Kornimate/medical-research-clean huggingface dataset:
envasarc: envafolimab and envafolimab with ipilimumab in patients with undifferentiated pleomorphic sarcoma or myxofibrosarcoma

Conditions: Undifferentiated Pleomorphic Sarcoma; Myxofibrosarcoma

Summary: this is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort a and c) or envafolimab combined with ipilimumab (cohort b and d) in patients with locally advanced, unresectable or metastatic undifferentiated pleomorphic sarcoma (ups)/myxofibrosarcoma (mfs) who have progressed on one or two lines of chemotherapy.

this is a multicenter open-label, randomized, non-comparative, parallel cohort pivotal study of treatment with envafolimab (cohort a and c) or envafolimab combined with ipilimumab (cohort b and d) in patients with locally advanced, unresectable or metastatic ups/mfs who have progressed on one or two lines of chemotherapy. patients were previously assigned at random into one of two cohorts: cohort a of 80 patients who received single agent envafolimab (300 mg every 3 weeks by subcutaneous (sc) injection) or cohort b of 80 patients who received envafolimab (300 mg every 3 weeks by sc injection) in combination with ipilimumab (1 mg/kg every 3 weeks intravenously for four doses). following amendment #3, patients will be assigned at random into one of two cohorts: cohort c of 80 patients who will receive single agent envafolimab (600 mg every 3 weeks by subcutaneous (sc) injection) or cohort d of 80 patients who will receive envafolimab 600 mg every 3 weeks by sc injection) in combination with ipilimumab (1 mg/kg every 3 weeks intravenously for four doses). following amendment #4, enrollment into cohort d was terminated and no further interim analyses will be conducted on this cohort.

Eligibility criteria:
inclusion criteria: * histologically confirmed locally advanced or metastatic undifferentiated pleomorphic sarcoma (ups) or grade ≥ 2 myxofibrosarcoma (mfs) * documented progression following systemic chemotherapy * at least one measurable lesion * eastern cooperative oncology group performance status of 0 or 1 * adequate hematologic and organ function exclusion criteria: * more than two prior lines of chemotherapy for ups/mfs * prior immune checkpoint inhibitor or immunomodulatory therapy * active autoimmune disease that has required systemic treatment * major surgery within 4 weeks of dosing of investigational agent * active additional malignancy * pericardial effusion, pleural effusion, or ascites * central nervous system metastases and/or carcinomatous meningitis * active hepatitis or cirrhosis * interstitial lung disease * unwilling to apply highly effective contraception during the study * other concurrent severe and/or uncontrolled medical conditions that would, in the investigator's judgment, contraindicate patient participation in the clinical study

Keywords: sarcoma
effect of low gi/ glycemic load (gl) diet in diabetic nephropathy patients

Conditions: Diabetic Nephropathy; Medication Compliance

Summary: low gi and low gl diet have more beneficial effect for diabetic nephropath patients compared with conventional diet. low gl may have more favorable effect than low gi diet.

according to body weight status of participants, the investigators considered a slight calorie restriction ranged from 200 to 300 kcal/d. planed meals and exchange list prescribed for all volunteers. dietary records forms were given to all subjects and they were educated how to record their dietary intakes. the investigators asked subjects not to change their physical activity level during the study and monitored them for their physical activity level by 3 days physical activity records monthly.

Eligibility criteria:
inclusion criteria: * diabetic nephropathy, medication stable exclusion criteria: * poor adherence of dietary recommendations, any changes in kind or dosage of medications

Keywords: glycemic index diabetic nephropathy low glycemic load inflammation
presurgical cognitive evaluation via digital clockfacedrawing

Conditions: Cognitive Dysfunction

Summary: this study leverages a modernized digital version of a well-known cognitive screening tool to examine pre and post operative cognitive function after surgery in adults age 65 years or more. machine learning algorithms will be applied to the hospital wide standard of care cognitive metric to identify risk for post-operative cognitive complications.

this proposal innovatively leverages a brief but informative digital test with machine learning to examine the subtlety of pre-surgery cognition within an extremely large number of older individuals screened preoperatively within an academic tertiary medical center. it also incorporates a unique group of well characterized non-surgery peers for demographic matching to assist with normal versus abnormal machine learning analyses.

Eligibility criteria:
inclusion criteria: * \>/= 65 years of age * screening within the university of florida (uf) health preoperative clinic * presurgical cognitive screening with the digital clock drawing tool (dcdt) exclusion criteria: * \< 65 years of age * did not complete screening within the uf health preoperative clinic * did not complete the presurgical cognitive screening with the digital clock drawing tool (dcdt)

Keywords: cognitive processes perioperative cognition neurocognitive impairment
therapeutic efficiency and response to 2.0 gbq (55mci) 177lu-eb-psma in patients with mcrpc

Conditions: Prostate Cancer

Summary: in recent years, quite a few studies have demonstrated the possibility of 177lu-psma-617 therapy as a viable treatment option in metastatic castration resistant prostate cancer (mcrpc), which has been shown desired effect. to increase tumor accumulation and retention for radioligand therapy, and reduce dosage of 177lu, we conjugated a truncated evans blue (eb) molecule and dota chelator onto psma-617 (eb-psma) and labeled it with 177lu. this study is designed to assess the efficiency and response to 177lu-eb-psma (55 mci) in patients with mcrpc.

prostate cancer is one of the most common cancers and the second most frequent cause of cancer deaths for adult men. with the advances in the diagnosis and treatment of prostate cancer, some patients with localized prostate cancer can achieve good curative results, but there are still 10%～20% of patients progress to metastatic castration-resistant prostate cancer (mcrpc) every year, only one third of patients with mcrpc survive more than five years. radioligand therapy targeting prostate specific membrane antigen (psma), which is overexpressed in most prostate cancer and even further increased in metastatic and castration-resistant carcinomas, has been demonstrated as an effective and safe therapy in men with mcrpc. 177lu-psma-617 has also shown desired effect. however, 177lu-psma-617, as a small molecule imaging agent, is cleared very quickly from the circulation. therefore, radiotherapy that is based on small molecules requires high doses and frequent administrations, leading to systemic toxicity. to increase tumor accumulation and retention for radioligand therapy, and reduce dosage of 177lu, the investigators conjugated a truncated evans blue (eb) molecule and dota chelator onto psma-617 (eb-psma) and labeled it with 177lu. the investigators have published some articles demonstrated 177lu-eb-psma had much higher accumulation in prostate cancer lesions than 177lu-psma-617 and also showed an ideal effect. this study is designed to assess the efficiency and response to 177lu-eb-psma (55 mci) in patients with mcrpc.

Eligibility criteria:
inclusion criteria: * all the patients had progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy; * distant metastases with high psma expression were confirmed on 68ga-psma pet/ct within one week before the injection of 177lu-eb-psma. exclusion criteria: * the exclusion criteria were a serum creatinine level of more than 150 μmol per liter, a hemoglobin level of less than 10.0 g/dl, a white-cell count of less than 4.0× 109/l, a platelet count of less than 100 × 109/l, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia.
safety and efficacy of biphasic human insulin compared to ex1000 in type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia and africa. this trial aims for a comparison of blood glucose control of biphasic human insulin 100 iu/ml and ex1000.


Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least 12 months * current biphasic human insulin (bhi) for at least 3 months - as monotherapy or as the only insulin in combination with oads * body mass index (bmi) less than or equal to 40.0 kg/m2 * hba1c less than or equal to 9.5% * fpg (smpg) less than or equal to 12 mmol/l exclusion criteria: * treatment with more than 1iu/kg insulin daily * treatment with glucagon-like peptide 1 mimetics or dipeptityl peptidase iv inhibitors * known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the investigator * known or suspected allergy to trial products or related products * receipt of any investigational drug within one month prior to this trial * any other condition that the investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
exergaming in people with major neurocognitive disorder

Conditions: Randomised Controlled Trial; Major Neurocognitive Disorder; Long-term Care Facility; Physical Activity; Cognitive Impairment

Summary: this randomized controlled trial explores the efficacy of an 8-week standing exergaming program in people with major neurocognitive disorder (mncd) residing in long-term care facilities.

this randomized controlled trial explores the efficacy of an 8-week standing exergaming program in people with major neurocognitive disorder (mncd) residing in long-term care facilities. fifty inpatients with mild to moderate mncd will be randomly assigned to three times weekly for eight weeks 15 min of exergaming versus watching preferred music videos. the montréal cognitive assessment (moca), short physical performance battery (sppb), neuropsychiatric inventory (npi), cornell scale for depression in dementia (csdd), dementia quality of life (dqol), katz activities of daily living (adl) and instrumental adl (iadl) are measured at baseline and post intervention.

Eligibility criteria:
inclusion criteria included: * a diagnostic and statistical manual of mental disorders (dsm) 5 diagnosis of mncd (american psychiatric association, 2013) * aged 65 years or older * a score of minimum 10 on the mini-mental state examination (mmse) * residing at least two weeks in the care facility at the time of inclusion * being physically capable of doing standing exercises (whether or not with extra support). possible causes of mncd were vascular dementia, alzheimer's disease, mixed dementia, parkinson's disease or lewy body disease. exclusion criteria consisted of: * any unstable cardiovascular or other health condition which according to the american college of sports medicine standards might lead to unsafe participation * a score lower than 10 on the mmse * a planned transfer to another setting within the following two months.
myocardial perfusion, risk factors, and coronary calcium

Conditions: Cardiovascular Diseases; Coronary Arteriosclerosis; Coronary Disease; Heart Diseases

Summary: to determine whether an impairment of myocardial perfusion reserve is an early indicator of coronary artery disease.

background: impairment of coronary vasofunction is believed to be one of the earliest manifestations of coronary heart disease (chd). the impact of risk factors such as elevated cholesterol levels, diabetes, hypertension, and smoking on the coronary microcirculation remains largely unknown. design narrative: the cross-sectional study will determine whether an impairment of the myocardial perfusion reserve provides a marker of coronary heart disease (chd) by comparing it to other novel measures of subclinical vascular disease, and by testing its association with risk factors for chd. the study is ancillary to the multi-ethnic study of atherosclerosis ("mesa"), which is an nhlbi funded, prospective observational study of the characteristics of subclinical cardiovascular disease, i.e. disease detected non-invasively before it has produced signs and symptoms. in mesa new measures of subclinical disease such as coronary artery calcium and impaired brachial artery reactivity are to be examined to investigate their relationships to well-established risk factors and clinical events. myocardial perfusion reserve (mpr)is a useful measure of coronary vasofunction that should be included in an evaluation of new measures of subclinical disease. an impaired mpr appears to be a specific early indicator of the functional impairment of the microcirculation in patients with risk factors for coronary artery disease. magnetic resonance imaging (mri) will be used as an advanced, quantitative imaging modality to determine in short (20 minute) exams the myocardial perfusion reserve in a group of 400 mesa participants. the study tests the hypothesis that impaired myocardial perfusion reserve indicates the presence of subclinical coronary atherosclerosis and coronary microvascular disease. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
stress reduction during in vitro fertilization

Conditions: Infertility

Summary: the goal of this study is to determine the effect of healing touch (ht) on the stress, anxiety, and self-efficacy experiences of women undergoing in vitro fertilization (ivf) in a randomized, controlled design. ht is a gentle, non-invasive form of energy-balancing work that promotes relaxation.

once enrolled, each participant will be randomized to one of three groups: the healing touch (ht) treatment arm, the desensitization therapy (dt) arm, or the no-intervention arm. subjects in group 1 will receive three, 45-minute ht sessions during the first two weeks of their ivf cycle prior to oocyte retrieval. group 2 will receive three, 45-minute dt sessions during the first two weeks of their ivf cycle prior to oocyte retrieval. group 3 will receive no intervention. subjects in group 3 will be offered two ht sessions after completing study participation. all subjects and their partners will be asked to complete the spielberger state trait anxiety inventory (stai), the perceived stress scale (pss) and the infertility self-efficacy scale (ises) at three time points: 1) baseline 2) one day prior to oocyte retrieval and 3) 5-7 days post embryo transfer. in addition, subjects in all groups will complete a short pre-study questionnaire to assess expectation of therapeutic effect, and subjects in the two intervention groups will complete a short post-study questionnaire to evaluate their treatment experience. demographic and pregnancy outcome data will be collected for all subjects.

Eligibility criteria:
inclusion criteria:-age \<43 * fsh \<= 14 * about to enter an ivf cycle at the stanford fertility and reproductive medicine center * planning a transfer of their own fresh embryos during this cycle * speak and read english fluently * not planning to use concomitant energy work interventions (ht, reiki, qigong, acupuncture)during the ivf cycle.
laryngoscope asssited lightwand intubation

Conditions: Cervical Spine Surgery

Summary: to evaluate the success rate for intubation of laryngocope assisted lightwand intubation.

light wand intubation is well known for safety intubation in cervical injury patiets. traditional method of using light wand can damage the supraglottic cavity by scooping the apparatus. the investigators try to evaluate the efficacy of laryngoscope assisted light wand intubation compared to traditional method of using light wand alone.

Eligibility criteria:
inclusion criteria: * patient scheduled for cervical spine surgery under general anesthesia exclusion criteria: * congenital or acquired abnormalities of the upper airway, tumours, polyps, trauma, abscesses, inflammation, or foreign bodies in the upper airway * history of gastro-esophageal reflux disease, previous airway surgery, an increased risk of aspiration, coagulation disorders * american society of anesthesiologists physical status ≥ 3
monoclonal antibody treatment for non-hodgkin's lymphoma (low-grade)

Conditions: Non-Hodgkin's Lymphoma

Summary: epratuzumab is currently being studied in combination with rituximab, for the treatment of patients with low-grade nhl who failed previous chemotherapy and have never received rituximab or who received rituximab as a single agent or in combination with chemotherapy as their last treatment and who demonstrated a partial response or complete response for at least 12 months.


Eligibility criteria:
* diagnosis of relapsed or refractory low-grade, cd20+, b-cell nhl \* received and failed at least 1 prior regimen of chemotherapy \* rituximab-naive or received prior rituximab in their last treatment (single agent or in combination with chemotherapy) and demonstrated a time to progression of at least 12 months.
routine or selective stress testing after revascularization: rosstar trial rct outline

Conditions: Coronary Heart Disease; Coronary Artery Disease

Summary: the rosstar trial is a pragmatic trial that will directly compare the strategies of routine and selective stress imaging testing (with radionuclide imaging (rni)) late after pci or cabg in asymptomatic patients. the study will be a single center trial based at the jewish general hospital (jgh), a mcgill university teaching hospital (montreal, quebec). a total of 1100 patients who are either \>5 years post-cabg or \>2 years post-pci will be randomized. half of the patients will be randomized to a routine rni testing, and the other half to selective rni testing.

there is no consensus in current guidelines regarding the role of stress imaging testing late after revascularization. the issue to be resolved by the trial is whether routine stress imaging testing (stress test with nuclear perfusion imaging) benefits patients late after percutaneous coronary intervention (pci) or coronary artery bypass graft surgery (cabg). what are the principal research questions to be addressed? 1. is a strategy of routine stress imaging testing late after pci or cabg associated with lower clinical event rates than a strategy of selective stress imaging testing? 2. is a strategy of routine stress imaging testing late after pci or cabg associated with better quality of life than a strategy of selective stress imaging testing? 3. what are the resources utilization associated with routine vs. selective stress imaging testing? what is the primary hypothesis? the primary hypothesis is that routine stress imaging testing late after pci or cabg is associated with lower clinical event rates than a strategy of selective stress imaging testing.

Eligibility criteria:
inclusion criteria: * 1.patients who have undergone cabg or pci. * 2.cabg surgery occurred \>5 years and pci \>2 years prior to randomization. * 3.patients must have had at least one svg in the cabg group. * 4.patients are asymptomatic or have minimal chronic anginal symptoms. exclusion criteria: * 1.participation in a conflicting clinical study. * 2.rni testing already planned or performed within the past 12 months. * 3.unable to give informed consent. * 4.contraindications to or inability to perform exercise treadmill testing or pharmacological testing. * 5.medical condition with a prognosis of less than 3.25 years. * 6.likely to be unavailable for follow-up. * 7.unable to read and understand english or french.

Keywords: myocardial infarction physiological stress test nuclear image perfusion angioplasty coronary artery bypass graft percutaneous coronary intervention angina ischemia
backwards walking programme following hip and knee arthroplasty

Conditions: Hip Osteoarthritis; Knee Osteoarthritis; Hip Arthroplasty; Knee Arthroplasty

Summary: backwards walking has been shown to improve balance and walking in patients who have knee osteoarthritis. it is not known if these benefits may also be seen after surgery in patients who have had a hip or knee replacement because of osteoarthritis. this study will look to see if it is possible to conduct a bigger study into how effective backwards walking may be after joint replacement. patients who come to the nuffield orthopaedic centre in oxford for a hip or knee replacement will be invited. they will be placed into one of two groups at random: a group where they have a course of physiotherapy plus a backwards walking programme or a group where they have a course of physiotherapy. the physiotherapy will last for 12 weeks and those who take part will have two study assessments. the first will be before any treatment and patients will complete five measures and also be issued with a simple tick box diary to complete over the 12 weeks. the second assessment will be after the treatment and will involve the same five measures and the diaries will be collected in. participants at this assessment will also be asked if they would like to take part in an interview for the study. this is to see what the patients thought of the study. during the study the researcher will record things such as how many patients say 'yes' to the study and how many participants drop out of the treatment, to understand if a bigger study could take place.


Eligibility criteria:
inclusion criteria: * men and women aged 65 or older. * participant is willing and able to give informed consent for participation in the study. * participants who have received a primary unilateral hip or knee arthroplasty due to osteoarthritis. exclusion criteria: * post-operative weight bearing restrictions. * post-operative complications such as infection, a deep vein thrombosis or pulmonary embolism, or failure of the wound to heal. * inability to undertake a backwards walking programme due to conditions such as severe cardiovascular or pulmonary disease (new york heart association iii-iv). * severe dementia or communication difficulties that would prevent completion of study assessments. * any neurological condition. * further planned treatment on the same or contralateral hip or knee within the next 6 months. * registered as visually impaired.
efficacy of the modified free gingival graft technique

Conditions: Modified Free Gingival Graft , Connective Tissue Graft

Summary: gingival recessions can be defined as the exposure of the root surface after an apical migration of the gingival margin in relation to the cemento-enamel junction. gingival recessions affect both younger and older populations. various surveys revealed that 88% of people ≥65 years of age and 50% of people between 18 and 64 years of age have ≥1 site with gingival recession. gingival recessions can occur due to anatomical, pathological factors or trauma and will result in a loss of attachment.


Eligibility criteria:
inclusion criteria: * patients with at least two or less localized recession in mandibular incisors * cairo type 1 recession * patients who have good plaque control of less than 20% * patients between 18-64 years old exclusion criteria: * systemically compromised patients * smoker patients * pregnant women, breastfeeding or use of oral contraceptives * patients who are taking medication that may affect healing and coagulation * previous periodontal surgeries in the rg area * patients with periodontal disease * patients who have undergone chemotherapy and radiotherapy

Keywords: gingival recession surgical flaps connective tissue