cyrilzakka/clinical-trials huggingface dataset:
Assessment of Supportive Care and Educational Needs to Guide Quality Care Improvements for Patients With Locally Advanced and Metastatic Bladder Cancer

The overall goal of this study is to facilitate care improvements for bladder cancer patients with locally advanced or metastatic disease by designing and evaluating a patient need assessment screening tool to be used, in the future, as standard screening measure. Adult individuals diagnosed with Stage 4 incurable locally advanced or metastatic bladder cancer will be included in this study and asked to participate in a focus group, complete a screening tool, or complete a survey. All data collected will be linked to a study ID number and HIPAA identifiers will not be linked to study data. Identifying information (ie: name, mrn, email, phone number) will be utilized for study recruitment and identifying eligible patients. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation.


Eligibility Criteria:
Inclusion Criteria:

* Patients are eligible to participate if they are diagnosed with Stage 4 incurable locally advanced or metastatic bladder cancer
* between 18 years and older (18-89 years)
* have initiated any systemic treatment for advanced urothelial carcinoma
* speak English speaking and are able to consent.

Exclusion Criteria:

* Have a diagnosis of another advanced cancer that has required systemic therapy
* Or have any condition that, in the opinion of the investigator, would compromise the well- being of the subject or the study or prevent the subject from meeting or performing study requirements.
A Single-Arm, Virtual Clinical Trial to Evaluate the Effects of a Sleep Supporting Beverage and Two Coffee Substitute Products

This is a virtual, single-arm clinical trial that will last 12 weeks. Participants will trial three different products, each for 4 weeks. Participants will trial Clevr Blends Sleeptime during weeks 1-4, Clevr Matcha for weeks 5-8, and Clevr Blends Chai for weeks 9-12. Participants will complete questionnaires at Baseline and Week 2, 4, 6, 8, 10, and 12. In addition to data will be collected from participants' sleep tracking devices at Baseline, Week 2, and Week 4.


Eligibility Criteria:
Inclusion Criteria:

* Female.
* Age 28-42.
* Generally healthy without any uncontrolled or chronic disease.
* Must consume a beverage containing low to moderate amount of caffeine once daily, defined as consuming the caffeine equivalent of less than or equal to one cup of coffee daily.
* Looking for healthier alternatives to caffeine.
* Currently owns a wearable sleep tracking device (e.g. Fitbit, Whoop, Oura etc) and has been wearing consistently for 4 weeks.
* Resident of the USA.

Exclusion Criteria:

* Allergies to any of the ingredients in the three products.
* Anyone with a formal diagnosis of insomnia.
* Any pre-existing or chronic conditions that would prevent participants from adhering to the protocol.
* Women that are pregnant, breastfeeding or attempting to conceive during the duration of the trial.
* Unwilling to follow the protocol.
* Participants that consume more than two caffeinated drinks daily.
* Participants that have little to no caffeine daily, equivalent to less than 1 cup of coffee daily.
* Is not a resident of the USA.
Age-dependent Changes in the Responsiveness of Hypothalamic Pituitary Gonadal Axis in Men

The present study was designed to assess the responsiveness of the hypothalamic pituitary gonadal axis to kisspeptin administration with increasing age in men.

Little is known about the involvement of kisspeptin signalling in the causation of senescence-basal modulation of the GnRH-LH unit in any model and particularly in advance age men. The present study was therefore designed to assess the response of hypothalamic pituitary gonadal axis to kisspeptin administration with increasing age in healthy men. Sequential blood samples (2 ml) were obtained for 30 minutes pre and 120 minutes post-kisspeptin injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120). Kisspeptin-10 was administered (1 µg/kg BW) as an intravenous bolus, immediately after collecting 0 min sample to assess the response of GnRH neurons to kisspeptin-10 with increasing age in men by determining plasma levels of LH and testosterone.

Eligibility Criteria:
Inclusion Criteria:

• Age

Exclusion Criteria:

* Hepatic and renal complications
* Epilepsy
* Pneumonia
* Asthma
* Orchitis
* Hernia
* Cryptorchidism
* Cardiovascular diseases
* Reproductive disorders
* Mental retardation
Study of Safety and Efficacy of BCL201 and Idelalisib in Patients With FL and MCL

This is a phase Ib multi-center, open-label study: escalation part followed by expansion part. The primary purpose of the Phase Ib CBCL201X2102C study is to characterize the safety and tolerability of BCL201 combined with idelalisib in patients with FL and MCL.

Approximately 65 patients are to be enrolled.

The primary endpoint for the Phase Ib is frequency, severity and seriousness of AEs, lab abnormalities and other safety parameters such as ECG changes. An adaptive Bayesian logistic regression model (BLRM) will guide the dose escalation to determine the MTD/RDE in phase Ib. In addition Bayesian regression models will be used to estimate the dose-exposure relationships for both BCL201 and idelalisib in order to guide the escalation steps. A Bayesian method for the expansion part will be used for the primary activity objective.

The study data will be analyzed and reported based on all patients' data of the escalation and expansion part.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of FL or MCL according to WHO 2008
* Relapsed or refractory with at least one (FL) or two (MCL), but not more than four, prior lines of antineoplastic regimens.
* Either FDG-avid on FDG-PET or measurable disease by CT on cross sectional imaging: \> 1.5 cm for nodal lesion, \> 1.0 cm for extra nodal lesion.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

Exclusion Criteria:

* For dose escalation part: Patients with MCL at high risk for tumor lysis syndrome
* Prior treatment with PI3Kδ or Bcl-2 inhibitors.
* Any other malignant disease
* History of serious allergic reactions including anaphylaxis and toxic epidermal necrolysis
* Inadequate organ function
* Concomitant treatment with:
* Strong CYP3A4/5 inducers or inhibitors
* Sensitive CYP3A4/5 substrates or CYP3A4/5 substrates with narrow therapeutic index (NTI)
* Sensitive CYP2D6 substrates or CYP2D6 substrates with NTI
* Selected dual substrates of CYP3A4/5 and CYP2C8
* Selected dual substrates of CYP3A4/5 and CYP2D6
* Selected dual substrates of OATP and CYP450
* Selected dual substrates of CYP3A4/5 and P-gp
* NTI P-gp substrates
* QT prolonging drugs with a known risk to induce TdP
* Proton pump inhibitors
* Treatment by warfarin or equivalent vitamin K antagonists.
* Other investigational therapies
* Herbal preparations/ medications
* Grapefruit, Seville oranges or products containing either juice

Other protocol-defined inclusion/exclusion may apply.
Study for Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)

This is a phase 2, single-arm, open-label, multi-center study to establish the safety and efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to subjects with AML.

This is a phase 2, single-arm, open-label, multi-center study to establish the safety and efficacy of Troxatyl™ (troxacitabine) administered as a continuous infusion for 5 days to subjects with AML. The study will primarily assess the complete response (CR) rate of a 5-day continuous infusion of troxacitabine at 12 mg/m2/day given as second salvage therapy in adult patients with AML, with secondary objectives to determine the overall, relapse-free and event-free survival and remission duration; to determine the duration of response; to determine the complete response with incomplete platelet recovery (CRp) rate; to evaluate the tolerability and safety of 5-day continuous intravenous (IV) infusion of troxacitabine; and to determine the relationship between troxacitabine plasma concentrations, anti-leukemic activity and adverse events. Additional cycles of treatment may be given at the investigator's discretion, provided that the subject does not have progressive disease or experience a dose limiting toxicity. Bone marrow transplantation in responding subjects will be allowed.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of acute myeloid leukemia (AML) in the second salvage setting: refractory to two prior courses of therapy or primary refractory without response to two previous courses of leukemia therapy.
* Patients must have received at least two previous courses of induction chemotherapy to be considered in the second salvage setting.
* Patients who are in second relapse, must have had a duration of their second CR or CRp of less than six months.
* Subjects must have adequate organ and immune function as indicated by the following laboratory values:

  * Creatinine clearance ≥ 45 mL/min and ≤ 125 mL/min;
  * Total bilirubin ≤ 2.0 mg/dL (≤ 34.2 µmol/L);
  * AST (SGOT) and ALT (SGPT) ≤ 3 x upper limit of normal (ULN).
  * Subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of \< 2, and an estimated life expectancy of at least eight weeks.

Exclusion Criteria:

* Clinical evidence of active central nervous system (CNS) leukemic involvement
* Active and uncontrolled infection
* Uncontrolled medical problems unrelated to the malignancy that impair patient ability to give informed consent or unacceptably reduce the safety of the proposed treatment
* Neurologic or psychiatric disorders that would interfere with informed consent or study follow-up
* Known or suspected intolerance or hypersensitivity to Troxatyl® or closely related compounds such as lamivudine or any of the stated ingredients
* A recent history of alcohol or other substance abuse
* Subjects who have used another investigational agent or participated in a clinical trial within the last 14 days prior to enrolment
* Females with a positive pregnancy test at screening
* Subjects who have previously been enrolled into this study and subsequently withdrew
Clinical Approaches to Correcting Vitamin D Inadequacy and Maintaining Adequacy

Vitamin D is available in two forms, vitamin D2 and vitamin D3. It has previously been assumed that these two forms maintain blood vitamin D equally. However, this may not be the case. This study will evaluate whether D2 and D3 produce equal elevation of blood vitamin D. Additionally, it will evaluate whether once per month vitamin D dosing is as effective in maintaining blood vitamin D levels as daily dosing.


Eligibility Criteria:
Inclusion Criteria:

1. Community dwelling men and women age ≥ 65 years.
2. Able and willing to sign informed consent.
3. Serum 25OHD concentration ≥ 10 and less than 60 ng/ml by HPLC.
4. Willing to avoid use of cod-liver oil and non-study vitamin D supplementation; standard multiple vitamins containing ≤ 400 IU used no more than once daily will be allowed

Exclusion Criteria:

1. Current hypercalcemia (serum calcium \> 10.5 mg/dl) or untreated primary hyperparathyroidism.
2. History of nephrolithiasis.
3. Screening 25OHD concentration ≥ 60 ng/ml.
4. Baseline 24-hour urine calcium \> 250 mg if female, \> 300 mg if male.
5. Known risk factors for hypercalcemia, e.g., malignancy, tuberculosis, sarcoidosis, Paget's disease
6. History of any form of cancer within the past five years with the exception of adequately treated squamous cell or basal cell skin cancer.
7. Renal failure defined as a calculated creatinine clearance (Cockroft-Gault method) ≤ 25 ml/minute
8. Severe end-organ disease, e.g., cardiovascular, hepatic, hematologic, pulmonary, etc., which may limit ability to complete the study
9. Known malabsorption syndromes, e.g., celiac disease, radiation enteritis, active inflammatory bowel disease, etc.
10. Use of medications known to alter bone turnover including bisphosphonates, estrogen, selective estrogen receptor modulators, PTH, testosterone or calcitonin
11. Vitamin D intake greater than 5,000 IU daily
12. Treatment with any active metabolites of vitamin D within six months of screening
13. Treatment with any drug which may interfere with vitamin D metabolism, e.g., phenobarbital, phenytoin.
CARD for Community Pharmacy Vaccinations

To integrate CARD in community pharmacy-led vaccinations and document impact on vaccine clients and pharmacy staff.

It is estimated that 1 out of 5 children and adults are not vaccinated because of concerns about pain and fear. The CARD (Comfort Ask Relax Distract) system is a new vaccine delivery system proven to reduce pain, fear and immunization stress-related responses. Improving the vaccination experiences of patients can improve attitudes about vaccination and increase vaccine acceptance.

The objective of this cluster randomized trial is to evaluate scaling of CARD across community pharmacies on patients vaccination symptoms, beliefs and attitudes and pharmacy staff beliefs and attitudes.

Eligibility Criteria:
Inclusion Criteria:

* vaccine clients being vaccinated in community pharmacies participating in the project
* pharmacy staff in community pharmacies participating in the project

Exclusion Criteria:

* unable to understand and read English
Hysteroscopic Injections of Autologous Endometrial Cells and Platelet-rich Plasma in Patients With Thin Endometrium

The investigation is devoted to the study of the effect of the introduction of autologous platelet-rich plasma (PRP) on the thickness of the endometrium. It was found that the injection of PRP and endometrial cells resuspended in PRP into the endometrium of patients with thin endometrium leads to an increase in the proliferation of endometrial cells, and as a result, to an increase in its thickness.

The study enrolled 115 patients with thin endometrium (\<7 mm at implantation window) and infertility. The cohort was divided into groups based on the treatment regimen.

Group 1 (the control, n=30) underwent conservative therapy. Group 2 (n=42) received intraendometrial injections of autologous PRP instead of the conservative therapy. Group 3 (n=38) received identical injections after conservative therapy. Group 4 (n=5) received injections of the minimally manipulated autologous endometrial cells suspended in autologous PRP.

Injections of PRP and endometrial cells suspended in autologous PRP into basal layer of endometrium facilitate the reconstitution by enhancing cell proliferation and angiogenesis.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-40 years
* Normal karyotype
* Normal karyotype of the partner
* Regular ovulatory and menstrual cycle
* Endometrium \<7 mm thick as measured at implantation window
* Availability of ≥2 vitrified blastocysts of good quality
* History of implantation failure and/or embryo transfer (ET) cancellation due to insufficient endometrial thickness

Exclusion Criteria:

* Pathospermia in partner
* Use of donor gametes
* Premature ovarian failure
* Internal genital anomalies
* Systemic blood diseases and coagulopathy
* Hemoglobin \<100 g/L
* Platelets \<100×109/L
* Antiplatelet/anticoagulant therapy recipient status
Blood Biomarkers of Injury and Outcome in Traumatic Brain Injury

Blood samples will be drawn on traumatic brain injury patients who are participating in the ProTECT III study.

Blood samples will be drawn on traumatic brain injury patients who are participating in the ProTECT III study just prior to the initiation of the study drug infusion and 24 and 48 hours from the time they are enrolled in the study to test for biomarkers that may help predict how severe the injury is and how well they improve. The investigators will also test to see if the study medication is being absorbed and is staying at a consistent level in the blood stream.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe brain injury (iGCS 12-4 or motor response 2-5 if intubated).
* Age \>18 years (or developmental stage Tanner 5 in patients where age is not known)
* Blunt, traumatic, closed head injury (altered mental status due to brain injury)
* Able to initiate study drug infusion within 4 hours from time of injury -

Exclusion Criteria:

* Non-survivable injury as determined by treating
* Bilateral dilated unresponsive pupils
* Spinal cord injury with neurological deficits, pre-injury paralysis (quad/paraplegic)
* Inability to perform activities of daily living (ADL) without assistance
* Cardiopulmonary arrest
* Status epilepticus on arrival or concern for post ictal state
* systolic blood pressure \< 90 for two consecutive readings at least 5 minutes apart any time prior to randomization
* O2 Sat \< 90 for at least 5 consecutive minutes any time prior to randomization
* Prisoner or ward of state
* Known active breast or reproductive organ cancers (via medical records or family interview)
* Known allergy to progesterone or Intralipid components (egg yolk) (via medical records or family interview)
* Known history of blood clotting disorder (Protein S or C deficiency, etc.) or history of pulmonary embolism (via medical records or family interview) or active/ongoing thromboembolic event (myocardial infarction, ischemic stroke, pulmonary embolism, deep vein thrombosis).
* Blood or serum ethanol (EtOH) ≥ 250 mg %
* Positive qualitative urine or serum pregnancy test
* Concern for inability to follow up at 6 months (residence in foreign country, homeless with limited contacts,
* undocumented immigrants, or high likelihood of becoming incarcerated during study period, etc.)
* Patient in Opt Out registry or wearing Opt Out bracelet -
Effect of Inflation on the Angiographic Result After Balloon Angioplasty in the Femoropopliteal Segment

Percutaneous angioplasty with balloon dilation is the method of choice for the treatment of most femoropopliteal artery lesions. After balloon dilatation, arterial wall dissection with flow limiting dissection or recoil with residual stenosis often require additional procedures such as stent placement or prolonged balloon dilation. A shorter balloon inflation time of 30 sec will be accompanied by a higher number of flow limiting dissection or recoil, demanding a time consuming and expensive stent placement or balloon redilatation. The effect of different balloon inflation times has only been assessed ones in peripheral balloon angioplasty with better outcomes after prolonged balloon inflation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic atherosclerotic stenotic lesions of the femoropopliteal artery suitable for angioplasty in the adult population

Exclusion Criteria:

* Artery lesions shorter than 1 cm and longer than 10 cm length, total occlusions, severe calcification, previous angioplasty with current restenosis, previous stenting with current insistent restenosis and subintimal recanalization of the lesion
* No pregnant and nursing women will be included.
A Prospective Study of Monitoring Immune Response in Locally Advanced Cervix Cancer

Perspectives:

To analyse if the change of specific immune response will correlate with clinical effect of advanced cervix cancer after radio-chemotherapy.

To evaluate the specific immune response throughout monitor the change of the programmed death-1(PD-1) in CD8 T cell and CD4 T cell and Treg cell in blood at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.

To use immunohistochemistry (IHC) technique to monitor the change of programmed death-ligand 1 (PD-L1),CD68,CD8,CD4,PD1 and Treg expression in biopsy at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.

To detect the change of T cell receptor(TCR) repertoire and Tumor mutation burden (TMB) at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.

Cervical cancer is the fourth most common cancer among women worldwide. At present, patients with cervical cancer are treated with radical hysterectomy and pelvic lymphadenectomy or chemoradiation. To improve the prognosis of cervical cancer patients, novel immunotherapeutic strategies need to be developed. Now there are some clinical phase I/II trials ongoing to assess the effects of ipilimumab, pembrolizumab and nivolumab in advanced cervical cancer,but information on the clinical significance of PD-L1 expression in cervical cancer is largely lacking.In this study, the investigator's primary objective:

To analyse if the change of specific immune response will correlate with clinical effect of advanced cervix cancer after radio-chemotherapy.

To evaluate the specific immune response throughout monitor the change of PD-1 in CD8 T cell and CD4 T cell and Treg cell in blood at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.

To use IHC technique to monitor the change of PD-L1, CD68,CD8,CD4,PD1 and Treg expression in biopsy at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.

To detect the change of TCR repertoire and TMB at baseline, before first brachytherapy and before the last brachytherapy in the advanced Cervix Cancer patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18-70 years.
2. All FIGO stages cervical cancers which are the matter for radiochemotherapy and exclusive brachytherapy indications.
3. ECOG:0-1.
4. Ability to give informed consent.

4. Patients must be affiliated to a Social Security System. 6. Patient information and written informed consent form signed.

Exclusion Criteria:

1. Known autoimmune disorder.
2. History of HIV and/ or active hepatitis infection.
3. History of pelvic radiation or radio-chemotherapy.
4. Recurrent or metastatic cervical cancer.
5. Contra-indication for cisplatin.
6. Patient pregnant and/or breastfeeding.
7. Patients with psychological or familial disease potentially hampering compliance with the study protocol and follow-up schedule