cyrilzakka/clinical-trials huggingface dataset:
Study of the Safety and Efficacy of Apadenoson for Detection of Myocardial Perfusion Defects Using SPECT MPI

The purpose of this study is to see whether apadenoson is as effective as adenosine when used as a pharmacological stress agent in myocardial SPECT-imaging (SPECT-MPI)to detect defects in the supply of blood to the heart muscle (myocardial perfusion defects). The study will also look at whether apadenoson is better tolerated than adenosine when used in SPECT-MPI.

Adenosine is an effective vasodilator used in SPECT-Myocardial Perfusion Imaging (SPECT-MPI). However, it produces transient symptoms that are poorly tolerated by most subjects. This is a multi-center, randomized double-blind study to compare the tolerability and effectiveness of apadenoson to adenosine (Adenoscan®) in SPECT-MPI. Subjects who are clinical candidates for SPECT-MPI will be enrolled to undergo two sequential SPECT-MPI studies. The first study will use adenosine as the stress agent in approximately 1250 subjects. Eligible subjects will then be randomized in a 1:1 assignment ratio to receive a second SPECT-MPI using either adenosine or apadenoson as the pharmacologic stress agent, with the goal of obtaining a total of 670 subjects who complete both studies. The agreement of the results from the two adenosine:adenosine stress tests will be compared to that from the adenosine:apadenoson tests to assess efficacy. The incidence and intensity of commonly reported side effects will be compared to evaluate improved tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Referred for a clinically indicated rest/pharmacologic stress SPECT-MPI test
* High pretest probability (90% or greater) of CAD based on the ACC/AHA guidelines for relative risk, or past medical h/o CAD

Exclusion Criteria:

* Acute MI, new onset of ischemia or PCI within 30 days prior to SPECT-MPI at either Period 1 or Period 2; or CABG within 90 days prior to SPECT-MPI at either Period 1 or Period 2
* Active severe asthma or severe chronic obstructive pulmonary disease (COPD) which, in the Investigator's opinion, places the subject at risk for severe bronchoconstriction
* History or evidence of clinically significant cardiac condition and rhythm disorder, in the absence of a functioning permanently implanted pacemaker
* Hemodynamically significant valvular disease, outflow tract obstruction, or uncontrolled severe hypertension
* Known history of cerebral vascular accident or suspected transient ischemic attack within 30 days prior to signed informed consent
* Current significant medical, surgical, psychiatric, or other illness or pathology that could potentiate any adverse pharmacological event associated with an investigational drug
A Bioequivalence Study of SCH 530348 2.5 mg Tablets (P06558)

The purpose of this study is determine if SCH 530348 2.5 mg tablets containing a high percentage of drug as the free base are equivalent to tablets with the standard percentage when given to participants.


Eligibility Criteria:
Inclusion criteria:

* Body Mass Index (BMI) between 18 and 32, inclusive
* Clinical laboratory tests within normal limits
* Free of any clinically significant disease that would interfere with the study evaluations
* Screening 12-lead electrocardiogram (ECG) conduction intervals within gender-specific normal range
* Vital sign measurements within the following ranges: oral body temperature, 35.0°C to 37.5°C; systolic blood pressure, 90 to 140 mmHg; diastolic blood pressure, 45 to 90 mmHg; pulse rate, 40 to 100 beats per minute
* Female participants must be postmenopausal, surgically sterile, abstinent, or using medically accepted method of contraception for 3 months prior to the screening period, during the trial, and for 2 months after stopping the trial. Non-vasectomized men must agree to use acceptable contraception or to abstain from sexual intercourse during the trial and for 3 months after stopping the medication

Exclusion Criteria:

* Female participants who are pregnant, intend to become pregnant (within 3 months of ending the study), or are breastfeeding
* History of coagulation disorder(s), thrombocytopenia, bleeding tendency, ulcers, or gastrointestinal bleeding
* History of cardiac abnormalities including clinically relevant ECGs, frequent palpitations or syncopal episodes
* Any surgical or medical condition that might significantly alter the absorption, distribution, metabolism or excretion of any drug
* History of any infectious disease within 4 weeks prior to drug administration
* Positive for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus (HIV)
* Positive screen for drugs with a high potential for abuse
* History of alcohol or drug abuse in the past 2 years
* Blood donation in the past 60 days
* Previous treatment with SCH 530348
* Currently participating in another clinical study or has participated in a clinical study within 30 days
* Demonstrated allergic reactions
* Smokes more than 10 cigarettes or equivalent tobacco use per day
* History of malignancy
* Has received any protocol-defined treatment which could interfere with ability to participate in the trial
Virtual Reality for Parent Training Intervention

Previous research has shown how parental responses can affect ADHD symptoms by triggering dysfunctional cyclic processes. Therefore, it may be useful within rehabilitative treatments to include parent training (PT). Recent literature data have demonstrated the potential of using virtual reality in the rehabilitation of children with ADHD. No study has been conducted on the use of virtual reality (VS) within a PT program. It is possible to hypothesize that virtual reality, by providing a controlled environment can help the parent improve his or her ability to self-control and perceive the child's difficulties. This allows the parent's empathizing skills to be implemented and reinforces the educational techniques learned during the parent training intervention.

The investigators designed a single-blind, randomized, controlled study on ADHD patients and their parents, with the aim of evaluating the effects of virtual reality support during PT program compared to traditional PT sessions.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with ADHD, according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria;
* Age including 6 to 10 years;
* Subjects with IQ \>70;
* Signed informed consent and the availability of at least one family member to participate in the diagnostic/therapeutic process.

Exclusion Criteria:

* Important comorbidities with psychiatric or neurological syndromes (e.g., epilepsy, known genetic syndromes, infantile cerebral palsy, sensory deficits);
* Subjects under the age of 6 years;
* Subjects older than 10 years of age;
* Subjects diagnosed with intellectual disability (IQ ≤70);
* Informed consent not signed and/or unavailability of at least one family member to participate in the diagnostic/therapeutic process.
ILUMIEN-V - AERO: All-comEr Registry of OCT (AERO)

The study aims to assess contemporary practice in OCT use during routine interven-tional practice and to assess the impact of the MLD-MAX algorithm on real-world PCI in a large unselected European all-comer-study cohort.

Angiography is the current standard method to guide PCI strategy in clinical practice. However, angiography has a number of well-described limitations, primarily through only providing an assessment of luminal dimensions without delineation of the burden of atheroma-tous disease. Angiography also provides suboptimal assessment of post PCI complications such as stent underexpansion or malapposi-tion, residual dissections or thrombus, and tissue prolapse. These limi-tations may be overcome in part by intravascular imaging (IVI), which allows tomographic, cross-sectional imaging of the vessel wall. Meta-analyses of randomized and registry studies of IVI-guided vs. angi-ography-guided PCI have suggested that IVI-guidance may improve clinical outcome following PCI.

Optical coherence tomography (OCT) provides high-resolution (10-20 μm) cross-sectional images of plaque microarchitecture, stent place-ment and size and strut coverage. Recently the MLD-MAX algorithm was developed to guide and stand-ardize coronary stent implantation based on sizing of the vessel at the proximal and distal reference using the EEL.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patients with evidence of myocardial ischemia (e.g. stable angi-na, silent ischemia, unstable angina, or acute myocardial infarc-tion) undergoing OCT-guided lesion evaluation (OCT-scan using the devices must be performed either to guide PCI (following the MLD-MAX-algorithm) or to investigate a coronary lesion for fur-ther clinical treatment)
* Written informed consent (defined as legally effective, docu-mented confirmation of a subject's (or their legally authorized representative or guardian) voluntary agreement to participate in a particular clinical study) to participate in this clinical inves-tigation

Exclusion Criteria:

* none
An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects

The international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult patients with perimembranous ventricular septal defects (PmVSD).

This is a non-randomized, multicenter, international, non-interventional, observational, retrospective post-marketing clinical follow-up study designed to evaluate the feasibility, safety, and efficacy of transcatheter closure of perimembranous ventricular septal defects (PmVSD) using commercially available device occluders, whether specifically designed for this purpose or used off-label.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with perimembranous ventricular septal defects (PmVSD), as defined by 2D transthoracic echocardiography according to previously published classifications.
2. Defect size between 3 mm and \<20 mm on the left ventricular side, as measured by 2D echocardiography.
3. Left-to-right ventricular shunt.
4. Age ≥3 months and body weight≥5 kg.
5. Symptomatic patients (heart failure, failure to thrive, recurrent respiratory infections, and rest or exercise dyspnea) or asymptomatic patients with progressive heart enlargement.
6. History of infective endocarditis related to the PmVSD or hemodynamically significant PmVSD with: Qp/Qs \>1.5 on catheterization, left ventricular volume overload (LVEDD z-score \>2) based on echocardiography, or pulmonary hypertension on catheterization (mean pulmonary artery pressure \>20 mmHg).
7. Presence or absence of aortic valve prolapse, with or without regurgitation.
8. Presence or absence of a membranous septal aneurysm, with or without inlet or outlet extension.

Exclusion Criteria:

1. Eisenmenger physiology (pulmonary vascular resistance \> 8 Wood units, nonreactive) with an exclusive right-to-left shunt.
2. Pre-existing complete heart block or high-risk proximity of the conduction system to the defect without prior pacemaker implantation.
3. Severe aortic or tricuspid valve disease requiring surgical or catheter-based intervention.
4. Pregnancy or planned pregnancy if the procedure involves X-ray exposure.
5. Extensive congenital cardiac anomalies requiring surgery.
6. Thrombus at the implant site or documented venous thrombus in access vessels.
7. Sepsis, active endocarditis, or bacterial infections within one month pre-procedure.
8. Uncontrolled bleeding or clotting disorders.
9. Contraindications to antiplatelet therapy or refusal of blood transfusions.
10. Cardiac malformations dependent on the presence of a perimembranous ventricular septal defect (PmVSD).
11. Lack of informed written consent for the procedure
12. Failure to attend any follow-up visit post-discharge.
13. Patients under guardianship or curatorship
14. Patients deprived of liberty
15. Patients under court protection
16. Patients or legal guardians refusing the use of personal data for this research
Observational Study to Develop Dosing Chart

To confirm the predictors based on patient specific characteristics and ovarian response and develop dosing chart when Follitrope™ PFS is administered to infertility women patients.


Eligibility Criteria:
Inclusion Criteria:

* Female aged of 19 to 39 years
* Mean menstrual cycle in 25 to 35 days
* Patients to whom Follitrope PFS will be administered in those scheduled to undergo the IVF-ET according to the GnRH agonist or antagonist protocol
* In the past continuous IVF cycle failure less than 2 times

Exclusion Criteria:

* Patients having a history of ovarian, breast, uterus, hyperthalamus, or pituitary tumor
* Abnormal uterine bleeding of undetermined origin
* Prior hypersensitivity to a component of recombinant FSH
* Ovarian cyst or enlargement of undetermined origin
* Clinically significant endocrine abnormalities
* Patients having polycystic ovary syndrome (PCOS) history
* Poor Ovarian responder (Bologna criteria)
* Patients who received Clomiphene citrate, Letrozole (Pemara), or Gonadotropin within 30 days prior to enrollment in this study
Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions

The objective of this study was to show the bioequivalence of a Roxane Laboratories' Zaleplon Capsules, 10 mg, to Sonata ® Capsules, 10 mg (Jones Pharma) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Zaleplon or any comparable or similar product.
Diagnostic Accuracy and Safety of DBV1605 for the Diagnosis of Non-IgE Mediated Cow's Milk Allergy in Children

Study to assess the diagnostic accuracy (sensitivity, specificity, positive and negative predictive value) of DBV1605 for the diagnosis of non-Immunoglobulin E (IgE) mediated cow's milk allergy (CMA) in children with symptoms suggestive of non-IgE mediated CMA.


Eligibility Criteria:
DISEASE GROUP

Inclusion Criteria:

* Male or female subjects aged \> 28 days to ≤ 24 months at Screening Visit
* Subjects with clinical symptoms suggestive of non-IgE mediated Cow's Milk Allergy
* Subjects with any type of diet containing daily products with cow's milk protein (e.g. cow's milk consumption, cow's milk partial elimination, partially hydrolyzed milk) prior to Screening Visit or who have started a cow's milk elimination diet not more than 4 weeks prior to Screening Visit,
* Subjects/parents/guardians who agree to follow a strict cow's milk-free diet and other mammalian milks (such as sheep and goat's milk) as per study requirements.

Exclusion Criteria:

* Subjects with an established diagnosis of non-IgE mediated CMA
* Breast-fed subject at Screening Visit
* Subjects with a convincing history of IgE-mediated CMA
* Subjects on a cow's milk protein-free diet including an AA-based formula or an extensively hydrolyzed formula initiated more than 4 weeks prior to Screening Visit.
* Generalized dermatologic disease (e.g. severe atopic dermatitis, ) extending widely on the skin.
* Any contraindication to a cow's milk challenge

CONTROL GROUP

Inclusion Criteria:

* Male or female subjects aged \> 28 days to ≤ 24 months at Screening visit
* Subjects having no medical history of any type of allergy
* Subjects who tolerate at least 200 mL of cow's milk or equivalent dairy foods daily within 4 weeks prior to Screening visit

Exclusion Criteria:

* Subjects with history of persistent gastro-intestinal symptoms
* Exclusively breast-fed subjects at Screening visit
A 56-day Clinical Study on Facial Skin Rejuvenation

This clinical trial aims to learn about the efficacy of MLYAAT-1002® (a proprietary anti-aging complex, MLYAAT is short for "multi-layer anti-ageing technology" ) in female subjects who have newly received the rejuvenation treatment by comparing visual clinical scores, skin attributes measurement and image analysis.

The main expectations are:

* After the 8-week continuous use of the test formulations with MLYAAT-1002® on one split-face side, the clinical manifestations and scores of photoaging improve compared to those of the control side using the placebo formulations.
* After the 8-week continuous use of the test formulations with MLYAAT-1002®, indicators of skin tone, individual type angle (ITA), CIELAB color space, pores and wrinkles improve compared to those of the control side using the placebo formulations.

Eligibility Criteria:
Inclusion Criteria:

* self-reported facial aging problems such as roughness, fine lines, and dull skin
* no symptoms of itching, tingling, or burning on the face
* no symptoms of facial flushing, erythema, papules, desquamation, or spot haemorrhage as evaluated by a dermatologist
* photodamage scores above 2 (evaluated by a dermatologist)
* compliance with split-face use of the assigned formulations for 56 days
* no antibiotics remedy in the past three months
* regular use of sunscreen products at least five times a week
* no plans to leave Shanghai during the period of the trial
* compliance with no use of any cosmetics that may bias the study results during the period of the trial
* written informed consent and portrait right consent were obtained from all participants before study entry

Exclusion Criteria:

* female subjects who are pregnant, lactating or planning to become pregnant
* history of alcoholism
* history of allergies
* subjects who have received medical rejuvenation treatment within the past one year
* being a participant in any other clinical trial within the past one month
* subjects who are suffering from facial skin diseases (melasma, acne, and herpes simplex, etc.)
* subjects with scar constitution or that predispose to Koebner's phenomenon (such as vitiligo and lichen planus, etc.)
* subjects who had skin diseases (such as psoriasis, eczema, and skin cancer, etc.)
* taken/injected anti-allergy medication in the past one month
* subjects who had a high fever in the past 2 weeks
* received anticancer chemotherapy or immunotherapy in the past 6 months
* anyone that the investigator thinks of not eligible.
A Safety and Tolerability Study of the Combination of Aliskiren/Valsartan in Patients With High Blood Pressure, Followed by Long-term Safety and Tolerability of Aliskiren, Valsartan and Hydrochlorothiazide.

Assessment of the long-term safety and tolerability of the combination of aliskiren and valsartan (300 mg/ 320 mg) in patients with high blood pressure,followed by assessment of long-term safety and tolerability of the combination of aliskiren/valsartan/Hydrochlorothiazide(HCTZ).


Eligibility Criteria:
Inclusion Criteria: -

* Male and female outpatients 18 years of age and older.
* For newly diagnosed/untreated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg at Visit 1 and Visit 4
* For previously treated patients with essential hypertension defined as msDBP ≥ 90 and \< 110 mmHg after 2 to 4 weeks of washout (Visit 4)
* Patients who were eligible and able to participate in the study and who consented to do so after the purpose and nature of the investigation had been clearly explained to them (written informed consent).

Exclusion Criteria:

* Severe hypertension (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg)
* Women of child-bearing potential, unless they met definition of post-menopausal or were using acceptable methods of contraception.
* History or evidence of a secondary form of hypertension.
* History of hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined inclusion/exclusion criteria may apply.
Factors Associated With the Use of a High Volume Cancer Center by Black Women With Ovarian Cancer: A Qualitative Study

The purpose of this study is to explore the experiences of Black women who receive care for ovarian cancer at Memorial Sloan Kettering Cancer Center, or "MSK" for short. The study consists of interviews with Black women who recently obtained some part of their ovarian cancer care at MSK.


Eligibility Criteria:
Inclusion Criteria:

* Participant must have been diagnosed with ovarian, fallopian tube or primary peritoneal cancer and treated by an MSK physician.
* Participants must be able to provide verbal informed consent.
* Participants must be 18 years of age or older.
* Participants must self-identify as Black/African American.
* Participant must be able to understand and speak in English

Exclusion Criteria:

* Inability or refusal to identify race/ethnicity.
* Presence or development of a physical, cognitive or psychiatric deficit resulting in an inability to provide meaningful informed consent or to understand the study or complete the interview.
Head and Neck Cancer Patients With Oral Mucositis Treated With Ketamine Oral Rinse

This 2-arm phase II study proposes to determine the efficacy of ketamine oral rinse in pain relief from mucositis in head and neck cancer patients undergoing radiation treatment.

Patients with histologically proven head and neck cancer undergoing radiation or concurrent chemoradiation as part of their treatment plan, will either receive ketamine oral rinse or unmedicated oral rinse to use 4 times a day if they develop oral mucositis during their radiation.

Patients will be monitored during treatment and up to 30 days after and will utilize a pain diary to document daily.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent signed and dated by the patient prior to the performance of the study-specific procedure.
2. At least 18 years-of-age at the time of signature of the informed consent form (ICF).
3. Patients with histologically proven HNSCC undergoing radiation of concurrent chemoradiation as part of their treatment plan.
4. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2.
5. The patients has received at least one radiation treatment for (HNSCC) the current disease.
6. CTCAE v. 5.0 grade 2 or greater oral cavity or pharyngeal mucositis documented to have developed after initiation of radiotherapy.
7. Males or female patients. Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their participation in the study and for 30 days following last dose. Male patients must also refrain from donating sperm during participation in the study.

Exclusion Criteria:

1. Inability to sign an informed consent form.
2. Any other malignancy diagnosed or treated within 10 years prior to enrollment.
3. Any documented hypersensitivity to ketamine.
4. Contraindication for ketamine use, including allergy.
5. Patients with schizophrenia, acute psychosis, or any psychiatric disorder that could be dangerous if exacerbated.
6. Women who are pregnant, nursing, or who plan to become pregnant while in the study and for at least \<\<6\>\> months after the last administration of study treatment.
7. Men who plan to father a child while in the study and for at least 6 months after the last administration of study treatment.
8. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, uncontrolled diabetes mellitus, active bleeding diatheses, or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus. Screening for chronic conditions is not required.
9. Patients with a prior or concurrent malignancy whole natural history or treatment does not have potential to interfere with the safety or efficacy assessment of the investigational regimen should be included.
10. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol and/or follow-up procedures outlined in the protocol.