Kornimate/medical-research-clean huggingface dataset:
translation, cultural adaptation and validation of urdu version of visa-a questionnaire

Conditions: Achilles Tendinopathy

Summary: this study is designed to translate and validate the visa-a questionnaire to the urdu language, to interpret its psychometric properties, and to determine the reliability of scores obtained from the population of pakistan. the translated version of the gold standard tool will be used by the local population as well as urdu-speaking immigrants across the globe to better understand and report the severity of their symptoms. hence, to improve quality of life across cultures, there is a need of standard outcome measures in urdu language.


Eligibility criteria:
inclusion criteria: * individuals aged over 18 years and both genders. * athletic population with the diagnosis of unilateral mid-portion or insertional achilles tendinopathy, paratendinosis, partial tendon rupture with or without retrocalcaneal bursitis. * with positive painful arc sign and royal london hospital test. * healthy individuals. exclusion criteria: * complete rupture of achilles tendon, * pregnant women and those with any history of radicular pain or lower extremity injury * previous surgery

Keywords: achilles tendinopathy validity reliability translation visa-a
ruxolitinib and steroid as first line therapy for acute gvhd

Conditions: Acute GVHD

Summary: the purpose of this study is to evaluate the efficacy of ruxolitinib in combination with methylprednisolone as first line therapy in patients with grades ii to iv acute graft-versus-host disease (gvhd).

treatment: once patients are diagnosed with grade ii\~iv acute gvhd, the combination therapy should be initiated as soon as possible. 1. methylprednisolone: 2mg/kg/d, iv or iv gtt, in two or three divided doses. taper steroid every one or two weeks according to patient's response. 2. ruxolitinib 5\~10mg bid po for at least 28 days. if patient's anc\<0.5×10e9/l or plt\< 20×10e9/l, cease ruxolitinib until recovery of anc higher than 0.5×10e9/l or plt higher than 20×10e9/l. indication for stopping ruxolitinib treatment: 1. no response after ruxolitinib treatment for 28 days. 2. develop life-threatening complication. 3. anc\<0.5×10e9/l or plt\< 20×10e9/l. indication for second line acute gvhd treatment: 1. deterioration of acute gvhd in 3 days 2. no response after 7 days 3. no complete remission after 2 weeks. suggestions of second line therapy: basiliximab 20mg, d1, d4, d8.

Eligibility criteria:
inclusion criteria: 1. diagnosed with hematological diseases. 2. recipients of allogeneic peripheral blood stem cell transplantation. 3. new onset of grade ii\~iv acute graft versus host disease within 100 days post-transplantation. exclusion criteria: 1. recipients of second allogeneic stem cell transplant. 2. acute gvhd induced by donor lymphocyte infusion, interferon. 3. received treatment other than steroid before enrollment. 4. overlap gvhd syndrome. 5. pregnant or breast-feeding women. 6. absolute neutrophil count (anc) \<0.5×10e9/l or platelet count (plt) \< 20×10e9/l 7. non-gvhd related liver dysfunction: glutamic pyruvic transaminase\>= 4 times of upper normal limit, direct bilirubin \>= 4 times of upper normal limit 8. renal dysfunction: creatinine clearance \< 15 ml/min or glomerular filtration rate\< 15 ml/min 9. uncontrolled infection 10. human immunodeficiency virus infection 11. active hepatitis b virus, hepatitis c virus infection and need antivirus treatment. 12. relapse of primary malignant hematological diseases, or graft rejection. 13. allergic history to janus kinase inhibitors.
clinical study of ibi362 in healthy chinese male subjects

Conditions: Overweight/Obesity

Summary: this is a study to evaluate the pharmacokinetic characteristics and safety of ibi362 lyophilized powder and ibi362 liquid formulation in healthy chinese male subjects.

pharmacokinetic；safety

Eligibility criteria:
inclusion criteria: 1. 20 years old≤ healthy males≤45 years old 2. 19 kilograms per meter squared (kg/m²)≤body mass index≤26 kg/m² 3. willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff exclusion criteria: 1. subjects who have previously completed or discontinued from this study, or who have used ibi362. 2. abnormal vital signs and physical examination during the screening period; 3. having cardiovascular, respiratory, liver, kidney, digestive, endocrine, hematologic, neurological, or muscle degenerative diseases can significantly affect drug absorption, metabolism, or elimination, or participation in the study increases risk or interferes with data interpretation. 4. have a previous or current mental illness. 5. a family history of medullary thyroid carcinoma or multiple endocrine tumor syndrome type 2. 6. there are other factors judged by the investigators that are not suitable for inclusion in this study.

Keywords: pharmacokinetic safety
maintenance tislelizumab + capecitabine to treat metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer，NED

Summary: surgery with integrated treatment for metastatic colorectal cancer (mcrc) has created a new clinical setting known as mcrc with no evidence of disease (ned). however, these patients have a high risk of developing persistent cancer. this study aimed to investigate the efficacy and safety of tislelizumab combined with capecitabine as a maintenance treatment for patients with mcrc-ned.

this is a phase 2, randomized, open-label, single-center study designed to compare the efficacy and safety of tislelizumab+ capecitabine versus best-supported care as a first-line maintenance treatment in participants with mcrc-ned. patients who underwent synchronously or staged removal of primary and metastatic lesions, achieving ned, and histologically confirmed colorectal adenocarcinoma were recruited in this trial. the primary endpoint was disease-free survival (dfs). secondary endpoints included overall survival (os) and adverse events. this study will provide novel data on the efficacy and safety profile of the combination of tislelizumab and capecitabine in patients with mcrc-ned.

Eligibility criteria:
inclusion criteria: 1. age ≥ 20 years, \< 80 years 2. written informed consent 3. histologically or cytologically confirmed crc 4. surgery with integrated treatment for metastatic colorectal cancer (mcrc) and achieved a statute of no evidence of disease (ned), as determined by a multidisciplinary tumor board. 5. cytoreduction surgery achieves cc0 (no visible residual tumor) if there is peritoneal metastasis 6. no previous chemotherapy 7. synchronous or metachronous metastatic disease: maximum of two distant organs or regions involved 8. eastern cooperative oncology group (ecog) performance status score of 0 or 1 9. adequate hematologic and organ function exclusion criteria: 1. presence of any other active cancer 2. presence of active infections requiring antibiotics 3. history of active autoimmune disease requiring systemic treatment

Keywords: metastatic colorectal cancer，ned
wide-field optical coherence tomography imaging of excised breast tissue.

Conditions: Breast Cancer Female

Summary: this is a single-arm, multi-center data collection study designed to collect wf-oct imaging data of excised breast tissue margins with corresponding margin status from histopathology.

data collected during this study will be used for product development by the study sponsor, perimeter medical imaging.

Eligibility criteria:
inclusion criteria: * female * age 18 years or older * invasive ductal breast carcinoma and ductal carcinoma in situ having undergone breast conservation surgery * may include neo-adjuvant treated subjects (chemotherapeutic, endocrine therapy, or radiation) * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * metastatic cancer (stage iv) * lobular carcinoma as primary diagnosis
zips study - zip incision approximation vs. staple

Conditions: Arthroplasty, Replacement, Knee

Summary: study designed to evaluate the zip surgical skin closure device versus conventional steel staple placement when utilized for surgical wound closure after bi lateral unicompartmental or bi later total knee replacement.

this is a randomized, within patient control study aiming to enroll up to 25 subjects requiring bi lateral knee arthroplasty (unicompartmental or toal) at a single study center. subjects will be followed for up for 6 weeks post surgery to evaluate wound healing and overall satisfaction of closure methods.

Eligibility criteria:
inclusion criteria: * patients requiring epidermal closure after bi lateral total or partial (unicompartmental) knee arthroplasty; * patients willing to be evaluated at discharge and 6-weeks post op. exclusion criteria: * known bleeding disorder not caused by medication * known personal or family history of keloid formation or scar hypertrophy * known allergy or hypersensitivity to non-latex skin adhesives * atrophic skin deemed clinically prone to blistering * any skin disorder affecting wound healing * any other condition that in the opinion of the investigator would make a particular patient unsuitable for this study

Keywords: bi lateral knee surgery uni compartmental
seroquel switching study: feasibility of switching any antipsychotic treatment to seroquel in patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to document the clinical benefit of quetiapine (seroquel) sustained release (sr) after switching from another ongoing antipsychotic treatment, regardless of the reason for the switch. please note: seroquel sr and seroquel xr refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * patients who in their own and/or in the investigator's opinion, consider ongoing antipsychotic treatment inadequate, because of insufficient efficacy and/or tolerability. * female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study. * able to understand and comply with the requirements of the study, as judged by the investigator. exclusion criteria: * meeting the criteria for any other (than schizophrenia) diagnostic and statistical manual of mental disorders, 4th edition (dsm-iv) axis i diagnosis, concomitant organic mental disorder or mental retardation. * substance abuse or dependence as defined by dsm-iv and not in full remission. a urine drug screen test will be performed. the investigator will evaluate the results along with medical history to determine if the patient meets dsm-iv criteria for substance abuse or dependence. * risk of transmitting human immunodeficiency virus (hiv) or hepatitis b, via blood or other body fluids, as judged by the investigator. * patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.

Keywords: schizophrenia
efficacy study of risedronate to prevent cancer treatment-induced bone loss in prostate cancer

Conditions: Prostate Cancer

Summary: prostate cancer patients treated with lhrh agonists (e.g., leuprolide) lose bone mineral density. this is similar to post-menopausal osteoporosis. risedronate is approved to prevent osteoporosis. we hypothesize that risedronate may also be effective in prostate cancer patients treated with lhrh agonists.

iv bisphosphonates have proven effective in treating bone loss in prostate cancer patients treated with lhrh agonists. however, it is yet to be determined if an oral bisphosphonate such as risedronate could offer the same benefits.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age. * histologically confirmed diagnosis of prostate cancer without metastases. * patient must have negative bone scan to rule out bone metastases. * patient for whom androgen deprivation therapy with leuprolide acetate is indicated for at least 1 year. * eastern cooperative oncology group (ecog) score of 0 - 2. * study medication must be started within 3 months of initiation of adt. * signed written informed consent. exclusion criteria: * prior adt (greater than 3 months). * history of treatment with calcitriol or bisphosphonates. * suppressive doses of thyroxine within the previous year. * concomitant or prior history of long-term treatment (greater than or equal to 3 months) with systemic glucocorticoids. * evidence of any of the following conditions per subject self-report or chart review: current hyper- or hypothyroidism (stable on thyroid replacement therapy is allowed, if tsh is within normal reference range). paget's disease, cushing's disease, hyperprolactinemia, chronic liver disease. unstable systemic disease including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months before randomization. major surgery or significant traumatic injury occurring within 1 month prior to randomization. * known hypersensitivity to leuprolide acetate or any of the components found in eligard * any concurrent condition that would make it undesirable, in the physician's opinion, for the subject to participate in the study or would jeopardize compliance with the protocol.

Keywords: prostate cancer prostatic adenoma prostatic neoplasm
comparison of intravitreal anti-vegf versus combination therapy in central retinal vein occlusion

Conditions: Central Retinal Vein Occlusion With Macular Edema

Summary: to compare the effect of intravitreal-bevacizumab and triamcinolone with intravitreal-bevacizumab alone on visual acuity and central foveal thickness in patients with macular edema secondary to central retinal vein occlusion.


Eligibility criteria:
inclusion criteria: * subjects of either gender, age 40-80 years, having macular edema secondary to crvo, best-corrected visual acuity (bcva) of less than or equal to 0.3 on log mar chart (snellen equivalent of 6/12), central foveal thickness cft greater than or equal to 250 microns on heidelberg spectralis spectral domain optical coherence tomography (sd-oct) and clinical diagnosis of crvo. exclusion criteria: * previously received laser treatment and/or intravitreal injection of any anti-vegf agent, having one eye, diagnosed case of glaucoma, family history of glaucoma, young patient, and anyone who has received any treatment for crvo before presenting to us.

Keywords: central retinal vein occlusion macular edema intravitreal bevacizumab
intellicare in college students

Conditions: Depression; Anxiety

Summary: this study is an 8-week usability and feasibility trial of the smartphone student stress-management app intellicare for college students. this intervention will be tested with university of illinois at chicago (uic) and northern illinois university (niu) students. during this period, research surveys assessing depression and anxiety can be completed on the app. also, user feedback interviews will be conducted viatelephone at four weeks and at eight weeks to gain insight on the user experience of intellicare for college students.

in this study, students will be recruited for an 8-week trial in which they will be given the intellicare hub app and encouraged to use it daily. to ensure a sample representative of likely end users, 10 students from each site will be recruited: 5 with elevated distress as measured by scores \> 10 on either the phq-9 or gad-7 and 5 without elevated scores on either measure, for a total of 20 participants. the rationale for 10 participants in each group is based on past usability research indicating saturation is typically reached within 10 participants. this trial aims to identify software bugs and usability problems that emerge over extended use and to examine preliminary effects of program use. during the trial, participants will be prompted to complete the phq-8 and gad-7 every week. at baseline, 4 weeks, and 8 weeks, participants will be prompted within the app to complete the depression literacy questionnaire and anxiety literacy questionnaire to measure mental health literacy, the knowledge and beliefs about services scale to measure knowledge of campus mental health services, the barriers to mental health help-seeking questionnaire to measure treatment barriers, and the cognitive and behavioral response to stress scale to measure cognitive and behavioral coping skills. at 4 and 8 weeks participants will be asked to participate in a user-feedback interview via the telephone. this is to gain insight on the user's experience with the app.

Eligibility criteria:
inclusion criteria: participant is a student at the university of illinois in chicago or northern illinois university. participant owns a smartphone capable of running android 7 (or higher) or ios11 (or higher). participant is 18 years of age or older exclusion criteria: none

Keywords: mental health app mobile phone stress management
epirubicin versus docetaxel plus cyclophosphamide in lymph node negative, er-positive, her2-negative breast cancer

Conditions: Breast Neoplasms

Summary: the purpose of this study is to compare the safety and efficacy of epirubicin plus cyclophosphamide versus docetaxel plus cyclophosphamide in lymph node negative, estrogen receptor (er) positive, human epithelial growth factor receptor 2 (her2) negative breast cancer patients as adjuvant chemotherapy.

this is a non-inferiority study. according to previous study results, the investigators hypothesize the incidence of grade 3-4 neutropenia is 40%, with a α of 0.05 and β of 0.8, a sample size of 264 cases if needed.

Eligibility criteria:
inclusion criteria: 1. women aged ≥18 years and \ 12 months 2. have finished radical operation, pathologically verified no lymph node involvement 3. operation specimens are available for er, progesterone receptor (pr) and her2 detection, patients should be with er positive, her2 negative tumor. 4. adequate bone marrow function 5. adequate liver and renal function 6. has eastern cooperative oncology group (ecog0 performance score 0-1; 7. women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study; 8. written informed consent according to the local ethics committee requirements. exclusion criteria: 1. prior systemic or loco-regional treatment of breast cancer, including chemotherapy; 2. metastatic breast cancer; 3. with a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma; 4. patients with medical conditions that indicate intolerant to adjuvant chemotherapy and related treatment, including uncontrolled pulmonary disease, diabetes mellitus, severe infection, active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease; 5. has active hepatitis b or hepatitis c with abnormal liver function tests (lfts) or is known to be hiv positive; 6. history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction; poorly controlled hypertension; 7. has peripheral neuropathy ≥ grade 1; 8. patient is pregnant or breast feeding; 9. known severe hypersensitivity to any drugs in this study; 10. treatment with any investigational drugs within 30 days before the beginning of study treatment.
safety study of analgesia after craniotomy surgery with end tidal (et) carbon dioxide (co2) monitoring

Conditions: Pain

Summary: this research is being done to compare two methods of giving fentanyl, a narcotic often given to patients following brain surgery and determine if one method has more side effects than the other. both of these methods are available in the postoperative treatment of pain. this research also is being done to determine if patients receiving narcotic pain medicine will benefit from additional monitoring of carbon dioxide levels. since narcotic pain medicines can slow down breathing, the investigators want to see if measuring exhaled carbon dioxide levels will help identify a slower breathing rate and improve safety.

see brief summary

Eligibility criteria:
inclusion criteria: * adult male and female, english speaking patients undergoing supratentorial craniotomy for tumor under general anesthesia at the johns hopkins hospital will be eligible for this study. exclusion criteria: * pregnant women * patients with post operative neurological changes * patients who remain intubated post-operatively * patients who require the use of concomitant administration of sedatives * patients who are unable to initiate a pca bolus * patients who are unable to communicate verbally * patients who are allergic to fentanyl * patients who have a history of narcotic abuse * patients who have a history of chronic pain requiring opioids * patients who have been in any investigational drug trial within 1 month of the treatment day * patients who have chronic respiratory insufficiency

Keywords: pain management opioid analgesic therapy safety craniotomy
evaluation of a digital care system in the follow-up care of atrial fibrillation patients

Conditions: Cardiovascular Diseases; Atrial Fibrillation

Summary: the present study aims to investigate whether care improvement in patients after catheter ablation/cardioversion compared with standard care can be realized by using a digital ehealth platform with connected mobile sensors through early detection of atrial fibrillation recurrence and patient empowerment.

the main objective of the study is to compare the reliability of detection of atrial fibrillation of 2 measurement methods or protocols in terms of earliest possible detection: (1) digital ehealth platform with tethered 1-lead ecgs vs (2) standard-of-care long-term ecg. in addition, the quality of the acquired ecgs with both protocols will be compared by physician reporting based on the number of false positive abnormal findings as well as possible effects of using different mobile 1-lead ecgs. secondary goals are the collection of data on patient adherence (e.g., reliability of performing recommended actions such as measuring ecgs, blood pressure and body weight, and taking medications), on the course of the disease, and on the use of the health care system.

Eligibility criteria:
inclusion criteria: * ≥ 18 years * diagnosis of atrial fibrillation according to icd-10 i48.0, i48.1, i48.2, or i48.9. * catheter ablation or cardioversion no more than 72 hours ago at the time of inclusion. * possession and use of a smartphone that allows installation and use of the iatros app. * possession of the physical and mental abilities to use and apply the iatros app. * patients undergoing ablation or cardioversion after a confirmed diagnosis of atrial fibrillation. exclusion criteria: * \< 18 years * no use of a smartphone * lack of the physical and mental abilities necessary to use the iatros app, or to use so-called "apps" on a smartphone or tablet computer in general * absolute contraindications: * tumor disease * immunosuppression * dementia in an advanced stage * any disease associated with a reduced life expectancy of less than 1 year * any disease/condition that restricts participation in the study * pregnant or breastfeeding patients * participation in another clinical trial * addictive diseases * stroke in the last 3 months * transient ischemic attack (tia) in the last 3 months

Keywords: ehealth cardiology atrial fibrillation