Kornimate/medical-research-clean huggingface dataset:
a randomized phase 2 study of at-101 in combination with docetaxel in relapsed/refractory non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this is a double- blind, multicenter, randomized phase ii study to evaluate the efficacy and safety of at-101 in combination with docetaxel in relapsed/refractory non-small cell lung cancer

further study details provided by ascenta.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed stage iiib with pleural/pericardial effusion or stage iv non-small cell lung cancer (nsclc). * progression of disease after one prior systemic chemotherapeutic regimen for locally advanced or metastatic nsclc. (systemic therapies given in the adjuvant setting are counted only if the patient relapses within 6 months of the last cycle of therapy.) in addition to the one prior chemotherapeutic regimen, patients may have received erlotinib in any setting. * all patients must have measurable disease. * no unstable or progressive brain metastases. * patients may have received prior radiation therapy but they must have recovered from all treatment-related toxicities. * ecog performance status 0-1 * adequate hematologic function * adequate liver and renal function * ability to swallow oral medication exclusion criteria: * prior chemotherapy regimen containing docetaxel. * active secondary malignancy. * uncontrolled concurrent illness including, but not limited to: serious uncontrolled infection, symptomatic congestive heart failure (chf), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with the study requirements. * failure to recover from toxicities related to prior therapy (e.g., surgery, radiation, chemotherapy).

Keywords: at101 at-101 cancer lung non-small cell docetaxel bcl
multimodal psychotherapy training for chinese medical students

Conditions: Mental Illness

Summary: providing evidence-based, well-designed psychotherapy teaching to train them to get a basic understanding of psychotherapy and to gain required skills for clinical practice would be fundamental to medical students, residency. this study will be a two-arm randomized controlled trial (rct) to evaluate the effectiveness of multimodal psychotherapy training program for medical students in china.

background and aims: providing evidence-based, well-designed psychotherapy teaching for medical students and residents is urgently needed. the aim of this project is to measure the effectiveness of a newly multimodal psychotherapy teaching program for medical students and residents in china. design: this study will be a two-arm randomized controlled trial (rct). the intervention group will receive a two-day multimodal-based intensive educational intervention with 8 weeks follow-up (supervision based online teaching). the wait-list control group will not receive the intervention until the end of the study. both groups will be followed up to 8 weeks. setting: this trial will be conduct at the sir run run shaw hospital. participants: this study aims to recruit about 160 medical students and residents, with approximately 80 in each group. measurements: the primary outcome measure is the changes of the facilitative interpersonal skills task (fis) scores. secondary outcome measures include: training program acceptability; trainees' psychotherapy knowledge; utilization of psychotherapy; and self-reported self-efficacy and self-reported motivation for psychotherapy. comments: if this cbt-based brief and short-term psychotherapy skill training program is proven effective, the mental health impact of its expansion nation-wide could be enormous.

Eligibility criteria:
inclusion criteria: 1. medical student, residents, health care providers 2. 18 years of age or older 3. expressing an interest in psychotherapy 4. willingness to received randomization 5. willing to provide informed consent to participate in the study exclusion criteria: 1. not health care providers 2. below 18 years old 3. unwilling to be randomized 4. unable to provide informed consent

Keywords: multimodal teaching psychotherapy training chinese medical students randomized controlled trial
sinefix-2022 pilot phase

Conditions: Rotator Cuff Tears (RCTs)

Summary: shoulder pain is one of the most commonly reported musculoskeletal complaints, which negatively affects upper limb use, night rest, daily life activities, work, sports performance and autonomy. rotator cuff disease represents the most common cause of shoulder pain and it is responsible for up to 70% of all shoulder related visits to clinicians. its incidence furthermore is expected to grow as the population ages. a wide range of conditions are included under the umbrella term of rotator cuff disease, including rotator cuff tendinopathy, subacromial bursal pathology, and partial-thickness or full-thickness rotator cuff tears (rcts). the latter ones, i.e. rotator cuff tears, form the indications for which the test devices, the sinefix implant and instruments, are intended. despite the high prevalence of this condition, the pathophysiology and healing potential are not well understood, making the condition challenging to predictably treat in some patient populations. rcts may occur in young people as a consequence of trauma (e.g. acute shoulder dislocation), however rcts typically present in middle-aged or elderly people and cannot always be attributed to precipitating events or trauma. instead, they can be attributed to degenerative processes, and are therefore referred to as degenerative rcts. for rcts, treatment options include both surgical and non-surgical (conservative) procedures. in this context, the sinefix implant and instruments were developed to treat adult patients with rotator cuff lesions of size up to 2 cm through arthroscopic reconstruction.


Eligibility criteria:
inclusion criteria: * patient indicated for surgical repair of the rotator cuff tear according to current guidelines * patient aged 18 years or older * up to 2 cm tear size of supraspinatus, infraspinatus (medio-lateral) * up to 2 cm tear size of supraspinatus, infraspinatus (anterior-posterior) exclusion criteria: * subject has had previous rotator cuff, arthroplasty or fracture procedures on the operative shoulder * history of alcoholism, drug abuse, psychological or other emotional problems likely to interfere with participation in the study follow-up schedule and assessments * inflammatory arthropathies * subject with a contraindication/non-compliance for mri examination * subject 's unwillingness to undergo surgical rotator cuff repair, participate in post-operative rehabilitation program, and / or adhere to follow up schedule * pregnant and breastfeeding woman
sorafenib plus tace versus sorafenib alone as postoperative adjuvant treatment for resectable primary advanced hcc

Conditions: Hepatocellular Carcinoma

Summary: this trial is a multi-center, phase iii, randomized (1:1) clinical trial. the aim is to explore the efficacy and safety of sorafenib combined with transarterial chemoembolization as adjuvant treatment for resectable advanced hepatocellular carcinoma, compared with sorafenib alone. the primary endpoint is recurrence-free survival. this trial planned to recruit 158 patients who received curative hepatic resection with resectable advanced hepatocellular carcinoma. the patients will be randomized into sorafenib group and sorafenib+tace group as 1:1 ratio.


Eligibility criteria:
inclusion criteria: 1. primary hepatocellular carcinoma without any treatments. 2. received curative hepatic resection 3. ecog score 0-1 4. child-pugh grade a 5. sufficient liver and kidney function exclusion criteria: 1. diffused lesions; tumor thrombosis in smv or ivc. 2. extra-hepatic metastasis. 3. contraindication of tace, like portal-systemic shunt, obvious atherosclerosis, etc. 4. allergic to the contrast agent of tace 5. dysfunction of liver, kidney or bone marrow. 6. concomitant other malignant tumor or hiv infection
physical activity during social isolation

Conditions: Social Isolation

Summary: the aim of the study is to evaluate the physical activity level and the factors affecting physical activity among young adults who are socially isolated due to coronavirus.


Eligibility criteria:
inclusion criteria: * being between the ages of 18-50 * being volunteer exclusion criteria: * being unable to communicate in turkish * not knowing read and write in turkish

Keywords: physical activity young adult coronavirus
olaparib in the treatment of brca1/2 unmutated and brca1 promoter methylated recurrent and metastatic triple-negative breast cancer

Conditions: Solid Tumor

Summary: this is an open-label, single-arm, single-center,exploratory clinical study.

this is an open-label, single-arm, single-center,exploratory clinical study initiated by the investigator to evaluate the efficacy of olaparib in recurrent and metastatic tnbc without brca1/2 mutation and methylated brca1 promoter.

Eligibility criteria:
inclusion criteria: * 1. age 18-70 years old, female; 2. histologically confirmed recurrent and metastatic tnbc patients without brca1/2 mutation and brca1 promoter methylation. note: triple-negative breast cancer is defined as estrogen receptor (er), progesterone receptor (pr), and human epidermal growth factor receptor (her2) negative. er and pr negative were defined as: er\<1% positive, pr\<1% positive. her2 negativity was defined as: her2 (-) or (1+) or her2 (2+) fish negative by immunohistochemistry. 3. the number of treatment lines at the stage of recurrence and metastasis should not exceed 2 lines. 4. according to recist1.1 criteria, there is at least one evaluable lesion; 5. ecog physical condition score ≤ 1 point; 6. expected survival period ≥ 3 months; exclusion criteria: * 1. pregnant, breastfeeding women, or those who are fertile and unwilling to take effective contraceptive measures; 2. patients who have received chemotherapy, radiotherapy, targeted therapy and other anti-tumor treatments within 4 weeks before enrollment; 3. previous use of parp inhibitors, including olaparib and other parp inhibitors; 4. known serious cardiovascular disease, myocardial infarction, or arterial thrombosis, or unstable angina pectoris, or known heart failure in the past 6 months, qt interval\>450ms; 5. the toxicity of the previous treatment regimen has not recovered before enrollment, and there are still toxic reactions of grade 1 or above (except for alopecia); 6. clinically obvious gastrointestinal abnormalities that may affect the intake, transport or absorption of drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.) or patients with total gastrectomy; 7. patients with known or suspected brain metastases, including central nervous system and spinal cord compression or meningeal metastases; 8. history of severe central nervous system disease (including epilepsy patients); 9. in the past 5 years, suffering from a second primary malignant tumor other than breast cancer and receiving related treatment; 10. known congenital or acquired immunodeficiency, active hepatitis, active tuberculosis and other active infections; 11. patients who are allergic to this test drug or similar drugs; 12. those who have participated in clinical trials of other drugs within 28 days before screening, or plan to participate in any other clinical trials during this study; 13. any other disease or condition of clinical significance (such as active or uncontrolled infection, etc.) that the investigator believes may affect compliance with the protocol or affect the patient's signing of icf
comparison of diagnostic performance of an algorithm and a high definition classical iterative algorithm positron emission tomography (pet) to 18fluoro-deoxy-glucose (18fdg) in the evaluation of axillary lymph node invasion of breast tumors

Conditions: Breast Cancer

Summary: the primary endpoint of this study is to show that this algorithm in high definition is superior to the classical algorithm in the diagnosis of lymph node metastases.


Eligibility criteria:
inclusion criteria: * informed consent and signed by the patient * age ≥ 18 years * breast tumor for which the therapeutic indication for surgery has from the outset: breast surgery (conservative or radical) associated with a conventional axillary dissection * proof of infiltrating ductal carcinoma histology * no known metastasis * no cons-indication to anesthesia. exclusion criteria: * history of neoadjuvant therapy * patients with invasive lobular carcinoma * indication of the use of sentinel node (if invasive carcinoma uni-centric, ≤ 2 cm in diameter, without palpable lymphadenopathy (n0)) * diabetes is not controlled by conventional treatment (blood glucose\> 1.8 g / l) * inability to capital * patients who are pregnant or nursing or of childbearing potential and not using adequate contraception * persons deprived of their liberty * major subject of a measure of legal protection or unable to consent * refusal to participate

Keywords: cancer breast 18fdg axillary positron emission tomography
perianal versus endoanal application of glyceryl trinitrate 0.4% ointment for chronic anal fissure

Conditions: Chronic Anal Fissure

Summary: perianal topical nitroglycerin has been widely used as a means for avoiding surgery in patients with anal fissure. however, nitroglycerin has not been universally accepted for this application because of inconsistency of efficacy and side effects. recent studies (dis colon rectum. 2007 apr;50(4):509-16) have demonstrated that nitroglycerin ointment products compounded by pharmacies did not meet the usp specifications for potency and/or content uniformity when filling a prescription for 0.3 percent nitroglycerin ointment. these results raise significant issues as to whether the patient is put at undue risk relative to the relief of their anal fissure pain. in addition, one study (dis colon rectum. 2006 jun;49(6):865-8) has demonstrated that intra-anal dosing of topical nitroglycerin produces a significantly greater reduction in sphincteric pressure and lower incidence of headaches than with perianal administration of the same dose of ointment. topical glyceryl trinitrate 0.4% ointment has been developed and tested in clinical trials and is effective in healing chronic anal fissures. it assures exactly dose and concentration of nitroglycerin. hypothesis: the endoanal application of exactly dose and concentration of nitroglycerin must reduced headache and the final recurrence. the purpose of this study is: 1. principal end-point: to compare perianal vs endoanal application of rectogesic and evaluate the different morbidity of the two presentation

inclusion criteria: chronic anal fissure. outcome measures: recurrence and headache.

Eligibility criteria:
inclusion criteria: * before a definitive definition of chronic anal fissure and ensuring inclusion in the study, all patients diagnosed as having chronic anal fissure based on their medical history and physical exploration were treated for a minimum of six weeks with conservative medical treatment (high residue diet, analgesics, and warm sitz baths). chronic anal fissure was defined by the presence of a fibrous induration or exposed internal sphincter fibres. exclusion criteria: * associated anal pathologies (incontinence, stenosis, abscess, fistula and haemorrhoids) * patients with associated conditions (inflammatory bowel disease, acquired immunodeficiency syndrome, tuberculosis, sexually transmitted disease and immunosuppression) * cardiopathy * headache and pregnancy.

Keywords: anal fissure nitroglycerin medical treatment
empagliflozin as adjunctive to insulin therapy over 26 weeks in patients with t1dm (ease-3)

Conditions: Diabetes Mellitus, Type 1

Summary: the study will investigate the efficacy, safety, tolerability and pharmacokinetic(pk) of 3 doses of empagliflozin compared with placebo over 26 weeks in 960 patients with type 1 diabetes mellitus as adjunctive therapy to insulin


Eligibility criteria:
inclusion criteria: * signed and dated written informed consent * male or female patient receiving insulin for the treatment of documented diagnosis of type 1 diabetes mellitus (t1dm) \> 1 year * c-peptide value of \< 0.7 ng/ml * use of multiple daily injections (mdi) of insulin or insulin pump user with total daily insulin \>= 0.3 and \<= 1.5 u/kg * glycated haemoglobin (hba1c) \>= 7.5% and \<= 10.0% * good understanding of t1dm * age \>= 18 years * body mass index (bmi) \>= 18.5 kg/m2 * estimated glomerular filtration rate \>= 30 ml/min/1.73 m2 * women of child-bearing potential must use highly effective methods of birth control * compliance with trial medication administration between 80% and 120% during placebo run-in period further inclusion criteria apply exclusion criteria: * history of type 2 diabetes mellitus, maturity onset diabetes of the young (mody), pancreatic surgery or chronic pancreatitis * pancreas, pancreatic islet cells or renal transplant recipient * t1dm treatment with any other antihyperglycaemic drug except subcutaneous basal and bolus insulin within last 3 months * occurrence of severe hypoglycaemia within last 3 months and until randomisation * occurence of diabetic ketoacidosis within 3 months prior to visit 1 and until visit 6 * irregular sleep/wake cycle * acute coronary syndrome, stroke or transient ischaemic attack (tia) within last 3 months * severe gastroparesis * brittle diabetes * liver disease * eating disorders * treatment with anti-obesity drugs, weight-loss surgery or aggressive diet regimen * treatment with systemic corticosteroids * change in dose of thyroid hormones within last 6 weeks and until randomisation * cancer or treatment for cancer in the last five years * blood dyscrasias or any disorders causing haemolysis or unstable red blood cells * women who are pregnant, nursing, or who plan to become pregnant whilst in the trial * alcohol or drug abuse * intake of an investigational drug in another trial within last 30 days further exclusion criteria apply
effects of intravenous lidocaine on ed50, ed95 and nti values of propofol induced unconsciousness

Conditions: General Anesthesia

Summary: the effect of intravenous lidocaine on ed50 and ed95 of propofol, which causes unconsciousness, is unclear. in addition, it is not clear whether the depth of anesthesia induced by propofol changes when lidocaine is used in combination. therefore, the purpose of this study was to study the effects of intravenous lidocaine on ed50, ed95 and nti values of propofol induced unconsciousness .

intravenous lidocaine has many advantages in perioperative period, in addition to reducing the amount of opioids and propofol, thus reducing the incidence of adverse reactions caused by them, it also has the effect on organ protection, can shorten the length of hospital stay, and promote postoperative recovery. the effect of intravenous lidocaine on ed50 and ed95 of propofol, which causes unconsciousness, is unclear. in addition, it is not clear whether the depth of anesthesia induced by propofol changes when lidocaine is used in combination. therefore, the purpose of this study was to study the effects of intravenous lidocaine on ed50, ed95 and nti values of propofol induced unconsciousness .

Eligibility criteria:
inclusion criteria: 1. the informed consent is signed 2. aged 18 to 65 years old 3. asa is rated from i to ii 4. body mass index ranged from 18.5 to 24.9 kg/m2 exclusion criteria: 1. unwilling to sign informed consent or refuse to participate in the study 2. patients with serious arrhythmia and organic heart disease before surgery 3. sedative and analgesic drugs were taken within 1 week before surgery 4. lidocaine allergy 5. patients with mental and neurological diseases 6. patients with difficult airway 7. people with hearing impairment

Keywords: ed50 ed95 intravinious lidocaine propofol nti
anterior resin bonded restorations for adolescent

Conditions: Missing Teeth

Summary: a 24 patients above 12 years old with missing upper incisor were divided into two groups, group 1: 12 patient will be treated by resin bonded bridge (rbb) with no preparation protocol, group 2: 12 patient will be treated by resin bonded bridge (rbb) with minimal preparation protocol. (rbb) retention/survival, patient's speech as well as thermal sensitivity and patient's satisfaction will be evaluated for 12 month at 3,6,9 and 12 month.


Eligibility criteria:
inclusion criteria: 1. 12-18 years old 2. full set of permanent teeth. 3. missing upper incisor 4. controlled dental disease - no active caries or periodontal diseases 5. patients will be available to be clinically reviewed up to 1 year exclusion criteria: 1. patients with uncontrolled active tooth decay or periodontal disease (i.e. 4+ mm probing depth and bleeding on probing). 2. patients with teeth missing opposite to the planned rbb 3. abutment tooth mobility of 2 or greater (millers classification) 4. patients with debilitating illnesses or complicating medical conditions 5. heavily restored tooth abutment not suitable for an rbb

Keywords: missing incisors resin bonded bridge
antidepressant treatment of mexican-americans: ucla pharmacogenetics and pharmacogenomics research group

Conditions: Major Depressive Disorder; Major Depression; Unipolar Depression

Summary: our goal is to study pharmacogenetics in mexican-americans, using depression treatments as a proof of the concept that pharmacogenetic approaches can be used to optimize treatment strategies for common and complex disorders in this population.

this is a single site, 8-week, double-blinded, placebo lead-in trial with fluoxetine or desipramine. all subjects have a comprehensive psychiatric and medical assessment, and if enrolled, continued with two consecutive phases of the study: 1) a one-week, single-blind placebo lead-in phase to eliminate placebo responders. 2) subsequent random assignment to one of two treatment groups: fluoxetine 10-40 mg/day or desipramine 50-200 mg/day. given the proven efficacy of these antidepressant medications, a placebo lead-in period followed by active treatment for all patients has been utilized in order to minimize human subjects at risk.

Eligibility criteria:
inclusion criteria: 1) at least 3 out of 4 grandparents born in mexico \[12\]. 2) dsm-iv diagnosis of current, unipolar major depressive episode \[13\]. 3) 21-item hamilton depression rating scale (ham-d) \[14\] score of 18 or greater with item #1 (depressed mood) rated 2 or greater. 4) age between 18-70 years. - exclusion criteria: 1) any axis i disorder other than major depressive disorder (e.g. dementia, psychotic illness, bipolar disorder, adjustment disorder) or primary anxiety disorders. 2) active medical illnesses that could be related to the ongoing depression (e.g. untreated hypothyroidism, recent myocardial infarction or cerebrovascular accident within the past six months, uncontrolled hypertension or diabetes). 3) current suicidal ideation with a plan and strong intent, or recent serious suicide attempt. 4) pregnant or lactating women, or women of childbearing age not using contraception. 5) history of electroconvulsive therapy in the last six months. 6) current use of medications with central nervous system activity which interfere with eeg activity (e.g. benzodiazepines) or any other antidepressant treatment within the 2 weeks prior to enrollment. 7) history of poor response to therapeutic treatment with desipramine or fluoxetine. 8) illicit drug use and/or alcohol abuse in the last three months. 9) current enrollment in counseling or psychotherapies. -

Keywords: depression mood disorders affective disorders pharmacogenetics pharmacogenomics