cyrilzakka/clinical-trials huggingface dataset:
Trilaciclib vs Placebo in Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) Receiving Topotecan

This is a multicenter, randomized, double-blind, placebo-controlled study to assess whether trilaciclib administered prior to topotecan is non-inferior to placebo administered prior to topotecan with regard to overall survival.

The study will include 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. Patients randomized in this study will receive trilaciclib/placebo + topotecan 1.5 mg/m2 until disease progression, unacceptable toxicity, withdrawal of consent, Investigator decision to discontinue treatment, or the end of the trial, whichever comes first.

Trilaciclib was approved by the United States (US) Food and Drug Administration (FDA) as a treatment to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC. As a post-marketing requirement, the FDA asked the Sponsor to conduct a study in patients with ES-SCLC undergoing chemotherapy to evaluate survival and disease progression following trilaciclib administration in patients treated with a platinum/etoposide-containing regimen or topotecan-containing regimen with at least 2 years of follow-up. This study is designed to fulfill this requirement.

Eligibility Criteria:
Inclusion Criteria:

1. ES-SCLC with confirmed diagnosis of SCLC by histology or cytology
2. Progression during or after prior first or second line chemotherapy. First-line regimen must have been a platinum-containing combination.
3. Measurable or evaluable disease as defined by RECIST v1.1

Exclusion Criteria:

1. History of topotecan (or other topoisomerase I inhibitor) or trilaciclib treatment for SCLC
2. Any chemotherapy, immunotherapy, biologic, investigational, or hormonal therapy for cancer treatment within 3 weeks, except for adjuvant hormonal therapy for breast cancer and prostate cancer
3. Presence of brain metastases/leptomeningeal disease requiring immediate treatment with radiation therapy or steroids
4. Radiotherapy within 2 weeks
5. History of ILD/pneumonitis
6. History of other malignancies, except for curatively treated solid tumors with no evidence of disease for ≥ 2 years or other NCS cancers
ASk Questions in GYnecologic Oncology (ASQ-GYO)

The goal of this clinical trial is to determine the effectiveness of the ASk Questions in GYnecologic Oncology question prompt list (ASQ-GYO QPL) at improving patient self-efficacy, distress, physician trust, and knowledge compared to usual care during new patient gynecologic oncology visits. Also to determine the acceptability of the ASQ-GYO QPL with new gynecologic oncology patients.

* Potential participants who are scheduled for a new patient appointment will be contacted via phone or email to determine if they are interested in participating.
* If a participant is interested, they will choose their preferred method of consenting (phone, email, or in person) and if they would like to complete the pre-visit survey now or at a later time prior to their appointment
* If consented, all participants will be provided with the pre-survey questionnaire. If eligible, participants will then be randomized to usual care or the intervention (ASk Questions in GYnecologic Oncology question prompt list (ASQ-GYO QPL)
* If randomized to receive the ASQ-QYO QPL, they will be emailed this document and given a paper copy of the ASQ-GYO QPL in the waiting room prior to their visit to ensure they have received the intervention.
* Directly after the participant's visit, all participants will be asked to complete the post-visit survey on a tablet in the clinic waiting room, or via a secure link in an email within 1 week of the appointment.
* After completion of the post-visit survey and within one month of their visit, participants who were not randomized to receive the ASQ-GYO QPL will be sent the ASQ-GYO QPL via email so that they may also have access to this resource.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* Understands spoken and written English
* Able to consent to study participation
* Biopsy confirmed gynecologic cancer diagnosis (ovarian, endometrial, cervical, vulvar, or vaginal cancer or Gestational Trophoblastic Disease) OR have imaging and/or laboratory findings highly concerning for a cancer diagnosis and have not seen a Gynecologic Oncologist

Exclusion Criteria:

* pathologic diagnosis of dysplasia only (cervical, vulvar, or endometrial)
* History and/or imaging/laboratory findings more indicative of a non-cancer diagnosis
* Previous treatment discussion with a Gynecologic Oncologist
Defining the Functional and Neuro-Protective Potential of ACTHAR in Acute Optic Neuritis

The goal of the study is to determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.

Determine the earliest structural changes in the optic nerve during the acute event and during the twelve months of recovery following Acthar treatment.

Eligibility Criteria:
Inclusion Criteria:

* unilateral acute demyelinating optic neuritis
* Able to provide informed consent
* age 18 or older
* can perform the above listed electrophysiologic diagnostic testing
* can perform high and low contrast visual acuity and visual field perimetry

Exclusion Criteria:

* prior diagnosis of remitting/relapsing multiple sclerosis(RRMS)
* secondary progressive MS(SPMS)
* primary progressive MS (PPMS)
* undergoing treatment with medications approve for treatment of RRMS(except corticosteroids for a condition not involving central nervous system demyelination)
* prior diagnosis of systemic lupus erythematosis
* mixed connective tissue disease
* vasculitis
* sarcoidosis
* neuro-myelitis optica
Comparison of Beta-cryptoxanthin Bioavailability From Biofortified Maize in Humans

The purpose of this study is to determine how well the body absorbs the carotenoid beta-cryptoxanthin (BCX) from a type of corn that has been naturally bred (not genetically engineered) to contain higher amounts of BCX than traditional breeds of corn. Because this new type of corn contains higher amounts of BCX, it appears more orange in color than traditional types of corn. Understanding how well the body can absorb the BCX from the corn may help companies develop food products that may have improved nutritional quality.

Randomized, blinded, 3 x 3 crossover intervention. Each treatment will last 12 d, followed by a 7-d wash-out period. After the washout, subjects will go back to their regular diet for two weeks before beginning the next cycle. Subjects will report to the research kitchen in the Nutritional Sciences building for their breakfast. Maize will be incorporated into two muffins. Other food choices will be yogurt and other low-fiber foods. Blood samples will be taken at baseline and days 3, 6, 9, 12, 15, and 19. Natural abundance measurements of 13-carbone to 12-carbon will be taken at baseline, day 12 and day 19. Retinol isotope dilution testing will be done at the end of the study to determine total body stores of vitamin A in the subjects. This will include the day 19 blood sample of intervention phase 3 and a final blood sample 14 days after the isotope dose administration.

Eligibility Criteria:
Inclusion Criteria:

* Age 20 - 28 y, BMI 19 - 26 kg/m2, non-smoking, not pregnant or trying to become pregnant, and not lactating.

Exclusion Criteria:

* Smoker
* BMI \< 19 kg/m\^2 or BMI \> 26 kg/m\^2
* Women: pregnant or trying to become pregnant, breast-feeding
* Weight loss greater than or equal to 10 pounds (4.5 kilograms) during the 3 months prior to recruitment
* Actively trying to lose weight
* Fat malabsorptive disorders
* Inability to refrain from drinking alcohol when requested
* Amenorrhea
* Acute or chronic illness, including hepatitis
* Current or previous history of anorexia or bulimia
* History of iron deficiency anemia
* Inability to pick up food from research facility and eat meals on site when requested
* Planned vacation of \>1 week duration during the study
* Known scheduling conflict with the blood draws
* Major food allergies/intolerance to ingredients used in the meals
* Unwillingness to discontinue personal nutritional supplements/vitamins when asked to
* Concurrent participation in other studies
* Social circumstances that would make it difficult to consume a study food
* Family member already enrolled in the study
Tools to Improve Discharge Equity (TIDE) Pilot RCT

The investigators will test the impact of a package of linguistically appropriate discharge teaching tools against current standard of care for patients with Limited English proficiency (LEP) in an unblinded randomized controlled trial. The tools include an expanded medication calendar in English and the patients' preferred language, pictographics to illustrate return precautions (what signs/symptoms require further evaluation), an audio recording of the nurse reviewing the After Visit Summary (composed by providers) to allow for review by patients and caretakers after discharge.

The investigators will evaluate the effectiveness of the package of discharge teaching tools on patients' understanding/recall, key implementation outcomes, and secondary clinical outcomes via a structured interview 1-2 weeks after discharge and chart review 30 days after discharge.

The objectives of this research study are:

1. test the effectiveness of a linguistically appropriate toolkit for improving patient understanding of discharge instruction content
2. Assess the feasibility and fidelity of the intervention in anticipation of a multi-site implementation trial
3. assess the feasibility and appropriateness of the linguistically appropriate toolkit to nurses and in-person interpreters
4. to assess the acceptability of the intervention to patients and their satisfaction with it
5. to collect data on implementation context in anticipation for a multi-site trial
6. to collect preliminary data on the toolkit's impact on clinical outcomes including medication adherence and hospital re-utilization.


Eligibility Criteria:
Inclusion Criteria:

Patients

* Labeled in medical record as preferring one of the following four languages: Spanish, Haitian Creole, Cape Verdean Creole, or Vietnamese
* Admitted to medicine team at BMC
* Age 18 years or older
* Being discharged home (to the community)
* Admitted to Boston Medical Center (BMC) hospital units (Menino 7 East, 7 West, and Menino Observation)

Nurses and Interpreters

* Caring for patient enrolled in trial

Family/Visitors

* Present at time of discharge for patient enrolled in trial

Exclusion Criteria:

Patients

* On airborne infections precautions
* On clostridium difficile (C diff) precautions
* On suicide precautions
* Nurse report of participant displaying cognitive impairment, delirium, or aggression
* Enrolled in trial during a prior admission

Nurses and Interpreters

* None

Family/Visitors

* None
Study of Eribulin in Children With Cancer to Determine Safety

This is a study for children with cancer with no curative treatment options. The investigators will be giving eribulin, a new chemotherapy agent, for the first time to children. This study is designed to determine a safe dose the investigators can give to children in larger studies. The investigators will be monitoring the children on this study for the safety of the treatment and levels of eribulin in the blood after treatment. The investigators will also study the effect of the agent on the cancer.

This is a phase I study of eribulin, a novel tubulin inhibitor in children with relapsed and refractory solid tumors including lymphoma. Dose escalation will be performed in a classic 3+3 design starting with 75% of the adult maximum tolerated dose (MTD). Pharmacokinetics will be done on each patient. Primary endpoint will be the pediatric MTD.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≤ 21 years of age at the time of study enrollment
* Diagnosis: refractory or recurrent solid tumors, including lymphomas, except those with CNS tumors or known CNS metastases
* Disease Status: measurable or evaluable disease
* Adequate organ function as defined in protocol

Exclusion Criteria:

* Pregnant or breastfeeding
Urinary Activin A as Apredictive Marker for Assessement of Acute Kidney Injury Severity in Patient Admitted at Assuit University Hospital

Urinary Activin A as amarker for assessement of acute kidney injury severity in patient admitted at Assuit University Hospital

Acute kidney injury has been ahealth problem all over the world , It's prevelance in developing and developed countries is increasing due to pre renal , renal , post renal causes .

Estimates of AKI prevalence range from \<1% to 66%. These variations can be explained by not only population differences but also inconsistent use of standardized AKI classification criteria. The aetiology and incidence of AKI also differ between high-income and low-to-middle-income countries.(1)

* It can be presented in different stages according to AKIN classification (stage l (Increase in serum creatinine ≥0.3md/dl (≥26.4μmol/l) or increase to \>150% to 200% (1.5 fold to 2 fold) from baseline , and urine output (\<0.5 ml/kg/h for \>6 h ))

  * stage ll (Increase to \>200% to 300% (\>2 fold to 3 fold) from baseline) , and urine output (\<0.5 ml/kg/h for \>12 h ))
  * stage lll(Increase in serum creatinine to \>300% (\>3 fold) from baseline, or serum creatinine \>4.0mg/dl (\>354μmol/l) with acute increase of atleast 0.5mg/dl ) Urine output(\<0.3ml/kg/hr for 24 hours, or anuria for 12 hours). (2)
* In ischemic kidney, there is acytokine belong to the transforming growth factor (TGF)-B ( Activin A) that regulates the growth and differantiation of cell in variuos organs was significantly increasd in ischemic kidney . (3)
* level of Activin A in urine correlate to the severity of the acute kidney injury (AKI), as the level of urinary Activin A in first stages of acute kidney injury is less than the second and third stages . (4)
* so follow up of urinary Activin A in patients with acute kidney injury can be avery useful biomarker for assessement of severity of acute kidney injury. (4)

Eligibility Criteria:
Inclusion Criteria:

* The study will include patient with acute kidney injury with no history of chronic kidney diseases

Exclusion Criteria:

* patient with history of chronic kidney diseases , diseases associated with icreased activin A level such as ( heart failure , cancers , COPD , systemic sclerosis ,pregnant , viral infection , and Mycosis Fungoides and Sézary Syndrom
Homeless Youth Study - Stepping Stone 2.0

Housing instability is both a cause and consequence of mental health problems. As such youth experiencing housing instability (e.g., homeless or marginally housed) have higher rates of mental health problems.Because of their circumstances, these youth also face significant barriers to mental health care and are therefore less likely to receive the treatment that they need. Mobile technology may offer a novel platform for increasing access to mental health care in this population. The primary goals of this pilot study are to (1) establish the feasibility and acceptability of delivering automated mental health interventions via smartphone technology, (2) examine the extent to which automated mental health interventions delivered via mobile technology improve mental health in homeless, marginally-housed, and exiting foster youth.


Eligibility Criteria:
Inclusion Criteria:

* 16-25 years
* English-speaking
* Youth must meet one of the following risk criteria

  * Experiencing housing instability as defined by:

    * lacking a fixed, regular, and adequate nighttime residence OR whose primary nighttime residence is a shelter, institution, or a "public or private place not designed for, or ordinarily used as, a regular sleeping accommodation for human beings"
    * sharing the housing of other persons due to loss of housing \[or\] economic hardship.
    * frequent moves, poor housing quality (e.g., living in severely overcrowded housing).
  * Imminently leaving the foster care system
* Willingness and ability to comply with requirements of the study protocol

Exclusion Criteria:

\* Inability to understand study procedures and participate in the informed consent process.
Duration of Continuous Positive Airway Pressure and Pulmonary Function Testing in Preterm Infants

The primary aim of this study is to quantify and compare changes in lung volumes (as measured by functional residual capacity) in premature infants stable on continuous positive airway pressure (CPAP), and then randomized to two additional weeks of CPAP and room air versus room air alone. We hypothesize that infants randomized to additional CPAP will demonstrate an increased functional residual capacity (at the end of the two week study period and prior to discharge) compared to those randomized to room air.


Eligibility Criteria:
Inclusion Criteria:

* Gestational age at birth \<33 weeks
* Required CPAP for a minimum of 24 hours for respiratory distress
* Patient on CPAP and room air at time of randomization

Exclusion Criteria:

* Complex congenital heart disease other than patent ductus arteriosus or atrial septal defect
* Major malformations or chromosomal anomalies
* Multiple gestation greater than twins
* Culture proven sepsis or unstable at time of randomization
A Two Centre Study to Assess the Stability and Long-term Performance of the C-Stem™ AMT in a Total Primary Hip Replacement

The purpose of this study is to monitor the stability of the C-Stem™ AMT hip within the thigh bone when used in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical, standard x-ray assessments and special x-rays which allow the stability of the implant to be determined.


Eligibility Criteria:
Inclusion Criteria:

i) Male or female subjects, aged between 60 and 80 years inclusive.

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects who, in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects undergoing primary total hip replacement that are considered suitable for a cemented femoral stem and metal femoral head and an all polyethylene acetabular cup.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study.

ii) Subjects undergoing revision hip replacement

iii) Subjects undergoing simultaneous bilateral hip replacements.

iv) Subjects with a contralateral hip replacement, which was implanted less than six months previously or is not performing satisfactorily.

v) Women who are pregnant.

vi) Subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes.

vii) Subjects who have participated in a clinical study with an investigational product in the last 12 months.

viii) Subjects who are currently involved in any injury litigation claims.
Oropharyngeal Exercises and Inspiratory Muscle Training in Obstructive Sleep Apnea

The effects of orofarangeal exercises (OE) and inspiratory muscle training (IMT) on sleep quality, disease severity, and airway muscle tone have been investigated in several studies. IMT and OE exercise modalities for patients and practitioners have advantages and disadvantages. It is recommended to compare exercise modalities in the studies. Whether OE or IMT exercise type is more effective on disease severity, sleep quality and snoring has not been investigated. The aim of this study was to compare the effectiveness of inspiratory muscle training and oropharyngeal exercises in patients with OSAS in terms of disease severity, snoring, daytime sleepiness, respiratory muscle strength and sleep quality.


Eligibility Criteria:
Inclusion Criteria:

\*To be diagnosed with mild, moderate and severe OSAS.

Exclusion Criteria:

* Patients with a history of stroke,
* neurological disease,
* severe obstructive nasal disease,
* and infection in the last month,
* BMI being 40 kg /m2 or more.
Genetic and Molecular Characteristics of Mexican Adults With Acute Myeloid Leukemia: a Prospective Multicentric Study.

Newly diagnosed adults patients with Acute Myeloid Leukemia will be assessed as traditionally by the treating institution using classic clinical, demographic and cytogenetic variables. Complementary molecular tests will be performed in the patients included in the study using PCR to detect classic CBF (Core Binding Factor) rearrangements: CBFB-MYH11 \[inv(16)(p13;q22), isoforms A, E and D; AML-ETO (RUNX1-RUNX1T1) (t8;21)(q22;q22). NGS (Next Generation Sequencing) to detect mutations in: FLT3-ITD and TKD, NPM1, CEBPA, RUNX1, TP53, ASXL1, IDH1, IDH2 and KIT


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed AML
* Over 15 years of age
* Flow cytometry confirmation
* Candidate for treatment (intensive or not intensive)

Exclusion Criteria:

* Acute Promyelocytic Leukemia
* Mixed phenotype leukemias
* Isolated myeloid sarcoma
* Blastic plasmacytoid dendritic cell neoplasm
Post-stroke Depression Treatment Effect on Stroke Recurrence

It is not clear whether depresssion can predispose, or precipitate stroke recurrence in patients with stroke. We sought the relationship of post stroke depression with stroke recurrence.

A large body of evidence suggests that depression is associated with a increased risk of many chronic diseases, including hypertension, diabetes, stroke and particularly coronary heart disease. Post stroke depression (PSD) may develop as a result of vascular disease. A previous meta-analysis showed that depression significantly increased the risk of development of stroke, and this increase was probably independent of other risk factors, including hypertension and diabetes.

Clarifying this issue has important implications; if depression increases the risk of development of recurrent stroke, so treating PSD might decrease the occurrence of recurrent stroke. To our knowledge there is no study attempting to clarify the relationship between PSD treatment and stroke recurrence. To fill these gap, we systematically conducted a study to assess whether PSD is associated with recurrent stroke, cardiovascular events or death. Thus, in the current study, three different arms of follow-up of patients with first-ever stroke, were used to predict the outcome over 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

• Patients who met DSM-IV and V criteria for depression

Exclusion Criteria:

* Severe or unstable medical disorders (eg, myocardial infarction within past 3 months, end-stage cancer, decompensated cardiac failure)
* Known primary neurological disorders including dementia, delirium, Parkinson disease, brain tumors, multiple sclerosis, seizure disorder
* Drugs (eg, systemic steroids)
* Pancreatic cancer, uncorrected hypothyroidism
* Current suicidal risk
* Use of psychotropic prescription or nonprescription drugs, certain hypnotics
* Mini-Mental State Examination (MMSE) score of 21 or lower