Kornimate/medical-research-clean huggingface dataset:
the effects of calorie restriction with or without metformin on weight and insulin resistance

Conditions: Body Weight; Insulin Resistance

Summary: this is a study to: * determine the difference between strong hypo-energetic "standard diet advice" and modest hypo-energetic "personal diet advice"; and * determine the influence of insulin-insensitivity on obesity and weight reduction by treating patients with metformin or placebo.

the aim of the present study was to determine what the difference is of a strong hypo-energetic "standard diet advice" and a modest hypo-energetic "personal diet advice" which was determined by the energy needs of a person as calculated with a combination of basal metabolic rate (bmr) and physical activity level (pal) on weight loss and insulin sensitivity. secondly, this study wanted to determine what the influence is of insulin-insensitivity on obesity and weight reduction by treating the patients with metformin or placebo. the subjects were therefore randomised into two double blinded groups receiving either metformin (2 x 850 mg per day) or placebo in combination with a moderate energy restriction and a exercise regimen of 30 minutes per day for 1 year. treatment effects of both diets and the effect of metformin on weight reduction and insulin sensitivity were determined after a treatment period of 20 and 52 weeks. insulin sensitivity was quantified using the homeostasis model assessment (homa) and the ogtt. body composition was determined with the bioelectrical impedance method. blood was also drawn for hormonal and biochemical analyses after 20 and 52 weeks of treatment. furthermore, the patients had to fill out a 3-day food diary at baseline, after 20 weeks and after 52 weeks.

Eligibility criteria:
inclusion criteria: * 20-55 years of age * body mass index (bmi) equal to or greater than 30 kg/m² * insulin resistance as determined by oral glucose tolerance test (ogtt) and homa exclusion criteria: * diabetes mellitus, kidney insufficiency, or hepatic insufficiency * hypogonadism with other etiology than overweight * pregnancy * bmi equal to or greater than 40 kg/m²
clinical and medico-economic evaluation of a rapid test (eplex-bcid®, genmark) for the diagnosis of bacteremia and fungemia.

Conditions: Bacteremia Sepsis; Fungemia

Summary: this study evaluates the clinical benefit of a rapid test for fast diagnosis of bacteremia and fungemia from positive blood cultures in case of sepsis. this assay enables rapid identification of bacteria and fungi and allows to evaluate bacterial resistance to first line antibiotics. the clinical and medico-economic impact of this assay used in addition to the current diagnosis strategy (half of the patients) will be compared to the current diagnostic strategy alone (other half of the patient).

bacteremia and fungemia are severe complications, sometimes life-threatening, of every sepsis. during septicemia, every hour matters to start an appropriate antibiotic or antifungal treatment as every hour of delay is associated to higher death rate. the rapid multiplex pcr assay that is evaluated in this study allows to identify in 60 to 90 minutes, the bacteria or fungi that is present in the positive blood culture bottles and to identify resistance markers to first line antibiotics that are used to treat sepsis. this strategy allows quicker adaptation of antibacterial or antifungal treatment based on the species of the bacteria or fungi identified and on the results of the resistance markers compared to current diagnosis strategy of bacteremia or fungemia. this quicker adaptation could lead to improved survival rate, reduced complications of sepsis, reduced hospital stay length and could reduce the use of large spectrum antibiotics.

Eligibility criteria:
inclusion criteria: * patient with bacteremia and/or fungemia defined by : 1/ the presence of clinical signs of sepsis; and 2/ a positive blood culture, i.e. the growth of at least one species of bacteria or micromyces in at least one blood culture vial * patient hospitalized at grenoble university hospital (only north site) and seen by a physician from the antibiotic stewardship team * first blood culture positive for the patient's sepsis episode * informed and written consent signed by the patient or his legal representative or the doctor in case of emergency. exclusion criteria: * patients mentioned in the law articles l1121-5 to l1121-8 from french health code * patients hospitalized in palliative care unit * persons with an estimated survival of less than one month

Keywords: multiplex pcr blood culture rapid diagnosis
combination of nivolumab and dhap in patients with relapsed or refractory classical hodgkin lymphoma (nivo-dhap)

Conditions: Hodgkin Lymphoma

Summary: a clinical study of safety and efficacy of treatment with nivolumab and dhap in patients with relapsed/refractory hodgkin's lymphoma

a clinical study of safety and efficacy of treatment with nivolumab and dexamethasone, cytarabine and cisplatin (dhap) in patients with relapsed/refractory hodgkin's lymphoma

Eligibility criteria:
inclusion criteria: * signed informed consent * histologically confirmed hodgkin's lymphoma * measurable disease (at least one lesion that can be accurately measured in at least two dimensions with spiral ct scan, min \> 15 mm in the longest diameter or \> 10 mm in the short axis) * world health organization (who) performance status \< 2 * relapsed or refractory to at least one prior treatment line * no prior therapy with dhap or nivolumab * no severe concurrent illness exclusion criteria: * history of hiv * active hepatitis b or hepatitis c infection * uncontrolled infection (requiring intravenous treatment) at the time of enrollment * pregnancy or breastfeeding * somatic or psychiatric disorder making the patient unable to sign informed consent * active or prior documented autoimmune disease requiring systemic treatment * no receiving a live vaccine within 30 days prior to first dose of nivolumab * history of non-infectious pneumonitis that required steroids * other malignancy
pre- and postoperative nutrition in head and neck cancer patients

Conditions: Head and Neck Cancer

Summary: the purpose of the project is to investigate the effect of wound healing of a combined pre- and postoperative oral supplement, consisting of zinc, vitamin c, arginine and multivitamin, as a supplement for adequate nutrition in patients operated for head and neck cancer.

the project will be conducted as an open, randomized intervention study, and includes patients with head and neck cancer that are planned for operation. 40 participants are allocated to the intervention or control group, respectively. for both groups, the experiment will last for five to six weeks, depending on when the trial participants are planned for surgery. the intervention group must take a dietary supplement and a protein drink for 35 days (7 days preoperatively and 28 days postoperatively), which is delivered 7 days preoperatively. the same applies to the control group that only receives protein drinks. the length of the intervention period is based on the design of previous studies. during the project, compliance will be evaluated by counting the amount of remaining dietary supplements and protein drinks that the participants return on a regular basis. the control group receives standard treatment as well as protein drinks. for all participants included in the experiment blood tests and an ultrasound scanning will be performed.

Eligibility criteria:
inclusion criteria: * authorized/legal age (\> 18 years) * patients who understand written and oral danish, and are able to give written consent * patients diagnosed with head and neck cancer, which are set for surgery * patients operated on the outside of the neck exclusion criteria: * patients who do not understand, speak or write danish * not authorized/not legal age (\<18 years) * pregnant and breastfeeding women * patients previously employed in the field of surgery within the last 5 years (prior years)

Keywords: head and neck cancer wound healing pre and post-surgical nutrition zinc, arginine, vitamin c, protein, oral supplements
teams-bp (the enhancement of social networks to augment management of stroke-blood pressure)

Conditions: Stroke, Acute Ischemic; Hypertension

Summary: this study aims to compare the efficacy of a social network intervention versus individual hypertension counseling to improve blood pressure control after stroke. the investigators hope to understand whether the involvement of family, friends and other members of individual's social network can help achieve better blood pressure after experiencing a stroke. participants will be stratified to two groups according to network size (\<5 vs 5 or more) and randomized to receive individual hypertension counseling (control) or the social network intervention. the primary outcome of the study will be the absolute reduction in systolic blood pressure at 3 months follow-up. the secondary outcomes will be attainment of a post-stroke hypertension treatment goal and patient-reported physical function.


Eligibility criteria:
inclusion criteria: 1. first acute ischemic stroke defined clinically with support from imaging if necessary 2. 21 years of age or older 3. within 14 days after stroke 4. history of hypertension or has been newly prescribed blood pressure medications during index admission exclusion criteria: 1. prior ischemic or hemorrhagic stroke 2. nihss \> 21 3. significant aphasia (score\>1 on the language section of the nihss) 4. medical conditions for which death is likely within 6 months 5. does not have capacity to consent for the project or participate in survey interview 6. diagnosis of dementia 7. patient has no phone or incapable of using text messages 8. patient has opted out of participating in research noted within mgb epic ehr system

Keywords: social networks
impact of pelvic floor rehabilitation combined with ultrasound therapy on osteomyoarticular symptoms in chronic perineal pain

Conditions: Chronic Perineal Pain; Pelvic Floor Disorders

Summary: the purpose of the study is to find out the effect of pelvic floor rehab combined with ultrasound have effect in chronic perineal pain subjects associated with osteomyoarticular symptoms .

chronic perineal pain is the anorectal and perineal pain without underlying organic disease, anorectal or endopelvic, which has been excluded by careful physical examination, radiological and endoscopic investigations. so, perineal and vaginal pain after vaginal delivery has been associated with tissue trauma related to operative vaginal delivery, perineal laceration, and episiotomy. studies assessing chronic pain after vaginal delivery report 2% to 10% of women with pain at six months and later, almost exclusively in mothers who had an assisted vaginal birth. postpartum pain intensity is usually higher when it is related to vaginal delivery than to cesarean delivery and more severely affects the woman's quality of life and mood.

Eligibility criteria:
inclusion criteria: 1. the age of the subjects will be ranged from 20 to 35 years. 2. all participants had vaginal delivery with episiotomy. 3. they are in late post partum period over 6 months 4. their bmi will be ranger from 25 to 30 kg/m2. 5. all participants have mechanical low back pain. 6. all participants have perineal pain. 7. the number of parity ranged from 2-3 times. exclusion criteria: 1. females will be excluded if they have any spine or lower extremities injuries or previous surgeries. 2. females with radicular back pain. 3. inability to understand the written and verbal instruction. 4. females had irregular menstrual cycle

Keywords: pelvic floor rehabilitation ultrasound osteomyoarticular symptoms chronic perineal pain
comparative effects of stabilization exercises and muscle energy techniques in sacroiliac joint pain

Conditions: Sacroiliac Joint Somatic Dysfunction

Summary: sacroiliac joint is in pelvis. it links the iliac bone (pelvic) bone to the sacrum. this joint pain is due to hyper mobility or instability of the joint, it may also cause by damage to joint between the spine and hip. this pain is typically felt in the lower back, or hip and may radiate to groin area. the aim of this study will be to compare the effects of stabilization exercises and muscle energy techniques on pain and disability in patients with sacroiliac joint pain.

a randomized clinical trial will be conducted at ibn- e- siena hospital and research institute multan and in bakhtawar amin hospital multan through convenience sampling technique on 30 patients which will be allocated through simple random sampling through sealed opaque enveloped into group a and group b. after giving common treatment of hot pack and transcutaneous electrical stimulation and assessing pre-treatment patient's condition group a will be treated with stabilization exercises in which iliopsoas, gluteal and hamstring muscles will be stabilized. total twelve sessions will be given as three sets three times per week for four weeks. group b will be treated with muscle energy technique, this is active form of manual therapy in which patient will exert force against physiotherapist force through autogenic inhibition and reciprocal inhibition. (20% patient force against that applied by the physiotherapist and hold contractions for 10 seconds over 5 to 12 repetitions, 3 times per week for 4 weeks). post-treatment assessment will be done after one month. outcome measure will be conducted through pain and disability questionnaire after 6 weeks. data will be analyzed using spss software version 21. after assessing normality of data by shapiro -wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups. stabilization exercises and muscle energy techniques will be applied for comparing their effectiveness in patients with sacroiliac joint pain.

Eligibility criteria:
inclusion criteria: * both men and women age between 30-50 with positive laslett's criteria. the cluster of laslett is a group of four test used for sacroiliac joint pain, the four tests are: 1. sacroiliac distraction (gapping) test 2. thigh thrust test 3. sacroiliac compression (squish) test 4. sacral thrust test * if a patient has three or more positive pain provocation tests, and then there is a 59% chance that the patient will have sacroiliac joint pain. exclusion criteria: * trochanteric bursitis * pelvic bone fracture * pelvic implants * pregnancy * lumbosacral disc herniation * sacroiliac joint inflammation * inflammatory bowel disease * malignancy

Keywords: pain disability physical muscle strength
effect of modified time-restricted feeding in preventing progression of non-alcoholic fatty liver disease (nafld).

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: the purpose of the study is to examine the effects of modified time-restricted feeding and conventional dietary approaches in motivated obese fatty liver patients on biochemical markers, imaging studies, and anthropometric measurements.


Eligibility criteria:
inclusion criteria: * motivated obese fatty liver patients aged 8 -18yrs with alt \>80 exclusion criteria: * patients with metabolic disorders, * on certain medications (i.e., amiodarone, corticosteroids, methotrexate, select antipsychotics /antidepressants, haart, valproic acid), * kwashiorkor * alcohol abuse, * rapid surgical weight loss, * history of parenteral nutrition and * hepatitis c.
mechanisms, predictors, and social determinants of cardiotoxicity in breast cancer

Conditions: Breast Cancer; Cardiotoxicity; Drug-Related Side Effects and Adverse Reactions; Cardiovascular Diseases

Summary: this is an observational study for patients with breast cancer that will be treated with doxorubicin (adriamycin) and/or trastuzumab (herceptin). the study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients' medical history and social determinants of health (such as race, gender identity, education, occupation, access to health services and economic resources). patients on this study will have echocardiograms, blood draws, and answer questions about their symptoms and activity level. patients will be followed on this study for up to 15 years.

the investigators propose a prospective longitudinal cohort of breast cancer patients treated with anthracyclines and/or trastuzumab to determine the associations between social determinants of health (sdoh) and cardiotoxicity risk and to determine whether associations between sdoh and cardiotoxicity risk differ according to race. patients will be followed with serial echo, blood draw, and surveys every 3 months for the first year, then annually for two years. after 3 years following start of cancer therapy, patients will have study visits every other year for up to 15 years.

Eligibility criteria:
inclusion criteria: * women older than 18 years of age * breast cancer with treatment plan that includes doxorubicin and/or trastuzumab * ability to provide written informed consent exclusion criteria: * pregnancy at enrollment * inability or unwillingness to provide consent

Keywords: cardiotoxicity of chemotherapy cardio-oncology social determinants of health
comparison of the healing properties on corneal cells of groth factor-enriched plasma and autologous serum from aniridia patients

Conditions: Aniridia

Summary: keratopathy of patients with aniridia leads to epithelial scarring disorders and a progressive clouding of the cornea linked to this abnormal healing (fibrosis). treatment with autologous serum is usually undertaken to promote epithelial healing. however, autologous serum does not prevent the formation of fibrosis, whereas growth factor-rich plasma appears to be associated with a reduction in the in vitro expression of fibrosis markers. this study seeks to compare the in vitro healing and anti-fibrotic properties of autologous serum and growth factor rich plasma from aniridia patients and healthy controls.

blood collection from aniridia patients and healthy controls, half of which will be used to make autologous serum and the other half to make growth factor rich plasma, used for in vitro studies. a conjunctival impression will also be taken at the inclusion of the patients.

Eligibility criteria:
inclusion criteria: for patients with aniridia: * with aniridia * patient weighing more than 43 kg * if the patient is being treated with autologous serum, a delay of 8 weeks after the last blood collection * if a blood donation has been made, a delay of 8 weeks must be respected after the last donation for controls: * non-aniridia (no clinical signs) * weighing more than 43 kg * matched to a case for sex and age +/-10 years * no known diabetes * if a blood donation has been made, a delay of 8 weeks must be respected after the latter exclusion criteria: * insufficient sample volume * no conjunctival print * hbv, hcv, hiv serology positive * aniridia not genetically confirmed for cases for each patient excluded, a new patient will be included in order to maintain the number of patients required for data analysis.

Keywords: growth factor rich plasma conjunctival impression
fenoldopam and acute renal failure

Conditions: Acute Renal Failure

Summary: patients undergoing cardiac surgery could develop postoperative acute renal failure requiring renal replacement therapy. fenoldopam, already used for patients with hypertensive emergencies, could improve renal function in critically ill patients with or at risk for acute renal failure.


Eligibility criteria:
inclusion criteria: * adult patients * who underwent cardiac surgery * have risk of acute renal failure (r of rifle score) exclusion criteria: * glaucoma * already on renal replacement therapy * study drug in the past 30 days * inclusion in other protocols

Keywords: fenoldopam acute renal failure renal replacement therapy mortality cardiac surgery cardiac anesthesia intensive care unit
an acupuncture functional magnetic resonance imaging (fmri) study on chronic pain: response reliability and dose effect

Conditions: Osteoarthritis, Knee

Summary: in this proposal, we plan to dynamically investigate brain response to verum acupuncture (of two different "doses") and placebo acupuncture, using a paradigm that approximates clinical acupuncture practice across multiple treatment sessions in knee osteoarthritis (oa) patients. this proposal aims to: 1) characterize session-to-session brain responses to verum / sham acupuncture treatment (reliability of response) for oa patients, and 2) investigate how different "doses" of acupuncture influence brain response and acupuncture efficacy (impact of dose). the findings of this project will deepen our biological understanding on why and how acupuncture can treat chronic pain and what happens in the brain during the multiple-session acupuncture treatment.


Eligibility criteria:
inclusion criteria: 1. volunteers 40-70 years of age. 2. meet the classification criteria of the american college of rheumatology for osteoarthritis of the left / right knee for at least the past 3 months, as determined by the referring physician. 3. radiographic evidence of grade 2 or 3 knee oa using the kellgren-lawrence scale \[78, 85-87\]. 4. patients must have moderate or greater clinically significant pain on most days during the past month (more than 15 days out of 30, of average daily pain of \>3/10) in the left or right knee. 5. at least a 10th grade english-reading level; english can be a second language provided that the patients feel they understand all the questions used in the assessment measures. exclusion criteria: 1. any interventional procedure for knee pain, including corticosteroid injections (within 6 months, \[88\]) to the knee. 2. prior acupuncture treatment for any condition. because we are using a placebo needle as a control, acupuncture-naive patients are necessary to maximize the benefits of blinding and to control expectancy. 3. the intent to undergo surgery during the time of involvement in the study. 4. presence of any illness or medication use that is judged to interfere with the trial. for example: skin irritations around the knee such as psoriasis; bleeding disorders or anticoagulant use that would be contraindications for acupuncture; opioids or benzodiazepines, which may alter pain sensitivity and bold response. 5. knee pain due to other causes, such as inflammation or malignancy, other pain disorders that may refer pain to the leg, oa of ipsilateral hip, diagnosis of ra. 6. non-ambulatory status. 7. history of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. for example: asthma or claustrophobia. 8. presence of any contraindications to fmri scanning. for example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.

Keywords: acupuncture osteoarthritis fmri