Kornimate/medical-research-clean huggingface dataset:
the variations of macular thickness in juvenile subjects

Conditions: Cataract;Macular Thickness

Summary: it is reported that it takes a period form 22 weeks pregnant to the first 45 months of life for macular region to develop from structural formation to functional integrity. however, children are still in the critical period of plastic visual development, for their visual acuity has not yet reached the level of adults. similarly macular retinal structure may develop with age. it is very important to study in macular thickness of this period and to have a proper cognition of it and the relation between macular thickness and other ocular parameter for the research of retinal development and diseases and the early screen of fundus diseases.

it is reported that it takes a period form 22 weeks pregnant to the first 45 months of life for macular region to develop from structural formation to functional integrity. however, children are still in the critical period of plastic visual development, for their visual acuity has not yet reached the level of adults. similarly macular retinal structure may develop with age. it is very important to study in macular thickness of this period and to have a proper cognition of it and the relation between macular thickness and other ocular parameter for the research of retinal development and diseases and the early screen of fundus diseases. optical coherence tomography (oct) is an imaging technique widely used in clinic in last twenty years. according to the base theory of dim coherent light interference machine, oct detect the back-reflection or scattering signal of biological tissue to the incident dim coherent light, and acquire the two-dimension or three- dimension image of biological tissue by scan. it enables the characteristic of tissue's microstructure in vivo and makes it possible to observe dynamically developing process of diseases so that it has become an essential test for macular and optic nerve diseases with unmatched measurement reproducibility. it also enables high-resolution and noninvasive imaging of the retinal lamina, the organizational structure of macular. it is most often used clinically to demonstrate the macular morphology, treatment response and disease progression clinically. however, who researchers studyed in through oct were mostly patients with retinal disease and adults. there was few study focused on oct's application to children. in this study, the investigators aims to measure macular thickness (mt) using spectral-domain optical coherence tomography (sd-oct) and to investigate mt variations with sex, age, laterality, refraction error (re) and axial length (al).

Eligibility criteria:
inclusion criteria: * age from 4 to 17 years * children with the mild-to-moderate refraction error(from 0 to -6.00d) exclusion criteria: * children with visual complaints

Keywords: juvenile subjects'characteristics
paclitaxel and bryostatin 1 in treating patients with advanced pancreatic cancer

Conditions: Acinar Cell Adenocarcinoma of the Pancreas; Duct Cell Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer

Summary: phase ii trial to study the effectiveness of combining paclitaxel and bryostatin-1 in treating patients who have locally advanced unresectable or metastatic pancreatic cancer. drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. bryostatin-1 may help paclitaxel kill more cancer cells by making tumor cells more sensitive to the drug.

primary objectives: i. to determine the response rates to weekly, sequential paclitaxel/ bryostatin-1 in patients with unresectable and metastatic pancreatic cancer. ii. to determine the toxicity of therapy. iii. to determine patient survival after therapy. iv. to determine bryostatin-1 pharmacokinetics. outline: this is an open-label, multicenter study. patients receive paclitaxel iv over 1 hour on day 1 followed by bryostatin 1 iv over 1 hour on day 2 of weeks 1-3. courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Eligibility criteria:
inclusion criteria: * histologic proof of adenocarcinoma of the pancreas that is locally advanced and considered surgically not resectable or metastatic * patients with or without prior treatment are eligible for treatment on protocol; prior treatment may have included one treatment course of chemo/rt and/ or one course of chemotherapy, but not two prior courses of chemotherapy; * measurable disease * ecog performance status of 0-1 * ability to sign an informed consent form indicating awareness of the investigational nature of this study, in keeping with the policies of the hospital * patients may not be receiving any other concurrent chemotherapy, immunotherapy, or radiotherapy; the most recent treatment for pancreatic cancer, within the limitations of allowed prior therapy must be 28 days or longer prior to enrollment on study * absolute granulocytes \> 1,500/mm\^3 * platelets \> 150,000/mm\^3 * serum bilirubin \< 1.5 mg/dl * serum creatinine \< 1.5 mg/dl exclusion criteria: * presence of any ongoing toxic effect from prior treatment * brain metastases * history of active angina or myocardial infarction within 6 months; history of significant ventricular arrhythmia requiring medication with antiarrhythmics; well controlled atrial fibrillation on standard management will be permitted * pregnant or lactating women * pre-existing neurotoxicity that is graded 3+ or greater * serious intercurrent infections, or nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this therapy * psychiatric disorders rendering patients incapable of complying with the requirements of the protocol * hiv infection * any other medical condition or reason that, in the investigator's opinion, makes the patient unsuitable to participate in a clinical trial (for example a history of prior poor compliance with treatment)
effectiveness and tolerability of аgomelatine in the treatment of patients with depression after sars-cov-2 (telesphor)

Conditions: Depression; COVID-19

Summary: this is a multi-centre, observational, non-interventional study, which will prospectively collect clinical and socio-demographic data from patients with depression occurred after covid 19 in real clinical settings during 8 weeks of treatment. 10 clinics and 10 of psychiatrists and neurologists across the country will participate in the study and it is estimated that each investigating physician will enroll 10 patients.

a patient with depression occurred within 3 month period after onset of confirmed covid 19 infection who has already been recommended to initiate antidepressive treatment with agomelatine will be asked to provide a consent to participate in the study and in case of consent is positive the patient will be invited for 3 more visits starting from the date of the inclusion in the study according to clinical practice. therefore clinical parameters needed for describing effectiveness and tolerability of agomelatine treatment will be prospectively collected at each of these visits. antidepressive treatment of enrolled outpatients can be modified by investigating psychiatrist or neurologist at any time of the observation if required. following visits are planned: 1. inclusion visit 0 (v0) - inclusion in the study 2. follow up visits 1-2 (v1-v2) - visits at week 2 and week 4 after v0. 3. final visit 3 (v3) - visit at week 8 after v0.

Eligibility criteria:
inclusion criteria: * obtained signed informed consent from the patient. * age of 18-65 years old. * out-patient with confirmed covid 19 infection within 3 months period before the date of inclusion. * confirmed depression with total hamd-17 score of 8-24 required treatment with antidepressive medicines. * decision to administer agomelatine preceeds the decision to include a patient in the study. exclusion criteria: * current participation in any clinical trial or during 30 day period from inclusion visit. * suicide risk (accoding clinical evaluation of investigator). * psychotics symptoms (according clinical evaluation of investigator). * schizophrenia, schizo-affective disorders, organic damages of cns, dementia, epilepsy, multiple sclerosis, parkinson disease, alzeimert disease, bipolar disorders. * alcohol abuse or drug addiction in anamnesis. * severe or decompensated somatic or neurological disorders. * mao inhibitors during last 2 weeks. * treatment by others psychotropic products (antipsychotics, anxiolitics etc.). * any contraindications to agomelatine in accordance to the local smpc. * patients with severe/decompensated psychiatric, somatic or neurological disorders. * patients with any sign of liver failure (increase of transaminase up to 3 times higher), which needs to stop treatment with agomelatine. * patients who participate in any clinical trial or survey.
plasmapheresis in amyotrophic lateral sclerosis with autoantibody against nrip

Conditions: Amyotrophic Lateral Sclerosis; Plasmapheresis

Summary: patient with amyotrophic lateral sclerosis (als) having anti-nrip autoantibody showed titer-dependent detrimental effects. plasmapheresis might benefit this subgroup of patients via removal of anti-nrip autoantibody


Eligibility criteria:
inclusion criteria: 1. patients with amyotrophic lateral sclerosis (als) at the age more than 20 years and having plasma anti-nrip autoantibody. 2. agree to receive plasmapheresis intervention. 3. agree to participate in the trial and receive serial examinations and follow up. exclusion criteria: 1. patients without plasma anti-nrip autoantibody. 2. patients requiring permanent ventilator support for als progression. 3. not able to receive plasmapheresis or trial-related examinations. 4. under pregnancy. 5. blood fibrinogen level less than 50 mg/dl. 6. specific als subtypes, including primary lateral sclerosis, progressive muscular atrophy, flail arm syndrome, or flail leg syndrome.
clinical trial evaluating iti-007 (lumateperone) as a monotherapy for the treatment of bipolar depression

Conditions: Bipolar Depression

Summary: the study will evaluate the efficacy and safety of iti-007 (lumateperone) in patients diagnosed with bipolar i or bipolar ii disorder having a major depressive episode. the study will be conducted in two parts, part a and part b. part a is a randomized, double-blind, placebo-controlled study. in part b, patients who safely complete participation in part a may be enrolled in an open-label extension.


Eligibility criteria:
major inclusion criteria: * male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis of bipolar i or bipolar ii disorder * experiencing a current major depressive episode major exclusion criteria: * any subject unable to provide informed consent * any female subject who is pregnant or breast-feeding * any subject judged to be medically inappropriate for study participation
an open-label study of lamictal in neurotic excoriation

Conditions: Neurotic Disorders; Obsessive-Compulsive Disorder

Summary: the goal of the proposed study is to evaluate the efficacy and safety of lamictal in neurotic excoriation. twenty subjects with neurotic excoriation will receive 12 weeks of open-label treatment with lamictal. the hypothesis to be tested is that lamictal will be effective and well tolerated in patients with neurotic excoriation. the proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.


Eligibility criteria:
inclusion criteria: * men and women age 18-65 * current diagnosis of neurotic excoriation exclusion criteria: * unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination * history of seizures * myocardial infarction within 6 months * current pregnancy or lactation, or inadequate contraception in women of childbearing potential * a need for medication other than lamictal with possible psychotropic effects or unfavorable interactions with lamictal * clinically significant suicidality * lifetime history of dsm-iv bipolar disorder type i, dementia, or schizophrenia or any other dsm-iv psychotic disorder * current or recent (past 3 months) dsm-iv substance abuse or dependence * illegal substance use within 2 weeks of study initiation * initiation of psychotherapy or behavior therapy from a mental health professional within 3 months prior to study baseline * previous treatment with lamictal * treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline * current treatment with an anti-epileptic medication and * patients who have previously been diagnosed with a medical condition that cause skin itchiness (e.g. liver, kidney, and blood diseases, etopic allergies)

Keywords: skin picking pick neurotic excoriation
study to evaluate the safety, tolerability, and efficacy of cilofexor in adults with primary sclerosing cholangitis without cirrhosis

Conditions: Primary Sclerosing Cholangitis

Summary: the primary objective of this study is to evaluate the safety and tolerability of cilofexor in adults with primary sclerosing cholangitis (psc).


Eligibility criteria:
key inclusion criteria: * diagnosis of psc based on cholangiogram (magnetic resonance cholangiopancreatography (mrcp), endoscopic retrograde cholangiopancreatography (ercp), or percutaneous transhepatic cholangiogram (ptc)) within the previous 12 months * serum alkaline phosphatase (alp) \> 1.67 x upper limit of the normal range (uln) * for individuals on ursodeoxycholic acid (udca), the dose of udca must have been stable for at least 12 months prior to screening through the end of treatment. for individuals not on udca, no udca use for at least 12 months before screening through the end of treatment * for individuals being administered biologic treatments (eg, antitumor necrosis factor (tnf) or anti-integrin monoclonal antibodies), immunosuppressants or systemic corticosteroids, the dose must have been stable at least 3 months prior to screening and anticipated to remain stable throughout the trial * screening fibrosure/fibrotest® \<0.75 unless a historical liver biopsy within 12 months of screening does not reveal cirrhosis. in adults with gilbert's syndrome or hemolysis, fibrosure/fibrotest® will be calculated using direct bilirubin instead of total bilirubin. key exclusion criteria: * alanine aminotransferase (alt) \> 10 x uln * total bilirubin \> 2 x uln * international normalized ratio (inr) \> 1.2 unless on anticoagulant therapy * small-duct psc (histologic evidence of psc with normal bile ducts on cholangiography) * other causes of liver disease including secondary sclerosing cholangitis and viral, metabolic, alcoholic, and other autoimmune conditions. individuals with hepatic steatosis may be included if there is no evidence of nonalcoholic steatohepatitis (nash) in the opinion of the investigator or on liver biopsy; * ascending cholangitis within 60 days of screening * presence of a percutaneous drain or bile duct stent * use of fibrates or obeticholic acid within 3 months prior to screening through the end of treatment * cirrhosis of the liver as defined by any of the following: * historical liver biopsy demonstrating cirrhosis (eg, ludwig stage 4 or ishak stage ≥ 5) * prior history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding * liver stiffness \> 14.4 kilopascal (kpa) by fibroscan * current, active inflammatory bowel disease (ibd) defined as a partial mayo score of \> 1 and/or a score on the rectal bleeding domain \> 0. note: other protocol defined inclusion/exclusion criteria may apply.
a prospective randomised multi - center trial on the repair of large hiatal hernias: absorbable mesh vs. pledgeted sutures vs. sutures only

Conditions: Hiatal Hernia

Summary: a prospective randomised multi - center trial on the repair of large hiatal hernias with sutures versus pledgeted sutures versus absorbable mesh the primary objective of the present trial is to compare the hiatal hernia recurrence rate between three different methods of cruroplasty in large hiatal hernias: hiatal closure with sutures versus pledgeted sutures versus absorbable mesh (phasix™st mesh). the duration of the study is not limited and depends on the number of cases planned. after enrollment in the study, patients will be followed - up with standardized questionnaires and gastroscopy at 6 months, 1 year, 3 years and 5 years after surgery.


Eligibility criteria:
inclusion criteria: * patients with a large hiatal hernia - admitted for surgery (laparoscopic / robot-assisted) * written informed consent * ≥ 18 years of age * hiatal hernia documented by barium x-ray and/or gastroscopy and/or manometry by one or more of the following criteria: * \> 5cm hiatal hernia * 1/3 of the stomach in the thorax exclusion criteria: * lack of patient consent for study participation * lack of consent to study due to linguistic or mental incomprehension * patients in poor general condition (lack of anesthesia ability) * pregnancy * prior surgery on the stomach or gastroesophageal junction * simultaneous surgery because of another illness

Keywords: hiatal hernia pledgets mesh hernia recurrence
a study with arctic root compared with the extract when combined with schizandra and russian root (adapt 232), standardized ginseng extract and placebo regarding impact on the level of energy, ability to work under stress, quality of life and wellbeing, in middleaged women who are still employed

Conditions: Depression; Stress

Summary: this is clinical trial to document the efficacy of a proprietary standardized extract of arctic root in comparison to a standardized commercial extract of ginseng and placebo from an every day consumer perspective to ameliorate mild depression, reduce stress and improve quality of life. a newly developed adaptogenic formulation, adapt 232, was included into the study in order to evaluate its effect in comparison to the others.


Eligibility criteria:
inclusion criteria: * healthy females, over 40 years of age, who have stated that they for a longer period of time have felt stressed due to demanding daily activities at work and/or at home. exclusion criteria: * suffering from any known medical disease, e.g. cardiovascular, joint, and liver or kidney diseases, cancer, or psychiatric disease. * with a psychiatric diagnose, using narcotics or suffering from hiv. * with known allergy to any of the study medications. * misusing euphorizing or pain killing drugs * having used any adaptogenic product the last 2 months. * having used cortisol or any other corticosteroid products the last 6 months * being pregnant or breast-feeding * which at the first interview are judged to be not cooperative or not to be able to finalize the study

Keywords: quality of life and subjective well-being in middle aged women
genetic susceptibility biomarkers in children with neuroblastoma (also known as neuroblastoma epidemiology in north america [nena])

Conditions: Neuroblastoma

Summary: this research trial studies the genes biomarkers in children with neuroblastoma. studying the genes in a child's cancer cells may help doctors improve ways to diagnose and treat children with neuroblastoma.

primary objectives: i. evaluate the independent association of common genetic polymorphisms involved in folate, vitamin a, and related metabolic and transport pathways and the risk of neuroblastoma (nb). ii. evaluate the joint effects of multiple genes on the risk of nb. iii. evaluate the effects of gene-exposure interactions on the risk of nb. iv. evaluate genetic effects within nb subgroups defined by age at diagnosis and a children?s oncology group classification schema based on age, v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (mycn) oncogene status, histology, and deoxyribonucleic acid (dna) ploidy. v. recontact mothers of participating nena case children, conduct brief web-based screen to ascertain whether the pregnancy including the index nena child was a multiple (twin, triplet, etc), whether the mother knew if the children were monozygotic (mz) or dizygotic (dz), and obtain a complete pregnancy history. vi. request a saliva sample from the other twin/multiple sibling of the nena child. vii. extract dna from saliva samples and securely store. viii. clean new survey data and merge with main nena study database. outline: the biologic mother of the patient is asked to complete a diet history questionnaire about diet during pregnancy, and information on demographics, lifestyle factors, medication used during pregnancy, history of breast feeding, and family history of cancer or birth defects. parents are given oragene saliva collection kits for self-collection. saliva bio-specimen samples are collected from both biologic parents and the patient. tissue samples previously stored in a tissue bank are obtained for deceased patients, if available. dna is extracted from samples, amplified and analyzed using real-time polymerase chain reaction (pcr) quantitation assay, and genotyped using single nucleotide polymorphisms.

Eligibility criteria:
inclusion criteria: * primary diagnosis of neuroblastoma made at a north american cog institution * diagnosed between 12/24/2007- 7/31/2013 * diagnosed at \< 6 years of age * biological mother is alive and willing to participate * questionnaire respondents must understand english or spanish * are only those participating in ccrn who have agreed to be contacted for future studies
safety study of abatacept to treat rheumatoid arthritis (b)

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to compare the incidence rates of targeted infections, malignancies and mortality among patients with rheumatoid arthritis who are treated with abatacept and those who are treated with other anti-rheumatic medications.


Eligibility criteria:
inclusion criteria: * signed informed consent * diagnosis of rheumatoid arthritis * \> 18 years at index treatment initiation or switch * starting treatment with abatacept or new disease-modifying anti-rheumatic drug (including switching or adding) or biologic disease modifying drug. * read/write english exclusion criteria: * none