Kornimate/medical-research-clean huggingface dataset:
safety study of a genetically modified adenovirus in ovarian cancer patients

Conditions: Ovarian Cancer; Primary Peritoneal Cancer

Summary: the primary purpose of this study is to determine the maximally tolerated dose and spectrum of toxicities encountered with intraperitoneal delivery of a rgd modified conditionally replicative adenovirus (ad5-delta 24rgd) in patients with recurrent ovarian cancer. secondary objectives : * to determine the biologic effects encountered with intraperitoneal delivery of ad5-delta 24rgd in patients with recurrent ovarian cancer cells * to determine immunologic response generated against ad5-delta 24rgd when administered intraperitoneally to patients with recurrent ovarian adenocarcinoma * to determine potential clinical activity of ad5-delta 24rgd when administered intraperitoneally to patients with recurrent ovarian adenocarcinoma


Eligibility criteria:
inclusion criteria: * patients must have histologically documented invasive epithelial ovarian or extra-ovarian adenocarcinoma * patients must have persistent or recurrent disease after standard debulking/staging surgery and conventional chemotherapy.prior chemotherapy must have included a taxane/platinum based regimen * patients must have evidence of intraabdominal disease; disease may be measurable or nonmeasurable * patients must have a gog performance status of 0, 1, or 2, and have a life expectancy of greater than 3 months * patients must have adequate hematologic, renal, cardiac, pulmonary, coagulation, and hepatic function defined as: 1. wbc\> 3,000 ul 2. granulocytes\> 1,500 ul 3. platelets\> 100,000 4. creatinine clearance (actual or calculated) \>80 mg/dl or serum creatinine \<2.0 5. serum transaminases \<2.5x upper limits of normal 6. normal serum bilirubin 7. pt/ptt/inr \< 1.5 x institutional uln 8. ejection fraction on echocardiogram \> 55% 9. o2 saturation \> 92% * patients must be 19 years or older (as mandated by alabama state law) and must have signed informed consent exclusion criteria: * patients with epithelial ovarian tumors of low malignant potential (with or without invasive implants), with ovarian stromal tumors, or with germ cell tumors of the ovary are ineligible to participate in the study * patients with the only site of disease located beyond the abdominal cavity are ineligible to participate in the study * patients who are pregnant or lactating are ineligible to participate in the study * patients with a gog performance status of 3 or 4 are ineligible to participate in the study * patients with active heart disease (characterized by angina, unstable arrhythmia, congestive heart failure or ef \< 55%, pulmonary hypertension), active or chronic debilitating pulmonary disease (i.e., active pneumonia, severe copd, pulmonary edema, o2 saturation \< 92%), or coagulation disorders (i.e., bleeding disorders, on therapeutic anti-coagulants)

Keywords: ovarian cancer study
radical gastrectomy within enhanced recovery programs(eras): a prospective randomized controlled trial

Conditions: Gastrostomy Complications

Summary: this study is a prospective, single-center, randomized controlled trial. the study protocol was approved by the ethics committee at the first hospital of jilin university.eras is combined with the laprascopic gastrectomy to assess the efficacy and safety in patients with advanced gastric carcinoma.the hospitalized patients were randomly divided into eras group and conventional pathway group . inter-group differences were evaluated for clinical recovery index, economic indicators, length of hospital stay, 3 years to 5 years long-term survival, etc.


Eligibility criteria:
inclusion criteria: * (1) a preoperative cancer stage of t2, t3, t4, any n, m0 without digestive obstruction confirmed by whole body ct scan, which could be treated with laparoscopic gastrectomy; (2) age 18-75 years; (3) pathologic confirmation of gastric adenocarcinoma by endoscopic biopsy; (4) normal hematological, renal, hepatic, and cardiac parameters, asa score \< iii without severe systemic disease; and (5) no history of treatment with neoadjuvant chemotherapy and/or radiotherapy. exclusion criteria: * patients requiring conversion to open gastrectomy; excessive bleeding (˃ 500 ml);and patients opting out of the study.

Keywords: eras,gastric cancer
misoprostol in missed abortion

Conditions: Abortion; Attempted

Summary: in this study we compare between the effectiveness of combined foley's catheter with misoprostol and intracervical foley's catheter alone for termination of second trimester abortion.

termination of pregnancy (top) is defined as elective expulsion or extraction of products of conception from uterus instead of spontaneous onset of process irrespectable of duration of pregnancy. worldwide mid-trimester abortion constitutes 10-15% of all induced abortions but responsible for two-thirds of all major complications despite the recent advances in prenatal diagnosis in first trimester. termination of pregnancy in second trimester due to foetal abnormalities and intrauterine foetal death still accounts for large number of abortions, and has increased the demand for rapid termination of pregnancy. in intrauterine fetal death in 2nd trimester, expulsion may take several weeks. this is associated with psychological trauma, coagulopathy and intrauterine infection. among various methods of second trimester termination, evacuation and curettage induces risk of bleeding, infection, uterine perforation and cervical trauma. the introduction of misoprostol , a synthetic prostaglandin e1 analogue (pge1) has become an important for cervical ripening and uterotonic action. it is economic, stable at room temperature and is associated with few side effects such as fever, vomiting and diarrhea. there is still debate about doses, routes and regimes of pge1 for termination of pregnancy during 2nd trimester. it is active orally but more effective and better tolerated when administrated vaginally and has fewer side effects. vaginal route is preferred in first and second trimester. the use of foley's catheter has been recommended in many developing countries. the reports from different countries have mentioned excellent results with the use of foley's catheter either alone or in combination with prostaglandins. the scope of our study: is to compare the use of foley's catheter combination with misoprostol versus foley's catheter alone for pre induction cervical ripening and induction of second trimester abortion.

Eligibility criteria:
inclusion criteria: * women aged between 18 - 40 years of age with mid-trimester fetal death inutero. * singleton pregnancies from 18-24 weeks. * women with unfavourable cervix (bishop score \< 5) at the time of recruitment. * previous one cs and non-previous cs pregnant women. exclusion criteria: * • previous 2 cs or more. * medical contraindications for prostaglandin therapy (allergy to prostaglandins or severe asthma). * co-morbidities like severe anemia (hb \< 7g/dl), hypertension, diabetes, or coagulopathy . * women with excessive vaginal discharge or rupture of membrane. * women having any complication in previous caesarean like endometritis, reopening, scar dehiscence etc. * active genital infection e. g. active genital herpes simplex infection.

Keywords: abortion misopristol foley catheter
a randomised single centre study to compare the long-term performance of acryloc™ and palacos® r bone cements in primary total hip replacement

Conditions: Osteoarthritis; Post-traumatic Arthritis; Avascular Necrosis

Summary: the purpose of this study is to monitor the stability of a total hip replacement within the thigh bone when used in artificial hip joints implanted with two different bone cements, acryloc™ and palacos® r, in the treatment of patients with hip joint disease requiring a total hip replacement. patients who enter the study will be randomly allocated to acryloc™ or palacos® r and will be evaluated at regular intervals following hip surgery using patient, clinical, x-ray assessments and special x-rays which allow the stability of the hip implant to be determined


Eligibility criteria:
inclusion criteria: i) male or female subjects, aged 60 to 75 years (inclusive), and with a weight of less than 100kg. ii) subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. iii) subjects who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups. iv) subjects with non-inflammatory arthritis of the hip. v) subjects who require a primary total hip arthroplasty and are treated at the arthroplasty section of the orthopaedics department at the investigational centre. vi) subjects who are considered suitable for a cemented femoral stem and cemented acetabular component. exclusion criteria: i) subjects who, in the opinion of the investigator, have an existing condition such as malignancy, severe osteoporosis, disabling musculo-skeletal problems (other than in the hips) or any other condition that would compromise their participation and follow-up in this study. ii) women who are pregnant. iii) subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes. iv) subjects who have participated in a clinical study with an investigational product in the last 6 month(s). v) subjects who are currently involved in any injury litigation claims. vi) subjects undergoing corticosteroid treatment. vii) subjects with any condition for whom the use of conventional bone cement is contra-indicated.

Keywords: hip cement
antigen-specific immune response to hepatitis b virus in utero

Conditions: Hepatitis B

Summary: this study aims to gain an understanding of the key components of the immune response to hepatitis b present in cord blood of hbv infected mothers.

despite the development of an effective preventive hbv vaccine, the spread of hbv virus continue, particularly in asia, where the majority of hbv infection is acquired at birth by vertical transmission from mother to baby. hbv vertical transmission has been hypothesized to cause immune tolerance to hbv and thus promoting the subsequent hbv chronicity. such hypothesis has never been tested and nothing is known about hbv-specific adaptive immune response occurring before birth in baby born form hbv chronically infected mothers. this study aims to gain an understanding of the key components of the immune response to hepatitis b present in cord blood of hbv infected mothers. the characterization of the hbv immune response in utero will provide informations about the cause of hbv chronicity in asian patients in the management of baby born from hbsag+ mothers.

Eligibility criteria:
inclusion criteria: * pregnant women with hbsag+ exclusion criteria: * pregnant women without hbsag+

Keywords: hepatitis b carrier
minimally invasive surgery techniques for one-level degenerative lumbar deformities correction

Conditions: Intervertebral Disc Degeneration; Spinal Fusion

Summary: this study will be conducted at research institute of traumatology and orthopedics (nrito) n.a. ya.l.tsivyan, novosibirsk, russia. the current study is prospective pilot clinical study to demonstrate the possibility and effectiveness of performing modified technique of mis tlif, supplemented by segmental vertebrotomy, to correct segmental deformity of lumbar spine. it is expected to enroll 10 patients aged 18-70 with segmental deformity of lumbar spine, caused by degenerative spondylolisthesis and/or degenerative stenosis.


Eligibility criteria:
inclusion criteria: * given written informed consent; * single-level segmental deformity caused by degenerative spondylolisthesis and/or degenerative stenosis at the one level of lumbar spine l4-l5 or l5-s1; * mono- and/or polyradicular leg pain and/or neurogenic claudication with or without back pain; * symptoms persisting for at least three months prior to surgery; * able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements. exclusion criteria: * lumbar deformation of non-degenerative etiology; * spondylolisthesis grade ii or higher (25% slip or greater) of any etiology; * patient that has already undergone a lumbar fusion surgery; * other non-degenerative spinal conditions (e.g. infectious, traumatic, metabolic, inflammatory, neoplastic, structural or other pathology) that may have an impact on subject safety, wellbeing or the intent and conduct of the study * concurrent participation in another clinical study that may confound study results.
long term vitamin d therapy in hcv treated patients

Conditions: Chronic Hepatitis C

Summary: treatment of hepatitis c virus (hcv) infection was carried out using pegylated interferon (peg-ifn), ribavirin (rbv) and vitamin d (vit d) for 48 weeks in hcv genotypes 4a subjects. the purpose of this study is to determine the effect of vitamin d on liver affection in such patients.

fifty patients study group administered vit d were compared with 50 patients control group without vit d. the results showed a significant elevation in vit d levels during the time period, and significant reduction on hcv rna from the 12th wk to reach zero level in 24th wk. interleukin 6 (il-6), visfatin and hyaluronic acid levels were reduced significantly to reach normal values. these concentrations reduction by the effect of vit d on hcv indicated the reduction in inflammation, infection and liver cirrhosis and nearly amelioration hcv.

Eligibility criteria:
inclusion criteria: * chronic hcv infection (positive hcv ab more than 6 months) * treated with pegylated interferon and ribavirin exclusion criteria: * coinfection with hepatitis b or hepatitis d or human immunodeficiency virus * previous non response to antiviral therapy. * other causes of chronic liver diseases as schistosomiasis, wilson disease and alcoholic liver disease.

Keywords: hepatitis c infection vitamin d
role of multi-detector ct and mri in diagnosis of congenital inner ear anomalies

Conditions: Ear Disease, Inner

Summary: evaluation of combined value of multi-detector computed tomography (mdct) and magnetic resonance imaging (mri) in the diagnosis of congenital abnormalities of the inner ear and internal auditory canal in patients with congenital hearing loss and preoperative evaluation of cochlear implant candidates.

introduction: inner ear malformation (iem) with associated sensoryneural hearing loss (snhl) is a major cause of childhood disability. the embryology of the inner ear must be known as many of the inner ear malformations present as a result of the arrest during the various stages of embryology. congenital malformations of the inner ear may be considered in two broad categories: 1. malformations with pathologic changes that involve only the membranous labyrinth. 2. malformations that involve both the osseous and the membranous labyrinth. congenital sensorineural hearing loss arises as a result of abnormalities in the inner ear, the vestibulocochlear nerve, or the processing centres of the brain. the abnormality may have a genetic cause or be a sequel of infection or injury at birth; in some cases, no cause is identified. one of the paths in the investigation of congenital sensorineural hearing loss (csnhl) is to try to characterize its aetiology through the inner ear evaluation using high resolution computer tomography (ct) scans. with minor malformation, it is not always possible for a simple visual inspection to recognize if the structure in the inner ear is normal or not. both ct and mr can be used to look at inner ear malformations but often both techniques are complementary. ct is preferred when associated middle or external ear malformations must be excluded. magnetic resonance is preferred when subtle changes in the membranous labyrinth or abnormalities of the nerves in the internal auditory canal must be visualised moreover, some changes inside the membranous labyrinth can only be seen on sub-millimetric heavily t2-weighted mr images. only mr can demonstrate the abnormal course, hypoplasia or aplasia of the vestibulocochlear nerve (or one of is three branches) and facial nerve. hrct and mri temporal bone are complementary to each other in evaluating children for cochlear implantation as hrct is excellent for demonstrating bony details but, lack in providing details of inner ear neural structures and mri is better than ct in demonstrating vestibulocochlear nerves. combined hrct and mri studies are mandatory for evaluation of inner ear, the radiologist must be familiar with imaging findings that absolutely contraindicate implantation (cochlear aplasia, cochlear nerve aplasia and labyrinthine aplasia), and with those that relatively contraindicate implantation (labyrinthitis ossificans, other inner ear dysplasia) and with other findings that could significantly alter or complicate surgery (hypo plastic mastoid process, facial nerve dehiscence, oto-mastoiditis)

Eligibility criteria:
inclusion criteria: * all patient of inner ear anomalies exclusion criteria: * studied groups ,mri

Keywords: mri ct ear disease
effect of chewing gum and wechat enhanced instructions on the bowel preparation quality in patients with constipation

Conditions: Colonoscopy; Colonic Polyp; Constipation

Summary: patients with constipation are more likely to have poor bowel preparation quality due to slow gut motility and poor emptying ability. gum chewing, as a proxy of sham feeding, is a very simple way used to accelerate gut motility. and a previous study found that enhanced instructions by wechat could improve bowel preparation quality. thus, investigators conducted a single-center randomized controlled trial to explore the effect of chewing gum combined with manual enhanced instructions by wechat on the bowel preparation quality for colonoscopy in patients with constipation.

in this randomized controlled trial, consecutive outpatients with constipation for colonoscopy are screened and then randomized into two groups. all enrolled patients will receive 3 liter polyethylene glycol (peg) for bowel preparation. patients in the chewing gum and wechat group (n = 75) are further advised to chew one piece of sugarless gum for 20 minutes after drinking each 1 liter peg; additionally, they will receive enhanced instructions via wechat before two days and one day of colonoscopy to further inform how to chew gum and highlight the importance of adequate bowel preparation. patients in the control group (n = 75) are guided by regular instructions.

Eligibility criteria:
inclusion criteria: 1. patients undergoing colonoscopy at the department of gastroenterology of the general hospital of northern theater command. 2. patients aged ≥18 years, no gender limitation. 3. patients who sign informed consent. 4. patients who are diagnosed with constipation. exclusion criteria: 1. patients who are pregnant or breastfeeding. 2. patients who are allergic to polyethylene glycol. 3. patients who are suspected with intestinal obstruction, stenosis or perforation. 4. patients with mental illness. 5. patients with serious heart, brain, liver, and kidney diseases. 6. patients who use wechat unconditionally by themselves or their family members. 7. patients who are allergic to chewing gum related ingredients. 8. patients with the history of colorectal surgery.

Keywords: bowel preparation chewing gum enhanced instructions wechat colonoscopy
intravenous zoledronic acid for the treatment of osteoporosis and osteonecrosis in children with leukemia: a pilot study

Conditions: Osteoporosis; Osteonecrosis; Acute Lymphoblastic Leukemia

Summary: this study explores the effect of zoledronic acid on incident vertebral fractures and osteonecrotic lesions in children recently diagnosed with acute lymphoblastic leukemia.


Eligibility criteria:
inclusion criteria: 1. subject or subject's legally acceptable representative has provided informed consent. 2. children aged 8 to 16 years at the time of enrolment with a confirmed diagnosis of acute lymphoblastic leukemia (all). 3. children with vertebral fractures or osteonecrotic lesions according to the following criteria: 1. children with vertebral fractures on lateral spine x-ray and/or osteonecrotic lesions on mri of the hips and/or knees identified through routine clinical screening at least 8 weeks following chemotherapy initiation or 2. children with vertebral fractures on lateral spine x-ray and/or osteonecrotic lesions of the hips and/or knees on mri that are identified at any time in the first 12 months after chemotherapy initiation following presentation with back pain (in the case of vertebral fractures, identified by lateral spine x-rays) and/or hip pain (in the case of osteonecrotic lesions, identified by mri) and/or knee pain (in the case of osteonecrotic lesions, identified by mri). exclusion criteria: 1. any child for whom the treating physician feels participation is not advised. 2. prior treatment with an osteoporosis agent (e.g. bisphosphonate). 3. co-morbidities affecting musculoskeletal health (e.g. cerebral palsy). 4. children with renal failure (egfr\<60ml/min/1.73m2). 5. children with untreated vitamin d deficiency (vitamin d \<50nmol/l). 6. children with hypocalcemia. 7. children planning dental procedures and/or dental surgery during the course of the study. 8. children with asthma who are acetylsalicylic acid (asa) sensitive. 9. children with a documented history of atrial fibrillation. 10. currently pregnant or planning a pregnancy during the study. 11. currently breastfeeding or planning on breastfeeding during the study.
tissue oxygen deprivation as detected with raman in association with umbilical artery catheters

Conditions: Tissue Oxygenation

Summary: umbilical artery catheters (uacs) are associated with significant morbidity in preterm neonates however are necessary for the management of this high risk population. uacs have been linked to serious adverse events (saes) including arterial thrombosis, necrotizing enterocolitis, limb ischemia, and renal failure. resonance raman spectroscopy (rrs), raman for short, is a technology that utilizes vibrational spectroscopy, rather than absorbance spectroscopy, to determine the oxyhemoglobin concentration in tissues. in this prospective, observational study, daily measurements of sto2 of low birth weight neonates using raman spectroscopy will be correlated with uacs.the study team hypothesizes that raman can detect changes in peripheral tissue oxygenation in the ipsilateral extremity to the uac and that raman is more sensitive at detecting changes in peripheral tissue oxygenation then common metrics used to monitor neonatal hemodynamics. if successful, this study would demonstrate that raman can be used as an early marker of tissue oxygen deprivation in neonates with uacs and maybe used to guide management in other clinical scenarios where sto2 is affected.


Eligibility criteria:
inclusion criteria: * neonate inclusion criteria: 1. birth weight less than 1500 grams. 2. admitted to the nicu. 3. uac placed on admission. * mother inclusion criteria: 1. admitted to the labor and delivery or antenatal floors with reasonable chance of delivery of a neonate weighing less than 1500 grams as determined by the obstetrics team. exclusion criteria: * neonate exclusion criteria: 1. neonates with congenital heart defects or major congenital anomalies such as known or suspected inborn errors of metabolism, ambiguous genitalia, neural tube defects, malignancy, abdominal wall defects, airway defects and chromosomal anomalies. * mother exclusion criteria: 1. mother is pregnant with fetus with congenital heart defect or major congenital anomaly as described above.

Keywords: neonates low birth weight spectroscopy umbilical artery catheter (uac)