Kornimate/medical-research-clean huggingface dataset:
pregabalin for the prevention of chemotherapy induced nausea and vomiting

Conditions: Nausea

Summary: phase ii randomized, double-blind, placebo-controlled trial to investigate whether pregabalin can improve the complete control of nausea and vomiting (primary end point)

chemotherapy-naive patients, scheduled to receive moderately and highly emetogenic chemotherapy. all patients will receive iv ondansetron 8 mg, dexamethasone 10 mg and ranitidine 50 mg before chemotherapy on day 1 and oral dexamethasone 4 mg, bd, on days 2 and 3. patients will be randomly assigned to take pregabalin 75 mg or placebo, bd, from the night before chemotherapy to day 5.

Eligibility criteria:
inclusion criteria: * patients scheduled to receive their first cycle of moderately to highly emetogenic chemotherapy; * 18 years or older; * eastern cooperative oncology group \< 2 exclusion criteria: * nausea or vomiting 24h before randomization * aspartate aminotransferase / alanine aminotransferase above 3 times the upper limit * severe cognitive compromise; * regular use of corticosteroids, opioid, benzodiazepines, tricyclic antidepressant, or cannabinoids within 30 days before randomization; * brain metastasis; * chronic alcoholism;

Keywords: pregabalin nausea
tissue perfusion indices as predictor of outcome in poly trauma patients

Conditions: Multiple Trauma

Summary: early intervention and resuscitation based upon a lot of clinical, laboratory findings make a big difference regarding outcome in poly trauma patients, the study uses the dynamic lactate change and the difference between arterial and venous co2, oxygen tension or content as indicators for tissue perfusion.

poly trauma patients have high incidence of mortality and morbidity in spite of improvements and advances in facilities. however, no doubt that early resuscitation and interventions make a big difference upon the overall outcome. a lot of methods, indices, laboratory and biomarkers have been utilized to evaluate the progress and quality of resuscitation and the early hospital interventions in such group of critically ill patients including central venous pressures, urine output, mixed venous oxygen saturation, and gastric tonometry. most of recent means focus upon the regional tissue perfusion rather than global, however some researches have tried the difference between arterial and venous co2,oxygen tension or content ( pv -a co2\& pa -v o2 ) in addition to dynamic changes in lactate(3) as predictors for tissue perfusion in sepsis patients after establishment of sepsis campaign (bundle).

Eligibility criteria:
inclusion criteria: * multiple trauma patients adult patients exclusion criteria: * cardiac renal chronic chest disease diabetic more than 3 years
behavioral treatment for children with conduct problems and callous-unemotional traits

Conditions: Conduct Disorder; Oppositional Defiant Disorder

Summary: the purpose of this study is to modify behavior therapy so that it is optimized for children with conduct problems and callous-unemotional traits by emphasizing reward components and de-emphasizing punishment components.

several studies have demonstrated that standard behavioral treatments do not appear to be sufficient for children with conduct problems (cp) and callous-unemotional (cu) traits. other research suggests that children with cpcu are less responsive to punishments as evaluated using controlled laboratory tasks. based on these two sets of findings, it was hypothesized that behavioral treatment modified to emphasize reward and de-emphasize punishments would be advantageous when used to treat children with cpcu. this hypothesis was tested in a treatment development study that had three phases. during phase 1, which occurred in 2010, the intervention was planned and treatment procedures and manuals were developed. during phase 2, which occurred in 2011, a pilot study was conducted in which the intervention was tested in an iterative manner in a group of 12 children with conduct problems and callous-unemotional traits. in phase 3, a larger trial was conducted using a cross over design, with one-half of participants getting standard behavioral treatment for four weeks followed by modified behavioral treatment for four weeks and remaining participants receiving treatments in the reverse order.treatments were evaluated using parent ratings, counselor ratings, and frequency counts of behavior during treatments.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of oppositional defiant disorder or conduct disorder * ages 7 to 12 years old * t-score of 65 or above on cu scale of antisocial process screening device as rated by parents or teacher * at least parent/caregiver fluent in english * able to participate in vigorous outdoor activities * parent/caregiver agreement to keep psychoactive medication treatment constant throughout the study exclusion criteria: * full scale intelligence quotient (iq) of less than 75 * medical conditions that contra-indicate participation in treatment * current or past clinical diagnosis of pervasive developmental disorder, schizophrenia or other psychotic disorders, sexual disorder, organic mental disorder, or eating disorder * lack of functional impairment * current or past seizures or other neurological disorders

Keywords: conduct problems callous-unemotional traits disruptive behavior disorders
trigger point massage in chronic tension headache

Conditions: Tension-Type Headache

Summary: patients with ihs criteria of chronic tension headache , considering inclusion and exclusion criteria, enrolled to this study. they will be randomized to intervention or control group by block randomization method, then treat by standard drug( nortriptyline 10 mg daily) or trigger point massage. they report severity, frequency, duration of headaches and number of analgesic drugs in diary during week 1 and week 4. then data based on dairy will be analysis.


Eligibility criteria:
inclusion criteria: 1. chronic tension type headache according to ihs criteria 2. finding painful trigger point in physical examination 3. no contraindication for massage 4. no prophylactic treatment 5. written inform consent exclusion criteria: 1. dementia or severe cognitive impairment 2. under treatment with drugs with prophylactic effect 3. history of ra or cervicocephalic fracture or other skeletal deformity 4. other complementary treatment

Keywords: massage trigger point
social media effects on mental health

Conditions: Mental Health Issue; Mental Health Wellness 1; Mental Health Wellness 2; Social Media Addiction; Internet Addiction

Summary: in the last decade, research on social media and mental health has produced mixed results. overall, the current findings suggest that the negative effects on mental health are exacerbated by longer and more frequent social media usage, whereas the positive effects are bolstered when social media is used to connect with other people. with the largest number of global users, facebook is the most frequently studied social media network. over the past few years, the increasing concerns about the risks associated with facebook have even translated to wider pop culture conversations, as exemplified by the 2020 documentary the social dilemma. in response, facebook has rolled out a series of features supposed to mitigate these risks and encourage responsible social media usage. these features include activity trackers and reminders, unfollow and snooze buttons, and data sharing regulators. currently, there is no research done to address whether (1) these features are used at all, and (2) whether they are successful in moderating the negative mental health consequences of facebook usage. this study seeks to address the gap in literature through a survey done on the crowdsourcing platform amazon mechanical turk (mturk).


Eligibility criteria:
inclusion criteria: * healthy adult volunteers, aged 21 and above * english proficiency * facebook users exclusion criteria * participants below 21 years old * non-facebook users

Keywords: social media facebook mental health wellbeing
safety and efficacy of donepezil in mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this study will evaluate the safety and efficacy of donepezil in treatment of ad patients in china.

this study is a multi-center, single-arm, open labeling clinical trial, which the objective is to evaluate the safety and efficacy of donepezil in alzheimer's disease( ad) patients in china, and investigate the relationship between apo-e gene type with adverse events of donepezil.

Eligibility criteria:
inclusion criteria: 1. patients between 50 and 85 years of age. 2. patients newly diagnosed as probable ad based on diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) criteria and national institute of neurologic and communicative disorders and stroke-ad and related disorders association (nincds-adrda) criteria; mild to moderate ad with mini-mental state examination (mmse) 10-24, modified hachinski ischaemic scale (mhis)≤4, activity of daily life scale (adl)≥23, and hamilton depression scale (hamd) \<7. 3. mri image supports the diagnosis of ad (medial temporal lobe atrophy, fazekas scale of white matter lesions≤2 within 6 months prior to the screening). 4. 5mg daily of donepezil for at least four weeks before the screening. 5. patient with exclusive caregiver. 6. patient should be ambulatory or ambulatory aided by a walker or cane. 7. with good eyesight and hearing, can cooperate with the examination and treatment. exclusion criteria: 1. patients with vascular dementia, other types of dementia or with other psychiatric or neurological disorders (e.g. delirium, depression, parkinson's disease, etc.). 2. patients with type i diabetes, obstructive lung disease or asthma, vitamin b12 or folic acid deficiency, thyroid dysfunction, severe liver or kidney dysfunction, severe cardiac insufficiency (congestive heart failure, myocardial infarction, sick sinus syndrome, ii-iii degree atrioventricular block or heart rate\<50 beats/minute \[bpm\]). 3. epilepsy or head trauma resulting in unconsciousness that occurred in the two years prior to the screening. 4. patients with hematologic diseases (such as anemia, granulocytes, leukemia, etc.), tumor, neoplasms within 2 years prior to the screening. 5. patients with a history of alcohol dependence and drug abuse. 6. patients with known hypersensitivity to medicines or foods; 7. patients taking anticholinergic agents or antihistaminic agents; 8. patients who had been hospitalized continuously for more than 3 months before the screening.

Keywords: ad donepezil safety
aladdin study - phase iii: antigonadotropin-leuprolide in alzheimer's disease drug investigation (vp-ad-301)

Conditions: Alzheimer's Disease

Summary: the study is designed to investigate the activity of the hormone drug leuprolide acetate in stabilizing cognitive function in mild-to-moderate ad patients.

vp4896 is a gonadotropin releasing hormone (gnrh) agonist that binds to and inactivates gnrh receptors on the pituitary gland. this decreases the amount of luteinizing hormone released by the pituitary. the hypothesis upon which this trial is designed is that luteinizing hormone is the cause of alzheimer's disease. vp4896 decreases the amount of luteinizing hormone in the body and, therefore, may decrease or halt the progression of alzheimer's disease. this is a double-blind, placebo-controlled, study designed to assess the safety and efficacy of vp4896 (a novel formulation of leuprolide acetate) in the treatment of subjects with mild-to-moderate ad. the study duration is 56 weeks. approximately 555 participants will be recruited from approximately 80 sites in the united states, canada, and south america. the study drug will be administered every eight weeks over a 48 week period. male subjects randomized to active treatment will also receive testosterone replacement gel. the change from baseline in adas-cog (cognitive test) score at week 50 and adcs-cgic (global cognitive and behavioral measure) at week 50 will be the primary efficacy endpoints. safety will be assessed at all visits and by phone at week 1.

Eligibility criteria:
inclusion criteria: * 60 years of age or older * diagnosis of probable mild-to-moderate alzheimer's disease * on a stable dose of an acetylcholinesterase inhibitor (including, but not limited to: donepezil, galantamine, rivastigmine, and tacrine) for at least 120 days prior to baseline and will likely remain on the drug throughout the trial; all participants must be on acetylcholinesterase inhibitors * no other significant or interfering medical conditions exclusion criteria: * significant neurological disease affecting the brain or psychiatric disease other than ad, such as current untreated major depression, schizophrenia, epilepsy, parkinson's disease, creutzfeldt-jakob's disease, or clinical episode of stroke * laboratory or clinical signs of untreated, clinically significant abnormal thyroid function, in the investigator's opinion * received other investigational drugs within 30 days or 5 half-lives prior to baseline, whichever is longer * taking other medications, with the exception of estrogen, known to affect serum gonadotropin (gn) concentrations, including but not limited to goserelin, danazol, or leuprolide * other exclusion criteria exist--eligibility can be assessed by the trial site

Keywords: gonadotropins hormone therapy hrt antigonadotropin leuprolide
a study in ovarian cancer patients evaluating rucaparib and nivolumab as maintenance treatment following response to front-line platinum-based chemotherapy

Conditions: Epithelial Ovarian Cancer; Primary Peritoneal; Fallopian Tube Cancer; Newly Diagnosed; FIGO Stage III-IV; Partial Response; Complete Response

Summary: this is a phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. response to treatment will be analyzed based on homologous recombination (hr) status of tumor samples.


Eligibility criteria:
inclusion criteria: * newly diagnosed advanced (figo stage iii-iv) epithelial ovarian, fallopian tube, or primary peritoneal cancer. * completed cytoreductive surgery, including at least a bilateral salpingo-oophorectomy and partial omentectomy, either prior to chemotherapy (primary surgery) or following neoadjuvant chemotherapy (interval debulking) * completed first-line platinum-based chemotherapy and surgery with a response, in the opinion of the investigator * sufficient tumor tissue for planned analysis * ecog performance status of 0 or 1 * patients must be 20 years of age to consent in japan, taiwan and south korea; in all other participating countries patients must be 18 years of age to consent exclusion criteria: * pure sarcomas or borderline tumors or mucinous tumors * active second malignancy * known central nervous system brain metastases * any prior treatment for ovarian cancer, other than the first-line platinum regimen * evidence of interstitial lung disease or active pneumonitis * active, known or suspected autoimmune disease * condition requiring active systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications

Keywords: parp inhibitor parpi hrd athena homologous recombination dna repair loh dna defect dna anomaly rucaparib nivolumab pd-1 immuno- oncology tumor mutational burden brca first-line primary therapy primary treatment
an open-label safety and tolerability study of nusinersen (isis 396443) in participants with spinal muscular atrophy who previously participated in isis 396443-cs1 (nct01494701)

Conditions: Spinal Muscular Atrophy

Summary: the primary objective of this study is to examine the safety and tolerability of nusinersen (isis 396443) administered intrathecally to participants with spinal muscular atrophy (sma) who previously participated in isis 396443-cs1 (nct02865109). the secondary objective was to examine the plasma pharmacokinetics of a single dose of isis 396443 administered intrathecally to participants with sma who previously participated in isis 396443-cs1.

this study was conducted and the protocol was registered by ionis pharmaceuticals, inc. in august 2016, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
key inclusion criteria: * clinical signs attributable to spinal muscular atrophy * satisfactory completion of dosing and all study visits in isis 396443-cs1 (nct01494701) with an acceptable safety profile, per investigator judgement. * able to complete all study procedures, measurements and visits and parent/participant has adequately supportive psychosocial circumstances, in the opinion of the investigator * estimated life expectancy \> 2 years from screening * meets age-appropriate institutional criteria for use of anesthesia/sedation, if use is planned for study procedure key exclusion criteria: * have any new or worsening of existing condition which in the opinion of the investigator would make the participant unsuitable for enrollment, or could interfere with the participant participating in or completing the study. * dosing in isis 396443-cs1 (nct01494701) within 270 days (9 months) of screening, or longer ago than 450 days (15 months) * dosing in isis 396443-cs2 (nct01703988) * hospitalization for surgery (i.e. scoliosis surgery) or pulmonary event within 2 months of screening or planned during the duration of the study * presence of an untreated or inadequately treated active infection requiring systemic antiviral or antimicrobial therapy any time during the screening period * clinically significant abnormalities in hematology or clinical chemistry parameters * treatment with investigational drug, biological agent, or device within 1-month of screening or 5 half-lives of study agent, whichever is longer. treatment with valproate or hydroxyurea within 1 months of screening. any history of gene therapy or cell transplantation note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: spinal muscular atrophy sma smn smnrx isis-smnrx isis 396443
post-market study of the biodesign hernia graft

Conditions: Ventral Hernia

Summary: the purpose of this study is to collect data on the performance of the biodesign® hernia graft when used to reinforce soft tissues during ventral hernia repair.

this multicenter, open-label, prospective clinical study will evaluate the performance of the biodesign hernia graft to reinforce soft tissues during ventral hernia repair. this post-market study will enroll up to 95 patients at up to 10 clinical sites. each clinical site will be limited to a maximum of 50 patients to ensure a variety of patients and surgical techniques are represented. there is no minimum enrollment number per site. this study has been designed as a multicenter, open-label, prospective study to collect data on the performance of the biodesign hernia graft. the inclusion and exclusion criteria for this study have been selected based on the instructions outlined in the ifu so that the results from this study can provide data on the real-world use of the device.

Eligibility criteria:
inclusion criteria: 1. primary or recurrent ventral hernia in need of surgical repair utilizing a biodesign hernia graft exclusion criteria: 1. known sensitivity to porcine material for the study, the following patients will also be excluded: 2. age \< 18 years 3. unable or unwilling to provide informed consent 4. life expectancy of less than one year from the date of the index procedure 5. patients will be excluded from the study if they never receive a biodesign hernia graft during their index procedure.
study in participants with early-stage or locally advanced human epidermal growth factor receptor (her) 2-positive and estrogen receptor/progesterone receptor negative breast cancer to evaluate the efficiency and safety of treatment with trastuzumab plus (+) ql1209/pertuzumab + docetaxel.

Conditions: Breast Cancer

Summary: this is a randomized, double-blind, multicenter trial，parallel control designed to evaluate treatment with trastuzumab + ql1209 + docetaxel compared with trastuzumab + pertuzumab + docetaxel in the participants with early-stage or locally advanced her2-positive and estrogen receptor/progesterone receptor negative breast cancer. the anticipated treatment duration is approximately 140 days.

this is a multi-center, randomized, double-blind, parallel control，comparative clinical trial. the primary objective is to evaluate whether the clinical efficacy of ql1209 and pertuzumab are similar in patients with early-stage or locally advanced her2-positive and estrogen receptor/progesterone receptor negative breast cancer. the secondary objective are to evaluate whether the clinical safety and immunogenicity of ql1209 and pertuzumab are similar in patients with early-stage or locally advanced her2-positive and estrogen receptor/progesterone receptor negative breast cancer.

Eligibility criteria:
inclusion criteria: 1. volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (icf); 2. age ≥ 18 years and ≤ 80 years when icf is signed; 3. histologically confirmed invasive breast carcinoma with a primary tumor size of more than (\>) 2 centimeters (cm) by standard local assessment technique; breast cancer stage at presentation: early-stage (t2-3, n0-1, m0) or locally advanced (t2-3, n2 or n3, m0; t4, any n, m0); her2-positive breast cancer confirmed by immunohistochemistry or her2 gene amplification by in situ hybridization; estrogen receptor and progesterone receptor negative. 4. eastern cooperative oncology group performance status equal to or less than (\<=) 1. 5. baseline left ventricular ejection fracture \>= 55% measured by echocardiography (preferred) or multiple gated acquisition scan exclusion criteria: 1. stage iv metastatic breast cancer; 2. inflammatory breast cancer; 3. previous anti-cancer therapy or radiotherapy for any malignancy; 4. history of malignancies other than colorectal cancer within 5 years prior to randomization, excluding cutaneous basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary adenocarcinoma of non-melanoma after radical treatment; 5. concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy; 6. major surgical procedure within 4 weeks prior to randomization or from which the participant has not fully recovered; 7. serious cardiac illness or medical condition; 8. other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness; 9. sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol; 10. pregnant or lactating