Kornimate/medical-research-clean huggingface dataset:
study of changes in estrogen levels and grip strength in postmenopausal women who have received 4 to 6 years of hormone therapy for breast cancer and are currently receiving letrozole on clinical trial ibcsg-35-07

Conditions: Breast Cancer

Summary: rationale: studying samples of blood in the laboratory from patients receiving treatment for cancer may help doctors learn more about changes that may occur in dna and identify biomarkers related to cancer. purpose: this clinical trial is studying changes in estrogen levels and grip strength in postmenopausal women who have received 4 to 6 years of hormone therapy for breast cancer and are currently receiving letrozole on clinical trial ibcsg-35-07.

objectives: primary * to determine the serum level of estrogens (estradiol \[e2\], estrone \[e1\], and estrone sulphate \[e1s\] and sex hormone binding globulin \[shbg\]) in postmenopausal women with prior endocrine-responsive, node-positive, resectable breast cancer completing 4 to 6 years of adjuvant endocrine therapy and enrolled on clinical trial ibcsg-35-07 receiving letrozole. * to determine the degree of recovery of e2, e1, and e1s during the 3-month letrozole-off gap. secondary * to determine the association between estrogen level changes and the clinical outcomes of toxicity and quality of life. * to determine the effect of prior adjuvant endocrine therapy, age, body mass index, and type of menopause on estrogen levels. * to determine the variability of estrogen level changes and its association with germline single nucleotide polymorphisms. * to examine changes in grip-strength score. outline: this is a multicenter study. all patients undergo blood sample collection at baseline for the analysis of single nucleotide polymorphisms, after randomization on clinical trial ibcsg-35-07 and prior to the beginning treatment on ibcsg-35-07. patients also undergo serum collection at baseline and at 9, 10.5, and 12 months for the analysis of estrogen levels and sex hormone binding globulins. patients undergo measurement of grip strength at baseline and at 9 and 12 months. samples may be banked for future research studies. patients complete quality-of-life questionnaires (breast cancer prevention trial \[bcpt\] symptom scales on form 35-prs and ibcsg trial 35-07 ql form) periodically.

Eligibility criteria:
disease characteristics: * previously diagnosed with breast cancer * endocrine-responsive, node-positive, resectable disease * disease-free following 4-6 years of prior adjuvant endocrine therapy with selective estrogen-receptor modulators and/or aromatase inhibitors * patient must be currently enrolled on clinical trial ibcsg-35-07 as well as the quality-of-life substudy * hormone receptor status not specified patient characteristics: * postmenopausal prior concurrent therapy: * see disease characteristics

Keywords: stage ia breast cancer stage ib breast cancer stage ii breast cancer stage iiia breast cancer
effect of pp-01 on cannabis withdrawal syndrome

Conditions: Cannabis Withdrawal

Summary: this study will be a randomized, double-blind, placebo-controlled, multicenter trial conducted to evaluate whether pp-01 mitigates the withdrawal symptoms associated with discontinuing cannabis in participants with moderate to severe cannabis use disorder (cud). the study will enroll approximately 225 participants with moderate to severe cud and will include 5 arms, including a placebo arm, to help assess the incidence and severity of withdrawal symptoms in heavy long-term users of cannabis. participants receive study medication for 34 days and participate in 11 visits (7 at a clinic and 4 telemedicine).


Eligibility criteria:
inclusion criteria: 1. generally healthy individuals between the ages of 18 and 55, inclusive 2. meets diagnostic and statistical manual (dsm)-5 diagnostic criteria for current moderate to severe cud as confirmed by a licensed physician or psychologist or addiction medicine specialist 3. bmi within 18.0 to 38.0 kg/m2, inclusive 4. seeking to minimize withdrawal symptoms related to cannabis discontinuation in people seeking to discontinue cannabis 5. meet dsm-5 cannabis withdrawal 6. report heavy use of daily/near daily cannabis 7. have a urine drug screen positive for tetrahydrocannabinol (thc)/thc metabolites at screening and randomization 8. capable of giving informed consent and complying with study procedures 9. stated willingness to comply with all study procedures including twice weekly visits, daily evening video calls, restrictions, and availability for the duration of the study exclusion criteria: 1. lifetime history of dsm-5 diagnosis of schizophrenia or schizoaffective disorder, or bipolar 1 within the previous 2 years 2. current dsm-5 criteria for a psychiatric disorder that in the investigator's judgment is unstable, would be disrupted by the study medication, or is likely to require new pharmacotherapy or psychotherapy during the study period. individuals who are currently stable on psychotropic medication for at least 3 months may be included at the discretion of the investigator's judgement 3. participants who meet dsm-5 criteria for any substance use disorder other than cannabis, nicotine, or caffeine use disorders 4. participants using cannabis for a medical condition requiring use such as epilepsy 5. clinically significant unstable medical disorders 6. any clinically important abnormalities on screening physical examination (pe), assessments, ecg, or laboratory tests 7. use of an investigational drug or biologic within 30 days or 5 times the half-life (whichever is longer) prior to the screening visit 8. pregnant or lactating female participants, or a positive urine pregnancy test 9. covid-19

Keywords: cannabis use disorder marijuana use disorder
lung cancer focus - long-term monitoring of bronchogenic carcinoma patients (lucas)

Conditions: Lung Cancer

Summary: long-term non-interventional monitoring of diagnostics and treatment patterns in newly diagnosed patients in selected pneumology centers in czech republic.

diagnosis, treatment and care of patients with bronchogenic carcinoma (bca) is, as with most other oncological diseases, a complex multidisciplinary process. due to the lack of information on the speed and success of the initial diagnosis, the use of the necessary laboratory techniques, and the individual therapeutic steps leading to cure or medical failure, the czech pneumological and phtizeology society (cpps) decided to carry out long-term non-interventional monitoring of newly diagnosed patients. this monitoring is non-interventional, so the usual diagnostic and therapeutic procedures will be used according to the decision of the physician. all patients with bronchogenic carcinoma diagnosed from june 1, 2018 will be enrolled with up to 60 months of follow-up.

Eligibility criteria:
inclusion criteria: - clinical diagnosis of lung cancer (c34 in mkn classification) exclusion criteria:

Keywords: lung cancer bronchogenic carcinoma diagnosis treatment non-interventional
sparing diaphragm; iso block versus low volume scalene block

Conditions: Shoulder Arthropathy Associated With Other Conditions

Summary: for shoulder analgesia, both iso block and low volume scalene (lvs) block (using 5 ml of local anesthetics) are suggested to have a low incidence of hemi-diaphragmatic pariesis (hdp). the aim of this study was to compare the incidence of hdp and the analgesic efficacy of the lvs block versus iso block.


Eligibility criteria:
inclusion criteria: * patients who were scheduled for arthroscopic shoulder surgery exclusion criteria: * aged \<18y * bmi \>35, * asa greater \>iii, * an infection at the injection site * has a contraindication for laryngeal mask or the medications used in this study.
a clinical study of 9mw2821 in advanced malignant solid tumors

Conditions: Advanced Malignant Solid Tumors

Summary: this study is a phase 1, first-in-human, open-label, dose-escalation and cohort expansion study designed to characterize the safety, tolerability, pharmacokinetics, preliminary antitumor activity and immunogenicity of 9mw2821 administered by intravenous (iv) infusion.


Eligibility criteria:
inclusion criteria: * competent to comprehend, sign, and date an independent ethics committee/institutional review board/research ethics board (iec/irb/reb) approved informed consent form. * male or female subjects aged 18 to 80 years (including 18 and 80 years). * eastern cooperative oncology group (ecog) performance status of 0 or 1. * phase ia：histologically or cytologically confirmed advanced malignant solid tumors (except sarcoma). phase ib：only local advanced or metastatic uc tumors. * subjects must have received icis or gc/gp therapies in the previous treatment. * subjects must submit tumor tissues for test. * life expectancy of ≥ 3 months. * subjects must have measurable disease according to recist (version 1.1). * adequate organ functions. * sexually active fertile subjects, and their partners, must agree to use methods of contraception during the study and at least 6 months after termination of study therapy. * subjects are willing to follow study procedures. exclusion criteria: * chemotherapy、radiotherapy or immunotherpy within 14 days prior to the first dose of study drug. * preexisting treatment related toxicity grade ≥ 2 (except alopecia). * major surgery within 28 days prior to first dose of study drug. * history of uncontrolled diabetes mellitus. * preexisting peripheral neuropathy grade ≥ 2. * received treatment of adcs with mmae payload. * any live vaccines within 4 weeks before first dose of study drug or during the study. * documented history of clinically significant cardiac or cerebrovascular diseases within 6 months prior to the first dose of study drug. * other severe or uncontrolled disease, i.e. severe respiratory system disease, thromboembolic events, active bleeding or active infection. * uncontrolled central nervous system metastases. * history of another malignancy within 3 years before the first dose of study drug. subjects with curable malignancies are allowed. * history of autoimmune disease requiring systemic treatment within 2 years before the first dose of study drug. * has ocular conditions that may increase the risk of corneal epithelium damage. * known sensitivity to any of the ingredients of the investigational product; history of drug abuse or mental illness. * any p-glycoprotein (p-gp) inducers/inhibitors or cyp3a4 inducers/inhibitors for high and medium effect within 14 days prior to the first dose of study drug. * use of any investigational drug or device within 30 days prior to the first dose of study drug. * conditions or situations which may put the subject at significant risk.
the superficial lesions in the peri-auricular region

Conditions: Superficial Cyst or Mass and Sinus on and Around the Ear

Summary: superficial lesions on and around the ear are uncommon with many differential diagnoses and different characteristic histopathologic features. the purpose of this study was to describe a series of peri-auricular superficial lesions and characterize the distinctive types of these lesions.

data included in this descriptive retrospective study were collected from records of 70 patients with superficial lesions around the auricle, i.e., periauricular (preauricular, auricular, and postauricular) during the period extending between 2017 and 2019, who were primarily diagnosed and operated. data were retrieved, reviewed, and analyzed. the primary analysis outcome measures were patient history (age, gender, complaint, medical advice clinic, and associated medical diseases), lesions examination (site, laterality, clinical presentation, and the number of lesions). also, the needed investigations for diagnosis, type of intervention, postoperative patient satisfaction were evaluated. evaluation of the patients' follow up was done.

Eligibility criteria:
inclusion criteria: * patients with superficial lesions around the auricle, i.e., periauricular (preauricular, auricular, and postauricular) operated during the period extending between 2017 and 2019 * available full demographic, clinical and histopathological data exclusion criteria: * deep lesions involving parotid or parapharyngeal space * missed demographic, clinical and histopathological data
maintenance of multivitamin supplements after sleeve gastrectomy

Conditions: Iron Deficiency Anemia

Summary: a prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was performed. patients were randomized into 2 groups: those patients receiving the multivitamin supplement during 3 months (group 1), and those receiving the supplement during 12 months (group 2). laboratory data were recorded: vitamins and oligoelements at 3, 6 and 12 months after surgery.

a prospective randomized study of patients undergoing a laparoscopic sleeve gastrectomy was performed. patients were randomized into 2 groups: those patients receiving the multivitamin supplement (multicentrum, pfizer, 1 tablet/day) during 3 months (group 1), and those receiving the supplement during 12 months (group 2). laboratory data were recorded: vitamins (d, b12 and folic acid) and oligoelements (calcium, iron, phosphorus, magnesium and zinc) at 3, 6 and 12 months after surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic sleeve gastrectomy * bmi \>40 kg/m2 * bmi \> 35 kg/m2 with the presence of comorbidities associated to obesity exclusion criteria: * documented gastroesophageal reflux * patients with uncontrolled psychiatric disorders * active infections or malignancies * any other concomitant pathology considered as a contraindication for bariatric surgery.
association of keratinised mucosa around implants and teeth with peri-implant/periodontal disease and soft tissue conditioning

Conditions: Peri-Implantitis; Soft Tissue; Bone Gain

Summary: lack of keratinised mucosa around dental implants and teeth is associated with plaque accumulation and worse tissue conditions. however, there is lack of data on the influence of the presence/lack of keratinised mucosa on the periodontal condition. hence, soft tissue conditioning by grafting with a gingival graft is aimed at improving the quality of the peri-implant conditions


Eligibility criteria:
inclusion criteria: * partial edentulous patients with adjacent teeth * lack of keratinised mucosa * healthy patient exclusion criteria: * pregnancy * complete edentulous patients * patients taking any medication * smokers
correlation patterns of brain temperature-pressure in acute brain injury

Conditions: Intracranial Pressure; Brain Injuries, Traumatic; Subarachnoid Hemorrhage; Cerebral Hemorrhage

Summary: the goal of this prospective, multicenter, observational, cohort trail is to explore the pattern of brain temperature-brain pressure association in acute brain injury and to clarify its predictive value for prognosis and neurological function 30 days after acute brain injury.

temperature abnormalities have long been recognized as signs of disease. brain temperature, as part of body temperature, reflects body temperature and brain metabolism during physiologic states. there is growing evidence that brain cell function is unequivocally temperature dependent and that brain temperature after brain injury cannot be reliably predicted by core body temperature. brain temperature is therefore increasingly becoming an important alternative to brain pressure, enabling patients with a variety of brain injuries to benefit from continuous brain temperature monitoring. meanwhile, the correlation between intracranial pressure, which is currently the most widely used indicator in clinical practice, and brain temperature in patients with acute brain injury remains unelucidated. whether the correlation between brain temperature and intracranial pressure has certain patterns and rhythms that can indirectly reflect the brain function of patients under the condition of injury and have a predictive value for clinical outcomes is the main research objective of this study. it is hoped that the present study will explore the correlation between brain temperature and brain pressure and the pattern of the correlation, as well as its impact on clinical prognosis. it provides a more precise target for intervention to further improve the prognosis of patients with acute brain injury.

Eligibility criteria:
inclusion criteria: 1. adults, male or female, 18 to 65 years of age; 2. acute brain injury due to subarachnoid hemorrhage, cerebral hemorrhage, or craniocerebral trauma; 3. glasgow coma scale (gcs) score of 3-12; 4. have undergone intracranial pressure monitoring probe placement, which allows continuous recording of brain temperature and pressure data; 5. signed informed consent. exclusion criteria: 1. gcs ≥13 points; 2. patients with concomitant intracranial infections, cerebral ischemia, congenital malformations, autoimmune encephalitis, or craniocerebral tumors; 3. at the time of onset, there was a combination of systemic malignant tumor, acute stage of major systemic organ disease, or stage of functional decompensation; 4. maternity; 5. undergoing experimental drug or instrumental trials.

Keywords: brain temperature monitoring intracranial pressure monitoring severe brain injury subarachnoid hemorrhage cerebral hemorrhage traumatic brain injury
preterm rna in maternal serum

Conditions: Preterm Birth

Summary: preterm birth is defined as a birth occurring before the completion of 37 weeks gestation. the incidence of preterm birth in israel in the last years is around 7-8%. despite various diagnostic modalities as well as newly therapeutic approaches the incidence of preterm birth remains unchanged and is considered to be the leading cause of neonatal morbidity and mortality. in the last decade, small rnas have emerged as an important player in both physiological and pathophysiological responses. these single strands, non-coding regulatory rna molecules are responsible for post transcriptional regulation of target genes. hence, may provide a new opportunity for biomarkers discovery in the field of preterm birth. the main objective of this study is to identify a distinctive expression profile of maternal circulating rnas that will be used as biomarkers for preterm birth.


Eligibility criteria:
inclusion criteria: 1. women with singleton pregnancy at 26-32 week of gestation with no clinical symptoms of preterm labor. 2. women with singleton pregnancy 24-34 week of gestation who present to the labor suite with symptoms suspected for preterm labor. 3. women with singleton pregnancy in term active labor (weeks 37-40). exclusion criteria: exclusion criteria will include: 1. multiple gestation, 2. major fetal anomalies, 3. iufd, 4. severe preeclampsia, 5. chronic steroid or immunosuppressive drug use, 6. active immunological illness, 7. and/or pregestational and gestational dm.
nutritional study in preterm infants

Conditions: Preterm Infants

Summary: an evaluation of a preterm infant formula containing ingredients similar to those found in breastmilk


Eligibility criteria:
inclusion criteria: * birthweight 500-1800 g * less than 33 wks gestational age * enteral feeding initiated by 21 days of life * asymmetrical small-for-gestational age (sga) infants and infants with patent ductus arteriosus (pda) are eligible to participate * singleton or twin births only * infant is 21 days of age or less at time of randomization exclusion criteria: * serious congenital abnormalities that may affect growth and development * grade iii or iv intraventricular hemorrhage (ivh) * maternal incapacity * history of major surgery * extracorporeal membrane oxygenation (ecmo) * asphyxia * confirmed nec or positive blood cultures at the time of randomization
tobacco dependence in alcoholism treatment (nicotine patch/naltrexone)

Conditions: Alcoholism; Smoking

Summary: the purpose of this study is to determine the effectiveness of naltrexone (revia) or matched placebo combined with nicotine patch (nicotrol) or placebo patch using a 2x2 design in reducing drinking and smoking in patients with both nicotine and alcohol dependence.

eligible individuals will be randomly assigned to a 12-week trial of a fixed daily dose of either naltrexone (revia) and nicotine replacement patch or placebos. all individuals will receive weekly coping skills and smoking-cessation behavioral therapy. followup interviews will be conducted 3 and 6 months after treatment to determine smoking and drinking status and persistence of any dependence symptoms.

Eligibility criteria:
inclusion criteria: * meets criteria for alcohol dependence and nicotine dependence. * expresses a desire to cut down or stop drinking and smoking. exclusion criteria: * currently meets criteria for dependence on substances other than alcohol and nicotine. * any history of opiate dependence or evidence of current opiate use. * significant medical disorders that will increase potential risk or interfere with study participation. * liver function tests more than 3 times normal or elevated bilirubin. * females who are pregnant, nursing, or not using a reliable method of birth control. * meets criteria for a major psychiatric disorder and is in need of or currently undergoing drug therapy. * inability to understand and/or comply with the provisions of the protocol and consent form. * treatment with an investigational drug during the previous month. * chronic treatment with any narcotic-containing medications during the previous month. * sensitivity to drug as evidenced by adverse drug experiences especially with narcotic- containing analgesics or opioid antagonists. * current treatment with disulfiram (antabuse) or nicotine replacement therapy. * more than 6 weeks of abstinence.
safety and efficacy of tocotrienols in post-cabg atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study is a prospective, randomized, controlled trial with parallel groups to assess the effects of tocotrienol in the occurrence of atrial fibrillation (af) post-cabg.

at present, guidelines exist in europe and the usa on the pharmacological prophylaxis and management of postoperative af. however, these are subject to a number of limitations including treatment failure, toxicity and pro-arrhythmogenicity. hence, efforts have been made to develop alternative preventive strategies. the understanding of the role of oxidative stress as a mechanism for af development has made way for antioxidant vitamins as novel therapeutic and preventive agents. in view of emerging evidence on the hmg-coa reductase inhibitory role in the incidence of af and established inhibitory properties of tocotrienols, we postulate that supplementation with tocotrienols may exert therapeutic advantage in the safety endpoints of post-cabg. the modulation of oxidative stress status and anti-inflammatory via hmg-coa reductase inhibition may work synergistically in affecting the incidence of af post-cabg.

Eligibility criteria:
inclusion criteria: 1. males or females 2. more than 18 years of age 3. elective, on-pump surgery of coronary artery revascularization, isolated or combined valve surgery exclusion criteria: 1. less than 18 years of age 2. refusal to have surgery 3. urgent or emergency surgery 4. off-pump surgery 5. poor lv (ef \< 30%) 6. inability to give informed consent 7. documented allergy to palm oil or vitamin e 8. documented af or any form of arrhythmia pre-operatively 9. currently on or indicated for long-term corticosteroid treatment 10. patients who have been included in any other clinical trial within the previous three months 11. patients who are on supplementation of vitamin e or other potent anti-oxidants up to 1 month before randomisation

Keywords: atrial fibrillation,tocotrienol,coronary artery bypass grafting