Kornimate/medical-research-clean huggingface dataset:
clinical trial of rifampin and azithromycin for the treatment of river blindness

Conditions: Onchocerciasis

Summary: the purpose of this study is to determine whether rifampin and/or azithromycin are effective in the treatment of river blindness (onchocerciasis).

mass treatment with ivermectin (mectizan, merck \& co) is the mainstay of the current efforts to control onchocerciasis, but the drug is not lethal to adult onchocerca volvulus parasites. wolbachia, an endosymbiotic bacterium necessary for the fecundity of o. volvulus, can be eradicated with four-six week courses of doxycycline, but this cannot be implemented in current mass drug administration programs. the purpose of this study is to evaluate if a shorter course (five days) with antibiotics that could be used in children and potentially pregnant women would likewise be effective. guatemalan patients with onchocercal nodules will be enrolled in an open label trial with four treatment groups: group a (rifampin 20 mg/kg by mouth \[po; maximum 600 mg/day\]); b (azithromycin 12 mg/kg po \[maximum 500 mg/day\]); c (combination of rifampin 20 mg/kg po \[maximum 600 mg/day\] and azithromycin 12 mg/kg po \[maximum 500 mg/day\]); d (control group, multivitamin). at the end of the five day treatment course all participants will receive a single dose of ivermectin (150 mcg/kg). nodulectomies will be performed 9 months after treatment and the o. volvulus will be analyzed by immunohistochemical staining specific for wolbachia.

Eligibility criteria:
inclusion criteria: * males and non-pregnant/non lactating females \>5 years of age * one onchocercal nodule in an anatomical position where it can be easily removed surgically exclusion criteria: * pregnancy (based on urine pregnancy test) * breast-feeding * women taking oral contraceptives * allergy or other adverse reaction to either medication * use of other medications that might interact with rifampin * clinical evidence of liver disease (jaundice, swollen abdomen) * clinical evidence of chronic disease/alcoholism

Keywords: onchocerciasis wolbachia therapy
promote study: prediction of response of hormonal treatment in advanced and recurrent endometrial cancer

Conditions: Endometrial Cancer Stage III; Endometrial Cancer Stage IV; Endometrial Cancer Recurrent

Summary: the promote study aims at optimising use of hormonal therapy in advanced stage and recurrent endometrial cancer analysing tumor tissue taken before start of hormonal therapy

there is limited consensus about the position of hormonal treatment in advanced and metastatic endometrial carcinoma (ec). this is due to lack of good quality data on patient selection, and predictive biomarkers. consequently, consideration of hormonal therapy is subjected to personal experience of the treating physician, rather than on refined clinical and up-to-date molecular criteria. hormonal therapy has limited side-effects, and is better tolerated than systematic chemotherapy. since ec patients are often elderly women with comorbidities, more effective and less aggressive treatment options are needed, underlining the urgency of an explorative study on this topic. endometrial cancer is the most common malignancy of the female genital tract in developed countries, with increasing incidence due to obesity and increased life expectancy. most patients are diagnosed at an early stage, and have a favourable prognosis with surgery alone. yet, 20% of the patients present with advanced or metastatic ec and have a poor outcome even with systemic treatment. response rate of chemotherapy in advanced or metastatic ec is 30-60%, dependent of previous chemotherapy, with a progression free survival (pfs) of 3-14 months and 40% treatment related morbidity. in comparison, response to hormonal therapy is 20%-40%, with side effects in less than 5%. the overall pfs is 3 months, yet for those who respond the pfs can be up to several years. to improve selective use of hormonal therapy in ec by evaluating applied hormonal therapy in advanced and metastatic ec and correlate response to molecular tumour analysis and translate this knowledge after validation into clinical practice

Eligibility criteria:
inclusion criteria: * advanced stage (figo stage iii and iv) and recurrent endometrial cancer * all histologic types of endometrial carcinoma * planned treatment with any type of hormonal therapy * biopsy taken within 120 days prior to start of hormonal therapy with no intercurrent therapy between biopsy and start of hormonal therapy. exclusion criteria: * adjuvant hormonal therapy started following complete resection of endometrial carcinoma * synchronous use of hormonal therapy for other indications * endometrial sarcoma or endometrial stroma cell sarcoma

Keywords: hormonal therapy endocrine therapy translational research tumor factors
what benefit of a full analysis of exome? routine care study in patients with solid tumors

Conditions: Carcinoma

Summary: the management of cancers and their therapeutic guidance was until shortly mostly based on histopathological considerations of the tumor. the development of targeted therapies is a turning point and keeps increase. these molecules target a specific molecular defect in the tumor making it more effective and more specific treatment. but these treatments are only effective if the tumor has a specific molecular abnormality that is characterized and known. these therapeutic progresses have been made possible through the decoding of the human genome and the molecular defects occurring during the carcinogenesis process. now, dozens of therapies targeting a specific molecular abnormality are available in the therapeutic arsenal and dozens more are under development in clinical trials phase 1 to 3. in recent years, the democratization of next generation sequencing has opened a new era in cancer research but also for molecular diagnostics. indeed, the enormous sequencing capabilities offered by high-throughput sequencing technologies allow analysis in a limited time the entire coding sequence of the genome (exome), or even the entire genome of a tumor (whole genome sequencing). thus, the evolution and the development of broadband and associated bioinformatics tools for genomics techniques now make it possible to establish the genetic profile of a tumor. targeted diagnosis of molecular abnormalities and allows to propose and specifically targeted direct therapeutic identified genetic alterations and supposedly responsible for tumor development. an analysis of tumor exome by next-generation sequencing (ngs) and provides information on genetic modifications of these tumors. this study did not aim to evaluate a therapeutic strategy or treatment. the objective of this study is to evaluate the clinical benefit of an analysis of exome performed in current practice at the centre georges-françois leclerc from dijon. the analysis will be performed by quantifying the number of patients undergoing therapeutic proposal based on the results of the analysis of the profile of the tumor.


Eligibility criteria:
inclusion criteria: * over 18 years * histological and cytological diagnosis of solid evidence of malignancy metastatic or locally advanced non-curable and non-curable * disease for which a treatment under the national standards do not exist or will not exist if it escapes the current treatment * availability of equipment or new tumor biopsy / puncture a feasible accessed injury (biopsiable disease), only if it is deemed necessary in the treatment by the investigator. * patient affiliated with a social security scheme * patient non opposition exclusion criteria: * no tumor material available for the establishment of the tumor profile. * patient refusal * psychiatric illness and / or patient condition compromising the understanding of the information or the conduct of the study * patient under guardianship or subject to major people protection regime
lung us for peep optimization in robotic radical prostatectomy or cystectomy patients

Conditions: Prostate Cancer; Urinary Bladder Cancer; Surgery; Positive End Expiratory Pressure; Lung Ultrasound

Summary: there is an increasing trend in the use of robotic-assisted radical prostatectomy or cystectomy (rarpc). preventing lung atelectasis without inducing overdistention of the lung is challenging. many studies tried to optimize peep titration by using methods such as dead space fraction guided and static pulmonary compliance directed techniques, or by using electrical impedance tomography. however, the use of these methods is limited by inaccuracy and the need for sophisticated devices. bedside lung ultrasound is fast, easy and economic technique that is gaining interest in the operating room. ultrasound-guided peep titration has been used in bariatric surgeries (different position and usually shorter procedure time) and proved effective in improving oxygenation, compliance and reducing the incidence of postoperative pulmonary atelectasis and hypoxia without causing hemodynamic instability. the aim of this study is to evaluate the effectiveness of intraoperative individualized lung ultrasound-guided stepwise peep optimization in patients undergoing rarpc on oxygenation, intraoperative and early postoperative pulmonary complications.


