louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00768313: Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis.
Official title: A Multi-Centre Randomized Phase IV Clinical Trial Comparing Rods of Varying Yield Strengths and Their Ability to Hold Correction of Adolescent Idiopathic Scoliosis.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Scoliosis
Keywords: scoliosis correction rod strength adolescent
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: DePuy Orthopaedics
First posted: 2008-10-08
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: OTHER

Brief summary: There has been a growing trend amongst surgeons to use a construct for correction of scoliosis which involves segmental instrumentation with pedicle screws. Pedicle screw proponents cite greater curve control in all planes, which results in improved spinal curve correction. Some surgeons have noted due to the increased strength of the all screw construction that the rod is now the weak part of the spinal fixation. Although no evidence has been raised in regards to hardware failure there is a perception that a loss of balance in the sagittal plane is the result of flex in the titanium rod. A novel solution to the issue of rod flexibility is raised with the expedium super steel instrumentation which allows for greater stiffness than a 5.5 mm titanium rod with the same lower profile. This study aims to compare the new super steel technology with other established instrumentations used to correct spinal stenosis.

Detailed description: screw purchase was to be recorded but study has been withdrawn.

Eligibility criteria: Inclusion Criteria:

* aged 10-20;
* presenting with a progressive lenke type 1A, N; or
* type idiopathic adolescent scoliosis measuring greater than 45 degree cobb angle

Exclusion Criteria:

* rigid scoliosis requiring a three column release or osteotomy;
* patients that can not have pedicle screw instrumentation due to technical concerns

Primary outcomes:
measure: percent correction in both frontal and sagittal planes for idiopathic scoliosis
timeFrame: pre-op, 3, 6, 12, 24 months
Secondary outcomes:
measure: screw purchase
timeFrame: intraoperative
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Queen's Univeristy
state: Ontario
Study officials:
affiliation: Queen's Univeristy
name: Daniel Borschneck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00390013: To Evaluate if the Medication Gabapentin Lessens Vulvar Pain
Official title: Vulvar Pain: Treatment Trial Using Gabapentin-placebo in a Cross-over Design, Pilot Study.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vulvar Pain Symptoms
Vulvodynia (Chronic Vulvar Pain)
Keywords: Vulvar Pain
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2006-10-19
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to evaluate if the medication gabapentin lessens the vulvar pain some women experience.

Detailed description: There is not a "best" treatment plan for vulvar pain including vulvodynia (chronic vulvar pain) and vulvar vestibulitis syndrome (VVS, chronic vulvar pain localized to the vaginal opening). We propose that vulvodynia is a neuropathic pain (pain that effects the nervous system) as characterized by pain from stimuli that is not usually painful, stimuli that would not usually be painful causing significant pain, and burning pain. Gabapentin has been shown to be effective in treating chronic pain.

Eligibility criteria: Inclusion Criteria:

* All women, ages 18 years and older with the diagnosis of vulvodynia or VVS (by Friedrich's criteria), who present to the University of Iowa Vulvar Vaginal Disease Clinic.

Exclusion Criteria:

* Vulvar Vaginal Disease clinic patients who are pregnant, less than 3 months postpartum, breast-feeding, non-English speaking, or have contraindication to use of gabapentin due to allergy or renal disease (serum creatinine level greater than 1.4).

Primary outcomes:
measure: Change From Baseline in Vulvar Pain
timeFrame: 19 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa Hospital and Clinics, Department of Ob/Gyn
name: Colleen Kennedy Stockdale, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06637813: Establishment of a Database of HIV Subjects Initiating or Simplifying Dual Therapy With Dolutegravir/Lamivudine
Official title: Establishment of a Database of HIV Subjects Initiating or Simplifying Dual Therapy With Dolutegravir/Lamivudine
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: HIV -1 Infection
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 1220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV subjects treated with Dovato from 2015 to 2022. (retrospective cohort) or who will start treatment from clinical practice with Dovato

Brief summary: The introduction of combination antiretroviral therapy (cART) has completely revolutionized the management of HIV-positive patients, drastically reducing HIV-associated mortality and morbidity. In fact, the course of HIV infection has transformed into a chronic disease. The availability of different classes of antiretroviral drugs, such as nucleoside and non-nucleoside reverse transcriptase inhibitors (NRTIs, NNRTIs), protease inhibitors (PIs), integrase inhibitors (INSTIs) and viral entry inhibitors (IEs) that act in different phases of the HIV life cycle, together with careful patient management, has allowed us to obtain long-lasting therapeutic efficacy in the vast majority of Italian patients, making this infection a chronic disease.


Eligibility criteria: Inclusion Criteria:

* signed informed consent
* patients treated with triple therapy who simplify to 3TC+DTG
* patients treatment-naive who start a dual therapy with 3TC+DTG from clinical practice

Exclusion Criteria:

* lack of willingness to provide informed consent

Primary outcomes:
measure: Establishment of a database
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Simona Di Giambenedetto
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03680313: Cardio-ankle Vascular Index (CAVI) in Hypertension Patients After One Year of Treatment
Official title: Cardio-ankle Vascular Index (CAVI) in Hypertension Patients After One Year of Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Cardio-ankle vascular index (CAVI)
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
First posted: 2018-09-21
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The eligible patients were prospectively monitored to evaluate CAVI in hypertension treatment for every 3 months. All participants will be asked directly medical history, clinical examination and performed blood pressure measurement thoroughly. All clinical information will be retained in medical record.

Brief summary: This study aimed to evaluate the role of the cardio-ankle vascular index (CAVI) in evaluating arterial stiffness changes, the degree of atherosclerosis in patients with hypertension after 1 year of treatment and analysis the correlation between CAVI and cardiovascular risk factors.


Eligibility criteria: Inclusion Criteria:

* Patients have never been diagnosed with hypertension.
* Patients have been diagnosed with primary hypertension, but not take any treatment

Exclusion Criteria:

* Cases with non-primary hypertension or suffering from cardiovascular complications such as myocardial infarction, cerebral stroke, vascular disease, severe heart failure (EF\<1) in the time of measurement.

Primary outcomes:
measure: CAVI score in hypertension group after one year of treatment
timeFrame: 1 year
Secondary outcomes:
measure: Correlation between CAVI and smoking status
timeFrame: 1 year
measure: Correlation between CAVI and overweight status
timeFrame: 1 year
measure: Correlation between CAVI and diabetes status
timeFrame: 1 year
measure: Correlation between CAVI and dislypidemia status
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04277013: Ultrasound Assessment of Gastric Content in Fasted Pregnant Women
Official title: Ultrasound Assessment of Gastric Content in Fasted Pregnant Women : a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Ultrasound
Fasting ( 6H for Solid ; 2H for Clear Fluid )
Pregnant Women
Keywords: Anaesthesia
Obstetric
Diagnostic imaging
Stomach
Ultrasonography
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Investigator would like to perform an ultrasound assessment of gastric content to every fasted pregnant women before surgery or during ultrasound exam happening during standard pregnancy monitoring.

Brief summary: Pulmonary aspiration of gastric content is one of the most feared perioperative complication of general anesthesia. Pregnant women are usually considered as high risk of pulmonary aspiration but there is no epidemiological study evaluating gastric content in pregnant women during the entire gestation periode.

The main objective is evaluating prevalency of "full stomach" in differents stages of pregnancy in fasted pregnant women.

Detailed description: Subjects will be recruited at Montpellier University Hospital, from fasted pregnant women before surgery or from ultrasound exam performed during pregnancy.

Eligibility criteria: Inclusion criteria

An subject must fulfill all of the following criteria in order to be eligible for study enrollment:

* Aged at least 18 years old
* Pregnant women
* Fasted ( at least 6h for solid , 2h for clear fluid )

Exclusion criteria

* Previous Bariatric surgery / upper gastro-intestinal surgery
* Adult under protection

Primary outcomes:
measure: Qualitative assessment of gastric content
timeFrame: 1 day
Secondary outcomes:
measure: Quantitative assessment of gastric content
timeFrame: 1 day
measure: Feasibility evaluation of gastric ultrasound
timeFrame: pregnancy
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Christophe DADURE, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00898313: Molecular Predictors of Cancer in Patients at High Risk of Lung Cancer
Official title: Molecular Predictors of Lung Cancer Behavior
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Keywords: lung cancer
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People who may have lung cancer.

Brief summary: RATIONALE: Using samples of blood, urine, sputum, and lung tissue from patients at high risk of cancer for laboratory studies may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at molecular predictors of cancer in patients at high risk of lung cancer.

Detailed description: OBJECTIVES:

* To use fixed lung tissue for histological evaluation and fresh tissue samples for molecular studies to study DNA, RNA, and protein abnormalities in lung preneoplastic and neoplastic lesions.
* To use proteomic techniques, including matrix-assisted laser desorption ionization-mass spectrometry (MALDI-MS), to develop a method of diagnosing and staging both pre-invasive and invasive lesions, using less invasive methods.

OUTLINE: Blood, urine, nasal cell, and sputum samples are collected. Lung tissue samples are also collected using fluorescence bronchoscopy and epithelial cell collection.

Samples are studied by genetic and proteomic analyses, including comparative genomic hybridization, expression microarray, and protein profiling.

Eligibility criteria: Inclusion Criteria:

-All adults referred to Vanderbilt Medical Center, Veterans Administration Medical Center, St. Thomas Hospital and Meharry Medical Center for evaluation of signs or symptoms of lung cancer.

Exclusion Criteria:

* Inability to provide informed consent
* Minors
* Pregnant women

Primary outcomes:
measure: To quantitate the molecular changes during lung cancer development
timeFrame: After collection of designated samples
Secondary outcomes:
measure: Develop a method to diagnose and stage pre-invasive and invasive lesions
timeFrame: After collection of designated samples
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Veterans Affairs Medical Center - Nashville
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Fabien Maldonado, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03134313: Accuracy of Noninvasive Rainbow Adhesive R1 Pulse Oximeter Sensor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the concentration of hemoglobin will be measured using a noninvasive pulse oximeter sensor and compared with the hemoglobin value from a blood sample of the volunteer. The accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.


Eligibility criteria: Inclusion Criteria:

* Greater than 18 years old
* Healthy

Exclusion criteria:

* Do not understand the study and the risks involved
* Deemed ineligible by study test personnel

Primary outcomes:
measure: Accuracy of SpHb on R1-25 by Arms Calculation
timeFrame: 1-5 hours per subject
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Clinical Lab
state: California
Study officials:
References:
Clinical trial NCT01055613: Investigational Multi-purpose Contact Lens Care Solution.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contact Lens Wear
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-25
Enrollment: 312
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: This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.


Eligibility criteria: Inclusion Criteria:

* must be an adapted contact lens wearer
* best corrected distance visual acuity must be 20/25 or better in each eye
* must be wearing their habitual lenses on a daily wear basis
* must be willing to refrain from swimming during the study

Exclusion Criteria:

* any systemic diseases that may interfere with contact lens wear
* any clinically significant ocular disease
* any ocular infection
* use of certain medications
* any grade 2 or greater slit lamp findings
* any know sensitivity to marketed contact lens care solutions
* currently pregnant or lactating
* monovision corrected

Primary outcomes:
measure: Slit Lamp Findings
timeFrame: 3 months
measure: Distance Visual Acuity (LogMAR)
timeFrame: Up to 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Fresno
country: United States
state: California
city: Pismo Beach
country: United States
state: California
city: Louisville
country: United States
state: Colorado
city: Bloomfield
country: United States
state: Connecticut
city: Jacksonville
country: United States
state: Florida
city: Overland Park
country: United States
state: Kansas
city: East Lansing
country: United States
state: Michigan
city: Warrensburg
country: United States
state: Missouri
city: Grove City
country: United States
state: Ohio
city: Grants Pass
country: United States
state: Oregon
city: Kingston
country: United States
state: Pennsylvania
city: Sioux Falls
country: United States
state: South Dakota
city: Memphis
country: United States
state: Tennessee
city: Salt Lake City
country: United States
state: Utah
city: Laramie
country: United States
state: Wyoming
Study officials:
References:
Clinical trial NCT05864313: Gaze and Gait Training With rTMS
Official title: Gaze and Gait Training With Neuromodulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the feasibility of combining repetitive transcranial magnetic stimulation (rTMS), gaze and gait training to improve walking and balance in people with or without mild cognitive impairment.

Detailed description: The study plan is to recruit a total of 15 cognitively impaired and 15 healthy adults. The study will involve two visits. Each study visit will involve:

* Real rTMS or sham rTMS that last about 60 minutes
* Gaze stabilization exercise via a virtual reality headset for about 1-hour
* Target stepping on a treadmill for about 1-hour

Researchers will compare changes in gaze and gait following training sessions with real rTMS and sham rTMS.

Eligibility criteria: Inclusion Criteria:

* Age 18 - 80 years
* Capable of providing informed consent and complying to the experimental procedures

Exclusion Criteria:

* Significant gait difficulty requiring ambulatory aids
* Presence of implanted device such as a neurostimulator, cochlear implant or pacemaker
* History of epilepsy
* History of hearing issues

Primary outcomes:
measure: Change in Foot Placement Error from baseline 1
timeFrame: Beginning and end of Visit 1, an average of 8 hours
measure: Change in VOR Gain from baseline 1
timeFrame: Beginning and end of Visit 1, an average of 8 hours
measure: Change in Foot Placement Error from baseline 2
timeFrame: Beginning and end of Visit 2, an average of 8 hours
measure: Change in VOR Gain from baseline 2
timeFrame: Beginning and end of Visit 2, an average of 8 hours
Secondary outcomes:
measure: Change in Timed Up and Go (TUG) from baseline 1
timeFrame: Beginning and end of Visit 1, an average of 8 hours
measure: Change in Timed Up and Go (TUG) from baseline 2
timeFrame: Beginning and end of Visit 2, an average of 8 hours
Other outcomes:
Locations:
Study officials:
affiliation: University of Florida
name: Julia Choi, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05556213: The Relation Between MiR-125b-5p and Staging of Endometriosis
Official title: Estimation of Plasma Levels of MicroRNA 125b-5p and Transvaginal Ultrasonography May Spare Laparoscopy for Staging of Endometriosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 89
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 78 endometriosis patients presented with infertility were clinically examined and the diagnosis was assured by US imaging. The study also included 11 control fertile women free of gynecological problems as a control for lab tests. Patients and controls gave blood samples for lab investigations. All patients underwent diagnostic abdominal laparoscopy under general anesthesia for disease staging. Quantitative determination of expression levels of genes of microRNA-125b-5p and 203a was conducted using qRT-PCR.


Eligibility criteria: Inclusion Criteria:

* Patients who presented clinical pictures suggestive of EM disease

Exclusion Criteria:

* Patients with previous pelvic or abdominal surgery that may hinder the laparoscopic examination,
* patients who were suspicious of having malignancy elsewhere in the body region,
* pregnant women,
* patients who had diabetes mellitus,
* body mass index (BMI) of \>30 kg/m2, coagulopathies, and autoimmune disorders.

Primary outcomes:
measure: Validity of Plasma expression level
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta university
state: El-Gharbyia
Study officials:
References: