Kornimate/medical-research-clean huggingface dataset:
phase 1 placebo-controlled, randomized trial of an adenoviral-vector based norovirus vaccine

Conditions: Norovirus Gastroenteritis

Summary: a phase 1, randomized, double-blind, placebo-controlled, dose-ranging trial to determine the safety and immunogenicity of an adenoviral-vector based norovirus vaccine (vxa-g1.1-nn) expressing gi.1 vp1 and dsrna adjuvant administered orally to healthy volunteers

the study will enroll 66 subjects in four cohorts. all subjects will receive a single administration of vxa-g1.1-nn at a low dose, a high dose or placebo. two sentinel groups will enroll 3 subjects each in an open-label manner (cohorts 1 and 3) to receive vxa-g1.1-nn prior to enrolling either of the randomized, controlled cohorts (cohorts 2 and 4). within the double-blinded cohorts (2 and 4), placebo subjects will receive the same number of tablets as the vaccine subjects in that cohort. subjects will be enrolled and dosed in the low dose groups prior to initiation of dosing in the high dose group. cohort 1: 3 subjects at low dose cohort 2: 20 subjects at low dose and 10 placebo cohort 3: 3 subjects at high dose cohort 4: 20 subjects at low dose and 10 placebo subjects will be followed for 28 days post vaccination for preliminary immunogenicity. subjects will continue to be followed for 1 year post-vaccination for long term safety.

Eligibility criteria:
inclusion criteria: 1. male or female volunteers aged 18 - 49 years, inclusive 2. able to give written informed consent 3. healthy (no clinically significant health concerns) 4. safety laboratory values within the following range criteria normal range 5. body mass index between 17 and 35 at screening exclusion criteria: 1. receipt of any investigational norovirus vaccine within two years prior to study 2. receipt of any investigational vaccine, drug or device within 8 weeks preceding vaccination 3. administration of any licensed vaccine within 30 days prior to study 4. presence of significant uncontrolled medical or psychiatric illness (acute or chronic) including institution of new medical/surgical treatment or significant dose alteration for uncontrolled symptoms or drug toxicity within 3 months of screening and reconfirmed at baseline 5. history of drug, alcohol or chemical abuse within 1 year prior to vaccination 6. presence of a fever ≥ 38oc measured orally at baseline 7. stool sample with occult blood at screening -
estramustine, docetaxel and zoledronate treatment in hormone-refractory adenocarcinoma of the prostate

Conditions: Hormone-Refractory Prostate Cancer

Summary: purpose: the aim of this clinical trail is to evaluate the effectiveness of zoledronate (zometa) combined with estramustine and docetaxel (taxotere) in the treatment of patients with hormone-refractory prostate cancer.

hormone refractory prostate cancer refers to advanced disease in which the patient no longer responds to conventional hormonal treatment. when hormone therapy is no longer successful, chemotherapy is a treatment option. however, current single-agent treatment has shown to have limited benefit. in this clinical trail, investigators are evaluating the effectiveness of zoledronate(zometa) combined with estramustine and docetaxel (taxotere) in the treatment of patients with hormone refractory prostate cancer. zometa is a bisphosphonate, and may reduce or delay skeletal complications caused by bone metastases. estramustine and taxotere are chemotherapy drugs that have shown activity in hormone refractory prostate cancer. eligible patients will be randomized to receive estramustine and docetaxel (taxotere) in combination with zometa or zometa given alone.

Eligibility criteria:
all patients must have a histologic diagnosis of hormone-refractory adenocarcinoma of the prostate, and hormone refractory disease must be demonstrated by the appearance of new lesions on bone or ct scan and/or a rising psa value. (no evidence of brain metastasis or untreated spinal cord compression.) patients on total androgen suppression therapy must undergo nonsteroidal antiandrogen withdrawal and demonstrate a rising psa 4 weeks after withdrawal from flutamide and 6 weeks after withdrawal from bicalutamide. patient must not be undergoing current chemotherapy, biologic therapy, other investigational or alternative anti-cancer directed therapy or radiation therapy. prior radiation therapy must have completed more than 4 weeks prior to registration. patients may not have received prior taxane-based cytotoxic chemotherapy for hormone refractory disease.

Keywords: zometa prostate cancer metastatic prostate cancer
repeatability of magnetic resonance imaging in patients with idh1 mutant glioma on ivosidenib

Conditions: Low Grade Glioma of Brain

Summary: the purpose of this study is to evaluate the repeatability of magnetic resonance imaging (mri) in patients with isocitrate dehydrogenase 1 (idh1) mutant (midh1) low-grade diffuse glioma \[world health organization (who) grade 2\] who are receiving off-label ivosidenib.

40 adult patients with histologically low-grade midh1 glioma (who grade 2) who are being seen at duke preston robert tisch brain tumor center (prtbtc) for treatment or evaluations, will be included in this protocol. patients included in this protocol must currently be receiving off-label ivosidenib per recommendation of their treating physician and must be scheduled to receive a routine contrast-enhanced brain magnetic resonance imaging (mri) scan as part of their clinical care. the images from the routine mri scan will be obtained as part of the patient's clinical care and will only be used in this research study if the patient agrees to be on-study by signing the informed consent form (icf). subjects will undergo a routine brain tumor imaging protocol mri scan with additional imaging sequences, in order to create a database of short interval "coffee break" repeat mri sets. subjects will begin their mri by having t1-pre, t2w, and volumetric 3d fluid attenuated inversion recovery (flair) images. the subject will be brought out of the magnet, sat up and then have the standard brain tumor imaging protocol mri scan performed. subjects will remain on this study for the one day during which they are scheduled to receive their mri scan

Eligibility criteria:
inclusion criteria: 1. written informed consent prior to beginning specific protocol procedures 2. scheduled for contrast-enhanced magnetic resonance imaging (mri) as part of clinical care 3. histologically idh1 mutant low-grade glioma (who grade 2) and actively receiving ivosidenib 4. active patient treatment or evaluations at the preston robert tisch brain tumor center at duke 5. age ≥18 years and ≤70 years 6. karnofsky performance index ≥70% 7. primary treating physician approval exclusion criteria: 1. inability to have mris

Keywords: idh1 mutant ivosidenib pro00116521 low grade glioma mri
expression of hypoxia-inducible factor-α in oral precancers and cancers

Conditions: Oral Cancer

Summary: expression of hypoxia-inducible factor-α in oral precancers and cancers

expression of hypoxia-inducible factor-α in oral precancers and cancers

Eligibility criteria:
inclusion criteria: * oral cancer specimens exclusion criteria: * not oral cancer specimens

Keywords: oral precancers oral cancer hypoxia-inducible factor
mgb/oagb and lsg effects on lower esophageal sphincter (les) function

Conditions: Morbid Obesity; Gastroesophageal Reflux; Bariatric Surgery Candidate

Summary: background while several articles have reported about the effects of laparoscopic sleeve gastrectomy (lsg) on the lower esophageal sphincter (les), to date, just one paper has discussed this issue with regard the mini/one anastomosis gastric bypass (mgb/oagb). this is expected to be the first randomized trial exploring and comparing these two interventions. setting "federico ii" university hospital, naples - italy. methods fifty morbid obese patients are going to be studied. all patients presenting with a normal preoperative les function will be randomly assigned to undergo lsg (arm 1 - 25 pts) or mgb (arm 2 - 25 pts). patients undergo clinical assessment for reflux symptoms, and esophago-gastro-duodenoscopy (egds) plus high-resolution impedance manometry (hrim) and 24-hour ph-impedance monitoring (mii-ph) before, two months and 1 year after both lsg or mgb/oagb. objective endpoint 1: does this surgery affect the les area function in both arm 1 or arm 2 patients determining a possible increase in gastroesophageal acid or non acid reflux? endpoint 2: does one between the two procedures outperform the other one in terms of eventual les area modifications? endpoint 3: in the case of a good performance of lsg or mgb/oagb or both the procedures, is this to be primarily related to surgery per se or to weight loss?


Eligibility criteria:
inclusion criteria: * 80 morbid obese patients are going to be studied. all patients presenting with a normal preoperative les function will be randomly assigned to undergo lsg (arm 1 - 40 pts) or mgb (arm 2 - 40 pts).- exclusion criteria: * patients lost at follow up. cancer patients at any stage.

Keywords: mini/one anastomosis gastric bypass sleeve gastrectomy gastro-esophageal sphincter function
distal radius fractures in adults: a multi-center study in south kivu

Conditions: Distal Radius Fracture

Summary: the goal of this observational study is to describe the epidemiological, radiological, therapeutic, and evolutionary characteristics of distal radius fractures in adults in the bukavu health district, south kivu, drc. . the main question it aims to answer is: • what are the epidemiological, radiological, therapeutic, and evolutionary characteristics of distal radius fractures in adults in south kivu, and how does intrafocal nailing influence outcomes such as consolidation time and complication rates in this population? participants who have already operated for distal radius fracture will be enrolled in this study.


Eligibility criteria:
inclusion criteria: * patients aged 17 years or older at the time of injury. * diagnosed with a distal radius fracture via clinical and radiological assessment. * admitted, treated, and followed up at one of the 16 participating institutions. * complete medical records available, including epidemiological, clinical, radiological, therapeutic, and outcome data. exclusion criteria: * patients under 17 years of age. * incomplete or missing medical records. * fractures not involving the distal radius. * patients transferred to non-participating facilities without follow-up data.

Keywords: distal radius fractures
gestation diabetes n'teractive media-based education (gdnme)

Conditions: Gestational Diabetes

Summary: this study is a prospective randomized controlled trial. subjects with newly diagnosed gestational diabetes will be randomized to either standard of care diabetes education versus standard of care plus an interactive educational application.

gestational diabetes is a condition diagnosed during pregnancy that causes blood sugars to rise. diet and exercise can effectively control blood sugar levels in 70-85% of women diagnosed with gestational diabetes according to the american diabetes association. at the investigator's institution, only 50-54% of women with this diagnosis effectively reach the target blood sugar levels with diet and exercise alone. this has become a more commonly seen problem throughout the us. those that fail to achieve target blood sugar levels require medication and have higher risks of poor maternal and neonatal outcomes. studies have shown that an increase in education can increase compliance to diet and education. specifically, media based education that are interactive may more effectively lead to changes in a person's behavior.

Eligibility criteria:
inclusion criteria: * obtaining prenatal care in the ambulatory care network (acn) * speaks either english or spanish * newly diagnosed with gestational diabetes between 24-32 weeks * will deliver at cuimc's main institutions, children's hospital of new york (chony) or the allen hospital. exclusion criteria: * diagnosed with a fetal anomaly * have multiple gestation * known diagnosis of pregestational diabetes

Keywords: media education gestational diabetes pregnancy
zeiss® iolmaster 700 corneal topography module comparison with schwind's sirius corneal topography®

Conditions: Cataract

Summary: in order to determine the intraocular lens to be implanted during cataract surgery, keratometry and axial length must be measured in preoperative. the axial length is obtained by ocular ultrasound mode b. keratometry is obtained by means of an automatic refractometer or corneal topography. currently, ultrasound scanners are being developed with a topography module to combine axial length and keratometry measurement. the investigators want to evaluate the corneal topography module of the zeiss® iol master 700 biometer.


Eligibility criteria:
inclusion criteria: * men and women requiring chv cataract surgery * aged 18 or over * insured under a social security scheme * having been informed of the clinical study and having given oral express consent exclusion criteria: * person unable to express consent * patient with a history of corneal dystrophy, corneal refractive surgery or keratoconus. * history of chronic corneal disease
comparison of psb and rifpb combination with psb and espb combination in cardiac surgery with sternotomy

Conditions: Post Operative Pain

Summary: the goal of this study is to compare the analgesic efficacy of the combination of psb and rifpb and the combination of psb and espb in patients undergoing cardiac surgery with sternotomy.

this study will consist of two randomized groups: group rifpb (n=12), group esp (n=12). all patients will receive standard general anesthesia. group rifpb patients will receive psb and rifpb with 0.25% bupivacaine (total volume 60 ml) bilaterally. group espb patients will receive psb and espb with 0.25% bupivacaine (total volume 60 ml) bilaterally. all blocks will be performed after induction of general anesthesia and before surgical incision. all patients in the study will be given 50 mg dexketoprofen and 1 g paracetamol intravenously (i.v.) 10 minutes before skin closure. within the first 24 hours after surgery, all patients will be given 3x1 g iv paracetamol and 2x50 mg dexketoprofen. numerical rating scale (nrs) will be used to assess postoperative pain at 1, 6, 12, 18 and 24 hours. all patients will receive morphine via a patient-controlled analgesia (pca) device within 24 hours of surgery. if pain score is ≥ 4 despite this protocol, 50 mg tramadol iv (maximum dose 300 mg/day) will be administered as rescue analgesia.

Eligibility criteria:
inclusion criteria: * adult patients over 18 years of age who will undergo cardiac surgery with sternotomy under general anesthesia and who are in classes i-iiiii according to the american society of anesthesiologists (asa) risk classification. exclusion criteria: * patients who did not give consent, * patients with coagulopathy, * patients with signs of infection at the block application site, * patients using anticoagulants, * patients with local anesthetic drug allergies, * patients with unstable hemodynamics, * patients who could not cooperate during postoperative pain assessment

Keywords: sternotomy cardiac surgery parasternal block recto-intercostal fascial plane block erector spinae plane block regional anesthesia postoperative pain
the inspire-lung study

Conditions: Lung Cancer

Summary: lungtalk and leveraging facebook-targeted advertisement (fbta) addresses the call to develop and test multi-level, cancer communication interventions using innovative methods and designs. the study's long term goal is to increase lung cancer screening uptake among appropriate, high-risk individuals nationwide.


Eligibility criteria:
inclusion criteria: * ≥20-pack-year smoking history; * individuals who currently smoke or quit smoking within the past 15 years exclusion criteria: * previously undergone ldct for early detection of lung cancer, have a lung nodule or nodules that are currently being followed * has ever been diagnosed with lung cancer * individuals with impaired decision-making (because our primary outcome is decision-making, we will not include individuals with impaired decision-making)

Keywords: lung cancer screening social media tailored interventions
novel diagnostics with optical coherence tomography: imaging the anterior eye

Conditions: Fuch's Dystrophy; Corneal Disorders; Prior Surgery

Summary: the purpose of this research is to evaluate the optical coherence tomography (oct), to image diseases of the eye. oct may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as fuch's dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes.

the purpose of this research is to evaluate the optical coherence tomography (oct), to image diseases of the eye. oct may be useful for the early diagnosis and monitoring of a variety of diseases involving the eye, such as fuch's dystrophy (type of eye disease) and retinal damage (eye diseases in the back of the eye) due to diabetes. oct may also be useful for assessing contact lens and surgical procedures, such as lasik (type of ophthalmic surgical procedure). the oct is food and drug administration (fda) approved. the ultra high oct is a non-significant risk device (it does not present a possible serious risk to your health, your safety, or your welfare) that has not been approved by the fda. this study will also be conducted at the massachusetts institute of technology and tufts-new england medical center new england eye center in massachusetts

Eligibility criteria:
inclusion criteria: female subjects who are pregnant or breastfeeding will be included (no risks to fetus). normals: normal appearing cornea, no history of corneal trauma, surgery or disease, no historical or current contact lens wear. thirty subjects from 6 different age groups (\> 18 yrs; 20-30 yrs; 30-40 yrs; 40-50 yrs; 50-60 yrs; \> 60 yrs) will be recruited to determine the normal variations in anterior eye structure. lasik patients: to participate as a lasik patient, the subject is previously normal but may have worn contact lenses, and is scheduled to undergo lasik. contact lens wearers: to participate as a contact lens wearer the patient otherwise fulfills all criteria specified for normalcy, with the exception of contact lens wear. fuchs' dystrophy patients: fuchs' dystrophy is characterized by guttata and clinically significant corneal edema, with a corneal thickness of \>700 microns, and/or reduced visual acuity in the morning which improves over the course of the day. diabetic patients: for diabetic patients are specified in the posterior segment imaging section. - exclusion criteria:subjects will be excluded from the study if their media are opaque, or if they are unwilling or unable to participate in the study. if participants choose they may also participate in other imaging research protocols. no risk is associated if entering multiple imaging protocols, while being a participant in this research study. -

Keywords: fuch's dystrophy corneal disorders cornea lasik refractive surgery
cost-effectiveness of a non-pharmacological treatment (active monitoring) vs. a pharmacological treatment for major depression in primary care.

Conditions: Mild to Moderate Depression.

Summary: major depression (md) is highly prevalent and has associated a high burden and economic costs. mild levels of md could be treated without antidepressants at primary care (pc). main objectives: 1) to calculate the cost-effectiveness of active monitoring (recommended by nice) vs pharmacological antidepressant treatment to treat mild md at pc level. methods: 300 patients (≥18 years) with md (diagnosed by the gp) will be recruited at the pc center. depending on the level of symptoms, the gp will choose between: a) active monitoring (n=150) and b) pharmacological treatment (n=150). patients will be followed-up for one year and data will be collected at baseline, 6 and 12 months. severity will be assessed by patient health questionnaire (phq-9), quality of life with the euroqol-5d (5 health dimensions), and the use of services with an adapted version of the client service receipt inventory (including lost productivity). cost-effectiveness and cost-utility analysis will be calculated and 5000 bootstrapping replications will be conducted to asses uncertainty. cost-acceptability curves will be done using two perspectives: the national health service perspective and the societal perspective. the propensity score technique will minimize the absence of randomization, matching cases from both treatment options.


Eligibility criteria:
inclusion criteria: 1. patients whose gp considers to have major depression. the indication of pharmacological or non-pharmacological treatment will be based strictly on the clinical judgment of the physician. 2. adults (≥18 years) 3. informed consent signed by the physician and the patient to participate in the study. exclusion criteria: 1. use of antidepressant drugs during the previous 60 days to inclusion date. 2. alcohol or other toxic abuse. 3. psychosis or bipolar disorder identified in the psychiatric interview 4. use in the last 6 months of antipsychotic drugs, lithium or antiepileptic 5. health status (pregnancy) and / or disease and / or treatments that contraindicate the use of antidepressant drugs. 6. terminal illness.

Keywords: depression primary care cost-effectiveness pharmacological treatment watchful-waiting or active monitoring.