Kornimate/medical-research-clean huggingface dataset:
assessment of masticatory performance in periodontitis

Conditions: Periodontitis, Chronic; Chewing Problem; Inflammation

Summary: the loss of periodontal attachment contributes to reduced masticatory performance and has a negative impact on general health.this clinical trial aims to assess the status of masticatory performance among patients with stage i, stage ii, stage iii and stage iv periodontitis, along with those with healthy periodontium.

periodontal disease manifestations include gingival bleeding, halitosis, tooth mobility and loss of teeth in advanced cases. the loss of periodontal attachment contributes to reduced masticatory performance and has a negative impact on general health. loss of periodontium leads to reduced ability of tooth to withstand masticatory loads. thus, biting abilities of subjects with healthy periodontium are significantly greater than those of chronic periodontitis patients. even though the new periodontitis classification includes masticatory dysfunction in stage 4, but clinical periodontal parameters do start influencing objective masticatory efficiency in early stages. since the masticatory function is an important point for the classification of periodontitis, standardized procedures with corresponding reference values are needed to consider these parameters in the assessment of periodontitis and to be able to make specific therapy recommendations. this clinical trial aims to assess the changes in masticatory performance among periodontitis patients of all stages and healthy individuals using test methods easily applicable in daily practice.

Eligibility criteria:
inclusion criteria: 1. adult patients with age group 30-50 years diagnosed with generalized periodontitis 2. presence of minimum 20 teeth (eichner group a1, a2, a3) excluding third molars. exclusion criteria: * systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases) * systemic diseases that may affect masticatory ability of the patient (sarcopenia, tmj disorders, xerostomia, acute pulpitis) * grade c periodontitis (evaluated indirectly by radiographic bone loss/age criteria) * smoking or substance abuse * pregnant and lactating women
yl-13027 and/or hy-0102 combined with ag regimen chemotherapy for metastatic pancreatic cancer

Conditions: Metastatic Pancreatic Cancer

Summary: in phase 1b study, six subjects will be enrolled in arm a (yl-13027 + ag regimen) and arm b (hy-0102 + ag regimen). the first 12 subjects will be evaluated for safety after one cycle. after safety assessment, subjects will start to enroll in arm c (yl-13027 + hy-0102 + ag regimen). each group is planned to include 12-20 subjects. according to the safety and efficacy results of 3 arms of subjects in phase ib, 1-2 groups were selected for expansion, and a randomized controlled study will be conducted with the standard treatment ag （arm 4）regimen chemotherapy.


Eligibility criteria:
inclusion criteria: * subject aged between 18 and 75 years. * subject has histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma. * subject has at least one evaluable metastatic lesion according to recist 1.1 criteria; * subject has an ecog score of 0-1 and is expected to survive more than 3 months; * subjects have a good level of organ function. exclusion criteria: * subject suitable for potentially curative surgery. * the subject confirmed by tissue or cytology as other pathological types, such as acinar cell carcinoma, neuroendocrine carcinoma, etc. * the subject has previously received gemcitabine and nab-paclitaxel combination therapy within 6 months of progression or intolerance.
effect of modality on discharge instruction in patients receiving outpatient antibiotic prescriptions from the emergency department

Conditions: Modality of Discharge Instructions

Summary: outpatient antibiotics are frequently prescribed from the emergency department, and limited health literacy may impact compliance with recommended treatments. the investigators are looking to determine if patient preference for multimodality discharge instructions for outpatient antibiotic therapy varies by health literacy level, and if modality effected patient-reported antibiotic compliance and 72-hour antibiotic pick-up.

this is a prospective randomized trial that includes consenting patients discharged with outpatient antibiotics. health literacy is assessed using a validated health literacy assessment, the newest vital sign (nvs). patients are randomized to a discharge instruction modality: 1) standard of care, typed and verbal medication and case-specific instructions; 2) standard of care plus text messaged instructions sent to the patient's cell phone; or 3) standard of care plus voicemailed instructions sent to the patient's cell phone. antibiotic pick-up is verified with the patient's pharmacy at 72 hours. patients are called at 30 days to determine antibiotic compliance.

Eligibility criteria:
inclusion criteria: * emergency department patient being prescribed an outpatient antibiotic or the parent of a patient under the age of 18 being prescribed on outpatient antibiotic exclusion criteria: * doesn't have a cell phone that can receive text messages and voicemail messages * unable to provide informed consent * prisoners
effects of diatermy in patients with fibromyalgia.

Conditions: Fibromyalgia

Summary: diathermy is a non-invasive pain therapy based on the local application of high-frequency electromagnetic waves. this procedure produces deep heat promotes tissue repair and influences pain sensitivity. the main characteristic of fibromyalgia (fm) is generalized musculoskeletal pain. this may be accompanied by muscle and joint stiffness, sleep and mood disorders, anxiety and depression, cognitive dysfunction, and chronic fatigue. endemic in developed countries, with a higher prevalence among women than men, and the etiology is still unknown. diagnosis is made on chronic generalized pain and through the presence of tender points. the objective of this study will be to analyze the efficacy of diathermy on pain in patients with fibromyalgia

the researchers aimed will be to observe the effect of diathermy (dt) on chronic fatigue, anxiety, and depression; analyze whether there are improvements in the impact of the disease in patients with fm after the application of dt; and check if there is an improvement in the quality of sleep after the application of dt. the aim is to collect a sample of more than 30 patients with fibromyalgia. variables to be collected include the overall pain experienced by the patients (visual analog scale), presure pain threshold using an algometer of the right and left trochanteric prominence, the fibromyalgia impact questionnaire (fiq) measures the impact of fm, the hospital anxiety and depression scale (hads) to measure anxiety and depression, the pittsburgh sleep quality questionnaire (psqi) to measure sleep quality and the modified fatigue impact scale (mfi-s) to measure self-reported general fatigue. subjects will be randomized into two groups: a control group (cg) that will not recive treatment and a experimental group (eu).

Eligibility criteria:
inclusion criteria: * experience chronic generalized pain and be diagnosed with fm for at least three months exclusion criteria: * recent surgery, skin conditions unsuitable for dt application, presence of certain neuropathic conditions (lupus, rheumatoid arthritis, diabetic polyneuropathy), ongoing pharmacological treatment such as anticoagulants within three days before participation, any underlying medical conditions like fractures or tumors; cardiac pathologies including heart failure, uncontrolled arterial hypertension, arrhythmias, phlebitis thrombi arteriopathies; having a pacemaker or suffering from epilepsy.

Keywords: fibromyalgia diathermy pain quality of life chronic fatigue anxiety
hero: a study to evaluate the safety, tolerability, and pharmacokinetics (pk) and pharmacodynamics (pd) of ion269 in participants with down syndrome (ds) at risk for alzheimer's disease (ad)

Conditions: Alzheimer Disease; Down Syndrome

Summary: the primary purpose of this study is to evaluate the safety and tolerability of ion269 in adults with down syndrome with evidence of brain amyloid positivity.

this is a phase 1b multi-center, open-label, single ascending dose (sad) study in adult participants with down syndrome with evidence of brain amyloid positivity. participants will be examined in 3 separate cohorts and will receive a single dose of study drug during the 36-week treatment period, followed by a 4-week follow-up period.

Eligibility criteria:
inclusion criteria: 1. has a reliable study partner, that is, a parent, sibling, or caregiver ≥ 21 years of age, who has known the participant for \> 6 months (i.e., a reliable and competent individual with a close relationship with the participant) and is capable of providing accurate information about the participant's history, can attend all scheduled study visits and provide feedback regarding the participant's symptoms and performance as described in the protocol, and can comply with all study requirements and activities. 2. has a diagnosis of down syndrome and has an intelligence quotient (iq) ≥ 45. 3. has evidence of amyloid pathology on amyloid-positron emission tomography (pet) scan. 4. is assessed as being cognitively stable. 5. is in good health as evidenced by medical history, physical, and neurological examination, and with no diagnosis of dementia or mild cognitive impairment. exclusion criteria: 1. has unstable psychiatric illness, including psychosis, or untreated major depression within 90 days before screening, as determined by the investigator. 2. has any unstable medical condition likely to hamper the evaluation of safety and/or efficacy of the study drug (e.g., moderate or severe untreated obstructive sleep apnea, medical history of clinically significant b12 or folate deficiency that is currently uncontrolled, clinically significant abnormalities of thyroid function, stroke, or other cerebrovascular conditions), as per investigator's judgment. 3. is unable to complete mri and amyloid/tau-pet procedures or has any contraindications to having a brain mri (e.g., mri-incompatible pacemaker, aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia that cannot be medically managed without requiring general anesthesia). note: other protocol defined inclusion/exclusion criteria may apply.
combined effects of blow bottle device and postural drainage in moderate to severe elderly copd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: it will be a randomized clinical trial. age of selected subjects will be between 40 to 70 years. data will be collected from wazirabad institute of cardiology. there will be 2 groups i.e. group a will receive combination of blow bottle technique and postural drainage and group b will receive postural drainage. spirometer will be used to evaluate pulmonary functions and breathless, cough and sputum scale (bcss) will be used to evaluate the improvement in sputum diary of patients. interventions will be given to the patients for 20-25 minutes twice a day for 6 days per week. after data collection, data will be analyzed using spss version 25.


Eligibility criteria:
inclusion criteria: * diagnosed moderate to severe gold (2017) copd * 40-60 years old * both male and female * patients hemodynamically stable * pft showing irreversible airflow limitation. exclusion criteria: * type ii diabetic mellitus * systemic illness * thoracic deformation or rib fracture. * pulmonale decompensation and signs of an unstable heart condition.

Keywords: dyspnea postural drainage
effects of neuromuscular electrical stimulation on flexor spasticity and function in stroke patients

Conditions: Stroke; Spastic Hemiplegia

Summary: in this study, the investigators aimed to determine the effects of botulinum neurotoxin type a injections for wrist and finger flexor spasticity and neuromuscular electrical stimulation therapy applied to wrist and finger flexors or extensors on upper extremity flexor spasticity and function in stroke patients.

neuromuscular electrical stimulation therapy applied to wrist and finger flexors (agonist application) or wrist and finger extensors (antagonist application) after botulinum neurotoxin type a injections in stroke patients with wrist and finger flexor spasticity in upper extremity flexor spasticity, to determine the effects on motor recovery, upper extremity and hand functions, hand grip strength, range of motion, functional independence, quality of life, hand skills and sonographically evaluated muscle thickness and to compare these different applications.

Eligibility criteria:
inclusion criteria: 1. diagnosed with ischemic or hemorhagic stroke after imaging with ct/mri 2. first time stroke survivor 3. between 45-75 years old 4. stroke duration \> 3 months 5. neurologically stable 6. affected wrist and finger flexor muscle spasticity with mas≥2 7. patients whose cognitive status is at a level to understand the study instructions mmt\> 23) exclusion criteria: 1. presence of another neurological disorder other than stroke causing motor impairment/spasticity 2. fixed contracture in the hand-wrist 3. use of medical treatment for spasticity 4. having received neurolytic therapy, bont-a injection or nmes treatment in the last 3 months 5. skin problem (disease, allergy, infection, etc.) on the contact surface of the nmes 6. complex regional pain syndrome (crps), sequelae of previous trauma or surgery (muscle tendon adhesion, peripheral nerve damage) in the affected extremity 7. having a pacemaker 8. epilepsy 9. malignancy

Keywords: stroke neuromuscular electrical stimulation rehabilitation hemiplegia spasticity
menevit study: menevit anti-oxidant therapy for the treatment of male infertility

Conditions: Infertility, Male; Oxidative Stress

Summary: oxidative stress related damage to sperm is believed to be a major cause of male infertility. the object of the menevit study is to investigate the role of a novel anti-oxidant preparation (menevit) on sperm function, embryo quality and pregnancy rates in an in vitro fertilization (ivf) setting.

men will be screened for oxidative stress (free radical) related damage to their sperm. this will include screening for lipid peroxidation of sperm using the lpo-586 assay, host test and for sperm dna fragmentation using the tunel technique. those men found to have free radical related damage will be enrolled in a randomized control trial in which they will receive either the menevit anti-oxidant or placebo (in a 2:1 randomization ratio respectively). the menevit anti-oxidant is a capsule containing several different anti-oxidants, taken orally once per day. the placebo is identical in appearance and taste. after 3 months of menevit/placebo the female partners of these men will undergo an ivf oocyte retrieval operation and embryo transfer. pregnancy rates and embryo quality will be compared between groups. changes in semen characteristics (count, motility, morphology, membrane integrity) and lipid peroxidation (lpo-586) plus sperm dna fragmentation (tunel assay) will be assessed at trial entry, 6 weeks and 3 months. comparisons between the patients embryo quality in the ivf cycle immediately before and during the menevit trial will also be compared when possible

Eligibility criteria:
inclusion criteria: * evidence of oxidative stress to sperm on lpo-586 assay or poor host result or clinical evidence for oxidative stress (heavy smoker, varicocele, poor motility in the abscence of anti-sperm antibodies etc) * evidence of significant sperm dna damage (25% or more dna fragmentation as assessed by tunel assay). * female partner willing to undergo ivf treatment within 3 months of starting menevit trial exclusion criteria: * female partner 40 years of age or older at trial entry. * significantly reduced ovarian reserve in female partner (day 3-5 fsh \> 10 iu/l if no prior ivf cycle or less than 5 oocytes on a prior ivf cycle. * sperm count below 0.5 million per ml (impossible to conduct all sperm function assays

Keywords: male infertility sperm pregnancy ivf (in vitro fertilisation) oxidative stress free radicals dna damage
body composition analysis for patient with lung cancer using computed tomography image analysis

Conditions: Lung Cancer

Summary: rationale: with 1.6 million new cases diagnosed each year and 1.3 million deaths, lung cancer is the leading cancer-related death worldwide and it represents a pressing health issue. patients with lung cancer are more likely to experience cachexia, a severe debilitating disorder causing fatigue, weight loss, muscle wasting and associated with reduced physical function, increased chemotherapy toxicity and reduced survival. this syndrome occurring in about 80% of advanced cancer patients is the direct cause of death in about 20% of cases. however, despite the importance of cachexia in lung cancer, it has been mainly studied from several assessment methods which do not usually differentiate muscle from other tissues. aim: to analyze body composition of patients with lung cancer at diagnosis using computed tomography (ct-scan) image analysis. methods: this is a retrospective study extending over a period of 3 years conducted at the institut universitaire de cardiologie et de pneumologie de québec (2009-2012). we listed patients newly diagnosed with lung cancer who had a thoraco-abdominal ct-scan performed in our institution. following the collection of clinical data from patient records, we used sliceomatic software to quantify muscle area, visceral fat area and subcutaneous fat area from a single abdominal cross-sectional image at the level of the third lumbar vertebra.


Eligibility criteria:
inclusion criteria: * men or women * between 40-80 years of age * primary lung cancer diagnosed between 2009 and 2012 * ct-scan done at the time of the diagnosis exclusion criteria: * chemotherapy, radiotherapy or surgery at the time of the first ct-scan image * history of other cancer (during the last five years)

Keywords: lung cancer body composition analysis ct-scan muscle mass cachexia
improving rates of colorectal cancer screening among never screened patients

Conditions: Colorectal Neoplasms

Summary: the united states preventive services task force (uspstf) recommends colorectal cancer (crc) screening using fecal occult blood test (fobt), sigmoidoscopy, or colonoscopy, beginning at age 50 and continuing until age 75. despite this recommendation, rates of crc screening remain inadequate and large disparities exist. screening rates are lower among black and hispanic populations, in areas with high poverty rates, among individuals with low education, and for those who utilize medicaid or lack health insurance. this study will determine the effectiveness of a multifaceted intervention to increase the number of patients who have never been screened for crc and are cared for at a community health center (chc) that complete a fecal immunochemical test (fit) within 6 months of randomization to an intervention group compared to patients in a usual care group. we believe that the proposed intervention will improve the crc screening rate in a cost-effective and sustainable way, ultimately leading to a reduction in the high rate of crc. aim 1: to conduct a randomized controlled trial to determine if a multifaceted intervention increases the proportion of patients who complete a fobt within 6-months of randomization. hypothesis 1: compared to usual care, the intervention will increase the proportion of never-screened patients who complete fobt within 6 months of randomization. aim 2: assess the costs of the intervention and the costs per additional initial screening compared to patients who receive usual care.


Eligibility criteria:
inclusion criteria: * age 50 to 75 * no documentation of previous crc screening (fobt, flexible sigmoidoscopy, or colonoscopy) * preferred language english or spanish * 2 visits to erie family health center in the past 2 years exclusion criteria: * any of the following: 1. colonoscopy within 10 years 2. flexible sigmoidoscopy within 5 years 3. a clinician order or referral for fobt prior to the due date (indicating concern for gastrointestinal bleeding) 4. medical conditions suggesting crc screening through fobt may be inappropriate, including chronic diarrhea, inflammatory bowel disease, iron deficiency, previous colonic polyp, use of medications in the previous 1 month that elevate the risk of a false-positive fobt (i.e., plavix or warfarin), and medical conditions that make crc screening inappropriate (metastatic cancer or previous total colectomy)

Keywords: colorectal cancer screening fecal occult blood testing
individual patient expanded access for ab-sa01, an investigational anti-staphylococcus aureus bacteriophage therapeutic


Summary: the purpose of the expanded access program is to allow physicians to provide treatment with investigational drug, ab-sa01, for patients with serious or immediately life-threatening staphylococcus aureus infections, for which no alternative treatment(s) are currently available, and who meet the criteria for treatment under fda's expanded access regulations and criteria set forth by ampliphi biosciences corporation. to be considered for expanded access, the request should be submitted to ampliphi by a qualified and licensed physician with expertise and facilities appropriate for the administration of the investigational medicine. treating physicians should contact ampliphi by emailing expandedaccess@ampliphibio.com with "expanded access request" in the subject line, and include in the email the treating physicians name, organization/hospital/institution, physical address, email address, telephone number, and a brief description of the indication/condition. any approval of expanded access to investigational medicine must always comply with the applicable laws and regulations.


Eligibility criteria:
inclusion criteria: - exclusion criteria: -