louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00758342: Azopt (Brinzolamide 1.0%) Plus Travatan (Travoprost 0.004%) in Treating Patients With Chronic Angle-Closure Glaucoma (CACG)
Official title: A Double-Masked, Parallel-Group, Efficacy and Safety Study of Brinzolamide 1.0% (AZOPT) as Adjunctive Therapy to Travoprost 0.004% (TRAVATAN) in Patients With Chronic Angle-Closure Glaucoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Intraocular Pressure
Keywords: IOP lowering efficacy and safety of Azopt plus Travatan
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 37
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: To evaluate the IOP (Intraocular Pressure) lowering efficacy and safety of Brinzolamide 1.0% (Azopt), dosed twice daily as adjunctive therapy in patients treated with Travoprost 0.004% (Travatan) once daily. The study is double masked. The patients will receive either treatment for 12 weeks.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years;
* CACG (Chronic Angle Closure Glaucoma) ≥ 1eye
* have been treated with PGA (prostaglandin analogues) once daily ≥ 2 weeks prior to the screening visit and IOP=19-32 mmHg (millimeters mercury) in at least one eye and ≤ 32 mmHg in both eyes
* clinical stability of VA (Visual Acuity) and optic nerve throughout the study

Exclusion Criteria:

* Abnormality restricts exam of the fundus or anderior chamber
* conjunctivitis, keratitis or uveitis
* unable to be discontinued from using all ocular hypotensive medication(s) except Travatan (Travoprost 0.004%) and/or Azopt (Brinzolamide 1.0%) for 12days-4weeks
* ocular surgery prior to the study

Primary outcomes:
measure: Mean IOP (Intraocular Pressure)
timeFrame: Screening: Week 12; (At 9 am and 4 pm time points)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06595342: A Prospective Cohort of Patients With Cervical/Intracranial Arteries Stenosis in China
Official title: A Prospective Cohort of Patients With Cervical/Intracranial Arteries Stenosis in China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cervical Artery Stenosis
Intracranial Artery Stenosis
Keywords: Cervical Artery Stenosis
Intracranial Artery Stenosis
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were diagnosed with cervical artery stenosis and/or intracranial artery stenosis.

Brief summary: The aim of this study is to establish a prospective cohort of patients with cervical/intracranial arteries stenosis in China.

Detailed description: A prospective cohort of patients with cervical/intracranial arteries stenosis from various regions of China will be established. This prospective cohort is used to identify the distribution of risk factors in the patients with cervical/intracranial arteries stenosis.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 40 and ≤ 80 years;
2. Ultrasound or imaging examinations indicating cervical artery stenosis and/or intracranial artery stenosis (including mild, moderate, severe stenosis, or occlusion);
3. Willing to participate and signing the informed consent form.

Exclusion Criteria:

1. Patients with stroke occurring within the past year;
2. Patients with severe systemic diseases, such as respiratory failure, renal failure, gastrointestinal bleeding, coagulation disorders, malignancies, etc.;
3. Patients with a life expectancy of less than one year or those who are unable to complete the study for other reasons.

Primary outcomes:
measure: Incidence of stroke
timeFrame: One year
Secondary outcomes:
measure: Changes in the stenosis rate of cervical and intracranial arteries
timeFrame: One year
measure: Incidence of new clinical vascular events
timeFrame: One year
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT03150342: Presentations of Hypertrophic Cardiomyopathy on Myocardial Perfusion Imaging
Official title: Presentations of Hypertrophic Cardiomyopathy on Myocardial Perfusion Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertrophic Cardiomyopathy
Myocardial Perfusion Imaging
Keywords: CZT scanner
myocardial perfusion imaging
Hypertrophic Cardiomyopathy
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HCM patients with patent coronary artery who underwent MPI

Brief summary: Chest pain and myocardial ischemia are prevailing features in patients with hypertrophic cardiomyopathy (HCM). Recently introduced single-photon emission computed tomography (SPECT) cameras with solid-state cadmium-zinc-telluride (CZT) detectors have been shown to decrease imaging time and improved the imaging quality of gated myocardial perfusion imaging (MPI). The investigators also correlate the MPI parameters with echocardiographic parameters. This study is to examine the spatial distribution of stress perfusion abnormalities and tissue injury in patients with HCM using a CZT SPECT camera.

Detailed description: The investigators will retrospectively evaluate myocardial perfusion patterns and cardiac function with Thallium (Tl)-201 gated dipyridamole MPI in patients with clinical diagnosis of HCM and patent coronary angiography between January 2013 and October 2016. The inclusion criteria included a spade-like configuration on left ventriculogram, or echocardiographic findings suggestive of HCM. The participants will be then divided into the following three groups: apical, concentric and septal forms. Regional perfusion would be analyzed using a 17-segment model from 0-4 degree (0=normal, to 4=absent perfusion); and summed stress score (SSS), summed rest score (SRS) and summed difference score (SDS) were calculated. Gated SPECT would be processed by quantitative gated SPECT (QGS) software (Cedars-Sinai Medical Center, Los Angeles, CA, USA) and ejection fraction phase analysis. Diastolic parameters would be also acquired by Doppler echocardiography, and correlated with MPI parameters.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of HCM and patent coronary angiography between January 2013 and October 2016.

Exclusion Criteria:

* patient with prior myocardial ischemia, conduction abnormality, valvular disease or other cardiomyopathy

Primary outcomes:
measure: MPI results
timeFrame: January 2013 and October 2016.
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
affiliation: Far Eastern Memorial Hospital
name: Yen-Wen Wu, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00190970: The Effect of Ruboxistaurin on Small Fiber Function
Official title: The Effect of Ruboxistaurin Mesylate (LY333531) on Small Fiber Function as Measured by Microvascular Skin Blood Flow, C-Fiber Quantitations in Skin and Quantitative Sensory Testing of Cold and Heat.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Neuropathy
Lead sponsor: Chromaderm, Inc.
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 52
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: To determine the effect of Ruboxistaurin on small fiber function.


Eligibility criteria: Inclusion Criteria:

* Patients must have Type 1 or Type 2 diabetes mellitus
* Patients must have bilateral sensorimotor distal peripheral neuropathy attributable to diabetes mellitus
* Patients must have blood glucose control measured as HbA1c=\<11%
* Patients must be 18 years of age or older.
* Patients must be able to return to all follow-up visits

Exclusion Criteria:

* Patients must not have symptoms of diabetic peripheral neuropathy that cannot be distinguished from other etiologies
* Patients must not have a neurologic disease or neuropathy from a cause other than diabetes mellitus that would interfere with correct evaluation of symptomatic peripheral neuropathy.
* Patient currently has uncontrolled high blood pressure
* You have other medical problems that your doctor feels would make it unsafe for you to participate in this study such as liver or kidney problems
* You are a woman of childbearing age and unwilling or unable to use effective contraceptive.

Primary outcomes:
measure: The objectives of this study is to evaluate the effect of ruboxistaurin on subjects with diabetic peripheral polyneuropathy
Secondary outcomes:
measure: Ruboxistaurin will improve quantitative sensory testing and increase nerve fiber density in subjects with diabetic peripheral polyneuropathy.
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday-Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
state: Virginia
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Casellini CM, Barlow PM, Rice AL, Casey M, Simmons K, Pittenger G, Bastyr EJ 3rd, Wolka AM, Vinik AI. A 6-month, randomized, double-masked, placebo-controlled study evaluating the effects of the protein kinase C-beta inhibitor ruboxistaurin on skin microvascular blood flow and other measures of diabetic peripheral neuropathy. Diabetes Care. 2007 Apr;30(4):896-902. doi: 10.2337/dc06-1699.
Clinical trial NCT00514670: A Randomized Controlled Trial of a School Disinfection and Hand Hygiene Program
Official title: A Randomized Controlled Trial of a School Disinfection and Hand Hygiene Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory Infections
Gastrointestinal Diseases
Keywords: Prevention of gastrointestinal and respiratory illness
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Study funds provided by The Clorox Company
First posted: 2007-08-10
Enrollment: 285
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the trial is to assess the impact of a disinfection and hand hygiene program on absenteeism in elementary school classrooms. Students in intervention classrooms will use alcohol-based hand sanitizers at school, and their classrooms will be disinfected using quaternary ammonium wipes. We hypothesize that the use of disinfectants and hand hygiene products in elementary school classrooms will reduce absenteeism.


