Kornimate/medical-research-clean huggingface dataset:
bendamustine in combination with bortezomib and pegylated liposomal doxorubicin for multiple myeloma

Conditions: Multiple Myeloma

Summary: this is an open label phase i/ii trial to determine the safety and the biologic activity of the bendamustine, bortezomib and pegylated liposomal doxorubicin combination.

phase i component bortezomib 1.3 mg/m2 iv bolus, days 1, 4, 8, and 11 doxorubicin 30 mg/m2 iv over 1 hour, day 4 bendamustine escalating cohorts iv over 1 hour, days 1 and 4 1 cycle = 28 days phase ii component bortezomib 1.3 mg/m2 iv bolus, days 1, 4, 8, and 11 doxorubicin 30 mg/m2 iv over 1 hour, day 4 bendamustine at mtd iv over 1 hour, days 1 and 4 filgrastim (if defined in mtd) 5 µg/kg/day sc, starting day 6 until neutrophil recovery to anc \>1000 1 cycle = 28 days; patients will continue treatment for a total of up to 8 cycles. ecog performance status: 0-2 hematopoietic: * absolute neutrophil count (anc) ≥ 1.2 x k/mm3 * platelets ≥ 75 x k/mm3 hepatic: * total bilirubin ≤ 1.5 x upper limit of normal (uln) * ast ≤ 2.5 x uln * alt ≤ 2.5 x uln renal: * serum creatinine \< 3.0 mg/dl cardiovascular: * lvef \>45% corrected by muga scan or echocardiogram. * no unstable angina pectoris or recent myocardial infarction (within 6 months)

Eligibility criteria:
inclusion criteria: * a histologically established diagnosis of multiple myeloma with evidence of relapse or refractory disease. * must have a detectable serum or urine m-protein by protein electrophoresis that is at least 500 mg/dl (serum) or 1 gm/24 hours (urine), respectively, or serum free light chain level \>100 mg/l for the involved free light chain. * must have received at least one (1) prior line of systemic treatment that has included either lenalidomide or thalidomide. * must be willing to provide correlative blood samples. exclusion criteria: * must not have received an excessive cumulative dose of anthracycline * no ≥ grade 2 peripheral neuropathy. * no cytotoxic chemotherapy within 30 days prior to registration for protocol therapy. * no autologous stem cell transplant within 6 months prior to registration for protocol therapy * no prior radiation therapy to \> 25% of bone marrow forming bones (i.e., pelvis) within 30 days prior to registration for protocol therapy. see study procedures manual to calculate percent of prior radiation. * no current corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions. * no known central nervous system involvement by myeloma. * no poorly controlled intercurrent illness including, but not limited to, ongoing or active infection, poorly controlled diabetes, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social climate that in the opinion of the investigator would limit compliance with study requirements. * no patients known to be positive for hiv, or active hepatitis a, b, or c. * no major surgery within 30 days prior to registration for protocol therapy. placement of a venous access device within 30 days prior to registration for protocol therapy is allowed.
design of optimally-diagnostic skin test solutions for diagnosis of sensitisation to a pollen and dust mite mixture.

Conditions: Type I Allergy

Summary: multicenter skin prick test


Eligibility criteria:
inclusion criteria: * anamnesis referring to suspicion of an ige-mediated allergy * positive skin prick test in the medical history to at least one of the investigational allergens with an existing anamnesis exclusion criteria: * serious chronic diseases * other perennial allergies
predictive factors and subthalamic stimulation in parkinson's disease

Conditions: Parkinson's Disease

Summary: this study identify preoperative predictors of response to subthalamic stimulation at 1 year, 3 years and 5 years in terms of quality of life, from a broad prospective multicenter study french with standardized collection of clinical data , imaging and genetic . the investigators want to identify factors that predict the improvement of quality of life for one year corresponding to a decrease of pdq39 score of at least 20 %. they believe that improvement would be less likely to become zero to 3 or 5 years and question the indication of the subthalamic stimulation (risks and costs). this is part of a process of "personalization" of the therapeutic care that is of any interest to the subthalamic stimulation. it is a therapeutic option that could be dangerous if patient selection is not optimal , and expensive, if the benefit is not large enough to reduce the number of medications and hospitalizations medium term . in addition, it will quantify the improvement of quality of life in the longer term and harmonize national assessments .


Eligibility criteria:
inclusion criteria: * patients receiving a pre- therapeutic assessment and therapeutic monitoring for one year , 3 years and 5 years as part of the regular monitoring of the subthalamic stimulation * bilateral stn stimulation considered * patient able to provide their free and informed consent * patient with insurance coverage exclusion criteria: * atypical parkinson's disease do not meet the criteria of stuff . * mp under 5 years * severe cognitive impairment or dementia ( score moca \<24 and dsm-iv criteria) * parkinson's psychosis * reply to l- dopa \<30 % * against indication for surgery * severe brain atrophy or abnormal mri * the presence of another very serious condition terminal life- short-term prognosis ( malignancy ) is an indication against .

