Kornimate/medical-research-clean huggingface dataset:
study of amg 162 in subjects with advanced cancer currently being treated with intravenous (iv) bisphosphonates

Conditions: Bone Metastases in Men With Hormone-Refractory Prostate Cancer; Bone Metastases in Subjects With Advanced Breast Cancer; Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma

Summary: the purpose of this trial is to determine the effectiveness of amg 162 in reducing urinary n-telopeptide in advanced cancer subjects with bone metastases.


Eligibility criteria:
inclusion criteria: * patients at least 18 years of age with histologically confirmed solid tumor carcinomas (except lung) or multiple myeloma * radiographic evidence of 1 or more bone lesions or lytic lesion in myeloma * currently receiving iv bisphosphonates * urinary n-telopeptide (untx) greater than 50 nm bce/mm creatinine * eastern cooperative oncology group (ecog) 0, 1 or 2 exclusion criteria: * more than 2 prior skeletal related events (sre) * known brain metastases * prior history or current evidence of osteonecrosis/osteomyelitis of the jaw * active dental or jaw conditions which requires oral surgery * non-healed dental/oral surgery * prior administration of amg 162 * evidence of impending fracture in weight bearing bones * pregnancy or breastfeeding. subjects must be surgically sterile, postmenopausal, or must agree to use effective contraception during the study.

Keywords: bone metastases amg 162 bisphosphonates solid tumor carcinomas advanced
real world treatment experience of patients with breast, lung, ovarian, multiple myeloma, or acute myelogenous leukemia using remote symptom monitoring

Conditions: Breast Cancer; Lung Cancer; Multiple Myeloma; Ovarian Cancer; Acute Myelogenous Leukemia

Summary: the goal of this study is to create a data set to add to carevive's registry from real world clinical and patient reported data collected using an electronic care planning system (cps) with remote symptom monitoring that is used in routine care for cancer patients on active treatment. patients will complete a baseline survey in person using a secured device or remotely using their own electronic device in a location of their choice. weekly electronic patient reported outcome (pro) surveys are collected from the patients using the carevive platform for a minimum of 12 weeks. patients may continue weekly surveys as long as they are receiving treatment.


Eligibility criteria:
inclusion criteria: * all participants must be 18 years of age or older. * subjects may be any stage and anywhere in the treatment continuum. * subject participants must have a diagnosis of a breast, lung, aml, ovarian cancer or multiple myeloma. * subjects must be able to complete on-line surveys using a cell phone, tablet, or computer. * all participants must be able to understand english. exclusion criteria: * any patient who cannot understand written or spoken english. * any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer. * any patient on a treatment clinical trial. * any prisoner and/or other vulnerable persons as defined by nih (45 cfr 46, subpart b, c and d).
the finnish study of intraoperative irrigation versus drain alone after evacuation of chronic subdural hematoma (finish)

Conditions: Chronic Subdural Hematoma

Summary: finish-trial is a prospective, randomized, controlled, parallel group non-inferiority trial comparing single burr-hole evacuation of chronic subdural hematoma (csdh) with intraoperative irrigation (ir) and evacuation of csdh without irrigation (n-ir).

finish-trial is a prospective, randomized, controlled, parallel group non-inferiority trial comparing single burr-hole evacuation of chronic subdural hematoma (csdh) with intraoperative irrigation (ir) and evacuation of csdh without irrigation (n-ir). in both groups, a passive subdural drain is used for 48 hours as a standard of treatment. the study will be conducted in all five neurosurgical departments in finland. to determine whether operation without irrigation results in non-inferior outcome to operation with irrigation, we will randomize 426 patients into two groups and follow them up for 6 months using recurrence rates as the primary outcome. secondary outcomes in our study include mortality, neurological outcome and complications.

Eligibility criteria:
inclusion criteria: * patients with a symptomatic unilateral or bilateral csdh requiring burr-hole evacuation o predominantly hypodense or isodense on imaging (ct/mri). * clinical symptoms correlating with the csdh * patients with bilaterally operated csdhs will be treated with the same protocol on both sides and analyzed as a single study participant exclusion criteria: * csdh requiring surgical treatment other that burr-hole evacuation (e.g. craniotomy) * csdh in a patient who has a cerebrospinal fluid shunt * patients who have undergone any intracranial surgery before * comatose patients (gcs 8 or lower) with absent motor responses to painful stimuli; decerebrate or decorticate posturing * patient's postoperative cooperation is suspected to be insufficient for drain usage, i.e. disoriented or semiconscious patient * patient has a hematogenic malignancy that has obtained active treatment within the previous five years * patient has a central nervous system tumor or malignancy * patient has acute infection with fever and requires antibiotic treatment at the moment * patient has a high risk of life-threatening thrombosis (e.g. recent coronary stent, recent pulmonary embolism, low cardiac valve replacement) and discontinuation of antithrombotic medication is not recommended

Keywords: chronic subdural hematoma surgical evacuation recurrence irrigation fluid
study of orbec® as monotherapy in the treatment of patients with upper gi symptoms caused by chronic graft versus host disease (gvhd)

Conditions: Chronic Gastrointestinal Graft vs Host Disease

Summary: use of an oral topically-active glucocorticoid with limited side effects may control the gastrointestinal inflammatory process of gvhd and minimize glucocorticoid exposure.


Eligibility criteria:
inclusion criteria: * receipt of allogeneic hematopoietic cell transplant \>100 days prior to consent * documented cgvhd as defined by the nih consensus criteria in at least one organ system other than the gi tract (for example, cgvhd of the oral cavity would qualify as a criterion) * endoscopic findings consistent with gi gvhd * must be able to swallow tablets * must be able to read and understand informed consent * adequate birth control methods for the duration of the study exclusion criteria: * \>500 ml/day of diarrhea on any 1 day within 3 days prior to the first dose of study drug * gi infection * multi-organ failure or other condition that, in the opinion of the investigator, would compromise the patient's ability to complete the study. * hiv seropositivity * pregnant or nursing female * use of any investigational drug to treat chronic gvhd within 28 days of the first dose of study drug * evidence of recurrent or progressing malignant disorder that was the indication for hct

Keywords: bdp orbec gvhd beclomethasone dipropionate bone marrow transplant hematopoietic cell transplant hct stem cell transplant marrow transplant sct beclomethasone 17,21-dipropionate
a multicenter, open label, to evaluate the efficacy and satisfaction of patrex® in men with erectile dysfunction.

Conditions: Erectile Dysfunction

Summary: a multicenter open label study to assess the efficacy of sildenafil rapid dose titration to 100 mg in men with erectile dysfunction, based on the erectile function (ef) domain score of the international index of erectile function (iief) questionnaire.


Eligibility criteria:
inclusion criteria: * documented clinical diagnosis of erectile dysfunction (ed) by international index of erectile function (iief) erectile function (ef) domain score less than or equal to 25. * subjects must be in a stable relationship exclusion criteria: * subject with resting sitting hypotension (bp \ 170/110 mmhg) and orthostatic hypotension. * subjects receiving any pde (phosphodiesterase)-5 inhibitors within 4 weeks prior to the date of screening. * subjects with severe hepatic impairment, a known history of retinitis pigmentare. * subjects with significant cardiovascular disease in the last 3 months (per medical history.
performance of ellume·lab group a strep test versus culture for the rapid detection of group a streptococcus in patients with acute pharyngitis.

Conditions: Group A Streptococcal Infection

Summary: participants who meet the eligibility criteria and who consent to participation or whose parents/legal guardian consent to their participation, will be enrolled in the study for a period of up to 14 days. enrolment visit (day 1) assessments for all participants will include the collection of throat swabs, testing by staff at the site using the ellume·lab group a strep test and testing for group a streptococcus by a central laboratory using bacterial culture and polymerase chain reaction (pcr). all participants will be followed up with a phone assessment of adverse events between days 2-14.


Eligibility criteria:
inclusion criteria: * male and female participants aged 3 years of age or older * must currently be presenting with symptoms characteristic of pharyngitis, possibly group a strep, including: * acute onset of sore throat; * fever ≥ 37.8° c (100° f) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° c or feeling feverish within 24 hours of presentation and; * at least one of the following: * red and swollen/inflamed tonsils; * pharyngeal or tonsillar exudate; o cervical lymphadenopathy * ≤ 5 days from onset of signs and symptoms of pharyngitis * parent/legal guardian of participants \< 18 years of age capable and willing to give informed consent * participants ≥18 years of age capable and willing to give informed consent exclusion criteria: * participants \< 3 years of age * participants undergoing treatment with antibiotics, or those who have undergone treatment with antibiotics for current episode of pharyngitis * participants who have pharyngitis with clinical features that suggest a viral etiology such as, cough, runny nose, upper respiratory symptoms, and/or oral ulcers * currently enrolled in another clinical trial or used any investigational device within 30 days preceding informed consent * participants 18 years of age or older unable to understand english and consent to participation * parent/legal guardian of participants \< 18 years of age unable to understand english and consent to participation of child
clipped versus handsewn arteriovenous fistula anastomosis

Conditions: Arteriovenous Fistula Complications and Failure

Summary: the purpose of this study is to determine whether handsewn anastomosis versus clipped technique is associated with more complications, fistula failures, surgical cost and surgical time.

end stage renal disease requiring hemodialysis has become more prevalent in recent years. achieving vascular access is an important step in receiving hemodialysis. recent national goals have established that approximately 65% of all dialysis access points should be arteriovenous fistulas due to higher patency rates and decreased rates of further surgeries. multiple studies have been done to assess optimal suture technique for arteriovenous anastomoses. the use of clips versus a handsewn technique has been evaluated in retrospective studies with some reports indicating a higher primary patency rate with a clip technique. further study is needed to definitively determine the technique that results in the highest patency rates and lowest rate of re-operation. the purpose of this study is to determine whether hand-sewn anastomosis versus a clipped technique is associated with more complications, failures, surgical cost and surgical time by randomizing patients to either a clipped anastomosis group or a handsewn anastomosis group.

Eligibility criteria:
inclusion criteria: * 18 years of age or older. * need for avf creation for vascular access for planned hemodialysis (within 1 year). * the planned avf site must be naïve of prior avf creations. * vein mapping studies completed * 2.5 - 3mm minimum vein diameter on mapping exclusion criteria: * less than 18 years of age. * inability to provide consent. * previous failed avfs in both arms. * contraindications to avf creation: * ipsilateral proximal venous and arterial occlusion or stenosis * systemic or local infection * too ill to operate * anticipated inability to keep 30-day postoperative follow-up appointment.

Keywords: chronic kidney disease arteriovenous fistula surgical anastomosis complications patency dialysis access
effect of whole body vibration versus weight bearing exercises on osteoporosis in breast cancer patients after chemotherapy

Conditions: Osteoporosis; Breast Cancer

Summary: chemotherapy can damage bone marrow and therefore impair the production of white blood cells, platelets and red blood cells with the resulting anemia and osteoporosis.

purposes of this study were: 1. to determine the therapeutic efficacy of the whole-body vibration (wbv) in improving osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months. 2. to determine the therapeutic efficacy of the weight bearing exercise in improving osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months. 3. to gain knowledge about the whole-body vibration (wbv) and the weight bearing exercise in improving osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months. 4. to share in designing an ideal protocol for the treatment of the osteoporosis in breast cancer patients after receiving chemotherapy within 3-6 months.

