Kornimate/medical-research-clean huggingface dataset:
fet-pet and multiparametric mri for high-grade glioma patients undergoing radiotherapy

Conditions: Glioblastoma Multiforme; Anaplastic Astrocytoma; Radiotherapy

Summary: glioblastoma is the most common malignant brain tumor in adults. the primary treatment consists of maximal tumor removal followed by radiotherapy (rt) with concomitant and adjuvant temozolomide. tumor recurrence after chemoradiotherapy has previously been shown to be predominantly within or at the margin of the irradiated volume, but distant failure are not rare, especially in patients with mgmt methylation.traditionally, rt has been planned based on on planning ct with co-registered postoperative mri, with the addition of a clinical target volume margin of 2-3 cm to account for infiltrative odema. to better characterize the disease, more specific physiological and/or metabolical markers of tumor cells, vascularization and hypoxia measured on multiparametric mri as perfusion, diffusion and spectroscopy alongside with pet tracer like fluoroéthyl-l-tyrosine (\[18f\]-fet) are now available and suggest that aggressive areas, like uptake of pet tracer and vascularity are present outside areas of contrast enhancement usually irradiated. these informations could be incorporated to optimize the treatment of radiotherapy.


Eligibility criteria:
inclusion criteria: * 18 years or older * histologically confirmed newly diagnosed glioblastoma or anaplastic astrocytoma * patients must have undergone surgery with macroscopic complete resection or incomplete resection with residual disease less than 5 cm on mri * an mri or a scan 48h after surgery should be available * who ≤ 2 * indication for adjuvant radiotherapy * surgery must have been performed 45 days before the start of radiotherapy. * ability to understand and to give consent exclusion criteria: * age \< 18 years. * prior radiation therapy to the brain * any usual formal indication against mri (claustrophobia, metallic objects or implanted medical devices in body: pacemaker, clips, prostheses ...) * allergic reaction to fet * pregnant women or nursing mothers * refusal to use effective contraception at study entry and throughout the study if patient is of childbearing age.
acupuncture for symptom control during assisted reproductive treatments procedures

Conditions: Infertility; Pain

Summary: rationale for conducting the experiment: israel performed ivf treatments since 1980. although art (advanced reproductive treatments) have evolved over the years implantation and pregnancy rates have not met the expectations yet. success rates of fertility treatments are about 15-18% (clinical pregnancy rates =cpr). as a result additional methods (clinical, technological and complimentary) have been tried to improve the cpr. in some reviews the effects of acupuncture practice during fertility treatments showed certain benefits, including pain relief and relaxation. unfortunately those trials were not randomized and lacked methodological rigor. the aim of this study is to evaluate the effect of acupuncture on pain, anxiety, and cpr of women undergoing ivf as compared to standard care alone.

women planned for ivf at the investigators' institution will be offered to participate in this trial. following consent, women will be randomized to acupuncture in addition to standard care or standard care only according to the working days of the acupuncture practitioner (working alternately three days a week). after ivf stimulation protocol the patients in the acupuncture group will have three acupuncture treatments: the first will take place right after oocytes retrieval and the second treatment will be right before embryo transfer, and lastly 20-30 minutes after embryo transfer. patients in the control group will receive standard care only. patients in both groups will fill out questionnaires regarding expectations from complementary medicine (likert scale no expectation--high expectation), anxiety level (visual analogue scale= vas) before the procedures, as well as pain assessment (vas) before and after the ivf procedures. in addition, a general satisfaction questionnaire from the overall care at the ivf unit will be completed at the last visit (likert scale very unsatisfied--highly satisfied). finally, the physicians will report procedure ease or complexity on a likert scale (very easy-very difficult).

Eligibility criteria:
inclusion criteria: * any patient who under going an ivf treatment in the investigators' unit. exclusion criteria: * patient who disagree to participate in the study, * patient who are undergoing ovulation induction or aid.
scapular mobilization versus capsular stretch

Conditions: Frozen Shoulder

Summary: the goal of this study is to compare the effect of scapular mobilization versus posterior capsular stretch on pain, function, range of motion, and posterior capsular tension in patient with frozen shoulder

frozen shoulder is a musculoskeletal condition that is commonly encountered in physical therapy practice. it is characterized by a painful, gradual loss of both active and passive glenohumeral motion resulting from progressive fibrosis and ultimate contracture of the glenohumeral joint capsule. frozen shoulder affects about 2% of the general population, with a higher prevalence in people between their 40s and 60s. frozen shoulder occurs more in diabetic patient. the traditional principles of treatment of frozen shoulder are to relieve pain, maintain range of motion, and ultimately to restore function. the physiotherapy treatment of frozen shoulder consists of different modalities such as transcutaneous electrical nerve stimulation (tens), interferential therapy (ift), ultrasound, short wave diathermy (swd) etc., and the physical therapy exercises such as stretching, codman exercise can be used. scapular-mobility exercises, or scapular-mobilization (sm) techniques is widely used in the management of musculoskeletal disorders of the shoulder. scapular mobilization can cause pain reduction with improvement in the shoulder range of motion. scapular mobilization can reduce the disability in patients with shoulder dysfunction. posterior capsular stretch is applied along with mobilization which causes significant improvement in increasing range of motion and functional disability. capsular stretching showed a more significant reduction in pain when compared to general exercises. therefore, what are the possible effect of scapular mobilization versus posterior capsular stretch in treating patients with frozen shoulder?

Eligibility criteria:
inclusion criteria: * males and females aged from 40-65 years old. * diabetic and non-diabetic patients' diagnosis of stage 3 frozen shoulder (frozen phase) by an orthopedist. * the presence of pain and limited movement in the shoulder for at least 2 months. * passive joint movements are limited when compared with the normal side. * unilateral involvement. exclusion criteria: * recent joint infection or surgery. * history of shoulder subluxation, dislocation, or ligamentous injury. * shoulder arthroplasty. * shoulder and cervical pathology. * recent trauma. * neurological disorders with muscle weakness in the shoulder joint. * infection, pregnancy, carcinoma patients, severe cardiac or psychiatric conditions. * previous shoulder surgeries to the affected shoulder. * previous manipulations under anesthesia of the affected shoulder. * radiological evidence for glenohumeral joint arthritis.
a study to evaluate the safety and efficacy of a new silicone hydrogel contact lens design

Conditions: Myopia

Summary: the objective of this study is to evaluate the safety and efficacy of a new silicone hydrogel contact lens compared to the bausch + lomb purevision contact lens when worn by adapted soft contact lens wearers.


Eligibility criteria:
inclusion criteria: * subjects must have clear central corneas and be free of any anterior segment disorders. * subjects must be myopic, and wear contact lenses in each eye. * subjects must be adapted soft contact lens wearers and agree to wear their study lenses on a daily wear basis for approximately 3 months. exclusion criteria: * subjects who are older than age 40 on the date the informed consent (icf) is signed. * subjects with any systemic disease currently affecting ocular health or which in the investigator's opinion may have an effect on ocular health during the course of the study. * subjects using any systemic or topical medications that will, in the investigator's opinion, affect ocular physiology or lens performance. * subjects with an active ocular disease or who are using any ocular medication. * subjects with any grade 2 or greater finding during the slit lamp examination. * subjects with corneal infiltrates, of any grade, are not eligible. * subjects with any "present" finding during the slit lamp examination that, in the investigator's judgment, interferes with contact lens wear. * subjects who are allergic to any component in the study care products.

Keywords: contact lens
ctc, free dna, stem cells and emt-related antigens as biomarkers of activity of cabazitaxel in crpc.

Conditions: Prostate Cancer; Metastatic Cancer; Castration-resistant Prostate Cancer; Circulating Tumor Cells

Summary: identification of biomarkers (circulating tumor cells (ctc), free dna, stem cells and emt-related antigens) that may be predictive of outcome of activity of cabazitaxel treatment in castration-resistant prostate cancer.

circulating tumor cells, free dna, stem cells and emt-related antigens as biomarkers of activity of cabazitaxel in castration-resistant prostate cancer primary objectives: to evaluate the prognostic role of response of the copy number of androgen receptor (ar) and phosphatase and tensin homolog (pten) and ar-v7 and other gene expression biomarkers in ctc and the investigators will compare these results with those obtained in plasma cell free dna and rna. eligible patients must have histologically or cytologically confirmed prostate cancer or unequivocal increased psa . metastatic and/or inoperable disease and received prior therapy with docetaxel and candidate to cabazitaxel treatment. all patients receive cabazitaxel at standard schedule 25 mg/m2 q21. blood sample will be collected for ctc evaluation at baseline, after the first cycle of therapy (optional), at first radiological evaluation (after 3 months), at disease progression (optional) or after 9-12 months of treatment for patients who did not show disease progression (optional). disease progression defined according to prostate cancer working group 2 (pcwg2) criteria. on blood samples from castration-resistant prostate cancer (crpc) patients the investigators will investigate the presence of the previously presented ctc, dna and rna free markers. as an option, it will be possible to require a sample of the tumor collected during prostate surgery or during the biopsy. all patients will be treated and monitored according to the local clinical practice. no additional procedures/patient visits in comparison with the usual clinical practice are planned for the study.

Eligibility criteria:
inclusion criteria: 1. ability to understand and the willingness to sign a written informed consent document 2. male aged \>18 years with metastatic castration-resistant disease with documented clinical (imaging) and/or biochemical progression (psa increasing values) during or after a previous docetaxel-based chemotherapy 3. patients must have metastatic and/or inoperable disease 4. patients must have received prior therapy docetaxel based and must be candidate to cabazitaxel 5. life expectancy of greater than 3 months 6. eastern cooperative oncology group (ecog) performance status \<2 exclusion criteria: 1. participants who are unable to provide informed consent 2. participation in another clinical trial

Keywords: circulating tumor cells castration-resistant prostate cancer cabazitaxel biomarker free dna stem cells emt related antigens
bioequivalence study (candesartan 16 mg and amlodipine 5 mg) - a

Conditions: Hypertension

Summary: the purpose of this study is to compare the safety and pharmacokinetics of ckd-330 (fixed-dose combination of candesartan 16 mg and amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.


Eligibility criteria:
inclusion criteria: 1. healthy male volunteer in the age between 19 and 45 years old. 2. body weight ≥ 55 kg and body weight in the range of calculated ibw ±20%. 3. subjects without a hereditary problems and chronic disease. 4. subjects whose clinical laboratory test values are inside the accepted normal range. 5. understand the requirements of the study and voluntarily consent to participate in the study. exclusion criteria: 1. previous history or present of clinically significant hepatobiliary, nephrological, neurologic, respiratory, hemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system. 2. history of gastrointestinal disease or gastrointestinal surgery to affect drug absorption. 3. history of clinically significant allergies of amlodipine or candesartan or ccb or arb or aspirin or antibiotic. 4. subjects with galactose intolerance. 5. sbp ≥ 140 mmhg or\< 90 mmhg, dbp ≥ 95 mmhg or \< 60 mmhg, pulse ≥ 100 bpm. 6. ast or alt \> 2\*uln, total bilirubin \> 2\*uln 7. serum creatinine \> uln 8. previous history or present of drug abuse. 9. subjects treated metabolizing enzyme inducers or inhibitors such as barbitals within 1 month prior to the first dosing. 10. subjects treated ethical drug or herbal medicine within 2 weeks, otc or vitamin within 1 week prior to the first dosing. 11. subjects treated ip within 2 months prior to the first dosing. 12. subjects with whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing. 13. alcohol \> 21 units/week or cannot stop drinking. 14. cigarette \> 10 cigarettes/day. 15. subjects with the plan dental treatment(extraction, orthodontic, nerve treatment) or any surgery(plastic surgery, eye surgery - lasik, lasek). 16. not eligible to participate for the study at the discretion of investigator.
bc3402 in combination with durvalumab in patients with advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: phase ib: dose exploration: to assess the safety, tolerability, and determine the recommended phase 2 dose (rp2d) of bc3402 in combination with durvalumab in subjects with advanced hepatocellular carcinoma (hcc) phase ii: dose expansion: to assess the antitumor activity of bc3402 in combination with durvalumab in subjects with advanced hcc.