Keywords: subthalamic neurostimulation
eligibility screening for national institute of dental and craniofacial research studies

Conditions: Fibromyalgia

Summary: this screening protocol is designed to evaluate patients for participation in clinical studies in the gene therapy and therapeutics branch (gttb) of the national institute of dental and craniofacial research. to participate, patients must meet the specific requirements of at least one of the available research studies; this protocol serves as a first step for admitting patients to an appropriate program. people with diagnosed or undiagnosed conditions may participate in this screening protocol. they will undergo procedures that may include questionnaires, a physical examination, routine laboratory tests, and diagnostic imaging or radiological studies. eligibility screening will be limited to three visits within 12 months of entry into the protocol. if an appropriate study is not found by the end of this time, the candidate's participation in the screening program will terminate. no experimental treatments are offered under the screening protocol. patients who are found eligible for a current gttb study will be notified of their options and invited to enroll.

this protocol is designed to screen patients with either diagnosed or undiagnosed conditions, and provides for determining eligibility for approved protocols within the gene therapy and therapeutics branch (gttb), national institute of dental and craniofacial research. the purpose of the protocol is to allow evaluation of patients who do not meet the requirements for other screening protocols, such as the screening protocol for sjogren's syndrome patients. each subject will be evaluated to determine whether they are suitable candidates for inclusion in any protocols in the gttb. the screening evaluation will include past and current medical history, and an appropriate physical examination. further routine diagnostic tests may also be performed to determine eligibility for approved studies. the tests and procedures are of minimal risk. when the screening has been completed, subjects will be informed of the options available at the time for participation in available, approved research protocols.

Eligibility criteria:
inclusion criteria: all patients who may be eligible for other currently approved protocols. inclusion and exclusion criteria will vary according to the protocol(s) for which the patient is being screened. patients may be eligible if they have rare, unusual, interesting or unknown conditions that require diagnosis.

Keywords: questionnaires eligibility history physical examination tests fibromyalgia
education and group support for diabetic hispanics

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: the purpose of this ongoing work in starr county, located on the texas-mexico border, is to conduct clinical studies to determine the effectiveness of diabetes self-management programs designed specifically for mexican americans. the programs meet national standards for diabetes self-management education. they are provided in community settings with the primary purpose of improving the health of mexican americans with diabetes and their family members, who either have diabetes or are at risk for developing diabetes. the diabetes self-management programs are provided in spanish and are directed by bilingual hispanic clinical nurse specialists, dietitians, and community health workers. key elements of the programs include instruction on nutrition, self-monitoring of blood glucose, exercise, and other diabetes self-management topics, as well as group support to promote behavioral changes. in the original study (1994-1998), 256 mexican american adults diagnosed with type 2 diabetes and 256 family members or other support persons were enrolled. for one year, the people with diabetes, along with their family members, attended small group sessions held in churches, community health clinics, adult day care centers, and schools. information on the effectiveness of the program was collected at 3, 6, and 12 months; and annually thereafter. findings of the original study suggested that the program had a positive impact on diabetes metabolic control. levels of diabetes knowledge and rates of glucose self-monitoring and attendance suggested that a shorter program - one that incorporated critical elements of the previous successful strategy - might result in similar improvements. thus, the goal of the new study, funded in june 1999, was to shorten the original program and to compare it to the previous successful program in terms of short- and long-term health outcomes. to identify key components of the previous program, we are exploring differences between subjects who successfully integrated self-care components of the program and who experienced significant improvements in metabolic control and those who were not as successful. the program is being revised and shortened, based on this information. beginning in april 2000, we will start recruiting participants for the clinical trial of the revised program.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes (\[a\] two verifiable fbs test results of 140 mg/dl or above or \[b\] taking or have taken insulin or hypoglycemic agents for at least one year in the past) * willing to participate * a family member, preferably a spouse or first-degree relative, who agrees to participate exclusion criteria: * migrant farm workers (not available for the year-long program) * pregnant * medical conditions for which changes in diet and exercise levels would be contraindicated

Keywords: diabetes mellitus, type 2 diabetes self-management education diabetes self-care blood glucose self-monitoring health education patient education
comparing paroxetine and duloxetine on cardiovascular measures

Conditions: Depressive Symptoms

Summary: this double-blind placebo-controlled trial is designed to test and to compare the cardiovascular profile of paroxetine controlled release (cr) with duloxetine in outpatients with depressive symptoms.

this double-blind placebo-controlled study will test the hypothesis that greater reduction in heart rate variability will be associated with duloxetine than paroxetine in outpatients with major depressive disorder. we will also examine the relationship between changes in heart rate variability to the magnitude of serotonin and norepinephrine transporter occupancy produced by each drug.

Eligibility criteria:
inclusion criteria: * depressive symptoms * ages 20-60 * in good medical health and not pregnant exclusion criteria: * bipolar disorder * schizophrenia or other psychotic disorder * alcohol or other substance abuse within the last 3 months * cognitive impairment * history of attempted suicide in the past 2 months and who score 4 or more on the suicide item of the madrs
influence of medical nutrition therapy and eating behavior on gestational weight gain

Conditions: Weight Gain; Eating Behavior

Summary: to assess the association of the number of medical nutrition therapy (mnt) consultations and eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) with gwg in women with type 2 diabetes mellitus (t2dm) and gestational diabetes mellitus (gdm).

women in puerperium with known t2dm or gdm diagnosed at the hospital were invited to participate in the study. gestational diabetes was diagnosed with a 75-g oral glucose tolerance test. weight (kg) and height (m) were measured using a mechanical column scale (seca). the specific dimensions of eating behavior were measured through the 18-item three-factor eating questionnaire-18 (tfeq-18). the medical nutrition therapy (mnt) was offered every 2-4 weeks. this therapy consists of providing a food plan with the following recommendations: limiting carbohydrate intake to 35-45% of total calories calculated as 30 kcal/kg based on pregestational bmi for an ideal weight . we evaluated the effect of mnt on gwg using a multiple linear regression model

Eligibility criteria:
inclusion criteria: * women in puerperium with known t2dm or gdm diagnosed at the hospital. exclusion criteria: * women with a twin or other multiple pregnancy, type 1 diabetes mellitus (t1dm), or intolerance to carbohydrates, and those with additional diseases (hypertensive disorders of pregnancy, hyper- or hypothyroidism, lupus, kidney or liver disease).

Keywords: gestational diabetes type2 diabetes
reduction of progesterone elevation at trigger in por after long acting cos compared with daily cos: a prospective randomized trial

Conditions: Infertility

Summary: the overarching objective of this research is to generate clinical evidence to argue the benefits of long acting stimulation protocol compared to the daily stimulation protocol in poor ovarian responder bologna' criteria patients after controlled ovarian stimulation. reduction in the proportion of subjects with progesterone \> 1.1 ng/ml on the day of triggering (day + 13) in the experimental group compared to the control group is expected.

each patient will receive a first visit for infertility where will be collected subject history and baseline information, and meet all the inclusion / exclusion criteria. eligible patients who agreed to participate will be randomized to either long acting standard cos with corifollitropin alpha or standard cos with daily fsh in a fixed gnrh antagonist protocol. all patients will be allowed to participate in the study only once and a written informed consent will be obtained from all, following consultation and before the initiation of the treatment. the endocrine profile of all the patients will be evaluated by analysis of serum progesterone, 17b-estradiol (e2), fsh and lh at different time points: basal condition, during stimulation, at the hcg day and at pick-up. transvaginal follicular aspiration will be performed by ultrasound guidance 36 hours after hcg administration. the day of pick up oocytes will be fertilized with partner's semen; after 3-5 days, on the base of its evolution, embryo will be transferred. 14 days after embryo-transfer a preg-nancy test will be performed. follow up in case of obtained pregnancy will be done until 20 weeks of gestation and considered as ongoing pregnancy. the entire duration of the study is 24 months, the follow up of the last patients enrolled will be 6 months.

Eligibility criteria:
inclusion criteria: * indication to ivf treatment * normal bmi (18.5-24.9 kg/m2) * amh level \< 1.1 ng/ml and/or afc \< 5 follicles and/or \< 3 oo-cytes retrieved in previous cycle * regular menstrual cycles * signed informed consent exclusion criteria: * freeze all cycles for abnormal bleeding * pcos * history of untreated autoimmune * endocrine or metabolic disorders * ovarian cystectomy or oophorectomy * fsh ≥ 20 lu/l
vision ii: evaluation of galileo intravascular radiotherapy system

Conditions: Coronary Artery Disease

Summary: to assess the safety and effectiveness of intravascular brachytherapy for the treatment of intrastent restenosis of coronary lesions with the galileo system

the purpose of this study is to evaluate the cardiac events (mace) and adverse extra cardiac events at 6 month follow up and up to 24 months for the patients treated with galileo system

Eligibility criteria:
inclusion criteria: * patient with angor, patients with only one de novo lesion. target zone must be \ 2,25 mm exclusion criteria: * vessel with extremely tortuous proximal segment, lesion with angulous segments (\>90°) unstable ventricular arrhythmia, dialysis, mi within the last 72 hours etc...
phase 2 study of xaf5 (xoph5) ointment for reduction of excess eyelid fat (steatoblepharon)

Conditions: Lower Eyelid Steatoblepharon (Excess Eyelid Fat)

Summary: this study will test whether xaf5 (xoph5) ointment, applied once daily to the lower eyelids for 10 weeks, reduces the prominence of lower eyelid fat in adults with moderate to severe steatoblepharon (excess eyelid fat).


Eligibility criteria:
inclusion criteria (abbreviated): * moderate to severe lower eyelid steatoblepharon (less score of 2-4 bilaterally) * men and women 40-70 years old * healthy facial skin * must understand and provide informed consent exclusion criteria (abbreviated): * best corrected visual acuity worse than 20/40 in either eye * regular use of ophthalmic medication in either eye * planned use of contact lenses during the study * any history of lower eyelid surgery

Keywords: steatoblepharon blepharoptosis dermatochalasis blepharoplasty periorbital orbital eyelid eyebags eye bags
return of bowel function after one or two level anterior lumbar interbody fusion with chewing gum

Conditions: Spondylosis; Spondylolisthesis; Neurogenic Claudication; Foraminal Stenosis

Summary: researchers are trying to identify is chewing gum improves bowel function after anterior lumbar interbody fusion

aims, purpose, or objectives: 1. observe changes in bowel pattern based on gum-chewing 2. examine bowel function after anterior lumbar interbody fusion 3. measure length of time to return of bowel function after anterior lumbar interbody fusion 4. compare return of bowel function in patients who chew gum and patients standardized to usual post-operative care 5. measure the hospital length of stay amongst study groups 6. measure post-operative pain amongst study groups background (include relevant experience, gaps in current knowledge, preliminary data, etc.): one or two level anterior lumbar interbody fusions are designed to correct lumbar spondylosis and spondylolisthesis, which can cause debilitating back and leg pain. this surgery involves an anterior approach, which often requires displacement of bowel for the length of the surgery. patients frequently have a slow return of bowel function secondary to anesthetic time, opioid use, and primarily due to the bowel displacement intraoperatively. because this is a one or two level surgery, many patients would benefit from same-day discharge but often remain inpatient several days due to slow return of bowel function. gum chewing has been shown to decrease the time for return to bowel function (rbf) in colorectal and gynecology patients postoperatively. gum chewing and rbf has been studied in the spine population for posterior operations but not anterior spine surgery. this study aims to identify whether chewing gum has an impact on patient's report of pain, rbf, length of stay, and subjective report of satisfaction post-operatively. this could be an outpatient operation; however, pain and rbf often prevent patients from discharging home the same day of surgery.

Eligibility criteria:
inclusion criteria: 1. undergoing one or two level anterior lumbar interbody fusion 2. diagnosis of spondylosis, spondylolisthesis, revision of foraminal stenosis or neurogenic claudication exclusion criteria: 1. previous bowel surgery 2. diagnosis of an inflammatory bowel disease 3. allergy to xylitol 4. pregnancy some participants may subsequently undergo a posterior spinal fusion on the same-day of surgery. they will not be excluded, but the investigators will include this group in a different data subset.
frequent standardized oral care using human milk in the neonatal intensive care unit

Conditions: Ventilator Associated Pneumonia; Bronchopulmonary Dysplasia; Respiratory Disease

Summary: premature infants are susceptible to complications related to infrequent and non-standardized oral care. although the benefits of frequent standardized oral care are known to reduce oral dysbiosis (increased level of potentially pathogenic bacteria) and its associated complications in critically ill adults leading to established evidence-based guidelines, no such information exists for vlbw infants. the proposed study will prospectively follow 168 vlbw infants for 4 weeks following birth.

premature very low birth weight (vlbw) infants are susceptible to complications related to infrequent and non-standardized oral care. although the benefits of frequent standardized oral care are known to reduce oral dysbiosis (increased level of potentially pathogenic bacteria) and its associated complications in critically ill adults leading to established evidence-based guidelines, no such information exists for vlbw infants. premature vlbw infants are highly susceptible to costly, life threatening and potentially preventable morbidities, such as ventilator associated pneumonia (vap), bronchopulmonary dysplasia (bpd; oxygen requirement at 28 days of life) and need for prolonged respiratory support which require additional treatments, increase cost of care, and can lead to chronic illness, re-hospitalization, and developmental delay. a dearth of information exists regarding oral care in vlbw infants, and no such guidelines exist for infants admitted to the neonatal intensive care unit (nicu) which may negatively affect their health. thus, research regarding the effect of frequent, standardized oral care on the health of vlbw infants is essential to develop guidelines thus potentially improving the health of this vulnerable population. if successful, this research could change practice in nicus across the nation.

Eligibility criteria:
inclusion: * mother ≥18 years of age * ≤ 30 weeks gestation * born weighing ≤ 1500 grams exclusion: * congenital anomalies of the face, lungs, or gastrointestinal system * not expected to live \> 7 days following delivery.