Kornimate/medical-research-clean huggingface dataset:
brain irradiation for childhood cancer - endocrine monitoring during the first years

Conditions: Endocrine; Deficiency; Hypothalamo-Pituitary Disorder; Radiotherapy Side Effect

Summary: biche- 1: brain irradiation for childhood cancer - endocrine monitoring during the first five years is a study of endocrine monitoring after cerebral radiotherapy. the study concerns patients in remission at the end of oncological treatment aged between 4 and 18 years at the time of inclusion and who have had radiotherapy before the age of 16, irradiating all or part of the brain, with a delay between the end of radiotherapy and inclusion of less than 5 years. patients will be included during a routine visit to the paediatric endocrinologist. the protocol for the biche 1 study has been designed and discussed in a multidisciplinary and multicentre manner, based on data from the literature and the french reference document (september 2021) "national protocol for diagnosis and care - congenital pituitary deficiency". in this population, the investigators will conduct a descriptive and exploratory study to establish recommendations for medium-term follow-up; to improve screening for endocrine deficiencies affecting the hypothalamic-pituitary axis in order to improve patients' quality of life and state of health; and to better define dose-volume constraints on the axis. the study will also focus on better detection and characterisation of chronic fatigue as a potential sequela of pituitary deficiencies, in particular by means of a questionnaire assessing fatigue (pedsql multidimensional fatigue scale) which will also be systematically administered and completed annually.the expected sample size is 100-150 patients treated for a brain tumour and 60-80 patients treated for another tumour but with an irradiation field covering all or part of the brain.


Eligibility criteria:
inclusion criteria: * patient aged 4 years or more (≥4) and less than 18 years (\<18) at inclusion * treated with radiotherapy to part or all of the brain for cancer or hematological malignancy before age 16 (≤15) * post-radiotherapy time less than or equal to 5 years (≤5) * in remission of this pathology at the end of oncological treatments, or, with stable residual disease without treatment for 2 years or more (≥2) * signature of informed consent from parents or legal guardian * patient affiliated to the social security system or beneficiary of such a system exclusion criteria: * patients who have relapsed or developed a second cancer with a post-treatment delay of \< 1 year * patient in palliative situation * brain irradiation with dosimetric data showing sparing of the hypothalamic-pituitary axis (dmax hypothalamic-pituitary axis \< 15 gy) * patient with a known hypothalamic-pituitary axis endocrine deficit prior to radiotherapy * refusal of child or parents

Keywords: hypothalamic-pituitary axis deficiency cerebral radiotherapy brain tumours endocrine monitoring follow-up protocol
zoledronic acid-loaded bone cement as a local adjuvant therapy for giant cell bone tumor after intralesional curettage

Conditions: Giant Cell Tumor of Bone

Summary: the purpose of this study is to investigate whether zoledronic acid-loaded bone cement (4mg zol+ gentamicin pmma ) as adjuvant method can decrease local recurrence in patients with giant cell bone tumor following intralesional curettage surgery. the hypothesis is that patients with local administration of zoledronic acid to the bone cement has lower relapse rate compared those with traditional bone cement(gentamicin pmma ).

the purpose of the clinical study is to investigate whether the local delivery of zoledronic acid (4mg zol-loaded gentamicin pmma bone cement) as a surgical adjuvant can decrease the local recurrence rate of giant cell tumor (gct) of bone. the investigators will also evaluate whether patients with zoledronic acid as a surgical adjuvant improves secondary outcomes, including function (msts and tess), surgery related complications (henderson's failure mode) and zol-related complications.

Eligibility criteria:
inclusion criteria: * patients with primary resectable gct of bone * lesion amenable to reconstruction (intralesional curettage) defined as having at least one intact column of bone after removal * no previous systemic bisphosphonate or denosumab therapy * with expected longer than 18 months of survival time * sign the informed consent form exclusion criteria: * patients with recurrent gct or extensive gct which is impossible or inappropriate to use curettage surgery due to its "unresectable" nature. * conduct unexpected surgery at other center * the primary goal for surgery is revision * patient conduct en-bloc/wide resection instead of curettage surgery * patient can not conduct self-assessment during follow up * difficulty in complete postoperative follow-up * previous use of bisphosphonate/zol or denosumab drug * patients have participated in similar research projects * refused to sign informed consent

Keywords: zoledronic acid, intralesional curettage
the effectiveness of mental wellness youth hubs in hong kong

Conditions: Mental Stress

Summary: this study sets out to evaluate (i) whether the model in phase two can improve symptoms, quality of life, functioning, and psychological outcomes in young people utilising the hub services (n = 600) compared to those in the community controls (n = 600), (ii) the mechanisms that may drive these improvements, and (iii) whether any particular subgroup(s) of youths (e.g., gender, socio-economic status, migrant status) may benefit more from this service model. the experiment group will include 600 hub users who are not currently using psychiatric medications and do not have a formal diagnosis at the time of enrolling in the hub activity. the control group will also comprise of 600 young people, recruited from a community cohort managed by the research team. the community cohort is accessible via the youth epidemiological study online platform (yes online), which recruits young people aged 12 to 24 years. only yes online participants who are not using the service of levelmind@jc and psychiatric medications will be recruited for this study. the two groups will be matched in age, gender, and baseline distress level measured by the 6-item kessler psychological distress scale (k6). there will also be a substudy assessing the effect of four service models: nlpra eclinic, integrated community centre for mental wellness (iccmw) step-up care, general practitioners, and hub casework support service on symptom-based mental health outcome, comparing a cohort of young people receiving these four services respectively. a total of 252 participants will be recrruited. another substudy will be conducted to investigate the extent to which participation in tier 1 activities contributes to improvements in targeted outcome areas, assessing young people (n = 675) before and after their participation of tier 1 activities. a consecutive sampling will be used, where a subject who meets the criteria of inclusion will be selected until this required sample size is achieved.


Eligibility criteria:
inclusion criteria: * for hub user group: 12- to 24-year-old hub users who receive community-based mental wellness youth hub services for young people. * for community control group: 12- to 24-year-old community youths who do not receive any youth services in the community. * for eclinic user group: 12- to 24-year-old eclinic service users. exclusion criteria: * youths with known diagnosis of psychiatric disorders (including depression, generalized anxiety disorder, panic disorder, phobia, obsessive compulsive disorder, bipolar disorder, eating disorder, personality disorder, post-traumatic stress disorder and psychotic disorder) * youths who receive psychiatric medication (including antidepressants, antipsychotics and antiepileptic drugs)

Keywords: youth mental health
treatment with lenalidomide, bendamustine and prednisone (rbp) in patients with relapsed or refractory multiple myeloma

Conditions: Multiple Myeloma

Summary: define maximum tolerable dose of the combination lenalidomide, bendamustine, prednisone.


Eligibility criteria:
inclusion criteria: 1. understand and voluntarily sign an informed consent form. 2. age 18 years at the time of signing the informed consent form. 3. life expectancy of at least 3 months 4. able to adhere to the study visit schedule and other protocol requirements 5. relapsed or refractory mm (only first or second relapse) in stage ii or iii after autologous sct or conventional chemotherapy (histologically or cytologically proven/ salmon and durie criteria) with detectable myeloma protein in blood or urine 6. all previous cancer therapies, including radiation, cytostatic therapy and surgery, must have been discontinued at least 4 weeks prior to treatment in this study, without corticosteroids therapy. 7. ecog performance status of £ 2 at study entry (see appendix 01). 8. laboratory test results within ranges 9. females of childbearing potential must agree to contraception or abstinence 10. disease free of prior malignancies for ³ 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast exclusion criteria: 1. any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form. 2. pregnant or breast feeding females. 3. any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study. 4. patients with contraindications (exclusion criteria) for treatment with lenalidomide, bendamustine and prednisone. 5. uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months before study entry, new york heart association class iii or iv heart failure, uncontrolled angina or severe uncontrolled ventricular arrhythmias (≥ lown 3). 6. use of any other experimental drug or therapy within 28 days of baseline. 7. known hypersensitivity to thalidomide or purine analogues 8. the development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs. 9. any prior use of lenalidomide or bendamustine in the last six months 10. concurrent use of other anti-cancer agents or treatments other stated in this treatment plan. 11. known positive for hiv or infectious hepatitis, type a, b or c.

Keywords: lenalidomide bendamustine multiple myeloma myeloma revlimid phase i/ii refractory myeloma relapsed myeloma
prognosis and therapeutic biomarkers for glioblastoma patients

Conditions: Glioblastoma

Summary: the purpose of this study is to investigate if the potential biomarkers identified could be used for facilitating the diagnosis and prognosis of patients with glioblastoma (gbm).

the objective of this proposed study is to determine the expression levels of a panel of markers including cd133, cd44, abcc3, tnfrsf1a, akt1, idh2, and mgmt in gbm tissues and the csf, blood, and saliva from patients with gbm receiving different types of treatment (optune only or optune with tmz) and the non-brain tumor patients (controls). our aims are: 1) to compare the differences of cd44 between the control group and the combined cancer groups at baseline; and 2) to compare the levels of cd44 and other markers among the 3 different groups such as control vs. gbm patients and optune vs. optune + tmz after 8 weeks of treatment. exploratory analysis of all other markers will be performed.

Eligibility criteria:
inclusion criteria: * 22 years old * control group (only patients evaluated for neurological disorders whose evaluation require a lumbar puncture) * non-control group - diagnosed with gbm (glioblastoma) exclusion criteria: * pregnancy * infectious disease to include cold, flu, hiv, etc. * blood disorder (example:low platelets, anemia, thrombosis) * vascular malformations

Keywords: glioblastoma brain tumor
micronutrient supplementation in patients with heart failure

Conditions: Heart Failure

Summary: there is some evidence to suggest that patients with heart failure may have a reduced dietary intake of vitamins and essential minerals (micronutrients) and that this may worsen the function of the heart. this study is designed to investigate if supplementation with micronutrients (including high-dose vitamin d) will improve the function of the heart in patients with heart failure.


Eligibility criteria:
inclusion criteria: * new york heart association class ii and iii * already on or tried on best known medical treatment (ace inhibitor and beta-blocker) * stable for a period of at least 6 weeks * left ventricular ejection fraction less than or equal to 45% exclusion criteria: * history of significant alcohol ingestion (more than 40 units per week) * severe renal dysfunction (gfr less than 30ml/min) * severe hepatic dysfunction (known liver disease or transaminases greater than 3 times the upper limit of normal) * atrial fibrillation (in the absence of a pacemaker) * frequent ventricular ectopics * on waiting list for cardiac transplantation * uncontrolled diabetes mellitus * inability to give informed consent * estimated life span less than 12 months * already taking a multivitamin/mineral supplement * already taking a vitamin-d containing fish oil * woman of child-bearing potential * history of renal stones, hypercalcaemia, sarcoidosis, haemochromatosis or lactose intolerance

Keywords: heart failure micronutrients vitamin d inflammation oxidative stress quality of life physical functioning
efficacy and safety of super-hyperfractionation pulse radiotherapy combined with icis for advanced nsclc

Conditions: Lung Cancer; Immune Checkpoint Inhibitor; Radiotherapy

Summary: investigators intend to combine low-dose hypersensitivity with high-dose immunopotentiation effect, and use super-hyperfractionation pulse radiotherapy, which is expected to achieve the effect of in situ vaccine that can enhance tumor killing, protect normal tissues, reduce immune cell damage and enhance tumor immunogenicity at the same time, and play a stronger immunopotentiation effect in combined immunotherapy. thereby inducing a stronger abscopal effect of radiotherapy.


Eligibility criteria:
inclusion criteria 1. informed consent has been signed and, in the judgment of the investigator, the patient is able to comply with the study protocol and sign a written informed consent. 2. participants diagnosed with stage iiib or above non-small cell lung cancer confirmed by histopathology (whether newly diagnosed or not) meet the requirements of sbrt radiotherapy (mass limited, less than 5 cm) and immune checkpoint inhibitor therapy (according to csco guidelines). 3. age ≥ 18 and less than 75. 4. eastern cooperative oncology group performance status score (ecog ps) 0-3. exclusion criteria 1. the participant's compliance is poor and the test regulations are violated. 2. dysfunction of important organs of liver and kidney, such as myocardial infarction, angina pectoris, and significant increase of liver transaminase. 3. any disease requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to enrollment. 4. serious infection within 4 weeks before enrollment, including but not limited to hospitalization due to infection complications, bacteremia or severe pneumonia. 5. severe chronic or active infections (including tuberculosis infection) requiring systemic (oral or intravenous) antibiotic therapy within 14 days before enrollment. 6. participants with untreated chronic hepatitis b or hbv carriers with hepatitis b virus (hbv) dna ≥ 500 iu/ml, or patients with active hepatitis c virus (hcv) should be excluded. note: inactive hepatitis b, hbsag carriers, treated and stable hepatitis b carriers (hbv dna \< 500 iu/ml), and cured hepatitis c patients can be included in the group. 7. known history of hiv infection. 8. receive any other investigational drug treatment or participate in other clinical trials within 28 days. 9. there are no contraindications to stereotactic radiotherapy and immune checkpoint inhibitors.
lenalidomide in combination with a fixed dose of sorafenib for the treatment of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the combination of revlimid® (lenalidomide) and nexavar® (sorafenib) for the treatment of hepatocellular carcinoma that can't be cured with surgery.


Eligibility criteria:
inclusion criteria: * clinical or pathological diagnosis of unresectable hepatocellular carcinoma (hcc) based on radiologic criteria, elevated alpha fetoprotein and/or tissue biopsy * all previous cancer therapy, including radiation, hormonal therapy and surgery, must have been discontinued at least 28 days prior to treatment in this study * child-pugh liver function class a/b9 * eastern cooperative oncology group (ecog) performance status of \</= 2 at study entry * laboratory test results within protocol-specific ranges * disease free of prior malignancies for \>/= 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast. * all study participants must be registered into the mandatory revassist® program, and be willing and able to comply with the requirements of revassist® (revlimid is only available under a restricted distribution program called "revassist.") * females of childbearing potential must have two negative pregnancy tests before starting lenalidomide and must agree to use two methods of birth control and submit to pregnancy tests throughout the study. * able to take aspirin daily as prophylactic anticoagulation * age \>18 years at the time of signing the informed consent form * life expectancy of at least 30 days exclusion criteria: * no serious medical condition, laboratory abnormality, or psychiatric illness (including no evidence of hepatic encephalopathy) that would prevent the subject from signing the informed consent form * no pregnant or breast feeding females. (lactating females must agree not to breast feed while taking lenalidomide) * no patients who have undergone surgical resection or received chemotherapy, percutaneous ethanol injection, radiation therapy or chemoembolization within 30 days prior to commencement of the study * no condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study * no use of any other experimental drug or therapy within 28 days of baseline * no known hypersensitivity to thalidomide * patients who developed erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs will be excluded * no prior use of lenalidomide * no concurrent use of other anti-cancer agents or treatments * no known positivity for hiv or infectious hepatitis, type b-8/9 or c * no active infection not controlled effectively with antimicrobial or antiviral therapy
diagnostic values of c-reactive protein and procalcitonin in predicting bacterial infection in acute exacerbations of chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease is a serious disease . exacerbations of chronic obstructive pulmonary disease is an acute worsening condition of chronic obstructive pulmonary disease, which always accompanied by clinical symptoms such as, shortness of breath and increased production of sputum. respiratory infection (bacteria or viruses or mixed) is thought to be the main cause in most exacerbations.


Eligibility criteria:
inclusion criteria: - patients admitted to the hospital exclusion criteria: * patients with malignancies * patients with other systemic infection
effect of serial remote ischemic conditioning on dynamic cerebral autoregulation in patients with intravenous thrombolysis (sricdca-ivt)

Conditions: Acute Ischemic Stroke

Summary: the purpose of this study is to determine the effect of serial remote ischemic conditioning on dynamic cerebral autoregulation in patients with intravenous thrombolysis with alteplase.

in this study, cases of ischemic stroke who undergo intravenous thrombolysis with alteplase within 4.5 hours from the onset are included according to the principle of random, and parallel control. the experimental group receive basic treatment and remote ischemic conditioning for 200mmhg, 2 times per day for 7 consecutive days. the control group receive basic treatment and remote ischemic conditioning control for 60mmhg, 2 times per day for 7 consecutive days. both groups underwent dynamic cerebral autoregulation measurements at days 1,3,and 7 of onset and recorded the relevant indexes. we aimed to determine the effect of serial remote ischemic conditioning on dynamic cerebral autoregulation in patients with intravenous thrombolysis with alteplase.

Eligibility criteria:
inclusion criteria: * 1) age≥18 years, regardless of sex; * 2) patients with clinically definite diagnosis of acute ischemic stroke and undergo intravenous thrombolysis with alteplase in 4.5 hours; * 3) baseline mrs 2-5; and premorbid mrs ≤ 1； * 4) baseline nihss\>= 4, and \<= 24; * 5) signed and dated informed consent is obtained; exclusion criteria: * 1) patients who have the contraindication of intravenous thrombolysis with alteplase; * 2) patients with consciousness disorder or restlessness who cannot cooperate with dynamic cerebral autoregulation; * 3) patients whose stable cerebral blood flow velocity envelope cannot be obtained by transcranial doppler ultrasound or whose cerevral blood vessels have not been detected; * 4) the patients who have the contraindication of remote ischemic conditioning treatment, such as severe soft tissue injury, fracture or vascular injury in the upper limb. acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc; * 5) pregnant or lactating women; * 6) previous remote ischemic conditioning therapy or similar treatment; * 7) laboratory indicators are not qualified: alanine transaminase (alt) or glutamic-oxalacetic transaminase (ast) continued to rise more than 3 times the upper limit of normal, serum creatinine \> 265 umol/l (\> 3.0 mg/dl); * 8) previous history of atrial fibrillation or ecg showing atrial fibrillation or arrhythmia; * 9) patients with a life expectancy of less than 3 months or patients unable to complete the study for other reasons; * 10) unwilling to be followed up or treated for poor compliance; * 11) he/she is participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to admission; * 12) other conditions that the researchers think are not suitable for the group.
study of ntbc for tyrosinemia i

Conditions: Tyrosinemia I

Summary: objectives: i. assess the safety and efficacy of ntbc in children with tyrosinemia i. ii. evaluate the effects of ntbc on survival, rate of neurologic crises, improvement in renal tubular damage, reduction in the need for liver transplantation, and reduction in the development of hepatocarcinoma in these patients.

protocol outline: patients are stratified according to age at onset of symptoms (0-2 months vs 2-6 months vs greater than 6 months). patients receive oral ntbc twice a day. treatment continues in the absence of unacceptable toxicity. patients are followed once a month for 6 months, then every 3 months thereafter. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
* confirmed diagnosis of tyrosinemia detected through newborn screening before the onset of symptoms or diagnosed on the basis of symptoms (liver disease, neurological crises, growth failure) and succinylacetone in urine or blood and/or fumarylacetoacetate dehydratase deficiency in cultured fibroblasts or liver biopsy

Keywords: inborn errors of metabolism rare disease tyrosinemia i