Kornimate/medical-research-clean huggingface dataset:
clinical profile and antivenom use in hump-nosed pit viper bites in kerala, south india: a review.

Conditions: Envenomation, Snakebite; Envenomation

Summary: several controversies exist in hypnale bite management in kerala. even though leading bodies like who recommend against using antivenom for hypnale bites, many physicians still administer antivenom for snakebites even when the culprit snake is identified. anecdotal experience suggests that the reasons for doing so range from lack of confidence in the identification of the snake, confusion as to whether or not to approach it syndromically and symptomatically rather than relying on the species identification, doubts as to whether there exists para-specific neutralization capability for the available polyvalent antivenom and fear of medicolegal culpability in denying antivenom in a case of 'snake envenomation'. to date, these domains and rationale have not been studied. it is also to be kept in mind that the evidence behind the who recommendation against the use of antivenom in hypnale is based on expert opinion and case reports. the investigators intend to compare clinical manifestation and outcome amongst hypnale hypnale bite patients who received the polyvalent antivenom to those who did not. the investigators also intend to describe the clinical and laboratorical profile of patients with hypnale hypnale envenomation .

hump-nosed pit viper bites are the second most common snakebite presented to our institute as evidenced by the data in our snakebite registers. acute kidney injury is reported in nearly 10% of the cases in our institute. since 2016, the participating institute maintains a snakebite register that records the patient's name, hospital number, date and time of the bite, hospital admission, and snake identification data after expert confirmation, if done. the investigators intend to review the cases with confirmed hypnale envenomation and describe the clinical and laboratory profile of patients and their course of hospitalization. hump-nosed pit viper envenomation, the venom components, and the pharmacodynamics of the venom are unique to the region that it has missed the attention of many experts in the field. the current available polyvalent antivenom does not utilize the venom of hypnale. yet, antivenom is used by physicians for snakebites even when the culprit snake is identified, citing many reasons. the reasons range from snake misidentification to doubts as to whether para-specific neutralization capability exists for the available polyvalent antivenom. often fear of medicolegal culpability in denying antivenom in a case of 'snake envenomation', and confusion as to whether or not to approach it syndromically and symptomatically rather than relying on the species identification also comes into play.

Eligibility criteria:
- inclusion criteria: case records of all snakebite in which the specimen brought is identified as hump-nosed pit viper (hypnale hypnale) exclusion criteria: * incomplete case records from which no meaningful data can be abstracted.

Keywords: hump-nosed pit viper anti venom
assessment of myeloid cell constitution in the follicular fluid of women undergoing in-vitro fertilization

Conditions: Infertility

Summary: the investigators will study the immune cell subpopulations in follicular fluid of patients undergoing in-vitro fertilization (ivf) treatment in our clinic. the investigators will corelate the presence of immature myeloid cells to the ovarian stimulation response as indicated by follicle stimulating hormone (fsh) and number of follicles or estradiol level developed on the day of human chorionic gonadotropin (hcg) administration.

the study will be an observational study using discarded material from patients undergoing ivf treatment. on the day of ovum pick up, the fluid aspirated from the first follicle in each ovary will be saved and analyzed for cellular content by fluorescence-activated cell sorter (facs) analysis and cytokine and hormone by enzyme-linked immunosorbent assay (elisa) and quantitative polymerase chain reaction (qpcr). in addition, a total of 5cc of blood will be drawn from the patient when introducing the intravenous line for analysis of immune cell composition,hormones and cytokine levels. during the whole study number of oocytes retrieved,number of mature oocytes,number of fertilizations,implantation rates and clinical pregnancy rates will be documented as well.

Eligibility criteria:
inclusion criteria: * women undergoing ivf treatment * infertility caused by one of the following : endometriosis, severe male factor, tubal occlusion, or unexplained. exclusion criteria: * an early follicular phase (day 2-4) fsh level \> 20 miu/ml * abnormal uterine cavity * any contraindication for pregnancy * systemic disease * history of alcohol or drug abuse
comparison of open laparoscopic and robotic surgery in gastric cancer resection.

Conditions: Stomach Neoplasms

Summary: gastric cancer is a common gastrointestinal tumor, and surgical operation is still the main method of gastric cancer treatment. reported for the first time since 1994, the laparoscopic gastric cancer radical prostatectomy, laparoscopic technique is widely applied in the field of gastrointestinal surgery, has gradually replaced the traditional open operation as the main mode of surgical treatment for gastric cancer. although laparoscopy has many advantages, there are still disadvantages, such as the discomfort of the physician, the reverse operation, and the ease of shaking, which hinder the application of laparoscopy. in recent years, the da vinci robot assisted gastric resection has become a new way to treat gastric cancer. compared with the traditional laparoscopy and laparotomy, the operation of the robot is more precise and flexible, with obvious advantages of minimally invasive and good application value and prospect. the aim of the study is to compare value (outcomes/costs) of surgery in patients with gastric cancer by 3 approaches: open, laparoscopic, and robotic.first of all, the investigators will collect 500 cases of gastric cancer patients, randomly assigned for the open, laparoscopic, and robotic group. secondly, to analyzing the demographic data,basic treatment and follow-up data, including the operation time, blood loss, the number of cut edge positive, the distances of cut edge away from the tumor edge, the cases of anastomotic fistula bleeding, stenosis, average such confinement, the meal time, cost of treatment, tumor recurrence rate, the presence of residual stomach, upset stomach and frequency, reflux esophagitis, bile reflux gastritis and other indicators.


Eligibility criteria:
inclusion criteria: * patients without contraindications gastroscope，surgery and anesthesia; * there is no history of abdominal surgery, no severe abdominal cavity adhesion * patients signed informed consent exclusion criteria: * patients with preoperative assessment of distant metastasis; * patients with preoperative radiation and chemotherapy or hormone therapy; * patients with acute obstruction, bleeding or perforation of the emergency surgery * patients with a history of abdominal trauma or abdominal surgery. * patients with contraindications gastroscope，surgery and anesthesia;
comparison of three methods for ng tube placement

Conditions: Unconsciousness

Summary: background and aim: tubular feeding is used, in patients who cannot take food through their mouths, but the digestive system has the ability to digest food. this method is safe and affordable for the patient and results in maintaining the function of the digestive system and reducing the risk of infection and sepsis. the purpose of this study was to compare the three methods of the ng tube placement in intubated patients in the emergency department of university-affiliated hospitals of isfahan from2016 to 2018. materials and methods: this study was a randomized and prospective clinical trial. the statistical population of this study was all patients who had been referred to the emergency department of al-zahra and ayatollah kashani hospitals in isfahan between2016and2018. the sample size was 25 in each group, and in total 75 subjects. the first group was ng tube insertion by the conventional method, the second group was using brake cable and the third group was embeddedby highwayman's hitch or draw hitch, using a silk thread. for all patients, demographic characteristics and possible complications were recorded. finally, the data were analyzed using spss20 software at two statistical levels of descriptive and inferential.


Eligibility criteria:
inclusion criteria: * all intubated patients, referred to the emergency department exclusion criteria: * the presence of symptoms of skull base fracture, * bleeding disorders and coagulopathies, * maxillofacial trauma, which led to deformity and impairment of ng tube, * upper respiratory tract diseases and anomalies, * nasal congestion and nostril stenosis, * esophageal disorder (esophageal stenosis and esophageal varicose vein), * and a history of head and neck radiotherapy. * patients who had been intubated in other centers and being referred to these two centers were also excluded.
trifluridin/tipiracil in metastatic colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: a non-interventional, prospective, open, multicenter study in germany in patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies and with decision for treatment with trifluridin/tipiracil.

the purpose of this nis, after market approval of trifluridin/tipiracil as treatment for mcrc patients who have been previously treated with, or are not considered candidates for, available therapies, is to evaluate effectiveness, qol, treatment details and safety of trifluridin/tipiracil treatment in a real-world setting. in addition, therapy management and health economic parameters regarding trifluridin/tipiracil treatment will be assessed.

Eligibility criteria:
inclusion criteria: * aged 18 years or older. * patients with mcrc who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-vegf agents, and anti-egfr agents. * indication for treatment as assessed by the treating physician. * decision for treatment with trifluridin/tipiracil. * signed written informed consent. * criteria according to current summary of product characteristics (smpc) for patients treated with trifluridin/tipiracil. * ability to read and understand german. exclusion criteria: * contraindications according to smpc for metastatic colorectal cancer patients treated with trifluridin/tipiracil. * participation in a clinical trial within 30 days prior to enrollment or simultaneous participation in a clinical trial.

Keywords: mcrc trifluridin/tipiracil
effectiveness of back care pillow in addition to physical therapy in chronic non-specific low back pain treatment

Conditions: Chronic Nonspecific Low Back Pain

Summary: this study aim to investigate the effects of back care pillow, in adjective with standard physical therapy treatment for chronic non-specific low back pain.


Eligibility criteria:
inclusion criteria: * males or females * age 20 - 69 years old. * patients who have daily routine in so long bending of sitting or standing position at least 2 hours per day * patients with low back pain who have pain for more than 3 months * patients have pain at lower back without refer to leg * patients have moderate to severe pain of numerical rating scale (pain score ≥ 4) exclusion criteria: * pregnant patients * underlying systematic or visceral disease, and specific condition such as neoplasm, ankylosing spondylitis, previous low back surgery * patients have quada equine syndrome * patients with nerve root symptoms (neurological deficit) 1. patient have refer pain to leg area of same dermatome is problem. 2. abnormal reflex of lower extremity. 3. muscle weakness of area myotome is problem.

Keywords: back care pillow chronic non-specific low back pain randomized controlled trial
teleneurorehabilitation for the continuity of care post-stroke: a multicentric pilot study

Conditions: Stroke

Summary: the main aim of this longitudinal, pilot study is to evaluate the feasibility of a multi-domain (i.e., motor, language and cognitive domains) telerehabilitation system using the virtual reality rehabilitation system (vrrs, khymeia) in patients with stroke. furthermore, data on patients' needs and clinical data will be collected before and after treatment and then analyzed.


Eligibility criteria:
inclusion criteria: * single ischemic stroke documented by ct/ mri; * 2 to 18 months after the event. exclusion criteria: * medical history or presence of cognitive decline (moca\<17.54) * recent fractures * history of mental disorders (major depression, psychosis) * history/presence of other neurological disorders that may interfere with outcome * presence of other internal pathologies that may interfere with outcome or treatment

Keywords: stroke telerehabilitation feasibility virtual reality
a pharmacokinetic study of udenafil in adult subjects with or without impaired hepatic function

Conditions: Hepatic Impairment

Summary: this study is designed to assess the effect of hepatic impairment on the pharmacokinetics, safety and tolerability of udenafil in subjects with hepatic impairment compared to healthy subjects.


Eligibility criteria:
inclusion criteria: 1. adult males aged 20 to 64 years at screening. 2. non-smokers 3. in case of hepatic impaired patients 4. in case of healthy volunteers, the subjects aged ± 10 years old of hepatic impaired patients 5. subjects within ±20% of the ideal body weight 6. subjects who have received and understood completely the information regarding the current study and given written informed consents to voluntarily participate in the study and followed all instructions specified in the protocol. exclusion criteria: 1.history of portosystemic shunt surgery.

Keywords: udenafil,da-8159,hepatic impairment,healthy volunteers
stopping aminosalicylate therapy in inactive crohn's disease

Conditions: Crohn Disease; Remission

Summary: the purpose of this study is to assess whether withdrawal of aminosalicylate (5-asa) is non-inferior to continuation of 5-asa therapy in crohn's disease (cd) subjects in remission.

aminosalicylate (5-asa) agents have proven effective for inducing and maintaining remission in mild to moderate ulcerative colitis (uc) and thus are commonly used as first-line agents for patients with crohn's disease (cd) in remission. however, there is uncertainty regarding their effectiveness for cd. in this open-label, randomized study, participants with cd in remission will be allocated to either continue their 5-asa therapy or withdraw their 5-asa. the purpose is to investigate if withdrawal of 5-asa therapy is not unacceptably less effective than continuing on 5-asa in maintaining cd remission over a 24 month period.

Eligibility criteria:
inclusion criteria: * documented diagnosis of cd at least 3 months prior to enrollment * taking any brand or dosage of an oral aminosalicylate for at least 6 months * subject-confirmed compliance with current aminosalicylate therapy (taking at least 75% of prescribed doses) * cd currently in clinical remission * able to participate fully in all aspects of the clinical trial * written informed consent obtained and documented exclusion criteria: * a current diagnosis of uc, indeterminate colitis, microscopic colitis, or diverticular disease-associated colitis * a diagnosis of short-bowel syndrome * active perianal disease * active fistulizing disease * a flare of cd within 3 months prior to enrollment requiring initiation/escalation of medical therapy or surgery * use of systemic corticosteroids for cd (2 continuous weeks or more) within 3 months prior to enrollment * any major resective bowel surgery for cd (ileal resection, ileocecal resection, proctocolectomy, colectomy, enterectomy, ostomy formation and repair, anastomosis/reanastomosis) within 6 months prior to enrollment * unwillingness to stop taking aminosalicylates for the duration of the trial * untreated bile salt malabsorption that, in the opinion of the investigator, may interfere with accurate study hbi assessment * serious underlying disease other than cd that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study * history of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures * currently participating in another interventional trial, or previous participation within the last 3 months
the impact of expandable cryoballoon on autonomic control of the heart

Conditions: Paroxysmal Atrial Fibrillation

Summary: approximately 40% of patients following cryoballoon ablation show signs of parasympathetic denervation. the presence of such effect is related to better outcomes in terms of clinical efficacy (freedom from atrial fibrillation). it could be hypothesized that larger sized balloon (polarxfit system) because of more antral position within the left atrium (and hence smaller distance from ganglionated plexi) might enhance this beneficial modulation of the autonomic system of the heart. this study intends to compare the effects of cryoablation employing expandable balloon (polarxfit) vs. standard balloon (polarx) on autonomic system of the heart.


Eligibility criteria:
inclusion criteria: * primary pvi * paroxysmal atrial fibrillation * sinus rhythm at the admission * participant meets clinical criteria for pvi exclusion criteria: * la diameter \ 50 mm * lvef \<40% * intrinsic sinus node disease * advanced atrioventricular block (pr interval \>300 ms, ii or iii degree av block) * previous cardioneuroablation procedure * pregnancy * contraindications to anticoagulation treatment * any other clinical contraindications to pvi * known atropine intolerance

Keywords: atrial fibrillation ganglionated plexus autonomic modulation cryoablation cryoballoon expandable balloon
a pharmacokinetic and safety study of risperidone long acting injectable in schizophrenic patients

Conditions: Schizophrenia

Summary: the purpose of this study is to explore the pharmacokinetic profile and safety after biweekly (every 2-week) intramuscular (im) injections (6 injections) of risperidone long acting injectable 25, 37.5, or 50 mg/dose in schizophrenic patients. the efficacy of the study medication will also be assessed.

this is an open-label, multicenter, randomized, 3-arm trial to compare the pharmacokinetic profile and the safety profile between 3 dose groups. there are 2 periods in this study: a 10-week treatment period and an 8-week follow-up period. patients will receive 6 injections of long acting injectable risperidone at one of the dose levels (25, 37.5 and 50 mg) every 2 weeks according to their randomly assigned treatment. blood samples will be collected throughout the 10-week treatment and 8-week follow-up period to determine the changes in study drug concentration in the plasma. safety will be assessed by monitoring of adverse events, subjective symptoms/objective findings, laboratory tests, physical examinations, electrocardiograms, injection site reactions, and the drug-induced extrapyramidal symptoms scale (diepss). efficacy of the study drug will be assessed based on the positive and negative syndrome scale (panss) and the clinical global impression - severity (cgi-s) and clinical global impression - change (cgi-c) scales. the patients will receive injections of long acting injectable risperidone (either 25, 37.5, or 50 mg) in their muscle every 2 weeks for 10 weeks for a total of 6 injections.

Eligibility criteria:
inclusion criteria: * japanese patients with a dsm-iv diagnosis of schizophrenia * a positive and negative syndrome scale (panss) total score between 60 (included) and 120 (excluded) * in- or out-patients (change of institutionalization status during the trial period is allowed). exclusion criteria: * no dsm-iv diagnosis other than schizophrenia * no convulsive disorders such as epilepsy * no neuroleptic malignant syndrome or physical fatigue associated with dehydration, malnutrition * no present illness or history of diabetes or risks of diabetes such as hyperglycemia and obesity * no hemorrhagic diathesis.

Keywords: schizophrenia risperidone intramuscular injection pharmacokinetics
restore ef observational study

Conditions: Coronary Artery Disease; Unstable Angina; Angina, Stable; NSTEMI - Non-ST Segment Elevation MI

Summary: a multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard of care prophylactic impella support for a non-emergent percutaneous coronary intervention (pci).

1. hypothesis the prophylactic use of impella 2.5 or cp heart pumps during a non-emergent pci in hemodynamically stable patients at high-risk for periprocedural complications during the procedure is associated with a significant improvement in the patient's lvef and clinical status (heart failure symptoms and hospital readmissions) in the intermediate-term follow-up period post-propci 2. objectives the primary objective of this study is to assess the patient's lvef at 90 days post-propci (60 to 180 days window) as assessed in routine clinical practice and collected from ehr by clinical investigators. the secondary objective of the study is to assess the potential association between the completeness of revascularization and the clinical status at 90 days post-propci (60-180 days window). clinical status includes nyha heart failure functional class and hospital readmission. 3. sample size: the study will enroll more than 1,000 patients at up to 30 investigational sites with experienced impella operators (≥ 25 cases). 4. primary endpoint: subject's lvef at 90 days post-propci (60 to 180 days window) collected from the subject's ehr. 5. secondary endpoints: * completeness and extent of revascularization * nyha functional class at 90 days post-propci (60 to 180 days window) * readmission at 90 days post-propci (60 to 180 days window)

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * subject has previously undergone (≥ 60 days) an impella protected pci (propci) at a study site as identified in the impella quality (iq) assurance database (patients who expired or were lost to follow-up prior to opening of the follow-up study window (day 60 post impella protected pci) will not be included in the study exclusion criteria: * subject with cardiogenic shock at the time of impella insertion. cardiogenic shock defined as: systemic hypotension (systolic blood pressure (sbp) \ 90mmhg) * subject with st elevation myocardial infarction at the time of impella insertion. * subject underwent coronary bypass surgery after the index impella propci * subject underwent repeat revascularization with pci after the index impella propci * subject underwent other cardiac procedures including valve therapies (surgical or percutaneous) after the index impella propci * subject underwent cardiac resynchronization therapy (crt) initiated after the index impella propci * any known medical condition with a life expectancy \<6 months

Keywords: impella hemodynamic mechanical support left ventricular ejection fraction surgical turndown high risk pci