Kornimate/medical-research-clean huggingface dataset:
effect of a low-calorie and high-protein diet specially rich in animal protein compared to a low-calorie and high-protein diet specially rich in plant protein on glucose metabolism in subjects with prediabetes or type 2 diabetes and overweight or obesity.

Conditions: Diabetes Mellitus, Type 2; Overweight and Obesity; PreDiabetes

Summary: the aim of the study is to explore the effect of a low-calorie diet rich in protein (with a content of 35% of the total calories of the diet), mostly coming from animal sources (75% of total protein), compared to a hypocaloric diet rich in protein (with a content of 35% of the total calories of the diet), mostly coming from plant sources (75% of total proteins), in subjects with prediabetes or type 2 diabetes and overweight or obesity, on body composition, glucose and lipid metabolisms, after 6 months of intervention. to achieve the objective, a nutritional intervention study is carried out by randomizing participants to: a) a hypocaloric and high-protein diet (35% of total calories), mostly of them coming from animal sources (75% of total protein); b) a hypocaloric and high-protein diet (35% of total calories), mostly of them coming from plant sources (75% of total protein). the study has a total duration of 6 months and include the assessment of clinical, anthropometric, biochemical and lifestyle parameters, at the beginning of the study and after 3 and 6 months of intervention.


Eligibility criteria:
inclusion criteria: * aged between 18 and 80. * bmi between 27.5 kg/m2 and 40 kg/m2. * diagnosed as prediabetes or type 2 diabetes according to ada criteria. * informed consent to be signed. exclusion criteria: * taking antidiabetic drugs (except for metformin with stable dose in the previous 6 months). * taking lipid-lowering drugs in unstable dose in the previous 2 months. * taking functional foods (i.e. sterols enriched food) or any other dietary supplement with a significant effect on lipid and glucose metabolism and body weight. * uncontrolled type 2 diabetes (i.e. glycated hemoglobin over 8%) * any disease that could affect study results (i.e. uncontrolled hypothyroidism). * alcohol intake over 30 g/day. * pregnancy or breastfeeding. * any other condition that investigators consider that could interfere with study outcomes.
feasibility of ayurveda in patients with mild-to-moderate covid-19: a community-based participatory research

Conditions: Covid19

Summary: innovative strategies are required to manage covid-19 in the communities. back to roots community based project was a collaborative, pilot intervention program in british asian community to assess the efficacy and safety of ayurveda intervention in relieving symptoms of mild-to-moderate covid-19.


Eligibility criteria:
inclusion criteria: * with sars-cov-2 infection confirmed through reverse transcription followed by polymerase chain reaction (rt- pcr), * with mild or moderate manifestations of covid-19 * willing to participate, and consent by signing the informed consent and * not involved in another clinical trial during the study exclusion criteria: * patients suffering from severe covid-19 disease as per world health organisation criteria (ref) * any of the known covid-19 complications and emergency procedures which may require shift/admission in hospital for oxygen support or intensive care unit * patients with ongoing immunosuppressive therapy for any reasons * active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy. * pregnancy and lactation * ayurveda practitioner decision that involvement in the study is not in the patient's best interest

Keywords: ayurveda intervention, community based participatory research
syncardia freedom driver system study

Conditions: Biventricular Failure

Summary: the purposes of this study are to confirm that the freedom driver system is a suitable pneumatic driver for clinically stable tah-t subjects, and that patients and lay caregivers can be trained to manage the freedom driver system safely outside the hospital.


Eligibility criteria:
inclusion criteria: * patients who are implanted with the tah-t and are clinically stable. exclusion criteria: * patients who are implanted with the tah-t and are not clinically stable.

Keywords: biventricular failure
effects of resveratrol on endothelial function in type 2 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: the present study is designed to test the hypothesis that resveratrol supplementation will improve the function of the endothelium in patients with type 2 diabetes mellitus. the function of the endothelium will be tested with a non-invasive technique that uses ultrasound to measure the amount of dilation that occurs in the brachial artery following 5-minute cuff occlusion. to help us understand potential mechanisms of benefit, we will also collect blood, urine, and cell samples and test the effects of treatment on protein expression, nitric oxide production, and function of mitochondria.


Eligibility criteria:
inclusion criteria: * male and female subjects * age over 21 years old * body mass index less than 38 kg/m2 * clinical stable type 2 diabetes mellitus exclusion criteria: * women who are lactating or pregnant * treatment with an investigations product within 30 days of screening * clinically evident major illness of other organ systems, including cancer, renal failure, or other conditions in the opinion of the investigators that would make clinical study inappropriate * liver transaminase levels greater than 3 times the upper limit of normal * history of psychological illness or condition that would interfere with the subject's ability to understand the requirements of the study * vitamin supplements exceeding two times the recommended daily allowance * resveratrol or other dietary supplements except for a daily multivitamin

Keywords: endothelium mitochondria reactive oxygen species vascular biology arterial stiffness nitric oxide
safety study of an oral vaccine to prevent avian influenza

Conditions: Avian Influenza; Bird Flu

Summary: the purpose of this study is to demonstrate the safety and immunogenicity of an oral vaccine to prevent avian influenza. volunteers will receive either one or two doses of research vaccine or placebo as part of this study.


Eligibility criteria:
inclusion criteria: * in good health as established by medical history, physical examination and laboratory testing at the time of enrollment. exclusion criteria: * has had any other vaccines within the past 8 weeks. * has had prior h5 avian influenza investigational vaccine. * current history of chronic alcohol consumption and/or illicit and/or recreational drug use. * history of autoimmune related disease. * history of any confirmed or suspected immunodeficient or immunosuppressive condition (no congenital or acquired condition that impedes normal immune response, no concurrent immunosuppressive therapy). * positive serology for hiv, hcv, or hbv. * previous serious reactions to vaccination such as anaphylaxis, respiratory problems, hives or abdominal pain. * history of irritable bowel disease or other inflammatory digestive or gastrointestinal conditions that could affect the intended distribution or safety evaluation of an orally administered vaccine targeting the mucosa of the small intestine. * use of proton pump inhibitors (nexium, prilosec) that substantially increases stomach ph. * stool sample with occult blood at baseline exam

Keywords: influenza pandemic avian influenza h5n1 flu
study to assess the safety and effectiveness of beltavac® polymerized with house dust mites

Conditions: Rhinoconjunctivitis With or Without Allergic Asthma

Summary: non-interventional study to assess the safety and effectiveness profile of a scit therapy with beltavac® polymerised with house dust mite in pediatric allergic patients

this prospective open multi-center non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with beltavac polymerized with house dust mite pediatric allergic patients in routine medical care. patients receive a rush schedule administration every month for a year. they attend at least 5 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.

Eligibility criteria:
inclusion criteria: * patients from 3 to 11 years suffering from a clinically relevant dermatophagoides farinae and dermatophagoides pteronyssinus induced allergic rhinitis or rhinoconjunctivitis associated with or not with asthma * positive skin testing * positive serum-specific ige determination * parental or legal representative informed consent * clinical sintomatology on the inclusion period exclusion criteria: * patients suffering from acute or chronic infections or inflammations * patients suffering from uncontrolled and severe asthma * patients with a known autoimmune disease * patients with active malignant disease * patients requiring beta-blockers * patients having any contraindication for the use of adrenaline * patients with previous immunotherapy with this allergen or another allergen with cross-reaction * patients with immunotherapy treatment at the time of inclusion
a digital health tool for insulin titration (dhit) individuals with type 2 diabetes: a prospective outcomes study with a retrospective control group

Conditions: Diabetes Mellitus, Type 2

Summary: the digital health tool is an application ("app") available on ios and android enabled mobile phones. health care providers ("hcps") configure algorithms which can be tailored to individual patient's needs and then prescribe the app to support optimal basal insulin titration and dosing. in this study, participants will be recruited from a medical practice in which an hcp has prescribed a once-daily basal insulin. participants will be trained on the use of the app utilizing their own mobile phone. during training, a brief self-assessment survey will be administered. after 90 days of usage, a telephone survey will be conducted. the baseline a1c results and the end of study a1c results will be collected from the patients' routine clinical care records. data from the retrospective control group will be collected from a chart review of the same practice.


Eligibility criteria:
inclusion criteria: - prospective cohort: the participants will be patients with type 2 diabetes mellitus who are not at goal on their current dose of prescribed basal insulin (e.g. lantus, toujeo, levemir, tresiba, or basaglar). participants shall be age 21 or older, prescribed basal insulin within the past 18 months, own a compatible mobile phone, able to receive/make calls and read messages on their phone. there is no predefined gender or ethnic group. participants should be generally healthy and not expected to be hospitalized for surgery or other medical care during the study period. - retrospective cohort: this will be a chart review. participants will be matched to the prospective cohort for age, gender and baseline a1c. patients should have been prescribed one of the basal insulins above. exclusion criteria: - prospective cohort: participants with stage 4 or 5 kidney disease, active malignancies, variable glucocorticoid doses during the study period, severe visual impairment, or dementia will be excluded. also, participants prescribed rapid-acting or premixed insulins (any insulin not on the above list) will be excluded. - retrospective cohort: same as above.

Keywords: insulin basal titration digital health
a dye for the detection of cancer of the tongue and mouth

Conditions: Oral Squamous Cell Carcinoma (OSCC)

Summary: the purpose of this study is to test if an investigational dye, called parpi-fl, can be used to detect this type of cancer. this will be the first time that parpi-fl is being tried in people. first, the investigators will test the safety of parpi-fl at different doses to find out what effects, if any, it has on people. the investigators will also see which amount of parpi-fl is best suited to detect cancers of the mouth and tongue.


Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years old * histologically or cytologically proven squamous cell carcinoma of the oral cavity or pharynx (oscc) * scheduled to undergo surgery at msk * any tumor stage, any n, m0 * ecog performance status 0 or 1 exclusion criteria: * any surgical therapy in the area of the oral cavity or pharynx within the last 2 weeks * prior or ongoing treatment with a parp1 inhibitor * known hypersensitivity to olaparib * known hypersensitivity to peg eligibility criteria will be assessed by an experienced oral surgeon, typically the co-pi of the study.

Keywords: tongue mouth fluorescent parp1 binding imaging agent parpi-fl 15-336
evaluation of accelerated sampling techniques for vessel wall imaging

Conditions: Vasculopathy

Summary: the purpose of this study is to compare and evaluate a faster mr image that has been optimized to look at participants blood vessel walls.

the purpose of this study is to compare and evaluate a faster mr image that has been optimized to look at participants blood vessel walls. this faster mr image technique will image participants blood vessel walls in a shorter period of time and will be compared to the routine mr images that is typically used to image participants blood vessel walls. the purpose of testing these faster images is to compare the image quality with longer conventional images. the goal is to ensure the investigators maintain high image quality over a shorter period of time. these faster images over a shorter period of time have the advantage of fewer motion-related artifacts. the hypothesis of this research study is that the compressed sensing (fast acquisition technique) based acquisitions will considerably reduce the scan time and will maintain the diagnostic image quality necessary for the assessment of participants blood vessel walls. thus, the information gained from this study will help us to determine the efficacy of the accelerated protocols for vessel wall imaging.

Eligibility criteria:
inclusion criteria: 1. patients 18 years of age and scheduled to undergo clinical vessel wall mr imaging exams as part of their standard of care. exclusion criteria: 1. any person under the age of 18 2. presence of artifact-producing intracranial devices (aneurysm clips/coils, ventricular drains, craniectomy mesh, etc.) 3. any person with contraindications to mri (medical instability, non-mri compatible implanted devices, retained metallic foreign bodies, claustrophobia) 4. large space-occupying lesions (50 ml) or substantial mass effect (herniation, 5mm midline shift) on preceding brain imaging, 5. imminently life-threatening co-morbid conditions 6. a history of premorbid disabling neurological or psychiatric disease, current substance abuse or remote substance abuse with permanent organic sequelae 7. pregnancy or lactation
laparoscopy-assisted surgery for carcinoma of the low rectum

Conditions: Rectal Carcinoma

Summary: the purpose of this study is to evaluate the safety and oncological feasibility of laparoscopy-assisted surgery for low rectal carcinoma compared with open surgery.


Eligibility criteria:
inclusion criteria: * histologically proven rectal adenocarcinoma * inferior edge of the tumor located within 5 cm from the dentate line as determined by rigid proctoscopy * diagnosis of rectal cancer amenable to curative surgery either by anterior resection or abdominoperineal resection or extralevator abdominoperineal excision * t3-4a,n0 or t1-4a,n1-2 treated with neoadjuvant chemoradiotherapy * no evidence of distant metastases * tumor size \<6cm * sufficient organ function * no contraindication to laparoscopic surgery * without other malignancies in medical history exclusion criteria: * concurrent or previous diagnosis of invasive cancer within 5 years * locally advanced cancers requiring en bloc multivisceral resection * intestinal obstruction * intestinal perforation * history of colorectal surgery * american society of anesthesiologists(asa) class 4 or 5 * pregnant or breast-feeding women * history of mental disorder * participation in another rectal cancer clinical trial relating to surgical technique
a study evaluating efficacy and safety of vx-993 for acute pain after a bunionectomy

Conditions: Acute Pain

Summary: the purpose of this study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of vx-993 in treating acute pain after a bunionectomy.


Eligibility criteria:
key inclusion criteria: before surgery: * participant scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., austin procedure) and internal fixation under regional anesthesia (mayo block) after surgery: * participant is lucid and able to follow commands * all analgesic guidelines were followed during and after the bunionectomy key exclusion criteria: before surgery: * prior history of bunionectomy or other foot surgery on the index foot * history of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) within the last 2 years * a known or clinically suspected active infection with human immunodeficiency virus or hepatitis b or c viruses after surgery: * participant had a type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair, or had medical complications during the bunionectomy other protocol defined inclusion/exclusion criteria may apply.
cerebral blood perfusion changes after general anesthesia for craniotomy

Conditions: Brain Neoplasms; Surgery; Hyperemia

Summary: few studies look into cerebral blood flow (cbf) changes during emergence from general anesthesia for craniotomy. the purpose of this study is to demonstrate cbf changes during emergence from general anesthesia for craniotomy, through monitoring blood oxygen saturation of jugular vein bulb and transcranial doppler.

30 patients undergoing selective craniotomy (craniotomy group) for supratentorial brain tumor removal and 30 patients undergoing selective abdominal surgery (abdominal surgery group) are planned to be enrolled in the study. mean blood flow velocity in middle cerebral artery (vmca), mean arterial pressure (map), blood oxygen saturation of jugular vein bulb (sjvo2) (only measured in craniotomy group)and arterial co2 partial pressure (paco2) will be measured before general anesthesia, at tracheal extubation, and 30,60, 90, 120 min after extubation in both groups.

Eligibility criteria:
inclusion criteria: * american society of anesthesia (asa) physical status i or ii * scheduled for selective supratentorial tumor removal surgery or major abdominal surgery. exclusion criteria: * patients with evidence of systemic hypertension, intracranial hypertension, cerebrovascular diseases, other coexisting medical conditions likely to affect cerebral autoregulation. * preoperatively planned delayed tracheal extubation. * pregnant or nursing women

Keywords: cerebral blood flow transcranial doppler emergence from general anesthesia
inflammatory response after colorectal cancer surgery

Conditions: Colorectal Cancer

Summary: laparoscopic technique and epidural anesthesia have been proposed to improve postoperative outcome following colorectal cancer surgery. the investigators hypothesize that the inflammatory response is attenuated by laparoscopic surgery and epidural anesthesia compared to traditional open surgery under general anesthesia.

patients scheduled for open colorectal cancer surgery were randomly allocated to receive general anesthesia (con group, n=22) or general anesthesia with thoracic epidural anesthesia (epi group, n=21). patients undergoing laparoscopic surgery (lap group, n=20) composed the third arm of the study. measurement of perioperative changes in several hormones and cytokines were blinded to group assignment. primary outcome: compare simultaneously two types of surgical and anesthesia techniques for colorectal cancer surgery and measure to what extent the stress response is lessened.

Eligibility criteria:
inclusion criteria: * patients scheduled for colorectal cancer surgery exclusion criteria: * emergent surgery * intestinal obstruction * contraindication for epidural catheter placement * concomitant autoimmune disease * concomitant infectious disease * recent corticosteroids or anti-inflammatory medications

Keywords: laparoscopy anesthesia, epidural
radiotherapy with cisplatin versus radiotherapy with cetuximab after induction chemotherapy for larynx preservation

Conditions: Larynx Cancer; Hypopharynx Cancer

Summary: larynx preservation remains a very challenging approach in patients with larynx/pharynx cancer. a first attempt consisted of induction chemotherapy followed in good responders by irradiation. this approach allowed to preserve 60 % of the larynx without any significant difference in survival. the second attempt consisted of concurrent chemo-irradiation. this approach provided a higher larynx preservation rate but survival remained unchanged and mucosal toxicity was also higher. a third approach is currently under evaluation: induction chemotherapy followed by concurrent chemo-irradiation in good responders.

at asco 2004 there were 3 major presentations issuing an increasing in survival: * the update of the mach-nc meta-analysis showed that actually only concurrent chemo-irradiation trials found a significantly improved survival (in particular the addition of cisplatinum alone to radiotherapy) * the addition of docetaxel to the cisplatinum-5fu regimen (tpf) when compared with cisplatinum--5fu (pf) * the addition of cetuximab to irradiation on this basis we decided to carry-out a randomized phase ii for previously untreated patients requiring a total laryngectomy: all patients after a complete work-up including a ctscan will receive 3 cycles of tpf(t: 75 mg/m², p: 75 mg/m² and 5fu 750 mg/m²). patients with response over 50 % (endoscopy and ctscan) will be randomized to receive either irradiation (70 gy) and cisplatinum (100 mg/m² on d1, d22 and d43) or irradiation (70 gy) with cetuximab (loading dose of 400 mg followed by weekly 250 mg for a total of 8 cycles. patients with less than 50% decease in tumour volume after tpf, patients with residual or recurrent disease after either rt-cddp or rt-cetuximab will get salvage total laryngectomy.

Eligibility criteria:
inclusion criteria: * larynx or hypopharynx squamous cell carcinoma proven by histology, locally advanced, only eligible for surgery as total or sub-total (pharyngo-)laryngectomy * performance status 0-1 * neutrophils \>=1.5 x 109/l, platelets count \>=100 x 109/l, haemoglobin \>=10 g/dl * total bilirubin \<= 1.5 x upper reference range * asat and alat \<= 2.5 x upper reference range, alkaline phosphatases \<= 5 x upper reference range * serum creatinine \<= 120 µmol/l * weight loss \< 10 % within last 3 months * written inform consent exclusion criteria: * infiltrative transglottic tumor or clinical cartilage invasion * distant metastasis * previous chemotherapy or radiotherapy * contra-indication to chemotherapy

Keywords: larynx cancer hypopharynx cancer larynx preservation concomitant radiochemotherapy cisplatin cetuximab randomized trial
relationship between pten and glycemic variability and outcome in critically ill patients

Conditions: Critical Illness; Hyperglycemia

Summary: glycemic variability in critically ill patients is a recognized negative prognostic factor. the molecular mechanisms determining inter-patients variability in glucose metabolism during stress are not fully understood. the phosphatase and tensin homolog (pten) is known to influence glucose homeostasis by interfering in intracellular insulin signaling. aim of this study is to ascertain whether differential expression of pten in critically ill patients correlates with glycemic variability and clinical outcome.


Eligibility criteria:
inclusion criteria: * trauma * provision informed consent exclusion criteria: * diabetes * impaired fasting glucose levels

Keywords: icu hyperglycemia length of stay