Kornimate/medical-research-clean huggingface dataset:
role of 200 mg versus 400mg vaginal progesterone in prevention of preterm labor in twin gestation

Conditions: Twin; Pregnancy, Affecting Fetus or Newborn

Summary: the objective of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome.

the use of progesterone in the prevention of preterm birth(ptb) in both singleton and multiple pregnancies has been extensively investigated. arguably, the use of progesterone is biologically plausible given that uterine quiescence is maintained throughout pregnancy by progesterone and progesterone receptor-mediated inhibition of inflammation, which causes suppression of the contractile genes. there is no benefit of universal vaginal progesterone to reduce ptb rates in multiple pregnancies. one meta-analysis showed a benefit in adverse perinatal outcome in a subgroup of women with a short cervix ≤25 mm, suggesting it may be useful in this group, but the numbers in the study were small and further research is needed. there appears to be no long-term harm caused to infants exposed to progesterone in utero. so the aim of the present study is to evaluate the effectiveness of two doses of vaginal progesterone(200mg versus400mg) and placebo in improving gestational age in twin pregnancy and its subsequent impact on perinatal outcome

Eligibility criteria:
inclusion criteria: * women pregnant in dichorionic twins. * transvaginal sonographic cervical length is \<25 mm at 18-22 weeks gestational age. * no symptoms, signs or other risk factors for preterm labor. exclusion criteria: * known allergy or contraindication (relative or absolute) to progesterone therapy. * monochorionic twins. * known major fetal structural or chromosomal abnormality. * intrauterine death of one fetus or death of both fetuses. * fetal reduction in the current pregnancy. * cervical cerclage in the current pregnancy. * medical conditions that may lead to preterm delivery. * rupture of membranes. * vaginal bleeding.

Keywords: preterm birth twin gestation vaginal progesterone
three types of nucleotide/nucleoside analogues therapy in patients with chronic hepatitis b

Conditions: Chronic Hepatitis b

Summary: this study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of chronic hepatitis b

chronic hepatitis b (chb) remains a serious public health problem in china. nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. entecavir, tenofovir disoproxil fumarate and tenofovir alafenamide are first line drug in china. but there still lacks of data of tenofovir alafenamide in treatment of chb. this study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of chb.

Eligibility criteria:
inclusion criteria: 1. positive hepatitis b surface antigen or hepatitis b virus dna \> 0.5 year; 2. age from 18 to 65 years old; 3. hbeag-positive: hbv dna≥20000iu/ml，hbeag-negative: hbv dna≥2000iu/ml； 4. alt≥2×uln； 5. do not receive nucleotide/nucleoside analogues treatment in the past half year. exclusion criteria: 1. other active liver diseases; 2. hepatocellular carcinoma or other malignancy; 3. pregnancy or lactation; 4. human immunodeficiency virus infection or congenital immune deficiency diseases; 5. severe diabetes, autoimmune diseases; 6. other important organ dysfunctions; 7. using glucocorticoid; 8. patients can not follow-up; 9. investigator considering inappropriate.

Keywords: chronic hepatitis b nucleoside nucleotide
high-dose furmonertinib in the treatment in patients with advanced, metastatic nsclc with progressed after first- or second-line treatment with osimertinib

Conditions: Non-Small Cell Lung Cancer

Summary: this is a prospective, randomised, uncontrolled phase ii clinical trial planned to include 84 subjects with metastatic lung adenocarcinoma that had progressed after first- or second-line treatment with osmertinib, who were randomly assigned to trial group 1 and trial group 2, and were given furmonertinib 160 mg and 240 mg once/day, orally, respectively, with efficacy evaluated every 6 weeks until disease progression, intolerable toxic side effects, or subjects voluntarily withdrew informed consent.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed metastatic lung adenocarcinoma * progression of imaging-confirmed extracranial lesions after first- or second-line treatment with osimertinib * previous genetic testing for a definite egfr-sensitive mutation and imaging-confirmed extracranial lesion progression after first-line treatment with osimertinib; or previous genetic testing for a definite t790m mutation and imaging-confirmed extracranial lesion progression after second-line treatment with osimertinib. * pre-existing clinical benefit after treatment with osimertinib, including cr, pr, sd (duration \>6 months); * patients with at least 1 measurable lesion according to the criteria for evaluating the efficacy of solid tumors (recist 1.1) * normal functioning of major organs * pre-menopausal women of childbearing potential with a negative serum or urine pregnancy test within 7 days prior to the first dose of the drug * subjects volunteered and signed a written informed consent form. exclusion criteria: * previous chemotherapy or immunotherapy * patients with non-lung adenocarcinoma, including squamous lung cancer or mixed histological types * progression of imaging-confirmed extracranial lesions after prior osimertinib treatment with accessible treatment options after genetic testing * patients with symptomatic brain metastases, meningeal metastases or spinal cord compression * any unrecovered ctcae \> grade 1 toxicity reaction following prior osimertinib treatment at the start of study drug therapy * other malignant tumors within 5 years or history of other malignant tumours; except effectively controlled basal cell carcinoma of the skin, carcinoma in situ of the uterine cervix, ductal carcinoma in situ of the breast, papillary carcinoma of the thyroid, superficial bladder tumors, etc. * history of interstitial pneumonia with previous diagnosis * other circumstances that, in the judgement of the investigator, make them unsuitable for inclusion in the study

Keywords: furmonertinib
lifestyle enhancement for adhd program

Conditions: ADHD

Summary: the purpose of this study is to investigate if physical activity (pa) can increase in children with attention deficit/hyperactivity disorder (adhd) using a modified behavioral management training (bmt) program.

the purpose of this study is to increase physical activity (pa) in children with adhd using a novel, family-based intervention that promotes pa within the context of evidence-based behavioral management training (bmt) for parents, enhanced with mobile health (mhealth) behavior change strategies. our first aim is to test the feasibility and acceptability, of an 8-week, family-based, multi-level intervention (bmt-health) to promote pa in young children with adhd. our second aim is to derive an estimate of the effect size of the intervention on pa.

Eligibility criteria:
inclusion criteria: * age 5-10 years * adhd diagnosis * cgi-s rating \>4 and \<7 * per caregiver report, engage in \<60 min/day of mvpa for at least 5 days per week * one adult caregiver willing to participate in the study and complete baseline/follow-up measures * caregiver able to complete forms in english * caregiver owns a smart phone or similar garmin compatible mobile device (e.g. ipod touch) or willing to borrow ipod from study coordinators during the study period * agree to install and share data from the garmin smart phone app with investigators exclusion criteria: * younger than 5 years old or older than 10 years old * do not meet criteria for adhd diagnosis * meet diagnostic criteria for psychiatric co-morbidities including autism spectrum disorder, depressive disorder, mood disorder, psychotic disorder, or intellectual disability that could interfere with intervention uptake * per caregiver report, engage in \>60 min/day of mvpa for at least 5 days per week

Keywords: adhd physical activity behavioral management training mobile health
bone marrow mesenchymal stem cells transfer in patients with st-segment elevation myocardial infarction

Conditions: Myocardial Infarction

Summary: to investigate the effect and safety of intracoronary autologous bone morrow mesenchymal stem cells (bm-mscs) transplantation in patients with st-segment elevation myocardial infarction（ stemi） .

to investigate the safety of intra-coronary injection of autologous bone marrow mesenchymal stem cells (bm-mscs) in patients with st-segment elevation myocardial infarction and its effect on cardiac function and viable myocardium. we plan to include approximately 40 patients with st-segment elevation myocardial infarction as a research object, and conduct a randomized, single-blind, parallel-controlled multi-center clinical trial. the patients were randomly divided into a bm-mscs group and a control group, and were given the best drug treatment and percutaneous coronary intervention (pci). the primary study endpoint was the change in myocardial metabolic activity 6 months after autologous bm-mscs transplantation and the change in left ventricular ejection fraction (lvef) at 12 months; the incidence of adverse events. the above indexes were evaluated by cardiac color echocardiography and single photon emission computed tomography (spect).

Eligibility criteria:
inclusion criteria: * age\> 18 years old; * diagnosed acute st-elevation myocardial infarction (stemi) * stemi onset \<1 month * successful vascular remodeling, blood flow of infarct-related blood vessels recovered to timi level 3 * all patients included in the study signed an informed consent form and promised to complete all follow-up plans exclusion criteria: * refractory persistent ventricular tachycardia * high cardiac block and no pacemaker control * liver or renal dysfunction (alt\>80u/ l, cr\> 440mmol / l) * bleeding disorders, malignant tumors * autoimmune disease or any serious fatal disease * contraindications for coronary intervention * combined with other heart disease: congenital heart disease (ventricular deficiency, atrial deficient, patent ductus arteriosus and other congenital alformations),primary valvular disease, active myocarditis, pulmonary heart disease,hyperthyroidism, mucous edema heart disease and so on * mental illness, no self-awareness, and no precise expression and cooperation

Keywords: myocardial infarction mesenchymal stem cells bone marrow stem cells transplantation
restoring hand function utilizing nerve transfers in persons with cervical spinal cord injuries

Conditions: Cervical Spinal Cord Injury; Spinal Cord Injuries; Traumatic Spinal Cord Compression

Summary: the primary objective of this study is to evaluate the safety and efficacy of nerve transfer surgery for restoring hand function as a therapy for patients with cervical spinal cord injury.


Eligibility criteria:
inclusion criteria: * american spinal injury association (asia) grade of a, b, or c, or with a diagnosis of central cord syndrome, showing minimal to no evidence of functional improvement in motor examination after at least 6 months of non-operative therapy post-injury * \>6 months post-injury * international classification of surgery of the hand in tetraplegia (icsht) category 0-4 * cervical spinal cord injury resulting in arm \& hand functional impairment, with at least preserved elbow flexion * physically and mentally willing and able to comply with study protocol * lives in the immediate area and has no plans to relocate * provides informed consent and hipaa release of medical information exclusion criteria: * active infection * any return or ongoing clinical recovery of distal motor function within 6 months after injury * physically/mentally compromised * systemic disease that would affect the patient's welfare or the research study * immunologically suppressed or immunocompromised * currently undergoing long-term steroid therapy * active malignancy * pending litigation or receiving workers compensation related to injury or accident * pregnancy * significant contractures and/or limitations in passive range of motion in the arm or hand * poorly controlled upper extremity spasticity * uncontrolled pain or hypersensitivity * previous or current injury preventing use of tendon transfers to restore upper extremity function * history of brachial plexus injury or systemic neuropathic process * in the opinion of the principal investigator the subject would not be a candidate for the procedure
thoracic epidural analgesia vs surgical site infiltration with liposomal bupivacaine following open gynecologic surgery

Conditions: Surgery; Analgesia

Summary: the goal of this study is to test the hypothesis that surgical site infiltration with liposomal bupivacaine (lb) is non-inferior to and more cost effective than thoracic epidural analgesia (tea) for patients undergoing open gynecologic surgery on an established enhanced recovery program (erp) using a non-inferiority randomized trial design. the impact of tea and surgical site infiltration with lb on neuroendocrine and inflammatory mediators of surgical stress response (ssr) will also be investigated as a translational endpoint.


Eligibility criteria:
inclusion criteria: * individuals ≥ 18 years of age * planned laparotomy by the gynecologic oncology service at the sponsor institution. exclusion criteria: * individuals who have a contraindication to thoracic epidural analgesia * individuals with a coagulation disorder * individuals with an infection at the site of epidural placement * individuals with intracranial pathology such as non-communicating increased intracranial pressure or obstruction of cerebrospinal fluid flow related to mass lesions * individuals with spinal pathology: abnormal spine anatomy, surgical fusion, or spinal column lesions * individuals who have a contraindication to liposomal bupivacaine * individuals with a known allergic reaction to liposomal bupivacaine * individuals with childs-pugh class b or c liver disease * individuals who have a history of long-term opioid use for chronic pain, defined as use of opioid pain medications for ≥4 weeks prior to surgery.
bascom cleft lift for primary wound healing in complex and recurrent sacrococcygeal pilonidal sinus disease

Conditions: Pilonidal Sinus

Summary: the goal of this observational study is to improve care for patients with complex or recurrent pilonidal sinus disease by developing and implementing a best practice care pathway, including a standardized cleft lift operation. the main question it aims to answer is: does a best practice care pathway with standardized cleft lift operation lead to shorter wound healing time and time to return to normal activities, compared to current standard care, with traditional excision techniques.


Eligibility criteria:
inclusion criteria: * 16 years of age and older * symptomatic complex or recurrent pilonidal sinus disease * planned for surgical treatment * signed informed consent exclusion criteria: * pregnant * insufficient understanding of the dutch language or otherwise unable to give consent

Keywords: pilonidal sinus bascom cleft lift
trial of concurrent chemoradiotherapy for locally advanced esophageal cancer

Conditions: Esophageal Cancer

Summary: this trial is going to evaluate the efficacy and safety of imrt / nab-tp chemotherapy for unresectable esophageal cancer, and to investigate the optimal concurrent chemotherapy regimen for local advanced and unresectable esophageal cancer patients.

esophageal carcinoma is the sixth leading cause of cancer-related mortality from cancer with 407000 deaths and the eighth most common cancer worldwide. concurrent chemoradiotherapy remains the mainstay of treatment for locally advanced esophageal cancer. paclitaxel combined with radiotherapy was high efficiency and achieved encouraging results. compared with paclitaxel, nab-paclitaxel has a low toxicity, low allergy and the tolerance is better than paclitaxel. according to the pre-clinical results, investigators designed a prospective study, which is combined nab-paclitaxel and cisplatin with concurrent chemoradiotherapy for the patients with locally advanced esophageal cancer, and evaluated the tolerability and efficacy. we design enrolled 30 patients, the end point included toxicity, progression-free survival and overall survival.

Eligibility criteria:
inclusion criteria: 1. inoperable locally advanced histologically confirmed esophageal cancer (t3n0m0-txnxm1a（ajcc 2002) 2. ecog performance status scale 0-1 3. at least 1 measurable target lesions 4. white blood count ≥ 3,500/mm3, absolute neutrophil count ≥ 1,500/mm3, platelet count ≥ 100,000/mm3, hemoglobin count ≥ 90 g/dl, serum bilirubin level \< 1.5 of the upper limit of normal (uln) for the institution, aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase ≤ 2.5 uln, serum albumin ≥ 30g/l, serum creatinine ≤ 1.5 uln; and 5. normal cardiac function with no severe heart disease. exclusion criteria: 1. history of esophagectomy 2. pregnancy or breast feeding 3. past history of other cancers except for cured non-melanoma skin cancer or cervical cancer; 4. concomitant treatment with other anticancer drugs.

Keywords: nab-paclitaxel imrt esophageal cancer
a pilot study of xifaxan to treat patients with psc

Conditions: Primary Sclerosing Cholangitis (PSC)

Summary: in the current protocol, we propose the assessment of potential beneficial effects of the antibiotic xifaxan on liver biochemistries, liver related symptoms and mayo risk score in 15 adult and 5 pediatric patients with psc. adult patients will receive xifaxan, 550 mg twice daily over a 12-week period. pediatric patients with psc whose weight is greater than or equal to 40 kg will receive xifaxan, 550 mg twice daily.


Eligibility criteria:
inclusion criteria: * diagnosis of psc established by all of the following criteria: * alkaline phosphatase \>1.5 times upper limit of normal for at least 6 months duration * gamma-glutamyl transferase (ggt) \>1.5 times upper limit of normal in pediatric patients * cholangiography demonstrating intrahepatic and/or extrahepatic biliary obstruction, beading, or narrowing consistent with psc * liver histology in the past (if available for review) with features consistent with or diagnostic of psc * both genders * adults: ages 18-75 years. * pediatric: weight \> 40 kg * patient's informed consent for study participation exclusion criteria: * treatment with systematic antibiotics, azulfidine, ursodeoxycholic acid, corticosteroids, colchicine, methotrexate, azathioprine, cyclosporine, chlorambucil, budesonide, pentoxifylline, tacrolimus, vitamin e or prednisone in the preceding three months * active drug or alcohol use * prior history of allergic reaction to the antibiotics which will be used in the study * any condition that, in the opinion of the investigator, would interfere with the patient's ability to complete the study safely or successfully * evidence of decompensated liver disease such as recurrent variceal bleeding, refractory ascites or spontaneous hepatic encephalopathy * anticipated need for transplantation in one year (mayo survival model \<80% one-year survival without transplant) * findings highly suggestive of liver disease of other etiology such as chronic alcoholic liver disease, chronic hepatitis b or c infection, hemochromatosis, wilson's disease, 1-antitrypsin deficiency, non-alcoholic steatohepatitis, primary biliary cirrhosis or secondary sclerosing cholangitis * treatment with any study medications in the preceding three months * pregnancy or current lactation; subjects becoming pregnant during the study despite all the precautions will be withdrawn and referred to their primary physicians

Keywords: primary sclerosing cholangitis xifaxan
a pilot study of krx-0502 (ferric citrate, administered without food, in treating iron-deficiency anemia

Conditions: Anemia of Chronic Kidney Disease

Summary: the objective of the study is to evaluate the efficacy and safety of krx-0502, administered without food, in treating iron deficiency anemia in subjects with stage 3 to 5 non-dialysis dependent chronic kidney disease (ndd-ckd).

previous clinical trials have tested krx-0502 administered with food, in dialysis-dependent and ndd-ckd patients. this clinical trial will evaluate the safety and efficacy of krx-0502 in treating iron deficiency anemia in anemic, stage iii to v ndd-ckd patients in a new dosing regimen (without food).

Eligibility criteria:
inclusion criteria: * males and non-lactating females with negative serum pregnancy test (for females of child-bearing potential) at screening * age ≥ 18 years * serum ferritin ≤ 300 ng/ml and tsat ≤ 25% at screening * hemoglobin ≥9.0 g/dl and ≤11.5 g/dl at screening * egfr \<60 ml/min at screening using the 4-variable modification of diet in renal disease (mdrd) equation exclusion criteria: * subjects receiving phosphate binder medication(s) at, or within 4 weeks prior to, screening * symptomatic gastrointestinal bleeding, inflammatory bowel disease, inflammatory bowel syndrome and/or crohn's disease within 24 weeks prior to \\ screening * evidence of acute kidney injury or requirement for dialysis within 8 weeks prior to screening * kidney transplant anticipated or start of dialysis expected within 16 weeks of screening * history of hemochromatosis * iv iron administered within 4 weeks prior to screening * erythropoiesis-stimulating agent (esa) administered within 4 weeks prior to screening * blood transfusion within 4 weeks prior to screening * receipt of any investigational drug within 4 weeks prior to screening * cause of anemia other than iron deficiency or chronic kidney disease * history of malignancy in the last five years * active drug or alcohol dependence or abuse (excluding tobacco use) within the 12 months prior to screening * any known allergies to iron products * previous intolerance to oral ferric citrate * psychiatric disorder that interferes with the subject's ability to comply with the study protocol * planned surgery or hospitalization during the trial * any other medical condition that, in the opinion of the pi, renders the subject unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the subject
can computer-based telephone counseling improve long-term adherence to strength training in elders with knee oa?

Conditions: Osteoarthritis of the Knee

Summary: the purpose of this research is to determine whether computer-based telephone counseling will improve adherence to strength training in a population of elders with knee osteoarthritis.


Eligibility criteria:
inclusion criteria: * osteoarthritis of the knee (icd-9 code of 715.16, 715.09 or 715.9) * lives within interstate 95 * age 55 or older * english speaking exclusion criteria: * stroke or heart attack in last 3 months * treatment for cancer * severe systemic disease * medical condition that limits physical activity * inflammatory arthritis * plans for knee replacement * dementia or inability to follow exercise instructions and tlc system

Keywords: osteoarthritis exercise