Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of the use of memantine for preserving cognition in adult patients with epilepsy

Conditions: Epilepsy

Summary: people with epilepsy often experience problems with their memories and other thinking skills that get worse over time. the investigators hope to learn more about whether a drug called memantine can help improve or stabilize (keep the same) memory and other thought processes in people with epilepsy by blocking a chemical that is released in the brain during seizures. the investigators also want to see if memantine changes the frequency (how often) people with epilepsy have seizures. memantine is currently approved by the united states food and drug administration (fda) for treatment of patients with alzheimer's disease.

this is a double-blind, placebo-controlled trial of the effects of memantine in adult epilepsy patients. patients will be assessed for neurocognitive outcomes, seizure frequency and side effects. after a two-month prospective baseline during which seizure frequency and neurocognitive parameters are documented, patients will be randomized to either memantine or placebo and evaluated after twelve months on study drug. the treatment period will consist of a one month dose escalation phase, followed by an eleven month maintenance phase. the dose escalation is 5 mg in pm for days 1-7, 5 mg twice daily for days 8-14, 5 mg in am and 10 mg in pm for days 15-21 and 10 mg twice daily from day 22 and continue. the neuropsychological battery performed during baseline will be repeated at the end of the twelve month treatment period. no special procedures are required for this study, except the neuropsychological testing, which is not a routinely performed evaluation for adult epilepsy outpatients.

Eligibility criteria:
inclusion criteria: 1. adult patients with temporal lobe epilepsy, aged 18-65 2. seizure frequency of less than three per month 3. stabilized treatment for epilepsy, including aeds and vagus nerve stimulation 4. intelligence quotient of \>70 5. native english speaker (most of the neuropsychological/cognitive tests have yet to be translated and/or validated in non-english speaking populations. thus, at this point we are limited to testing english speakers, only.) 6. able to count seizures accurately and maintain a seizure diary 7. recent aed levels performed within the last month within therapeutic range exclusion criteria: 1. progressive neurologic disease 2. severe medical illness, including renal insufficiency 3. severe depression, bipolar disease or psychosis 4. pregnant or lactating women.

Keywords: epilepsy memory cognition memantine
safety and efficacy of ba1302 in patients with advanced solid tumors

Conditions: Non-Small Cell Lung Cancer; Pancreatic Adenocarcinoma; Breast Cancer; Melanoma

Summary: this is a first-in-human (fih), multicenter, open-label phase i study to evaluate the safety, tolerability, pk profile, immunogenicity, and preliminary efficacy of ba1302 in patients with advanced solid malignancies. the study includes a dose-escalation phase (part a) and a dose-expansion phase (part b).


Eligibility criteria:
inclusion criteria: * 1. metastatic or unresectable solid malignancy that is histologically or cytologically confirmed. patients who have progressed on or after standard therapy, or are intolerant of standard therapy, or have no appropriate standard therapy available. 1. part a: advanced malignant solid tumors; 2. part b: metastatic melanoma, advanced breast cancer, advanced non-small cell lung cancer (nsclc), advanced pancreatic adenocarcinoma. * 2.participants should be able to provide adequate tumor tissue for biomarker analysis * 3.ecog performance status ≤ 1. * 4.measurable disease per response evaluation criteria for solid tumors version 1.1 (recist v1.1) exclusion criteria: * 1. malignant disease within 5 years prior to the first dose of investigational drug other than that being treated in this study. except completely resected basal cell carcinoma, cutaneous squamous cell skin carcinoma and papillary thyroid carcinoma and completely resected carcinoma in situ of any type. * 2. received any chemotherapy, radiotherapy, targeted therapy, cell therapy, immunotherapy, adc medication or other anti-cancer treatment within 28 days prior to the first dose. * 3.history of severe hypersensitivity reactions to any ingredient of study drugs. * 4.pregnant or lactating women. * 5.any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns, compliance with clinical study procedures or interpretation of study results.
clinical characteristics and pathophysiology of post-traumatic headache

Conditions: Post-Traumatic Headache; Concussion, Mild

Summary: to better understand the clinical characteristics and complex pathophysiological events that constitute persistent post-traumatic headache (ppth) and to identify possible calcitonin gene-related peptide (cgrp) hypersensitivity in ppth patients.

the present project will embark upon identifying novel pth-specific biomarkers by incorporating a plethora of scientific approaches. first, clinical biomarkers will be assessed by deep phenotyping of clinical characteristics and associated comorbidities using a semi-structured interview and multiple validated questionnaires. second, biochemical biomarkers will be determined by plasma levels measurements of blood markers for headache hypersensitivity and neuronal/axonal damage. third, imaging biomarkers will be established by magnetic resonance imaging (mri) to assess structural and functional changes in the brain. lastly, molecular biomarkers will be identified by examining whether intravenous infusion of calcitonin gene-related peptide (cgrp) provokes headache attacks mimicking the usual headache phenotype in subjects with pth. this would determine whether pth patients exhibit hypersensitivity to cgrp (molecular biomarker) and advance our understanding of the complex pathophysiological events that constitute the headache phenotypes in pth sufferers.

Eligibility criteria:
inclusion criteria for ppth patients: * 18-65 years of age * subject has ppth in accordance with the diagnostic criteria of the international headache society (ihs) * concussion (mild traumatic brain injury) occured \> 12 months ago * subject, who are fertile women, must be on safe contraceptives exclusion criteria for ppth patients: * pre-trauma existing primary headache disorder (maximum 1 day/per month with tension-type headache) and medication-overuse headache * \> 1 episode with a sustained concussion * whiplash * pregnant or lactating women * cardiovascular disease of any kind * hypertension on the experimental day * hypotension on the experimental day * pre-trauma existing psychiatric disorder of any kind - unless well-regulated * any anamnestic or clinical signs of any kind deemed relevant for the study by the physician examining the subject * any mri contraindication and a wish of not being informed about unexpected mri changes
effect of homeopathy, acupuncture or anthroposophic medicine in women's quality of life

Conditions: Anxiety; Depression; Premenstrual Tension; Hot Flashes; Muscular Diseases

Summary: patients will be randomly assigned to two separate groups. both patient groups will be evaluated using the whoqol-bref questionaire. evaluations will be carried out just before the study begins and at intervals of six months during a period of one year for a total of three evaluations. group one will be made up of patients who will begin homeopathy or acupuncture or anthroposophic medicine treatment and patients from group two will start homeopathy or acupuncture or anthroposophic medicine six months after the beginning of the study. each one of these three research branches will be done independently (homeopathy versus control; acupuncture versus control; anthroposophic medicine versus control). conventional medical treatment will be available for all patients in both groups. a data sheet will be filled out on each patient with data as to age, education level, marital status and the patient's own perception of their health status. during the interviews the interviewer will have no influence whatsoever over the respondents' answers. integrative/complementary or traditional medicine doctors do not participate in the research and will not be informed about which patients are participating in this project, and as such the research will be blinded for these doctors. minitab software, version 16, was used for sample calculation through the module power and sample size. sample calculation option for paired t-tests before and after intervention demonstrated the need to randomize 906 patients: 450 patients for homeopathy branch (225 patients in the homeopathy group and 225 patients in the control group), 228 patients for acupuncture branch (114 patients in the acupuncture group and 114 patients in the control group), and 228 patients for anthroposophic medicine branch (114 patients in the anthroposophic medicine group and 114 patients in the control group).


Eligibility criteria:
inclusion criteria: * women over 18 years of age * patients with chronic diseases exclusion criteria: * women below 18 years of age * previous treatment with homeopathy (for homeopathy versus control branch) * previous treatment with acupuncture (for acupuncture versus control branch) * previous treatment with anthroposophic medicine (for anthroposophic medicine versus control branch)
coagulation factors, cytokines and tissue injury markers in sepsis

Conditions: Sepsis

Summary: in an effort to better understand the interaction between the different mediators, the investigators propose to examine the time course of mediators, the indexes of organ injury and the coagulation cascade.

all patients admitted to the icu (including va medical center, university hospital and presbyterian hospital) will be screened for enrollment in the study. patients who have the diagnosis of sepsis will be asked to volunteer. we will match sepsis patients with other icu patients without the diagnosis of sepsis. the latter will also be asked to volunteer. patients will be stratified into three groups: * sepsis * sirs of non-septic origin * other icu patients routine laboratory data and clinical data (see flow sheet) will be collected. the plasma or serum will be frozen separately until the target number of patients is met. measurements of inflammatory mediators and other cytokines/injury markers will be carried out at that point.

Eligibility criteria:
inclusion criteria: * admission to the icu exclusion criteria: * no blood draws scheduled * hemoglobin level \< 6.5 gm/dl

Keywords: histones organ failure sepsis
radiation therapy on pelvic floor disorders in women

Conditions: Colorectal Cancer

Summary: investigators propose a retrospective cohort study to examine the impact of radiation therapy on the global pelvic floor function of women who have completed the immediate surveillance period for colorectal cancer

primary objective: to characterize the impact of radiation therapy on the lower urinary and bowel tract symptoms, (featuring urinary incontinence, irritative voiding symptoms, voiding dysfunction, bowel incontinence, and defecatory dysfunction) of female survivors of colorectal cancer 2-5 years after treatment. secondary objectives: * to characterize sexual dysfunctions present in female colorectal cancer survivors 2-5 years after treatment and to determine the impact of radiation therapy compared to surgical treatment alone. * to examine the impact of radiation therapy on the sexual function of the partner of female survivors of colorectal cancer treated with radiation treatment.

Eligibility criteria:
inclusion criteria: * living, female patients. * age 18 or older with a diagnosis of colorectal cancer (current or past, regardless of stage)-confirmed by pathology report - made between the years of 2015 and 2018. * history of treatment for colorectal cancer in the wake forest baptist health system. * sexual partners of the above participants (subjects can participate even if they are not sexually active or if no sexual partner is available). * english speaking. exclusion criteria: * no internet access. * non-english speakers (validated instruments are only available in english).

Keywords: survivors of colorectal cancer lower bowel tract symptoms urinary incontinence irritative voiding symptoms voiding dysfunction bowel incontinence defecatory dysfunction lower urinary tract symptoms
single dose study in patients with chronic obstructive pulmonary disease (copd) associated pulmonary hypertension.

Conditions: Hypertension, Pulmonary; Pulmonary Disease, Chronic Obstructive

Summary: this study is to demonstrate the safety, tolerability, pharmakokinetic and pharmacodynamic effect of a single oral dose of bay63-2521 in patients with pulmonary hypertension due to chronic obstructive pulmonary disease (copd).

in addition to the pharmacodynamic and pharmacokinetic variables, the following laboratory variables were assessed: * hematology: leucocytes, erythrocytes, hemoglobin, hematocrit, mean corpuscular volume (mcv), mean corpuscular hemoglobin (mch), mean corpuscular hemoglobin concentration (mchc), platelets, white blood cell (wbc), partial thromboplastin time (ptt), prothrombin time (quick), international normalized ratio (inr) (prothrombin time expressed in relation to normal value) ; * clinical chemistry: aspartate aminotransferase (ast), alanine aminotransferase (alt), alkaline phosphatase (ap), gamma glutamyl transpeptidase (ggt), creatine phosphokinase (ck), lipase, cholinesterase (che), glucose, creatinine, urea, uric acid, bilirubin, total protein, serum albumin, sodium, potassium, calcium, chloride. and due to the small number of subjects analyzed at several local labs, no summary statistics were provided.

Eligibility criteria:
inclusion criteria: * patients with pulmonary hypertension due to copd, undergoing routine invasive measurement of hemodynamic parameters. * catheters for measurement of hemodynamic parameters (pap \[pulmonary artery pressure\], pcwp \[pulmonary capillary wedge pressure\], co \[cardiac output\], sbp \[systolic blood pressure\]) must be in place independent of the trial. exclusion criteria: * acute exacerbation of copd, * pre-existing lung disease other than copd, * acute or severe chronic left heart failure, * severe coronary artery disease, * uncontrolled arterial hypertension; * severe left ventricular hypertrophy, * congenital or acquired valvular or myocardial disease, * systolic blood pressure \< 100 mmhg, * heart rate \ 105 bpm, * pao2 (arterial partial oxygen pressure)/fio2 (fraction of inspired oxygen) \< 50 mmhg, * paco2 (arterial partial pressure of carbon dioxide) \> 55 mmhg, * severe hepatic insufficiency, * severe renal insufficiency.

