, one, six and 12 months after the intervention
Secondary outcomes:
measure: Self-assessed foot health
timeFrame: before intervenion, right after the intervention, one, six and 12 months after the intervention
measure: Musculoskeletal health
timeFrame: before intervenion, right after the intervention, one, six and 12 months after the intervention
measure: Self-perceived work ability
timeFrame: before intervenion, right after the intervention, one, six and 12 months after the intervention
Other outcomes:
Locations:
city: Turku
country: Finland
facility: University of Turku
state: Varsinais-Suomi
Study officials:
References:
Clinical trial NCT04172545: Observational Study on Effect of Anesthetic Conditions on Stapling Thickness
Official title: Impact of Anesthetic Conditions on Stapling Quality Measured as Staple Thickness During Laparoscopic Sleeve Gastrectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Surgery
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 10
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: obese patients undergoing bariatric surgery for the first time and where a sleeve gastrectomy is performed.

Brief summary: Measure anesthetic condition used during laparoscopic sleeve gastrectomy stapling. Measure quality of stapling in resected stomach by measuring staple thickness. Find if any relation exists.

Detailed description: During each staple firing the staple size, time of compression and anesthetic conditions being systolic arterial pressure, fluids transfused and intra abdominal pressure used are recorded.

After removal of stapled stomach during surgery, thickness of stomach wall and thickness of staple line are measured and compared to evaluate quality of staple formation.

the closer the staple height to the wall thickness the better the quality of stapling. Because no one has ever analyzed this relationship, and certainly not under different anesthetic conditions it is not clear yet if any relationship will be found.

the analysis will help to understand the relation and help to start perhaps a randomised trial to learn what conditions are best to improve staple quality.

Eligibility criteria: Inclusion Criteria:

* primary sleeve gastrectomy

Exclusion Criteria:

* stomach disease
* prior surgery on the stomach

Primary outcomes:
measure: thickness of staple line
timeFrame: intra operative on excised stomach before being discarded
Secondary outcomes:
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Azsintjan
Study officials:
affiliation: AZSint Jan AV
name: Jan Paul Mulier
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06359145: Prediction of COPD Severity Using Electrical Impedance Tomography
Official title: Prediction of COPD Chest CT Severity Using Electrical Impedance Tomography by Machine Learning Methods
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Electric Impedance
Respiratory Function Tests
Pulmonary Disease, Chronic Obstructive
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical physicians suspect a patient may have COPD based on symptoms and physical examination, but a definitive diagnosis has not been confirmed through PFTs.

Brief summary: The purpose of this study is to predict the CT visual score of emphysema with EIT-based parameters, in order to provide a non-invasive and convenient method for the evaluation of lung structure and physiological and pathological progression of COPD.

Detailed description: Methods: By collecting pulmonary function data, CT visual scores, and EIT data, and employing deep machine learning algorithms to compare the predictive capabilities of EIT and PFT for CT visual scores of pulmonary emphysema, this study aims to validate the ability of EIT to assess the progression of COPD.

Eligibility criteria: Inclusion Criteria:

* Clinical physicians suspect a patient may have COPD based on symptoms and physical examination, but a definitive diagnosis has not been confirmed through PFTs.
* Age \> 20 years, and be able to communicate with doctors.
* Willing to sign informed consent for the course of the study.

Exclusion Criteria:

* Patient refusal of EIT examination.
* The CT scan information is incomplete, and the interval between the pulmonary function test and the CT scan is more than 180 days.

Primary outcomes:
measure: The predictive power of EIT and PFT for CT visual scoring of emphysema
timeFrame: 1 mounths
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: PLA
state: Beijing
Study officials:
References:
Clinical trial NCT04673097: Performance of Different Resin Infiltration Materials on White Spot Lesions: Clinical and Laboratory Assessments
Official title: Performance of Different Resin Infiltration Materials on White Spot Lesions: Clinical and Laboratory Assessments
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: White Spot Lesion
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is a clinical controlled trial. Ethical approval will be obtained from Imam Abdulrahman bin Faisal University, Dammam. The study participants will be recruited from the dental hospital and conducted between November 2020 to November 2020. This will be a single-center, randomized, single blinded with a 1:1:1 allocation ratio for the application of Icon® resin infiltration, MI Paste Plus and both treatments


Eligibility criteria: Inclusion Criteria:

* Patients who are willing and able to observe good oral hygiene and attend for the study visits.
* Subjects with ≥1 visible and accessible early caries lesion present.
* No prior white spot lesion treatment utilized except tooth brushing with fluoridated toothpaste.

Exclusion Criteria:

* Active carious lesions
* Facial surface restorations
* Deciduous teeth
* Enamel alteration (fluorosis, opacity, hypocalcification, hypoplasia)
* Intrinsic and extrinsic strains
* Physically and mentally challenged volunteers
* Patients with systemic diseases under medication
* Smokers

Primary outcomes:
measure: Color improvements
timeFrame: Change from 0 day, 1 month and 6 months
measure: Patient self satisfaction
timeFrame: Change from 0 day, 1 month and 6 months
measure: Change in lesion status
timeFrame: Change from 0 day, 1 month and 6 months
measure: Cracks of enamel.
timeFrame: Change from 0 day, 1 month and 6 months
measure: Microbial composition.
timeFrame: Change from 0 day, 1 month and 6 months
measure: Effects on clinical parameter: sensitivity to percussion
timeFrame: Change from 0 day, 1 month and 6 months
measure: esthetic improvement
timeFrame: Change from 0 day, 1 month and 6 months
measure: Patient esthetic self perception
timeFrame: Change from 0 day, 1 month and 6 months
measure: change in lesion size
timeFrame: Change from 0 day, 1 month and 6 months
measure: fracture of enamel.
timeFrame: Change from 0 day, 1 month and 6 months
measure: Effects on clinical parameter: prolonged response to hot or cold.
timeFrame: Change from 0 day, 1 month and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dammam
country: Saudi Arabia
facility: Imam Abdulrahman Bin Faisal University
Study officials:
References:
Clinical trial NCT06935097: Mediterranean Diet Intervention Among Men at LBJ Hospital With Prostate Cancer
Official title: Mediterranean Diet Intervention Among Men at LBJ Hospital With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study, we will build upon our prior work and test the feasibility of a Mediterranean diet intervention for medically underserved men with prostate cancer seen at LBJ Hospital, a large safety net facility in Harris County, TX.

Detailed description: Primary Objectives:

To determine the feasibility of a Mediterranean diet-based intervention adapted for underrepresented minority men with prostate cancer, defined based on the following process measures68:

* Enrollment (completion of 25 patient accrual within 2 years)
* Retention (completion of the study through the 6-month time point, with ≥80% defined as successful)
* Adherence (the percentage of completed study sessions and clinic visits, with ≥70% considered successful).

Secondary Objectives:

To determine changes due to the Mediterranean diet intervention in the following measures:

* Mediterranean diet score (define using MEPA I calculated using FFQ data)
* Weight/BMI
* QoL (EQ-5D-5L)
* Physical activity (IPAS)
* Non-invasive biomarkers
* Gut microbiome
* Metabolomics

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the prostate that is localized based on metastatic workup ordered by the treating physician (which may include CT scan, bone scan, MRI and/or other imaging). Note that metastatic workup is not required for enrollment.
* Diagnosis within 12 months prior to enrollment OR
* Currently managed on active surveillance, with initial biopsy being \<5 years from date of enrollment
* Self-identified Hispanic and/or Black/African American
* Patient at LBJ Hospital

Exclusion Criteria:

* Special dietary requirements such that patient is unwilling to attempt dietary change
* Inability to complete a food record
* Unwillingness to participate in study activities
* Inability to keep appointments
* Food allergy prohibitive of a Mediterranean diet, i.e. nuts allergy

Primary outcomes:
measure: Safety and Adverse Events (AEs)
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Justin Gregg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05260697: The Effect of Sexual Counseling Based on PLISSIT Model to Women Undergoing Open Heart Surgery on Sexual Function and Sexual Quality of Life
Official title: The Effect of Sexual Counseling Based on PLISSIT Model to Women Undergoing Open Heart Surgery on Sexual Function and Sexual Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PLISSIT Model
Sexual Counselling
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study is about sexual counseling after cardiac surgery; It can contribute to the counseling planning of nurses and other health professionals regarding sexual problems that may occur after surgery. Increasing the quality of life in the rehabilitation process after cardiac surgery and facilitating adaptation to life after surgery; but not enough.


Eligibility criteria: Inclusion Criteria:

* Volunteering to participate in the research
* Being a woman
* Being over 18 years old
* Willingness to undergo open heart surgery
* Euroscore score ≤ 6 (low mortality risk due to cardiac surgery)
* Being sexually active
* Absence of sexual health problems in the spouse
* Ability to communicate verbally and be literate
* Women without neurological or psychiatric disorders
* Knowing Turkish

Exclusion Criteria:

* Unwillingness to participate in the research
* Euroscore score \>6 (high risk of mortality)
* Not being sexually active
* Having a diagnosed sexual health problem in the spouse
* Women with neurological and psychiatric disorders

Primary outcomes:
measure: 'Female Sexual Function Index' scores will increase after sexual counseling based on the PLISSIT model will be given to individuals who will undergo open heart surgery.
timeFrame: 1 year
measure: After the sexual counseling based on the PLISSIT model to be given to the individuals who will undergo open heart surgery, the scores of the "Sexual Quality of Life Scale-Female Form" will increase.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Merve TUNCER
Study officials:
References: