louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03082118: Vesair Continued Access Trial
Official title: Vesair Continued Access Trial: Use of the Vesair® Bladder Control System in the Treatment of Post-Menopausal Female Subjects With Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Urinary Incontinence
Lead sponsor: Solace Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-03-17
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All women enrolled are treated.
Primary purpose: TREATMENT

Brief summary: Single arm study of the Vesair Balloon in postmenopausal women.

Detailed description: All women enrolled will be treated with the vesair balloon and followed for a maximum of 3 years, with balloon replacement annually.

Eligibility criteria: Inclusion Criteria:

* Post-menopausal women with SUI or stress predominant mixed incontinence
* Maximum score on IQOL of 60
* Positive cough test for leakage
* Willing to undergo procedures
* Free from infection
* Have previously tried (and failed) noninvasive treatment for SUI

Exclusion Criteria:

* SUI due to SUI
* Urge-predominant mixed incontinence
* Incontinence of neurogenic etiology
* 2 or more UTIs in past year and 1 in past 3 months
* Surgery for SUI in the past 6 months
* taking medication that can be used to treat SUI
* taking medication that affects urinary symptoms for less than 3 months
* undergoing biofeedback
* Grade 3 or worse cystocele
* last menstrual period within 12 months
* oral progesterone or estrogen in the past 12 months
* BMI \> 40
* involuntary detrusor contractions or discomfort during bladder filling
* previous stage III or worse cancer
* previous cancer of the urinary tract
* previous symptoms for early stage cancer in the past 2 years
* anticoagulation therapy other than aspirin
* history of prosthetic heart valve
* neurological or connective tissue condition or disease affecting bladder function
* known allergy to device components

Primary outcomes:
measure: Improvement on patient-reported outcomes
timeFrame: 3-12 months
Secondary outcomes:
measure: Reduction in leakage events
timeFrame: 3-12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Kaiser Permanente Urology
state: California
city: San Diego
country: United States
facility: Kaiser Permanente Urogynecology
state: California
city: Atlanta
country: United States
facility: Georgia Center for Women
state: Georgia
city: Shreveport
country: United States
facility: Regional Urology
state: Louisiana
city: Allentown
country: United States
facility: Institute for Female Pelvic Medicine and Reconstructive Surgery
state: Pennsylvania
city: Media
country: United States
facility: Riddle Hospital, Main Line Health
state: Pennsylvania
city: Pittsburgh
country: United States
facility: West Penn Hospital, Allegheny Health Network
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04456218: Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract
Official title: Clinical Evaluation of a Custom-made and Disposable Endoscope System for Biliary Tract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Biliary Tract
Neoplasms
Stone - Biliary
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: A disposable endoscopy system (NCKU-scope-01) was developed for the evaluation of bile duct stone or neoplasm. This system consists of a camera, light sources, a working channel, and a water injection channel. The endoscope could be inserted into the common bile duct via the working channel of a commercial duodenoscope. This study aims to test the feasibility and safety of this system. The efficacy of stone and neoplasm diagnosis will also be analyzed.


Eligibility criteria: Inclusion Criteria:

* Patients with complicated bile duct stone (stone size \> 1.5 cm or number of stone \> 3 )
* Patients with indeterminate biliary stricture or obstruction

Exclusion Criteria:

* Pregnant woman;
* Patients who are not suitable for ERCP (e.g. behavior disorder, major cognitive-perceptual deficit, etc.).

Primary outcomes:
measure: A complete common bile duct accessing rate
timeFrame: 1 day
measure: Image quality evaluation: the light brightness and the imaging sharpness in Likert scale
timeFrame: 1 day
Secondary outcomes:
measure: Number of complications (ablation, bleeding, perforation in percentage) or system malfunction
timeFrame: 1 day
measure: In biliary stone arm: The biggest residual stone size (in cm).
timeFrame: 1 day
measure: In biliary stricture arm: Number of the lesions with or without presenting of the specific features for DDx of the benign or malignant stricture
timeFrame: 1 day
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References:
Clinical trial NCT01693718: A Multicenter Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer
Official title: A Multicenter Phase II Study of Intensive Concomitant Chemoradiotherapy With Filgrastim (GCSF) for Patients With Locoregionally Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Head and Neck
Keywords: cancer
advanced
oral cavity
larynx
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 44
Sex: ALL
Minimum age (years): 59
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of the study is to test a particular combination of drugs and determine their ability to completely eliminate head and neck cancer.