Eligibility criteria:
inclusion criteria: 1. willing to participate in the study and sign an informed consent form; 2. male or female aged ≥ 18 years and ≤ 75 years; 3. patients with advanced hepatocellular carcinoma confirmed by histology or cytology, or cirrhosis which meets the clinical diagnostic criteria of hepatocellular carcinoma by the by american association for the study of liver disease (aasld) (2018 edition); 4. ecog performance status of 0 or 1; 5. hbv patients with hbv infection must be treated with antiviral therapy to ensure adequate viral suppression prior to enrollment; 6. adequate organ and marrow function; 7. male or female subjects with childbearing potential must agree to use reliable contraceptive methods. exclusion criteria: 1. received local hepatic therapy within 4 weeks prior to initiation of the study drug; 2. history of hepatic encephalopathy within the past 12 months or a requirement for medications to prevent or control encephalopathy; 3. the subject has clinically significant ascites requiring therapeuticc peritonrocentesis or peritoneal drainage. 4. the subject has main portal vein thrombosis on baseline imaging; 5. documented history of gi bleeding within the past 6 months or at a high risk of gi bleeding per the investigator's clinical judgement; 6. current or prior use of systemic corticosteroids or other immunosuppressive agents within 2 weeks before initiation of study drug; 7. prior treatment with any anti-tim3 antibody; 8. prior treatment with an anti-pd-1 or anti pd-l1 immune checkpoint inhibitor antibody (only applicable for dose expansion part). other protocol-defined inclusion/exclusion may apply.
cough monitoring study

Conditions: Cough; Reflux

Summary: the aim of the study is to establish the accuracy of a new device designed specifically to record and detect cough episodes. cough is an important defense mechanism of the respiratory tract. the presence of chronic cough may indicate the presence of underlying diseases, including reflux. despite the increased number of patients suffering from cough in the ent and gi practice, to date, there has been no method/device to objectively assess the frequency of cough episodes in a given patient. pulmotrack-cc, manufactured by karmelsonix (haifa, israel), has recently introduced an innovative device that is able to record cough episodes and then automatically detect and count them with the help of a specific software program. this study will assess the accuracy of this novel cough monitoring and counting technology and validate potential clinical use in patients with chronic cough.


Eligibility criteria:
inclusion criteria: arm 1: healthy volunteers: 1. male and female volunteers 18 years of age and older 2. no history of chronic or acute cough and throat clearing 3. ability to read a 5th grade script written in english for approximately 20 minutes arm 2: patients: 1. male and female volunteers 18 years of age and older 2. cough as chief complaint 3. referred to the gi clinic to evaluate if reflux is the cause of their chief complaint 4. ph testing for standard of care purposes exclusion criteria: * subjects who are not able to give informed consent

Keywords: cough chronic cough reflux
effect of spinal manipulation on electromyography of the masseter muscle

Conditions: Bruxism; Muscle Disorder

Summary: research problem: to know the immediate effects of high speed and low amplitude cervical manipulation on the electromyographic activity of the masseter muscles of physiotherapy students at the university of the americas course objective: to compare the immediate effects of high-speed, low-amplitude cervical manipulation on the electromyographic activity of the masseter muscles versus a placebo intervention in kinesiology students at the university of the americas. specific objectives: to describe the changes in the electromyographic activity of the masseter muscles of the high-speed cervical manipulation group in students of the physiotherapy school of the university of the americas of the santiago centro campus. to describe the changes in the electromyographic activity of the masseter muscles of the placebo group in students of the physiotherapy school of the university of the americas of the santiago centro campus. methodology: single-blind, randomized clinical trial. expected results: significant differences are expected between the intervention group and the control group. this is reflected in a decrease in electromyographic activity in the masseter muscles after high-speed cervical manipulation.


Eligibility criteria:
inclusion criteria: * male and female physiotherapy students over 18 years of age who regularly attend face-to-face classes who have a mobility pass and a health declaration. * students who read and sign the informed consent. exclusion criteria: * orthognathic surgery. * recent head and neck injury or fracture (equal to or less than 3 months) * dental or medical diagnosis of mandibular disorder or manifest facial pain. * contraindication (red flag) to perform high speed and low amplitude cervical manipulation (bone cancer, osteoporosis, vertebral artery injury, etc.)
optimizing ocular outcomes: a dual-armed study for periorbital burn management

Conditions: Periorbital Burns

Summary: the purpose of this study is to evaluate the effectiveness in using subcutaneous 5-fu/kenalog \& topical maxitrol ophthalmic ointment as different therapeutic adjuncts in the prevention of pathologic remodeling after periorbital burns.


Eligibility criteria:
inclusion criteria: * male or female, age greater than or equal to 18 years at the time of signing informed consent * mechanism of injury including explosion, thermal, electrical * clinical diagnosis of periorbital burn wound * second degree or less periorbital or lid bur * no previous surgical treatment for wound management * partial deep thickness periorbital burn * partial thickness burn * superficial burn * periocular lesions with globe involvement exclusion criteria: * recent surgical intervention for wound * full thickness and or "third degree burns" * imprisoned inmates * chemical burn * pregnant women * individuals whom are not adults \>18 years of age
linezolid for syphilis pilot study

Conditions: Syphilis

Summary: the study aims to evaluate the efficacy of linezolid for the treatment of syphilis.

this will be a randomized, open-label, non-comparative, adaptive pilot trial to evaluate the efficacy of linezolid 600mg orally, twice a day, for five or ten days, using a contemporaneous historical control group benzathine penicillin g (single dose of 2.4 million units) in participants with and without hiv infection. in total, 24 participants will be enrolled across multiple clinical sites in the united states. participants will participate in follow-ups to monitor clinical outcomes and serological response (rpr titer) at 1 month, 3 months, and 6 months. study findings may identify an efficacious alternative syphilis treatment to penicillin that is effective for people living with hiv. study findings may also help address the crisis of penicillin shortages, difficulty in administration, and offer options for those with penicillin allergy.

Eligibility criteria:
inclusion criteria: * 16 years of age or older * diagnosed cases of primary, secondary, or early latent syphilis with rpr titer ≥1:8 within 3 weeks prior to enrollment * able to provide informed consent * for plhiv: on treatment for hiv-infection and most recent viral load \ 350 cells/ml exclusion criteria: * pregnancy or a positive pregnancy test on the day of enrollment * participants who receive certain psychotropic medications, e.g., mao inhibitors, snris, ssris * patients showing signs and symptoms of neurosyphilis * serofast rpr titer * recent (\<7 days) or concomitant antimicrobial therapy with azithromycin, doxycycline, ceftriaxone, cefixime, or other beta lactam antibiotics (e.g. amoxicillin) * linezolid or penicillin allergy

Keywords: linezolid treponema pallidum penicillin early syphilis
evaluation of a hemostatic and sealing agent to prevent surgical complications after axillary lymphadenectomy

Conditions: Seroma

Summary: this study was intended to assess the value of a hemostatic and sealing agent, a collagen sponge coated with human coagulation factors (fibrinogen and thrombin) (tachosil®), for decreasing occurrence of seroma after axillary lymphadenectomy.


Eligibility criteria:
inclusion criteria: * patients with axillary lymphadenectomies performed for oncological conditions. exclusion criteria: * patients that did not want to participate in the study.

Keywords: axillary seroma axillary lymphadenectomy morbidity morbidity postlymphadenectomy lymphadenectomy