Kornimate/medical-research-clean huggingface dataset:
phase ii placebo-controlled study of 4-aminosalicylic acid for ulcerative colitis

Conditions: Ulcerative Colitis

Summary: objectives: i. assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis.

protocol outline: this is a randomized study. patients are stratified by extent of disease. patients are randomly assigned to oral 4-aminosalicylic acid (4-asa) or placebo administered daily for 6 weeks. optional 4-asa is available to all patients for up to 1 year. concurrent therapy with low-dose sulfasalazine, prednisone, or equivalent is allowed.

Eligibility criteria:
protocol entry criteria: * mildly to moderately severe ulcerative colitis * patient age: 18 to 80

Keywords: gastrointestinal disorders rare disease ulcerative colitis
image-guided stereotactic biopsy of high grade gliomas

Conditions: Brain Cancer; Glioma

Summary: the purpose of this study is to evaluate high and low areas of growth, or proliferation, within the tumor. an imaging technique using a very small amount of a radioactive tracer called 18ffluoro-deoxy-l-thymidine (18f-flt) can detect areas of rapid growth within the tumor. this imaging technique is called a flt pet imaging. this present study involves obtaining one scan using flt pet imaging. the goal of this study is to investigate associations between the imaging findings showing differences in growth rate within the tumor and the biology of the tumor that is measured in the sampled tumor tissue. this information may be used in future brain tumor patients to determine the best combination of treatment for individual patients. these studies may also improve our understanding of the types of changes taking place in brain tumor tissue that could improve individual patient outcome. flt is produced for human use by the mskcc cyclotron facility under an investigational new drug (ind) approval issued by the us food and drug administration (fda). this means that flt is produced under strict rules and regulations, is considered safe, and has been approved for use in humans for certain disease conditions. 18f-flt has been used in several research studies to date at this institution.


Eligibility criteria:
inclusion criteria: * age \> or = to 18 years old. * radiographic appearance of a lesion presumed to be high-grade glioma. * planned surgical resection. exclusion criteria: * all patients who have been previously treated with radiation, chemotherapy, or other targeted drugs (patients only) for their brain tumor. * pregnant (confirmed by serum b-hcg in women of reproductive age) or breast feeding. * patients with other active malignancies or prior treatment for non-cns malignancies.

Keywords: pet scan ct scan 09-060 cns
gastric cancer prevention for indigenous peoples

Conditions: Gastric Cancer

Summary: the incidence of gastric cancer in local indigenous peoples is higher than the non-indigenous counterpart in taiwan. how to design an effective prevention strategy for gastric cancer is of importance. the present study aimed to identify the causes that may account for the health inequalities, allowing generation of a plan of action on the whole population scale.

owing to the continuing gap in cancer burden between indigenous and non-indigenous peoples, reducing health disparities has drawn worldwide attention. evidence indicates that the gastric cancer incidence and mortality rates in indigenous peoples are much higher than those of non-indigenous counterparts living in the same areas. exposure to more risk factors from social habits, lifestyle, and helicobacter pylori infection has been considered the cause. however, even though gastric cancer has been repeatedly shown to be preventable by eliminating risk factors, eradication policies are rarely designed for indigenous peoples. possible obstacles may include the lack of indigenous health statistics, inadequate access to care, difficulty in modifying social habits and lifestyles, and the presence of environmental and cultural barriers. developing and implementing a preventive strategy following the evidence-based principle remains a challenge. in taiwan, the number of indigenous peoples has grown; however, their life expectancy remains substantially lower than that of the non-indigenous population. cancer is the most prevalent cause of death for indigenous peoples and a disproportionate prevalence of certain kinds of cancer is noted for indigenous peoples. these observations provide an opportunity to establish a plan of action, in which a specific intervention is developed to decrease the threat from each specific cancer so that the overall disparate burden can be reduced in a stepwise manner.

Eligibility criteria:
inclusion criteria: * aged 20-60 years * mentally competent to be able to understand the consent form * able to communicate with study staff for individuals exclusion criteria: * pregnancy * individuals with major comorbid diseases

Keywords: cancer prevention antibiotics inequality
pilot for the analysis of usability in the use of the diacare platform for people with type 2 dm and their professionals

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of this study is to evaluate the usability, utility and feasibility of the diacare platform and the ability of users to use the platform and receive valuable information from it to help address the management of type 2 diabetes outside the healthcare environment.

type 2 diabetes mellitus is a chronic disease that increases the risk of patients suffering from heart disease, embolisms and microvascular complications such as blindness, kidney failure and peripheral neuropathies. in order to achieve an optimum level of independence in their self care, it is essential that type 2 dm patients take responsibility for the situation and be actively involved in the control of their health. technology can solve some of the current challenges of chronic diseases such as type 2 dm, and in fact there are studies that suggest that chronic diseases can be more manageable with the support of mhealth. in this context, the diacare platform has been designed with the idea of improving the self-management and self-care of patients with type 2 dm in a more personalized and individual way. the diacare platform consists of an application, a fitbit wristband for activity monitoring and a web platform for professionals. this research project wants to evaluate the usability, utility and feasibility of the diacare platform and the ability of users to use the platform and receive valuable information from it to help address the management of type 2 diabetes outside the healthcare environment. for this, a total of 35 patients and their respective health professionals will be recruited for the study and will use the diacare platform for 3 months. the results of this pilot will be collected through qualitative and quantitative data through the diacare platform and from questionnaires that will be administered to patients and professionals and will allow the evaluation of the technology developed.

Eligibility criteria:
inclusion criteria: * people diagnosed with type 2 dm based on clinical criteria * people who own a smartphone and have competences in the use of technology exclusion criteria: * people that cannot go to the primary care center * people with cognitive deterioration * people with limitations in the practice of physical exercise * people with a life expectancy lower than 6 months

Keywords: diabetes self-management mhealth
bone structure in patients with adult onset growth hormone deficiency assessed using high resolution peripheral quantitative computed tomography

Conditions: Adult Onset Growth Hormone Deficiency

Summary: the aim of the study is to assess bone geometry, bone compartment specific volumetric densities and micro-architecture as well as to evaluate non-invasive estimates of bone strength in patients with adult onset growth hormone deficiency.


Eligibility criteria:
inclusion criteria: * men and women diagnosed with adult onset growth hormone deficiency * age between 18-80 * informed consent exclusion criteria: * competing bone disease (e.g.. mb. paget, myelomatosis, osteogenesis imperfecta, osteoporosis, primary hyperparathyroidism) * ongoing medical treatment affecting bone metabolism (eg. osteoporosis medications) * ongoing pregnancy or breast feeding
a study measuring and tracking changes in overactive bladder (oab) medication

Conditions: Overactive Bladder (OAB)

Summary: the purpose of this study is to track changes in overactive bladder (oab) medical regimen and/or oab medication dosage requirements.

subjects will complete a study specific survey questionnaire at screening and the month 1 through month 6 visits. subjects will be followed for 6 months.

Eligibility criteria:
inclusion criteria: * subject has overactive bladder as determined by their prescribing physician * subject is currently receiving pharmacotherapy for overactive bladder * subject is willing to comply with required protocol/study requirements exclusion criteria: * subject has a history of a clinically significant illness or medical condition prior to screening that would preclude participation in the study * male subjects with lower urinary tract symptoms (luts) or bladder outlet obstruction (boo)

Keywords: overactive bladder (oab) observational registry
prospective strength measurement involving muscles altered in arthroscopic latarjet

Conditions: Shoulder Instability

Summary: open and arthroscopic latarjet procedures are used to treat shoulder instability as primary and salvage procedures. during surgery the coracoid process is detached and repositioned to the anterior glenoid through a subscapularis split and fixed in place, resulting in an enlarged glenoid and therefor articular surface. however, before this is done, the pectorals minor, which inserts at the coracoid process, has to be detached and is left without further treatment. moreover, the conjoint tendon, the origin of the short head of the biceps and coracobrachialis, is repositioned with the coracoid and therefor distalized and medialized. no study currently followed up on the strength of the muscles altered. the aim of this study is therefor, to prospectively measure range of motion and strength of the operated shoulder at different time points pre- and postoperatively, comparing it with the healthy shoulder in each individual.

strength, range of motion and stability will be assessed pre-operatively and at 6 weeks, 12 weeks, 6 months, 12 months and 24 months post-operatively. next to standard radiological follow up, including x-ray, arthrographic computed tomography as well as arthrographic magnetic resonance imaging, specific shoulder scores will be utilised. strength for general shoulder motion as well as specifically for the subscapularis, the pectorals minor, the coracobrachialis and the biceps will be measured with a shoulder dynamometer. data will be analysed and published.

Eligibility criteria:
inclusion criteria: * patients who experienced at least one shoulder dislocation. * patients who are willing to participate in the study * patients who receive arthroscopic latarjet procedure for treatment of glen-humeral instability * patients who are at least 18 years old. * patients with an isi-score of at least 4 points. exclusion criteria: * patients older than 50 or younger than 18 years of age. * patients with painful unstable (multidirectional) instability * patients with congenital defects of the bones involved (humerus, scapula). * patients with an isis of smaller 4 points.

Keywords: shoulder, instability, latarjet, dislocation, strength
effectiveness of a rehabilitation treatment with nordic walking in obese or overweight patients

Conditions: Cardiovascular Diseases; Diabete Type 2; Overweight and Obesity

Summary: nordic walking (nw) is a biomechanically correct walking technique that originated in finland in the 1930s as an off-season training method for cross-country skiers. in the nw, the use of special sticks is combined with "conventional" walking: this involves a greater caloric expenditure, with an energy consumption higher by 20-30% compared to walking without sticks, and also toning of the upper part of the body, in particular triceps, shoulders and back, and the involvement of about 90% of the body's muscles, while maintaining a reduced load on ligaments and joints (baek \& ha, 2021). the nw acts simultaneously and effectively on different components of fitness: coordination, endurance, strength, and mobility. it does not require sudden accelerations and is based on a technique that is easy to learn (with the help of an instructor), especially as regards maintaining correct posture. finally, in addition to the cardiovascular benefits, nw has also been shown to effectively reduce the risk of falls in the elderly. the study is a single-center, randomized controlled trial (rct), with a three-parallel-arm design, open-label. the primary objective is to evaluate the efficacy (in terms of cardiovascular performance), safety, and adherence (in terms of dropout rate) to the exercise prescription after 6 and 12 months follow-up of a 3-month nw intervention compared with standard rehabilitation training (sr, 3 months) in obese/overweight diabetic patients with cardiovascular (cv) complications. the study will enroll in parallel a control group that can access only generic cardiological counseling with a prescription for unsupervised home exercise.


Eligibility criteria:
inclusion criteria: - overweight \[body mass index (bmi) ≥ 27 kg/m2\] or obese (bmi ≥30 kg/m2) adult patients with diabetes mellitus and with a recent cardiovascular event and/or coronary revascularization in the previous three months exclusion criteria: * inability to walk independently and constantly; * acute joint or spine pathologies that make movement impossible; * the presence of dementia as approved by consultation of the patient's medical record and/or administration of the montreal cognitive assessment (moca) test ≤ 15.5 (nasreddine et al., 2005); * chemotherapy 6 months before surgery; * advanced renal failure; * acute cardiovascular event \< 3 months (unstable angina, ami with fe \<40%, arrhythmias, valvular disease, intracerebral/subdural haemorrhage, uncontrolled ai); * home oxygen therapy and non-invasive ventilation (niv) \[excluding continuous positive airway pressure (cpap)\].

Keywords: nordic walking (nw) cardiovascular disease diabetes type ii overweight obesity six minute walking test (6mwt) adherence rehabilitation
a study of abatacept in patients with active ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this clinical research study is to learn if abatacept can improve signs and symptoms of active ulcerative colitis in patients who have not had an adequate response to other therapies. the safety of this treatment will also be studied

the induction period first cohort (ip1c) arms (30/10 mg/kg and 10 mg/kg) were placebo-controlled arms that were used for the primary endpoint and its analysis. the induction period second cohort arms (ip2c 30/10 mg/kg and 10 mg/kg) were not placebo-controlled, their sole purpose being to provide sufficient numbers of participants for the maintenance phase. the first cohort (ip1c) was randomized to receive placebo or 1 of 3 doses of abatacept. following completion of the ip1c randomization, a second cohort (ip2c) was randomized to receive 1 of 2 doses of abatacept. after all participants in the ip1c completed or discontinued, the data was locked and the formal analysis for the induction period primary endpoint was performed. summary tables for the second cohort (ip2c) and the maintenance and open-label phases were generated from a second, subsequent data lock.

Eligibility criteria:
inclusion criteria: * men or women 18 years or older * ulcerative colitis for at lease 3 months * moderate to severe active ulcerative colitis * inadequate response or intolerance to standard ulcerative colitis treatment
the mechanism of micrornas network in alzheimer's disease

Conditions: Alzheimer Disease

Summary: micrornas network, such as micrna107 et al, regulate the pathology of alzheimer's disease and the clinical validation in diagnosis ad.


Eligibility criteria:
inclusion criteria: * nia-aa mci due to ad clinical criteria for mci due to ad * nia-aa ad clinical criteria for ad exclusion criteria: * other type of dementia

Keywords: micrornas alzheimer's disease validation
cystic fibrosis treatment adherence cayston proof-of-concept pilot study

Conditions: Cystic Fibrosis

Summary: real-world adherence to inhaled and oral therapies for cystic fibrosis (cf) patients remains discouragingly low, ranging between 31-53% for inhaled antibiotics and 41-72% for hypertonic saline. programs to enhance adherence, including comprehensive behavioral interventions with adolescents, have met with mixed success. advances in therapy, treatment delivery systems, and data capture technology offer the potential for enhancing adherence by providing immediate and more frequent feedback to the patient regarding his or her fidelity to the prescribed treatment regimen. we propose to conduct a proof-of-concept study to evaluate a systematic approach to linking treatment and feedback components to enhance adherence.

study design: this will be a single group intervention involving a 28-day baseline (phase 1), a 28-day treatment period with enhanced adherence feedback. subjects will be treated with cayston via a blue tooth enabled nebulizer.

Eligibility criteria:
inclusion criteria: * subjects will be 18 non-adherent cf patients * stratified by age as adult supervised (8-12) adolescents (12-18) and young adults (19-30) and gender * balanced for ethnicity and disease severity -non-adherence status will be determined at screening based on an maq score \< 6. - exclusion criteria: * inability to give informed consent or assent

Keywords: adherence cystic fibrosis adolescents adults
the clinical trial protocol for the influenza virus vaccine (split virion, inactivated)

Conditions: Influenza

Summary: the purpose of this study is to evaluate the safety and the immunogenicity of influenza virus vaccine (split virion, inactivated) that do not contains preservative .

influenza virus vaccine (split virion, inactivated) that do not contains preservative. ha contents 15μg/0.5ml per dose includ h1n1、h3n2 and b. inactivated split influenza vaccine was manufactured by sanofi pasteur ha contents 15μg/0.5ml per dose includ h1n1、h3n2 and b. this is a randomized, blind phase 3 clinical trial. total 1200 adults (above ages 36 months ) were selected, randomized to two groups \[influenza virus vaccine (split virion, inactivated) and inactivated split influenza vaccine , each group n=600\], adults in each group will be vaccinated with one dose of either influenza virus vaccine (split virion, inactivated) or sanof ivv respectively.

Eligibility criteria:
inclusion criteria: * males and females, age above 36 months ; * adults, parent(s) or guardians are able to understand and sign informed consent for participation; * participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions; * infants no vaccinated with influenza or other preventive biologicals in recent 7 days; * axillary temperature ≤37℃. exclusion criteria: * have medical record of participants or their family on allergy and egg, convulsion, falling sickness, encephalopathy and psychopathy; * low platelet or bleeding disorder do not allow vaccination into the muscle; * have damaged or lower immunological function; * received blood, plasma or immunoglobulin treatment since birth; * have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( down syndrome, diabetes, sickle cell anemia or neural guillain-barre syndrome ); * have or be doubtful of following diseases: respiratory system diseases, acute infection or active chronic, cardiovascular diseases, liver and kidney diseases, skin diseases, hiv.

Keywords: influenza virus vaccine (split virion, inactivated) influenza
prospective interventional study on reversibility of type 2 diabetes mellitus with hypocaloric diet

Conditions: Type 2 Diabetes Mellitus in Obese

Summary: t2dm, a chronic progressive disorder has an epidemic status in india. remission (hba1c of \< 6.5% without any anti-diabetic medication) of t2dm is achievable with diet modifications in recently diagnosed obese t2d individuals. studies suggest very low calorie diet (600 - 800kcal) and low calorie diet-lcd (800 -1000 kcal) using meal replacers (mr) are helpful. the investigators aimed to study the effects of lcd without any anti diabetic medication in intervention group and later comparing it with control group (on standard medical treatment).

the objective is to study the effect of lcd in anthropometric , biochemical and nafld (non alcholic fatty liver disease) parameters after 8 weeks and 24 weeks from enrollment. purposive sampling is used to enroll participants in the study. the lcd is a combination of one meal replacer and modified major meals. calculated exchanges of food groups is taken care of in the other two major meals and snacks in between. inorder to adhere compliance clinical (at baseline, after 8 weeks, after 24 weeks) as well as virtual visits through whatsapp, e-mails, sms, phone calls (once a week during 8 weeks of intervention and further once a month upto 24 weeks) are scheduled. after 8 weeks of lcd, calorie is increased to 1200-1400 kcal/day. in the control group the standard medical treatment is continued. the data is collected in case report form and analysed using spss software by statistician.

Eligibility criteria:
inclusion criteria: * patients with bmi ≥ 30 kg/m\^2 * dm history of less than 6 years. * hba1c of 6.5-8.5 %. * on two or less than two diabetes medication. exclusion criteria: * patients on insulin * patients having any co morbidity like severe diabetic nephropathy, neuropathy and any other serious illness. * evidence of type 1 diabetes, ketones and acidosis.

Keywords: type 2 diabetes mellitus, low calorie diet, meal replacer