Kornimate/medical-research-clean huggingface dataset:
study on prolonging bone metastasis-free survival in men with hormone refractory prostate cancer

Conditions: Hormone Refractory Prostate Cancer

Summary: the purpose of this study is to compare the treatment effect of denosumab with placebo on prolonging bone metastasis-free survival in men with hormone refractory (androgen independent) prostate cancer who have no bone metastasis at baseline.

participants were randomized to receive denosumab 120 mg or placebo every 4 weeks (q4w) until approximately 660 participants developed bone metastasis or died and the primary efficacy and safety analyses were completed. all participants undergoing scheduled assessments were offered open-label denosumab 120 mg subcutaneous (sc) until they either developed a bone metastasis, obtained access to commercially available product in this setting, or for up to 3 years, whichever came first. for participants who ended participation before the open-label extension (ole) phase or withdrew from investigational product during the ole phase, their survival data was to be collected every 6 months for up to 3 years after their last dose of investigational product. participants in the czech republic and united kingdom were enrolled under a separate protocol for the ole phase per health authority request, and are reported separately (study 20080585; nct01824342).

Eligibility criteria:
inclusion criteria: * men with histologically confirmed prostate cancer * bilateral orchiectomy at least 6 months before randomization or continuous androgen-deprivation therapy (adt) with a gonadotropin releasing hormone (gnrh) agonist or antagonist for at least 6 months before randomization * total testosterone level less than 50 ng/dl, * hormone refractory (androgen independent) prostate cancer demonstrated during continuous adt/post-orchiectomy defined as: 3 consecutive prostate-specific antigen (psa) values with psa1 \< psa2 \< psa3, each psa value must be separated by at least 2 weeks, psa2 and psa3 greater than or equal to 1.0 ng/ml, * high risk for development of bone metastasis defined as psa value greater than or equal to 8.0 ng/ml, obtained no more than 3 months before randomization or psa doubling time less than or equal to 10.0 months exclusion criteria: * prior or current evidence of radiographically detectable bone metastasis * known prior or current evidence of any metastatic involvement of distant organs (lymph node metastases in any region is acceptable) * prior or current intravenous bisphosphonate administration

Keywords: hormone refractory prostate cancer androgen independent adt bone metastasis
a study of ql1706 combined with platinum-containing chemotherapy in adjuvant treatment of stage ii-iiib non-small cell lung cancer after complete surgical resection.

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to evaluate the efficacy and safety of ql1706 combined with platinum-based chemotherapy versus placebo combined with platinum-based chemotherapy in adjuvant treatment of stage ii-iiib nsclc without egfr-sensitizing mutations and alk fusions after complete surgical resection.the subjects were randomly divided into two groups according to 1:1, with about 316 subjects in the experimental group and the control group.


Eligibility criteria:
inclusion criteria: * subjects voluntarily participated, signed an informed consent form (icf), and were able to follow the study procedures. * histopathologically confirmed squamous or non-squamous non-small cell lung cancer * stage ii-iiib according to the 8th edition of the american joint committee on cancer (ajcc) , and had received radical surgical resection (r0) treatment. * participants were enrolled to receive adjuvant therapy within 10 weeks after surgery (≤70 days) and had to recover sufficiently from surgery. * non-squamous nsclc subjects without egfr-sensitizing mutation or alk fusion gene. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * subjects (including women and men) agreed to use effective contraception from the time of signing the informed consent to 180 days after the last use of the study drug. exclusion criteria: * currently participating in and receiving study treatment or participating in an investigational drug study and receiving study treatment or using an investigational device within 4 weeks prior to the first dose of study treatment. * previous treatment with neoadjuvant/adjuvant chemotherapy or immune checkpoint inhibitor therapy. * cardiovascular and cerebrovascular diseases with clinical significance. * gastrointestinal disease of clinical significance. * clinically significant lung damage. * human immunodeficiency virus (hiv) antibody positive; treponema pallidum antibody positive. * active uncontrolled hepatitis b or active hepatitis c. * administer a live vaccine within 30 days prior to the first dose of study treatment. * other malignancies occurred within 5 years prior to study enrollment. (except: bowen's disease; cured basal cell or squamous cell skin cancer; prostate cancer with a gleason score of 6; treated cervical carcinoma in situ.) * previously allergic to macromolecular protein preparations, or to any component of ql1706 and other investigational drugs; history of severe allergy to chemotherapy drugs (pemetrexed, vinorelbine, paclitaxel, cisplatin, carboplatin) or their preventive drugs, etc. * history of psychotropic substance abuse, alcohol or drug abuse; prior history of clear neurological or psychiatric disorders, including epilepsy or dementia.
randomized controlled trial of vaginal cryotherapy for pelvic floor myofascial pain

Conditions: Pelvic Floor Myofascial Pain; Pelvic Pain; Myofascial Pain

Summary: this is a placebo-controlled, randomized controlled trial to investigate the role of vaginal cryotherapy on pelvic floor myofascial pain in women. this study involves randomizing patients who are found to have pelvic floor myofascial pain on examination into one of two treatment groups: transvaginal cryotherapy or transvaginal application of a room-temperature tube. patients will be followed up at two different time points in order to assess response to treatment. follow-up times include immediately after application (specific aim #1) and two weeks following use of the intervention alone (specific aim #2). patients will receive verbal and written instructions on using the intravaginal tubes by the research assistant who will not be blinded to treatment allocation. patients will not be blinded to their treatment assignment but will not be given information on the alternative treatment. patients will be referred to pelvic floor pt, which is considered the standard of care for treatment of pelvic floor myofascial pain at this time. as it typically takes 2-3 weeks to get in to see one of the pelvic floor pt providers at wash u, follow up for this study will be completed prior to their attendance at pelvic floor pt. patients will complete validated questionnaires assessing their pain, other pelvic floor symptoms, and acceptance of the intervention as a treatment option at the follow up time points.


Eligibility criteria:
inclusion criteria: * adult (\>18yo) * women * patients found to have pelvic floor myofascial pain of at least 4/10 in severity at any of the four sites (right obturator internus, right levator ani, left levator ani, left obturator internus) exclusion criteria: * age \<18 * non-english speaking * current diagnosis of dementia * limited physical mobility that would prevent full participation in pelvic floor pt. * prior use of vaginal cryotherapy * chief complaint or known history of pelvic pain
a study to examine the distribution of pf-05212377 in the brain of healthy volunteer subjects using positron emission tomography and a radioactive tracer following oral administration of one dose of pf-05212377

Conditions: Healthy

Summary: this study will see how pf-05212377, an experimental drug to treat symptoms from alzheimer's disease, distributes in the brain after one dose of pf-05212377 is administered orally to healthy volunteer subjects. the study will also evaluate the safety and tolerability of pf-05212377 in these subjects and will measure the level of pf-05212377 in the blood.


Eligibility criteria:
inclusion criteria: * males and females must be at least 18 years of age and no older than 55 years of age with a body mass index (bmi) must be between 17.5 and 30.5. * subjects must sign a consent form and comply with all scheduled visits, treatment plan, lab tests and other study procedures. exclusion criteria: * females must not be pregnant, breastfeeding, or able to have children. * subjects must not have a severe acute or chronic medical or psychiatric condition history or evidence of blood, kidney, glandular, lung, stomach, intestine, heart, blood vessel, liver, psychiatric, nerve, or allergic problems (including drug allergies), except mild seasonal allergies. * subjects must not drink alcohol excessively or take illicit drugs. * male subjects use condoms to prevent the potential transfer of drug through the semen to their partner beginning with the dose of study drug and use a highly effective method of birth control with any partner(s) of childbearing potential through 28 days after the last dose.

Keywords: pf-05212377 phase 1 open-label 5-ht2a receptor occupancy positron emission tomography healthy subjects brain cortex alzheimers disease
automated guidance tool for medical encounters addressing therapeutic lifestyle changes (augment).

Conditions: Heart Disease; Diabetes

Summary: abstract although most primary healthcare practitioners recognize the important relationship among nutrition, physical activity and health, few incorporate either dietary or physical activity counseling into routine practice. augment will employ interactive technology to support effective patient life-style counseling during routine office visits. augment technology will automate the administration, collection, and analysis of dietary and physical activity questionnaires, and it will guide counseling and present intervention resources and strategies tailored to the patient's unique needs. using tablet computers, wireless lans, and inexpensive internet communications, augment will have advantages over existing tools: 1.) lower usage costs (minimal office personal required), 2.) ability to customize the system, and 3.) real-time, comprehensive assessment. the augment system efficiently and relentlessly gathers important healthcare information (such as total fat, type of fat consumption; fruit and vegetable consumption; fiber and micronutrient intake; and energy output). this means patients are less likely to have their preventive needs overlooked by a busy practitioner. the assessment includes questions to determine the amount of effort the patient will commit to improved health. this will enable the physician to effectively guide the patient via targeted recommendations, obtainable goals, and a course of action that is both preventive and prescriptive; and to monitor progress. patients who receive objective assessments of their healthcare practices and recommendations based on their own unique health history will be more likely to accept and act on the recommendations. the specific aims of the study are to: 1) incorporate key elements of a previously developed prototype tool into a dietary and physical activity risk assessment system, 2) create a provider training tool to build proficiency in using augment for counseling to reduce disease risk. 3) validate the augment dietary and physical activity assessments using dietary recalls and accelerometer data, 4) complete a process evaluation of the augment program by using it in interventions managed by six physicians with at least 240 patients, and 5) survey participating providers and patients to assess acceptability of augment within a clinical setting.


Eligibility criteria:
inclusion criteria: * adult patients at staywell community health center, waterbury ct exclusion criteria: * terminally ill * pregnant women * children * decisionally impaired / dementia

Keywords: reduction in risk of heart disease and diabetes
strategies for coping with negative thoughts

Conditions: Depressive Symptoms; Anxiety; Negative Thinking

Summary: the primary objective of this study is to assess the impact of two strategies for coping with negative automatic thoughts (positive thinking and cognitive restructuring) on one's belief in negative thoughts and one's affect. another main objective is to assess whether participating in a positive mood induction (versus no mood induction) prior to using one of the two coping strategies impacts belief in negative thoughts and affect. we will also explore the interaction between strategy condition and mood induction condition. as secondary outcomes, we will evaluate whether there are changes in positive thinking skills and cognitive restructuring skills and depressive symptoms after one week of using the strategy.

participants will be randomized to learn about positive thinking or cognitive restructuring, which will involve watching brief videos, being presented with examples of how one might apply the strategy when experiencing negative thoughts, and practicing with a personal example using a worksheet. participants will also be randomized to positive mood induction, which is comprised of an autobiographical recall exercise in which participants are asked to recall a pleasant memory before filling out the worksheet. participants will be asked to use the strategy and complete a worksheet online once per day for six days. participants will respond to questionnaires at baseline and after 6 days of strategy use.

Eligibility criteria:
inclusion criteria: * 18 years old or older. exclusion criteria: * a level of visual impairment that would prevent them from being able to answer questions on an electronic screen.
laparoscopic-robotic hysterectomy for uterine transplantation in live-donor patient.

Conditions: Uterine Anomaly

Summary: currently, there is no standard and indicated standard access route for uterine removal in the uterine transplant donor patient. the aim of the study is to show the feasibility of performing this procedure by replicating in our center the results found in other recent studies and to try to reduce the surgery time for both the donor and recipient patients.

few cases have been performed worldwide by laparotomic and, more recently, laparoscopic and assisted robotic access pathways. this is a clinical trial with 6 participants (3 donors and 3 recipients) to investigate the feasibility of an assisted laparoscopic-robotic surgical access route for uterine removal in the donor patient in uterine transplants. in the receiving patient, conventional surgery (midline incision) will be performed for uterine transplantation and vascular anastomoses.

Eligibility criteria:
inclusion criteria: * desire for uterine transplantation as a donor of the uterus (with family relationship with the donor patient); * at least one pregnancy before exclusion criteria: * comorbidities that contraindicate a surgical procedure * women who do not understand the study; * women subject to the regime that determines significant vulnerability to the participant (eg prisoners, indigenous, etc.) * abo blood test mismatch between donor and recipient patient.

Keywords: uterine transplant robotic surgery donor recipient uterine anomaly
escalating temporary gastric electrical stimulation (ges) for severe gastroparesis

Conditions: Gastroparesis

Summary: the purpose of this study is to determine the physiologic effects of temporary gastric electrical stimulation in subjects with severe gastroparesis.

this study will look to determine the clinical benefit placing temporary gastric electrical stimulation, the ability to predict the clinical response to surgical implantation of ges, and the feasibility and patient tolerability of endoscopic placement of temporary gastric electrical stimulator (t-ges),

Eligibility criteria:
inclusion criteria: * at least 3 months of gastroparesis-related symptoms, such as nausea, emesis, and/or retching * solid phase 4-hr gastric scintigraphy is consistent with gastroparesis within 3 months of study enrollment\* * retention at 2 hr: \>60% or * retention at 4 hr: \>10% \*based on international consensus on gastric scintigraphy exclusion criteria: * gastric outlet, small bowel, or colon obstruction. * small bowel malrotation * inflammatory bowel disease * contraindication for surgical implantation of ges * presence of illness that may require mri during the study; such as pituitary tumor, herniated disc, spinal stenosis, multiple sclerosis, etc. * significant comorbidity due to sever cardiovascular, renal, pulmonary, or liver disease. * significant coagulopathy * non-ambulatory patients: bed-ridden, nursing home resident, etc. * pregnancy * unable to give own informed consent * prisoners

Keywords: gastroparesis gastric electrical stimulator ges vomiting nausea bloating postprandial fullness epigastric pain
effect of citalopram on reflux episodes in healthy volunteers

Conditions: Gastro Esophageal Reflux

Summary: citalopram is sometimes used in the treatment for gastro-esophageal reflux disease, however, there are no empirical data to support this. the investigators would like to know if citalopram has an effect on the lower esophageal sphincter pressure, transient lower esophageal sphincter relaxations and reflux episodes. the investigators will investigate this by performing high resolution impedance manometry in healthy volunteers before and after a solid meal. this will be compared to placebo, in a cross-over, randomized, double-blind condition.


Eligibility criteria:
inclusion criteria: * between 18 and 65 years exclusion criteria: * history of upper gi symptoms * history of upper gi surgery * psychological disorders * any drug history * use of medication altering gi motility * nursing and pregnant woman
to investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer

Summary: to investigate efficacy and safety of pemetrexed as second or third line therapy in patients with non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * clinical stage iii or iv * previously treated with one or two chemotherapeutic regimens * performance status: 0-2 exclusion criteria: - inability or unwillingness to take folic acid or vitamin b12 supplementation
a study of ly3295668 erbumine in participants with extensive-stage small-cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: the purpose of this study is to determine the recommended phase 2 dose of ly3295668 erbumine in participants with platinum-sensitive, extensive-stage small-cell lung cancer.


Eligibility criteria:
inclusion criteria: * have histological or cytological evidence of a diagnosis of platinum sensitive small cell lung cancer that is extensive stage. * have adequate organ function. * have a performance status (ps) of ≤1 on the eastern cooperative oncology group (ecog) scale. * have discontinued previous treatments for cancer. * are able to swallow capsules. exclusion criteria: * currently enrolled in a clinical study. * have a serious concomitant systemic disorder. * have a symptomatic human immunodeficiency virus infection or symptomatic activated/reactivated hepatitis b or c. * have a significant cardiac condition. * have previously received an aurora kinase inhibitor.

