Kornimate/medical-research-clean huggingface dataset:
paclitaxel in treating patients with advanced, refractory, or recurrent cervical or vaginal cancer

Conditions: Cervical Cancer; Vaginal Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of paclitaxel in treating patients with advanced, refractory, or recurrent cervical or vaginal cancer.

objectives: i. estimate the frequency and duration of objective response, duration of progression-free interval, and survival of patients treated with paclitaxel for advanced, persistent, or recurrent clear cell adenocarcinoma of the vagina and cervix who have failed higher priority treatment protocols. ii. determine the frequency and severity of observed adverse effects on this study. outline: single-agent chemotherapy. paclitaxel, tax, nsc-673089. projected accrual: 25 evaluable patients per histologic stratum will be accrued over 10-12 months for the nonsquamous cell carcinoma stratum and over 23 months for the clear cell adenocarcinoma stratum. if more than 3 patients in a given stratum respond, an additional 25 patients will be accrued to that stratum. as of 07/95, the study is open only to patients with clear cell adenocarcinoma of the vagina or cervix.

Eligibility criteria:
disease characteristics: histologically confirmed advanced, persistent, or recurrent clear cell adenocarcinoma of the vagina or cervix documented disease progression after local therapy required disease must be considered incurable bidimensionally measurable disease required by physical examination or medical imaging patient characteristics: age: any age performance status: gog 0-2 hematopoietic: wbc at least 3,000 agc at least 1,500 platelets at least 100,000 hepatic: bilirubin no more than 1.5 times normal ast no more than 3 times normal alkaline phosphatase no more than 3 times normal renal: creatinine no more than 2.0 mg/dl other: not eligible for a higher priority gog protocol no significant infection no prior or concomitant second malignancy except nonmelanomatous skin cancer prior concurrent therapy: at least 3 weeks since therapy directed at malignancy biologic therapy: not specified chemotherapy: no more than 1 prior chemotherapy regimen (either single or combination cytotoxic drug therapy) no prior paclitaxel recovery from prior chemotherapy required endocrine therapy: not specified radiotherapy: no prior radiotherapy for recurrent disease except a low dose, single fraction used to abrogate menorrhagia recovery from prior radiotherapy required surgery: recovery from prior surgery required

Keywords: recurrent cervical cancer recurrent vaginal cancer vaginal clear cell adenocarcinoma cervical adenocarcinoma
sms maama project covid-19

Conditions: Pregnancy Complications; Birth Injuries

Summary: the study's purpose is to demonstrate the ability of an mhealth platform as a feasible way of sharing information in a time of restricted movement in order to inform future studies.

the primary objective of this trial is to assess whether an mhealth platform increases maternal health knowledge in the areas of birth preparedness, pregnancy, and birth complications as measured by the pre- and post-surveys in comparison to routine antenatal care. the secondary objectives of this trial are; 1. to provide knowledge of covid-19 symptoms, transmission, diagnosis, and treatment, in a time of social distancing and learning. 2. to improve access and linkages to maternal health services and information as well as provide appropriate referrals for pregnant females. 3. inform the adoption of mhealth into future health delivery plans.

Eligibility criteria:
inclusion criteria: * own a personal mobile phone * attend anc at kisenyi health centre iv, kawempe hospital or rubaga hospital * are at least 24-26 weeks estimated gestational age * literate in english or luganda * capable of sending/receiving text messages exclusion criteria: - females who plan to travel out of uganda during the study period
control of mrsa in nursing homes: decolonization vs standard precautions

Conditions: Methicillin-Resistant Staphylococcus Aureus

Summary: the purpose of this study is to determine the better approach between the currently procedure (i.e. standards precautions) and a reinforced strategy to control mrsa transmission in the institutionalized population of nursing homes in canton of vaud, switzerland.

mrsa carriage among nursing homes residents of canton vaud, switzerland, is increasing, despite use of standard precautions. recommendation to prevent mrsa transmission in long term care facilities are lacking. we aim to reinforce the current infection control strategy by general mrsa screening of institutionalised residents and decolonisation of mrsa carriers. because the uncertainties in the impact of this reinforced strategy, we aim to compare this action to the policy actually applied.

Eligibility criteria:
inclusion criteria: * all nursing homes of canton vaud, switzerland, that give the consent of participation exclusion criteria: - refusal to participate inclusion criteria for decolonisation in intervention nursing homes: - all mrsa positive residents living in a nursing home included in the intervention group exclusion criteria for decolonisation: * residents that refuse to be screened or refused the decolonisation * life expectancy shorter of 7 days * known intolerance of disinfectant/ topical antibiotics used in the protocol * active mrsa infection * asymptomatic mrsa bacteriuria * stage iv wound (according to national pressure ulcer advisory panel)

Keywords: methicillin-resistant staphylococcus aureus decolonisation nursing homes infection control
a dose ranging study of the aeris polymeric lung volume reduction (plvr) system in patients with advanced upper lobe predominant emphysema

Conditions: Advanced Emphysema

Summary: this is a multi-center, open-label, non-controlled pilot study. approximately 24 patients will be assigned to one of 3 treatment groups (8 patients each group). patients in each group will receive 2, 4, and 6 (3 followed by a retreatment of 3) subsegmental treatments, respectively. all patients will receive treatment in a single lung under conscious sedation or general anesthesia. patients will be followed for 24 weeks after completion of plvr treatment(s). upon completion of 12-week follow-up, all safety and efficacy data will be analyzed to determine an effective treatment dose. thereafter, group 1 patients may elect to be retreated at additional sites so that their total dose received is consistent with the effective dose. all study patients will receive standard medical therapy in addition to plvr.


Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of advanced upper lobe predominant (ulp) emphysema or advanced disease in the superior lower lobes as defined by fev1/fvc \ 100% of predicted, and rv \> 135% predicted. * patients must have persistent symptoms despite medical therapy and either not be candidates for lung volume reduction surgery (lvrs) or have elected not to undergo lvrs. * patients must be \> 40 years of age, have symptoms despite medical therapy, and have none of the pre-specified co-morbid conditions that could influence study outcomes or their ability to tolerate bronchoscopy.

Keywords: emphysema aeris plvr blvr germany treatment device breathing
titanium vs. peek fusion devices in 1 level tlif

Conditions: Spine Fusion; Lumbar Spondylolisthesis; Lumbar Stenosis

Summary: the objective of this study is to evaluate and follow the clinical and radiographic outcomes of patients undergoing 1 level tlif randomized to either a titanium or a peek spacer to 24 months after surgery.

transforaminal lumbar interbody fusion (tlif) remains a common surgical technique for the management of lumbar spondylosis requiring decompression and fusion. the choice of interbody spacer remains dependent on surgeon preference with a variety of options available for use. two of the most commonly used interbody spacers are made of polyetheretherketone (peek) and titanium.1 while both spacers have produced reliable rates of fusion with good clinical outcomes, debate remains as to which interbody spacer is superior. proponents of peek argue that it is radiolucent and has an elastic modulus similar to bone thus decreasing rates of subsidence. however, peek is a hydrophobic material that does not integrate with bone. titanium on the other hand demonstrates osseointegration and may lead to increased rates of fusion.while there are retrospective studies available comparing the two materials, the studies are small and there is a paucity of prospective data comparing the radiographic and clinical outcomes of these spacers. given the frequency with which these spacers are used, it is important to determine which spacer produces better clinical and radiographic outcomes for patients.

Eligibility criteria:
inclusion criteria 1. patients undergoing 1 level tlif for the treatment of lumbar stenosis and spondylolisthesis who have failed at least 6 weeks of non-operative treatment. 2. patients between 18-70 years of age at the time of surgery. exclusion criteria 1. patients under 18 or over 70 years of age at the time of surgery. 2. patients undergoing more than 1 level of surgery. 3. patients who have had prior lumbar fusion. 4. patients requiring surgery for the management of infection, tumor, or trauma. 5. patients who are pregnant.
hemodialysis vascular access imaging study

Conditions: Chronic Kidney Disease; Fistula; Hemodialysis Fistula Thrombosis

Summary: the goal of this study is to find the best techniques to take non-invasive images of the arteriovenous fistula (avf) in hemodialysis patients.

the vascular access is at the same time both the 'lifeline' and the 'achilles' heel' of hemodialysis patients. despite improved understanding of the pathophysiology of stenosis and thrombosis of the vascular access, unfortunately translating these advances into either improved therapies or a superior process of care has not been very successful. as a result, there continues to be an epidemic of arteriovenous fistula (avf) maturation failure, a proliferation of relatively ineffective interventions such as angioplasty and stent placement, an extremely high incidence of catheter use (1). a major problem is the timely diagnosis of avf access dysfunction, which - undiagnosed and untreated - will eventually result in its loss. current methods of diagnosing impending avf deterioration utilize measurement of access flow, access flow recirculation, ultrasound imaging and angiography. none of these methods are applicable on a per-treatment basis and require some sort of intervention. recent advances in video-imaging open the opportunity to non-invasively track avf movements, possibly on a routine basis. these avf movements are created by the arterial pulse and routinely checked manually prior to each avf cannulation. in this research the investigators plan to film the actual avf movements with the goal to explore the technical feasibility of video-imaging based access surveillance.

Eligibility criteria:
inclusion criteria: * age \> 18 years; routinely cannulated avf in place exclusion criteria: * inability to communicate in english * skin maladies which render meaningful avf imaging impossible * vascular access procedures in the last 8 weeks

Keywords: arteriovenous fistula hemodialysis vascular access
acupuncture for symptom control in hematopoietic stem cell transplantation patients

Conditions: Multiple Myeloma

Summary: this is a prospective randomized controlled trial to obtain preliminary data for the design of a future definitive efficacy study. a randomized controlled trial is needed because comparison to historical data would be biased. the investigators will use sham acupuncture as the control to account for effect from attention from and interaction with the therapist.


Eligibility criteria:
inclusion criteria: * age 21 or above (those age below 21 are usually treated in the pediatric transplant service) * diagnosis of multiple myeloma * scheduled to receive conditioning chemotherapy followed by upfront or salvage autologous peripheral blood hematopoietic stem cell transplantation exclusion criteria: * absolute neutrophil count less than 200/microliter * platelet count less than 20,000/microliter * acupuncture treatment in the preceding 4 weeks prior to day 1

Keywords: acupuncture hematopoietic stem cell transplantation (hsct) 13-038
intraoperative dexamethasone in pediatric cardiac surgery

Conditions: Cardiac Surgery; Congenital Heart Defects; Cardiopulmonary Bypass

Summary: perioperative administration of steroids has been demonstrated to reduce systemic inflammatory response in infants undergoing cardiac surgery with cardiopulmonary bypass. however, data on effects of steroids on clinical outcomes are lacking. hence the hypothesis of the present study: intraoperative administration of dexamethasone reduces complication rates and improves clinical outcomes in infants undergoing repair of congenital heart defects under cardiopulmonary bypass.


Eligibility criteria:
inclusion criteria: * elective repair of congenital heart defects under cardiopulmonary bypass exclusion criteria: * absence of written informed consent signed by parent or guardian; * hypoplastic left heart syndrome; * participation in conflicting randomised studies; * emergency surgery; * inotropic support prior to surgery; * mechanical ventilation prior to surgery; * bacterial, viral or fungal infection in the preceding 30 days; * gestational age less that 37 weeks; * perinatal central nervous system damage.

Keywords: pediatric cardiac surgery dexamethasone steroids cardiopulmonary bypass congenital heart defects infants
a phase ii trial of cg 8020 and cg 2505 in patients with nonresectable or metastatic pancreatic cancer

Conditions: Metastatic Pancreatic Cancer; Nonresectable Pancreatic Cancer

Summary: to evaluate the safety and effectiveness of cg8020 and cg2505.

to evaluate clinical and laboratory safety of cg 8020 and cg 2505 and to evaluate the efficacy of cg 8020 and cg 2505 as measured by clinical benefit response, progression-free survival, survival and ca 19-9 serum marker levels in chemotherapy naive or experienced patients with nonresectable or metastatic adenocarcinoma of the pancreas

Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of nonresectable or metastatic pancreatic adenocarcinoma * chemotherapy naïve or chemotherapy experienced pancreatic cancer exclusion criteria: * prior cancer vaccines or gene therapy * history of clinically significant autoimmune disease (eg, systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis) * history of another malignancy in the past five years, except adequately treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix, unless approved by the medical monitor

Keywords: cancer vaccine pancreatic cancer metastatic pancreatic cancer unresectable pancreatic cancer immunotherapy
non-invasive brain stimulation as a treatment for dysarthria post-stroke

Conditions: Dysarthria; Stroke

Summary: the proposed study aimed to determine if tdcs can help post-stroke patients with dysarthria.

a total of 9 cantonese-speaking chronic post-stroke patients who are suffering from dysarthria was recruited and randomly divided into treatment group and sham group. for the treatment group, an anodal high-definition tdcs of 2 milliampere (ma) lasting for 15 minutes was delivered to the primary motor cortex (sm1) in 10 daily sessions during a 2-week period. for the sham tdcs group, the same setting of tdcs electrodes was applied on the scalp, but the stimulation only lasted for 30 sec in order to cause similar sensation on the scalp as the other group. simultaneous to the tdcs stimulation, both groups will receive speech and voice therapy for 30 minutes. an array of outcome measures reflecting speech production ability including acoustic, kinematic, perceptual and self-perceptual qualities was obtained before and after stimulation. it was anticipated that post-stroke dysarthric patients will see improvement in speech production after stimulation. the results provided important insights into the effects of tdcs on articulatory movement in individuals with dysarthria post-stroke.

Eligibility criteria:
inclusion criteria: * cantonese-speaking adults * at least 6 months after their initial stroke * dysarthria post-stroke exclusion criteria: * a personal or family history of epilepsy or seizures * a history of another neurological condition * speech disorders * voice disorders * oro-maxillo-facial surgery involving the tongue and/or lip * severe cognitive impairment * severe aphasia * heart disease * metallic foreign body implant * on medications that lower neural thresholds (e.g. tricyclines, antidepressants, neuroleptic agents, etc.)
open-label "compassionate" use study of spiramycin for the treatment of diarrhea due to chronic cryptosporidiosis in immunocompromised patients

Conditions: Cryptosporidiosis; HIV Infections

Summary: this protocol provides for the availability of spiramycin under compassionate-use conditions for the treatment of chronic diarrhea due to cryptosporidium in patients with a compromised immune system, thus deriving additional information regarding its safety and efficacy profile.


Eligibility criteria:
exclusion criteria co-existing condition: patients with known sensitivity to macrolide antibiotics are excluded. consideration must be given to the fact that spiramycin is a macrolide antibiotic and, therefore, may have the potential to induce hepatotoxicity. * patients with a compromised immune system may have hepatic abnormalities or even hepatitis. if the benefit-to-risk ratio does not favor the use of spiramycin, the patients must be excluded from the study. concurrent medication: excluded: * other investigational drugs. patients with known sensitivity to macrolide antibiotics are excluded. consideration must be given to the fact that spiramycin is a macrolide antibiotic and, therefore, may have the potential to induce hepatotoxicity. * patients with a compromised immune system may have hepatic abnormalities or even hepatitis. if the benefit-to-risk ratio does not favor the use of spiramycin, the patients must be excluded from the study. prior medication: excluded within 7 days of study entry: * other investigational drugs. diagnosis of chronic diarrhea due to cryptosporidiosis and a compromised immune system but not limited to patients with aids. * patients receiving chemotherapy for a malignancy. * patients who are iatrogenically immune-suppressed following organ transplantation.

