louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00793091: Safety and Efficacy Study of an Ophthalmic Solution in Patients With Age-Related Cataract
Official title: A Phase 2, Randomized, Placebo-Controlled, Double-Masked, Multicenter Safety and Efficacy Study of C-KAD Ophthalmic Solution in Patients With Loss of Visual Acuity Due to Age-Related Cataract
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cataract
Lead sponsor: Chakshu Research, Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-19
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
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 determine the safety and efficacy of C-KAD Ophthalmic Solution in improving visual acuity relative to placebo in patients with age-related cataract


Eligibility criteria: Inclusion Criteria:

* Presence of age-related cataract in the study eye
* Best-corrected visual acuity of 20/25 to 20/50 in the study eye

Exclusion Criteria:

* Any other clinical condition in the eye that may compromise vision
* Presence or History of Glaucoma
* Presence or history of diabetes
* Use of eyedrops
* Use of steroids

Primary outcomes:
measure: Best-corrected visual acuity by ETDRS
timeFrame: 120 Days
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Pacific Eye Specialists
state: California
city: Overland Park
country: United States
facility: Hunkeler Eye Institute
state: Kansas
city: Minneapolis
country: United States
facility: Minnesota Eye Consultants, PA
state: Minnesota
city: Charlotte
country: United States
facility: Charlotte Eye, Ear, Nose & Throat Associates
state: North Carolina
Study officials:
affiliation: Chakshu Research, Inc.
name: Ira Wong, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06999291: Ovarian Reserve in Intensive Care Patients
Official title: Evaluation of Ovarian Reserve in Critically Ill Patients Followed in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anti-Mullerian Hormone Deficiency
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: a group of healthy women without any disease and a group of patients hospitalized in intensive care unit.

Brief summary: Gastrointestinal, pulmonary, nephrological, cardiac, neurologic and psychological effects in critically ill patients followed in the intensive care unit have been shown in the literature. However, the effects on ovarian reserve in these patients have not been sufficiently investigated and studies investigating this issue are limited in the literature. The synthesis, release frequency and amplitude of reproductive hormones change under stress. In addition, changes in ovarian homeostasis affect ovarian reserve. The aim of this study was to evaluate ovarian reserve in critically ill patients followed up in the intensive care unit.


Eligibility criteria: Inclusion Criteria:

* 18-35 years of age
* Female patients followed in the intensive care unit for more than 24 hours for internal or surgical reasons,
* Women whose ovarian reserve is being evaluated,

Exclusion Criteria:

* Previous ovarian surgery, endometriosis, endometrioma,
* History of chemotherapy, radiotherapy,
* Ovarian cyst, malignancy and other ovarian pathologies,
* Women with single ovary,
* Women receiving hormone therapy,
* Polycystic ovary syndrome,
* Surgical intervention within the last 6 months,
* History of drug, alcohol, substance use,
* Women in pregnancy, puerperium, lactation,
* History of vaccination within the last 6 months

Primary outcomes:
measure: ovarian follicle count
timeFrame: 24 hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kayambankadzanja RK, Schell CO, Gerdin Warnberg M, Tamras T, Mollazadegan H, Holmberg M, Alvesson HM, Baker T. Towards definitions of critical illness and critical care using concept analysis. BMJ Open. 2022 Sep 5;12(9):e060972. doi: 10.1136/bmjopen-2022-060972.
citation: Moolhuijsen LME, Visser JA. Anti-Mullerian Hormone and Ovarian Reserve: Update on Assessing Ovarian Function. J Clin Endocrinol Metab. 2020 Nov 1;105(11):3361-73. doi: 10.1210/clinem/dgaa513.
Clinical trial NCT02915991: User Evaluation Study of SyncVision System With Software v4.X
Official title: Prospective, Single Arm, Open Label, User Evaluation Sudy of SyncVision System With Software v4.X
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Coronary Artery Disease
Keywords: Coronary catheterization
Instantaneous wave free ratio (iFR)
Fractional Flow Reserve (FFR)
automated co-registration
Lead sponsor: Volcano Corporation
Sponsor class: INDUSTRY
First posted: 2016-09-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patiets that undergo a cardiac catheterization and pressure-wire assessment in the coronary arteries as per standard hospital practice.

Brief summary: This is a prospective, single-arm, unblinded, case observation study evaluating a commercially released 'Conformité Européenne' (CE)-mark co-registration software system along-side of a commercially- released CE-mark coronary physiology and X-ray system during routine clinical workflow. The purpose of this study is to collect Professional user feedback regarding clinical utility of the SyncVision 4.X system.

Detailed description: The PREPARE II study will enroll a maximum of 200 patients in up to 5 sites. No follow-up will be performed. The PREPARE II study will only collect data during diagnostic angiogram or percutaneous coronary intervention (PCI) procedure, when performed as per standard hospital care.

Eligibility criteria: Inclusion Criteria:

* Patients eligible and indicated for cardiac catheterization and pressure-wire assessment in the coronary arteries as per standard hospital practice
* Males over the age of 18 years and post-menopausal females
* Patient is able to give written informed consent prior to using his/her study data for evaluation and documentation

Exclusion Criteria:

- Patient is unable to give written informed consent prior to using his/her study data for evaluation and documentation

Primary outcomes:
measure: Professional user feedback regarding clinical utility of the SyncVision 4.X system
timeFrame: Day 1 (Post-Procedure)
Secondary outcomes:
measure: Difference between assessments
timeFrame: Day 1 (Post-Procedure)
measure: Distinguish tandem, diffuse and mixed disease
timeFrame: Day 1 (Post-Procedure)
measure: Comparison of pre-intervention expected distal-most iFR with post-intervention actual distal-most iFR values
timeFrame: Day 1 (Post-Procedure)
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: The medical research and development fund for health services Hillel Yaffe
city: Haifa
country: Israel
facility: Rambam Health Corporation
Study officials:
affiliation: The medical research and development fund for health services Hillel Yafe
name: Aaron Frimerman, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Healthcare Campus
name: Ariel Roguin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06409091: Short Term Outcomes of Heavy-weight Versus Medium-weight Synthetic Mesh
Official title: Short Term Outcomes of Heavy-weight Versus Medium-weight Synthetic Mesh in a Retrospective Cohort of Clean-Contaminated and Contaminated Retromuscular Ventral Hernia Repairs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia, Ventral
Hernia Incisional
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2024-05-10
Enrollment: 1496
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent open ventral hernia repairs with synthetic mesh in contaminated and clean-contaminated hernia repair surgeries.

Brief summary: This study compares short term outcomes of patients undergoing a hernia repair with heavy weight mesh vs medium weight mesh in clean-contaminated and contaminated cases.

Detailed description: The Abdominal Core Health Quality Collaborative was queried for patients undergoing open retromuscular hernia repairs with both heavy weight polypropylene (PP) mesh and medium weight PP mesh in cases where there was clean-contaminated and contaminated surgeries. The short term outcomes were then evaluated including wound infections, readmissions, recurrences of the hernia, and quality of life scores.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing open ventral hernia repairs with synthetic mesh in contaminated and clean contaminated surgery

Exclusion Criteria:

* Laparoscopic or robotic surgery
* clean cases or dirty cases
* pregnancy
* under age of 18

Primary outcomes:
measure: Wound complications
timeFrame: 30 days post op
Secondary outcomes:
measure: Mesh removal
timeFrame: 30 days post op
measure: Readmissions
timeFrame: 30 days post op
measure: Reoperations
timeFrame: 30 days post op
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
References:
Clinical trial NCT00148291: Phase III Study of Docetaxel Vs Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer
Official title: Phase III Study of Docetaxel Vs Vinorelbine in Elderly Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Lead sponsor: West Japan Thoracic Oncology Group
Sponsor class: OTHER
First posted: 2005-09-07
Enrollment: 180
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vinorelbine is currently the standard treatment for elderly patients with advanced non-small cell lung cancer (NSCLC). Docetaxel has also shown promising results against elderly patients in phase II studies. We conducted a randomized phase III trial to evaluate whether docetaxel provided better overall survival than vinorelbine in elderly patients with advanced NSCLC.


Eligibility criteria: Inclusion Criteria:

Chemotherapy- and radiotherapy-naïve patients with histologically or cytologically diagnosis of stage IIIB or IV NSCLC and who were ≧ 70 years old with measurable or assessable disease were eligible for this trial. They had to have a life expectancy of at least 3 months. Additional entry criteria were as follows: (a) a performance status (PS) 0 to 2 on the Eastern Cooperative Oncology Group scale; (b) adequate function of bone marrow (leukocyte count ≧ 4,000/μL, absolute neutrophil count ≧ 2,000/μL, hemoglobin concentration ≧ 9.5 g/dL, platelet count ≧ 100,000/μL), kidney (serum creatinine ≦ 1.2 mg/dL), liver (total bilirubin ≦ 1.5 times the institutional upper limits of normal, transaminase of AST and ALT ≦ 2.5 times the institutional upper limits of normal).

Exclusion Criteria:

Patients with symptomatic brain metastasis or apparent dementia were ineligible. Patients with active concomitant malignancy, massive pleural effusion or ascites, active infection, severe heart disease, grade 2 or higher ECG abnormality, uncontrolled diabetes mellitus, ileus, pulmonary fibrosis, diarrhea, and a bleeding tendency were excluded.-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: West Japan Thoracic Oncology Group
name: Shinzoh Kudoh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03879291: Assessment of Utility of accelerateIQ in the Care of Patients Participating in a Pulmonary Rehabilitation Program
Official title: Assessment of Utility of accelerateIQ in the Care of Patients Participating in a Pulmonary Rehabilitation Program
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: COPD
Pulmonary Rehabilitation
Lead sponsor: physIQ, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Sunovian
First posted: 2019-03-18
Enrollment: 5
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be patients diagnosed with COPD participating in a pulmonary rehabilitation program.

Brief summary: The proposed study seeks to assess the performance of continuous biosensor data and machine learning analytics in assessment of health patient status in a pulmonary rehabilitation program.

It is hypothesized that using continuous physiologic biosensor data and machine learning analytics to detect changes in physiology may play a role in managing patients in the pulmonary rehabilitation setting.


Eligibility criteria: Inclusion Criteria:

* Male or female, at least 40 years of age;
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD);
* Enrolled in the study site's 12-week pulmonary rehabilitation program;
* Capable of completing a 6-minute walk test;
* Willing and able to comply with scheduled protocol procedures and follow up;
* Signed and dated informed consent and HIPAA materials indicating that the patient has agreed to participate in this study and has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

* Patient has cognitive or physical limitations that, in the opinion of the investigator, limit the patient's ability to utilize the System as instructed;
* Patient is actively enrolled in another clinical investigation that, in the opinion of the investigator, interferes with or compromises either that patient's ability to participation in this study or the ability for the study to generate results;
* Patients who have implanted defibrillators or pacemakers;
* Patient is allergic to hydrocolloid adhesive;
* Patient does not speak English.

Primary outcomes:
measure: Clinical Utility
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
Study officials:
References:
Clinical trial NCT04759391: Effects of Digital Pelvic Floor Muscle Training in Patients With Multiple Sclerosis Having Lower Urinary Tract Symptoms
Official title: Effects of Digital Pelvic Floor Muscle Training and Lifestyle Recommendations in Patients With Multiple Sclerosis Having Lower Urinary Tract Symptoms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Urinary Tract Symptoms
Keywords: Lower Urinary Tract Symptoms
Multiple Sclerosis
Pelvic Floor Muscle Training
Lead sponsor: Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly divided into two groups (control and exercise) for treatment.
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the effects of digital pelvic floor muscle training and lifestyle recommendations in patients with Multiple Sclerosis having lower urinary tract symptoms.

Detailed description: Multiple sclerosis (MS) is an autoimmune, neurodegenerative disease of the central nervous system. Lower urinary tract symptoms (LUTS) are very common in MS. Pelvic floor muscle training (PFMT) is one of the first-line choices for the conservative treatment of LUTS.

According to our knowledge, no study has investigated the effects of digital pelvic floor muscle training and lifestyle recommendations in MS having LUTS, yet.

Eligibility criteria: Inclusion Criteria:

* Having a diagnosis of MS and having at least two of the lower urinary symptoms
* Not having an attack in the last 1 month,
* No change in medical treatment in the last 3 months
* "Expanded disability status scale-EDSS" score is less than 6.5
* Not having any cognitive problems that would hinder cooperation and understanding
* Those who use digital devices such as computers, laptops, smartphones and tablets
* Volunteering to participate in the study

Exclusion Criteria:

* Pregnancy status
* Active urinary tract infection
* Another neurological disease that can cause incontinence
* A history of malignancy
* Prostate surgery
* Those with missing evaluation parameters
* Those who do not regularly participate in treatment programs

Primary outcomes:
measure: Incontinence symtoms
timeFrame: change from baseline at 8 weeks
measure: Overactive bladder symptoms
timeFrame: change from baseline at 8 weeks
Secondary outcomes:
measure: bladder functions
timeFrame: change from baseline at 8 weeks
measure: Quality of life level
timeFrame: change from baseline at 8 weeks
measure: subjective perception of improvement
timeFrame: after treatment (8th week)
measure: patient satisfaction
timeFrame: after treatment (8th week)
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazit University
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00885391: QT Variability Pre and Post Cardioversion
Official title: QT Variability Pre & Post Cardioversion in Patient's With Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Cardioversion
Direct Current Cardioversion
QT Interval
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Wake Forest University Health Sciences
First posted: 2009-04-22
Enrollment: 219
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cardiology Clinic Hospital inpatient

Brief summary: The purpose of this study is to learn whether the chemicals in the blood and urine are different when the heart is atrial fibrillation compared to normal sinus rhythm.

Detailed description: Atrial Fibrillation variably activates the renin-angiotensin-aldosterone system (RAAS), stimulates the sympathetic nervous system, generates oxidant stress, produces natriuretic peptides, and increases ventricular rate. These are interrelated responses and the extent to which these or other pathophysiologic responses determine QT interval during and after Atrial Fibrillation (AF) is unknown. In this study, the QT variability is related to those potential markers in patients with AF undergoing elective DC-cardioversion.

Eligibility criteria: Inclusion Criteria:

* At least 21 years of age
* Scheduled to undergo an elective DC-Cardioversion of atrial fibrillation or atrial flutter at Vanderbilt University Medical Center

Exclusion Criteria:

* Undergoing emergent DC-Cardioversion of atrial fibrillation for hemodynamic instability
* Undergoing DC-Cardioversion for post-cardiac surgery
* Dual chamber pacemakers

Primary outcomes:
measure: QT variability before and after direct current cardioversion
timeFrame: 1.5
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Dawood Darbar, M.D., Ph.D., F.A.C.C.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02856191: Study on the Frequency of de Novo Atrial Fibrillation in Septic Shock in Medical Intensive Care
Official title: Prospective Study on the Frequency of de Novo Atrial Fibrillation in Septic Shock in Medical Intensive Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Septic Shock
Atrial Fibrillation
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of this pilot study is to determine, as exhaustively as possible thanks to the continuous and precise recording of heart rhythm, the frequency of de novo atrial fibrillation in septic shock, which is currently unknown, and to identify specific factors that could be associated with the condition. These will be investigated more precisely in a future study. This constitutes the first step in a reflection on the management of Cardiac Arrhythmia by Atrial fibrillation (ACFA) in septic shock in Medical Intensive Care, known as a major prognostic factor for morbimortality, but for which management is uncertain in the absence of reference data.


Eligibility criteria: Inclusion Criteria:

* All patients in septic shock (defined as hypotension that is not reversed by fluid resuscitation and requires the use of vasopressor agents) hospitalized in Medical intensive care
* Patients with national health insurance cover
* Age: at least 18 years with no upper limit

Exclusion Criteria:

* Transferred from another intensive care unit for septic shock
* Adults under guardianship
* History of atrial fibrillation

Primary outcomes:
measure: Atrial fibrillation diagnosed on a Holter recording
timeFrame: Over 7 days following the onset of septic shock, or until death or discharge, if one of these events occurs in the 7 days following the onset of the shock.
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT01675791: A Dose-response Evaluation of ALK (the Sponsor) Tree Allergy Immunotherapy Tablet
Official title: A Dose-response Evaluation of ALK Tree AIT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Birch Pollen Allergy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2012-08-30
Enrollment: 637
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of this trial is to evaluate the dose-response relationship for the ALK tree AIT administered once daily in order to define a dose-range that would be suitable for at-home administration.


Eligibility criteria: Inclusion Criteria:

* A history of moderate to severe birch pollen allergy
* Use of symptomatic medication for treatment of birch pollen allergy
* Positive skin prick test to birch extract
* Positive specific IgE against Bet v 1

Exclusion Criteria:

* Overlapping perennial allergies
* History of uncontrolled asthma within the last 3 months
* FEV1 \< 70% of predicted value in adults or FEV1 \< 80% of predicted value in adolescents
* Previous or ongoing treatment with immunotherapy

Primary outcomes:
measure: Allergy symptom severity scores on a scale from 0-3
timeFrame: During the birch pollen season 2013, an expected average of 3 weeks
measure: Adverse events frequency
timeFrame: Throughout the trial, an expected average of 8 months
Secondary outcomes:
measure: Adverse events severity
timeFrame: Throughout the trial, an expected average of 8 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Skin and Allergy Hospital, Helsinki University Central Hospital
state: HUS
city: Amsterdam
country: Netherlands
facility: Slotervaart Ziekenhuis
Study officials:
References: