louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05868993: Optimal Effective Local Anesthetic Volume for Pain Relief Using Brachial Plexus Block
Official title: Optimal Effective Local Anesthetic Volume for Pain Relief Using Brachial Plexus Block Utilizing Continuous Reassessment Method for Arthroscopic Rotator Cuff Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Post Operative Pain
Keywords: brachial plexus block
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, patient-blinded study utilizing a novel Continuous Reassessment Method that concomitantly considers both block success and block side effects (lung dysfunction) for brachial plexus nerve blocks.

Detailed description: Success or failure of the brachial plexus block for any given volume will be determined by the verbal analogue pain scale score obtained 60 minutes after surgical end time. Volumes will be determined by continuous reassessment method.

Eligibility criteria: Inclusion Criteria:

* Surgical candidate for Arthroscopic rotator cuff surgery
* ASA I-III
* BMI\<40
* Age \>18

Exclusion Criteria:

* Inability to give informed consent
* Inability to complete consent process in English
* allergy to ropivacaine
* neuropathy
* contraindications to peripheral nerve block per ASRA guidelines
* chronic opioid use
* infection at the injection/catheter site
* limb restriction due to medical history
* history of moderate - severe lung disease.

Primary outcomes:
measure: Block Success
timeFrame: 60min after surgery
measure: Lung Function
timeFrame: 60 mins after surgery
measure: Block Success
timeFrame: 60 mins after surgery
Secondary outcomes:
measure: Diaphragm Excursion
timeFrame: 60 minutes after surgery
measure: Vital Capacity
timeFrame: 60 minutes after surgery
measure: Pulse Oximetry
timeFrame: 60 minutes after surgery
measure: Side Effects
timeFrame: 60 minutes after surgery
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
Study officials:
References:
Clinical trial NCT01372293: 71A/G HSD17B5 SNP and Effects of Oral Contraceptive Pill in PCOS Women
Official title: 17-hydroxysteroid Dehydrogenase Type 5 Gene Polymorphism (71A/G HSD17B5 SNP) and Effects of Oral Contraceptive Pill on Hirsutism, Androgens and Metabolic Profile in Non-obese PCOS Women: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
oral contraceptive pill
polymorphisms
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Hospital de Clinicas de Porto Alegre
name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2011-06-13
Enrollment: 49
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An association of the single nucleotide polymorphism (SNP) in the promoter gene that codify for 17b-HSD5 enzyme (71A\>G) with polycystic ovary syndrome (PCOS) and hyperandrogenemia has been suggested in previous studies.

Given the role of 17b-HSD5 in androgenic metabolism producing testosterone from precursors, the investigators hypothesis is that women with PCOS and with the variant allele G have a poor response on hirsutism and on hormonal and metabolic variables after oral contraceptive pill (OCP) treatment for 6 months.


Eligibility criteria: Inclusion Criteria:

* hirsute women with polycystic ovary syndrome

Exclusion Criteria:

* Use of any drugs known to interfere with hormone levels for at least 3 months before the study
* Women with type 2 diabetes, homa index \> 3.8, liver or renal disease or thyroid dysfunction
* Other hyperandrogenic disorders than PCOS

Primary outcomes:
measure: Changes at Ferriman- Gallwey score
timeFrame: 6 months
Secondary outcomes:
measure: Changes at testosterone levels
timeFrame: 6 months
measure: Changes in lipid profile
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Maier PS, Mattiello SS, Lages L, Spritzer PM. 17-Hydroxysteroid dehydrogenase type 5 gene polymorphism (-71A/G HSD17B5 SNP) and treatment with oral contraceptive pills in PCOS women without metabolic comorbidities. Gynecol Endocrinol. 2012 Aug;28(8):606-10. doi: 10.3109/09513590.2011.650760. Epub 2012 Feb 14.
Clinical trial NCT00629993: Dissemination of Cervical Cancer Screening to Primary Care Physicians in Underserved Communities
Official title: Dissemination of Cervical Cancer Screening to Primary Care Physicians in Underserved Communities
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cervical Cancer
Keywords: cervical cancer screening
medically underserved women
HPV vaccine
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2008-03-06
Enrollment: 282
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Primary care physicians have an important role to play in the delivery of cancer prevention and detection services to patients. Face-to-face counseling of physicians, called academic detailing, involves a brief and focused intervention, modeled on the practices of pharmaceutical companies. This type of intervention may increase physicians' attention to preventive opportunities and increase their screening behaviors.

