Kornimate/medical-research-clean huggingface dataset:
a trial to investigate the impact of a low glycemic index (gi) diet on body mass index and obesity related cardiovascular and hormonal factors in chinese adolescents

Conditions: Adolescence Obesity

Summary: epidemiological studies suggest a role for a low glycemic index (gi) diet in the management of obesity and associated metabolic risks including diabetes. however, evidence from long-term, randomized controlled trials exploring the relationship between low gi diet, weight reduction and glycemia, particularly in children and adolescents, is lacking. modern food-processing technology has produced many food products with high gi which may contribute to the burgeoning epidemic of obesity worldwide. since dietary habits are shaped in early life, adolescence is a critical period to educate our young people to acquire a healthy eating habit to prevent obesity. the investigators hypothesized that, in chinese adolescents, low gi diet results in greater reduction in body mass index and body fat percentage, enhanced insulin sensitivity and favorable changes of cardiometabolic risk factors compared to conventional diet after 12 months of intervention. this study is a randomized controlled trial of a low gi (\ /=70) in adolescents (12-month intervention followed by a 6-month observational period) to study; 1) the changes in body mass index and obesity associated changes in cardiometabolic profile; 2) the underlying hormonal factors associated with these changes.

this is a 12-month randomized controlled dietary interventional trial followed by a 6-month observational period. the objectives of this study include: 1. to study changes of body mass index, body fat percentage, insulin secretion, insulin resistance and obesity associated cardiometabolic factors; 2. to explore underlying neurohormonal mechanisms associated with these changes in both short- and long-term.

Eligibility criteria:
inclusion criteria: * age between 15 and 18 years (inclusive) * male or female of chinese ethnicity * body mass index \>/= 95th percentile of hong kong local age- and sex-specific reference * no major medical illness * not on any chronic medications * post-pubertal as ascertained by clinical assessment by endocrinologist * willingness to give written informed consent by participants and his/her parents/guardian exclusion criteria: * concurrent participation in any clinical trial, dietary intervention or weight loss program * concomitant intake of weight reducing agent * active and uncontrolled endocrine diseases including hypo- or hyperthyroidism, cushing's syndrome, diabetes mellitus, etc. * significant renal impairment, defined as serum creatinine \>150 umol/l and/or estimated glomerular filtration rate \<60ml/min/1.73m2 * significant liver impairment, defined as \>2 times upper limit of alanine aminotransferase and asparate aminotransferase levels * gastrointestinal problems that would prevent them from following the test diets * active malignant disease * pregnant or lactating * any medical illness or condition including known non-compliance, as judged by the investigators as ineligible to participate the study

Keywords: low glycemic index diet
quality of life among children and adolescents with cancer

Conditions: Cancer

Summary: this descriptive study aims to allow children and adolescents who have cancer to self-evaluate their quality of life. it is hypothesized that treatment affects quality of life in the areas of physical and social functioning. it is further hypothesized that these effects dissipate within 6 months after treatment is completed.

study participants will include all children and adolescents (aged 7 to 21 years old) currently receiving care from the hematology/oncology clinic at the cmhc, which will serve as the study site. these individuals will be identified by the health care professionals working in the clinic. specific study criteria will include only those individuals who (1) can read or write in the english language (due to limited availability of translators); (2) appear to not possibly suffer psychological harm by participating (as determined by any health care professional working in the clinic); and (3) do not have a health condition and/or medical need that supersedes study participation. the weekly list of appointments will be reviewed by the researchers who already work in the clinic for appropriateness (jh, jb and ks). to prevent participation coercion, solicitation for participation will be provided through the child life specialist (cls). the cls is known to each participant and will function as a data collector for this study.

Eligibility criteria:
inclusion criteria:study participants will include all children and adolescents (aged 7 to 21 years old) currently receiving care from the hematology/oncology clinic at the cmhc, which will serve as the study site. these individuals will be identified by the health care professionals working in the clinic. specific study criteria will include only those individuals who (1) can read or write in the english language (due to limited availability of translators); (2) appear to not possibly suffer psychological harm by participating (as determined by any health care professional working in the clinic); and (3) do not have a health condition and/or medical need that supersedes study participation. - exclusion criteria: (1) those electing not to participate; (2) those with no guardian available to consent or (3) those not yet diagnosed with a cancer condition. -

Keywords: cancer quality of life adolescents
radiation therapy in preventing liver metastases in patients with uveal melanoma who havemonosomy 3 or decisiondx class 2 disease and are more likely to develop liver metastases

Conditions: Iris Melanoma; Medium/Large Size Posterior Uveal Melanoma; Stage IIA Uveal Melanoma; Stage IIB Uveal Melanoma; Stage IIIA Uveal Melanoma; Stage IIIB Uveal Melanoma; Stage IIIC Uveal Melanoma

Summary: this clinical trial studies giving radiation therapy to the liver in patients with uveal (eye) melanoma who have a specific chromosome loss (monosomy 3) or are decisiondx class 2 and therefore more likely to have their disease spread from the eye to the liver. radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. early radiation to the liver may reduce the development of tumors in the liver and the overall risk of disease recurrence.

primary objectives: i. progression free survival in patients treated with prophylactic hepatic irradiation. secondary objectives: i. acute and late term toxicity and overall survival. outline: patients undergo external beam radiation therapy daily over 20 minutes on monday-friday for 10 fractions over approximately 2 weeks. after completion of study treatment, patients are followed up every 6 months for 5 years.

Eligibility criteria:
inclusion criteria: * histologically confirmed uveal melanoma * monosomy 3 status (by fluorescent in situ hybridization \[fish\] or multiplex ligation-dependent probe amplification \[mlpa\]) or decisiondx class 2 * tumor thickness \> 3.0 mm * has received definitive treatment of uveal melanoma with brachytherapy, proton therapy, stereotactic radiosurgery, or enucleation * karnofsky performance status (kps) \>= 70 or eastern cooperative oncology group (ecog) * total bilirubin \< 1.5 mg/dl * aspartate transaminase (ast) up to two times normal limit * alanine transaminase (alt) up to two times normal limit * creatinine \< 2.0 mg/dl * functional left kidney based on computed tomography (ct) imaging * positron emission tomography (pet)/ct demonstrating no evidence of metastatic disease * if a woman is of childbearing potential, a negative serum pregnancy test must be documented; women of childbearing potential must agree to use contraception for the duration of radiation therapy (approximately 3 weeks) * understands the trial and procedures and is willing and able to sign the informed consent form exclusion criteria: * previous malignancy, other than localized cutaneous squamous cell carcinoma or basal cell carcinoma * history of prior irradiation to the thorax or abdomen * inadequate hepatic or kidney function (as specified above) * active peptic ulcer disease * upper gastrointestinal bleeding * pregnant women or women that refuse to use contraception throughout the entire study period * currently receiving chemotherapy * refuses to sign the informed consent form
haic combined with bevacizumab and toripalimab for advanced hepatocellular carcinama

Conditions: Hepatocellular Carcinoma; Bevacizumab; Liver Neoplasms; Toripalimab; Oxaliplatin

Summary: this is an open-label, single-arm clinical study to preliminarily observe and evaluate the efficacy and safety of hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin synchronous combined with bevacizumab and toripalimab as the first-line therapy for advanced hcc.

hepatic arterial infusion chemotherapy (haic) of oxaliplatin, 5-fluorouracil and leucovorin was effective and safe for hepatocellular carcinoma. bevacizumab, an angiogenesis inhibitors was effectively used for hepatocelluar carcinama (hcc) therapy. toripalimab, an programmed cell death protein-1 (pd-1) antibody, was effective and tolerable in patients with hepatocellular carcinoma and portal vein tumor thrombus. no study has evaluated haic plus bevacizumab and toripalimab. thus, the investigators carried out this prospective, single-arm study to find out it.

Eligibility criteria:
inclusion criteria: 1. hcc diagnosed by histopathological examination or guidelines for diagnosis and treatment of primary liver cancer or the recurrent hcc after surgery; 2. age between 18 and 75 years; 3. stage b (middle stage) or c (late stage) hcc determined in accordance with barcelona clinic liver cancer staging system (bclc stage). in case of stage b. 4. no previous use of any systemic therapy or recurrent hcc. 5. child-pugh class a or b; 6. eastern cooperative group performance status (ecog) score of 0-2; 7. hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/l serum albumin ≥ 32 g/l asl and ast ≤ 5 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 8. prothrombin time ≤18s or international normalized ratio \< 1.7. 9. ability to understand the protocol and to agree to and sign a written informed consent document. exclusion criteria: 1. cholangiocellular carcinoma (icc); 2. patients with cancer thrombus in the main trunk of portal vein (vp4), or cancer thrombus in inferior vena cava should be excluded; 3. accepting ablation or surgery or other system therapy as firt line therapy after diagnose for primary hcc, ablation or system therapy as first line therapy for recurrent hcc. 4. serious medical comorbidities. 5. evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy 6. known history of hiv 7. history of organ allograft 8. known or suspected allergy to the investigational agents or any agent given in association with this trial. 9. cardiac ventricular arrhythmias requiring anti-arrhythmic therapy 10. evidence of bleeding diathesis. 11. patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
personal protective equipment effects

Conditions: Speech Disorders; Voice Disorders

Summary: severe acute respiratory syndrome coronavirus-2 transmits through droplets; thus, oral, nasal, and conjunctival mucosas are related to contamination, and wearing personal protective equipment (ppe) is strongly suggested. several communication problems between the patient and healthcare workers related to ppe use are reported. in this study, investigators aimed to investigate changes in the acoustic parameters of speech sounds when different ppe are used.

it was planned as a cross-sectional study enrolled 18 healthy male and female participants. after the informed consent, participants were asked to pronounce a \[ɑː\] vowel for at least 3 seconds for voice quality estimation. afterward, all turkish vowels were produced for a minimum of 200 ms. finally, three turkish fricative consonants (\[f\], \[s\], \[ʃ\]) were produced in consonant/vowel/consonant format and in different vowel contexts within a carrier sentence. recordings were repeated for the following conditions: no ppe, surgical-mask, n99-mask, face shield, surgical-mask+faceshield, and n99+faceshield. all recordings were analyzed with proper statistical methods.

Eligibility criteria:
inclusion criteria: * native turkish speakers exclusion criteria: * having an acute respiratory system infection history of any vocal fold surgery

Keywords: speech acoustics
remote postpartum blood pressure monitoring and cardiovascular education

Conditions: Pre-Eclampsia; Complicating Pregnancy; Gestational Hypertension

Summary: the goal of this clinical trial is to learn if patient education and regular text reminders are a feasible intervention to engage patients and reduce post partum hypertension. the main questions it aims to answer are: is a structured postpartum remote blood pressure monitoring intervention with education and individualized medication initiation/adjustment follow-up by televisit feasible? does a structured program reduce the occurrence of postpartum hypertension, ed visits, hospital readmissions, and adverse outcomes? participants will: view an educational video on hdp post-delivery receive 1-2 times daily text messages for 6 weeks postpartum have their blood pressure medications adjusted to lower targets post partum


Eligibility criteria:
inclusion criteria: 1. age of at least 18 years. 2. postpartum status. 3. experience new-onset hypertension during pregnancy. 4. enrollment in connected mom. 5. ability to provide informed consent. 6. establish medical care within the ochsner system to facilitate data collection. exclusion criteria: 1. history of preeclampsia or gestational hypertension during previous pregnancy 2. history of chronic hypertension 3. history of coronary artery disease (myocardial infarction, coronary stent placement, coronary artery bypass grafting, spontaneous coronary artery dissection) 4. history of ischemic cva 5. history of congestive heart failure 6. renal dysfunction 7. liver dysfunction 8. left ventricular dysfunction 9. congenital heart disease 10. still birth at delivery
trial of lenalidomide in patients with lymphoma of the mucosa associated lymphoid tissue (malt) type

Conditions: MALT Lymphoma

Summary: the activity of monotherapy with lenalidomide will be evaluated in patients with lymphoma of the mucosa associated lymphoid tissue (malt).

the primary objective of the study is to evaluate the clinical potential of lenalidomide to induce objective/histologic responses in patients with malt lymphoma. the secondary objectives are to evaluate the safety of lenalidomide in this patient population and to evaluate the impact of lenalidomide on progression free survival.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed malt lymphoma with measurable disease (stage i - iv) * with first or greater relapse after hp-eradication, radiation or chemotherapy in case of gastric lymphoma * age \> 18 years * must be able to tolerate therapy, and have adequate cardiac, renal, and hepatic function, ecog status of 0 - 2 * must be capable of understanding the purpose of the study and have given written informed consent exclusion criteria: * lymphoma histology other than malt lymphoma or malt lymphoma with a diffuse large cell lymphoma ("high grade lymphoma") - component * use of any investigational agent within 28 days prior to initiation of treatment with lenalidomide * history of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years * major surgery, other than diagnostic surgery, within the last 4 weeks * evidence of cns involvement * a history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs * severe peripheral polyneuropathy * clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months * inadequate hematological status at baseline prior to study entry: dependency on red blood cell and/or platelet transfusions, anc (absolute neutrophil count (segmented + bands)) \< 1.0 x 109/l * patients with active opportunistic infections * pregnancy * uncontrolled diabetes mellitus * preexisting thromboembolic events at start of study

Keywords: malt lymphoma advanced or helicobacter pylori-refractory malt lymphoma
risks and benefits of urinary catheter in elective cesarean section

Conditions: Urinary Catheterization

Summary: this study aims to compare the routine use versus non-use of urethral catheterization in women undergoing first elective cesarean section as regard to intraoperative and postoperative complications

this randomized controlled trial will be done at ain shams university maternity one hundred and seventy pregnant women scheduled for first elective cs attending at outpatient clinic will be chosen after complete history and physical examination to determine eligibility for inclusion after taking their consent with full explanation of the study including potential benefits and risks. the study population will be randomized using computer sequence program in 1:1 ratio. allocation of every patient to one of the studied groups will be done using opaque envelops. the studied groups will be either group c or group n for both groups * a written consent will be taken. * full history to exclude medical problems that need special care. * full history to exclude uti or recurrent uti during pregnancy. * a single dose of 2 gm cefazolin will be given iv pre-incision for preoperative antibiotic prophylaxis (sullivan et al., 2007). * midstream urine samples will be collected preoperative to exclude uti and 24 hours postoperatively after giving the instructions to the patients (washing hands and genitals ,pass some urine into the toilet then without stopping catch some urine in a sterile container ) to be analyzed for presence of uti

Eligibility criteria:
inclusion criteria: * pregnant women undergoing first elective cs at term pregnancy (37-41w gestation). * haemodynamically stable exclusion criteria: * history of recurrent uti during pregnancy, current uti * presence of medical complications that requiring special care e.g: diabetes with pregnancy, hypertensive disorders with pregnancy, cardiac disease, chronic renal disease, * previous cesarean section * previous abdominal surgery which may be associated with extensive adhesions, -polyhydraminos * fetal macrosomia * significant vaginal bleeding * contraindication for the antibiotic used e.g: anaphylaxis * need for extensive use of antibiotics more than the prophylactic dose * spinal anesthesia.

Keywords: catheter cesarean section urinary tract infection patient's satisfaction
registry for eosinophilic gastrointestinal disorders (regid)

Conditions: Eosinophilic Gastrointestinal Disorders (EGID); Eosinophilic Esophagitis; Eosinophilic Disorder

Summary: develop registry tool

the purpose of this research study is to develop a registry tool used for the management and care of patients with eosinophilic disorders, and create a research resource that will provide further insights into these disorders.

Eligibility criteria:
inclusion criteria: * eosinophilic gastrointestinal disorder diagnosis

Keywords: eosinophilic gastrointestinal disorders egid eosinophilic esophagitis registry eosinophils eosinophilia eosinophilic enteropathy eosinophilic enteritis eosinophilic gastritis eosinophilic gastroenteritis eosinophilic gastroenteropathy
phase ii study of preoperative imrt combined with capecitabine and bevacizumab in locally advanced rectal cancer

Conditions: Locally Advanced Malignant Neoplasm

Summary: pathological complete response, (pcr) correlates with a favourable overall prognosis in locally advanced rectal cancer patients underwent preoperative chemoradiation, so obtaining a pcr might be beneficial. the aim of the study is to investigate safety and efficacy of preoperative imrt combined with bevacizumab and capecitabine. primary endpoint is pathological complete remission rate.


Eligibility criteria:
inclusion criteria: * male or female patients with histologically proven adenocarcinoma of the rectum ,t3/4 or any node positive disease (clinical stage according the tnm classification system) * no evidence of metastatic disease. * age 18 - 65 years * kps 80-100 * no prior radiotherapy, chemotherapy or any targeting therapy for rectal cancer * normal hematological, hepatic and renal function, ability to swallow tablets * signed informed consent * patients must be willing and able to comply with the protocol for duration of the study exclusion criteria: * malignancy of the rectum other than adenocarcinoma * other co-existing malignancy or malignancy within the past 5 years, with the exception of adequately treated in situ carcinoma of the cervix or basal cell carcinoma of the skin * significant heart disease (uncontrolled hypertension despite of medication (\> 150/100 mmhg), nyha class iii or iv heart disease,unstable angina or myocardial infarction within the past 1 year prior the study entry, history of significant ventricular arrhythmia requiring treatment) * evidence of active peptic ulcer or upper gi bleeding * evidence of bleeding diathesis or coagulopathy * patients receiving a concomitant treatment with drugs interacting with capecitabine such as flucitosine, phenytoin, or warfarin * known hypersensitivity to biological drugs * treatment with any investigational drug within 30 days before beginning treatment with the study drug * pregnant or lactating patient

Keywords: preoperative chemoradiotherapy bevacizumab locally advanced rectal cancer
asct with nivolumab in patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: this is an open-label, single center trial of autologous stem cell transplantation (asct) with nivolumab in multiple myeloma patients to determine the efficacy and safety of asct and pd1 inhibitor combination. for this purpose, 30 multiple myeloma patients, who have received induction therapy and have achieved a partial response (pr), stable disease (sd) or progression, and thus have unfavorable prognosis, will be treated with nivolumab administered iv at a dose of 100 mg on days 3 before and 17 after high-dose melphalan with autologous stem cell transplantation.


Eligibility criteria:
inclusion criteria: * subjects with mm (multiple myeloma) * partial response, stable disease or progression after induction therapy (including asct) * measurable disease * successful peripheral blood stem cell collection with g-csf * eastern cooperative oncology group (ecog) performance status (ps) 0-2 * signed informed consent * patients after first-line induction therapy exclusion criteria: * another malignancy requiring treatment at the time of inclusion * history of interstitial lung disease or pneumonitis * patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure nyha class iii or iv, myocardial infarction within 6 months, and poorly controlled hypertension) which, in the opinion of the investigator could compromise participation in the study * uncontrolled bacterial or fungal infection at the time of enrollment * pregnancy * somatic or psychiatric disorder making the patient unable to sign informed consent * active or prior documented autoimmune disease requiring systemic treatment * prior treatment with anti-pd-1, anti-pd-l1, or anti-ctla4 therapy

Keywords: multiple myeloma nivolumab melphalan autologous hematopoietic stem cell transplantation