Kornimate/medical-research-clean huggingface dataset:
a patient decision aid for patients with superficial basal cell carcinoma

Conditions: Superficial Basal Cell Carcinoma

Summary: a patient decision aid (pda) was tested in a population of patients with superficial basal cell carcinoma. this study evaluates whether the use of a pda improved outcomes like decisional conflict and knowledge.

background patients with a superficial basal cell carcinoma (sbcc) can choose between several treatment options with specific advantages and disadvantages. a patient decision aid (pda) might facilitate a personalized decision. objectives this study evaluates whether the use of a pda results in a decreased level of decisional conflict, improved satisfaction with the treatment decision, and increased knowledge on prevention, recognition of bcc, and treatment options. methods a prospective multicentre pre- and post-implementation study was performed amongst patients with a newly diagnosed sbcc comparing a group that did not use the pda (control group) with a group that did (pda group). the primary outcome was the level of decisional conflict measured by the total mean score on the 'decisional conflict scale' (dcs) directly before treatment. higher scores correspond with higher levels of decisional conflict (scale 0-100). knowledge of disease and treatment options was evaluated by using a questionnaire. results questionnaires were completed by 103 patients in the control group and 109 patients in the pda group. the mean total score on the dcs in the control group was 22.78 (sd 14.76) compared to 22.34 (sd 14.54) in the pda group. the adjusted mean difference was -0.39 (95% ci -4.47-3.70, p=0.851). cohen's effect size for the total score on the dcs was 0.03. use of the pda resulted in a significant increase of knowledge on recognition of bcc (p\<0.001) and treatment options for sbcc (p=0.005). according to exploratory subgroup analyses the unadjusted mean difference in dcs score was higher in patients with sbcc in the head and neck area (-4.53, p=0.378), patients without a history of bcc (-3.76, p=0.251), and patients with higher educational level (-4.71, p=0.196). conclusion in the total study population with newly diagnosed sbcc, use of a pda increased knowledge on relevant issues, but had no significant effect on the level of decisional conflict when compared with a control group. exploratory subgroup analyses suggest that specific subgroups of patients may benefit from the use of a pda, but these results need to be verified in larger studies.

Eligibility criteria:
inclusion criteria: * patients older than 18 years * patients with a clinically or histologically confirmed sbcc exclusion criteria: - patients that could not read (dutch)
evaluation of low-dose irinotecan and cyberknife® sbrt to treat colorectal cancer with limited liver metastasis

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine the effects of cyberknife stereotactic body radiotherapy in combination with irinotecan chemotherapy in patients with colon or rectal cancer that has spread to the liver. conventional radiation therapy has a limited role in the treatment of patients with liver metastases because the radiation doses are limited by liver toxicity. the cyberknife system is a type of radiation machine that precisely focuses large doses of x-rays on the tumor, so that injury from radiation to the nearby normal tissue will be minimal. it is approved by the u.s. food and drug administration to treat tumors, lesions and conditions anywhere in the body when radiation therapy is required. while the device is no longer classified as "investigational", the best treatment dose and times are still being evaluated. chemotherapy delivered with radiation therapy can increase the effectiveness of treatment, and may allow for a lower dose of radiation therapy to be utilized, thereby limiting negative side effects. in this study, patients will receive cyberknife radiosurgery directed to liver metastasis for 3-5 treatments, given every other day. irinotecan 40mg/m2 will be administered intravenously daily for 3-5 days (5 treatments within 10 elapsed days), and prior to radiation therapy. patients will have follow-up visits at months 1,2,4,6,9,12,15,18, 24, 30, 36, and every 6 months thereafter for 3 years.


Eligibility criteria:
* age\>18 years * histologically confirmed primary colorectal cancer * stage iv colorectal cancer with \</= 3 metastases, up to 5cm in size. * ct scan or mri of the abdomen with contrast, 60days prior to enrollment * if patient is allergic to contrast, imaging without contrast is acceptable * positron-emission tomography 60 days prior to enrollment * no additional sites of metastasis at the time of protocol enrollment. history of other sites of metastasis that are currently controlled are acceptable. * no malignant ascites * at least 4 weeks from any chemotherapy * no prior liver radiation therapy * ecog performance status 0-1 * life expectancy\>3months * laboratory evaluations completed 60 days prior to treatment including cmp, cbc with differential, liver function test, and prothrombin time.

