Kornimate/medical-research-clean huggingface dataset:
temozolomide in treating patients with leptomeningeal metastases from a solid tumor or lymphoma

Conditions: Brain Tumors; Central Nervous System Tumors; Leptomeningeal Metastases

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of temozolomide in treating patients who have leptomeningeal metastases from a solid tumor or lymphoma.

objectives: * determine the objective response rate, survival time, and quality of life of patients with leptomeningeal metastases from a solid tumor or lymphoma when treated with oral temozolomide. * determine adverse events related to this regimen in this patient population. * measure temozolomide concentrations in csf and serum and correlate with appropriate pharmacodynamic parameters (e.g., response) in these patients. outline: patients receive oral temozolomide daily for 6 weeks. courses repeat every 10 weeks in the absence of unacceptable toxicity or disease progression. patients with a complete response (cr) receive 2 additional courses after achieving cr. patients with a cr except for residual radiographic abnormalities that persist unchanged for 2 full courses continue for 4 courses past best response. quality of life is assessed at baseline, weekly for the first 4 weeks of therapy, and then monthly thereafter. projected accrual: a total of 14-24 patients will be accrued for this study.

Eligibility criteria:
* documented leptomeningeal metastases * carcinomatous meningitis that is previously untreated or failed prior therapy or * lymphomatous meningitis * systemic disease that is responding or stable on current therapy not eligible if discontinuing therapy would be deleterious * age 18 and over * karnofsky performance status 60-100% * life expectancy of at least 6 weeks * absolute neutrophil count greater than 1,500/μl * platelet count greater than 100,000/μl * creatinine no greater than 2.0 mg/dl * no congestive heart failure * no unstable angina * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no contraindication to diagnostic sampling of csf via lumbar puncture or reservoir * no medical conditions that would interfere with absorption of oral medication (e.g., malabsorption, obstruction, or frequent vomiting) * no uncontrolled infection * prior neuroaxis chemotherapy (lumbar puncture, reservoir, or systemic) allowed * no other concurrent chemotherapy for other sites of disease * no prior radiotherapy to areas of measurable meningeal disease unless there is clear radiographic progression in these areas * no prior radiotherapy to greater than 30% of bone marrow * prior radiotherapy to the neuroaxis allowed * no concurrent radiotherapy for other sites of disease or for progressive disease * recovered from any prior recent therapy

Keywords: leptomeningeal metastases temozolomide
portal pressure effects of phlebotomy combined to vasopressin use in cirrhotic patients undergoing liver transplantation

Conditions: Liver Transplantation; Portal Hypertension; Blood Transfusion; Blood Loss, Surgical

Summary: liver transplantation is the standard treatment for chronic advanced liver disease, whether or not associated with a primary liver tumor. the intraoperative bleeding and the need for blood transfusion, encountered in this major surgery are associated with increased morbidity and mortality. however, this hemorrhagic risk has been drastically reduced in the last 20 years and liver transplants without the use of blood products are now possible. indeed, improvements in medical and surgical techniques associated with a better understanding of the pathophysiology of the cirrhotic patient have enabled this advance. one of the targeted therapeutic strategies is the control of portal hypertension. several treatments have been sought, such as the use of splanchnic vasoconstrictors (such as vasopressin) and hypovolemic phlebotomy. these techniques reduce portal pressure and seem to reduce intraoperative bleeding with, even, a protective effect on kidney function. their single-use or their combination is currently used in certain centers of expertise in liver transplantation. however, the hemodynamic effects of the combination of these 2 treatments on portal pressure has never been demonstrated. in this study, the effect of vasopressin, combined with a hypovolemic phlebotomy, on portal pressure in cirrhotic patients undergoing liver transplantation will be evaluated.

methods objectives the primary objective will be to measure the hemodynamic effects of vasopressin on portal pressure in cirrhotic patients who have had a hypovolemic phlebotomy during a liver transplant. the secondary objectives will be to measure the effects of vasopressin on portal pressure in patients who have not had a phlebotomy and to compare this effect between patients who have or have not had a hypovolemic phlebotomy. the tertiary objective will be to assess the effect of the variation in portal pressure under vasopressin, associated or not with a hypovolemic phlebotomy, on hemorrhagic clinical outcomes (intraoperative bleeding and blood transfusions).

Eligibility criteria:
inclusion criteria: * cirrhotic patients undergoing a liver transplantation * 18 years and older * planned use of vasopressin during the surgery exclusion criteria: * fulminant or sub-fulminant hepatitis without underlying chronic liver disease * anesthetic plan does not include the use of vasopressin (contraindication or not relevant according to the anesthesiologist)
pten-akt-foxo3 gene expression relation with low-ovarian reserve in endometriomas

Conditions: Ovarian Reserve, Endometrioma, PTEN-AKT-FOXO3 Gene Expression

Summary: in this study, we aimed to investigate the relationship between pten-akt-foxo3 gene expression and decrease in ovarian reserve in the presence of endometrioma and other benign ovarian pathologies.

it is known that the presence of endometrioma negatively affects ovarian reserve. the development of endometriosis and the effect of the presence of endometrioma on ovarian reserve due to decreased pten expression are considered. this study was designed to compare ovarian pten-akt-foxo3 gene expression and ovarian reserve in patients with underwent surgery caused by endometrioma and those who had ovarian pathology due to other benign causes and pten-akt-foxo3 gene expression level will be evaluated by rt-pcr analysis.

Eligibility criteria:
inclusion criteria: * 1) to be in the range of 18-40 years 2) patients with an operation indication with \>=5 cm endometrioma 3) patients with operation plan due to non-endometrioma ovarian pathologies exclusion criteria: * 1)patients over the age of 40 2)patients with suspected malignancy 3)follow-up patients without indications for operation
a study of shr2554 alone or in combination with shr3680 in the treatment of mcrpc

Conditions: Prostate Cancer; Castration-resistant Prostate Cancer

Summary: the aim of this trial is to study the tolerance, pharmacokinetics (pk) and efficacy of shr2554 alone or in combination with shr3680 in the treatment of patients with metastatic castration resistant prostate cancer.

this is a multicenter, open, non-randomized and dose-escalating and -expansion phase i/ii trial and it studies the tolerance, pk and efficacy of shr2554 alone or in combination with shr3680 in the treatment of patients with metastatic castration resistant prostate cancer. the phase i part is a dose-escalating study including ia (dose-escalation monotherapy) and ib (dose-escalation combination therapy). approximately 18-30 patients in phase ia will only receive one of five dose levels of orally shr2554. approximately 30\~48 patients in phase ib trial will receive shr2554 combined with shr3680, in which 2\~3 different dose levels of shr2554 will be selected based on the result of the phase ia. phase ii part is a dose-expansion study. primary endpoints of the study are dose-limiting tolerance (dlt), maximum-tolerated dose (mtd) and prostate specific antigen (psa) response rate.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed prostate cancer; 2. eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1; 3. radiographic evidence of metastasis; 4. sustained therapy of luteinizing hormone-releasing hormone analogue（lhrha）or received bilateral orchiectomy; patients who did not receive bilateral orchiectomy are willing to receive sustained therapy of lhrha; 5. evidence of prostate cancer progression under the sustained therapy of lhrha or bilateral orchiectomy; 6. adequate hepatic, renal, heart, and hematological functions; 7. patients have given voluntary written informed consent before performance of any study-related procedure not part of normal medical care,with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. exclusion criteria: 1. have received any anti-tumor therapy in the past 4 weeks,including radiotherapy, chemotherapy, operation, targeted therapy, immunotherapy, and endocrinotherapy; 2. planned to initiate any other anti-tumor therapies during the study; 3. unable to swallow, chronic diarrhea and intestinal obstruction, or the presence of a variety of other factors that affect drug use and absorption; 4. clinically significant cardiovascular diseases; 5. history of seizure or certain conditions that may predispose to seizure; 6. severe concurrent disease and infection that, in the judgment of the investigator, would make the patient inappropriate for enrollment.

