louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01845038: Multi-Arm Feasibility Study Evaluating OTX-TP Compared to Timolol in Treatment of Subjects With Open Angle Glaucoma
Official title: A Prospective, Multicenter, Randomized, Double-Masked, Multi-Arm Feasibility Study Evaluating the Safety and Efficacy of OTX-TP Compared to Timolol Drops in the Treatment of Subjects With Open Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glaucoma
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 41
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: The purpose of this study is to evaluate how OTX-TP, a sustained release travoprost drug product, when placed in the canaliculus of the eyelid compares to timolol drops for the lowering of intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Subject must be greater than or equal to 18 years of age at Screening.
* Subject must have a documented diagnosis of ocular hypertension, open angle glaucoma.
* Subject has a mean baseline (Day -7 and Day 0) Hour 0 (T0) untreated IOP of ≥ 24 mm Hg and ≤ 34 mm Hg in each eye, and (T0 + 4h) and (T0 + 8h) IOP of ≥ 22 mm Hg at Baseline Visit 2. Untreated IOP must be ≤ 34 mm Hg in each eye at all time points at both baseline visits.
* Subject has a BCVA of 0.6 logMAR (20/80 Snellen) or better in each eye as measured using an ETDRS chart.

Exclusion Criteria:

* Presence of any uncontrolled systemic or debilitating disease (e.g. cardiovascular disease, hypertension, diabetes, or cystic fibrosis).
* Punctum size is smaller than 0.4mm or greater than or equal to 1.0mm.
* Any single IOP in either eye at any time point during the Screening or either Baseline (Day -7/Day 0) Visits of \>34 mm Hg.

Primary outcomes:
measure: Mean IOP change from baseline
timeFrame: 90 days
Secondary outcomes:
measure: Visualization of OTX-TP punctum plug by subject
timeFrame: 90 days
Other outcomes:
measure: Best corrected visual acuity
timeFrame: 90 days
Locations:
city: Durban
country: South Africa
facility: Umhlanga Hospital Medical Centre
Study officials:
References:
Clinical trial NCT02896738: MRI Screening for Auditory Pathway Malformations in Visually Impaired Children
Official title: MRI Screening for Auditory Pathway Malformations in Visually Impaired Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Visual Impairment
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-12
Enrollment: 126
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Visually impaired children undergoing MRI exploration.

Brief summary: This pilot study aims to assess the interest to add an auditory pathway morphological analysis during the MRI exploration of visual pathway in visually impaired children.


Eligibility criteria: Inclusion Criteria:

* age \< 18 years old
* visual impairment
* MRI scheduled to explore their visual impairment
* parents' informed consent for participation in the study

Exclusion Criteria:

* tumoral origin for the visual impairment
* no health insurance coverage

Primary outcomes:
measure: number of patients with Auditory Pathway Malformation
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Louise Boyeldieu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06253338: Optimization of Radiation Protection Through Genomic Analyses
Official title: Optimization of Radiation Protection Through Genomic Analyses in the Analysis of Changes in Cells of the Hematopoietic System Before and During High Dose External Beam Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: DNA
Cancer
Radiation
Keywords: DNA
cancer
sequencing technologies
lymphocyte
genomic
loosely ionizing radiation
Linear Energy Transfer
outcome
thoracic radiotherapy
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The long-term goal is to define "signatures" in the form of genomic changes through sequence analyses of genomic DNA using modern Next Generation Sequencing (NGS) methods, which

1. determine the radiation exposure of humans.
2. provide information about the exposure (dose).
3. determine the radiation quality.
4. predict the repair capacity and radiation resistance of an individual.

Detailed description: The planned research work will investigate structural changes in DNA caused by loosely ionizing and high-LET (Linear Energy Transfer) radiation as well as their attribution to double-strand break repair pathways, which will be analysed in parallel using modern microscopy methods. Our aim is to incorporate sequencing technologies into the spectrum of methods used in radiation research and radiation protection. It is important for us to consider the practical requirements of radiation protection and to extend our experimental approaches to cell types relevant to radiation protection. For this reason, we have now created a separate work program that will focus specifically on sequence analyses in irradiated human lymphocytes. The aim is to successfully transfer the experimental approaches and bioinformatic analyses established in previous experiments in human skin fibroblasts to lymphocytes. Subjects can donate blood samples on a voluntary basis at predetermined times. Only subjects without previous radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc. and without a previous tumor diagnosis in the medical history and in good performance status (ECOG 0-1) will be included.

Eligibility criteria: Inclusion Criteria:

ECOG 0/1 no prior treatment no prior cancer diagnosis thoracic or head and neck cancer

Exclusion Criteria:

prior treatment (chemotherapy, radiotherapy, etc.) prior cancer diagnosis

Primary outcomes:
measure: Alteration of the genome under radiotherapy
timeFrame: 5 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 5 years
measure: Progression Free Survival
timeFrame: 5 years
measure: Radiation induced changes in the genome
timeFrame: 2 months to 5 years
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Department for Radiotherapy, University Hospital Essen, National Center for Tumor Diseases (NCT) West
state: Germany / NRW
Study officials:
References:
Clinical trial NCT01653938: A Trial of a CPR Video in Heart Failure Patients
Official title: A Randomized Controlled Trial of a CPR Video in Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congestive Heart Failure
Keywords: CHF
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-07-31
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a randomized controlled trial of a CPR video decision aid in patients with advanced congestive heart failure (CHF).

Detailed description: Aim 1: To compare the care preferences for CPR and intubation among subjects randomized to video and subjects randomized to the current standard of care without the video.

Hypothesis 1: Subjects randomized to the video intervention will be significantly more likely to opt against CPR and intubation compared to those who do not see the video.

Aim 2: To compare code-status documentation in the electronic medical records between subjects randomized to the video and those who are receiving the current standard of care without the video.

Hypothesis 2: Subjects randomized to the video are more likely to have their code status correctly documented in the electronic medical records compared to those who do not see the video.

Aim 3: To compare knowledge and decisional conflict of subjects randomized to video and subjects randomized to the current standard of care without the video.

Hypothesis 3: When compared to subjects randomized to the current standard of care, subjects in the video intervention group will have higher knowledge and lower decisional conflict (lower decisional conflict scores) when asked to choose CPR and intubation preferences.

Eligibility criteria: Inclusion Criteria:

1. A diagnosis of advanced heart failure:

   * New York Heart Association Class III or IV (III: marked limitation in activity due to symptoms, even during less-than-ordinary activity; IV: severe limitations, experiences symptoms while at rest). AND
   * Two or more hospitalizations for heart failure in the last year. AND
   * Either a systolic blood pressure ≤ 120 mm Hg OR Na ≤ 135 mEq/L.
2. Ability to provide informed consent.
3. Ability to communicate in English.
4. Age 65 or older.

Primary outcomes:
measure: preferences
timeFrame: 5 minutes after survey
Secondary outcomes:
measure: knowledge
timeFrame: 5 minutes after survey
measure: decisional conflict
timeFrame: 5 minutes after survey
measure: advance care planning documentation
timeFrame: by the end of one year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT00736138: Hyperpronation and Foot Pain
Official title: Effect of Training and Pellots in Treatment of Foot Pain Caused by Hyperpronation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthritis of Knee
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2008-08-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effects of training and pellots


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Northern Orthopaedic Division, Klinik Aalborg
state: Northern Jutland
Study officials:
affiliation: Northern Orthopaedic Division
name: Ole H Simonsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06970938: Cardiac Rehabilitation After Coronary Artery Bypass Graft Surgery
Official title: Effect of Cardiac Rehabilitation Program on Quality of Life, Sleep Quality, Anxiety, Depression and Cardiopulmonary Function After Coronary Artery Bypass Graft Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Rehabilitation
Coronary Artery Bypass Surgery
Lead sponsor: Muhammed Onur Hanedan
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 28
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: This study aimed to evaluate the effects of cardiac rehabilitation program after CABG surgery on quality of life, sleep quality, anxiety, depression and cardiopulmonary functions.

Detailed description: Hypothesis 1:

H0: Cardiac rehabilitation has no effect on quality of life patients with CABG surgery.

H1: Cardiac rehabilitation has an effect on quality of life patients with CABG surgery.

Hypothesis 2:

H0: Cardiac rehabilitation has no effect on sleep quality patients with CABG surgery.

H1: Cardiac rehabilitation has an effect on sleep quality patients with CABG surgery.

Hypothesis 3:

H0: Cardiac rehabilitation has no effect on anxiety and depression patients with CABG surgery.

H1: Cardiac rehabilitation has an effect on anxiety and depression with CABG surgery.

H0: Cardiac rehabilitation has no effect on cardiopulmonary function patients with CABG surgery.

H1: Cardiac rehabilitation has an effect on cardiopulmonary function patients with CABG surgery.

Eligibility criteria: Inclusion Criteria:

- Patients who had isolated CABG surgery 3 months ago, patients with EF 50% and above, patients who are eligible for the CR program, patients who agree to participate in the study, patients who are 18 years of age and above

Exclusion Criteria:

* Patients who did not consent to participate in the study, patients who had emergency CABG surgery, patients who had minimally invasive CABG surgery, patients who had repeat cardiac surgery, patients with a disease that was not suitable for the CR program (e.g., stage IV heart failure, unstable angina), patients with EF \< 50%, patients with a psychiatric diagnosis and patients using medications

Primary outcomes:
measure: Evaluation of quality of life of groups
timeFrame: ıt ranges from 3 months to 6 months
measure: Evaluation of sleep quality of groups
timeFrame: ıt ranges 3 months to 6 months
measure: Evaluation of depression and anxiety of groups
timeFrame: ıt ranges 3 months to 6 months
measure: Evaluation of cardiopulmonary functions of groups
timeFrame: ıt ranges 3 months to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Ahi Evren Göğüs Kalp ve Damar Cerrahisi Eğitim ve Araştırma Hastanesi
Study officials:
References:
Clinical trial NCT00260338: Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia
Official title: Stem Cell Therapy for Vasculogenesis in Patients With Severe Myocardial Ischemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Myocardial Ischemia
Coronary Heart Disease
Keywords: myocardial ischemia
stem cell
mesenchymal
myocardial perfusion
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2005-12-01
Enrollment: 31
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue.

The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.

Detailed description: Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue.

The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.

4o patients with reversible ischemia on a SPECT will be treated with direct intramyocardial injections of autologous isolated and expanded mesenchymal stem cells.Clinical and objective evaluations will be performed at baseline and during 12 months follow-up.

Eligibility criteria: Inclusion Criteria:

* Age 30 to 80 years Reversible ischemia on a stress SPECT Angina pectoris CCS class \>_ 2 Reduced exercise time \< 10 min No further revascularization options

Exclusion Criteria:

* Pregnant Present or history of cancer Proliferative retinopathy Systemic severe disease LVEF \< 25 % NYHA \> II

Primary outcomes:
measure: Improvement in myocardial perfusion measured by SPECT
timeFrame: 6 months after treatment
Secondary outcomes:
measure: Safety
timeFrame: 6 months after treatment
measure: Improvement in myocardial perfusion and function measured by PET and MR
timeFrame: 6 months after treatment
measure: Exercise time
timeFrame: 6 months after treatment
measure: Clinical angina status
timeFrame: 6 months after treatment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Cardiovascular Lab. 2014, The Heart Centre, Rigshospitalet, Blegdamcvej 9
Study officials:
affiliation: Rigshospitalet, Denmark
name: Jens Kastrup, MD DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mathiasen AB, Haack-Sorensen M, Jorgensen E, Kastrup J. Autotransplantation of mesenchymal stromal cells from bone-marrow to heart in patients with severe stable coronary artery disease and refractory angina--final 3-year follow-up. Int J Cardiol. 2013 Dec 10;170(2):246-51. doi: 10.1016/j.ijcard.2013.10.079. Epub 2013 Oct 28.
Clinical trial NCT00844038: Stevens-Johnson Syndrome Antimicrobial
Official title: Stevens-Johnson Syndrome Associated With Antimicrobial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stevens-Johnson Syndrome
Keywords: Steven-Johnson syndrome
erythema multiform
autoimmune disease
Lead sponsor: University of Pernambuco
Sponsor class: OTHER
First posted: 2009-02-13
Enrollment: 1
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1

Brief summary: Steven-Johnson's syndrome, or great multiform erythema, appears as a systemic disturbance, with skin involvement and mucous membranes, related to several factors, such as, viral or bacterial infections and mainly the administration of medicines, in general painkillers and antibiotics. The objective of this work is report the emergence of ulcerative vesicle -bubble chronic disease in areas of lips, gum, tongue and genital mucous membrane in a 26 year-old patient, leucoderma and masculine gender, in treatment of breathing infection with sulfametoxazol-trimetropima, having been diagnosed as syndrome of Steven-Johnson.

Detailed description: Among the serious medicaments reactions, there are as great representative the Mucocutaneous Disorders immunological mediated. Steven-Johnson's syndrome, or great multiform erythema, appears as a systemic disturbance, with skin involvement and mucous membranes, related to several factors, such as, viral or bacterial infections and mainly the administration of medicines, in general painkillers and antibiotics. The objective of this work is report the emergence of ulcerative vesicle -bubble chronic disease in areas of lips, gum, tongue and genital mucous membrane in a 26 year-old patient, leucoderma and masculine gender, in treatment of breathing infection with sulfametoxazol-trimetropima, having been diagnosed as syndrome of Steven-Johnson.

Eligibility criteria: Inclusion Criteria:

* Stevens-Johnson syndrome associated with antimicrobial

Exclusion Criteria:

* Not sick

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: University of Pernambuco
state: Pernambuco
Study officials:
affiliation: University of Pernambuco
name: Edwaldo Dr Dourado, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vanfleteren I, Van Gysel D, De Brandt C. Stevens-Johnson syndrome: a diagnostic challenge in the absence of skin lesions. Pediatr Dermatol. 2003 Jan-Feb;20(1):52-6. doi: 10.1046/j.1525-1470.2003.03012.x.
Clinical trial NCT04692038: Evaluate the Diagnostic Value of Puncture Biopsy for PPL Under the Guidance of Navigation and Radial EBUS: a Real-World Study
Official title: A Real-World Study to Evaluate the Diagnostic Value of Puncture Biopsy for Peripheral Lung Nodules Under the Guidance of Augmented Reality Navigation System Combined With Radial EBUS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung; Nodes
Keywords: Peripheral pulmonary nodules
biopsy
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who meet all inclusion criteria and do not meet any exclusion criteria will be enrolled in the study consecutively.

Brief summary: The study is designed to evaluate the safety and effectiveness of biopsy forceps combined with puncture biopsy for the diagnosis of peripheral pulmonary nodules under the guidance of Augmented Reality Navigation System combined with radial endobronchial ultrasound (r-EBUS), and to explore the factors influencing the diagnosis rate.

Detailed description: The study will last for no longer than 12 months. Patients will be first screened, and only after meeting all the inclusion criteria, not meeting any exclusion criteria, and signing the informed consent, could they be enrolled in the group to receive forceps biopsy combined with puncture biopsy to sample the target nodules. The primary endpoint is the combined diagnostic yield of forceps biopsy and puncture biopsy. The secondary endpoints include the success rate of biopsy, the operation time of the bronchoscope and so on.

Eligibility criteria: Inclusion Criteria:

* 1. Age ≥ 18 years old; 2. Chest CT shows that the peripheral lung noduleswith uncertain diagnosis are adjacent or far from the airway, and/or are difficult to obtain samples by routine biopsy as assessed by investigators; 3. Understand the research and sign the informed consent form.

Exclusion Criteria:

* 1. Contraindications for bronchoscopy; 2. Severe cardiopulmonary dysfunction and other diseases that may significantly increase the risk of surgery; 3. Bronchoscopy shows visible intra-airway nodules above the 3rd bronchus; 4. The investigator believes that the patient has other conditions that are not suitable for inclusion in this study.

Primary outcomes:
measure: Combined Diagnostic yield
timeFrame: Six months
Secondary outcomes:
measure: Diagnostic yield
timeFrame: Six months
measure: The success rate of biopsy
timeFrame: Immediately after bronchoscopy biopsy
measure: Operation time of the bronchoscopy
timeFrame: Immediately after bronchoscopy biopsy
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Disease, The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References: