Kornimate/medical-research-clean huggingface dataset:
toripalimab combined with definitive ccrt for lacc patients

Conditions: Cervical Cancer; Chemoradiotherapy; Immunotherapy

Summary: cervical cancer constitutes a significant health burden for women globally. while most patients with early-stage disease can be cured with radical surgery or chemoradiotherapy, patients with high-risk locally advanced disease or with recurrent/metastatic disease have a poor prognosis with standard treatments. immunotherapies are a rational treatment for this hpv-driven cancer that commonly expresses programmed cell death ligand-1. toripalimab, a humanized immunoglobulin g4 monoclonal antibody against pd-1, showed promising anti-tumor efficacy in multiple solid tumors. this randomised study is evaluating toripalimab combined with ccrt versus ccrt alone for treatment-naïve lacc.


Eligibility criteria:
inclusion criteria: * more than 18 years old females * had newly diagnosed and previously untreated locally advanced squamous cell carcinoma of the uterine cervix * figo 2018 stage ib3 to iva with no evidence of distant metastasis * ecog ps 0-1 without major organ failure * signed informed consent voluntarily exclusion criteria: * previously suffered from immunodeficiency disorders * had any condition that researchers believed to be associated with increased risk of treatment * previously received or currently receiving other pd-1 antibody treatments or other immunotherapies targeting pd-1/pd-l1
media project and health study - spanish version

Conditions: Depression, Anxiety

Summary: we seek to test the efficacy of the spanish version of the "catalina" web-app intervention compared to an attention control web-app in reducing symptoms of depression and/or anxiety and motivate women to take action to get help.


Eligibility criteria:
inclusion criteria: * self identifies as latina * scores 10 or more on patient health questionnaire-8 (phq-8) or general anxiety disorder (gad)-7 * can read, write, and speak spanish * has access to the internet exclusion criteria: * currently getting treatment for depression or anxiety * suicidal ideation identified at screening
caffeine to reduce mechanical ventilation in preterm infants

Conditions: Prematurity; Apnea; Respiratory Failure

Summary: most premature infants require mechanical ventilation for prolonged periods of time and a significant proportion of them develop bronchopulmonary dysplasia (bpd). caffeine is a stimulant of the respiratory center and has been used for the treatment of apnea of prematurity in infants not requiring mechanical ventilation or to facilitate weaning from mechanical ventilation by starting therapy shortly before extubation. recently the use of caffeine in ventilated infants has been initiated earlier because of the reported reduction in bpd. however there is paucity of data supporting this practice. because protracted mechanical ventilation and supplemental oxygen increase the risk of developing bpd, a therapy that would facilitate the reduction of the respiratory support and shorten its duration is desirable. therefore, it is of importance to evaluate the effects of early caffeine initiation and administration during the course of mechanical ventilation in preterm infants by means of a randomized placebo-controlled trial. hypothesis: the primary hypothesis of this study is that early use of caffeine in mechanically ventilated preterm infants will reduce the time to first elective extubation and secondarily, that this will reduce the total duration of mechanical ventilation and oxygen supplementation, and reduce the incidence and severity of bpd. objective: the objective of this trial is to evaluate the effects of early caffeine use during mechanical ventilation on the time to first elective extubation, total duration of mechanical ventilation and oxygen supplementation, and the incidence of bpd. study design: this will be a single-center prospective, randomized, double-blind, placebo controlled clinical trial. population: premature neonates born between 23 and 30 completed weeks of gestation, who require mechanical ventilation within the first 5 days of life will be enrolled. infants with major congenital anomalies or small for gestational age will be excluded. methods: infants will be randomized within the first 5 days to receive a study drug consisting of either blinded caffeine citrate or blinded placebo (equivalent volume of normal saline). infants will continue to receive the study drug until the first elective extubation.


Eligibility criteria:
inclusion criteria: * premature neonates born between 23 and 30 completed weeks of gestation. * requiring mechanical ventilation within the first 5 postnatal days * written-informed parental consent for the study exclusion criteria: * major congenital anomalies * small for gestational age

Keywords: premature infants caffeine methylxanthines mechanical ventilation oxygen weaning bronchopulmonary dysplasia
evaluation of a parenting and stress management programmme

Conditions: Parenting; Parent Mental Health; Child Behaviour Problems

Summary: the study will use a randomised controlled trial design to evaluate the effects of a combined intervention of triple p-positive parenting program discussion groups and stress control in comparison to a waitlist condition. the combined intervention will be evaluated with parents in glasgow, united kingdom, with a 3-8 year old child.


Eligibility criteria:
inclusion criteria: * has a child aged between 3 and 8 years old * able to attend the group sessions held at langside halls, shawlands in glasgow, united kingdom * able to read a newspaper without assistance exclusion criteria: * child has a diagnosis of a developmental or intellectual disability or other significant health impairment
efficacy and safety of diclofenac 1.16% gel in subjects with acute neck pain

Conditions: Neck Pain

Summary: the purpose of this study is to evaluate the efficacy and safety of diclofenac 1.16% gel compared with placebo applied four times a day in subjects with acute neck pain.


Eligibility criteria:
inclusion criteria: * male or female subjects, age range 18 and over. * patient with acute neck pain meeting baseline pain intensity level and duration exclusion criteria: * pain medication was taken within the 6 hours that precede randomization. * patient with chronic neck pain as defined as pain for 3 months or longer * any neck pain that is attributable to any organic disease, such as prolapsed disc, spondylolisthesis, osteomalacia, inflammatory arthritis, metabolic, neurological diseases or tumors. * any recent strains of the neck muscles documented by the clinical evaluation and anamnesis
evaluation of the efficacy and safety of bumetanide in parkinson's disease

Conditions: Parkinson Disease

Summary: this is multicentre, proof of concept, randomized, double-blind, parallel-group, placebo-control study in 40 parkinson's disease (pd) patients. patients will be randomized in 2 groups receiving bumetanide or placebo for 4 months: * group 1 (20 pd patients): bumetanide * group 2 (20 pd patients): placebo intake identically to group 1.


Eligibility criteria:
inclusion criteria: 1. idiopathic parkinson's disease fulfilling the uk parkinson's disease brain bank (ukpdsbb) criteria (cf. appendix vii) 2. 40 \< age \< 80 years old 3. hoehn \& yahr 1.5-4 (off stage) 4. walking and balance or freezing ≥ 1in the mds-updrs ii 5. motor fluctuation defined by a score ≥ 1 on the item "time spent in the off state" of the mds-updrs iv 6. dose of l-dopa ≥ 150 mg/d (concomitant treatment) 7. pd medications regimen stable for at least 3 months 8. patients expected to remain on stable doses of pd medications during all the study 9. covered by health insurance system 10. able to understand and to sign the informed consent prior to selection 11. negative pregnancy test at screening 12. blood pressure (bp) and heart rate (hr) considered non clinicaly significant (ncs) by investigators 13. electrocardiogram (ecg) recording on a 12-lead ecg considered ncs by investigators 14. laboratory parameters within the normal range of the laboratory. individual values out of the normal range can be accepted if judged clinically non relevant by the investigator exclusion criteria: 1. atypical parkinsonism or drug-induced parkinsonism 2. cognitive impairment (mmse ≤ 24) 3. active psychiatric disorder (mood disorders, hallucinations or delirium with strong functional impact and not controlled by medication or which happened during the last 3 months before inclusion) 4. treatment by deep brain stimulation or continuous infusion of apomorphin/dopa gel 5. renal or hepatic insufficiency 6. electrolyte disturbances 7. a corrected qt (qtcf) interval \>450ms for male or \>470ms for female on the electrocardiogram 8. any medical condition that might interfere with the protocol except those defined in section 5.3 9. contraindications to bumetanide : persistent anuria, hepatic encephalopathy included coma 10. women pregnant, nursing or of childbearing age without effective contraception. patients should not be enrolled if they plan to become pregnant during the time of study participation 11. patient unable to attend scheduled visits or to comply to the protocol 12. patient under legal guardianship or judicial protection 13. patient in the exclusion period of another protocol 14. no possibility of contact in case of emergency 15. known allergic reactions induced by burinex (bumetanide)
effectiveness of mulligan mobilization technique

Conditions: Neck Pain; Disability Physical; Kinesiophobia

Summary: the aim of this study was to investigate the effects of the mulligan mobilization technique (mmt) on pain intensity, joint position sense (jps), kinesiophobia, and disability level in individuals with nonspecific neck pain. a total of 34 female individuals with nonspecific neck pain were included in the study. pain intensity, jps, kinesiophobia, and disability levels of all participants were evaluated before and after the 3-week intervention. participants were randomly divided into two groups. in the first group, the participants received mmt by the physiotherapist twice a week for 3 weeks, and self-mobilization techniques as a home exercise program. the second group was trained only self-mobilization techniques.

a total of 34 female individuals with nonspecific neck pain that persisted for at least 3 months were included in the study. individuals who had a surgical indication for the cervical region and/or had undergone surgery, who had received physiotherapy or other treatment in the last year due to neck pain, who had a history of trauma to the cervical and thoracic region, and who additionally had a musculoskeletal system disease were excluded. all participants were evaluated for pain intensity, jps, kinesiophobia, and disability levels before and after the 3-week intervention. participants were randomly divided into two groups using the coin toss method. in the first group, the participants received mmt by the physiotherapist twice a week for 3 weeks, and self-mobilization techniques as a home exercise program. the second group was trained only self-mobilization technique.

Eligibility criteria:
inclusion criteria: * nonspecific neck pain exclusion criteria: * history of trauma to the cervical and thoracic region
safety of buprenorphine transdermal patch (btds) in osteoarthritis pain: a 52-week extension phase

Conditions: Osteoarthritis

Summary: the purpose of this phase is to evaluate the long-term safety and tolerability of btds. qualified subjects are started on btds 5 and the dose may be titrated, if necessary, to a maximum of btds 20 to achieve stable pain control.

buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain.

Eligibility criteria:
inclusion criteria: * subjects who completed all visits of the double-blind phase on study drug and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase. exclusion criteria: * subjects who prematurely discontinue study drug in the double-blind phase due to adverse event, subject's choice, administrative reason or lost to follow-up are not eligible to enter the extension phase * subjects with electrocardiograms (ecgs) that show any qt data corrected for heart rate using fridericia formula (qtcf) interval ≥ 500 millisecond (msec) will be discontinued from the extension phase. * subjects requiring long-acting opioid analgesics (once- or twice-daily dosing with an every (q) 24 hour (h) or q12h drug) or transdermal fentanyl during the extension phase should be discontinued from the study. refer to core study for additional inclusion/exclusion information.

Keywords: osteoarthritis opioid transdermal
the efficacy and safety study in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: the efficacy and safety study of saxagliptin 5mg, once daily for 24 weeks in patients with type 2 diabetes mellitus.

a multicenter, single arm, cohort study to evaluate the efficacy and safety of saxagliptin 5mg, once daily for 24 weeks, in patients with type 2 diabetes mellitus who are treatment naive or who have inadequate glycaemic control on metformin alone

Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures diagnosed with type 2 diabetes * men or women who are \>18 years of age at time of consenting upon visit 1 * hba1c \>7.5% and ≤11.0% patients should be drug naive or treated with metformin alone on stable doses of for at least continues 8 weeks prior to visit 1 * drug naive patients are defined as patients who have not received medical treatment for diabetes (insulin and/or oral hypo) exclusion criteria: * pregnant or breastfeeding patients * insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes) * previous treatment with any dpp-iv inhibitors or glp-1 analogue * history of administration of any antihyperglycemic therapy (other than metformin) during the 8 weeks prior to visit 1(12 weeks for previous tzd) * treatment with systemic glucocorticoids other than replacement therapy * inhaled, local injected and topical use of glucocorticoids is allowed

Keywords: type 2 dm
combination study of bms-754807 and erbitux® in subjects with advanced or metastatic solid tumors

Conditions: Colorectal Cancer; Head and Neck Cancer; Neoplasm Metastasis

Summary: the study is expected to identify a safe dose of bms-754807 to be given in combination with a standard dose of cetuximab and the recommended dose or dose range for phase ii studies. the study is also intended to collect first data on the effects of the combination of bms-754807 with cetuximab on tumors of patients with colorectal cancer or squamous cell cancer of the head and neck for whom cetuximab-containing therapies have not been effective


Eligibility criteria:
for additional information, please contact the bms oncology clinical trial information service at 855-216-0126 or email mycancerstudyconnect@emergingmed.com. please visit www.bmsstudyconnect.com for more information on clinical trial participation. inclusion criteria: * ecog status 0 - 1 * dose escalation: subjects with locally advanced or metastatic solid tumors who are eligible to receive cetuximab treatment and have archived tumor biopsy material available. colorectal cancer subjects must be confirmed kras wild type * dose expansion: crc (kras-wt) and head \& neck cancer subjects only 1. must be able to provide 2 fresh tumor biopsy samples 2. must have failed one prior cetuximab-containing treatment exclusion criteria: * symptomatic brain metastasis * prior treatments with anti-egfr (except cetuximab) or anti-igf-1r agents, experimental or licensed * any condition requiring chronic use of steroids * any disorder with dysregulation of glucose homeostasis (history of type 1 or 2 diabetes mellitus or prediabetic symptoms) * history of glucose intolerance * history of cetuximab infusion reactions * women of child-bearing potential unwilling or unable to use acceptable contraception methods
does coronavirus disease 2019 (covid-19) pandemic cause a delay in the diagnosis of gastric cancer patients?

Conditions: Stomach Cancer; Corona Virus Infection

Summary: the aim of this study is to analyze whether covid-19 causes a delay in the diagnosis of gastric cancer patients particularly in the tnm staging of the tumor, or not and to compare the number of newly diagnosed patients with gastric cancer before and during the covid-19 pandemic period.

the study included the patients diagnosed with gastric cancer during the period between march 1, 2020, and december 31, 2020, in the pandemic group at the adana city training and research hospital, department of general surgery, divisions of gastroenterological surgery and surgical oncology. for the baseline group, patients diagnosed with gastric cancer between january 1, 2019, and december 31, 2019, was included in the same department. clinical and pathological data of the patients were retrospectively collected from the hospital medical records. the following parameters were compared between the pandemic and baseline periods; age and gender distributions, mean monthly numbers of newly diagnosed patients, cea and cea-19.9 levels, the type of the surgery, the location of the tumor, the frequency of the patients receiving neoadjuvant treatment, american society of anesthesiologists (asa) score, length of the hospital stay, clinical staging and pathologic tnm staging.

Eligibility criteria:
inclusion criteria: patients newly diagnosed with gastric cancer at specified intervals will be included in the study. exclusion criteria: * having an additional second primary tumor

Keywords: gastric surgery covid-19 sars-cov-2 pandemic stomach surgery cancer surgery
aflibercept (eylea) in routine clinical practice in patients with wet age-related macular degeneration in italy

Conditions: Wet Macular Degeneration

Summary: the main objectives of this non-interventional cohort field study are to evaluate effectiveness of eylea and to describe follow-up as well as treatment patterns in patients with wamd (wet age-related macular degeneration) in routine clinical practice in italy for a study population of "naïve" patients


Eligibility criteria:
inclusion criteria: * "naïve" patients with wet amd(age-related macular degeneration) treated with eylea (in accordance with the local summary of product characteristics, spc). exclusion criteria: * exclusion criteria as listed in the local spc. scar, fibrosis, or atrophy involving the center of the fovea in the study eye. * any concomitant therapy with another agent to treat wet amd in the study eye. * any prior or concomitant therapy with another drug for wamd.

Keywords: wet amd
comparison of percutaneous coronary intervention optimization with fractional flow reserve versus intravascular ultrasound in the treatment of long coronary artery lesions

Conditions: Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction

Summary: a single center, prospective, observational study to compare fractional flow reserve (ffr) and intravascular ultrasound (ivus) percutaneous coronary intervention (pci) optimization strategies on the functional pci result (assessed with ffr) immediately post pci and at 9-12 months after the treatment of long coronary artery lesions.


Eligibility criteria:
inclusion criteria: * chronic coronary syndrome (stable angina; staged pci to other lesions after acute myocardial infarction with st segment elevation); * acute coronary syndrome without st segment elevation (unstable angina or myocardial infarction without st segment elevation); * functionally significant (ffr ≤ 0.8) lesion requiring a stent length of ≥ 30 mm and amenable for percutaneous coronary intervention. exclusion criteria: * patient's age ≤ 18 years; * acute myocardial infarction with st segment elevation; * treatment with dual antiplatelet therapy contraindicated; * survival expectancy ≤ 1 year; * known allergy to sirolimus, everolimus or zotarolimus.
efficacy and safety of everolimus (rad001) in patients with advanced gastric cancer

Conditions: Advanced Gastric Cancer

Summary: the purpose of this study is to assess the efficacy and safety of everolimus 10mg daily in patients with advanced gastric carcinoma (inoperable, recurrent or metastatic gastric cancer) whose cancer has progressed despite prior treatment.


Eligibility criteria:
inclusion criteria: * histological proven gastric adenocarcinoma * progressive disease during/ after prior treatment * treated with 1 or 2 chemotherapy regimen for advanced disease * at least one measurable lesion by recist criteria * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * history of another primary malignancy within 3 years * treated with 3 or more regimens for advanced gastric cancer * chronic treatment with steroids or another immunosuppressive agent * a known history of hiv or hepatitis b seropositive, or active hepatitis c infection * patients with active, bleeding diathesis other protocol-defined inclusion/exclusion criteria may apply

Keywords: gastric cancer rad001 mtor