Kornimate/medical-research-clean huggingface dataset:
a comparative study of 3-point with 1-point mesh fixation in tapp for gilbert type iii inguinal hernia

Conditions: Hernia, Inguinal; Chronic Pain; Seroma; Recurrence; Infections; Hematoma

Summary: this study was designed to compare the outcome of 3 point with 1 point lightweight mesh fixation in tapp surgery for patients with type ⅲ gilbert inguinal hernia. the main outcome include seroma, chronic pain, recurrence, et al.


Eligibility criteria:
inclusion criteria: unilateral indirect inguinal hernia according to preoperative physical examination and imaging examination. the inclusion criteria were as follows: primary indirect inguinal hernia classified as gilbert iii (defect size diameter ≥3cm, including scrotal hernias) exclusion criteria: age below 18 years or older than 80. direct hernia, femoral hernia, recurrent hernia, incarcerated hernia, strangulated hernia, and other types of hernias. patients not suitable for general anesthesia. patients requiring open surgery; patients requiring emergency surgery loss to follow-up or communication difficulties, or poor compliance.
effects of oral levosimendan on respiratory function in patients with amyotrophic lateral sclerosis (als): open-label extension

Conditions: Amyotrophic Lateral Sclerosis

Summary: this study provides an opportunity for subjects in the refals (3119002; nct03505021) study to continue treatment with oral levosimendan. the study will also provide more information about long-term safety and effectiveness of oral levosimendan in patients with als. this is an open-label study, so that all eligible subjects that complete the double-blind refals study (48-weeks of treatment) will have the opportunity to receive oral levosimendan treatment. the primary objective, in addition to continuing treatment for subjects enrolled in the refals study, is to evaluate long-term safety of oral levosimendan in als patients. another important objective is to explore long-term effectiveness of oral levosimendan in the treatment of patients with als. this study is open only to patients taking part in the refals study.


Eligibility criteria:
inclusion criteria: * written or verbal informed consent (ic) for participation in the study * subjects who completed 48 weeks of treatment according to the refals study protocol * able to swallow study treatment capsules at the time of completing 48 weeks dosing in the refals study exclusion criteria: * development (or significant worsening from baseline of the refals study) of serious cardiovascular disease (e.g.: myocardial infarction, heart failure, arrhythmia, stroke, or second or third degree atrioventricular (av) block) * pulse/heart rate repeatedly \>100 bpm after 5-minute rest at baseline. if the pulse/heart rate is \>100 bpm in the first recording, then a second recording must be done after another 5 min rest to confirm pulse/heart rate \>100 bpm * systolic blood pressure (sbp) \<90 mmhg * severe renal impairment (creatinine clearance \ 170 µmol/l at 48 week visit of the refals study, or on dialysis * severe hepatic impairment at the discretion of the investigator * women of reproductive age without a negative pregnancy test and without a commitment to using a highly effective method of contraception (e.g.: oral hormonal contraceptive associated with inhibition of ovulation, intrauterine devices and long acting progestin agent), if sexually active during the study, and for 1 month after the last dose of the study treatment. women who are postmenopausal (1 year since last menstrual cycle), surgically sterilised or who have undergone a hysterectomy are considered not to be reproductive and can be included * subject judged to be actively suicidal by the investigator * any other clinical significant cardiovascular, gastrointestinal, hepatic, renal, neurological or psychiatric disorder or any other major concurrent illness that in the opinion of the investigator could interfere with the interpretation of the study results or constitute a health risk for the subject if he/she took part in the study
advanced telemonitoring of patients with heart failure in home environment

Conditions: Heart Failure

Summary: heart failure is currently not only a major medical but also a socio-economic problem. its prevalence is estimated at 1-2% of the population with an exponential increase in older age groups. a very important part of the treatment of heart failure is the gradual uptitration of therapy to the maximum tolerated doses. properly conducted therapy titration requires more frequent patient contact. thanks to the introduction of telemedicine techniques, the investigators can communicate more effectively with the patient, reach the target doses of heart failure medication faster and subsequently reduce the number of hospitalizations due to worsening of heart failure. this study investigates effect of advanced telemonitoring of patients with heart failure in home environment.


Eligibility criteria:
inclusion criteria: * lvef ≤ 40% * exclusion of obstructive coronary artery disease * ntprobnp ≥ 125pg/ml * ≥ 60 years of age * informed written and verbal consent * able to participate in study activities exclusion criteria: * lvef ≥ 40% * ischaemic ethiology of cardiomyopathy * ntprobnp ≤ 125pg/ml * severe psychological disturbances * absence of collaboration (informed consent) * bp ≤ 110mmhg without hypertensive medication
intravascular ultrasound versus angiography guided drug-coated balloon treatment for stemi patients：a prospective, multicenter, randomized controlled trial

Conditions: STEMI

Summary: objectives: the present study aimed to investigate the difference in late luminal loss (lll) at 9-month after drug-coated balloon (dcb) treatment with intravascular ultrasound (ivus) versus angiography for st-segment elevated myocardial infarction （stemi）patients. background: in primary percutaneous coronary intervention for stemi, dcb angioplasty has proved to be a safe and feasible strategy. compare with angiography guidance, ivus-guided pci significantly improve clinical outcome. with ivus guidance, stemi patients undergo dcb angioplasty might have be beneficial results. methods: a total of 208 stemi patients who required dcb treatment were randomly assigned either an ivus guidance and angiography guidance group. the primary endpoint was late luminal loss at 9-month. stent thrombosis (st) was the safety endpoint.


Eligibility criteria:
inclusion criteria: * acute myocardial infarction eligible for ppci: 1. \>20 min of chest-pain and at least 1 mm st-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction (confirmed by ecg or echocardiography) . 2. reperfusion is expected to be feasible within 12 h after onset of complaints. * infarct related artery eligible for ppci and: 1. de novo lesion in a native coronary artery 2. reference-vessel diameter 2.5 mm and 4 mm 3. diameter stenosis of \>50% (by visual assessment) after thrombus aspiration and pre-dilatation. exclusion criteria: * - age \ 85 yr * history of myocardial infarction * lesion length \> 30m * left main lesion * ostial lesion * none-target vessel need to treat with pci * severe calcification * severe tortuosity * severe angulation * cardiogenic shock before pre-dilation or any serious cases can not perform ivus * known contraindication/resistance for bivalirudin, fondaparinux, heparin, aspirin, prasugrel and/or ticagrelor * participation in another clinical study, interfering with this protocol uncertain * known intracranial disease (mass, aneurysm, avm, haemorrhagic cva, ischemic cva/tia \<6 months before inclusion or ischemic cva with permanent neurological deficit) gastrointestinal/urinary tract * bleeding \<2 months before inclusion refusal to receive blood transfusion * planned major surgery within 6 weeks * stent implantation \<1 week before inclusion * expected mortality from any cause within the next 12 months

Keywords: stemi drug-coated balloon ivus
a perioperative sintilimab and chemotherapy in esophageal squamous cell carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this study is aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy versus chemotherapy in perioperative treatment of locally advanced esophageal squamous cell carcinoma.

this study was designed as an open-label, randomized controlled, phase ii trial. subjects will be systematically randomized at a ratio of 1:1 and will be assigned to either the experimental group (sintilimab combined with chemotherapy group) or the control group (chemotherapy alone group). they will receive 2-3 cycles of neoadjuvant therapy followed by radical esophagectomy and lymph node dissection and adjuvant therapy determined by investigators. the primary endpoint is 1-year event-free survival (efs) rate.

Eligibility criteria:
inclusion criteria: * esophageal squamous cell carcinoma suggested by gastroscopic histopathology. * the primary tumor is located in the middle and lower of the esophagus. * ct2-4an0～3m0 or ct1n+m0 diagnosed by enhanced ct/mri scan. * tumor was evaluated as resectable by surgeon before neoadjuvant therapy. * eastern cooperative oncology group (ecog) performance status of 0 to 1. * can eat semi-liquid food. * less than 20% body weight loss within 6 months prior to enrollment. * sign the consent form before treatment and be able to comply with the relevant procedures such as treatment and visits stipulated in the protocol. * with adequate organs function 1 week before enrollment and tolerable to chemotherapy and surgery. * female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age should take effective contraceptive measures throughout the treatment period and 180 days after the last dose of the test drug. * agree and be able to provide archived or fresh pathological tissue and whole blood, urine and fecal samples for biomarker testing. exclusion criteria: * with metastases or unresectable primary lesion suggested by imaging before treatment. * history of previous subtotal gastrectomy. * patients with active malignancy within 2 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer. * received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional chinese medicine therapy. * with signs of pre-esophageal perforation. with any active autoimmune disease or has a history of autoimmune disease.

Keywords: perioperative esophageal cancer programmed cell death protein-1 inhibitor
sealls (sealing evaluation of air leaks after lung surgery) trial using hemopatch

Conditions: LUNG DISEASES

Summary: the primary objective is to assess the efficacy and safety of hemopatch™ sealing hemostat in reducing the incidence and duration of air leaks after lung resection compared to standard techniques. hypothesis: "the routine application of hemopatch sealing hemostat on the visceral pleura in lung resection areas, during lung resection procedures, is more efficient to reduce the incidence and duration of prolonged air leaks as compared to standard surgical measures."


Eligibility criteria:
inclusion criteria: * patients over the age of 18 years who are able to give their informed consent * patients undergoing lung resection surgery for either malignant or benign conditions including: * lobar and sublobar resections * open, video-assisted thoracoscopic or robotic surgeries * diagnostic or therapeutic procedures exclusion criteria: * traumatic pulmonary contusion or laceration * lung reduction surgery * planned removal of more than 10 lung lesions * pneumonectomy * known hypersensitivity to bovine protein * known hypersensitivity to brilliant blue fcf (e133) * presence of active infection

Keywords: lung surgery air leak prevention
fexinidazole in human african trypanosomiasis due to t. b. rhodesiense

Conditions: Trypanosomiasis, African; Sleeping Sickness; Trypanosoma Brucei Rhodesiense; Infection

Summary: the ultimate goal of this study is to show that fexinidazole offers an alternative over the existing treatments of human african trypanosomiasis due to trypanosoma brucei rhodesiense (r-hat): melarsoprol in patients with stage 2 r-hat and suramin in patients with stage 1 r-hat. the main questions it aims to answer are: * is the short-term fatality rate and failure rate associated with fexinidazole lower than those of melarsoprol in patients with stage 2 r-hat? * is the long-term failure rate associated with fexinidazole lower than that of melarsoprol in patients with stage 2 r-hat? * can fexinidazole in patients with stage 1 r-hat replace the treatment with suramin? * is fexinidazole treatment safe in patient with r-hat, regardless of stage? participants will receive fexinidazole oral treatment for 10 days. regular blood draws and lumbar punctures will be performed over 12 months to confirm the cure of the disease. other assessments will include the recording of adverse events, signs and symptoms of the disease, laboratory tests, vital signs, electrocardiograms.


Eligibility criteria:
inclusion criteria: * signed informed consent form (plus assent for children) * ≥ 6 years old * ≥ 20 kg body weight * ability to ingest at least one complete meal per day (or at least one plumpy'nut® sachet) * karnofsky index ≥ 40 * parasitological confirmation of t. b. rhodesiense infection * having a permanent address or being traceable by others and willing and able to comply with follow-up visit schedule * agreement to be hospitalised for a minimum of 13 days and to receive the study treatment exclusion criteria: * active clinically relevant medical conditions other than hat that may jeopardize subject safety or at the investigator discretion may interfere with participation in the study. * compromised general health or severely deteriorated general condition, such as severe malnutrition, cardiovascular shock, respiratory distress, or terminal illness * patients with severe hepatic impairment (e.g.: clinical signs of cirrhosis or jaundice) * known hypersensitivity to fexinidazole, to any nitroimidazole drugs (e.g. metronidazole, tinidazole), or to any of the excipients * patients previously enrolled in the study or having already received fexinidazole

Keywords: trypanosoma brucei (t. b.) rhodesiense hat neglected tropical disease
early detection of lung cancer in patients with chronic chest diseases

Conditions: Chest--Diseases

Summary: * to evaluate the effectiveness of ldct in detecting early-stage lung cancer in patients with chronic lung conditions compared to standard chest x-rays. * to improve lung cancer outcomes through optimized use of radiological technologies for early detection in high-risk patients with pre-existing lung conditions.

the early detection of lung cancer is crucial, as it is one of the most common and deadly types of cancer worldwide. early detection is especially important in patients with chronic chest diseases, as these underlying conditions can make lung cancer more difficult to diagnose at later stages. radiological imaging techniques play a key role in the early detection of lung cancer in this high-risk patient population. recent advances in imaging technologies have improved our ability to detect small lung abnormalities indicative of cancer at earlier stages, even before symptoms appear . techniques such as low-dose ct scanning have been shown to reduce lung cancer mortality by up to 20% compared to chest radiography alone . advanced imaging allows clinicians to identify subtle nodules or masses in the lungs that may represent cancer . determining the type, size, and extent of lung lesions is important for prognosis and treatment planning . imaging technologies help characterize lesions as benign or malignant and determine cancer stage . this information guides decisions around surgery, chemotherapy, radiation therapy, or other interventions . early detection through radiological screening has been associated with improved survival rates for lung cancer patients with chronic lung diseases . screening finds a higher portion of early-stage, potentially curable cancers in this high-risk group . overall, advanced imaging techniques play a vital role in the early detection and management of lung cancer in patients with underlying chronic chest conditions.

Eligibility criteria:
inclusion criteria: 1- chronic chest diseases patients . exclusion criteria: 1 - age: less than 45 years. 2-patients diagnosed with lung cancer 3-unstable patients or need for icu admission
myocardial microvascular disease in esrd

Conditions: End Stage Renal Disease; Myocardial Microvascular Disease

Summary: cardiovascular diseases are the leading cause of mortality in patients with end stage renal disease (esrd). they often have myocardial ischemia (a major predictor of mortality) on non invasive testing (stress echocardiography and/or myocardial perfusion scintigraphy) but the incidence of significant coronary stenosis (\>70%) is low. the goal of this observational study is to evaluate the incidence and clinical outcomes of proven myocardial microvascular disease in patients with end stage renal disease scheduled or not for kidney transplantation. these patients routinely undergo non invasive detection of myocardial ischemia. patient included in the study will be followed up for 2 years for major cardiovascular events. patients with detected myocardial ischemia during non invasive testing are being explored by coronary angiography. during coronary angiography additional detection of myocardial microvascular disease is being performed by simultaneous measurement of fractional flow reserve (ffr) and coronary flow reserve (cfr) followed by calculation of the index of microcirculatory resistance (imr). comparison of cardiovascular outcomes between patients with and without myocardial ischemia and patients with and without myocardial microvascular disease will be performed.


Eligibility criteria:
inclusion criteria: * patients age \> 18 years with end stage renal disease under dialysis and/or scheduled for kidney or kidney + pancreatic transplantation * having a non invasive detection of myocardial ischemia and agreeing to participate (signed informed consent document) exclusion criteria: past medical history of * acute coronary syndrome * hypertrophic cardiomyopathy * severe aortic and/or mitral valvular disease (grade ≥ 3) * known contraindications to adenosine injection: av block grade ≥ 2 and/or sinoatrial block unless prior implantation of a pace maker, asthma, allergic reaction to adenosine.

Keywords: end stage renal disease myocardial microvascular disease cardiorenal syndrome coronary flow reserve index of microvascular resistance patients with end stage renal disease scheduled or not for kidney or kidney + pancreatic transplantation
breakthrough pain computer integrated patient controlled epidural analgesia

Conditions: Pain

Summary: the computer-integrated patient controlled epidural analgesia (cipcea) system can automatically adjust the background infusion rate during combined spinal-epidural (cse) analgesia based on the parturient's need as labour progresses. analysis of parturients experiencing breakthrough pain may identify associated factors that can also be related to obstetric or foetal outcomes

computer integrated patient controlled epidural analgesia (cipcea) is a novel epidural analgesic delivery system that is currently used in daily practice in kk women's and children's hospital. it has enabled us to monitor the infusion pumps through wireless connection to a central monitoring system and hence, collect pump utilisation data electronically. the cipcea system is programmed to analyse the la usage across the last hour and adjust the background infusion rate according to a preset algorithm. breakthrough pain is defined as maternal complaint of pain or pressure that required and was successfully treated with supplemental epidural medications. we investigated the potential factors associated with breakthrough pain in patients who receive cse epidural analgesia with cipcea, with the aim of elucidating the important associated factors.

Eligibility criteria:
inclusion criteria: * nulliparous women, * requested for epidural analgesia exclusion criteria: * multiparous women, * unable to perform combined spinal epidural technique

Keywords: epidural analgesia pain
preemptive analgesia for primary dysmenorrhoea

Conditions: Primary Dysmenorrhea

Summary: preemptive analgesia before the release of pain mediators

spasmodic dysmenorrhea is one of the most distressing symptoms in women. adolescents shows a usual absence from school . prostaglandin release is one of the most accepted theory responsible for spasmodic dysmenorrhea. non steroidal anti inflammatory drugs were proved to be one of the alternative medications for spasmodic dysmenorrhea. getting the idea of what is called preemptive anesthesia by blocking the receptors before catching pain mediators the study participants will be divided randomly into 2 group group 1 receiving ttt 2 days before the anticipated menstruation and group 2 receiving ttt only during menstruation as analgesia

Eligibility criteria:
inclusion criteria: * nulliparous ladies * with regular menstrual cycle pattern * those experienced history of dysmenorrhea (primary or spasmodic) * patients able to sallow tables exclusion criteria: * irregular cycles * any associated local causes( pelvic infection, endometriosis, fibroid or others) * patients with familial mediterranean fever or other intermenstrual attacks of abdominal pain * gastric or duodenal ulcers or gastritis * other contraindications to non steroidal anti-inflammatory drugs * patients with severe diminution of vision or color discrimination * patients with any depressive or mood disorders * patients receiving any hormonal treatment

Keywords: primary dysmenorrhea preemptive analgesia
randomized controlled trial of the effects of combined resistance and aerobic exercise on health-related quality of life in patients undergoing first-line chemotherapy for metastatic colorectal cancer (reach)

Conditions: Metastatic Colorectal Cancer (mCRC)

Summary: the primary objective of this trial is to compare the effects of 18 weeks structured exercise training versus on control on healt-related quality of life in patients with unresectable mcrc.


Eligibility criteria:
inclusion criteria: - adults (≥18 years of age) schduled to undergo chemotherapy for the treatment of unresectable metastatic colorectal cancer. exclusion criteria : * pregnancy. * a life expectancy of \< 6 months. * absolute contraindications to maximal exercise, as per the recommendations by the danish society of cardiology. * ecog (eastern cooperative oncology group) performance status \> 2. * inability to understand the danish or english language. * engagement in structured moderate-to-high aerobic exercise training for \>30 min \>1 times/week for the past 3 months at the time of inclusion.

Keywords: exercise physical activity metastatic colorectal cancer colorectal cancer endurance training oncology chemotherapy