Kornimate/medical-research-clean huggingface dataset:
study of pomalidomide in anal cancer precursors

Conditions: High Grade Squamous Intra-epithelial Lesion (HSIL)

Summary: this is a single centre open label phase ii trial to determine the antitumor efficacy of the oral immunomodulatory agent pomalidomide in persistent human papillomavirus (hpv) -associated high grade squamous intra-epithelial lesions (hsil) in patients with and without human immunodeficiency virus (hiv) infection.


Eligibility criteria:
inclusion criteria: 1. persistent high grade squamous intra-epithelial lesion (hsil) which must meet all of the following criteria: i. pathologically confirmed grade 2 or 3 ain demonstrated by high resolution anoscopy with grade on each occasion re-confirmed at screening by nominated study pathologist from douglas hanly moir (dhm) (pathology case review to be conducted prior to enrolment) ii. lesion must have been visualised on at least three sequential occasions over at least 12 months, including the pre enrolment screening high resolution anoscopy (hra). iii. lesion must have persistent geographical characteristics consistent with a single lesion observed over time (as defined in the manual of operations). 2. no history of thromboembolic disease 3. no evidence of anal cancer or superficially invasive squamous cell carcinoma of the anus (siscca) 4. willingness to use appropriate contraception (including refraining from sperm donation) 5. age 18 years or older 6. provision of written informed consent in addition, for subjects with hiv: 7. adherence to a stable suppressive antiretroviral therapy (art) regimen, unchanged for at least two months 8. cd4+ count ≥ 200 cells/µl 9. hiv viral load \< 200 copies/ml for at least six months exclusion criteria: 1. absolute neutrophil count (anc) \<1000 cells/μl 2. haemoglobin \<10.0 g/dl 3. platelet count \<75,000 cells/μl 4. aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> three times upper limit of normal 5. calculated or measured creatinine clearance (clcr) ≤ 50 ml/min (calculated by cockcroft-gault formula) 6. patients with significant cardiac dysfunction including congestive heart failure, ny heart association class ii; myocardial infarction within 12 months of starting study; unstable of poorly controlled angina 7. current pregnancy or breastfeeding 8. any condition not already outlined above which, in the opinion of the clinical investigator, would place the subject at risk if they participated or would jeopardise adherence or follow up
stem cell heart injections during laser revascularization surgery for treatment of chronic ischemic heart disease

Conditions: Chronic Ischemic Heart Disease

Summary: assess the safety and effectiveness of stem cell application with regard to improvement in regional myocardial function in patients receiving trans-myocardial laser revascularization (tmr) and stem cells.

multiple case experiences and studies have been published reviewing clinical experiences with carbon dioxide trans-myocardial laser revascularization (tmr) and autologous bone marrow derived cell application. these experiences have demonstrated perfusion improvements, ejection fraction improvements and improvements in angina or heart failure symptoms. the investigators elected to examine the use of cd133 positive (cd133+) bm-derived stem cells because of their pluripotent nature and the fact that during the cd133 selection process inflammatory cells present in the bone marrow are being discarded. cd133+ is a recently discovered marker for more primitive bone marrow derived multipotent stem and endothelial progenitor cells and is of particular interest in studies directed to therapeutic angiogenesis, as these cells have been shown to differentiate into endothelial and myogenic cell lines. multiple studies have utilized bm derived cells for myocardial regeneration. patients who received cd133+ cells showed improved perfusion at injection sites of stem cells leading to a significant increase in volume of left ventricular ejection fraction, regional wall motion in the infarct zone, and a reduction in end systolic left ventricular volume.

Eligibility criteria:
inclusion criteria: * presence of at least two vessel coronary artery disease not amenable to direct revascularization * area of interest defined as part of free left ventricular vall with reduced contractility * demonstration of reduced perfusion in the area of interest (\>30% of free wall) * global ejection fraction 30-45% with symptoms class \>_ ii on the nyha scale * significant refractory angina defined as symptoms class \>_ iii that are refractory to maximal medical and anti-angina therapy * expected survival of at least two years exclusion criteria: * any condition that prevents successful stem cell collection or application, e.g. systemic infection, puncture for stem cell collection impossible * any condition that may adversely affect bone marrow such as malignancy or prior irradiation to the pelvic bone * mitral valve insufficiency \> moderate grade * history of ventricular arrhythmias not controlled by medication and/or aicd * need for additional heart surgery (i.e. valve replacement) * emergency or salvage operation defined as within 48 hours of diagnosis * evidence of left ventricular thrombus * previous heart surgery within the last 6 months * increased troponin t (\> 3x uln) in patients with unstable angina at time of intervention * history of symptomatic carotid disease within the last 3 months prior to study intervention * ejection fraction \< 30% * end stage renal disease * untreatable cancer, current or within preceding 5 years * severe copd
efficacy and safety of armodafinil as adjunctive therapy in schizophrenic adults with cognitive deficits

Conditions: Schizophrenia

Summary: the primary objective of this study is to evaluate if adjunctive armodafinil treatment can improve the cognitive deficits in patients with schizophrenia


Eligibility criteria:
key inclusion criteria: * the patient has a diagnosis of schizophrenia according to the dsm-iv-tr criteria as determined by the scid and has been clinically stable in a nonacute phase of their illness for at least 8 weeks prior to the baseline visit. * the patient has received treatment with olanzapine, oral risperidone, or paliperidone for schizophrenia for at least 6 weeks prior to the screening visit and has been on a stable dose of olanzapine, oral risperidone, or paliperidone for at least 4 weeks prior to the screening visit. the patient is prepared to remain at these stable dosages for the duration of the study. * the patient is a man or woman 18 through 60 years of age. * the patient is in good health (except for the diagnosis of schizophrenia) as judged by the investigator on the basis of medical and psychiatric history, medical examination, ecg, serum chemistry, hematology, and urinalysis. * women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study. * the patient must be willing and able to comply with study restrictions, to remain at the clinic for the required duration during the study period, and to return to the clinic for the follow-up evaluation as specified in this protocol. key exclusion criteria: * the patient has any axis i disorder, including schizoaffective disorder and sleep disorders, apart from schizophrenia, and nicotine dependence. * the patient has tardive dyskinesia or any other clinically significant movement disorder. * the patient has any clinically significant uncontrolled medical (including illnesses related to the cardiovascular, renal, or hepatic systems) or surgical condition. * the patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets. * the patient is a pregnant or lactating woman. (any woman becoming pregnant during the study will be withdrawn from the study.)
the effects of selective site right ventricular pacing

Conditions: Bradycardia

Summary: this is a pilot study into the effects on heart function when pacing the right ventricle (rv). this study aims to enrol a population with structurally normal hearts. the investigators aim to measure heart function directly when pacing. when normal conduction within the heart fails, the treatment may be to implant a permanent pacemaker. pacing involves passing a lead via a vein to the heart and using an electrical impulse to stimulate a beat. the usual site for pacing is the tip of the rv. this has been shown to be less efficient than the normal conduction system of the heart and in some cases leads to markedly reduced function. what the investigators do not know is why this is the case. much effort has been directed at looking at features within the left ventricle (lv) for markers of disease progression but little has been investigated regarding the rv. there may be some benefit to pacing the heart preferentially from different parts of the rv and the investigators aim to measure if any differences are detectable from stimulating the heart at various sites within the rv.

inclusion criteria; * patients undergoing elective electrophysiological studies +/ablation * age 18-80 * normal heart on pre-procedural echocardiogram exclusion criteria; * atrial fibrillation * evidence of anterograde conducting accessory pathway * permanent pacemaker insitu * pregnant * breast feeding outcome measures; change in load-independent indices of lv and rv contractility before and after pacing intervention. lv and rv function measured by transthoracic echocardiography and tissue doppler imaging.

Eligibility criteria:
inclusion criteria: * patients undergoing elective electrophysiological studies +/ablation * age 18-80 * normal heart on pre-procedural echocardiogram exclusion criteria: * atrial fibrillation * evidence of anterograde conducting accessory pathway * permanent pacemaker insitu * pregnant * breast feeding

Keywords: pacing haemodynamics pilot
efficacy, safety and tolerability of sulthiame in patients with obstructive sleep apnea (osa)

Conditions: Obstructive Sleep Apnea

Summary: multi-center, randomized, double-blind, placebo-controlled, dose-finding, 4-arm, parallel assignment study to evaluate the efficacy of three different doses of sulthiame (stm) compared to placebo on sleep apnea activity in adult patients with obstructive sleep apnea.

primary objective: to evaluate the efficacy of 3 different doses of sulthiame (stm) compared to placebo on sleep apnea activity in adult patients with moderate to severe obstructive sleep apnea (osa) after at least 12 weeks of treatment at target dose secondary objectives: to evaluate the effect of 3 different doses of stm after at least 12 weeks of treatment at target dose in patients with moderate to severe osa on apnea/hypopnea events, hypoxic burden, sleep quality, daytime sleepiness, patient's perception of symptoms and well-being, comorbidity-related outcomes and safety and tolerability of stm exploratory objective: to evaluate potential predictive biomarker (eg, blood gas analysis parameters or additional polysomnography \[psg\] variables) with regard to efficacy

Eligibility criteria:
key inclusion criteria: * osa diagnosis according to the international classification of sleep disorders - third edition criteria with an ahi of ≥15 documented by psg or polygraphy (pg). * currently not treated with continuous positive airway pressure (cpap) or mandibular advancement device (mad) due to patient-reported: * non-tolerability; and/or * non-compliance; and/or * not willing to use cpap or mad (treatment-naïve patients) key exclusion criteria: * any osa treatment within the last 4 weeks prior to screening * fulfill criteria for a dominant central sleep apnea syndrome or dominant cheyne stokes respiration * other clinically significant sleep disorder including periodic limb movement disorder, restless leg syndrome, periodic limb movement arousal index (plmai) of \>15\*, insomnia, parasomnia or narcolepsy * as part of psg baseline assessment * hypoventilation or hypoxemia due to chronic obstructive pulmonary disease or other respiratory condition * clinically relevant craniofacial malformation * any upper airway surgery for osa within the last 12 months prior to baseline * patients who underwent an obesity surgery within the last 2 years prior to baseline or patients actively participating in any weight loss treatment program or use of any weight loss medication (prescription or over-the-counter) within 1 month prior to the first psg night.

Keywords: sulthiame obstructive sleep apnea
regional analgesia for anterior cervical disc and fusion surgery

Conditions: Postoperative Pain; Shoulder Pain; Anesthesia, Local; Disc Herniation

Summary: erector spina plane (esp) block has been widely used in recent years, and it is also used in the control of postoperative analgesia in many types of surgery due to its proximity to the central area and its wide spread feature. in this study, the investigators aimed to demonstrate the effectiveness of esp block on postoperative pain management in anterior cervical disc and fusion surgeries.

this study includes asa i-ii patients aged 18-65 years who will undergo anterior cervical disc and fusion surgery at c5 or c6 level under general anesthesia under elective conditions. in the preoperative period, the participant groups will be divided into two separate groups, group cesp and group scpb, according to the type of block applied. groups will be compared according to demographic data, duration of surgery, perioperative drug consumption, postoperative pain scores, additional analgesic requirement and presence of shoulder pain. the blocks will be applied with the help of an 8-12 mhz linear probe after the patients are determined by the closed envelope method. in group cesp, block will be applied using in-plane technique at the level of c6 or c7 transverse vertebral corpus in the fascia between the semispinalis capitis muscle and the posterior scalene muscle. during the block, a total of 20 ml volume of 0.25% bupivacaine concentration will be given bilaterally to all patients. group scpb will be administered using 10 ml of 0.25% bupivacaine by entering from the c4 level from the right side of the neck from the posterior side of the sternocleidomastoid muscle. it was planned to routinely administer 10 mg/kg paracetamol and 2x10 mg tenoxicam iv to all patients for postoperative pain control. patients will be taken to the recovery unit in the postoperative period, where their analgesic needs, frequency of nausea-vomiting, vas scores, and additional problems will be followed up by the nurse who was included in the study blindly. after 1 hour of follow-up in the recovery unit, the participants will be directed to the service. the participants' vas scores and additional analgesic needs will be recorded at 6, 12, and 24 hours postoperatively.

Eligibility criteria:
inclusion criteria: * asa (american society of anesthesiologists) classification i-ii * anterior cervical disc and fusion surgery exclusion criteria: * patients with bleeding diathesis * neurological disease, * bmi (body mass index) less than 19 or greater than 30 * the presence of infection in the neck area * patients who do not accept the procedure

Keywords: cervical erector spinae block anterior cervical disc and fusion surgery postoperative analgesic consumption superficial cervical plexus block
trastuzumab, pyrotinib combined with dalpiciclib and endocrine therapy for hr +/her2 + advanced breast cancer

Conditions: Breast Neoplasm Female

Summary: this study investigates the efficacy and safety of trastuzumab, pyrotinib combined with dalpiciclib and endocrine therapy for patients with advanced hr+/her2+ brest cancer, providing more possible effective regimens for the survival benefit of these patients in clinical practice.

this study is a single-arm, open-label, multicenter, phase ii clinical study. subjects were eligible for screening and entered the trial period after enrollment and received treatment with pyrotinib（320mg/day), trastuzumab(8 mg→6mg/every 3 week), dalpiciclib(125mg once daily for 3 weeks, followed by 1 week off in each 4-week cycle), endocrine therapy until disease progression, or intolerable toxicity, or withdrawal of informed consent, or discontinuation of medication at the investigator 's discretion. on-study imaging assessments were performed according to recist 1.1 criteria and the site assessment was final.

Eligibility criteria:
inclusion criteria: 1. female breast cancer patients of any menopausal status aged 18-75 years. 2. eastern cooperative oncology group (ecog) performance status score of 0-2. 3. female breast cancer patients with her2-positive hr-positive of recurrence or metastasis and are not suitable for surgical resection or radiation therapy with the purpose of cure. 4. er and/or pr +: defined as positively stained tumor cells representing ≥ 10% of all tumor cells (confirmed by investigator review at the site) and her2 +: defined as ihc 3 + or ihc 2 + and fish +/cish +. 5. measurable lesions by recist 1.1 criteria. 6. patients' previous treatment should meet: a) prior systemic (neo) adjuvant therapy is allowed but not required, and if received, the disease-free interval (dfi) must be \> 24 months (dfi is defined as the time from surgery to the first recurrence); b) ≤ 1 line of systemic therapy for the tumor (including anti-her2 targeted therapy, endocrine therapy and chemotherapy) is received at the metastatic stage; 7. stable patients with brain metastases are allowed. 8. life expectancy ≥ 12 weeks. 9. adequate organ and bone marrow function. 10. adequate cardiac reserve, left ventricular ejection fraction (lvef) ≥ 45% on echocardiogram. exclusion criteria: 1. patients who are not suitable for endocrine therapy as judged by the investigator. including symptomatic, advanced patients with disseminated visceral disease who are at short-term risk of life-threatening complications (including patients with uncontrolled large exudates \[pleural, pericardial, abdominal\], pulmonary lymphangitis and more than 50% hepatic involvement). 2. previous treatment with cdk4/6 inhibitors. 3. previous treatment with tki. 4. visceral crisis. 5. major surgery, chemotherapy, radiation therapy, any investigational agent, or other anticancer therapy within 2 weeks before entering the study. 6. have been diagnosed with any other malignancy within 3 years before entering the study, except for curatively treated non-melanoma skin cancer, basal cell or squamous cell skin cancer, or cervical carcinoma in situ.
pilot study of augment rotator cuff for surgical treatment of full thickness rotator cuff tears

Conditions: Full Thickness Rotator Cuff Tear

Summary: study purpose: to evaluate the safety and performance of augment rotator cuff as a primary surgical treatment for full thickness rotator cuff tears. the hypothesis is that augment rotator cuff will be easy to deliver as an inter-positional graft placed between the rotator cuff tendon and the humeral head providing further enhanced tendon to bone healing without adding any additional safety risk to the patient. study rationale: to evaluate the safety and performance augment™ rotator cuff in surgical intervention of a torn rotator cuff and to obtain preliminary data to support the rationale for a subsequent pivotal clinical trial.


Eligibility criteria:
inclusion criteria: * the subject has a repairable rotator cuff tear with an estimated full thickness size of ≥ 2 cm to \< 5 cm confirmed with diagnostic mri in ap or ml dimension * the subject is independent, ambulatory, and can comply with all post-operative evaluations and visits * the subject is at least twenty one (21) years of age and considered to be skeletally mature. exclusion criteria: * the subject has undergone previous rotator cuff repair surgery to the affected shoulder * the subject has a partial thickness rotator cuff tear * the subject requires a concomitant subscapularis repair * the subject requires a concomitant labral repair * the subject has an irreparable rotator cuff tear * the subject has an allergy to yeast-derived products or a known bovine collagen allergy * the subject has implanted metallic devices (cardiac pacemakers, insulin pumps, and nerve stimulators), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an mri scan of the shoulder * the subject has tested positive or has been treated for a malignancy in the past or is suspected of having a malignancy or is currently undergoing radiation or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed augment rotator cuff implantation site * the subject's condition represents a worker's compensation case * the subject is currently involved in a health-related litigation procedure * the subject is pregnant or able to become pregnant but not practicing a medically-accepted form of birth control, and/or intending to become pregnant during this study period

Keywords: tendon shoulder rotator cuff glenohumeral
participation to colorectal cancer screening with fecal occult blood test and colonoscopy

Conditions: Colorectal Cancer

Summary: adherence rate to screening colonoscopy (tc) in the average-risk general population is still unclear. aim of this study was to compare the uptake of tc screening with that of fecal occult blood (fobt) in the general population of different italian areas.

a nationwide, population-based, multicenter, randomized trial comparing attendance to tc with that to fobt was performed. sixty-four general practitioners (gps), overall including in their lists 9,889 average-risk subjects aged 55-64 years, were randomized between tc and fobt screening programs. eligible subjects were mailed a personal invitation letter co-signed by their gp and the coordinator of the area-reference gi centre. attendance rate and detection rate for advanced neoplasia (colorectal cancer, adenoma \>10 mm or with villous histology or high-grade dysplasia) for each arm of the study were assessed.

Eligibility criteria:
inclusion criteria: * asymptomatic 55-64 years subjects exclusion criteria: * already studied for colorectal cancer, severe comorbidities

Keywords: average-risk subjects for