Kornimate/medical-research-clean huggingface dataset:
rituximab in treating patients with hodgkin's lymphoma

Conditions: Lymphoma; Hodgkin Lymphoma (Category); Nodular Lymphocyte Predominant Hodgkin Lymphoma

Summary: phase 2 trial to study the effectiveness of rituximab in treating patients who have lymphocyte-predominant hodgkin's lymphoma.

this study will evaluate the partial, complete, and overall response rates to rituximab of subjects with lymphocyte-predominant hodgkin's lymphoma. subjects will receive rituximab by iv infusion over several hours once a week for 4 weeks, followed by maintenance therapy as repeat course of the same dose and schedule rituximab at 6, 12, and 18 months. this was a single-arm study with multiple treatment periods added by amendment (ie, secondary group), with results reported by treatment period. as this was always considered a single-arm study, there was no intent to report the results for the initial treatment period separately as the initial group vs the secondary group.

Eligibility criteria:
inclusion criteria * age ≥ 3 years * lymphocyte-predominant hodgkin's disease (lphd) of b-cell lineage * biopsy-confirmed expression of cd20 antigen * at least one tumor mass measuring \> 1.0 cm in largest dimension * no evidence of active infection * subjects at high risk of hepatitis b virus (hbv) infection should be screened prior to enrollment. * performance status of 0 to 2 * absolute neutrophil count (anc) \> 1500/ml * platelet count \> 50,000/ml * serum creatinine (cr) \< 1.5 x upper limit of normal (uln) * alkaline phosphatase \< 2 x uln, unless related to primary disease * bilirubin \< 2 x uln, unless related to primary disease * aspartate transaminase (ast) and alanine transaminase (alt) \< 2 x uln, unless related to primary disease * subjects must be able to read and sign institutional review board-approved informed consent exclusion criteria * life expectancy at least 12 weeks * evidence of other active malignancies other than cured carcinomas in situ of the cervix or basal cell carcinoma of the skin * active hbv infection or hepatitis. * serious non-malignant disease (eg, congestive heart failure, or active uncontrolled bacterial, viral, or fungal infections) * concomitant or treatment within prior 4 weeks with radiotherapy or chemotherapy (within prior 6 weeks for nitrosourea compounds) * concurrent treatment with prednisone or other systemic steroid medication * treatment with any investigational drug within 30 days prior to entry into the study * treatment with any investigational drug within 5 half-lives of that drug prior to entry into the study * major surgery, other than diagnostic surgery, within 4 weeks * any other conditions which, in the opinion of the investigator and/or sponsor, would compromise other protocol objectives * female patients must be of non-childbearing potential or using adequate contraception with a negative pregnancy test at study entry
study of safety and efficacy of a basiliximab, mycophenolate mofetil, cyclosporine microemulsion and prednisone combination treatment regimen in pediatric renal allograft recipients

Conditions: Pediatric Kidney Transplantation

Summary: the aim of this study is assess the safety and efficacy of the treatment regimen of basiliximab ,cyclosporine microemulsion, mmf, and prednisone combined compared to cyclosporine microemulsion, mmf and prednisone in the time to first biopsy proven acute rejection episode or treatment failure during the first 6 months post-transplantation in pediatric renal allograft recipients.


Eligibility criteria:
inclusion criteria: * patients who are recipients of primary or secondary renal allograft. * patients who are single-organ recipients (kidney only). exclusion criteria: •patients who are recipients of hla-identical renal transplants. patients whose donor kidney cold ischemia time (cit) is greater than 36 hours. patients whose transplant kidney is obtained from a non-heart beating donor other protocol-defined exclusion criteria may apply.

Keywords: pediatric, kidney transplantation, basiliximab
gemcitabine and capecitabine in patients with advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to test the effectiveness and safety of the drug combination of gemcitabine and capecitabine (xeloda) in patients with advanced pancreatic cancer.


Eligibility criteria:
inclusion criteria: * metastatic or unresectable pancreatic cancer * no prior chemotherapy except radiation-sensitizing doses of 5-fu * no radiotherapy less than 4 weeks prior to the start of the study exclusion criteria: * prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fu * moderate to severe renal impairment * uncontrolled diabetes * inability to swallow tablets
study of bemnifosbuvir/ruzasvir as a fixed-dose combination in subjects with normal or severely impaired renal or hepatic function

Conditions: Healthy Volunteer Study; Hepatic Impairment; Renal Impairment

Summary: to assess the effect of severe hepatic or renal impairment on the pharmacokinetics of bemnifosbuvir/ruzasvir after a single dose


Eligibility criteria:
inclusion criteria: * must agree to use two methods of birth control from screening through 90 days after administration of the last dose of study drug * females must have a negative pregnancy test at screening and prior to dosing * bmi of 18.5 to 43.0 kg/m2 * willing to comply with the study requirements and to provide written informed consent renal impaired subjects (group 1): * considered stable in the judgement of an investigator * presence of severe renal impairment or kidney failure (as defined by egfr\< 30 ml/ min) hepatic impaired subjects (group 2): * considered stable for at least 1 month prior to screening, as per the judgement of an investigator * presence of severe hepatic impairment (child-pugh class c: score of 10 to 15). subjects with normal hepatic and renal function (group 3): * medically healthy, in the opinion of an investigator * must match by gender, age (± 10 years), and bmi (within 20%) to the pooled mean values of subjects with severe renal and hepatic impairment exclusion criteria: * pregnant or breastfeeding * infected with hepatitis b virus, hepatitis c virus or hiv * abuse of alcohol or drugs * use of other investigational drugs within 28 days of dosing * other clinically significant medical conditions or laboratory abnormalities renal and hepatic impaired subjects (group 1 and 2): * presence of poorly controlled type 1 or type 2 diabetes as defined by hemoglobin a1c \> 10% * undergoing any method of dialysis * subjects requiring treatment for hepatic impairment or other chronic disease must be on a stable treatment plan renal impaired subjects (group 1): * history of renal transplant * concurrent use of medications known to affect the elimination of serum creatinine hepatic impaired subjects (group 2): * history of liver transplant * evidence of hepatic carcinoma presence at screening
genetic testing decision aid

Conditions: Epithelial Ovarian Carcinoma; Pancreas Adenocarcinoma

Summary: this is a randomized trial to evaluate the effectiveness of an electronic decision aid tool versus a traditional genetic counselor session for multi-gene panel testing for people with ovarian or pancreatic cancer

the research study procedures include: screening for eligibility and study questionnaires that would be performed in conjunction with either the genetic counselor visit or use of the electronic decision aid. the study questionnaires include: * knowledge survey * shared decision making process survey * decisional conflict scale the research study will last up to 2 weeks. it is expected that about 350 people will take part in this research study. the national cancer institute (nci) is supporting this research study by providing funding for the research

Eligibility criteria:
inclusion criteria: * 18 years or older * being seen in clinic at massachusetts general hospital or boston medical center * diagnosed with malignant epithelial ovarian carcinoma or malignant pancreatic adenocarcinoma. exclusion criteria : * unable or unwilling to provide informed consent, undergo randomization, or complete the surveys associated with the study * previous germline genetic testing * history of hereditary pancreatitis * members of the following vulnerable populations: adults unable to consent, individuals who are not yet adults

Keywords: pancreas adenocarcinoma. epithelial ovarian carcinoma decision aid inherited cancer syndrome genetic testing
a research study looking at how semaglutide works in people with type 2 diabetes in france, as part of local clinical practice (sure france)

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to collect information on how semaglutide works in real world patients. participants will get semaglutide prescribed by their study doctor. the study will last for about 6 to 8 months. the participants will be asked to complete some questionnaires about their health and their diabetes treatment. participants will complete these during their normally scheduled visits with their study doctor.


Eligibility criteria:
inclusion criteria: * signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol) * the decision to initiate treatment with commercially available semaglutide has been made by the patient/legally acceptable representative and the treating physician before and independently from the decision to include the patient in this study * male or female, age greater than or equal to 18 years at the time of signing informed consent * diagnosed with type 2 diabetes at least 12 weeks prior to inclusion * available and documented haemoglobin a1c (hba1c) value less than or equal to 12 weeks prior to initiation of semaglutide treatment exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * treatment with any investigational drug within 90 days prior to enrolment into the study * hypersensitivity to semaglutide or to any of the excipients
evaluate the safety and efficacy of a 5-ht4 agonist in chronic constipation (accord trial)

Conditions: Chronic Constipation

Summary: study 0038 compares the safety and effectiveness of an investigational drug, td-5108 with placebo (a sugar pill) for the treatment of chronic constipation.


Eligibility criteria:
inclusion criteria: * meet rome iii criteria exclusion criteria: * constipation caused by:colonic etiology, pelvic floor dysfunction, metabolic disturbances, neurologic disturbances,concomitant medications affecting bowel function * chronic treatment with anticholinergics, narcotic analgesics * irritable bowel syndrome

Keywords: constipation chronic bowel function
determinants of adherence to post-stroke/transient ischemic attack secondary prevention treatment: cohort study in the rhône

Conditions: Stroke; Transient Ischemic Attack

Summary: the effectiveness of emergency management of acute ischemic stroke has improved considerably in recent years with thrombolysis and more recently thrombectomy. this improvement is accompanied by an increase in the number of stroke survivors. one of the major issues for these ever-increasing survivors is the prevention of recurrence. according to data from the 3 french registries, more than 20% of patients have at least one recurrence. secondary prevention treatment has demonstrated his efficacy to prevent stroke recurrence. this evolution justifies identifying factors associated with adherence to secondary prevention treatment, measured at 1 year post-stroke / transient ischemic attack (tia), in patients included in the stroke 69 cohort.


Eligibility criteria:
inclusion criteria: * consecutive patients treated for a stroke suspicion at the acute phase, * with symptom onset (the last time the patient was seen without deficit ) less than 24 hours, * managed by the rhône's emergency medical help service (samu), in one of the emergency unit or stroke unit of the rhône area * having given their written consent for the extraction of their healthcare consumption data from the health insurance databases exclusion criteria: * hemorrhagic stroke, * patient institutionalized in the year following the stroke / transient ischemic attack, * patient unable to take treatment alone.
treatment of subclinical hyperthyroidism

Conditions: Subclinical Hyperthyroidism; Atrial Fibrillation

Summary: objective: to determine if the treatment of subclinical hyperthyroidism will reduce the rate of atrial fibrillation, the main complication of this condition.

randomized open-labelled multicentre study comparing radioiodine vs medical supervision without treatment

Eligibility criteria:
inclusion criteria: * men and women aged 50 and greater * isolated decreased thyroid-stimulating hormone (tsh) with normal ft4 and ft3 levels exclusion criteria: * iodide overload * non sinusal heart rhythm * severe heart disease

Keywords: hyperthyroidism atrial fibrillation quality of life radioiodine treatment
a study on radiation therapy guided by the reflectance confocal microscopy (rcm)/optical coherence tomography (oct) device in people with basal cell carcinoma

Conditions: Basal Cell Carcinoma

Summary: the purpose of this study is to find out if radiation therapy (rt) guided by the new reflectance confocal microscopy (rcm)/optical coherence tomography (oct) device is an effective treatment for basal cell carcinoma (bcc). the researchers will also look at the side effects from rt guided by the rcm/oct device. in addition, will determine the quality of life before and after treatment by having the participant fill out questionnaires.


Eligibility criteria:
inclusion criteria: * biopsy proven basal cell carcinoma °up to 3 tumors per patient can be treated per protocol synchronously or metachronously * clinical stage t1 or t2 by union international to control cancer 8th edition system * ≤40 mm in maximum dimension * no deep invasion (beyond subcutaneous fat or \>6 mm from granular later of dermis to deepest point of carcinoma) * no perineural invasion of nerves ≥0.1 mm diameter or deeper than dermis * no intraneural invasion * no bone erosion, invasion or foraminal transgression note: for the purposes of protocol inclusion, if any of the features mentioned above is not included in the pathology report they will considered absent. * ≥18 years old * amenable to rcm/oct and radiation therapy in opinion of investigator * some anatomic locations may preclude imaging by rcm/oct may not be amenable to rcm/oct imaging * some medical comorbidities may preclude the delivery of radiation therapy (conditions rendering patients hypersensitive to ionizing radiation, or unable to undergo treatment) * able and willing to complete the skindex 16 and skin cancer index (must be able to understand english or spanish) exclusion criteria: * medical contraindication to radiation therapy in the opinion of the investigator * prior cancer radiotherapy which precludes the ability to safely deliver radiation therapy in the opinion of the investigator * high likelihood of protocol non-compliance in the opinion of the investigator °patients who demonstrate unwillingness to undergo protocol-defined treatment or follow-up procedures will be ineligible to participate

Keywords: radiation therapy reflectance confocal microscopy (rcm)/optical coherence tomography (oct) 20-553
retrospective study to capture dosing and treatment outcome data in participants with severe congenital protein c deficiency who were treated with protein c concentrate under an emergency use ind

Conditions: Protein C Deficiency

Summary: this is a data collection study with the purpose of capturing dosing and treatment outcome data in participants with severe congenital protein c deficiency who were treated with protein c concentrate under an emergency use investigational new drug application (ind).


Eligibility criteria:
inclusion criteria: * participant treated with protein c concentrate under a baxter healthcare corporation emergency use ind. * participant with diagnosis of severe congenital protein c deficiency. * participant or parent/legally authorized representative has provided written informed consent.

Keywords: severe congenital protein c deficiency
seneca: first line metastatic pancreatic cancer primary and distant (if oligometastatic) lesion directed radiotherapy

Conditions: Radiation Therapy; SBRT; Pancreatic Cancer Metastatic

Summary: thisi is an interventional drug-free randomized 1:1 open-label, multicenter, phase 3 trial in patients with first-line metastatic pancreatic cancer. the interventional group of patients will undergo radiotherapy on the primary lesion and sbrt on distal metastatic sites before receiving standard systemic therapy (chemotherapy), while the other group of patients will receive only standard systemic therapy (chemotherapy) without undergoing radiotherapy.


Eligibility criteria:
inclusion criteria: * patients diagnosed with pancreatic cancer, metastatic, candidate for first-line treatment standard systemic; either newly diagnosed in metastatic stage or first progression to metastasis. * obtaining informed consent * patients \>18 years of age * ecog 0-2 * performance of imaging (ct with mdc, mri with mdc, ct-pet with appropriate tracer) adequate for baseline local and systemic staging and likely to be similarly repeatable at 6 and 12 months after randomization * confirmation at the time of randomization, by the radiotherapy center, that it is possible to perform all treatments potentially planned for the patient (if enrolled in experimental arm) within a maximum of 25 total days prior to referral to the medical oncology center for systemic therapy exclusion criteria: * metastatic picture of line subsequent to the first * technical or organizational impracticality to the eventual termination of radiation treatments within 25 days after randomization * inability to express independent consent to treatments * pregnancy * patient in hospice or with prognosis \< 6 months * predicted unavailability for follow-up at 6 months * absence of adequate or likely non-repeatable pretreatment imaging study at 6 and 12 months * previous radiation therapy * previous radiometabolic therapy * inability to maintain treatment position for sbrt * symptomatic emergent or other presentation precluding study development as planned (e.g., epidural compression of the spinal cord or cauda equina) * previous chemotherapy, immunotherapy or target therapy
pragmatic research of acupuncture and counseling extended to inpatient services

Conditions: Malignant Solid Tumor; Pain

Summary: despite improved assessment and pharmacologic management, cancer pain is still undertreated. using non-pharmacologic treatments alongside medications may better address patients' total pain experience by relieving physical and psychological symptoms and reducing the adverse effects of drugs. however, our knowledge of the benefits of multidisciplinary approaches in real-world hospital settings is limited. patients want to know "how can i get the most pain relief with the fewest side effects?" this study proposal is designed to address this question by testing how combining pharmacologic and non-pharmacologic (acupuncture and pain counseling) treatments can: (1) maximize effectiveness, (2) minimize harms, and (3) align with patients' preferences.

this study compares clinically-relevant therapeutic options in two high-volume hospitals (one public, one university) to address the core research question of whether non-pharmacologic approaches improve symptom management among diverse inpatients. study investigators will assess the effectiveness of acupuncture and of pain counseling independently and in combination. participants will be randomized to two factors each with two levels, yielding four experimental conditions: (1) standard pharmacologic pain management, (2) pharmacologic pain management + acupuncture, (3) pharmacologic pain management + pain counseling, (4) pharmacologic pain management + acupuncture + pain counseling. patient outcomes will be assessed using a mixed-methods approach, with validated scales for quantitative measures and qualitative interviews to elicit stakeholder perspectives (patients, caregivers, providers). the study will be conducted as a pragmatic clinical trial at two hospitals to address these aims: 1. determine the effectiveness of adjunctive acupuncture and of pain counseling for improving pain management. 2. determine the extent that adjunctive acupuncture and pain counseling reduce use of opioid analgesics and side effects. 3. examine stakeholder perspectives on non-pharmacologic approaches to pain management.

Eligibility criteria:
inclusion criteria: 1. patients admitted to university of california san francisco (ucsf) or zuckerberg san francisco general (zsfg) with a malignant solid tumor 2. speak cantonese, english, or spanish 3. have an anticipated stay of ≥ 48 hours 4. be aged 21 or older 5. have pain intensity of ≥ 4 out of 10 for worst pain in the prior 24 hours when enrolled exclusion criteria: 1. acupuncture contraindication 2. unstable medical condition (e.g., severe pulmonary disease, myocardial infarction) 3. admission to the psychiatric ward (e.g., for severe depression) 4. inability to consent (e.g., cognitive impairment) 5. prior involvement with the study (e.g., readmissions) 6. platelets \< 50,000 microliters 7. absolute neutrophil count \< 500 microliters 8. c. difficile infection

Keywords: cancer inpatient non-pharmacologic approaches pain management acupuncture pain counseling