Kornimate/medical-research-clean huggingface dataset:
a regulatory requirement non interventional study to monitor safety and effectiveness of trajenta duo in type 2 diabetes patients in korea

Conditions: Diabetes Mellitus, Type 2

Summary: the primary objective of this study is to monitor the safety profile of trajenta duo in korean patients with type 2 diabetes mellitus (t2dm) in a routine clinical setting.

study design: post marketed study- observational study

Eligibility criteria:
inclusion criteria: potential subjets must meet all of the following inclusion criteria to enter this trial: 1. no previous exposure to trajenta, trajenta duo 2. should have been started on trajenta duo in accordance with the approved label in korea 3. no current participation in clinical trials 4. no metformin is inappropriate due to contraindications 5. must sign on the data release consent form exclusion criteria: individuals with any of the following characteristics will not be able to enter this study: 1. previous exposure to trajenta, trajenta duo 2. current participation in clinical trials 3. patients for whom metformin is inappropriate due to contraindications
tap block for postoperative pain control

Conditions: Pain, Postoperative

Summary: this clinical trial will examine differences in the effectiveness between three (3) commonly used methods and/or medications used to perform a transversus abdominis plane (tap) block for post-operative pain control. the transversus abdominis muscle is either side between the lowest rib and the hip bone. group a subjects will undergo post-operative pain relief treatment with a single injection of bupivacaine injected into the tap. group b subjects will undergo post-operative pain relief treatment with a single injection of exparel®, a liposomal form of bupivacaine into the tap. group c subjects will be treated with a continuous infusion of the local anesthetic ropivacaine with the on-q® pump. there will be no placebo group in this study.


Eligibility criteria:
inclusion criteria: * ability to give written informed consent * scheduled for open abdominal surgery * american society of anesthesiologists physical status 1 to 3 exclusion criteria: * inability to understand the study or provide written informed consent * inability to follow protocol instructions * complicated history of chronic opioid use including daily use of opioids for a period greater than 2 weeks prior to surgery * allergy to local anesthetic agents * contraindication to regional nerve block such as: * bleeding disorder * sepsis * infection at site of block * body mass index (bmi) \>40 * pregnancy

Keywords: transversus abdominis plane postoperative pain
subcutaneous treatment with icatibant for acute attacks of hereditary angioedema (hae)

Conditions: Hereditary Angioedema

Summary: primary outcome measures: the primary endpoint was the time to onset of symptom relief of the first attack in the double blind phase. h0: λ icatibant/λ tranexamic acid =1 versus h1: λ icatibant/λ tranexamic acid ≠1 where: λ icatibant refers to the hazard rate under icatibant and λ tranexamic acid refers to the hazard rate under tranexamic acid. secondary outcome measures: * additional efficacy assessments (time to almost complete symptom relief) * safety and tolerability * pharmacoeconomics

this was a phase iii, randomised, double blind, double dummy, multicentre, controlled,parallel group study of a 30 mg s.c. formulation of icatibant for the treatment of patients with moderate to very severe symptoms of cutaneous and/or abdominal symptoms of hae. the study consisted of two parts: controlled phase and ole phase. for the primary endpoint, efficacy was determined by evaluating the differences in study outcomes using a visual analogue scale for patients treated with icatibant and tranexamic acid.

Eligibility criteria:
inclusion criteria: * age above 18 years; * documented diagnosis of hae type i or ii (confirmed c1-inh deficiency); * current edema in the cutaneous, abdominal and/or laryngeal areas; * current edema moderate to severe according to the investigator's symptom score. exclusion criteria: * diagnosis of angioedema other than hae, * participation in a clinical trial of another investigational medicinal product (imp)within the past month * treatment with any pain medication since onset of the current angioedema attack * treatment with replacement therapy, including c1-inh products, less than 3 days before onset of the current angioedema attack * treatment with tranexamic acid replacement therapy within a week before onset of the current angioedema attack * treatment with ace inhibitors * contraindications for tranexamic acid * evidence of coronary artery disease based on medical history or screening examination in particular unstable angina pectoris or severe coronary heart disease * congestive heart failure (class 3 and 4) * serum creatinine level of ≥ 250 μmol/l * serious concomitant illness that the investigator considered to be a contraindication for participation in the trial * pregnancy (as assessed prior to treatment) and/or breast-feeding
clinical study to evaluate the efficacy of prasterone treatment for atrophy vulvovaginal in postmenopausal women with vulvar / vestibular pain

Conditions: Vulvovaginal Atrophy

Summary: a prospective, open, randomized and controlled clinical intervention study in women over 45 years of age with a diagnosis of vulvovaginal atrophy (dryness and / or dyspareunia, etc.) and vulvar and / or vestibular pain. the efficacy of prasterone treatment is evaluated in those patients willing to undergo the treatment compared to the control group.

a sample of 50 women over 45 years of age with at least one year of amenorrhea and who require treatment for vulvovaginal atrophy of moderate and / or severe intensity and who present vulvar and vaginal pain within these symptoms will be chosen. at the beginning of the study, after passing the selection criteria and signing the informed consent, the patients will be randomly assigned to one of the two arms of the study, (active group) or (control group), said assignment will be made randomly. through a computer program where one or the other arm of treatment will be assigned to the patient at random to guarantee the homogeneity of both study groups and thus avoid selection biases.

Eligibility criteria:
inclusion criteria: * women over 45 years of age with at least one year of amenorrhea and at least one symptom of vulvovaginal atrophy of moderate and / or severe intensity. * women with moderate to severe vulvar / vestibular pain * women without symptoms or signs of acute vaginal infection. * women without symptoms of urinary infection and a negative urine strip result. * woman willing to carry out the study procedures and comply with the visits. * woman who signs the informed consent. exclusion criteria: * hormone treatment in the last three months for vulvovaginal atrophy * treatment with vaginal moisturizers in the last week for vulvovaginal atrophy * laser treatment in the last 6 months. * acute and recurrent urinary tract infections in the last 3 months. * acute genital infections (herpes, candida, etc) * personal history of cancer at any level * present alterations in the area to be treated, such as lacerations, abrasions or ulcers (resolution time at the medical discretion) * decompensated non-communicable chronic diseases (diabetes mellitus, heart disease ...) * participation in a clinical study 3 months before inclusion or during this study. * hypersensitivity to the active principle or any of the excipients * undiagnosed vaginal bleeding. * untreated endometrial hyperplasia * acute liver disease or a history of liver disease while liver function tests remain impaired. * current diagnosis or history of venous thromboembolism (deep vein thrombosis, pulmonary embolism) * known thrombophilic disorders (protein c, protein s, or antithrombin deficiency) * current or recent diagnosis of arterial thromboembolic disease (angina, myocardial infarction) * porphyria

Keywords: vultar/vestibular pain dyspareunia vaginal dryness
compassionate use of concizumab if you have haemophilia

Conditions: Congenital Haemophilia

Summary: the compassionate use programme will give participants concizumab for free, even though it is not yet approved by health authorities. this is because participants need this medicine to treat their haemophilia properly. the programme will check that participants are safe and that the medicine works for them. the programme may last for years. participants will take one injection under their skin every day. participants will have 4-5 visits with the study doctor for the first half year. after that they will have 1 visit every half year. at all clinic visits participants will have blood samples taken. participants will fill in a diary between the visits. a patient is considered to have completed the programme when any of the following criteria occurred first: 1) when the patient is included in a clinical trial with concizumab or 2) up to 6 months after concizumab is commercially available in the patient's country and approved for the patient (the time span of 6 months should provide ample time for the patient to obtain concizumab commercially) or 3) the sponsor decides to discontinue concizumab clinical development for the patient's population.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any programme-related activities. programme-related activities are any procedures that are carried out as part of the programme. * patients with congenital haemophilia: 1. severe haemophilia a (coagulation factor viii (fviii) less than 1%) or moderate/severe haemophilia b (coagulation factor ix (fix) less than or equal to 2%) without inhibitors or 2. any haemophilia severity with documented history of inhibitors (more than or equal to 0.6 bethesda unit (bu)) who cannot be treated satisfactorily with authorised and marketed medicines (example: due to inhibitors or allergic reactions to factor-containing products, or due to poor venous access), and who are not able to enrol in clinical trials designed to support the development and registration of concizumab medicines (example: due to inhibitors or allergic reactions to factor-containing products, or due to poor venous access) as per investigator and novo nordisk assessment. * the potential benefit for the individual patient justifies the potential risks of treatment. exclusion criteria: * known or suspected hypersensitivity to investigational medicinal product or related products. * any condition (current or medical history), which in the investigator's or novo nordisk's opinion might jeopardise patient's safety or compliance with the protocol.
abnormal coronary vasomotion in patients with suspected coronary artery disease (cad)

Conditions: Coronary Vasospasm; Microvascular Angina; Coronary Artery Disease

Summary: in patients with chest pain and/or shortness of breath coronary artery disease (cad) is suspected depending on the pattern of symptoms and the electrocardiogram (ecg). coronary angiography is the method of choice to verify this suspicion. if the patient coronary arteries on coronary angiography are totally normal or unobstructed, one can only speculate if the patients' discomfort is from the heart or not. a possibility to get further information about the healthiness of the coronary arteries is the acetylcholine test (ach-test). when injecting this natural, body produced-substance into the coronary arteries one can test if the vessels develop coronary spasm which can be the reason for the patient's symptoms. the investigators therefore use this test in this study to look for coronary spasm in patients with suspected cad but normal/unobstructed coronary arteries. in case of a positive test, the patient profits from having found a cause for his/her symptoms making treatment with special tablets possible. furthermore, the investigators want to analyze blood samples of every patient to look for signs of inflammation, vasoconstriction and genetic variants that seem to be linked with coronary spasms. on the basis of these results the ach-test could probably be avoided in the future.


Eligibility criteria:
inclusion criteria: * adults between 35 and 95 years old with angina pectoris and/or dyspnea suggestive of coronary artery disease with non-invasive proof of coronary ischemia or high pre-test probability for cad who will be referred for coronary angiography * serum creatinine \< 1,4 md/dl * left ventricular ejection fraction \> 50% exclusion criteria: * patients under 35 years and above 95 years of age * severe chronic obstructive pulmonary disease (contraindication for acetylcholine-testing)

Keywords: acetylcholine
effectiveness of physical exercise on chronic non-specific neck pain

Conditions: Neck Pain

Summary: neck pain is a common medical condition among office workers all over the world. the purpose of this study was to see if physical exercise, such as basic body awareness, neck-specific training exercises, and ergonomic modifications, could help reduce pain, disability, and job stress while also improving quality of life among office workers. participants will be assigned at random to either an experimental (exercise therapy and ergonomic modification) or a control group (ergonomic modification).


Eligibility criteria:
inclusion criteria: * age 25-60 years * greater than 3 months of chronic nsnp. * office workers and computer users * the ability to continue working exclusion criteria: * a history of severe injury * previous physical therapy treatments * joint instability * frequent migraines * spasmodic torticollis * inflammatory rheumatic diseases * peripheral nerve entrapment * severe psychiatric illness * pregnancy * other conditions that prevent physical loading.
a multi-site rct of a stepped-care intervention for emergency department patients with panic attacks and panic disorder

Conditions: Panic Attacks and Disorders

Summary: using a randomized controlled trial (rct) design, the main objective of this study is to evaluate the clinical, patient-centered, and economic effectiveness of a stepped-care intervention for patients with panic attacks and panic disorder presenting to the busiest accident and emergency (a\&e) departments of the largest public healthcare group in singapore. the rct will have two arms: 1) treatment via an enhanced care pathway consisting of a stepped-care intervention for panic attacks and panic disorder; and 2) a control arm consisting of screening for panic attacks and panic disorder in the a\&e and discharge (routine care). in addition to the baseline assessment, the study follow-up visits will occur at 1, 3, 6, and 12 months.

specific aims and hypotheses aim 1 (primary): to evaluate the clinical effectiveness of a stepped-care intervention for a\&e patients with panic attacks and panic disorder as compared to screening alone. aim 2: to evaluate the patient-centered effectiveness of a stepped-care intervention for a\&e patients with panic attacks and panic disorder as compared to screening alone. aim 3: to evaluate the incremental cost-effectiveness of a stepped-care intervention for a\&e patients with panic attacks and panic disorder compared to screening alone from the health system perspective.

Eligibility criteria:
inclusion criteria: 1. male or female 2. 21+ years of age 3. triage level 2 or 3 4. english or mandarin speaking 5. able to provide informed consent and read study materials 6. presenting complaint of chest pain, palpitations, dizziness, or difficulty breathing 7. score ≥ 3 on cdr screener 8. diagnosis of panic attack or panic disorder confirmed on scid interview 9. willing to enter randomized trial exclusion criteria: 1. altered mental status (dementia, psychosis, substance intoxication/withdrawal) 2. triage level 1 3. non-english or mandarin speaking 4. unwilling or unable to complete study procedures 5. symptoms of clear cardiac origin as determined by a\&e physician 6. deemed unfit due to possible adverse respiratory or cardiac outcomes by a\&e physician 7. clear organic cause for panic symptoms as evidenced by laboratory tests (fbc, ue, ecg, troponin t, cxr) 8. does not meet criteria for panic attack or panic disorder on scid interview 9. received cbt for panic symptoms in previous 12 months
early versus late voiding trials after prolapse repair

Conditions: Urinary Retention; Pelvic Organ Prolapse

Summary: the primary aim of this study is to determine if normal bladder function (the ability to empty the bladder during spontaneous urination) after surgical repair of pelvic organ prolapse returns faster in patients who have a retrograde voiding trial the day of surgery versus patients who have a retrograde voiding trial on postoperative day one. half of participants will have a voiding trial 4 hours after surgery, while the other half will have the voiding trial postoperative day one.

overnight indwelling catheterization is a prevalent practice after surgical repair of pelvic organ prolapse. a voiding trial is performed postoperative day one to determine if urinary retention or abnormal bladder function exists. a significant number of patients ranging from 26-47% will require continued catheterization post-op for urinary retention in order to avoid injuries associated with over distention of the bladder and ureteral reflux. this study aims to explore a strategy to reduce the length of catheterization post-operatively by testing the bladder at a closer interval to surgery. an earlier voiding trial may improve patient perioperative satisfaction and decrease catheter associated urinary tract infections. additional benefits that may also be seen are earlier first ambulation and quicker achievement of post-op discharge milestones (pain control, ambulation with symptoms, oral intake tolerance and completion of a voiding trial). to date, few studies have attempted a day of surgery voiding trial in patients being admitted for repair of pelvic organ prolapse that requires an overnight admission.

Eligibility criteria:
inclusion criteria: * surgical management of pelvic organ prolapse requiring an overnight hospital admission exclusion criteria: * same day surgery * non-ambulatory (allowed to use an assistive device) * inability to provide informed consent, age \< 21 years * pregnancy or desire for future pregnancy * systematic disease known to affect bladder function (parkinson's disease, multiple sclerosis, spina bifida, spinal cord injury or trauma and neurogenic bladder) * known preoperative urinary retention (defined as a post-void residual \> 100ml) * an untreated urinary tract infection at the time of surgery * treatment at the time of surgery for urinary tract infection * symptoms of urinary tract infection on the day of surgery

Keywords: voiding trial pelvic organ prolapse post-operative catheterization
vitamins, breastmilk hiv shedding, and child health

Conditions: Maternal and Child Health Outcomes

Summary: the purpose of this study is to analyze stored samples and data collected during the conduct of the study "a trial of vitamins in hiv progression and transmission" (hd32257). the aims are to examine the effect of vitamin supplementation on hiv infected women during pregnancy on a number of parameters in breastmilk.

the purpose of this study is to analyze stored samples and data collected during the conduct of the study "a trial of vitamins in hiv progression and transmission" (hd32257). the aims are to examine the effect of vitamin supplementation on hiv infected women during pregnancy

Eligibility criteria:
this study is analyzing samples previously collected from the study "a trial of vitamins in hiv progression and transmission" (hd32257). the inclusion criteria in this study was: * hiv infected women presenting to antenatal care between 12 and 27 weeks of gestation

Keywords: hiv breastfeeding vitamins tanzania children
the pharmacokinetics study of fotagliptin in patients with different degrees of renal insufficiency

Conditions: Type 2 Diabetes Mellitus (T2DM); Renal Insuficiency

Summary: the trial was designed in a single dose, open, non-randomized, multi-dose parallel control group. the study of patients were mild and moderate renal insufficiency, and matched healthy subjects.


Eligibility criteria:
inclusion criteria: 1. age 18 to 75 (including 18 and 75 years old), both male and female; 2. weight: male ≥ 50 kg, female ≥ 45 kg; bmi in the range of 18 to 30 kg/m2 (including 18 and 30 kg/m2); 3. during screening, the glomerular filtration rate (gfr) met the staging criteria of renal insufficiency or normal renal function in the corresponding group; 4. the subjects can communicate well with the researchers, fully understand the purpose and requirements of the trial, voluntarily participate in the clinical trial and sign a written informed consent. 5. during screening, the investigators judged that the kidney disease of the subjects was stable from 4 weeks before screening to the end of the study, and gfr did not change significantly; 6. patients who had not taken or were on stable medication for renal insufficiency and/or other comorbiditions during the 4 weeks prior to screening and agreed to continue treatment during the study period; 7. patients with diabetes who have not used hypoglycemic drugs in the 4 weeks prior to screening, or who are receiving stable antidiabetic therapy (including lifestyle interventions, use of stable doses of drugs, except for prohibited drugs described in the trial protocol) and agree to continue treatment during the study period. exclusion criteria: 1. people who are known to be allergic to dpp-4 inhibitors or drug excipients in this study; 2. previous medication history: 1. use of dpp-4 enzyme inhibitors or similar within 2 weeks prior to screening; 2. inhibitors or inducers of the cyp 2d6 enzyme used within 30 days prior to screening or required during the trial; 3. vaccination within 4 weeks prior to screening; 4. pregnant or lactating women; the subject and his or her spouse or partner have plans to become pregnant, or plan to donate sperm or eggs, or do not agree to an acceptable and effective method of contraception within 3 months of dosing; 5. hepatitis b surface antigen, hepatitis c antibody, treponema pallidum antibody, hiv antigen antibody composite test any item is positive。
tumor classification and its application in surgical treatment of craniopharyngioma

Conditions: Craniopharyngioma

Summary: with the preliminary anatomical and histological study, the membranous structures of the sellar region was considered to be closely related with the growth pattern of craniopharyngiomas(cp). by combined considering of the tumor-membrane relationship, this project was trying to classify the cp through retrospectively summarizing the pre- and postoperative imaging (mri and ct), the intrasurgical findings, and the endocrine data of 198 cps with primary surgery in our hospital (since 1997 until now). as a result, a distinct and systematic cp classification was proposed. the possible originate site, surgical skills and postoperative treatment of all the subtype tumors were discussed and analyzed to provide a normalized surgical treatment for this kind of tumor. then in the prospective cohort, the anticipated 100 cp patients will accept the normalized surgical treatment. and by the long term follow up, the postsurgical quantity of life (qol) of patients was evaluated with aspect in cognition, circadian rhythm, endocrine, water-electrolyte and body weight, et al. by comparing with the long-term results of the retrospective cohort, the totally follow up data was statistically analyzed to assess the rationality of this standard treatment of cp.


Eligibility criteria:
inclusion criteria: 1. primary craniopharyngioma(initial diagnosis); 2. the sufficient pre-, intra and postoperative information (including patient's information, presenting manifestation, the pre- and postsurgical mri, ct; intrasurgical image, and endocrine data); 3. after surgery, patients are followed periodically. quality of life is assessed at baseline and then periodically thereafter.

Keywords: craniopharyngiomas classification membranous structure pituitary stalk obesity panhypopituitarism