louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01638858: Treatment of Diabetic Macular Edema With 0.5mg Intraocular Ranibizumab (Lucentis)
Official title: A Prospective, Non-randomized, Mono-center, Cohort Study of Evaluate the Effects of 0.5mg Intraocular Ranibizumab (Lucentis)Injections on Retinal Function in Patients With Diabetic Macular Edema (DME) During Twelve Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-Related Macular Degeneration
Lead sponsor: University of Luebeck
Sponsor class: OTHER
First posted: 2012-07-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this prospective, open-label clinical study is to investigate the behavior of the retinal functions during development of diabetic macular disease (DME) under the influence of Lucentis. Measurements with the multifocal electroretinogram (ERG) and microperimetry is used here as an objective criteria to information about the retinal function obtain.


Eligibility criteria: Inclusion Criteria:

1. diabetic macular edema with center involvement in at least one eye
2. patients with a central retinal thickness
3. patients with a BCVA of 78-24 EDTRS letters
4. decrease in vision is due to DME and not due to other causes, in the opinion of the investigator
5. Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening

Exclusion Criteria:

1. history or evidence of severe cardiac disease
2. clinical or medical history uncontrolled hypertension or diabetes
3. of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months
4. ventricular tachyarrhythmias requiring ongoing treatment
5. history or evidence clinically significant peripheral vascular disease, such a intermittent claudication or prior amputation
6. clinically significant impaired renal or hepatic function

Primary outcomes:
measure: Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months
timeFrame: 12 months
Secondary outcomes:
measure: to document changes in best corrected visual acuity measured on 4 meters
timeFrame: 12 months
measure: to document changes in microperimetry
timeFrame: 12 months
measure: to document changes in optical coherence tomography (OCT)
timeFrame: 12 months
Other outcomes:
Locations:
city: Lübeck
country: Germany
facility: University of Luebeck - Department of Ophthalmology
Study officials:
affiliation: University of Luebeck - Department of Ophthalmology: Germany
name: Salvatore Grisanti, M.D. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01131858: Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency
Official title: A Placebo Controlled Double Blinded Study of Vitamin D3 Substitution to Patients With Primary Immunodeficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Primary Immune Deficiency Disorder
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2010-05-27
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Hypothesis: Cholecalciferol (vitamin D3) prevent respiratory tract infections in patients with primary immunodeficiency.


Eligibility criteria: Inclusion Criteria:

* Age 18-75
* Increased number of respiratory tract infections
* At least 42 days of infections during 2008 or 2009
* S-25 OH vitamin D3 \< 250 nM
* Not planning a pregnancy during the coming year
* Accepting the use of contraceptives during 1 year

Exclusion Criteria:

* Continuous antibiotic treatment
* Hypercalcemia
* Sarcoidosis
* Kidney disease
* Tuberculosis
* Pregnancy
* Kidney stone
* Heart medication (glycosides)

Primary outcomes:
measure: Infectious score
timeFrame: 12 months
Secondary outcomes:
measure: Antimicrobial peptide expression in nasal fluid
timeFrame: 12 months
measure: Serum levels of 25-OH Vitamin D3
timeFrame: 12 months
measure: Consumption of antibiotics
timeFrame: 12 months
measure: Number of positive bacterial cultures in nasal swabs
timeFrame: 12 months
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Univerisity Hospital
Study officials:
affiliation: Karolinska University Hospital
name: Jan Andersson, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bergman P, Norlin AC, Hansen S, Bjorkhem-Bergman L. Vitamin D supplementation improves well-being in patients with frequent respiratory tract infections: a post hoc analysis of a randomized, placebo-controlled trial. BMC Res Notes. 2015 Sep 29;8:498. doi: 10.1186/s13104-015-1504-2.
citation: Bergman P, Norlin AC, Hansen S, Bjorkhem-Bergman L. Vitamin D supplementation to patients with frequent respiratory tract infections: a post hoc analysis of a randomized and placebo-controlled trial. BMC Res Notes. 2015 Aug 30;8:391. doi: 10.1186/s13104-015-1378-3.
Clinical trial NCT00366158: EVITA: Evaluation of VIP Feature in Pacemaker Patients
Official title: EVITA: Evaluation of VIP Feature in Pacemaker Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmia
Keywords: Patients with intact AV conduction
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2006-08-21
Enrollment: 461
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 primary efficacy objective of this clinical investigation is to demonstrate that the Ventricular Intrinsic Preference (VIP™) feature allows to reduce the medium- and long-term incidence of unnecessary ventricular pacing in patients with intact AV conduction.


