Kornimate/medical-research-clean huggingface dataset:
axitinib in metastatic renal cell carcinoma patients with favorable prognostic factors

Conditions: Carcinoma, Renal Cell; Clear Cell Renal Cell Carcinoma

Summary: aim of the favorax study is to evaluate preliminary efficacy and safety of axitinib in metastatic renal cell carcinoma patients with favorable imdc prognostic factors who had progressed on sunitinib or pazopanib in the first-line setting.

axitinib is a tyrosine kinase inhibitor of vascular endothelial growth factor receptor, platelet-derived growth factor receptor-α, and c-kit. the trial of comparative effectiveness of axitinib versus sorafenib in advanced renal cell carcinoma (axis) was an international randomized phase iii study designed for registration purposes. this trial randomized 723 metastatic renal cell carcinoma patients with any prognostic features to axitinib or sorafenib in the second-line setting and demonstrated significant clinical benefit of axitinib. aim of present favorax study is to evaluate preliminary efficacy and safety of axitinib in metastatic renal cell carcinoma patients with favorable imdc prognostic factors who had progressed on sunitinib or pazopanib in the first-line setting.

Eligibility criteria:
principle inclusion criteria: * histologic confirmation of renal cell carcinoma with a clear cell component * patients must have measurable disease * previous treatment with sunitinib or pazopanib * favorable prognosis according to imdc criteria * must have available tumor tissue for submission * subjects must also meet various laboratory parameters for inclusion * patients must give written informed consent prior to initiation of therapy exclusion criteria: * any underlying medical condition, which in the opinion of the investigator, will make the administration of study drug hazardous or obscure the interpretation of adverse events * patients who have history of uncompensated diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk from treatment complications.
tislelizumab plus tp as neoadjuvant therapy for local advanced cervical carcinoma

Conditions: Cervical Squamous Cell Carcinoma

Summary: the goal of this clinical trail is to investigate the efficacy and safety of pd-1 antibody tislelizumab plus tp regimen (taxane combined with platinum) as neoadjuvant therapy for patients diagnosed as local advanced cervical carcinoma (figo staging ib2-iib).

this phase i study is being conducted to establish efficacy and safety of tislelizumab plus tp regimen (taxane combined with platinum) as neoadjuvant therapy for patients diagnosed as local advanced cervical carcinoma (figo staging ib2-iib). all enrolled patients will receive same intervention. treatment naïve patients who are diagnosed as local advanced cervical squamous cell carcinoma will receive tislelizumab plus tp regimen before surgery for 3 cycles. after treatment, radiographic evaluation will be performed to assess clinical efficacy. patients who have objective response will undergo radical surgery. patients who are disease stable or progression will undergo radical chemoradiotherapy. the primary endpoint is major pathological response rate (mpr).

Eligibility criteria:
inclusion criteria: 1. histologically confirmed cervical squamous cell carcinoma. 2. clinical staging figo ib2-iib, treatment naive. 3. female patients aged≥18 years. 4. ecog performance status 0 or 1, expected lifetime≥3 months. 5. adequate organ function: absolute neutrophil count (anc) ≥1.5x109/l, white blood count ≥3.5x109/l, platelets ≥75x109/l, hemoglobin (hb) ≥90g/l, alt/ast ≤2.5x uln, serum bilirubin ≤1.5x uln, serum creatinine ≤1.5x uln. 6. hbv infected patients (inactive/asymptomatic carrier, chronic or active) with hbv dna\<500iu/ml (or 2500 copies/ml). 7. pregnancy test of female patients with fertile activity should be negative within 7 days before enrollment. patients should keep contraception during treatment. 8. willingness and ability to comply with the protocol for the duration of the study including scheduled visits, examinations, investigations and treatment plans with informed consent form. exclusion criteria: 1. pregnancy or children bearing potential. 2. brain or meningeal metastasis. 3. with second primary malignant diseases. 4. with uncontrolled auto-immune diseases, interstitial pneumonia, ulcerative colitis, or patients who should receive long-term glucocorticoid treatment (\>10mg/d prednisone). 5. with uncontrollable complications 6. inadequate organ function 7. known hypersensitivity reaction to any of the study drugs or components. 9. other unsuitable conditions determined by investigators.
study of recombinant factor ix product, ib1001, in previously treated pediatric subjects with hemophilia b

Conditions: Hemophilia B

Summary: the study's primary objective is to evaluate the pharmacokinetics, safety (acute effects associated with infusions, and inhibitor development) and efficacy (breakthrough bleeding and control of hemorrhaging during prophylaxis) of ib1001 in previously treated pediatric subjects with hemophilia b.


