cyrilzakka/clinical-trials huggingface dataset:
A Phase 1/2 Study of BA3071 in Patients With Solid Tumors

The objective of this study is to assess safety and efficacy of BA3071 in solid tumors

This is a multi-center, open-label study designed to evaluate the safety, tolerability, PK, immunogenicity, and antitumor activity of BA3071. Phase 2 is open and currently recruiting patients with:

1. Melanoma - 1L
2. nonsquamous or recurrent NSCLC (Type IIB, IIIA, IV) with single or any combination of the following mutations: KRAS mutation STK11 mutation KEAP1 mutation PD-L1 tumor proportion score (TPS) \<1%

Eligibility Criteria:
Inclusion Criteria:

* Patients must have measurable disease.
* Age ≥ 18 years
* CLTA-4 blocking-antibody naïve
* Adequate renal function
* Adequate liver function
* Adequate hematological function
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Patients must have single or any combination of the following mutations: KRAS, STK11, KEAP1 and/or PD-L1 TPS \<1%
* Patients must be eligible for surgery (NSCLC Stage IIB-IIIA only)

Exclusion Criteria:

* Patients must not have clinically significant cardiac disease.
* Patients must not have known non-controlled CNS metastasis.
* Patients must not have a history of ≥ Grade 3 allergic reactions to mAb therapy as well as known or suspected allergy or intolerance to any agent given during this study.
* Patients must not have had major surgery within 4 weeks before first BA3071 administration.
* Patients must not have known human immunodeficiency virus (HIV) infection, active hepatitis B and/or hepatitis C.
* Patients must not be women who are pregnant or breast feeding.
The Role of Epicardial Adiposity in Heart Failure With Preserved Ejection Fraction

In this study the investigators are aiming to recruit 130 patients with heart failure with preserved ejection fraction who are obese and non-obese to undergo CT and MRI scans, as well as some other investigations including blood tests, to help investigate if having more fat around the heart leads to worse heart function in this condition. This may lead to the development of new treatments aimed at lowering fat levels around the heart and in the rest of the body, specifically to treat HFpEF.

Dysregulated adipose tissue, in particular epicardial adipose tissue (EAT; fat around the heart) may be central to the pathogenesis of obesity related HFpEF. Existing studies have been limited by selection bias (only including obese cohorts), limited cardiac structural and functional assessment (primarily using echocardiography) and lack of corroborating biological data to imply causality. Pilot data demonstrate important associations between EAT with concentric LV remodelling in cohorts at high risk of HFpEF.

Further exploration of the role of EAT and other ectopic fat depots in patients with HFpEF with and without obesity, will provide novel insights into mechanisms by which adiposity drives development of HFpEF.

In this single centre, prospective, case-control study the investigators will recruit participants with HFpEF with and without obesity (total N=130) and utilise multimodality imaging to comprehensively characterise the role of excess adiposity and ectopic fat, specifically EAT, to cardiac dysfunction in HFpEF.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Aged ≥18 years old
* Diagnosed with HFpEF and diagnosis confirmed by an experienced cardiologist using the HFA-PEFF diagnostic algorithm
* Echocardiogram performed within 12 months
* Able to understand written English

Exclusion Criteria:

* LV ejection fraction \<45%
* Severe primary valvular heart disease
* HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy/pericardial disease or congenital heart disease
* Known heritable, idiopathic or drug-induced pulmonary arterial hypertension
* Absolute contraindications to cardiac CT or MRI including estimated glomerular filtration rate (eGFR) ≤30ml/min/1.73m2. Patients with MRI-compatible devices are be excluded.
* Women who are pregnant
Prevalence of Sleep Apnea in Patients Presenting for Hip or Knee Replacement Surgery

The study hypothesis is that the prevalence of obstructive sleep apnea in patients presenting for total knee or total hip arthroplasty is higher than generally suspected. The study will include just one arm and results will be compared to a literature control group. Participants referred for preoperative evaluation will be screened using a standard questionnaire. Those at high risk of obstructive sleep apnea will then undergo a formal overnight sleep study (polysomnography).

The study hypothesis is that the prevalence of obstructive sleep apnea in patients presenting for total knee or total hip arthroplasty is higher than generally suspected. The study will include just one arm and results will be compared to a literature control group, a study performed by Harrison et al. and published in the December 2003 issue of The Journal of Arthroplasty. Participants referred for preoperative evaluation will be screened using a standard questionnaire. Those at high risk of obstructive sleep apnea will then undergo a formal overnight sleep study (polysomnography). The Berlin questionnaire is being used for screening.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and older
* Planned total hip or total knee arthroplasty
* Referral to the internal medicine preoperative evaluation clinic

Exclusion Criteria:

• None
Persantine: Variation in Response Trial

The primary objective of this study is to understand why different people respond differently to the medication Persantine. The effects of Persantine will be evaluated by performing echocardiograms, blood tests and by measuring the flow of blood in the arteries of the heart in patients undergoing a clinically indicated percutaneous coronary intervention.

Participants will receive three doses of Persantine intravenously for the research study. Before and after receiving the Persantine doses, patients will have an echocardiogram and coronary artery blood flow will be measured. Blood tests,measure the function of the adenosine transporter. In addition variations in the gene for the adenosine transporter will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 21 years old
* Patient undergoing cardiac catheterization with planned PTCA or with a significant coronary lesion of either the LAD or Circumflex

Exclusion Criteria:

* Theophylline or oral Persantine use in 24hrs
* Second or third degree AV block, or sick sinus syndrome without a functioning pacemaker
* Active asthma or bronchospasm
* Patients with severe hepatic insufficiency
* Patients experiencing an acute transmural infarction at the time of the index visit
* Conditions that are known to affect resistive vessel function or myocardial flow
Cardiovascular Longitudinal ALSPAC Research Investigations Following Hypertensive Pregnancy in Young Adulthood

The purpose of this study is to understand more about why young people who were born to a hypertensive pregnancy may have increased risk of high blood pressure and are often at increased risk of heart and blood vessel disease later in life.

Women who develop blood pressure problems during pregnancy are more likely to have high blood pressure (hypertension) in later life as well as heart attacks or strokes. The children born to the pregnancy also tend to have higher blood pressure and are often at increased risk of heart and blood vessel disease later in life. Previous work has shown that children born to pregnancies where the mother has high blood pressure have changes in their blood vessels, heart and brain that can be measured long before they develop high blood pressure or other clinical symptoms. By understanding the pattern of changes cross multiple parts of the body, over a lifetime, the investigators can identify how advanced the underlying disease is for an individual and how their disease is likely to develop over the next few years.

The aim of this study is to understand the heart and blood vessel changes of people born to a hypertensive pregnancy once they are in their 20s and 30s. The investigators then hope to use this information to develop new ways to prevent early onset heart and blood vessel disease in these people.

Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study
* Male or female, aged 30 to 40 years at time of enrolment
* Participant previously took part in the ALSPAC study
* Able (in the investigator's opinion) and willing to comply with all study requirements
* Adequate understanding of verbal and written English

Exclusion Criteria:

* Pregnant or lactating when they are due to attend for study visit 1
* Less than six months postpartum
* Planning to donate blood within two weeks prior to study visit 1
* Any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study
* Evidence of congenital heart disease or significant chronic disease relevant to cardiovascular or metabolic status

For exclusion of MRI component only:

* Unsuitable for MRI based on participant screening; the participant may still be included in other parts of the study
Foreign Body Swallows in Pediatrics

Foreign Body Ingestion (FBI) is a common clinical emergency in children. Most FBs smoothly pass through the digestive tract without complications; nevertheless, some FBs can cause severe morbidity and mortality. The current work aimed at evaluating how FBI can cause respiratory distress and stridor as well as their severity according to age, gender, lodgment site, and type of the object. Factors influencing morbidity and mortality among studied patients will be deliberated as well.

Background: Foreign Body Ingestion (FBI) is a common clinical emergency in children. Most FBs smoothly pass through the digestive tract without complications; nevertheless, some FBs can cause severe morbidity and mortality. The current work aimed at evaluating how the FBI can cause respiratory distress and stridor as well as their severity according to age, gender, lodgment site, and type of the object. Factors influencing morbidity and mortality among studied patients will be deliberated as well.

Methods: It is a hospital-based descriptive study where all children between birth and 16 years of age who were admitted from January 1 st, 2018 to December, 31th 2021 for FBs removal were analyzed. All cases were subjected to complete history taking, physical, radiological, and bronchoscopic examination.

Eligibility Criteria:
Inclusion Criteria:

* children between birth and 16 years of age FBs removal
* history suggestive of foreign body swallow

Exclusion criteria:

- none
Renal Sympathetic Denervation From the Adventitia on Resistant Hypertension（RSDARH）

As one of the most common chronic diseases,The adult prevalence of hypertension is approximately 26.4% at present and will rise to 29.2% by 2025.Renal sympathetic denervation from the intima of renal artery has emerged as a potential treatment for resistant hypertension. However, renal sympathetic nerve are mainly located in the adventitia,and there is no report on renal sympathetic denervation from the adventitia of renal artery.This study is a multicenter,randomized,single-blind study,and aimed to observe the safety and efficacy of radiofrequency ablation of the renal artery from the adventitia on the basis of laparoscopic techniques for patients with resistant hypertension.

This study is a multicenter,randomized,single-blind study,and aimed to observe the safety and efficacy of radiofrequency ablation of the renal artery from the adventitia on the basis of laparoscopic techniques for patients with resistant hypertension.

Eligibility Criteria:
Inclusion Criteria:

1.18 years old ≤ age ≤ 65 years old; 2.Patients with clear diagnosis of resistant hypertension prior to enrollment：On the basis of improving lifestyle, a reasonable and tolerable amount of 3 or more kinds of antihypertensive drugs (including diuretics) for more than one month, clinic SBP≥140mmHg or (and) DBP≥90mmHg, 24 hours dynamic Blood pressure monitoring SBP\>130mmHg or (and) DBP\>80mmHg; 3.Estimated GFR (eGFR) ≥ 60ml/min/1.73m2; 4.The patient or his legal guardian has signed the informed consent; 5.Patients who are willing and able to perform follow-up visits.

Exclusion Criteria:

1. Patients with secondary hypertension caused by any known cause;
2. pregnant or planning to be pregnant;
3. Patients with renal artery diameter \<4mm or length \<20mm;
4. Patients with renal artery abnormalities include: hemodynamic or anatomically significant stenosis (≥50%) of renal arteries on either side;renal arterial balloon angioplasty or stenting;renal involvement on either side Multiple renal arteries,and renal arteries supply \<75% of the kidneys;abnormal renal artery anatomy,such as tumor expansion;
5. Patients with cardiovascular instability factors includes:acute myocardial infarction within six months,unstable angina or cerebrovascular disease;heart valve disease with significantly altered hemodynamics;
6. Patients with other serious organic diseases;
7. Patients participated in other studies.
Safe Generations Plus: Swaziland PMTCT LTF Study

This study is to understand how to improve retention in care and treatment services to HIV positive pregnant women and their babies in Swaziland. The investigators will evaluate outcomes of patients who are lost-to-follow-up (LTF) under a new approach for prevention of mother-to-child (PMTCT) called Option B+, where all HIV positive pregnant women initiate lifelong antiretroviral therapy (ART) regardless of their disease stage. The goal is to understand the outcomes of patients who are LTF from care, and the reasons for disengagement from care in the context of PMTCT in order to inform efforts to improve retention in care among patients under Option B+.

The study will be conducted among approximately 1,600 women and their infants who received Option B+ PMTCT services at ten facilities in Swaziland. These facilities were included in another study on Option B+ called Safe Generations in which routinely collected patient-level data was abstracted from medical registers. This study has three parts: the first is a review of alternative patient medical records among women and their infants who were documented as LTF in the Safe Generations study. The second component consists of tracing women who are LTF on the phone or in the community to administer a questionnaire. Lastly, an in-depth interview will be conducted among a sub-group of women to explore patterns of care.

Eligibility Criteria:
Inclusion Criteria:

* Mothers and their infants who were enrolled in PMTCT at Safe Generations study sites after the sites transitioned to Option B+.
* Determined to be LTF per the Safe Generations study protocol (i.e., have not attended a clinic visit in the 90 days prior to their 6-month postpartum appointment and are not known to be dead or transferred out, according to clinical visit data abstracted to the Safe Generations study database).

Exclusion Criteria:

* Mothers that are not a PMTCT client.
Comparing Two Forms of Head Immobilization for Stereotactic Radiotherapy

Fractionated stereotactic radiotherapy (SRT) requires extremely precise and reproducible immobilization of the patient's head. This randomized study compares the efficacy of two commonly used forms of immobilization used for SRT.

PRIMARY OBJECTIVE:

1) To compare the efficacy of two commonly used, generally accepted forms of immobilization for the treatment of lesions in the head with fractionated stereotactic radiotherapy. Specifically, this study will use the ExacTRAC kilovoltage imaging system to assess positioning accuracy for these two systems.

OUTLINE:

Two routinely used methods of immobilization, which differ in their approach to reproduce head position from day-to-day are the Gill-Thomas-Cosman (GTC)frame and the BrainLab thermoplastic mask. The GTC frame fixates on the patient upper detention and thus us in direct mechanical contact with the cranium. The BrainLab mask is a two-part masking system custom-fitted to the front and back of the participant's head. After patients sign an IRB-approved informed consent form, eligible participants are either randomized to either the GTC frame or the mask for their course of SRT. Participants are treated as per standard procedure; however, prior to each treatment, a set of digital kV images (ExacTrac, BrainLabAB, Germany) is taken. These images are fused with reference digitally constructed radiographs obtained from treatment planning CT to yield lateral, longitudinal, and vertical deviations of isocenter and head rotations about respective axes. The primary endpoint of the study is to compare the two systems with respect to mean and standard deviations (SDs) using the distance to isocenter measure.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are eligible for fractionated stereotactic radiotherapy

Exclusion Criteria:

* Severe claustrophobia
Integration of Neurocognitive Biomarkers Into a Neuro-Oncology Clinic

This is prospective observational registry study that will assess 1) if the neurocognitive function app (Brainlab Cognition) can be used in a widespread neuro-oncology clinic setting and 2) if patient reported quality of life parameters can be obtained electronically and integrated into clinic.


Eligibility Criteria:
Inclusion Criteria:

1. All adult (18+) patients with central nervous system (CNS) tumors, both primary brain malignancies and brain metastases, treated with radiotherapy (partial brain, stereotactic radiosurgery, stereotactic fractionated radiotherapy, or whole-brain radiotherapy), surgery, and/or antineoplastic therapy and followed thereafter at Miami Cancer Institute (MCI)
2. Life expectancy ≥ 6 months
3. Willingness to participate in ongoing registration study

Exclusion Criteria:

1. Patients receiving radiotherapy to the brain for functional disease (arteriovenous malformations, trigeminal neuralgia, essential tremors, etc.)
2. Pediatric patients (\<18 years old), pregnant women, and prisoners.
Comparing the Efficacy of Urinary and Recombinant Human Chorionic Gonadotropin (hCG) on Oocyte Maturity

This study is a prospective randomized clinical trial to compare the efficacy of the urinary and recombinant hCG on oocyte quality for ovulation induction in women undergoing IVF/ICSI.

The study population comprised of all infertile patients aged 20-37 years which underwent of in-vitro fertilization in royan institute, Tehran Iran.

In this study all patients were treated with a long stimulation protocol in which GnRH-analogue (Buserelin subcutaneous, 0.5cc daily) was given as a pre-treatment and recombinant FSH (rFSH) administration was started when pituitary desensitization was confirmed. From the 7th day of stimulation in both groups, daily monitoring of follicle size by ultrasound was performed and the dose of rFSH was adjusted according to the response of each patient. When at least two follicles \> 18 mm diameter were seen, ovulation was triggered with hCG and patients allocated into three different study groups as per the following:

1. Group A consisted of 60 women who received recombinant hCG(250 µg Ovitrelle)
2. Group B consisted of 60 women who received recombinant hCG(500 µg Ovitrelle)
3. Group C consisted of 60 patients received 10,000 IU urinary hCG Oocyte retrieval performed about 34-36 hours after hCG administration and then oocytes were assessed for nuclear maturity. Embryos transferred 2-3 days thereafter.

Data collection will be performed by using questionnaire to be filled as per the available records and laboratory results. Data analysis will be done through descriptive and perceptive statistical methods by using SPSS software version 16 for windows.

Eligibility Criteria:
Inclusion Criteria:

* Indication for IVF/ICSI and Long Protocol ovarian stimulation
* Age 20-37
* Body mass index (BMI) ≤ 30 kg/m2
* Regular menstrual cycles of 25-35 days
* Tubal or male factor
* Existence of both ovary and normal uterine cavity
* Basal FSH≥10
* Physical health

Exclusion Criteria:

* Poly Cystic Ovarian Syndrome patients
* Contraindications of gonadotropins administration
* Poor response to ovulation induction in recent cycle
A Multi-Site Clinical Evaluation of the LIAISON NES FLU A/B, RSV & COVID-19 Assay in Symptomatic Patients

The DiaSorin Molecular LIAISON® NES FLU A/B, RSV \& COVID-19 real-time polymerase chain reaction (RT-PCR) assay is intended for use on the DiaSorin LIAISON® NES instrument for the in-vitro qualitative detection and differentiation of nucleic acid from influenza A, influenza B, RSV and SARS-CoV-2 virus from dry nasal swabs (NS) from human patients with signs and symptoms during the acute phase of respiratory tract infection in conjunction with clinical and epidemiological risk factors.

The LIAISON® NES FLU A/B, RSV \& COVID-19 assay is intended for use as an aid in the differential diagnosis of influenza A, influenza B, RSV and SARS-CoV-2 infection in a professional laboratory setting.

Negative results do not preclude influenza A, influenza B, RSV or SARS-CoV-2, infection and should not be used as the sole basis for patient management decisions. The assay is not intended to detect the presence of the influenza C virus.


Eligibility Criteria:
Inclusion Criteria:

* The specimen is a NPS or NS from a patient collected and preserved in 3 mL Universal Transport Media (UTM), BD Universal Viral Transport (UVT), or MicroTest M4RT transport media, or 1 mL Copan Eswab (Liquid Amies).
* The specimen is from a patient who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility.
* The specimen is from a human patient with active signs and symptoms of respiratory tract infection at time of collection
* Specimen stored at 2-8°C for up to 72 hours from collection. If there is a delay in testing, store specimen at ≤-70 °C.
* The total volume of the leftover specimen received is ≥1.5 mL, except for specimens collected in Liquid Amies which requires a total leftover volume of ≥0.5 mL
* The specimen was received in good condition (no leakage or drying of the specimen).

Exclusion Criteria:

* Incorrect swab type
* Incorrect transport media
* Incorrect specimen handling (e.g. specimens not stored at recommended temperature)
* The specimen has undergone more than two freeze/thaw cycles
* Specimens collected with calcium alginate or organic swabs