cyrilzakka/clinical-trials huggingface dataset:
Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab

The ONYX study is an Open-Label, Multicenter, Extension study that will evaluate the long-term safety and efficacy of Apitegromab in Patients with Type 2 and Type 3 SMA who have completed TOPAZ or SAPPHIRE.


Eligibility Criteria:
Inclusion Criteria:

* Patients have completed the Phase 2 TOPAZ (Study SRK-015-002) trial or the Phase 3 SAPPHIRE (Study SRK-015-003) trial. (For TOPAZ, completed is defined as completion of Visit EC14 in Extension Period C or participating in TOPAZ at the time the trial is ended. For SAPPHIRE, completed is defined as completion of Visit 14 or participating in SAPPHIRE at the time the trial is ended)
* Estimated life expectancy \>2 years from the Baseline Visit (Day 1)
* Able to receive study drug infusions and provide blood samples through the use of a peripheral IV or a long-term IV access device that the patient has placed for reasons independent from the trial
* Able to adhere to the requirements of the protocol, including travel to the trial site and completing all trial procedures and trial visits
* Females of childbearing potential must have a negative pregnancy test at the Baseline Visit and agree to use at least 1 highly effective method of contraception throughout the trial and for 20 weeks after the last dose of apitegromab

Exclusion Criteria:

* Patient permanently discontinued study treatment during the feeder trial (i.e., TOPAZ or SAPPHIRE)
* Nutritional status that was not stable over the past 6 months and is not anticipated to be stable throughout the trial or medical necessity for a gastric/nasogastric feeding tube, where the majority of feeds are given by this route, as assessed by the Investigator
* Patient is currently enrolled in any investigational drug trial other than TOPAZ or SAPPHIRE
* Prior history of severe hypersensitivity reaction or intolerance to SMN-targeted therapies
* Prior history of severe hypersensitivity reaction or intolerance to apitegromab
* Use of chronic daytime noninvasive ventilatory support for \>16 hours daily in the 2 weeks before dosing, or anticipated to regularly receive such daytime ventilator support chronically throughout the trial
* Any acute or comorbid condition interfering with the well-being of the patient at the patient's last visit in TOPAZ or SAPPHIRE, (including active systemic infection, the need for acute treatment, or inpatient observation due to any reason). After resolution of the condition, the patient can be enrolled in the trial if they meet all the other eligibility criteria.
* Pregnant or breastfeeding
* Any other condition or clinically significant laboratory result or ECG value that, in the opinion of the Investigator, may compromise safety or compliance, would preclude the patient from successful completion of the trial, or interfere with the interpretation of the results
Data Collection Study of the Nidek Optical Coherence Tomography RS-3000 for 3D Measurements of the Eye

The purpose of this clinical study is to collect and evaluate the data from eye scans using an investigational three-dimensional eye imaging photography device called the Nidek Optical Coherence Tomography (OCT) RS-3000. OCT stands for Optical Coherence Tomography, a technique that uses invisible wavelengths of light to make detailed images of the tissues at the back of the eye. These images provide information that physicians may use to help diagnose eye conditions and/or to monitor changes in the eye during treatment.

This is a prospective, open-labeled, multi-center clinical study. After qualifying examination of a subject, 3D retinal measurement in the proximity of the optic disc and the macula are carried out for eligible subjects with normal eyes using an investigational three-dimensional eye imaging photography device called the Nidek Optical Coherence Tomography (OCT) RS-3000. The primary objective of this clinical study is to develop age-specific normal ranges for the thickness of the retina and retinal nerve fiber layer (RNFL) etc. using the Nidek Optical Coherence Tomography (OCT) RS-3000 with normative database. The secondary objective is to evaluate any adverse events found during the clinical study.

Eligibility Criteria:
Inclusion Criteria:

* Normal and healthy male and female subjects at least 20 years of age.

Exclusion Criteria

* Subjects who have extensive or debilitating systemic diseases.
* Subjects who have significant ocular disease.
* Subjects who are extremely far sighted or extremely near sighted.
Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics

Nutritional Prehabilitation Program and Cardiac Surgery Outcome in Pediatrics. A randomized controlled trial.

Nutritional Prehabilitation Program and Cardiac Surgery in Pediatrics. A randomized controlled trial to compare the outcome of malnourished congenital heart surgery patients who randomly received nutritional rehabilitation program 2 weeks and 1 week before surgical intervention.

Eligibility Criteria:
The study included all infants with CHD, admitted to the cardiothoracic unit for either palliative or corrective surgery, and suffering from nutritional deficiencies with moderate or severe malnutrition .

Infants received long-term nutritional prehabiliatation. Those with congenital or acquired anomaly of the gastrointestinal tract; multiple congenital anomalies; chromosomal, metabolic,or endocrine diseases; any systemic illness; or fever or infection within 1 wk before the study entry were excluded
Extracellular RNA Markers of Liver Disease and Cancer

The study will examine and evaluate the use of extracellular RNA in blood as markers for the diagnosis of liver disease or cancer, and as markers for prediction of response to treatment or recurrence of cancer after surgery

The goal is to identify an extracellular RNA candidate for the detection and diagnosis of liver cancers such as hepatocellular cancer or biliary cancer, and chronic liver diseases. The use of selected exRNA biomarkers for diagnosis of hepatocellular cancer (HCC) or biliary tract cancers in patients with cirrhosis will be evaluated in a prospective case-control study. The study will create a registry of patients who have chronic liver disease, cirrhosis, liver and biliary tract cancers. A risk factor questionnaire will be administered to facilitate identification of risk factors for development of liver cancer. Patient information will be obtained from the medical record, and include demographics, medical history, liver disease, smoking and alcohol history, etiology, family history, and clinical laboratory data.

Eligibility Criteria:
Inclusion Criteria:

* Lab results from within the previous 90 days.
* Diagnosis of HCC or biliary tract cancer
* Diagnosis of cirrhosis based on histology, imaging, or ultrasound.
* Diagnosis of a chronic liver disease without cirrhosis.

Exclusion Criteria for the HCC/biliary tract cancer group:

* Prior solid organ transplant.
* Previous cancer history with the last 5 years (excluding non-melanoma skin cancer), participation in a treatment trial for HCC

Exclusion criteria for the cirrhosis and chronic liver disease groups:

* Prior solid organ transplant.
* Previous or current cancer history within the past 5 years (excluding non-melanoma skin cancer).
Role of Simulators in Improving Obstetric Vaginal Examination Skills

A prospective study will be performed at the Department of Obstetrics and Gynecology at (VESSALKA unit),at El kasr Al_Ainy hospital, cairo university. Sample of house officers without obstetric experience in vaginal examination that will begin their clinical rotation in the department will be eligible for inclusion in the study. All patients involved in the study must not be high risk pregnancy nor have any indication of cesarean section and they will be examined by house officers in the first stage of labor. House officers and patients will provide verbal informed consent for participation in the study .all house officers assigned in the obstetric and gynecology department for their clinical rotation at the time of study will receive about a (30-mins) standardized course summarizing how to perform an obstetric vaginal examination . All house officers assigned in the study will be trained on vaginal examination simulators in about (15) training sessions and giving them a score to each one about their performing results on simulators.

This prospective study will be done on a group of house officers without obstetric experience in vaginal examination.

They will perform multiple vaginal examination training procedures using a simulators in about (15) training sessions and giving them a score to each one then testing them on patients who are in the 1st stage of labor and giving them another score after collection of their results .

All house officers will report the findings of examinations of each time in terms of six items (1): cervical dilatation. (2): cervical effacement. (3): presenting part and position. (4): caput or not. (5): station. (6): condition of membrane intact or ruptured.

The findings that will be obtained by the house officers will then be revised by the same staff experienced obstetrician and gynaecologist {whose answers will be considered to be the gold standard} who will examine the same patients at the same time for accuracy of results.

Two simulators will be used in the study:

1. st ) : PROMPT Flex Birthing Simulator Advanced - Light (PRODUCT NO. 80106).UK, 2020 .
2. nd) : PROMPT Flex Cervical Dilatation \& Effacement Module -Light (PRODUCT NO. 80102),Uk,2020

Eligibility Criteria:
Inclusion Criteria:

* House officers must be without any experience in vaginal examination at the start of study.
* Study group must attend at least (15) simulator training sessions before testing them.

Exclusion Criteria:

* House officers with any experience in vaginal examination.
Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Extension Protocols MK-0462-022, MK-0462-025, MK-0462-029)

This record describes pooled data for three extension studies: MK-0462-022 (NCT00897949); MK-0462-025 (NCT00899379); and MK-0462-029 (NCT00897104). These studies examined the long-term safety and efficacy of rizatriptan used for the treatment of acute migraine and migraine recurrence.


Eligibility Criteria:
Inclusion Criteria:

* Participant took part in study MK-0462-022, MK-0462-025, or MK-0462-029
* History of migraine headache
Assessment of Research Digest Impact for Minority with Prostate Cancer, MiCAP Phase III Study

This phase III trial determines how well the Minority Prostate Cancer (MiCaP) Research Digest works in providing information to black men about the latest prostate cancer research. MiCaP Research Digest may be an effective method to help people learn about prostate cancer.This goal of this trial is to create educational programming that helps Black men make informed decisions about their prostate healthcare since Black men are diagnosed with prostate cancer more than any other race or ethnicity.

PRIMARY OBJECTIVE:

I. To develop a research dissemination program, the Minority Prostate Cancer (MiCaP) Research Digest, which will spread information about CaP scientific discoveries, evidence-based interventions, and open clinical trials instantly among black males (BM).

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants watch MiCaP Research Digest video on study. Participants complete a survey throughout the trial.

ARM II: Participants watch an alternative video on study. Participants complete a survey throughout the trial.

Eligibility Criteria:
Inclusion Criteria:

* Identify as a Black male
* Between the ages of 35 and 70
* For virtual data collection, have access to the internet and Zoom (if joining study online)
* For virtual data collection, reside anywhere in the U.S.
* For in-person data collection, reside in one of the nine (9) catchment areas of the Mayo Clinic Cancer Center: Baker, Duval, Nassau, Clay, St. John's, Putnam, Flagler, Volusia and Brevard

Exclusion Criteria:

* Identify as a race or ethnicity that is not Black
* Identify as female
* Be younger than age 35 and older than age 70
* Lack access to internet and Zoom (if joining study online)
Optimization of Cardiac Resynchronization Therapy by Non-Invasive Imaging of Cardiac Electrophysiology

The principal aim is to analyze total left and right ventricular activation time in different CRT device programming algorithms (SyncAV) measured by non-invasive electrophysiology

Patient specific anatomic parameters taken from the cardiac magnetic resonance examination will be the base for a semiautomatic model incorporating the conductivity of the heart, the lungs, blood and the torso. For this reason, a software package (AMIRA Developer, TGS Template Graphics Software, France) has been adapted to calculate a quasi static approximation of Maxwell equations.

After fusion of the T1 CMR scan and the ECG electrodes a model-based bidomain FEM is used for a step-wise measurement of the local activation times (resting potential: 290 mV; plateau: 0 mV; acceleration time: 3 ms) both Ende- and epicardially.

Eligibility Criteria:
Inclusion Criteria:

* patients after successful implantation of a CRT-D or CRT-P device in whom a cardiac magnetic resonance examination is possible and the device is equipped with the SyncAV® programming software
* left bundle branch block before CRT implantation
* PQ interval ≤ 250 ms before implantation

Exclusion Criteria:

* high-grade AV block
* any contraindication concerning a safe CMR performance including claustrophobia
* terminal heart failure (NYHA IV) or cardiac decompensation
* life expectancy \< 1 year
* women with child-bearing potential, pregnancy
* drug abusus
Standard PET/CT vs. Digital PET/CT

The investigators wish to determine if standard and digital PET/CT scanners provide equivalent results for disease detection and diagnosis.

There will be a single injection of the PET radiopharmaceutical followed by a standard PET/CT scan and immediately after by the digital PET/CT scan, or vice versa. The investigators wish to determine if image quality is equivalent with the digital PET/CT scanner.

Eligibility Criteria:
Inclusion Criteria:

* Patient is ≥ 18 years old at the time of the scan
* Patient provides written informed consent
* Patient is referred for standard (F18 FDG; F18 NaF; Ga68 DOTATATE) or research (68Ga PSMA or 68Ga RM2) PET/CT
* Patient is capable of complying with study procedures
* Patient is able to remain still for duration of imaging procedure (approximately 60 minutes total for both PET/CT)

Exclusion Criteria:

* Patient is pregnant or nursing
Intrauterine Device Insertion Pain Management

The goal of this clinical trial is to learn if use of topical benzocaine prior to the injection of lidocaine is effective in decreasing pain experienced during IUD insertion in patients 18 or older. The main question it aims to answer is:

Does topical use of benzocaine prior to lidocaine injection during IUD insertion effectively decrease pain experienced?

Researchers will compare benzocaine/lidocaine to benzocaine/placebo, placebo/lidocaine, and placebo/placebo to see if use of benzocaine prior to lidocaine injection works more effectively to decrease pain experienced rather than lidocaine, benzocaine, or placebo use alone.

Participants will:

* Arrive to clinic for previously scheduled IUD insertion
* Be screened, approached by research staff, and consented to join the trial
* Complete a demographic questionnaire
* Be randomly and blindly assigned to one of four groups
* Placebo/Placebo
* Placebo/Lidocaine
* Benzocaine/Placebo
* Benzocaine/Lidocaine
* All groups will be given 600mg of ibuprofen prior to procedure
* Be asked to rate their pain on a visual scale of 1-10 during several distinct points of the procedure.
* Be sent an optional survey to their email after the procedure

The goal of the researchers is to determine if use of a topical benzocaine spray prior to lidocaine injection will cause a significant reduction in pain experienced by patients undergoing an IUD insertion. Participants will be screened, approached, and fully consented by research staff in the clinic prior to their IUD insertion. Demographics will be gathered from all participants through a questionnaire. All participants will be given 600mg of ibuprofen prior to the procedure, but will be randomized into one of 4 groups as to what interventions/placebos they will receive during their insertion. Interventions studied are benzocaine spray and lidocaine injection. Placebos will be saline spray and paracervical needle stick without injection. Participants will be asked to rate their pain on a visual scale of 1-10 at the following timepoints during the procedure:

* At the time of tenaculum placement
* At the time of uterine sounding
* At the time of IUD insertion and deployment
* Immediately after removal of instrumentation
* 15 minutes after the procedure Participants who provided an email will be sent an additional questionnaire to be responded to within 24 hours of the procedure. At the conclusion of the trial statistical analysis will be done to determine significance of pain reduction varying between the 4 groups.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Undergoing IUD insertion

Exclusion Criteria:

* IUD insertion \<6 weeks postpartum
* Age \<18 years
* Allergy or history of adverse effect of lidocaine, benzocaine (and inactive ingredients: flavor, isobutane, propane, polyethylene glycol, sodium saccharin), or ibuprofen
* Not undergoing IUD insertion
* Undergoing IUD insertion under general anesthesia
* Usage of anti-inflammatory or as-needed anxiety medications (not daily use) in the 12 hours prior to IUD insertion
Person-Environment Fit for Persons With Dementia

This trial will assess feasibility of a non-pharmacological intervention for persons living with Alzheimer's disease and related dementias (ADRD) to improve behavioral and psychiatric symptoms of dementia and functional performance.

Using a two-arm, prospective randomized controlled trial, 38 dyads (person with ADRD and caregiver) will complete an 8-week telehealth occupational therapy intervention provided via Zoom with caregivers and persons with dementia or receive an active control with 8 telehealth sessions to discuss publicly available caregiver education with a non-clinical research assistant.


Eligibility Criteria:
Inclusion Criteria: Participants with Dementia

* Men or women aged 60-99, inclusive.
* Living at home in the community with one primary caregiver.
* Diagnosis or probably diagnosis of dementia (confirmed by Clinical Dementia Rating Scale score of 1.0+)
* If on psychotropic medication, they are at a point where dosage and treatment are stabilized for the duration of the study.
* Functional sensory abilities with or without aids (hearing, vision, smell, touch, taste)
* Caregiver report of challenges related to behaviors within 4 weeks of study enrollment.
* Caregiver willing to participate throughout duration of study.
* Contact with University of Kentucky Alzheimer's Disease Research Center or Kentucky Neuroscience Institute medical provider within 12 months of study recruitment.

Inclusion Criteria: Caregiver for Participants with Dementia

* Men or women aged 21-99, inclusive.
* Willingness to participate in study and implement recommended data collection tools.
* English speaking, able to read and write.
* Ability to retrieve and send mail.

Exclusion Criteria: Participants with Dementia

* Unstable medical conditions within one month prior to screening visit such as poorly controlled blood pressure, diabetes, current cancer diagnosis, or breathing problems, etc.
* Wheelchair or bed bound.
* Residence in skilled nursing facility or facility-based care.
* Caregiver report of physically violent behaviors.
* Initiation of antipsychotic medication within 4 weeks prior to screening or unpredictable use of such medications
* Diagnosis of profound or total sensory altering disorders including macular degeneration, legal blindness, total deafness, severe peripheral neuropathy, anosmia.
* Major depression in past 12 months (DSM-IV criteria), major mental illness such as schizophrenia, bipolar disorder, personality disorders, or recent (in past 12 months) alcohol or substance abuse.
* Major infection within 4 weeks prior to the Baseline Visit.

Exclusion Criteria: Caregiver for Participant with Dementia:

• Diagnosis of mild cognitive impairment or dementia.
11C-PIB PET/CT in Patients With Parkinson's Disease and Parkinsonian Dementia Syndromes

To evaluate the potential contribution of amyloid burden, as indexed by 11C-Pittsburgh compound B (PiB) retention, to the progression of cognitive impairments in patients with Parkinson's disease(PD).

Study design:

Multi-center, Five-arm

Subjects:

Patients with PD without dementia; Patients with PD with mild cognitive impairment (MCI); Patients with PD with dementia; Patients with a dementia with Lewy bodies(DLB); Healthy person

Sample size:

200, including a PD without dementia group of 75 patients, a PD with MCI group of 30 patients, a PD with dementia group of 20 patients, a DLB group of 25 patients and a normal control group of 50 subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with Parkinson's disease and parkinsonian dementia syndromes
2. Males and females, ≥40 years old
3. The diagnosis of PD is established using the UK Parkinson's Disease Society Brain Bank Research Center Clinical diagnostic criteria. Criteria for PD-MCI and PD-dementia are consistent with those of the Movement Disorder Society. The DLB Consortium consensus criteria are used for DLB.
4. They rely on a combination of neurologic examination and neuropsychological assessment with a battery of tests. Clinical diagnosis was established by sophisticated neurologists.

Exclusion Criteria:

1. Females planning to bear a child recently or with childbearing potential
2. Renal function: serum creatinine \>3.0 mg/dL (270 μM/L)
3. Liver function: any hepatic enzyme level more than 5 times upper limit of normal.
4. Known severe allergy or hypersensitivity to IV radiographic contrast.
5. Patients not able to enter the bore of the PET/CT scanner.
6. Inability to lie still for the entire imaging time because of cough, pain, etc.
7. Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
8. Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the Investigator, may significantly interfere with study compliance.

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