Kornimate/medical-research-clean huggingface dataset:
prolonged enoxaparin in primary percutaneous coronary intervention

Conditions: Myocardial Infarction

Summary: this is a feasibility study aiming to generate pilot data on safety and efficacy of a novel anticoagulant regimen (enoxaparin bolus and prolonged infusion) compared to the local standard-of-care in opiate-treated patients undergoing primary percutaneous coronary intervention.

delayed absorption of oral p2y12 inhibitors in patients undergoing primary percutaneous coronary intervention (ppci) may increase the risk of stent thrombosis. parenteral treatment is needed mitigate this risk. we have recently shown a novel regimen of enoxaparin (bolus 0.75 mg/kg followed by an infusion of 0.75 mg/kg/6h) to provide consistent antithrombotic effects until the end of the infusion (1). we have also demonstrated the high prevalence of delayed platelet inhibition in opiate-treated patients (1). this is a feasibility study for a larger randomised controlled trial (rct). we aim to assess recruitment rate and collect pilot data on safety and efficacy. this will be a single-centre, open-label rct comparing this novel regimen of enoxaparin to the local standard-of-care which usually consists of unfractionated heparin and a glycoprotein iib/iiia inhibitor. the study population will be opiate-treated patients undergoing ppci. pre ppci, patients will be allocated in 1:1 ratio using a simple randomisation method using sealed envelopes, to either enoxaparin 0.75 mg/kg bolus followed by 0.75 mg/kg infusion over 6 hours (n=50) or the standard-of-care of ufh and tirofiban (n=50).

Eligibility criteria:
inclusion criteria: * age \>18 * confirmation of the diagnosis of stemi by the clinical team on the basis of history and ecg changes * intention to proceed with ppci * treated with opiates for analgesia * feasibility to obtain informed verbal consent pre ppci exclusion criteria: * active bleeding that cannot be controlled by local measures * pregnant patients * patients with end-stage renal failure requiring renal replacement therapy * patients with cardiogenetic shock * known thrombocytopenia (platelet count \<100,000) * known history of intracranial haemorrhage * known current treatment with oral anticoagulants * known history of major surgery or trauma or history of gi/gu haemorrhage within the last month * known intracranial malignancy or aneurysm * known allergy to enoxaparin * known hypersensitivity to benzylalcohol * patients with known acute bacterial endocarditis * known active gastric or duodenal ulceration * inability to easily understand verbal information given in english for any reason * inability to give informed consent due to either temporary or permanent mental incapacity * current participation, or participation within the last month, in an interventional clinical trial.
platelet-rich fibrin on nerve regeneration after bilateral sagittal split osteotomy

Conditions: Paresthesia; Anesthesia, Local; Neurosensory Disorder

Summary: patients who have mandibular deformity and will undergo bilateral sagittal split osteotomy will be included in the study.one side of the osteotomies randomly will be considered as study group and another side as a control group.in the study group , platelet rich fibrin will be placed after osteotomy and before rigid fixation.in the control group, fixation will be done without platelet-rich fibrin (prf).neurosensory disturbance will be evaluated 6 and 12 months after surgeries.

patients who have mandibular deformity and will undergo bilateral sagittal split osteotomy will be included in the study.one side of the osteotomies randomly will be considered as study group and another side as a control group.in the study group , platelet rich fibrin will be placed after osteotomy and before rigid fixation.in the control group fixation will be done without platelet-rich fibrin. before starting the surgical procedure, 20 ml of venous blood will take and placed in a centrifuge for 12 minutes with 28000rpm. after centrifugation, the cap will be removed from each tube and they will be placed into a sterile rack l-prf™. fibrin matrix will prepare. the l-prf™ will be removed from the tube. then, the clot right beneath the red blood cell clot will be placed on the surface tray and covered. five minutes will be waited before removing and using the fibrin matrix.neurosensory disturbance will be evaluated in 6 and 12 months after osteotomies by two-point discrimination (tpd) test and pin tactile discrimination(ptd) tests.

