louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00626847: How Does Your Genetic Make-up (Profile) Influence Your Glaucoma?
Official title: Nuclear Genetic and Mitochondrial Influences in Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Open Angle Glaucoma
Keywords: primary open angle glaucoma
Nuclear Genetics
Mitochondrial DNA
POAG
Lead sponsor: Wills Eye
Sponsor class: OTHER
Collaborators: name: Jefferson Medical College of Thomas Jefferson University
name: Thomas Jefferson University
First posted: 2008-02-29
Enrollment: 97
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: glaucoma clinic

Brief summary: Glaucoma is a group of diseases in which visual loss occurs because of damage to the optic nerve. Research has shown that certain genes may cause glaucoma in some cases. So far, research has only been able to find the genes responsible for glaucoma in a small percentage of people who have glaucoma. The purpose of this project is to study the genes in patients with and without glaucoma to find additional genes that may be responsible for causing glaucoma.

Detailed description: Four tubes of blood will be taken from 100 people. Of those, half will have primary open angle glaucoma (POAG) and the other half will be controls (normals), half will be caucasians and the other half will be african americans, half male and half female. All groups will have a routine ophthalmic eye exam, color vision, snellen vision, and visual field done.

Eligibility criteria: Inclusion Criteria:

* 40 yrs
* Caucasian or African American
* Male or female with POAG, PACG, PXFG,
* Normal

Exclusion Criteria:

* Other ophthamic co-morbidities
* Other ethnic groups
* Unable to understand and give informed consent

Primary outcomes:
measure: The investigators will quantify the spectrum of changes in mitochondrial respiration, relative mitochondrial DNA content, and oxidative stress associated with different types of glaucoma.
timeFrame: one blood draw
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Wills Eye Glaucoma Service
state: Pennsylvania
Study officials:
affiliation: Wills Eye Institute
name: George L Spaeth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abu-Amero KK, Azad TA, Spaeth GL, Myers J, Katz LJ, Moster M, Bosley TM. Unaltered myocilin expression in the blood of primary open angle glaucoma patients. Mol Vis. 2012;18:1004-9. Epub 2012 Apr 21.
citation: Abu-Amero KK, Azad TA, Spaeth GL, Myers J, Katz LJ, Moster M, Bosley TM. Absence of altered expression of optineurin in primary open angle glaucoma patients. Mol Vis. 2012;18:1421-7. Epub 2012 Jun 1.
Clinical trial NCT00442247: A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse
Official title: A Randomised, Controlled Study of Bimesh, Pelvicol for Vaginal Wall Prolapse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Prolapse
Keywords: anterior vaginal wall prolapse, Pelvicol, biomesh
Anterior vaginal wall prolapse
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2007-03-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Anterior vaginal wall prolapse is a common problem. Until now many different surgical techniques have been evaluated but so far recurrence is often still observed. Therefore, synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced.

Detailed description: Anterior vaginal wall prolapse is a common problem. Until now many different surgical techniques have been evaluated but so far recurrence is often still observed. Therefore, synthetic mesh or biomesh for vaginal prolapse reconstruction have been introduced. However, is is now known whether these methods are superior to the replication of the pubocervicale fascia, a method which is well described and have been used for many years. Furthermore, most studies evaluating the used of mesh for anterior vaginal wall prolapse have not been controlled studies and been irrespective to whether the repair was a primary or secondary operation.

Eligibility criteria: Inclusion Criteria:

* Anterior vaginal wall prolapse greater than grade 2 ICS qualifications, International Continence Society Committee for Standardisation of Terminology

Exclusion Criteria:

* Recurrent vaginal prolapse, wault prolapse

Primary outcomes:
measure: Difference in POP-Q measurements for vaginal prolapse
Secondary outcomes:
measure: Affect on bladder function after surgery for anterior vaginal wall prolapse
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Dept. of Obstetrics and Gynecology
Study officials:
affiliation: Roskilde County Hospital, Dept. of Obstetrics and Gynecology, Roskilde University Hospital, Denmark
name: Ulla Hviid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04967547: Effect of Pre-emptive Assessment of Self-care Peritoneal Dialysis (PD) Ability on PD Choice in Patients With Stage 5 Chronic Kidney Disease
Official title: Effect of Pre-emptive Assessment of Self-care Peritoneal Dialysis (PD) Ability on PD Choice in Patients With Stage 5 Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease (CKD) Stage 5
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2021-07-19
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Peritoneal dialysis is an effective renal replacement therapy with higher quality of life and lower treatment cost than hemodialysis.However, the application rate of peritoneal dialysis is much lower than that of hemodialysis. One of the reasons is that patients need to complete fluid changing operation independently, which is especially challenging for elderly and frail patients. Assisted peritoneal dialysis can help patients with independent dialysis disorders to complete dialysis. Currently, there is a lack of standard tools to assess patients' ability to conduct independent dialysis and to determine whether assisted dialysis is needed. Moreover, routine assessment is arranged after the training of dialysis operation, which leads to some patients giving up the procedure at an early stage, resulting in a low selection rate of the procedure.The purpose of this study was to investigate the effect of using a standard scale to evaluate the ability to perform abdominal dialysis in patients with stage 5 chronic kidney disease (CKD) before deciding on dialysis modality.


Eligibility criteria: Inclusion Criteria:

1. Age \>=18 years old;
2. Need dialysis within 6 months;
3. Informed consent.

Exclusion Criteria:

1. Absolute PD contraindications;
2. Need urgent dialysis;
3. RTX as initial renal replacement therapy.

Primary outcomes:
measure: The rate of PD choice
timeFrame: up to 90 days
Secondary outcomes:
measure: The aPD utilization rate
timeFrame: up to 180 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
Study officials:
affiliation: RenJi Hospital
name: Wei Fang, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02384447: Comparing the Ultrasound Appearance of the Sciatic Nerve With Its Appearance Under a Microscope
Official title: Correlation of the Ultrasound Appearance of the Sciatic Nerve With Its Histologic Appearance in Pathology Specimens Obtained From Patients Undergoing Above Knee Amputation
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes
Keywords: above knee amputation
sciatic nerve
ultrasonography
histology
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2015-03-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects suffering from long standing diabetes and scheduled to undergo an above knee amputation

Brief summary: The investigators are proposing to conduct this study to compare the ultrasonographic appearance of the sciatic nerve with their corresponding histologic architecture. Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes will be enrolled. We intend to do an ultrasound examination of the sciatic nerve at its bifurcation (about 4 inches above the knee). The investigators would mark the area on the skin where the image is obtained. Following surgery we will conduct a histologic examination of the nerve at the same site.

Ultrasound examination is not standard of care, but is a fairly noninvasive procedure and does not add any risk to the subject. Histologic examination of the nerve is also not standard of care, but is conducted on a pathology specimen


Eligibility criteria: Inclusion Criteria:

* Diabetes
* Patients that are scheduled to undergo above knee amputation due to complications associated with diabetes

Exclusion Criteria:

* Minors

Primary outcomes:
measure: ultrasonographic appearance
timeFrame: at examination before surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo, Health Science Campus
state: Ohio
Study officials:
affiliation: University of Toledo
name: Shashi B Bhatt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05760547: The Translational Initiative to Map Epigenetics in Aging (TIME-A)
Official title: The Translational Initiative to Map Epigenetics in Aging (TIME-A)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Biological Aging
Lead sponsor: Elysium Health
Sponsor class: INDUSTRY
First posted: 2023-03-08
Enrollment: 25000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults 18 or older

Brief summary: The Translational Initiative to Map Epigenetics in Aging (TIME-A) study aims to advance our understanding of the connections between epigenetics, lifestyle, demographics, and health and aging.

Detailed description: TIME-A is a longitudinal research initiative. Anyone who has ever taken an Index test registered through Elysium Health is eligible to participate. Participation involves answering questions that will be administered via a survey format. Research participants' survey responses will be combined with their epigenetic Index data with the primary aim of identifying the contributions of 1) environmental and lifestyle factors, 2) general health, and 3) medical history, on biological age. Exploratory aims include the development of epigenetic signatures that are predictive of health status, and exploring the relationship between epigenetically-derived health phenotypes and biological age. These findings will lay the foundation for personalized health recommendations using Index (including, but not limited to: workout routines, diets, supplement regimens, medications, lifestyle changes).