Eligibility criteria: Eligibility Criteria:

1. Patients with Stage IV carcinoma of the nasal or oral cavity, nasopharynx pharynx, larynx, paranasal sinuses, cervical esophagus, or hypopharynx are eligible. Patients with Stage III carcinoma of the nasopharynx, base of tongue and hypopharynx are also eligible. Therapy is given with curative intent.

   Prior to entry in the study the resectability and standard treatment options for each patient will be determined during a joint evaluation by a team composed of an attending surgeon, a radiation oncologist and a medical oncologist. In addition the timing and feasibility of surgery will be determined in each patient prior to initiation of therapy. The unequivocal demonstration of distant metastasis confers in eligibility.
2. Measurable disease is not required, but all disease will be carefully evaluated.
3. Patients must have a histologically or cytologically confirmed diagnosis of squamous cell carcinoma or lymphoepithelioma.
4. Patients must have not received prior chemotherapy or radiotherapy.
5. Patients must have performance status of \>60%
6. Patients must have a WBC count of \>3.5, an ANC count \>1500 and a platlet count of \>100,000.
7. The serum creatinine must be equal to or less than 1.5 m/dlor the calculated creatinine clearance must exceed 50cc/min.
8. Patient must be free of significant infection or other severe complicating medical illness.
9. Pregnancy will constitute an absolute contraindication to entrance on this protocol. Females of child-bearing age should be using adequate contraception.

Primary outcomes:
measure: Response Rates
timeFrame: 2-5 years
Secondary outcomes:
measure: Feasibility of administering adjuvant CRA and interferon alfa2a
timeFrame: 2-5 years
measure: Side effects of study regimen
timeFrame: 2-5 years
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
affiliation: The University of Chicago Medical Center
name: Everett Vokes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01167218: Study to Assess Platelet Dysfunction With Verify Now Assay
Official title: "In-vitro Characterization of Platelet Dysfunction in Common Hematological Disorders Using the Verify Now Assay"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Platelet Aggregation Defects
Keywords: verify now assay for hematological disorders
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2010-07-22
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with platelet defects

Brief summary: The purpose of this study is to conduct a Verify now assay to detect platelet aggregation defects in patients with Myelodysplastic syndrome(MDS), immune thrombocytopenia purpura (ITP) and myeloproliferative disorders (MPD).

Detailed description: Verify Now is a rapid, simple, point-of service assay to measure platelet aggregation. The verify now assay is designed to assess platelet function based on the ability of activated platelets to bind fibrinogen. It is hoped that this study will detect the subtle platelet functional abnormalities in patients with hematological disorders.

Eligibility criteria: Inclusion Criteria

- Patients with common blood disorders such as immune thrombocytopenia purpura(ITP) myelodysplastic syndrome MDS)and myeloproliferative disorders (MPV)

Exclusion Criteria

- Patients with normal platelet counts

Primary outcomes:
measure: platelet aggregation defects
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Mineola
country: United States
facility: Winthrop University Hospital Oncology/Hematology Division
state: New York
Study officials:
affiliation: Winthrop University Hospital
name: Nina D'abreo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00185718: Impact of Treatment Induced Premature Menopause on Quality of Life
Official title: Impact of Treatment Induced Premature Menopause on Quality of Life Following Blood and Marrow Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause, Premature
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women become menopausal as a result of BMT

Brief summary: To understand the impact of treatment induced menopause on quality of life and sexuality following blood and marrow transplantation.


Eligibility criteria: Inclusion Criteria:

* premenopausal
* sexually active women
* able to read and write English

Exclusion Criteria:

- postmenopausal females

Primary outcomes:
measure: Quality of life
timeFrame: 1 year
measure: Sexuality
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Karl G. Blume
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04197518: Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy
Official title: Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Child Neurocognitive Function
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2019-12-13
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation the Neurocognitive Functions Among Children With Enlargement Adenoid and Tonsils, Before and After Tonsillectomy or Adenotonsillectomy


Eligibility criteria: Inclusion Criteria:

* children between 6-18 years old.
* children with enlarged tonsils or adenoids.
* a sleep lab test before the procedure.

Exclusion Criteria:

* children under 6 years old and above 18 years old.
* patience that treated in ADHD / ADDOR with other neurocognitive disorder.

Primary outcomes:
measure: Neurocognitive Functions Among Children
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02424318: Topiramate and Cerebrovascular Response in Migraineurs
Official title: Effect of Topiramate on Cerebrovascular Response to Photic Stimulation in Migraineurs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Migraine Disorders
Lead sponsor: SMG-SNU Boramae Medical Center
Sponsor class: OTHER
First posted: 2015-04-23
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of topiramate on cerebrovascular reactivity and mean flow velocity to photic stimulation in migraineurs.


