Kornimate/medical-research-clean huggingface dataset:
dolastatin 10 in treating patients with advanced kidney cancer

Conditions: Kidney Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of dolastatin 10 in treating patients with advanced kidney cancer.

objectives: i. evaluate the response rate to dolastatin 10 in patients with advanced renal cell carcinoma. ii. describe the toxicities of this regimen in this patient population. iii. assess the development of peripheral neuropathy in this patient population using this regimen. iv. assess a limited sampling of pharmacokinetics and correlate with toxicity in these patients. outline: patients receive dolastatin 10 iv every 3 weeks. treatment continues for at least 4 courses in the absence of disease progression or unacceptable toxicity. patients with documented complete response receive an additional 2 courses, and may receive retreatment at the time of progression at the discretion of the investigator. patients are followed every 3 months for 3 years. projected accrual: a total of 15-30 patients will be accrued for this study over 4-15 months.

Eligibility criteria:
disease characteristics: histologically confirmed renal cell carcinoma considered incurable by surgery and not amenable to radiation therapy with curative intent locally advanced disease or locally recurrent disease or metastatic disease no transitional cell carcinoma measurable disease no cns metastases or carcinomatous meningitis patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: at least 12 weeks hematopoietic: wbc at least 3,500/mm3 absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: ast less than 3 times upper limit of normal (uln) bilirubin normal renal: creatinine less than 1.5 times uln cardiovascular: no new york heart association class iii or iv heart disease metabolic: oral intake at least 1,200 calories per day other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception no uncontrolled infection no known seizure disorder no other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix no other medical or psychiatric condition that would interfere with compliance prior concurrent therapy: biologic therapy: at least 4 weeks since prior biologic therapy no concurrent immunomodulating agents chemotherapy: no prior chemotherapy for renal cell carcinoma no other concurrent cytostatic or cytotoxic therapy endocrine therapy: at least 4 weeks since prior hormonal therapy no concurrent hormonal agents radiotherapy: see disease characteristics at least 3 weeks since prior radiotherapy no prior radiotherapy to greater than 15% of bone marrow no concurrent radiotherapy surgery: see disease characteristics

Keywords: stage iv renal cell cancer recurrent renal cell cancer
donafenib monotherapy for previously treated metastatic gastric cancer

Conditions: Gastric Cancer

Summary: this open-label, one-center, noncomparative, two-stage phase 1b trial assessed the donafenib in advanced gastric cancer.

this open-label, one-center, noncomparative, two-stage phase 1b trial assessed the tyrosine kinase inhibitor donafenib tosilate tablets (400 mg/d,200mg bid) in patients with advanced, inoperable gastric cancer progressing after chemotherapy . the primary endpoint is the safety.the secondary endpoints are tumor response and progression-free survival time.

Eligibility criteria:
inclusion criteria: * all patients provided written, informed consent. * have histological or cytological documentation of gastric adenocarcinoma; * have received currently approved standard therapies and to have disease progression during or within 3 months after the last administration of the last standard therapy or to have stopped standard therapy because of unacceptable toxic effects. * standard therapies include as many of the following as were licensed: a fluoropyrimidine,oxaliplatin,irinotecan, paclitaxel,docetaxel;and trastuzumab for patients who had her-2 positive tumours; * have an eastern cooperative oncology group (ecog) performance status of 0 or 1; * life expectancy of at least 3 months; * have adequate bone-marrow, liver, and renal function at the start of the trial. * prothrombin time international normalized ratio≤1.5； exclusion criteria: * patients with brain metastases. * patients receiving cytotoxic chemotherapy, immunotherapy or hormonal therapy, radiotherapy to site of measurable or evaluable disease within the previous 4 weeks. * patients had evidence of clinically active interstitial lung disease or abnormal blood results by predefined criteria (serum bilirubin \>1.5 times upper limit of reference range, aspartate or alanine aminotransferase\>2.5 times the upper limit of normal if no demonstrable liver disease).

Keywords: donafenib
a study to evaluate and compare alendronate and risedronate on bone mineral density in women with postmenopausal osteoporosis (mk-0217-211)

Conditions: Postmenopausal Osteoporosis

Summary: this study is to evaluate and compare the effects of alendronate and risedronate to treat women with postmenopausal osteoporosis. the primary hypothesis for this study is that in postmenopausal women with osteoporosis, treatment with oral alendronate 70 mg once weekly will produce a mean percent increase from baseline in hip trochanter bone mineral density (bmd) at 12 and 24 months which is greater than that observed with oral risedronate 35 mg once weekly.


Eligibility criteria:
inclusion criteria: * women with postmenopausal osteoporosis exclusion criteria: * bilateral hip replacements * esophageal abnormalities * metabolic bone disease (example - vitamin d deficiency) * medications that would affect the breakdown or build-up of bone turnover
inositol treatment in different type of pcos phenotype

Conditions: Polycystic Ovary Syndrome

Summary: evaluation of the efficacy of inositol treatment in women with pcos in relation to the phenotype (according to the rotterdam criteria)


Eligibility criteria:
inclusion criteria: * women with pcos of any phenotype exclusion criteria: * hormonal treatment (such as contraceptive pill) * use of supplements containing myo-inositol * severe co-morbidities
emergency department, rapid assessment for sexually transmitted infection

Conditions: Infection

Summary: to evaluate if a rapid urine nucleic acid amplification testing (naat) is non-inferior to the traditional swab naat for gonorrhea and chlamydia when performed in the emergency department.

all patients presenting to the emergency department during the study period who are tested for gonorrhea and chlamydia by the traditional swab naat will concurrently have their urine tested for gonorrhea and chlamydia using the cepheid genexpert rapid naat. the result of both tests will be compared to determine if the rapid assay is non-inferior to the current traditional naat. both the traditional and cepheid genexpert rapid naat are fda and cdc approved for evaluation of gonorrhea and chlamydia. however, the cepheid genexpert rapid naat has not been prospectively validated in the emergency department setting. we intend for both the provider obtaining the sample and the technician running the rapid assay sample to be blinded to the result of the traditional naat. the cepheid genexpert rapid naat will not be used in patient care decisions.

Eligibility criteria:
inclusion criteria: * clinical concern for gonorrhea and/or chlamydia infection * concurrent testing for gonorrhea and chlamydia using traditional naat assay exclusion criteria: * age \<18 years

Keywords: sexually transmitted infection gonorrhea chlamydia presumptive therapy
effect of an intervention based on back school in an aquatic environment on non-specific low back pain

Conditions: Low Back Pain; Exercise; Healthy

Summary: a controlled and randomized clinical trial will be conducted, in which scores on dependent variable measures will be compared before and after the intervention, both in the experimental group (eg) (individuals who will attend the in an aquatic program based on the back school) and in the control group (cg) (individuals who will not attend the in an aquatic program based on the back school). the experimental procedure will follow the recommendations of the consort and tidier guidelines. the study protocol will be approved by the research ethics committee of the university of vigo. this study will be conducted under the declaration of helsinki (2013 version). participants will sign a written informed consent after being informed of the benefits and risks of the research. participants in the eg will participate in an aquatic program based on the back school. this program will follow the recommendations of the biopsychosocial model of chronic pain and will be conducted in an aquatic environment. the intervention will be carried out by physiotherapists in a sports centre. the duration of the intervention will be six weeks, with a frequency of two sessions per week, totalling 12 sessions of 45 minutes each. of all the sessions, 10 will have a practical focus and the other two will have a theoretical focus.


Eligibility criteria:
inclusion criteria: * 18-65 years of age. * with non-specific low back pain for at least three months, with pain intensity (30-70 on a vas). exclusion criteria: * history of cancer, spine infection, rheumatologic diseases, history of spine fracture, history of trauma, red flag signs including unwanted weight loss (exceeding 10 percent of the total body weight) in the past six months and fever, history of psychological disease and history of spine surgery, radiculopathy, anatomical and congenital disturbance. * missing more than two back school sessions. * not being able to attend the measurement sessions.
identification of risk patients in emergency medical services

Conditions: Malnutrition; Falling; Cognitive Impairment

Summary: background: inadequate nutrition has been associated with growing risk of falling and impaired ability in elderly patients. falling is a significant threat to the health of the elderly. it is estimated that one third of people over the age of 65 experience at least one falling each year. over 60% of the falls cause serious injury or disability. adequate nutrition increases the muscle strength of the elderly. therefore, determining and managing the nutrition level is important for preventing falling. as far as we know emergency medical services has never before reported being a part of prevention by performing risk identification.

aim: the purpose of the study is to assess whether it is possible to use a simple screening tool to find out the risk of falling, the nutritional status and the level of cognitive functioning activity when the ems faces the elderly over the age of 70 years. in addition, the flow of information between primary care and emergency services and nutritionists is examined. material and method: identification of poor nutrition is carried out in the helsinki university hospital area. all people over the age of 70 requiring ambulance transport will be included in the study for 4 months during 2018. a structured electronic form is used to identify the malnutrition, the level of cognitive functioning activity and the risk of falling. the assessment is performed during the transport. the data is analyzed by the spss statistical program both by descriptive and statistical significance by looking at the methods suitable for the data. conclusion: the information produced by the research aims to develop (a) identifying in the ambulance those patients who are at risk; and (b) activating nursing staff and nutritionists and, by means of these measures, increase the number of patients receiving effective nutrition therapy.

Eligibility criteria:
inclusion criteria: * all people over the age of 70 requiring ambulance transport will be included in the study for 4 months during 2018. exclusion criteria: -

Keywords: ems elderly nutrition falling cognitive functioning
open-label, multi-center protocol to provide qti571 to pah patients who participated in the extension study (a2301e1) in japan

Conditions: Severe Pulmonary Arterial Hypertension

Summary: to provide continued treatment to pulmonary arterial hypertension (pah) patients who are benefitting from treatment with qti571.

this was a multi-center open label study to provide continued supply of qti571 to patients in japan who were treated in the extension study (a2301e1) and were judged by the investigator to benefit from continued qti571 treatment.

Eligibility criteria:
inclusion criteria: * patient is receiving qti571 for the treatment of pulmonary arterial hypertension (pah) and is currectly enrolled in a long-term extension study (cqti571a2301e1) in japan. * patient is currently benifitting form the treatment with qti571 in the opinion of the investigator. exclusion criteria: * patient has been permanently discontinued from qti571 study treatment in the parent study. * concomitant use of oral vitamin k antagonist medication.

Keywords: pulmonary arterial hypertension, qti571, open label study
skeletal metastasis registry

Conditions: Metastatic Bone Tumor

Summary: this is a prospective, observational study designed to contribute data from patients with symptomatic metastatic bone disease treated at sibley memorial hospital and johns hopkins medicine to an international registry hosted by the swedish regional cancer centrum in stockholm, sweden. this protocol supports a worldwide effort to collect and store information from patients treated for symptomatic bone metastases within the international skeletal metastasis registry (ismr)

the registry is designed to update a suite of clinical decision-support tools designed for use when treating patients with metastatic bone disease. the models estimate the likelihood of survival at 1, 3, 6, 12, 18, and 24 months post surgery, which in turn, may be used for surgical decision-making.

Eligibility criteria:
inclusion criteria: * adult patients, age 22 or older * biopsy-proven or clinically-obvious metastatic bone disease * symptomatic bone lesion requiring intervention o including, not limited to, radiotherapy, cryotherapy, radiofrequency ablation, operative fixation, prosthetic replacement, amputation, or any combination of the above.

Keywords: biopsy-proven or clinically-obvious metastatic bone disease
a pilot trial of mindfulness based intervention program for people with intellectual disabilities in a low income setting

Conditions: Intellectual Disability

Summary: the proposed study is a pre-post intervention study to investigate the acceptability and feasibility of a mindfulness based program for people with intellectual disabilities and their caregivers in a low income setting in pakistan.

in pakistan, prevalence of intellectual disability is 19.1/1000 severe intellectual disability and 65/1000 for mild level of intellectual disability. disability not only affects the individual but also the family in general and caretaker specifically. several researches proved that parents of children with disabilities experience number of problems related to parenting stress. there is a dire need to develop feasible, cost-effective, community level interventions, that would augment existing healthcare systems. mindfulness as a relatively new therapeutic strategy, has not been practiced as far as individuals with intellectual disability are concerned. this study aims to explore the feasibility and acceptability of mindfulness-based strategies for individuals with intellectual disability and their care takers in improving their well-being. a sample of 12 participants will be recruited from rehabilitation centers. the study will be conducted in karachi. the group intervention will consist of twelve sessions; approx. 90-minutes per session weekly. therapy logswill be used to measure feasibility and acceptability of the intervention and the full psychological therapies outcome scale - intellectual disabilities (ptos)-id (psychological distress and positive well-being scales) will be used as secondary outcome measure. in addition, the positive well-being section of the ptos-id will also be administered at session 3 and 6 as an interim measure of well-being. baseline assessment will be done following the consent. post assessments will be conducted at the end of intervention (at 3 months).

Eligibility criteria:
inclusion criteria: * age 18 years and above * able to cope with 90 minute session (with 10 minute break) * able to be in a group setting * able to get to the location of the group * able to attend most sessions * all abilities welcome (including individuals who may struggle with language comprehension/expression) * able to attend with a consistent staff member/carer for all sessions. exclusion criteria: * unable to cope with 90 minute session (with 10 minute break) * person struggles with proximity of others or bring in a group setting * if physically unwell (new onset of severe illness) * inconsistent staff team/carers supporting person to sessions * ongoing experience of trauma or symptoms of post-traumatic stress disorder

Keywords: care givers adults intellectual disability mindfulness
single center registration study on her2 expression and clinical pathological characteristics in prostate cancer

Conditions: HER2 Expression and Clinical Pathological Characteristics in Prostate Cancer

Summary: this study is a single center, non-interference, retrospective registration study: her2 testing and disease information collection were conducted on patients diagnosed with prostate cancer and able to obtain tumor tissue in our hospital from january 2018 to july 2023. statistical analysis was conducted on the collected information to analyze the expression of her2 in chinese prostate patients and the correlation between her2 and disease type.

1. to explore the expression of her2 protein in prostate cancer patients admitted to qilu hospital of shandong university, especially the expression rate of her2 protein under different pathological characteristics (age, tnm grade, primary and metastasis), and to explore the correlation between her2 protein expression level, efficacy, and prognosis based on patient clinical information. 2. (1) main purpose analyze the expression of her2 in prostate cancer patients admitted to qilu hospital of shandong university. (2) secondary purpose the expression of her2 protein under different clinical and pathological characteristics (age, tnm grade, primary, and metastasis). 3.main indicators: the expression of her2 in prostate cancer patients. secondary indicators: 1. the correlation between her2 expression (ihc0/1+/2+/3+) and disease characteristics in locally advanced or metastatic prostate cancer patients; 2. the distribution of her2 expression in different ages, different parts, different degrees of differentiation, and different tnm stages; evaluate the expression of primary and metastatic lesions in patients with metastasis

Eligibility criteria:
inclusion criteria: * 1. prostate cancer patients confirmed by histopathology in our hospital from january 2018 to july 2023; 2. men aged ≥ 18 years old; 3. the expected survival time is greater than 12 weeks; 4. the kps functional status score is greater than 60, and the ecog status score is 0-2 points; 5. the subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up. exclusion criteria: - 1. those who have been diagnosed with tumors in other parts, such as lung cancer, liver cancer, stomach cancer, colorectal cancer, breast cancer, etc. (except for cancer in situ or non melanoma skin cancer, or combined tumors with low recurrence probability within a few years); 2. according to the researcher's judgment, there are other patients who are not suitable for inclusion.

Keywords: her2 prostate cancer clinical pathological characteristics
pharmacokinetic study of aerosolized colimycin in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: pharmacokinetics of colimycin will be assessed during 12 hours after administration of 2m ui colimycin either as an aerosol or after iv injection, the administration being separated by 5 to 10 days intervals


Eligibility criteria:
inclusion criteria: * males and females, adults. * suffering from stable cystic fibrosis * colonized by p. aeruginosa * having given informed consent. * able to follow the protocol * having a social insurance exclusion criteria: * renal insufficiency * allergy to colistin or polymixins * myasthenia * recent severe hemoptysis * liver cirrhosis and hepatic insufficiency * hypoalbuminemia * colonization by burkholderia cepaea or stenotrophomonas maltophilin * pregnancy
salt for patients with hepatic cirrhosis

Conditions: Liver Cirrhosis; Liver

Summary: hepatitis b virus (hbv) infection is a very difficult public health problem in the world. patients often experience the trilogy of "hepatitis-cirrhosis-liver cancer". patients with decompensated cirrhosis may develop a variety of complications, such as portal hypertension, hypersplenism, esophageal and gastric variceal bleeding, ascites, spontaneous peritonitis, hepatic encephalopathy, etc. liver transplantation is the only way to cure hepatitis b cirrhosis. however, the shortage of liver donors still severely limits its development. in 2015, line and others proposed a new surgical method, namely resection and partial liver segment 2-3 transplantation with delayed total hepatectomy (rapid). this surgery innovatively combines auxiliary liver transplantation and allps surgery, which can greatly alleviate the problem of liver donor shortage and improve the overall prognosis of the above-mentioned patients. our center has designed the sequential adult left lateral liver transplantation (salt) procedure based on the principles of rapid surgery and the characteristics of patients with cirrhosis. compared with rapid surgery, salt surgery can dynamically monitor and regulate the blood flow of the residual liver and transplanted liver, reducing the risk caused by portal hypertension. this study will evaluate the safety and effectiveness of salt in the treatment of post-hepatitis b cirrhosis.


Eligibility criteria:
inclusion criteria: * ①age 18-75 years old; * have a history of hepatitis b infection; * the imaging results are consistent with the manifestations of liver cirrhosis; * one of the following conditions: meld score 15-40 points, esophageal and gastric variceal bleeding, refractory ascites, recurrent hepatic encephalopathy, hepatorenal syndrome, or hepatopulmonary syndrome; ⑤ps score 0-1 points; ⑥sign the informed consent form. exclusion criteria: * ①severe thrombosis or cavernous degeneration in the portal vein system, and liver transplantation is contraindicated upon evaluation; * hepatic encephalopathy stage iv; * pulmonary arterial hypertension (moderate to high risk, who grade iii-iv) that does not improve after medical treatment or is assessed to have contraindications for surgery; ④special types of anatomical variations; * inability to tolerate surgical anesthesia (such as severe infection, cardiopulmonary insufficiency, cerebrovascular disease, etc.); ⑥severe mental illness; ⑦other reasons that the researcher believes are not suitable for participation.