Keywords: stage iv colorectal carcinoma liver metastasis cyberknife stereotactic body radiotherapy sbrt irinotecan hcl cpt-11
a phase i study of ibi325 in patients with advanced solid tumor

Conditions: Solid Tumor

Summary: the primary objective of this phase i study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (rp2d) of ibi325 combined with sintilimab in patients with advanced solid tumors


Eligibility criteria:
inclusion 1. histologically confirmed, locally advanced unresectable or metastatic tumors. 2. at least one measurable lesion per recist 1.1 3. male or female subject at least 18 years old and no more than 75 years old. 4. eastern cooperative oncology group performance status (ecog ps) performance status 0 or 1. 5. must have adequate organ function 6. be able to provide archived or fresh tumor tissues exclusion 1. any anti-tumor treatment with 4 weeks, except anti-cd73 monoclonal antibody. 2. subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies. 3. unstable central nervous system netastases 4. known active autoimmune disease or inflammatory disease 5. known active infectious disease 6. other uncontrolled systematic disease that may increase the risk of participating the study
immune cell dysfunction in severe alcoholic hepatitis

Conditions: Hepatitis

Summary: through bio-sampling this study investigates the relationship between the frequency and function of the cells of a patients immune system and how these change and impact on the outcome of alcoholic hepatitis. the investigators will examine the role of different cells of the immune system and how they may determine the outcome of this condition. the investigators will also look at how established treatment strategies impact on the frequency and function of these cell subsets.

through bio-sampling this study investigates the relationship between the frequency and function of the cells of a patients immune system and how these change and impact on the outcome of alcoholic hepatitis. the investigators will examine the role of different cells of the immune system and how they may determine the outcome of this condition. the investigators will also look at how established treatment strategies impact on the frequency and function of these cell subsets. alcohol is the most common cause of liver disease in the developed world and results in the death of 2.5 million people annually. it is a causal factor in more than 60 major types of diseases and injuries and approximately 4.5% of the global burden of disease and injury is attributable to alcohol. acute alcoholic hepatitis (aah) is perhaps the most florid form of ald and the leading cause of mortality in these patients is the development of sepsis which occurs in up to 40% of these patients and has a mortality rate of 50%. by gaining a better understanding of the relationship between elements of the immune system and the progression to severe alcoholic hepatitis, it will allow the formulation of more effective treatment strategies for this condition. patients who agree to participate in this study will have an extra 40mls of blood drawn for scientific studies at the same time as routine blood samples are taken as part of their ongoing care.

Eligibility criteria:
inclusion criteria: 1. age 18-65 years 2. patients presented with severe alcoholic hepatitis with a maddrey score (discriminant function) of \>32 (the maddrey score uses various blood results on a patient to define the severity of alcoholic hepatitis e.g.bilirubin etc). 3. ongoing abuse of alcohol (drinking in excess of 28 units/wk) exclusion criteria: 1. co-infection with hiv/hepatitis b / hepatitis c virus infection. 2. patients with autoimmune liver disease. 3. patients with metabolic liver disease. 4. patients with significant psychiatric and/or neurological co-morbidity. 5. hepatocellular carcinoma or other neoplastic disease 6. pregnancy or breast feeding of infants.

Keywords: hepatitis alcohol
phase 3 study of pelabresib (cpi-0610) in myelofibrosis (mf) (manifest-2)

Conditions: Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis

Summary: a phase 3, randomized, blinded study comparing pelabresib (cpi-0610) and ruxolitinib with placebo and ruxolitinib in myelofibrosis (mf) patients that have not been previously treated with janus kinase inhibitors (jaki). pelabresib is a small molecule inhibitor of bromodomain and extra-terminal (bet) proteins.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years * confirmed diagnosis of myelofibrosis (primary, post-polycythemia vera, or post essential thrombocythemia) * adequate hematologic, renal, and hepatic function * have at least 2 symptoms with an average score ≥ 3 or an average total score of ≥ 10 over the 7-day period prior to randomization using the mfsaf v4.0 * prognostic risk-factor score of intermediate-1 or higher per dynamic international prognostic scoring system (dipss) scoring system * spleen volume of ≥ 450 cm\^3 * eastern cooperative oncology group (ecog) performance status ≤ 2 exclusion criteria: * splenectomy or splenic irradiation in the previous 6 months * chronic or active conditions and/or concomitant medication use that would prohibit treatment * had prior treatment with any jaki or bet inhibitor for treatment of a myeloproliferative neoplasm

Keywords: pelabresib ruxolitinib
pilot phase i/ii study of amino acid leucine in treatment of patients with transfusion-dependent diamond blackfan anemia

