Kornimate/medical-research-clean huggingface dataset:
intravenous (iv) vitamin c with chemotherapy for cisplatin ineligible bladder cancer patients

Conditions: Bladder Cancer

Summary: bladder cancer is a common disease with high rates of mortality, especially at advanced stages. neo-adjuvant cisplatin-based chemotherapy (nac) followed by radical cystectomy is considered standard of care for patients with muscle invasive disease, as nac improves surgical outcomes in these patients. however, some patients are ineligible for cisplatin-based chemotherapy due to other medical issues. although a combination of carboplatin and gemcitabine has been used with limited success, most patients proceed directly to cystectomy without realizing the potential survival benefit afforded by nac. intravenous ascorbate (vitamin c) administration (ivc) has been shown to improve both carboplatin and gemcitabine-based therapy in other models. this trial will add ivc to gemcitabine/carboplatin chemotherapy to evaluate whether co-treatment will increase therapeutic efficacy.

see protocol

Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status = 0 -- 2 * cisplatin-ineligible, muscle invasive bladder cancer * adequate organ and marrow functions * women of child-bearing potential and men with partners of child-bearing potential must agree to use protocol specified forms of birth control exclusion criteria: * patient simultaneously enrolled in any therapeutic clinical trial * current or anticipated use of other investigational agents while participating in this study * psychiatric illness/social situations that would limit compliance with study requirements * pregnant or breast feeding. there is a potential for congenital abnormalities and for this regimen to harm breast feeding infants * histology of pure adenocarcinoma, pure squamous cell carcinoma, or pure small cell carcinoma in the turbt sample * prior systemic chemotherapy (prior intravesical therapy is allowed) and/ or prior radiation therapy to the urinary bladder * uncontrolled intercurrent illness * current consumption of tobacco products * history of glucose-6-phosphate dehydrogenase (g6pd) deficiency

Keywords: intravenous (iv) ascorbic acid (vitamin c)
plus pink: hhrp+ adaptation for women with hiv under community supervision

Conditions: HIV

Summary: after enrollment, participants will be randomized to either receive the intervention (treatment) from trained health educators or undergo observation as usual (control group). randomization will be stratified by hiv serostatus. a control group is appropriate because participants will still receive services offered through probation and will be offered the intervention after completion of the trial. subjects will be paid, not for participating in the intervention, but for providing research assessments. the newly adapted intervention will be delivered over no more than a 3-month period (it will be shorter if the adaptation process is supportive). baseline assessments will assess the pre-intervention period. the 3-month assessment will be the end-of-intervention effects and the post-intervention assessments will be at 6, 9 and 12 months. hiv prevention knowledge will be assessed based on quizzes used previously for hhrp+; though final quiz content will depend on final selected materials for the intervention. subjects will be followed for 12 months with assessments by trained research assistants.

the aim of this study is to adapt and pilot test the holistic health recovery program for women with and at risk for hiv (hhrp+), a cdc evidence-based secondary hiv prevention intervention, that will serve as a framework to optimize hiv treatment outcomes and reduce hiv-associated risk for women under correctional community supervision. hypotheses 1. it will be feasible to recruit and retain hiv+ and at-risk women under community correctional supervision in the pilot study. 2. using the adapt-itt methods, we will be able to adequately adapt hhrp+ for hiv-infected and at-risk women under community supervision. 3. the adapted intervention will be feasible to implement and acceptable to participants. 4. the adapted intervention will produce higher measureable preliminary effects on hiv-focused treatment outcomes in the intervention group compared with the control group.

Eligibility criteria:
inclusion criteria: * age ≥18 years old * female * have laboratory confirmed hiv or are at-risk for hiv (ever injected drugs, ever engaged in commercial sex work, were incarcerated in prison or jail within the past 2 years, had condomless sex with an hiv+ partner or partner whose hiv status is unknown in the past 90 days, or had a diagnosed sexually transmitted infection in the past 90 days), * and are under or anticipating transfer to probation.are either a) sentenced to probation or on intensive pretrial supervision by a probation officer; b) sentenced to parole; or c) incarcerated in jail or prison in the prior 60 days. potential participants will be excluded exclusion criteria: * unable or unwilling to provide informed consent, * have \<3 months of remaining scheduled supervision term, * or are threatening to staff

Keywords: women hiv prevention criminal justice
palliative care oncology in patients with relapsed, refractory, and high-risk leukemias or mds

Conditions: Leukemia, Acute; AML, Adult; ALL, Adult; Myelodysplastic Syndromes

Summary: the purpose of this study is to estimate the potential benefit of early and continued palliative care (pc) consultation on end of life issues.

participants in this study will be randomized to either an intervention group or a standard of care group. participants in the intervention group will participate in regular visits with a palliative (or supportive) care specialist, while participants in the standard of care group will only see palliative care specialists if the clinician requests a referral. all participants will be asked to complete monthly questionnaires regarding their general well-being. participants have a greater chance of being assigned to the intervention group than to the standard of care group. on average, in every 5 people randomized, 3 will be randomized to the intervention and 2 will be randomized to standard of care.

Eligibility criteria:
inclusion criteria: 1. ability to provide informed consent 2. stated willingness to comply with all study procedures and availability for the duration of the study 3. any of the following: 1. patients with a new diagnosis of aml, all, high risk myelodysplastic syndrome (mds), or high risk chronic myelomonocytic leukemia (cmml) who are age 65 and older. or 2. patients with relapsed aml, all, high risk mds or high risk cmml, ages 18 and older. or 3. patients with refractory aml, all, high risk mds or high risk cmml, ages 18 and older. refractory aml/all will be defined as persistent leukemia despite two or more cycles of induction chemotherapy. refractory mds will be defined according to the 2006 iwg response criteria refractory cmml will be based on the assessment of the treating investigator. exclusion criteria: 1. participants must not have a diagnosis of acute promyelocytic leukemia (apl)
bronchial hyperreactivity during histamine passive exposure

Conditions: Asthma; Bronchial Hyperresponsiveness

Summary: bronchial hyperresponsiveness consists in excessive response to bronchial stimuli.bronchial challenge test is used to confirm/exclude asthma (metacholine or histamine).protection are used to avoid passive exposure of the technicians performing the test, despite the absence of evidence that they could develop a bronchoconstriction even if they suffer from bhr.the purpose of the study is to determine if patients with a high level of bronchial hyperreactivity and exposed passively to histamine during a bronchial challenge, are developing a bronchoconstriction, when placed in the same conditions that the technicians performing these tests.

bronchial hyperresponsiveness (bhr) consists in excessive response to bronchial stimuli.bronchial challenge test is used to confirm/exclude asthma.bhr is also present in other diseases such as allergic rhinitis, chronic obstructive pulmonary disease,heart failure.. thes test is performed with metacholine or histamine with spirometric documented response to incremental doses.protection are used to avoid passive exposure of the technicians performing the test, despite the absence of evidence that they could develop a bronchoconstriction if they suffer from bhr. the purpose of the study is to determine if patients, newly diagnosed with a high level of bronchial hyperreactivity and exposed passively to histamine during a bronchial challenge, are reacting to histamine when placed in the same conditions that the technicians performing these tests.

Eligibility criteria:
inclusion criteria: * adult patients with positive histamine challenge test (first dose) exclusion criteria: * other active respiratory disease

Keywords: asthma bronchial hyperresponsiveness histamine challenge test spirometry
the post-vitrectomy lenstatin™ study

Conditions: Cataract, Nuclear Progressive

Summary: to determine the efficacy of lenstatin™, an over-the-counter nutritional supplement, in inhibiting the progression of nuclear cataract in eyes after pars plana vitrectomy.