Eligibility criteria:
inclusion criteria: * breast cancer patients after receiving chemotherapy within 3-6 months and complaining from osteoporosis. * their age ranges from 35-55 years old. * all patients will have the same medical and nursing care. * all the patients will receive a good explanation of treatment and measurement device. * they are neurologically free. exclusion criteria: patients will be excluded from this study for any of the following causes: * uncooperative patients. * instability of patient's medical condition. * association of another medical problem. * patients who have diabetes. * patients who have history of medical chronic relevant diseases. * patients who have acute or chronic hepatitis. * patients who have pacemaker. * patients who have genitourinary infections.
electrical vestibular nerve stimulation (vens) in the management of parkinson's disease

Conditions: Parkinson Disease

Summary: parkinson's disease burdens an increasing number of elderly populations in the country. parkinson disease is a chronic, progressive neurodegenerative disorder, affects approximately 1% of the population by the age of 65 years and 4% to 5% of the population by the age of 85 years. mild cognitive impairment in parkinson's disease leads to parkinson's disease dementia (pdd) for which currently there is no drug therapy. the existing treatments for pd were associated with side effects and does not offer complete cure. hence there is a need of alternative therapy which can prevent or delay the onset of pd with less or no side effects. vestibular stimulation is known to modulate cognitive processing, enhance learning and spatial memory. vestibular dysfunction is present in pd patients. so long term vestibular stimulation may be effective in enhancing cognition by reducing the cognitive, neurodegenerative, neuroinflammatory changes and behavioral deficits observed as predictors of mild cognitive impairment in parkinson's disease dementia. in this project, the plan is to administer electric vestibular nerve stimulation to pd patients which might be effective and ideal treatment with minimum or no side effects in the management of parkinson's disease.


Eligibility criteria:
inclusion criteria: * fulfilled the hoehn \& yahr classification of disability 79,80 stage 1-2 * ambulate with or without an assistive device for at least 50 feet * were able to get up and down from the floor with minimal assistance or less and * score of 24 or above on the folstein mini-mental state exam exclusion criteria: * decline in immune function such as pneumonia or systemic infection * progressive degenerative disease besides pd * spinal fusion or other orthopedic surgery in the past six months * mental disease/psychosis such as dementia * greater than minimal assistance required for gait and transfers * inability to make regular time commitments to the scheduled intervention sessions * experience with regular practice of any form of vestibular stimulation within the past year
effect of vestibular stimulation on motor proficiency and balance among children with down syndrome

Conditions: Vestibular System Disorder

Summary: this was a randomized controlled trial study where there the total participants were 22and these participants were randomly selected and then distributed in to two groups all participants were selected according to the inclusion exclusion criteria of the study and then they were randomly distributed in two groups named as group a and group b both of the contain equal number of participants which are randomly distributed in groups each group contain 11 participants .group a received the vestibular stimulation by swing in different positions supine, prone and with or without support in each position for 10minnts 3 times a week for 10 weeks along with general strengthening exercises of upper and lower limb and group b will receive general strengthening exercises of whole body for same time period. data will be then analyzed by using spss windows version 25

this was a randomized controlled trial study where there the total participants were 22and these participants were randomly selected and then distributed in to two groups all participants were selected according to the inclusion exclusion criteria of the study and then they were randomly distributed in two groups named as group a and group b both of the contain equal number of participants which are randomly distributed in groups each group contain 11 participants .group a received the vestibular stimulation by swing in different positions supine, prone and with or without support in each position for 10minnts 3 times a week for 10 weeks along with general strengthening exercises of upper and lower limb and group b will receive general strengthening exercises of whole body for same time period.

Eligibility criteria:
inclusion criteria:• down syndrome * age 6 to 11 years * having no other medical history (6) exclusion criteria: * • visual impairment * patient with hearing impairment * patient with poor cognition (6, 8)

Keywords: vestibular stimulation (ves) hypotonic cerebral palsy
the effect of colistin inhalation on ventilator associated pneumonia

Conditions: Ventilator Associated Pneumonia

Summary: the study has been conducted to measure the clinical outcome of early intervention with colistin inhalation in patients with ventilator associated pneumonia suspected to have multidrug resistant gram -ve bacteria


Eligibility criteria:
inclusion criteria: * age 18 years patients presenting with signs of infection 48 hours of intubation exclusion criteria: * patients with documented bronchiectasis cystic fibrosis known allergy to polymyxin. patients presenting with chest infection or signs of infection before intubation. patients with creatinine clearance less than 30ml/min.
a clinical study in patients with chronic idiopathic thrombocytopenic purpura in r788

Conditions: Idiopathic Thrombocytopenic Purpura

Summary: the purpose of this study is to investigate the efficacy, safety and pharmacokinetics of r788 compared with placebo, and to investigate the safety and efficacy of long term dosing of r788 in patients with chronic idiopathic thrombocytopenic purpura.


Eligibility criteria:
inclusion criteria: * japanese patients * patients diagnosed with idiopathic thrombocytopenic purpura at least 6 months before acquisition of consent * patients with a platelet count averages \<30000/μl during screening period. each platelet count should not exceed 35000/μl. * patients who have used and failed or who were intolerant at least 1 typical regimen for the treatment of itp before informed consent (with or without splenectomy) exclusion criteria: * patients with thrombocytopenia associated with other disease * patients with autoimmune hemolytic anemia * patients with poorly controlled hypertension * patients with a history or active coagulopathy
remotely delivered behavioral weight loss using an ad libitum plant-based diet versus a balanced calorie deficit diet

Conditions: Obesity; Overweight

Summary: this pilot randomized controlled trial will compare a remotely delivered behavioral weight loss program with a balanced calorie deficit diet (the current gold-standard) to a behavioral weight loss program with an ad libitum whole food plant-based diet (wfpbd) amongst adults with overweight/obesity (n = 52). the 6-month intervention will consist of 3 months of moderate-intensity intervention (weekly online modules and brief coaching calls), then a low-intensity period (3 calls over 3-months). assessments will occur at baseline, 6-weeks, 12-weeks, and post-treatment (6-months). acceptability, dietary adherence, weight, quality of life, depressive symptoms, and subjective appetite will be assessed.


Eligibility criteria:
inclusion criteria: * bmi 27-50 kg/m2 * ages 18-75 years * resides in the u.s. * consistent access to internet at home * proficient skill level in speaking, writing, and understanding english * reporting a desire to lose weight * consistently available for 15-minute once-weekly video appointment between the hours of 8 am and 7 pm est * willing to follow a whole food plant-based diet or a traditional calorie-reduced diet for the study duration * individuals must provide consent for the research team to contact their personal physician if necessary, to provide clearance or to consult about rapid weight loss exclusion criteria: * currently pregnant or breastfeeding or planned pregnancy within the study period * recent weight loss (≥ 5% weight loss in 3-months prior to the study) * history of bariatric surgery * currently following a low-fat plant-based diet * medical condition (e.g., cancer, type i diabetes, renal failure), current substance use problem, or psychiatric condition (e.g., active substance abuse, eating disorder) that may pose a risk to the participant during intervention or cause a change in weight * recently began or changed the dose of a medication that can cause significant change in weight * planning on quitting cigarette smoking over the program period * participation in a concurrent weight loss program during the study period * medical diagnosis currently influencing weight or appetite * medical condition that would limit ability to participate in this program (for example, mild stroke, diabetes if taking insulin, head trauma, cognitive disorder) * acute suicidality * currently meets criteria for regular loss-of-control eating (i.e., ≥ 9 binge episodes in past 3 months * currently reports engaging in a compensatory behavior

Keywords: vegetarian behavioral weight loss weight loss dietary self-monitoring obesity