Kornimate/medical-research-clean huggingface dataset:
an extended use study of safety and efficacy of talimogene laherparepvec in melanoma

Conditions: Melanoma

Summary: the purpose of this study is to learn about the safety and the risks of using talimogene laherparepvec in patients who already received treatment with talimogene laherparepvec in study 005/05 (nct00769704), and to see if extended treatment with talimogene laherparepvec can destroy melanoma tumors.


Eligibility criteria:
inclusion criteria: 1. previously participated in protocol 005/05 (nct00769704) and: 1. received the maximum number of talimogene laherparepvec treatment injections or cycles of gm-csf allowable for that patient on study 005/05, or 2. new injectable lesion(s) appeared after previous resolution of all injectable disease while on study 005/05. new injectable lesions must have appeared within ≤ 12 months from the end of treatment visit on the 005/05 study. 2. in the opinion of the investigator and the sponsor's medical monitor further treatment is warranted \[e.g., those patients who do not have clinically relevant progressive disease (pdr)\]. 3. performance status (eastern cooperative oncology group, ecog) 0 or 1. 4. for patients randomized to talimogene laherparepvec only: injectable disease (i.e. suitable for direct injection or through the use of ultrasound guidance) defined as at least 1 injectable cutaneous, subcutaneous or nodal melanoma lesion. there is no minimum size for injection. exclusion criteria: 1. prior common terminology criteria for adverse events (ctcae) grade 3 or 4 toxicity related to talimogene laherparepvec of any organ system (with the exception of injection site reactions, fever and vomiting). 2. history of grade 3 fatigue lasting \> 1 week while on talimogene laherparepvec treatment. 3. history of grade 3 arthralgia/myalgias while on talimogene laherparepvec treatment. 4. history of ≥ grade 2 autoimmune reactions, allergic reactions or urticaria or other talimogene laherparepvec related non-hematological toxicities while on talimogene laherparepvec treatment that required a dose delay or discontinuation of talimogene laherparepvec therapy. 5. pdr while participating in study 005/05 6. patient requested to be withdrawn from study 005/05 or was unable to comply with the demands of the 005/05 trial. 7. at the discretion of the investigator, patient was withdrawn from the 005/05 trial.

Keywords: melanoma stage iiib, iiic and iv disease oncolytic oncovex oncovex^gm-csf
comparison of wavelight analyzer and alcon ladarwave

Conditions: Healthy; Keratoconus

Summary: comparison of repeated wavelight analyzer and alcon ladarwave measurements in phakic and pseudophakic eyes.


Eligibility criteria:
inclusion criteria: * healthy eyes or eyes with the study conditions exclusion criteria: * age \< 18, eye disorders other than mentioned above, participation in any other study,

Keywords: wavefront measurements of the entire eye
class iii malocclusion and alt-ramec

Conditions: Face Mask; Rapid Maxillary Expansion; Maxillary Retrognathism

Summary: diverse viewpoints exist regarding the correlation between the conventional rapid maxillary expansion (rme) and facemask approach and the alternative rme and facemask hybrid technique (alt-ramec) in terms of the degree of maxillary protraction. the findings of the study may offer a novel approach to protocol selection based on the anomaly's degree of severity. the objective of this investigation is to assess and contrast the skeletal and dentoalveolar outcomes of three distinct alt-ramec techniques.

alternating rapid maxillary expansion and constriction (alt-ramec) procedure is one of the most frequently used methods in the treatment of class iii cases caused by maxillary retrognathia. the objective of this investigation is to conduct a comparative analysis of the skeletal and dentofacial outcomes of three distinct techniques for maxillary protraction following the primary recording, the patients were evaluated using bonded-type rapid maxillary expansion (rme) devices and three discrete alt-ramec techniques (1, 3, and 5 weeks). lateral cephalograms were obtained from a sample of 40 patients (18 males and 22 females) with a mean age of 10.64 ± 0.98. these images were taken both before (t1) and after the 6th month of facemask treatment (t2), and were subjected to total and local superimpositions. the wilcoxon sign, kruskal-wallis and mann-whitney u tests were used to evaluate the data.

Eligibility criteria:
inclusion criteria: * maxillary retrognathia (sna ≤ 79°) * skeletal class iii malocclusion (anb ≤ -1°) * anterior cross-bite * class iii molar relationship * horizontal growth pattern (sn/go-gn \< 30°) exclusion criteria: * previous orthodontic treatment * systemic disorders
pain management in corneal collagen crosslinking for keratoconus

Conditions: Pain

Summary: this is a prospective, randomized, single blind study. patients enrolled in the study were randomly assigned to a ketorolac or a gabapentin group for pain control. different pain scores and variables will be evaluated, along with others side effects variables.

this is a prospective, randomized, single blind study. patients enrolled in the study were randomly assigned to the ketorolac or gabapentin group. the gabapentin (neurontin, pfizer, mexico) group was instructed to take one 300-mg capsule the night before surgery and 1 capsule every 8 hours on the day of surgery and for the first 3 postoperative days. the ketorolac group (dolac, siegfried rhein, mexico) was instructed to take their 10-mg tablets every 8 hours on the day of surgery and for the first 3 postoperative days. different pain scores and variables will be evaluated, along with others side effects variables.

Eligibility criteria:
inclusion criteria: * patients with keratoconus older than 18 years with documented bilateral keratometric progression in the previous 6 to 12 months. exclusion criteria: * previous ocular or systemic diseases that could affect epithelial healing; use of topical or systemic non-steroidal anti-inflammatory drugs, or chronic use of any other pain medication, pregnancy and allergy to the drugs of the study.
effects of the shared-decision making training program

Conditions: Competence

Summary: the goal of this intervention study is to test the effectiveness of a training program for hospital-based midwives. the main questions it aims to answer are: •does sdm combined ebp training improve midwives' sdm and ebp competency? • what are factors related to sdm competency in midwives? participants will participate in a 20-hour training program, including lectures and hands-on practice sessions. researchers will compare groups that receive sdm training with or without ebp training to see if there are changes in midwives' sdm and ebp competency.

this study aimed to evaluate the effect of sdm training program, with or without ebp, on the level of midwives' sdm and ebp competency. this randomized controlled trial recruited participants from 18 departments of an obstetrics and gynecology hospital in vietnam. 72 midwives (36 in each group) and 404 patients were required. eligible midwives were ones who provided the hands-on care of patients for at least three months, were licensed to practice midwifery, and were willing to participate in the study. each participating midwife conducted three encounters with real patients who were conveniently selected. patients at least 18 years old, having sure test scores less than 4, and willing to participate in the study were invited. patients requiring emergency medical attention were excluded. the intervention group received a tailored training program that combined sdm with ebp, while the control group received sdm training alone. the outcomes related to sdm (measured by sdm-q-doc, sdm-q-9, dsc, option5, dsat10, and 4hcs) and ebp (measured by hs-ebp) were evaluated at baseline, week 2, and/or week 4.

Eligibility criteria:
inclusion criteria for midwives: * provide hands-on care to patients for at least three months * licensed to practice midwifery * willing to participate in the study. inclusion criteria for patients: * having sure test score less than 4 (sure was a decisional conflict screening tool. a score less than 4 was a positive result for decisional conflict) * willing to participate in the study exclusion criteria for patients: * patients requiring emergency medical attention

Keywords: shared-decision making evidence-based practice midwife
effect of dorzagliatin on renal function outcomes in people with type 2 diabetes: a multicentric, prospective, randomized study.

Conditions: Diabetic Nephropathy Type 2

Summary: the main purpose of this study is to explore the improvement of renal function before and after the intervention of dorzagliatin in patients with type 2 diabetes.

as soon，metformin、sglt-2i、glp-1ra have been confirmed to have protective effect on the kidneys in the statement of consensus at home and abroad. dorzagliatin exerts a potent hypoglycemic effect by activating glucokinase and is not affected by the patient's renal function. however, previous studies of this drug have rarely involved studies that improve markers related to renal function. on the one hand, in this study, changes of renal function (egfr, creatinine, cystatin c, tnf-1) are collected to investigate whether dorzagliatin is benefit to kidney. on the other hand, renal magnetic resonance imaging(mri) results are analysed to explore the differences among control subjects and patients treated with dorzagliatin.

Eligibility criteria:
inclusion criteria: 1. age:18-75 years old, male and female. 2. patients with type 2 diabetes mellitus, type 2 diabetes mellitus diagnosis criteria: according to the "chinese type 2 diabetes mellitus prevention and treatment guide (2020 edition). 3. uacr 30-299mg/g. 4. egfr ≥60ml/min/1.73m². 5. hba1c 7.0-10.5%. exclusion criteria: 1. pregnant and lactating women and women of childbearing age who do not want to take reliable contraceptive measures. 2. known allergic history to dorzagliatin/gliclazide/metformin. 3. diabetic acute and chronic complications, including diabetic ketoacidosis, a hyperglycemic hyperosmolar state or hypoglycemic coma, etc. 4. serious impairment of heart, liver, kidney and other organs. 5. with hypertension(≥140/90mmhg). 6. fasting c-peptide \<300pmol/l. 7. contraindications of mri examination, such as implantation of metal prosthesis in vivo, claustrophobia, wearing insulin pumps, etc.
chronic inflammatory demyelinating polyneuropathy (cidp) and treatment with subcutaneous immunoglobulin (igpro20)

Conditions: Chronic Inflammatory Demyelinating Polyneuropathy; Polyradiculoneuropathy

Summary: this is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group 3-arm study to investigate 2 different doses of subcutaneous (sc) igpro20 compared with placebo for maintenance treatment of patients with cidp. patients who received at lease 1 dose of intravenous immunoglobulin (ivig) within 8 weeks before screening will be assessed during 4 separate study periods. patients first undergo a screening period, followed by an igg dependency test period of up to 12 weeks to test for ongoing need of igg. those patients experiencing cidp relapse during this test period will be administered a standardized ivig regimen during an ivig re-stabilization period. patients with improved and maintained adjusted inflammatory neuropathy cause and treatment scale (incat) in the ivig re-stabilization period will continue to the sc treatment period of the study. patients entering the 24 week sc treatment period will be randomized to receive weekly infusions of 1 of 2 igpro20 doses (0.2 or 0.4 g/kg body weight) or placebo. the overall study duration is up to 52 weeks. clinical outcomes will be assessed by the inflammatory neuropathy cause and treatment (incat) score, maximum grip strength, the medical research council (mrc) sum score, the rasch-built overall disability scale (r-ods), and electrophysiological evaluations.


Eligibility criteria:
inclusion criteria: * definite or probable cidp according to the european federation of neurological societies/peripheral nerve society (efns/pns) criteria 2010. * an ivig treatment during the last 8 weeks prior to enrollment. * age ≥18 years. * written informed consent for study participation obtained before undergoing any study-specific procedures. exclusion criteria: * any polyneuropathy of other causes * any other disease (mainly neurological or chronic orthopedic) that has caused neurological symptoms or may interfere with treatment or outcome assessments * severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study * history of thrombotic episodes within the 2 years prior to enrolment * known allergic or other severe reactions to blood products including intolerability to previous ivig
red blood cell distribution width and charlson comorbidity indeces in the frail polytraumatized patient.

Conditions: Polytrauma; Red Blood Cell Distribution Width; Comorbidities and Coexisting Conditions

Summary: in this study patients who were admitted to our hospital with critical injuries were enrolled retrospectively from january 2012 to december 2015. patients with an iss\>16 points, an ais \>3 in one body region and at least 2 different body regions affected were included. rdw values on admission as well as preexisting comorbidities were evaluated.


Eligibility criteria:
inclusion criteria: * iss \>16 points * ais \>3 in one body region * at least 2 body regions affected exclusion criteria: * patients younger than 18 years of age * isolated traumatic brain injury * minor injuries (ais \<3 or iss \<16 points)
postmenopausal health and disease (palladia) study

Conditions: Menopause

Summary: this is a prospective study of the incidence and risk factors of chronic diseases that are associated with menopause.


Eligibility criteria:
inclusion criteria: postmenopausal women exclusion criteria: men women of reproductive age

Keywords: menopause
study evaluating the impact of short message service on compliance with surveillance of patients with germ-cell tumors

Conditions: Follow-up; Compliance, Patient; Text Messaging; Germ Cell Tumor

Summary: this study will evaluate the impact of short message service (sms) on compliance with surveillance of patients with germ-cell tumors. patients will be randomized in a 2:1 ratio to get 2 groups : (1) patients will receive reminder sms before appointment detailing the date of consultation and exams to be performed before; (2) standard of care without sms.


Eligibility criteria:
inclusion criteria: * patient with germ cell tumor. * patient with a mobile phone. * patient on surveillance. exclusion criteria: * testicular cancer without germ cell component. * prior history of other malignancy except for: cutaneous cancers excluding melanoma, superficial bladder tumor, localized prostate cancer with undetectable psa. * cognitive condition that would preclude patient's understanding and completion of study procedures.

Keywords: surveillance compliance germ cell tumors short message service
the influence of talocrural manipulation on proprioception in stroke

Conditions: Stroke

Summary: the aim of the study is to investigate the effect of talocrural joint manipulation on the ankle proprioception of patients with stroke.

the study, utilizing a randomized crossover design, is planned to be conducted on a minimum of 26 patients with stroke who meet the inclusion and exclusion criteria. patients included in the study will be randomly assigned to receive both placebo talocrural joint manipulation and talocrural joint manipulation interventions.

Eligibility criteria:
inclusion criteria: 1. two months or longer elapsed since the stroke, 2. a mini-mental state examination score of 24 or higher, 3. being between 45 and 75 years of age, 4. having a brunnstrom stage of 4 or above exclusion criteria: 1. the presence of severe osteoarthritis in the lower extremity, 2. the presence of cancer or diabetic neuropathy, 3. the presence of vestibular disorder, 4. the presence of lower extremity ulceration or amputation, 5. hemodynamic instability, 6. the presence of other neurological disorders (such as multiple sclerosis, parkinson's disease), 7. having experienced an acute lower extremity injury in the last six weeks, 8. history of lower extremity surgery 9. lack of available range of motion values required for the ankle proprioception test

Keywords: proprioception
operative correction of rectus muscle diastasis (ard): the effect on low back pain and movement control

Conditions: Diastasis Recti

Summary: this study is a randomized controlled trial comparing two adr repair methods: nylon suturing and nylon suture with mesh enforcement. the adr correction is performed simultaneously with abdominoplasty/ modified skin reduction abdominoplasty.

abdominal diastasis recti (adr) persists after pregnancies in one third of women. traditionally plain adr has been managed conservatively. there is some evidence that adr reduces abdominal integrity and functional strength, contributing to pelvic instability and back pain. however, patients are referred to a surgeon mainly because of some other primary concern and adr is an additional condition: in the case of excess skin-subcutis, the person is referred to a plastic and reconstructive surgeon for abdominoplasty and in the case of midline hernia, to a general surgeon. in combination with abdominoplasty the plication of the superficial aponeurosis of recti muscles is the most commonly used reconstructive technique. there is a wide variety of different plication procedures available. convincing data of the long-term results of adr repair are lacking especially when adr is severe. some studies have reported large recurrence rates. polypropylene mesh repair is an evidence-based technique to ensure a strong and reliable abdominal wall repair in ventral hernias or in high risk laparotomy wounds. large retromuscular or intraperitoneal meshes have been used also in ard repair. this study reports a novel surgical technique aimed at reliable and mini-invasive open repair of adr with or without midline hernia combined by abdominoplasty for symptomatic adr patients. in rmb (roll mesh in between) method the investigators bury a narrow piece of self-gripping mesh inside the plicated linea alba to give tensile strength to plication. patients are randomized to a suture plication group or rmb group. outcome evaluation is performed by clinical examination with video recorded movement control tests and with structured questionnaires for quality of life (rand36) and for low back pain (lbp) (oswestry 2.0). evaluation is done three times: when recruiting the patient, after a conservative 3-6 months therapy with written instructions and one year after the intervention. complications and recurrences are recorded as well. outcomes the effect of adr repair on lbp and movement control problems patient satisfaction and complications of adr repair after the two techniques

Eligibility criteria:
inclusion criteria: * symptomatic diastasis recti (\> 3 cm) after pregnancies, with or without a midline hernia exclusion criteria: * bmi \> 28, * smoking * less than a year since the previous pregnancy or still breast feeding * planning further pregnancies
effectiveness of antipsychotic combination with psychosocial intervention on outcome of patients with schizophrenia

Conditions: Schizophrenia

Summary: antipsychotic alone is limit to improve the overall outcome of schizophrenia and has a high discontinue rate.to solve these problems, we provide practical and available psychosocial intervention. we hypothesize that there will be significant difference in the overall effectiveness between antipsychotic and antipsychotic combination with psychosocial intervention.

the study is designed as a national, multicenter, randomized, naturalistic trial, with research assessors intended to be blind to the intervention status. we plan to recruit 1400 patients at 10 china sites and randomly assign them to two group. the control group only receive antipsychotic and the study group receive antipsychotic combination with psychosocial intervention. the course is 12 months. patients use one of the seven study drugs (chlorpromazine, sulpiride, clozapine, olanzapine, risperidone, quetiapine, and aripitrazole)to the maintain treatment. the psychosocial intervention include psychoeducation, family intervention, skills training, and cognitive-behavioral therapy. the primary aim is to delineate differences in the overall effectiveness of the two treatment model.the assessments include the outcome of symptomatology，neurobiology，social psychology，medical economics.

Eligibility criteria:
inclusion criteria: * eligible patients were 16 to 50 years of age; * had received a diagnosed of schizophrenia in accordance with criteria set out in the diagnostic and statistical manual of mental disorders-fourth edition (dsm-iv); * were confirmed to be clinically stable by the investigator (the total score ≤60 on the positive and negative syndrome scale \[panss\] or a decrease of fifty percent from acute period in the total score on panss) * and taken maintenance treatment with any one of the following seven oral antipsychotics: * chlorpromazine * sulpiride clozapine * risperidone * olanzapine * quetiapine * aripiprazole exclusion criteria: * patients were excluded if they had received a diagnosis of schizoaffective disorder, mental retardation, or other cognitive disorders; * had a history of serious adverse reactions to the proposed treatment; * were pregnant or breastfeeding; or had a serious and unstable medical condition. * patients were excluded if they were unable to provide informed consent

Keywords: schizophrenia antipsychotic outcome psychosocial intervention
effect of cough assist device on hemodynamic status and oxygen saturation for ventilated children

Conditions: Pneumonia Childhood; Intensive Care Unit; Children

Summary: statement of the problem: •is there an effect of the cough assist device on hemodynamic status and oxygen saturation for ventilated children? null hypothesis there will be no effect of cough assist device on hemodynamic status and oxygen saturation for ventilated children.

subjects: the study targets the children from both sexes.diagnosed with pneumonia in intensive care unit. sample size estimation will be carried out to determine the recruited number of children, selected randomly from cairo university pediatric specialized hospital, cairo to participate in the study. study design: randomized controlled clinical trial. children will receive intervention type randomly,25 child will receive traditional chest physical therapy (postural drainage, percussion and vibration, end expiratory pressure) and bed mobility exercise.and the other 25 child will receive cough assist device in addition to traditional chest physical therapy (postural drainage, percussion and vibration, end expiratory pressure) and bed mobility exercise. children will be assessed by measuring heart rate, respiratory rate, blood pressure which reflect the physiological status, oxygen saturation,expired tidal volume and dynamic lung compliance which reflect clinical improvement of chest condition before and after receiving intervention

Eligibility criteria:
inclusion criteria: 1. children of both sexes, with age ranged from 4-9 years old. 2. children will diagnosed with pneumonia. 3. children will intubated on mechanical ventilation. 4. all children should be vitally stable during the study period. exclusion criteria: exclusion criteria: 1. hemodynamically unstable child. 2. child with diaphragmatic hernia. 3. child with pneumothorax (if chest tube is present). 4. child with raised intracranial pressure. 5. child with recent upper gastrointestinal surgery