background and rationale there are conflicting reports on the effectiveness of nutritional antioxidants in preventing or slowing the growth of age related cataracts, despite extensive laboratory evidence suggesting that oxidative damage to lens epithelial cells is a common underlying etiologic factor in cataractogenesis. one reported review of nine clinical trials involving over 117,000 patients suggested that beta-carotene, vitamin e, and vitamin c had no effect in preventing or slowing the progression of age-related cataract. conversely, a randomized trial of over 14,000 us male physicians indicated that long-term daily multivitamin use modestly and significantly decreased the risk of cataract. cataract formation following pars plana vitrectomy is a well recognized post-operative complication of the procedure, with the reported incidence of clinically significant cataract development as high as 80% within 2 years after pars plana vitrectomy. investigational agent lenstatin™ is a proprietary formulated nutritional supplement containing 11 micronutrients and anti-oxidants intended to be taken for the nutritional support of the human crystalline lens. intervention participants will be randomized to treatment with lenstatin or placebo for (6) months following pars plana vitrectomy. study methods participants will have baseline nuclear density (cataract) measurements using the pentacam nucleus staging (pns) program. the pentacam scheimpflug imaging system is a non-contact and non-invasive anterior segment imaging device which has been shown to provide an immediate, quantitative, examiner-independent measurement of lens density which correlates with the locs iii cataract grade. serial pentacam nuclear density measurements will be taken on each participant at (1) month intervals for (6) months.

Eligibility criteria:
inclusion criteria: * adults over the age of 18 * post pars plana vitrectomy surgery exclusion criteria: * pediatric patients under the age of 18 * pregnant women * hypersensitivity to any of the ingredients in lenstatin

Keywords: cataract nutritional supplement
cosmetic appeal, hrqol and effectiveness of simple and pseudotesticular techniques of orchidectomy in prostate cancer

Conditions: Prostate Cancer; Quality of Life; Orchiectomy

Summary: the therapeutic efficacy of three types of orchidectomy was ascertained as well as the qol and scrotal cosmetic satisfaction of patients in the three surgical arms. two of these surgeries produced a pseudotesticle (bsco, beso) while one (bso) did not.

patients with prostate cancer (pca) were grouped into three surgical arms: bso (bilateral simple orchidectomy), bsco (bilateral subcapsular orchidectomy) and beso (bilateral epididymal-sparing orchidectomy). preoperatively, baseline serum testosterone, psa, quality of life (qol) and pre-operative testicular volumes were obtained. timed interval sampling for serum testosterone and psa variation was done post-operatively. by three months post-op, the cosmetic appeal of the scrotal appearance, post-operative pseudotesticular volumes and qol were also assessed. the therapeutic efficacy of the surgeries was determined by the rates of decline of serum testosterone and psa, as well as the nadirs achieved. the variations in the pre-and post-operative qol was analysed.

Eligibility criteria:
inclusion criteria: * consecutive consenting patients with histologically confirmed locally advanced or metastatic pca who have accepted to have an orchidectomy exclusion criteria: * patients who have had bilateral orchidectomy * those who opt for medical castration

Keywords: orchidectomy pseudotesticle
ticagrelor and clopidogrel on platelet effects in chinese patients with stable coronary artery disease

Conditions: Platelet Reactivity

Summary: dual antiplatelet therapy (dapt) with aspirin and a p2y12 inhibitor reduces thrombotic events in patients with coronary artery disease, but these benefits come at the expense of increased risk of bleeding when compared with aspirin monotherapy. increased evidence showed that p2y12 inhibitor monotherapy still maintain antiischemic efficacy while reducing the bleeding risk compared with dapt. therefore, the investigators performed this study to observe the efficacy of ticagrelor in comparison to clopidogrel in chinese patients with stable cad.

ticagrelor is a novel, direct-acting, reversibly binding p2y12 receptor antagonist. when related with clopidogrel, ticagrelor exhibits a more potent and more predictable antiplatelet effect with a faster onset and offset of action. current guidelines give a recommendation on the use of dual antiplatelet therapy support ticagrelor 90 mg twice daily over clopidogrel 75 mg daily in addition to aspirin in cad patients. however, increasing evidence showed ticagrelor increased the risk of bleeding. recent studies showed that p2y12 inhibitor monotherapy still maintain antiischemic efficacy while reducing the bleeding risk compared with dapt. so the investigators performed this randomized, single-blind, crossover clinical trial to observe the effects of standard-dose ticagrelor and standard-dose clopidogrel on platelet reactivity in chinese patients with stable cad.

Eligibility criteria:
inclusion criteria:• * aged ≥18 years * subjects had documented with stable cad * women were required to be postmenopausal or surgically sterile * patients were required to discontinue clopidogrel or ticagrelor at least 14 days before randomization * patients were required to discontinue aspirin at least 14 days before randomization. exclusion criteria: * acute coronary syndrome * planned use of glycoprotein iib/iiia receptor inhibitors, adenosine diphosphate (adp) receptor antagonists other than the study medication, or anticoagulant therapy during the study period * platelet count \<10×10\^4/μl * hstory of bleeding tendency * diagnosed as respiratory or circulatory instability * allergy to ticagrelor or clopidogrel

Keywords: ticagrelor clopidogrel coronary artery disease platelet function tests
oncosweep cancer spotlight and spectrum product line

Conditions: Lung Cancer

Summary: conquer cancer study: to collect blood samples from cancer and non-cancer participants for development and validation of the 'oncosweep cancer spotlight and spectrum product line'

oncosweep cancer spotlight and spectrum product lines are qualitative in vitro diagnostic devices testing plasma specimens for detecting circulating mirna expression, ctdna methylation status, platelet rna analysis, and tumor marker expressions by utilizing real-time polymerase chain reaction (qpcr) and next-generation sequencing (ngs). this is a two-arm, open-label, non-randomized controlled pilot study intends to screen adults 18 years or older, who are treatment-naïve for cancers and have pulmonary nodules or mass detected by low-dose computerized tomography (ldct) or standard computerized tomography (ct) scans. oncosweep lung spotlight will be utilized with venous blood samples collected in the healthcare facility where the study is being conducted. the x-ray, ldct/ standard ct scan, blood laboratory test data, or biopsy results will be collected from the control group, and the blood sample will be analyzed by oncosweep lung spotlight. results generated from both groups will be evaluated against each other. the result of oncosweep lung spotlight provides additional evidence to support or assist medical diagnoses when used in combination with ldct/ standard ct scan data.

Eligibility criteria:
inclusion criteria: * inclusion 1. individual who is not mentally impaired, capable to read, understand, and is willing to provide signed and dated informed consent form. 2. individual is aged 18 years old or above. 3. individual who is willing to provide information on the given questionnaire. test group: individual was diagnosed with pulmonary nodules or masses by low-dose ct (ldct)/ ct, and evaluated by the physician needed to conduct a biopsy or/ and surgery has been arranged. control group: individual is willing to undergo ldct or ct scan with 3-5 mm spatial z-axis resolution, pulmonary function examination, x-ray, laboratory blood test, and blood drawing. 4. control group: individual has no abnormal finding from ldct or ct scan with 3-5 mm spatial z-axis resolution and pulmonary function examination(fev1/fvc ratio≧70%). 5. individual did not donate blood or receive blood transfusion within two months before joining the study. exclusion criteria: * exclusion 1. individual who is not suitable for participating as per investigator's judgement. 2. individual who has undergone gene therapy or related product within one year prior to enrolling in this study. 3. individual who is attending another clinical study at the time of enrollment. 4. individual who is known to be pregnant. 5. individual who has received a vaccine within two weeks. 6. individual who has a history of any cancer occurrences other than lung cancer.

Keywords: cancer study
pbmt for the management of cia ( hairlaser )

Conditions: Breast Cancer; Chemotherapy-induced Alopecia; Alopecia

Summary: chemotherapy (ct) remains an important treatment modality for breast cancer patients. unfortunately, this systemic treatment comes with many quality of life impairing complications. chemotherapy-induced alopecia (cia) occurs in about 65% of the patients. hair loss due to ct is reversible, but hair regrowth requires several months to a year after ct. currently, the only available preventive measure is based on scalp cooling. nevertheless, this treatment has a highly variable success rate and it brings along several side effects. photobiomodulation therapy (pbmt) is a new, preventive and therapeutic technique in the supportive care of cancer patients. it uses visible and (near)- infrared light produced by laser diodes or light-emitting diodes (led) at a low power to stimulate tissue repair and reduce inflammation and pain. the investigator's research team demonstrated already that pbmt can prevent oral mucositis and acute radiodermatitis. the aim of this project is to explore the use of pbmt in the management of cia. results of this project will lead to an improvement of the patients' quality of life after ct.


Eligibility criteria:
inclusion criteria: * informed consent as documented by signature. * age 18 years or above * female * use of a wig for at least 2 hours a day * able to read and converse in dutch * skin type i to iv on the fitzpatrick skin type scale * diagnosis of non-invasive (stage 0) or invasive (stage 1, 2 and 3a) breast adenocarcinoma. * treatment with neoadjuvant (preoperative) or adjuvant (postoperative) chemotherapy: anthracycline and taxane containing (paclitaxel or docetaxel) chemotherapy regimen. * diagnosed with cia grade 2 according to common terminology criteria for adverse events (ctcae) * have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis). exclusion criteria: * metastatic disease * severe or unstable cardio- respiratory or musculoskeletal disease * pregnancy * presence of cognitive impairment that might impact study outcomes * previously (before start of chemotherapy) diagnosed with a hair loss condition * receiving scalp cooling during chemotherapy * active infection on the scalp * chronic dermatologic condition (e.g. eczema, psoriasis, infection) * take any of the following medications for 6 months prior to initiation of the study: minoxidil, finasteride (or any other 5α-reductase inhibitor medications), medications with anti-androgenic properties (e.g. cyproterone, spironolactone, ketoconazole, flutamide and bicalutamide)n medications that can potentially cause hypertrichosis (ciclosporin, diazoxide, phenytoin and psoralens), and oral glucocorticoids

Keywords: photomodulation therapy supportive cancer care epirubicin cyclophosphamide
short duration versus standard response-guided therapy with boceprevir combined with pegintron and ribavirin in previously untreated non-cirrhotic asian participants with chronic hcv genotype 1 (mk-3034-107)

Conditions: Hepatitis C, Chronic

Summary: the purpose of this study is to estimate the difference in the efficacy between a 16-week treatment regimen of boceprevir (boc) in combination with peg-intron alpha 2b (p) plus ribavirin (r) (boc + pr) and a 28-week treatment regimen of boc + pr in previously untreated participants with chronic hepatitis c (chc) genotype 1 in asia who achieve undetectable hepatitis c virus ribonucleic acid (hcv rna).


Eligibility criteria:
inclusion criteria: * weigh ≥ 40 kg and ≤ 125 kg * have chc genotype 1 infection * has had a liver biopsy or non-invasive liver fibrosis test that shows no evidence of cirrhosis and hepatocellular carcinoma * must agree that the participant and the participant's partner will each use acceptable methods of contraception for at least 2 weeks prior to day 1 and continue until at least 6 months after last dose of study medication, or longer if dictated by local regulations (for a female participant who is of childbearing potential or male participant with female sexual partner who is of childbearing potential) exclusion criteria: * participates in any other interventional clinical trial within 30 days of the screening visit in this trial or intends to participate in another interventional clinical trial during participation in this trial * is co-infected with human immunodeficiency virus (hiv) or hepatitis b virus * has evidence or history of chronic hepatitis not caused by hcv, including but not limited to nonalcoholic steatohepatitis (nash), drug-induced hepatitis, and autoimmune hepatitis * has evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy * has evidence of hepatocellular carcinoma (hcc) or is under evaluation for hcc * has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years * has been previously treated with an interferon or ribavirin regimen or hcv direct acting anti-viral regimen, or treated for hepatitis c with any investigational medication * taking/plans to take significant inducers of inhibitors of cytochrome p450 3a4 (cyp3a4) substrates 2 weeks prior to start of study medications, or herbal supplements, including but not limited to st. john's wort 2 weeks prior to start of study medications (day 1) * has pre-existing psychiatric condition(s) * has a clinical diagnosis of substance abuse * has any known medical condition that could interfere with the participation in and completion of the trial including immunologically-mediated disease, chronic pulmonary disease, or current or history of any clinically significant cardiac abnormalities/dysfunction * is pregnant or nursing (for female participant) or female partner intends to become pregnant (for male participant)