louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01473459: Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome Patients
Official title: Comparison Between Two Fertility Protocols in Obese Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obese
Infertility
Polycystic Ovary Syndrome
Keywords: best fertility protocol
(BMI > 30)
women
PCOS
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2011-11-17
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two fertility protocols in obese women with Polycystic Ovarian Syndrome who are candidates for In Vitro Fertilization (IVF). These protocols carry less risk of ovarian hyperstimulation syndrome which these women may experience.

Detailed description: The purpose of this study is to compare two fertility protocols in obese women with Polycystic Ovarian Syndrome who are candidates for In Vitro Fertilization (IVF). These protocols carry less risk of ovarian hyperstimulation syndrome which these women may experience.The patients in the IVM group will not be exposeD to gonadotropin treatment for controlled ovarian hyperstimulation. In the antagonist group we will use GnRH agonist to induce ovulation which may reduce the risk for ovarian hyperstimulation.

Eligibility criteria: Inclusion Criteria:

* BMI \> 30
* PCOS
* Failure of COH treatment

Primary outcomes:
measure: Fertility results
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: IVF unit Hillel-Yaffe medical Center
name: Tal Shavit, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05548959: Outflow Facility AIT vs Microshunt
Official title: Differences in Nycthemeral IOP Variation and Outflow Facility After Filtering Microshunt Versus Canal-Based Ab Interno Glaucoma Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: outflow facility
microshunt
ab interno trabeculectomy
pneumatonometer
intraocular pressure
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to asses differences in nycthemeral (24-h) intraocular pressure (IOP) profiles and outflow facilities between patients who have undergone epibulbar microshunt implantation and ab interno trabeculectomy, respectively.

Detailed description: Recent studies involving continuous, 24-hour intraocular pressure (IOP) monitoring in glaucoma patients linked IOP variation to disease progression.

No study has previously compared the postoperative IOP variation of microshunt (Preserflo, P) implantation to ab interno trabeculectomy (Trabectome, T).

In this prospective cohort, the investigators analyzed 68 patients (34 P and 34 T) who presented for 24-hour IOP monitoring 6 to 12 months after surgery. Surgery must have been conducted between October 2020 and July 2021. Patients were assigned to each study group according to the intervention undergone, P or T. IOP and tonographic outflow facility were measured in the habitual position using a pneumatonometer. The IOP variation was considered the primary outcome measure.

Eligibility criteria: Inclusion Criteria:

* Patients that have undergone microshunt implantation or ab interno trabeculectomy between 6-12 months ago
* patients suffering from open-angle glaucoma

Exclusion Criteria:

* Patients that have undergone microshunt implantation or ab interno trabeculectomy less than 6 months or over 12 months ago
* patients suffering from angle-closure glaucoma

Primary outcomes:
measure: Intraocular pressure variation
timeFrame: Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight).
Secondary outcomes:
measure: Outflow facility
timeFrame: Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight).
measure: Intraocular pressure
timeFrame: Obtained 6-12 months after patients have undergone microshunt implantation and ab interno trabeculectomy, respectively. Measurements were taken at 5 points in time over 24 hours (at 5 AM, 11 AM, 4 PM, 8 PM, and midnight).
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: Department of Ophthalmology University Hospital Wuerzburg
state: Bavaria
Study officials:
References:
Clinical trial NCT01777659: Transcutaneous Electrical Nerve Stimulation Improves Vascular Conductance After Coronary Artery Bypass Graft Surgery
Official title: Transcutaneous Electrical Nerve Stimulation Improves Vascular Conductance After Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: exercise
neuromodulation
blood flow
exercise capacity
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
Collaborators: name: University of Brasilia
name: Hospital Sao Joao
First posted: 2013-01-29
Enrollment: 38
Sex: ALL
Minimum age (years): 48
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will test the hypothesis that transcutaneous electrical nerve stimulation (TENS) may attenuate peripheral vasoconstriction and to improve blood flow redistribution during handgrip exercise in acute myocardial infarction (AMI) patients after Coronary Arterial Bypass Graft Surgery (CABG).

Detailed description: Thirty-eight patients will be randomized to a (4 times/day; 30 min/session) for 5-day program of TENS (n = 20) or to placebo-TENS (P-TENS, n = 18) applied on cervical region (C7-T4). Acute sympathetic stimulation by cold pressor test (CPT), Maximal voluntary contraction (MVC), Femoral blood flow (FBF) and femoral vascular conductance (FVC) will be measured as primary outcome pre and post-CABG, even as the 6-minute walk test (6-MWT), Inspiratory and expiratory muscle strength (PImax and PEmax) and β-endorphin as a secondary clinical parameters. In addition, amount of opioid analgesic and pain intensity also will be measured throughout at first 24 hours after CABG (immediately, 6, 12 and 24 hours).

