Kornimate/medical-research-clean huggingface dataset:
phase i/ii study of oral s-1 plus gemcitabine in patients with metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: to assess the usefulness of gemcitabine plus s-1 therapy based on the antitumor effect and survival period. by performing a phase i/ii study of this combination in patients with inoperable or with postoperative pancreatic cancer.

a multicenter open-label, single-arm, phase i/ii clinical trial is conducted on patients with histological stage iv pancreatic cancer given gemcitabine plus s-1. the usefulness of this regimens as 1st line therapy for pancreatic cancer was evaluated by the disease-free survival(dfs), median survival time (mst), incidence and severity of adverse event.

Eligibility criteria:
inclusion criteria: 1. histological diagnosis of pancreatic adenocarcinoma. 2. measurable or assessable lesions(except for phase i). 3. age: 20 \~ 75 years. 4. kar-nofsky performance status (kps) \> 70. 5. no prior chemotherapy 6. no history of treatment with gemcitabine or s-1. 7. no history of radiotherapy to the abdomen. 8. oral intake of s-1 is possible. 9. adequate function of major organs (bone marrow, heart, lungs, liver etc.). wbc 3,500/mm3 and neutrophil 2,000/mm3. hb 9.0 g/dl. platelet count 100,000/mm3. got and gpt 2.5 times the upper limit of normal (excluding liver metastasis). t-bil 2.0 mg/dl. creatinine within the upper limit of normal). normal ecg (not considering clinically unimportant arrhythmias and ischemic changes). 10. predicted survival for \>3 months. 11. able to give written informed consent. exclusion criteria: 1. severe pleural effusion or ascites. 2. metastasis to the central nervous system (cns). 3. active gastrointestinal bleeding. 4. active infection. 5. liver cirrhosis 6. uncontrolled ischemic heart disease. 7. serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure). 8. active multiple cancer. 9. severe mental disorder. 10. pregnancy, possible pregnancy, or breast-feeding. 11. flucytosine treatment 12. judged to be ineligible for this protocol by the attending physician.
topotecan weekly versus topotecan day 1-5 in patient with platin-resistant ovarian cancer

Conditions: Ovarian Cancer

Summary: comparison of topotecan weekly vs. topotecan day 1-5. the compatibility and activity are to be examined.

topotecan belongs to the most effective medicaments in the therapy of relapsed platin-resistant ovarian cancer. due to the low rate of hematological toxicities of grade 3 or 4 weekly application may be an improvement of therapy. none randomised study exists comparing a weekly topotecan application with an application on day 1-5. this study will compare the two applications in regard to: rate of complete or partial remissions, rate of toxicity, quality of life, progression free survival, overall survival.

Eligibility criteria:
inclusion criteria: * patients with histologically-confirmed ovarian cancer * relapse within 6 month after primary therapy * primary therapy with platin and taxan * ecog 0-2 * \>= 18 years * leukocytes \>= 3.000/ µl * platelet \>= 100.000/ µl * neutrophil \>= 1.500/ µl * written informed consent exclusion criteria: * earlier topotecan therapy * simultaneous or planned radiotherapy * secondary malignancy
single anastomosis duodeno-ileal bypass vs standard duodenal switch as a second step after sleeve gastrectomy in the super-morbid obese patient

Conditions: Morbid Obesity

Summary: single-anastomosis duodeno-ileal bypass with a 250 cm common/alimentary loop is a modification of standard duodenal switch in which a roux-en-y duodeno-ileal anastomosis is performed at 250 cm from the cecum and a 60 cm to 100 cm common channel is build up. hypothesis of the study is that single-anastomosis duodeno-ileal bypass behaves at least equally to standard duodenal switch as a second step after sleeve gastrectomy in the super-morbid patient. secondary aims are to demonstrate that single-anastomosis duodeno-ileal bypass is simpler to perform, quicker and has less postoperative short, mid and long-term complications.

