Kornimate/medical-research-clean huggingface dataset:
eus-gbd vs antibiotics for patients at high risk for cholecystectomy

Conditions: Acute Cholecystitis

Summary: objectives acute cholecystitis commonly occurs in elderly patients who are at high-risk for surgery. whether upfront endoscopic ultrasound-guided gallbladder drainage (eus-gbd) is advantageous over antibiotics first for mild acute cholecystitis is uncertain. hypothesis to be tested the aim is to compare eus-gbd versus standard protocol (antibiotics first) as a definitive treatment, in very high-risk patients suffering from mild to moderate acute cholecystitis. we hypothesize that eus-gbd can reduce the 1-year risk of recurrent acute cholecystitis. design and subjects this is an international randomised controlled study including consecutive patients suffering from acute cholecystitis that are very high-risk for cholecystectomy. the patients would be randomized to receive eus-gbd or antibiotics first. interventions: eus-gbd versus antibiotics main outcome measures: the primary outcome is the rate of recurrent acute cholecystitis in 1 year. other outcomes include technical and clinical success, post-procedural pain scores, analgesic requirements, adverse events, re-admissions, re-interventions, quality of life and cost analysis. data analysis all outcomes would be analysed according to the intention-to-treat principle. kaplan-meier method with the log-rank test will be used to compare differences in recurrent acute cholecystitis in 1 year. a health economic analysis will also be performed. assuming a 17.1% difference in recurrent acute cholecystitis rates, a 2-sided p value of 0.05, a power of 80%, and a 10% dropout rate, 110 patients is required. expected results the findings of this study can help establish the role of eus-gbd in management of high-risk patients suffering from acute cholecystitis over antibiotics alone and percutaneous transhepatic gallbladder drainage.


Eligibility criteria:
inclusion criteria: 1. consecutive patients aged ≥ 18 years old 2. suffering from grade 1 or 2 acute calculous cholecystitis\* 3. at very high-risk for early laparoscopic cholecystectomy due to poor premorbid conditions\*\* or elderly patients suffering from acute cholecystitis but refused operations exclusion criteria: patients with the following conditions are excluded from the study: * pregnancy * patients unwilling to undergo follow-up assessments * patients with suspected gangrene or perforation of the gallbladder * grade iii acute cholecystitis33 * patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevated serum amylase more than three times the upper limit of normal) * altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum * patients with liver cirrhosis, portal hypertension and/or gastric varices * abnormal coagulation: international normalized ratio (inr) \> 1.5 and/or platelets \< 50.000/mm3 * previous drainage of the gallbladder * patients suffering acute cholecystitis due to malignant cystic duct obstruction * patients with life expectancy of less than 3 years

Keywords: acute cholecystitis eus-guided gallbladder drainage antibiotics
pharmacokinetics, pharmacodynamics and safety study of z-213 to iron deficiency anemia

Conditions: Iron Deficiency Anemia

Summary: the safety, tolerability, pharmacokinetics and pharmacodynamics of z-213 will be investigated in patients with iron-deficiency anemia after administration of a single dose (100 mg, 500 mg, 800 mg or 1,000 mg iron).


Eligibility criteria:
inclusion criteria: * patients with mild iron deficiency anemia exclusion criteria: * patients with anemia caused by conditions other than iron deficiency * patients with abnormal laboratory test values at screening for c-reactive protein, serum phosphorus, aspartate aminotransferase, alanine aminotransferase, total bilirubin * patients with liver, kidney or circulatory system disease * patients with a history or present illness that is a malignant tumor or autoimmune disease * patients who underwent intravenous administration of an iron preparation, administration of an erythropoiesis stimulation agent or blood transfusion within 8 weeks before the screening * patients who underwent oral administration of an iron preparation (including an over-the-counter drug or supplement) within 4 weeks before the screening

Keywords: z-213, ferric carboxymaltose, iron, iron-deficiency-anemia
resistance exercise program and branched chain amino acid supplementation in heart failure patients

Conditions: Heart Failure

Summary: heart failure (hf) is a complex syndrome which can include the physiological, neural hormonal and metabolic complications known as "cardiac cachexia" (cc). in the development of cc there is a release of catabolic cytokines (tumor necrosis factor-α, interleukins 1 and 6)that cause a decrease of fat free mass and fat mass. these changes in body composition might be reversed with a therapeutic combination of resistance exercise and branched chain amino acid supplementation (bcaa). thus the purpose of this study is evaluate changes in body composition after a resistance exercise program and bcaa supplementation in patients with hf.

heart failure (hf) is a complex syndrome which results from structural and/or functional alterations that limit the ability to respond to physiological demands(1,2).these abnormalities involve metabolic and neuro-hormonal factors such as tumor necrosis factor-α (tnf-α), one of the most important catabolic cytokines related with changes in body composition, interleukin 1 (il-1), il-6, interferon y, and transmission growth factor β (3-9), which produce catabolic and anabolic imbalance and promote loss of fat free mass (ffm) with or without loss of fat mass (fm) in patients with hf. this syndrome is called "cardiac cachexia" (cc) (10). signs and symptoms such as fatigue, anorexia and decreased muscle strength reflect altered body composition (9, 10). there are two possible ways to counteract these catabolic factors and restore body compartments. in one of them, protein supplementation promotes protein synthesis and inhibits proteolysis (3,11,12); in the other resistance exercise (re) increases muscle mass and muscle strength, maintaining heart rate (13,14). previous studies report the association of protein supplementation (15-17) and exercise (18-23) with changes in muscle strength in some cases and exercise capacity in hf patients. however, these therapies were not combined, and the studies did not provide enough information about changes in body composition. based on these reports, our hypothesis is that the combination of re and protein supplementation in form of branched chain amino acids (bcaa) might have an anabolic effect in patients with hf since the supplementation of bcaa could be helpful as "fuel" during the exercise and maintain the muscle mass metabolism (24).

Eligibility criteria:
inclusion criteria: * more than 18 years * confirmed stable heart failure (2) exclusion criteria: * no myocardial revascularization * unstable angina or stroke in the previous 3 months * with no other chronic illness which contributed to loss of muscle mass (arthritis, renal failure, cancer, hiv) previous study inclusion * extra cardiac conditions that made patients unable to perform exercise

Keywords: body composition amino acids supplementation resistance exercise
nonabsorbable versus absorbable sutures for anterior colporrhaphy

Conditions: Pelvic Organ Prolapse

Summary: the objective of this is to compare surgical outcomes of anterior colporrhaphy using nonabsorbable sutures with anterior colporrhaphy using absorbable sutures.

this trial is a prospective, randomized trial conducted with the aim to determine superiority of anterior colporrhaphy using nonabsorbable sutures over absorbable sutures with regard to the primary outcome. participants will undergo reconstructive surgery for prolapse, including anterior colporrhaphy using the assigned suture materials under general or spinal anesthesia. the anterior colporrhaphy will be performed in a traditional manner with midline plication of the fibromuscular layer using either 2-0 nonabsorbable (polyester or polypropylene; ethicon, somerville, nj) or absorbable (polyglactin 910 or polydioxanone; ethicon) sutures. concomitant procedures will be performed as intended prior to surgery. women with a uterus in situ will undergo hysterectomy and all women will receive an apical suspension procedure, including uterosacral ligament suspension, sacrospinous ligament fixation, and iliococcygeal suspension, according to the preference of surgeon. posterior colporrhaphy and incontinence surgery will also be performed, if indicated (i.e. women with bp ≥-1 or documented urodynamic stress incontinence). enrollment, treatment and data collection will be standardized by all sites. the study will be a single-blind study, as it is impossible to blind the study surgeon for the surgical procedure to which the subject in assigned. however, all outcomes assessors and the subjects will be blinded to the treatment assignment. postoperative follow-up will take place after 5 weeks, 6 months and 12 months. patients will undergo a standard gynecological examination including popq and fill in questionnaires.

Eligibility criteria:
inclusion criteria: * anterior vaginal descent beyond the hymen (i.e. popq ba\>0) * vaginal bulge symptoms (i.e. an affirmative response to the question 3 from the pfdi-20) * reconstructive surgery is planned exclusion criteria: * recurrent anterior vaginal wall prolapse * reconstructive surgery using mesh or obliterative surgery for prolapse is planned * known pelvic malignancy * systemic glucocorticoid or immunosuppressant treatment * subject wishes to retain her uterus * subject is unable and unwilling to participate in
weekly docetaxel and cmf in the adjuvant treatment of elderly women with high-risk breast cancer

Conditions: Breast Cancer

Summary: this trial will evaluate the effectiveness of standard adjuvant treatment with cmf chemotherapy versus treatment with weekly docetaxel in patients with high-risk breast cancer who are 65 years of age and older or are poor candidates for anthracycline-containing regimens. this cmf regimen has decreased dose intensity and may be slightly less active in patients with metastatic breast cancer; however, the patient population in this trial has tolerated more intensive cmf regimens poorly in other trials.

upon determination of eligibility, patients will be randomly assigned to one of two treatment arms: * docetaxel * cyclophosphamide + methotrexate + 5-fluorouracil this is not a blinded study so both the patient and the investigator will know which treatment has been assigned. chemotherapy will be followed by breast and/or regional radiotherapy in appropriate patients, and by hormone therapy with tamoxifen for 5 years in patients who are estrogen-receptor positive. patients who are considered poor candidates to receive tamoxifen may receive hormonal therapy with anastrazole.

Eligibility criteria:
inclusion criteria: to be included in this study, you must meet the following criteria: * female patients with adenocarcinoma of the breast confirmed by biopsy * age 65 or older * under age 65 must have significant medical illness, or general frailty * adequate bone marrow, liver or kidney function * normal heart function * less than 84 days from mastectomy/lumpectomy or axillary dissection * signed consent obtained prior to initiation of any study procedures exclusion criteria: you cannot participate in this study if any of the following apply to you: * received neo-adjuvant therapy * primary tumor is locally advanced at diagnosis * received prior chemotherapy within five years * received previous radiation therapy within 5 years * peripheral neuropathy please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
laparoscopic myomectomy using barbed or conventional sutures

Conditions: Fibroid

Summary: the aim of this study is to compare operative data and early postoperative outcomes of laparoscopic myomectomy using barbed sutures with those of laparoscopic myomectomy using conventional sutures .

• till now , there is only one small randomized controllrd study (n=22 in each arm) which compared the use of barbed suture with conventional suture in laparoscopic myomectomy .the myoma bed was closed with either conventional polyglactin suture or unidirectional barbed suture . the operative time was shorter in the barbed suture group (73.3 ± 21.4 min vs. 80.7 ± 18.6 min) but this difference failed to reach statistical significance because of small sample size . however, the time required to suture the myoma beds was significantly lower in the barbed suture group .

Eligibility criteria:
inclusion criteria: * the presence of one to three symptomatic intramural or subserosal myomas (with largest fibroid diameter less than 10 cm). exclusion criteria: * submucosal myoma * calcified myomas * uterine size more than 16 weeks * suspension of genital malignancy * coagulation defects or concurrent anticoagulant therapy * pregnancy * compromised cardiopulmonary status * previous treatment with gonadotropin-releasing hormone analogue * contraindications for general anesthesia.

Keywords: myomectomy ,laparoscopy , barbed sutures
study evaluating the safety, tolerability and efficacy of pbt2 in patients with early alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of the study is to determine the safety, tolerability and efficacy of 2 doses of pbt2 administered for 12 weeks compared to placebo in patients with early alzheimer's disease treated with an acetylcholinesterase inhibitor.


Eligibility criteria:
inclusion criteria: * diagnosis of probable early alzheimer's disease * stable dose of acetylcholinesterase inhibitor * community dwelling * stable medical condition exclusion criteria: * unstable and significant medical conditions * recurrent major psychiatric disorder * treatment with memantine
a pilot study of a blended intervention targeting emotion dysregulation in adults with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the current study aims to investigate the feasibility and preliminary clinical effects of a blended psychological intervention targeting emotion dysregulation in adults with adhd.

adults with adhd with co-occurring deficits in emotion regulation are expected to have more severe impairment than those without such deficits in several life domains. both pharmacological and psychological treatment interventions for adults with adhd tend to target core symptoms of inattention and hyperactivity, and there are few available interventions targeting emotional symptoms. the current study aims to investigate the feasibility and preliminary clinical effects of a blended psychological intervention targeting emotion dysregulation in adhd. the intervention consists of eight face-to-face group sessions and a companion app to be used by the participants between the sessions for skills training. the investigators seek to recruit between 15 to 20 adults with adhd to participate in the pilot study. feasibility outcomes include adherence, treatment satisfaction and treatment credibility. self-report questionnaires assessing emotion dysregulation, adhd symptoms, quality of life, anxiety and depression will be used to examine preliminary clinical effects. there will also be conducted qualitative process interviews to examine the participants expectations and experiences with the program. the investigators expect the intervention to be feasible and to find positive preliminary effects. the findings from the study will be of importance for to further improve the intervention for for a future randomized-controlled trial.

Eligibility criteria:
inclusion criteria: 1. 18 years old or older 2. a diagnosis of adhd 3. current problems with emotion regulation as indicated with a score above 80 on the difficulties in emotion regulation scale (ders) 4. access to a smartphone exclusion criteria: 1. current self-reported diagnosis of severe psychiatric illness such as ongoing substance abuse or psychosis. 2. high risk of suicidality, as indicated by a) has attempted suicide within the last year, b) has previously attempted suicide and reports suicidal ideation, or c) reports current ideations and has a plan or preferred method. 3. other ongoing psychological treatment for adhd or other psychiatric illnesses.
establishing nomograms of penile length and width throughout the weeks of pregnancy

Conditions: Micropenis

Summary: the purpose of this study is to establish nomograms of penile length and width throughout the weeks of pregnancy.

identifying pathology of male genitalia is important. it can be an isolated pathology, or connected to disorders in other organs, as part of genetic syndromes or endocrine disorders. micropenis is a disorder, which is important to diagnose in the womb. micropenis is defined as a penis which is measured 2.5 standard deviation below average. it is also thinner by diameter. this finding can also be the first expression of a lethal hormonal deficiency, hence the reason for early detection by ultrasound during pregnancy. past prenatal diagnosis ultrasound studies, measured the penis from the scrotum to the tip of the penis. another study evaluated formalin fixated fetuses after pregnancy terminations, in which the penis was measured from the abdominal wall to the tip of the penis. to date there are no nomograms for penile length, via ultrasound measurement from abdominal wall or for penile width. the investigators assume that measuring the penis from the abdominal wall is more accurate and standard than from the end of the scrotum, which is a less definitive reference point. the investigators aim to establish nomograms of penile length throughout the weeks of pregnancy. exceptional penile width can also point out a problem with male genitalia. therefore the investigators wish, as well to establish nomograms of penile width.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * proper pregnancy dating * normal fetal anatomical scan * gestational age 14 to 37 weeks * women aged 18 to 50 exclusion criteria: * multiple pregnancy * gestational age under 14 or above 37 weeks * fetus small or large for gestational age * abnormal anatomical scan or women who didn't perform such scan * minors

Keywords: penis micropenis nomograms ultrasound fetus
cyclophosphamide and hydroxychloroquine for thrombocytopenia in sle

Conditions: Thrombocytopenia

Summary: treating severe thrombocytopenia is a challenge in the management of systemic lupus erythematosus. although rheumatologists have followed some rules in real practice,there is very few evidence to support the current treatment algorithm. the purpose of this study is to compare the complete remission rate and partial remission rate of cyclophosphamide and hydroxychloroquine for treating severe thrombocytopenia in chinese sle patients.

this is a prospective,randomized,open-label,multi-center clinical trial. the aim of this study is to test the efficacy of gc(gluco-corticosteroid)+hcq(hydroxychloroquine) and gc(glucocorticosteroid)+ctx(cyclophosphamide) with sequential aza(azathioprine) in the induction and maintenance therapy of severe thrombocytopenia in sle patients.

Eligibility criteria:
inclusion criteria: 1. patients fulfilled the 1997 acr modified or slicc classification criteria of sle； 2. new onset thrombocytopenia: platelet count \<30x109/l(by both routine test and citric acid anti-coagulated blood count test) within 3 months exclusion criteria: 1. thrombocytopenia caused by other reasons, including drugs； 2. positive for active hav(hepatitis a virus)/hbv(hepatitis b virus) infection 3. active hiv(human immunodeficiency virus) or hcv(hepatitis c virus) infection; 4. active hp(helicopter pylori) infection; 5. severe liver and kidney dysfunction； 6. severe neuropsychiatric lupus； 7. no response to high dose steroid and/or cyclophosphamide 1 month prior to study enrollment； 8. uncontrolled diabetes or hypertension before entry 9. active gi bleeding 3 months before entry 10. intolerant to hcq in the past treatment history； 11. severe bone marrow suppression or liver damage caused by cyclophosphamide in the past history； 12. active infection , including bacteria, virus, fungi, mycobacteria 13. allergy to any of the study medications 14. confirmed ttp(thrombolic thrombocytopenic purpura)or caps(catastrophic anti-phosphilipid syndrome) 15. platelet count less than 20x109/l with active bleeding 16. myelodysplastic diseases 17. patients with heart and lung function impairment 18. thiopurine s-methyltransferase (tpmt) gene positive -

Keywords: thrombocytopenia systemic lupus erythematosus hydroxychloroquine cyclophosphamide remission
the efficacy of extract of allium cepae, allantoin and heparin in patients with proven scar development

Conditions: Cicatrix

Summary: to investigate the efficacy of prophylactic use of a topical gel containing extract of allium cepae, allantoin and heparin after surgical removal of the primary cesarean scar in the second cesarean section.

120 patients who are admitted for the second cesarean delivery, not taking prophylactic medication after the first cesarean section, whose scar development and measurements are taken will be included in the study. first caesarean section scars will be removed surgically for all patients. 60 out of 120 patients (treatment group) will use prophylactic topical scar gel 2 times in a day, and remaining 60 patients (control group )won't use. the efficacy of the drug will be evaluated by taking strict measurements of the incision and posas (the patient and observer scar assessment scale) and vancouver scales at 6.12 and 24 weeks. steps; 1. observation of the primary cesarean scar by taking scar measurements and using vancouver and posas scales. 2. surgical removal of the primary cesarean scar in the second cesarean section. 3. 24 weeks topical application of gel containing extract of allium cepae, allantoin and heparin(only treatment group). 4. observation of the skin incision at 6,12 and 24 weeks by taking scar measurements with using vancouver and posas scales.

Eligibility criteria:
inclusion criteria: * patients who are admitted for the second cesarean delivery * not to use topical scar gel after the first c-section exclusion criteria: * chronic illness, immunosuppressive therapy or smoking * development of wound infection during the second c- section * allergies and hypersensitivities to components of the gel

Keywords: scar prevention sectio extract of allium cepae allantoin heparin