Kornimate/medical-research-clean huggingface dataset:
long term safety of amifampridine phosphate in spinal muscular atrophy 3

Conditions: Spinal Muscular Atrophy Type 3

Summary: a long term safety study of amifampridine phosphate in patients with spinal muscular atrophy (sma) type 3.

this open-label outpatient extension study was designed to evaluate the long-term safety and tolerability of amifampridine in patients diagnosed with sma type 3. in addition, the evaluation of the effects of amifampridine on the qol was performed. the study was planned to enroll those patients who had completed the sma-001 study and after all final evaluations for that study had been completed, or those who demonstrated benefit after completing the dose titration period but failed to meet the randomization criteria on day 0 of sma-001. the duration of participation for each patient was expected to be at least 12 months as patients could continue in the study until amifampridine was approved by regulatory agencies or the clinical development of amifampridine was terminated for this indication. in addition to amifampridine, patients continued to receive previous concomitant medications, as needed.

Eligibility criteria:
inclusion criteria: individuals eligible to participate in this study must meet all the following inclusion criteria: 1. participated in the sma-001 study 2. willing and able to provide written informed consent after the nature of the study has been explained and before the start of any research-related procedures. 3. female patients of childbearing potential must have a negative pregnancy test (urine human chorionic gonadotropin \[hcg\] at the end of sma-001 study); and must practice an effective, reliable contraceptive regimen during the study and for up to 30 days following discontinuation of treatment. 4. ability to participate in the study based on overall health of the patient and disease prognosis, as applicable, in the opinion of the investigator; and able to comply with all requirements of the protocol, including completion of study questionnaires. exclusion criteria: individuals who met any of the exclusion criteria in the original protocol or those listed below are not eligible to participate in the study: 1. epilepsy and currently on medication. 2. uncontrolled asthma. 3. concomitant use with sultopride. 4. concomitant use with medicinal products with a narrow therapeutic window. 5. concomitant use with medicinal products with a known to cause qtc prolongation. 6. clinically significant abnormalities in 12 lead ecg, in the opinion of the investigator. 7. subjects with congenital qt syndromes. 8. breastfeeding or pregnant at screening or planning to become pregnant at any time during the study. 9. intolerable amifampridine-related side effects 10. treatment with an investigational drug (other than amifampridine) or device while participating in this study. 11. any medical condition that, in the opinion of the investigator, might interfere with the patient's participation in the study, poses an added risk for the patient, or confound the assessment of the patient. 12. history of drug allergy to any pyridine-containing substances or any amifampridine excipient(s).

Keywords: type 3
long-term extension study of tak-438 for the prevention of recurrent gastric or duodenal ulcers during therapy of non-steroidal anti-inflammatory drug (nsaid)

Conditions: Gastric Ulcers; Duodenal Ulcers

Summary: the purpose of this study is to evaluate the safety of tak-438, once daily (qd), during long-term concomitant non-steroidal anti-inflammatory drug (nsaid) therapy in patients with a history of gastric or duodenal ulcer who require long-term therapy of nsaid.


Eligibility criteria:
inclusion criteria: 1. participants who require continuous nsaid therapy during the treatment period with the study drug 2. participants who have completed the preceding study 3. outpatient (including inpatient for examinations) exclusion criteria: 1. participants deemed to be ineligible to participate in the study by the principal investigator or investigator due to the occurrence of adverse events in the preceding study 2. participants who are scheduled to change the type and dosage regimen of nsaid 3. participants with ulcers or bleeding in stomach or duodenum, endoscopically confirmed during the preceding study 4. participants with small intestine bleeding, large intestine bleeding, or gastrointestinal bleeding of unknown etiology 5. participants who have a history of surgery which affects gastric acid secretion (e.g., resection of upper gastrointestinal tract, vagotomy) or who are scheduled to undergo such surgery 6. participants with a previous or current history of zollinger-ellison syndrome, or other gastric acid hypersecretion disorders 7. participants with a previous or current history of aspirin-induced asthma

Keywords: drug therapy
comparison of topography guided lasik with wavelight® ex500 to smile with zeiss visumax

Conditions: Myopia; Astigmatism

Summary: the purpose of this study is to compare topography guided laser in situ keratomileusis (lasik) corneal surgery to small incision lenticule extraction (smile) corneal surgery for the treatment of myopia with astigmatism.


Eligibility criteria:
inclusion criteria: * subjects in singapore must be 21 years of age or older and subjects in korea must be upon completion of 19 years of age or older due to local regulations; * able to comprehend and sign an informed consent form; * willing and able to complete all postoperative visits; * myopia requiring (a) refractive error correction of -0.5 to -8.0 d optical infinity adjusted manifest refraction sphere with (b) astigmatism correction of -0.75 to -5.0 d manifest refraction cylinder and (c) at least 0.75 d of corneal astigmatism. * intended treatment targeted for emmetropia; * preoperative best-corrected visual acuity (bcva) of 0 logmar or better; * other protocol-defined inclusion criteria may apply. exclusion criteria: * pregnant or lactating, current or planned, during the course of the study; * dry eye; * corneal disease; * diagnosis of advanced glaucoma; * uncontrolled diabetes; * other protocol-defined exclusion criteria may apply.
evaluation of liver disease with elastography measurements in patients undergoing liver transplant surgery

Conditions: Liver Transplantation

Summary: the purpose of the study is to compare ultrasound measurements of the liver obtained prior to surgery on the skin to measurements obtained during surgery directly on the diseased liver. the objective is to determine if ultrasounds of the liver on the skin can provide accurate measurements of disease of the liver to provide an alternative option to liver biopsies.

a non-invasive, ultrasound platform based, shearwavetm elastography measurement will be obtained at two time points on each qualified patient. the first time point will be in the operating room before the initial incision is made. the second time point involves placement of a small, hand-held modified ultrasound probe directly on the patient's diseased liver during the liver transplant surgery. the probe used in this study is the supercurved™sc6-1, capable of a band width of 1-6mhz with 192 elements.

Eligibility criteria:
inclusion criteria: * males and females over the age of 18 * patients undergoing a liver transplant surgery exclusion criteria: * any person unable to provide informed consent
magnetic resonance (mr) spectroscopy in familial mediterranean fever (fmf) patients

Conditions: Familial Mediterranean Fever

Summary: familial mediterranean fever (fmf) is an inherited disorder of unknown etiology, characterized by recurrent episodes of fever, peritonitis and/or pleuritis. fever is the cardinal manifestation of fmf and is present in most attacks accompanied by abdominal pain. another clinical manifestation in patients with fmf is exertional muscle pain, usually in the thigh, which appears even after minor exercise or physical activity in young patients with generally good health (other than fmf) and in good physical condition. some patients also complain of ankle edema after relatively minor physical activity, which subsides after a night rest. although these manifestations are quite common in fmf patients and form part of the minor criteria for the diagnosis, the etiopathogenesis has not been examined. the purpose of the suggested study is to evaluate and characterize the anatomical and biochemical changes in the muscles of the thigh and in the ankle triggered by physical activity in fmf patients complaining of exertional lower leg myalgias and edema after minor physical exercise.


Eligibility criteria:
inclusion criteria: 1. fulfilling the tel hashomer criteria for the diagnosis of fmf \[5\]. 2. suffering from episodes of exertional leg pain and or exertional ankle edema 3. 18-45 years old 4. on a stable (≥ 2 weeks) dose of oral colchicine therapy 5. non-smokers exclusion criteria: 1. with known peripheral vascular disease (pvd) and/or multiple risk factors for pvd (such as diabetes, hypertension, hyperlipidemia) 2. suffering from muscular or neurological diseases not related to fmf 3. with elevated serum creatinine / liver enzymes/ creatine phosphokinase (cpk) levels. 4. suffering from claustrophobia, or with metal fragments in body tissue, or with other contraindications for mri.

Keywords: fmf, exertional leg pain
an efficacy and safety study of tramadol hydrochloride-paracetamol in treatment of moderate to severe acute neck-shoulder pain and low back pain

Conditions: Low Back Pain; Shoulder Pain; Neck Pain

Summary: the purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride-paracetamol tablets in treatment of moderate (medium level of seriousness) to severe (very serious) acute neck, shoulder and low back pain in orthopedics (pertaining to the bones) outpatient or emergency setting.

this is an open-label (all people know the identity of the intervention), non-randomized, multi-center (when more than one hospital or medical school team work on a medical research study) and prospective (study following participants forward in time) study of tramadol hydrochloride-paracetamol tablets. participants will receive 1 to 2 tablets of tramadol hydrochloride-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram \[mg\] and paracetamol 325mg). participants may be given the additional dose according to the clinical requirement. the total treatment duration will be 6 hours. the total study duration will be 4 months. efficacy will be evaluated primarily by pain intensity and pain relief. participants will evaluate the pain severity and pain relief at 0.5, 1, 2, 3, 4 and 6 hours respectively after the first dose; and the drug efficacy and overall satisfaction level at the end of 6 hours after the first dose. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * intermittent or persistent pain for less than 3 months, required analgesic therapy, orthopedic surgery and emergency call participants suffering with severe neck, shoulder, low back pain or chronic neck, shoulder, lower back pain, acute (a quick and severe form of illness in its early stage) exacerbation pain * pain intensity to be assessed using numerical rating scale (nrs), nrs score more than or equal to 4 (from 0 to 10, 0 = no pain, 10 = extreme pain) * during normal pain and stable feeling, can study pain assessment methods and can fill in pain control diary * be willing to participate in the study and must give written informed consent exclusion criteria: * have used strong opium kind of medication 7 days prior to the enrolment * have severe mental disease or using antipsychotic (agent that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect) medication for medical treatment * drug abuse/dependence, or chronic alcohol abuse/depend on history * pregnant or lactating women * unable to tolerate tramadol or any failed treatment in past by using tramadol * comparatively more severe pain in other parts of the body than that of the pain mentioned in the research

Keywords: low back pain shoulder pain neck pain tramadol hydrochloride paracetamol
postoperative pain after colorectal surgery

Conditions: Postoperative Pain

Summary: this study aimed to evaluate pain after elective colorectal surgery and to identify risk factors for postoperative pain. patients:all elective colorectal surgeries at the department of surgery, umeå university hospital, umeå, sweden from march 2013 to april 2017 primary outcome:the primary outcome measurement is the numeric rating scale (nrs), graded from 0-10, on day of surgery, postoperative (pod) 1, 2, 3. the patients are questioned by nurses each morning on four postoperative days to score the maximum pain during the previous 24 hours using the nrs.

this study aimed to quantify pain after elective colorectal surgery and to identify risk factors for postoperative pain. patients: this prospective cohort study includes all consecutive patients undergoing elective colorectal surgery at umeå university hospital in sweden between march 2013 and april 2017. exclusion criteria: patients who do not score pain at any of 4 postoperative days. primary outcome:the primary outcome measurement is the numeric rating scale (nrs), graded from 0-10, where 0 = no pain and 10 = the worst imaginable pain \[18\]. moderate pain is defined as nrs 4-6 and severe pain as nrs 7-10. the patients are questioned by nurses each morning after day of surgery, postoperative day. 1, postoperative day 2 and postoperative day 3 to score the maximum pain during the previous 24 hours using the nrs. all data are registered in enhanced recovery after surgery database (eisa) clinical variables: baseline clinical variables are assessed preoperatively. they included age, gender, body mass index (bmi), smoking, a diabetes mellitus diagnosis and american society of anesthesia (asa) class. the postoperative course is registered prospectively in enhanced recovery after surgery register (eias) and include preoperative oncological treatment, a histopathologically verified cancer diagnosis, the length of hospital stay and complications, including any complication, clavien-dindo 3b or more and anastomotic leakage within 30 days after surgery high-sensitivity c-reactive protein (crp) is measured every postoperative morning.

Eligibility criteria:
inclusion criteria: consecutive adults undergoing elective open and minimally invasive colorectal surgery at the department of surgery, umeå university hospital, from march 2013 to april 2017 exclusion criteria: patients not scoring pain at any of 4 postoperative days.

Keywords: postoperative pain colorectal surgery numeric rating scale minimally invasive surgery risk factors
eus-guided drainage of refractory malignant ascites

Conditions: Malignant Ascites

Summary: this study evaluates the efficacy and safety of drainage of refractory malignant ascites by endoscopic ultrasound-guided (eus-guided) implantation of plastic prostheses. patients with cancer older than 18 years with a life expectancy of less than 6 months who undergo eus-guided will be included in the study.

malignant ascites is described as the presence of fluid in the abdominal cavity due to the presence of tumors. its appearance is a predictor of worse prognosis in the evolution of malignant neoplasm and reduces the quality of life of patients. the use of prostheses with drainage to the gastric cavity has shown good clinical results as the reduction of paracentesis evacuation needs. this achieves the reduction of hospital admissions and the improvement of the quality of life of the patient. in order to verify the usefulness of this drainage technique, a prospective observational study has been designed. patients with cancer over 18 years of age will be included, with a life expectancy of less than 6 months and who have undergone drainage of refractory malignant ascites through the implantation of plastic prostheses. participants receive the intervention in the same manner and intensity if they are not enrolled in the study.

Eligibility criteria:
inclusion criteria: * cancer patients in terminal phase with refractory malignant ascites older 18 years of age exclusion criteria: * patients under 18 years of age * patients with a life expectancy greater than 6 months * patients who are receiving cancer treatment for curative purposes or who suffer from a psychiatric disorder that prevents them from understanding and accepting the procedure * patients who do not accept to participate in the study.

Keywords: endoscopic ultrasound-guided eus-guided transgastric plastic prostheses
rituximab for serious aplastic anemia with platelet transfusion refractoriness

Conditions: Severe Aplastic Anemia; Platelet Transfusion Refractoriness

Summary: due to long-term dependence on platelet transfusion, some severe aplastic anemia (saa) patients suffer platelet transfusion refractoriness (ptr). unlike immune thrombocytopenia (itp), glucocorticoids and human immunoglobulin (ivig) are generally ineffective for ptr. due to the lack of effective intervention methods, patients with ptr suffer increased platelet transfusions, bleeding events and treatment costs, prolonged hospital stays, and decreased survival rate. saa with ptr has become a challenge for physicians. the experiment aims to explore the efficacy of rituximab in the treatment of saa with ptr, and establish a new effective, safe treatment method with relatively low treatment cost.

during the treatment period, rituximab is administered at a dose of 100mg per week, a total of 4 times.

Eligibility criteria:
inclusion criteria: * initial diagnosed saa with ptr * age\>18 years old, regardless of gender * initial diagnosed saa with ptr * age\>18 years old, regardless of gender exclusion criteria: * allergy to rituximab * severe active infection * hypogammaglobulinemia * pregnant and lactating women * heart failure (nyha classification iv) * individuals with epilepsy, dementia, and other mental disorders that require medication treatment who cannot understand or follow the research protocol * chronic infections or other chronic diseases that may be risk to the experiment * the researchers believe that it is not suitable for participants

Keywords: severe aplastic anemia platelet transfusion refractoriness rituximab
timely acquirement of 12-lead ecg using patchy-type wireless device by emergency medical technician in ambulance

Conditions: Chest Pain; Electrocardiography

Summary: in this study, the investigators compare timely acquirement and effectiveness of 12-lead ecg using patchy-type wireless versus using defibrillator which contain ecg examination function in ambulance. the purpose of this study is to determine the difference of timely acquirement of 12-lead ecg using two different systems and the difference of efficiency of ecg examination in ambulance between two groups. the participants in this simulation study were divided randomly into 2 groups : group a is performing an ecg examination on mock patient using defibrillator which contained 12-lead ecg checking function. and take a 15 minutes wash out period. after the wash out period, group a subject performing an ecg examination using patchy-type wireless device. group b subject is performing an ecg examination on mock patient using patchy-type wireless device first, and take a 15 minutes wash out period. after the wash out period, group b performing an ecg examination using defibrillator which contain 12-lead ecg function. both group's ecg examination is performing in the ambulance.


Eligibility criteria:
inclusion criteria: * who have a certification of emergency medical technician in korea and have a nurse license in korea. * who currently engaged of emergency medical dispatch. exclusion criteria: * a subject who did not agree with this study

Keywords: 12-lead electrocardiography emergency medical technician chest pain wireless technology simulation study
interval training study in psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: psoriatic arthritis is a chronical inflammatory disease characterized by pain and reduced physical function. patients have a higher risk of cardiovascular disease and a higher body mass index. a pilot study in patients with rheumatoid arthritis has shown positive effect on inflammation after 12 weeks of high-intensity interval training. the primary aim of this study is to determine whether high-intensity interval training affects the disease activity in psoriatic arthritis. this intervention is believed to result in benefits in terms of inflammation, body composition and risk factors for cardiovascular disease.


Eligibility criteria:
inclusion criteria: * fulfilling the caspar criteria of psoriatic arthritis * ability to exercise. exclusion criteria: * inability to exercise * very high disease activity * unstable ischemic cardiovascular disease * severe pulmonary disease * pregnancy * breastfeeding * drug- and alcohol addictions

Keywords: exercise therapy
evaluation of immediate preoperative instillation (ipoi) of mitomycin c compared to early postoperative instillation (ipop) in non-muscle invasive bladder cancer

Conditions: Non Muscle-invasive Bladder Cancer

Summary: the aim of this pilot study is to assess the efficacy and toxicity of immediate pre-operative instillation of mitomycin c compared to the standard early post-operative .


Eligibility criteria:
inclusion criteria: * age \> 18 years, * primary or recurrent bladder tumor with endoscopic papillary aspect, * one or two bladder tumors, * cytology before turb showing no high-grade cells, * patients without tutorship or subordination (ou curatorship), * patients under the general social security system or qualifying through a third party, * informed consent signed by the patient after clear and fair information. exclusion criteria: * age \< 18 years, * allergy to mitomycin c, * traumatic stenting, * upper tract urothelial cancer, * urethral invasion, * history of muscle invasive bladder cancer, * extensive tumor (3 cm or more), * any contraindication to turb, * simultaneous participation in another clinical research study, * patients not insured by the social security or not qualifying through a third party, * patients with enhanced protection, namely pregnant or lactating women, persons deprived of their liberty by a judicial or administrative decision, people staying in a health or social institution, adults under legal protection, and finally patients in emergency situations, * pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study (i.e. hormonal / mechanical contraceptive : oral, injectable, transdermal, implantable, intrauterine or surgical device: tubal ligation, hysterectomy, total oophorectomy).

Keywords: low-grade nmibc