Kornimate/medical-research-clean huggingface dataset:
a single-blind, placebo-controlled, dose-ranging trial of oral hdv-insulin in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: a study designed to determine the appropriate doses of oral hdv insulin at meal times.


Eligibility criteria:
inclusion criteria: patients must satisfy all of the following inclusion criteria to be included in the study: 1. be male or female between the ages of18 and 65 years, inclusive; 2. have a current diagnosis of type 2 dm, which is currently managed with oral hypoglycemic agents for at least 3 months; 3. have a current physical examination that reveals no clinically significant abnormalities; 4. have no clinically significant abnormalities in vital signs; 5. have a body mass index (bmi) \<38; 6. have a glycosylated hemoglobin (hba1c) \> 8 and \<12; 7. have a c-peptide level \>3 ng/ml; 8. have a typical fasting blood glucose levels of \< 200 mg/dl (+/- 25 mg/dl); 9. be available for the entire study period, and be able and willing to adhere to protocol requirements; 10. if female of childbearing potential, must be using a reliable form of birth control; and, 11. provide written informed consent prior to admission into the study. exclusion criteria: 1. have a history or presence of significant cardiac, gastrointestinal, endocrine, neurological, liver, or kidney disease, or conditions known to interfere with the absorption, distribution, metabolism, or excretion of insulin; 2. have a history of drug or alcohol dependency or psychological disease; 3. have any clinically significant illness during the 4 weeks prior to admission into the study; 4. require regular use of medication that interferes with the absorption and/or metabolism of insulin; 5. recent use (within 48 hours) of medications that interfere with blood glucose analyses, i.e., mannose, acetaminophen, dopamine, and ascorbic acid, which are all reported to alter glucose-oxidase type blood glucose analytical methods; 6. use of avandia or actos for treating diabetes; 7. participation in a clinical trial or use of an investigational drug within 30 days prior to admission to this study; 8. use of mao inhibitors or enzyme-inducing or enzyme-inhibiting agents (eg, phenobarbital or carbamazepine) within 30 days prior to admission to this study; 9. are pregnant or lactating; 10. have an episode of severe hypoglycemia with seizure or coma within the past year; 11. have a history of ketoacidosis; 12. have any acute illness within 2 weeks prior to screening; or, 13. have elevated liver enzymes (alt, ast, alkaline phosphatase) \>1.5 times the upper limit of normal.

Keywords: diabetes type 1 and type 2 diabetes
strength training in nonagenarians

Conditions: Elderly

Summary: the health enhancing strength training in nonagenarians (strong) is a randomised control trial to assess the effectiveness of an aerobic and strength training program for improving functional capacity and quality of life in nonagenarians. sixty (51 women) nonagenarians (age range: 90-102 years) who live in a geriatric nursing home will be randomly assigned to either a usual care (control) group (n=30) or an intervention (training) group (n=30). participants allocated in the usual care group will receive general physical activity guidelines and participants allocated in the intervention group will also enroll in three weekly non-consecutive individualized training sessions (\~45-50 min each) during 8 weeks. the exercise program will consist of muscular strength \[with a special focus on leg press at 30% (start of the program) to 70% 1 repetition maximum (end)\] and aerobic exercises (cycle-ergometry during 3-5 to 15 minutes at 12-14 points in the rate of perceived exertion scale). results from strong will help to better understand the potential of regular physical activity for improving the well-being of the oldest population groups.


Eligibility criteria:
inclusion criteria: * age: 90 years or over. * planning to stay in the same nursing home during the study. * able to ambulate, with or without assistance. * able to communicate. * informed consent: must be capable and willing to provide consent. exclusion criteria: * acute or terminal illness. * myocardial infarction in the past 3 months. * not capable to ambulate. * unstable cardiovascular disease or other medical condition. * upper or lower extremity fracture in the past 3 months. * severe dementia. * unwillingness to either complete the study requirements or to be randomised into control or training group. * presence of neuromuscular disease or drugs affecting neuromuscular function.

Keywords: functional capacity quality of life depression falls body composition physical activity
study to determine if there are specific clinical factors to determine stent encrustation

Conditions: Kidney Stones

Summary: ureteral stent placement is one of the most common procedures performed within urology. the stents are generally placed for relief of obstruction or to prevent obstruction following a urological procedure. most patients with ureteral stents will eventually form stent encrustations. however, patients form these encrustations at dramatically different degrees and rates ranging from no encrustation at 1 year of stenting to severe encrustation in just a few weeks. the purpose of this study is to determine if the degree of encrustation on a stent for any given patient can be predicted based on 24 hour urine parameters prior to stent placement, with the stent in place and after stent removal. patients who will be receiving stents for other urological reasons will have a 24 hour urine sample collected before stent placement, while the stent is in place and after the stent has been removed. the parameters examined in the 24 hour urine collected will then be compared to the amount of encrustation there is on the stent to see if there is any correlation between the two.


Eligibility criteria:
inclusion criteria: * patient at uci * scheduled to undergo surgery (standard of care) where ureteral stent will be placed exclusion criteria: * minors

Keywords: ureteral stent kidney stones
vgr accelerated tms treatment for depression

Conditions: Depression

Summary: intermittent theta burst stimulation (itbs), a variant of repetitive transcranial magnetic stimulation (rtms), is a well documented method for treatment of depression. the aim of the study is to assess the effect of an accelerated itbs protocol compared to a routine itbs protocol. in the accelerated protocol patients will receive 1200 pulses per session (2 sessions per day, 15 treatment days) and in the routine protocol patients will receive 600 pulses per session (1 session per day, 30 treatment days). participants (n = 146) will be recruited among patients referred to itbs and randomized to treatment. participants will be assessed by a psychiatrist, or a resident psychiatrist, prior to treatment to assure that they fulfill all inclusion criteria and non of the exclusion criteria. a psychiatrist, or a resident psychiatrist, will assess depressive symptoms 3 and 6 weeks after first day of treatment. patients will complete self-rating questionnaires during screening, weekly for 6 weeks starting from the first day of treatment, and 6 months after end of treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of depression verified through a mini international neuropsychiatric interview (m.i.n.i.) * madrs-s \>= 20 * unchanged medication last month * unchanged psychological treatment last month * admitted to psychiatric ward last month * no ect or tms last six months * provision of signed informed consent form * indication for tms is depression exclusion criteria: * addiction (illicit drugs or alcohol) * pregnancy * epilepsy * conductive ferromagnetic or other metals implanted in the head or within 30 cm of the treatment coil * implanted device that is activated or controlled in any way by physiological signals * implanted mediation pumps * intracardiac lines, even when removed * regular use of benzodiazepines * any condition that seriously increases the risk of non-compliance or loss of follow-up

Keywords: itbs rtms depression
treatment of perirectal fistula with cutting seton vs. collagen plug

Conditions: Anal Fistula

Summary: the purpose of this study is to determine if the collagen plug method heals perirectal fistulae as well as the conventional seton method.

traditional treatments for transsphincteric perirectal fistulae rely upon an immediate (fistulotomy) or delayed (seton) transsection of the sphincter muscle possibly resulting in fecal incontinence, take a long time to heal, and/or are associated with significant failure rates (ex. fibrin glue). newer treatment concepts such as the collagen plug do not physically interrupt the sphincter muscle, avoid and minimize the risk of fecal incontinence, and decrease the time to fistula healing. exciting initial reports have confirmed the collagen plug's utility in treating perirectal fistulae, but a systematic scientific comparison is needed to validate the new, less invasive plug method. the primary goal of this study is to show that the collagen plug heals transsphincteric perirectal fistulae as well as the conventional seton method.

Eligibility criteria:
inclusion criteria: 1. patients that are undergoing surgery for perirectal fistulae by the usc colorectal group 2. patients that are older than 18 years of age and are able to understand and sign consent 3. patients that are suitable candidates for either seton or collagen plug placement exclusion criteria: 1. preoperative patient exclusion factors: * pregnant patients * patients with a tumor-related fistula * patients with known allergies to porcine products * patients with known crohn's disease 2. intraoperative patient exclusion factors: * patients with an active purulent infection (pus draining from the fistula tract or abscess associated with the fistula tract) at the time of surgery * patients with a large diameter fistula (\>3mm) * patients with a superficial fistula * patients with a short fistula (\<1 cm in length)

Keywords: fistula-in-ano anal fistula perirectal fistula collagen plug surgisis seton
data collection for patients with low grade ovarian or peritoneal tumors

Conditions: Low Grade Ovarian Serous Adenocarcinoma; Malignant Ovarian Neoplasm; Ovarian Carcinoma; Primary Peritoneal Carcinoma; Primary Peritoneal Low Grade Serous Adenocarcinoma; Psammocarcinoma

Summary: this study collects information to maintain a database on patients with low-grade ovarian or peritoneal tumors. collecting information about the type of cancer and treatment, as well as details about follow-up care, may help researchers learn and better understand these tumor types and help develop better treatments for them.

primary objectives: i. to collect, both prospectively and retrospectively, data on disease characterization, treatment, and outcomes for approximately 1600 female patients with low-grade ovarian and peritoneal tumors. ii. to organize clinical information in order to support multifaceted queries of patient characteristics, treatment, and disease outcome data and to facilitate correlation of these characteristics with patient outcome. iii. to have a single data repository, kept on a secure platform that will integrate clinical information and research findings and serve as a secure archive for future research. secondary objective: i. to obtain and store human tumor samples in the form of blocks or slides for the purpose of establishing a tumor bank. outline: patients' medical records are reviewed for retrospective and prospective data collection. patients may also have residual tissue samples collected and stored.

Eligibility criteria:
inclusion criteria: * patients whose disease progressed to a higher-grade carcinoma since the time of original diagnosis: * ovarian tumor of low malignant potential * low-grade serous carcinoma of the ovary * primary peritoneal tumor of low malignant potential * low-grade serous carcinoma of the peritoneum * psammocarcinoma
torq clinical study

Conditions: Post Cardiac Surgery; Sternal Closure

Summary: the proposed trial is to evaluate the use of the torq closure assistance device and how it affects pain in the sternum, breathing and quality of life compared to traditional use of needle drivers or similar to close sternal wires.


Eligibility criteria:
inclusion criteria: * referred for elective cardiac surgery at st paul's hospital * expected to live greater than 12 months * capable of giving written informed consent * willing to participate in follow-up * greater than 18 years of age, and of legal age of consent in host country exclusion criteria: * patient has had previous median sternotomy, requiring redo sternotomy * surgeon has, prior to enrollment, elected to use alternative closure technique to the interrupted single wire circlage technique (e.g. figure of 8 technique) * surgeon has elected, prior to enrollment. to treat with the torq as a prophylactic measure (e.g. in high risk cases where use of the torq has been shown to be effective in preventing dehiscence)
comparison of three treatments for lower extremity apophysitis

Conditions: Osgood-Schlatter Syndrome (OSS); Sinding-Larson and Johansson Syndrome (SLJ); Sever's Disease; Apophysitis

Summary: the purpose of this study is to compare three different treatments for these types of lower extremity apophysitis- osgood-schlatter syndrome (oss), sinding-larsen and johansson syndrome (slj), or sever's disease. the investigators hypothesize that adolescents who perform a home exercise program (hep) consisting of active elongation exercises will have decreased pain and earlier return to sports and activities as compared to those who perform a hep that consists of static stretching exercises or those who use symptomatic treatment with ice, acetaminophen or nsaids and activity modification.

osgood-schlatter syndrome (oss), sinding-larsen and johansson syndrome (slj), or sever's disease are three types of apophysitis, or secondary growth center irritation, that frequently affect children and teens. although these conditions are common, there is very little data from high quality studies to support a particular treatment method in affected patients. the purpose of this study is to compare three different treatments for these types of apophysitis. the investigators plan to compare two types of home exercise program (hep), one involving active elongation exercises and one utilizing static stretching, with symptomatic treatment consisting of icing, over-the-counter medications and relative rest. the investigators hypothesize that the active elongation hep will result in improvement in pain and earlier return to athletic activities when compared to the static stretching hep and symptomatic care. this pilot study will recruit subjects at the ann \& robert h. lurie children's hospital outpatient sports medicine and orthopaedic clinics with any of the following types of lower extremity apophysitis: oss, slj or sever's disease. subjects will complete a baseline evaluation and questionnaire and will be randomized into one of the three treatment groups. at 2, 4, 6, and 8 weeks, subjects from all groups will use a secure website to complete an online survey to complete questions regarding current pain level, compliance with their home exercise program, if applicable, use of other forms of treatment or pain management (e.g. splinting, icing, rest from activities) and current activity level. the investigators will compare results from each group to determine which treatment(s) resulted in the largest improvements in pain scores and the highest rates of participation in sports and recreational activities.

Eligibility criteria:
inclusion criteria: * diagnosis of oss, slj, or sever's disease * must have regular access to the internet exclusion criteria: * history of prior treatment for oss, slj, or sever's disease * history of previous injury to the affected joint requiring more than 1 week off of sports or activities

Keywords: osgood-schlatter syndrome (oss) sinding-larsen and johansson syndrome (slj) sever's disease apophysitis growth knee
a study comparing ketoconazole shampoo, 2% and ketoconazole 2% shampoo (rs) in the treatment of tinea versicolor.

Conditions: Tinea Versicolor

Summary: to demonstrate the efficacy, therapeutic equivalence and safety of ketoconazole shampoo, 2% (taro pharmaceuticals u.s.a., inc.) and ketoconazole 2% shampoo (reference standard) in the treatment of tinea versicolor.

a multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing ketoconazole shampoo, 2% (taro pharmaceuticals u.s.a, inc.) to ketoconazole shampoo, 2% (reference standard) and both active treatments to a placebo control in the treatment of tinea versicolor.

Eligibility criteria:
inclusion criteria: 1. healthy male or non-pregnant female aged ≥ 18 years 2. subjects must have provided irb approved written informed consent. 3. subjects must have clinical diagnosis of tinea versicolor. 4. subjects must be willing to refrain from using all other tinea versicolor medications or antifungals during the study, other than the investigational product. 5. female subjects of childbearing potential (excluding women who are premenarchal, surgically sterilized (by hysterectomy) or postmenopausal for at least 1 year), in addition to having a negative urine pregnancy test, must be willing to use an acceptable form of birth control during the study from the day of the first dose administration to 30 days after the last administration of study drug. exclusion criteria: 1. female subjects who are pregnant, nursing or planning to become pregnant during study participation. 2. subjects with a history of hypersensitivity or allergy to ketoconazole, other imidazole antifungals, and/or any of the study medication ingredients. 3. subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of tinea versicolor (e.g., vitiligo, pityriasis alba, post inflammatory hypopigmentation and hyperpigmentation, seborrheic dermatitis, pityriasis rosea, guttate psoriasis, tinea corporis, nummular eczema, secondary syphilis, confluent reticulated papillomatosis of gougerot and carteaud, and mycosis fungoides). 4. treatment for tinea versicolor within the past 6 months that had been unresponsive to prescription topical or oral antifungals.
cyanophyta aphanizomenon flos-aquae, and adipose stroma vascular fraction, in heart failure patient

Conditions: Congestive Heart Failure Chronic

Summary: this study is a prospective, randomized, controlled trial to assess the efficacy of transplantation of autologous stroma vauscultar fraction and/or afa in 15 patients with ischemic heart failure

stem cells therapy may be a choice therapy for advanced heart failure patients refractory to medical therapy, and a previous history of coronary artery diseases. in this study the investigators have evaluated consecutive 15 selected patients, the amelioration in failing heart nyha class, hospitalization rate, echocardiographic left ventricle functionality, serum of natriuretic peptide level and associated to reduction of angina after a treatment with stroma vascular fraction infusion y/or stemregen capsule per oral.

Eligibility criteria:
inclusion criteria: * ef \< 45 % * nyha 2 - 3 exclusion criteria: * acute coronary syndrome within last 6 weeks. * pregnancy * fev1 \<20 % * cancer * any severe disease which could interfere with the treatment or the outcome * patient with immunodeficiency * candidate who are judged to be not applicable to this study by doctors.

Keywords: heart failure stem cell stroma vascular fraction afa
mobile evidence-based smoking cessation for veterans living with hiv (mesh)

Conditions: Human Immunodeficiency Virus; Smoking

Summary: smoking is a significant cause of damage to health and quality of life specifically for veterans with human immunodeficiency virus (hiv). smoking cessation interventions for this population are lacking. the primary aim of this project is to explore smoking cessation treatment preferences among veteran smokers living with hiv. the study team will refine the design and content of a smoking cessation treatment for veteran smokers living with hiv. the intervention uses mobile health and telehealth technology to personalize smoking cessation counseling and medications and provide relapse prevention text messaging.

although smoking is a significant cause of damage to health and quality of life specifically for veterans with human immunodeficiency virus (hiv), smoking cessation interventions for this population are lacking. the primary aim of this project is to qualitatively explore smoking cessation treatment preferences among veteran smokers living with hiv. the study team will refine the design and content of an intervention that uses mobile health and telehealth technology to a)individually personalize smoking cessation counseling and pharmacotherapy, and b) provide relapse prevention messaging support. it is a personalized, tailored, multi-component intervention for smoking cessation specifically designed for veteran smokers living with hiv. this project is highly significant given that: 1) smoking is prevalent among and particularly harmful for hiv-positive veterans; 2) there is a dearth of research on smoking cessation for veterans with hiv; 3) current approaches to smoking cessation in this population are not effective; 4) as the largest us provider of hiv health services, vha is an ideal setting; and 5) the proposed intervention follows the va blueprint for excellence, which prioritizes mobile health and treatment personalization to increase reach/efficacy.

Eligibility criteria:
inclusion criteria: * vha patient * hiv positive serostatus * currently smoking 7 cigarettes per week * willing to complete study procedures. exclusion criteria are: exclusion criteria: * current hospitalization * acute risk for suicide documented in the medical record * inability to complete study procedures.

Keywords: human immunodeficiency virus smoking veterans
endoscopic full thickness resection for gastric gist

Conditions: Gastric GIST

Summary: this is a clinical trial to evaluate the efficacy and safety of endoscopic full thickness resection for treatment of gastric gist

to evaluate the clinical safety and efficacy of endoscopic full thickness resection (eftr) for treatment of gastric gist. a total of 30 patients will be recruited

Eligibility criteria:
inclusion criteria: 1. age \> 18 and ≤ 80 2. gastric submucosal tumors located at cardia, lesser curvature and antrum 3. size of the submucosal tumor between 10mm to 30mm as assessed by endoscopic exclusion criteria: 1. patients who are considered as unfit for general anesthesia 2. asa class ≥ iv or moribund patients 3. pregnancy 4. gastric submucosal tumors located at greater curvature and fundus
prophylactic cholecystectomy is not mandatory in patients candidate to the resection for small intestine neuroendocrine neoplasms: a propensity score-matched and cost-minimization analysis

Conditions: Neuroendocrine Tumors; Surgery; Gut Tumor

Summary: to evaluate two competitive strategies in patients undergoing resection of small-intestine neuroendocrine neoplasms (si-nen): prophylactic cholecystectomy (pc) versus on-demand delayed cholecystectomy

this is a retrospective study based on 230 si-nens candidates to the primary tumor resection. patients were divided into two arms: pc and oc. propensity score matching was performed, reporting the d value. the primary outcome was the re-hospitalization rate for any cause. the secondary endpoints were the re-hospitalization rate for biliary stone disease (bsd), the mean number of re-hospitalization (any cause and bsd), the complication rate (all and severe), and the total costs. a p-value \< 0.05 was considered significant, and nnt\< 10 was considered clinically relevant.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of si-nen; * resection of the primary tumor with or without concomitant cholecystectomy; * absence of a history of a biliary stone disease or cholecystectomy before si-nen diagnosis exclusion criteria: - presence of a history of a biliary stone disease or cholecystectomy before si-nen diagnosis