cyrilzakka/clinical-trials huggingface dataset:
of Androgen Receptor Expression in Breast Cancer With or Without BRCA Mutation

Androgen Receptor is extensively expressed in BRCA and its role in the disease may differ depending upon molecular subtypes and stages. Androgen Receptor (AR) may act as an antagonist of estrogen receptor α (ERα), in ERα induced effect, whereas in the absence of estrogens, AR may act as an agonist, of ERα- promoting tumor. Thus, depending on the BRCA micro-environment, both agonists and antagonists of the AR have been suggested for therapeutic approaches.

The rate of AR positivity in breast cancer is about 60% to 80%. Biologically the AR pathway has cross talk with several other key signaling pathway, including the PI3K/Akt/mTOR and MAPK Pathways, and with other receptor, including estrogen receptor and human epidermal growth factor receptor-2. In clinical trials in patients with breast cancer, AR targeted therapies such as AR agonists, AR antagonists, PARP inhibitors, and PI3K inhibitors have shown promising results. The use of AR targeted therapies in conjunction with other agent has been investigated for overcoming resistance to AR focused treatments. Thus, the value of AR positivity as a prognostic marker has not been identified. Several retrospective clinical studies have shown that AR might be a prognostic or predictive factor in breast cancer. BRCA1 mutation accounts for the progress of hereditary breast cancers and is in connection with unique clinicopathological characteristics compared with sporadic breast cancers. The database is still evolving and newer mutation and their significance is being found every day. Also, there were several limitations to these previous studies. First, the cut-off for AR positivity was arbitrary. In most of the studies, the cut-off points were 1% or 10% and weren't enough to predict carcinoma survival. Moreover, quite 90% of the studies were conducted in non-Asian regions. Most of the studies involving Asian patients studied the prognostic role of AR in TNBC patients, with inconclusive results. There are only a few studies from Indian continents and none has correlated the AR expression with BRCA.

After the written inform consent in case of fresh recruitment the blood will be collected and tissue blocks will be obtained, use of already available blocks of patients who earlier participated in another study is also proposed.

(a) Samples will be stored for DNA study and will be frozen in liquid nitrogen and stored at -80 °C until further processing.

(samples will store in 10% formalin at room temperature (RT) for Immunohistochemistry

Eligibility Criteria:
Inclusion Criteria:

* Histology proven cases of breast cancer

Exclusion Criteria:

* Patients with prior treatment
* Pregnant and lactating women
FX-322 in Sensorineural Hearing Loss

This is a phase 1/2 study of FX-322 at two dose levels compared to placebo in male and female adults otherwise healthy with stable sensorineural hearing loss.

Sensorineural hearing loss (SNHL) accounts for about 90% of all cases of hearing loss. The study will assess the safety of FX-322 (laduviglusib and sodium valproate) given as a single intratympanic injection in subjects with a medical history of sensorineural hearing loss that is associated with noise exposure or sudden hearing loss. Safety will be evaluated both systemically (lab and clinical monitoring) and locally (otoscopy and audiometry) in 24 subjects, and a blood PK profile of FX-322 will also be determined.

Eligibility Criteria:
Inclusion Criteria:

1. Adult aged 18-65 years.
2. Established diagnosis of stable sensorineural hearing loss (no changes of 10 dB or more at any frequency) by standard audiometric measures for \>6 months.
3. Documented medical history consistent with hearing loss being caused by noise exposure or sudden sensorineural hearing loss (documented audiogram at least 6 months prior to screening required).
4. Female subjects must be of non-childbearing potential or will need to utilize two methods of highly effective contraception during the study participation (e.g. hormonal contraception or an intrauterine device and condoms) or remain abstinent. Male subjects should use condoms with spermicide during the course of the study or remain abstinent. Subjects should not donate sperm or ova during the study period.

Exclusion Criteria:

1. Perforation of tympanic membrane or other tympanic membrane disorders that would interfere with the delivery and safety assessment of an intratympanic medication or reasonably be suspected to affect tympanic membrane healing after injection in either ear. This includes a current tympanostomy tubes.
2. Any conductive hearing loss of 10 dB or more at two or more frequencies in either ear.
3. A pure tone average of 70 dB or greater at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the ear to be injected.
4. Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
5. Subject has had an intratympanic injection in either ear within 6 months of the screening visit.
6. History of clinically significant vestibular symptoms at the discretion of the investigator.
7. History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
8. History of head or neck radiation treatment or exposure.
9. History of substance abuse within 2 years of the Screening Visit.
10. Positive urine pregnancy test or breast-feeding.
11. Any known factor, condition or disease that, in the view of the investigator, might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease or suicidal tendencies.
A Study of LY3502970 in Healthy Male Participants

The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to eliminate it. This study will involve a single dose of ¹⁴C radiolabelled LY3502970. This means that a radioactive substance will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to 8 weeks (maximum).


Eligibility Criteria:
Inclusion Criteria:

* Are overtly healthy males
* Body weight within 50 and 100 kilograms (kg), inclusive, and body mass index within the range 18.0 and 32.0 kilograms per square meter (kg/m²) (inclusive)

Exclusion Criteria:

* Females
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product (IP); or of interfering with the interpretation of data
* Have a history of Gilbert's syndrome or have total bilirubin level (TBL) above upper limit of normal (ULN) at screening
* Have evidence of significant active neuropsychiatric disease, as determined by the investigator
* Have had any exposure to LY3502970 or any other glucagon-like peptide-1 (GLP-1) analogs, or other related compounds within the prior 3 months, or any history of allergies to these medications
* Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study
* Have participated, within the last 3 months, in a clinical study involving an IP. If the previous IP has a long half-life, 5 half-lives or 3 months (whichever is longer) should have passed, prior to check-in
* Have participated in any clinical trial involving a radiolabeled IP within 12 months prior to check-in
* Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies
* Show evidence of hepatitis C and/or positive hepatitis C antibody
* Show evidence of hepatitis B and/or positive hepatitis B surface antigen
* Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (e.g., serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)
Reconnecting to Ourselves and Others in Virtual Meetings (ROOM)

This study aimed to determine the feasibility and acceptability of delivering Resilience Training in multi-user virtual reality.


Eligibility Criteria:
Inclusion criteria for college student participants:

1. 18-30 years old
2. Enrolled in an undergraduate program

Inclusion criteria for healthcare provider participants:

1. At least 18 years old
2. Employed in the healthcare field with some direct patient contact

Exclusion Criteria:

1. Inability to provide informed consent
2. Not proficient in English
3. Acute symptoms of a psychiatric illness needing immediate care (such as acute psychotic symptoms, current suicidality, serious active alcohol or substance use, marked deterioration in functioning over the prior month) determined by self-report that necessitates close monitoring or inpatient or partial hospitalization.
4. Enrolled in current psychotherapy with frequency of more than once per month
Effect of a Topical Spray on Itch Relief in Moderate-to-severe Childhood Eczema

Pruritus is defined as an unpleasant sensation of the skin that provoke the desire to scratch or rub. Its presence is an essential diagnostic feature. According to some European studies, 91% of patients with Atopic Dermatitis report suffering from pruritus at least once daily. And 58.1% of them experience chronic pruritus, leading to great deterioration in quality of life. Various internal and external factors may trigger pruritus. Mediators secretion such as keratinocyte-derived Thymic Stromal Lymphopoietin (TSLP) and Nerve Growth Factor (NGF) could activate nerve fibres which will eventually transmit signals to the brain causing the sensation of itching.

Although being one of the major annoying symptoms faced by patients with Atopic Dermatitis, effective anti-itching treatments are not available. There is no consistent evidence that topical antihistamines can relief itch.

Recently, a new spray named Atoderm 'SOS' is developed. The skin relief technology (by ambora extract and Epigallocatechin gallate (EGCG), associated to enoxolone) claimed to inhibit the release TSLP and NGF which eventually could reduce nerve signals to the brain for itchy feelings. Therefore, our group would like to test the efficacy of this proprietary anti-itch product with our paediatric patients using a wait-list approach as a control. It is aimed to demonstrate that the using the Atoderm 'SOS' spray topically whenever necessary can reduce the unpleasant itchy Atopic Dermatitis's symptom, improve quality of life, as well as to reduce the need for topical treatment.


Eligibility Criteria:
Inclusion Criteria:

* A pruritus frequency of more than 3 days in previous week recorded by Q1 in The Patient Oriented Eczema Measure (POEM)
* History of known moderate-to-severe eczema
* Able to read Chinese
* voluntarily willing to participate into the study by written consents endorsed by patients and their legal guardians

Exclusion Criteria:

* No history of known eczema
* Concurrently participating into another clinical trial
* History of known drug allergy
* unable to read Chinese
Premature Termination of Resuscitation in Survivors of Cardiac Arrest

The study Premature Termination of Resuscitation in Survivors of Cardiac Arrest focuses on using innovative knowledge translation strategies to improve appropriate neuroprognostication for survivors of cardiac arrest and prevent premature termination of life sustaining therapies. This is important because any early gains achieved during resuscitation will be nullified if clinicians terminate life-sustaining therapies prematurely based on inadequate prognostic information. An effective translation strategy for neuroprognostication will result in improved physician adherence to evidence-based medicine and an increase in the proportion of patients surviving to achieve a good neurological outcome following cardiac arrest.

A stepped wedge cluster randomized trial design will be employed in order to properly evaluate the impact of this intervention. Each of the 18 participating hospitals will be randomized one of the four wedges according to a random schedule; each wedge will consist of 4 to 5 hospitals. With this design, the implementation of the intervention will be rolled out sequentially to the participating hospitals over a 5 month period for each wedge. All hospitals will have received the intervention by the end of the study.

Note that the study design fields provided by ClinicalTrials.gov do not allow for describing this type of study design; therefore, the investigators have listed the study as a single arm. In reality, this study will have 4 wedges, each containing randomized clusters of 4-5 hospitals.

Eligibility Criteria:
Inclusion Criteria:

* Patients =/\> 18 years of age
* Non-traumatic out of hospital cardiac arrest
* Sustained return of spontaneous circulation (palpable pulse for \> 20 minutes)
* Comatose (i.e. without full neurological recovery; non-responsive to verbal commands)
* Surviving to at least 6 hours after emergency department arrival

Exclusion Criteria:

* Patients who die within 6 hours of emergency department arrival
Hand Transplantation: Functional and Quality of Life Outcomes

There is an urgent need to develop hand transplant programs in this country. To this end, the University of Michigan Hospital and Health Systems is developing such an interdisciplinary program. The Transplant Center would like to track the patient experience from pre-operative care through surgery and post-operative care.

Detailed information will be collected from the patient medical records, including: Pre-operative screening, demographics, medications; Surgical information ; Post-operative inpatient and out-patient care; laboratory and other test results; physical assessments, psychological assessments and quality of life assessments.

Vascularized composite tissue allotransplantation (VCA) is the transplantation of multiple tissues containing skin, muscle, bone, joint, cartilage, nerve, tendon, vessels. VCA is useful for functional restoration of patients with severe tissue loss as encountered with massive burns, traumatic injuries, congenital anomalies, and following tumor resection. VCA, and specifically hand transplantation, combines the technical excellence of hand surgery/microsurgery with the complex multidisciplinary care rendered in modern solid organ transplantation. The technical demands of hand transplantation, enhanced donor antigen burden of the hand allograft, and complex psychosocial issues pertaining to the recipient account for much of the discrepancy between these 2 related fields.

Detailed information will be collected from the patient medical records, including: Pre-operative screening, demographics, medications; surgical information ; post-operative inpatient and out-patient care; laboratory and other test results; physical assessments, psychological assessments and quality of life assessments.

Specific outcomes will include allograft survival, allograft rejection, allograft functionality, and quality of life from transplant through 5 years.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have been evaluated and listed for hand transplantation will be approached to participate in this study.

Exclusion Criteria:

* Those deemed not to be appropriate for listing by the University of Michigan interdisciplinary evaluation team.
Culture and Well-being: Art as Prescription Therapy ("Art on Prescription")

Stratified randomised controlled trial with two arms: arts intervention (any of the arts interventions, see list), which we call here Active Group (AG) vs waitlist control (WL).

Design:

Stratified randomised controlled trial with two arms: arts intervention (any of the arts interventions, see list), which we call here Active Group (AG) vs waitlist control (WL). Stratifying will happen at each site.

Invastigators want to measure AG and WL, then WL becomes AG after 3 months and both the initial AG and the WL. AG will be measured in exactly the same way for another 3 months.

AG for 3 months. Then goes into 3 month follow up. WL for 3 months. Then this group receives intervention and becomes AG and has measurements for 3 months as the AG did.

There will be a 2-month break between T3 and T4 due to summer vacation.

In the beginning, an open invitation to institutions of culture and mental health had been sent. Culture institutions i.e. Opera House, Contemporary Art Museum, National Theater etc. presented their action plans for interventional courses. Investigators did the connection between mental health and culture institutions.

Potential participants declared their preference for the interventional course such as dance, cinema etc. and they listed while an external investigator did the blind randomization into AG or WL group.

Frequency of Measurement:

The primary outcome will be measured at time points (for adults):

* T0: (before the randomisation; patient's personal data and demographics)
* T1: (before the start of the intervention for the active group or the entry into the study for the WL group)
* T2: 6 weeks (after the start of the intervention for the active group or the entry into the study for the WL group)
* T3: 12 weeks (after the start of the intervention for the active group or the entry into the study for the WL group) The secondary outcomes will be measured at time points 0 (T4) and 12 weeks (T5) for both AG and WL.

The primary outcome will be measured at time points (for children/adolescents):

* T0: (before the randomisation; patient's personal data and demographics)
* T1: (before the start of the intervention for the active group or the entry into the study for the WL group)
* T3: 12 weeks (after the start of the intervention for the active group or the entry into the study for the WL group) The secondary outcomes will be measured at time points 0 (T4) and 12 weeks (T5) for both AG and WL.

Eligibility Criteria:
Inclusion Criteria:

* age range: 10-99 years
* be able to communicate effectively in order to provide answers to questionnaires that he/she will be asked to complete
* be able to commit to monitoring the action
* be able to participate in the activity alone (unaccompanied, without a carer),
* be able to answer the questionnaires
* to have legal capacity

Exclusion Criteria:

* active dependency,
* patients that are not consistent in following pharmaceutical drugs,
* patients from different Patient Association which is not "affiliated" with a Mental Health Professional Therapist.
Prospective Analysis of the Feasibility of the PASCAL Spacer Technology for Transcatheter Mitral Valve Repair in an All-comers Cohort

To identify changes on mitral valve morphology and functionality by the application of the PascalTM in MR.

Transcatheter mitral valve repair (TMVR) in mitral regurgitation (MR) is increasingly applied in patients on high surgical risk. Interventional mitral valve repair can be applied is routinely applied in primary and secondary mitral regurgitation. While the edge-to-edge technique has been the solely available technlology in the marked for the last years, the recently introduced PascalTM technology represents a novel concept and is characterized by a central spacer, wider paddles, and larger dimensions. Implications of implantation of the PascalTM device on the mitral valve morphology and functionality concerning potential changes on mitral regurgitation as well as changes on mitral valve orifice area are to date not fully understood. The current study will identify anatomical changes to optimize ideal patient selection and optimal treatment approaches of the PASCALTM device.

Eligibility Criteria:
Inclusion Criteria:

• All patients who undergo TVMR for MR (age \>18yrs) at the PI´s site

Exclusion Criteria:

* \<18yry
* Subject does not provide full consent
Prevalence of Sexually Transmitted Infections Among People Attending the Sexual Assault Centre in Oslo, Norway.

In this study the investigators seek to register the prevalence of sexually transmitted infections (STI) among people attending the Sexual Assault Centre in Oslo, Norway. The main aim of this study is to gather representative data on STIs after sexual assaults. Consequently, if the attendance for medical follow up turns out to be good/sufficient, prophylactic (antibiotic) treatment can potentially be omitted.

Patients who attend sexual assault centres are often concerned about being infected with STIs. Therefore, the patients attending sexual assault centres are offered examination and often receive prophylactic treatment against some STIs (e.g. chlamydia trachomatis, HIV and hepatitis B).

In this study, the investigators seek to register the prevalence of STI among people attending the Sexual Assault Centre in Oslo, Norway. The primary aim of the study is to gather representative data on STIs after a sexual assault. Furthermore, the investigators want to evaluate if there are any variables that can predict transmission after a sexual assult. Results from this study will also be compared with findings of STI in the general population.

At the Sexual Assault Centre in Oslo, Norway, patients are routinely offered three medical follow up consultations. Consequently, if the attendance at follow up visits turns out to be adequate, prophylactic (antibiotic) treatment can potentially be omitted.

Since victims of assault are in a vulnerable situation, it would be useful to be able to inform them more precisely about infection risk and provide adequate prophylactic treatment. More knowledge about the incidence of infection after abuse will increase patient safety and improve the quality of treatment for these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients attending and examined after sexual assault at the Sexual Assault Centre in Oslo (at Oslo Accident and Emergency Outpatient Clinic).
* Written informed consent

Exclusion Criteria:

* Patients who only had a consultation only with a social worker and no medical examination.
* Unable to communicate in Norwegian, Swedish, Danish or English language