Keywords: castration-resistant prostate cancer shr2554 shr3680
internet weight control for bingeing adolescents

Conditions: Obesity; Eating Disorders

Summary: the purpose of this study is to determine if an internet-based intervention designed to reduce binge eating and improve healthy weight regulation skills will result in reductions in binge eating and weight loss, or weight maintenance, in overweight adolescents who binge eat.

the purpose of this study is to determine if an internet-based intervention designed to reduce binge eating and improve healthy weight regulation skills will result in reductions in binge eating and weight loss, or weight maintenance, in overweight adolescents who binge eat.

Eligibility criteria:
inclusion criteria: * female and male high school students in hayward unified school district or meridian school district * 85th or greater percentile for age-adjusted weight * objective binge eating one or more times weekly for a duration of ≥ 3 months * access to a computer with internet access * english literacy at a sixth grade reading level exclusion criteria: * current (or history of) diagnosis of anorexia or bulimia nervosa * active suicidal ideation * current enrollment in a formal weight loss or binge eating program (e.g., weight watchers) * any medical condition in which the actual condition or treatment affects weight and/or appetite (i.e., cancer, diabetes)

Keywords: binge eating weight loss obesity
study of inhaling carbon monoxide to treat patients with intestinal paralysis after colon surgery.

Conditions: Ileus

Summary: post operative ileus (poi), a temporary paralysis of the intestines, is a serious health care problem. it normally occurs in all patients after surgery to the abdomen but in some cases can result in serious complications. the objective of this study is to determine if inhaling very low doses of carbon monoxide (co) before and after colon surgery will shorten the duration of normal poi and/or prevent the development of poi complications in patients undergoing colon surgery. a preliminary study will be conducted in six healthy volunteers to monitor for blood levels and adverse effects that occur at 3 different doses of inhaled co to establish a safe dose for patients in the main trial. for the main trial, patients requiring surgery to their colon will be assigned randomly to receive one hour treatments of either co or oxygen by face mask before and after their operation. length of normal poi and occurrence of poi complications will be compared between the two groups. side effects that occur from inhaling co or oxygen will also be recorded. we hypothesize that inhaling co before and after colon surgery will shorten the length of normal poi and decrease the occurrence of poi complications with minimal side effects.


Eligibility criteria:
inclusion criteria: * men and women, age \> 18 years. * women must be using acceptable contraceptives, post-menopausal or surgically sterile. * no prior smoking history. * bmi between 16 and 30 inclusive. * no significant abnormalities on history, physical examination or laboratory parameters. exclusion criteria: * exposure to any carbon monoxide source during the 48 hours prior to the study day or occupational exposure to co. * significant disease or disorder (as explained in study b). * complete bowel obstruction. * intra-abdominal inflammation (diverticulitis, inflammatory bowel disease, colitis). * retroperitoneal hematomas. * known gi motility disorder. * underlying lung disease such as pneumonia, asthma or copd. * sepsis. * planned pregnancy, already pregnant or breastfeeding. * electrolyte disturbance (hypokalemia, hypomagnesemia, hyponatremia). * significant opioid and laxative use 4 weeks prior to surgery. * anti-inflammatory use 2 days prior to surgery. * drugs such as antacids, coumadin, amitriptyline, chlorpromazine. * baseline oxygen saturation \<92% on room air. * baseline blood level of cohb \>2%. * baseline hemoglobin \<90 g/dl. * participation in another clinical trial within 2 months prior to study.
clinical outcomes of tiotropium plus fluticasone propionate/salmeterol compared with tiotropium for chronic obstructive pulmonary disease (copd) in korea

Conditions: Chronic Obstructive Pulmonary Disease

Summary: study title * a randomized, open label, multicenter, phase 4 study for the comparison of efficacy of tiotropium plus salmeterol/ fluticasone propionate compared with tiotropium alone in copd patients study objectives * to investigate clinical outcomes of combining tiotropium with fluticasone propionate/salmeterol (fsc) 250/50μg bid compared with tiotropium alone in patients with moderate or severe copd in korea study design * randomized, open-label, multicenter, parallel-group, two group study study assessment * fev1 * inspiratory capacity (ic) * history of copd exacerbation * history of hospitalization for copd exacerbation and all causes * qol (sgrq-c)


Eligibility criteria:
inclusion criteria: * subjects aged 40 to 80 years. * subjects diagnosed with copd. * tobacco smoking 10 pack-years or more. * subjects with post-bronchodilator fev1/fvc \< 0.7 and fev1 \< 65% predicted. exclusion criteria: * subjects with a history of physician-diagnosed asthma or a respiratory disorder other than copd which is clinically significant such as diffuse bilateral bronchiectasis. * subjects suffering from serious diseases likely to interfere with the study such as chronic congestive heart failure. * subjects who used systemic corticosteroids within 4 weeks prior to study entry. * subjects with any malignant disease. * subjects with a history of severe glaucoma, urinary tract obstruction. * previous lung volume reduction surgery. * subjects who are pregnant or breastfeeding. * subjects with a known hypersensitivity or intolerance to tiotropium or fluticasone-salmeterol.
quilt-2.017: phase 1b/2 study of amg 479 in combination with paclitaxel and carboplatin for 1st line treatment of advanced squamous non-small cell lung cancer

Conditions: Advanced Squamous Non-Small Cell Lung Cancer

Summary: this is a global, multicenter, 2-part, open-label phase 1b and single-arm phase 2 study designed to evaluate the safety and efficacy of amg 479 in combination with paclitaxel and carboplatin for the first-line treatment of advanced squamous non-small cell lung carcinoma.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed advanced squamous nsclc * measurable disease as defined per modified recist criteria * ecog performance status of 0 or 1 * ≥18 years old * adequate glycemic function, for subjects with known diabetes exclusion criteria: * untreated or symptomatic central nervous system (cns) metastases * prior anti-cancer therapy as follows: any prior chemotherapy for squamous nsclc; any prior adjuvant or neoadjuvant chemotherapy for squamous nsclc; any prior chemoradiation for squamous nsclc; central (chest) radiation therapy ≤ 28 days prior to enrollment, radiation therapy for peripheral lesions≤14 days prior to enrollment for squamous nsclc

Keywords: amg 479 igf-1r apoptosis monoclonal antibody advanced squamous non-small cell lung cancer antibody 1st-line
toothbrush in the genesis and prevention of dental recessions

Conditions: Recession, Gingival

Summary: the aim of this research is to evaluate the effect of brushing on gingival recessions and to understand the impact of manual brushing and brushing with mechanical aid on their evolution. the study involves the recruitment of 90 patients with or without gingival recessions at the dentistry service of the university of genoa. the first phase involves the evaluation of the brushing force on the genesis of gingival recessions. a questionnaire will be filled out and the same toothbrushes and toothpastes will be provided for one month to 30 patients with recessions and 30 patients without recessions. after a month, the "wear" of the manual toothbrush and the gingival health indices will be measured. in this phase 60 patients with recessions will be divided into two groups according to the oral hygiene method that will be recommended. in the first group a super soft toothbrush will be delivered, in the second group a mechanical toothbrush. gingival health indices will be taken and an intraoral scan will be done to measure recessions. at 6 months and 12 months the indices will be measured again and compared between the two groups. this research has two objectives: 1. evaluate the differences in wear of the manual toothbrush head after one month of use between patients with gum recession and patients without gum recession. in the case of greater wear among patients with recessions it could be assumed that a greater brushing force is able to determine the formation of recessions. 2. try to understand if there are differences between the super soft manual toothbrush and the mechanical toothbrush regarding the effectiveness of use and the "delicacy" on recession. both tools are currently recommended for patients with recessions, but there are no studies in the literature comparing the two tools.


Eligibility criteria:
inclusion criteria: * age 18-60 years old; * fully dentate participants; * periodontal health exclusion criteria: * patient with periodontitis * previous ortho treatment * insufficient restorations or prostheses. * systemic disease affecting the periodontal tissues (e.g. bleeding disorders, diabetes mellitus etc.) * patients under medication associated with gingival enlargement (e.g. calcium channel blockers, immunosuppressants or anticonvulsants).
creation of a pressure reducing areas in socks

Conditions: Pressure Ulcers

Summary: evaluation of the ability of socks weaved with pressure relieving areas to reduce the pressure on the foot when weight bearing.

increased pressure in weight bearing areas of the foot, especially in insensate feet may lead to the development of pressure sore. the creation of socks with pressure relieving areas by special weaving technique may prevent the development of these complications. three (3) volunteers will be examined walking on a tekscan pressure mat, barefoot and then wearing socks weaved in a new technique, from cotton, nylon and acrilan.

Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * foot deformity

Keywords: pressure ulcers socks foot pressure
a phase i study of lintuzumab combined with lenalidomide in patients with myelodysplastic syndromes (mds)

Conditions: Myelodysplastic Syndrome (MDS)

Summary: this study is a phase i, open-label, single-arm, dose escalation trial to determine the safety and activity of lenalidomide combined with lintuzumab in patients with mds. small groups of 3-6 patients will be treated with pre-specified doses of lenalidomide and lintuzumab and will receive 3-week cycles of combination therapy.


Eligibility criteria:
inclusion criteria: 1. disease confirmation of mds. 2. between 5% and 30% blasts in the bone marrow. 3. received treatment for cytopenias within 2-months 4. ecog ≤ 2. exclusion criteria: 1. received prior therapy with lenalidomide, gemtuzumab ozogamicin (mylotarg®). 2. received chemotherapy/radiotherapy within 4 weeks of study registration. 3. received prior bone marrow transplant. 4. 5q- chromosomal deletion in malignant cells.

Keywords: lintuzumab antigens, cd33 antibodies, monoclonal combined modality therapy myelodysplastic syndromes hematologic diseases preleukemia
pelvic floor disorder education in prenatal care

Conditions: Pelvic Floor Disorders

Summary: pelvic floor disorders (pfds) are common conditions that can have significant impacts on patients' quality of life and psychosocial well-being. it is well known that patients who have experienced pregnancy and childbirth are at risk of developing these conditions, either during pregnancy, postpartum, or later in life. however, many women are unaware of this predisposing risk factor. additionally, overall knowledge of these conditions is low in both the general and obstetrics population. video education has been used in various fields with success in improving patient knowledge of specific topics and conditions. to the researchers' knowledge, no studies have evaluated this modality for educating obstetrics patients on pfds. the aim of this study is to determine whether the use of an educational video will improve knowledge of pfds compared to routine prenatal counseling, using a validated knowledge questionnaire.

once verbal consent is obtained, participants will be randomly assigned in a 1:1 ratio to the intervention (video education) or control group (routine prenatal visit only). group assignments will be performed using computer-generated randomization. all participants will complete a paper questionnaire including basic demographic information, prior history of pelvic floor disorders, and current pfd symptoms. participants assigned to the routine prenatal visit only will be instructed to complete the prolapse and incontinence knowledge questionnaire (pikq). the pikq is a validated 24-item questionnaire designed to assess knowledge of pfds, including two 12-item subscales on urinary incontinence (pikq-ui) and prolapse (pikq-pop).

Eligibility criteria:
inclusion criteria: * women 18 years or older in their third trimester of pregnancy (37 weeks of gestation or greater) * english-speaking exclusion criteria: * non-english-speaking patients * gestational age \< 37 weeks

Keywords: pelvic floor disorders education prenatal education video education