Detailed description: The specific aims of this proposal are:

1. To test the hypothesis that an intervention, multi-component academic detailing, will increase the rate of physician cervical cancer screening at 3- and 6-months post-randomization, compared to the rate observed in a service-as-usual control.
2. To develop models predicting which physician offices are most and least likely to adopt the intervention, and to generate hypotheses about tailoring the dissemination of cervical cancer screening guidelines to different physician subgroups.
3. To conduct a cost-effectiveness analysis comparing the incremental societal costs and effects (in lives saved, life-years saved, and quality-of-life-years saved) of the cervical cancer intervention implemented in physicians' offices.

The long-term goal of this project therefore is to reduce cervical cancer risks among ethnic and racial minorities, by influencing the screening behaviors of their primary care physicians.

Eligibility criteria: Inclusion Criteria:

* Charts of female patients age 18-85 with at least one visit to the primary care provider over the last two years will be reviewed

Exclusion Criteria:

* Exclusion criteria will include: diagnosis of cancer other than non-melanotic skin cancer and removal of the uterus.

Primary outcomes:
measure: Number of asymptomatic female patients age 18-85 who receive or are referred for a recto-pelvic bimanual examination with the collection of the Pap smear (per ACS guidelines); collected via medical chart review
timeFrame: 12-month followup
Secondary outcomes:
measure: Physician knowledge, attitudes and beliefs toward cervical cancer prevention, screening, and treatment
timeFrame: 12-month followup
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Sherri Sheinfeld Gorin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06405893: What Makes People Better at Naming Pictured Objects
Official title: What Makes People Better at Naming Pictured Objects
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Healthy Aging
Keywords: Aging
Mindfulness
Speech Production
Lead sponsor: University of Colorado, Colorado Springs
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is being conducted to learn more about how mindful breathing might be related to the ability to produce names for pictured objects. Participants will engage with an exercise about mindful breathing or an auditory presentation and then name pictured objects as quickly as they can. They will also complete some surveys and other measures and wearing equipment on their finger to monitor their heart rate throughout the study. Participation will take approximately 1 hour.

Detailed description: This study is being conducted to learn more about how mindful breathing might be related to the ability to produce names for pictured objects. Up to 200 participants between ages 18-35 or 60-80 who are native, fluent speakers of English will engage with an exercise about mindful breathing or an auditory presentation. They will then name pictured objects as quickly as they can. Sessions will be audio recorded for later scoring. Participants will also complete demographics forms, a vocabulary test, and a measure of their current anxiety. Those over age 60 will also complete a cognitive function assessment. Participants will be wearing equipment on their finger to monitor their heart rate throughout the study. Participation will take approximately 1 hour.

Eligibility criteria: Inclusion Criteria:

* Ages 18-35 or 60-80
* Fluent English speaker

Exclusion Criteria:

* Younger than 18 years old
* Between ages 36-59
* Older than age 80
* Not a fluent English speaker

Primary outcomes:
measure: Response Accuracy for Naming Pictures (% correct)
timeFrame: Under 1 hour
measure: Response Time for Naming Pictures (onset time in ms)
timeFrame: Under 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: UCCS
state: Colorado
Study officials:
References:
Clinical trial NCT06652893: Efficacy and Safety of Sinovial®HL Single Injection in the Knee Osteoarthritis
Official title: Real-world Efficacy and Safety of Sinovial®HL Single Injection in the Treatment of Symptomatic Knee Osteoarthritis: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis of Knee
Keywords: knee osteoarthritis
hialuronic acid
knee function
Lead sponsor: Sporto Clinic
Sponsor class: OTHER
Collaborators: name: IBSA Institut Biochimique SA
First posted: 2024-10-22
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with symptomatic OA of the knee KL II-III with unsucsessful conservative treatment with NSAIDS for 6 weeks. Age 45 -80 without axial deformation of the lower leg more than 10 deg.

Brief summary: The prevalence of knee osteoarthritis (OA) is rising worldwide, leading to disability and a reduced quality of life, particularly in elderly patients. While there are several treatment options, there is little consensus in the scientific community over which methods are most effective. Viscosupplementation with hyaluronic acid (HA) has been found to reduce pain in patients with knee OA over a period of up to 6 months, with little to no side effects. The aim of this prospective open-label, uncontrolled, observational, single-site study was to assess the efficacy and safety of a single hybrid HA injection over a period of 6 months in subpopulations of patients with low to severe symptomatic knee OA in everyday clinical practice.