sleeve gastrectomy is a restrictive operation for morbid obesity which has a 60% success rate in solving both morbid obesity and related co-morbidities, mainly diabetes mellitus. when the sleeve is not enough for the patient, due to alimentary habits or to an excessive initial bmi before surgery (usually over 50 - 55), a second-step operation should be performed to increase effectiveness. some patients are submitted to a second restrictive operation, i.e.: a re-sleeve, a gastric plication or sleeve banding. other group are offered a gastric bypass. and, finally, a subset of patients, generally those with higher initial bmi, are offered a malabsorptive operation. while re-sleeve is adequate for many patients, gastric bypass is not offering a greater weight loss rate, and it is a complex operation requiring sectioning of the sleeve and two anastomoses. we support the performance of malabsorptive operations which warrant a better weight loss result for "resistant" patients needing a second-step. as single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (sadi-s) has behaved as a good primary operation for morbid obesity, we decided to test this one-loop reconstruction as a second step operation. results will be compared to those obtained with a roux-en-y duodenal switch performed as a second step after a "failed" sleeve.

Eligibility criteria:
inclusion criteria: morbid obesity with initial bmi over 50 submitted to sleeve gastrectomy more than 18 months earlier. excess weight loss with the sleeve under 50%. - exclusion criteria: mental retard, alcoholism, age over 60, concomitant neoplastic disease. -

Keywords: morbid obesity sleeve gastrectomy duodenal switch sadi-s
autoimmune blistering diseases study

Conditions: Pemphigus Vulgaris; Pemphigus Foliaceus; Bullous Pemphigoid

Summary: pemphigus and bullous pemphigoid (bp) are severe autoimmune blistering diseases (aibd) that pose a critical need for new therapeutic approaches. clinical trials in pemphigus and bp will require the availability of validated disease severity measures that can be used to define primary outcomes.

the disease severity instruments for pemphigus and bp, the pemphigus disease area index (pdai) and the bullous pemphigoid disease area index (bpdai), respectively, have the potential to capture changes in all grades of disease activity, including mild disease, and therefore represent a substantial improvement over simple lesion counts or measurements of affected body surface area. however, full validation of the pdai and bpdai for use in clinical trials will require additional and more extensive measurements that will enable us to classify patients correctly by disease severity and be able to define the minimal change in score that is clinically significant. this database study will compare the pemphigus disease area and severity index (pdai) and the bullous pemphigoid disease area index (bpdai) against other disease severity measures, including the autoimmune bullous skin disorder intensity score (absis) and a physician's global assessment. additionally, patients will be asked to rate their overall disease severity using a visual analogue scale, the patient's global assessment. participants will also have the option to donate blood samples to our aibd blood bank for immunologic and pathophysiologic studies. the purpose of this database study will also be to evaluate quality of life (qol) measures and correlate these qol measures with disease severity in patients with pemphigus and bp. qol is an important and independent component of disease impact on patients. this database study will use the following qol measures: the sf-36, which is a nonspecific qol measure; the skindez-29 and the dermatology life quality index (dlqi), which are dermatology-specific instruments; the autoimmune bullous disease quality of life (abqol) and treatment of autoimmune bullous disease quality of life (tabqol) questionnaires, which are aibd-specific tools. the results will be utilized in planning future clinical studies. the aibd study will be conducted only at penn at this time. data from the study will be entered into a password protected, web-based database that is used only at penn.

Eligibility criteria:
inclusion criteria: * gender/age: males or females above 18 years old * diagnosis: pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid * subjects able to give informed consent exclusion criteria: * patients who are under age 18 years. * patients without pemphigus or pemphigoid diseases * penn employees * penn students * cognitively impaired persons
ultrasound contrast-enhanced accurate diagnosis of preoperative staging of bladder cancer

Conditions: Bladder Cancer; Staging; Contrast Enhanced Ultrasound

Summary: ultrasound and magnetic resonance imaging (mri) technologies have become essential tools for the diagnosis and preoperative staging assessment of bladder cancer. however, establishing a precise system suitable for clinical application remains a significant challenge, and accurate prediction of bladder cancer staging is not yet possible. therefore, exploring a system for the precise diagnosis of preoperative staging of bladder cancer using ultrasound contrast enhancement or a combination of ultrasound contrast enhancement and mri is of great importance. the applicant has previously demonstrated the accuracy of multimodal data analysis in the diagnosis and prediction of malignant tumors. preliminary results from this study have shown that ultrasound contrast enhancement has a high diagnostic efficacy for the preoperative staging assessment of bladder cancer, with a high area under the curve (auc) of 0.88, sensitivity of 83.3%, specificity of 92.5%, and accuracy of 90.8%. in this project, the applicant intends to further expand the sample size and, based on the combination of ultrasound contrast enhancement and mri, develop a precise diagnostic system for the preoperative staging of bladder cancer to aid clinical treatment decisions.


Eligibility criteria:
inclusion criteria: * (a) eligible patients should be 18-year-old or older; * (b) patients should have a histologically or cytologically confirmed diagnosis of primary bladder cancer; * (c) patients should not have had any surgery, chemotherapy, immunotherapy, or any therapy before ceus diagnosis. exclusion criteria: * (a) participants with confirmed to have no carcinoma of the bladder; * (b) participants with previous pelvic surgery, who had undergone therapy, any bladder surgery, or had received chemotherapy, radiotherapy or immunotherapy; * (c) participants diagnosed with tumor recurrence or metastasis; (d) participants who were allergic to ultrasound contrast agents or could not tolerate ceus examination, for instance, with recent myocardial infarction, angina pectoris, cardiac insufficiency, severe cardiac arrhythmia, a right/left cardiac shunt, severe pulmonary hypertension, uncontrolled systemic hypertension, acute respiratory distress syndrome, or chronic obstructive pulmonary disease.

Keywords: bladder cancer contrast-enhanced ultrasonography
determining prognostic immune markers in patients with ovarian cancer

Conditions: Epithelial Ovarian Cancer

Summary: the improve study is a prospective, non-interventional, explorative cohort study to determine prognostic immune markers in patients with epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (eoc).

tumor material, ascites (if possible) and blood samples for immune monitoring will be collected from patients with primary and recurrent eoc undergoing surgery, chemotherapy and/or immunotherapy.

Eligibility criteria:
inclusion criteria: * patients with (suspicion of) primary or recurrent eoc with an indication for surgery, chemotherapy and/or immunotherapy. * age ≥18 years. * who performance status 0-2. * accessible for treatment and follow-up. * written informed consent. exclusion criteria: * other active malignancy in past 5 years prior to entry into the study, except for treated non-melanoma skin cancer. * any known severe infection like hiv, hepatitis a, b and c. * receiving immune suppressive treatment. * medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.

Keywords: epithelial ovarian cancer fallopian tube cancer primary peritoneal cancer eoc immunity improve prognostic immune markers
gait characteristics of women with breast cancer-related lymphedema

Conditions: Breast Cancer Related Lymphedema

Summary: upper extremity lymphedema is one of the most common problems associated with cancer treatments in breast cancer survivors. lymphedema causes asymmetry, changes posture, decreases arm swing due to increased weight, and as a result, may affects the patients' gait. the aim of this study is to examine the gait parameters in women with breast cancer-related lymphedema. women diagnosed with breast cancer who are referred to the gazi university health sciences faculty physiotherapy and rehabilitation department oncological rehabilitation unit to receive physiotherapy recommendations and healthy volunteers will be included in the study. the demographic and clinical characteristics of the individuals will be recorded. body mass index (bmi) will be calculated. then, presence of lymphedema and lymphedema severity will be evaluated by measuring the circumference of the arms with a tape measure. active shoulder joint movements will be evaluated with goniometer, handgrip strength with k-force hand dynamometer, spatiotemporal parameters of gait and pelvic symmetry will be evaluated using bts g-walk wearable motion analysis system. women with breast cancer related lymphedema will be compared with healthy women in terms of relevant parameters of gait. in addition, the relationship between lymphedema severity, shoulder joint movement limitation and grip strength with gait parameters in women with breast cancer and lymphedema will be analyzed.


Eligibility criteria:
inclusion criteria: * having breast cancer related lymphedema * being between the ages of 25-70 * completing cancer treatments exclusion criteria: * having orthopedic, neurological or vision problems that may affect walking * being in the active treatment process (being in the acute phase after surgery, receiving chemotherapy or radiotherapy)

Keywords: breast cancer lymphedema gait disorders upper extremity disorders
study of shr-1209 administered by single-site or multiple-site subcutaneous injections in healthy volunteers

Conditions: Hypercholesterolemia and Hyperlipidemia

Summary: in order to improve the medication convenience and compliance of patients and facilitates in the long-term control of disease condition, it is planned to reduced the number of injections to one per administration. the study aims to compare the safety and pharmacokinetics data to assess feasibility of single-site and multiple-site injection for administration.


Eligibility criteria:
inclusion criteria: 1. understanding the research procedures and methods, being able to complete the research in accordance with the procedure requirements, and sign the informed consent; 2. the age on the date of signing the informed consent must be ≥18 years old and ≤55 years old; 3. body mass index (bmi) at screening period must be ≥19.0 kg/m2 and \<28.0 kg/m2, weight of male must≥ 50.0 kg and \<90.0 kg, and female≥ 45.0 kg and \<90.0 kg; 4. the subjects and their female partners are willing to have no reproductive plan from signing the informed consent to 16 weeks after the last administration of the study drug, and voluntarily take effective contraceptive measures and do not plan to donate sperm or ovum. exclusion criteria: 1. serious infection within 3 months before screening; 2. history of food or drug allergy or atopic allergic disease (asthma, urticaria); 3. positive blood pregnancy test; 4. have a history of drug abuse; 5. women who are pregnant or breastfeeding; 6. subjects who are considered by the investigator to have any other factors which are not suitable for participating in this study.
a study to examine the safety and tolerability of mk0517 for the prevention of post-operative nausea and vomiting (0517-015)

Conditions: Post-Operative Nausea and Vomiting

Summary: a new intravenous medication is being tested for the prevention of the nausea and vomiting that occurs after surgery. this new medication is being compared to another intravenous medication that is already available to patients for this indication.


Eligibility criteria:
inclusion criteria: * open abdominal surgery requiring 24 hour hospital stay * general anesthesia * post-operative opioids * asa status of i-iii exclusion criteria: * patient exhibits evidence of any clinically significant respiratory, metabolic, hepatic, renal dysfunction, or cardiovascular condition or congestive heart failure (chf) * morbid obesity * patient is mentally incapacitated or has a significant emotional or psychiatric disorder
retrospective and prospective disease progression and quality of life in xlh

Conditions: X-linked Hypophosphatemia (XLH)

Summary: there is limited empirical data documenting disease progression and impact on quality of life for patients with x-linked hypophosphatemia (xlh). this study seeks to investigate the impact of xlh in adults living in the uk retrospectively and prospectively over a 12 month period, using qualitative interviews, seiqol-dw, eq-5d-5l, sf36 quality of life tools. xlh is a rare, genetic, chronically debilitating and deforming condition (www.nice.org.uk/guidance/hst8). xlh is characterised by renal phosphate wasting, hypophosphatemia and defective bone mineralisation. the incidence of xlh is reported to be between 1:20,000 and 1:25,000 live births. in the uk, it is estimated that there are around 250 paediatric xlh patients and around 2,500 adult xlh patients (delmestri,et al \[unpublished report\]2018). the clinical phenotype of xlh is varied amongst patients, even among affected members of the same family. this can range from no signs or symptoms, slow growth in children, short stature, bone abnormalities that can affect movement and result in pain, bowed legs and knocked knees (where lower legs are positioned at an outward angle), tooth abscesses and excessive dental caries and hearing loss (adult patients only). this study will recruit 36 adults living with xlh, who are aged 28 years or over and living in the uk. the study will be advertised by the sponsor and funder medialis ltd and via the patient organisation metabolic support uk. all study activities will take place via tele-visits and online questionnaires. the study will last approximately 2 years, allowing for one-year recruitment and a further 12 months to conduct all study visits.


Eligibility criteria:
inclusion criteria: * • participant has a diagnosis of xlh * participant is aged 28 years and above. * participant is capable of providing informed consent * participant is able to read and converse in english * participant is able to comply with the study schedule (5 tele-visits over a 12-month period) exclusion criteria: * • participant does not have a diagnosis of xlh * participant is aged under 28 years * participant is not capable of giving informed consent * participant is unable to read and converse in english * participant is unable to comply the with study schedule (5 tele-visits over a 12-month period)
postoperative pain associated with three endodontic rotary systems

Conditions: Acute Pulpitis

Summary: assessment of postoperative pain after root canal treatment using different rotary systems.

randomized controlled clinical trial comparing three types of endodontic rotary files to assess their effect on postoperative pain after single visit root canal treatment of premolar teeth diagnosed with acute irreversible pulpitis.

Eligibility criteria:
inclusion criteria: * systematically healthy patients, * maxillary or mandibular premolar teeth with acute irreversible pulpitis and indicated for conventional endodontic treatment. exclusion criteria: * non-vital teeth, * teeth with apical periodontitis, * teeth requiring endodontic retreatment, * root resorption, * immature / open apex, * root canals with radiographic evidence of calcification, * presence of more than one symptomatic tooth in the same quadrant, * pregnancy, * medically compromised patients, * patients receiving medication for chronic pain, * patients who have taken analgesics in the last 12 hours before treatment. * teeth that have initial apical size more than 20, * teeth that could not be treated in a single session, * if any evidence of extrusion of root filling material noticed radiographically, patient will be excluded.

Keywords: single file. one endo. f6 skytaper. protaper universal. irreversible pulpitis. postoperative pain.
psychometric properties of adapted turkish version of isyqol questionnaire in patients with ais

Conditions: Adolescent Idiopathic Scoliosis; Health Related Quality of Life

Summary: the isyqol questionnaire was translated into turkish and was assessed the psychometric properties of the turkish version of the isyqol in terms of test-retest reliability, internal consistency, and construct validity in this research.

hrqol is considered one of the most relevant outcomes of both conservative and surgical treatment of scoliosis, for this reason, several questionnaires (e.g. srs-24 and srs-22) have been developed. srs-22 has been reported as the most commonly used scale to measure hrqol in patient with scoliosis in many countries. however, current literature showed that srs-22 has poor measurement properties, it does not satisfy fundamental measure requirements, i.e. additivity, generalizability and unidimensionality. according to rasch analysis study srs-24 and srs-22 presents high ceiling effects in conservative care, for the reason that was developed for surgical candidates. the italian spine youth quality of life (isyqol) questionnaire originally in italian, is the first hrqol questionnaire developed according to the rasch analysis. it was developed in a conservative treatment setting for all type of spinal deformities, including also patients with surgical curves. the isyqol has recently been translated into english, however, its adaptation to the turkish language is necessary for use in the turkish population. the psychometric properties of any scale may be affected by translation into another language, that's why it is important for the scale to be evaluated psychometrically. therefore, the purpose of this study was to translate the isyqol questionnaire to turkish and to assess the psychometric properties of the turkish version of the isyqol in terms of test-retest reliability, internal consistency and construct validity when used on patients with idiopathic scoliosis. adolescent girls with idiopathic scoliosis who applied to formed scoliosis treatment and brace center between september 2018 to 2020 are inviting in this stud by mailing

Eligibility criteria:
inclusion criteria: * who has diagnosed with ais * aged 10 to 18 years * curvature between 10 ° to 45 ° , * native turkish speaker adolescents who accepted to participate in the study and approved by their parents. exclusion criteria: * non-idiopathic scoliosis * history of spinal surgery, * spinal trauma, tumor, infection

Keywords: adolescent idiopathic scoliosis quality of life