Keywords: spiramycin aids-related opportunistic infections immune tolerance cryptosporidiosis diarrhea drugs, investigational acquired immunodeficiency syndrome
multimorbidity and sarcopenia feasibility study in chronic kidney disease

Conditions: Chronic Kidney Diseases; Sarcopenia

Summary: the aim of this research study is to look at the body composition (such as muscle and fat) in people with chronic kidney disease (ckd) and comparing it with body composition is people without ckd. the investigators currently understand loss of muscle function and mass (sarcopenia) affect the general health of people as they age, but this process seems to be more common, accelerated, and occurs earlier in people with ckd. there is limited evidence in this area, and we believe that if we understand when and how sarcopenia affects people with ckd, investigators can guide future trials and treatments to help treat sarcopenia, and in turn improve quality of life and health outcomes in people with ckd.

in this study, the investigators will follow up people with ckd in two visits a year apart. in both visits, the investigators will measure the participants body composition and estimated kidney function using 2 different testing methods - cystatin c egfr and creatinine egfr. using both the results in a formula, the creatinine muscle index can be calculated. if this index correlated with sarcopenia, it will be helpful tool in the care of people with ckd as will be a easy to use screening tool for sarcopenia in this population.

Eligibility criteria:
inclusion criteria: subjects capable of giving informed consent ≥18 years of age chronic kidney disease stages 3-5 looked after in secondary care nephrology healthy volunteers with normal kidney function (control) exclusion criteria: * pregnancy * subjects with known neuromuscular diseases, e.g. myopathy, muscular dystrophy, muscular atrophy * renal transplant recipients * patients with pacemakers
react integrated consent model to compare two standard of care regimens

Conditions: Breast Cancer

Summary: the integrated consent model is being increasingly used internationally to improve patient care. in this feasibility study we will explore whether the model is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials, and address the critical issue around the optimal febrile neutropenia prevention by randomizing eligible patients to either g-csf or ciprofloxacin.


Eligibility criteria:
inclusion criteria: * histologically confirmed primary breast cancer * planned tc chemotherapy * ≥19 years of age * able to provide verbal consent * willing to complete a survey exclusion criteria: • contraindication to either ciprofloxacin or g-csf

Keywords: breast
use of eye movement tracking to detect oculomotor abnormality in traumatic brain injury patients

Conditions: Brain Concussion; Cerebral Concussion; Concussion, Intermediate; Concussion, Mild; Concussion, Severe; Trauma, Nervous System; Craniocerebral Trauma; Brain Injuries

Summary: the purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for the emergency department (ed) or concussion clinic.


Eligibility criteria:
inclusion criteria: * provide written informed consent. * be between the ages of 4 and 67 years old. * have a diagnosis of traumatic brain injury with a potential for concussion. * subjects must have baseline vision correctable to within 20/500 bilaterally. * subjects must have intact ocular motility. * subjects must have ability to provide a complete ophthalmologic, medical and neurologic history as well as medications/drugs/alcohol consumed within the 24 hours prior. exclusion criteria: * er visit has been more than 2 weeks since the injury which may have caused the concussion. * have received penetrating trauma or have a head ct demonstrating evidence of acute brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read). * suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability. * blind (no light perception), are missing eyes, do not open eyes. * it is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant. * previous history of: ocular motility dysfunction or extensive prior eye surgery. * any physical or mental injury or baseline disability rendering task completion difficult. * obvious intoxication or blood alcohol level greater than 0.2.

Keywords: eye tracking concussion outcome measures