Fifty patients who met the inclusion criteria participated in the study. A single intra-articular ultrasound-guided injection of hybrid HA (Sinovial®) was administered. Patients submitted Visual Analog Scale (VAS) and Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaires at 28-, 42-, 84-, and 168-days post-treatment.


Eligibility criteria: The inclusion criteria

1. medical indication for viscosupplementation therapy with hybrid HA 2 patients aged between 45 and 80 years 3.diagnosis of gonarthrosis 4. gonarthrosis symptoms for at least 6 months 5. patients who failed to respond to analgesics and/or regular NSAIDs, 6. grade 2 to 3 OA in the Kellgren-Lawrence grading scale 7. pain on walking measured by the Visual Analog Scale (VAS; 0-100 mm) of at least 40 mm on the targeted knee; 8. contralateral knee pain when walking with aVAS of less than 10 mm.

The exclusion criteria were:

1. inability to understand the aim of the study
2. inability to provide acceptable consent
3. pregnancy
4. serious psychiatric disorders
5. allergy or intolerance to hybrid HA
6. secondary gonarthrosis due to systematic and inflammatory disorders.

Primary outcomes:
measure: Visual Analog Scale
timeFrame: 6 month
measure: The Western Ontario and McMaster Universities Arthritis Index
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Sporto Clinic
Study officials:
References:
Clinical trial NCT02733393: Sphenopalatine Ganglion Block to Treat Shoulder Pain After Thoracotomy
Official title: Sphenopalatine Ganglion Block to Treat Shoulder Pain After Thoracotomy- An Open Label Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ipsilateral Shoulder Pain
Keywords: Thoracotomy
Postoperative
Lidocaine
Sphenopalatine Ganglion Block
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP) after thoracotomy. This will be an open label preliminary pilot study to determine if SPG block has potential utility to manage ISP in post-thoracotomy patients. The primary outcome variable will be reduction of shoulder pain.

Detailed description: This is an open label preliminary pilot study which will evaluate the utility of sphenopalatine ganglion (SPG) block to manage ipsilateral shoulder pain (ISP). It will determine if SPG block has potential utility to manage ISP in post-thoracotomy patients One hundred (100) patients will initially be consented in this study. Patients have to develop ISP and have a pain VAS \>= 5. The study is seeking ten (10) eligible participants.

Patients will be followed after the SPG block(s), and the duration of pain relief will be monitored by serial assessments of the VAS. This assessment will occur for the initial SPG block and for all follow-up blocks, if performed. The follow-up assessments will only involve having the patient rate the ISP using a verbal VAS; This will take less than a minute of patients time. In addition, all patients will have PRN access to standard systemic analgesics as routinely ordered by the surgical service Safety assessments will be performed on all subjects. Blood pressure, heart rate and respiratory rate will be obtained every 15 minutes after each SPG block for 90 minutes. Dr. Grant will monitor the subjects for 90 minutes after each SPG block.

Eligibility criteria: Inclusion Criteria:

* Any type of open thoracotomy or video-assisted thoracoscopic surgery (VATS)
* Presence of post-operative ISP, VAS\>5/10
* American Society of Anesthesiologists Class 1 - 4
* No allergy to lidocaine

Exclusion Criteria:

* American Society of Anesthesiologists Class 5
* Allergy to lidocaine
* Nasal pathology (e.g., deviated septum)
* Bleeding diathesis
* Any patient who the PI feels will be unable to comply with all protocol related procedures
* Shoulder pain prior to thoracotomy

Primary outcomes:
measure: Shoulder Pain Reduction
timeFrame: 90 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Gilbert Grant, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03461393: The Effects of Regular Eye-training With a Mobile Device on Adult Patients With AMD
Official title: The Effects of Regular Eye-training With a Mobile Device on Adult Patients With AMD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: AMD
Keywords: AMD
Mobile Device
Training
Lead sponsor: University of Applied Sciences Upper Austria
Sponsor class: OTHER
Collaborators: name: Krankenhaus der Barmherzigen Schwestern Ried
First posted: 2018-03-12
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the study, 11 patients were included. In five of those, both eyes were affected by AMD; in the six other patients, only one eye was affected. The age of the patients was 72 ± 14.7 years (mean ± standard deviation, range 44 - 86 years). Eight eyes had received a lutein therapy for more than 2 years, according to the Age-Related Eye Diseases Study (AREDS) study. In two eyes an anti-VEGF (vascular endothelial growth factor ) therapy had been performed before (3.5 and 4 years ago, respecitvely); and in one eye a photodynamic therapy (PDT) had been performed 9 years ago. All eyes had been affected by dry AMD for 3.5 years or more. The visual acuity had been unchanged for at least a year in all patients. None of the patients reported any previous occurrence of epilepsy.

Brief summary: Data collection and observation of changes within AMD patients performing visual training on mobile devices

Detailed description: In the presented study a training-therapy in patients with dry AMD war evaluated. The main focus was on remote visibility and thus better handling of daily activities.

Therapy with high-contrast administration is used for amblyopia in childhood. Furthermore, simulation therapy is used in hemianopsia in the adult age, in which case the lesion is usually not located in the eye.

This stimulating therapy for children and adult patients led to the hypothesis that this treatment could also improve AMD's situation. The entire visual procedure also shows the possibility of change even in adult patients.

The presented study investigates if regular training with a device that provides a moving grating-stimulus, the "Medical Eye Trainer" (MET), can improve the subjective perception of visual performance during typical activities of daily living. The aims of the study were not to show improvement of reading vision nor to show changes in the retinal structure.

Eligibility criteria: Inclusion Criteria:

* All eyes had been affected by dry AMD for 3.5 years or more

Exclusion Criteria:

None

Primary outcomes:
measure: Visual Acuity
timeFrame: Baseline - 3 months
Secondary outcomes:
measure: Subjective Satisfaction
timeFrame: Baseline - 3 months
Other outcomes:
Locations:
city: Ried Im Innkreis
country: Austria
facility: Krankenhaus der Barmherzigen Schwestern Ried
state: Upper Austria
Study officials:
References:
Clinical trial NCT00265993: Enoxaparin in Acute Venous Thromboembolic Disease
Official title: The Efficacy of Subcutaneous Enoxaparin Once Daily in the Treatment of Acute Venous Thromboembolic Disease: an Open-labelled, Non-comparative, Multicentric, Phase IV Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Venous Thrombosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-12-15
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study objectives :

* To evaluate the efficacy/safety profile of enoxaparin once a day treatment in acute venous thromboembolic disease.


Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic lower-extremity deep venous thrombosis confirmed by doppler USG (ultrasonography), with or without confirmed symptomatic pulmonary embolism associated with provoked risk factors

Exclusion Criteria:

* Patients with a history of heparin or warfarin treatment longer than 24 hours,
* Patients requiring thrombolytic treatment,
* Patients having thrombophilia diagnosis,
* Patients with prior deep vein thrombosis or pulmonary emboli evidence,
* Patients with familial bleeding disorder,
* Patients who are at any known bleeding risk, such as active bleeding, active ulcerative bowel disease, angiodysplasia and having oculary, spinal or central nervous system surgery within the last month
* Patients with renal failure (serum creatinine concentration \> 180 mmol/L or \> 2.03 mg/dL),
* Patients with severe hepatic failure
* Patients with history of allergy against heparin and protamine,
* Patients with history of thrombocytopenia associated with heparin administration or of skin necrosis after heparin or warfarin treatment,
* Patients participating in another clinical study within the last 4 months
* Patients who are pregnant

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Frequency of bleeding emerged during the study drug administration; Frequency of bleeding emerged during 3 months of monitorization when the patient is on oral anticoagulants.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Edibe Taylan
role: STUDY_DIRECTOR
References:
Clinical trial NCT02026193: IVF Hyper-responders: Oocyte Vitrification Compared With Embryo Freezing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 11
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The chances to achieve pregnancy after retrieving \>15 oocytes are not good, probably because of bad effect on the endometrium (uterine inner lining). Therefore, in most such cases the investigators prefer to freeze all embryos, and transfer in a thaw cycle. With the introduction of oocyte vitrification (very fast cooling) technology, a new option emerged: to freeze un-fertilized eggs, to be fertilized and used later in a thaw cycle.

The purpose of this study is to compare the outcome of these two approaches.


Eligibility criteria: Inclusion Criteria:

* IVF patients
* ovulation trigger with Decapeptyl 0.2 mg because of ovarian hyper-response: E2 on trigger day .12,000 pmol/l and/or \>15 oocytes.
* Normal uterus

Exclusion Criteria:

* \<20% fertilization rate

Primary outcomes:
measure: Fetal Heart Activity 1 Month Post Embryo Transfer
timeFrame: 1 month after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: IVF Unit, Rambam medical Center
Study officials:
References:
citation: Devroey P, Polyzos NP, Blockeel C. An OHSS-Free Clinic by segmentation of IVF treatment. Hum Reprod. 2011 Oct;26(10):2593-7. doi: 10.1093/humrep/der251. Epub 2011 Aug 9.