Kornimate/medical-research-clean huggingface dataset:
a research study looking at how semaglutide works in people with type 2 diabetes in the netherlands, as part of local clinical practice (sure netherlands)

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to collect information on how semaglutide works in real world patients. participants will get semaglutide prescribed by their study doctor. the study will last for about 6 to 8 months. the participants will be asked to complete some questionnaires about their health and their diabetes treatment. participants will complete these during their normally scheduled visits with their study doctor.


Eligibility criteria:
inclusion criteria: * signed informed consent obtained before any study-related activities (study-related activities are any procedures related to recording of data according to protocol) * the decision to initiate treatment with commercially available semaglutide has been made by the patient/legally acceptable representative and the treating physician before and independently from the decision to include the patient in this study * male or female, age greater than or equal to 18 years at the time of signing informed consent * diagnosed with type 2 diabetes at least 12 weeks prior to inclusion * available and documented haemoglobin a1c (hba1c) value less than or equal to 12 weeks prior to initiation of semaglutide treatment exclusion criteria: * previous participation in this study. participation is defined as having given informed consent in this study * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation * treatment with any investigational drug within 90 days prior to enrolment into the study * hypersensitivity to semaglutide or to any of the excipients
pre-operative preparation using 2% chlorhexidine cloth for shoulder surgery

Conditions: Post-operative Surgical Site Infections

Summary: we intend to determine how effective the use of a 2% chlorhexidine cloth is in terms of eliminating the bacterial load on patients undergoing shoulder surgery. we will be comparing the chlorhexidine cloths with a control group which will be performing an ordinary shower prior to surgery. at this time, it is standard of care to only take an ordinary shower the evening prior, and the morning of surgery.

the use of home preoperative chlorhexidine wash has been used in various surgical fields for the prevention of perioperative infections. however, it's use in shoulder surgery has not been published up to this point. the shoulder has a unique microbial flora due to the prevalence of propionibacterium acnes, a bacteria implicated in surgical site infections after shoulder surgery. this study is designed to examine the efficacy of using a preoperative sage 2% chlorhexidine cloth in reducing bacterial load in the pre-operative area as well as in reducing post-operative surgical site infections after shoulder surgery. this study will compare the rate of post-operative infections and also the rate of positive skin cultures. the skin cultures will be obtained in the preoperative area from subjects who used the sage 2% chlorhexidine cloth protocol pre-operatively (n=50) versus those who used only soap and water (n=50).

Eligibility criteria:
inclusion criteria: * patient undergoing shoulder surgery (open or arthroscopic) exclusion criteria: * patient unwilling to comply with instructions * active infection in the operative extremity * documented allergic reaction to chlorhexidine

Keywords: surgical site infections chlorhexidine shoulder surgery
hyperbaric oxygen therapy after stroke - pilot

Conditions: Cerebral Stroke

Summary: the goal of this pilot study is to establish more information about hyperbaric oxygen therapy for this group of patients, and give us more information of how to initiate the best possible main study. can we find any indications that support the use of this therapy for patients suffering from chronic disability after cerebral infarction? can we improve physical and cognitive function.

this is a pilot project including 6 patients for one session of 20 treatments of hyperbaric oxygen therapy. the objective is to establish knowledge of hbo for this group of patients in a norwegian context, so that we can prepare for the main study afterwards, including about 60-70 patients. we need to know how to optimize the administrative and technical systems for the larger study. we want to collect feedback from the patients undergoing the pilot study. we want more information about the treatment table, if 20 treatments are enough, if 2,4 bar pressure is adequate. the treatment table is based on existing research, and is considered safe. the patients are to be treated at table 14/90, at 2,4 absolute atmospheres, and daly 90 minutes of oxygen inhalation (medical oxygen).

Eligibility criteria:
inlcution criteria: * no age restriction * suffered from ischemic stroke (cerebral infarction) 6-12 months before inclusion. * stable phase after standard rehabilitation * measurable physical function failure and / or reduced adl function. * sufficient physical function / mobility to be able to move into / out of the pressure chamber with the help of only one person (tender). patients to participate in the study must be physically, mentally and cognitively fit for pressure chamber treatment. they must be able to stand for their own help, move with support, and be able to follow instructions. this is ensured by discretionary assessment after observation and interview with the patient. exclusion criteria: * claustrophobia * psychosis, severe anxiety * inability to equalize pressure in the middle ear * severe copd and asthma, pathological lung sounds * hypertension (blood pressure \> 140/90 mmhg) * pregnancy * hernia * earlier fractures, or suspected fractures in the face * ongoing chemotherapy * previous treatment with bleomycin * aphasia that prevents necessary communication * cognitive failure that prevents necessary co-operation in the pressure chamber. * previous or current pneumothorax, other lung injury * increased risk of pneumothorax * known or suspected injury to the chest * marfan syndrome * homocystinuria * family history of pneumothorax * chronic lung disease (copd, emphysema, asthma eller cystic fibrosis) * tuberculosis

Keywords: stroke hyperbaric oxygen
first-in-human experience using novel ultraflexible low-impedance electrode arrays: an ideal stage 1 study

Conditions: Epilepsy; Focal Cortical Dysplasia

Summary: the goal of this first-in-human study is to evaluate a novel ultraflexible microelectrode in children undergoing neurosurgery to remove tissue that causes epilepsy (seizures) in focal cortical dysplasia (fcd) or long-term epilepsy-associated tumours (leat). the main questions it aims to answer are: 1. the safety and feasibility of the novel microelectrode into current operative workflow 2. the unique electrophysiological tissue signatures in fcd or leat

epilepsy affects 100,000 people under 25. many children with epilepsy also have a learning disability or developmental problems and 25-30% continue to have seizures despite best medical treatment. neuromodulation or brain stimulation is the delivery of electricity to the brain cells. it may alter the brain activity and overall brain connectivity and currently is rarely used as a treatment for epilepsy. however, it has the potential to reduce the number of seizures and improve other problems that children with epilepsy may have such as concentration, memory and learning. 'precision neuromodulation', which involves individually tailored treatments requires us to identify where in the brain to stimulate and what the best settings are in each individual. a limitation of current neuromodulation treatment is limited understanding of the abnormal signatures of electrical activity in abnormal tissue. the investigators have developed a novel electrode that can record signals from the brain at higher resolution than current electrodes. the 2 micrometer, ultraflexible, low-impedance electrode arrays are smaller, less damaging, and provide multiple contacts at multiple depths. the investigators propose a first-in-human study to investigate the feasibility and safety of using these electrodes in patients undergoing surgery for epilepsy - either focal cortical dysplasia (fcd) or long-term associated epilepsy tumours (leat). the investigators will insert the electrode into brain tissue that is going to be removed as part of the planned surgery. the extent of tissue damage caused by insertion will be examined, and whether the electrode is able to capture signals at difference scales from the brain will be assessed; this includes signals from an area of tissue (termed local field potential) and signals from single nerve cells (termed single unit recordings). if safe, it will lay the foundation to use these electrodes in future precision neuromodulation platforms that can be applied to epilepsy and other neurological diseases.

Eligibility criteria:
inclusion criteria: 1. radiologically visible epileptogenic lesion (focal cortical dysplasia or long-term epilepsy associated tumour) undergoing planned resective surgery exclusion criteria: 1. unable to provide informed consent

Keywords: epilepsy fcd leat neurosurgery microelectrode local field potential epileptic zone
the incidence of hypocalcemia in pregnant women at siriraj hospital

Conditions: Hypocalcemia in Pregnancy

Summary: calcium is an essential element for fundamental physiological functions and during pregnancy. however, higher calcium intake can induce constipation, flatulence, nausea, or kidney stones. this study aims to evaluate the incidence of hypocalcemia among pregnant women in the first half of pregnancy in thailand. also, comparison of calcium level in pregnant women in the third trimester who received and not received calcium during pregnancy.

the primary outcome is the incidence of hypocalcemia among pregnant women in the first half of pregnancy. this study also has secondary objectives. the one is associating factors with calcium level. after getting the results of maternal calcium level, the normal calcium level group will be divided into 2 groups for receiving calcium 1 g/day and no receiving calcium supplement. another with hypocalcemia group will be decided into 2 groups for receiving calcium 1 g/day and 2 g/day. the calcium level was collected again in the third trimester.

Eligibility criteria:
inclusion criteria: * pregnant women who attend antenatal care clinic in siriraj hospital * pregnant women with gestation less than 20 weeks of gestation * singleton pregnancy exclusion criteria: * pregnant women who has underlying diseases including liver disease and vitamin d deficiency * pregnant women are malnutrition patients * pregnant women who receive calcium supplement before enrollment
effects of continuous passive movements vs intermittent compression in patients with post acl reconstruction surgery

Conditions: Anterior Cruciate Ligament Injuries

Summary: acl reconstruction surgery remains a prevalent and debilitating condition, despite invasive and non-invasive approaches aimed at reducing pain and improving function. this study investigates the additional benefits of continuous passive motion (device based exercise) and intermittent compression therapy (device based program) in individuals with post acl reconstruction surgery.

the researcher employs a randomized controlled trial methodology. participants are enrolled into two groups: one receiving continuous passive motion (cpm), and the other receiving intermittent compression therapy(ic).

Eligibility criteria:
inclusion criteria: * diagnosed by orthopedic surgeon and patients who have undergone acl reconstruction surgery * patients who have undergone arthroscopic acl reconstruction surgery * both male and female * patients who are within 4th week post-operatively * aged between 20-50 exclusion criteria: * concomitant injuries such as meniscal tears or ligament sprains * patients who have undergone previous knee surgery, including acl reconstruction * neurological condition * cardiovascular disease * patients with allergies or sensitivities to the materials used in the cpm or ic devices
sodium-hf: study of dietary intervention under 100 mmol in heart failure

Conditions: Heart Failure

Summary: sodium-hf is a multicenter clinical trial in ambulatory patients with chronic hf to evaluate the efficacy of a low sodium containing diet on a composite clinical outcome composed of of all-cause mortality, cardiovascular hospitalizations and cardiovascular emergency department visits. the hypothesis of this study is that patients following a low-sodium containing diet will have fewer clinical events (fewer hospital readmissions or emergency department visits, longer survival) than those randomized to usual care.


Eligibility criteria:
inclusion criteria: * patients recruited if they are 18+ years or older, with confirmed diagnosis of hf (both reduced and preserved systolic function are eligible), nyha class ii-iii, and willing to sign informed consent. exclusion criteria: subjects will be excluded if: * average dietary intake of \<1500 mg/ day by a quantitative or semi-quantitative method * serum sodium \<130mmol/l * renal failure (glomerular filtration rate \<30 ml/min) * hepatic failure * uncontrolled thyroid disorder * cardiac device (icd or crt) or revascularization procedure (pci or cabg) in previous month or planned in next 3 months * hospitalization due to cardiovascular causes in previous 1 month * uncontrolled atrial fibrillation (resting heart rate \>90 bpm) * active malignancy * moderate-severe dementia * enrolled in another interventional research study * patients will be excluded, if in the opinion of the investigator, another condition exists that would preclude dietary compliance or compliance with the protocol.

Keywords: diet dietary sodium reduction salt restriction nutrition
cleancision intraoperative contamination prevention study

Conditions: Wound Contamination; Colorectal Surgery

Summary: this study entitled, an evaluation of the safety and efficacy of the cleancision wound retraction and protection system in protecting surgical incisions from intraoperative contamination when used during colorectal surgery, is designed to evaluate contamination at the wound incision site when the cleancision is used during surgery.

this study entitled, an evaluation of the safety and efficacy of the cleancision wound retraction and protection system in protecting surgical incisions from intraoperative contamination when used during colorectal surgery, is designed to evaluate bacterial contamination at the wound incision site when the cleancision is used during surgery. the cleancision is a surgical tool that is designed to be used for the primary purpose of protecting the wound from contamination that occurs to the incision site during surgery ultimately reducing the occurrence of surgical site infections (ssi). this is a prospective, multi-center, single-arm (non-randomized) clinical study.

Eligibility criteria:
inclusion criteria: * age 18 and older * bmi 15-45, inclusive * colorectal surgery patient, planned resection * incision length meets labeling requirements * written informed consent using the governing irb approved form exclusion criteria: * patients with a pre-existing stoma * patients undergoing emergent colorectal surgery * known history of contact hypersensitivity or allergy to device materials * prior laparotomy or abdominal surgery within a timeframe that may present a safety risk or compromise study results * active infection, sepsis or systemic antibiotic therapy within timeframe that may impact safety or study results * active participation in any other clinical study of an experimental drug or device that may impact safety or study results * postsurgical life expectancy is less than the study follow up period * subject is pregnant or lactating * subject is under incarceration * subject considered to be inoperable following exploratory surgery
mri guided prostate cancer focal laser ablation

Conditions: Prostate Cancer

Summary: the study is a prospective, single-arm, non-randomized, unblinded trial to determine the safety and efficacy of mri guided focal laser ablation of localized low and intermediate risk prostate cancer. all subjects meeting the inclusion exclusion criteria and are enrolled will undergo a mri guided focal laser ablation procedure. the primary aim of the study is to study the safety and efficacy of the procedure.

prostate cancer should be viewed as a spectrum of diseases ranging from a very indolent low-risk process to an aggressive high-risk potentially fatal disease. active surveillance has been introduced as an alternative treatment to patients with low- risk prostate cancers.focal therapy techniques have been introduced in prostate cancer to destroy the tumor itself with adequate safety margin with the advantage of preserving the surrounding non-cancerous tissue. thus maintaining disease control at acceptable levels, while minimizing complications. with the advent of multiparametric mri (mp-mri), it is now possible to identify suspicious prostate gland focal lesions, determining their extent and targeting them for biopsy and focal ablation. laser interstitial thermal therapy (litt) is well suited for mri environment. laser fibers are flexible so they can fit into the mri gantry. laser has been shown to produce homogenous tissue necrosis that can be monitored by real time temperature maps, a feature that facilitates effective and safe ablation. 20 subjects with localized low and intermediate risk prostate cancer that meet the inclusion and exclusion criteria will be enrolled. during baseline evaluation, subjects will undergo lab tests, mr imaging, and will complete qol questionnaires. subsequently, subjects will undergo the magnetic resonance imaging (mri) guided focal laser interstitial thermal ablation procedure. subjects will be followed immediately after the procedure, at 3 weeks, 3 months, 6 months, one year and two years after procedure for adverse events and recurrence of prostate cancer

Eligibility criteria:
inclusion criteria: * age ≥18 years * patients with primary organ confined prostate cancer (≤t2c) and gleason score ≤4+3=7 * lesions visible on multiparametric mri and subsequently diagnosed by targeted mri guided biopsy exclusion criteria: * multifocal intra-prostatic disease, defined as the presence the presence of ≥ 3 non- contiguous pathologically proven foci of cancer. * gleason score \>4+3=7. * extracapsular spread. * nodal or distant metastasis * contraindications to mri or general anesthesia. * uncorrectable coagulopathy. * refusal of participation. * lesions not visualized on the multiparametric mri

Keywords: cancer/carcinogenesis laser treatment magnetic resonance imaging (mri) radiology
childhood adiposity and neurodevelopmental outcomes among offspring of women with type 1 diabetes (conceptt kids)

Conditions: Neurologic Disorder; Adiposity

Summary: this is a follow-up study of children born to mothers who participated in the conceptt trial. conceptt (a multicentre randomized controlled trial of continuous glucose monitoring (cgm) in women with type 1 diabetes during pregnancy). the purpose of this study is to examine the association of maternal glycemic measures on childhood intelligence quotient (iq), behavioural outcomes, language scores and weight measures. the children of the women who participated in conceptt will be assessed.

the assessments will occur between the children's ages of 3-7 years. the assessment will include obtaining consent and child measurements including weight, height, waist circumference and skinfold thickness (at the triceps, subscapular, flank and quadriceps). body mass index (bmi) and waist-height ratio will be calculated. the other procedures will include: 1. the wechsler preschool and primary scale of intelligence-fourth edition (1); 2. adhd rating scale iv (2) and adhd rating scale-iv preschool version (3); 3. social responsiveness scale-2 for asd behaviours (4); 4. children's performance on the speed naming and phonological processing subscales of the nepsy-ii (5) 5. parent reported language development on the children's communication checklist-2 for children over four years of age (6) or the language use inventory (lui) for children 36 to 47 months of age (7). basic demographic questions will be asked regarding the child's mother and father including age, ethnicity, education, occupation, family arrangement, presence of major illnesses, and diabetes complications. questions regarding maternal diabetes, maternal and paternal family history of diabetes and risk factors for heart disease will be collected at the clinic visit.

Eligibility criteria:
inclusion criteria: * children of women who participated in the conceptt trial at selected recruiting sites. exclusion criteria: * children (of women who participated in the conceptt trial) with major congenital anomalies will be assessed on a case by case basis to determine eligibility.

Keywords: type 1 diabetes offspring continuous glucose monitoring
intravitreal bevacizumab vs laser vs combination of bevacizumab and modified laser in pdr

Conditions: Proliferative Diabetic Retinopathy

Summary: in this randomized 3-armed clinical trial, 105 eyes with pdr will be included and divided randomly into 3 groups: ivb group (35 eyes) that receive 4 monthly ivb injections and then rescue ivb, prp group (35 eyes) that undergo full prp in 2 or 3 sessions and then rescue ivb, and combination group (35 eyes) that receive 2 bimonthly ivb injections and a modified laser (1 session anterior to the equator) and then rescue ivb or laser. diabetic macular edema (dme) will be treated independently in all groups by ivb. primary outcome will be the number and activity of neovascularizations at 4,8 and 12 months and secondary measures will be changes in best corrected visual acuity (bcva) and central macular thickness (cmt), and number of examinations and injection.


Eligibility criteria:
inclusion criteria: * presence of pdr with the indication of full prp according the intend of investigator * best corrected visual acuity of 20/320 or better * media clarity, pupillary dilation and patient's cooperation sufficient for full prp, wide-field fag and oct exclusion criteria: * history of prior prp with more than 100 burns outside the posterior pole * tractional retinal detachment involving the macula * evidence of neoplasia of angle on examination * macular edema due to a cause other than dme * any ocular condition which may change visual acuity during the study * substantial cataract which has declined the vision by 3 lines or more * history of intravitreal injection of anti-vegf agent in past 2 months * history of any use of corticosteroid during past 4 months * history of major intra-ocular surgery except cataract surgery * history of yag laser capsulotomy during past 2 months * aphakia and uncontrolled glaucoma according to investigator judgment