Keywords: chronic obstructive pulmonary disease copd pulmonary hypertension
acupuncture for vasectomy pre-procedural anxiety and pain control in the primary care setting

Conditions: Acupuncture; Pain, Postoperative; Vasectomy

Summary: this study compares auricular (ear) acupuncture and body acupuncture (koffman protocol) versus clinic standardized pre-vasectomy medications to determine which has better outcomes at improving pre-procedural anxiety and procedural pain relief and medication usage in adult male patients following vasectomy.

the investigators will compare auricular (ear) and body acupuncture (koffman protocol) versus clinic standardized pre-vasectomy medications to determine which has better outcomes at improving pre-procedural anxiety and procedural pain relief and medication usage in adult male patients following vasectomy. in this efficacy trial, the investigators hypothesize that acupuncture will provide therapeutic anxiety and pain relief during and after vasectomy. the investigators will measure anxiety immediately before and prior to the procedure and before and after the intervention via a standardized anxiety scale (comparative). the investigators will also measure pain control immediately after the procedure using defense and veterans pain rating scale (dvprs). at the post op check (2-4 days after procedure) subjects will fill out a patient satisfaction survey. during the recovery period over 2 weeks, a medication usage diary will be kept by the subject including the time when the patient returns to full duties.

Eligibility criteria:
\*\*patients must be able to get care at nellis air force base (a military installation) in order to participate in this study\*\* inclusion criteria: * male active duty members and dod beneficiaries aged 25 years or older * scheduled for a vasectomy exclusion criteria: * repeat vasectomy * chronic pain medication/benzodiazepine use * current pain contract/pain management * current anxiolytic medication * history of needle shock * diagnosis of anxiety * needle phobia * blood/injury phobia * history of vasovagal reflex response
dry needling in post-operative shoulder pain

Conditions: Proximal Humeral Fracture Fixated With PHILOS© Plate; Rotator Cuff Tear Surgical Repair

Summary: fractures of the proximal humerus account for between 5% and 8% off all reported fractures. post-operative shoulder pain is highly frequent. due to either surgical procedure, soft tissues surrounding the shoulder area can be damaged. the purpose of the current clinical trial was to compare the effects of physiotherapy versus physiotherapy plus trp-dn on pain and function in patients who exhibit post-operative shoulder pain after a philos procedure for proximal humeral fixation or rotator cuff tear repair.


Eligibility criteria:
inclusion criteria: * proximal humeral fracture * rotator cuff tear * open reduction and internal fixation with philos© plate (synthes, switzerland) * rotator cuff tear repair * post-operative shoulder pain * active trps in the neck-shoulder muscles exclusion criteria: * no active trps * multiple fracture * previous surgery * cervical radiculopathy or myelopathy * diagnosis of fibromialgia * having undergone any physical therapy intervention in the year before the surgery * fear of needles * any contraindication for dry needling
treatment of coronary artery bifurcation narrowing by axxess stent implantation

Conditions: Coronary Artery Disease

Summary: the axxess™ biolimus a9™ eluting coronary bifurcation stent system (axxess system; biosensors, international, morges, switzerland) is a dedicated bifurcation stent, designed to cover the lesion at the level of the carina. although deemed ideal for lesions involving only the proximal mv (1,0,0 according to medina classification ref), this device may be used also in more complex bifurcation lesions when additional des are required in the distal mv and/or in the sb. in the present registry the investigators report the performance and the efficacy of the self-expanding biolimus-eluting axxesstm stent for the treatment of bifurcation lesions in a real-world population.

despite a comprehensive understanding of the physiological and technical issues regarding the coronary bifurcations lesions, percutaneous coronary intervention (pci) in this setting remains challenging. when compared with non-bifurcation lesions, treatment of bifurcation lesions is associated with increased adverse clinical events and inferior angiographic outcomes including procedural complications. this is due to several technical challenges, including both anatomical (proximal-to-distal vessel mismatch \[tapering\], angulation and calcification) and procedural (plaque shift, and side-branch \[sb\] closure) features. current balloon-expandable drug-eluting stent (des) have not been designed to treat the bifurcation lesions; in particular, the inability of des to adequately scaffold and preserve the ostium of sb represents a the major reason of failure, because this is the most common site for restenosis. recently a large variety of dedicated bifurcation stents have been developed in order to 1) provide an easier access to the sb and to scaffold more effectively its ostium, and 2) adapt to main vassel (mv) tapering, and to the bifurcation anatomy.

Eligibility criteria:
inclusion criteria: 1. significant (≥70% diameter stenosis) bifurcation lesion; 2. mv reference diameter between 2.75 and 4.75 mm by visually estimated 3. sb reference diameter ≥2.25 mm by visual estimate; 4. bifurcation angle (between the distal mv and the sb) \<70° by visual estimate exclusion criteria: 1. patients with contraindications to prolonged dual-antiplatelet therapy, 2. known sensitivity to "limus" compounds, stainless steel, titanium, or nickel; 3. inclusion in others studies on bifurcation lesions; and 4. all bifurcation lesions not satisfying the angiographic inclusion criteria reported above

Keywords: coronary bifurcation coronary stent
expanded access to voxelotor for patients with sickle cell disease who have no alternative treatment options

Conditions: Sickle Cell Disease

Summary: the intent of this open-label, multicenter expanded access program (eap) is to provide early access to voxelotor prior to market authorization

the purpose of this program is to provide early access to voxelotor for patients with sickle cell disease who have exhausted alternative treatment options and are ineligible for actively-recruiting clinical trials of voxelotor. this eap may continue until such time that voxelotor is commercially available or the sponsor discontinues the voxelotor eap. discontinuation may occur earlier if an individual participant or physician or sponsor medical monitor decides to discontinue treatment.

Eligibility criteria:
inclusion criteria 1. documented diagnosis of sickle cell disease of any genotype confirmed by laboratory testing during screening 2. ineligible or unable to participate in actively recruiting clinical studies of voxelotor 3. hemoglobin (hb) ≤ 10.5 g/dl during screening 4. no alternative treatment options in the judgment of the treating investigator 5. participants, who if female and of child bearing potential, agree to use highly effective methods of contraception from study start to 30 days after the last dose of voxelotor, and who if male, agree to use barrier methods of contraception from study start to 30 days after the last dose of voxelotor 6. patient has provided documented informed consent (the informed consent form \[icf\] must be reviewed and signed by each participant),or for participants under 18 years of age, signed parental/legal guardian consent and participant assent. exclusion criteria 1. female who is breast feeding or pregnant 2. hepatic dysfunction characterized by alanine aminotransferase (alt) \>4 × uln 3. patients with clinically significant bacterial, fungal, parasitic, or viral infection which require therapy: * patients with acute bacterial infection requiring antibiotic use should delay screening/enrollment until the course of antibiotic therapy has been completed. * patients with known active hepatitis a, b, or c or who are known to be human immunodeficiency virus (hiv) positive 4. renal dialysis 5. non-scd conditions or complications of scd for which survival beyond 3 months is unlikely, in the opinion of the treating investigator 6. any condition affecting drug absorption, such as major surgery involving the stomach or small intestine (prior cholecystectomy is acceptable) 7. participated in another clinical trial of an investigational agent (or medical device) within 30 days or 5 half-lives of date of informed consent, whichever is longer, or is currently participating in another trial of an investigational agent (or medical device) 8. medical, psychological, or behavioral conditions, which, in the opinion of the investigator, may preclude safe participation, interfere with compliance or preclude informed consent the sponsor medical monitor makes the sole and final enrollment determination for any patient.