Eligibility criteria: Inclusion Criteria:

* Member of a designated elementary school classroom in the Avon school system

Primary outcomes:
measure: Absenteeism rate due to gastrointestinal or respiratory illness during the study period.
timeFrame: 8 weeks
Secondary outcomes:
measure: Bacterial colony counts and the presence of selected viruses on classroom surfaces.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Thomas J Sandora, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sandora TJ, Shih MC, Goldmann DA. Reducing absenteeism from gastrointestinal and respiratory illness in elementary school students: a randomized, controlled trial of an infection-control intervention. Pediatrics. 2008 Jun;121(6):e1555-62. doi: 10.1542/peds.2007-2597.
Clinical trial NCT04535570: Evolution of the Energy Expenditure During Hematopoietic Stem Cell Transplantation
Official title: Evolution of the Energy Expenditure During Hematopoietic Stem Cell Transplantation in Patients With Hematological Disease and Associated Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Marrow Transplantation
Hematopoietic Stem Cell Transplantation
Keywords: Bone Marrow Transplantation
Hematopoietic Stem Cell Transplantation
Indirect Calorimetry
Energy Metabolism
Basal Metabolism
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2020-09-02
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients of both sexes, older than 15 years old, hospitalized in the Bone Marrow Transplant sector of the Hospital das Clínicas of the Federal University of Minas Gerais and submitted to transplantation will be evaluated.

Brief summary: The treatment before bone marrow transplantantion is initiated by chemotherapy associated or not with radiotherapy, both of which cause various side effects on the patient as symptoms that impair food intake. The nutritional status of the patient is one of the factors related to the success of the transplant, so a complete nutritional assessment before transplantation is necessary in order to identify patients at nutritional risk, nutritional disorders and to perform appropriate and early intervention to promote recovery and / or health maintenance. Will be used for nutritional assessment: arm perimeter, arm muscle area; electrical bioimpedance, phase angle, and Indirect Calorimetry, a standard method of noninvasive nutritional assessment that expresses the nutritional demand and rate of utilization of energy substrates from oxygen consumption and carbon dioxide production through the air inhaled and exhaled by the individual's lungs.


Eligibility criteria: Inclusion Criteria:

* Patients with hematological disease
* Age equal or superior to 15 years old
* Both sexes
* Will be submitted bone marrow transplantation

Exclusion Criteria:

* Age below 15 years old
* Those who can't perform calorimetry (oxygen therapy, mechanical ventilation)
* Have hyper or hypothyroidism
* Admitted to the Intensive Care Unit (without at least one result of post-transplant indirect calorimetry)
* Don't agree to participate in the study

Primary outcomes:
measure: Energy expenditure
timeFrame: Up to 3 weeks after protocol termination
Secondary outcomes:
measure: Nutritional status of patients
timeFrame: Up to 3 weeks after protocol termination
measure: Caloric and protein adequacy
timeFrame: Up to 3 weeks after protocol termination
measure: Clinical outcomes
timeFrame: Up to 3 weeks after protocol termination
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Escola de Enfermagem - UFMG
state: MG
Study officials:
affiliation: Federal University of Minas Gerais
name: Simone V Generoso
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01628770: Use of Iron Isomaltoside 1000 (Monofer) in Postpartum Anemia
Official title: Iron Isomaltoside 1000 (Monofer)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Anemia
Keywords: iron
monofer
Pakistan
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2012-06-27
Enrollment: 271
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators hypothesized that both isomaltoside 1000 (Monofer), and oral iron preparation will be equally effective in correction of postpartum iron deficiency anemia.

Detailed description: Iron molecule iron isomaltoside 1000 (Monofer) have been introduced in the market, which can be given in intravenous infusion forms, in a relatively short period of time, in a single setting, after calculation of the required dose. This preparation has been used for treatment of anemia in patients with chronic renal disease, gastrointestinal disorders, anemia of malignancy and in gynecological disorders. It does not require a test dose to be given before total dose, nor does it require any premedication. It can be given in a dose of 20mg/kg. The drug has been licensed for use in Europe in 2009. It has been used for treatment of anemia in patients with chronic renal disease, inflammatory bowel disease and in anemia due to malignancies

Eligibility criteria: Inclusion Criteria:

* Women within 24-48 hours of delivery with hemoglobin concentration \< 10gm/dl

Exclusion Criteria:

* History of PPH, or significant blood loss in last 24 hours
* History of allergy to iron preparation
* Hemoglobin \< 7gm/dl.
* Sign \& symptoms of cardiac failure
* H/o blood transfusion in last 3 months
* H/O Chronic liver diseases.
* ↑ Creatinine \> 2mg/dl.

Primary outcomes:
measure: To see the rise in hemoglobin concentration of 2gm/dl or more.
timeFrame: 3 months
Secondary outcomes:
measure: secondary - time required for rise in hemoglobin concentration
timeFrame: 3 months
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: Sindh
Study officials:
References:
citation: Holm C, Thomsen LL, Langhoff-Roos J. Intravenous iron isomaltoside treatment of women suffering from severe fatigue after postpartum hemorrhage. J Matern Fetal Neonatal Med. 2019 Sep;32(17):2797-2804. doi: 10.1080/14767058.2018.1449205. Epub 2018 Mar 20.
Clinical trial NCT04642170: Urodynamics of Suprasacral Spinal Cord Injury Patients
Official title: Urodynamic Findings in Patients With Complete and Incomplete Suprasacral Spinal Cord Injury at Different Stages After Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Lead sponsor: Second Affiliated Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2020-11-24
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Traumatic spinal cord injury patients with voiding dysfunction and had urodynamic examination.

Brief summary: The medical records of 215 patients with spinal cord injury(SCI) at the Department of Rehabilitation Medicine of the 2nd Affiliated Hospital of Wenzhou Medical University, Wenzhou, China were evaluated between January 1, 2016 and December 20, 2019. According to the inclusion criteria and exclusion criteria, 101 patients were included. The patients were dichotomized into two groups: complete SCI group and incomplete SCI group, based on the American Spinal Injury Association Guidelines Impairment Scale (AIS) .The investigators retrospectively collected records of urodynamic evaluations of this patients and then analyze the urodynamic parameters,including detrusor overactivity (DO), bladder compliance (BC), bladder-filling sensation, maximum cystometric capacity (MCC), detrusor external sphincter dyssynergia (DESD), maximum urinary flow rate (Qmax), detrusor pressure at a maximum urinary flow rate(PdetQmax).


Eligibility criteria: Inclusion criteria were:

1. the period of the spinal shock has passed.
2. patients diagnosed with traumatic suprasacral SCI, based on AIS.
3. urodynamic investigations were performed by the same urologist.
4. patients with voiding dysfunction.

Exclusion Criteria:

The patient with voiding dysfunction before the injury were excluded.

Primary outcomes:
measure: detrusor overactivity (DO)
timeFrame: 0-365 days after injury
measure: bladder compliance (BC)
timeFrame: 0-365 days after injury
measure: bladder-filling sensation
timeFrame: 0-365 days after injury
Secondary outcomes:
measure: maximum cystometric capacity (MCC)
timeFrame: 0-365 days after injury
measure: detrusor external sphincter dyssynergia (DESD)
timeFrame: 0-365 days after injury
Other outcomes:
measure: maximum urinary flow rate (Qmax)
timeFrame: 0-365 days after injury
measure: detrusor pressure at a maximum urinary flow rate(PdetQmax)
timeFrame: 0-365 days after injury
Locations:
Study officials:
References:
Clinical trial NCT02445170: Heath-related Quality of Life of Diabetic Transmetatarsal Amputees and Below-knee Prosthetic Users
Official title: Heath-related Quality of Life of Diabetic Transmetatarsal Amputees and Below-knee Prosthetic Users
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Amputees
Diabetes Complications
Keywords: Diabetes
amputation
below-knee
transmetatarsal
[M01.150.100]
[C19.246.099]
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients who underwent transmetatarsal amputaion or below-knee prosthetic users in a time frame of 2-5 years from the amputation.

Brief summary: The present study assesses the health-related quality of life of diabetic transmetatarstal and below-knee prosthetic user. The study design is cross-sectional with a retrospective review of patient hospital records and an assessment with patient-reported outcome measure.

Detailed description: The present study aims to recruit 100 diabetic transmetatarsal and below-knee prosthetic user to assess the health-related quality of life (HRQoL) between these two patient groups. The 15D HRQoL instrument is applied. An additional comparison with the age-standardized Finnish general population will be performed.

Eligibility criteria: Inclusion Criteria:

* Patients with diabetes
* Transmetatarsal amputation
* Below-knee prosthetic user
* 2-5 years from surgery

Exclusion Criteria:

* No diabetes
* Other than transmetatarsal or below-knee amputation
* Below-knee amputation but not a below-knee prosthetic user
* Less than 2 years from the amputation
* Over 5 years from amputation

Primary outcomes:
measure: Health-related quality of life measured by the HRQoL score
timeFrame: 2-5 years
Secondary outcomes:
measure: The 15D health-related quality of life instrument
timeFrame: 2-5 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
state: Uusimaa
Study officials:
affiliation: Helsinki University Hospital and Helsinki University
name: Erkki J Tukiainen, professor
role: STUDY_DIRECTOR
References: