Kornimate/medical-research-clean huggingface dataset:
the safety and efficacy of long-term treatment of pins stimulator system for patients with obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: the purpose of this clinical study is to verify the long term effectiveness and safety of a bilateral deep brain stimulation (dbs) produced by beijing pins medical co., ltd. as a treatment option for patients with cognitive, behavioral, and functional disability of obsessive-compulsive disorder.


Eligibility criteria:
inclusion criteria: 1. obsessive compulsive disorder (according to dsm iv-criteria) as the primary psychiatric diagnosis. 2. severity level of ocd more than 25 on the yale-brown obsessive compulsive scale. 3. course of illness had to have been present for at least five years in a chronic or progressive form despite any treatment trials (treatment resistance). 4. treatment resistance: at least two serotonin reuptake inhibitors (ssri´s), or one ssri and clomipramine in 5.sufficient dosages for at least 10 weeks, an augmentation trial with lithium, buspirone or a neuroleptic lasting at least 10 weeks, and complete cognitive-behavioral psychotherapy, including "exposure and response prevention" of a minimum of 20 sessions with a documented lack of efficiency. 6.the ability to give written and informed consent. exclusion criteria: 1. co-morbid psychotic disorder according to dsm-iv criteria 2. suicidal tendencies in the last 6 months 3. history of cerebral trauma 4. clinically relevant internal or neurological disorder 5. substance misuse or dependence in the last six months 6. ineligibility to fulfill the neurosurgical and anesthesiological preconditions for the implantation of a dbs 7. participate in other clinical trial 8. the investigator and/or enrollment review committee, would preclude participation in the study
phase i trial of anti-cd74 (hll1) antibody therapy in b cell malignancies

Conditions: Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia

Summary: previous experience with antibody therapy in both nhl and cll warrants further exploration of new antibody treatments for these diseases. immunomedics has developed hll1 (previously designated epb-1), which is a cdr-grafted, fully humanized monoclonal antibody specifically targeting cd74.38 the human igg1 backbone for hll1 is the same as hll2 (epratuzumab), a monoclonal antibody whose safety has been demonstrated in clinical trials of patients with b-cell malignancies and autoimmune disorders. this is a phase i, open-label, study conducted in patients with recurrent non-hodgkin's lymphoma (nhl) or chronic lymphocytic leukemia (cll) who have progressed after at least one prior standard treatment. all patients will receive hll1 administered intravenously once daily monday through friday of each of 2 consecutive weeks (10 total doses.) patients will be assigned to a cohort for hll1 treatment dose assignment (escalating doses of hll1 per statistical plan) in order to determine the maximum tolerated dose (mtd) for this administration schedule.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of recurrent b cell non-hodgkin's lymphoma or diagnosis of recurrent chronic lymphocytic leukemia * patient has received at least one prior treatment with standard chemotherapy and at least one prior treatment with rituximab (negative haha test required if received prior humanized antibody treatment) * patient has not received anti-cancer therapy within 28 days of treatment unless disease progression has been demonstrated and toxicities from prior therapy have resolved * available tumor tissue (lymph node/mass, blood or bone marrow) for correlative analyses (paraffin or frozen, recent or archived) * measurable disease as defined by a tumor mass \> 1.5 cm in one dimension or wbc \> 5,000 (cll patients) * age \> 18 years * patient has kps \> 50% * absolute granulocyte count \> 1000 cells/mm3 * platelet count \> 50,000 cells/mm3 * creatinine \< 2.0 x uln * total bilirubin \< 2.0 x uln * patient agrees to use birth control if of reproductive potential * patient has signed irb-approved informed consent exclusion criteria: * known central nervous system (cns) involvement by lymphoma * known hiv disease * patient is pregnant or nursing * patient is receiving other investigational drugs * known serum human anti-human antibodies (haha) * estimated life expectancy of \< 3 months
diagnostic accuracy of quantitative flow ratio

Conditions: Coronary Artery Disease

Summary: the aim of this study was to investigate the accuracy of quantitative flow ratio (qfr) for predicting fractional flow reserve (ffr) ≤0.80 in an independent core laboratory.