Eligibility criteria: Inclusion Criteria:

* All adults aged 18 and above
* Have registered at least one Index kit via the Elysium Health website
* Able and willing to provide digital consent to the Research Consent Form, and the TIME-A Research Subject Consent Form

Exclusion Criteria:

* Consent to participate not given

Primary outcomes:
measure: Effect of environmental and lifestyle factors on biological age
timeFrame: At baseline and throughout study (approximately every 6 months up to 120 months)
measure: Effect of general health on biological age
timeFrame: At baseline and throughout study (approximately every 6 months up to 120 months)
measure: Effect of medical history on biological age
timeFrame: At baseline and throughout study (approximately every 6 months up to 120 months)
Secondary outcomes:
Other outcomes:
measure: Develop epigenetic signatures that are predictive of health status
timeFrame: At baseline and throughout study (approximately every 6 months up to 120 months)
Locations:
Study officials:
affiliation: Elysium Health
name: Dayle Sampson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Elysium Health
name: Holly Holmes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04220047: Effects of Left Atrial Appendage Resection and Marshall Ligament Amputation on Clinical Outcome in Patients Undergoing Off-pump Coronary Artery Bypass
Official title: Fuwai Hospital, Chinese Academy of Medical Science
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Stroke
Atrial Fibrillation
Keywords: off-pump coronary artery bypass
postoperative new-onset atrial fibrillation
left atrial appendage
Marshall ligament
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
First posted: 2020-01-07
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Surgical occlusion of the left atrial appendage (LAAO) is sometimes performed during the cardiac surgery to reduce long-term risk of stroke.A previous study found that LAAO may be associated with increased risk of postoperative atrial fibrillation.New-onset atrial fibrillation (NOAF) after coronary artery bypass graft is related to an increased short-term and long term risk of stroke and mortality.Marshall ligament amputation may reduce the occurence of atrial fibrillation. However, little is known whether this approach is justified during the coronary artery bypass graft.Therefore, this study aimed to investigate whether LAAO and Marshall ligament amputation during off-pump coronary artery bypass was associated with reduced risks of postoperative new-onset atrial fibrillation and stroke.


Eligibility criteria: Inclusion Criteria:

* isolated first off-pump coronary artery bypass

Exclusion Criteria:

* Preoperative atrial fibrillation or a history of atrial fibrillation;
* Concurrent cardiac or non-cardiac surgery
* Intraoperative convert to bypass bypass surgery
* Emergency surgery
* History of previous cardiac surgery
* Severe organ dysfunction

Primary outcomes:
measure: postoperative new-onset atrial fibrillation
timeFrame: 7 days
Secondary outcomes:
measure: stroke
timeFrame: 1 months,3 months, 1years, 3years, 5years.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Hansong Sun, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03402347: Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage
Official title: Ex Vivo Evaluation of Laser Induced Thermal Tissue Damage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Bypass Surgery
Keywords: Ex vivo
Gastric bypass
Lead sponsor: RSP Systems A/S
Sponsor class: INDUSTRY
First posted: 2018-01-18
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Excess skin from corrective surgery will be evaluated ex vivo.
Primary purpose: BASIC_SCIENCE

Brief summary: This clinical study has been initiated to assess the effect of laser exposure on human skin and determine the threshold for tissue damage. The tissue specific effects will be evaluated through histological evaluation. Excess skin from corrective surgery (gastric bypass or similar) will be donated for this study. Skin samples will be subjected to titrating laser treatment with varying laser intensity and exposure time.

Detailed description: The dosimetry of laser induced hyperthermia and threshold for tissue damage will be evaluated. A dose escalation study will be performed by varying irradiance (mW) and time (minutes). Surface temperature will be monitored concurrently. Acute lesions occurring within 5 minutes of irradiation will be assessed and histological damage will be observed microscopically in slice sections of punch biopsies and qualitative assessed. Irradiation regimes above the anticipated threshold will be employed to properly titrate the irradiation necessary to elicit a thermal damage response.

Eligibility criteria: Inclusion Criteria:

* Male and female subject 18 years of age or older
* Gastric bypass operated or similar
* Excess abdominal skin to be removed surgically
* Abdominal skin tone 4 or below

Exclusion Criteria:

* Extensive skin changes, tattoos or diseases on skin explant to be donated
* Medical history or any condition that may in investigator's opinion compromise the subject's ability to participate.