Eligibility criteria: Inclusion Criteria:

* a previous history of more than 1 vessel coronary artery disease,
* lifelong abstinence from tobacco, and
* formal indication for CABG, according to established guideline.

Exclusion Criteria:

* Patients older than 70 years of age, with chronic renal failure, or with unstable angina in the 48 h prior to CABG, moderate or severe valve disease, complex cardiac arrhythmias, stroke, and/or inability to exercise the lower limbs.

Primary outcomes:
measure: Blood flow redistribution - baseline and 5 days later
timeFrame: 1 day
Secondary outcomes:
measure: Inspiratory and Expiratory Muscle Function
timeFrame: 5 day
Other outcomes:
measure: Pain Intensity
timeFrame: 5 day
measure: Opioid Analgesic Amount
timeFrame: 5 day
measure: β-Endorphin Analysis
timeFrame: 5 day
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Gaspar R Chiappa, Dr, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04420559: Intramuscular Benzathine Penicillin Injection Procedure
Official title: The Use of Virtual Reality and Distraction Cards to Reduce Pain During Intramuscular Benzathine Penicillin Injection Procedure in Adults: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injection Site Discomfort
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 91
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: OTHER

Brief summary: The aim of this study was the determination of the effect of applying VR and DC distraction methods on patients' pain and satisfaction levels during IM benzathine penicillin injection.

The research hypothesis:

1. Are Virtual Reality and Distraction Card effective in reducing pain due to injection of IM benzathine penicillin?
2. Does the use of Virtual Reality and Distraction Card during the injection process of IM benzathine penicillin have an effect on patient satisfaction?


Eligibility criteria: Inclusion Criteria:

* agree to participate in the research,
* being over the age of 18,
* being native speaker,
* not having vision and hearing problems,
* being prescribed benzathine penicillin with a dose of 1.200.000 IU,
* being experienced of IM injection,
* not having IM injection for the last 1 month

Exclusion Criteria:

* volunteers who have scar, incision, lipodystrophy, abscess, necrosis, hematoma, ecchymosis, infection, pain and paralysis at the VG site
* volunteers are excluded if the injection process cannot be performed at one time

Primary outcomes:
measure: Visual Analog Scale for pain measurement
timeFrame: 4 months
Secondary outcomes:
measure: Visual Analog Scale for satisfaction measurement (Minimum score: 0 ; Maximum score:10)
timeFrame: 4 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane Training and Research Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Tulay Basak
role: PRINCIPAL_INVESTIGATOR
References:
citation: Basak T, Demirtas A, Yorubulut SM. Virtual reality and distraction cards to reduce pain during intramuscular benzathine penicillin injection procedure in adults: A randomized controlled trial. J Adv Nurs. 2021 May;77(5):2511-2518. doi: 10.1111/jan.14782. Epub 2021 Feb 19.
Clinical trial NCT01879059: The Effects of Altering Physical Activity on Cardiometabolic Health
Official title: The Effects of Altering Physical Activity on Endothelial Function, Glycemic Control, and the Blood Flow Response to an Oral Glucose Tolerance Test.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Keywords: insulin resistance
exercise
continuous glucose monitoring
blood flow
endothelial function
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 13
Sex: ALL
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The effects of physical inactivity on variations in blood glucose and vascular health are not fully understood. The purpose of this study is to determine if an acute transition from physical activity to inactivity alters vascular health. Specifically, the investigators wish to examine in healthy, lean physically active individuals (obtaining greater than 10,000 steps/day) if decreasing physical activity (obtaining less than 5,000 steps/day) will alter blood flow following a meal a marker of vascular health. Furthermore, the investigators wish to examine if a one day return to physical activity (obtaining \>10,000 steps/day) can restore the detrimental effects on blood flow following a meal.

Detailed description: Herein, we tested the hypothesis that an acute reduction in daily activity (from \>10,000 to \<5,000 steps/day) for 5 days in healthy individuals reduced meal-stimulated blood flow and if a 1 day return to activity improved this outcomes.

Eligibility criteria: Inclusion Criteria:

* BMI: less than 30 kg/m2
* Physically active: exercise greater than 60mins per week

Exclusion Criteria:

* smoking
* type 2 diabetes
* Underlying conditions that limit ability to exercise safely
* Recent weight gain or loss(\> 5% of body weight in 3 months)
* Recent (\< 3 mo) changes in medication use or dose
* Pregnancy

Primary outcomes:
measure: Effects of Physical Inactivity on Post Prandial Blood Flow
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: John P Thyfault, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mikus CR, Oberlin DJ, Libla JL, Taylor AM, Booth FW, Thyfault JP. Lowering physical activity impairs glycemic control in healthy volunteers. Med Sci Sports Exerc. 2012 Feb;44(2):225-31. doi: 10.1249/MSS.0b013e31822ac0c0.
citation: Mikus CR, Fairfax ST, Libla JL, Boyle LJ, Vianna LC, Oberlin DJ, Uptergrove GM, Deo SH, Kim A, Kanaley JA, Fadel PJ, Thyfault JP. Seven days of aerobic exercise training improves conduit artery blood flow following glucose ingestion in patients with type 2 diabetes. J Appl Physiol (1985). 2011 Sep;111(3):657-64. doi: 10.1152/japplphysiol.00489.2011. Epub 2011 Jul 7.
Clinical trial NCT05145959: Meibomian Gland Probing in the Sub-Acute Phase of Patients With Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
Official title: Meibomian Gland Probing in the Sub-Acute Phase of Patients With Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stevens-Johnson Syndrome
Toxic Epidermal Necrolyses
Ocular Surface Disease
Meibomitis
Meibomian Gland Dysfunction
Dry Eye
Keywords: Stevens-Johnson Syndrome
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators' aim is to study the effects of mechanical expression of meibomian glands on eyelid disease, ocular surface health in the subacute phase of SJS/TEN.

The primary outcome is to use meibomian gland imaging to assess the health and caliber of the meibomian glands of both lower eyelids, between the treated and non-treated eyes before and after the intervention. Monitoring of outcomes will be measured by comparing the results of meibography at the initial visit and at the 6-month follow-up.

The secondary outcome assessed will be patient symptoms. The Ocular Surface Disease Index survey will be administered before each treatment and patients will be asked to differentiate their symptoms between the two eyes, both before and after the intervention.

The investigators hypothesize that mechanical expression of meibomian glands within the first 6 months of SJS/TEN onset will significantly improve ocular surface disease and symptoms in those patients.


Eligibility criteria: Inclusion Criteria:

* Patients with SJS/TEN presenting to the Massachusetts Eye and Ear Infirmary (MEEI) ophthalmology clinic or who were seen by the ophthalmology team acutely at the Massachusetts General Hospital (MGH).
* Patients must be in the Sub-acute phase of ocular SJS (within 6 months)
* Patients must have evidence of Meibomitis
* Patients must be adults (18 years of age or older)

Exclusion Criteria:

* Patients with unconfirmed diagnosis of SJS vs. Erythema multiforme (or other condition).
* Patients beyond the sub-acute phase of SJS
* Patients without evidence of Meibomitis (See above criteria)
* Patients under the age of 18

Primary outcomes:
measure: Meibomian gland imaging (Meibography) - Qualitative description
timeFrame: 6 months
Secondary outcomes:
measure: Ocular Surface Disease Index survey
timeFrame: 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT04943159: Afamelanotide in Patients Suffering With Acne Vulgaris
Official title: A Phase II, Randomised, Open Label Pilot Study to Evaluate the Efficacy and Safety of Two Dosage Regimens of Subcutaneous Bioresorbable Afamelanotide Implants in Patients With Mild to Moderate Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Clinuvel Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2021-06-29
Enrollment: 3
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of afamelanotide on the facial inflammatory acne-related lesions in patients with mild to moderate acne vulgaris, including tolerability of afamelanotide by patients with moderate acne vulgaris and effects of the treatment on quality of life in eligible patients.


Eligibility criteria: Inclusion Criteria:

* Male subjects with a diagnosis of mild to moderate acne vulgaris, defined as an Investigator's global assessment (IGA) score of 2-3;
* Chronic course of acne vulgaris;
* Acne-related lesions both on the face, chest and back;
* Indication for treatment of acne vulgaris;
* Aged 18-30 years (inclusive);
* Fitzpatrick skin types I-III;
* Providing written Informed Consent prior to the performance of any study-specific procedure.

Exclusion Criteria:

* Female subjects;
* Diagnosis of severe acne vulgaris;
* Allergy to afamelanotide or the polymer contained in the implant or to lidocaine or other local anesthetic to be used during the administration of the implant;
* Use of topical acne medication such as retinoids, benzoyl peroxide or topical antibiotics within 2 weeks prior to the first dose;
* Use of oral antibiotics for acne within 4 weeks prior to the first dose;
* Use of topical corticosteroids on the face, chest and back or systemic corticosteroids within the past 4 weeks prior to the first dose;
* Use of systemic retinoids within 6 months prior to the first dose;
* Use of anti-androgenic agents such as finasteride within 4 weeks prior to the first dose;
* Use of phototherapy devices for acne such as ClearLight™ or Zenozapper within 1 week prior to the first dose;
* Use of tanning booths or lamps within 1 week prior to the first dose;
* Active skin disease that may interfere with evaluation;
* Other forms of acne such as acne rosacea, acne excoriée, chloracne, acne conglobata, acne fulminans, acne inversa or drug-induced acne;
* Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit.

Primary outcomes:
measure: The Change in Number of Facial Inflammatory Acne-related Lesions.
timeFrame: From baseline to Day 56.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03058159: Sleep Inertia and Functional Connectivity
Official title: Sleep Inertia and Functional Connectivity Between Brain Regions at Awakening : a Functional Magnetic Resonance Imaging (fMRI) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-02-20
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to investigate the functional connectivity between the brain regions of the default mode network before and after a 40 min nap slot in the afternoon. The hypothesis is that connectivity between brain regions will be decreased after the nap as compared to before the nap.


Eligibility criteria: Inclusion Criteria:

* 65 \> age \> 18
* high or law dream recall frequency

Exclusion Criteria:

* history of psychiatric or neurologic or sleep pathologies
* counter indication for MRI

Primary outcomes:
measure: Measure: Change of correlation values between the BOLD (Blood Oxygenation Level Dependent) signal time series of the brain regions of the default mode network (DMN) between the scans before and after the nap slot.
timeFrame: fMRI scans will be acquired 5 min before, 5 min after and 25min after the nap slot.
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: CH le VINATIER
Study officials:
affiliation: CH le VINATIER
name: Alain NICOLAS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04640259: Epidemiology of Young Lung Cancer - Survey
Official title: This is a 100% Virtual (Remote) Study (Survey, and Voluntary Blood Donation) to Explore Potential Environmental, Lifestyle and Genetic Factors That May be Associated With Driver Mutations of Young Lung Cancer in the USA.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NSCLC
Lead sponsor: Addario Lung Cancer Medical Institute
Sponsor class: OTHER
Collaborators: name: University of Southern California
name: Ohio State University Comprehensive Cancer Center
First posted: 2020-11-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A minimum of 250 subjects distributed with at least 50 subjects among the most common driver mutation groups will be enrolled into the study:

1. EGFR (del19 and L858R) - 50 subjects
2. ROS1 - 50 subjects
3. ALK - 50 subjects
4. KRAS - 50 subjects
5. Other Groups:

   1. Uncommon activating mutation for which specific targeted therapy exists (RET fusion, NTRK fusion, BRAF V600E, MET Exon14 skipping mutations, other activating EGFR mutations) - 25 subjects
   2. Non-targetable other mutations (p53, NF1, ATM, PIK3CA, RB, non-V600E BRAF, NTRK mutation) or no identified mutation. - 25 subjects Subjects with more than one mutation will be included.

Brief summary: This is a 100% virtual (remote), case-case study to explore potential environmental, lifestyle and genetic factors that may be associated with driver mutations of young lung cancer in the U.S.


Eligibility criteria: Inclusion Criteria:

1. Male or female aged 18 years and over; or the age of majority for their residential state at the time of enrollment
2. Documentation of primary NSCLC, any stage
3. Less than 50 years of age at the time of NSCLC diagnosis
4. Documentation of testing by a CLIA certified lab for genomic drivers of lung cancer
5. Willingness to undergo all study procedure
6. Provision of written informed consent

Exclusion Criteria:

1. Male or female aged less than 18 years; or less than the age of majority for their residential state
2. Greater than or equal to 50 years of age at the time of NSCLC diagnosis
3. No documentation of mutation testing
4. Unwilling to undergo all study procedures
5. Unable or unwilling to provide consent

Primary outcomes:
measure: Exploratory epidemiology correlates
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Keck School of Medicine
state: California
city: San Carlos
country: United States
facility: Addario Lung Cancer Medical Institute
state: California
Study officials:
affiliation: University of Southern California
name: Jorge Nieva, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: Barbara Gitlitz, MD
role: PRINCIPAL_INVESTIGATOR
References: