louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03097614: Dry Eye Symptom Relief Assessment With Use of TrueTear in a Controlled Adverse Environment
Official title: Prospective, Single-Arm Clinical Trial to Evaluate Acute Dry Eye Symptom Relief Assessed During Exposure to a Controlled Adverse Environment (CAE®) Following a 45 Day Period With Application of TrueTear™
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Dry Eye Syndromes
Lead sponsor: Oculeve, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-31
Enrollment: 57
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study characterizes acute dry eye symptom control, assessed during exposure to a Controlled Adverse Environment, following use of the TrueTear for 45 days.

Detailed description: Subjects will be instructed to use the TrueTear daily for approximately 45 days with assessments in the Controlled Adverse Environment taking place on Day 0 and Day 45. Upon entering the CAE, participants will complete dry eye symptom questionnaires every five minutes and will administer the device when a certain level of ocular discomfort has been reached.

Eligibility criteria: Inclusion Criteria:

* Have used and/or desired to use an artificial tear substitute for dry eye symptoms within 6 months prior to the Screening Visit
* Normal lid/lash anatomy, blinking function and closure as determined by the Investigator
* Literate, able to speak English, and able to complete questionnaires independently

Exclusion Criteria:

* Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the opinion of the Investigator, may lead to risk of clinically significant increased bleeding
* Nasal or sinus surgery (including history of application of nasal cautery) or significant trauma to these areas
* Contact lens use within 7 days prior to the Screening Visit or anticipate the use of contact lenses at any time during the study
* Corneal transplant in either or both eyes
* Cardiac demand pacemaker, implanted defibrillator, or other active implanted metallic or active implanted electronic device in the head
* A woman who is pregnant, nursing an infant, or planning a pregnancy during the duration of the study
* Currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to the Screening Visit

Primary outcomes:
measure: Eye Dryness Score
timeFrame: Day 45
Secondary outcomes:
Other outcomes:
Locations:
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
affiliation: Andover Eye Associates
name: Gail Torkildsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01039714: Vitamin D Levels and Postoperative Hypocalcemia After Total Thyroidectomy
Official title: Preoperative Vitamin D Levels as a Prognostic Factor for Postoperative Hypocalcemia and Hypoparathyroidism After Total Thyroidectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypocalcemia
Hypoparathyroidism
Vitamin D Deficiency
Thyroidectomy
Keywords: Hypocalcemia
Hypoparathyroidism
Vitamin D deficiency
Total thyroidectomy
calcium
PTH
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2009-12-25
Enrollment: 200
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: Patients subjected to total thyroidectomy in Third Surgical Clinic of AHEPA University Hospital

Brief summary: Hypocalcemia is one of the most frequent complications of total thyroidectomy, a procedure used for benign as well as malignant conditions of the thyroid gland. Postoperative hypocalcemia is usually caused by hypoparathyroidism. Vitamin D is implicated in calcium metabolism as it increases intestinal calcium transport and regulates parathormone production. Aim of the present study is to evaluate preoperative vitamin D levels as a prognostic factor for postoperative hypocalcemia and hypoparathyroidism.


Eligibility criteria: Inclusion Criteria:

1. Patient is over 18 years old
2. Patient scheduled for total thyroidectomy
3. Patient signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures

Exclusion Criteria:

1. Primary hyperparathyroidism
2. Primary hypoparathyroidism
3. Chronic Renal Failure
4. Hypoalbuminemia
5. Neck irradiation
6. Systematic Diseases (e.g., infections)
7. Thyroid or parathyroid cancer
8. Osteoporosis
9. Drugs that influence calcium metabolism (vitamin D analogues, oral calcium supplements, biphosphonates, teriparatide, thiazide diuretics)

Primary outcomes:
measure: Impact of preoperative vitamin D levels on postoperative hypocalcemia after total thyroidectomy.
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Impact of preoperative vitamin D levels on parathyroid function after total thyroidectomy.
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: AHEPA University Hospital Thessaloniki, Greece
state: Makedonia
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Spyros T Papavramidis, Prof
role: STUDY_DIRECTOR
References:
citation: Erbil Y, Barbaros U, Temel B, Turkoglu U, Issever H, Bozbora A, Ozarmagan S, Tezelman S. The impact of age, vitamin D(3) level, and incidental parathyroidectomy on postoperative hypocalcemia after total or near total thyroidectomy. Am J Surg. 2009 Apr;197(4):439-46. doi: 10.1016/j.amjsurg.2008.01.032.
Clinical trial NCT04415814: Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases
Official title: Unilateral Versus Bilateral Pedicle Screw Fixation for Lumbar Degenerative Diseases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fusion of Spine
Keywords: degenerative spine
unilateral fixation of the spine
fusion of the lumbar spine
posterior stabilization
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Determining the treatment strategy for patients with degenerative diseases of the spine is extremely difficult, without an accurate understanding of the nature of stress distribution in the vertebral-motor segments of the spine, as well as biomechanical changes that are associated with degenerative diseases of the spine. In this clinical study, we want to compare the use of unilateral and bilateral transpedicular fixation for treating the patients with degenerative diseases of the lumbar spine.

Detailed description: It is planned to use posterior stabilization without interbody fusion. In the postoperative period, all the patients receive antibacterial and analgesic therapy. The early postoperative period is spent in a hospital. Repeated appearances for control examinations (3, 6, 12 months) are provided for physical examination (EQ-5D, Oswestry Disability Index) and performing radiographs or computed tomography (CT) of the spine. All patients undergo a standard rehabilitation course.

Eligibility criteria: Inclusion Criteria:

* Written informed consent of the patient to participate in the study;
* Patients with degenerative diseases of the lumbar spine.
* The opportunity for observation during the entire study period (12 months);
* Mental adequacy, ability, willingness to cooperate and follow the doctor's recommendations.

Exclusion Criteria:

* The refusal of a patient from surgery
* The presence of contraindications to surgery
* Severe forms of diabetes (glycosylated hemoglobin \>9%);
* Blood diseases (thrombopenia, thrombocytopenia, anemia with Hb\< 90g\\l);
* The unwillingness of the patient to conscious cooperation.

Primary outcomes:
measure: fusion rate of the operated spine segment
timeFrame: in 3 months after surgery
measure: fusion rate of the operated spine segment
timeFrame: in 6 months after surgery
measure: fusion rate of the operated spine segment
timeFrame: in 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sechenov University
Study officials:
affiliation: IM Sechenov University
name: Alexey Lychagin, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06935214: The Repeatability of the Effect of Caffeine Supplementation on Submaximal Physiological Responses and Cycling Time Trial Performance
Official title: The Repeatability of the Effect of Caffeine Supplementation on Submaximal Physiological Responses and Cycling Time Trial Performance
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caffeine
Keywords: caffeine
genetics
cycling
time trial
Lead sponsor: St. Mary's University, Twickenham
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Recently, Grgic (2018) discussed the concept of responders and non-responders to caffeine supplementation highlighting the importance of the repeatability of results. However, the number of studies that have investigated this idea by repeating the same time-trial performance test multiple times with the same caffeine dose is sparse (Astorino et al., 2012; Del Coso et al., 2019). Furthermore, studies have shown that differences in the CYP1A2 genotype may account for some of the variation in time-trial performance (Guest et al., 2018). Thus, the current study aims to identify whether the effects of moderate caffeine supplementation (5 mg/kg) on time-trial performance are repeatable to aid the identification of responders and non-responders. Additionally, the study aims to determine if the CYP1A2 genotype may explain any of the variability in time-trial performance in trained male cyclists.


Eligibility criteria: Inclusion Criteria:

* To be considered for inclusion in the study, participants must be regular cyclists, between 18 and 35 years of age, capable of completing a 20 km cycling time trial at a minimum speed of 30 km/h (arbitrary inclusion criteria to ensure a sufficient standard of athlete).

Exclusion Criteria:

-

Primary outcomes:
measure: Blood lactate concentration
timeFrame: From baseline to completion, up to 31 days
measure: Heart rate
timeFrame: From baseline to completion, up to 31 days
measure: Oxygen uptake
timeFrame: From baseline to completion, up to 31 days
measure: Perceived exertion
timeFrame: From baseline to completion, up to 31 days
measure: Time trial completion time
timeFrame: From baseline to completion, up to 31 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00808314: Lexiscan(TM) Rb-82 Myocardial Perfusion PET: A Comparison With Dipyridamole Stress
Official title: Lexiscan(TM) Rb-82 Myocardial Perfusion Positron Emission Computed Tomography: A Comparison With Dipyridamole
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Lexiscan(TM)
Dipyridamole
Myocardial Perfusion
Positron Emission Computed Tomography
Lead sponsor: Cardiovascular Imaging Technologies
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2008-12-15
Enrollment: 32
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Lexiscan(TM) has ideal properties for Rb-82 PET imaging and the stress response it invokes may offer multiple advantages for the diagnosis of coronary disease and functional abnormalities. The goal of this investigation is to establish quantitative equivalence of Lexiscan(TM) rest/stress Rb-82 PET images to dipyridamole rest/stress images.


Eligibility criteria: Inclusion Criteria:

* BMI \<35
* No intervention or change in management between dipyridamole and Lexiscan(TM) PET

Exclusion Criteria:

* BMI \>35
* An intervention or change in management between dipyridamole and Lexiscan(TM) PET

Primary outcomes:
measure: Quantitative analysis of local and regional myocardial perfusion between Lexiscan(TM) and dipyridamole rest/stress Rb82 PET
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Saint Luke's Cardiovascular Consultants
state: Missouri
Study officials:
affiliation: Cardiovascular Imaging Technologies
name: Timothy M Bateman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03353714: The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings
Official title: The Effect of Pudendal Blocks on Voiding Dysfunction Following Slings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2017-11-27
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine the effect of a bilateral pudendal block on voiding dysfunction following midurethral slings.

Detailed description: Midurethral slings (MUS) are commonly performed to treat stress urinary incontinence in women. One common complication is short-term postoperative voiding dysfunction. Approximately 20% of patients undergoing MUS have difficulty voiding in the immediate postoperative period and are discharged home with an indwelling bladder catheter. A pudendal block provides analgesia to the vulva, vagina, and perineum and is used in various fields, ranging from obstetrical indications to hemorrhoidectomies. The colorectal literature has demonstrated an improvement in postoperative voiding dysfunction with intraoperative bilateral pudendal blockade, presumably due to pain relief. However, only one study has explored the effect of a pudendal blockade on postoperative voiding in patients undergoing MUS. This was a small French case series of 9 patients, and it concluded that it was a safe procedure with good patient satisfaction. Given the scant literature evaluating voiding dysfunction following pudendal blocks in MUS, and the encouraging data from anorectal surgeries, we aim to study this effect via a randomized, placebo-controlled, double-blinded trial.

Eligibility criteria: Inclusion Criteria:

* Women undergoing a midurethral sling without concomitant procedures under general anesthesia

Exclusion Criteria:

* Unable to consent (lacking capacity)
* Under 18 years of age
* Pregnant women
* Prisoners
* Using intermittent self-catheterization preoperatively
* Neurological disease or spinal cord injury resulting in voiding dysfunction
* Allergy to bupivacaine
* Diagnosis of chronic pain syndromes
* Daily use of narcotics
* Intra-operative bladder injury necessitating use of a prolonged indwelling Foley catheter

Primary outcomes:
measure: Postoperative voiding dysfunction
timeFrame: Prior to discharge home (within 24 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Deepali Maheshwari, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: UMass Medical School
name: Michael K Flynn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maheshwari D, Sierra T, Leung K, Hall C, Flynn M. Effect of Pudendal Blockade on Bladder Emptying After Midurethral Sling: A Randomized Controlled Trial. Female Pelvic Med Reconstr Surg. 2021 Feb 1;27(2):e465-e468. doi: 10.1097/SPV.0000000000000963.
Clinical trial NCT00593814: GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms
Official title: A Clinical Evaluation of the GORE EXCLUDER® Bifurcated Endoprosthesis - Low Permeability in the Primary Treatment of Infrarenal Abdominal Aortic Aneurysms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aortic Aneurysm, Abdominal
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2008-01-15
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms.


Eligibility criteria: Inclusion Criteria:

1. Infrarenal Abdominal Aortic Aneurysms less than 4.5 cm in diameter
2. Anatomy meets EXCLUDER Bifurcated Endoprosthesis - Low Permeability specification criteria per Instructions for Use
3. Access vessel able to receive 18 French introducer sheath
4. Life expectancy \> 2 years
5. Appropriate candidate for endovascular repair
6. Ability to comply with protocol requirements including follow-up
7. 21 years of age or older, male or infertile female\*\*

Exclusion Criteria:

1. Mycotic or ruptured aneurysm
2. Participating in another investigational device or drug study within one year
3. Documented history of drug abuse within six months
4. Myocardial infarction or cerebral vascular accident within six weeks
5. Pulmonary insufficiency requiring chronic home oxygen or inability to ambulate due to pulmonary function
6. Iliac anatomy that would require occlusion of both internal iliac arteries
7. Planned occlusion or reimplantation of significant mesenteric or renal arteries
8. Planned concomitant surgical procedure or previous major surgery within 30 days
9. Previous prosthesis placement in the aorta or iliac arteries
10. Degenerative connective tissue disease (e.g., Marfan's and Ehlers Danlos Syndrome)

Primary outcomes:
measure: Number of Subjects With Aneurysm Volume Increase Greater Than 10% at 2 Years Post-procedure
timeFrame: 2 years
Secondary outcomes:
measure: Number of Subjects With Device Efficacy Events
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Mark F Fillinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03367455: Interaction of Potassium and Genetic Risk Variants on Diabetes Risk
Official title: Interaction of Potassium Measures With Potassium Channel Genetic Variants on Diabetes Risk: The Atherosclerosis Risk in Communities (ARIC) Study and Jackson Heart Study (JHS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: Potassium
Genetic Variants
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: University of Colorado, Denver
name: University of Mississippi Medical Center
First posted: 2017-12-08
Enrollment: 11812
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The ARIC study is a prospective cohort of 15,792 adults between the ages of 45 and 64 years at the baseline visit. Participants were recruited from four communities in the US-Forsyth County, North Carolina, Jackson, Mississippi, Minneapolis, Minnesota, and Washington County, Maryland. All participants attended an initial baseline visit between 1987-1989. JHS is a community-based, prospective cohort study of 5301 African-American adults, aged 21-95 years at the baseline visit, from the Jackson, Mississippi metropolitan area. Participants had baseline data collected between 2000 and 2004.

Brief summary: The investigators propose to study the association of the KCNJ11 (Potassium Voltage-Gated Channel Subfamily J Member 11) polymorphisms on diabetes risk in the Atherosclerosis Risk in Communities (ARIC) and Jackson Heart Study (JHS) cohorts. The investigators also propose to test for an interaction between serum K and these genetic variants. By testing for such an interaction, it will be determined if, among participants with these genetic variants, a low-normal serum K was a stronger predictor of diabetes risk compared to those participants without these genetic variants.


Eligibility criteria: Inclusion Criteria:

* Member of the Atherosclerosis Risk in Communities (ARIC) Study or Jackson Heart Study (JHS) cohorts

Exclusion Criteria:

* Had not fasted 8 or more hours for the baseline visit
* Prevalent diabetes at baseline exam
* Missing information on serum potassium
* Missing single nucleotide polymorphism (SNP) data
* Evidence of kidney dysfunction
* Race other than black/African American or white/Caucasian
* Missing other covariates

Primary outcomes:
measure: Associations of serum potassium and KCNJ11 variants with incident diabetes as represented by odds ratio
timeFrame: through study completion, mean of 8 years of follow-up
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duke Health
name: Ranee Chatterjee, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04953455: Translation and Verification of English Lysholm Knee Scoring Scale
Official title: Translation and Verification of English Lysholm Knee Scoring Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Evaluations, Diagnostic Self
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Through the diagnosis of MRI and clinicians, patients who are determined to be ligament rupture, patella dislocation, meniscus injury or total knee replacement surgery before and after surgery, the patient should have the ability to read or communicate with others normally, and the age range is 18-80 years old .

Brief summary: Through the translation and verification of the Lysholm Knee Score Scale, a Chinese version of the Lysholm Knee Score Scale supported by experimental data was obtained. And on this basis, explore the knee joint score scale that fits the Chinese situation

Detailed description: Lysholm Knee Scoring Scale needs to be translated and back translated into Chinese version of Lysholm Knee Scoring Scale. Through data collection and analysis, the reliability, validity and sensitivity of the Chinese version of the Lysholm Knee Score Scale were studied, and on this basis, the advantages and disadvantages of the scale were analyzed, and a new knee score scale was developed based on the domestic situation.

Eligibility criteria: Inclusion Criteria:

* Patients with ruptured ligaments, dislocation of the patella, meniscus injury or total knee replacement before and after surgery, and have the ability to read or communicate with others normally.

Exclusion Criteria:

* Patients with other injuries to the joints of the lower limbs, or patients who do not have the ability to read or communicate with others normally.

Primary outcomes:
measure: Chinese version of Lysholm Knee Score Scale
timeFrame: 1 year after operation
measure: IKDC Knee Joint Score Scale
timeFrame: 1 year after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university third hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: yingfang ao, M.D.
role: STUDY_CHAIR
References: