louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01459692: Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps
Official title: Reduction and Prevention of Seizure Occurrence From Exposure to Auditory Stimulation in Individuals With Neurological Handicaps
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seizures
Epilepsy
Keywords: Seizures
Epilepsy
Auditory Stimulation
Music
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: MIND Research Institute
First posted: 2011-10-26
Enrollment: 40
Sex: ALL
Minimum age (years): 5
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neurologically-impaired individuals may have significant neurologic morbidity related to epilepsy and seizure disorders. Finding safe, noninvasive methods of decreasing seizures, and potentially reversing the epileptogenic process, is of paramount importance in improving the lives of those with epilepsy.


Eligibility criteria: Inclusion Criteria:

* Resident of Thad E. Saleeby Center
* Epilepsy or seizure disorder
* At least one year of detailed seizure reporting prior to study starting date

Exclusion Criteria:

* Severe hearing impairment

Primary outcomes:
measure: Changes in seizure rates
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Robert P Turner, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
affiliation: MIND Research Institute
name: Mark Bodner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bodner M, Turner RP, Schwacke J, Bowers C, Norment C. Reduction of seizure occurrence from exposure to auditory stimulation in individuals with neurological handicaps: a randomized controlled trial. PLoS One. 2012;7(10):e45303. doi: 10.1371/journal.pone.0045303. Epub 2012 Oct 11.
Clinical trial NCT06092892: IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients with Breast Cancer with Nodal Metastases
Official title: IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients with Clinical T1-2N0 ER+ Her2- Breast Cancer with Ultrasound Detected Nodal Metastases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Axillary Nodal Disease
Female Breast Cancer
Axilla; Breast
Mastectomy; Lymphedema
Tumor, Breast
Keywords: T1-2N0 ER+ invasive
biopsy
upfront lumpectomy
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 45
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open label, single arm
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the recurrence rates and survival of patients with clinical T1-2N0 ER+/Her2- invasive breast cancer who have biopsy proven image detected nodal disease treated with upfront lumpectomy or mastectomy with TAD followed by adjuvant therapy. This is a prospective, single arm phase II clinical trial. Patients will be screened and enrolled per eligibility criteria. Patient, tumor, and treatment data will be documented.


Eligibility criteria: Inclusion Criteria:

* Women age ≥ 45
* Clinical T1-2N0 ER+ invasive breast cancer
* US detected biopsy proven axillary nodal disease
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Palpable nodes on physical exam
* Her2+ or ER- invasive breast cancer
* Extranodal extension \> 3 mm on nodal biopsy
* More than 2 suspicious nodes on preoperative imaging

Primary outcomes:
measure: Regional recurrence rate
timeFrame: 5 Years
Secondary outcomes:
measure: Local recurrence rate
timeFrame: 5 Years
measure: Disease-free survival (DFS)
timeFrame: 5 Years
measure: Breast cancer specific survival (BCSS) rate
timeFrame: 5 Years
measure: Overall survival (OS)
timeFrame: 5 Years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
state: California
city: Pasadena
country: United States
facility: CS Cancer at Huntington Cancer Center
state: California
city: Tarzana
country: United States
facility: CS Cancer at Valley Oncology Medical Group
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Alice Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06540092: Early Pregnancy Ultrasound Measurements and Prediction of First Trimester Pregnancy Loss.
Official title: Early Pregnancy Ultrasound Measurements and Prediction of First Trimester Pregnancy Loss.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: First Trimester Abortion
Keywords: ultrasound measurments
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 126 pregnant women between 6- 13 weeks

Brief summary: Ultrasound measurements of fetus during first trimester may be an indicator of first trimester pregnancy loss. Investigators took 4 measurements of the fetus on 2 intervals during first trimester to confirm this hypothesis.

Detailed description: Ultrasound examination of gestational sac (GS) diameter, yolk sac (YS) diameter, crown rump length (CRL) diameter, embryonal heart rate (HR) using Samsung Medison SonoAce R3 through transvaginal probes (6.5 MHz) was conducted on 126 pregnant women. At least 2 scans were done for each participant one between 6-8 weeks and another one by the end of first trimester. Results then were compared to get the cut off values that can predict pregnancy loss.

Eligibility criteria: Inclusion Criteria:

* • Healthy pregnant female patient in the reproductive age group; 18 - 40 years old.

  * Gestational age: 6 - 13 weeks of gestations.
  * Singlton or multifetal pregnancy.
  * Any mode of conception included spontaneous, after superovulation with clomiphene citrate or letrozole with, or without, intrauterine insemination (IUI), and in vitro fertilization (IVF) after superovulation with gonadotropins.

Exclusion Criteria:

* • Patient with unsure date for the last menstrual period.

  * Pregnant women above 13 weeks gestation.
  * Patient with symptoms of threatened abortion or ectopic pregnancy at the initial antenatal visit.
  * Patient unable to come for follow up.
  * Any medical disorders as DM, HTN, ...

Primary outcomes:
measure: The relation between early pregnancy ultrasound measurements (GSD, YSD, CRL, HR), viability, and continuation of pregnancy till 13 weeks of gestation.
timeFrame: 6-7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: kasr Al Aini, Faculty of Medicine, Cairo University
state: Old Cairo
Study officials:
References:
Clinical trial NCT04269044: The Efficacy of a Novel, Non-contact EKG in the NICU
Official title: The Efficacy of a Novel, Non-contact EKG in the NICU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Electrocardiogram Electrode Site Reaction
Lead sponsor: Northwestern Medicine
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 10
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will be studying neonates in the NICU. They have sensitive skin and thus a suspected benefit from switching to a non-contact EKG

Brief summary: We will be comparing a novel, non-contact EKG waveform and heart rate to the standard of care, contact-based EKG waveform and heart rate in neonates, who have sensitive skin.


Eligibility criteria: Inclusion Criteria:

* Apgar at 5 min \>/= 7
* Admitted to the NICU
* Indication for standard EKG monitoring

Exclusion Criteria:

* Apgar \< 7 at 5 min
* Not in the NICU
* Not being monitored with standard EKG monitors

Primary outcomes:
measure: difference in heart rate
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Forest
country: United States
facility: Northwestern Lake Forest Hospital
state: Illinois
Study officials:
References:
Clinical trial NCT04828044: Microwave Ablation of Breast Tumors
Official title: Microwave Ablation of Breast Tumors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Keywords: Breast Cancer
Tumors
Lead sponsor: St. Joseph Hospital of Orange
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of primary breast tumor for which a surgical resection (excisional, biopsy, segmentectomy or mastectomy) is planned.

Brief summary: The purpose of this protocol is to pathologically evaluate the amount of destruction of cancer cells by Microwave Ablation (MWA) in primary breast tumors.

Detailed description: Minimally invasive surgical alternatives are becoming more attractive for the treatment of malignancy due to improvements in technology, reduced costs and reduced morbidity. The main objective of this protocol is to determine the extent of ablation based on time and power parameters of the MedWaves in breast cancers. This would be accomplished in patients diagnosed with breast cancer who are already scheduled for breast cancer surgery. Prior to the surgical removal of the cancer, the microwave antenna would be inserted into the tumor under ultrasound guidance (either percutaneously or open). The tumor would be ablated, and then surgically resected in a standard, curative fashion.

Eligibility criteria: Inclusion Criteria:

* a diagnosis of primary breast tumor for which a surgical resection (excisional, biopsy, segmentectomy or mastectomy) is planned.
* Tumor is palpable or visible on ultrasound or both
* All participants need to be fully able to give informed consent

Exclusion Criteria:

* Gender: male
* Mental or legal incompetence
* Impaired decision-making capacity
* Pregnant women may not participate
* Implanted Pacemaker

Primary outcomes:
measure: Amount of tissue destruction with MedWaves Microwave Ablation/ Coagulation System.
timeFrame: 30 days
Secondary outcomes:
measure: Provide the differences between percutaneous and open Microwave Ablation
timeFrame: 30 Days
measure: Amount of toxicity of microwave ablation in patients.
timeFrame: 30 Days
Other outcomes:
Locations:
city: Orange
country: United States
facility: St. Joseph Hospital of Orange
state: California
Study officials:
affiliation: St. Joseph Hospital of Orange
name: Lawrence Wagman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03894644: Simulation-based Learning for Neurosurgical Instruments in Perioperative Nurses
Official title: Knowledge Transfer and Retention of Simulation-based Learning for Neurosurgical Instruments: a Randomized Trial of 100 Perioperative Nurses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of Study: Simulation Technology
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Rapid technological advances in the last 20 years have led to the exponential adoption of simulation-based learning in nursing education.

Detailed description: Simulation-based learning is designed to engage, challenge and enrich the learner's knowledge base and skill set. It presents the opportunity to experience a variety of clinical scenarios, both common and uncommon, in a safe environment allowing repeated skills training and facilitating the transfer of classroom-knowledge to real situations.Research demonstrates that simulation can improve student engagement and learning and is being increasingly used as an educational strategy for nursing students. This prospective randomized controlled study that was undertaken with the following goals:

1. to investigate the effectiveness of simulation-based training in a large sample of perioperative nurses, measured as nurses' learning progress in the simulation environment;
2. to determine whether the learning acquired through this training is transferable to recognizing real surgical instruments; and
3. to evaluate whether simulation-based learning is retained at least one week.

Eligibility criteria: Inclusion Criteria:

* Perioperative nurse
* Employed at Queen Elizabeth II Health Sciences Center

Exclusion Criteria:

-Unable to provide informed consent

Primary outcomes:
measure: Change in time saved for simulation task
timeFrame: Day 1 and Day 7
measure: Change in number of errors for simulation task
timeFrame: Day 1 and Day 7
measure: Change in total score for simulation task
timeFrame: Day 1 and Day 7
measure: Difference in total score for knowledge transfer task
timeFrame: Day 7
measure: Difference in time for knowledge transfer task
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NSHA
name: David Clarke
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05982444: Long Term Follow up of Water Vapor Thermal Therapy (Rezum) for Benign Prostatic Hyperplasia (BPH)
Official title: Long Term Post-operative Effectiveness and Morbidity of Rezum Therapy for Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 50
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: in this study the investigators are assessing the effectiveness and morbidity of rezum therapy for benign prostatic hyperplasia by collect data and assess all patient who treated by rezum from 2 to 4 years and report these results.


Eligibility criteria: Inclusion Criteria:

* patients underwent rezum procedure for benign prostatic hyperplasia from 2 to 4 years

Exclusion Criteria:

* previous prostatic intervention
* concurrent urological morbidity like urethral stricture
* neurological disease like parkinson's disease

Primary outcomes:
measure: prostate assessment
timeFrame: 4 years
measure: symptoms assessment
timeFrame: 4 years
measure: sexual function
timeFrame: 4 years
Secondary outcomes:
measure: durability of procedure
timeFrame: 4 years
measure: complication of procedure
timeFrame: 4 years
Other outcomes:
Locations:
city: Helwan
country: Egypt
facility: Faculty of Medicine Helwan University
state: Cairo
Study officials:
References:
Clinical trial NCT05050344: Moya Moya Syndrome With or Withtout Sickle Cell Disease
Official title: Descriptive Bicentric Study of Moya Moya Syndrome and Disease in Sickle Cell Disease Patients and Not Sickle Cell Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Moya Moya Disease
Keywords: Moya Moya syndrome
Moya Moya
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients \>=15 years of age at diagnosis of Moya Moya disease and syndrome from january 2010 to february 2021 at Montpellier and Martinique University Hospital

Brief summary: Moya Moya disease or syndrome ar characterized by a progressive or occlusion of the intracranial carotid arteries and their mainproximal branches, followed by the development of fragile neovessels at the base of the skull, leding to a high risk of both ischemic and hemorragic stroke over time. Moya Moya syndrome are associated to a variety of disease, which main frequent is sickle cell disease (SCD).

Among patients with SCD who had suffered from at least one ischemic stroke, the prevalence of moya moya syndrome was estimated up to 43%. In general, therapeutic strategies in Moya Moya to prevent first ever ou recurrent stroke can be divided into conservative medical treatment and surgical revascularisation (direct bypass, indirect bypass or combined bypass).

The aim of this study is to compare prognosis of patients with Moya Moya syndrome associated with sickle cell disease or not. The investigators retrospectiveluy analysed medical chart from 2010 to 2021 of patients with Moya Moya disease or syndrome at two French university hospitals (including a center of the french West Indies where prevalence of sickle cell disease is high). The diagnosis was based on angiography or MRI records showing uni- or bilateral stenosis of distal intracranial internal carotide arteries or middle cerebral arteries associated wirh classic collateral network.

Main endpoint will be comparison of a composite outcome defined as time from Moya Moya diagnosis to first or recurrent stroke or bad prognosis achivement (defined by modified Rankin score \>2)


Eligibility criteria: Inclusion criteria:

* age \>=15
* patients at diagnosis of Moya Moya disease and syndrome

Exclusion criteria:

* misclassified patients
* clinical diagnosis of MM not confirmed by angiography or MRI

Primary outcomes:
measure: time from Moya Moya diagnosis to first or recurrent stroke or bad prognosis achivement
timeFrame: 1 day
Secondary outcomes:
measure: Time from MM diagnosis to Stroke
timeFrame: 1 day
measure: poor prognosis or death
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Estelle BRITHMER, Resident
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05439044: A Real-World Study of Anti-SARS-CoV-2 Monoclonal Antibodies
Official title: A Real-World Study of Anti-SARS-CoV-2 Monoclonal Antibodies in Patients at High Risk of Severe Forms of Covid-19
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Immunocompromised Patients
Keywords: Covid-19
SARS-CoV-2
Immunocompromised
Monoclonal Antibodies
Mortality
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-06-30
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult hospital patients treated with anti-SARS-CoV-2 monoclonal antibodies.

Brief summary: Absence of anti-SARS-CoV-2 vaccine response or insufficient vaccine response may occur in immunocompromised patients. Being at high risk of a severe form of Covid-19, they may be eligible to receive recombinant anti-SARS-CoV-2 monoclonal antibodies (mAbs). This study aims to describe patients who received anti-SARS-CoV-2 mAbs, in prophylaxis and/or curative of covid-19, and to analyze the hospitalization and mortality rates. This study is multicentric on all the university hospitals of Paris (AP-HP).


Eligibility criteria: Inclusion Criteria:

* Adult ≥ 18 years old
* Patients who received at least one administration of the following therapies: casirivimab-imdevimab, bamlanivimab-etesevimab, tixagevimab-cilgavimab, regdanvimab, sotrovimab or adintrevimab

Exclusion Criteria:

* Patients opposed to the collection of their personal data

Primary outcomes:
measure: Mortality rate
timeFrame: 29 days after last administration
Secondary outcomes:
measure: Hospitalizations rate
timeFrame: 29 days after last administration
measure: Mortality rate
timeFrame: 29 days after last administration
measure: Hospitalizations rate
timeFrame: 90 days after last administration
measure: Mortality rate
timeFrame: 90 days after last administration
measure: Hospitalizations rate
timeFrame: 29 days after last administration
measure: Mortality rate
timeFrame: 29 days after last administration
measure: Hospitalizations rate
timeFrame: 90 days after last administration
measure: Mortality rate
timeFrame: 90 days after last administration
measure: Proportion of hospitalizations
timeFrame: 29 days after last administration
measure: Proportion of deaths
timeFrame: 29 days after last administration
measure: Proportion of hospitalizations
timeFrame: 90 days after last administration
measure: Proportion of deaths
timeFrame: 90 days after last administration
Other outcomes:
Locations:
city: Paris
country: France
facility: Assistance Publique - Hôpitaux de Paris (AP-HP) - Cochin Hospital
state: Ile De France
Study officials:
affiliation: Pharmacy Department, Cochin Hospital, Assistance Publique des Hôpitaux de Paris (AP-HP)
name: Jeremie Zerbit, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00638144: Prevention of Graft Reinfection After Liver Transplantation With Anti HCV Monoclonal Antibodies Identified in Chronically Infected Patients or in Patients With Resolved Hepatitis C
Official title: Prevention of Graft Reinfection After Liver Transplantation for HCV Related End-stage Liver Disease . Study of Humoral Anti-HCV Response
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Keywords: Hepatitis C
liver transplantation
antibodies mediated neutralization
monoclonal antibodies
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2008-03-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with resolved infection chronically infected patients

Brief summary: End stage HCV-related cirrhosis has become a major indication for liver transplantation (LT). Unfortunately, recurrence of HCV infection on the liver graft occurs in almost all patients following transplantation and causes a persistent infection that leads to chronic hepatitis and cirrhosis in a significant proportion of patients. To date there is no effective way to prevent HCV reinfection of the liver graft in the early phase after transplantation. . Early passive immunotherapy with neutralizing antibodies against HCV should be considered for preventing reinfection of liver transplanted patients associated with HCV. This approach is well established in the case of patients undergoing liver transplantation for chronic hepatitis B virus infection. Our purpose is to produce neutralizing monoclonal antibodies to prevent reinfection of the liver graft.


Eligibility criteria: Inclusion Criteria:

* Health insurance
* Resolved HCV infection ( HCV RNA negative since more then 6 months ) -HCV chronically infected ( RNA positive )
* Anti- HCV antibodies positive
* Volunteers and informed patients

Exclusion Criteria:

* Immunosuppression
* HBV or HIV infection
* Pregnancy
* Breast feeding

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Hépato-Gastro-Entérologie - Hôpital Civil
city: Strasbourg
country: France
facility: Service d'Hématologie et Oncologie - Hôpital de Hautepierre
city: Strasbourg
country: France
facility: Service de Chirurgie Générale et Transplantation Multiorganes - Hôpital de Hautepierre
Study officials:
affiliation: CHRU Strasbourg
name: Michel DOFFOEL, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Strasbourg
name: Albert FARADJI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU Strasbourg
name: Philippe WOLF, MD
role: PRINCIPAL_INVESTIGATOR
References: