cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess the Effects of Talazoparib on Cardiac Repolarization in Patients With Advanced Solid Tumors

This study is designed to evaluate the effects of talazoparib on cardiac repolarization in patients with advanced solid tumors with no available standard treatment options.

For further talazoparib treatment, patients must enroll and initiate continued talazoparib treatment in a separate open label extension study within 30 days after the last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years of age and willing and able to provide informed consent.
2. Histologically or cytologically confirmed advanced solid tumor with no available standard treatment options in the opinion of the investigator.
3. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
4. Estimated life expectancy of ≥ 3 months.
5. Able to swallow the study drug, have no known intolerance to the study drug or excipients, and comply with study requirements.
6. Female patients of childbearing potential must have a negative pregnancy test at screening and must agree to use a highly effective birth control method from the time of the first dose of study drug through 45 days after last dose of study drug.
7. Male patients must use a condom when having sex with a pregnant woman or with a woman of childbearing potential from the time of the first dose of study drug through 105 days after last dose of study drug. Contraception should be considered for a nonpregnant female partner of childbearing potential.
8. Male and female patients must agree not to donate sperm or eggs, respectively, from the first dose of study drug through 105 days and 45 days after the last dose of study drug, respectively.
9. Female patients may not be breastfeeding at screening and must not breastfeed during study participation through 45 days after the last dose of study drug.

Exclusion Criteria:

1. Use of antineoplastic therapies within 21 days before day 1.
2. Use of any other investigational agent within 21 days before day 1.
3. Have not recovered (recovery is defined as National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\] grade ≤ 1) from the acute toxicities of previous therapy, except treatment related alopecia or laboratory abnormalities otherwise meeting eligibility requirements.
4. Electrolyte abnormality that has not responded to correction, including hypokalemia or hypocalcemia less than the lower limit of normal, or hyperkalemia or hypercalcemia greater than the upper limit of normal (ULN).
5. Major surgery within 14 days before day 1.
6. Diagnosis of myelodysplastic syndrome (MDS) or a hematologic malignancy.
7. Clinically significant cardiovascular disease.
8. Significant organ dysfunction.
9. Gastrointestinal disorder affecting absorption.
10. Current or anticipated use of a strong P-gp inhibitor, strong P-gp inducer, or strong inhibitor of BCRP.
11. Any condition (concurrent disease, infection, or comorbidity) that interferes with ability to participate in the study, causes undue risk, or complicates the interpretation of safety data, in the opinion of the investigator or medical monitor.
Effect of Clear Masks on Patient Satisfaction With Communication

The purpose of this research study is to evaluate participants' experience and satisfaction during the awake deep brain stimulation (DBS) procedure. Normally, the neurologist will ask the participant questions and also ask the participant to perform tasks during surgery. During this time, the neurologist will be talking to the participant and the participant will be responding by answering questions or participating with the tasks.

For some study participants, there will be one small change made to the typical way the neurologist conducts this evaluation. The study staff will then ask the study participants about their experience with the neurologist's evaluation. The subject will not be told what part of the evaluation is changed for the study, until after they have responded to the questionnaire.

All participants scheduled for a DBS phase I surgery will be contacted via telephone in the days prior to their scheduled surgery to discuss the possibility of study participation. This will be done to give the participant time to consider study participation in order to avoid delays the morning of surgery. The morning of surgery the participant will be approached in pre-operative holding room to discuss participation in the study and if amenable sign consent for participation. This discussion will inform the participant that minor changes are being made in an attempt to improve the participant experience, but limited information will be shared to reduce potential bias that might result from the participant knowing what is being studied.

Eligibility Criteria:
Inclusion Criteria:

* Patients electing to undergo deep brain stimulator placement
* Patient in whom general anesthesia is not planned for stimulator target localization

Exclusion Criteria:

* Patients who do not give consent
* Patients who do not undergo DBS placement
* Patients who are blind or have a severe visual impairment
* Non-English speaking patients (i.e., patients for whom an interpreter would be needed to conduct the intra-operative assessment)
Cardiovascular Rehabilitation and Reeducation (CVRR) in Patients With Cardiac Pathologies and the 6-minute Stepper Test

The objective is to study the validity of the 6-minute stepper test (ST6) in order to determine tolerance to effort in cardiovascular patients

The 6-minute stepper test (ST6) is an test used and validated in patients with respiratory disorders (chronic obstructive pulmonary disease) in order to evaluate their tolerance to exercise. It is well tolerated and reproducible in these patients, with the advantage that it can be performed without spatial constraints.

However, this test is not yet used in cardiology. This study proposes to validate the ST6, to evaluate the exercise tolerance of patients suffering from cardiovascular pathologies.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old,
* Patient with a cardiac pathology (coronary bypass, valve replacement, heart transplant, coronary angioplasty),
* Registered in Cardiovascular Rehabilitation at the Mitterie Clinic,
* Number of rehabilitation sessions at least equal to 30,
* Ejection fraction ≥ 45%,
* Signed written consent of the patient,
* Affiliation to a social security scheme.

Exclusion Criteria:

* Cardiac decompensation,
* Severe functional limitation,
* Unstable acute coronary syndrome,
* Decompensated heart failure,
* Severe ventricular rhythm disorders,
* Presence of an intracardiac thrombus with high embolic risk,
* Presence of a medium to large pericardial effusion (effusion of more than 10mm circumferential or 14mm localized on ultrasound),
* Recent history (months prior to inclusion) of thrombophlebitis with or without pulmonary embolism,
* Severe and/or symptomatic left ventricular ejection obstruction,
* Any progressive inflammatory and/or infectious disease,
* Severe pulmonary arterial hypertension,
* Oxygen therapy,
* Musculoskeletal or balance problems that would limit the ability to do any of the following the fiscal year.
* Pregnant or breastfeeding women,
* Incapacity to consent (including persons under guardianship or curatorship)
BRUSH Sign: Radiolographic Marker of Cerebral Infarctus Prognosis

Today the treatment of ischemic stroke in acute phase is based on medicinal or endovascular revascularization. Cerebral MRI sequences help the diagnostic. This procedure uses deoxyhemoglobin as an endogenous tracer. This is also a scorer of cerebral ischemia and the increase lets visualized transcerebral veins in the suffering zone giving a brush aspect. Several studies show the interest of this sign and conclude that deoxyhemoglobin presence is a predictive factor of cerebral ischemia. The aim of the study is to evaluate this brush-sign and correlate it with the prognosis retrospectively.


Eligibility Criteria:
Inclusion Criteria:

* age\>18 years old
* hospitalized for cerebral infarction
* MCA territory
* MRI within 24hours
* Sequence of magnetic susceptibility (SWAN)

Exclusion Criteria:

* Incomplete cerebral infarct
* MRI not possible
Art and Physical Therapy in Pediatric HCT

The purpose of this study is to compare the effect of a combination of art therapy (AT) and physical therapy (PT) to PT only in children undergoing hematopoietic cell transplant (HCT). Each child will receive daily AT and PT or only PT for 5 days per week for 2 weeks. These sessions will begin approximately on day 15 following the transplant. Prior to starting the sessions and following 2-weeks of sessions, self-care and mobility skills will be measured. During each session, the following variables will be measured: heart rate variability (i.e., time between heart beats) using a small monitor on the chest (about the size of a quarter), walking distance using an accelerometer (similar to wearing a watch), and self-reported happiness and excitability. Although results cannot be guaranteed, it is expected that each group will benefit and demonstrate improvements in emotional state, self-care, and mobility skills.

This quantitative randomized clinical trial will examine the effect of a collaborative art therapy (AT) and physical therapy (PT) intervention as compared to a PT only intervention in children undergoing a hematopoietic cell transplant. We hypothesize that physiological, emotional, selfcare, and mobility as measured by heart rate variability, Self-Assessment Manikin, walking distance and steps, and Pediatric Disability Inventory Computerized Adapted Test will demonstrate greater improvement for the AT and PT group as well as identify media that more effectively impact these physiological and health outcomes. Findings from this project may provide scientific evidence for increasing the uptake of AT and PT in children undergoing HCT.

Eligibility Criteria:
Inclusion Criteria:

* between ages 5 to 18
* Clinical Diagnosis of hematological disease
* Undergoing Hematopoietic Cell Transplantation (HCT)
* Within the inpatient hospital treatment phase of HCT

Exclusion Criteria:

* Less than age 5
* Older than age 18
* Central nervous system impairments (e.g., cerebral palsy)
* Genetic diseases (e.g., Down syndrome)
* Cognitive impairment
Study of IFN-K in Dermatomyositis

This study is a Proof of Concept study aiming to evaluate the production of anti-IFNα antibodies (immune response) in adult subjects with dermatomyositis


Eligibility Criteria:
Inclusion Criteria:

* Patient newly diagnosed or relapsing with "definite" or "probable" dermatomyositis based on ENMC criteria (2004)
* Patient requiring corticosteroids (CS) at a dose of 1 mg/Kg and ≤ 70 mg of prednisone equivalent/day or currently receiving CS at a dose of 1 mg/Kg and ≤ 70 mg of prednisone equivalent/day
* Is a male or female, aged between 18 and 65 years, inclusive, at the time of the screening visit
* study patient and his/her partner of child bearing potential has to use effective method of contraception

Exclusion Criteria:

* Is high-risk human papilloma virus (HPV) positive by (RT-PCR) on a cervical swab
* Has cytological abnormalities ≥ HSIL on a cervical swab
* Is positive for autoantibodies anti-NXP2, TIF1ɤ, MDA5 associated with severe pulmonary disease or anti-synthetase antibodies
* Is positive for any malignancy or has a history of any malignancy
* Has received IV pulse dose CS (≥ 250 mg prednisone equivalent/day)
* Has received intravenous immunoglobulin (IVIg)
* Has received potent immunosuppressive drugs such as cyclophosphamide, methotrexate, azathioprine, mycophenolate, cyclosporine A, oral tacrolimus
* Has received abatacept, anifrolumab, belimumab, TNF antagonists or another registered or investigational biological therapy
* Has received anti-B-cell therapy (e.g. rituximab, epratuzumab)
* Has received any live vaccine
* Has used any investigational or non-registered product , or any investigational or non-registered vaccine
* Has inflammatory joint or skin disease other than dermatomyositis that may interfere with study assessments
* Has frequent recurrences of oral or genital herpes simplex lesions
* Is at high risk of significant infection and/or has any current signs or symptoms of infection at entry or has received intravenous antibiotics
Citalopram for Sx/Util in Acute Coronary Syndrome Patients

Symptoms (chest pain, shortness of breath, dizziness, etc.) and treatment usage (doctor or emergency room visits, testing, hospital days, etc.) in patients with Acute Coronary Syndromes are known to be related to emotional distress (Anxiety, Depression and Anger). In addition, behavioral treatment of emotional distress is known to decrease symptoms, and treatment usage. The present protocol tests whether the addition of a medication known to reduce emotional distress can also reduce symptoms and treatment usage.

This will done by recruiting patients with ACS during their hospital stay, randomizing them to receive citalopram or placebo, and then examining their symptoms and treatment usage at 6 months.

Not applicable. Study not funded.

Eligibility Criteria:
Inclusion Criteria:

* Admission to hospital for chest pain/dyspnea, typical ECG changes plus positive tropinins

Exclusion Criteria:

* age less than 18
* cognitive impairment (per MMSE)
* geographic unavailability for followup
* unwillingness to participate
* illiteracy
* Hx cardiac transplant
* untreated hypothyroidism
* hepatic dysfunction
* prior adverse reaction to citalopram
* history of Bipolar Disorder
* untreated Sleep Apnea
* chronic steroid therapy
* active substance abuse (e.g., within past year)
* near term mortal illness
* current mental health treatment
* signitificant suicide risk
Changes in Footwear Comfort and Performance in High School Football Players

The objective of this proposal is to determine the effects of footwear stiffness on a large cohort of high school football players during a football season. The investigators expect that functional athlete groups will be developed, based on subject specific assessments (biomechanical, morphological, performance, comfort), and lead to important translational findings that may impact footwear modification and recommendation to a population of American football players. Two standard cleats will be randomized and provided during a season of high school football. Ratings of comfort, performance, and injury will be collected throughout the season.


Eligibility Criteria:
Inclusion Criteria:

* Participate on a club or school sponsored football team

Exclusion Criteria:

* Current injury that limits sport participation
Improving Sexual Function After Myocardial Infarction

The study is completely digital. Men and women who recently had an MI will be invited through a written brochure that will be present in all Norwegian departments of cardiology. Post-MI patients can check the investigators web site (www.sefh.no) to determine whether they are eligible for the study. After consent and answering the baseline questionnaire, each participant will be randomized to either the intervention or control group.

Control group: Standard surveillance after MI (no specific focus on sexual activity and functioning) Intervention group: Online sexual counselling including a short information film.

In order to assess the generalizability of the results, we will compare the age, sex and MI treatment of the respondents with data on Norwegian MI-patients in general.

The investigators will include 600 women and 600 men within 4 weeks after an acute MI. The investigators will invite the same number of women and men from the general population, invited through mass and social media.

All participants will be provided the same questionnaire at 4 weeks. Then outcome data will be obtained by a follow-up quest after 6 and 12 months.

The intervention is a film with the following main message:

* Sexual activity after MI does not increase risk of recurrence or death
* Sexual activity is associated with improved outcome after MI
* Resuming sexual activity as normal is recommended and completely safe

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥18 years old
* Acute MI during the last 6 weeks
* Informed consent for participation

Exclusion Criteria:

* Lack of ability to cooperate
* Known alcohol- or drug-abuse, or use of narcotics
* Pregnancy or breast-feeding
* Serious comorbidity with a life expectancy \<12 months
* Unstable or refractory angina
* Uncontrolled hypertension
* Congestive heart failure (NYHA class III/IV)
* High-risk arrhythmias
* Hypertrophic obstructive and other cardiomyopathies
* Severe valvular disease
Ovarian Damage in Young Premenopausal Women Undergoing Chemotherapy for Cancer

RATIONALE: Comparing results of diagnostic procedures, such as ultrasound, done before, during, and after chemotherapy may help doctors learn about the side effects of chemotherapy and help plan the best treatment.

PURPOSE: This clinical trial is studying ovarian damage in young premenopausal women undergoing chemotherapy for cancer.

OBJECTIVES:

* Determine the incidence and timing of ovarian dysfunction/damage in younger premenopausal women undergoing cytotoxic chemotherapy for cancer.
* Determine the feasibility of a prospective, randomized study to assess if gonadotropin analogues can protect the ovary from the cytotoxic effects of chemotherapy.
* Determine the number of patients required for adequate power to test the hypothesis.

OUTLINE: This is a pilot, prospective study.

Patients undergo a transvaginal or transabdominal ultrasound to measure the ovarian volume and count the number of antral follicles at baseline, 3 months after beginning cytotoxic chemotherapy, and at 6 months after completion of treatment. Patients undergo blood collection at the same time points for follicle-stimulating hormone, estradiol, and inhibin B levels. Patients are also asked to fill out questionnaires on estrogen-depletion symptoms at those times. Patients also keep a calendar of menstrual bleeding and hormonal medications.

PROJECTED ACCRUAL: A total of 22 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of cancer, including, but not limited to, any of the following:

  * Acute lymphocytic leukemia
  * Acute myeloid leukemia
  * Hodgkin's lymphoma
* Must have primary disease with significant chance for long-term survival after therapy
* Scheduled to receive chemotherapeutic agents known to be associated with ovarian failure, including any of the following:

  * Cyclophosphamide
  * Mechlorethamine hydrochloride
  * Busulfan
  * Procarbazine hydrochloride
  * Chlorambucil
  * Melphalan
  * Ifosfamide
  * Cisplatin
  * Carboplatin
* Postmenarchal and premenopausal

PATIENT CHARACTERISTICS:

* Female
* Weight ≤ 250 pounds
* Not pregnant

PRIOR CONCURRENT THERAPY:

* No prior or concurrent total-body irradiation or radiotherapy to the pelvis
* Concurrent bone marrow transplantation allowed
* Concurrent oral contraception and/or gonadotropin releasing-hormone analogue allowed
Thyroid Profiles in Patients With Acute Illness

Patients admitted to the hospital with acute illness may have a wide spectrum of thyroid function abnormalities. It is largely unknown whether such aberrations are temporary or persist for a long time, and whether they impact prognosis of such patients.

Recently, there has been a growing body of evidence that subclinical thyroid dysfunction as a contributor to the increase of cardiovascular events. Elevated serum thyroid-stimulating hormone (TSH) levels and normal free thyroxine (FT4) and free triiodothyronine (FT3) levels have been associated with worse heart failure and dyslipidemia. Furthermore, higher risk of atrial fibrillation has been linked tp thyroid abnormalities in these patients.

Patients admitted to the hospital with acute illness may have a wide spectrum of thyroid function abnormalities. It is largely unknown whether such aberrations are temporary or persist for a long time, and whether they impact prognosis of such patients. This study aimed at evaluating the prevalence of thyroid function abnormalities in patients admitted to hospital with acute illness and their temporal changes and impact on mortality during hospitalization and at 1 year. Serum level of thyroid stimulating hormone and free T4 and T3 measured on admission. Clinical and laboratory profiles of patients with abnormal thyroid function (ATF group) will be compared to those with normal thyroid function (NTF group). Short and long term survival of both groups were compares as well.

Eligibility Criteria:
Inclusion Criteria:

* Hospital admission
* Adults aged 18 years and above
* Willing to sign an informed consent
* Diagnosis on admission is acute illness that includes: heart failure, acute coronary syndrome, sepsis, acute stroke, hypotension, acute system-organ failure including renal and hepatic failure.

Exclusion Criteria:

* Age less than 18 years.
* Refusal to sign consent.
* Admission for a reason not classified as acute illness.
Physiotherapy Led Community Intervention for Older Adults Discharged From the Emergency Department

ED PLUS Emergency Department Discharge Physiotherapy Led Community Service is a pilot feasibility randomized controlled trial investigating the role of an integrated care intervention consisting of comprehensive geriatrics assessment in older adults in the emergency department and a physiotherapy-led community based intervention.

All patients who are aged 65 years and over will be screened using the Identification of Seniors at Risk (ISAR) Tool in the emergency department of a University Teaching Hospital. Those with a score of 2 or above in the ISAR and suitable for discharge home will be randomised. The first treatment arm will undergo geriatric medicine item directed Comprehensive Geriatric Assessment (CGA) from admission to emergency department (ED). The non-treatment arm will under usual patient care. The second treatment arm will undergo geriatric medicine team directed CGA from admission to ED and a physiotherapy led community based 6 week intervention in the patient's home. A dedicated multidisciplinary team of geriatric medicine trainee, occupational therapist, physiotherapist and medical social worker will carry out the assessment. For those randomised to the second treatment arm, a physiotherapist will assess and carry out a 6 week interventions that arise from that assessment and liaise with the patients General Practitioner (GP), medical social worker and other health care professionals. The overall aims of ED PLUS are assess the feasibility of the 6 week physiotherapy led intervention. Feasibility will be determined by the following outcomes:

i) Recruitment rate

ii) Adherence rate

iii) Acceptability of the programme

iv) Retention

v) Incidents

The secondary aims are to improve function, reduce anxiety and depression, improve quality of life and prevent unnecessary ED admission.

Eligibility Criteria:
The inclusion criteria for participants include:

* Adults aged ≥65 years with undifferentiated medical complaints presenting to an ED.
* Medically stable as deemed by the treating physician
* Display a score of ≥2 on the Identification of Seniors at Risk (ISAR) screening tool.
* Be community dwelling
* Be discharged from the ED within 72 hours of index visit.

Exclusion criteria include:

* Individuals under the age of 65 years.
* Have a score of less than 2 on the ISAR.
* Older adults who present with acute myocardial infarction, stroke or non-medical problems e.g. surgical or psychiatric issues.
* Older adults who are medically unstable will be excluded.
* If neither the patient nor carer can communicate in English sufficiently to complete consent or baseline assessment, they will be excluded.
* Older adults who are admitted to hospital from the ED will be excluded.
* Older adults who have a confirmed COVID 19 diagnosis or those with symptoms highly suggestive of COVID 19 will be excluded.