Eligibility criteria: Inclusion Criteria:

* aged 18 to 65 years
* newly-diagnosed patients with migraine without aura (International Headache Society classification)
* symptom frequency (at least 2 episodes of migraine attack/month)

Exclusion Criteria:

* prior use of preventive medication
* patients with cardiovascular risk factors (hypertension, diabetes, hyperlipidemia, smoking)
* patients who take antihypertensive agent or antidepressant
* patients who were pregnant, breast-feeding or actively smoking
* patients with neurological or cerebrovascular diseases

Primary outcomes:
measure: Comparison of the Cerebrovascular reactivity
timeFrame: between baseline and after 2-month treatment of topiramate
Secondary outcomes:
measure: Comparison of the mean flow velocities in the middle and posterior cerebral artery
timeFrame: between baseline and after 2-month treatment of topiramate
Other outcomes:
Locations:
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Hyunwoo Nam, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00951418: Serum Clozapine and Cognition
Official title: Serum Clozapine and Cognition
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Keywords: clozapine
schizophrenia
cognition
t-wave morphology
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2009-08-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICD-10 Schizophrenia (f20.0-3; F20.9) treated with clozapine

Brief summary: This study aim to investigate the relationship between serum levels of clozapine and cognitive performance in patients with ICD-10 Schizophrenia and treated with clozapine monotherapy. The hypothesis is that higher serum levels of clozapine are associated with cognitive dysfunctions. Furthermore, ECG changes and the relation to serum level of clozapine are studied. The design is cross-sectional.


Eligibility criteria: Inclusion Criteria:

* Treated with clozapine for minimum 6 months.
* Fixed dosage of clozapine last month before inclusion.

Exclusion Criteria:

* Substance misuse.
* Depression (Calgary Depression score ≥7).
* Somatic disease that interfere with cognitive performance.
* Treatment with benzodiazepines (half-lives \>15 hours not allowed up 14 days prior inclusion and during study. Half-lives \< 15 hours not allowed 3 days prior cognitive testing).
* Electroconvulsive therapy.
* Treatment with other antipsychotics.
* Withdrawal of informed consent.
* Compulsory measures.
* Treatment with anticholinergics except for atropine drops administered sublingually.
* Changes in use of tobacco last month before inclusion.

Primary outcomes:
measure: Cognitive function measured by CANTAB
timeFrame: once
Secondary outcomes:
measure: T-wave morphology
timeFrame: Once
measure: Sedation VAS,ACES and SWAI scale
timeFrame: once
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Psychiatric Hospital
Study officials:
affiliation: Aalborg Psychiatric Hospital
name: Rene Ernst Nielsen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02491918: Clinical Trial : Complications of in the Bag IOL Versus Optic Capture of IOL in Pediatric Cataract Surgery
Official title: Visual Axis Obscuration and Postoperative Complications Following Pediatric Cataract Surgery With Introacular Lens Implantation In-the-bag Versus Posterior Optic Capture : A Randomized, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posterior Capsule Opacification
Postoperative Complications
Lead sponsor: Iladevi Cataract and IOL Research Center
Sponsor class: OTHER
First posted: 2015-07-08
Enrollment: 61
Sex: ALL
Minimum age (years): 15
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This prospective, randomized, clinical trial looks to compare children undergoing congenital cataract surgery with intraocular lens (IOL) implantation in terms of visual axis obscuration as well as postoperative complications such as glaucoma, inflammation and IOL centration when IOL fixation is performed using two different techniques : 1) conventional in the bag IOL implantation with anterior vitrectomy, and, 2) posterior optic capture of the IOL through the posterior capsulorhexis without any vitrectomy. 61 eyes of 61 children randomized to receiving IOL implantation using one of the two techniques will be followed up until 12 months postoperatively.

Detailed description: This prospective, randomized, controlled, clinical trial compares visual axis obscuration as well as intra and postoperative complications in children undergoing cataract surgery with IOL implantation using one of two techniques :

1. in the bag IOL with limbal anterior vitrectomy
2. posterior optic capture of IOL optic through the posterior capsulorhexis without any vitrectomy.

The aim is to evaluate whether avoiding anterior vitrectomy is a feasible option, particularly younger children, where anterior vitrectomy has become an integral part of the routine surgical strategy.

