Kornimate/medical-research-clean huggingface dataset:
the effects of long-acting methylphenidate on academic activity and related constructs in children with adhd

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this study aims at investigating the direct effects of methylphenidate on school performance of primary school children. although behavioral effects of this frequently prescribed drug are thoroughly studied (and confirmed), the effects of methylphenidate on school performance are less clear. recent overviews indicate that effects are mainly quantitative and subject-specific. to gain more insight in this issue, the current double blind placebo controlled crossover study investigates not only the effects of methylphenidate on school performance but also it's effect on related variables such as short term memory, motivation and behavior. 60 children with adhd are included and tested twice (with medication and with placebo) at their primary school.

rationale: adhd (attention deficit hyperactivity disorder) is a common childhood developmental disorder. besides the behavioural symptoms of adhd, many children with adhd experience problems with academic activities. more specifically, these children show problems with math, spelling and reading. the most common treatment for adhd is medical treatment with methylphenidate (mph). this treatment is effective in the reduction of adhd symptoms. however, it is unclear whether treatment with mph can also improve academic activity. if mph improves academic activity, it is of great interest to understand which variables influence or mediate this effect. the results from this study can give more insight in the working mechanisms and effectiveness of mph in reducing the academic problems commonly observed in children with adhd. objectives: the main objective of this study is to assess the impact of mph on academic activity and to estimate the role of three putative mediators in this relation. study design and population: this study is a randomised, double-blind, placebo-controlled cross-over design with a patient group and a control group. main study parameters/endpoints: the main study parameters are changes in academic activity (ability, effort and engagement). in addition, changes in putative mediators are assessed.

Eligibility criteria:
inclusion criteria: * adhd diagnosis (dsm-iv) * primary school education * sufficient knowledge of dutch language exclusion criteria: * neurological or psychiatric disorder other than odd, cd, learning disorder, dyslexia, anxiety disorder healthy volunteers are accepted for the control group

Keywords: adhd methylphenidate academic motivation
long-term atazanavir experience in a high hiv caseload primary care practice in sydney, australia

Conditions: HIV

Summary: this observational study will aim to determine long-term atazanavir experience in a high hiv caseload primary care practice in sydney, australia.

this observational study will aim to determine long term atazanavir experience in hiv-1 infected patients in a primary care setting. 3. objectives of the study i. primary objective long-term (2 years or greater) atazanavir experience in hiv-1 infected patients in a primary care setting through retrospective data collection. ii. secondary objectives 1. to illustrate long term therapeutic efficacy of atazanavir in art naïve and experienced hiv-1 infected patients. 2. to illustrate long term tolerability to atazanavir in art naïve and experienced hiv-1 infected patients. 3. to identify art treatment history in art naïve and experienced hiv-1 infected patients on atv. 4. to identify contraindicated therapy in art naïve and experienced hiv-1 infected patients on atv.

Eligibility criteria:
inclusion criteria: 1. hiv-1 positive 2. have commenced atv between 2002-2008 (baseline) 3. follow-up data (clinical and laboratory) available from baseline exclusion criteria: 1. patients not commenced atv between 2002-2008 2. no follow-up data (clinical and laboratory) available from baseline 3. patient 'lost to follow-up' with \< 2 years of follow-up data (clinical and laboratory)

Keywords: atazanavir long-term primary care setting sydney
efficacy and safety of algrx 4975 in treatment of postoperative pain after hernia repair

Conditions: Postoperative Pain

Summary: hernia repair is one of the most common operations. whilst there are few complications, pain may last for several weeks and extend the period of convalescence. algrx 4975 is an ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term pain relief following a single administration. this study will determine whether algrx 4975 can provide pain relief following hernia repair.

inguinal hernia correction in adults is one of the most common operations with an annual rate of approximately 2,800 per 1 million people in the united states. whilst there is little intra and postoperative morbidity, pain may persist for one to several weeks postoperatively and may extend the period of convalescence. algrx 4975 is an ultra-pure form of capsaicin, which is a pain medicine that has the potential for long-term pain relief following a single administration. the purpose of this study is to determine whether a single dose of algrx 4975, administered by instillation, is able to reduce the postoperative pain following inguinal hernia correction and to evaluate the potential for long term pain relief.

Eligibility criteria:
inclusion criteria: • the subject has a primary hernia and will undergo hernia repair by standard lichtenstein mesh repair. exclusion criteria: * the subject has undergone a lower abdomen surgical procedure in the past. * the subject is currently scheduled to undergo bilateral inguinal hernia repair. * personal or familial contraindications in undergoing general anesthesia. * systolic blood pressure greater than 150 mmhg or diastolic greater than 95 mmhg

Keywords: postoperative pain inguinal hernia repair capsaicin
the maintenance treatment of uft in advanced gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of tegafur-uracil (uft) after the standard first-line chemotherapy in advanced gastric cancer.


Eligibility criteria:
inclusion criteria: * histologically confirmed advanced or metastatic adenocarcinoma of the stomach * ecog ps 0-2 * at least one measurable or evaluable lesion in the first-line chemotherapy (5-fu based regimen: ecf/eof/eox/folfox/xelox) with the efficacy evaluation of non-pd * adequate hepatic,renal,heart, and hematologic functions (platelets ≥75×109/l, neutrophil≥1.5×109/l, hemoglobin≥80 g/l, serum creatinine ≤1.5mg/dl, total bilirubin ≤1.5mg/dl, and serum transaminase≤2.5×the uln) exclusion criteria: * receiving more or more than 2 regimens of chemotherapy * pregnant or lactating women * concurrent cancer * history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * neuropathy, brain, or leptomeningeal involvement * clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia * uncontrolled significant comorbid conditions and previous radiotherapy

Keywords: disease control survival
congenital cytomegalovirus: prevalence in buenos aires city (ccmv prevalence)

Conditions: Congenital Cytomegalovirus

Summary: the goal of this observational study is to recognise the prevalnce of congenital cytomegalovirus (ccmv) and to follow up positive babies until 12 months the main questions it aims to answer are: pevalence of ccmv, ccmv clinicals outcomes during the first year of life. participants will be screened with a salive swab for cmv dna. babies with positive results will be follow up for one year.

cytomegalovirus (cmv) is a frequent cause of congenital infection and a leading nongenetic cause of sensorineural hearing loss. in most infants with congenital cmv infection, clinical abnormalities do not manifest at birth; rather, the infection is asymptomatic. however, sensorineural hearing loss eventually develops in approximately 10 to 15% of cmv positive children. the prevalence of congenital cytomegalovirus has been reported as 0·2% to 2·0% (average of 0·64%). there is not any publication of the prevalence of ccmv in buenos aires city. we aim the study to find the prevalence in this population screening of newborns for cmv infection permit early identification of at-risk congenitally infected infants for purposes of targeted monitoring and intervention during critical stages of speech and language development. testing saliva via dna detection of the virus through polymerase chain reaction testing (pcr) or rapid culture is shown to have a high sensitivity (\>97%) and specificity (99%) for detecting congenital cmv infection. our objective is to describe the prevalence of ccmv using saliva specimens for pcr detection. secondary objectives includes describing prevalence of neurosensorial hearing loss and visual impairments during 1 year follow up.

Eligibility criteria:
inclusion criteria: * newborns between 1 and 21 days * informed consent exclusion criteria: * lethal malformation
sgp130 in chronic human liver disease

Conditions: Alcoholic Liver Disease; Chronic Hepatitis C Virus Infection

Summary: chronic liver disease are characterized by increased levels of plasma il-6, but the bioactivity of this cytokine in this disease is not well known. il-6 receptor complex is regulated by multiple receptors subunits: the soluble form of il-6 receptor enhance il-6 signal by a process called trans-signaling on cells expressing few membrane il-6 receptors. soluble gp130 is the natural inhibitor of il-6 trans-signaling. the aim of this study is to characterize circulating and liver levels of theses compounds of il-6 receptor complex, to unravel the bioactivity of il-6 in this disease.

consecutive patients undergoing transjugular liver biopsies for alcoholic liver disease or hepatitis c virus infection will be included in the study to measure plasma cytokines levels, peripheral blood mononuclear cells cytokine release and liver il-6r compounds mrna levels.

Eligibility criteria:
inclusion criteria: * alcohol excess intake and suspected liver disease * alcohol excess intake and clinical liver cirrhosis * chronic hepatitis c virus infection and suspected liver disease * chronic hepatitis c virus infection and clinical liver cirrhosis exclusion criteria: * other (superimposed) liver disease

Keywords: liver alcohol hcv
evaluation of sectg vs. laser-dgg in management of gingival recessions.

Conditions: Gingival Recession

Summary: this study evaluates laser de-epithelialized gingival graft to be as effective as subepithelial connective tissue graft in management of multiple gingival recessions using tunneling technique. half pf participants will be treated from gingival recession using tunneling technique with laser de-epithelized gingival graft, while the other half will be treated using tunneling technique with subepithelial connective tissue graft.

tunneling technique is a minimal invasive method for coronal advancement during gingival recession coverage. the technique provide better blood supply which enhances wound healing and results in successful root coverage and attachment gain. tunneling technique is suggested to be incorporated with a soft tissue tissue for better recipient site outcome. in a systemic review and meta-analysis conducted in 2019 there was limited evidence available comparing subepithelial connective tissue graft to the de-epithelialized gingival graft. however the de-epithelialized gingival graft showed superior mean root coverage, keratinized tissue gain and clinical attachment gain over the subepithelial connective tissue graft making it the technique of choice when incorporated with coronal advancement flap in treatment of gingival recession. laser de-epithelization may enrich the advantages of the conventional de-epithelization method where more uniform predictable epithelization can be obtained.

Eligibility criteria:
inclusion criteria: 1. anterior teeth and premolars with multiple miller's class i and ii gingival recessions. 2. identifiable cemento-enamel junction. 3. the teeth with gingival recessions are vital teeth. 4. plaque index and gingival bleeding index less than 20% after phase one therapy. exclusion criteria: 1. patients with systemic diseases and medical conditions that may affect the treatment outcomes. 2. prosthetic crown, restoration or tooth decay involving the cej. 3. previous periodontal surgery in the area of interest. 4. smokers. 5. pregnancy.
a trial of robotic-assisted versus laparoscopic abdominoperineal resection for treating low rectal cancer

Conditions: Rectal Cancer

Summary: in this study, the investigators assessed the difference in efficacy and safety among robotic-assisted versus laparoscopic abdominoperineal resection for patients with low rectal cancer.

patients will be eligible for inclusion if their primary tumors is low rectal cancer. eligible patients will be randomly assigned to robotic-assisted (arm a) versus laparoscopic (arm b) abdominoperineal resection.

Eligibility criteria:
inclusion criteria: * histologically proven rectal adenocarcinoma * inferior edge of the tumor located within 5 cm from the anal verge as determined by colonoscopy withdrawing and digital rectal examination * no evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc) according to ultrasound, ct, pet-ct, etc * tumor assessed as ct1-t3 or yct1-t3 after preoperative neoadjuvant chemoradiotherapy by pelvic mri * no other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri * suitable for both robot-assisted and laparoscopic surgery * american society of anesthesiologists (asa) class i - iii * no other preoperative treatment except neoadjuvant chemoradiotherapy * informed consent exclusion criteria: * tumors assessed as ct1n0 and suitable for local excision * signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery * more than one colorectal tumor * familial adenomatosis polyposis, lynch syndrome, acute inflammatory bowel disease * schedules need for other synchronous colon surgery * absolute contraindications to general anesthesia or prolonged pneumoperitoneum (asa class \> iii) * pregnancy or lactation * patients and/or family members can not understand and accept this study * patients received chemoradiotherapy or other anti-tumor therapy before surgery

Keywords: low rectal cancer robotic laparoscopic abdominoperineal resection
an open label trial of ald403 (eptinezumab) in chronic migraine

Conditions: Migraine Disorder

Summary: an evaluation of long term safety of repeat ald403 doses in chronic migraine


Eligibility criteria:
inclusion criteria: * males and females between 18 and 65 years of age, inclusive, who were diagnosed with migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months before screening. exclusion criteria: * receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening. * confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome). * psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. patients with a lifetime history of psychosis, mania, or dementia are excluded. * history or diagnosis of complicated migraine (ichd-iii beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine.
endostar in combination with chemotherapy in her-2 negative advanced breast cancer

Conditions: Breast Cancer

Summary: this research study is studying endostar in combination with chemotherapy as a possible treatment for her-2 negative advanced breast cancer.

this is a multi-center phase ii open label single-arm study to assess the safety and efficacy of endostar in combination with chemotherapy for patients with locoregionally recurrent or metastatic her-2 negative breast cancer. endostar is an anti-angiogenesis drug. it is prepared by adding 9 amino acids to the n-terminal of the peptide chain on the basis of endostatin. studies have shown that there may be a synergistic effect between endostar and chemotherapeutic agents.

Eligibility criteria:
inclusion criteria: * locoregionally recurrent or metastatic breast cancer confirmed by histology. * her-2 negative breast cancer. * at least one measurable lesion according to recist 1.1.. * chemotherapy for recurrent and metastatic lesions should be discontinued for more than 2 weeks. * 18-70 years old. * ecog ps 0～1. * participants must have normal organ and marrow function as defined below: anc ≥ 1.5×109/l,plt ≥ 75×109/l,hb ≥ 100 g/l;tbil≤1.0uln；alt and ast≤3×uln（alt and ast≤5×uln if liver metastasis）;bun and cr≤1.5×uln and ccr≥50 ml/min. * life expectancy is not less than 12 weeks. * signed informed consent. exclusion criteria: * uncontrolled central nervous system metastasis. * not recovered to 0-1 degree (ctc ae 4.0) from toxic reactions of previous treatments.. * history of allergy to biological agents in the past. * important organ dysfunction and severe heart disease, including congestive heart failure, uncontrollable arrhythmia, angina, valvular disease, myocardial infarction, and refractory hypertension. * pregnant or lactating women.. * the patient had a history of other malignant tumors, except for the cured skin basal cell carcinoma and cervical cancer. * the risk of uncontrolled infection, thrombosis and bleeding exists. * a history of immunodeficiency, including hiv positive, hcv, active hepatitis b, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known. * researchers consider it inappropriate to carry out the study.

Keywords: breast cancer endostar
radio frequency ablation in the management of pancreatico-biliary disorders: a multicenter registry

Conditions: Cholangiocarcinoma; Pancreatic Cancer; Bile Duct Cancer; Biliary Stricture; Bile Duct Obstruction

Summary: the objective of this protocol is to establish a multicenter registry to evaluate the impact of radiofrequency ablation in the management of patients with pancreatico-biliary disorders including malignancies.

bile duct cancer and pancreatic cancer are cancers that cannot be surgically removed. as the cancer grows, it blocks the drainage of the bile ducts that carry digestive juices from the gall bladder and pancreas to the small intestine. ercp (endoscopic retrograde cholangiopancreatography) is often prescribed during which a tube with a tiny camera attached is inserted through the subject's mouth and advanced to a place in the small intestine where the bile duct empties. through this scope the doctor enlarges the ducts with tiny balloons and places plastic or metal stents (straws) that help keep the bile ducts open so they can drain properly. however, due to the cancer, the stents are blocked eventually. the purpose of this registry is to record information and evaluate the impact of radiofrequency ablation (rfa) of endoscopic radiofrequency ablation (rfa) probes in improving the management of bile duct cancer or pancreatic cancer by ablating the tissue in the bile duct(s) before the stent(s) are implanted. by using radiofrequency (rf) energy to heat the tissue in the duct(s) prior to stent(s) insertion, the surrounding tissue becomes coagulated and this may delay tumor growth and the time before the stent lumen becomes blocked. thereby, allowing increased periods between the need for intervention and further stent implantation(s). the registry will evaluate the efficacy and safety of rfa procedures conducted for pancreatico-biliary disorders. the safety and efficacy of various radio frequency ablation probes have been assessed in a series of studies. this multi-center registry has been initiated: 1. to document the immediate and post procedure clinical performance of radio frequency ablation in a 'real world' patient population requiring stent implantation for pancreaticobiliary disorders. 2. to assess the immediate and 6 months post procedure adverse event rate in patients. 3. to assess the impact of rfa on the life expectancy of patients suffering from pancreaticobiliary malignancies.

Eligibility criteria:
inclusion criteria: * patients who have undergone rfa for pancreaticobiliary disorders * above 18 years of age exclusion criteria: * patients who have not undergone rfa * below 18 years of age

Keywords: cholangiocarcinoma pancreatic cancer bile duct cancer biliary stricture bile duct obstruction endohpb radio frequency ablation rfa ercp endoscopic retrograde cholangiopancreatography registry multicenter
a dose response evaluation of slitone ultra hdm mix immunotherapy

Conditions: Allergic Rhinitis

Summary: the primary objective of the trial is to evaluate the dose-response relationship with regards to change in immunological parameters and safety for slitone ultra house dust mite mix in adult subjects with moderate to severe hdm allergic rhinitis.


Eligibility criteria:
inclusion criteria: * aged 18 or older * moderate to severe persistent hdm allergic rhinitis with or without asthma * moderate to severe hdm allergic rhinitis symptoms during a baseline period * positive skin prick test response (wheal diameter ≥ 3 mm) * positive specific ige ≥ ige class 2, ≥ 0.70 ku/l) exclusion criteria: * previous treatment with immunotherapy with house dust mite immunotherapy * ongoing treatment with any allergen specific immunotherapy product * reduced lung function * clinical history of uncontrolled asthma * inflammatory conditions in the oral cavity with severe symptoms * history of anaphylaxis with cardiorespiratory symptoms * history of recurrent generalised urticaria * a history of drug induced facial angioedema or hereditary angiooedema * any clinically relevant chronic disease (≥3 months duration) * systemic disease affecting the immune system * immunosuppressive treatment * currently treated with tricyclic antidepressants; catecholamine-methyltransferase inhibitors and mono amine oxidase inhibitors

Keywords: house dust mite allergy rhinitis asthma