ffr is an invasive physiological index used to define coronary stenosis that causes ischemia. several studies have suggested that ffr-based percutaneous coronary intervention (pci) can reduce adverse clinical outcomes compared to angiography-guided pci. although ffr is highly recommended in current guidelines, it is underused in real-world practice. qfr is a method for evaluating fractional flow reserve ffr without the use of an invasive coronary pressure wire or pharmacological hyperemic agent. the aims of this study were: 1. to investigate diagnostic accuracy of angiography-based qfr for hemodynamic assessment of coronary artery stenosis compared to pressure wire-based ffr. 2. to compare the diagnostic performance of qfr versus % diameter stenosis (ds) in identifying physiologically significant coronary artery disease (cad) using ffr as the reference standard. 3. to identify factors affecting qfr accuracy. 4. to compare the coronary ct data with qfr.

Eligibility criteria:
inclusion criteria: * patients suspected with cad undergoing diagnostic coronary angiography with an indication for to perform invasive ffr exclusion criteria: * suboptimal angiographic image quality for qfr analysis * primary myocardial or valvular disease * left ventricular ejection fraction ≤40% * patients with cardiogenic shock
homologous recombination inquiry through ovarian malignancy investigations

Conditions: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Summary: to investigate the frequency and clinical significance of homologous recombination deficiency (hrd) in japanese patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer).

in this study, investigators plan to clarify the frequency of homologous recombination deficiency (hrd) in japanese patients with ovarian cancer (including fallopian tube cancer and primary peritoneal cancer). and investigators will also investigate whether hrd-positive ovarian cancer patients show the clinical characteristics of highly platinum-sensitivity and good prognosis, comparing to hrd-negative ovarian cancer patients. in addition, it is planned to investigate any association between progression free survival (pfs) / platinum-sensitivity and germline mutation in breast cancer susceptibility gene (brca1/2 gene) in ovarian cancer patients who can provide the patients' gbrca1/2 gene information for this study.

Eligibility criteria:
inclusion criteria: 1. patients who can approve informed consent and sign it. patients who show their will to participate in this study and can sign the informed consent forms by themselves. 2. patients who are clinically diagnosed as having ovarian cancer and can provide written informed consent before the surgery. 3. patients who can provide tumor tissue specimens. (except ascites cytology and cell block specimens) 4. patients who are 20 years old and over at the enrollment. 5. patients with ecog performance status (ps): 0-2. exclusion criteria: 1. patients with active concomitant malignancy\* except breast cancer. \*includes synchronous multiple cancer and metachronous multiple cancer with less than 5 years of disease free survival. however, excludes skin basal cell carcinoma, skin squamous cell carcinoma, and any other curable lesions with local therapy such as carcinoma in situ or intramucosal carcinoma. 2. patients who are diagnosed as any other acute/chronic, physically/mentally severe diseases and judged by the primary physician as inappropriate to enroll this study because of safety reasons or any influence to study outcomes. 3. any other cases that are inappropriate to enroll this study, judged by study principal investigator.

Keywords: ovarian cancer fallopian tube cancer primary peritoneal cancer germline breast cancer susceptibility gene (brca1/2 gene) homologous recombination deficiency (hrd)
a study of ly4170156 in participants with selected advanced solid tumors

Conditions: Ovarian Neoplasms; Endometrial Neoplasms; Uterine Cervical Neoplasms; Carcinoma, Non-Small-Cell Lung; Triple Negative Breast Neoplasms; Pancreatic Neoplasm; Colorectal Neoplasms

Summary: the purpose of this study is to find out whether the study drug, ly4170156, is safe, tolerable and effective in participants with advanced solid tumors. the study is conducted in two parts - phase ia (dose-escalation, dose-optimization) and phase ib (dose-expansion). the study will last up to approximately 4 years.


Eligibility criteria:
inclusion criteria: * have one of the following solid tumor cancers: * cohort a1: ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer, endometrial cancer, cervical cancer, non-small cell lung cancer (nsclc), triple-negative breast cancer (tnbc), pancreatic, and colorectal cancer (crc) * cohort a2/a3/a4/a5/b1/b2: ovarian (epithelial ovarian, primary peritoneal, and fallopian tube) cancer * cohort c1/c2: endometrial cancer, cervical cancer, nsclc, tnbc, crc or pancreatic cancer exclusion criteria: * individual with known or suspected uncontrolled central nervous system (cns) metastases * individual with history of carcinomatous meningitis * individual with active uncontrolled systemic bacterial, viral, fungal, or parasitic infection * individual with evidence of corneal keratopathy or history of corneal transplant * any serious unresolved toxicities from prior therapy * significant cardiovascular disease * prolongation of qt interval corrected for heart rate using fridericia's formula (qtcf) ≥ 470 milliseconds (ms) * history of pneumonitis/interstitial lung disease * individuals who are pregnant, breastfeeding or plan to breastfeed during study or within 30 days of last dose of study intervention

Keywords: folate receptor alpha nsclc ovarian cancer cervical cancer endometrial cancer solid tumor lung cancer breast cancer pancreatic cancer colorectal cancer anti-drug conjugate phase i chemotherapy
intraoperative fluorescent staining combined with microsurgery for gliomas

Conditions: Glioma

Summary: through the modified formulation of sodium fluorescein and methylene blue, the surface of the suspected cut edge of the patient's glioma was stained intraoperatively, and the surgical microscope image acquisition and processing system was used to determine whether the cut edge of the surgically resected tissue was positive or not. and combined with the existing multimodal surgical techniques (imaging, electrophysiology, neuronavigation and other equipment), the glioma is precisely resected.


Eligibility criteria:
inclusion criteria: 1. any gender, age 5-90 years old; 2. patients with a confirmed diagnosis of glioma (primary tumor or metastatic tumor) by imaging or biopsy; 3. patients who can tolerate the surgery by preoperative evaluation; the expected volume of tumor specimen to be resected intraoperatively is more than 1cm3; 4. subjects who voluntarily enroll in the study, sign the informed consent form, and have a good adherence to the study and cooperate with the follow-up visits; 5. patients with expected survival of not less than 12 months as judged by clinician; and 6. patients who are not in the clinical trial. the expected survival period, as judged by the clinician, is not less than 12 months. exclusion criteria: 1. serious or unstable diseases of the heart, lungs, kidneys and hematopoietic system that cannot tolerate surgery 2. pregnant or lactating women 3. other factors that, in the judgment of the investigator, could lead to termination of the study, such as other serious medical conditions or serious laboratory abnormalities or other family or social factors that would affect the safety of the subject or the collection of test data and samples.

Keywords: glioma
comparison of thromboembolic events in patients undergoing thromboprophylactic treatment with enoxa® vs lovenox®

Conditions: Gastrointestinal Neoplasms; Thromboembolic Event

Summary: prospective, monocentric, randomized, parallel group, rater-blinded study using two formulations of enoxaparin sodium (enoxa® vs lovenox®) to compare the thromboembolic events (symptomatic and asymptomatic) in patients undergoing gastrointestinal cancer surgery and thromboprophylactic treatment with either enoxaparin formulations. the study has a secondary focus as to evaluate the immunogenicity of the two formulations of enoxaparin through a subgroup analysis. study followup duration is up to 30 days post surgical procedure.


Eligibility criteria:
inclusion criteria: * male or female over 18 years * gastrointestinal (gi) cancer * elective or emergency surgery * preventive administration of enoxaparin sodium exclusion criteria: * patients participating in another study * unfractionated heparin (ufh) use up to 30 days prior to surgical procedure * renal failure with creatinine clearance \<30 ml / min * known history of peripheral venous thrombosis and/or deep venous thrombosis in the 3 months prior to inclusion * pregnant or breastfeeding women or women of childbearing age not using medically accepted contraceptive method * anticoagulant use in the 3 months prior to inclusion * patients with known haemostatic disorder * patients not consenting to participate in the study, or not capable of understanding its objectives

Keywords: enoxaparin immunogenicity
rehabilitation for improved cognition

Conditions: Exhaustion; Syndrome; Burnout Syndrome

Summary: many patients with exhaustion disorders continue to have significant difficulties with attention and memory function which reduce their work ability. this randomized study investigates whether the addition of a 12-week period of specific cognitive training or physical fitness training could further enhance cognitive function in patients with exhaustion disorder participating in a multimodal rehabilitation program.

this study was performed at the stress rehabilitation clinic at the university hospital of umeå. in total 161 patients with diagnosed exhaustion disorder were recruited consecutively to the study from march 2010 until june 2013. participants were all in age span 18-60 years old, had an ongoing employment and were assessed as suitable for a 24-week multimodal rehabilitation, which consisted of cognitive behavioural therapy in group (maximum eight persons), prescription of physical activity/exercise (far©) and vocational measures with rehabilitation meetings. a randomization by group was performed after 12 weeks of multimodal rehabilitation to one of three conditions; a/ continued multimodal rehabilitation, b/ addition of a computer-based cognitive training, and c/ addition of physical fitness training. the added training was performed during the last 12 weeks of rehabilitation (week 12 to 24) and with three weekly training occasions. primary endpoint was change in cognitive functioning, estimated as a global brain score. secondary endpoints were changes in different specific neuropsychological tasks, estimated psychological wellbeing, physical capacity, work ability, health-related quality of life and cost-effectiveness. a long-term follow-up was performed one year after termination of the interventions (at week 76).

Eligibility criteria:
inclusion criteria: * confirmed exhaustion disorder according to criteria established by the swedish national board of health and welfare * 18 - 60 years of age * current employment * considered suitable for multimodal rehabilitation in group exclusion criteria: * need of other treatment or rehabilitation * abuse of alcohol or drugs * participation in another intervention study
freedom: innovative strategy for the management of copd exacerbations

Conditions: Oxygen Deficiency; COPD Exacerbation

Summary: the main objective of the study is to assess the "freedom" innovative strategy (freeo2 at domicile) to reduce hospitalization duration in patients with copd exacerbation. this strategy associates early hospital discharge, automated o2 flow weaning with freeo2 system, telemedicine and tele-rehabilitation. the main hypothesis of this study is that the freedom strategy will reduce the number of hospitalization day by 50 percent at day 30.

the main objective of the study is to assess the "freedom" innovative strategy (freeo2 at domicile) to reduce hospitalization duration in patients with copd exacerbation. this strategy will enable an early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (freeo2 system) coupled to telemedicine and tele-rehabilitation. the main hypothesis of this study is that a strategy for an early return home with a home hospitalization managed by telemedicine will reduce the length of hospitalization by 50 percent from 30 days.

Eligibility criteria:
inclusion criteria: all patients hospitalized for copd exacerbation for less than 48 hours will be considered. * known or suspected copd to entry * age \> or = 40 years * ex-smoker history (10 pack / year or more) * acute exacerbation: dyspnea of recent onset (less than 15 days) * the need for oxygen therapy with a moderate rate: \ 90% (for oxygen dependent patient, the oxygen flow must be higher than flow at home) exclusion criteria: * refusal to consent to participate in the study, * indication for an imminent intubation according to the pulmonologist, * sleep apnea * niv used at home * lack of freeo2 system available at the time of randomization * non-autonomous and alone at home * patient alone at home * patients who live more than 50 km from the hospital * patient already included in the study within 3 months

Keywords: copd homecare oxygen telemedicine automated oxygen adjustment rehabilitation program
insulin glargine (lantus) vs sulfonylurea (su) for beta cell function (beta study)

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to compare long-term glycemic control and preservation of beta cell function when basal insulin or sulfonylurea is added on metformin in the early type 2 diabetes mellitus patients secondary objective: to assess the change of insulin resistance, microvascular complication incidence, patient satisfaction with treatment


Eligibility criteria:
list of inclusion and exclusion criteria: inclusion criteria: * type 2 diabetes mellitus patients on metformin monotherapy * 7% ≤ hba1c ≤ 12% * 20 kg/m² ≤bmi ≤ 35 kg/m² * diabetes duration: at least 6 months exclusion criteria: * type 1 diabetes mellitus patients * clinical evidence of active liver disease, or serum alanine aminotransferase 3 times the upper limit of the normal range * serum creatinine: 1.5 mg/dl for males, 1.4 mg/dl for females * acute and chronic metabolic acidosis, including diabetic ketoacidosis * history of alcohol or other substance abuse * pregnancy or not using contraceptive in childbearing aged women * known hypersensitivity to lantus, su or metformin * any disease or condition that in the opinion of the investigator may interfere with completion of the study the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
a new monitor to measure dermal blood flow in critically ill patients: a preliminary study

Conditions: Positive-Pressure Respiration, Intrinsic; Critically Ill Patients

Summary: background: conditions of reduced perfusion are characterized by redistribution of blood flow away from the skin to more vital organs. study objectives: to assess the efficacy of a non-invasive, dermal blood flow (dbf) monitor in detecting changes in perfusion in critically ill patients. preliminary study study population: critically ill patients in a general icu

dbf, finger plethysmography and invasive mean arterial pressure (map) were recorded over an 8-hour period. dbf was measured using the i.s. medtech dbf monitor, based on the hot-wire principle of thermal balance of a heater cooled by a moving medium, via a skin probe placed on the anterior chest wall. sensitivity was evaluated by visual inspection during active states, either induced, e.g. fluid administration, or spontaneous, e.g. altered hemodynamics. specificity was evaluated during stable states (minimal fluctuations of map and no active interventions applied or required). data are expressed in terms of standard deviation (sd) and of the difference (sdd) between the map and each of the tested methods.

Eligibility criteria:
inclusion criteria: * all patients were ventilated and sedated during an 8-hour period of measurement exclusion criteria: * age \< 18 years old

Keywords: dermal blood flow critically ill
relations between residual renal function and oxidative and carbonyl stress in peritoneal dialysis patients

Conditions: Chronic Renal Failure

Summary: residual renal function is reported to contribute to the survival and cardiovascular disease of peritoneal dialysis patients. oxidative and carbonyl stress are increased in peritoneal dialysis patients and are associated with cardiovascular risk. the aim of this study was to determine the relations between residual renal function and oxidative and carbonyl stress in peritoneal dialysis patients.


Eligibility criteria:
inclusion criteria: * chronic renal failure on peritoneal dialysis exclusion criteria: * malignancy, peritonitis

Keywords: residual renal function oxidative stress carbonyl stress peritoneal dialysis
overfeeding induced fat-tissue stimulation

Conditions: Lipid-induced Insulin Resistance

Summary: type 2 diabetes is the most common metabolic disease worldwide, characterized by hyperglycemia, decreased whole body insulin sensitivity, and white adipose tissue (wat) dysfunction. a key factor in its development is chronic overnutrition, usually with a high-fat diet (hfd), leading to disturbances of glucose and lipid metabolism. however, the mechanism of short-term hfd-induced tissue-specific insulin resistance remains poorly understood. this project aims to further unravel the underlying mechanisms of short-term hfd overnutrition-mediated wat insulin resistance. the model described here corresponds to a randomized, single- blinded parallel-grouped trial, consisting of two interventions: a macronutrient-balanced diet and or a hypercaloric diet over three weeks in order to investigate differences in interorgan fatty acid and glucose metabolism between the studied groups. based on recent studies, the hypothesis is that 21-day hypercaloric hfd induces wat insulin resistance via a diacylglycerol, novel protein kinase c-insulin receptor signaling model in both fasting and insulin-stimulated states.


Eligibility criteria:
inclusion criteria: * age between 18 and 40 years * bmi \< 29 kg/m2 * sport inactive (\<1x /week) * capacity to consent exclusion criteria: * diabetes mellitus disease * acute coronary heart syndrome (myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack in the last 3 months before study participation) * acute infectious disease * taking blood glucose-lowering drugs * diseases or drugs affecting the immune system and allergies to drugs used in the study * drugs with potential metabolic effects * chronic liver disease (hepatitis, gallbladder disease, elevated liver enzymes (alt \> 300 u/l)) * chronic inflammatory bowel diseases * rheumatic diseases * hyper- or hypothyroidism of the thyroid gland * renal insufficiency, administration of iodine-containing contrast media in the last 2 days * chronic lung diseases * cancerous diseases * addictive diseases, psychiatric diseases * pregnancy, breastfeeding * shift workers * anemia (hb \<12 g/dl) * disorders of hemostasis * regular use of antithrombotic drugs * alcohol consumption, smoking * conditions that do not permit an mri examination