Primary outcomes:
measure: Thermal damage threshold
timeFrame: Within 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of plastic surgery Z OUH
Study officials:
affiliation: Department of plastic surgery Z OUH
name: Jens Ahm Sørensen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05180877: Asthma During Pregnancy; Impact of Severity
Official title: Asthma During Pregnancy; Impact of Asthma Severity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bronchial Asthma
Keywords: Bronchial asthma
Asthma
pregnancy
Asthma severity
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 137
Sex: FEMALE
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: Pregnant asthmatic female patients presenting in first trimester to inpatient or outpatients clinic of chest department.

Brief summary: bronchial asthma (BA) may affect pregnancy and this affection may increase with increasing asthma severity. This study was designed to detect the effect of asthma severity on the course of asthma during pregnancy and its effect on the pregnancy and perinatal outcome

Detailed description: This was prospective study conducted in sohag university hospital ( obstetric outpatient clinic, chest outpatient clinic and emergency department ).This study aimed to detect the effect of baseline asthma severity on the course of asthma during pregnancy and its effect on the pregnancy and perinatal outcome in the setting of advancements in the management and pharmacotherapy of asthma compared with that previously

Eligibility criteria: Inclusion Criteria:

* pregnant women in ages 18y or more with confirmed diagnosis of bronchial asthma presenting in1st trimester to inpatient or outpatients clinic of chest department.

Exclusion Criteria:

* Patients with Chest diseases other than bronchial asthma and patients with cardiac disease.

Primary outcomes:
measure: maternal complications
timeFrame: from the start of inclusion to the study till termination of pregnancy, average 9 months period
measure: perinatal complications
timeFrame: from the start of inclusion to the study till termination of pregnancy, average 9 months period
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
citation: Dharmage SC, Perret JL, Custovic A. Epidemiology of Asthma in Children and Adults. Front Pediatr. 2019 Jun 18;7:246. doi: 10.3389/fped.2019.00246. eCollection 2019.
citation: Robijn AL, Murphy VE, Gibson PG. Recent developments in asthma in pregnancy. Curr Opin Pulm Med. 2019 Jan;25(1):11-17. doi: 10.1097/MCP.0000000000000538.
citation: National Asthma Education and Prevention Program. Expert Panel Report 3 (EPR-3): Guidelines for the Diagnosis and Management of Asthma-Summary Report 2007. J Allergy Clin Immunol. 2007 Nov;120(5 Suppl):S94-138. doi: 10.1016/j.jaci.2007.09.043.
Clinical trial NCT01412177: OTO-104 for the Treatment of Meniere's Disease
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2b Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meniere's Disease
Keywords: Meniere's Disease
Vertigo
Definitive vertigo
Vertigo episodes
Vertigo frequency
Tinnitus
Hearing loss
Aural fullness
Lead sponsor: Otonomy, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-09
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.


Eligibility criteria: Inclusion Criteria:

* Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
* Subject has experienced active vertigo during the lead-in period.
* Subject has documented asymmetric sensorineural hearing loss.
* Subject agrees to maintain their current treatments for Meniere's disease while on-study.
* Subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the study.

Exclusion Criteria:

* Subject is pregnant or lactating.
* Subject has a history of immunodeficiency disease.
* Subject has a history of previous endolymphatic sac surgery.
* Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
* Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
* Subject has experienced an adverse reaction to IT injection of steroids.
* Subject has used an investigational drug or device in the 3 months prior to screening.
* Subject has previously been randomized to a trial of OTO-104.

Primary outcomes:
measure: Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease
timeFrame: 4 months
Secondary outcomes:
measure: Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability
timeFrame: 4 months
measure: Evaluation of tinnitus patient reported questionnaire and daily diary as a measure of impact of tinnitus on activities of daily living
timeFrame: 4 months
measure: Evaluation of patient reported questionnaires as a measure of impact on patient daily activities
timeFrame: 4 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Many sites in US and Canada. Refer to the contact info listed below.
state: California
city: Cincinnati
country: United States
facility: UC Health Otolaryngology - Head and Neck Surgery
state: Ohio
Study officials:
affiliation: Otonomy, Inc.
name: Carl LeBel, PhD
role: STUDY_CHAIR
References: