Kornimate/medical-research-clean huggingface dataset:
study of teriparatide in the treatment of postmenopausal women with osteoporosis

Conditions: Osteoporosis, Post-Menopausal

Summary: to see if using teriparatide for 12 months will increase bone mineral density at the lumbar spine in postmenopausal women with osteoporosis


Eligibility criteria:
inclusion criteria: * are postmenopausal women at least 55 years old and at least 2 years postmenopausal at the time of entry into the trial, and who have given informed consent before entering the study and after being informed of the risks, medications, and procedures to be used in the study. in addition, women below the age of 60 years with indeterminate menopause due to premenopausal hysterectomy must have their postmenopausal status confirmed with a serum fsh level \> 30 iu/l. * posterior-anterior lumbar spine (l1-l4) bmd and/or femoral neck bmd measurement at least \< 2.5 standard deviation (sd) from the mean of healthy, pre-menopausal women. * results of lumbar bmd (l1-l4) measurement must be available. the initial lumbar spine assessment and the determination of the patient's eligibility for entry into the screening phase will be made by the individual investigator. if the l-1 vertebra cannot be analyzed due to artifact, vertebral fracture, osteophytes, or other abnormalities, that vertebra should be excluded from the analysis. * normal or clinically insignificant abnormal laboratory values (as defined by the investigator) including serum calcium, 25 hydroxyvitamin d levels and alkaline phosphatase. * willing to be trained on and use a pen type injection delivery system on a daily basis for 12 months. exclusion criteria: * active liver disease - liver enzymes (alt, ast) more than three times the upper normal range, or a bilirubin of \> 2.0 mg/dl, or clinical jaundice. * abnormal thyroid function not corrected by therapy. normal thyroid function will be documented by a normal tsh during screening phase * history of active nephrolithiasis or urolithiasis in the prior 2 years. patients with any documented history of nephro- or urolithiasis must have had an appropriate imaging procedure within the prior 6 months, such as, an intravenous pyelography (ivp), supine radiograph of the kidney ureter bladder (kub), or renal ultrasound, which must document the absence of stones * history of malignant neoplasms within the prior 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated. if malignant neoplasm was ever diagnosed, patient must presently be free of disease. * current pharmacological treatment for osteoporosis, other than calcium and vitamin d * history of paget's disease, renal osteodystrophy, osteomalacia, any secondary causes of osteoporosis, hyperparathyroidism (uncorrected), and intestinal malabsorption
transfusion reaction by washed red blood cell (rbc)

Conditions: Orthopedic Disorder

Summary: the hypothesis is that transfusion of washed red blood cell can decrease the complication by transfusion.


Eligibility criteria:
inclusion criteria: * patients undergoing total hip replacement arthroplasty exclusion criteria: * patients who do not agree with this clinical study. * patients who have a history of transfusion for recent 1 month. * patients who have rare blood types.
effect of chemotherapy on tmb in nsclc

Conditions: Chemotherapy Effect; Immunotherapy; Tumor Mutation Burden; PD-1/L1 Inhibitor

Summary: tumor mutation burden is identified as an important biomarkers for predicting pd-1/pd-l1 inhibitors in advanced non-small cell lung cancer. several previous clinical trials have demonstrated that chemotherapy could enhance the efficacy of pd-1/l1 immunotherapy in nsclc such as checkmate-227, impower-150, keynote-189, etc. pre-clincial experiment shows that chemotherapy could increase cd8 til infiltration in tumor microenvironment, activate t cell immune reaction. however, it remains unclear whether chemotherapy could affect tumor mutation burden in advanced nsclc patients. the present study aims to evaluate whether tumor mutation burden will change after receiving chemotherapy in advanced nsclc patients.


Eligibility criteria:
inclusion criteria: * advanced nsclc diagnosed histologically; expected survival ≥ 6 month; * without druggable molecular events (egfr, alk, c-met, braf, ret, etc) * ecog / ps score: 0-2, and the main organ function to meet the following criteria: hb ≥ 90g / l, anc ≥ 1.5 × 109 / l, plt ≥ 80 × 109 / l,bil \<1.5 times the upper limit of normal (uln); liver alt and ast \<2.5 × uln and if liver metastases, alt and ast \<5 × uln; serum cr ≤ 1 × uln, endogenous creatinine clearance ≥50ml/min exclusion criteria: * patient can not comply with research program requirements or follow-up; * patient will receive immunotherapy;
effect of erector spinae (esp) block on opioid reduction and enhanced recovery after posterior cervical spine surgery

Conditions: Postoperative; Pain

Summary: patients undergoing spine surgery frequently experience significant pain after surgery. this can limit patient activity and hinder rehabilitation. if inadequately treated, severe pain can result in emotional and psychological distress and ultimately impact long-term function, and increase the risk of developing pain that lasts longer than six months associated with depression, anxiety and disability. more specifically, erector spinae plane (esp) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. it has shown to be an effective modality for postoperative pain management as a part of multimodal analgesia in spinal surgery.

patients undergoing spine surgery frequently experience significant pain after surgery. currently, standard management of acute pain after surgery consists mainly of systemic opioid narcotics and nonsteroidal anti-inflammatory drugs (nsaids). generally, opiates and nsaids are not completely effective at managing pain, and they carry significant risk of addiction and overdose, particularly with prolonged or increased dosing. the concept of multimodal or ''balanced'' analgesia is rapidly becoming the 'standard of care' for preventing post-operative pain. it consists of the use of combinations of analgesics of different classes with different sites of action in an attempt to provide superior pain relief with reduced analgesic related side effects. local anesthetic injection to block specific nerves has been widely recognized as a useful adjunct in a multimodal approach to postoperative pain management. erector spinae plane (esp) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. it has shown to be an effective modality for postoperative pain management as a part of multimodal analgesia in spinal surgery.

Eligibility criteria:
inclusion criteria: all adult patients aged 18-80 years with asa class i - iii undergoing posterior cervical (c3-t2) decompression and instrumented fusion for cervical stenosis in prone position. exclusion criteria: 1. in patients who are allergic to local anesthetics. 2. asa iv patients 3. lack of informed consent 4. pregnant patient. 5. fracture cervical spine 6. extradural or intradural cervical tumors 7. surgery of c1 and c2 spine

Keywords: opioid reduction enhanced postoperative recovery
translation and psychometric properties of the fatigue severity scale in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: the study will employ a cross-sectional validation study design. the study will be conducted at the department of physical therapy, university of lahore teaching hospital, located on defence road, lahore. the anticipated duration of the study will be 09 months, commencing after the approval of the synopsis. the sample size will be determined following the kline method, resulting in a total of 90 participants. a purposive sampling technique will be utilized to select the study participants.

study type: cross-sectional validation study location: department of physical therapy, university of lahore teaching hospital, defence road, lahore duration: 06 months (post-synopsis approval) sample size: 90 participants sampling technique: purposive sampling consent and ethics: participants will provide written informed consent. ethics approval will be obtained from the university of lahore ethics committee. translation of fss: the fatigue severity scale (fss) will be translated into urdu for data collection. two independent bilingual translators will create reports on translation difficulties and rationale. these reports will inform a consensus meeting to develop a unified urdu version, with comments documented. the unified version will be backtranslated into english by native english-speaking translators unaware of the questionnaire's concept. expert committee: an expert committee comprising physical therapists, linguists, and a methodologist will review both language versions. the goal is to ensure semantic, idiomatic, experiential, and conceptual equivalence and reach consensus on the final urdu version of the fss. patient involvement: the final urdu fss version will be administered to 20 fibromyalgia patients. these patients will also be interviewed to assess their understanding of questionnaire items. participants will receive additional information about fibromyalgia to prevent confusion. data collection: data will be collected from 100 fibromyalgia patients using the final urdu fss version. a retest will be conducted after 48 hours. additional assessment: all 90 participants will complete the multidimensional fatigue inventory (mfi).

Eligibility criteria:
inclusion criteria: * both genders with age of 18 years and above * diagnosed and referred patients of fibromyalgia according to the american college of rheumatology (acr) criteria. * the ability to provide informed consent and wiling to participate in the study. * fluency in the study language (i.e. urdu in this case). exclusion criteria: * any other chronic pain condition that could affect fatigue and sleep. * diagnosed sleep disorder (such as sleep apnea or insomnia) that could affect the results. * history of a psychiatric disorder that could affect the results. * history of substance abuse. * participation in any other study that could affect the results at the time of recruitment.

Keywords: fatigue severity scale translation psychometric properties
a study that uses data from routine eye examinations of patients participating in studies fidelio-dkd and figaro-dkd to explore whether finerenone can delay the progression of a diabetes complication that affects the eyes (diabetic retinopathy ,dr)

Conditions: Diabetic Retinopathy

Summary: diabetic retinopathy (dr) is a diabetes complication caused by damage to the small blood vessels inside the retina at the back of the eye. diabetic retinopathy may cause mild vision problems or eventually blindness. diabetes is a condition that makes your blood sugar levels higher than they should be. in the early stages of diabetic retinopathy - called non-proliferative diabetic retinopathy (npdr)- increased blood sugar levels lead to damage to the tiny blood vessels of the retina. this damage results in small outpouchings of the vessel lumens leading to rupture. at the same time the blood vessels can leak and making the retina swell and can cause so called macula edema. in these early stages of dr current treatment to reduce the risk of this eye complication is focused on controlling blood sugar levels and blood pressure. participants in this study have npdr, type 2 diabetes (t2d) and chronic kidney disease (ckd), a condition in which the kidneys become damaged and do not work as they should. these participants are already taking part in one of the phase 3 studies (fidelio-dkd and figaro-dkd). they study the effect of finerenone on delaying kidney disease progression and reducing the risk of events that may cause damage to the heart and blood vessels to learn more about the effect of finerenone on diabetic retinopathy, data from routine eye examinations performed during the two phase 3 studies will be collected and analyzed. all male and female participants included in this study are at least 18 years.


Eligibility criteria:
inclusion criteria: * signed informed consent to participate in refinedr * included in fidelio or figaro, and with dr as medical history * documented npdr in at least one eye, as documented by ophthalmological records within 6 months prior to baseline in fidelio or figaro, and up to one month after baseline in fidelio or figaro * an ophthalmological assessment available 6 month before or maximum 1 month after the baseline examination in fidelio or figaro, and at least one additional assessment afterwards. exclusion criteria: * patients with pdr, macular edema or anterior segment complications present at baseline in fidelio or figaro in at least one eye. * patients with any documentation of prior or planned retinal laser treatment, intravitreal injection or vitrectomy at baseline in fidelio or figaro in at least one eye. * patients with any other retinal disease documented at baseline in fidelio or figaro in at least one eye that would likely interfere with the study objectives (e.g. neovascular age-related macular degeneration or retinal vein occlusion).
a phase 2 study of ph-10 for the treatment of atopic dermatitis

Conditions: Atopic Dermatitis

Summary: ph-10 is a formulation of rose bengal disodium (rb) for topical administration to the skin. ph-10 is capable of undergoing photochemical reactions when activated by ambient light. this phase 2 study will assess whether topical ph-10 applied once daily to mild, moderate or severe areas of atopic dermatitis (including atopic eczema) may ameliorate inflammation of the skin when activated by ambient light.


Eligibility criteria:
inclusion criteria: * men or women, age 18 or older. * mild, moderate or severe atopic dermatitis. * presence of atopic dermatitis areas outside the head and face with a baseline investigator global assessment (iga) of 2 (mild disease), 3 (moderate) or 4 (severe disease) at screening. * written informed consent by the subject or legal guardian. exclusion criteria: * women who are pregnant, attempting to conceive, or nursing an infant. * subjects who have received phototherapy (uvb, puva) or systemic therapy (immunosuppressants, cytostatics, corticosteroids) within 4 weeks. * subjects who have received systemic antibiotics within 2 weeks. * subjects who have received topical therapy (tar, corticosteroids) within 7 days. * subjects who have received investigational drugs in a clinical research study within 4 weeks. * subjects who have received agents posing a clinically significant risk of photosensitivity reaction within 5 half-lives of initiation of study treatment. * subjects with a history of porphyria, systemic lupus erythematosus or xeroderma pigmentosum. * subjects with clinical conditions that may pose a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.

Keywords: eczema
clinical study of smile 4.0-visulyze in correcting refractive errors

Conditions: Refractive Surgery; Myopia; Refractive Error

Summary: the aim of this study is to further optimize the surgical input parameters for patients undergoing small incision lenticule extraction (smile) using the regression model established by the smile 4.0-visulyze system, thereby achieving satisfactory postoperative refractive outcomes. in this study, patients scheduled for smile surgery at the investigators' hospital will be divided into two groups: a conventional group, where the input parameters are adjusted based on historical experience according to the patient's refractive error, and a 4.0-visulyze group, where the input parameters are optimized using the smile 4.0-visulyze system. the investigators will compare the postoperative outcomes between the two groups, including uncorrected visual acuity (ucva), best-corrected visual acuity (bcva), spherical power, cylindrical power, spherical equivalent (se), and the proportions of patients achieving postoperative visual acuity ≥0.8, ≥1.0, and ≥1.2 at 1 day, 10 days, 1 month, 3 months, 6 months, and 1 year post-surgery. additionally, the investigators will evaluate the proportions of patients with postoperative se within ±0.50d and ±1.0d, as well as postoperative cylindrical power within ±0.50d and ±1.0d, to assess the efficacy and safety of the smile 4.0-visulyze system in treating refractive errors.


Eligibility criteria:
inclusion criteria: 1. the diopter is relatively stable (the diopter increases within -0.50d per year for 2 consecutive years); 2. age: 18 to 40 years old; 3. optimal preoperative corrected visual acuity ≥4.8; 4. more than 2 weeks for soft contact lenses and more than 3 months for hard contact lenses before surgery 5. patients who are willing to perform smile surgery exclusion criteria: 1. patients with history of eye surgery and trauma; 2. patients with keratoconus tendency; 3. systemic connective tissue diseases and autoimmune diseases; 4. patients with high blood pressure, diabetes and heart disease history; 5. other eye disease history such as uveitis, scleritis and other eye inflammation patients; 6. patients with scar constitution.
effects of docosahexaenoic acid (dha) on heart rate variability in elderly patients

Conditions: Arrhythmia

Summary: the purpose of this study is to test the hypothesis that dietary supplementation with an algal source of docosahexaenoic acid (dha) can improve the heart rate variability in elderly patients.

in western countries, sudden cardiac death (scd) represents the most common form of cardiovascular death. scd is often caused by ventricular arrhythmias in patients with a known history of ischemic heart disease but it may also occurs in healthy persons. in the last years has been extensively studied the protective role of long-chain n-3 polyunsaturated fatty acids (n-3 lcpufa) against scd both in healthy persons and in patients affected by coronary artery disease. the hypothesis that these evidences could be ascribed to an antiarrhythmic effect of n-3 lcpufa, has been corroborated by the observation of a direct relationship between the dietary intake of these nutrients and a better cardiac autonomic control. this pathway, in particular, has been confirmed by the analysis of changes in heart rate variability. most studies in this field used n-3 lcpufa derived from fish oil, composed by a combination of eicosapentaenoic acid (epa) and docosahexaenoic acid (dha). at our knowledge there are few studies available evaluating the isolated role of dha, derived from alternative sources of n-3 lcpufa, as the microalgae, in the prevention of fatal arrhythmias.

Eligibility criteria:
inclusion criteria: * age above 65 years exclusion criteria: * treatment with or allergy to polyunsaturated fatty acids * diagnosis of arrhythmia or antiarrhythmic therapy * anticoagulant therapy (except acetylsalicylic acid) * pacemaker * bleeding diathesis * recent cerebral hemorrhage (less than 6 months) * thyroid dysfunction

Keywords: heart rate variability docosahexaenoic acid dha long chain fatty acids long chain polyunsaturated fatty acids algal fatty acids schizochytrium omega 3 death, sudden, cardiac arrhythmias, cardiac
residual gastric area and weight loss after sleeve gastrectomy

Conditions: Obesity, Morbid

Summary: background: the aim of this study is to evaluate the impact of the actual size and area of the remnant stomach, as measured by upper gastrointestinal tract radiography, on weight loss after lsg. materials and methods: from may 2017 to december 2019, 56 patients with morbid obesity were admitted to the department of medical and surgical sciences, university of foggia and underwent laparoscopic sleeve gastrectomy. ugi tract radiography was performed on day two after the operation to rule out leakage.

study design and setting from may 2017 to december 2019, 56 patients with morbid obesity were admitted to the department of medical and surgical sciences, university of foggia and underwent laparoscopic sleeve gastrectomy. ugi tract radiography with water-soluble contrast medium was performed on the second day after the operation to rule out leakage. the radiographic images were collected through a software program called "pacs" which combined with a viewer for image processing, allows for the calculation of the residual stomach area (rsa). rsa was correlated with postoperative weight (ewl) at 1, 6, and 12 months. eligibility criteria adult patients of both genders with morbid obesity defined as bmi\>40 kg/m2 or bmi\>35 kg/m2 with at least one associated major comorbidity were included. we excluded patients with secondary obesity due to endocrine and psychological disorders, patients with previous bariatric procedures and patients unwilling to comply with postoperative diet and exercise program. statistical analysis continuous data were expressed as mean and standard deviation (sd) and they were analyzed using student's t test. the correlation between gastric volume before and after lsg and bmi and weight loss was measured using pearson correlation coefficient test. correlation coefficients were classified as strong (-1.0 to -0.5 or 0.5 to 1.0), moderate (-0.5 to -0.3 or 0.3 to 0.5), and weak (-0.3 to -0.1 or 0.1 to 0.3). p\<0.05 was considered statistically significant. this work is fully compliant with the strocss criteria

Eligibility criteria:
inclusion criteria: * adult patients of both genders with morbid obesity defined as bmi\>40 kg/m2 * adult patients of both genders with morbid obesity defined as bmi\>35 kg/m2 with at least one associated major comorbidity exclusion criteria: * patients with secondary obesity due to endocrine and psychologic disorders * patients whit previous bariatric procedures * patients unwilling to comply with postoperative diet regimen and exercise program.
postoperative pain management on patients undergoing lung tumor resection

Conditions: Postoperative Pain; Lung Cancer; Lung Tumor

Summary: multimodal analgesia (mma) is an essential part of enhanced recovery after surgery (eras) protocol. the principle of mma is to manage pain with analgesics of multiple classes acting on distinct target sites through different strategies. mma can reduce the adverse reaction caused by opioids and improve the quality of recovery from surgery. inadequate postoperative pain management will increase the risk of complications, including pneumonia, deep vein thrombosis, infection, delayed surgical healing, and chronic postoperative pain.

this prospective, observational study is planned to investigate the efficacy of different mma regimens conducting in our hospital. patients undergoing video-assisted thoracoscopic (vats) lung tumor resection will be invited to participate in the study and grouped based on the mma regimens. anxiety, quality of recovery, pain intensity will be evaluated pre- and post-operatively. demographic data, surgery record, medicine record and postoperative complications will be gained from medical history system and analyzed.

Eligibility criteria:
inclusion criteria: 1. aged above 18. 2. diagnosed as lung cancer. 3. planning to undergo primary, video-assisted thoracoscopic lung tumor resection. 4. american society of anesthesiology physical class 1\~3. exclusion criteria: 1. unable to take assessments of the endpoints. 2. having this surgery in an emergency. 3. surgery involving other orangs, such as esophagus and stomach. 4. severe abnormality of cardiac, hepatic, or renal function. 5. allergic to opioids. 6. allergic to nsaids. 7. diagnosed as chronic pain or chronic use of analgesics. 8. unsuitable for participation judged by investigator.

Keywords: video-assisted thoracoscopic (vats) lung tumor resection naldebain dinalbuphine sebacate multimodal analgesia enhanced recovery after surgery eras mma