louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01695642: Long-term LASIK Follow up Study
Official title: Long-term Outcomes After Laser in Situ Keratomileusis (LASIK): Mechanical Microkeratome vs Femtosecond Laser
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lasik Eye Surgery
Keywords: lasik, intralase, microkeratome
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects who had LASIK surgery for correction of myopia or myopic astigmatism at the Kellogg Eye Center with either the microkeratome or femtosecond laser for LASIK flap creation between 2002 to 2005.

Brief summary: Laser in situ keratomileusis (LASIK) is the most common corneal refractive surgery performed for correction of myopia. There are very few studies that have been performed to evaluate long-term outcomes after LASIK.

In this study, we will assess long-term outcomes 5 - 10 years after LASIK to assess stability of visual outcomes and long-term effect on corneal morphology with in vivo confocal microscopy. Clinical and corneal morphology outcomes will also be compared between patients who had flaps created with the microkeratome and femtosecond laser.

Detailed description: Volunteers will be eligible for enrollment into the study if have had LASIK surgery for correction of myopia or myopic astigmatism at the Kellogg Eye Center with either the microkeratome or femtosecond laser for LASIK flap creation between 5 and 10 years prior.

A complete ophthalmic examination and corneal confocal microscopy will be performed. The study visit will take approximately one hour.

Eligibility criteria: Inclusion Criteria:

* lasik surgery at the kellogg eye center between 2002 and 2005; at least 3 months of follow up after surgery

Exclusion Criteria:

Primary outcomes:
measure: Compare flap creation with mikrokeratome and Intralase
timeFrame: 8 to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Kellogg Eye Center
state: Michigan
Study officials:
affiliation: University of Michigan Kellogg Eye Center
name: Roni Shtein, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03852342: Reactive Doses and Times During Oral Food Challenge to Peanut
Official title: Reactive Doses and Times During Oral Food Challenge (OFC) to Peanut
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peanut Allergy
Keywords: Anaphylaxis
Oral Food Challenge
Hypersensitivity
Food Allergy
Peanut
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 262
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with a clinical suspicion of peanut allergy who underwent an open OFC to peanut between June 2001 to July 2018 in the Allergy Unit of the University Hospital of Montpellier (France).

Brief summary: Peanut allergy is a growing public health problem in developed countries with more and more hospitalizations for anaphylaxis. It has been determined that sensitization to certain peanut proteins such as rAra h 2, is predictive of allergy and could predict the severity of reaction (anaphylaxis) during Oral food challenges (OFC). So far, consensual threshold for cutaneous test and IgE as predictor in the positivity of OFC have not been determined. Identification of reactive doses for OFC and phenotype of patients would help to personalize management of patients subgroups, with an optimal security.


Eligibility criteria: Inclusion criteria:

* Patients with a clinical suspicion of peanut allergy who underwent OFC to peanut
* Patients not objecting to participate in the study
* Men and women are included

Exclusion criteria:

• The patient refused to participate in the study

Primary outcomes:
measure: Reactive doses of peanut (mg) at which an allergic reaction appears in patients with positive peanut Oral Food Challenge
timeFrame: 1 day
Secondary outcomes:
measure: Time between the reaction and the last administered dose
timeFrame: 1 day
measure: Identifying risk factors of peanut hypersensitivity
timeFrame: 1 day
measure: Risk factors of anaphylaxis during a positive peanut OFC
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital of Montpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Pascal DEMOLY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03289442: Supine Position for Colonoscopy Insertion
Official title: Impact of Supine Position on Colonoscopy Insertion: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy Insertion
Patient Position
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: No.85 Hospital, Changning, Shanghai, China
First posted: 2017-09-21
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether the supine position is better than the left lateral horizontal body position to decrease cecal intubation time, patients' pain and the difficulty of colonoscopy insertion.

Detailed description: Left lateral position is conventionally performed to initiate colonoscopy, yet no evidence has demonstrated its efficacy and advantages. Left lateral position for insertion, which results in air rising away from the left colon and producing acute bends in the sigmoid,might increase the risk of colonoscopy loop formation.When there is difficulty advancing the colonoscope, supine position can be employed to ensure cecal intubation. Therefore, we perform a randomized controlled trial to compares supine position with left lateral position for the safety and efficacy of colonoscopy insertion.

Eligibility criteria: Inclusion Criteria:

1. aged between 18-75 years
2. underwent screening, surveillance, and diagnostic colonoscopy

Exclusion Criteria:

1. \<18 or \>75 years old
2. major psychiatric disorders, colonic resection, pregnancy, presence of any contraindications for colonoscopy (eg, severe heart failure, renal insufficiency)
3. Patients with severe cardiopulmonary and renal disease
4. Patients who are unwilling or unable to consent

Primary outcomes:
measure: cecal intubation time
timeFrame: 2 hour
Secondary outcomes:
measure: descending colon intubation time
timeFrame: 1 hour
measure: patients' pain score
timeFrame: 3 hour
measure: patients' acceptance to unsedated or sedated colonoscopy in the future screening or examination
timeFrame: 3 hour
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
References:
citation: Willcock H, Gold DM. Supine Colonoscopy: An Advantage over Left Lateral in Synchronous Proctological Surgery. J Laparoendosc Adv Surg Tech A. 2016 Jun;26(6):475-7. doi: 10.1089/lap.2015.0609. Epub 2016 Mar 16.
citation: Waye JD, Yessayan SA, Lewis BS, Fabry TL. The technique of abdominal pressure in total colonoscopy. Gastrointest Endosc. 1991 Mar-Apr;37(2):147-51. doi: 10.1016/s0016-5107(91)70673-1.
citation: Zhao S, Yang X, Meng Q, Wang S, Fang J, Qian W, Xia T, Pan P, Wang Z, Gu L, Chang X, Zou D, Li Z, Bai Y. Impact of the supine position versus left horizontal position on colonoscopy insertion: a 2-center, randomized controlled trial. Gastrointest Endosc. 2019 Jun;89(6):1193-1201.e1. doi: 10.1016/j.gie.2019.01.009. Epub 2019 Jan 18.
Clinical trial NCT00516542: Dehydroepiandrosterone (DHEA) and Letrozole in Treating Patients With Metastatic Breast Cancer
Official title: A Phase I Study of DHEA in Combination With Letrozole in ER- Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: stage IV breast cancer
recurrent breast cancer
male breast cancer
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-08-15
Enrollment: 6
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Androgens can cause the growth of breast cancer cells. Hormone therapy using dehydroepiandrosterone (DHEA) may fight breast cancer by blocking the use of androgen by the tumor cells. Letrozole may stop the adrenal glands from making androgens. Giving DHEA together with letrozole may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of DHEA when given together with letrozole in treating patients with metastatic breast cancer.

Detailed description: OBJECTIVES:

* To determine the maximum tolerable dose, dose-limiting toxicity, and pharmacokinetics of dehydroepiandrosterone (DHEA) when given together with letrozole in patients with androgen receptor-positive and estrogen receptor- and progesterone receptor-negative metastatic breast cancer.

OUTLINE: Patients receive oral dehydroepiandrosterone and oral letrozole once daily. Physical exams and blood collections are performed every two weeks. Tumor assessments are performed once every three months.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer

  * Metastatic disease
* Hormone receptor status

  * Estrogen receptor- and progesterone receptor-negative
  * Androgen receptor-positive

PATIENT CHARACTERISTICS:

* ECOG performance status 0-3
* Postmenopausal (\> 60 years of age)
* Leukocyte count \> 3,000/uL
* Absolute neutrophil count \> 1,500/uL
* Platelet count \> 100,000/uL
* Total bilirubin normal
* AST and ALT \< 2.5 times upper limit of normal
* Creatinine normal OR creatinine clearance \> 60 mL/min

PRIOR CONCURRENT THERAPY:

* At least 4 weeks since prior chemotherapy
* At least 4 weeks since prior biologic therapy
* At least 4 weeks since prior radiotherapy
* At least 30 days since prior investigational agents
* No concurrent dehydroepiandrosterone or androstenedione supplements
* No concurrent chemotherapy or radiotherapy
* No concurrent hormone therapy or immunotherapy (including trastuzumab \[Herceptin®\])

Primary outcomes:
measure: Dose-limiting toxicity
timeFrame: One year from drug start
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Knight Cancer Institute at Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Rodney F. Pommier, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02375542: Characterization of Aortic Tissue at Reoperation
Official title: Clinical Observation and Pathological Characterization of Aortic Tissue at Reoperation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aortic Aneurysm
Aortic Dissection
Lead sponsor: CryoLife Europa
Sponsor class: INDUSTRY
First posted: 2015-03-02
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Prospective, Single center, single arm study.

Brief summary: This study will analyse factors contributing to cardiac re-operation to determine causative effects

Detailed description: This study will collect clinical data on the characteristics of aortic tissue on which BioGlue has been applied during a previous cardiovascular surgery. This is a post market surveillance study.

Eligibility criteria: Inclusion Criteria:

* Subjects undergoing an aortic re-operation
* Subject has had BioGlue used during previous aortic surgery
* Subject is willing and able to give written informed consent for participation

Exclusion Criteria:

* Subject with a history of vasculitis
* Subject with active infection (endocarditis)
* Subject with a history of chronic inflammatory condition which may have led to ongoing tissue damage
* Subject with a history of auto immune disease

Primary outcomes:
measure: The microscopic evaluation of the presence of BioGlue on aortic tissue
timeFrame: "participants will be followed for the duration of their surgery, an expected average of 5 hours
Secondary outcomes:
measure: Observation and characterization of BioGlue usage during the reoperation procedure
timeFrame: "participants will be followed for the duration of their surgery, an expected average of 5 hours
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: S.Orsola Malpighi Hospital
Study officials:
affiliation: Cardiac Surgeon
name: Davide Pacini, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03000842: Effects of Transcutaneous Vagal Nerve Stimulation on Hemodynamics Parameters
Official title: Effects of Transcutaneous Vagal Nerve Stimulation (tVNS) on Blood Pressure, Heart Rate and Autonomic Control in Hypertensive Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: autonomic control
transcutaneous vagal nerve stimulation
transauricular vagal nerve stimulation
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2016-12-22
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The vagal stimulation is a promising therapy for a lot of disorders as well as hemodynamic regulatory way. In order to minimize the harm of a surgery chip implantation, actually it was developing a non-invasive device that is able to stimulate the auricular branch of vagal nerve. It has been shown that trans-auricular vagal stimulation (tVNS) causes direct stimulation of the vagal nerve. However, there are still no strong evidences about it actions regarding the autonomic modulation. The aim of this study is to evaluate effects of tVNS on heart rate, blood pressure and the autonomic control in healthy and hypertensive subjects, at rest and after orthostatic position


Eligibility criteria: Normotensive group Inclusion Criteria:

* healthy volunteers
* sign the consent term

Normotensive group Exclusion Criteria:

* smokers
* alcoholism
* drug treatment
* skin lesion in the ear region
* chronic or acute diseases
* pregnancy
* be participating in another research protocol
* high performance athletes
* recent surgery
* vaso-vagal syndrome

Hypertensive group Inclusion Criteria:

* hypertensive diagnosis (with or without anti-hypertensive drugs treatment) or
* ambulatory blood pressure monitoring (ABPM) \>130/85
* sign the consent term

Hypertensive group Exclusion Criteria:

* smokers
* alcoholism
* beta-blockers treatment
* skin lesion in the ear region
* associated diseases
* pregnancy
* be participating in another research protocol
* high performance athletes
* recent surgery
* vaso-vagal syndrome

Primary outcomes:
measure: Autonomic control response to transcutaneous vagal nerve stimulation
timeFrame: 40 minutes
Secondary outcomes:
measure: Blood pressure changes to transcutaneous vagal nerve stimulation
timeFrame: 40 minutes
measure: Heart Rate changes to transcutaneous vagal nerve stimulation
timeFrame: 40 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03650842: Changes in Cerebral Oxygenation During Laparoscopic Pyloromyotomy
Official title: Changes in Cerebral Oxygenation During Laparoscopic Pyloromyotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pyloric Stenosis
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 25
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A prospective study that will assess the effect of laparoscopy on tissue oxygenation in the patients undergoing a laparoscopic pyloromyotomy at Nationwide Children's Hospital. Tissue oxygenation will be assessed non-invasively using near infrared spectroscopy, a device that is commonly used in our operating rooms to assess cerebral and tissue oxygenation.

Detailed description: This prospective study will include 50 patients under the age of 18 years who are having laparoscopic pyloromyotomy. There will be no change in the anesthetic or perioperative care of these patients. Tissue and cerebral oxygenation will be monitored using near infrared spectroscopy (NIRS). Prior to anesthetic induction, the NIRS monitor will be placed on the forehead. The device is non-invasive like pulse oximetry using a non-painful adhesive sticker. The device can be applied to different sites on the body to measure cerebral, tissue or even organ oxygenation. For the purpose of the study, the investigators will place one monitor on the forehead to measure tissue oxygenation and a second over the lower back to measure tissue (muscle or renal) oxygenation. These devices are used routinely in the operating room and the cardiothoracic intensive care unit for cardiac patients. Although not used on every surgical procedure, NIRS monitoring can be used on all patients who are undergoing major surgical procedures. Tissue and cerebral oxygenation will be recorded continuously starting just prior to anesthetic induction until the completion of the procedure.

Eligibility criteria: Inclusion Criteria:

* Children at Nationwide Children's Hospital under the age of 18 years who are having laparoscopic pyloromyotomy

Exclusion Criteria:

* None

Primary outcomes:
measure: Cerebral Regional Oxygen Saturation (rSO2)
timeFrame: At time of incision
measure: Cerebral Regional Oxygen Saturation (rSO2)
timeFrame: At the end of laparoscopy
measure: Renal Regional Oxygen Saturation (rSO2)
timeFrame: At time of incision
measure: Renal Regional Oxygen Saturation (rSO2)
timeFrame: At the end of laparoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
References:
citation: Kamata M, Hakim M, Walia H, Tumin D, Tobias JD. Changes in cerebral and renal oxygenation during laparoscopic pyloromyotomy. J Clin Monit Comput. 2020 Aug;34(4):699-703. doi: 10.1007/s10877-019-00356-2. Epub 2019 Jul 19.
Clinical trial NCT00786942: Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy
Official title: Bone Graft Necessity in Opening-Wedge High Tibial Osteotomy. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: osteotomy
knee
varus deformity
bone graft
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2008-11-06
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine wether autologous bone graft from iliac crest enhances bone union of tibial osteotomies, in the treatment of varus knee deformity.

Detailed description: Opening-Wedge High Tibial Osteotomy is a classic procedure,but the use of autologous bone graft from iliac crest causes pain and bleeding. Bone union occur even without bone graft, but no clinical trials compared results of the twoo procedures.

Eligibility criteria: Inclusion Criteria:

* varus knee deformity
* unicompartmental arthrosis

Exclusion Criteria:

* patellar arthrosis
* lateral arthrosis
* inflammatory diseases
* bone healing impair drugs or diseases

Primary outcomes:
measure: Clinical based bone union time
timeFrame: after 8 weeks
Secondary outcomes:
measure: X-ray femoro-tibial angle
timeFrame: 6 months, 1 year
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Departamento de Ortopedia do Hospital de Clínicas da Unicamp
state: São Paulo
Study officials:
affiliation: University of Campinas, Brazil
name: Alessandro R Zorzi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Campinas, Brazil
name: João B Miranda, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02955342: Back and Neck Pain in Adolescence
Official title: Back and Neck Pain in Adolescence: A Prospective Cohort Study Using a German Version of the Young Spine Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Back Pain
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2016-11-04
Enrollment: 244
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescents between 10 and 16 years with and without back and neck pain.

Brief summary: To validate the German version of the Young Spine Questionnaire (G-YSQ) and to study back and neck pain in adolescents between 10 and 16 years during one year by means of G-YSQ.

Detailed description: In two settings (school, clinics) back and neck pain of 10 to 16 years old adolescents will be assessed by the German Version of the Young Spine Questionnaire at 6 points in time during one year.

Validity, reliability and responsiveness of the G-YSQ will be determined and the development of back and neck pain within a year will be described.

Eligibility criteria: Inclusion Criteria:

* 10 to 16 years old

Exclusion Criteria:

* younger than 10, older than 16

Primary outcomes:
measure: Changes in a German Version of the Young Spine Questionnaire
timeFrame: change from baseline to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: Balgrist University Hospital
name: Barry K Humphreys, Professor
role: STUDY_DIRECTOR
References:
citation: Lauridsen HH, Hestbaek L. Development of the young spine questionnaire. BMC Musculoskelet Disord. 2013 Jun 12;14:185. doi: 10.1186/1471-2474-14-185.
citation: Wirth B, Knecht C, Humphreys K. Spine Day 2012: spinal pain in Swiss school children- epidemiology and risk factors. BMC Pediatr. 2013 Oct 5;13:159. doi: 10.1186/1471-2431-13-159.
citation: Wirth B, Humphreys BK. Pain characteristics of adolescent spinal pain. BMC Pediatr. 2015 Apr 17;15:42. doi: 10.1186/s12887-015-0344-5.
citation: Nyiro L, Potthoff T, Siegenthaler MH, Riner F, Schweinhardt P, Wirth B. Translation and validation of the German version of the Young Spine Questionnaire. BMC Pediatr. 2021 Aug 24;21(1):359. doi: 10.1186/s12887-021-02804-y.