Kornimate/medical-research-clean huggingface dataset:
metformin for abdominal aortic aneurysm growth inhibition

Conditions: Abdominal Aortic Aneurysm

Summary: a multi-centre population-based open-label randomized controlled trial with allocation concealment and blinded outcome assessment will examine if up to 2g metformin daily slows aaa growth in patients with small aaas who do not have diabetes.

subjects with no history of diabetes will be recruited from a cohort of patients with diagnosed aaa and a maximum aortic diameter of 30-49mm for men and 30-44mm for women. a total of 500 subjects with aaa will be included in the study, 250 in each study arm. patients will be randomised to metformin or standard care in a 1:1 ratio. ct imaging and aaa us will be performed at baseline, 24 months and end of study, as well as if necessary according to clinical routine. study drug will start at baseline and continue through completion. when all enrolled subjects have completed the 24-month follow-up (including imaging) an interim analysis will be performed to assess for efficacy and safety; if there is no trend towards a positive effect or signs of a harmful effect of metformin, the study will be stopped at this phase.

Eligibility criteria:
inclusion criteria: 1. provision of written informed consent. 2. male and female patients. 3. age 50-80 years. 4. documented aaa ø 30-49 mm for men and 30-44 mm for women. 5. fasting p-glucose \<7.0 mmol/l. fasting is defined as no caloric intake for ≥8 h. exclusion criteria: 1. short expected survival. 2. history of current or previous diabetes mellitus. 3. current or previous use of metformin. 4. not expected to tolerate metformin. 5. contraindications to metformin treatment according to smpc 6. known or suspected connective tissue disorder (marfans syndrome, etc), infected or inflammatory aneurysm, aneurysm development after aortic dissection or previous surgery of the infrarenal aorta. 7. enrollment in either another investigational drug or medical device study or another investigational study of an approved drug or medical device within 30 days prior to enrollment of the current study. 8. if, in the opinion of the investigator, it is not in the patient's medical interest to participate in the study or the patient is unlikely to be able to comply with the study protocol. 9. pregnancy.
efficacy and safety of ledipasvir/sofosbuvir, with or without ribavirin, in hcv infected participants who have failed prior treatment with sofosbuvir-based therapies

Conditions: Hepatitis C Virus Infection

Summary: the primary objective of this study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (ldv/sof) fixed dose combination (fdc) for 12 weeks with or without ribavirin (rbv) in participants without cirrhosis, and ldv/sof fdc for 12 weeks with rbv or ldv/sof fdc for 24 weeks without rbv in participants with cirrhosis.


Eligibility criteria:
key inclusion criteria: * hcv rna \> 15 iu/ml at screening * hcv genotype 1 or 4 * chronic hcv infection (≥ 6 months) * prior virologic failure after treatment with sof in combination with simeprevir (smv) ± rbv or with rbv ± pegylated interferon (peg) * cirrhotic and non-cirrhotic as determined by standard methods * male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception key exclusion criteria: * prior exposure to approved or experimental non-structural protein (ns5a) inhibitors * prior exposure to nucleos(t)ide polymerase inhibitors, other than sof * pregnant or nursing female or male with pregnant female partner * coinfection with hiv or hepatitis b virus * current or prior history of clinical hepatic decompensation * hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers) * chronic use of systemic immunosuppressive agents * history of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: hepatitis c virus (hcv) ledipasvir/sofosbuvir ribavirin
cyclosporine-a versus prednisolone for induction of remission in auto-immune hepatitis

Conditions: Autoimmune Hepatitis

Summary: untreated autoimmune hepatitis (aih) is a progressive disease. mainstay of treatment are corticosteroids (cs). in addition to being ineffective a substantial minority of cases, corticosteroid side-effects hamper effective therapy in another subgroup. alternative options for induction of remission are limited. there are reports of successful salvage therapy with cyclosporine-a (csa) in steroid refractory cases. in addition, open-labeled studies have shown efficacy of cyclosporine-a in treatment-naive aih patients. there are no studies comparing csa and cs in a head to head trial. the investigators aim to assess the efficacy and tolerability of csa directly to the cs for induction of remission in treatment-naive aih patients.


Eligibility criteria:
inclusion criteria: * 16-65 years old individuals with probable of definite aih according to the revised aih criteria. * willing and able to participate in the study exclusion criteria: * non-consenting patients * decompensated cirrhosis, i.e. clinical ascites, hepatic encephalopathy, history of variceal bleeding * presence of serious concomitant cardiovascular, pulmonary or renal condition * presence of active malignant disorder

Keywords: autoimmune hepatitis corticosteroids cysclosporine-a treatment treatment-naive induction of remossion efficacy tolerability
amg 335 expanded access program for igg4-related disease


Summary: expanded access requests for amg 335 may be considered for adult patients with a confirmed diagnosis of igg4-related disease. to request access, use responsible party contact information provided in this record.


Eligibility criteria:
inclusion criteria: - exclusion criteria: -
ultrasound guided aspiration of hydrosalpingeal fluid and ivf-et outcomes

Conditions: Infertility

Summary: the aim of this study is to determine whether the ultrasound guided aspiration of hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of ivf-et .

a cochrane review of prospective randomized trials of laparoscopic salpingectomy confirmed the beneficial effect of laparoscopic salpingectomy on ivf et outcomes in patients with hydrosalpinges. surgery is not usually safe especially in patients with extensive adhesions, morbid obesity and previous multiple laparotomies. other less invasive options for patients with hydrosalpinges as ultrasound guided aspiration of hydrosalpingeal fluid, antibiotics and hysteroscopic occlusion of fallopian tube were studied in order to find an alternative to salpingectomy. although these methods are simple and getting popular,current data are inadequate to recommend these treatment options instead of salpingectomy. the aim of this study is to determine whether the ultrasound guided aspiration of hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of ivf-et .

Eligibility criteria:
inclusion criteria: * patients with unilateral or bilateral hydrosalpinges visible by ultrasound * age between 18 - 37 years * period of infertility \> 1 year * body mass index between 19-29 * normal basal luteinizing hormone (lh), follicle stimulating hormone (fsh) and prolactin concentrations * normal recent semen analysis (according to world health organization criteria) exclusion criteria: * uterine fibroid requiring surgical removal * endometriosis * male factor of infertility requiring icsi * previous ivf cycles * history of recurrent miscarriage * endocrinologic disorders * presence of systemic disease contraindicating pregnancy

Keywords: infertility hydrosalpinx ivf-et
nonsurgical or surgical treatment of acl injuries

Conditions: Anterior Cruciate Ligament Injury

Summary: the aim of this study is to evaluate knee function, sports participation and knee reinjuries over 2 years in a group of patients who choose either nonsurgical or surgical treatment for an anterior cruciate ligament (acl) injury

this study is a part study of an overall study with the title 'dynamic stability of the acl-injured knee'. the overall study prospectively follows a cohort of newly injured patients with total rupture of the anterior cruciate ligament in the knee.

Eligibility criteria:
inclusion criteria: * anterior cruciate ligament rupture within 3 months of injury * preinjury participation in level i or ii sports at least twice a week exclusion criteria: * current or previous injury to the contralateral leg * another grade iii ligament injury, fracture, full-thickness articular cartilage damage
pleural abrasion plus minocycline versus apical pleurectomy for primary spontaneous pneumothorax

Conditions: Pneumothorax

Summary: optimal surgical management of primary spontaneous pneumothorax has been a matter of devate, especially regarding the method of pleurodesis. previous studies have shown that thoracoscopic apical pleurectomy is a reliable method with a very low incidence of recurrence. however, this procedure is more technical demanding and time consuming through thoracoscopy. in addition, a more extensive pleural injury may cause impaired pulmonary function and a higher risk of perioperative complication such as hemothorax. in our previous studies, we have shown that thoracoscopic pleural abrasion with minocycline instillation is an easy and convinent method of pleurodesis which decreases the rate of recurrence without affecting pulmonary function. in this study, we hypothesized that pleural abrasion with minocycline instillation is as effective as apical pleurectomy in preventing pneumothorax recurrence while the short-term and long-term complications are less.

optimal surgical management of primary spontaneous pneumothorax has been a matter of devate, especially regarding the method of pleurodesis. previous studies have shown that thoracoscopic apical pleurectomy is a reliable method with a very low incidence of recurrence. however, this procedure is more technical demanding and time consuming through thoracoscopy. in addition, a more extensive pleural injury may cause impaired pulmonary function and a higher risk of perioperative complication such as hemothorax. in our previous studies, we have shown that thoracoscopic pleural abrasion with minocycline instillation is an easy and convinent method of pleurodesis which decreases the rate of recurrence without affecting pulmonary function. in this study, we hypothesized that pleural abrasion with minocycline instillation is as effective as apical pleurectomy in preventing pneumothorax recurrence while the short-term and long-term complications are less.

Eligibility criteria:
inclusion criteria: * age between 15 and 50 years old undergoing thoracoscopic bullectomy had multiple blebs or no identified blebs during the operation exclusion criteria: * with underlying pulmonary disease with major systemic disease or acute infection underwent ipsilateral operation previously bleb number = 1 or 2

Keywords: video-assisted thoracoscopic surgery spontaneous pneumothorax pleurectomy pleural abrasion minocycline
prp use in treatment of fistula ano

Conditions: Fistula in Ano

Summary: in treatment of perianal fistula several methods are described. however, since the hippocrates basics of surgical treatment has not changed very much. the aim of this study is to evaluate the effectiveness of prp gel in treatment of perianal fistula.

perianal fistula is a chronic condition that seriously affects the patients' quality of life. there are different treatment modalities used in treatment. recently sphincter preserving methods are becoming more popular with low complication rates. most of this methods aiming the closure of fistula tract by different pathways. platelet rich plasma (prp) is used in a wide range of conditions in medicine. the investigator's team showed the effective treatment of pilonidal disease by use of prp gel. in the recent study, aim to evaluate the effectiveness of prp gel in treatment of perianal fistula. patients with perianal fistula will be evaluated for the study. after taking permission with informed consent; cases will be included in the study. cases with inflammatory bowel disease, platelet function disorders or connective tissue disorders that may alter wound healing will be excluded from the study. after, prp application to the fistula tract patients will be taken to follow up. perianal fistulas will be followed by magnetic resonance imaging 1 month after the application. pre-application and post-application scans will be used for the evaluation of the treatment success.

Eligibility criteria:
inclusion criteria: * patients with perianal fistula * signing the informed consent form * above the age of 18 exclusion criteria: * inflammatory bowel disease * previous radiation therapy * having connective tissue disorders
phase iia study of wbi-1001 cream for atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: wbi-1001 is a synthetic,new, non-steroid, small molecule being developed as a candidate drug for the topical, cream treatment of inflammatory skin diseases. as such, it affects t-cells through inhibition of t-cell activities including their infiltration processes, and it shows direct anti-inflammatory manifestation in the mouse edema model. this was a 28 day study (plus one follow-up week) on patients with atopic dermatitis, and 36 patients were treated randomly, bid with either 0.5%, 1.0% or placebo. blood samples were taken weekly for pk analysis.

a double-blind, single-centered, vehicle-controlled, randomized phase iia study of wbi-1001 on patients with mild to moderate atopic dermatitis (ad). all body areas were treatable except face, scalp, groin and genital areas. cream applied bid between 6.00 and 10.00am and 7.00 and 10.00pm daily for 4 weeks. blood draws for pk analysis were taken weekly at the study centre prior to the morning cream application. patients returned to the study centre approximately one week later for a follow-up visit.

Eligibility criteria:
inclusion criteria: * ad diagnosis (based on hanifin's criteria) presenting a minimum of 1% and a maximum of 10% body surface area (bsa) excluding face, groin, scalp and genital areas. * disease severity index (easi) of less than 12, investigator's global assessment (iga) of 2-3 at day 0. * in good general health and free of any condition that might impair evaluation of ad. * women of child bearing potential (wocbp) had to have a negative a negative serum human-beta chorionic gonadotropin pregnancy test before randomization. wocbp had to abstain from sex or they and their partners had to use adequate contraceptive precautions for the duration of the study. * willing and able to comply with the protocol and attend all study visits. * provide a written informed consent form prior to initiation of study procedures. exclusion criteria: * had spontaneously improving or rapidly deteriorating ad. * had ad lesions on only hands and/or feet. * had skin diseases other than ad. * had active allergic contact dermatitis or other non-atopic forms of dermatitis. * had other concomitant medical condition that could put the patient at risk during the study. * had a history of neurological/psychiatric disorders that could interfere with the patient's participation. * had systemic immunomodulatory therapies within 12 weeks prior to the baseline visit. * had prolonged exposure to natural or artificial ultraviolet radiation within 4 weeks of baseline visit. * had phototherapy (including laser), photo-chemotherapy or systemic ad therapy within 4 weeks prior to baseline visit. * had topical ad therapies in the areas to be treated within 2 weeks prior to the baseline visit. * had alcohol abuse in the last 2 years. * had allergic history to any non-medical ingredients of the study cream. * were treated with an investigational drug within 1 month of day 0 or were currently participating in another trial.

Keywords: non-steroid small molecule topical cream inflammatory disease skin
esp block in robotic cardiac surgery

Conditions: Heart Valve Diseases; Postoperative Pain, Acute; Analgesia

Summary: patients undergoing cardiac robotic surgery will receive different pain management after being randomized in 2 groups. control group will receive standard of care pain management with acetaminophen and morphine in pca pump, and the intervention group will receive an erector spinae plane block with a continous infusion of local anesthetic. at 3 months the patients will be contacted to assess for pain and ask them for they life quality.

patients undergoing cardiac robotic surgery will receive different pain management after being randomized in 2 groups. before the surgery and after checking eligibility criteria and exclusion criteria the patients will be asked to enroll to the study. if the agree to participate, they will sign de informed consent and fill the eql 5d-5l questionnaire. the day of the surgery, the perioperative process will be performed as usual unless the interventions detailed in this description. patients will be transferred to the surgical area, enter to the operating room, monitored and general anesthesia will be performed. standard postoperative analgesia group will receive a at the end of the surgery a bolus of iv morphine 0,05mg/kg, followed with infusion of iv morphine 0,25mg/h in patient controlled analgesia protocol (extra bolus on demand of 1mg with lockout interval 20 minutes), and paracetamol 1g every 8 hours. the experimental group will receive the standard analgesia and an esp block. in this group, after the induction of general anesthesia in the operating room, the patient is positioned in lateral decubitus. under strict aseptic conditions, and guided by ultrasound, an ipsilateral erector spinae plane block is performed injecting ropivacaine 0.2% 20ml, and a catheter is placed in this plane. an infusion of ropivacaine 0.16% at 10ml/h is started in the operating room. both groups of patients will emerge from anesthesia in the operative room or at the intensive care unit in the first 6 postoperative hours if possible. after the surgery they will be transfered to the intensive care unit where vital signs will be monitored continuously. the pain intensity and the total required opioid dose will be registered at 12, 24 and 48 postoperative hours. after acute phase of postoperative pain and typically until chest drainages are retired, the esp catheter and the iv morphine will be withdrawn. after discharge by usual criteria, 3 months after the surgery patients will be contacted by telephone. quality of life, pain and if present, its characteristics will be assessed.

Eligibility criteria:
inclusion criteria: * robotic cardiac surgery * accepts to participate exclusion criteria: * use of other regional anesthesia technics * presence of chronic pain * psychiatric pathology, drug abuse * allergy or intolerance to local anesthetics

Keywords: robotic cardiac surgery esp block postoperative pain heart valve disease
cartesia extend 3d study

Conditions: Parkinson Disease

Summary: the purpose of the study is to document patient outcomes including effectiveness for boston scientific corporation's vercise cartesia 16-contact directional lead(s) (x/hx) with deep brain stimulation (dbs) systems for the treatment of parkinson's disease (pd).

subjects will receive deep brain stimulation with a 16-contact directional lead to treat their parkinson's disease.

Eligibility criteria:
key inclusion criteria: * candidate for dbs implant in the treatment of parkinson's disease * must be on stable anti-parkinsonian medications for 28 days prior to informed consent * persistent disabling parkinson's disease symptoms such as dyskinesias, motor fluctuations, or disabling "off" periods despite optimal medical therapy * be willing and able to comply with all visits and study related procedures (e.g., using the remote control, charging system, etc.). key exclusion criteria: * any intracranial abnormality or medical condition that would contraindicate dbs surgery * have any significant psychiatric or cognitive condition likely to compromise the subject's ability to comply with requirements of the study protocol (e.g. bipolar, schizophrenia, mood disorder with psychotic features, cluster b personality disorders) * any current drug or alcohol abuse, as determined by the investigator * any history of recurrent or unprovoked seizures

Keywords: deep brain stimulation
percutaneous irreversible electroporation to treat liver cancer close to the gallbladder

Conditions: Hepatic Carcinoma

Summary: the purpose of this study is to investigate the safety and efficacy of irreversible electroporation for unresectable hepatic carcinoma close to the gallbladder, also progress free survival (pfs) will be recorded.

hepatic carcinoma is the fifth most common cancer worldwide and a large proportion of patients are unsuitable for tumor resection because of factors such as poor hepatic reserve(cirrhosis), multicentric tumors or near vital structures such as vessels, diaphragmatic dome and gallbladder. direct ablative treatments include radiofrequency ablation, microwave (mw) ablation and cryotherapy and irreversible electroporation had been used successful as a therapeutic choice for unresectable patients. at the same time，irreversible electroporation(ire)，which was applied with a novel ablation technology, can induce tissue necrosis by utilizing short pulses of high-voltage electrical energy. the technique also had many advantages, including short ablation time, preservation of vital structures within ire-ablated zone, avoidance of heat/cold-sink effect, complete ablation with well-demarcated margin and real-time monitoring of ire ablation.

Eligibility criteria:
inclusion criteria: * hepatic carcinoma diagnosed by positive biopsy or non-invasive criteria, * tumor from gallbladder is \<0.5 cm * not suitable for surgical resection or transplantation, * have at least one, but less than or equal to 3 tumors, * of the tumour(s) identified, each tumor must be ≤ 7 cm in diameter, * child-pugh class a,b * eastern cooperative oncology group (ecog) score of 0-1, * american society of anaesthesiologists (asa) score ≤ 3, * a prothrombin time ratio \> 50%, * platelet count \> 80x109/l, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure, * are able to comprehend and willing to sign the written informed consent form (icf), * have a life expectancy of at least 3 months. exclusion criteria: * eligible for surgical treatment or transplantation for hcc, * hepatic carcinoma developed on an already transplanted liver, * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.