Kornimate/medical-research-clean huggingface dataset:
toxicity after radiotherapy in breast cancer survivors (thoraces) - a retrospective cohort study

Conditions: Breast Cancer

Summary: rationale: the number of breast cancer (bc) patients at risk for long-term radiation-induced health problems is increasing, as their outcome is improving due to intensified treatment regimens, such as new systemic approaches and radiotherapy. therefore, identifying bc survivors with the highest risk for radiation-induced health problems is crucial for developing strategies for primary and secondary prevention, which may contribute to healthy ageing.


Eligibility criteria:
inclusion criteria: * female gender. * treated for stage i-iii invasive adenocarcinoma of the breast or ductal carcinoma in situ (dcis). * treated with curative breast-conserving surgery followed by radiotherapy of the breast, with or without irradiation of the regional lymph nodes. * start of radiotherapy is between 01-01-2005 and 31-12-2008. * available planning ct scan and dose distribution data of original breast cancer irradiation. exclusion criteria: * any prior malignancy other than non-melanoma skin cancer or breast cancer. * prior radiotherapy treatments in the thoracic region. * treated with neoadjuvant chemotherapy.

Keywords: radiation-induced health problems cardiovascular events lung toxicity
safety, tolerability, pharmacokinetics of intravenous rpx2014 and rpx7009 in healthy adult subjects

Conditions: Healthy Volunteers; Bacterial Infections

Summary: rpx7009 (beta-lactamase inhibitor) is being studied in combination with a carbapenem (rpx2014) to treat bacterial infections, including those due to multi-drug resistant bacteria.

the worldwide spread of resistance to antibiotics among gram-negative bacteria, particularly members of the eskape group of pathogens, has resulted in a crisis in the treatment of hospital acquired infections. in particular, the recent dissemination of a serine carbapenemase (e.g., kpc) in enterobacteriaceae in us hospitals now poses a considerable threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents. rempex is developing a fixed combination antibiotic of a carbapenem (rpx2014) plus a new beta-lactamase inhibitor (rpx7009) which has activity against serine beta-lactamases, including kpc. this phase 1 study will assess the safety, tolerability and pharmacokinetics of intravenous rpx2014 and rpx7009, administered alone and in combination, in healthy adult subjects.

Eligibility criteria:
inclusion criteria: 1. healthy adult males and females, 18 to 55 years of age (inclusive) at the time of screening. 2. body mass index (bmi) ≥ 18.5 and ≤ 29.9 (kg/m2) and weight between 55.0 and 100.0 kg (inclusive). 3. medically healthy with clinically insignificant screening results (e.g., laboratory profiles, medical histories, ecgs, physical examination) as deemed by the pi. 4. non-tobacco/nicotine-containing product users for a minimum of dose study 6 months prior to day 1. 5. voluntarily consent to participate in the study. 6. sexually abstinent or agree to use two approved methods of contraception. exclusion criteria: 1. history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease. 2. positive urine drug/alcohol testing at screening or check-in (day -1). 3. positive testing for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or hepatitis c antibodies (hcv). 4. history or presence of alcoholism or drug abuse within the 2 years prior to day 1. 5. use of any over-the-counter (otc) medication, including herbal products and vitamins, within the 7 days prior to day 1. up to 2 grams per day of acetaminophen is allowed for acute events at the discretion of the pi. 6. blood donation or significant blood loss (i.e., \> 500 ml) within 56 days prior to day 1. 7. plasma donation within 7 days prior to day 1. 8. participation in another investigational clinical trial within 30 days prior to day 1. 9. subjects who have any abnormalities on laboratory values at screening or check-in (day -1).
a phase iiib: long-term outcomes for hepatitis b (hepb) patients in some previous entecavir (etv) trials

Conditions: Hepatitis B

Summary: the purpose of this study is to follow patients treated in entecavir phase iii and rollover studies for safety experience and hepatitis b virus (hbv)-related complications.

observational model: only subjects who participated in entecavir phase iii studies ai463022, ai463023, ai463026, and ai463027. number of groups/cohorts: 1 (all subjects were observed in the same manner).

Eligibility criteria:
inclusion criteria: * all subjects who participated in entecavir phase iii studies ai463022, ai463023, ai463026, and ai463027.
temozolomide in treating young patients with high-risk relapsed or refractory neuroblastoma

Conditions: Neuroblastoma

Summary: rationale: drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. purpose: this phase ii trial is studying how well temozolomide works in treating patients with high-risk relapsed or refractory neuroblastoma.

objectives: primary * determine the anti-tumor activity of temozolomide in young patients with high-risk relapsed or refractory neuroblastoma. secondary * determine the duration of response in patients treated with this drug. * determine tolerability of this drug in these patients * determine the tumor expression of the cellular repair mechanisms which repair dna damage (o6-methylguanine-dna methyltransferase \[mgmt\] and mismatch repair \[mmr\] systems) in patients treated with this drug. * correlate mgmt and mmr expression with outcomes in patients treated with this drug. * determine if mgmt and mmr expression/activity changes in the tumor during initial presentation, treatment, and relapse/progression in patients treated with this drug. * determine the activity of mgmt in bone marrow taken at relapse, in terms of hematological toxicity, in patients treated with this drug. outline: this is a multicenter, open label, nonrandomized study. patients receive oral temozolomide once daily for 5 days. treatment repeats every 28 days for 2 courses. patients achieving stable or responding disease after completion of the 2 courses may receive up to 10 additional courses of treatment in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 25 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically proven neuroblastoma * high-risk relapsed or refractory disease, defined as 1 of the following: * metastatic disease * localized myc-n amplified disease * localized non myc-n amplified disease at second relapse * measurable primary or metastatic disease by cross-sectional imaging or mibg scan patient characteristics: * lansky performance status 40-100% * life expectancy \> 2 months * not pregnant or nursing * fertile patients must use effective contraception during the course of this study and for 6 months after study completion * organ toxicity \< grade 2 * platelets ≥ 100,000/mm\^3 (50,000/mm\^3 after stem cell transplant or in case of marrow involvement) * neutrophil count ≥ 500/mm\^3 * bilirubin \< 1.5 times normal * ast and alt ≤ 2.5 times normal * no known hiv positivity prior concurrent therapy: * more than 21 days since prior chemotherapy treatment (isotretinoin is counted as chemotherapy for this purpose) * more than 30 days since prior radiotherapy except local palliative treatment for pain control * no more than 2 prior treatments for neuroblastoma * no other concurrent investigative treatment for neuroblastoma

Keywords: recurrent neuroblastoma disseminated neuroblastoma localized unresectable neuroblastoma
maternal and fetal outcome with metformin therapy for obese pregnant women .

Conditions: Metformin for Obese Pregnant Women

Summary: to evaluate the role of metformin in pregnant women with obesity (bmi above 30) , on maternal and infant outcome.

obesity is defined as having an excessive amount of body fat based on the bmi, obesity can be classified based on the bmi to obese class i ,class ii ,and extreme obesity (class iii) , obesity can harm the fertility by inhibiting normal ovulation. even in women who regularly ovulate, the greater the bmi, the longer it appears to take to become pregnant. obesity can also affect the outcome of in vitro fertilization (ivf). (1) being obese during pregnancy increases the risk of various pregnancy complications, including : miscarriage ,stillbirth ,gd , preeclampsia , obstructive sleep apnea , difficult vaginal delivery ,need for c-section ,and complication of c-section ,fetal macrosomia , and increasing the risk for metabolic syndrome and childhood obesity , it also make it may be hard for the participants health care provider to diagnose birth defects during pregnancy even prenatal tests like ultrasound(2),(3) . normal weight gain during pregnancy for obese women having single pregnancy is between about (5-9) kg . normal weight gain during pregnancy for obese women having multiple pregnancy is between about (11-19) kg (4). for women who are extremely obese, gaining less than the recommended amount or losing weight during pregnancy might lower the risk of fetal and neonatal macrosomia . the fetus is regarded as suspected appropriate or gestational age (aga) when the sonographic estimated fetal weight (sefw) is at 10th to 90th percentile for gestational age (ga), and suspected lga when the sefw \> 90th percentile (5) . a baby diagnosed with fetal macrosomia has a birth weight of more than 8 pounds,(4,000 grams), regardless of his or her gestational age (6,7,8) . in this study the investigator will try to focus on diagnose undiagnosed diabetic using gtt (glucose tolerance test specially with women who has one or more risk factors a raised body mass index (bmi) over 30kg/m². a previous baby over 4kg or more ,confirmed gestational diabetes in a previous pregnancy or have a first degree relative that has diabetes all pregnant women who have not already been diagnosed with diabetes should be screened for diabetes with a fasting plasma glucose (fpg), an hba1c, or an untimed random plasma glucose test at their first prenatal visit * women who by 24 weeks' gestation have not yet been diagnosed with overt or gestational diabetes should, at between 24 and 28 weeks' gestation, undergo a 2-hour, 75-g ogtt for gestational diabetes * at 24-28 weeks' gestation, a result of 153-199 mg/dl for a 2-hour, 75-g ogtt indicates gestational diabetes, while a test result of 200 mg/dl or higher indicates overt diabetes(9),(10)

Eligibility criteria:
inclusion criteria: * pregnant women with bmi ≥ 30 kg/m2, and normal glucose tolerance test. exclusion criteria: * pregnant women who are diabetic, * had a history of previous gdm, * previous small baby, * pco or * previous early pre-eclampsia,
covid-19 and liver injury in patients with or without underlying liver disease: a multi-centre retrospective-prospective observational study

Conditions: COVID-19

Summary: covid-19 and liver injury in patients with or without underlying liver disease: a multi-centre retrospective-prospective observational study. all patients infected with sars-cov-2 and admitted to the covid-19 ward/icu of max hospital saket (either in east wing , max super specialty hospital, saket or max smart super specialty hospital, saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020- 30/5/2020 \& prospective data from approval till 30/6/2020), will be included

covid-19 and liver injury in patients with or without underlying liver disease: a multi-centre retrospective-prospective observational study. all patients infected with sars-cov-2 and admitted to the covid-19 ward/icu of max hospital saket (either in east wing , max super specialty hospital, saket or max smart super specialty hospital, saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020- 30/5/2020 \& prospective data from approval till 30/6/2020), will be included primary objectives 1. to study the prevalence of liver live injury \& factors associated with among patients in-fected with sars-cov-2. 2. to study the prevalence of new liver injury and factors associated with it, among patient with underlying liver disease who develops covd-19. secondary objectives 1. to correlate the presence and degree of liver dysfunction with the clinical outcomes in these patients. 2. to define the incidence of development of acute liver failure among these patients

Eligibility criteria:
inclusion criteria:all patients infected with sars-cov-2 and admitted to the covid-19 ward/icu of max hospital saket (either in east wing , max super specialty hospital, saket or max smart super specialty hospital, saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020- 30/5/2020 \& prospective data from approval till 30/6/2020), will be included. - exclusion criteria: 1. patients less that 18 years old with covid-19 2. pregnant ladies with covd-19 3. unwilling to give consent for inclusion
prediction of blood pressure outcomes following renal denervation (predict-rdn)

Conditions: Uncontrolled Arterial Hypertension

Summary: prospective, single arm trial to assess the effects of renal denervation on day-by-day blood pressure measurements and time in blood pressure target range, as well as establish a multivariate prediction model for blood pressure reduction after renal denervation.


Eligibility criteria:
inclusion criteria: 1. confirmed arterial hypertension with systolic or diastolic blood pressure \>140/90 mmhg in standardized office blood pressure measurement 2. treatment with 3 to ≤5 antihypertensive drug classes 3. age \>18 years 4. written informed consent exclusion criteria: 1. age ≤ 18 years 2. anatomy unsuitable for renal denervation (i.e. renal artery stenosis, single functioning kidney) 3. pregnancy 4. patients under legal supervision or guardianship 5. participation in other trials that might interfere with the study outcome according to the opinion of one of the investigators.
intralipid related effect on nkcells in patients with unexplained recurrent spontaneous abortion

Conditions: Recurrent Miscarriage

Summary: evaluating the effect of intralipid on the natural killer cells

this study will done on women with recurrent spontaneous abortions having increased nkcells activity and evaluate the effect of intralipid on them after re-estimation of nkcells activity again after one week of intralipid adminstration

Eligibility criteria:
inclusion criteria: * all women icluded having recurrent spontaneous abortions equal or more than twice. * alittle women having increased nkcells activity. exclusion criteria: * any other diseases causing miscarriage as autoimmune (lupus erythematosus or antiphospholipid antibodies syndrome )or endocrinopathy (diabetes mellitus, thyroid disorders and hyperprolactinaemia)or thrombophilia (factor v leiden mutation, protein c or s deficiency, prothrombin g20210a mutation, antithrombin iii deficiency ) or abnormal karyotyping to one or both of parents or previous history of hormonal contraception or intrauterine device usage at last 3 months or any contraindications for intralipid usage.

Keywords: intralipid nk cells recurrent miscarriage
comparative study of techniques in melanocyte-keratinocyte transplantation for the treatment of vitiligo

Conditions: Vitiligo

Summary: previous studies have evaluated the transplantation of pigment cells (melanocytes)and skin cells (keratinocytes) for the treatment of vitiligo. this procedure is known as mktp (melanocyte keratinocyte transplantation procedure). multiple studies have found this procedure to be both safe and effective for the treatment of vitiligo. the majority of these studies utilized trypsin to help isolate melanocytes and keratinocytes. trypsin is enzyme that helps to separate the different layers of skin. however, some cell biologists believe that the enzyme dispase (which can be used to separate the epidermis from the dermis) is less toxic to cells of the epidermis and can result in a greater number of viable melanocytes and keratinocytes for transplantation. this study will look at the repigmentation rates of mktp using trypsin to isolate cells, versus mktp using dispase to isolate cells.


Eligibility criteria:
inclusion criteria: 1. be at least 18 years old 2. have a diagnosis of generalized vitiligo-vitiligo affecting both sides of the body on one or more areas of the body (extremities, trunk, etc.) 3. have stable vitiligo, defined as no new lesion development (or expansion of existing lesions) in the 6 months prior to proposed procedure date 4. be able to understand the requirements of the study, the risks involved, and be able to sign the informed consent form 5. agree to follow and undergo all study-related procedures exclusion criteria: 1. female patients self-reported to be lactating, pregnant, or planning to become pregnant 2. patients with a history of developing vitiligo or hypertrophic scars at sites of trauma 3. patients self-reported as having hiv or hepatitis c 4. patients self-reported as having uncontrolled diabetes mellitus 5. the investigator feels the patient should not participate in the study for any reason 6. patients with acral vitiligo, defined as significant involvement of the fingers and/or toes 7. patients with focal or segmental vitiligo, defined as vitiligo affecting only one area of the body on only one side of the body 8. patients with vitiligo affecting greater than 30% of their body surface area
intraoperative protective ventilation for obese patients undergoing gynaecological laparoscopic surgery

Conditions: Anesthesia; Surgery--Complications

Summary: background. the use of a comprehensive strategy providing low tidal volumes, peep and recruiting maneuvers in patients undergoing open abdominal surgery improves postoperative respiratory function and clinical outcome. it is unknown whether such ventilatory approach may be feasible and/or beneficial in patients undergoing laparoscopy, as pneumoperitoneum and trendelenburg position may alter lung volumes and chest-wall elastance. objective. the investigators designed a randomized, controlled trial to assess the effect of a lung-protective ventilation strategy on postoperative oxygenation in obese patients undergoing laparoscopic surgery.


Eligibility criteria:
inclusion criteria: * scheduled for gynaecological laparoscopic surgery in the trendelenburg position * obesity with body mass index\>35 kg/m\^2 * written informed consent exclusion criteria: * clinical history or signs of chronic heart failure * history of neuromuscular disease * history of thoracic surgery * pregnancy * chronic respiratory failure requiring long-term oxygen administration

Keywords: mechanical ventilation
behavioral exercise training to reduce cardiovascular disease risk

Conditions: Prostate Cancer; Supportive Care

Summary: to test the preliminary effectiveness of a home-based exercise training (et) intervention to improve exercise capacity (vo2 peak \& 6-minute walk distance \[6mwd\]) among prostate cancer (pc) patients compared to controls receiving healthy living education (hle) at 12 weeks.


Eligibility criteria:
inclusion criteria: * be diagnosed with stage ii/iii/iv prostate cancer * be currently undergoing treatment with adt (intermittent or prolonged) * have completed local curative-intent treatment, including prostatectomy or definitive radiation; * be \>40 years of age up to 85; * be willing to sign an informed consent with hipaa authorization form; * not have any hearing or sight impairments that result in the inability to use the telephone or hear normal conversation; * must be able to join an intervention group by personal computer, smartphone or telephone call and should agree to recording of an interview; * be without any serious medical condition that precludes safe participation in an exercise program; * speak english exclusion criteria: * be unable to undergo mri (i.e., ferromagnetic materials in body, inability to lie flat, claustrophobia); * have contraindications to exercise testing; * have pre-existing overt cardiovascular disease/heart failure; * active illness/infection; * hemoglobin \< 7.0 grams/dl * platelet count \< 10 x 109/l

Keywords: prostate cancer supportive care exercise
hepatic sugar metabolism measured by pet/ct in patients and healthy subjects

Conditions: Liver Cirrhosis

Summary: the investigators wish to determine the lumped constant (lc), which is a correction factor necessary for converting measurements of hepatic fdg metabolism (measured by pet) to those of regular glucose in patients with cirrhosis and healthy subjects. working hypothesis * lc for fdg in liver tissue is not significantly different from unity in healthy subjects * lc for fdg in liver disease is significantly different from lc in healthy liver * insulin changes the lc for fdg in liver tissue, but not by the same factor in liver disease and healthy subjects.

the lc for fdg is determined in 8 patients with liver disease and 8 healthy volunteers with and without glucose-clamp on two different days at 3-5 week intervals. the individual order of the two examinations will be randomized. the subjects fast overnight before the examination but are allowed to drink water and take usual medication. when arriving at the pet centre, venflons are placed in a cubital vein in both arms and an icg infusion is started in one of them. on the day with the glucose-clamp, an infusion of insulin and glucose is started in the second venflon. next, an artflon is placed in one radial artery and a lever vein catheteter is placed via an introducer catheter in the left femoral vein under sterile conditions and local anesthetic (lidocaine). the position of the liver vein catheter is checked with fluoroscopy. on each experimental day, a bolus of 200 mbq fdg + 25 μci \[3h\] glucose (diluted with saline up to 10 ml) is given intravenously at the start of a 60-min pet scan of the liver. blood samples from a peripheral artery and a liver vein are collected for determination of blood concentrations of fdg and \[3h\]glucose at appropriate intervals. in the experiment with glucose-clamp, an intravenous infusion of insulin (0.6 mu/kg/min) is given and blood glucose is measured every 10 min and kept constant at around 5 mm by infusing 20% glucose (infusion rate adjusted according to blood glucose). during each study, the hepatic blood flow rate is measured by giving an intravenous infusion of indocyanine green (icg) and collecting arterial and liver vein blood samples (fick's principle). blood samples are analyzed for concentrations of fdg (gammacounter), \[3h\]glucose (liquid-scintillation counter), glucose (enzymatic assay) and icg (spectrophotometric). when the experiment is finished, all infusions are terminated and the liver vein catheter is removed and hemostasis ensured by manual compression (10 minutes) and bed rest for 30 minutes before the subject is allowed to stand. the artflon is then removed and hemostasis ensured by manual compression (10 minutes). finally, the venflons are removed.

Eligibility criteria:
inclusion criteria: * age between 40 and 70 years * bmi between 20 and 26 exclusion criteria: * diabetes mellitus * glucose intolerance * medical treatment of portal hypertension * people who have underwent surgery for obesity * pregnancy

Keywords: lumped constant fdg pet