Kornimate/medical-research-clean huggingface dataset:
phase iii study of concurrent radiotherapy in elderly patients with esophageal squamous cell carcinoma (eso-shanghai 15)

Conditions: Esophageal Squamous Cell Carcinoma; Chemoradiotherapy; Survival

Summary: so far, there is no specific clinical guideline for elderly patients (\>75 yr) with esophageal squamous cell carcinoma (escc). patients with locally advanced escc were enrolled and randomly assigned to either definitive radiotherapy group (61.2gy/34fx） or the chemoradiotherapy group (50.4gy/28fx；paclitaxel plus carboplatin). the primary end point was 3-year overall survival (os). the second end points included life quality, radiation side effects and 3-yr cancer specific survival.

up to now, definitive radiotherapy was major treatment plan for elderly escc patients. however, whether elective elderly patients can obtain survival benefits through chemoradiotherapy is not clear. thus we design the clinical trail to answer the question. three hundred and twenty elderly patients with escc would be recruited. there are two stratification factors including 80 years old and lymph node metastasis. the patients in the chemoradiotherapy group were treated with paclitaxel (45mg/m2) and carboplatin (auc=2) one cycle per week for five cycles.the primary end point was 3-year overall survival (os). the second end points included life quality, radiation side effects and 3-yr cancer specific survival. the life quality questionnaire included qlq-c30 and oes-18.

Eligibility criteria:
inclusion criteria: * indicates no limit on eligibility based on the sex of participants * the 76 years old for the minimum age a potential participant must meet to be eligible for the clinical study. * esophageal squamous cell carcinoma confirmed by pathology * no radiotherapy, chemotherapy or other treatments prior to enrollment * local advanced esophageal squamous cell carcinoma (t2-4n0-1m0-1a, txn1m0-1a, txnxm1a, txnxm1b (m1b only for supraclavicular lymph node metastasis) (ajcc 6th) * use of an effective contraceptive for adults to prevent pregnancy * no severely abnormal hematopoietic, cardiac, pulmonary, renal, or hepatic function * no immunodeficiency * ecog 0-1. * life expectancy of more than 3 months. exclusion criteria: * total radiotherapy dose cannot reach 61.2gy/34fx * esophageal perforation, or hematemesis * history of radiotherapy or chemotherapy for esophageal cancer * history of surgery within 28 days before day 1 * history of prior malignancies (other than skin basal cell carcinoma or cervical carcinoma in situ with a disease-free survival of at least 3 years) * participation in other interventional clinical trials within 30 days * pregnant or breast-feeding women or fertile patients * drug addiction, * alcoholism or aids * uncontrolled seizures or psychiatric disorders

Keywords: esophageal squamous cell carcinoma elderly patients chemoradiotherapy definitive radiotherapy survival
serotonin, impulsivity, and cocaine dependence treatment

Conditions: Cocaine Dependence

Summary: the purpose of this study is to compare the effects of citalopram versus placebo given in the context of contingency management for cocaine dependence.

cocaine dependence continues to be a significant public health problem, for which there is no fda approved pharmacotherapy. this study is a 12-week, double blind, placebo controlled trial of citalopram for cocaine dependence. the primary outcome measure is benzoylecgonine positive urines. secondary measures of side effects and craving are also examined.

Eligibility criteria:
inclusion criteria: * male and female subjects age 18 to 50 who currently meet dsm-iv criteria for cocaine dependence. * female subjects: a negative pregnancy test exclusion criteria: * current or past dsm-iv axis i disorder other than substance abuse/dependence * any serious non-psychiatric medical illness requiring ongoing medical treatment * substance dependence other than cocaine within the last 3 months * negative urine drug screen for cocaine at time of testing * for female subjects: a positive pregnancy test

Keywords: cocaine; citalopram; impulsivity; serotonin
hylacare in the treatment of acute skin changes in patients undergoing radiotherapy for breast cancer

Conditions: Breast Cancer

Summary: this will be a randomized, double blind, vehicle-controlled evaluation of the effectiveness and safety of hylacaretm. the study will employ the patient as her own control, a commonly used method for the evaluation of topical dermatologic agents. each patient will be randomized blindly as to whether the study serum will be applied to the medial or lateral portion of the treated breast, using the nipple as the dividing line. the product and placebo will also be applied to the contra-lateral breast in the same fashion, as a further control. the study drug and placebo will be applied three (3) times daily.

patients will be allocated to the treatment using a randomized permuted block. there will be no stratification. patients will be randomized to receive the investigational product to be applied to either the medial (inside) or lateral (outside) portion of the breast, a placebo product will be used on the other side. patients and clinical investigators will be blinded to the treatment assignments.

Eligibility criteria:
inclusion criteria: * female, age 18 or older * diagnosis of breast cancer * intact breast (not surgically absent) * planned fractionated external beam radiotherapy to be delivered by opposing, tangential beams to 50.4 gy in 28 fractions with a planned photon or electron boost of 10gy in 5 fractions (for a total of 33 fractions) * ability to understand and comply with the requirements of this study * ability to give informed consent * for sexually active females, patient agrees to use acceptable method of birth control exclusion criteria: * women who are pregnant or lactating * use of concomitant skin care preparations at any of the treated or control portal areas to be observed * any infection or unhealed wound of the radiotherapy portal areas, or generalized dermatitis * severe renal failure creatinine \> 3.0 within 6 months of study registration * allergic history, including anaphylaxis or severe allergies to products in study serum or placebo * planned relocation which would make follow-up visits impossible during the course of the study * collagen vascular disease such as lupus, or scleroderma

Keywords: external beam radiotherapy breast cancer
comparison of plain blocks for postoperative pain management in gynecological abdominal surgeries

Conditions: Surgery With General Anesthesia; Gynecologic Surgical Procedures; Plane Block; Postoperative Pain Management

Summary: this study compares the effects of transversus abdominis plane (tap) block, quadratus lumborum block (qlb), and erector spinae plane block (esp) on postoperative morphine consumption, pain scores, patient satisfaction, and side effects in patients undergoing gynecological abdominal laparotomy surgeries.

patients will be randomly assigned into four groups using a computer-generated randomization method. according to group allocation, patients will receive the following interventions before extubation under ultrasound (us) guidance except control group: group e (n=20): bilateral erector spinae plane (esp) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) at the t12 level, approximately 3-4 cm laterally from the midline, in the neurofascial plane between the transverse processes and the erector spinae muscle. group q (n=20): bilateral quadratus lumborum block (qlb) will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side), placed between the psoas major and quadratus lumborum muscles under us guidance, between the iliac crest and the 12th rib. group t (n=20): bilateral transversus abdominis plane (tap) block will be performed with 40 ml of 0.25% bupivacaine (20 ml on each side) in the neurofascial plane between the internal oblique and transversus abdominis muscles. group c (control group, n=20): no block will be applied, only the standard intravenous patient-controlled analgesia (pca) protocol will be used. the primary aim of this study is to assess the morphine consumption in the postoperative period, while secondary aims include pain score, patient satisfaction, the need for rescue analgesia and side effects

Eligibility criteria:
inclusion criteria: aged between 18 and 69 years, with asa 1-2 score scheduled to undergo major gynecological abdominal surgery exclusion criteria: asa score 3 or above, patients younger than 18 or older than 69 years, patients with bleeding disorders or using anticoagulants, patients with a body mass index over 40, patients with known allergies to any drugs used in the study, and patients who could not or did not wish to use patient-controlled analgesia (pca) device

Keywords: gynecologic surgery transversus abdominis plane block erector spinae plaen block quadratus lumborum block morphine consumption
effect of skate skin extract on body fat in overweight adults

Conditions: Body Fat

Summary: comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of low-molecular collagen peptides derived from skate skin on body fat reduction in adults

our aim is to investigate the effect of oral ingestion of low-molecular collagen peptides derived from skate skin on body fat reduction in adults by a randomized, double-blind, and control-group study.

Eligibility criteria:
inclusion criteria: * bmi 23\~30 kg/m2 exclusion criteria: * within the last 6 months, severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease(angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant diseases (however, although subjects have a history of cerebrovascular disease and heart disease, they can be included if their status are clinically stable) * patients with uncontrolled hypertension (blood pressure greater than 160/100 mmhg) * diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more * those who are treated with hypothyroidism or hyperthyroidism * creatinine levels: more than twice the normal upper limit * ast (got) or alt (gpt) levels: more than twice the normal upper limit * those complaining of severe gastrointestinal symptoms such as heartburn and indigestion * drugs that affect weight within the last month (absorption inhibitors and appetite suppressant, health food / supplements related to obesity improvement, psychiatric drugs, beta blockers, diuretics, birth control pills, steroids, female hormones) if you are taking * participated in the commercial obesity program within the last 3 months. * if you have participated or are planning to participate in another clinical trial within the past month if yes * alcohol abuser * smoking abstinence within 3 months * if they are pregnant or lactating or have a pregnancy plan during the clinical trial * those with allergic reactions to the constituent food * any person deemed inappropriate by the researcher for other reasons
endothelial function, inflammatory disease activity, and bone and cartilage markers in rheumatic patients: the influence of antirheumatic treatment

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Endothelial Dysfunction; Inflammatory Disease Activity

Summary: the aim of this study is to examine the associations between inflammatory disease activity and endothelial function in rheumatoid arthritis (ra) and spondyloarthritis patients treated with methotrexate and tumor necrosis factor alpha (tnfalpha)inhibitor in combination or methotrexate or tnfalpha-inhibitor alone. further, to look for improvement in endothelial function, and decrease in bone and cartilage destruction during treatment with the combination therapy of tnfalpha-inhibitor and methotrexate in ra and psoriatic arthritis (psa) patients. last, examine the tnfalpha inhibitors influence on endothelial function and levels of bone and cartilage markers in patients with ankylosing spondylitis (as).


Eligibility criteria:
inclusion criteria: * males and females 18-80 years * able and willing to give written informed consent, and to comply with the requirements of the study protocol. * fulfilling the acr 1987 revised diagnostic criteria for the diagnosis rheumatoid arthritis, or the diagnostic criteria by moll and wright for the diagnosis psoriatic arthritis, or the modified new york diagnostic criteria for ankylosing spondylitis. * clinical indication for starting treatment with methotrexate, tnfalpha- inhibitor or combination therapy. * use of reliable method of contraception for women with childbearing potential. exclusion criteria: * lack of cooperativity * positive serology for hepatitis b or c * history of positive hiv status. * history of tuberculosis or untreated tuberculosis. * ppd more than 15 mm in previously bcg immunized subjects. ppd 6 mm or more if not previously bcg immunized. * histoplasmosis or listeriosis * persistent or recurrent infections * any inflammatory disease of permanence not related to ra, psa or as. * pregnancy or breast-feeding. * use of prednisolone more than 10 mg daily for 2 weeks at inclusion. * use of tnfalpha-inhibitor the last 4 weeks. * history of cancer. * uncontrolled diabetes. * congestive heart failure (nyha 3-4) * recent stroke (within 3 months) * previous diagnosis or signs of central nervous system demyelinating disease. * previously diagnosed immunodeficiency.

Keywords: endothelial dysfunction bone and cartilage markers inflammatory disease activity rheumatoid arthritis psoriatic arthritis ankylosing spondylitis
evaluation of quality of life and utilities following surgical treatment of stage i-iv rectal cancer

Conditions: Rectal Adenocarcinoma; Stage I Rectal Cancer AJCC v8; Stage II Rectal Cancer AJCC v8; Stage IIA Rectal Cancer AJCC v8; Stage IIB Rectal Cancer AJCC v8; Stage IIC Rectal Cancer AJCC v8; Stage III Rectal Cancer AJCC v8; Stage IIIA Rectal Cancer AJCC v8; Stage IIIB Rectal Cancer AJCC v8; Stage IIIC Rectal Cancer AJCC v8; Stage IV Rectal Cancer AJCC v8; Stage IVA Rectal Cancer AJCC v8; Stage IVB Rectal Cancer AJCC v8; Stage IVC Rectal Cancer AJCC v8

Summary: this study evaluates quality of life and utilities following surgical treatment of stage i-iv rectal cancer. this study may help researches learn more about quality of life in patients who have or have had rectal cancer.

primary objective: i. to assess post-treatment related health state utilities among patients with rectal cancer after treatment at 2 years. secondary objectives: i. to longitudinally compare the effects of treatment on quality of life and utilities among patients treated with or without (neo)adjuvant radiation therapy. ii. to characterize the impact of treatment on quality of life and utilities among patients with rectal cancer. iii. to assess changes in quality of life and utilities among patients treated for rectal cancer over time. outline: patients complete quality of life questionnaires over 20-30 minutes at baseline, 6 and 12 months after surgery, and 2, 3, 4, and 5 years after surgery.

Eligibility criteria:
inclusion criteria: * patient has histologically proven adenocarcinoma of the rectum (stage i - iv) that is planned to be treated by surgical resection performed with curative intent, or who has already received surgical treatment * patient must sign an approved informed consent document and have the literary and physical ability to complete the questionnaire in english exclusion criteria: * patient has been treated with pelvic radiation therapy for a diagnosis other than rectal cancer * patient has a concurrent cancer diagnosis at the time of consent * patient has recurrent disease
study to assess the efficacy and safety of ublituximab and umbralisib in participants with chronic lymphocytic leukemia (cll) currently treated with ibrutinib, acalabrutinib or venetoclax

Conditions: Chronic Lymphocytic Leukemia

Summary: phase 2, two cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (mrd) negativity in participants with chronic lymphocytic leukemia (cll), who are currently on treatment with ibrutinib, alacabrutinib or venetoclax.

this is a phase 2 open label, two treatment cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (mrd) negativity in participants with cll, who fail to achieve mrd negativity, after a minimum 6-month treatment with ibrutinib, alacabrutinib or venetoclax.

Eligibility criteria:
inclusion criteria: * participants with chronic lymphocytic leukemia (cll) who have been on treatment for at least 6 months * minimal residual disease positive at screening * adequate organ system function as specified in the protocol * ability to follow protocol procedures. exclusion criteria: * participants receiving cancer therapy or any investigational drug within 21 days of cycle 1, day 1. * participants with a known histological transformation * active hepatitis b or hepatitis c.

Keywords: umbralisib ublituximab venetoclax ibrutinib cll acalabrutinib
rosuvastatin loading and clinical outcomes trial

Conditions: Atherosclerosis

Summary: the aim of the present study was to evaluate the effect of pre-procedural single high loading dose (40 mg) of rosuvastatin on the primary end-points of all cause mortality and composite of death or myocardial infarction from cardiovascular (cv) causes, target vessel revascularization (tvr), or stroke.


Eligibility criteria:
inclusion criteria: * statin-naive patients * stable ischemic heart disease * de novo lesions appropriate for pci exclusion criteria: * current statin use * statin allergic patients * acute coronary syndromes * lesions not appropriate for pci * refusal for participation * statin quitting during follow- up
salud en mis manos - breast and cervical cancer prevention and early detection - expansion 1

Conditions: Cervical Cancer; Breast Cancer

Summary: the purpose is to evaluate implementation of a community-based prevention project aimed at increasing early detection and prevention of breast and cervical cancer through education and navigation and to increase breast and cervical cancer screening and human papillomavirus (hpv) vaccination in underserved latinas.

this is an evaluation of the salud en mis manos community health worker-delivered breast and cervical cancer screening promotion program. the investigators evaluate the effect of the program on increasing participant breast and cervical cancer screening and hpv vaccination, using a one-group pre-post study design (march 2017 - may 2019). the investigators also describe the implementation of the program during a longer time period (november 2016 - may 2019).

Eligibility criteria:
inclusion criteria: * self identifies as hispanic or latina * lives in texas * breast cancer screening group: have not had a mammogram in the past 2 years, and are 40 years of age and older * cervical cancer screening group: have not had a pap test in the past 3 years and are 21 years of age and older * hpv vaccination group: are women 21-26 years of age, and have not initiated the hpv vaccine series * age limit for breast cancer screening group: 40 years and older * age limit for cervical cancer screening group (pap test): 21 years and older * age limit for hpv vaccination group: 21-26 years exclusion criteria: * current pregnancy * current or prior cancer diagnosis

Keywords: cervical cancer prevention breast cancer detection hpv vaccination
traumeel for pain after fracture of neck of femur

Conditions: Pain; Fracture of Neck of Femur

Summary: we hypothesize that traumeel s is more effective than placebo in reducing 48-hour mean cumulative morphine consumption in patients scheduled for surgical correction of fracture of neck of hip. 224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the trial. patients will be randomized to receive either intraoperative injection and post operative oral traumeel s tablets or placebo injection (normal saline) and indistinguishable oral placebo tablets. baseline measurements of relevant outcome measures will taken preoperatively. immediately after surgery, patients will receive an initial dose of morphine of 0.1mg/kg body weight. patients will take the oral study medication for 21 days. every four hours after surgery, patients will be asked to grade their pain on an nrs. subsequent doses of morphine will be calculated based upon the patient's weight and current nrs, according to a preplanned scheme. patients will be permitted to request additional morphine, beyond their calculated dose.


Eligibility criteria:
inclusion criteria: * patients of either sex undergoing surgical correction of unilateral fracture of neck of hip. * age over 18 years. * signature upon informed consent form exclusion criteria: * participation in another clinical trial within 4 weeks prior to enrollment. * refused to give verbal consent to the telephone interviews * impossibility to be reached during the 14-17 days post operative * inability to comply with the study protocol for any other reason * previous major surgical procedure on ipsilateral hip. * current use of analgesics for any other reason. * a history of chronic pain syndrome. * abused legal or illicit drug use. * hypersensitivity to botanicals of the compositae family * known sensitivity to paracetamol, codeine or tramadol.

Keywords: homeopathy pain traumeel s fracture of neck of femur surgical correction of fracture of neck of hip
daily dystonia practice - a trial to investigate nt 201, the duration of treatment effect after one injection session and in long-term treatment in cervical dystonia

Conditions: Cervical Dystonia

Summary: the aim of this study is to confirm efficacy and safety of nt 201 (xeomin®, also known as incobotulinumtoxina) after one injection session and to determine the efficacy and safety profile and the duration of treatment effect of nt 201 in long-term treatment with repeated injection sessions.


Eligibility criteria:
inclusion criteria: * toronto western spasmodic torticollis rating scale (twstrs) - total score at baseline \> / = 25 with twstrs - severity score \> / = 10 and twstrs - disability score \> / = 3 * patients must be on a stable dose of other medications * for pre-treated patients only: source documentation of the last two consecutive injection sessions with botulinum neurotoxin type a and stable treatment response directly prior to trial entry * for pre-treated patients only: at least 10 weeks must have passed between the last injection session of botulinum neurotoxin type a for cervical dystonia and the time of the baseline visit. * for pre-treated patients only: the most recent injection session with botulinum neurotoxin for cervical dystonia must have been at a dose of ≤ 300 units of botox® or xeomin®, or ≤ 1,200 units dysport®. * age \> / = 18 and \< 76 years
assessing outcomes after surgery for gastroesophageal reflux disorder

Conditions: Gastroesophageal Reflux Disorder

Summary: the purpose of this study is to review pre-operative studies and patient evaluation reports and compare those with the results of the post-operative studies, patient evaluation reports and subjective patients' outcomes following laparoscopic surgery for gastroesophageal reflux disorder. this will allow us to evaluate how patients have benefited from the procedure.

this study will include all patients who have laparoscopic surgery for gastroesophageal reflux disorder. patients who participate will be asked to answer questionnaires regarding symptoms of reflux before and after surgery. in addition medical charts will be reviewed for relevant data.

Eligibility criteria:
inclusion criteria: * patients must have gerd and must plan to have laparoscopic surgery for gerd. * patients must be at least 18 years of age

Keywords: gerd, laparoscopic surgery