Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of pimecrolimus ophthalmic suspension in patients with moderate to severe keratoconjunctivitis sicca

Conditions: Keratoconjunctivitis Sicca

Summary: this study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (kcs, dry eye syndrome) patients.


Eligibility criteria:
inclusion criteria: * history of artificial tear use * moderate to severe signs of dry eye * moderate to severe ocular discomfort exclusion criteria: * patients with uncontrolled systemic or ocular diseases. * have any history of refractive surgery * use any topical ocular medications other than those dispensed for the study, during the study other protocol-defined exclusion criteria may apply.

Keywords: kcs dry eye pimecrolimus keratoconjunctivitis sicca (dry eye syndrome)
low-dose bevacizumab with hsrt vs bvz alone for gbm at first recurrence

Conditions: Glioma; Recurrent Glioma

Summary: this randomized phase ii trial studies how well lose dose bevacizumab with hypofractionated stereotactic radiotherapy (hsrt) works versus bevacizumab alone in treating patients with glioblastoma at first recurrence. the primary endpoint is 6-month progress-free survivaloverall survival after the treatment. secondary endpoints included overall survival, objective response rate, cognitive function, quality of life and toxicity.

to establish an improvement in 6-month pfs in recurrent glioblastoma patients receiving low-dose bevacizumab and re-irradiation compared with patients receiving bevacizumab alone.

Eligibility criteria:
inclusion criteria: * 18-70 years of age; * karnofsky performance status (kps) ≥ 60; * original histopathologically proven diagnosis world health organization (who) grade 3/4 glioma; * underwent surgery, chemoradiotherapy and adjuvant chemotherapy (stupp protocol) after initial diagnosis, recurrent based on the response assessment in neuro-oncology (rano) criteria and/or histopathologically proven; * measurable disease; * estimated survival of at least 3 months, maximal diameter on t1+c mri ≤ 3.5 cm; * hgb \> 9 gm; absolute neutrophil count (anc) \> 1500/μl; platelets \> 100,000; creatinine \< 1.5 times the upper limit of laboratory normal value; bilirubin \< 2 times the upper limit of laboratory normal value; serum glutamate pyruvate transaminase (sgpt) or serum glutamate oxaloacetate transaminase (sgot) \< 3 times the upper limit of laboratory normal value; * signed informed consent form; * agreed to participate the follow-up. exclusion criteria: * prior invasive malignancy unless disease free; * received re-irradiation; * more than 3 relapses or evidence of subtentorial recurrent disease or tumor greater than 6 cm in maximum diameter; * prior therapy with an inhibitor of vascular endothelial growth factor (vegf) or vegfr; * pregnancy or or nursing mothers; * participated in other trials after diagnosis of recurrent; * influence factors toward oral medications; * patients with ctcae5.0 grade 3+ bleeding; * suffering from severe cardiovascular disease: myocardial ischemia or myocardial infarction above grade ii, poorly controlled arrhythmias (including men with qtc interval ≥ 450 ms, women ≥ 470 ms); according to nyha criteria, grades iii to iv insufficient function, or cardiac color doppler ultrasound examination indicates left ventricular ejection fraction (lvef) \<50%; * long-term unhealed wounds or fractures; * history of organ transplantation; * serious diseases that endanger patients' safety or affect patients' completion of research,according to the researchers' judgment.
second course of therapy for resistant patent ductus arteriosus (pda)

Conditions: Patent Ductus Arteriosus

Summary: patency of the ductus arteriosus (pda) is functionally essential for fetal circulation, however persistence of ductal patency postnatally may have significant adverse hemodynamic effects in the neonate. medical therapy for pda predominantly involves the administration of one of two non-steroidal anti-inflammatory drugs: indomethacin or ibuprofen. both of these therapies have been shown to be successful in mediating ductal closure in approximately 70% of treated infants. however, the need for a second course of treatment for pda closure remains quite common. the investigators hypothesize that, because of small differences between the two drugs, a greater percentage of infants who did not respond to a first course of therapy with indomethacin will respond to a second course with ibuprofen than to a repeat course of indomethacin. as such, the investigators aim to compare secondary therapy with a repeat course of indomethacin to secondary therapy with ibuprofen in infants whose ductus remained patent after a first course of therapy with indomethacin.


Eligibility criteria:
inclusion criteria: * inborn premature neonates (birth weight \[bw\] \<1500 grams) being treated in the neonatal intensive care unit of the shaare zedek medical center and diagnosed as still having a hemodynamically significant patent ductus arteriosus (hspda) after a first course of therapy with indomethacin, will be considered as potential candidates for study pending response to initial therapy and pending parental consent. exclusion criteria: * any baby not considered viable * any baby with intraventricular hemorrhage (ivh) grade 3-4 of recent onset (within 3 days). \[if no head ultrasound has been performed within the last 3-4 days, one should be performed prior to onset of study.\] * any baby with dysmorphic features or congenital abnormalities * any baby with structural heart disease other than pda * any baby with documented infection, * any baby with thrombocytopenia (\<50,000).

Keywords: pda indomethacin ibuprofen
clinical evaluation of the vipun balloon catheter 0.2 in critically ill patients

Conditions: Critical Illness; Intolerance; Nutritional; Delayed Gastric Emptying; Gastric Motor Dysfunction

Summary: an open label, non-randomized, monocentric, interventional investigation in a cohort of adult critically ill patients


Eligibility criteria:
inclusion criteria: * signed informed consent * of adult age (18 years or older) * icu patients in which enteral nutrition is planned to be initiated and are expected to stay at least 1 day in icu on enteral feeding. * patients should be mechanically ventilated or have an endotracheal tube or tracheostomy in place. exclusion criteria: * contra-indication for (re-) placement of nasogastric feeding catheters. * history of gastric or esophageal surgery * any gastrointestinal surgery or trauma that could significantly increase the risk related to the investigational medical device in the opinion of the investigator * fed by mouth or enterally prior to inclusion * patient is moribund * known pregnancy or breastfeeding women * receives gastroprokinetic medication (e.g., erythromycin, metoclopramide, domperidone)
accu-chek connect personal diabetes management study (pdm connect)

Conditions: Diabetes Mellitus, Type 1

Summary: this post-market, interventional, prospective, single arm, the united states (us) based multi-center study will assess the change in treatment satisfaction of participants who utilize the accu-chek connect diabetes management system over a period of 6 months.


Eligibility criteria:
inclusion criteria: * diagnosis of type 1 or type 2 diabetes for greater than or equal to (\>=) 6 months * currently using insulin as a component of the diabetes therapy * allow and be able to provide self-monitoring of blood glucose (smbg) data at least 1 month prior to study start * smbg frequency as confirmed by site smbg data download of participants meter(s): basal insulin treated participants - smbg \>=5 times per week and multiple dose insulin participants - smbg \>=2 times per day * glycosylated hemoglobin (hba1c) of \>=7.5 percentage (per local laboratory obtained less than or equal to \[\<= 3\] months of baseline) * able to read and write in english language * currently using a smartphone and have experience with downloading at minimum one application * smartphone compatibility; must be able to download the accu-chek connect system application accordingly * naive to the accu-chek connect system * willing to comply with study procedures exclusion criteria: * treatment with insulin pump therapy * any use of continuous glucose monitoring (cgm) to manage their diabetes during the course of the study * visually impaired * women who are pregnant, lactating or planning to become pregnant during the study period * diagnosed with any clinically significant condition (for example anemia, major organ system disease, infections, psychosis or cognitive impairment) * participant requires chronic steroid in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy * participant is the investigator or any sub-investigator, general practitioner, practice staff, pharmacist, research assistant or other staff or relative of those directly involved in the conduct of the study and design of the protocol
laparoscopic versus open appendectomy

Conditions: Acute Appendicitis

Summary: comparison of open and laparoscopic appendectomy

adult patients with presumptive diagnosis of acute appendicitis were were operated by laparoscopic appendectomy or open appendectomy group during a three-year period (between 2007 and 2009).

Eligibility criteria:
inclusion criteria: * patients older than 16 years with presumptive diagnosis of acute appendicitis exclusion criteria:appendectomy performed during diagnostic laparoscopy and incidental appendectomies patients with: * cirrhosis * ascites * coagulation disorder * diffuse peritonitis * shock on admission * large ventral hernia. appendectomy performed during diagnostic laparoscopy and incidental appendectomies were also excluded

Keywords: open appendectomy laparoscopic appendectomy appendicitis
a comparison of the 3m tm s surgical skin closure system to the standard vicryl suture closure of sternotomy incisions during cardiac surgery

Conditions: Wound Infection

Summary: following closure of surgical incisions, wounds may develop redness, swelling, and drainage which may result in increased pain and infection. this study will test to hypothesis that using the 3m tm s surgical skin closure system will reduce the incidence of pain, redness, swelling, and infections in a group of patients undergoing a mediastinotomy incision used for open heart surgical procedures.


Eligibility criteria:
inclusion criteria: * patients undergoing mediastinotomy for cardiac surgical procedures exclusion criteria: patients with: * allergies to skin adhesives * known keloid formation * prior sternotomies * conditions making them not candidates for vicryl skin closure

Keywords: sutures
lifestyle medicine for depression

Conditions: Depression

Summary: this study will examine the feasibility and efficacy of lifestyle medicine for the management of depression in chinese adult population. the main components of lifestyle intervention typically include physical activity, diet, relaxation/mindfulness, and sleep. while lifestyle medicine has been recognized for centuries as a means to improve physical health, the field of lifestyle medicine in the context of mental health is still in its infancy. in the existing literature, there is increasing evidence demonstrating the efficacy of individual components of lifestyle medicine (e.g, physical activities and sleep) on depression. however, there is very limited research on the effectiveness of an integration of multiple lifestyle adjustments on depression.


Eligibility criteria:
inclusion criteria: 1. hong kong residents aged ≥ 18 years; 2. cantonese language fluency; 3. patient health questionnaire (phq-9) score ≥ 10; and 4. willingness to provide informed consent and comply with the trial protocol. exclusion criteria: 1. pregnancy; 2. have suicidal ideation based on beck depression inventory (bdi-ii) item 9 score ≥ 2 (referral information to professional services will be provided to those who endorsed items on suicidal ideation); 3. using medication or psychotherapy for depression; 4. having unsafe conditions and are not recommended for exercising or a change in diet by physicians; and 5. have major psychiatric, medical or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle modification.

Keywords: depression lifestyle medicine
effect of vildagliptin on fat and muscle metabolism in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: please note this study is not being conducted in the united states. the purpose of this study is to test the hypothesis that acute dpp-4 inhibition with vildagliptin improves fat and muscle metabolism in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * must be able to complete a 3-week wash-out of current anti-diabetic medication * cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose * must discontinue beta-blockers and lipid lowering drugs * blood glucose criteria must be met * bmi in the range 30-35 exclusion criteria: * history of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes * need for insulin within 3 months or patients on thiazolidinediones * patients taking a sulfonylurea or metformin who cannot safely discontinue medication for the duration of the study * significant concomitant disease or complications of diabetes * patients with any history of gastrointestinal surgery or positive gastrointestinal symptons * high tryglycerides as defined by the protocol * smokers who cannot abstain from smoking during the treatment periods

Keywords: vildagliptin, type 2 diabetes
a phase ii trial comparing z-102 with placebo in patients with moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: thus study will test an experimental drug called z-102 (combination of prednisolone and dipyridamole) to treat patients with moderate to severe rheumatoid arthritis.

the primary objective of the study was to demonstrate the efficacy of z102 (2.7 mg prednisolone/360 mg dipyridamole) versus placebo on the disease activity score 28 using c reactive protein (das28-crp) in subjects with rheumatoid arthritis at the study endpoint of 12 weeks

Eligibility criteria:
inclusion criteria: * meet the acr / eular criteria for classification of ra * have moderate to severe ra, defined as involving a minimum (≥6 total swollen and ≥6 total tender) of the 28 joints assessed * have screening crp levels of at least 0.6 mg/dl and a das28-crp score ≥4.5 * have been on a stable dose of conventional dmard therapy for at least 90 days without dosage adjustment or modification and should be able to maintain the same dose of conventional dmard therapy during study participation (with or without glucocorticoid therapy exclusion criteria: * treatment-refractory patients are excluded * has active cardiovascular disease, unless well controlled by appropriate treatment for a minimum of 3 months prior to screening * is taking aspirin for reasons other than for cardiovascular prophylaxis or their total daily dose is greater than 325 mg * is currently taking steroids at a daily prednisone dose, or the equivalent, of \>10 mg * intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study * the need to continue the use of one or multiple nsaid's at the same time, or the use of acetaminophen on a chronic basis * all opiate use is prohibited * use of any other medications or herbs used for the treatment of pain is prohibited * patients with a history of or currently active tuberculosis as per specific country guidelines are excluded * has uncontrolled diabetes mellitus as defined by a serum glucose \>126 mg/dl * knowingly has hiv infection or hepatitis * has undergone administration of any investigational drug within 30 days of study initiation * all biologic agents are excluded for 90 days prior to screening and throughout the study. * has undergone administration of rituximab or any b-cell depleting investigational drugs within 6 months of study initiation * has had a history of alcohol or drug abuse within the past 2 years * has a history of hypersensitivity to glucocorticoids and/or dipyridamole

Keywords: rheumatoid arthritis moderate to severe
the incidence of linezolid-induced thrombocytopenia (lit) in critically ill patients, the risk factors for lit

Conditions: Thrombocytopenia; Drugs

Summary: * to identify the incidence of lit among critically ill patients, as limited studies have only addressed this population. * to evaluate the impact of several factors on the incidence of lit, the time to onset of lit, and the time to recovery of platelets. * to study the effect of concurrent medications (enoxaparin, unfractinated heparin, piperacillin, carbapenems, tigecycline, fluconazole or voriconazole, digoxin, amiodarone, acetaminophen, tirofiban, statins, and antiepileptics) frequently used in critically ill patients on the incidence of lit. * to investigate the impact of possible medications with an antioxidant effect on the prevention of lit. * to assess the impact of lit on composite end point (mortality, bleeding, and length of stay)


Eligibility criteria:
inclusion criteria: * all adult patients, age \> or = 18 years old, admitted to the icu with different indications. * candidates for intravenous linezolid therapy for \> or =1 day. exclusion criteria: * taking any myelosuppressive drug. * baseline platelets \< 50000. * patients with hematological malignancy. * covid-19 patients. * patients with immune thrombocytopenia

Keywords: linezolid thrombocytopenia
a phase 2b study of the efficacy, safety, and tolerability of m1095 (sonelokimab) in subjects with moderate to severe psoriasis

Conditions: Psoriasis

Summary: this is a multi-center phase 2b study in subjects with moderate to severe chronic plaque-type psoriasis. approximately 300 subjects will be enrolled at approximately 60 investigator sites in north america and europe.


Eligibility criteria:
inclusion criteria: 1. male and female subjects between 18 and 75 years of age. 2. moderate to severe plaque-type psoriasis for at least 6 months. 3. subject is a candidate for systemic biologic therapy. 4. subject has iga ≥3, involved body surface area (bsa) ≥10%, and pasi ≥12 at screening and at baseline. 5. subject is able to comply with the study procedures. 6. subject must provide informed consent. exclusion criteria (main): 1. non-plaque type psoriasis, drug-induced psoriasis, or other skin conditions (e.g., eczema). (psoriatic arthritis is allowed). 2. other medical conditions, including planned surgery or active infection / history of infection, as defined in the study protocol. subjects will be screened for tuberculosis and hepatitis b / hepatitis c. 3. laboratory abnormalities at screening, as defined in the study protocol. 4. prior use of systemic or topical treatments for psoriasis, as defined in the study protocol. 5. prior use of any compound targeting il-17, more than two biologic therapies, ustekinumab within 6 months, or tnf targeting therapies within 12 weeks. 6. history of suicidal thoughts within 12 months.
a study of the safety and efficacy interferon-gamma 1b in patients with idiopathic pulmonary fibrosis (ipf)

Conditions: Idiopathic Pulmonary Fibrosis

Summary: study gipf-001 is phase 3 study designed to determine the safety and efficacy of ifn-g 1b administered by subcutaneous injection; compared to placebo in patients with ipf who are unresponsive to steroids. 330 patients have been enrolled and were assigned to either a ifn-g 1b group or a placebo group.


Eligibility criteria:
male or female, 20-79 years old

Keywords: lung ipf
a longitudinal study on the safety and efficacy for subjects with asd who received mert

Conditions: Autistic Disorder

Summary: the purpose of this study is to continue to evaluate the long-term effectiveness of magnetic eeg/ecg-guided resonance therapy (mert) in children with autism spectrum disorder (asd). no active mert treatment will be performed in this study.

this clinical trial is a longitudinal study designed to evaluate the safety and efficacy for subjects with autism spectrum disorder (asd) who received magnetic eeg/ecg-guided resonance therapy (mert) in the irb approved clinical trial. a total of twenty-eight (28) subjects will be followed in this study. after providing informed consent, twenty-eight (28) subjects who participated in the previous protocol will be observed for up to three (3) years post-mert treatment. during this period, subjects will be evaluated at 104 and 156 weeks post-mert treatment.

Eligibility criteria:
inclusion criteria: 1. subject must have completed the mert-001 (formerly known as mrt-001) clinical trial conducted by the brain treatment center (btc) 2. age between 6 and 15 years (at day of informed consent) 3. willing and able to adhere to the study visits exclusion criteria: 1. subjects who did not participate in the mert-001 clinical trial. 2. any condition which in the judgment of the investigator would prevent the subject from completion of the study.

Keywords: autism asd autism spectrum disorder
effects of breathing exercises with and without inspiratory muscle training in copd patients

Conditions: COPD

Summary: chronic obstructive pulmonary disease (copd) is a major health issue that affects a large proportion of the population, especially those over 50 years old. it is characterized by breathlessness and reduced lung function. it has been hypothesized that practicing specific breathing exercises could potentially alleviate these symptoms and enhance lung volumes and capacities. in addition, there is a lack of clarity on the effects of inspiratory muscle training along with these breathing exercises, warranting further investigation. to determine the effects of breathing exercises with and without inspiratory muscle training on dyspnea, lung volumes and lung capacities in copd patients. a total of 46 patients, aged over 50, will be enrolled from national hospital and medical center, lahore and ittefaq hospital, lahore. these patients will be randomly divided into two groups a and b: the first group will be assigned to perform only diaphragmatic and pursed lip breathing exercises daily for 2 months. in contrast, the second group will also receive breather, which will involve inhaling through a mouthpiece with variable resistance and using breath-holding techniques. the trial will follow strict ethical guidelines, with all participants providing informed consent. outcomes will be measured through pulmonary function tests and the modified borg dyspnea scale. the study will also obtain the necessary approval from the respective ethical committees of the participating institutions. the data will be analyzed in spss 26.0.


Eligibility criteria:
inclusion criteria: * be aged between 35 and 50 years (23). * be of any gender. * have a clinical diagnosis of copd, severity ranging according to gold stages of copd ii to iii stages (24). * have the functional ability to perform the prescribed breathing exercises and inspiratory muscle training (25). * demonstrate a willingness to participate in the study by providing informed consent exclusion criteria: * diagnosed musculoskeletal disorders that could potentially interfere with the e execution of the exercises. * recent chest injuries that might complicate the respiratory function. * pregnancy, given the potential for altered respiratory mechanics and concerns for f fetal safety. * prior history of abdominal or pelvic surgeries, as these could affect diaphragmatic movement and overall respiratory function. * a history of malignancy, due to the potential for compromised overall health status and related complications. * active or latent tuberculosis, to prevent exacerbating the condition and potentially spreading the infection.

Keywords: respiratory muscles breathing exercises dyspnea