Eligibility criteria:
inclusion criteria: * patients who have class ii or iii deformity and will undergo bilateral sagittal split osteotomy exclusion criteria: * patients who have bad split or obvious nerve injury during surgery will be removed from study inclusion
clinical efficacy of prophylactic intravenous neostigmine and atropine in preventing post-dural puncture headache among parturient undergoing spinal anesthesia for cesarean section: a double-blind randomized placebo-controlled trial

Conditions: Acute Pain

Summary: post dural puncture headache is a distressing issue, many measures tried to treat symptoms but few delt with prevention.


Eligibility criteria:
inclusion criteria: * parturient ladies * age ranges from 18 to 35 years old. * asa ii with elective caesarean section under sub-arachnoid block exclusion criteria: * bmi \>35 * refusal to participate * surgical complications necessitating a blood transfusion * emergency caesarean section * the need for endotracheal intubation or vasopressors * any contraindication to regional anesthesia (such as a history of persistent cephalgia, convulsions, cerebrovascular events
deep learning signature for predicting aggressive histological pattern in resected non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer; Spread Through Air Space; Visceral Pleural Invasion; Lymphovascular Invasion

Summary: the purpose of this study is to evaluate the performance of a pet/ ct-based deep learning signature for predicting aggressive histological pattern in resected non-small cell lung cancer based on a multicenter prospective cohort.


Eligibility criteria:
inclusion criteria: (1) participants scheduled for surgery for radiological finding of pulmonary lesions from the preoperative thin-section ct scans; (2) pathological confirmation of primary nsclc; (3) age ranging from 20-75 years; (4) obtained written informed consent. exclusion criteria: (1) multiple lung lesions; (2) poor quality of pet-ct images; (3) participants with incomplete clinical information; (4) participants who have received neoadjuvant therapy.
canadian treat and extend analysis trial with ranibizumab

Conditions: wetAMD

Summary: this is an observational study to will evaluate and compare two ranibizumab treatment regimens (standard of care) in patients with neovascular (wet) age-related macular degeneration (wamd) aiming to achieve and to maintain a maximum visual function benefit. the results will be used to generate further recommendations on the timing of treatment administration for patients with neovascular (wet) age-related macular degeneration (wamd). in this context, the study will use the anatomical imaging (for example, optical coherence tomography \[oct\]) to evaluate wamd disease activity impacted by the recurrence of disease instability and for decision making in the treatment decision algorithm.


Eligibility criteria:
inclusion criteria: * infomed consent, * male and female, 50 years of age or older * diagnosis of treatment-naive cnv secondary to age-related macular degeneration(amd) in the study eye, * bcva score between 78 and 19 letters inclusive, exclusion criteria: * patients with structural foveal damage in the study eye, * patients with confounding severe oculare diseases, * patients with suspicion of ( polypoidal choroidal vasculapathy pcv) in the study eye, * patients with active or suspected or periocular infections in either eye or active intraocular inflammation in either eye, * patients who had previous subfoveal laser photocoagulation in the study eye or history of vitrectomy surgery in the study eye, * patients who had any prior treatment in the study eye, e.g., with visudyne\*, avastin\*, prior ranibizumab treatment, ozurdex\*, external radiation therapy, transpupillary thermotherapy (ttt), or any intravitreal injection, * patients with a known sensitivity to ranibizumab or any component of its formulation, * patients who have used any investigational agent in the last 30 days, * concurrent participation in a clinical trial or within 30 days prior to enrollment, * patients having received systemic treatment with any other anti-vascular endothelial growth factor (vegf) therapy ≤ 60 days prior to enrollment * patients with physical or mental disabilities that prevent accurate vision testing, * patients physically unable to tolerate intravenous fluorescein angiography, * pregnant or breastfeeding female patients, * any patient with recent history of new onset cardiac disease or thromboembolic central nervous system (cns) event (within 12 months of baseline visit), * patients with any other condition which, in the opinion of the investigator, would require treatment that would significantly impact the treatment assessments during this study.

Keywords: lucentis ranibizumab treat and extend wetamd age related macular degeneration
a health economic trial in adult patients undergoing ileostomy reversal ma402s23b501

Conditions: Retraction of Colostomy

Summary: this study is designed to compare the standard of care against exparel (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using exparel, therefore possibly reducing total hospitalization costs.

this is a phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with exparel (bupivacaine liposome injectable suspension) compared with postsurgical administration of standardized intravenous (iv) morphine sulfate or sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing ileostomy reversal with general anesthesia.

Eligibility criteria:
inclusion criteria: * male or female, 18 years of age or older. * patients scheduled to undergo ileostomy reversal. * ability to provide informed consent, adhere to study visit schedule, and complete all assessments. exclusion criteria: * patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol. * patients who abuse alcohol or other drug substance. * patients with severe hepatic impairment. * patients currently pregnant or who may become pregnant during the course of the study or who are unwilling to use acceptable means of contraception for at least one month before and one month after dosing. * patients with any psychiatric, psychological, or other condition that the investigator feels may make the patient an inappropriate candidate for this clinical study. * patients who have participated in an exparel study within the last 30 days. * patients who have received an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study. in addition, the patient will be ineligible if he/she meets the following criteria during surgery: * patients who have any concurrent surgical procedure. * patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents. * patients who receive entereg(r).

Keywords: ileostomy reversal
op-1250 (palazestrant) vs. standard of care for the treatment of er+/her2- advanced breast cancer

Conditions: Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer; ER Positive Breast Cancer; HER2 Negative Breast Carcinoma

Summary: this phase 3 clinical trial compares the safety and efficacy of palazestrant (op-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a cdk4/6 inhibitor.

this is an international, multicenter, randomized, open-label, active-controlled, phase 3 clinical trial. the purpose of this trial is to compare the safety and efficacy of palazestrant (op-1250) as a single agent to the standard of care endocrine therapy: either fulvestrant or an aromatase inhibitor (anastrozole, letrozole, or exemestane). this trial is seeking adult participants with er+, her2- advanced or metastatic breast cancer whose disease has relapsed or progressed on 1 or 2 prior lines of standard-of-care endocrine therapy for metastatic breast cancer. prior lines of therapy must include one line of endocrine therapy in combination with a cdk 4/6 inhibitor. in the dose-selection part of the trial, approximately 120 participants will be randomized to one of the two doses of palazestrant or to the standard-of-care endocrine therapy. thereafter, approximately 390 participants will be randomized to palazestrant at the selected dose or to the standard-of-care endocrine therapy.

Eligibility criteria:
key inclusion criteria: * adult female or male participants. * er+, her2- locally advanced or metastatic breast cancer that is not amenable to curative therapy. * evaluable disease (measurable disease or bone-only disease). * previously received a cdk4/6 inhibitor in combination with an endocrine therapy in the advanced setting. one additional line of et as a monotherapy is allowed. duration of the most recent prior et must be at least 6 months. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * adequate hematologic, hepatic, and renal functions. * female participants can be pre-, peri- or postmenopausal. * male and pre- or peri-menopausal female participants must be willing to take a gnrh (or lhrh) agonist. key exclusion criteria: * symptomatic visceral disease, imminent organ failure, or any other reason that makes the participant ineligible for endocrine monotherapy. * previously received chemotherapy in the advanced/metastatic setting. * previously received treatment with elacestrant or an investigational estrogen receptor-directed therapy. * history of allergic reactions to study treatment. * any contraindications to the selected standard-of-care endocrine therapy in the local prescribing information. * symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment. * clinically significant comorbidities such as significant cardiac or cerebrovascular disease, gastrointestinal disorders that could affect absorption of study treatment.
psychotherapy for depressed or anxious adolescents with cancer

Conditions: Depression; Anxiety; Cancer

Summary: at present, there are no established treatments for depression or anxiety in adolescents with cancer, creating an important clinical and research gap. fortunately, there is now substantial evidence documenting the efficacy of psychotherapy in the treatment of depressed and anxious adolescents in the general population.

despite the high prevalence of depression and anxiety in cancer patients, little is known about the efficacy of psychotherapy in depressed and anxious adolescents with cancer. behavioral activation therapy (bat) is a brief, manualized therapy that has shown efficacy in the treatment of major depressive disorder (mdd) and generalized anxiety disorder (gad) in several controlled trials patients, including adult cancer patients. the goal of this open label clinical trial is to obtain preliminary evidence of the efficacy of bat(6 sessions) in a group of adolescent cancer patients with mdd, gad or adjustment disorder with mood or anxiety features. we will test the efficacy of bat using the multidimensional anxiety scale for children at several time points of the treatment.

Eligibility criteria:
inclusion criteria: * a primary psychiatric diagnosis of major depressive disorder, generalized anxiety disorder or adjustment disorder with mood or anxiety features as defined by dsm-iv. * cancer patients. * parent consent and child assent to participate for patients younger than 18. patient consent for subjects 18-21. * diagnosis of cancer (stage 1-4), but healthy enough to complete study procedures. exclusion criteria: * lifetime history of psychosis or bipolar disorder. * current suicide risk. * history of substance abuse or dependence in the three months prior to the study. * patients who have ever failed bat in the context of cancer. * receiving other concurrent therapy for same disorder and patients who are receiving effective medication for depression. * mental retardation. * cns tumors. * patients undergoing stem cell transplantation.

Keywords: depression psychotherapy anxiety cancer
a study of patient management in hiv-1 infected patients found to have the genetic marker hla-b*5701

Conditions: HIV Infection

Summary: this is a retrospective observational study which follows on from cna106030 (a study evaluating whether prospective genetic screening for hla-b\*5701 can reduce the incidence of hypersensitivity reactions to abacavir). this study aims to collect data on approximately 35 subjects who withdrew from cna106030 when found to be hla-b\*5701 positive. hiv disease management and adverse event data in these subjects, where the risk/benefit ratio of treatment with abacavir may alter subsequent prescribing, will be collected


Eligibility criteria:
inclusion criteria: * subjects who have received notification not to receive abacavir in the cna106030 study because of a positive hla-b\*5701 screen result, and were subsequently withdrawn from protocol cna106030. * subjects willing and able to understand and provide written informed consent prior to participation in this study. * french subjects: in france, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. exclusion criteria: * subjects who were not enrolled in the cna106030 study * subjects who are not hla-b\*5701 positive * subjects who do not consent to being told their hla-b\*5701 status

Keywords: hla-b*5701 abacavir
the effects of peer co-led educational group intervention for adults with attention-deficit hyperactivity disorder

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: peer co-led education describes educators who are expert patients, user representatives or former patients, participating and teaching in educational interventions in cooperation with health care professionals. peer co-led education is included in the norwegian national guidelines for treatment of mental disorders, but despite some promising results for the treatment of other conditions, still little is known about the efficacy of peer co-led educational group interventions interventions for adults with attention deficit and hyperactivity disorder (adhd). this pilot trial will evaluate patient satisfaction with and preliminary efficacy of a 2-session peer co-led educational group program designed to address specific challenges faced by adults diagnosed with adhd at an outpatient clinics in mid-norway.


Eligibility criteria:
inclusion criteria: * confirmed adhd-diagnosis * speaking a scandinavian language exclusion criteria: * unable to give informed consent * psychosis * severe learning difficulties

Keywords: behavior therapy peer groups patient satisfaction feasibility studies
r115777 in treating patients who have metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: phase ii trial to study the effectiveness of r115777 in treating patients who have metastatic pancreatic cancer. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

objectives: i. determine the safety and effectiveness of r115777 in patients with metastatic pancreatic cancer. ii. determine the response rate, time to progression, and 6 month survival rate of these patients with this treatment regimen. iii. assess the pharmacokinetics of this treatment regimen in this patient population. outline: this is a multicenter study. patients receive oral r115777 twice daily for 21 consecutive days. treatment continues every 28 days in the absence of disease progression or unacceptable toxicity. patients are followed every 3 months for 1 year.

Eligibility criteria:
disease characteristics: * histologically confirmed adenocarcinoma of the pancreas * measurable metastatic disease no prior treatment for metastatic disease except immunotherapy (e.g., antibodies, vaccines, cytokines) patient characteristics: * age: 18 and over * performance status: ecog 0-2 * wbc at least 4,000/mm3 or granulocyte count at least 1,500/mm3 * platelet count at least 100,000/mm3 * bilirubin no greater than 2.0 mg/dl * sgot/sgpt no greater than 2 times normal * creatinine no greater than 2.0 mg/dl or creatinine clearance at least 50 ml/min * not pregnant or nursing * fertile patients must use effective contraception during and for 3 months after the study * no concurrent illness or active infection which would preclude study * no prior malignancy allowed unless disease free for the time period considered appropriate for cure of the specific cancer * no history of allergies to imidazole compounds (e.g., fluconazole, ketoconazole, miconazole, itraconazole, clotrimazole) prior concurrent therapy: * no prophylactic filgrastim (g-csf), sargramostim (gm-csf), or thrombopoietin * primary neoadjuvant or adjuvant chemotherapy allowed at least 6 months prior to detection of metastatic disease * primary radiotherapy allowed at least 6 months prior to detection of metastatic disease * no concurrent use of proton pump inhibitors (e.g., omeprazole)

Keywords: recurrent pancreatic cancer adenocarcinoma of the pancreas stage iv pancreatic cancer
safety, tolerability, and efficacy of jbt-101 in subjects with dermatomyositis

Conditions: Dermatomyositis

Summary: the purpose of this study is to evaluate the safety, tolerability and efficacy of jbt-101 in adult subjects with skin-predominant, dermatomyositis (dm) that is refractory to at least 3 months treatment with hydroxychloroquine.

part a: an interventional, double-blind, randomized, placebo-control design will be used to test jbt-101 in about 22 eligible male or female subjects ≥ 18 and ≤ 70 years of age with moderate-to-severe active skin-predominant dermatomyositis. part b: a one-year open-label design to test jbt-101 in subjects who completed part a without permanent discontinuation of study product because of safety or tolerability reasons.

Eligibility criteria:
inclusion criteria (part a): * cdasi activity score ≥ 14; * no difficulty with lifting or walking, and no more than 1.5 x the upper limit of normal of creatine phosphokinase or aldolase; * failed at least 3 months treatment with hydroxychloroquine; * stable treatment for dermatomyositis for at least 28 days before visit 1 (day 1). inclusion criteria (part b): * completion of dosing in part a without permanent discontinuation of study product because of safety or tolerability reasons exclusion criteria (part a and b): * significant diseases or conditions other than dm that may influence response to the study product or safety; * any one of the following values for laboratory tests at screening: 1. a positive pregnancy test (or at visit 1); 2. hemoglobin \< 10 g/dl; 3. neutrophils \< 1.0 x 10\^9/l; 4. platelets \< 75 x 10\^9/l; 5. creatinine clearance \< 50 ml/min according to modified cockcroft-gault equation; 6. aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase \> 2.5 x upper normal limit; 7. total bilirubin ≥ 1.5 x upper limit of normal. * any other condition that, in the opinion of the principal investigator, is clinically significant and may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.

Keywords: jbt-101, lenabasum, dermatomyositis