Eligibility criteria:
inclusion criteria: 1. subject's parent or legal guardian must give written institutional review board (irb)/independent ethics committee (iec)-approved informed consent and be willing to make the required study visits and follow instructions while enrolled in the study. for subjects ≥7 years of age, assent will be obtained if required by the institution. for subjects \< 7 years of age, legal assent is not reasonable to obtain. 2. severe (factor ix activity ≤2 iu/dl) hemophilia b subjects currently on-demand therapy with a minimum of 2 bleeding episodes requiring factor ix therapy over the preceding 6 months or 4 bleeding episodes over the preceding 12 months; subjects on prophylaxis with a bleeding pattern similar to that above demonstrated prior to starting prophylaxis 3. immunocompetent (cd4 count \>400/mm3) and not receiving immune modulating or chemotherapeutic agents 4. previously treated patients with a minimum of 50 exposure days to a factor ix preparation 5. platelet count at least 150,000/mm3 6. liver function: alanine transaminase \[alt\] and aspartate transaminase \[ast\] ≤2 times the upper limit of the normal range 7. total bilirubin ≤1.5 times the upper limit of the normal range 8. renal function: serum creatinine ≤1.25 times the upper limit of the normal range 9. willingness to participate in the trial for approximately 6 months (50 exposures) 10. age ≤12 years 11. hemoglobin ≥7 g/dl at the time of the blood draw exclusion criteria: 1. history of factor ix inhibitor ≥0.6 bethesda units (bu) 2. existence of another coagulation disorder 3. evidence of thrombotic disease, fibrinolysis, or disseminated intravascular coagulation (dic) 4. use of an investigational drug within 30 days prior to study entry 5. on medications that could impact hemostasis, such as aspirin 6. history of poor compliance, a serious medical or social condition, or any other circumstance that, in the opinion of the investigator, would interfere with participation or compliance with the study protocol 7. history of adverse reaction to either plasma-derived factor ix or recombinant factor ix that interfered with the subject's ability to treat bleeding episodes with a factor ix product

Keywords: recombinant factor ix
the effect of rapid fluid challenge under pulmonary artery catheter monitoring on physiological indexes of patients with septic shock

Conditions: Septic Shock

Summary: fluid challenge is often carried out in septic shock patients. its responsiveness usually requires invasive monitoring. the pulmonary artery catheter(pac) is the most effective means of monitoring.to use non-invasive methods is very tempting. investigators hypothesize that venous-to-arterial carbon dioxide difference,venous-to-arterial carbon oxygen difference, central venous-arterial carbon dioxide to arterial-venous oxygen content ratio and central venous so2 variations provides feasible estimation on fluid responsiveness in septic shock patients.


Eligibility criteria:
inclusion criteria: * more than 18 years old; less than 75 years old icu patients * septic shock * monitored with pulmonary artery catheter (swan-ganz catheter) * the decision of fluid challenge made by the treating physician exclusion criteria: * evidence of fluid overload * pregnancy * recently participated in other studies * severe heart failure
efficacy and safety of rad001 in treating plexiform neurofibromas (pn) associated with neurofibromatosis (nf1)

Conditions: Plexiform Neurofibroma Associated With Neurofibromatosis Type 1

Summary: this study was to evaluate the antitumor activity and safety of rad001 in patients with plexiform neurofibromas (pn) associated with neurofibromatosis type 1 (nf1). the aim of the study was to : 1. determine whether rad001, administrated orally daily on a continuous dosing schedule might: 1. increases time to disease progression (ttp) based on volumetric mri measurements in children and adults with nf1 in inoperable documented progressive pn (stratum 1). 2. results in objective radiographic responses based on volumetric mri measurements in children and adults with nf1 and inoperable pn in the absence of documented radiographic progression at the trail entry (stratum 2. to evaluate the tolerability and toxicity of chronic rad001 administration in this patient population as assessed by the nci common toxicity criteria, version 4.0.

approximately 20 patients were to be enrolled to receive everolimus in an open label manner. a total of 9 patients were enrolled to either stratum 1 or stratum 2. the study was open for enrollment up to 2 years. because the target enrollment was not achieved in this period, study was terminated with less patient than planned.

Eligibility criteria:
inclusion criteria: 1. clinically definite diagnosis of nf1 according to the nih consensus conference criteria. 2. patients must have pn that have the potential to cause significant morbidity, such as lesions that could compromise the airway or the great vessels, lesions that could cause nerve compression, lesions that could result in major deformity or significant cosmetic problems 3. measurable disease: patient must have at least one measurable pn amenable to volumetric mri analysis. exclusion criteria: 1. chronic treatment with systemic steroids or another immunosuppressive agent. 2. evidence of an active optic glioma, malignant glioma, malignant peripheral nerve sheath tumor, or other cancer requiring treatment with chemotherapy or radiation therapy. 3. clinical evidence of significantly impaired lung function 4. pregnancy or breast feeding. 5. prior therapy with mtor inhibitors (e.g.sirolimus, temsirolimus, everolimus). 6. no contraindications for mri assessments other protocol-defined inclusion/exclusion criteria may apply

Keywords: rad001, everolimus, plexiform neurofibroma, neurofibromatosis type 1
prediction of tei success in sciatica

Conditions: Lumbar Radiculopathy; Lumbar Disc Herniation; Lumbar Spinal Stenosis

Summary: rationale: treatment with transforaminal epidural injections is part of usual care in patients suffering from lumbar radiculopathy. however, not all patients experience a satisfactory result from this treatment and it is unclear what percentage of patients responds well and if any clinical or radiological factors exist that predict a positive response. objectives: primary: to develop a model based on demographic, clinical and radiological parameters for prediction of treatment success after tei secondary: to estimate the short-term efficacy of tei in patients with ldh and spinal stenosis based on pain, functionality and perceived recovery scores, to determine the correlation between clinical and radiological baseline parameters and physical and psychological patient outcome measures, to determine the rate of additional injections and rate of surgery after treatment with tei, to determine the short-term (cost)effectiveness of tei on physical and psychological patient outcome measures, and to determine the rate of complications associated with tei study design: prospective cohort study study population: patients that are scheduled for tei as part of usual care suffering from a new episode of lumbar radiculopathy main study parameters/endpoints: leg and back pain scores at baseline, 30 minutes, 2 and 6 weeks after treatment. odi, hads, quality of life and pci at baseline, 2 and 6 weeks after treatment. perceived recovery at 2 and 6 weeks after treatment. usage of healthcare at baseline, 2 and 6 weeks after treatment.

data collection schedule baseline weeks of follow-up 30 min. day 4 week 2 week 6 demographic data ✓ nrs leg pain ✓ ✓ ✓ ✓ nrs back pain ✓ ✓ ✓ ✓ odi ✓ ✓ ✓ hads ✓ ✓ ✓ qol vas ✓ ✓ ✓ pci ✓ ✓ ✓ likert score ✓ ✓ adjuvant therapy ✓ ✓ ✓ tei data ✓ ✓

Eligibility criteria:
inclusion criteria: * diagnosis of unilateral lumbar radiculopathy secondary to ldh or one-level spinal stenosis * diagnosis supported by magnetic resonance imaging (mri) findings * scheduled appointment for tei * access to e-mail * signed informed consent exclusion criteria: * diagnosis of unilateral lumbar radiculopathy secondary to ldh or one-level spinal stenosis * age under 18 years * severe multisegmental spinal disease * anatomical abnormalities that may complicate the procedure technically (e.g. severe scoliosis) * active malignancy or infectious disease * use of immunosuppressive drugs * use of systemic corticosteroids in preceding 3 months * previous treatment with tei for current episode of lumbar radiculopathy * history of lower back surgery at the same lumbar level * circumstances that prevent treatment with tei (e.g. use of anticoagulants that cannot be temporarily discontinued, allergy against steroids or local anaesthetic) * pregnancy * major language barrier

Keywords: transforaminal epidural injection lumbar spine prospective cohort study prediction of success
breast cancer subtype characterization through patient's derived organoids.

Conditions: Breast Cancer; Organoids

Summary: development of tools to predict patients chemo-sensitivity and identification of corresponding biomarkers is an urgent challenge for bc patients lacking targeted therapies, such as tnbc, or for patients experiencing relapse after adjuvant chemotherapy or targeted therapies. the refinement of 3d-cultivation techniques, experienced in the last decade, has allowed cultivation of patients-derived cancer cells in organotypic structures, named patient-derived organoids (pdo), which preserve histologic, genomic and transcriptomic features of primary tumors. pdo allow propagation, pharmacological treatment and genetic manipulation of patients-derived cancer cells in a close to physiology setting, thus representing a promising tool in the development of personalized therapies

pdo have been shown to efficiently recapitulate ex-vivo the in vivo response to hormonal treatment of bc patients. these observations point to pdo as potential valuable tools for a rapid, personalized prospective evaluation of patient-specific chemo-sensitivity. moreover, pdo can represent a valuable ex-vivo platform for screening new treatments, or combination of current treatments, in a medium-to-high-throughput fashion. thus, development of a stable collection of pdo representing the heterogeneity of bc subtypes, including the evolution of recurrent disease, represents an extremely useful resource for both prospective and retrospective studies aimed at understanding the molecular phenotype associated with chemoresistance.

Eligibility criteria:
inclusion criteria: * women diagnosed with primary bc, eligible for surgical resection of the tumor according to national and international guidelines. age between 18 and 70 years; newly diagnosed breast neoplasms, tumor size of at least 1.5 cm diameter. exclusion criteria: breast cancer diagnosed during pregnancy, neoadiuvant chemotherapy

Keywords: breast cancer new drugs organoids
conventional versus hypofractionated radiation in high risk prostate patients

Conditions: High-risk Prostate Cancer

Summary: hypofractionated regimen in high-risk prostate cancer will allow the investigators to deliver higher biological doses to targets in order to improve tumor control and with acceptable rectal toxicity compared to conventional fractionation.


Eligibility criteria:
inclusion criteria: * patient is 18 years of age or older * patient has histologically proven adenocarcinoma of prostate gland by needle core samples or turp with assigned gleason score. prostate biopsy performed within 180 days of enrollment (date of consent). * patient has high-risk prostate cancer (stage t3 or t4) and/or psa greater than or equal to 20 ng/ml and/or gleason score 8 to 10 * no clinical or radiological evidence of nodal or distant metastasis(es). * in the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate. patients are accessible for treatment and follow up. * patient does not have history of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases. * no history of prostatectomy, transurethral resection of prostate on more than one occasion or previous pelvic radiotherapy. * no history of androgen suppression for greater than or equal to 6 months and patient is willing for androgen suppression treatment as per standard or at physician's discretion. * no previous malignancy within last five years except bcc or scc skin or highly curable malignancy where a prognosis for cure is \> 80%. * patient signed informed consent.

Keywords: high risk prostate cancer hypofractionated radiation treatment higher biological doses acceptable rectal toxicity radiation treatment
the effects of antihypertensive agents on central blood pressure in healthy participants and participants with hypertension (mk-0000-166) (completed)

Conditions: Hypertension

Summary: this study will test the relationship between cbp (central blood pressure) and pbp (peripheral blood pressure) effects after single and multiple doses of isosorbide mononitrate extended release (ismn er) or amlodipine besylate in participants with hypertension.


Eligibility criteria:
inclusion criteria: * participant is a male or female between 30 and 65 years of age (inclusive) at the pre-study (screening) * female participant of childbearing potential must have a negative pregnancy test * participant has a brachial systolic blood pressure \>130 mm hg and \<180 mm hg * participant has a body mass index (bmi) that is \>20 kg/m\^2 and \<35 kg/m\^2 * participant has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months exclusion criteria: * female participant is pregnant or lactating * participant anticipates the use of non-steroidal anti-inflammatory drugs (nsaids) other than acetaminophen * participant is currently a user (including "recreational use") of any illicit drugs, has a history of drug or alcohol abuse within approximately 2 years, or has a positive prestudy urine drug screen * participant has a condition for which there is a warning, contraindication, or precaution against the use of ismn er including: acute myocardial infarction or congestive heart failure, hypotension, volume depletion, and pregnancy * participant has a history of significant drug allergy or any clinically significant adverse experience of a serious nature related to the administration of either a marketed or an investigational drug, including nitrates, nitrites, amlodipine, and ismn er
using radiation-free ultrasound for screening scoliosis among female school children in hong kong to reduce unnecessary x-ray exposure

Conditions: Scoliosis; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Disease

Summary: in the scoliosis screening program of the student health service (shs), department of health (dh), in hong kong, more than 50% of screened school children prescribed with x-ray examination basing on the screening protocol did not have cobb angle greater than the referral threshold of 20°; ie they did not need specialist referral and thus were subjected to unnecessary x-ray exposure. our primary objective is to determine whether a new radiation-free ultrasound system could identify subjects with cobb angle greater than the referral threshold of 20° thus avoiding unnecessary x-rays in the referral workflow. the secondary objective is to evaluate if angle of trunk rotation (atr) can further increase the accuracy of ultrasound assessment. this study is an extension of the registered project entitled "using radiation-free ultrasound for screening scoliosis among school children in hong kong to reduce unnecessary x-ray exposure", (clinicaltrials.gov identifier: nct03135665), however focusing on validity of ultrasound measurement for immature female subjects aged around ten with year since menarche equal to or less than 9 months, who are prone to curve progression, and thus are among the most critical group in clinical management of scoliosis for regular monitoring, treatment decision, and brace indication.


Eligibility criteria:
inclusion criteria: i. school children in hong kong attending school screening program provided by student health service ii. recommended for radiographic assessment in the scoliosis screening program iii. female with year since menarche of equal to or less than 9 months exclusion criteria: i. patients with standing height \ 2 m ii. patients with body mass index (bmi) ≥25 kg/m2 iii. subjects with skin diseases iv. subjects with fracture or wound that affect ultrasound scanning v. subjects with ferromagnetic implants vi. subjects with surgery done for the spine vii. subjects with winged scapula or other irregularity of back contour that affect ultrasound scanning viii. subjects who cannot stand steadily during scanning ix. subjects with allergy to ultrasound gel

Keywords: scoliosis, ultrasound, screening program, immature female
the jet study: a phase i trial of cabazitaxel, radiotherapy and long-term androgen deprivation

Conditions: Prostatic Neoplasms

Summary: this study utilizes a conventional phase i study design with a '3+3 cohort expansion' design(15), to determine the maximum tolerated dose(mtd) of 1) cabazitaxel, in part a, and 2) radiotherapy, in part b. the determination of the mtd is given in section 5.2, definition of dose - limiting toxicity. all patients who enter the study, and begin concurrent chemo-radiation are analyzable for the primary endpoint of the study.

this study utilizes a conventional phase i study design with a '3+3 cohort expansion' design(15), to determine the maximum tolerated dose(mtd) of 1) cabazitaxel, in part a, and 2) radiotherapy, in part b. the determination of the mtd is given in section 5.2, definition of dose - limiting toxicity. all patients who enter the study, and begin concurrent chemo-radiation are analyzable for the primary endpoint of the study. assuming that dose-limiting toxicity is not encountered, and both the maximum dose of cabazitaxel is reached, in part a of the study, and the maximum dose of radiotherapy is reached in part b of the study, the maximum number of patients required is as follows: clinical study protocol - the jet study date: september 11, 2012 part a: 3 patients per level x 5 levels, plus 3 patients (for a total of 6) at the highest dose level of cabazitaxel = 15 + 3 = 18 part b: 3 patients per level x 3 levels, plus 3 patients (for a total of 6) at the highest dose level of radiotherapy = 9 + 3 = 12 the total number of patients required is 30. patients that do not complete concurrent chemotherapy, radiotherapy, and androgen deprivation therapy, for reasons other than dlt will be replaced. given our experience in chemo-radiation studies in a similar patient population, our centre is anticipated to accrue 3 patients per month.

Eligibility criteria:
inclusion criteria: * high risk prostate cancer exclusion criteria: * mets