Conditions: Diamond Blackfan Anemia; Blackfan Diamond Syndrome; DBA; Congenital Hypoplastic Anemia; Pure Red Cell Aplasia

Summary: this study will determine the safety and possibility of giving the amino acid, leucine, in patients with diamond blackfan anemia(dba)who are on dependent on red blood cell transfusions. the leucine is expected to produce a response in patients with dba to the point where red blood cell production is increased. red cell transfusions can then be less frequent or possibly discontinued. the investigators will study the side effects, if any, of giving leucine to dba patients. leucine levels of leucine will be obtained at baseline and during the study. the drug leucine will be provided in capsule form and taken 3 times a day for a total of 9 months.

leucine will be provided to participants in the form of a capsule and will be taken three times daily. blood hemoglobin levels will be monitored every 3-4 weeks for 9 months. the entire study will last 12-15 months in length. subjects must be two years of age or older and on transfusion for more than six months prior to enrollment.

Eligibility criteria:
inclusion criteria: * diagnosed with diamond blackfan anemia as published in british journal of hematology * transfusion dependent * age 2 years and older * adequate renal function * adequate liver function * negative b-hcg if patient is a menstruating female and documentation of adequate contraception * signed informed consent exclusion criteria: * known hypersensitivity to branched chain amino acids * diagnosis of an inborn error of amino acid metabolism disorder * prior hematopoietic stem cell transplantation * pregnancy, or plans to become pregnant during duration of trial

Keywords: leucine administration red blood cell transfusion diamond blackfan anemia
fluorescence laparoscopic navigation for rectal cancer and sigmoid colon cancer

Conditions: Colorectal Neoplasms; Fluorescence; Lymph Node Excision

Summary: to explore the short-term and long-term outcomes of fluorescence laparoscopic navigation d2 lymph node dissection for colorectal cancer surgery by comparing it with d3 lymph node dissection.

lymph node metastasis is the most common metastatic mechanisms for colorectal cancer. therefore, regional lymph node dissection is the key part in radical surgery for colorectal cancer. in patients who have developed lymph node metastases, inadequate lymph node dissection will promote tumor recurrence. in patients who do not develop lymph node metastases, excessive lymph node dissection not only does not improve the patient's prognosis, but also increases surgical trauma and destroys the antitumor effect of the lymphoid immune system. there is still some controversy over whether to choose d3 lymph node dissection or d2 lymph node dissection for rectal and sigmoid cancer. fluorescence laparoscopic navigation techniques can guide lymph node dissection by visualizing lymph nodes more clearly during surgery. this study will compare the short-term and long-term oncological outcomes between fluorescence laparoscopic navigation d2 and d3 lymph node dissection by conducting a randomized controlled trial.

Eligibility criteria:
inclusion criteria: * participants are aged 18-75; * colonoscopy biopsy confirms colorectal adenocarcinoma; * colonoscopy shows that the lower edge of the tumor is located more than 10 cm from the margin or the tumor is located in the upper rectum and sigmoid colon by imaging diagnosis; * the tumor is staged ct1-4anxm0 by preoperative imaging; * participants have no local complications before surgery. exclusion criteria: * previous history of malignant colorectal tumor; * multiple primary colorectal tumors; * preoperative imaging reveals suspicious positive lymph nodes in the submesenteric artery root region (area 253); * patients undergoing neoadjuvant therapy before surgery; * with contraindications to laparoscopic surgery; * histoty of multiple abdominal and pelvic surgery or extensive abdominal adhesions; * other malignancies were diagnosed within the past 5 years; * history of severe mental illness; * pregnant or lactating women; * with uncontrolled infection before surgery.

Keywords: colorectal cancer fluorescence laparoscopic navigation lymph node dissection
study to evaluate the safety, tolerability and pharmacokinetics of single doses of pf-04958242 in healthy volunteers

Conditions: Healthy

Summary: this study aims to assess the safety, tolerability, and pharmacokinetics of pf-04958242 at a number of single ascending doses in healthy volunteers

this study was previously posted by pfizer, inc. sponsorship of the trial was transferred to biogen.

