Kornimate/medical-research-clean huggingface dataset:
positive energy i through overfeeding

Conditions: Obesity

Summary: the purpose of this trial is to examine the metabolic and behavioral effects of a positive energy balance induced by adding food to the usual level of activity. it is hypothesized that: 1) food intake will not differ significantly after 2 days of positive energy balance induced by a high carbohydrate vs. high fat diet when both diets are low in energy density, and 2) food intake will be higher after a positive energy balance induced by a high fat/high energy dense diet vs. a high fat/low energy dense diet.

the purpose of this trial is to examine the metabolic and behavioral effects of a positive energy balance induced by adding food to the usual level of activity. during this study, we will induce a positive energy balance for two days by increasing food intake to 140% of baseline energy requirements and keeping energy expenditure constant. the following three diets, which vary in dietary fat and energy density (kcal/g), will be used to induce the positive energy balance in a within subjects or cross over design: 1) high fat/high energy density, 2) high fat/low energy density, and 3) high carbohydrate/low energy density. food intake and activity will be measured for 4 days after each diet to quantify the response to positive energy balance and manipulation of dietary fat and energy density.

Eligibility criteria:
inclusion criteria: * you are between the ages of 18 and 50, inclusive, if you are a male or between the ages of 18 and 45, inclusive, if you are a female. * your body mass index (bmi) is between 20 and 40 kg/m², inclusive. * for females, if you have regular menstrual periods, with no less than 28 day cycles. monophasic birth control pills, copper iud, ortho evra patch, nuvaring or complete hysterectomy are also acceptable. exclusion criteria: * you have a chronic disease that affects body weight, appetite, or metabolism, such as diabetes and cardiovascular disease. * you have irregular menstrual cycles, had a partial hysterectomy (still maintain ovaries), or use an iud not made of copper. * you use prescriptions or over-the-counter medications or herbal products that affect metabolism or body weight (e.g. weight loss medications such as sibutramine, or orlistat). * you use a birth control pill that isn't monophasic or you receive depro-provera injections. * you have barriers to completing the study, such as work or family commitments. * you have symptoms of depression or excessive dietary restraint. * you use tobacco products. * you exercise more than 1 hour per day, 5 or more days per week.

Keywords: appetite satiety
icat for recurrent/refractory/hr solid tumors

Conditions: Pediatric Solid Tumor; Sarcoma; Neuroblastoma; Wilms Tumor

Summary: in this study tumor will be tested for cancer causing gene alterations such as mutations or copy number alterations. this is called tumor profiling. a panel of experts will review the tumor profiling results and determine whether there is a cancer-causing alteration present in the tumor. if there is, the experts will determine if there is a targeted drug available that could counteract this alteration. if there is an alteration identified and a targeted drug available the panel of experts will make an individualized treatment recommendation. the results of the tumor profiling and the individualized treatment recommendation can be shared with the primary oncologist.

some cancer-causing gene alterations (such as mutations or copy number alterations) are common or occur repeatedly in different types of cancers. for some of these alterations there are drugs, called targeted drugs that specifically counteract the alteration. in certain cancer types, these targeted drugs are very effective at fighting the cancer. a tumor specimen that has been obtained previously or is planned to be obtained as part of clinical care will be used to perform tumor profiling. additional procedures to obtain tumor will not be performed. an expert panel will review the results of the tumor profiling tests and determine whether a cancer-causing alteration is present and whether an individualized treatment recommendation can be made. if consent to sharing of the tumor profiling results and individualized treatment recommendation is provided then a study physician will discuss the profiling results and the individualized treatment recommendation with the primary oncologist. in addition, the primary oncologist will receive a letter detailing the tumor profiling results and the individualized treatment recommendation.

Eligibility criteria:
inclusion criteria: * diagnosis of recurrent, refractory of high risk pediatric solid tumor (excluding brain tumor) * histologic proof of malignancy at the time of diagnosis or recurrence * sufficient tumor specimen available for profiling from diagnosis or recurrence, or surgery/biopsy planned for clinical care exclusion criteria: * brain tumors

Keywords: refractory recurrent high risk
the anti-inflammatory effect of anesthetics in abdominal surgery

Conditions: Colorectal Cancer

Summary: clinical studies have shown that iv administration of anesthetics, lidocaine and ketamine with their anti-inflammatory properties, modulates the acute immune response associated with surgical tissue injury, and in this manner they are able to reduce postoperative pain. lidocaine has anti-inflammatory effects on polymorphonuclear granulocytes, il-6 and il-8 cytokines, complement component c3a and il-1ra in serum. ketamine produces its anti-inflammatory effects by reducing crp and il-6 in serum and by inhibiting nf-kb, which regulates gene transcription responsible for the production of proinflammatory factors. perioperative combinend iv administration of lidocaine and ketamine could have a more favorable anti-inflammatory effect compared to anesthetic given alone or with placebo. to investigate the effects of lidocaine and ketamine in patients undergoing abdominal surgery on: acute immune response following the level of proinflammatory factors in serum (crp, il-6, il-8); postoperative pain management; recovery of bowel function; administration of opioids; reduction of total treatment costs; length of hospital stay (lohs) a double-blind, placebo-controlled study will include 100 patients undergoing open colorectal surgery. patients will be randomly assigned to one of four groups: lidocaine, ketamine, lidocaine-ketamine, and placebo. lidocaine will be administered at a dose of 1.5 mg/kg prior to surgical incision followed by an infusion at a rate of 1.5-2 mg/kg/hr until the end of surgery. ketamine will be administered at a dose of 0.5 mg/kg in a bolus prior to surgical incision followed by an infusion at a rate of 0.1-0.2 mg/kg/hr until the end of surgery. bolus and continuous placebo infusion (0.9% nacl) will be equally administered at the same dose as the aforementioned anesthetics until the end of the surgery. proinflammatory markers in serum (crp, il-6, il-8) will be measured before induction of anesthesia, then 12 hours and 36 hours following the completion of surgery. the intensity of pain will be measured using the vas score 2 hours and 4 hours following surgery and every 12 hours the following days. the investigators will measure also the consumption of opioids during and after surgery, the length of stay in the icu, where pain control and analgesics use will be measured, as well as recovery of bowel function.


Eligibility criteria:
inclusion criteria: * elective surgery * expected duration of the operation \> 2 hours exclusion criteria: * patients ≤ 18 years of age * patients with history of allergy to local anesthetics * chronic opioid analgesic * patients who are unwilling or unable to participate

Keywords: anti-inflammatory effect surgical stress lidocaine ketamine abdominal surgery
investigating minimal residual disease in autopreserved ovarian tissue in cases of neoplastic pathology

Conditions: Neoplastic Pathology; Autopreserved Ovarian Tissue

Summary: cryopreservation of ovarian tissue is offered to young girls and women aged under 35 who have to undergo sterilizing gonadotoxic treatment, with the aim of preserving their fertility. the main part of the ovary is preserved, as primordial and primary follicles are resistant to freezing / thawing protocols. in the absence of other techniques (in vivo maturation, injecting isolated ovarian follicles, etc.) autografting this cryopreserved tissue is currently the only technique allowing fertility to be restored. autograft is possible only if the indication for ovary cryopreservation is a non-neoplastic pathology or a malignant pathology with a low risk of ovarian metastasis. in other cases of neoplastic pathologies, particularly in cases of acute leukemia, tissue cannot as yet be re-used due to the lack of any codified technique for evaluating residual disease (mrd). the team has for two years been developing and validating a technique to look for residual disease in fragments of ovarian cortex in cases of acute leukemia. this technique is based on an original protocol for dissociating ovarian tissue to obtain a population of isolated ovarian cells that may be analyzed by multicolor flow cytometry. the specificity and sensitivity of the technique have been demonstrated in an experimental model. this model consists in using 8 color flow cytometry to look for characterizable leukemia cells added in different dilutions to a population of isolated ovarian cells taken from model ovarian cortex and up to a dilution of 10-5. when the molecular markers were present on diagnosis, they were found by rq-pcr (real-time quantitative polymerase chain reaction) with the same dilutions. the model tissue came from laparoscopic ovarian drilling in patients with polycystic ovary syndrome. the main objective of this project is to validate techniques that have been previously codified with different populations of leukemia cells that may be characterized. we then aim to adapt and validate this technique to look for mrd using 8 color flow cytometry on cryopreserved fragments of ovarian cortex from leukemia patients that are at risk of metastasis. secondary objectives will be to implement procedures for oncological qualification of grafts in cases of malignant pathology and to consider the recommendations for using this cryopreserved ovarian tissue through the autograft technique for these indications.


Eligibility criteria:
inclusion criteria: * patients who have cryopreserved their ovarian tissue * patients with premature ovarian insufficiency * patients aged from 18 to 43 years for the restoration of ovarian function * no objection from the patient * patients who have already received ovarian tissue autograft exclusion criteria: * patients aged under 18 years (bone age) * patients older than 43 years * patient refusing to be included * patients (adults) under guardianship, curators and safeguard justice
evaluation of quality of life in patients with type 1 diabetes mellitus during the covid-19 pandemic

Conditions: Type 1 Diabetes Mellitus; Covid19

Summary: during the covid-19 pandemic, the time spent at the home of patients has increased because of national quarantine policies and patients' fear of getting sick. for this reason, in this ongoing process, patients have been unable to go to work regularly due to their chronic diseases (being on administrative leave) and their fear of going out. these reasons have prevented being physically active. the aim of the study is to evaluate the physical activity level, quality of life, glucose control, anxiety, depression, fear of hypoglycemia and loneliness perceptions of patients with type 1 diabetes mellitus during the covid-19 pandemic period and compared with healthy controls.


Eligibility criteria:
inclusion criteria: * having been diagnosed with type 1 diabetes mellitus * willing to participate in the study * participants whose native language is turkish exclusion criteria: * unwilling to participate in the study * having a cognitive disorder * not being literate * individuals who do not have sufficient knowledge and functional levels to fill out the online form
patient report outcome-reconstruction and oncoplastic cohort

Conditions: Patient Reported Outcome Measures; Breast Reconstruction; Oncoplastic Breast-conserving Surgery; Breast Cancer

Summary: available studies that focused on patient-reported outcomes (pros) were mainly from one institution or of small sample size. the variations across hospitals and regions were not fully analyzed. a multicenter prospective patient report outcome-reconstruction and oncoplastic cohort (pro-roc) will be planned to assess the pros for chinese breast cancer patients who will undergo breast reconstruction or oncoplastic breast-conserving surgery (obcs). the inclusion criteria are female breast cancer patients \>18 years old, who will undergo breast reconstruction (br) or obcs. this cohort will include at least 10000 patients (about 5000 patients who undergo br, and 5000 patients who undergo obcs). the exposures were the surgery types: br and obcs regardless of the techniques and materials they used. the primary endpoint will be pros, which include breast-q, quality of life (eortc qlq-c30), eortc qlq-br23). this study follows the helsinki declaration and chinese rules. all patients will be asked to to sign the informed consent and will be followed up 24 months after operations. all data will be collected using an app software.


Eligibility criteria:
inclusion criteria: 1. breast cancer patients; 2. adult (\>18 years old); 3. female; 4. must undergo breast reconstruction or oncoplastic breast-conserving surgery; exclusion criteria: 1. younger (\<18 years old); 2. male; 3. stage iv breast cancer patients; 4. refuse to undergo breast reconstruction or oncoplastic breast-conserving surgery.
screening for pregnancy related pelvic girdle pain

Conditions: Pelvic Girdle Pain

Summary: to perform clinical manual pain provocation tests of the pelvic joints in pain free pregnant women early in pregnancy, follow them until delivery, and compare those who develop ppgp with those who don't.

one arm study: pregnant women are informed about the study at their first visit in maternity care. those that are interested in participating sign an informed consent, and book an appointment with a manual therapist. during the appointment five pain provocation tests are performed to the pelvic joints, and about 13 questions regarding previous low back pain, trauma to the pelvic, or pelvic pain during previous pregnancies, number of previous pregnancies, number of years with contraception, any presence of lactosis intolerance, profession, degree of physical exercises, gestational week, age, and bmi are asked by the therapist. each participant is given a telephone call after delivery, to ask whether any pelvic pain ocurred or not, and whether sick-leave was necessary.

Eligibility criteria:
inclusion criteria: * pregnant women before gestational week 20 without any ongoing symptoms of pain from their pelvic joints. exclusion criteria: * fibromyalgia * sick-leave * working at home * treatment of the pelvic joints during the pregnancy
her 2 testing in indian patients with gastric cancer

Conditions: Gastric Cancer

Summary: gastric cancer remains a major health issue and a leading cause of cancer death worldwide, although the prevalence and mortality of the disease have gradually decreased. the investigators have very few options for patients with advanced disease. the trastuzumab for gastric cancer (toga) trial, a pivotal randomized clinical trial of patients with her-2 positive advanced, mostly metastatic, gastric cancer, proved the efficacy of trastuzumab (anti-her 2 therapy) in combination with chemotherapy. the median overall survival was significantly prolonged in the trastuzumab-containing arm (13.8 vs. 11.1 months; hr 0.74; p=0.0046) without unexpected toxicity including cardiac events. the survival benefit was most pronounced in the subgroup of high her-2/neu protein overexpression (median overall survival of 16 months). only 20% of the patients screened and subsequently enrolled for this study were found to be her2-positive when utilizing both immunohistochemistry and fish. her2 testing is recommended for all patients with advanced gastric cancers and type iii oesophageal adenocarcinomas. data on indian patients is lacking. hence, the investigators plan to test for her 2 in 100 patients with ihc and fish in 2+ and 3+ patients.

1. study objective/ aims aim: - rate of her 2 positivity in 100 consecutive gastric cancer patients primary objective test for her 2 in 100 consecutive gastric cancer patients immuno-histochemistry will be done in all patients. patients with 2 and 3+ ihc will also have fish done. 2. study design\& methodology patients will have the her2 tested in 100 consecutive gastric cancer samples by immunohistochemistry and patients with 2+ and 3+ result will also have fish done. this will not affect patient management 3. overview of data collection dr.bhawna sirohi the principal investigators will maintain and supervise data collection and maintaining records. the patient will be de-identified. 4. selection of study population inclusion criteria: 100 consecutive patients with gastric cancer who have a pathology specimen at tmh exclusion criteria: if histopathology blocks were not available 5) sample size 100 to be enrolled. patient consent waiver applied for as this does not affect patient care 6) statistical analysis it is an observational study so results will be given as %age of total population.

Eligibility criteria:
inclusion criteria: * 100 consecutive patients with gastric cancer who have a pathology specimen at tmh exclusion criteria: * if histopathology blocks were not available

Keywords: her2 testing (human epidermal growth factor receptor 2)
treadmill and music cueing for gait training in mild to moderate parkinson's disease

Conditions: Parkinson's Disease

Summary: sensory and motor cueing have been demonstrated as useful ambulation training techniques for parkinson's disease (pd). this study is aimed to evaluate the effectiveness of treadmill training program with music cueing for mild to moderate pd patients.


Eligibility criteria:
inclusion criteria: 1. male pd patients aged 60-80 years with hoehn and yahr stage 2-3 diagnosed by attending neurologist 2. good cognitive function with thai mental state examination \>23 3. stable medication without freezing 4. no prior exercise program within the last 2 months 5. no contraindication for exercise exclusion criteria: 1. medication change during the study program 2. inability to walk on treadmill (in treadmill groups) 3. cannot complete 80% of the prescribed program

Keywords: parkinson's disease cueing training treadmill training music
the effect of diet or medication to lose weight in people with type 2 diabetes and liver scarring

Conditions: Diabetes Mellitus, Type 2; Liver Fibrosis; Liver Steatoses; Hepatic Steatosis; Hepatic Fibrosis; Overweight or Obesity

Summary: in the netherlands, there are many people with type 2 diabetes. more than half of these people also have fatty liver. this is a build-up of fat in the liver and can lead to long-term scarring and even death of the liver. losing weight can help reduce this. losing weight can be done with medication such as mysimba®, which is often prescribed to people with type 2 diabetes, but losing weight can also be done with diet. in this study, the investigators want to combine a mediterranean diet (with lots of vegetables, fruits, whole grain products, nuts and olive oil) with intermittent fasting. in addition participants are not allowed to eat after the evening meal. the investigators will compare this with a group of participants receiving mysimba®, to see if a diet with intermittent fasting might be better for reducing fatty liver and liver scarring in people with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * moderate to severe liver fibrosis (lsm \>8.0 kpa and \<13.6 kpa) * bmi \> 27 kg/m2 * aged 18-75 years * written informed consent exclusion criteria: * an insufficient comprehension of the dutch language (spoken and written) * female who is pregnant, breast-feeding or intends to become pregnant * participants with an established diagnosis of liver pathology like, but not limited to: hepatitis b, hepatitis c, autoimmune hepatitis, wilson's disease, hemochromatosis, primary biliary cholangitis, primary sclerosing cholangitis, alcoholic liver disease * history of liver transplant, or current placement on a liver transplant list * history of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy or variceal bleeding * participants with active hiv infection and/or treatment * participants with diagnosed malignancies with or without active treatment * participants with history or pre-existing renal disease (egfr \<30 ml/min/1.73 m2) * participants with corticosteroid induced diabetes (while still using corticosteroids) * participants using glp-1 agonists for less than 3 months or not yet on a stable dose * participants using mao-inhibitors, opioids and/or methadone (due to contraindication) * known or suspected excessive alcohol consumption (\>21 drinks/week for males or \>14 drinks/week for females. one drink is equivalent to 10 grams of alcohol) * previous or planned (during the trial period) obesity treatment with surgery. however, previous interventions that, due to reversal or removal, do not have any influence on the patient's weight, in the opinion of the investigator, are allowed. * participants with a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the investigator, may compromise the patient's safety or ability to complete the study

Keywords: diabetes liver diseases liver fibrosis intermittent fasting mediterranean diet mysimba lifestyle