Eligibility criteria:
inclusion criteria: * asa i, ii \& iii. * normal respiratory functions or mild lung disease. exclusion criteria: * bmi more than 40. * moderate to severe obstructive pulmonary disease (fev1 \< 80% of predicted). * moderate to severe restrictive pulmonary disease (tlc \< 70% of predicted). * severe pulmonary hypertension (mean pap\>55). * previous lung surgery. * decompensated cardiac disease (nyha 3 or 4). * patients who received invasive mechanical ventilation within the last 30 days before surgery.

Keywords: radical cystectomy radical prostatectomy robotic anesthesia lung-ultrasound positive end expiratory pressure
a study to determine the efficiency for brain metastasis nsclc patients treated with icotinib alone or combined with radiation therapy

Conditions: Non Small Cell Lung Cancer; Brain Metastases

Summary: the purpose of this study is to evaluate the efficacy of icotinib alone or in combination with radiation therapy for nsclc patients harboring egfr mutation with brain metastases. the primary endpoint is overall survival .

non-small cell lung cancer (nsclc) is one of the malignant tumors with the highest incidence of brain metastases, and most patients died due to the progression of brain metastases. some research show that icotinib combined with radiation therapy can improve the efficiency of nsclc with brain metastases, but there is still controversial about the timing of radiation therapy intervention . this study is a prospective, multi-center, randomized, controlled trial of icotinib combined with early intervention or late intervention radiation therapy for nsclc patients harboring egfr mutation with brain metastases. they will be treated with icotinib and divided into 2 groups. group 1: the radiation therapy will start within 1 month after icotinib treatment; group2: the patients will be treated with icotinib first, radiation therapy intervene if disease progress.

Eligibility criteria:
inclusion criteria: * histological or cytological confirmation of non-small-cell lung cancer (nsclc) * positive egfr mutation（ex19del or 21l858r） * primary diagnosis of brain metastases * have one or more measurable encephalic lesions according to recist * extracranial transfer organ≤3 * ecgo:0-2 * adequate hematological function: absolute neutrophil count (anc) ≥1.5 x 109/l, and platelet count ≥100 x 109/l. * adequate renal function: serum creatinine ≤1.5 x uln, or ≥ 50 ml/min. * adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (uln) and -alanine aminotransferase (alt) and aspartate aminotransferase (ast) \< 2.5 x uln in the absence of liver metastases, or \< 5 x uln in case of liver metastases. * female subjects should not be pregnant. * all human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications. * written informed consent provided. exclusion criteria: * previous usage of egfr-tki : gefitinib, erlotinib, icotinib，or any other tki * csf or mri findings consistent with metastases of spinal cord, meninges or meningeal. * allergic to icotinib. * lack of physical integrity of the upper gastrointestinal tract, or malabsorption syndrome, or inability to take oral medication, or have active peptic ulcer disease. * pregnancy or breast-feeding women. * participate in the other anti-tumor clinical trials in 4 weeks. have quit from the trail before. * any other serious underlying medical, psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.

Keywords: egfr-tki nsclc icotinib radiotherapy
effectiveness of internet-based self-help money management program among adult with severe mental illness

Conditions: Severe Mental Illness

Summary: this experimental study aims to develop an internet-based self-help money management program that improve financial self-efficacy and its associated adverse outcomes among adult population with severe mental illness. in particular, this study compares the efficacy of the internet-delivered self-help money management program with the wait-list control group. the online money management program course will consist of 4 weekly modules, incorporating the key components of money management and the model of human occupation (moho). the program include the concept of money management, money management skill, and risk of financial exploitation. the main component of each module will be presented in video format, quiz, and homework. materials will be presented interactively to facilitate engagement.

money management is necessary for people with severe mental illness (smi) to live safely in the community. collective evidence has suggested that mental disorder leads to drift into poverty, is strong. most of them struggle to meet basic needs with their existing income. financial instability has been consistently linked to an increased risk of relapse. this experimental study aims to develop an internet-based self-help money management program that improve financial self-efficacy and its associated adverse outcomes among adult population with severe mental illness. its efficacy will be compared with the wait-list control group. we hypothesized that (1) participants who received a money management program will improve financial self-efficacy after the intervention as compared with the wait-list controls; (2) participants from the money management program will have better financial well-being after the intervention as compared with the wait-list controls. the online money management program course will consist of 4 weekly modules, incorporating the key components of money management and the model of human occupation (moho), including the concept of money management, money management skill, and risk of financial exploitation. each module will consist of the main component presented in video format, quiz, and homework. materials will be presented interactively to facilitate engagement.

Eligibility criteria:
inclusion criteria: * hong kong residents * age ≥18 years * carrying a diagnosis of mental illness * being able to read chinese * have a computer, tablet and/or smartphone device with internet access * willing to give informed consent and comply with the trial protocol exclusion criteria: nil

Keywords: money management program
standard dose versus high-dose inactivated flu vaccine in pediatric solid organ transplant patients

Conditions: Pediatric Solid Organ Transplant Patients

Summary: this is a phase i trial in which the both the safety and immunogenicity of the standard dose flu vaccine will be compared with high dose flu vaccine in children that have undergone solid organ transplantation (sot).

a prospective, randomized, double-blind phase 1 safety and immunogenicity study of the hd compared with the sd tiv in pediatric patients between the ages of three and 17 yr that have undergone sot (clin-trials.gov. nct01525004) was conducted. subjects were randomized in a 2:1 fashion to receive 0.5 ml of either the hd (60 μg) or sd (15 μg) tiv intramuscularly. subjects \<9 yr of age received either one or two doses of the vaccine based on acip recommendations \[19\]. the study was approved by institutional review boards at both institutions (vanderbilt university, nashville, tn, and the university of pittsburgh, pittsburgh, pa) and conducted during the 2011-2012 influenza season. subjects were randomly allocated to either the hd or sd group by a computer-generated allocation system. participants, their families, and research staff who performed clinical evaluations remained blinded to the child's assigned dosage, while designated unblinded nurses administered the requisite vaccine.

Eligibility criteria:
inclusion criteria: * pediatric sot patients (kidney, liver, heart, lungs, intestine, and/or multi-visceral) * must be at least 6 months after transplant. * 3-17 years of age, inclusive. * available for duration of study. * parent or guardian able to be reached by phone. exclusion criteria: * history of hypersensitivity to previous influenza vaccination or severe hypersensitivity to eggs/egg protein. * history of guillian-barre syndrome. * receipt of rituximab within the past one year. * rejection treatment with intravenous steroid bolus within 30 days. * rejection treatment with monoclonal antibody or antilymphocyte preparation (e.g. alemtuzumab, muromonab-cd3, etc.) within 90 days. * have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol. * have any condition that the investigator believes may interfere with successful completion of the study. * history of received 2011-2012 influenza vaccine. * pregnant female. * history of proven influenza disease after september 1, 2011. * history of known infection with hiv, hepatitis b, or hepatitis c. * history of known latex hypersensitivity.

Keywords: solid organ transplant flu vaccine
the effects of hypolipemic and antidiabetic treatment on cytokines

Conditions: Diabetes; Dyslipidemia; Inflammation; Cytokines

Summary: the study is planned to show whether combined hypolipemic and antidiabetic therapy with various daily dosages influence the fasting plasma glucose, insulin sensitivity and proinflammatory cytokines in diabetic and dyslipidemic subjects.