All children will be evaluated at 1 month, 3 months, 6 months and 12 months postoperatively.

Eligibility criteria: Inclusion Criteria:

* uncomplicated cataract,
* unilateral or bilateral cataract,
* corneal diameter \>9.0mmHg

Exclusion Criteria:

* pre-existing glaucoma,
* uveitis,
* ocular comorbidity,
* microphthalmos,
* microcornea,
* parents not consenting to participate in study,
* traumatic cataract

Primary outcomes:
measure: Posterior capsule opacification requiring surgery
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: inflammation on slitlamp examination
timeFrame: 12 months postoperatively
measure: inflammation on slitlamp examination
timeFrame: 12 months postoperatively
measure: intraocular pressure in mmHg
timeFrame: 12 months postoperatively
Other outcomes:
Locations:
Study officials:
affiliation: Iladevi Cataract & IOL Research Centre, Ahmedabad, India
name: abhay vasavada, MS,FRCS
role: STUDY_DIRECTOR
References:
Clinical trial NCT01422018: Effect of Intravitreal Bevacizumab on Focal Edema With Hard Exudates Secondary to Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Complications
Keywords: clinically significant macular edema
diabetic macular edema
focal edema
focal laser photocoagulation
hard exudates
intravitreal bevacizumab
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2011-08-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Purpose: To evaluate the efficacy of intravitreal bevacizumab (IVB) on focal edema with hard exudates secondary to diabetic retinopathy.

Design: Prospective interventional case series. Participants: Ten eyes of 10 consecutive patients showing focal edema with hard exudates secondary to diabetic retinopathy which are not eligible for focal laser photocoagulation due to central location (\< 500 µm from fovea).


Eligibility criteria: Inclusion Criteria:

1. patients of either gender aged \> 18 years
2. patients with type 2 diabetes
3. central macular thickness \> 300 µm on OCT
4. eyes not eligible for focal laser photocoagulation due to the central location of hard exudates (\< 500 µm)
5. an area of retinal thickening less than 2 disc areas in diameter
6. 67% or more of leakage associated with microaneurysms

Exclusion Criteria:

1. eyes with history of laser photocoagulation or pharmacological intervention for DME on study eye
2. eyes with any pharmacologic intervention on fellow eye within 6 months
3. history of ocular diseases other than diabetic retinopathy
4. surgical history other than cataract extraction with intraocular lens implantation
5. panretinal photocoagulation within 3 months of enrollment
6. media opacity
7. any thromboembolic event within 6 months, or evidence of active cardiac ischemia on electrocardiogram (ECG) at time of screening.

Primary outcomes:
measure: Changes in best-corrected visual acuity (BCVA)
timeFrame: from month 0 to month 6 in monthly schedule (upto 6 months)
Secondary outcomes:
measure: amount of hard exudates detected on fundus photography
timeFrame: from month 0 to month 6 in bimonthly schedule (upto 6 months)
measure: macular edema detected by optical coherent tomography
timeFrame: from month 0 to month 6 in bimonthly schedule (upto 6 months)
Other outcomes:
Locations:
city: Seocho
country: Korea, Republic of
facility: Seoul St Mary's hospital
state: Seoul
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Won ki Lee, MD Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06645418: Relative Hand Grip Strength and Functional Fitness in Diabetic Patient in Egypt
Official title: Relative Hand Grip Strength and Functional Fitness Among Elderly Patients with Type II Diabetes in Egypt: a Cross-sectional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type II Diabetes Mellitus
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: To show if there is significant relationship between hand grip strength and physical fitness in diabetic type II patients over 60 years old.

Detailed description: To show if there is significant relationship between hand grip strength and physical fitness in diabetic type II patients over 60 years old.

Eligibility criteria: Inclusion Criteria:

* Diabetes type II
* Ability to walk independently
* The cognitive and mental capacity to understand and perform tests

Exclusion Criteria:

* Musculoskeletal, neurological, rheumatological problems, or hand deformities that could hinder grasping

Primary outcomes:
measure: relative Hand grip strength
timeFrame: Baseline
measure: The 30-Second Chair Test
timeFrame: Baseline
measure: 8-feet Up-and-Go test
timeFrame: Baseline
measure: 2 min walk test
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kz hospital
state: Elgharbia
city: Cairo
country: Egypt
facility: Kz Hospital
Study officials:
affiliation: National institute for Gerontology
name: Mohammed Yo Elhamrawy
role: PRINCIPAL_INVESTIGATOR
References: