Kornimate/medical-research-clean huggingface dataset:
fludeoxyglucose f 18-pet imaging for early detection of residual disease in patients undergoing radiofrequency ablation of liver metastases from colorectal cancer

Conditions: Colorectal Cancer; Metastatic Cancer

Summary: rationale: diagnostic procedures, such as fludeoxyglucose f 18-pet imaging, may be effective in detecting residual disease after radiofrequency ablation of liver metastases in patients with colorectal cancer. purpose: this clinical trial is studying fludeoxyglucose f 18-pet imaging to see how well it works for early detection of residual disease in patients undergoing radiofrequency ablation of liver metastases from colorectal cancer.

objectives: primary * determine the sensitivity and specificity of fludeoxyglucose f 18 (fdg)-pet imaging in detecting residual disease within 48 hours after radiofrequency ablation (rfa) of liver metastases in patients with colorectal cancer. secondary * determine the findings on day 7 after rfa using fdg-pet imaging in these patients. outline: this is a prospective study. patients undergo fludeoxyglucose f 18 (fdg)-pet imaging at baseline. they then undergo percutaneous laparoscopic or intraoperative radiofrequency ablation (rfa). patients then undergo further fdg-pet scans within 48 hours and 7 days after rfa. fdg-pet images are evaluated for residual disease, including focal fdg uptake at the site of ablation. beginning 1 month after rfa, patients undergo contrast-enhanced mri for routine post-ablation follow-up. mri scans are performed at 1, 4, 7, 12, 18, and 24 months after completion of rfa.

Eligibility criteria:
disease characteristics: * diagnosis of colorectal cancer * disease metastatic to the liver * undergoing percutaneous, intraoperative or laparoscopic radiofrequency ablation for liver metastases at the university of north carolina gastrointestinal oncology clinic patient characteristics: * not pregnant prior concurrent therapy: * see disease characteristics * no chemotherapy within 7 days after rfa on study

Keywords: stage iv colon cancer stage iv rectal cancer recurrent colon cancer recurrent rectal cancer liver metastases
distinction risk of severe infection in febrile neutropenia after chemotherapy

Conditions: Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy

Summary: evaluate the reproducibility and validate a posteriori a new rule of clinical decision on a multi-center population of children with a post-chemotherapy febrile neutropenia


Eligibility criteria:
inclusion criteria: * child aged 1 to 18 years * child with hematology or cancer * child with a febrile neutropenia post-chemotherapy * child with social security * no opposition from the child and/or parents, in case of absence, the holder of the parental authority present, can consent, alone, to the participation of the unemancipated minor. exclusion criteria: * febrile neutropenia at diagnosis of tumor disease * child with palliative care * child having had a hematopoietic stem cell allo-graft in the preceding year * febrile neutropenia immediately post auto-transplant * antibiotherapy prior to admission * initial care in a non-investigative center.
registry on hypomethylating agents in myeloid neoplasms

Conditions: Chronic Myelomonocytic Leukemia; Myelodysplastic Syndromes; Acute Myeloid Leukemia

Summary: this registry is set up to collect real-world experience in the management of patients with myeloid neoplasms, in particularly in patients with mds, cmml or aml, treated with hypomethylating agents in austria and potentially other participating countries. this registry will collect data in a retrospective as well as in a prospective manner at various sites. the aim is to gain valuable insights on both efficacy and toxicity of these drugs in a routine clinical setting in patients with various comorbidities.


Eligibility criteria:
inclusion criteria: patients with mds, cmml, and aml * who begin with or already have received treatment with with a hypomethylating agent * who are willing to provide informed consent exclusion criteria: * due to the non-interventional design of this program there are no specific exclusion criteria.

Keywords: cmml mds aml registry vidaza
extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase iii studies with secukinumab

Conditions: Moderate to Severe Plaque-type Psoriasis

Summary: this was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase iii studies with secukinumab. subjects on secukinumab at the end of treatment period in phase iii studies (e.g., ongoing cain457a2302 and cain457a2303 and potentially other secukinumab phase iii studies) were eligible to join this extension study. this extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase iii studies. in this extension study, the prefilled syringe (pfs) liquid formulation of secukinumab were used.


Eligibility criteria:
key inclusion criteria: completed the full study treatment period of 52 weeks in preceding phase iii studies, and have been receiving secukinumab treatment during the maintenance phase of the preceding phase iii studies, and show at least a partial response (pasi 50 or better) at week 52 of the preceding phase iii studies. written informed consent form. key exclusion criteria: a protocol deviation in either of the preceding phase iii studies which according to the investigator prevented the meaningful analysis of the extension study for the individual subject. ongoing use of prohibited psoriasis or non-psoriasis treatments. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (\>10 miu/ml). women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unwilling to use effective contraception during the study and for 16 weeks after stopping treatment.

Keywords: psoriasis, inflammatory skin disease scaly patches secukinumab (ain457) psoriasis area and severity index (pasi) investigator global assessment (iga) mod 2011
pain of injection of lipuro propofol in children aged 1-7 years

Conditions: ASA 1-2 Requiring Intravenous Cannulation for General Anaesthesia

Summary: randomised controlled trial of pain of injection of lipuro in children age 1-7 versus the pain of injection of the standard formulation


Eligibility criteria:
inclusion criteria: * asa 1 or 2 requiring intravenous general anaesthetic exclusion criteria: -
ctdna screening in advanced her2 positive gastric cancer

Conditions: HER2-positive Gastric Cancer

Summary: to identify molecular biomarker panel correlating with efficacy of trastuzuamb in advanced her2 positive gastric cancer patients. to observe the molecular evolution of her2 positive gastric cancer during treatment by ctdna detection.

molecular events including gene mutation, fusion and amplification will be detected by next generation sequencing platform (oncoscreen plus paneltm) using ctdna collected from peripheral blood samples of gastric cancer patients. for her2 positive patients, samples will be collected at baseline, first surveillance after treatment and disease progression. for her2 negative patients, samples will be collected at baseline as negative control.

Eligibility criteria:
inclusion criteria: 1. male/female patients aged over 18 years. 2. histologically confirmed gastric adenocarcinoma. gastric tumors should be treatment naïve unresectable or metastatic disease, or recurrence over 6 months after finish of adjuvant chemotherapy. 3. her2 status is confirmed by ihc/fish. her2 positive: ihc 3+ or ihc 2+ plus fish positive, her2 negative: ihc 0/1+ or ihc 2+ plus fish negative. 4. at least one measurable lesion should be confirmed by imaging examination. 5. eligible peripheral blood samples 6. patients with enough organ function and performance status (ecog 0-2) can tolerant chemotherapy. 7. for her2 positive patients, trastuzumab should be used as first-line treatment. the regimen of chemotherapy should be platinum plus oral fluorouracil. 8. for her2 negative patients, clinicopathological characteristics should be matched to her2 positive patients. 9. willing to provide clinicopathological information and imaging information. exclusion criteria: 1. patients received systemic treatment before enrolled or finished adjuvant chemotherapy less than 6 months. 2. with second primary malignant diseases. 3. other situations assessed by investigator can disturb quality control of the investigation.
study comparing cortical function and dysfunction tests in low back pain

Conditions: Chronic Nonspecific Low Back Pain

Summary: the purpose of this study is to explore the cortical regulation of the paraspinal muscles in chronic low back pain. these (possible) changes in regulatory mechanisms are being compared to other motor control tests in order to determine whether correlations are found. furthermore the patients are being treated with repetitive transcranial magnetic stimulation (rtms) and tested afterwards. the purpose is to find out if rtms-therapy is capable of normalizing motor control deficits.


Eligibility criteria:
inclusion criteria: * chronic nonspecific low back pain for at least six months * male gender * age 25-50 yrs * average pain during last week 4-8/10 by vas * oswestry disability index 20-80 % exclusion criteria: * former spinal operations * rheumatic disease, marked spondylolysis and -olisthesis, other diseases that markedly reduce physical or psychological performance, history of epilepsy, history of taking epileptic or strong opioid drugs

Keywords: low back pain motor control cortical regulation transcranial magnetic stimulation
deep neural network stratification for use detecting endometriosis in women affected by chronic pelvic pain (endocheck)

Conditions: Endometriosis

Summary: the goal of this observational study is to determine the clinical validity of a deep neural network algorithm that utilizes protein biomarker detection of endometriosis - "endocheck" - as an "aid in diagnosis" for endometriosis and to show validity as a diagnostic test

the objective is to confirm the clinical performance (sensitivity and specificity) of endocheck when compared to laparoscopic surgical assessment as an "aid in diagnosis" for endometriosis in subjects who present with chronic pelvic pain. the primary endpoint of the study is to optimize the test to achieve the success criteria of at least 94% and 79% sensitivity and specificity, respectively. secondary endpoints include examining the performance of the test in patients stratified by pain severity and other clinical factors.

Eligibility criteria:
inclusion criteria: * participant is willing and able to provide written informed consent. * participant is a female aged 14 to 50 years old at time of consent. * participant is scheduled to undergo laparotomy or laparoscopy for symptomology consistent with possible endometriosis exclusion criteria: * participant is a female in a pre-menarchal state. * participant is pregnant. * participant has an active malignancy. * participant is known to have tested positive for human immunodeficiency virus or hepatitis a, b, or c. * participant has an active pelvic infection or other infections contraindicated for surgery. * participant has participated (±3 months of study enrollment) in a clinical trial where an investigational drug/ device/ procedure was or is planned to be administered. * participant has any general health or behavioral condition that, in the opinion of the investigator, should exclude the participant from participation. * participant is under 14 years old or over 50 years old

Keywords: endometriosis biomarkers deep neural network
effect of intrathecal magnesium sulfate versus intravenous magnesium sulfate on postoperative pain after abdominal hysterectomy

Conditions: Abdominal Hysterectomy

Summary: the present study aims to compare the effect of adding iv magnesium sulfate versus magnesium sulfate to intrathecal hyperbaric bupivacaine in total abdominal hysterectomy regarding the duration of postoperative analgesia, hemodynamic stability, and complications.

abdominal hysterectomy (ah) is associated with an intense inflammatory response that can result in moderate to severe postoperative pain, sometimes difficult to control. postoperative pain can cause many complications such as restlessness, increased sympathetic activity, high blood pressure, and tachycardia. opioids are effective analgesics; however, they produce unwanted side effects, such as respiratory depression, nausea, and vomiting. nonopioid drugs can decrease opioid usage and dependency. different adjuvants have been added to local anesthetics to increase the duration of the regional anesthesia, decrease pain-relieving drugs, and delay the onset of postoperative pain. according to numerous reports, magnesium sulfate has analgesic effects and lowers opioid consumption in many surgeries especially abdominal surgeries. the analgesic properties of magnesium are based on acting as a non-competitive antagonist of n-methyl-d-aspartate (nmda) receptors in central nervous system and regulating the calcium influx into the cell. these properties avoid the central sensitization mechanisms due to the stimulation of peripheral nociceptive nerves in the spinal cord, magnesium sulfate decreases pain transmission by hyperpolarizing spinal interneurons via g-protein-mediated activation of potassium channels and by decreasing the release of the neurotransmitters (substance p and glutamate) from primary afferent terminals. adequate postoperative pain relief can enhance recovery and increase patient satisfaction.

Eligibility criteria:
inclusion criteria: * patients between 40-65 years old * patients with asa clinical status i/ii * patients eligible for abdominal hysterectomy * oncological surgery exclusion criteria: * body mass index (bmi) ≥ 40/kg / m2 * previous abdominal surgery (except cesarean section) * severe cardiovascular, renal, and hepatic dysfunction * contraindications to spinal anesthesia * neuromuscular diseases * inappropriate for spinal anesthesia * patient refusal
preemptive genotyping and pain management

Conditions: Pain

Summary: the purpose of this study is to see if testing for genes related to pain and pain management before surgery affects how patients are treated for pain after surgery. the investigators want to know if this information will be used to effectively treat patients for pain after surgery if the clinical staff have a chance to review it before the surgery.

purpose: to determine the feasibility of preemptive (preoperative) cytochrome p450 isoenzyme (cyp2d6) testing and the variability of clinical measures (postoperative) in children whose opioid selection and dosing is influenced by preemptive cyp2d6 testing compared to children whose pain management does not include cyp2d6 preemptive testing. results from this pilot study will inform a future study investigating the utility of preemptive pharmacogenomic testing in children at risk for requiring inpatient acute pain management with opioids.

Eligibility criteria:
inclusion criteria: * children, 6-17 years of age and adults, 18 - 21 years with idiopathic scoliosis and/or pectus excavatum scheduled for surgical clinic visit * bmi \< 30 * cognitively able to use a 0 - 10 numerical rating scale (nrs) to report level of pain * parents give permission (and children give assent when appropriate) or adult participants give consent for cyp2d6 results to be placed in cincinnati children's hospital medical center (cchmc's) epic exclusion criteria: * • who had prior surgery for idiopathic scoliosis and/or pectus excavatum * who have prior cyp2d6 testing or genetic pharmacology service (gps) psychiatry panel documented in epic * who are taking prescription medication known to inhibit or induce cyp2d6 * who are taking prescription medication known to inhibit (e.g. voriconazole) or induce (e.g. carbamazepine and rifampin) cyp3a4 * who have liver or renal failure * who have history of narcotic abuse

Keywords: preemptive genetic testing pain pediatrics orthopedics pectus excavatum scoliosis
treatment for symptomatic peripheral neuropathy in patients with diabetes

Conditions: Diabetic Neuropathies; Diabetes Mellitus, Insulin-Dependent; Diabetes Mellitus, Non-Insulin-Dependent

Summary: the purpose of this protocol is to determine if an investigational drug is effective in treating nerve malfunction in diabetes.


Eligibility criteria:
inclusion criteria: * patients must have type i or type ii diabetes mellitus. * have clinically diagnosed positive sensory symptoms such as numbness, lancinating pain, burning pain, aching pain, allodynia and prickling sensation that have been present not greater than 5 years but stable for 6 months. * has a hba1c less than or equal to 12%. patients with hba1c greater than 9% must be on insulin therapy. * must be 18 years or older. * be able to visit the doctor's office approximately 3 times over a maximum of a 6-week period to determine if you can continue in the study. exclusion criteria: * history of significant liver problems. * have poor kidney function. * drink an excess of alcohol or abuse drugs. * have recently participated or currently participating in a medical study in which you receive an experimental drug. * are a woman and are pregnant or breastfeeding, intend to become pregnant within the next 2 years or a woman not using effective birth control.
effect of sclerotherapy on fistulas and sinus tracts in hidradenitis suppurativa

Conditions: Hidradenitis Suppurativa

Summary: this study evaluates the effect of hypertonic saline 23.4% injection in fistulas or sinus tracts in adult patients with hidradenitis suppurativa.

the clinical effect of the hypertonic saline treatment will be evaluated with physician assessments at week 2 (t=2), week four (t=4) and week 8 (t=8) and compared with the first visit (baseline) (t=0). if necessary, subjects will be eligible to receive another hypertonic saline injected in week 2 and/or week 4, with a maximum of three injections. simultaneously improvement will be assessed by ultrasound if possible, using the philips lumify ultrasound device, and by patients using hs improvement assessments. pain and stinging during treatment sessions will be monitored using numeric rating scales (nrs). for monitoring quality of life the dlqi will be used.

Eligibility criteria:
inclusion criteria: * male or female subjects are at least 18 years of age or older * a confirmed diagnosis of hs disease * presence of inflammatory hs lesion(s) and one or more fistula(s) or sinus tracts exclusion criteria: * receiving any other kind of treatment for fistulas including introduction of anti-inflammatory systemic therapy such as prednisone or adalimumab within the prior month. * are participating in another study using an investigational agent or procedure during participation in this study. * are currently pregnant or planning to get pregnant during the study. * have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study.
study of the safety and tolerability of pg545 in patients with advanced solid tumours

Conditions: Advanced Solid Tumours

Summary: this first-in-human study aims to establish the maximum tolerated dose of pg545 and to evaluate its safety in subjects with advanced solid tumours. in addition the study will explore whether pg545 exposure results in changes to chemicals produced by the body that are associated with cancer growth and spread.


Eligibility criteria:
inclusion criteria: * age \>=18 years. * histological or cytological documentation of non hematologic, malignant solid tumour. * have failed at least one previous therapeutic regimen. * measurable disease according to recist 1.1. * life expectancy \>= 12 weeks * ecog performance status of 0 or 1 * written, signed and dated informed consent * able and willing to meet all protocol-required treatments, investigations and visits. * have adequate organ function exclusion criteria: * clinically significant non-malignant disease. * active cns metastases. * subjects with uncontrolled diabetes. * history of clinically significant adverse drug reaction to heparin or other anti-coagulant agents * history of immune-mediated thrombocytopaenia or other platelet abnormalities or other hereditary or acquired coagulopathies. * concomitant use of aspirin (\> 150 mg/day), nsaids (except cox-2 selective inhibitors), vitamin k antagonists (other than low-dose prophylactic use), heparin within two weeks prior to randomisation, or other anti-platelet drugs. * history of severe allergic, anaphylactic or other significant adverse reaction to radiographic contrast media * known seropositivity to the human immunodeficiency virus (hiv) * women who are pregnant or breast-feeding. * women of child-bearing potential and male subjects who are partners of women of childbearing potential who are unable or unwilling to practice a highly effective means of contraception. * active substance abuse * subjects who have received an investigational agent within 28 days prior to cycle 1 day 1.

Keywords: pg545 phase i progen antimetastatic antiangiogenic advanced cancer patients solid tumors solid tumours
ilm flap transposition versus ilm peeling for macular holes: a pilot study

Conditions: Macular Holes

Summary: patients with macular hole \<400µm will be randomized for ilm flap transposition and ilm peeling for surgical repair of macular holes

patients with macular hole with a diameter larger than 400µm have better sucess with ilm flap transposition, but there are no data published examining the outcome of macular hole with a diameter \<400µm. therefore, patients with macular hole with a diameter \<400µm will be randomized for ilm flap transposition and ilm peeling for surgical repair of macular holes

Eligibility criteria:
inclusion criteria: * macular hole with a diameter \<400µm exclusion criteria: * prior ilm peeling