Kornimate/medical-research-clean huggingface dataset:
notch inhibitor in advanced cancer

Conditions: Advanced Cancer

Summary: the objective of this phase 1 study is to evaluate the safety and tolerability of notch inhibitor in participants with advanced cancer. this study includes dose escalation and dose confirmation components.


Eligibility criteria:
inclusion criteria: * the participants must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have ceased to provide clinical benefit for their disease. * the participants must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced and/or metastatic. * have adequate organ function including: * hematologic: absolute neutrophil count (anc) ≥1.5 x 10⁹/liter (l), platelets ≥100 x 10⁹/l, and hemoglobin ≥8 grams/deciliter (g/dl). * hepatic: bilirubin ≤1.5 times upper limits of normal (uln) and alanine aminotransferase (alt) ≤3.0 times uln. * renal: serum creatinine ≤1.5 times uln. * have a performance status less than or equal to 1 for dose escalation and less than or equal to 2 for dose confirmation on the eastern cooperative oncology group (ecog) scale. * have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug, and recovered from the acute effects of therapy (treatment-related toxicity resolved to baseline) except for residual alopecia. * males and females with reproductive potential must agree to use medically approved contraceptive precautions during the trial and for 3 months following the last dose of study drug. * females with childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of study drug. exclusion criteria: * have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively. * have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study (for example, inflammatory bowel disease or history of major surgical resection involving the stomach or small bowel). * have malabsorptive syndromes, enteropathies, gastroenteritis (acute or chronic), or diarrhea (acute or chronic). * females who are pregnant or lactating. * have central nervous system (cns) malignancy or metastasis. * have an acute leukemia. * have active bacterial, fungal and/or known viral infection.

Keywords: metastatic cancer solid tumors
evaluation of impact of nitrous oxide on ponv in breast surgeries

Conditions: Breast Cancer

Summary: postoperative nausea and vomiting (ponv) is considered one of the most unpleasant postoperative discomforts and lead to serious complications of aspiration of gastric contents, suture dehiscence, esophageal rupture, subcutaneous emphysema, or pneumothorax. the incidence of ponv is 30-40% in normal population and touches a peak of 75-80% in certain high-risk groups. ponv is associated with delayed recovery and prolonged hospital stay and is associated with significant morbidity. it may also result in delayed discharge, which is particularly significant after potentially ambulatory surgery. women are 2 to 3 times more susceptible to ponv than men and breast surgery, which is primarily done in an outpatient setting, is associated with high incidence of ponv, ranging between 15% and 84% in the absence of prophylactic treatment. nitrous oxide (n2o) has analgesic and sedative properties but may potentially increase the incidence of ponv. n2o might increase the incidence of ponv by several potential mechanisms: (1) increase in middle ear pressure (2) bowel distension, (3) activation of the dopaminergic system in the chemoreceptor trigger zone and (4) interaction with opioid receptors. n2o has been demonstrated to increase the incidence of ponv in some studies but not in others. the present study is undertaken to evaluate the effect of nitrous oxide- free general anesthesia on the undesirable clinical outcome of ponv.


Eligibility criteria:
inclusion criteria: 1. asa i and ii female patients aged 18 years or over posted for breast surgeries under general anesthesia in the main operating rooms exclusion criteria: 1. asa iii, iv, v female patients 2. age less than 18 years 3. patients undergoing breast reconstructive surgery 4. patients with contraindications to fentanyl, diclofenac, paracetamol, atracurium 5. chronic pain patients on long-term opioid medication 6. use of regional anesthetic technique (e.g. paravertebral block)
short post-surgical antibiotic therapy in spine infections - a prospective, randomized, unblinded, non-inferiority trial

Conditions: Infection

Summary: we implement a prospective, randomized, unblinded, non-inferiority trial regarding the duration of systemic, targeted antibiotic therapy after the first surgical debridement for spine infection; randomizing 1:1 between 1. six and twelve weeks of antibiotic therapy if there is an implant left in place 2. three and six weeks of antibiotic therapy if there is no implant left


Eligibility criteria:
inclusion criteria: * spine surgery and intraoperative debridement with any technique * at least 12 months of scheduled follow-up from hospitalization * bacterial spine infection of any nature, independently of implants or co-morbidities exclusion criteria: * mycobacterial, fungal, nocardial, and actinomyces infections in the spine * non-resected cancer in the infection site * bone marrow or recent solid organ transplant patient (recent: \<5 years) * any other infection in the patient requiring more than 6 weeks of antibiotic therapy * more than three intraoperative debridements performed for spine infection * absence of at least one surgical intraoperative debridement of infection
effect and efficacy of xpedition™/alpine™, everolimus-eluting stent for coronary atherosclerosis

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; Acute Coronary Syndrome; Angina Pectoris

Summary: the objectives of this study are 1. to establish a prospective registry of the whole patients who received percutaneous coronary intervention with xience xpedition™/alpine™ stent 2. to evaulate the long-term efficacy and safety of coronary stenting with the xience xpedition™/alpine™ stent 3. to compare the long-term efficacy and safety of coronary stenting between the xience xpedition™/alpine ™ stent and other contemporary drug-eluting stents which had established their own registry

secondary endpoints of this study are stent thrombosis-24 hours(acute), 30 days(subacute), 1 year(late), every 1 year till 3 years(very-late) after index pci target vessl failure composite rate of cardiac death and any mi, 3 years composite rate of all death and any mi composite rate of all death, any mi, and any repeat revascularization compliance and therapy interruptions with prescribed adjunctive antiplatelet therapy

Eligibility criteria:
inclusion criteria: * the patient agrees to participate in this study by signing the informed consent form. alternatively, a legally authorized patient representative may agree to the patient's participation in this study and sign the informed consent form exclusion criteria: * there are no exclusion criteria for this registry.

Keywords: coronary artery disease percutaneous coronary intervention everolimus-eluting stents
study of vx-809 in cystic fibrosis subjects with the ∆f508-cftr gene mutation

Conditions: Cystic Fibrosis

Summary: the primary objective of the study was to evaluate the safety and tolerability of vx-809 in participants with cystic fibrosis (cf) who are homozygous for the f508del mutation on the cf transmembrane conductance regulator (cftr) gene.

this was a phase 2, randomized, double-blind, placebo-controlled, multiple-dose study of orally-administered vx-809 in participants with cf who are homozygous for the specific cftr mutation known as ∆f508 or f508del. enrollment was planned for 90 participants at approximately 20 centers. participants were planned to be randomized in a 4:1 ratio to receive 1 of 4 doses of vx-809 or placebo once a day for 28 days in a parallel design. participants were outpatients during the study, except for overnight stays on day 1 and 28.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cf with ∆f508-cftr mutation in both alleles * forced expiratory volume in 1 second (fev1) greater than or equal to (\>=) 40 percent (%) of predicted normal for age, gender, and height * weight \>=40 kilograms (kg) and body mass index greater than or equal to 18.5 kilogram per square meter (kg/m\^2) * screening laboratory values, tests, and physical examination within acceptable ranges * negative pregnancy test (for women of child-bearing potential) * able and willing to follow contraceptive requirements * willing to remain on a stable medication regimen for the duration of study participation exclusion criteria: * history of any illness, or any ongoing acute illness, that could impact the safety of the study participant or may confound results of study * pulmonary exacerbation or changes in therapy for pulmonary disease within 14 days before receiving the first dose of study drug * impaired hepatic or renal function * history of organ or hematological transplant

Keywords: ∆f508 f508del cystic fibrosis transmembrane conductance regulator cftr pancreatic diseases lung diseases genetic disease, inborn infant, newborn, diseases
outcome study of the pipeline embolization device with vantage technology in unruptured aneurysms

Conditions: Brain Aneurysm; Intracranial Hemorrhages; Stroke

Summary: in this project the investigators study the safety and efficacy of the pipeline embolization device with vantage technology in treatment of unruptured brain aneurysms


Eligibility criteria:
inclusion criteria: * all patients treated with pipeline embolization device with vantage technology (pedv) * mra and/or dsa (or tomographic angiography) available for follow up exclusion criteria: * insufficient background data available e.g., to determine size of aneurysm and pipeline device * pedv used for causes other than aneurysms, e.g., fistulas and dissection.
a study to assess effectiveness and efficiency of vns therapy in patients with difficult to treat depression.

Conditions: Treatment Resistant Depression

Summary: the primary objective of this study is to assess short, mid and long-term clinical outcomes in patients with difficult to treat depression (such as patients with treatment resistant depression) treated with vagus nerve stimulation (vns) therapy as adjunctive therapy.

the population under study comprises a real-world patient population with difficult to treat depression: patients diagnosed with unipolar or bipolar disorder with chronic or recurrent depression who fail to achieve an adequate response to standard psychiatric management. the diagnosis of depression and comorbid disorders will be determined based on the mini international neuropsychiatric interview (mini). a minimum of five hundred (500) patients will be implanted with a vns therapy system and up to eighty (80) sites may participate in this study. enrollment will take 8 years, based on competitive enrollment. for each subject a baseline visit will occur between 1 and 6 weeks before implant. once implanted with the device, subjects will be followed-up for a minimum of 36 months and a maximum of 60 months. the study may stop when the last subject has reached the 36 months follow-up.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age. * have a documented primary diagnosis of chronic (\>2 years) or recurrent (2 or more prior episodes) major depressive episode that has not adequately responded to an adequate number of antidepressant treatments, as per local medical standards. this diagnosis must be confirmed using the mini. * provide written ethics committee (ec) or institutional review board (irb) approved informed consent and health insurance portability and accountability act (hipaa, us only) authorization (as applicable according to local requirements). * currently is receiving at least one antidepressant treatment (i.e., antidepressant drug, maintenance electroconvulsive therapy, or formal psychotherapy including supportive psychotherapy) or mood stabilizing treatment for bipolar patients (such as lithium, anticonvulsants, or atypical antipsychotics). * able and willing to comply with the frequency of (outpatient) clinic visits and to reliably complete all the evaluations as specified in the study protocol.hence based on the nature of their disease, the following patients should not be included: patients with mental retardation, current severe or significant substance/alcohol abuse, diagnosis of one or more schizophrenia-spectrum or other psychotic disorders, diagnosis of borderline or severe personality disorder as determined by clinical judgment which, in the investigator's opinion, would significantly interfere with subject's participation in the study) exclusion criteria: there are no exclusion criteria; the investigator should refer to the (local applicable) vns therapy physician's manual.

Keywords: difficult to treat depression trd vns therapy vagus nerve stimulation vns
efficacy and safety of danoprevir/r + pr 12-week triple therapy in treatment-naive, non-cirrhotic, g1 chc china ii

Conditions: Chronic Hepatitis C

Summary: the purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of ritonavir-boosted danoprevir (asc08) in combination with peg-ifn and rbv in treatment-naive non-cirrhotic patients who have chronic hepatitis genotype 1.


Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent * chronic hcv infection (≥ 6 months) ; * positive hcv antibody * serum hcv rna of ≥ 1 × 104 iu/ml * hepatitis c virus gt1 * never received prior-treatment for hcv with interferon, rbv, or other direct-acting or host-targeting antivirals for hcv * the liver biopsy methods in the protocol (non-cirrhosis is defined as: metavir score ˂ 4), or as determined by fibroscan defined as: ˂ 14.6 kpa. patients who have not obtained a liver biopsy or fibroscan in the last 1 years will have a study related fibroscan performed in order to confirm the diagnosis * others as specified in the detailed protocol exclusion criteria: * patients with fibroscan detection value \> 12.9 kpa, or histologic examination for liver cirrhosis patients * presence or history of non-hepatitis c chronic liver disease, including but not limited to, autoimmune hepatitis, α-1-antitrypsin deficiency, c282y homozygous hemochromatosis, wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, and porphyria cutanea tarda causing liver pathology or requiring phlebotomy * patients with a history of liver cell cancer, screening before or screening suspected hepatocellular carcinoma (hcc) patients, or imaging studies found suspicious nodules, or afp \> 50 ng/ml * positive hepatitis a antibody，positive hepatitis b surface antigen，syphilis antibody or hiv antibody at screening * others as specified in the detailed protocol

Keywords: danoprevir svr12 chinese hcv g1 non-cirrhotic
meditoxin® treatment in patients with post stroke upper limb spasticity

Conditions: Muscle Spasticity

Summary: botulinum toxin for the treatment of post stroke upper limb spasticity.

this study is "a multicenter, prospective, randomized, evaluator blinded, comparing phase 4 study to evaluate the impact of injection techniques on the effectiveness of botulinum toxin for the treatment of post stroke upper limb spasticity".

Eligibility criteria:
inclusion criteria: 1. male or female subject aged over 20. 2. subjects who has grade 1 + and more spasticity at least one of upper limb muscles as measured on modified ashworth scale after stroke. 3. subjects who was diagnosed stroke at least 1 month prior to study participation. 4. subjects or legal representatives who voluntarily decided the participation of the study and signed the informed consent. exclusion criteria: 1. subjects who had spinal injuries to be a factor of spasticity except for stroke prior to study enrollment. 2. subjects with allergy or hypersensitivity to the botulinum toxin. 3. subjects who have changed the muscle relaxant taking for treatment within past 4 weeks prior to study participation. 4. subjects who have taken injection treatments using alcohol or phenol in upper limb within past 6 months prior to study participation. 5. subjects with general neuromuscular synaptic disorder(e.g. myasthenia gravis, lambert-eaton syndrome, amyotrophic lateral sclerosis). 6. subjects who have been injected with botulinum toxin within past 3 months before the injection. 7. subjects who are pregnant or lactating of disagreed to avoid pregnancy during 3 months study period. 8. subjects who are scheduled to take part in other clinical trial during the study period. 9. patients who are not eligible for this study at the medical discretion of the investigator.

Keywords: botulinum toxin spasticity injection technique neuronox meditoxin
can brief high-intensity interval training mitigate the adverse consequences of high-fat overfeeding?

Conditions: Insulin Resistance

Summary: previous research has shown that indulging in 50% more calories than required for as little as 3 days can significantly impact markers of metabolic health in lean and overweight individuals. here, the investigators will determine if 3 brief sessions of high-intensity interval training can mitigate the adverse consequences of 7 days high-fat overfeeding in sedentary, overweight males.


Eligibility criteria:
inclusion criteria: * sedentary (no more than 2 sessions of structured moderate intensity aerobic exercise or resistance training per week) * overweight (bmi 25-29.9 kg/m2) exclusion criteria: * personal history of any major illness (i.e. cardiovascular disease, diabetes, hypertension, cancer, renal/liver impairments, major psychiatric disorders, eating disorders etc.) * history of chest pain (either at rest or during exercise.) * abnormal resting ecg at screening visit * chronic use of any prescribed or non-prescribed medications (i.e. anti-hypertensive, statins, metformin, anti-inflammatories, antidepressants etc.) * blood pressure or blood lipids outside of reference ranges * serum ferritin \<30ng/ml * uncontrolled asthma, current fever, or upper respiratory infection * current intake of \> 140g alcohol/week * current smokers of cigarettes/cigars/marijuana * current intake of any illicit substance * experience claustrophobia in confined spaces * donated blood in the past 3 months * migraines * unable to comprehend study protocol * unable to perform exercise on a cycle ergometer at second screening visit
improving survival for metastatic lobular breast cancer (plumb registry)

Conditions: Metastatic Breast Cancer; Lobular Breast Carcinoma

Summary: this is a prospective observational registry for patients with invasive lobular carcinoma (ilc) of the breast. after the first 1cohort is enrolled, the collected data will be utilized to develop an ilc specific response assessment tool.

primary aims: 1. to evaluate the feasibility of developing a histologic based registry for participants living with metastatic lobular breast cancer. 2. to understand the natural history, treatment patterns, and overall survival in patients with metastatic ilc using modern, real-world data. secondary aims: 1. to evaluate the correlation between imaging findings and disease progression. 2. to evaluate the correlation between ctdna and disease progression. 3. to develop an ongoing platform for evaluating new imaging tools, tumor markers, and participant recruitment for clinical trials. outline: participants will be recruited to participate in the registry during a regularly scheduled clinic visit with their treating oncologist, and consented to participate at this time. at each evaluation time point, participants will have a blood draw performed. participants will be followed until loss to follow up, death, or withdrawal from the registry.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed invasive lobular carcinoma. mixed lobular/ductal cancer is allowed. 2. age \>=18 years 3. any receptor subtype. 4. ability to understand a written informed consent document, and the willingness to sign it. exclusion criteria: 1. stage i-iii breast cancer. 2. lack of lobular histology on tumor biopsy. 3. other active cancer (prior treated cancer with no current evidence of disease is allowed).
nutritional status of cerebral palsy patients in turkey

Conditions: Nutritional Status

Summary: this is a single visit, non-interventional, cross sectional study about risk factors, etiology, nutritional status and feeding methods in cp patients.


Eligibility criteria:
inclusion criteria: * subject is greater than/equal to 12 months and less than 19 years of age. * subject is diagnosed with cerebral palsy (cp) by a physician. exclusion criteria: * subject presents with genopathies, cardiopathies, hypothyroidism or any pathology not related to cp. * subject is diagnosed with cp of postnatal origin. * subject has other concomitant diagnoses.
metformin in patients with ulcerative colitis treated with mesalamine

Conditions: Inflammatory Bowel Diseases

Summary: ulcerative colitis (uc) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however, the exact underlying mechanisms of uc remain poorly understood.uc is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to genetic, immune and environmental factors.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * both males and females will be included * negative pregnancy test and effective contraception exclusion criteria: * • * breast feeding * significant liver and kidney function abnormalities * diabetic patients * colorectal cancer patients * patients with severe uc * patients taking rectal or systemic steroids * patients taking immunosuppressives or biological therapies * addiction to alcohol and / or drugs * known allergy to the studied medications
vistakon investigational lens worn as a single use daily wear

Conditions: Myopia

Summary: this study is intended to show that the investigational contact lens is clinically equivalent to a currently approved contact lens, when worn as single-use on a daily basis.


Eligibility criteria:
inclusion criteria: * eyes must be best-corrected to a visual acuity of 20/30 or better in each eye * must be able and willing to wear soft contact lenses on a single use, daily wear basis for the duration of the study * distance spherical contact lens prescription must be within the range available for the study exclusion criteria: * systemic diseases which may interfere with contact lens wear * ocular infection or clinically significant ocular disease * any previous intraocular surgery * grade 2 or greater slit lamp findings * currently pregnant or lactating * more than 1.00d of refractive astigmatism in either eye
reinforcing therapist performance

Conditions: Substance Use

Summary: the specific aims of the proposed study are to evaluate the effectiveness and cost-effectiveness of providing monetary incentives to therapists as a method to improve implementation of evidence-based treatments.


Eligibility criteria:
inclusion criteria: * must work at one of the participating demonstration sites funded by the center for substance abuse treatment to deliver the adolescent community reinforcement approach and/or assertive continuing care.