Kornimate/medical-research-clean huggingface dataset:
oasis: osteoarthritis sensitivity integration study

Conditions: Osteoarthritis; Chronic Pain

Summary: the primary objective of this study is to evaluate the relative efficacy of a centrally-acting analgesic (duloxetine) versus a peripherally acting analgesic (topical diclofenac) for pain and associated symptom management in knee osteoarthritis. secondary objectives include the determination of which self-report and experimental pain measures best differentiate those who respond better to duloxetine than diclofenac.

this is a randomized, blinded, crossover, controlled study design comparing duloxetine and topical diclofenac for osteoarthritis pain. the study cohort will be individuals who have a confirmed diagnosis of knee osteoarthritis. subjects will be randomized only after all entry criteria have been met. these individuals will be evaluated at baseline, and then followed longitudinally following enrollment.

Eligibility criteria:
inclusion criteria: * diagnosed with knee osteoarthritis as defined by american college of rheumatology (acr) criteria * males and females age greater than 50 years at time of screening exclusion criteria: * history of chronic kidney disease or moderate to severe hepatic impairment * history of anemia * allergy or intolerance of drug intervention * inability to participate in outcome measures

Keywords: osteoarthritis chronic pain central pain
clinical study of shr-a1921 or shr-a2009 in previously treated advanced nsclc

Conditions: NSCLC

Summary: this study is an open-label phase ii clinical trial to evaluate the safety and efficacy of shr-a1921 or shr-a2009 in patients with advanced nsclc who progressed after standard therapy.


Eligibility criteria:
inclusion criteria: 1. voluntary participation and written informed consent; 2. aged 18-75 years (inclusive), males and females; 3. has a histologically or cytologically confirmed diagnosis of metastatic nsclc (according to 8th ajcc/uicc classification); 4. has failed to standard therapy and disease progressed after antibody-conjugated drugs therapy; 5. has at least 1 measurable lesion per recist 1.1; 6. patients with ecog score of 0-1; 7. life expectancy ≥12 weeks; 8. have adequate organ function; 9. participants agrees to use contraception, and be abstinent from heterosexual intercourse during the treatment period and for ≥180 days after the last dose of study treatment. exclusion criteria: 1. histologically or cytologically confirmed presence of small-cell lung cancer or other benefit-limiting tumor components; 2. untreated brain metastasis or accompanied by meningeal metastases, spinal cord compression; 3. cancerous ascites, pleural effusion or pericardial effusion with clinical symptoms; 4. subjects who have received systemic anti-tumor treatments prior to the initiation of the study treatment; 5. has received major organ surgery or high-intensity thoracic radiotherapy within before first dose of study therapy； 6. has a history of a second malignancy; 7. has a history of non-infectious ild/pneumonitis that required steroids, or has current ild/pneumonitis; 8. subjects with active pulmonary tuberculosis infection； 9. serious infection before the first dose； 10. uncontrolled cardiac diseases or symptoms; 11. arterial/venous thrombosis events occurred before the first dose； 12. hypertension that can not be well controlled through antihypertensive drugs，previous hypertensive crisis or hypertensive encephalopathy； 13. has a history of active chronic enteritis; 14. has a history of bleeding prior to the initiation of the study treatment; 15. history of immunodeficiency disease or organ transplant; 16. subjects with active hepatitis b or active hepatitis c; 17. has unresolved toxicities from previous anticancer therapy; 18. has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients of shr-a1921or shr-a2009; 19. subjects with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.
assessment of gonadal functions in uremic male patients

Conditions: ESRD

Summary: 1. study the prevalence of sexual dysfunction in male patients on hemodialysis aged 18-60 years (sexually active male) . 2. study the effect of hemodialysis on the male patients sexual functions by measurement of serum prolactin and free testosterone levels.

: gonadal dysfunction is a frequent finding in men with esrd on chronic hemodialysis ,erectile dysfunction is one of the most common manifestation of sexual dysfuncion whitch has been reported to be as high as 70 -80 %of hemodialysis patients . testosterone deficiency and insufficiency are frequent findings in hemodialysis male patients that were found to be 66% and 24% respectively the probleme is multifactorial , the most important factor is due to testesterone deficiency. total and free testosterone levels are typically reduced , that is usually accompanied by elevation of serum gonadotropins concentrations due to hypothalamic -pituitary-gonadal -axis disturbance(uremic hypogonadism) . alterations in the pulsatile release of gnrh, which leads to a hypogondal state due to uremia, which occurs due to inadequate nutrient intake, stress, and systemic illness . excess lh secretion is thought to result from the diminished release of testosterone from the leydig cells, because testosterone normally provides a feedback inhibition of lh release. the metabolic clearance rate of lh is reduced due to reduction of kidney clearance ,follicle stimulating hormone (fsh) secretion is also increased in men with chronic kidney failure. elevated plasma prolactin levels are commonly found in dialyzed men, it is thought to be due to increased its production , extreme hyperprolactinemia has been associated with infertility, loss of libido, low circulating testosterone levels, so,due to testosterone deficiency and hyperprolactinemia in esrd as one of most important factors and exclusion of other factors , men on chronic hemodialysis shows different degrees of subfertility or infertility due to erectile dysfunction , testicular damage and impaired spermatogenesis.

Eligibility criteria:
* inclusion criteria 1. male patients. 2. esrd on chronic hemodialysis with gfr lower than 15ml/min /1.73 m2 3. age (18_60)years old * exclusion criteria: 1-diabetic patients . 3-hypertesive patients . 3-patients with primary infertility before the event of esrd and starting dialysis. 4-manifest hypothyroidism . 5-patient with other causes that may lead to subfertility as varicocele . 6-patients with previous exposure to head and genital trauma , surgery or irradiation .

Keywords: uremic hypogonadism free testosterone level serum prolactin
choice architecture and colorectal cancer screening outreach

Conditions: Cancer of Colon

Summary: this pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in crc (colorectal cancer) screening outreach vs. colonoscopy outreach only, in patients between 50-74 years old, who have received care at the university city or valley forge cca (community care associates) practices, are due for screening, and are asymptomatic for crc. the three arms are: arm 1: direct schedule colonoscopy (control), arm 2: direct schedule colonoscopy followed by mailed fit(fecal immunochemical test) (sequential choice), and arm 3: choice of direct schedule colonoscopy or mailed fit (active choice).

this pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in crc screening outreach vs. colonoscopy outreach only. the investigators will randomize participants to one of three study arms: arm 1: direct schedule colonoscopy (control) arm 2: direct schedule colonoscopy followed by mailed fit (sequential choice) arm 3: choice of direct schedule colonoscopy or mailed fit (active choice).

Eligibility criteria:
inclusion criteria: * between 50 and 74 years old * has a primary care provider who is a university city or valley forge family medicine provider * has had at least 2 office visits at either practice * is due for colorectal cancer screening * is asymptomatic for crc * subject's zip code is within the philadelphia-wilmington-camden metropolitan statistical area exclusion criteria: * has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, or fobt/fit within twelve months of chart review (we will exclude patients who self-report any of the above procedures) * has a history of crc or colonic polyps * has a history of gi cancer * has a history of confirmed inflammatory bowel disease (ibd) * has a history of colitis other than crohns disease or ulcerative colitis) * has a first degree relative that has been diagnosed with crc * has had a colectomy * has been diagnosed with familial adenomatous polyposis (fap) * has been diagnosed with lynch syndrome (i.e. hnpcc) * has iron-deficiency anemia * has a history of lower gi bleeding * has metastatic (stage iv) blood or solid tumor cancer * has end stage renal disease * has cirrhosis * has heart failure * has dementia * has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
erectus nerve block for lumbar spine surgery

Conditions: Spine Surgery; Pain Relief; Morphine; AdverseEvent

Summary: : spine surgery induced severe postoperative pain. several techniques as intravenous multimodal analgesia have been proposed to reduce pain relief and morphine rescue over the first postoperative days. regional anesthesia using the erectus nerve block is a simple infiltration across lamina of the vertebra: ultrasound-guided posterior ramus of spinal nerve block for anesthesia and analgesia in lumbar spinal surgery this study compared erector nerve block with local anesthetic vs placebo to reduce pain and morphine rescue after lumbar spine surgery. the investigators hypothesized that eructor nerve block induced a large block from l1 to l5 that induced posterior nerve roots block anesthesia. this block reduced pain after surgery.


Eligibility criteria:
inclusion criteria: * age\> 18years and \<80 years * lumbar spine surgery (2-4 levels) * posterior approach * asa 1-3 exclusion criteria: * refusal * age \< 18yrs * \ 120 kg * pregnant * renal or hepatic severe desease * asa 4 * no french speaking * emergency surgery * local or systemic infection * surgical resumption of the surgical site * surgery involving a thoracic approach * allergy to local anesthetics
a study of the pk, safety and antiviral activity of a-831 in hcv carriers

Conditions: Chronic Hepatitis C

Summary: the purposes of this study are: * to determine the safety and tolerability of multiple doses of a-831 at various doses * to determine how multiple doses of a-831 are distributed through the bloodstream * to determine if a-831 reduces the amount of hepatitis c virus in the blood


Eligibility criteria:
inclusion criteria: * volunteers will be males of any race aged 18-60 years with a bmi between 18 and 32 kg/m2 at the time of the screening medical * volunteers who have given their written informed consent to participate in the study * volunteers who are willing and able to comply with the protocol and study procedures * volunteers who have a diagnosis of chronic hepatitis c infection and are in good health (other than history of hepatitis c infection) exclusion criteria: * voulnteers with concurrent medical conditions or taking concurrent medications

Keywords: hcv antiviral pk safety
a virtual prospective study exploring activity trackers and covid-19 infections

Conditions: Covid19; SARS-CoV Infection

Summary: prospective, observational, exploratory study exploring the relationship between passively-collected data from wearable activity devices and sars-cov-2 infection


Eligibility criteria:
inclusion criteria: * adults 18+ years of age * lives in the united states * speaks, reads, and understands english * willing and able to use and wear a wrist-worn activity device daily, during the day and during sleep, or as much as is possible, for the duration of the study * meets minimum software and device requirements for the wrist-worn activity device (apple ios 12 and up, android version 6.0 and up) * willing to answer daily, weekly and monthly surveys for the duration of the study * willing to provide weekly self-collected saliva samples, plus one additional sample if prompted to do so (up to 9 total samples), and ship back the sample(s) within 24 hours of sample collection exclusion criteria: * self-reported previous diagnosis of covid-19 * currently participating in any type of clinical trial * lives in the district of columbia (washington d.c.), alaska, hawaii, arizona, nevada, u.s. military base located overseas, or u.s. territories (puerto rico, u.s. virgin islands, guam, northern mariana island, or american samoa)

Keywords: covid-19 sars-cov infection sars-cov-2
new approach of assessing drug response for treatment of nasopharyngeal cancer

Conditions: Advanced Nasopharyngeal Carcinoma

Summary: the combination of pebv dna (half-life) and pet-ct following 1 course of chemotherapy allow earlier and more detection of drug response in advanced npc than recist method, in patients with previously untreated advanced npc who will receive platinum-based chemotherapy. this study will also determine if this new method can predict survival in these patients. this study may have far-reaching impact on drug development in npc as it may offer a more optimal way of evaluating drug efficacy in clinical trials and also in clinical management.


Eligibility criteria:
inclusion criteria: * undergo chemotherapy for any one of the following settings: 1. setting 1: neoadjuvant chemotherapy prior to cheom-rt 2. setting 2: palliative chemotherapy in chemonaive patients 3. setting 3: palliative chemotherapy in previously treated patients (i.e. 2nd line or 3rd line chemo) * age \>= 18 years * (ecog) performance status of 0-2 * have detectable levels of pebv dna at baseline * have measurable tumor sites by recist criteria * have adequate bone marrow, renal and hepatic functions
2-week evaluation of marketed silicone hydrogel contact lenses in indian population

Conditions: Visual Acuity

Summary: the primary objective of this study is to evaluate the clinical performance of two marketed silicone hydrogel contact lenses in an indian population in the following areas: physiological characteristics, comfort characteristics and vision characteristics.


Eligibility criteria:
inclusion criteria: 1. the subject must read, understand english, and sign the statement of informed consent and receive a fully executed copy of the form. 2. the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. the subject must be 18 and less than 40 years of age. 4. the subject's corrected spherical equivalent distance refraction must be in the range of -1.00 to -5.00d in each eye with visual acuity of 20/25 provided study lenses in each eye. 5. the subject must have less than -1.00 d of cylindrical refraction. 6. the subject must have best corrected visual acuity of 20/25 or better in each eye. 7. the subject must be an adapted soft contact lens wearer in both eyes. 8. the subject must have normal eyes. exclusion criteria: 1. currently pregnant or lactating (subjects who become pregnant during the study will be discontinued) 2. any ocular or systemic allergies or diseases that may interfere with contact lens wear. 3. any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. 4. entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia. 5. any previous, or planned ocular or interocular surgery (e.g. radial keratotomy, prk, lasik, etc.). 6. any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the fda classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g. past peripheral ulcer, or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear. 7. any ocular infections 8. any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. 9. participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment 10. history of binocular vision abnormality or strabismus. 11. any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. hiv) by self report. 12. employee of the investigational clinic (e.g. investigator, coordinator, technician)
baby smell visual stimulus program cortical and breast oxygenation milk amount mother-infant attachment

Conditions: Cesarean Delivery Affecting Fetus; Preterm Labor

Summary: in this study, the effect of infant odor and visual stimulus program applied to mothers who had delivered by cesarean section and whose babies were taken to the nicu on cortical and breast oxygenation (rso2), amount of breast milk and mother-infant bonding was investigated.

one of the conditions that prevent the preterm baby from being close to the mother in the early period is cesarean delivery and subsequent removal to the nicu. in the first hour of life, the process immediately after birth, when the newborn is alert, makes eye contact, focuses, finds the unaided mother's breast and begins to feed, deteriorates in babies in need of intensive care and mothers begin the experience of parenting with delayed attachment. the mother experiences high levels of stress due to changes in many parental roles such as being physically separated from her baby, not being able to breastfeed effectively, not being able to care for her baby and the intensive care environment, and experiencing a delay in lactation with the effect of cesarean delivery. in the literature, many interventions have been implemented to reduce the negative effects of mother-infant separation on lactation and attachment in mothers who have given birth by cesarean section. however, there is no published research examining the effect of infant odor and visual stimulus program applied to mothers who had delivered by cesarean section and whose babies were taken to the nicu on cortical and breast oxygenation (rso2), amount of breast milk and mother-infant bonding. in addition, being able to assess how the mother's cortical and breast oxygenation changes while smelling her baby's scent and watching her/his video will further strengthen the results of the measurement tools.

Eligibility criteria:
inclusion criteria: infant * born at 28-37 (36+6) weeks of gestation * admission to the nicu in the same hospital as the mother immediately after birth mother * to agree to participate in the study, * to give birth by cesarean section, * to be able to use the turkish language, * to pass the smell test (to correctly identify the 3 different types of smell presented), * not to have been diagnosed with depression etc. psychiatry at the time of the study exclusion criteria: infant * the presence of conditions that affect the baby's original smell (baby born with meconium, hepatitis c and hiv infected baby) * infant who underwent interventional intervention in the head area * the baby whose suction function is sufficient and who can suck breast milk mother * admission to intensive care, * being covid positive (as the sense of smell will be affected), * having a mental, neurological, nasal related disease, * having a communication problem

Keywords: breastmilk cortical and breast oxygenation infant odor mother-infant bonding nirs visual stimulus
impact of korean red ginseng on fatigue in patients with rheumatic disease

Conditions: Sjögren's Syndrome; Rheumatic Diseases; Korean Red Ginseng

Summary: the objective of a randomized, double-blind, placebo-controlled trial and open-label extension study is to figure out the impact of korean red ginseng (krg) on fatigue in patients with rheumatic diseases.

primary objective : improvement of fatigue after using krg in patients with rheumatic diseases according to secondary objectives 1. improvement of dryness after using krg in patients with rheumatic diseases according to eular sjögren's syndrome disease activity index (essdai) 2. improvement of quality of life after using krg in patients with rheumatic diseases according to euroqol 5 dimensions questionnaire (eq-5d) the study population will be adult patients with rheumatic diseases, especially primary or secondary sjögren's syndrome who have experienced dryness for more than 3 months. participants are ramdomly assigned to krg and placebo group and they are using krg or placebo for the first 12 weeks. after 12 weeks, the concealment of allocation is lifted and all patients are provided with krg for next 12 weeks with open-label extension study

Eligibility criteria:
inclusion criteria: * patients who meet for classification criteria for sjögren's syndrome * patients who have experienced fatigue for over 3 months * patients aged ≥ 19 and \<75 * patients who provide a written consent of participating in this study. exclusion criteria: * patients who have experienced hypersensitivity or adverse events to korean red ginseng * patients who used dietary supplements containing krg during recent 2 months * patients who are pregnant or breast-feeding * patients who use oral glucocorticoids or opioids continuously * patients who had other comorbidities which could lead to fatigue as symptoms including chronic kidney disease, chronic liver disease, endocrine disoders, malignancy, or depression. * patients having fibromyalgia or chronic fatigue syndrome * patients who presented abnormal laboratory findings at the time of enrollment white blood cell (wbc) ≤ 3.5 x 10\^9/l or, hemoglobin (hb) ≤ 8.5 g/dl or, platelet (plt) ≤ 100 x 10\^9/l or, serum creatinine (cr) ≥ 2.0 mg/dl or, aspartate aminotransferase (ast) or alanine aminotransferase (alt) ≥ 2.5 times of upper limits of normal

Keywords: sjögren's syndrome korean red ginseng
evaluation of a miniaturized microscope device for the detection of esophageal squamous cell cancer

Conditions: Squamous Cell Cancer

Summary: the overall objective of this study is to determine whether high-resolution imaging of the esophagus during routine diagnostic upper endoscopy can assist clinicians in detecting and discriminating dysplastic (precancerous) areas. this high-resolution microendoscope (hrme) was developed by our collaborators at rice university and provides \> 1000x magnified images of the esophageal mucosa. the purpose of this study is to determine whether this device can be used to enhance the diagnostic accuracy of routine endoscopic screening for squamous cell cancer of the esophagus.


Eligibility criteria:
inclusion criteria: * known or suspected squamous cell neoplasia * 18 years or older

Keywords: squamous cell cancer squamous cell neoplasia
fmri of active dbs stimulation in epilepsy

Conditions: Epilepsy

Summary: researchers are trying to incorporate a process known as functional mri (fmri) scanning to reveal a pattern in brain activity during deep brain stimulation (dbs), which will correlate to possible seizure freedom.


Eligibility criteria:
inclusion criteria * patients selected to undergo anterior thalamic nucleus dbs for refractory epilepsy exclusion criteria * contraindication to mri

Keywords: deep brain stimulation