Eligibility criteria: Inclusion Criteria:

* Patient has an indication for implantation of a dual-chamber pacemaker;
* Patient is implanted or scheduled to be implanted with a St Jude Medical Victory pacemaker, or newer device with the same study relevant feature.

Exclusion Criteria:

* Patient has persistent or permanent AF/AFl;
* Patient has permanent AV Block;
* Patient has a pacemaker replacement;
* Patient is in NYHA class IV;
* Patient is unable to attend the follow-up visits;
* Patient is pregnant;
* Patient is less than 18 years of age

Primary outcomes:
measure: Percentage of ventricular pacing
timeFrame: 6 and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Universitätskliniken Heidelberg
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
Study officials:
affiliation: Universitätskliniken Heidelberg, Heidelberg, 69115, Germany
name: Alexander Bauer, MD
role: STUDY_CHAIR
affiliation: Sahlgrenska University Hospital
name: Charles Kennergren, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bauer A, Vermeulen J, Toivonen L, Voitk J, Barr C, Peytchev P. Minimizing right ventricular pacing in pacemaker patients with intact and compromised atrioventricular conduction : Results from the EVITA Trial. Herzschrittmacherther Elektrophysiol. 2015 Dec;26(4):359-66. doi: 10.1007/s00399-015-0394-2. Epub 2015 Aug 28.
Clinical trial NCT04240158: IW-6463 Safety Study in Healthy Elderly Subjects
Official title: Evaluating the Safety, Tolerability, and Pharmacodynamic Properties of IW-6463 in Healthy Elderly Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Other
Lead sponsor: Tisento Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-01-27
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, double-blind, placebo-controlled, 2-way cross-over study in healthy male and female elderly participants.

Detailed description: Participants will receive up to a total of 30 daily doses of study drug (15 days of daily IW-6463, only; 15 days of daily placebo, only) administered across two 15-day dosing periods (Period 1 and Period 2). The dosing periods will be separated by a 27-day washout. Participants will be randomized to a sequence of receiving IW-6463 for Period 1 and then placebo for Period 2, or vice versa.

Eligibility criteria: Inclusion Criteria:

* Subject is an ambulatory adult at least 65 years old at the screening visit
* Subject is in good health and has no clinically significant findings on physical examination
* Female participants must be postmenopausal. A postmenopausal state is defined as no menses for ≥12 consecutive months without an alternative medical cause. A high follicle-stimulating hormone (FSH) level at screening (\>40 IU/L or mIU/mL) in the postmenopausal range may be used to confirm a postmenopausal state.
* Male participants who have not been surgically sterilized by vasectomy (conducted ≥60 days before the Screening Visit or confirmed via sperm analysis) must agree contraceptive use per protocol
* Men must also agree to not donate sperm throughout the study and for 3 months after the final dose of study drug
* Other inclusion criteria per protocol

Exclusion Criteria:

* Any active or unstable clinically significant medical condition
* Other exclusion criteria per protocol

Primary outcomes:
measure: Change From Baseline in Cerebral Blood Flow (CBF) at Day 15
timeFrame: Baseline, 15 days
measure: Number of Participants With ≥1 Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research (CHDR)
Study officials:
affiliation: Cyclerion Therapeutics, Inc
name: Chad Glasser, PharmD
role: STUDY_DIRECTOR
affiliation: Centre for Human Drug Research
name: Geert Jan Groeneveld, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05443958: The Role of Intracranial Electroencephalography (IEEG) in the Localization of Epileptogenic Zones (EZ) and Its Relationship With Prognosis
Official title: The Role of IEEG in the Localization of EZ and Its Relationship With Prognosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-07-05
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We reviewed consecutive patients with drug-resistant focal epilepsy who underwent intracranial electroencephalography (IEEG) evaluation as well as resective surgery in our epilepsy centre. They were all followed-up for \> 1 years after surgery. The patients had a comprehensive evaluation including detailed history, neuropsychological testing, neuroimaging study and video-EEG examination.

Brief summary: The mechanism of epilepsy pathogenesis is complex and not fully defined, and about 20-30% of patients with seizures that cannot be completely controlled by drugs become drug-resistant epilepsy. For focal drug-resistant epilepsy, surgical removal of the epileptogenic zone can control seizures, but the overall seizure-free rate in the long term after surgery is 60-70%, and the results are still not satisfactory. Accurate assessment of the location and extent of the epileptogenic zone and its adequate excision are prerequisites for the success or failure of surgery. Intracranial EEG (iEEG) has been shown to be the most accurate method for determining the location and boundaries of the epileptogenic zone. It can selectively record the local cortical electrical activity through intracranial electrodes and achieve high temporal resolution for long-range recording, reliably reflecting the continuous dynamic changes of EEG during interictal and ictal periods. The in-depth analysis of iEEG can improve the efficacy of epilepsy surgery and provide important information to reveal the pathogenesis of epilepsy.


Eligibility criteria: Inclusion Criteria:

1. Complete clinical history;
2. IEEG monitoring at least one habitual seizure；
3. Follow up for at least 1 year；
4. Signed informed consent.

Exclusion Criteria:

1. Habitual seizures were not found in iEEG monitoring;
2. No operation was performed;
3. Lost to follow-up for various reasons within 1 year after surgery.

Primary outcomes:
measure: Comparison of clinical data and IEEG characteristics in the seizure-free and not seizure-free groups
timeFrame: 1-2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Study officials:
References:
Clinical trial NCT00849758: Gene Polymorphisms and Gene Products as Biological Markers of Aging and Correlation With Clinical Geriatric Assessment, Tolerance of Chemotherapy and Outcome in Elderly Breast Cancer Patients
Official title: Gene Polymorphisms and Gene Products as Biological Markers of Aging and Correlation With Clinical Geriatric Assessment, Tolerance of Chemotherapy and Outcome in Elderly Breast Cancer Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Elderly
Keywords: breast cancer
elderly
biomarker
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2009-02-24
Enrollment: 110
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 70+, female, M0, all breast tumor types allowed (main goal is effect of chemo on the patient; looking at ER pos only would lead to insufficient numbers).

80 patients receiving adjuvant TC (taxotere cyclophosphamide 75/600) q3w, 4x Nadir systematically in first cycle (d10 and 15) to have idea on haematological toxicity grades III-IV.

No primary prophylaxis at first cycle, but allowed for secondary prophylaxis (febrile neutropenia or prolonged neutropenia = 5d \< 500 neutrophils).

Herceptin preferably given in HER2 positive patients after chemo (HERA like) in order to have similar treatment; but the investigator can also give concomitantly with chemo.

40 patients receiving 5y AI (control group).

Brief summary: The goal is to study the biology of aging in breast cancer patients, and to study the impact of chemotherapy on aging related blood biomarkers.


Eligibility criteria: Inclusion Criteria:

* 70 years or older
* Female
* Early breast cancer
* Candidate for systemic adjuvant therapy

Primary outcomes:
measure: the primary question is whether Chemotherapy affects biological aging markers, such as telomere length and immune status
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Jules Bordet Institute
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
References:
citation: Dalmasso B, Hatse S, Brouwers B, Laenen A, Berben L, Kenis C, Smeets A, Neven P, Schoffski P, Wildiers H. Age-related microRNAs in older breast cancer patients: biomarker potential and evolution during adjuvant chemotherapy. BMC Cancer. 2018 Oct 22;18(1):1014. doi: 10.1186/s12885-018-4920-6.
citation: Bailur JK, Pawelec G, Hatse S, Brouwers B, Smeets A, Neven P, Laenen A, Wildiers H, Shipp C. Immune profiles of elderly breast cancer patients are altered by chemotherapy and relate to clinical frailty. Breast Cancer Res. 2017 Feb 28;19(1):20. doi: 10.1186/s13058-017-0813-x.
Clinical trial NCT06786858: Hand Exoskeleton Training Study
Official title: Home Training for Upper Limb Stroke Rehabilitation Using a Hand Exoskeleton
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 15
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The goal of this study is to evaluate the HandMATE device's effectiveness in the rehabilitation of stroke patients and asses if the HandMATE application is received well by stroke survivors.

Participants will use the HandMate device in clinic and in the home. They will also complete clinical upper extremity assessments.

Detailed description: This study will evaluate the effectiveness of novel device and its potential to help stroke victims regain functional use of their hand and regain independent living. The study will also evaluate the potential of the device to be used at home, this would allow increased therapy intensity and decreased overall treatment costs (fewer therapist hours required and decreased travel costs).

Eligibility criteria: Inclusion Criteria:

* Age of 21 or older
* diagnosis of stroke more than 6 months prior confirmed from MRI or CT
* voluntary hand activity (score of 1 or more, finger extension item, Fugl-Meyer Test)
* adequate cognitive status
* Impaired ability to open affected hand

Exclusion Criteria:

* hemispatial neglect
* severe sensory loss (2 or more on the sensory item, NIH Stroke Scale/Score)
* receiving or planning to receive antispasticity medications during enrollment into the study
* less than full passive range of motion in finger joints
* receiving physical or occupational therapy outside of study protocols
* have excessive pain in any joint of the affected extremity that could limit ability to cooperate with the protocols

Primary outcomes:
measure: Fugl-Meyer Upper Extremity (FMA-UE) Test
timeFrame: Change from baseline Fugl-Meyer score at 6 weeks
measure: Action Research Arm Test (ARAT)
timeFrame: Change from baseline ARAT score at 6 weeks
measure: Motor Activity Log
timeFrame: Change from baseline MAL score at 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar National Rehabilitation Hospital
state: District of Columbia
Study officials:
affiliation: MedStar RI
name: Pete Lum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06165458: Whitening Efficacy and Tooth Sensitivity of Different Concentrations of Hydrogen Peroxide Photoactivated With Violet or Blue LEDs
Official title: Clinical Comparison of Whitening Efficacy and Tooth Sensitivity of Different Concentrations of Hydrogen Peroxide Photoactivated With Violet or Blue LEDs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Color
Bleaching Sensitivity
Lead sponsor: Universidade Federal do Para
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: This is a randomized, controlled, double-blind and repeated-measures clinical trial evaluated the photoactivation of hydrogen peroxide gels in different concentrations with blue or violet LED in terms of whitening efficacy and tooth sensitivity.


Eligibility criteria: Inclusion Criteria:

* at age 18 or older, with good general and oral health;
* possessing all six natural and healthy upper anterior teeth with a color shade of A2 or darker, determined by comparison with the Vita Classic scale;

Exclusion Criteria:

* pregnant and breastfeeding women;
* individuals with internal tooth discoloration (tetracycline stains, fluorosis or hypoplasias);
* smokers, or those with veneers or restorations on the teeth in questions were excluded;
* gingival recession;
* dentin exposure;
* periodontal disease.

Primary outcomes:
measure: Color
timeFrame: Color assessment was carried out before bleaching, 1 week after bleaching and 3 months after bleaching
measure: Bleaching Sensitivity
timeFrame: Assessments were carried out three times: before bleaching, immediately after bleaching, and 24 hours after bleaching.
Secondary outcomes:
Other outcomes:
Locations:
city: Belém
country: Brazil
facility: Federal University of Pará
state: Pará
Study officials:
References:
Clinical trial NCT01560858: Treatment Patterns Among Patients With Prostate Cancer Prior to Diagnosis of a Castration-resistant State
Official title: A Retrospective Observational Study to Describe Treatment Patterns Among Patients With Prostate Cancer Prior to Diagnosis of a Castration-resistant State, in Routine Clinical Practice in Spain.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2012-03-22
Enrollment: 407
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The purpose of the protocol is to describe treatment patterns among patients with prostate cancer prior to diagnosis of castration-resistant state.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patients with prostate cancer who had developed a castration resistant state in the last 24 months prior to starting the study
* Patient must give written informed consent before any study related procedure

Exclusion Criteria:

* Patients with medical histories lacking data required to evaluate the study objectives

Primary outcomes:
measure: Prior treatment before progression to advanced or metastatic disease.
timeFrame: Baseline
measure: Treatment of advanced or metastatic disease.
timeFrame: Baseline
Secondary outcomes:
measure: Clinical management of Castration-Resistant Prostate Cancer (CRPC) patients in the clinical practice.
timeFrame: Baseline
measure: Number of CRPC patients with signs and symptoms of metastatic disease.
timeFrame: Baseline
measure: Time to castration resistant state after beginning of hormonotherapy.
timeFrame: Baseline
measure: Demographic data.
timeFrame: Baseline
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Private practice, La Cañada, Paterna
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: