Kornimate/medical-research-clean huggingface dataset:
non-invasive assessment of graft fibrosis after living donor liver transplantation

Conditions: Liver Transplantation

Summary: the aim of this study is to compare prospectively the ability of mre and transient elastography in detection and staging of allograft fibrosis in comparison to liver biopsy in patients who underwent living donor liver transplantation for complications related to hcv.

the study included patients transplanted for hcv related disease diagnosed by positive serum pcr (hcv rna) and liver biopsy with elevated liver enzymes and/orhyperbilirubinemia with normal abdominal doppler ultrasound and mrcp.other aetiology for liver disease as indication for transplantation and other causes of post-transplant abnormal liver profile as post transplant biliary stricture or vascular liver diseases (if unresolved) were excluded from the study. patients with active cmv infection(proved by positive cmv pcr or positive inclusion bodies by histopathology) were also excluded. all patients were subjected tofull history taking and thorough clinical examination, laboratory investigations including cbc, liver profile tests, albumin, bilirubin (total and direct), alp(alkaline phosphatase), ast(aspartate aminotransferase), alt (alanine aminotransferase), inr (international normalization ratio),hcv rna quantitative,cmv pcr, ast/ platelet ratio, alpha feto-protein and fibro alpha score

Eligibility criteria:
inclusion criteria: * adult recipients who are candidate for ldlt due to hcv related esld and meeting the transplantation criteria of the ain shams center of organ transplantation (child pugh score ≥ 7and meld score ≥15). exclusion criteria: * adult recipients who underwent ldlt due to other causes rather than hcv. cardiopulmonary disease that cannot be corrected and is a prohibitive risk for surgery acquired immunodeficiency syndrome (aids) malignancy outside of the liver not meeting oncologic criteria for cure hepatocellular carcinoma with metastatic spread anatomic abnormalities that preclude liver transplantation uncontrolled sepsis acute liver failure with a sustained intracranial pressure \>50 mmhg or a cerebral perfusion pressure \<40 mmh persistent non adherence with medical care and lack of adequate social support advanced age older than 65y.
risk factors for bacterial stent colonization in patients with a double j ureteral stent

Conditions: Bacterial Colonization in Double J Ureteral Stent

Summary: the goal of this prospective study is to identify the risk factors associated with bacterial colonization of djs and report the common microorganisms isolated and drug susceptibility pattern.

this was a hospital-based prospective observational study performed at a tertiary academic center from march 2022 to august 2023. all patients coming to tuth opd and er for urological surgery were assessed for the placement of a djs (polyurethane). patients fulfilling inclusion criteria were admitted and underwent djs placement after their respective procedures. all patients received prophylactic antibiotic therapy with levofloxacin for 2 to 3 days at the time of djs insertion. the djs was in situ until the duration allocated according to the procedure. the djs was removed in 2 weeks postoperatively with aseptic precaution under local anesthesia (2% lignocaine jelly) with the help of a 30-degree karl storze scope with cystoscope sheath 19/21 and alligator forceps following the standard technique. the equipment was sterilized with a 2.45% cidex solution for 12 minutes prior to all djs removal. then the patient was positioned in the lithotomy position, with proper cleaning of the external genitalia with povidone-iodine 10%, complete separation of the labia in the female, and proper cleaning of the prepuce and glans in the male. then sterile xylocaine jelly 2% was instilled in the urethra, a cystoscope was inserted into the bladder, alligator forceps were inserted, and a djs was removed. after removal of the djs with sterile technique, the tips of both ends (renal end and bladder end) of the stent were cut with surgical blade number 10 and collected in a plastic screw-capped container, and sent for bacterial evaluation. the report of the culture and sensitivity pattern were collected and treated according to the sensitivity pattern with appropriate antibiotics correlating with the symptoms. colonization is defined as the growth of microorganisms in the tip culture of either end or both ends of djs. all the demographic data with other study variables were recorded in proforma. any amount of preoperative urine albumin from trace amounts and above (+,++, etc.) was considered in this study.

Eligibility criteria:
inclusion criteria: - patients undergoing dj stent placement exclusion criteria: * positive urine culture before stenting * taking antibiotics during djs removal * presence of yeasts in urine culture * declining informed consent

Keywords: colonization double j stent risk factors urinary tract infection
crc post-surgical assessment and recurrence monitoring

Conditions: Colorectal Cancer

Summary: the surgical therapeutic effect of stage ii-iv crc patients will be assessed by the plasma msept9 assay, and patients will be followed up by the same assay for recurrence monitoring.

assessment of surgical therapeutic effect of colorectal cancer (crc) relies on computer tomography (ct) and serum cea test. ct cannot be used frequently to monitor the instant change of lesions, while cea cannot cover all patients due to its low sensitivity. the objective of this study is to assess the performance of the methylated sept9 (msept9) in assessing the surgical therapeutic effect of crc. this study plans to recruit 50 crc patients with stage ii-iv crc. plasma samples before surgery, one day after surgery and seven days after surgery will be collected from each subject. msept9 level will be measured at 3 months, 6 months, 9 months, 12 months, 18 months after surgery and relevant chemotherapy to monitor the possible recurrence of crc. the msept9 level will be measured by the epi procolon 2.0 assay. the serum cea will be measured parallel at the identical time points. primary outcomes include the plasma msept9 levels before surgery, one and seven days after surgery. secondary outcomes include the serum cea levels before surgery, one and seven days after surgery. it also includes the size of cancer for each patients, the ratio of patients with msept9 complete response (cr), partial response(pr), progressive disease (pd) and stable disease (sd).

Eligibility criteria:
inclusion criteria: * stage ii-iv crc patients planning to perform surgery exclusion criteria: * stage 0-i crc patients, patients with history of crc or other cancers, patients not suitable for surgery, pregnant women, patients younger than 30 or older than 80.

Keywords: colorectal cancer septin 9 sept9 methylation cea
effects of green coffee extract supplementation on leptin, ghrelin, adiponectin,anthropometric measurements, lipid profile in breast cancer survivors

Conditions: Breast Cancer Survivors

Summary: to study the effects of green coffee supplement on leptin, adiponectin, ghrelin, anthropometric measurements, lipid profile in breast cancer survivors.50 breast cancer survivors who their treatment is over and referred to follow breast cancer clinic with will be randomly allocated to receive placebos or 2 capsules green coffe for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. at the first and the end of the intervention, leptin, adiponectin, ghrelin, anthropometric measurements, lipid profile will be assessed and compared between groups.


Eligibility criteria:
inclusion criteria: * age of 18 to 70 years * body mass index (bmi) between 25-40 treatment is over exclusion criteria: * -taking any kind of supplement for weight reduction * pregnancy or lactation * professional athletes
arteriovenous loop graft for free functional gracilis transfer in brachial plexus surgery

Conditions: Brachial Plexus Injury

Summary: free functional muscle transfer (ffmt) using the gracilis muscle as a donor muscle has become a standard treatment for reconstructing late-onset brachial plexus injuries. successful implementation of this procedure relies on the availability of functional donor vessels in the injured limb to supply the muscle flap. however, some brachial plexus injuries are accompanied by subclavian or axillary artery injuries, which compromise the viability of the muscle flap due to insufficient vascular supply. to address this, arteriovenous (av) loop grafts have been employed to extend donor vessels to the flap and have been utilized in various body regions, including the upper extremity. despite their widespread use, av loop grafts have not been previously utilized in ffmt for late-onset brachial plexus injuries with concurrent subclavian or axillary artery injuries. this study aimed to assess the feasibility of this surgical approach and report the long-term outcomes of the procedure.


Eligibility criteria:
inclusion criteria: * age equal or more than 20 years old * patients with brachial plexus injury with depletion of blood flow to the injured limb which confirmed by abnormal computed tomography arteriogram exclusion criteria: * patients who had sufficient thoraco-acromial or thoraco-dorsal artery blood flow for standard free functional muscle transfer operation without the need of an av loop graft

Keywords: brachial plexus injury brachial plexus palsy free functional muscle transfer arteriovenous loop graft subclavian artery injury axillary artery injury
safety and immunogenicity study of sev-g(np) hiv vaccine administered intranasally and ad35-grin hiv vaccine given intramuscularly in prime-boost regimens in hiv-uninfected volunteers

Conditions: HIV Infections

Summary: the purpose of this study is to evaluate the safety, tolerability and immunogenicity of sendai hiv vaccine sev-g(np) given intranasally and ad35-grin administered intramuscularly in prime-boost regimens in hiv-uninfected, healthy adult volunteers.

the study is a randomized, double-blind, placebo-controlled, dose-escalation trial assessing the safety, tolerability, and immunogenicity of sev-g(np) given intranasally by drops and ad35-grin administered intramuscularly in each of four prime-boost regimens. volunteers will be screened up to 42 days before the 1st vaccination and will be followed for 12 months after the last vaccine administration (16 months after the first vaccination). it is anticipated that it will take approximately 6 months to enroll the study. approximately 64 volunteers (48 vaccine and 16 placebo recipients) will be included in the study.

Eligibility criteria:
inclusion criteria: * healthy male or female adults, * 18 to 50 years of age (21 to 50 years of age for volunteers in rwanda), * who do not report high-risk behaviour for hiv infection, * who are available for the duration of the trial, * who are willing to undergo hiv testing, * use an effective method of contraception, and * who, in the opinion of the principal investigator or designee, understand the study and who provide written informed consent. exclusion criteria: * confirmed hiv infection, * pregnancy and lactation, * significant acute or chronic disease, * clinically significant laboratory abnormalities, * recent vaccination or receipt of a blood product, * previous receipt of an hiv vaccine, and * previous severe local or systemic reactions to vaccination or history of severe allergic reactions.

Keywords: hiv aids hiv vaccine hiv prevention
feasibility study of a novel single use robotic colonoscopy system

Conditions: Colonic Polyp; Colon Adenoma; Colorectal Cancer

Summary: this is a single centre, non-randomized, tandem colonoscopy trial of the nisinspire-c system, followed immediately by a conventional colonoscope (cc). each trial subject will undergo colonoscopy using the nisinspire-c system, followed immediately by cc. the purpose of this study is to obtain observational data on the safety profile, feasibility and usability of the nisinspire-c system in performing diagnostic colonoscopy in human subjects. the level of procedural pain experienced by subjects will also be explored.


Eligibility criteria:
inclusion criteria: * males aged between 40 and 70 years, inclusive, at the time of informed consent * females aged between 55 and 70 years, inclusive, at the time of informed consent (rationale: to include only women with non-childbearing potential to avoid completely pregnant trial subjects) * symptomatic adults indicated for elective colonoscopy, or asymptomatic adults willing to undergo a colonoscopic screening for polyps or colorectal cancer * adults without prior colonoscopy * able to provide a written informed consent form approved by an independent ethics committee (iec)/ institutional review board (irb), prior to any study-specific procedures * willing and able to comply with the study procedures exclusion criteria: * history of colorectal cancer, inflammatory bowel disease, polyposis syndrome, familial polyposis coli, hereditary nonpolyposis colorectal cancer syndrome, active diverticulitis or toxic megacolon * lower gastrointestinal bleeding within 28 days prior to the colonoscopy day * known bleeding tendency * received antiplatelet or anticoagulation therapy within 3 days prior to the colonoscopy day * known colonic stricture * known multiple sigmoid colon diverticula * history of any abdominal or pelvis surgical procedures including colonic and rectal surgical resection * known abdominal wall hernias * history of radiotherapy to the abdomen or pelvis * known coronary ischemia or cardiovascular stroke within 3 months prior to the colonoscopy day * contraindication to the proposed anaesthesia * received any investigational medicine or treatment within 28 days prior to screening * any condition, in the opinion of the investigator, that is unstable and could jeopardize the safety of the subject and their compliance in the study

Keywords: robotic colonoscopy tandem colonoscopy nisinspire-c system single use colonoscope colonoscopy
a phase 2 randomized, double-blind trial evaluating the effects of chloroquine in breast cancer

Conditions: Breast Cancer; Invasive Breast Cancer

Summary: chloroquine (cq) is a well known, well tolerated medication that has been used for many years traditionally for arthritis, lupus, and malaria. it has anti-inflammatory properties but is often the drug of choice for arthritis and malaria due to its few side effects. recently, laboratory investigations have proven that cq may potentially have anti-cancer properties, by inhibiting a process which allows cancers such as breast cancer to continue to grow (a process known as "autophagy"). therefore, this study will look at how well cq can inhibit the growth of breast cancers in patients while waiting for surgery.

patients diagnosed with breast cancer can sometimes wait up to 6 weeks for their surgery. the wait leading up to surgery is a potentially long and anxious time. since no treatment is happening during this period anyway, this study will allow patients to receive cq during this waiting period. this study will compare cq treatment before surgery with the standard approach during this time, which is no treatment. although cq is widely used for the treatment of arthritis and malaria, cq is considered investigational for use in breast cancer. the study will not interfere with the routine assessments as part of the pre-operative care, nor will it delay the date of surgery. this study compares the effects of the cq to placebo. participants will be randomized 1:1 and be provided with the blinded placebo or qc (500mg daily) during the wait time. biomarker testing will be performed on the initial biopsy tissue and at the time of surgery as well as blood work. there is also an opportunity for participants to enrol in the optional sample collection for future research.

Eligibility criteria:
inclusion criteria: * newly diagnosed histologically confirmed primary invasive breast cancer who is currently not undergoing any treatment while awaiting surgery in the next 2-6 weeks * tumour ≥ 1.5 cm by palpation or imaging * ecog performance status 0-2 * written informed consent for the study exclusion criteria: * known metastatic breast cancer * history of pre-existing known retinal or ocular pathology patient has only one functioning eye * abnormal hepatic function (serum ast or alt \>3x upper limit of normal) * currently on cq or hcq or has been on the drug within the past 3 months for other conditions * known history of psoriasis * known history of epilepsy or seizures * electrocardiogram showing qt prolongation based on qtc interval \>450 ms * inability to comply with a study protocol (abuse of alcohol, drugs or psychotic states) * current known pregnancy or actively nursing * allergic reactions to quinolones or cq * inability to consent.

Keywords: breast
retrospective clinical investigation of the safety and performance of 640pm trifocal iol implantation in patients with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia

Conditions: Cataract; Presbyopia; Hyperopia; Myopia; Pseudophakia

Summary: the clinical investigation objective is to evaluate safety and performance outcomes of trifocal iol implantation to improve vision in patients with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia. retrospective data from preoperative status up to 12 month postoperative status will be collected from patients that were implanted with medicontur's 640pm intraocular lens: * preoperative status: preoperative screening and baseline * surgery: iol implantation * m1: 1 month +/- 2 weeks postoperative follow-up * m3: 3 months +/- 1 month postoperative follow-up * m12: 12 months +/- 3 months postoperative follow-up


Eligibility criteria:
inclusion criteria: * adult males or females above 18 years of age; * pseudophakic patients implanted with 640pm iols (medicontur medical engineering ltd. inc., zsámbék, hungary); * diagnosis of cataract and/or ametropia and/or presbyopia; * subject who provided express consent authorizing the use of medical record data for biomedical research purposes. patients who have participated in at least two follow up visits in the 12 months following iol implantation * patients for which the retrospective data for the primary endpoint is available and at least half of all the secondary endpoints measured in the time ranges specified in the protocol. exclusion criteria: * patients with any eye condition that could affect vision (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.); * regular anterior corneal astigmatism ≥ 1.20 d or irregular astigmatism ≥ 0.5 μm measured with pentacam at 4 mm.
detection of emotions in a spoken language among tinnitus patients

Conditions: Tinnitus

Summary: tinnitus may affect the ability of patients to detect emotions in spoken language. this study will compare this ability between tinnitus patients and non-tinnitus patients.


Eligibility criteria:
inclusion criteria: * tinnitus lasting 3 months and longer * hebrew speakers exclusion criteria: * tinnitus which began less than 3 months ago learned hebrew after the age of 5
contrast-enhanced ultrasound in the evaluation of abdominal injuries in children

Conditions: Abdominal Injury

Summary: this study proposes to evaluate the accuracy of contrast-enhanced ultrasound (ceus) in diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be enrolled across approximately 8 sites in the us. all subjects will have had a computerized tomography (ct) scan as part of standard of care, confirming at least one solid organ abdominal injury. all subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent lumason. ultrasound and contrast-enhanced ultrasound results will be compared to the ct scan results. the study procedures will take place within 48 hours of injury.

this is an interventional study proposes to evaluate the accuracy of contrast-enhanced ultrasound (ceus) in diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be enrolled across approximately 8 sites in the us. all subjects will have had a computerized tomography (ct) scan as part of standard of care, confirming at least one solid organ abdominal injury. all subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent lumason. ultrasound and contrast-enhanced ultrasound results will be compared to the ct scan results. the study procedures will take place within 48 hours of injury. at conclusion of enrollment of all subjects a centralized review of ct vs. ceus will occur to compare to real time readings.

Eligibility criteria:
inclusion criteria: * hemodynamically stable, as determined by the trauma team * age 8 through 17 years * interpretable ct of the abdomen and pelvis that demonstrates at least one abdominal solid organ injury among the liver, spleen, pancreas, and kidneys * plan for observation or admission to the hospital * candidate for abdominal ultrasound based on body habitus * have a glasgow coma score of 15 * able to complete the study procedures within 48 hours of injury exclusion criteria: * known cardiac abnormality * pulmonary hypertension * known sensitivity to sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (dspc), dipalmitoylphosphatidylglycerol sodium (dppg-na), or palmitic acid * unable to roll over * unable to assent * pregnant * lactating * ct images not available for transmission to central image repository

Keywords: solid organ injury
efficacy of dexamethasone for prevent vomiting in leukemic children who receive intrathecal chemotherapy

Conditions: Acute Leukemic Patients in Children

Summary: null hypothesis the proportions of vomiting are not different between dexamethasone and placebo in the patient after sedation with intravenous ketamine and lumbar puncture with intrathecal chemotherapy alternative hypothesis the proportions of vomiting are different between dexamethasone and placebo in the patient after sedation with intravenous ketamine and lumbar puncture with intrathecal chemotherapy

does intravenous dexamethasone 0.25 mg/kg (8 mg/m2/dose) have an effect in the reduction of vomiting and retching after sedation with intravenous ketamine and lumbar puncture with intrathecal chemotherapy comparison with placebo?

Eligibility criteria:
inclusion criteria: * patients aged between 2-15 years who underlying acute lymphoid or nonlymphoid leukemia and need to receive ketamine and intrathecal chemotherapy. * personally signed and dated informed consent and assent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to study entry. exclusion criteria: * patients who had a known allergy to ketamine or dexamethasone. * patients who had contraindication for ketamine or dexemethasone such as hypertension, increased intracranial pressure or central nervous system mass lesion, major psychiatric , and hyperglycemia. * patients who concurrent with nausea and vomiting during that time. * patients who received ondansetron or other antiemetic before doing procedure. * patients who received other chemotherapy before or after 24 hours.

Keywords: crossover; double blinded; intrathecal chemotherapy; dexamethasone; ketamine;vomiting