Kornimate/medical-research-clean huggingface dataset:
a study of varlitinib in japanese subjects with advanced or metastatic solid tumours

Conditions: Advanced or Metastatic Biliary Tract Cancer; Advanced or Metastatic Solid Tumors

Summary: the purpose of this study is to explore safety and efficacy of varlitinib administered as monotherapy in japanese subjects with advanced or metastatic solid tumors, and administered as combination with capecitabine in japanese subjects with advanced or metastatic biliary tract cancer. also to evaluate pharmacokinetics (pk) of varlitinib, capecitabine and its metabolite.


Eligibility criteria:
inclusion criteria: * study i: subjects with a solid tumour (excluding haematologic tumors) in advanced or metastatic stage * study ii: subjects with advanced (unresectable) or metastatic biliary tract cancer (ihcc, ehcc, gallbladder cancer or ampullary carcinoma) exclusion criteria: * subjects with concurrent multiple primary cancers. * subjects with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis, or with a history of interstitial lung disease or current interstitial lung disease * subjects receiving proton pump inhibitors for established, symptomatic gastro-duodenal ulceration or gastroesophageal reflux disease (including the preventive use)
neoadjuvant chemoradiotherapy vs. chemotherapy with radical gastrectomy and adjuvant chemotherapy for advanced gastric cancer

Conditions: Gastric Cancer

Summary: patients with histologically confirmed gastric adenocarcinoma with locally advanced gastric cancer are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with dt45gy/25f plus three cycles of xelox therapy or neoadjuvant chemotherapy alone using xelox regimen following d2 gastrectomy and adjuvant chemotherapy for 3 cycles. the primary end point is disease free survival (dfs), and secondary end point is 5-year overall survival (os), pathological complete remission (pcr) and treatment safety.

background: literatures have shown that patitents with locally advanced gastric cancer could potentially benefit from neoadjuvant chemoradiotherapy, but whether this can improve patitents' outcome is still unclear. patients and methods: in this study , patients with histologically confirmed gastric adenocarcinoma with pre-operative staging are ct3n2/n3m0, ct4an+m0 and ct4bnanym0, aged between 18-75 years old, with adequate organ function and having an eastern cooperative oncology group performance status score ≤2, are randomized in a 1:1 ratio to receive neoadjuvant chemoradiotherapy with dt45gy/25f plus three cycles of xelox therapy (capecitabine 1000mg/m2, bid, d1-14; oxaliplatin 130mg/m2 on day 1 for a 21-day cycle) or neoadjuvant chemotherapy alone using xelox regimen following by d2 gastrectomy and adjuvant chemotherapy with same dosage of xelox therapy for up to 3 cycles. the primary end point is disease free survival (dfs), and secondary end point is 5-year overall survival (os), pathological complete remission (pcr) and treatment safety. the final study analytics are to be conducted at the end of the 5th year after the last patient's enrollment.

Eligibility criteria:
inclusion criteria: * informed consensus of the enrolled patients * being able to receive oral drug * from 18 to 75 years old * proven to be primary adenocarcinoma of gastric cancer and pre-operative staging ct3n2/n3m0, ct4an+m0, ct4bnanym0, * no prior other chemotherapy and/or radiation against the disease * normal function of all other vital organs including heart,liver ,kidney and so on * eastern cooperative oncology group performance status: 0\~2 exclusion criteria: * history of other malignancy * allergic reaction to capecitabine or oxaliplatin * enrolled in other clinical trials * abnormal gi tract function * dysfunction of other organs * pregnant or lactating females ,or refuse to receive contraception measures during chemotherapy * other situations judged as not adaptive to the study by investigators

Keywords: neoadjuvant chemoradiotherapy chemotherapy locally advanced gastric cancer pathological complete response d2 gastrectomy
moxonidine effects on neuropeptide y

Conditions: Obesity; Hypertension

Summary: treatment with monotherapy of moxonidine 0.6 mg daily in treatment-naïve subjects with mild or moderate hypertension

treatment with 0.6 mg moxonidine daily in treatment-naïve subjects with mild or moderate hypertension according to guidelines (stage 1: systolic blood pressure =140-159 mmhg, diastolic blood pressure =90-99 mmhg, and stage 2: systolic blood pressure=160-179 mmhg, diastolic blood pressure=100-109 mmhg) that require monotherapy and reevaluation after 12 weeks

Eligibility criteria:
inclusion criteria: * treatment-naïve subjects with mild or moderate hypertension according to joint national committee 7 and european society hypertension / european society cardiology 2008 (stage 1: systolic blood pressure =140-159 mmhg, diastolic blood pressure =90-99 mmhg, and stage 2: systolic=160-179 mmhg, diastolic=100-109 mmhg) that require monotherapy exclusion criteria: * age beyond 25-75 years, * not taking currently anti-hypertensive medication * not taking anti-diabetic or lipid lowering medication and other diseases or conditions that may influence blood pressure, heart rate and catecholamines' and neuropeptide y levels, including anemia, fever, stage iii hypertension, coronary artery disease, recent (less than 6 months) myocardial infraction or stroke, heart failure, secondary hypertension, diabetes mellitus, abnormal thyroid status or other obesity-related endocrinopathies, pregnancy, kidney failure, alcohol abuse, malignancies, depression or other psychiatric illnesses, such as schizophrenia,

Keywords: hypertension obesity neuropeptide y moxonidine
phase 1 clinical trial mpc-2130 treatment of blood cancers / refractory cancer

Conditions: Cancer

Summary: phase 1 open-label treatment with mpc-2130 for subjects with refractory cancer.

mpc-2130 phase 1 clinical study was designed to evaluate its safety and pharmacokinetic profile in patients with advanced metastatic tumors or blood cancers as well as refractory cancers that progressed despite previous chemotherapy.

Eligibility criteria:
inclusion criteria: 1. be capable of understanding the informed consent form (icf) and complying with the protocol, and must sign the icf prior to the performance of any study related procedures; 2. have cancer that is nonresponsive despite prior treatment with current standard of care regimens or for whom there are no available effective therapies; 3. have measurable or evaluable neoplastic disease; 4. be greater than or equal to age 18; 5. have and ecog performance status score of less than or equal to 2; 6. have adequate organ function defined by: 1. liver function tests (ast \& alt) less than or equal to 3 times the upper limit of normal (uln); 2. bilirubin less than or equal to 1.5 x uln; 3. serum creatinine less than or equal to 1.5 x uln; 4. hemoglobin greater than or equal to 8.0 g/dl; 7. have recovered or stabilized from clinically significant toxicities of prior chemotherapy, surgery, or radiotherapy; 8. have left ventricular ejection fraction (lvef) of greater than or equal to 45% by multiple gated acquisition (muga) scan or echocardiogram. exclusion criteria: 1. have had a prior serious, uncontrollable hypersensitivity reaction to cremophor el; 2. be pregnant or lactating (women of childbearing potential must use appropriate birth control (abstinence, barrier methods, oral contraceptives and/or intrauterine devices) during the entire duration of the study, or the patient must be surgically sterile (with documentation in the patient's medical records); 3. receive any other anticancer treatment or investigational therapy within 14 days prior to day 1; or within 6 weeks after prior mitomycin c or nitrosourea. patients with advanced prostate cancer may continue to receive leutinizing hormone-releasing hormone (lhrh) therapy while in this study; 4. have previously enrolled in this trial. -

Keywords: oncology cancer blood cancers
intensive care unit (icu) diary project

Conditions: PTSD; Post ICU Syndrome

Summary: psychological morbidity in both patients and family members related to the intensive care unit (icu) experience is an often overlooked, and potentially persistent, healthcare problem recognized by the society of critical care medicine as post-intensive care syndrome (pics). icu diaries are an intervention increasingly under study with potential to mitigate icu-related psychological morbidity, include icu-related ptsd (post-traumatic stress disorder), depression and anxiety.

the investigators compared the efficacy of the icu diary, prospectively written by third-parties during the patient's intensive care course, versus education-alone, on reducing acute ptsd symptoms after discharge. patients with an icu stay greater than 72 hours, and who were intubated and mechanically ventilated over 24 hours, were recruited and randomized to either receive a diary at bedside with psychoeducation, or psychoeducation alone. intervention patients received their icu diary within the first week of admission into the intensive care unit. psychometric testing with ies-r, phq-8, hads and gad-7 was conducted at weeks 4, 12, and 24 after icu discharge.

Eligibility criteria:
inclusion criteria: * admitted to the intensive care unit for at least 72 hours * sedated and mechanically ventilated for at least 24 hours. * available over-the-phone, up to 6 months post-icu discharge exclusion criteria: * any patients who do not voluntarily agree to participate * not fluent in the english language * patients who have stayed in the icu for less than 72 hours * patients who have been sedated and mechanically ventilated for less than 24 hours * patients with pre-existing severe psychotic illness, bipolar disorder, substance use disorder, ptsd, stroke, traumatic brain injury, neurocognitive impairment, or intellectual disability * patients with no phone number or reliable contact information for the sake of follow-up * prisoners * pregnant patients

Keywords: psychocognitive morbidity narrative medicine icu-related ptsd post-icu syndrome (pics) icu diary
a study to evaluate the pharmacodynamic effects of single oral doses of pf-06648671 on β-amyloid (aβ) concentrations in cerebrospinal fluid (csf)

Conditions: Healthy Subjects

Summary: this is phase 1 investigator-and-subject blind, sponsor open, randomized, placebo controlled, parallel study in healthy subjects to evaluate the pharmacodynamics effect of single oral doses of pf-06648671 on csf aβ concentrations using serial csf sampling methodology.

this study is investigator-and-subject blind, sponsor open, randomized, placebo-controlled, parallel study in healthy subjects to evaluate central (csf) and peripheral (plasma) pharmacodynamics effects (abeta) over 36 hours post single doses of pf-06648671. two cohorts will be run in sequential. the first cohort is to evaluate the abeta effect at top dose of 300 mg pf-06648671 and second cohort is to evaluate the abeta effect at top dose (if more subjects are required) and/or 1-2 lower doses

Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects of non childbearing potential * bmi of 17.5 to 30.5 kg/m2 and a total body weight \>50 kg (110 lbs) * evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study. exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated asymptomatic, seasonal allergies at the time of dosing) * treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer) * subjects with a history of significant active bleeding, coagulation disorder or clinically significant finding on prothrombin time/ partial thromboplastin time/international normalized ratio (pt/ptt/inr) at screening * subjects with lower spinal malformations (on physical examination), local spinal infection, or other abnormalities that would exclude puncture (lp) * other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study

Keywords: phase 1 double blind placebo-controlled parallel design csf aβ concentrations pf-06648671
regional lymph node metastasis and survival outcomes in advanced hcc

Conditions: Hepatocellular Carcinoma (HCC)

Summary: tumor-draining lymph nodes play an important role in anti-tumor immune responses. in patients with hepatocellular carcinoma (hcc), however, the relationship between regional lymph node metastasis (lnm) and immunotherapy-based efficacy is unclear. this study aimed to evaluate whether extrahepatic lnm is associated with worse survival outcomes as compared to other metastatic sites in patients with advanced hcc.

in patients with advanced-stage hepatocellular carcinoma (hcc), previous studies showed that transarterial chemoembolization (tace) in combination with immune checkpoint inhibitors (icis) and molecular target therapies exhibited better efficacy (pfs and os) as compared to the icis and molecular target therapies. besides, previous studies showed that tumor-draining lymph nodes play an important role in anti-tumor immune responses in vivo and in vitro studies. however, the relationship between regional lymph node metastasis (lnm) and immunotherapy-based efficacy is unclear. therefore, this study aimed to evaluate whether extrahepatic lnm is associated with worse survival outcomes as compared to other metastatic sites in patients with advanced hcc who received transarterial chemoembolization (tace) in combination with icis and molecular target therapies. this real-world study may provide further information on treatment selection for clinical practice and trials.

Eligibility criteria:
inclusion criteria: 1. has a diagnosis of hcc confirmed by radiology, histology, or cytology; 2. barcelona clinic liver cancer (bclc) stage c with the presence of extrahepatic spread; 3. has not received any previous systemic therapy for hcc (including chemotherapy, molecularly targeted therapy, immunotherapy); 4. both pd-1/pd-l1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to hcc approval; 5. tace was performed after the first pd-1/pd-l1 inhibitor/anti-angiogenic drug treatment or before treatment (within 3 months); 6. received at least 1 cycle of pd-1/pd-l1 inhibitor/anti-angiogenic drug combination therapy after tace treatment; 7. has repeated measurable intrahepatic lesions; exclusion criteria: 1. cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible; 2. unable to meet criteria of combination timeframe described above; 3. child-pugh c or ps \> 2 or severe hepatic encephalopathy

Keywords: hepatocellular carcinoma lymph node metastasis transarterial chemoembolization immune checkpoint inhibitors molecular target therapies
safety and tolerability of a single dose of fcm vs. standard of care in treating iron deficiency anemia

Conditions: Anemia

Summary: the objective of this study is to evaluate the safety of fcm in patients with anemia who are not dialysis dependent


Eligibility criteria:
inclusion criteria: * subjects ≥18 years of age and able to give informed consent * iron deficiency is the primary etiology of anemia * screening visit central laboratory hgb indicative of anemia ≤12 g/dl * screening visit ferritin indicative of iron deficiency anemia ≤100 ng/ml or ≤300 when tsat was ≤30% exclusion criteria: * previous participation in a fcm trial * known hypersensitivity reaction to fcm * requires dialysis for treatment of chronic kidney disease * current anemia not attributed to iron deficiency * received iv iron, rbc transfusion(s), or antibiotics 10 days prior and during the screening phase * anticipated need for surgery requiring general anesthesia 30 days prior to screening or during the study period * ast of alt greater than 1.5 times the upper limit of normal * received an investigational drug within 30 days of screening * pregnant or sexually-active females who are not able to use an effective form of birth control
adjuvant radiotherapy for stage ii/iii thymoma after complete resection

Conditions: Thymoma

Summary: this study is designed to investigate whether adjuvant radiotherapy after complete resection has a better survival for stage ii or iii thymoma.

it is confirmed by many studies that patients of thymoma with complete resection have better prognosis than those with either incomplete resection or without surgery. however,whether patients with stage ii or iii thymoma could benefit from adjuvant radiotherapy after complete resection remains controversial. the purpose of this study is to investigate whether adjuvant radiotherapy after complete resection can improve survival for stage ii or iii thymoma.

Eligibility criteria:
inclusion criteria: 18\~75 years old; eastern cooperative oncology group performance status of 0 to 2; pathologically confirmed masaoka stage ii or iii thymoma; have adequate bone marrow, hepatic, and renal function; patients receive complete resection within 3 months; written informed consent. exclusion criteria: patients with distant metastases; patients underwent radiotherapy or chemotherapy; patients who have malignancy history excluding carcinoma in situ of cervix in the previous five years; active clinical pulmonary infection; pregnant or nursing.

Keywords: thymoma adjuvant radiotherapy complete resection
impact of a sensory rehabilitation program on olfactory-gustatory alterations in patients treated with chemotherapy for haematological cancer

Conditions: Multiple Myeloma; Olfactivo-gustatory Disorder; Lymphoma; Haematological Cancer

Summary: proposition of a sensory rehabilitation program that could reduce the olfactory-gustatory alterations in patients who have been treated with chemotherapy for haematological cancer, and also improve their life quality, psychological well-being, and nutrition.

disturbances in taste and smell affect a considerable proportion of patients treated with chemotherapy. in hematology, dysgeusia depends on the type pathology and the treatments themselves. it impacts the quality of life, leads to significant emotional and social consequences, affects the intake, weight and nutritional status of patients. olfactory-taste disorders can be assessed using subjective and objective tests. there are no international clinical recommendations for the management of taste and olfactory disturbances associated with chemotherapy in hematological cancers. also, this study proposes to evaluate a taste and olfaction rehabilitation program based on national standards and recent research. it will help fill gaps in the assessment and management of patients treated for haematological cancer. hypothesis is that this sensory rehabilitation program should make it possible to reduce the olfactory-gustatory changes in patients who have been treated with chemotherapy for haematological cancer and significantly improve their quality of life, their psychological well-being and their nutrition.

Eligibility criteria:
inclusion criteria: * age between 18 and ≤ 75 years old * patient with olfactory or gustatory disorders * patient who has completed chemotherapy for haematological cancer exclusion criteria: * eating disorder known prior to anti-cancer treatment, bulimic, anorexic or binge eating disorder (dsm-v criteria) * refusal to sign the free and informed consent * hypersensitivity to one of the components of liposomal sprays (liposaliva® or liponasal®) * covid + patient in the previous 3 months * performance status ecog 3 or 4 * patient included in another clinical trial modifying taste / olfaction * artificial nutrition post-chemotherapy * known food allergies * having a reading level in french that may interfere with a good understanding of the protocol and the questionnaires * presenting visual or hearing deficits uncorrected to normal and which may affect the proper completion of the questionnaires * patient under curatorship or tutorship. * patient deprived of liberty * pregnant or breastfeeding patient * not be affiliated with a french social security scheme or beneficiary of such a scheme

Keywords: sensory rehabilitation autograft autologous stem cell transplantation multiple myeloma chemotherapy taste, smell quality of life nutrition lymphoma
sema4c as a relapse biomarker in breast cancer

Conditions: Breast Cancer

Summary: breast cancer remains the most common cancer in women worldwide. semaphorin4c (sema4c) has previously been identified as a highly expressed protein by breast cancer-associated lymphatic endothelial cells (lecs). the objective of this study is to investigate sema4c's potential role as an early relapse biomarker in breast cancer.

breast cancer remains the most common cancer in women worldwide, with approximately 1.68 million new cases, and 0.52 million deaths, annually. meanwhile the incidence of breast cancer continues to increase. although regular clinical examination, mammography, ultrasonography, and magnetic resonance imaging can detect some recurrence patients, the lack of robust biomarkers for monitoring of anti-tumor therapies and detection of recurrence reduce the treatment effectiveness of current strategies for breast cancer. semaphorin4c (sema4c) has been previously identified as a highly expressed protein by breast cancer-associated lymphatic endothelial cells (lecs) using in situ laser capture microdissection of lymphatic vessels, followed by cdna microarray analysis. moreover, membrane-bound sema4c is cleaved by matrix metalloproteinase (mmps) to release a soluble form of this protein. the study is undertaken to explore sema4c's potential role as an early relapse biomarker in breast cancer.

Eligibility criteria:
inclusion criteria: * have histologically confirmed new diagnosis of breast cancer according to biopsy or surgery exclusion criteria: * patients who are not mentally capable of giving written informed consent * serum samples doesn't qualified * patients who refuse follow-up on their conditions * patients with prior cancer history * patients with a diagnosis of other severe acute or chronic medical may increase the risk associated with study participation or may interfere with the interpretation of the study results and, in the judgement of the investigator, would make the patient inappropriate for enrollment in this study