louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00666471: Minimally Invasive Control of Epistaxis (MICE)
Official title: Minimally Invasive Control of Epistaxis: Efficacy and Economic Analysis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Epistaxis
Keywords: epistaxis
Epistaxis refractory to emergency physician treatment
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2008-04-25
Enrollment: 3
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: Epistaxis is a common disorder with 60% of the population suffering from one episode and 10% of these cases requiring medical attention. Between March 2006 and March 2007, in Calgary, Alberta, there were 1500 presentations of epistaxis to adult emergency rooms with 7% of these (105 patients) requiring packing with admission. Common methods to control epistaxis include, nasal packing (88%), operative arterial ligation (10%), and arterial embolization (2%). A cost analysis demonstrated that nasal packing had a lower cost compared to embolization and arterial ligation, and all modalities had similar lengths of stay (Goddard, Otolaryng Head Neck Surg. 2006). Arterial ligation is the current recommended therapy for recurrent or refractory epistaxis, with a success rate of 98%. With the advancement of endoscopic techniques, emergency room Minimally Invasive Control of Epistaxis (M.I.C.E.) allows for selective packing and cauterization, which provides the patient with retained function of their nasal cavity and prevents a hospital admission, resulting in significant cost savings.

Hypothesis:

Does the M.I.C.E. procedure provide significant cost savings compared to operative sphenopalatine artery ligation? Null hypothesis is that there is no difference in hospital admission rates between M.I.C.E. and operative sphenopalatine artery ligation.


Eligibility criteria: Inclusion criteria:

* Age ≥ 18 years old, Presenting to Rockyview General Hospital Emergency room
* No coagulopathy (must have INR reversed before inclusion)
* Available for follow-up at 1 week and 1 month in Calgary, Alberta
* Refractory or Recurrent Epistaxis defined as:

  * Refractory = unable to control epistaxis with bilateral Merocel™ Nasal Tampons fully inserted into nasal cavity
  * Recurrent = epistaxis after removal of Merocel™ Nasal Tampons following outpatient packing for 48 hours

Exclusion Criteria:

* Uncorrectable coagulopathy
* Unable to comply with procedure
* Pregnancy
* Non-Calgary emergency room presentation
* Severe posterior epistaxis requiring intubation for airway protection

Primary outcomes:
measure: Change in hospital admission requirement between M.I.C.E. and Operative Sphenopalatine Ligation
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Rockyview General Hospital / University of Calgary
state: Alberta
Study officials:
References:
Clinical trial NCT05607771: DaVitri: Semi-Automated Vitrificacion Clinical Study
Official title: Paired Non-inferiority Study Comparing Overture Semi-Automated Vitrification System ("DaVitri") to Standard Manual Process
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fertility Issues
Keywords: Vitrification
Lead sponsor: Overture Life
Sponsor class: INDUSTRY
First posted: 2022-11-07
Enrollment: 72
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The main objective of this clinical study is to demonstrate the non-inferiority of the semi automated device (DaVitri) developed by Overture Life in the preparation procedures for vitrification of human samples.

Detailed description: Vitrification is a manual technique that is routinely used in assisted reproduction clinics for the cryopreservation of oocytes and embryos in liquid nitrogen at -196oC. There are different methods of vitrification, the most used being the Cryotop of Kitazato. This is a manual process that requires precision and experience to achieve a good result. For this reason, the correct execution of the technique is considered key in in vitro fertilization (IVF) treatments, as it can favor the preservation of fertility and optimize clinical results.

The purpose of the study is to validate the viability of the semi automated vitrification process, to obtain survival rates similar to or superior to manual processes, and also the capacity to provide greater reproducibility in the results.

The semi automatic exchange of vitrification fluids in human oocytes is as efficient as the manual procedure, in terms of survival (85-90%), but with significantly lower variability between technicians and between centers (95% reproducibility), as well as reduced manual processing times.

The initial hypothesis is that semi automated vitrification equals or improves the manual technique, thus introducing a new standardized protocol for clinical use.

Eligibility criteria: Inclusion Criteria:

* Donors will be selected according to the clinic's usual inclusion criteria in terms of infectious diseases, genetic diseases, karyotype, etc.

Exclusion Criteria:

* BMI\<18.5 or BMI \>25
* Implantation failure
* Abnormal ovulation cycle
* Endometrial thickness \> 7mm

Primary outcomes:
measure: Thaw survival rates of oocytes
timeFrame: Day 1
Secondary outcomes:
measure: Blastocyst formation rate
timeFrame: Day 5
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: WeFIV Buenos Aires
city: Buenos Aires
country: Argentina
facility: Halitus Instituto Médico
Study officials:
affiliation: WeFiv
name: Fernando Neuspiller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01317771: Analysis of the Fixation of the Proximal Biceps Tendon
Official title: Analysis of the Fixation of the Proximal Long Head of the Biceps Tendon
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Disorder of Tendon of Biceps
Keywords: Proximal Biceps Pathology
Lead sponsor: West Penn Allegheny Health System
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This research study will collect the MRI and questionnaire data from 10 subjects that have undergone a subpectoral proximal biceps tendon tenodesis using the EndoButton.

Brief summary: Ten randomly selected patients that have undergone an open proximal biceps tendon tenodesis with an EndoButton for bicipital pathology with Christopher Schmidt, MD, will be asked to participate in the study. The study will assess the tendon healing to bone through magnetic resonance imaging (MRI). Individuals will also be asked to fill a visual analog scale (VAS) pain and disability of the arm shoulder and hand (DASH) assessment tools. The variables for our objective will include age, hand dominance, gender and chronicity of symptoms prior to surgery, and other related surgical procedures.


Eligibility criteria: Inclusion Criteria:

* Undergone open subpectoral proximal biceps tenodesis with the EndoButton

Exclusion Criteria:

* No history of surgery or disability in the contra-lateral extremity
* Not a member of a legally restricted group or protected population
* No prior surgery or further surgery on the extremity of interest
* No condition preventing the individual from undergoing a MRI

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Allegheny Imaging of McCandless
state: Pennsylvania
Study officials:
affiliation: WPAHS
name: Christopher C Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01699971: Randomized Controlled Study Comparing Three Different Techniques for Open Hernia Repair
Official title: Randomized Controlled Study Comparing Three Different Techniques for Open
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim is to evaluate if PSH and/or ultrapro mesch reduces chronic groin pain postoperatively compared to lichtenstein mesh. The second aim is to evaluate quality of life, recovery from surgery and frequency of recurrencies in the three groups


Eligibility criteria: Inclusion Criteria:

* 18-75 years
* unilateral primary hernia
* open surgery

Exclusion Criteria:

* Recurrent Hernia
* Bilateral Hernia
* laparoscopic surgery
* Female

Primary outcomes:
measure: postoperatively pain
timeFrame: Postoperative 36 month
Secondary outcomes:
measure: Quality of life
timeFrame: 36 month postoperative
measure: frequency of recurrencies
timeFrame: postopertive 36 month
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Ersta Hospital
Study officials:
affiliation: Karolinska Institutet
name: Anders Thorell, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01581671: Non-Invasive EndoPAT Increases Diagnostic Yield of CAD by Coronary Angiography
Official title: Non-Invasive Peripheral Arterial Tonometry (EndoPAT) Increases Diagnostic Yield of Coronary Artery Disease by Coronary Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Itamar-Medical, Israel
First posted: 2012-04-20
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients coming to the Cardiac Cath Lab to determine if they have coronary artery disease

Brief summary: The purpose of this study is to assess the non-invasive, Peripheral Arterial Tonometry (PAT) testing as another way of predicting potential coronary artery blockages in the heart.

Detailed description: We are conducting a 16 minute, non-invasive EndoPAT test on patients coming to our cath lab for a first-time angiogram. The angiogram results will be compared to the EndoPAT results to determine if the EndoPAT test, which generates a score, is successful in predicting who may have blockages in their coronary arteries.

Eligibility criteria: Inclusion Criteria:

* Patients without known coronary disease who are referred for coronary angiography.
* Adults 18 years and older.

Exclusion Criteria:

* Patients with known coronary disease, acute coronary syndrome, cardiac transplantation, and severe connective tissue disease.

Primary outcomes:
measure: To determine if the assessment of endothelial function by non-invasive peripheral arterial tonometry improves diagnostic yield of elective coronary angiography
timeFrame: same day as the angiogram
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman, B.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01619371: Engorgement Study With a Double Electric Breast Pump
Official title: Engorgement Study With the Simplisse Double Electric Breast Pump
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Engorgement
Keywords: breast pump
engorgement
lactation
Lead sponsor: Foundation for Maternal Infant and Lactation Knowledge
Sponsor class: OTHER
First posted: 2012-06-14
Enrollment: 21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First 20 women arriving at the Newborn Care Center clinic in Reno, Nevada during their first week postpartum seeking lactation management assistance for engorgement.

Brief summary: The purpose of this study is to analyze the effectiveness of an FDA approved Class II medical device, the Simplisse Double Electric Breast Pump, in relieving the symptoms of engorgement.


Eligibility criteria: Inclusion Criteria:

* first week postpartum seeking lactation management assistance for engorgement, identified as clinically engorged by health care practitioner.

Exclusion Criteria:

* greater than one week postpartum
* less than 18 years of age
* non-English speakers
* not willing to use double electric breast pump

Primary outcomes:
measure: Engorgement Relief
timeFrame: 10 minutes per subject
Secondary outcomes:
Other outcomes:
Locations:
city: Reno
country: United States
facility: Newborn Care Center Clinic
state: Nevada
Study officials:
affiliation: Foundation for Maternal Infant and Lactation Knowledge
name: Jimi Francis, MS,PhD,IBCLC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02815371: Laser Acupuncture Before and After Embryo Transfer Improves IVF Outcomes
Official title: Laser Acupuncture Before and After Embryo Transfer Improves in Vitro Fertilization Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embryo Implantation
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2016-06-28
Enrollment: 803
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluated whether laser acupuncture at the time of embryo transfer (following in vitro fertilization) improves implantation rates. Patients were randomized to one of 4 groups at the time of embryo transfer: 1) laser acupuncture, 2) needle acupuncture, 3) sham laser acupuncture, 4) no treatment.


Eligibility criteria: Inclusion Criteria:

* All patients seeking pregnancy via in vitro fertilization during the study period

Exclusion Criteria:

* Bleeding disorders (due to the possible use of needles)
* Prior exposure to acupuncture
* Preimplantation genetic screening or diagnosis

Primary outcomes:
measure: Implantation rate
timeFrame: Approximately 2 weeks after embryo transfer
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: Approximately 3 weeks after embryo transfer
measure: Live birth rate
timeFrame: 40 weeks after intervention
Other outcomes:
Locations:
city: Norwalk
country: United States
facility: Reproductive Medicine Associates of Connecticut
state: Connecticut
city: Morristown
country: United States
facility: Reproductive Medicines Associates of New Jersey
state: New Jersey
Study officials:
References:
Clinical trial NCT00701571: Video/Audio Distraction Analgesia for Simulated Oncology Procedure Pain
Official title: Video/Audio Distraction Analgesia for Simulated Oncology Procedure Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Virtual Reality
Oncology
Lumbar puncture
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Seattle Cancer and Aging Program
First posted: 2008-06-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the analgesic efficacy of three different types of video/audio distraction in normal volunteers subjected to carefully controlled and non-injurious thermal pain delivered to the skin of the lower back, simulating discomfort of a lumbar puncture. Two of the distraction techniques include immersive virtual reality (VR). The most efficacious distraction technique will be used in a subsequent clinical study in cancer patients.


Eligibility criteria: Inclusion Criteria:

* healthy men and women
* 18-21y, 40-60y, or older than 60y

Exclusion Criteria:

* a predisposition to motion sickness
* unusual sensitivity or lack of sensitivity to pain
* chronic pain
* peripheral neuropathy
* sensitive skin

Primary outcomes:
measure: To compare positional techniques and differing types of VR presentation (immersive vs. low tech). We will also compare age cohorts (18-21, 40-60, and older than 60 years).
timeFrame: upon completion of data collection
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Samuel R Sharar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00396071: Efficacy and Safety of Vildagliptin Compared to Placebo on the Incretin Effect in Patients With Type 2 Diabetes Treated With Metformin
Official title: A Single-center, Double-blind, Randomized, Placebo-controlled, Cross-over Study to Assess the Effect of Vildagliptin on the Incretin Effect in Patients With Type 2 Diabetes Treated With Metformin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
incretin effect
metformin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-11-06
Enrollment: 22
Sex: ALL
Minimum age (years): 30
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This mechanistic study will evaluate the effect of vildagliptin on glucose-stimulated insulin secretion to improve the incretin effect in patients with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes on metformin for at least 3 months and have been on a stable dose of at least 1500 mg daily for a minimum of 4 weeks
* Agreement to maintain the same dose of metformin throughout the study
* Body mass index (BMI) in the range of 22-35 kg/m2
* HbA1c in the range of 7.0 to 9.0%
* FPG \<200 mg/dl (11.1 mmol/L)
* Agreement to maintain prior diet and exercise habits during the full course of the study
* Ability to comply with all study requirements and signed informed consent to participate in the study

Exclusion Criteria:

* A history of type 1 diabetes
* A history of acute metabolic diabetic complications
* Evidence of significant diabetic complications
* Insulin treatment for longer than 10 days within the past 6 months
* Treatment with any oral anti-diabetic other than metformin within 3 months prior to visit 1

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change in C-peptide IAUC (0-4hr)
timeFrame: 2 weeks after treatment
Secondary outcomes:
measure: Change in insulin secretion rate (ISR) relative to glucose (0-2hr)
timeFrame: after 2 weeks of treatment
measure: Change in postprandial C-peptide
timeFrame: after two weeks of treatment
measure: Change in postprandial insulin
timeFrame: after two weeks of treatment
measure: Change in postprandial glucagon
timeFrame: after two weeks of treatment
measure: Change in postprandial GLP-1
timeFrame: after 2 weeks of treatment
Other outcomes:
Locations:
city: Bad Lauterberg
country: Germany
facility: Diabetes Zentrum Bad Lauterberg
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Vardarli I, Nauck MA, Kothe LD, Deacon CF, Holst JJ, Schweizer A, Foley JE. Inhibition of DPP-4 with vildagliptin improved insulin secretion in response to oral as well as "isoglycemic" intravenous glucose without numerically changing the incretin effect in patients with type 2 diabetes. J Clin Endocrinol Metab. 2011 Apr;96(4):945-54. doi: 10.1210/jc.2010-2178. Epub 2011 Jan 14.
Clinical trial NCT02421471: PMS to Evaluate the Safety and Efficacy of Picato® Gel
Official title: Post-Marketing Surveillance to Evaluate the Safety and Efficacy of Picato® Gel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Actinic Keratosis
Keywords: Actinic Keratosis
topical treatment
ingenol mebutate
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-04-20
Enrollment: 1324
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive adult patients with AK in involved PMS sites treated for the first time with ingenol mebutate 0.015 or 0.05 percent gel.

Brief summary: This study is a mandatory post launch observational study in South Korea of 3.000 patients receiving treatment for the first time with a new medicinal product, ingenol mebutate gel (Picato®), approved for topical treatment of actinic keratosis.

Each patient is observed for 8 weeks after treatment completion.

Detailed description: Picato® (ingenol mebutate) gel is a new topical therapy for Actinic Keratosis (AK) in adults which was approved by the Korean Ministry of Food and Drug Safety (MFDS) in December 2013. For AK in face or scalp the 0.015 percent gel is approved to be applied once a day for 3 consecutive days, and for AK in trunk or extremities the 0.05 percent gel is approved to be applied once a day for 2 consecutive days.

The re-examination period for Picato® runs from December 2013 to December 2019, during which at least 3,000 patients who are prescribed ingenol mebutate gel for the first time by investigator's medical judgment must be documented in a standard Post Marketing Surveillance (PMS) study.

Each patient is to be observed for 8 weeks following application of ingenol mebutate gel. If a patient is unable to visit the PMS site, the investigator may contact the patient by phone to assess the safety.

Eligibility criteria: Inclusion Criteria:

Adult patient with AK First time treatment with ingenol mebutate 0.015 or 0.05 percent gel

Exclusion Criteria:

* Children and adolescents

Primary outcomes:
measure: Adverse Events
timeFrame: 8 weeks after treatment completion
measure: Overall improvement
timeFrame: 8 weeks after treatment completion
Secondary outcomes:
measure: Complete clearance rate - Change in AK lesions count: Percentage (%) change in the total number of AK lesions compared to baseline*
timeFrame: 8 weeks after treatment
measure: Partial clearance rate
timeFrame: 8 weeks after treatment
measure: Change in AK lesion count
timeFrame: 8 weeks after treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Dermatology, Korea University Anam Hospital
Study officials:
affiliation: LEO Pharma Limited, Korea
name: Sun Choi, B.Sc.
role: STUDY_DIRECTOR
References: