louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05437302: Effectiveness of Prism Spectacles in Patients With Age Related Macular Degeneration
Official title: Effectiveness of Prism Spectacles in Patients With Age Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Macular Degeneration
Lead sponsor: University of Faisalabad
Sponsor class: OTHER
First posted: 2022-06-29
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A study is conducted to determine the effectiveness of prism spectacles in improving visual acuity with age related macular degeneration patients and to assess the improvement in quality of life in patients by using prism spectacles.

Detailed description: A random sampling technique will be used to allocate patient in interventional and non-interventional group. The diagnosed patients of age-related macular degeneration are assessed for prism spectacles for near vision and prism glasses will be dispensed to the patients. Each subject will be interviewed to fill the Proforma after taking the informed consent. The results of this study will show the effectiveness of prism glasses in patients with age related macular degeneration in their daily routine near work as compared to conventional glasses.

Eligibility criteria: Inclusion Criteria:

* Patients having age \>50 years with age related macular degeneration.
* Patients of both genders (male and female).
* Participants who will be willing to give informed consent for participation in the study.

Exclusion Criteria:

* Presence of all ocular disease and systemic ocular pathologies able to impair visual function.
* Presence of disorders causing choroidal neovascularization other than age related macular degeneration.
* Patients with mental illness, dementia, and severe physical limitations

Primary outcomes:
measure: Visual Acuity
timeFrame: Four week
measure: Visual Functional Quality of life (VFQOL)
timeFrame: Four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Mehreen
Study officials:
affiliation: University of Faisalabad
name: Ayesha Kiran
role: STUDY_DIRECTOR
References:
Clinical trial NCT02054221: Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With Severe Mitral Insufficiency.
Official title: Compare Results of Mitral Valve Replacement or Repair in the Surgical Treatment of Obstructive Hypertrophic Cardiomyopathy With Severe Mitral Insufficiency.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertrophic Obstructive Cardiomyopathy
Keywords: hypertrophic cardiomyopathy
mitral valve
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2014-02-04
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Compare the results of reconstruction and mitral valve replacement in the surgical treatment of obstructive hypertrophic cardiomyopathy with severe mitral insufficiency.

Detailed description: Many years myoectomy for Morrow was the gold standard in the treatment of obstructive hypertrophic cardiomyopathy. Currently more retrospective data in the literature about the good results the extended septal myectomy. But the question remains what is best for patients with obstructive hypertrophic cardiomyopathy and severe mitral insufficiency: use extended myoectomy with mitral valve repair a or replacement.

Eligibility criteria: Inclusion Criteria:

* Able to sign Informed Consent and Release of Medical Information forms
* Age ≥ 18 years
* obstructive hypertrophic cardiomyopathy
* surgically significant mitral insufficiency
* II-IV (NYHA),
* average systolic pressure gradient greater than 50 mm Hg. Art. at rest;
* basal or medium ventricular obstruction

Exclusion Criteria:

* Related defect of the aortic valve;
* Organic mitral valve disease (dysplasia, rheumatic fever, infective endocarditis);
* Surgically significant coronary artery lesions;
* Patients requiring implantation of a cardioverter-defibrillator

Primary outcomes:
measure: The function of the mitral valve (mitral regurgitation return, prosthesis dysfunction)
timeFrame: one year
Secondary outcomes:
measure: The pressure gradient in the output section of the left ventricle
timeFrame: one year
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Research Institute of Circulation Pathology
state: Novosibirsk territory
Study officials:
affiliation: Meshalkin Research Institute of Pathology of Circulation
name: Aleksandr V Bogachev-Prokophiev, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Surgical Treatment of Hypertrophic Obstructive Cardiomyopathy With severe Mitral regurgitation
citation: Bogachev-Prokophiev A, Afanasyev A, Zheleznev S, Fomenko M, Sharifulin R, Kretov E, Karaskov A. Mitral valve repair or replacement in hypertrophic obstructive cardiomyopathy: a prospective randomized study. Interact Cardiovasc Thorac Surg. 2017 Sep 1;25(3):356-362. doi: 10.1093/icvts/ivx152.
Clinical trial NCT03923621: Pilonidal Excision Versus Endoscopic Surgery
Official title: Pilonidal Excision Versus Endoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilonidal Sinus
Keywords: Endoscopic Pilonidal Sinus Treatment (EPSiT)
Lead sponsor: St Helens & Knowsley Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 39
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare clinical outcomes of endoscopic pilonidal sinus treatment (EPSiT) with excision treatment with a randomised clinical trial.

Detailed description: Primary outcome: complication rate Secondary outcomes: Quality of life, recurrence rate, length of stay, post operative pain (NRS), return to work time, time to complete wound healing, resource use.

Allocation ratio 2:1

Eligibility criteria: Inclusion Criteria:

* ASA I or II
* Pilonidal disease \<3 previous treatments
* Previous incision and drainage allowed
* Over 16 years

Exclusion Criteria:

* Co-morbidity \>ASA II
* Unable to consent themselves
* Under 16 years
* Vulnerable adults

Primary outcomes:
measure: Complication rate
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life (QoL)
timeFrame: 12 months
Other outcomes:
Locations:
city: Prescot
country: United Kingdom
facility: St Helens & Knowsley Hospitals NHS Trust
state: Merseyside
Study officials:
References:
Clinical trial NCT01028521: First in Man Clinical Study to Investigate Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of CM3.1-AC100
Official title: Single-centre, Randomised, Double-blind, Placebo-controlled Clinical Study to Investigate Safety and Tolerability and Pharmacokinetics of Single Ascending Doses of CM3.1-AC100 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: First time in man, safety study, Cm3.1-AC100
Male volunteer aged 18 to 50 years at Screening
Lead sponsor: CellMed AG, a subsidiary of BTG plc.
Sponsor class: INDUSTRY
First posted: 2009-12-09
Enrollment: 56
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: A first time in man, phase I study to assess the safety, tolerability and pharmacokinetics of single ascending doses of CM3.1-AC100 in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Provision of signed and dated informed consent prior to any study specific procedures
* Body weight between 60.0 to 100.0 kg (both inclusive) and BMI 19 to 29.9 kg/m2 (both inclusive)
* Judged as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination)

Exclusion Criteria:

* Any history or presence of a clinically relevant disease as judged to be relevant by the Investigator
* Blood donation within 3 month before administration of the IP
* Have a history of hypersensitivity to the IP or any of the excipients or to medicinal products with similar chemical structures

Primary outcomes:
measure: Safety measurements (Adverse events, ECG recordings, blood pressure, pulse, body temperature, laboratory variables,local tolerability, nausea questionnaire)
timeFrame: Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Parexel International GmbH
Study officials:
affiliation: CellMed AG, a subsidiary of BTG plc.
name: Peter Geigle, Dr. med.
role: STUDY_CHAIR
References:
Clinical trial NCT00002321: A Phase I Study of the Safety of Proleukin (Aldesleukin) in Combination With Ganciclovir and Antiretroviral Therapy in HIV Seropositive Patients With Cytomegalovirus (CMV) Retinitis
Official title: A Phase I Study of the Safety of Proleukin (Aldesleukin) in Combination With Ganciclovir and Antiretroviral Therapy in HIV Seropositive Patients With Cytomegalovirus (CMV) Retinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cytomegalovirus Retinitis
HIV Infections
Keywords: Retinitis
Interleukin-2
Ganciclovir
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
Antiviral Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the MTD and dose-limiting toxicities of a regimen of therapeutic ganciclovir, antiretroviral therapy, and recombinant interleukin-2 (aldesleukin; Proleukin) as an immune adjuvant in HIV-seropositive patients. To investigate the effect of increasing doses of Proleukin on the time to progression of CMV retinitis in patients being treated with therapeutic ganciclovir and antiretroviral therapy. To evaluate the incidence and level of anti-IL-2 antibody formation to subcutaneously administered Proleukin in this patient population.

Detailed description: Patients will receive subcutaneous Proleukin in combination with ganciclovir and antiretroviral therapy, and the MTD will be determined.

Eligibility criteria: Inclusion Criteria

Patients must have:

Documented HIV seropositivity.

Prior Medication:

Required:

* FDA-approved antiretroviral therapy for at least 2 months prior to study entry.

Allowed:

* Prior G-CSF.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: United States
facility: Med College of Ohio
state: Ohio
Study officials:
References:
Clinical trial NCT00806221: An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis
Official title: An Open-Label Study Investigating the Effects of Early Skin Barrier Protection on the Development of Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Prevention
Skin Barrier
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2008-12-10
Enrollment: 22
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether early use of a bland emollient in newborns, prior to the clinical signs of skin disease, will delay the onset or prevent the development of atopic dermatitis.

Detailed description: All neonates will be treated with Cetaphil cream starting within 1 week of birth. All neonates enrolled will have an increased risk of developing atopic dermatitis because they have a family history of either asthma, hay fever, or atopic dermatitis. These neonates will then be followed for 2 years for the signs and symptoms of atopic dermatitis.

Eligibility criteria: Inclusion Criteria:

* at least one parent diagnosed with Atopic Dermatitis
* one parent or sibling with hayfever or asthma

Exclusion Criteria:

* newborns with dermatitis at birth
* newborns born greater than four weeks prematurely
* newborns with medical problems necessitating prolonged hospitalization
* newborns diagnosed with any immune deficiency syndrome

Primary outcomes:
measure: Incidence of Skin Irritation
timeFrame: 1 and 2 year time points
measure: Incidence of Skin Infection
timeFrame: 1 and 2 year timepoints
measure: Compliance With Protocol
timeFrame: over two years
Secondary outcomes:
measure: Development of Eczema
timeFrame: 1 and 2 year time points
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University, Department of Dermatology
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Eric Simpson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03479021: SPOT Vision Screening
Official title: Accuracy of Welch Allyn Spot™ Vision Screener to Detect Amblyogenic Factors in Developmentally Delayed Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Vision Disorders
Lead sponsor: Children's Hospital Colorado
Sponsor class: OTHER
Collaborators: name: Welch Allyn
First posted: 2018-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The children have various disabilities or delays to include: Attention Deficit Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), chromosomal abnormalities such as Down Syndrome, Cerebral Palsy (CP), and mental retardation (MR).

Brief summary: The purpose of this protocol is to determine if the Welch-Allyn Spot Vision Screener (SPOT) is effective at detecting various risk factors for poor vision in developmentally delayed children. These children have a higher percentage of vision disorders than the average population. The SPOT screen itself takes about six seconds to complete. It produces a photograph of the eye and a print out with amount of hyperopia, myopia, astigmatism and pupil size. The subject will have three SPOT screens around the time of their standard of care eye exam. The data obtained from the three SPOT screens will be compared among themselves for accuracy and to the findings of the clinical eye exam.


Eligibility criteria: Inclusion Criteria:

child over 4 months of age social, behavioral, physical, or other handicap unable to complete age-appropriate vision screening

Exclusion Criteria:

glaucoma post intraocular surgery microphthalmia other serious eye disorder inability to complete SPOT screener

Primary outcomes:
measure: the SPOT will be effective in screening for amblyogenic risk factors
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
References:
Clinical trial NCT01747421: Validation of a High-risk Versus Low-risk Referral Model in Suspected Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2012-12-11
Enrollment: 495
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all acute admission to Emergency Department with the complaint Chestpain

Brief summary: In Emergency Departments patients admitted with chest pain may suffer from non-significant to lifethreatening conditions.

The aim of the present study is to develop and validate a referral model in chest pain patients which divide the patients with non- significant ECG changes into high risk and low risk groups for acute coronary syndrome.


Eligibility criteria: Inclusion Criteria:

* more than 15 years old

Exclusion Criteria:

* Patients with ST-elevations in ECG

Primary outcomes:
measure: Acute Myocardial Infarction
timeFrame: 24 hours after admission
Secondary outcomes:
measure: cardiac event
timeFrame: 1 year after admission
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Kolding Hospital
Study officials:
References:
Clinical trial NCT03001921: Wise Practice of Chinese Hemodialysis (WISHES)
Official title: Wise Practice of Chinese Hemodialysis (WISHES)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Haemolyses and Related Conditions
Keywords: Hemodialysis
Patient survival
Quality of life
Hemodialysis access
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2016-12-23
Enrollment: 30000
Sex: ALL
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: End stage renal disease patients receiving hemodialysis treatment

Brief summary: The investigators are registering all HD patients at recruited hospitals and developing a HD database in China. Patients will be follow-up every 3 months, and both baseline and follow-up information will be entered into the registration system. The patient survival, technical survival, patency rate of access, quality of life and residual renal function for HD patients will be compared using the HD database.

Detailed description: The investigators are registering all end stage renal disease (ESRD) patients receiving hemodialysis (HD) treatment, and developing a HD database in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education), clinical characteristics (including systolic blood pressure, diastolic blood pressure, primary cause of ESRD, and lab measurements of serum, urine, and access patency), complications, drug information and scores of quality of life at the baseline will be collected. Patients will be follow-up every 3 month, the demographic and clinical characteristics, complications and drug information of patients will be collected at each visit. The investigators also record the outcome at each visit, such as mortality (including all-cause mortality and cardiovascular disease mortality), technical survival, kidney transplantation, transfer to peritoneal dialysis, hospitalization, access failure，etc. The patient survival, technical survival, patency rate of access, quality of life and residual renal function for HD patients will be compared using the HD database.

Eligibility criteria: Inclusion Criteria:

End stage renal disease patients receiving hemodialysis treatment.

Exclusion Criteria:

No

Primary outcomes:
measure: Patient survival of HD patients
timeFrame: 10 years
Secondary outcomes:
measure: Quality of life evaluated using SF36 scale for HD patients
timeFrame: 10 years
measure: Patency rate of access for HD patients
timeFrame: 10 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The 1st Affiliated Hospital, Sun Yet-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT03475121: Treatment Protocol for Non-Metastatic Unilateral Retinoblastoma
Official title: GALOP II Protocol for the Treatment of Unilateral Retinoblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Unilateral Retinoblastoma
Lead sponsor: Hospital JP Garrahan
Sponsor class: OTHER_GOV
First posted: 2018-03-23
Enrollment: 84
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This protocol provides guidelines for the management of non-metastatic unilateral retinoblastoma and introduces an innovative adjuvant therapy for higher risk patients based upon the results of the Grupo de America Latina de Oncologia Pediatrica (GALOP) I study. Conservative therapy will be not protocolized.

Detailed description: Patients with non-metastatic retinoblastoma undergoing enucleation will be staged using the American Joint Committee on Cancer (AJCC), version 8, Tumor, Node, Metastasis (TNM)- H system and the International Retinoblastoma Staging System (IRSS). IRSS stage I patients recognized as higher risk will be assigned for adjuvant therapy. Those with standard risk will not receive adjuvant therapy after enucleation. Higher risk patients are defined as those with pathological retrolaminar optic nerve invasion and-or any degree of scleral invasion (pT3b, pT3c, pT3d). Based on the results of the GALOP I protocol, they will receive a reduced dose adjuvant chemotherapy regimen with 3 cycles of alternating cyclophosphamide, vincristine and idarubicin alternating with another 3 cycles of carboplatin and etoposide. Six doses of intrathecal topotecan will be given. Patients presenting with severe buphthalmia (cT3c-cT3e) will receive neo-adjuvant therapy with the same intensive regimen but including a higher dose of carboplatin as per GALOP I protocol plus intrathecal topotecan and secondary enucleation followed by adjuvant chemotherapy for a total of 8 cycles. Stage II patients (pT4) will receive the same adjuvant regimen plus orbital radiotherapy (45 cGy).

Eligibility criteria: Inclusion Criteria:

* Histological diagnosis of retinoblastoma confirmed at participating institutions
* Ophthalmological diagnosis of unilateral retinoblastoma in patients undergoing conservative therapy.
* No prior therapy for retinoblastoma
* Lansky Performance Scale greater or equal to 50
* Normal organ function in those patients assigned for chemotherapy
* Signed informed consent

Exclusion Criteria:

* Patients with unilateral retinoblastoma and germline mutations of the Rb1 gene or family history for retinoblastoma

Primary outcomes:
measure: Rate of extraocular relapses
timeFrame: 3 years
measure: Evaluation of number of patients experiencing acute, chronic and fatal toxicities
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital JP Garrahan
state: CF
Study officials:
References: