Kornimate/medical-research-clean huggingface dataset:
iop reduction and complications of polymethyl methacrylate gdd on glaucoma patient

Conditions: Glaucoma Eye

Summary: glaucoma is a group of diseases that damage the eye's optic nerve, result in progressive visual field defect and blindness. the aim of glaucoma management is to reduce iop, and glaucoma implant surgery is the alternative treatment that can be chosen. the effectiveness of the implant on the end stage glaucoma patients was evaluated by the reduction of intra ocular pressure (iop) and well formed blebs that were evaluated clinically and by using anterior scanning optical coherence tomography (as-oct). the safety of the implant was determined by the regression of the clinical symptoms and there were no severe complications such as implant extrusion. two patients developed improvement of the visual acuity. this was an unpredictable positive result.

the study is to measure the efficacy of new gdd that made with polymethyl methacrylate. the primary outcome is iop reduction. the secondary outcome is glaucoma medication post surgery and complication that occurred during the follow up. the subjects are refractory glaucoma patients that need glaucoma drainage device implantation. the measurement are collected on first day, first month, third month, sixth month and twelve month. the iop will be measured using gat (goldmann applanation tonometer), but if the subjects are not cooperative, they will be measured using i-care. on the follow up, the glaucoma medication needed will be noted and also for the complication and the need for other surgery, e.g. ac formation using viscoelastic, repair tube/plate exposure, cyclo photocoagulation, etc.

Eligibility criteria:
inclusion criteria: * end stage glaucoma patients whose iop is failed to be controlled by glaucoma medications * patients that are willing to participate in the study * patients with \<6/60 visual acuity * patients above 18 years exclusion criteria: * patients with combination surgery indication (eg. glaucoma with cataracts) * eyes with congenital disease of anterior segment dysgenesis * eyes with uneven surface of the cornea that the measurement iop with goldmann tonometer could be difficult * eyes with broad conjungtival cicatrix that are impossible to be implanted

Keywords: effectiveness glaucoma drainage device intraocular pressure tissue response
vitamin d for established type 2 diabetes (ddm2)

Conditions: Type 2 Diabetes

Summary: this research study in adults with established type 2 diabetes will test whether daily vitamin d supplementation affects how the body processes glucose (sugar).


Eligibility criteria:
inclusion criteria: * established type 2 diabetes, defined by one of the following two criteria: * age ≥ 25 years and ≤ 75 years * bmi: 23 to 40 kg/m2 inclusive * provision of signed and dated written informed consent prior to any study procedures. major exclusion criteria * "severe" diabetes defined by one of the following criteria: * - (a) symptoms of hyperglycemia; * - (b) screening hba1c ≥ 7.5 \[may indicate potential for rapid progression during the trial necessitating need to amplify diabetes-specific pharmacotherapy\] * history of nephrolithiasis or hypercalcemia
capecitabine and cyclophosphamide (xc) as maintenance therapy for advanced breast cancer

Conditions: Advanced Breast Cancer

Summary: to compare the efficacy and safety of capecitabine and cyclophosphamide (xc) versus physician's choice as maintenance therapy for patients with advanced breast cancer who achieved disease control after salvage treatment.


Eligibility criteria:
inclusion criteria: * female, age≥18 years old * ecog≤2 * pathologically confirmed primary breast cancer, with pathologically or radiologically confirmed recurrent or metastatic lesions * hr+/her2+ or hr-/her2+ or hr-/her2- * at least one measurable lesion or bone-only disease (osteolytic or mixed) according to recist v1.1 * disease control (complete response + partial response + stable disease) after salvage treatment * expected survival ≥6 months * adequate organ function exclusion criteria: * during pregnancy and lactation * patients with central nervous system metastasis
score system for prediction risk and early diagnosis of hcc in hiv/hcv patients

Conditions: Acquired Immunodeficiency Syndrome Virus; Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted; Hepatocellular Carcinoma

Summary: the aim of this study is to establish a clinical score panel based on clinical, molecular and genetic parameters that allow us to stratify and obtain an early detection of patients with an increased risk of developing hepatocellular carcinoma (hcc).

transversal study design like a "proof of concept". primary objective: the main objective is try to stablish a descriptive panel (first phase of a score system) based in the conjunction or sum of several clinical and laboratory parameters (molecular and genetic factors). the aim is to detect in a fast, early and successful way those patients that presents a high risk to develop an hepatocellular carcinoma (hcc) in the future in a specific population: hiv and hcv coinfected patients. the establishment of this panel will allow clinicians set up a correct treatment decreasing the probability of liver cirrhosis and hcc.

Eligibility criteria:
inclusion criteria: * human immunodeficiency virus chronic infection * hepatitis c virus chronic infection * no other liver viral coinfections exclusion criteria: * alcohol consume * immunosuppressor or immunoactive treatment
preventing persistent pain and reducing depressive and anxious symptoms following mastectomy and lumpectomy

Conditions: Persistent Postsurgical Pain; Breast Cancer Female; Ductal Carcinoma in Situ

Summary: the proposed study will be a pilot randomized controlled trial comparing treatment as usual (tau) to treatment as usual plus a brief acceptance and commitment therapy (act) intervention (tau + act) with mastectomy and lumpectomy patients identified as at-risk for developing persistent post-operative pain. the act intervention is a single individual therapy session scheduled two weeks following surgery. potential participants will be recruited from the university of iowa breast cancer clinic. a sample size of n = 30 for each arm will be recruited. an attrition rate of 20% is anticipated so the total n to be recruited for the study is 72 participants. study measures will consist of self-report questionnaires and medical record data. data will be collected prior to surgery, one-week after surgery, and 3 months after surgery.

psychological interventions addressing depression, anxiety, and psychological approaches to pain management in pre-surgical patients may serve to prevent the development of persistent post-surgical pain, depression, and anxiety in at-risk individuals. acceptance and commitment therapy (act) is a psychological therapy that has been shown to be effective in minimizing the impairing impact of chronic pain and in treating depression and anxiety. act is a behavior therapy incorporating mindfulness, which aims to increase psychological flexibility via facilitating psychological acceptance and committed action in the direction of one's personally identified values. act has also shown promise in brief interventions, including a one day act workshop with patients with comorbid migraine and depression. the current study proposes to identify pre-operative breast cancer patients who are at increased risk for developing persistent post-surgical pain and to offer a brief act intervention with the aim of reducing the incidence of persistence post-surgical pain and psychological sequela.

Eligibility criteria:
inclusion criteria: 1) ≥18 years of age, 2) scheduled for mastectomy or lumpectomy for breast cancer or dcis, 3) identified to be "at risk" (per guidelines below). at risk criteria: psychological distress (elevated anxiety, depression, or pain catastrophizing), under the age of 50, or with a pre-existing chronic pain condition. scores of 10 or above on the generalized anxiety disorders 7-item scale or the personal health questionnaire depression 8 item scale will indicate elevated anxiety or depression. a score of 30 or above on the pain catastrophizing scale will indicate elevated catastrophizing. exclusion criteria: 1) language or cognitive barriers preventing completion of questionnaires, 2) severe psychiatric disorder: bipolar or psychotic disorder, 3) significant surgical complications.
development of a prediction model for differential diagnosis between intestinal tuberculosis and crohn's disease

Conditions: Crohn's Disease; Intestinal Tuberculosis

Summary: the aim of this study is to develop a scoring system and a prediction model for differential diagnosis between intestinal tuberculosis and crohn's disease.

crohn's disease and intestinal tuberculosis mimic each other in clinical, endoscopic, and histological features. in addition, the yield of microbiological/histological test (afb stain, caseating granuloma) is not high in clinical setting. therefore, distinguishing cd from itb especially in highly endemic areas for tb is challenging. the aim of this study is to develop and to validate a scoring system and a prediction model for differential diagnosis between intestinal tuberculosis and crohn's disease

Eligibility criteria:
final diagnostic criteria: * crohn' disease (at least two of the following is met) 1. clinical history of abdominal pain, weight loss, malaise, diarrhea, and/or rectal bleeding 2. endoscopic findings of mucosal cobblestoning, linear ulceration, skip areas, or perianal disease 3. radiologic findings of stricture, fistula, mucosal cobblestoning, or ulceration 4. macroscopic appearance of bowel-wall induration, mesenteric lymphadenopathy, and "creeping fat" at laparotomy 5. pathologic findings of transmural inflammation and/or epithelioid granulomas * intestinal tuberculosis(at least one of the following is met) 1. histologic evidence of caseating granulomas 2. histologic demonstration of acid-fast bacilli 3. growth of m. tuberculosis on tissue culture 4. clinical, colonoscopic, radiologic, and/or operative evidence of intestinal tuberculosis with proved tuberculosis elsewhere 5. response to antituberculous therapy without subsequent recurrence in patients with clinical, colonoscopic, radiologic, and/or operative evidence of intestinal tuberculosis exclusion criteria: * refusal to participate in the study * age: 15 years or younger * comorbidity with acute infectious disease * pregnancy * previous history of medication including anti-tb drugs, immunosuppressive drugs, and chemotherapeutic agents\\ * use of antibiotics within the previous three months

Keywords: crohn's disease intestinal tuberculosis diagnosis, differential
type 2 diabetes self-management intervention for low-income women

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to assess the extent to which a culturally appropriate, self-management intervention that combines patient education with a patient outreach liaison strategy improves outcomes associated with type-2 diabetes among low-income diabetic women.

in recent years, the prevalence of diabetes has significantly increased among women and because of the expected fast growth rate of minority populations, the number of women in these groups who will be diagnosed with diabetes is also expected to increase significantly over the coming years. among women from minority groups diabetes is the fourth leading cause of death while it is the seventh among non-hispanic white females. non-compliance to diabetes self-care is a major concern for type 2 diabetic women of racial/ethnic groups because of the existing socio-economic and environmental barriers. often, these women live in poverty; have less than a high school education as well as language barriers and inadequate health literacy, which further place them at risk for complications, and the daily activities of diabetes self-care are implemented within the context of family responsibilities and patient's priorities. this study is a 12-month randomized controlled trial designed to compare a lifestyle intervention group (combination group) and a control group (education only group). participants assigned to either group will receive three group education sessions (baseline, 3 and 6 months) with an emphasis on self-management.

Eligibility criteria:
inclusion criteria: 1. low-income women ages 21 and older; with type 2 diabetes ( fasting plasma glucose \> 126 mg/dl); 2. at risk of developing diabetes related complications (treatments goals from the american diabetes association standards of medical care) as defined by: * hba1c \>8.0 % * any of the metabolic clusters such as pre-prandial plasma glucose \> 130 mg/dl; obesity (bmi \>25 kg/m2, or waist circumference \>88 cm (\>35 in); hypertension (systolic \>130 and diastolic \> 80 mmhg); hyperlipidemia (triglycerides \>150 mg/dl; hdl\ 100 mg/dl) exclusion criteria: * participants will be excluded if they are currently pregnant, have conditions (i.e., end stage diagnosis) or behaviors likely to affect conduct of the trial, and unwilling to accept treatment assignment by randomization.

Keywords: type 2 diabetes self-management minority women barriers to diabetes self-management
prediction of extubation success by the patient

Conditions: Mechanical Ventilation; Respiratory Failure; Extubation

Summary: the evidence-based approach to wean and consecutively extubate patients is based solely on objective criteria/tests. the introduction of subjective criteria could further improve the actual method.


Eligibility criteria:
inclusion criteria: * all intubated patients ready for a spontaneous breathing trial exclusion criteria: * not awake * not collaborative

Keywords: extubation prediction
evaluation of safety and tolerability of cor-101 in hospitalized patients with moderate to severe covid-19

Conditions: Covid19

Summary: primary objectives part 1: - to evaluate the safety and tolerability of cor-101 compared to placebo secondary objectives part 1: * to evaluate the preliminary efficacy of cor-101 compared to placebo in hospitalized patients with moderate to severe covid-19 * to assess the pharmacokinetics (pk), pharmacodynamics (pd), and immunogenicity of cor-101


Eligibility criteria:
key inclusion criteria: * hospitalized for covid-19 illness for ≤72 hours * positive sars-cov-2 test by standard rt-pcr assay or equivalent test * presence of moderate to severe clinical signs indicative of moderate or severe illness with covid19 prior to study treatment key exclusion criteria: * diagnosis of asymptomatic covid-19, mild covid-19, or critical covid-19 * in the opinion of the investigator, is not likely to survive for \>48 hours beyond day 1 * new onset stroke or seizure disorder during hospitalization and prior to day 1 * history of relevant cns pathology or current relevant cns pathology
gemcitabine and radiation therapy in treating patients with cancer of the pancreas

Conditions: Pancreatic Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. gemcitabine may make tumor cells more sensitive to radiation therapy. combining chemotherapy with radiation therapy after surgery may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining gemcitabine with radiation therapy in treating patients who have undergone surgery to remove cancer of the pancreas.

objectives: * determine the time to disease progression, local control, and survival of patients with previously resected pancreatic cancer treated with adjuvant gemcitabine and radiotherapy. outline: this is a multicenter study. patients receive gemcitabine iv over 30-60 minutes on days 1, 4, 8, 11, 15, 18, 22, 25, 29, and 32 and undergo radiotherapy on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38 in the absence of disease progression or unacceptable toxicity. beginning at least 4 weeks after chemoradiotherapy, patients without disease progression and with less than 10% weight loss during study receive additional gemcitabine iv over 30 minutes on days 1, 8, and 15. treatment repeats every 28 days for a total of 2 courses. patients are followed every 8 weeks for 6 months and then every 3 months for up to 2 years. projected accrual: a total of 72 patients will be accrued for this study within 2.2 or 3.4 years.

Eligibility criteria:
disease characteristics: * histologically confirmed invasive adenocarcinoma of the pancreas * prior gross total resection via a pancreaticoduodenectomy (whipple resection or total pancreatectomy) within the past 2 months * no clinical evidence of gross residual disease at time of surgery * no focally positive margins (tumor at the margin) * no unresected nodal disease or metastatic disease to the liver, peritoneal surfaces, or elsewhere patient characteristics: age: * over 18 performance status: * ecog 0-2 life expectancy: * more than 6 months hematopoietic: * granulocyte count greater than 1,500/mm3 * hemoglobin greater than 10 g/dl * platelet count greater than 100,000/mm3 hepatic: * bilirubin less than 2.0 mg/dl renal: * creatinine less than 2.0 mg/dl other: * able to maintain adequate oral nutrition * documented stable weight (no more than 5 lbs weight loss) for at least 2 weeks prior to study * no other malignancy within the past 2 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix or breast * non-metastatic prostate cancer allowed if more than 2 year survival likely * no other serious medical or psychiatric illness that would preclude study or limit survival to less than 2 years * not pregnant * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * no concurrent routine growth factors chemotherapy: * no prior chemotherapy for pancreatic cancer endocrine therapy: * not specified radiotherapy: * no prior abdominal radiotherapy for pancreatic cancer surgery: * see disease characteristics

Keywords: stage i pancreatic cancer adenocarcinoma of the pancreas
the effect of bariatric surgery on peripheral nerve function and axonal regeneration

Conditions: Peripheral Neuropathy; Obesity

Summary: the goal of this research is understand if obesity is a major factor for neuropathy development in patients with and without type 2 diabetes. this study will examine the relationship between weight, metabolism, and nerve function and regeneration.

peripheral neuropathy causes progressive injury to the longest nerves of the body, starting in the toes, then progressing slowly up the leg. neuropathy often causes pain, numbness, and weakness if the feet and can lead to reduced mobility, foot ulcers, and even amputation. the most common cause is diabetes, but work at the university of utah finds that prediabetes and other consequences of obesity, including abnormal cholesterol levels, may be associated with neuropathy. research has shown that these risk factors may damage nerves and interfere with the ability of nerves to grow back after an injury. this study aims to 1. characterize peripheral nerve function and cutaneous nerve structure in obese bariatric surgery candidates; 2. evaluate peripheral nerve regeneration capacity (and other nerve function measures) before and after bariatric surgery in obese subjects with no or mild neuropathy; 3. examine the relationship between ectopic lipid accumulation, lipotoxic mediators, neuropathy and regeneration capacity in surgical candidates before and one year after surgery.

Eligibility criteria:
inclusion criteria: * age 18-80 years old * subjects must fulfill criteria for bariatric surgery. exclusion criteria: * history of foot ulceration or neurogenic arthropathy * family history of non-diabetic neuropathy in a first-degree family member. * presence of any disease known to be associated with peripheral neuropathy including but not limited to vitamin deficiency, toxin exposure, paraproteinemia, heavy alcohol use, hepatitis c, hiv. * coumadin use. * inability to understand or cooperate with the procedures of the trial. * known history of sensitivity to capsaicin products.

Keywords: bariatric surgery obesity neuropathy
transverse dento-skeletal effects of two rapid palatal expansion appliances in cleft lip and palate patients

Conditions: Cleft Lip and Palate

Summary: aim of the study: to compare the effect of hyrax appliance and the haas appliance improving the transverse skeletal and dental dimensions in cleft lip and palate patients during mixed dentition.

•steps in short full records pre-treatment. bands selection for upper first molars then construction of expansion appliances(haas or hyrax) . delivery of appliances and instructions to the patients and their parents about their activation regimen 2 quarter turns in the morning and 2 in the evening.the posterior crossbite will be measured as the distance from the palatal cusp tips of upper first molars to central fossae of lower first molars then the needed time for expansion will be calculated .when the time calculated for correction ends, we will stop activation, we will take impressions for digital models to see if real expansion occurred or not and so testing the efficiency of the two appliances. afterthat, if correction was not yet achieved, activation of the appliances will continue till overcorrection at the molar region with the palatal cusp tip of the maxillary posterior teeth contacting the buccal cusp tip of the mandibular posterior teeth. we will then leave the appliance insitu for retention. after 6 months from the first cbct we will take a second cbct to see any bony changes .

Eligibility criteria:
inclusion criteria: * (1) mixed dentition; (2) both males and females; (3) lip repair performed between 3 and 6 months of age and palate repair performed between 12 and 24 months of age; (4) presence of maxillary constriction and posterior crossbite and need for maxillary expansion previous to the secondary bone graft; (5) permanent first maxillary molars present; (6) good periodontal health; (7) no previous orthodontic treatment; exclusion criteria: * (1) presence of a syndrome in companion with the present cleft defect (2) previous secondary alveolar bone grafting (3)taking medications affecting growth

Keywords: maxillary expansion