Eligibility criteria:
inclusion criteria: * age (35-64yr) * primary hyperlipidemia (total cholesterol \>200mg/dl, triglycerides \>150mg/dl) * type 2 diabetes * for women: * menopause (\>12 months) * post hysterectomy * mechanical contraception * obtained informed consent exclusion criteria: * secondary hyperlipidemia * morbid obesity (bmi\>40kg/m2) * alcohol or drug abuse * acute or chronic inflammation * congestive heart failure (nyha iii or iv) * unstable ischaemic heart disease * moderate or severe hypertension * cancer in less than 5 years * chronic kidney disease (stage iii-v) * liver failure * oral contraception * not compliant patient * laboratory results: * alanine transferase (\>3xuln) * creatine kinase (\>5xuln) * haemoglobin (\<10/dl) * plt (\<100g/l) * wbc (\ 10g/l)
emotional disclosure in hiv

Conditions: HIV Infections

Summary: the specific objective of this study are to examine whether or not a treatment aimed at emotional disclosure may have beneficial psychological, health and immune effects for hiv infected individuals. the goal of the current study is to test the efficacy of emotional disclosure through writing in patients with hiv infection. we will compare emotional disclosure through writing about traumatic experiences (experimental intervention) to a control intervention (writing about emotionally neutral topics). \[note that hiv rna viral load, cd4 t cells, urinary cortisol, health related dysfunction, psychological distress, and medication adherence are the 6 primary outcome variables.


Eligibility criteria:
inclusion criteria * 18-65 years of age inclusive * at least 8 years of formal education * literate * fluent in english all of the following three must apply: * no active category c hiv aids-defining symptoms * cd4 t-lymphocyte count between 150-499 * viral load \>1000 exclusion criteria * less than 8 years formal education * illiterate or non-english speaking * active systemic diseases that would interfere with participation * current alcohol or substance dependence * planned change in hiv medication in the next 6 months, or recent change in past 2 months * introduction of antidepressant medication within 30 days of study start * current psychological counseling, cognitive behavior therapy, support group or other psychological therapy, or plans to start any of the above * diagnosis of ptsd or major depression * unable to attend at least 4 treatment sessions

Keywords: complementary therapies
sinomenine versus glucocorticoid for knee oa

Conditions: Knee Osteoarthritis

Summary: both glucocorticoid and sinomenine are widely used in the routine clinical treatment of osteoarthritis, but there is still a lack of high level of clinical evidence for the direct comparison of efficacy between the two drugs. this trial aims to evaluate whether intraarticular injection of sinomenine was noninferior to intraarticular injection of glucocorticoid for symptom relief in patients with early knee arthritis, and whether intraarticular injection of sinomenine was superior to intraarticular injection of glucocorticoid for changes in tibial cartilage volume (measured by mean thickness) from baseline compared with intraarticular injection of glucocorticoid. 326 people will participate in the study at 3 different research/medical institutions, with centres competing for inclusion. this trial was designed by random blind method. this trial will last for 2 years and participants will receive 6 injections every 4 months.


Eligibility criteria:
inclusion criteria: 1. age \> 40 and \<70. 2. bilateral knee pain lasting for more than 6 months and most of the last month; 3. x-rays showed that kellgren and lawrence had grade 2 or 3 knee osteoarthritis. exclusion criteria: 1. kellgren and lawrence level 1 or 4. 2. radiographs showed that the reduction of the lateral joint space was greater than or equal to the medial joint space. 3. the affected knee had been injected with glucocorticoid or hyaluronic acid within the past 6 months. 4. have had knee surgery or plan to have joint surgery on the affected knee. 5. other medical conditions such as: systemic or inflammatory joint diseases (rheumatoid arthritis), history of crystalline or neurological joints, other muscular, joint or nervous system diseases affecting lower limb function. 6. have a needle phobia. 7. immunosuppression or acute infection is present. 8. patients are allergic to the drugs involved in the study. 9. have or have had cancer or tumours. 10. have a hemorrhagic disease or are receiving anticoagulant or antiplatelet therapy. 11. history of hyperlipidemia, or plasma total cholesterol ≥6.2mmol/l and triglycerides \>2.3mmol/l 12. have any other medical conditions that do not participate in the study, including contraindications to mri, such as pacemakers. 13. pregnancy. 14. body mass index (bmi) \> 40 kg/m2. 15. unable to attend all study appointments within 24 months; 16. inability to understand written and spoken chinese. 17. any history of mental and psychological illness.