cyrilzakka/clinical-trials huggingface dataset:
Breast Cancer Risk Assessment Using Optical Breast Spectroscopy (OBS)

This study aims to evaluate if a light based technique, called Optical Breast Spectroscopy (OBS) formerly known as Transillumination Breast Spectroscopy (TiBS), can be used to detect differences in breast tissue between high- and low-risk populations and within the high-risk population between BrCa1 or 2 carriers and non-carriers. These differences may include differences in breast tissue composition and metabolism at time of enrollment into the study (possibly reflecting changes occurring in adolescence) and in the rate of breast tissue change over time (possibly reflecting rate of tissue transformation from normal to ultimately malignant state).

Preliminary data show Optical Breast Spectroscopy (OBS)has the ability to detect tissue differences with various pathologies and age-related changes in breast tissue over a two year period. In the present study, we want to determine whether OBS has the ability to detect optical differences between women who harbor a mutation in the breast cancer susceptibility gene, BrCa1 or BrCa2, and their age-matched controls (non-carriers). More specifically, possible differences in the breast tissue at time of enrollment into the study (reflecting changes potentially occurring in adolescence) and in the rate of breast tissue change over time (reflecting rate of tissue transformation from normal to ultimately malignant state). The overall goal is to develop a pre-screening technique to survey or monitor the risk of breast tissue and to advise the earliest point when imaging techniques (e.g. MRI) should be initiated or when more drastic primary prevention measures are recommended.

Eligibility Criteria:
Inclusion Criteria:

BrCa carriers (cases)

* Attending one of the three participating high-risk screening centres
* Confirmed BrCa1 or BrCa2 mutation status through genetic testing

High-Risk (cases)

* Attending one of the three participating high-risk screening centres
* Confirmed negative BrCa1/2 status through genetic testing

BrCa non-carriers (controls)

* Attain a GAIL model score of \<1.1 and have \<10% risk of carrying the BRCa mutation Determined by the Penn II model)
* Controls from high-risk screening centre with confirmed BrCa1/2 negative status through genetic testing
* Preference will be given to sisters or first degree cousins of BrCa carriers

Exclusion Criteria:

Cases and Controls

* Prior diagnosis or Breast or Ovarian Cancer
* Bilateral biopsy or fine needle aspiration within 1 year of study start
* Bilateral mastectomy, lumpectomy or cosmetic alteration (reduction/augmentation)
* Previous or current chemotherapy or prevention therapy (Tamoxifen)
* Less than 3 years post pregnancy at study start
* inability to provide informed consent due to language or cognitive difficulties

  \*For controls only
* Family history of breast cancer where family member had an early diagnosis (before age 45 years)
* Family history or ovarian cancer
Haploidentical and Mismatched Unrelated Donors Hematopoietic Stem Cell Transplant

The primary objective of this study is to compare the 2-year progression free survival without acute graft versus host disease (GvHD) (aGvHD) grade III-IV or without moderate or severe chronic (cGVHD) after transplant from haploidentical hematopoietic stell cell transplant (HSCT) or from an unrelated Human Leukocyte Antigen (HLA)-9/10 mismatched unrelated donor (MMUD).

It will use a Phase II, multicenter, prospective, randomized clinical trial.

By setting a power of 80% and a type I error rate of 5% for a two-sided log-rank test (hypotheses tested: probability of event-free survival at 2 years 50% vs. 30 %), 92 patients need to be recruited in each arm, for a total of 184 patients.


Eligibility Criteria:
Inclusion Criteria:

* With a hematological malignancy requiring a HSCT and at least in partial response ie a) Acute Leukemia in complete remission, b) Myelodysplastic syndromes with less than 20% marrow, c) Myeloproliferative syndromes with less than 20% bone marrow blasts, d) Non Hodgkin Lymphoma (NHL), Hodgkin's disease, chronic lymphocytic leukemia at least in partial response, e) Myeloma at least in partial response.
* Without HLA matched related or unrelated donor
* Identification of a possible HLA-9/10 MMUD and a possible haplo-identical donor.
* Having read and understood the information letter and signed the informed consent
* With health insurance coverage

Exclusion Criteria:

* Organic or psychiatric disease, non related to the hematological malignancy, contraindicating the transplant.
* Performance Scale by the Eastern Cooperative Oncology Group (ECOG)\> 2
* Severe uncontrolled infection
* Cardiac contraindication of post-transplant Cy (coronary insufficiency, ejection ventricular fraction \<50%)
* Aspartate transaminase (AST) and alanine transaminase (ALT) \> 2.5 N, creatinine \> 150 mmol/L (except if related to malignancy)
* Previous active cancer in the last two years, except basal cell skin cancer and in situ carcinoma of the cervix
* Childbearing age woman refusing contraception
* Patients who did not accept the follow-up planned by the protocol
* Positive serology for HIV or Human T-Lymphotropic Virus (HTLV)-1, 2, or active viral infection by the Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV)
* Pregnant woman (positive β-HCG) or during lactation
* Adult patient on guardianship, or safeguard justice
Clinical Cohort Study - INTERCATH

Within a CAD patient cohort there is a wide variability of clinical manifestation and severity of coronary disease. Distinct determinants that would explain the variety of CAD phenotypes with differing prognosis are yet undiscovered. Aim of this study is to find genetic variants, biomarkers, and clinical cardiovascular risk factors that relate to specific coronary artery disease phenotypes and related pathologies in a patient population.

Atherosclerotic Coronary Artery Disease (CAD) is one of the leading causes of death in industrialized countries and accounts for a high lifetime prevalence. Within a CAD patient cohort there is a broad inter-individual difference with regard to clinical manifestation and severity of disease, e.g. stable angina vs. acute coronary syndrome, calcified vs. thrombotic coronary lesions or one vessel vs. complex three vessel disease or left main stenosis. Thus, depending on the CAD phenotype there is a broad difference in CAD patients' prognosis. Similarly, other non-atherosclerotic coronary pathologies such as Spontaneous Coronary Dissection (SCAD) are related with devastating illness in mainly young patients. For these patients there is an unmet need in the knowledge of epidemiology, presentation, current management and outcome. Aim of this study is to discover genetic variants, biomarkers, and clinical cardiovascular risk factors that relate to specific CAD (and related coronary pathologies) phenotypes in a national patient population. This may allow an improvement of individualized risk stratification and contribute to discover pathways in the pathogenesis and open the avenue for potential therapeutic targets.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with a minimum age of 18 years
* Any patient with an available complete coronary angiography
* Ability to provide written informed consent in accordance with Good Epidemiological Practice and local legislation

Exclusion Criteria:

* Physical or psychological incapability to take part in the study
* Known anaemia (Hemoglobin \< 7.5 g/dl)
Expanded Access to Glecaprevir/ Pibrentasvir

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to glecaprevir/ pibrentasvir prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.


Eligibility Criteria:
rTMS Treatment in Vascular Parkinsonism

Vascular parkinsonism (VP), parkinsonism resulting from ischemic cerebrovascular disease, was suggested in 1929. The main features are wide-based gait, postural instability, and falls, which make patients with VP frustrated. Currently, the treatment is challenging.

Transcranial magnetic stiumation is a noninvasive procedure using electromagnetic induction to stimulate brain, and repetitive transcranial magnetic stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim of this study is to explore the therapeutic effect of rTMS for the VP.


Eligibility Criteria:
Inclusion Criteria:

* Vascular parkinsonism
* age 18 and older

Exclusion Criteria:

* pregnant or any, other medical, surgical, neurological or psychiatric conditions
* other restrictions which prevent you from undergoing TMS recording, such as; surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), and/ or heart/cardiac lines
* any past or current history of seizure disorder or epilepsy
* unable to give informed consent
Physiologic Assessment Following Gadoxetic Acid and Gadobenate Dimeglumine Administration

The purpose of this study is to prospectively compare the physiologic response of patients who receive either intravenous gadoxetic acid (Eovist) or intravenous gadobenate dimeglumine (MultiHance).

Contrast-enhanced hepatic MRI is an accepted method for detecting and characterizing liver lesions. Liver lesion characterization is fundamental for patient management, because lesions that meet specific imaging criteria for hepatocellular carcinoma (HCC) are assumed to be HCC without tissue confirmation. There are a variety of gadolinium-based contrast agents that are used for this purpose. Two of the more commonly utilized are gadoxetic acid (an hepatobiliary contrast agent that permits 20 minute hepatobiliary phase imaging) and gadobenate dimeglumine (a weak hepatobiliary contrast agent that functions generally as an extracellular contrast agent). A recent study by our group has shown that patients who receive intravenous gadoxetic acid are much more likely to experience transient dyspnea after contrast injection that causes them to breathe rapidly through the arterial phase of imaging, degrading image quality. In that study, subjective complaints of dyspnea and respiratory motion artifact on imaging were scored. The investigators did not assess patient physiologic response. The goal of the proposed work is to build on our prior data and to determine whether there are non-invasively measurable physiologic parameters that can support our original study. Specifically, the investigators want to determine whether there are predictable changes in SpO2, pulse, respiratory periodicity, and respiratory regularity that correlate with arterial phase image degradation and patients complains of dyspnea. Both contrast agents to be assessed in this study are FDA approved with at least 4 years of post-marketing experience documenting safety and efficacy. The investigators will not be changing or altering our clinical approach in any way as a part of this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old and older
* Patients scheduled for MRI examination at the University of Michigan hospital
* Patients receiving either MultiHance or Eovist contrast agents during their clinical MRI examination

Exclusion Criteria:

* Patients under 18 years of age
* Patients who will not receive MultiHance or Eovist as part of their clinical MRI examination
USDA Behavior, Motivation & Nutrition Study

This study will be a cross-sectional study. The primary aim of this study is to compare the relationship between neurological function, metabolic measures and health-related behaviors between normal weight and overweight/obese perimenopausal women.

To examine physiological and behavioral factors that may help determine health in perimenopausal middle age women. Neuroendocrine function will be measured by broad assessment of hypothalamic-pituitary-adrenal (HPA) activity. We will also assess metabolic profiles and behavioral and emotional function. We plan to determine correlations between these measures and nutritional state. Other measures may include insulin, glucose, leptin, IGF-1, triglycerides, free fatty acids, and ghrelin and eating attitudes and physical reactivity.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass index 18-39.9 kg/m2
* Peri-menopausal status by self-report

Exclusion Criteria:

* Pregnant
* Plan to become pregnant
* Breastfeeding in the last 6 months
* Multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease
* Menopause confirmed
* Unable to refrain from smoking for five hours (self-report)
* Unable to refrain from consuming alcohol for two days (self-report)
* Weight change \> 10 lbs in the preceding 6 months
* Chronic corticosteroid use
* Oral corticosteroids used more than twice in the last 12 months
* Hormonal contraceptives
* Antipsychotic, anti-anxiety and anti-depressant medications
* Beta adrenergic blockers
* Sibutramine, orlistat, phentermine, phendimetrazine, topiramate, zonisamide
* Immunosuppressants
* Amphetamines and other stimulants
* Severe food allergies or intolerances to foods
* Insulin Dependent Diabetes Mellitus
Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated AML

In this prospective study, 30 newly untreated elderly patients with acute myeloid leukemia(AML) who were not suitable for standard chemotherapy were enrolled to observe the efficacy and side effects of venetoclax (VEN) combined with azacytidine (AZA) and chemotherapy in newly treated elderly patients with AML. Overall survival (OS), complete remission rate/complete remission with incomplete recovery of blood cell count (CR/ CRi) were used as the primary endpoints, and time to response (TTR), duration of response (DOR), mortality, and recurrence rate were used as secondary endpoints,and the incidence of adverse events were evaluated.

Induction therapy: venetoclax d1 100mg, d2 200mg, d3-28 400mg, po; azacytidine 75mg/m2, d1-7, sc. Consolidation therapy: Regimen A or B was chosen according to the wishes of the patients. In addition, venetoclax was used for 14 days for positive minimal residual disease(MRD) and 7 days for MRD negative.

regimen A: the first two cycles: venetoclax 400mg, d1-7/14, po; cladribine 5mg/m2, d1-3, ivgtt; cytarabine 10mg/m2, q12h, d1-10, sc; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; regimen B: the first two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 100mg/m2, d1-5/7, ivgtt; idarubicin 8mg/m2, d1-2/3, ivgtt; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; If the patient's ECOG performance status ≥2, the reduction of regimen IA(cytarabine+idarubicin)was 5+2. Maintenance therapy: azacytidine 75mg/m2, d1-7, sc.

Eligibility Criteria:
Inclusion Criteria:

1. The elderly patients(≥ 60) with AML diagnosed according to WHO criteria;
2. Participants are ineligible for induction regimen;
3. The Eastern Cooperative Oncology Group (ECOG) performance status is 0-3;
4. The patients and their families agree and sign the informed consent form.

Exclusion Criteria:

1. Previous treatment for AML (including hypomethylating agents and other chemotherapy drugs);
2. Infiltration of the central nervous system;
3. Drugs use history affecting CYP3A within 7 days before enrollment;
4. participants considered by the investigator to be unsuitable for inclusion.
Music in Reducing Distress in Participants with Cancer During Chemotherapy Treatment

This trial studies how well music works in reducing distress in participants with cancer during chemotherapy treatment. Music in participants receiving cancer treatment such as infusion treatment and caregiver may reduce pain, anxiety, and distress and improve participant's psychological and physiological wellbeing.

PRIMARY OBJECTIVES:

I. To test the effect of patients? listening to music on level of distress during cancer treatment.

SECONDARY OBJECTIVES:

I. To explore the influence of covariates (patients? sociodemographics, musical background, and clinical variables) on the association between patients? listening to music and level of distress during cancer treatment.

II. To explore the interdependence of adjustment among patients and their caregivers on the association between.

OUTLINE: Participants and caregivers are randomized to 1 of 2 groups.

GROUP I: Participants and caregivers listen to music of their choice for up to 60 minutes during infusion session.

GROUP II: Participants and caregivers do not listen to music during infusion session and are placed on music waitlist.

Eligibility Criteria:
Inclusion Criteria:

* Able to speak, read, write and understand English
* Have sufficient hearing capacity to hear music

Exclusion Criteria:

* Patients with cognitive or perceptual disturbances will be excluded
Primordial Dwarfism Registry

The goal of this registry is to collect information on individuals with forms of microcephalic primordial dwarfism. The study team hopes to learn more about these conditions and improve the care of people with it by establishing this registry.

The goal of this registry is to collect information on individuals with forms of microcephalic primordial dwarfism. The registry will enable detailed natural history studies of MOPD II and associated conditions. The study team hopes that identification of risk factors will allow for preventative treatments and thus a better quality of life for individuals with these diagnoses.

This study is limited to chart review, after signed informed consent obtained. There will be no additional visits or time in clinic because of participation in this registry. This study involves only the collection and storage of data extracted from the medical record. Records that may be requested and reviewed as a part of this study include but may not be limited to: specialist evaluations, surgical reports, results of blood and urine tests, genetic testing, x-rays, CT/MRI/MRA imaging. There are no special procedures, visits, or expectations of the individual as a result of participation in this registry. No one will be asked to have any specific testing for the sole purposes of this research.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with MOPDII, MOPDI/III, Meier-Gorlin syndrome, or unclassified or closely related types of microcephalic primordial dwarfism as diagnosed by a medical provider are eligible for this registry.

Exclusion Criteria:

* individuals without microcephalic primordial dwarfism or closely related conditions
Effect of Preoperative Exercise in Patients Undergoing Total Knee Arthroplasty

This study evaluates the effect of preoperative exercise in patients undergoing a total knee arthroplasty.

The objectives of this study were to investigate the effects of a single (9 sessions) prescription community based preoperative physical therapy in patients awaiting a Total Knee Arthroplasty, taking prognostic factors into account.

The investigators will use different outcome measures to evaluate any possible effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a Total Knee Arthroplasty
* Signed informed consent after being informed

Exclusion Criteria:

* Acute pain
* Weakness due to neurological problems
* Known or suspected non-compliance
* High BMI \> 28
* Patellar residual subluxation
* High patellar height
A Phase 3 Efficacy and Safety Study of Fosmanogepix for the Treatment of Adult Patients With Invasive Mold Infections.

The purpose of this study is to evaluate the efficacy and safety of fosmanogepix (administered IV or oral) for the treatment of adult patients with invasive mold infections. The study is looking for patients who have been diagnosed with invasive mold infections. The maximum study duration will be approximately 8 months, including a target study treatment duration of 84 days which can be extended up to 180 days and follow-up period.

The patient will be assigned to one of two treatment cohorts:

Cohort A (primary therapy): Patients will receive either the study drug or institutional standard of care antifungal treatment.

Cohort B (salvage treatment; i.e. treatment given after patients did not respond to previous treatments or did not tolerate them): Patients will receive the study drug

The primary aim is to compare the all cause mortality with a fixed threshold at Day 42.


Eligibility Criteria:
Main Inclusion Criteria:

1. Diagnosis of proven or probable Invasive mold infection (IMI) defined in accordance with the Revision and Update of the Consensus Definitions of Invasive Fungal Disease from the EORTC/MSGERC as adapted for this study and caused by Aspergillus spp. (in patients with limited treatment options), Fusarium spp., Lomentospora prolificans, Mucorales fungi, or other multi-drug resistant molds.
2. Patient's condition allows for appropriate infection source control measures.

Main Exclusion Critera:

1. Refractory hematologic malignancy.
2. Chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis.
3. COVID-19 associated mucormycosis.
4. Invasive fungal disease caused by more than one fungal pathogen are not permitted in Cohort A but are permitted in Cohort B.
5. Patients with a Karnofsky Performance Status \< 20 at Screening.
6. Requirement, or anticipated requirement, for hemodialysis, peritoneal dialysis, or hemofiltration.
7. Patients with known human immunodeficiency virus infection.
8. Ongoing neurological disorders.
9. Patients receiving hospice/comfort care only.
10. Other medical or psychiatric condition.
11. Current use of any prohibited concomitant medication(s).
12. Current/ previous administration of an investigational drug within 30 days.
13. Prior enrollment in this or any previous study of fosmanogepix.
14. Moderate or severe hepatic impairment.
15. Patient who is pregnant or lactating.
16. Known hypersensitivity to fosmanogepix, manogepix, or any of their excipients.