Kornimate/medical-research-clean huggingface dataset:
a clinical trial of lurasidone in treatment of schizophrenia

Conditions: Schizophrenia

Summary: this is a randomized, double-blind, double-dummy, parallel- controlled, adjustable dose, non-inferiority and multicentre study designed to evaluate the efficacy and safety of lurasidone on schizophrenia for 6 weeks treatment, and to compare with risperidone.


Eligibility criteria:
inclusion criteria: * provide written informed consent and aged between 18 and 65 years of age. * meets dsm-iv-tr criteria for a primary diagnosis of schizophrenia, had a panss total score ≥ 70 and ≤ 120 at screening and baseline, and a score ≥ 4 on the cgi-s at screening and baseline. * not pregnant, if of reproductive potential agrees to use adequate and reliable contraception for duration of study. * able and agrees to remain off prior antipsychotic medication for the duration of study. * willing and able to comply with the protocol, including the inpatient requirements and outpatient visits. exclusion criteria: * considered by the investigator to be at imminent risk of suicide or injury to self, others or property. * any chronic organic disease of the cns(other than schizophrenia) * subjects are participating or participated in other clinical studies including marketed drugs or medical devices within 30 days before signing the informed consent form. * clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months.

Keywords: schizophrenia lurasidone latuda
efficacy of arm training in copd patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: recent guidelines on pulmonary rehabilitation (pr) recommend upper extremity exercise training (ueet) in patients with chronic obstructive pulmonary disease (copd). the theory supporting the inclusion of upper extremity exercise training in the pulmonary rehabilitation for these patients, is based on the profound understanding of the activity of the accessory respiratory muscles, which are competitively involved in both the support of the upper extremities during activities and the ventilation. however, a systematic review of the literature carried out by our staff reveals that the clinical trials carried out up to now to verify the effectiveness of ueet are of poor methodological quality and the investigators cannot corroborate the recommendation recently made on the basis of the results of the investigators' review. therefore the investigators began this randomized, parallel groups, controlled clinical trial with the purpose of determining the short-term effect of unsupported ueet on the performance of the upper extremities and on symptoms perceived during activities by patients with copd.

we recruited inpatients with stable, moderate or severe copd referred to the pr program at the regional centre of villa pineta hospital. patients were randomized into two groups: control and intervention. patients randomized to the control group undertook an inpatient comprehensive pr that complied with the recommendations made by the ats/ers and included a minimum of 15 daily sessions of specific training for lower extremities. patients randomized to the intervention group undertook an experimental program consisting of 15 additional daily sessions of unsupported ueet over and above the same pr program used for control patients. measurements of upper extremity performance and symptoms perceived were taken in both groups at baseline (t0) and at the completion of the interventions (tend) by one physiotherapist unaware to the patient's group allocation. to verify if the experimental training leads to long-term results on the functional arm exercise capacity, some measurements were repeated at 6-months as the latest follow-up (t6months).

Eligibility criteria:
inclusion criteria: * diagnosis of copd * a degree of copd severity equal or above grade 2 (moderate) on the basis of the gold classification * clinical stability for a minimum of 4 weeks * degree of chronic dyspnea ≥ grade 2 on the medical research council dyspnea scale exclusion criteria: * muscular-skeletal abnormalities limiting the shoulder girdle functionality * cognitive impairment limiting participation * previous inclusion in ueet programmes within the last 3 years * malignancies

Keywords: pulmonary disease, chronic obstructive upper extremity exercise therapy
safety and efficacy of immunomodulator drug thalidomide in multi-transfused thalassemia patients

Conditions: Thalassemia

Summary: this study aimed to determine the safety and efficacy of thalidomide in multi-transfused thalassemic children.

given the significant burden of transfusion dependency, an effective and safe inducer is needed that could improve quality of life and reduce the healthcare costs associated with frequent transfusions and iron chelation therapy. if this study could establish the safety of thalidomide in terms of teratogenicity along with its efficacy, it would be a great support to multi-transfused thalassemic children.

Eligibility criteria:
inclusion criteria: * children of both genders * aged 2-5 years * with transfusion-dependent thalassemia (tdt) * whose parents/guardians showed willingness to adhere to follow-up visits exclusion criteria: * children with uncontrolled infections * significant hepatic or renal dysfunction * malignancy * known contraindications to thalidomide
charite™ vs. alif 5-year follow-up

Conditions: Degenerative Disc Disease

Summary: to assess the clinical and radiographic outcomes through 5-years following treatment with charité™ artificial disc vs. the bak cage for treatment of degenerative disc disease at one level (l4-s1).

this study is an extension out to 5 year follow-up of a randomized comparative ide trial of the charité™ artificial disc vs. alif with the bak cage for treatment of degenerative disc disease. the original 2-year trial demonstrated non-inferiority of the charité™ compared to alif. this extension will continue to follow-up the original outcome measures and will also examine adjacent segment progression.

Eligibility criteria:
inclusion criteria: * participated in either the training or randomized arm of the charité artificial disc ide study, * still have the original implant they received in their index surgery. exclusion criteria: * none

Keywords: arthroplasty lumbar disc
the efficacy of neoadjuvant atezolizumab treatment in patients with advanced urothelial bladder cancer

Conditions: Urothelial Carcinoma

Summary: recently, promising evidences that blocking pd-1 and pd-l1 is an efficacious way to treat advanced stage bladder cancer patients. atezolimumab is the first pd-l1 inhibitor approved by us fda for advanced ubc in june 2014. these novel agents will become the standard therapy for unhopeful ubc patients who fail to respond to cisplatin-based chemotherapy and finally, the first-line treatment would be changed from cisplatin-based chemotherapy to immune check point inhibitors for advanced ubc, particularly neoadjuvant setting. additionally, along with enormous analysis of genomic landscape of bladder cancer, a consensus was reached regarding the existence of a group of basal-squamous-like tumors - designated basq - characterized the high expression of krt5/6 and krt14 and low/undetectable expression of foxa1 and gata3. this novel molecular classification can improve the identification of optimal patient population for different treatment modalities. specifically, luminal type and basal type may have different treatment response and prognosis after initial definitive treatment, such as neoadjuvant treatments. however, there is no evidence for this topic, particularly the clinical efficacy of neoadjuvant pd-l1 inhibitors according to the basq classification in patients with advanced urothelial bladder cancer.


Eligibility criteria:
inclusion criteria: * ≥18 years of age * histologically confirmed muscle-invasive urothelial carcinoma * patients undergoing radical cystectomy * advanced status requiring neoadjuvant systemic therapy * ecog performance status score of 0 or 1 * adequate organ and hematologic functions * available ihc data for the basq classification exclusion criteria: * non-urothelial carcinoma histology * active autoimmune disease or inflammatory bowel disease * prior severe or persistent immune-related adverse events * previous exposure to anti-pd-1 or anti-pd-l1 therapy * requirement for 10 mg/d of prednisone or equivalent * inadequate liver, kidney function and hematologic dysfunction * inoperable case, such as untreated cns metastases * no available archival tumor tissue for evaluating the basq classification

Keywords: neoadjuvant chemotherapy atezolizumab
comparison of the acute effects of auricular vagus nerve stimulation and deep breathing exercise

Conditions: Vagus Nerve Stimulations

Summary: the goal of this clinical trial is to investigate whether vagus stimulation and breathing exercises are more effective in healthy adults. are vagal stimulation and breathing exercises effective on autonomic functions and the somatic system in healthy adults? participants' results for autonomic functions and somatic system will be compared for both groups.


Eligibility criteria:
inclusion criteria: * could read and write turkish exclusion criteria: * being 18 years or older having no known acute or chronic disease, and no previous treatment with vagus nerve stimulation

Keywords: auricular vagus nerve stimulation deep breathing exercises
limbo : breast reconstruction by lipomodeling alone or with flap: evaluation in franche-comté

Conditions: Breast Cancer; Surgery

Summary: the limbo study is a retrospective descriptive study which aims to establish the current state of breast reconstruction surgery at the besançon university hospital and hôpital nord franche-comté, between october 2017 and december 2021.


Eligibility criteria:
inclusion criteria: * patient who has undergone breast reconstruction using lipomodelling alone or in association with a flap (greater dorsal, diep deep inferior epigastric perforator flap or tram tranverse rectus abdominis myocutaneous flap), since october 2017. patient whose follow-up in plastic surgery is considered completed (final result obtained, patient lost to follow-up or not wishing to continue) at the time of data collection. exclusion criteria: * patient under 18 at first consultation * opposition of the patient to the collection of her data

Keywords: lipodelling breast reconstruction
metastatic castrate-resistant prostate cancer subjects treated with provenge® + one infusion of sipuleucel-t

Conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Summary: a multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mcrpc).

those enrolled in the booster study will have had their course of treatment with provenge® immunotherapy and then randomized to the booster study to be treated with a single booster dose of sipuleucel-t.

Eligibility criteria:
inclusion criteria: for a subject to be eligible for participation in this study, all of the following criteria must be satisfied: 1. potential subjects are men aged ≥18 years who are clinically indicated for treatment with provenge® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer). 2. have qualified for on-label provenge® infusion 3. have received all 3 infusions of provenge® prior to randomization 4. written informed consent provided prior to the initiation of study procedures 5. estimated life expectancy ≥12 months exclusion criteria: a subject will not be eligible for participation in this study if any of the following criteria apply. 1. men who are not clinically indicated for treatment with provenge® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer). 2. need for systemic chronic immunosuppressive therapy (eg, antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids). 3. uncontrolled, concurrent illness including, but not limited to the following:ongoing or active infection (bacterial, viral, or fungal), or psychiatric illness that would limit compliance with study requirements,as well as any condition that would preclude a subject from completing provenge® or sipuleucel-t treatment. 4. on experimental or investigational therapy. -

Keywords: single dose sipuleucel-t immune response rate safety adenocarcinoma of the prostate
administration of systemic corticosteroids and the recovery of gustatory functions in patients with covid-19

Conditions: COVID-19; Olfactory Dysfunction

Summary: coronavirus is a global pandemic with a high mortality rate; it is started in china in 2019 and rapidly spread worldwide, reaching its epidemic peak in march 2020 coronavirus is a family of viruses that usually affect animals. they also can affect the respiratory system of humans, causing different manifestations such as difficulty in breathing, coughing, fever, invasive lung lesions, and viral pneumonia

coronavirus is a global pandemic with a high mortality rate; it is started in china in 2019 and rapidly spread worldwide, reaching its epidemic peak in march 2020 coronavirus is a family of viruses that usually affect animals. they also can affect the respiratory system of humans, causing different manifestations such as difficulty in breathing, coughing, fever, invasive lung lesions, and viral pneumonia smell and taste dysfunction is more frequent in the initial stages of covid-19 infection that occur within the first five days and may be used as pivotal symptoms in the early diagnosis of the disease

Eligibility criteria:
inclusion criteria: * all signs and symptoms were recorded included fever \>38 °c, fatigue, myalgia, arthralgia, sore throat, headache, and its localization (diffuse, frontal, other localization), rhinorrhea, nasal obstruction, epistaxis, tinnitus, and hearing loss, sneezing, cough, sputum production, hemoptysis, dyspnea, respiratory rate \>22, crackling sounds during auscultation, nausea, vomiting, diarrhea, and abdominal pain. exclusion criteria: * patients with absolute contraindications for systemic corticosteroids administration, pregnant women, smokers, and patients with any systemic disease or taking any medications that cause loss of taste or smell were excluded from this study.

Keywords: covid-19 olfactory dysfunction gustatory dysfunction corticosteriods
hydrogel balloon assisted intracranial aneurysm coiling registry

Conditions: Intracranial Aneurysms; Aneurysm; Brain Aneurysm

Summary: the objective of the gelatin registry is to prospectively evaluate intracranial aneurysm occlusion and retreatment rates as well as adverse event rates in patients undergoing balloon-assisted coiling using the microvention scepter occlusion balloon catheter and second-generation microvention hydrogel coils for treatment of previously treated or untreated ruptured and unruptured intracranial aneurysms.

this is a prospective, single arm, single center study of patients with ruptured or unruptured saccular aneurysms that are embolized using microvention second-generation hydrogel coils and undergo balloon remodeling with the microvention scepter occlusion balloon catheter. data for each patient will be collected 6 ± 3 months post-procedure for the study.

Eligibility criteria:
inclusion criteria: * patient is 18-80 years of age. * patient has a documented, previously treated or untreated saccular intracranial aneurysm, 4- 20 mm unruptured or ruptured, suitable for treatment with balloon assisted coil embolization. * target aneurysm has a neck ≥4mm or the largest diameter to neck ratio of 2 or less. * patient has a hunt and hess score of 3 or less. * patient has a premorbid mrs of 3 or less. * patient or patient's legally authorized representative has provided written informed consent. * patient is willing to and can comply with study follow-up requirements. exclusion criteria: * inability to obtain informed consent. * patient is \ 80 years of age. * target aneurysm is dissecting, fusiform, mycotic, or arteriovenous malformation-related. * aneurysm that was treated previously with stent-assisted coiling. * implantation of the stent after the balloon-assisted coiling or combined stent and balloon assisted coiling. * target aneurysm is deemed unsuitable for balloon-assisted coiling by the treating physician prior to the procedure. * target aneurysm will be treated with a total coil length comprised of less than 80% second generation microvention hydrogel coils. * balloon-assisted coiling will be performed using a balloon catheter other than the microvention scepter balloon (scepter c, scepter xc, any future scepter configurations). * patients in which the target aneurysm is planned not to be coiled in one procedure (i.e. staged procedure). * patients with more than one aneurysm that requires treatment. (however, a second small low risk aneurysm that does not require therapy may be allowed.) * patients with a life expectancy of ≤ 9 months.

Keywords: aneurysm brain aneurysm
0.6 vs. 1.2 mg atropine together with neostigmine 2.5 mg on heart rate in patient receiving muscle relaxant

Conditions: Bradycardia; Neostigmine Adverse Reaction; Adverse Reaction to Belladonna or Atropine

Summary: balanced general anesthesia with neuromuscular blocking agents has been widely used for surgery.. at the end of surgery, neostigmine has been given for the reversal of neuromuscular blocking agents with several adverse effects such as bradycardia and profuse secretion. atropine has been used to prevent those side effects of neostigmine. the routine dosages of the two drugs are 2.5 mg of neostigmine and 1.2 mg of atropine. tribuddharat s ey al. (1) has demonstrated that after giving 0.9 mg atropine together with 2.5 mg of neostigmine the mean heart rate during 1-8 minutes after the administration was increase 2-26 beats/min (bpm). at 9 and 10 minutes after administration of the drugs, the mean heart rate were decrease 0.9 and 1.6 bpm in the control group which receiving 1.2 mg of atropine, the mean heart rate during 1-10 minutes after administration was increase 4-32 bpm. however this study did not report the incidence of bradycardia and blood pressure. the mean heart rate prior to atropine and neostigmine was 74.43 + 11.82 bpm.(1) salem mg et al. (2) has demonstrated that after receiving 1.2 mg of atropine and 5 mg of neostigmine the mean heart rate during 2-110 minutes was decrease 5-29 bpm with the lowest heart rate at 40 minutes after administration. this study also did not report the blood pressure. the baseline heart rate (hr) before administration of the reversal was associated with the following heart rate. heinonen j et al. (3) has demonstrated that 80% of the patients after receiving 0.015 mg/kg of atropine 3 minutes before 0.03 mg of neostigmine for the reversal of pancuronium experienced bradycardia (heart rate \< 50 bpm) compared with none in patients receiving alcuronium. however, before administration of atropine and neostigmine, the mean heart rate of patients was significantly lower in the pancuronium group. either tachycardia or bradycardia with hypotension causes adverse affect to patient especially in specific group like patient with coronary artery disease or undergoing craniotomy. the primary objective of our study is to demonstrate the effect on heart rate (hr) and blood pressure of 0.6 mg atropine and 2.5 mg neostigmine for the reversal of muscle relaxant compare to 1.2 mg atropine.


Eligibility criteria:
inclusion criteria: * asa physical status 1-3 * age = or \> 18 years * patient receiving neuromuscular blocking agent exclusion criteria: * baseline heart rate before administration of the study drugs \< 65 bpm * history of allergy to the study drugs * patient receiving either of the following drugs include beta-blockers, calcium channel blocker, amiodarone or digoxin * history of complete heart block or second degree av block.

Keywords: heart rate neostigmine atropine dosage
a prospective clinical evaluation of the total vascular access (tva) flex-1 device protocol flex-1-002-ir intervention reduction (ir)

Conditions: Chronic Kidney Disease (CKD)

Summary: the primary objective of this clinical study is to evaluate the preliminary safety and effectiveness of using the flex-1 device for the creation of an arteriovenous fistula (avf) including coiling of the brachial vein during the index procedure in patients requiring chronic hemodialysis.


Eligibility criteria:
inclusion criteria: * eligible for a native surgical arteriovenous fistula, as determined by the treating physician. * adult (age \>18 years old). * advanced chronic kidney disease (ckd), stage 4 or 5 electing for hemodialysis. * written informed consent obtained

Keywords: chronic kidney disease arteriovenous fistula hemodialysis vascular access
standalone observational study assessing the performance of an ai/ml tech-based samd on chest ldct images (reality)

Conditions: High Risk Cancer

Summary: this is a multinational, multicenter, retrospective study for the evaluation of the standalone efficacy and safety of an artificial intelligence/machine learning (ai/ml) technology-based end-to-end computer assisted detection/computer assisted diagnosis (cade/cadx) software as a medical device (samd) developed to detect, localize and characterize malignant, and suspicious for lung cancer nodules on low dose computed tomography (ldct) scans taken as part of a lung cancer screening (lcs) program. ldct digital imaging and communications in medicine (dicom) images of patients who underwent lung cancer screening were selected and included into the study. selected scans will then be analyzed by the cade/cadx samd and compared to radiologist generated reference standards including lesions localization and lesion cancer diagnosis. figures of merit at patient level and lesion level detection and diagnostic efficacy will be calculated as well as sub-class analysis to ensure algorithm performance generalizability.


Eligibility criteria:
inclusion criteria: * ≥50-80 years of age; * current or ex-smoker (\>=20 pack years); * patient screened and surveilled for lung cancer screening following lung cancer screening guidelines (equivalent to united states preventive services task force (uspstf) 2021 criteria); * received ldct due to inclusion in high-risk category for lung cancer. exclusion criteria: * prior lung resection; * pacemaker or other indwelling metallic medical devices in the thorax that interfere with ct acquisition; * patients/images used during ai model development; * patients with only hilar and/or mediastinal cancer(s); * patients with only ground glass cancer(s); * patients with nodules, solid or part-solid \>30mm (masses); * patients that are not accompanied with the required clinical information; * patients with imaging with any of the following: missing slices, slice thickness \>3mm; * partial cover of the lung.