Kornimate/medical-research-clean huggingface dataset:
a trial of panobinostat and trastuzumab for adult female patients with her2 positive metastatic breast cancer (mbc) whose disease has progressed on or after trastuzumab

Conditions: Breast Cancer

Summary: the primary purpose of this study is to identify the maximum tolerated dose (mtd) of both intravenous and oral panobinostat plus trastuzumab. the study will evaluate safety and efficacy of the combination in adult female patients with her2+ metastatic breast cancer

this phase ib/iia study was prematurely terminated due to lack of efficacy noted in 55 patients with her2-positive mbc who had progressed on or following a trastuzumab-based therapy.

Eligibility criteria:
key inclusion criteria: * age \> 18 year old * confirmed her2+ ve metastatic breast cancer * prior treatment and progression on trastuzumab * patients must have adequate laboratory values * eastern cooperative oncology group (ecog) performance status of \<2 key exclusion criteria: * patients with active central nervous system (cns) disease or brain metastases except those who have been previously treated and have been stable for at least 3 months. * impaired heart function or clinically significant heart disease * impairment of gastrointestinal (gi) function, or gi disease that may significantly alter the absorption of lbh589 * ongoing diarrhea * liver or renal disease with impaired hepatic or renal functions * concomitant use of any anti-cancer therapy or certain drugs * female patients who are pregnant or breast feeding * patients not willing to use an effective method of birth control

Keywords: breast cancer her2 positive adult-female lbh589 hdac inhibitor panobinostat
the effect of drain use on patient comfort in laparoscopic sleeve gastrectomy

Conditions: Obesity, Morbid

Summary: introduction laparoscopic sleeve gastrectomy surgeon; have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method. the purpose of this study is to determine the use of drain, which closely affects these criteria; and the effect on patient comfort.

question the necessity of routine use of drain in laparoscopic sleeve gastrectomy surgeon

Eligibility criteria:
inclusion criteria: * morbid obese patients exclusion criteria: * - cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during laparoscopic sleeve gastrectomy and those who had previously undergone obesity surgery (revision surgery) were excluded

Keywords: obesity vas pain laparoscopy sleeve
effect of myofascial release with tennis ball on spasticity and motor functions

Conditions: Stroke

Summary: impaired motor function and upper extremity spasticity are common concerns in patients after stroke. it is essential to plan therapeutic techniques to recover from the stroke. the objective of this study was to investigate the effects of myofascial release with the tennis ball on spasticity and motor functions of the upper extremity in patients with chronic stroke.

myofascial release is a therapeutic technique that aims to improve flexibility and sliding between layers of soft tissues, reduce the severity of muscle activity pain, and improve functional performance. a previous study included myofascial release with a tennis ball in the lower extremity in patients with chronic stroke and reported improved balance. different other unique therapeutic interventions have been proposed over the past two decades for stroke management; however, myofascial release with a tennis ball has not been included in them. therefore, the present study aimed to examine the effects of myofascial release with a tennis ball on spasticity and motor functions of the upper limb in patients with chronic stroke. participants were equally divided into two groups viz. experimental and control, with 11 participants in each group.

Eligibility criteria:
inclusion criteria: * unilateral stroke, * hemiplegia with upper extremity dysfunctions of more than 6 months and less than 2 years of duration * modified ashworth scale of grade 1-3, * mini-mental state exam (mmse) \>24 suggesting intact cognition, * full passive range of motion of the shoulder, elbow, wrist, and hand joints * voluntary control by brunnstrom of grade 3-5 for shoulder, elbow, and wrist joints exclusion criteria: * circulatory problems such as deep vein thrombosis, * impaired sensation over the affected upper limb, * recently injured area/open wounds, * arthritic or any other musculoskeletal condition of the upper extremity, shoulder instability based on the posterior or anterior apprehension test, and positive sulcus test, * history of brain surgery after stroke, * botox injection in the past four months, * medically unstable patients, * patients who have had multiple strokes.

Keywords: myofascial release chronic stroke motor functions spasticity modified ashworth scale fugl-meyer assessment scale
an ascending multiple dose study of vtp-38543 in adult participants with mild to moderate atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of vtp-38543 administered as a cream, twice-daily, for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis.

this is a randomized, double-blind, vehicle-controlled study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary clinical efficacy of vtp-38543 following twice-daily, every twelve hours (q12h) administration for 28 days in otherwise healthy adult male and female participants with mild to moderate atopic dermatitis. evaluation of three ascending doses in three dose panels is planned for this trial. dose panel 1 (vtp-38543 0.05%) and panel 2 (vtp-38543 0.15%) will each enroll 30 participants and randomize 20 to vtp-38543 and 10 to matching vehicle control (vehicle without transcutol®p). dose panel 3 (vtp-38543 1%) will enroll 40 participants and randomize 20 to vtp-38543 and 20 to matching vehicle control (vehicle with transcutol®p). a total of approximately 100 participants will participate in the trial.

Eligibility criteria:
inclusion criteria: * mild to moderate atopic dermatitis with a minimum of 3 to a maximum of 15% body surface area (bsa) involvement * investigator global assessments (iga) score of 2 or 3 * body mass index (bmi) = 18 - 35 kg/m\^2 * negative pregnancy test for females exclusion criteria: * treatment for atopic dermatitis with systemic medications, topical agents, and parenteral biological/monoclonal antibody agents, within specific time period prior to dosing. * organ dysfunction or any clinically significant deviation from normal in vital signs, physical examinations, labs, and electrocardiogram (ecg) findings * major surgery within 3 months of screening * use of prescription drugs, sedative antihistamine, medical devices for treatment of atopic dermatitis (ad), and topical products containing urea and/or ceramides within 14 prior to dosing * excessive sun exposures, use of tanning booths or other ultraviolet (uv) light sources 4 weeks prior to dosing

Keywords: eczema
association between triglyceride glucose index and severity of coronary artery disease

Conditions: Coronary Artery Disease

Summary: coronary artery disease (cad) is a chronic cardiovascular disease occurring due to atherosclerotic occlusion of the coronary arteries (1). acute coronary syndrome (acs) is the most severe type of coronary artery disease including unstable angina(ua) , st -elevation myocardial infarction (stemi) non st elevation mayocardial infarction (nstemi) (2). despite the use of current guidline-recommended therapeutics including percutaneous coronary intervention (pci) or coronary artery bypass grafting (cabg) and optimal drug treatments some patients with ischemic heart disease (ihd) remain at high risk for recurrent cardio vascular events(3). triglyceride glucose index (tyg) has a good potential in predicting poor cardiovascular prognosis in patients with ihd (4).


Eligibility criteria:
inclusion criteria: - this study will be conducted on patients investigated for ihd by coronary angiography at coronary catheterization unit at sohag university hospital exclusion criteria: * 1- patients younger than 18 years. 2- patients with malignant tumor disease . 3- patients with infectious or sever liver or kidney disease . 4- patients lacked data on hba1c,fpg,tg.
comparison of eccentric muscle training and proprioceptive neuromuscular facilitation techniques in neck pain

Conditions: Neck Pain; Chronic Pain

Summary: it was aimed to compare the eccentric exercise training given to the neck muscles of people with non-specific neck pain and the proprioceptive neuromuscular facilitation (pnf) technique on pain, endurance and functionality.

the study was planned as a quantitative study. volunteer individuals with nonspecific neck pain between the ages of 18-65 will be included in the study, and the participants will be randomly distributed into 3 groups. control group (n=15), proprioceptive neuromuscular facilitation technique application group (n=15), eccentric muscle training technique application group (n=15). people included in the study will be explained in detail and will be asked to sign a voluntary consent form approved by the ethics committee. demographic information of individuals in all three groups will be recorded first. participants in all three groups will be evaluated at the beginning and end of the applications. in our study, participants were evaluated with the mcgill pain questionnaire to evaluate the character and character of pain, their physical fitness with the deep neck flexor endurance test (dbfet), their functionality related to daily living activities with the neck disability index (nei), and their quality of life with the world health organization short form of quality of life (whoyka-cf). ) tampa kinesiophobia scale (tkö) and a goniometer for cervical region joint range of motion measurement will be used to evaluate kinesiophobia, which is the fear of pain and re-injury, as well as anxiety towards activity and physical movement. this study will be planned five times a week for six weeks. stretching and stabilization exercises will be applied to the control group in 3 sets of 10 repetitions.

Eligibility criteria:
inclusion criteria * being between the ages of 18-65 * history of neck pain that has persisted for at least 7 days * agreeing to participate in the study * having the ability to read and write turkish. exclusion criteria * radiculopathy and structural disorder in the cervical region, * surgery to the cervical region, * inflammatory disease, * severe psychological illness, * presence of infection in the bone and soft tissue in the cervical spine, * malignancy, * advanced osteoporosis, * those with upper extremity pathologies, * having a neurological disease that will prevent treatment * having previously undergone cervical region and spine surgery * having been included in a physiotherapy program for the neck and back area in the last 6 months, * it was defined as the administration of drugs such as nsaids (nonsteroidal anti-inflammatory drugs) and opioids in the last 24 hours.
optical detection of peripheral nerve bundles during surgery

Conditions: Malignant Lymphoma of Lymph Nodes of Inguinal Region; Malignant Lymphoma of Lymph Nodes of Axillary; Malignant Lymphoma of Lymph Nodes of the Cervix; Carcinoma of Parotid Gland; Colon Rectal Cancer Tubulovillous Adenocarcinoma; Tumor of Soft Tissue of Head, Face and Neck

Summary: investigation of application possibilities of optical spectroscopy within the field of surgical resection procedures to spare nerve tissue. optical spectroscopy enables the possibility to specifically differentiate between different (human) tissues. the hypothesis is that incorporation of this technique into existing medical devices (e.g. medical blade) would enlarge the accuracy and reliability of these devices. sparing of nerve bundles during surgery can lead to decreased postoperative morbidity rates.

the aim of this pilot study is to prove that an investigational optical spectroscopy system can provide accurate identification of nerve tissue during surgery. primary objective: the goal of this pilot study is to evaluate whether optical spectroscopy is able to differentiate between nerve tissue and surrounding tissue. secondary objective: during the measurement procedure, possible improvements of the measurement hardware will be recorded and the handling of the optical spectroscopy system during surgery will be evaluated.

Eligibility criteria:
inclusion criteria: * patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy , patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour. * patients that have provided a signed informed consent * patients ≥ 18 years old exclusion criteria: • patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy

Keywords: spectroscopy nerve muscle fat
study of alvimopan for the management of opioid-induced postoperative bowel dysfunction/ postoperative ileus

Conditions: Ileus

Summary: patients undergoing major abdominal surgery are at highest risk for developing postoperative ileus (poi), occurring in nearly all cases. signs and symptoms of poi may include abdominal distention and bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or inability to pass flatus or stool; and inability to tolerate a solid diet. this study will test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of surgery to hasten the recovery of gi function in patients undergoing major abdominal surgery (bowel resection or abdominal hysterectomy).

postoperative ileus (poi) is a temporary slowing down or stopping of bowel function and a slowing down of movement of contents of the intestines. this functional impairment persists for a variable duration following surgery, usually resolving within 1 day in the small intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. when poi persists for more than 5 days, it is generally considered severe, sometimes referred to as complicated or prolonged poi, and increases the risk for related morbidity. no drug therapy has been shown to consistently shorten the duration of poi. this study is designed to demonstrate that alvimopan, a novel, peripherally acting mu opioid receptor antagonist, accelerates the recovery of gi function in patients undergoing bowel resection or hysterectomy.

Eligibility criteria:
inclusion criteria: * subject is scheduled for a partial small/large bowel resection with primary anastomosis or total abdominal hysterectomy (simple or radical) via laparotomy * subject is scheduled to receive primary postoperative pain management with intravenous (i.v.) patient-controlled analgesia (pca) opioids exclusion criteria: * subject is scheduled for a total colectomy, colostomy, ileostomy * subject has complete bowel obstruction * subject has recently been on an acute course (1-10 days) of opioid analgesics and has not been off all opioids for at least 1 week prior to surgery subject has been on chronic (\>10 days) opioid analgesics and has not been off all opioids for at least 2 weeks prior to surgery.
mode of ventilation during critical illness pilot trial

Conditions: Respiratory Failure

Summary: landmark trials in critical care have demonstrated that, among critically ill adults receiving invasive mechanical ventilation, the use of low tidal volumes and low airway pressures prevents lung injury and improves patient outcomes. limited evidence, however, informs the best method of mechanical ventilation to achieve these targets. to provide mechanical ventilation, clinicians must choose between modes of ventilation that directly control tidal volumes ("volume control"), modes that directly control the inspiratory airway pressure ("pressure control"), and modes that are hybrids ("adaptive pressure control"). whether the choice of the mode used to target low tidal volumes and low inspiratory plateau pressures affects clinical outcomes for critically ill adults receiving mechanical ventilation is unknown. all three modes of mechanical ventilation are commonly used in clinical practice. a large, multicenter randomized trial comparing available modes of mechanical ventilation is needed to understand the effect of each mode on clinical outcomes. the investigators propose a 9-month cluster-randomized cluster-crossover pilot trial evaluating the feasibility of comparing three modes (volume control, pressure control, and adaptive pressure control) for mechanically ventilated icu patients with regard to the outcome of days alive and free of invasive mechanical ventilation.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * receiving mechanical ventilation through an endotracheal tube or tracheostomy * admitted to the study icu exclusion criteria: * patient is pregnant * patient is a prisoner * patient receiving invasive mechanical ventilation at place of residence prior to hospital admission * patient receiving extracorporeal membrane oxygenation at the time of admission to the study icu
sintilimab and decitabine for patients with relapsed/refractory or advanced nk/t-cell lymphoma

Conditions: Extranodal NK/T-cell Lymphoma

Summary: the purpose of this study is to evaluate the efficacy and safety of sintilimab in combination with decitabine in the treatment of relapsed/refractory or advanced nk/t-cell lymphoma patients

previous study has confirmed the efficacy of anti-pd-1 antibodies (including pembrolizumab or sintilimab). however, the cr rate of pd-1 antibody monotherapy is too low. previous studies have demonstrated that decitabine may activate the t cells and enhance the efficacy of pd-1 antibodies in hodgkin lymphoma. thus, the investigators aim to evaluate the efficacy and safety of sintilimab in combination with decitabine in the treatment of nk/t cell lymphoma.

Eligibility criteria:
inclusion criteria: histopathology and immunohistochemistry confirmed diagnosis of nk/tcell lymphoma according to who 2016 criteria. * refractory or relapsed after initial remission, or stage iii-iv de novo patients * pet/ct or ct/mri with at least one objectively evaluable lesion. * general status ecog score 0-3 points. * the laboratory test within 1 week before enrollment meets the following conditions: blood routine: hb\>80g/l, plt\>50×10e9/l. liver function: alt, ast, tbil ≤2 times the upper limit of normal. renal function: cr is normal. cardiac function: lvef≥50%, ecg does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above i blocking. * sign the informed consent form exclusion criteria: active infection requires icu treatment. concomitant hiv infection or active infection with hbv, hcv. patients who are infected with hbv but not active hepatitis at the same time are notexcluded. significant organ dysfunction pregnant and lactating women. had a history of autoimmune diseases, and disease was active in the last 6 months. those who were known to be allergic to drugs in the study regimen. patients with other tumors who require surgery or chemotherapy within 6 months. • other experimental drugs are being used.

Keywords: extranodal nk/t-cell lymphoma pd-1 blockade decitabine sintilimab hypomethylation epigenetics
impact of mayzent on aspms patients in a long-term nis in italy

Conditions: Active Secondary Progressive Multiple Sclerosis

Summary: this is an observational, multicenter, single-arm, prospective study conducted in italy

primary data will be collected over a period of three years. medical history of participants will be collected including edss, mri outcomes, relapses and previous medication to allow the estimation of the effects of siponimod treatment on an individual basis.

Eligibility criteria:
inclusion criteria: 1. signed informed consent: patient must provide written informed consent before any study assessment is performed. 2. male/female participants aged between 18 and 60. 3. documented diagnosis of active spms. 4. siponimod treatment as routine medical care: patients newly treated with siponimod (starting not more than 7 days before baseline visit), for whom the decision to start treatment has already been taken independently of study inclusion based on clinical practice and according to smpc and aifa criteria, and who successfully qualified for treatment with siponimod (i.e. passed the screening procedure mandated by the smpc and risk management plan (rmp) for this treatment, including genotyping for cyp2c9 to determine cyp2c9 metaboliser status). exclusion criteria: 1. patients treated outside the approved siponimod label or with any controindication indicated in the smpc. 2. pregnant or lactating women. 3. patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on the investigator's judgement. 4. current participation in an interventional trial. 5. treatment with siponimod prior to inclusion in this study (siponimod can be started not more than 7 days before baseline visit).

Keywords: secondary progressive multiple sclerosis aspms nis italy mayzent siponimod
adverse events report of inactivated covid-19 vaccine

Conditions: COVID-19; Vaccine Adverse Reaction

Summary: numerous vaccination studies are conducted to protect against covid-19 infection, and preclinical and clinical studies are still ongoing worldwide. during this extraordinary period, the necessity to perform covid-19 vaccine studies and immunization programs together has emerged. many manufacturing companies have started mass production of vaccines accepting the risk of failure of vaccines during trials. vaccine adverse effects (vaes) need to be documented quickly. we aimed to determine the vaes and to compare the frequency of vaes between groups according to socio-demographic characteristics after the inactivated vaccine (corona vac®) was administered to healthcare workers (hcws) in turkey. in this study, an online questionnaire was delivered to volunteer healthcare workers across the whole country. sociodemographic characteristics, medical history, history of covid-19 infection, and vaes occurring after the first and second doses of inactivated vaccine were evaluated.

a new coronavirus, severe acute respiratory syncytial coronavirus 2 (sars-cov-2) first appeared in china at the end of 2019 and attracted attention with clusters of pneumonia-like cases, which were later defined as coronavirus disease 2019 (covid-19). vaccine development is usually achieved over decades and therefore it is unprecedented to have access to such a large number of approved vaccines for covid-19. in this process, great efforts were made by many organizations to cope with this pandemic that affected the whole world. covid-19 vaccines with different features in the form of vector-mediated, messenger rna (mrna) or inactivated vaccines are being produced worldwide. coronavac® is an inactivated vaccine against severe acute respiratory syncytial coronavirus 2 (sars-cov-2) developed by sinovac biotech, china which was approved by world health organization (who) in june 2021. vaccine adverse effect (vae) is defined as "any adverse medical event that occurs after vaccination, which is thought to be due to a vaccine. the primary endpoint of our study was to evaluate the vaes reported after the first dose and the second doses following the inactivated vaccine (coronavac®), which was administered to hcws in our country as a dose of 3 µg twice, 28 days apart. the secondary endpoint was the comparison of the frequency of vae development between groups according to socio-demographic characteristics.

Eligibility criteria:
inclusion criteria: 1)the hcws vaccinated with two doses of coronavac. exclusion criteria: 1. the hcws under 18 years old 2. the hcws those couldn't be able to complete the questionnaire accurately.

Keywords: covid-19 vaccine vaccination adverse effect