Eligibility criteria:
key inclusion criteria: * healthy female subjects of non-childbearing potential and/or male subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests). * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>55 kg key exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing). * other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. note: other protocol defined inclusion/exclusion criteria may apply

Keywords: single ascending doses pharmacokinetics safety tolerability healthy volunteers cognitive impairment associated with schizophrenia (cias)
a study of arry-614 in patients with low or intermediate-1 risk myelodysplastic syndromes

Conditions: Myelodysplastic Syndromes

Summary: this is a phase 1 study during which patients with low or intermediate-1 risk myelodysplastic syndromes (mds) will receive investigational study drug arry-614. this study has 2 parts. in the first part, patients will receive increasing doses of study drug in order to achieve the highest dose of the study drug possible that will not cause unacceptable side effects. approximately 50 patients from the us will be enrolled in part 1 (completed). in the second part of the study, patients will receive the best dose of study drug determined from the first part of the study and will be followed to see what side effects and effectiveness the study drug has, if any, in treating the cancer. approximately 30 patients from the us will be enrolled in part 2 (completed).


Eligibility criteria:
key inclusion criteria (part 1 and part 2): * diagnosis of mds by bone marrow biopsy. * international prognostic scoring system (ipss) score of low or intermediate-1 risk mds. * may have received prior therapy for mds. * eastern cooperative oncology group (ecog) performance status (ps) of 0, 1 or 2. * adequate liver and renal function. * additional criteria exist. key exclusion criteria (part 1 and part 2): * history of bone marrow transplant. * treatment for mds other than transfusions or a stable dose (≥ 4 weeks) of hematopoietic growth factors on the day of the first dose of study drug. * concomitant malignancies or previous malignancies with less than a 2-year disease-free interval at the time of enrollment. * treatment with an investigational medicinal product that is not expected to be cleared by the first dose of study drug or that has demonstrated to have prolonged side effects. * treatment with azacitidine or decitabine within 2 weeks prior to first dose of study drug. * chronic use (\> 2 weeks) of greater than physiologic doses of corticosteroids (dose equivalent to \> 20 mg/day of prednisone) within 4 weeks prior to first dose of study drug. * treatment with an immunomodulatory agent within 4 weeks prior to the first dose of study drug. * additional criteria exist.
long-term extension from rcc phase ii (11515)

Conditions: Carcinoma, Renal Cell

Summary: extension to study 11515 (nct00661375) which was a multicenter study of sorafenib in patients with renal cell carcinoma (rcc).


Eligibility criteria:
inclusion criteria: patients are classified into two groups as below at transition date from study 11515 to this study. population i: patients who are willing to continue the study drug, for whom the investigator consider continuation of the study drug is appropriate, and who do not meet the criteria of removal from the study in study 11515 at the end of study 11515. population ii: patients who have been monitored only for survival status at the end of study 11515. population 1 1. patients who are willing to continue the study drug, 2. patients for whom the investigator consider continuation of the study drug is appropriate 3. patients who do not meet the criteria of removal from the study in study 11515 at the end of study 11515. 4. patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. population 2 1. patients who give written informed consent prior to any study specific screening procedures with the understanding that the patient has the right to withdraw from the study at any time, without prejudice. exclusion criteria: 1. substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results 2. any condition that could jeopardize the safety of the patient or that affect his/her compliance in the study 3. pregnant or breast-feeding patients. both men and women enrolled in this trial must use adequate birth control.

Keywords: sorafenib nexavar metastatic rcc renal cell carcinoma unresectable rcc
acceptability, gastro intestinal tolerance compliance of a paediatric tube-feed formula derived from food for children

Conditions: Child Nutrition Disorders

Summary: this is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of pediatric formula for the dietary management of participants with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding intolerances, developmental disabilities, disease related malnutrition the acceptability data from 15 participants will be collected in order to submit an application to the advisory committee on borderline substances (acbs).

patients well established and stable on a standard enteral tube feed will be changed to a paediatric formula for a period of seven days. this group will act as their own controls. each child will receive for a period of seven days the paediatric formula, a nutritionally complete standard enteral tube feed. the dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube. a baseline questionnaire will be completed by the dietitian to ensure eligibility of study, current stool patterns or symptoms, current oral intake and weight at the start of the study. the parents will complete a week intake chart to monitor how much feed has been consumed each day and a tolerance diary to review gastrointestinal symptoms at the start and end of the study.

Eligibility criteria:
inclusion criteria * require a tube feed (taking \>75% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition * paediatrics aged 1 year above. * patients well established and stable on a standard or peptide enteral formula (no gastrointestinal intolerances on current formula) * willingly given, written, informed consent from patient or parent/guardian. * willingly given, written assent (if appropriate). exclusion criteria * inability to comply with the study protocol, in the opinion of the investigator * known food allergies to any ingredients (see ingredients list) * patients with significant renal or hepatic impairment * change in current medication or use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file). * participation in another interventional study within 2 weeks of this study