cyrilzakka/clinical-trials huggingface dataset:
Ribociclib in Combination With Non-steroidal Aromatase Inhibitors in Patients With Advanced Breast Cancer

Observational, longitudinal (retrospective cohort), multicenter, national study aiming to evaluate the proportion of women with HR+/HER2- advanced breast cancer treated with ribociclib plus non-steroidal aromatase inhibitors who were alive and without disease progression at 1 year.

The study was conducted in 11 Brazilian sites specialized in the treatment of this condition. The study data were collected from the review of medical records by the Investigator (or designated).

The sites must have had adequate medical records to ensure robust medical record review. Therefore, a feasibility assessment was carried out at potential site prior to the study implementation to assess the adequacy of medical records and the data routinely available.

Eligibility Criteria:
Inclusion criteria

* Female patient ≥ 18 years of age. All the patients must have at least one year of follow-up
* Patients at an age not consistent with postmenopausal status could only participate if they had oophorectomy surgery or being on treatment with goserelin for ovarian suppression Post-menopausal women defined as age ≥ 60 years old or \< 60 years old and amenorrhea for 12 months or more (in the absence of chemotherapy, tamoxifen, toremifene or goserelin use for ovarian suppression)
* Confirmed diagnosis of HR+/HER2- locally advanced or metastatic BC
* Never in use of CDK 4/6i

Exclusion criteria

* Patients in menopause status other than postmenopausal (young patients must have undergone oophorectomy being on treatment with goserelin for ovarian suppression to be characterized as postmenopausal)
* Previous use, at any time, of CDK 4/6i
* The patient received any previous systemic therapy for advanced breast cancer Patients who have received (neo)adjuvant therapy for breast cancer are eligible. If previous (neo) adjuvant therapy has included letrozole or anastrozole, the disease- free interval should be longer than 12 months from completion of treatment until entry in this trial Patients who received ≤28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial are eligible
* Uncontrolled heart disease and/or clinically significant cardiac repolarization abnormalities
Multicomponent Risk Factor Intervention for People With a Severe Mental Illness: a Feasibility Study

This study is a feasibility study of a multi-component intervention to enhance healthy living among young people with psychotic disorders, specifically targeting smoking and weight.

We propose a feasibility study of a multi-component intervention to enhance healthy living among young people (18 to 40 years) with psychotic disorders, specifically targeting smoking and weight. Smoking is very common amongst people with psychotic disorders (around 70% of males, and over 50% of females) and this adds to the overall cardiovascular risk for this group. Obesity is also a common problem for people with psychosis, with an estimated 40-60% being obese or overweight. Obesity in this population may contribute to adverse medical and psychological consequences. For many obese people, targeted pharmacotherapy in addition to diet and increased physical activity can assist in both weight reduction and the maintenance of gains. Similarly, smoking cessation is enhanced by use of adjunctive medications such as nicotine replacement; such strategies continue to produce abstinence rates for up to 10 years.

The proposed study will assess the feasibility of a multi-component behavioural intervention focussing on smoking cessation/diet/physical activity.

The primary outcome measures from the feasibility study are smoking cessation and reduction in body mass index (BMI). Secondary outcomes will include tolerability and safety, as well as the impact the package has on other cardiovascular risk factors including serum lipids, blood sugar levels and depression in young people with psychosis. We will also establish whether smoking cessation and reduction in obesity is correlated with gains in terms of body image, quality and enjoyment of life and reduction in depression. Based on published data, behavioural interventions for smoking cessation and diet and physical activity lead smoking cessation in 20% of people at 12 months and to modest weight loss (around 5%).

Eligibility Criteria:
Inclusion Criteria:

* 18-40 yrs
* DSM-IV diagnosis of non-organic psychotic illness
* Obesity (BMI \> 30 or 27 if co-morbidities such as diabetes, hypertension or dyslipidaemia are present
* Current smoker ( \> 15 cigarettes per day) if also smoking cannabis regularly, they will still be able to participate

Exclusion Criteria:

* Medical contraindication to exercise or use of the nicotine patch
* Intellectual disability that would significantly impair ability to participate in the program
* Inability to give informed consent (acutely psychotic potential participants will be reassessed one month post screening
Endothelial Dysfunction and Coronary Artery Spasm

Non-obstructive coronary artery disease (NOCAD) frequently accounts for myocardial ischemia in women. Endothelial dysfunction is a pathogenic factor in coronary spastic angina (CSA). CSA is an important cause of NOCAD diagnosed invasively by coronary angiography (CAG). Digital reactive hyperemia peripheral arterial tonometry (RH-PAT) provides noninvasive evaluation of endothelial dysfunction. The investigators hypothesized that the fingertip RH-PAT could predict the presence of CSA in women.

Outline of methods:

RH-PAT was measured in women with chest pain prior to CAG. Coronary spasm was diagnosed by intra-coronary acetylcholine (ACh) provocation test. Using Flow-Wire, we assessed coronary endothelial function by coronary blood flow increase in response to ACh (ACh-CBF) and coronary flow reserve was assessed by adenosine (Ad-CFR).

Eligibility Criteria:
Inclusion Criteria:

* Stable post-menopausal women complaining angina-like chest pain

Exclusion Criteria:

* Severe valvular disease
* Hypertrophic cardiomyopathy
* Severe peripheral artery disease
* Uncontrolled hypertension
* Severe collagen diseases
* Acute coronary syndrome
The Effects of Nicotinamide Riboside Supplementation on Brain NAD+/NADH Ratio and Bioenergetics

The primary aim of this study is to investigate the effects of exogenously administered nicotinamide riboside (NR) on brain NAD+/NADH ratio and bioenergetics functions in healthy individuals using phosphorus magnetic resonance spectroscopy (31P MRS) imaging.

The secondary aims are to investigate the change in brain PCr/ATP and creatine kinase enzyme rate after NR use. In addition, NAD+/NADH ratio, PCr/ATP and CK enzyme rate will be measured in the calf muscle, as secondary outcome measures.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-80 year-old
2. Male or female
3. Without psychiatric diagnosis according to a structured psychiatric interview (Structured Clinical Interview for DSM-V Axis I Disorders (SCID))
4. Without history of a psychotic disorder and/or mood disorder among parents, siblings, or children, as obtained via self-report only.

Exclusion Criteria:

1. Significant medical or neurological illness.
2. Diagnosis diabetes mellitus (DM), uncontrolled hypertension (HTN), severe hypotension, coronary artery disease (CAD), metabolic syndrome, glaucoma, liver impairment, decreased renal function, respiratory disorders, uncontrolled peptic ulcer disease.
3. Taking any other medications, including over the counter supplements with the exception of oral contraceptives for women
4. Pregnancy. Females of child-bearing age must be using an effective contraceptive method.
5. History of smoking, substance abuse or dependence.
6. Contraindication to MR scan (claustrophobia, cardiac pacemakers, metal clips and stents on blood vessels, artificial heart valves, artificial arms, hands, legs, etc., brain stimulator devices, implanted drug pumps, ear implants, eye implants or known metal fragments in eyes, exposure to shrapnel or metal filings, other metallic surgical hardware in vital areas, certain tattoos with metallic ink, certain transdermal patches, metal- containing intrauterine devices)
7. Medical condition that would prevent blood draws, including current anti-coagulant or anti-aggregant therapy, tendency for abnormal scarring (e.g. keloids).
8. Difficulty in swallowing capsules.
Evaluation of Endometriosis With 18F-fluoroestradiol PET / MRI

Purpose: The primary objective is to evaluate the sensitivity and specificity of 18F-fluoroestradiol (FES) PET/MRI for evaluating endometriosis.

Participants: A total of 12 participants will be recruited from individuals with clinically suspected endometriosis who are scheduled for planned operative laparoscopy at the University of North Carolina at Chapel Hill (UNC).

Procedures (methods): This is a prospective, one arm, single center study of 12 subjects with clinically suspected endometriosis to demonstrate FES PET/MR's clinical utility for diagnosis of endometriosis. This study will be an evaluation of the radiotracer, FES, which binds to estrogen receptors and has previously been used to study estrogen receptor expression in tumors, to detect endometriosis. Participants will undergo one FES PET/MR scan within 4 weeks prior to their scheduled surgery. Participants will also complete questionnaires regarding their condition, pain, and quality of life.

This is a prospective, one arm, single center study of 12 subjects with clinically suspected endometriosis to demonstrate FES PET-MRI's clinical utility for diagnosis of endometriosis. The primary objective is to evaluate the sensitivity and specificity of 18F-fluoroestradiol (FES) PET/MRI for evaluating endometriosis. Secondary objectives include comparing PET to conventional MRI, using histopathology from laparotomy as the gold standard and evaluating association of uptake values (SUV-max) with Endometriosis Health profile -30 (EHP-30) and pain rating scales, controlling for covariates.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Female of childbearing age
* Clinically suspected (symptomatic) endometriosis.
* Scheduled for planned operative laparoscopy with no hormone treatment for at least two cycles
* Able to provide informed consent or assent

Exclusion Criteria:

* Male
* Institutionalized subject (prisoner or nursing home patient)
* Known history of breast, ovarian or endometrial cancer.
* Pregnant or breast-feeding women
A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis

The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of plaque psoriasis (PsO) for ≥ 6 months
* Body mass index 18 to 40 kg/m\^2 and total body weight \> 50 kg (110 lbs)
* Deemed by Investigator to be eligible for phototherapy or systemic therapy
* Psoriatic plaques must cover ≥ 10% of body surface area at baseline
* Psoriasis Area and Severity Index (PASI) score ≥ 12 and static Physician Global Assessment (sPGA) ≥ 3 at baseline

Exclusion Criteria:

* Diagnosis of non-plaque psoriasis (guttate, inverse, pustular, erythrodermic)
* Diagnosis of uveitis, inflammatory bowel disease, or other immune-mediated conditions that are commonly associated with PsO for which a participant requires current systemic immunosuppressant medical treatment
* Any significant acute or chronic medical illness

Other protocol-defined inclusion/exclusion criteria apply
Hyperimmune Colostrum and Oral Mucositis

To study the effect of daily intake of hyperimmune colostrum on prevention and treatment of oral mucositis in patients with head and neck cancer undergoing high-dose radiation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with: naso-pharynx, oral cavity, oro-pharynx and advanced localized laryngeal cancer.

Exclusion Criteria:

* Other tumors
* Non-epithelial tumors
* Pregnancy
* Poor functional status
QuickOpt Chronic Study

The purpose of this study is to demonstrate that QuickOpt optimization can be as an alternative method for CRTP/D patients' optimization in clinical practice through the comparison of the improvement differences between the CRTP/D patients with different optimization at 12 months after implantation.The hypothesis is that the Heart Remolding parameter (LVESV) improvement of patients using QuickOpt parameters at 12 months after implant is not inferior (10%) to the patients by Echo optimization。

Clinical studies have demonstrated that the AVTI from QuickOptTM related significantly to the max aorta VTI (AVTI) by Echo, the concordance correlation coefficient (CCC) was so high from 0.96 to 0.99.

But up to now, there are no clinical trials to evaluate mid-long term clinical outcome for CRTP/D patients by QuickOptTM and Echo optimization, this is indeed the main purpose of the study; in addition, the clinical impact, the status of arrhythmia and agents of all the enrolled patients, will be evaluated at 1 year after implant.

Eligibility Criteria:
Inclusion Criteria:

* • Patient meets current CRT-P indications and be implanted with an SJM CRT-P device with V-V timing and a compatible lead system

  * Patient is able to provide written informed consent for study participation

Exclusion Criteria:

* • Patient has limited intrinsic atrial activity (≤ 40 bpm)

  * Patient has persistent or permanent AF
  * Patient has a 2o or 3o heart block
  * Patient's life expectancy is \<12 months
  * Patient is \<18 years old
  * Patient is pregnant
  * Patient is on IV inotropic agents
  * Patients who are ongoing other devices or agents study
  * Patients with heart transplanted or waiting for heart transplant
  * Patients with Hypertrophic and obstructive cardiomyopathy
  * Patients with severe aortic valve and mitral valve stenosis or regurgitation without replacement
Cardiorespiratory Performance and Pulmonary Microbiome in Patients After Repair of Esophageal Atresia

The majority of the clinical research on esophageal atresia focuses on the upper gastrointestinal tract. However, the trachea and the lung are also affected in many of these children, so that a lifelong pulmonary impairment may result. The importance of respiratory function in the context of follow-up of these patients has therefore been increasingly recognized in recent years. Scientific work has shown significantly, that patients following esophageal atresia repair develop respiratory symptoms more frequently than the normal population. Mild impairment of the pulmonary function in adolescence and adulthood was demonstrated in some studies, but to date, there is no exact idea about the relationship between early childhood disease progression and later pulmonary impairment. Only a few scientific papers have dealt with the effect of impaired pulmonary function on the physical capacity of these adolescents and adults. Most of these studies show small case numbers, inconclusive stress tests, and divergent results.

The aim of this prospective study is to investigate the cardiopulmonary performance capacity and the pulmonary microbiome of adolescent and adult patients with corrected esophageal atresia and to compare the results with a control group. Another focus of the investigators is on the composition of the pulmonary microbiome of the participants. Changes of the pulmonary microbiome and the influence on the cardio-pulmonary performance capacity have not yet been investigated. Furthermore, it should be investigated whether the treatment measures and a complicated disease course in the neonatal period have long-term effects on lung function, exercise capacity and composition of the microbiome in the lungs.


Eligibility Criteria:
Inclusion Criteria:

* Age from 12 years
* Status post surgical correction of esophageal atresia with and without fistula
* Granted consent

Exclusion Criteria:

* Acute infections within the last 14 days
* Other associated serious malformations
* Acute, temporary respiratory complaints (cough, allergies etc.)
* Physical and mental illnesses or disabilities that do not allow the examination to be carried out
* non-granted consent
Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma (CheckMate 064)

The purpose of this study is to evaluate the safety and efficacy of a sequential combination therapy of Nivolumab and Ipilimumab

In order to evaluate the potential synergistic activity of nivolumab and ipilimumab and also because there may be differences in biology between tumors which are stable or responding to therapy and those that are clinically progressing, this study, CA209064, looked at two sequential combination regimens in which the second agent is administered immediately after a pre-specified duration of therapy with the first agent and not delayed until the time of progression after the first agent. This sequential study design looked at pharmacodynamic changes during treatment with one agent which may predict clinical activity to subsequent treatment with the alternate agent. This was done because it has not been scientifically proven whether or not the order in which nivolumab and ipilimumab are given is clinically important.

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Histologically confirmed unresectable Stage III or IV melanoma
* Treatment-naive or experienced disease recurrence or progression during or after one prior systemic regimen for advanced disease
* Measurable disease by Computed Tomography/Magnetic resonance imaging (CT/MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Known BRAF V600 mutation status or consent to BRAF V600 mutation testing
* Sufficient tumor tissue accessible for baseline and post-treatment biopsies.

Exclusion Criteria:

* Active central nervous system (CNS) metastases
* Carcinomatous meningitis
* Active, known or suspected autoimmune disease
* Condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization
* Prior therapy with anti-Programmed Death-1 (PD1), anti-Programmed Death-Ligand 1 (PD-L1), anti-PD-L2, anti-CD137, or anti-CTLA-4 (cytotoxic T lymphocyte antigen 4) antibody
* Prior treatment with other immunotherapies
* Prior therapy with BRAF inhibitor within 6 weeks of enrollment
BIOFLOW-III VIP Russia Registry Orsiro Stent System

Clinical evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES). Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the patient's body inflammation status correlates with the clinical outcome.

For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequences. Bare Metal Stents (BMS), designed to address the limitations of PTCA, reduced the angiographic and clinical restenosis rates in De Novo lesions compared to PTCA alone and decreased the need for CABG. BMS substantially reduced the incidence of abrupt artery closure, but restenosis still occurred in about 20 to 40% of cases, necessitating repeat procedures.

The invention of Drug Eluting Stents (DES) significantly improved on the principle of BMS by adding an antiproliferative drug (directly immobilized on the stent surface or released from a polymer matrix), which inhibits neointimal hyperplasia. The introduction of DES greatly reduced the incidence of restenosis and resulted in better safety profile as compared to BMS with systemic drug administration. These advantages and a lower cost compared to surgical interventions has made DES an attractive option to treat coronary artery disease.

Therefore this observational registry has been designed for the clinical evaluation of the ORSIRO LESS requiring coronary revascularization with DES. It is designed to investigate and collect clinical evidence for the clinical performance and safety of the Orsiro Drug Eluting Stent System in an all-comers patient population in daily clinical practice.

Along with it, an explanatory (hypothesis-finding) problem will be investigated, whether the patient's body inflammation status correlates with the clinical outcome.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic coronary artery disease
* Subject signed informed consent for data release
* Subject is geographically stable and willing to participate at all follow up assessments
* Subject is ≥ 18 years of age

Exclusion Criteria:

* Subject did not sign informed consent
* Pregnancy
* Known intolerance to aspirin, clopidogrel, Ticlopidine, heparin or any other anticoagulant/antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media
* Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
* Currently participating in another study and primary endpoint not reached yet
Safety Study of an Oral Vaccine to Prevent Seasonal Influenza

The purpose of this study was to demonstrate the safety and immunogenicity of an oral vaccine tablet to prevent seasonal influenza. The study was a placebo controlled, double blinded trial at a single site. The study was conducted under two separate protocols. Initially single administrations at two dose levels (low dose and mid dose) of the oral vaccine was tested in a placebo controlled study (37 subjects). And subsequently a single high dose of the oral vaccine was tested in a separate placebo-controlled study (24 subjects).

Low and mid dose study was conducted under protocol number VXA02-001

High dose study was conducted under protocol number VXA02-003

Eligibility Criteria:
Inclusion Criteria:

* In good health as established by medical history, physical examination, and laboratory testing at the time of enrollment.

Exclusion Criteria:

* Positive for H1 influenza by HAI.
* Has had an influenza vaccine in the past 2 years.
* Current history of chronic alcohol consumption and/or illicit and/or recreational drug use.
* History of any confirmed or suspected immunodeficient or immunosuppressive condition
* Positive serology for HIV, HCV, or HBV
* Previous serious reactions to vaccination such as anaphylaxis, respiratory problems, hives, or abdominal pain.
* History of irritable bowel disease or other inflammatory digestive or gastrointestinal conditions that could affect the intended distribution of the vaccine targeting the mucosa of the small intestine
* Use of proton pump inhibitors(Nexium, Prilosec).
* Stool sample with occult blood at baseline exam