Keywords: aurora kinase a kinase aurora a aurora kinase inhibitor aurora kinase a inhibitor kinase inhibitor aurka aura
impact of inspired oxygen fraction on outcome in patients with traumatic brain injury

Conditions: Traumatic Brain Injury | Patient

Summary: aim of the study is to investigate the impact of two different fractions of inspired oxygen (fio2) on outcome in patients with severe traumatic brain injury (tbi).

the high oxygen group is treated during mechanical ventilation with either a fraction of inspired oxygen of 0.7 (high oxygen group) or a fraction of inspired oxygen 0.4 (control group). the intervention continues until withdrawal of mechanical ventilation, icu discharge or until 14 days from icu randomisation. primary outcome is worse than expected outcome in the corresponding treatment arms based on outcome meas-ured by the probability of bad outcome using the crash® risk calculator (prognostic model for predicting outcome after traumatic brain injury). secondary outcome is occurence of lung injury during mechanical ventilation.

Eligibility criteria:
inclusion criteria: * patients with isolated non-penetrating traumatic brain injury * multiple trauma patient with brain injury and traumas outside abdomen, thorax or pelvis not affecting oxygenation * glasgow coma scale eight or less (inclusive) * expected need for intubation and for mechanical ventilation more than 24 hours. * are recruited \<18 hours after admittance to icu and * time from tbi is less than 36 hours * informed consent from patients representative exclusion criteria: * age \ 65 years, * anticipated brain death in 12 hours (donor treatment) or otherwise moribund patient expected to die in 24 hours * expected need for mechanical ventilation less than 24 hours * insufficient oxygenation assessed by a clinician or multiple trauma patients with brain injury and severe abdominal, thoracic or pelvic injury possibly affecting oxygenation. * no consent * insufficient oxygenation with the treatment modality of the lower oxygenation group (pa02 less than 13 kpa or spo2 95% with fi02 40%, peep 10 or less) or oxygenation failure probable during icu care (severe aspiration, multiple trauma patients with brain injury and severe abdominal, thoracic or pelvic injury possibly affecting oxygenation) * penetrating tbi * no consent * suspected pregnancy (perform urinary or serological pregnancy test if suspected)

Keywords: tbi normobaric hyperoxia outcome gos gose
tolerance of "on line" hemodiafiltration in chronic renal failure patients

Conditions: Cardiovascular Disease

Summary: the aim of this study is to appreciate the tolerance of "on line" hemodiafiltration and its impact on morbidity and cardiovascular risk factors in chronic renal failure patient.

the aim of this study is to appreciate the tolerance of "on line" hdf treatment versus conventional high flux hemodialysis in term of adverse events occuring during dialysis sessions between day 30 and day 120 of treatment and to evaluate: * quality of life evaluated with the kdqol questionnaire * incidence of cardiovascular events * influence of the technic on cardiovascular, inflammatory and infectious risk factors * mortality

Eligibility criteria:
inclusion criteria: * patient who has signed the written consent form * patient aged \> 65 and \< 90 years * with creatinine clearance \< 10 ml/min * on dialysis for a minimum of 3 months, with 3 times a week hemodialysis sessions * erythropoietin dosage needed to maintain hemoglobin at a constant level (range of hemoglobin: 9-13 g/dl without any variation of more than 2g/dl for less than 3 months) * without any problem of vascular access exclusion criteria: * patient aged \ 90 years * presence of severe malnutrition (albumin \< 20 g/l) * unstable clinical condition * unipuncture or failed vascular access flow * known problems of coagulation

Keywords: on line hemodiafiltration tolerance quality of life cardiovascular risk hemodialysis patients