Kornimate/medical-research-clean huggingface dataset:
phase ii clinical trial, use of kl16-012 in women with fibromyalgia refractary to conventional treatment.

Conditions: Fibromyalgia; Cannabis

Summary: a double blind randomized placebo controlled trial in 44 women with fibromyalgia and persistent symptoms in spite of use of conventional pharmacotherapy, will be performed in the city of valparaiso. patients will be randomized to either placebo or active principle and be followed for 3 months. assesment of efficacy and safety will be done by measurement of changes in their fibromyalgia impact questionnaire (fiq) score, insomnia severity index (isi) score, pain visual analogue scale (vas) score, plasma cytokine levels and detection of adverse effects. the active principle will be a standardized extract of cannabis sativa containing 1 milligram of tetrahydrocannabinol (thc) and 0.45 milligrams cannabidiol (cbd) per drop.


Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia based on acr 2010 criteria * fiq \> 39 (refractary symptoms) * previous use of at least 2 conventional pharmacotherapies exclusion criteria: * history of substance use disorder * history of major psychiatric or cardiovascular diseases * pregnancy * urine thc (+)

Keywords: cannabis fibromyalgia phytocannabinoids cannabinoid
ciclesonide for the treatment of airway hyperresponsiveness

Conditions: Asthma

Summary: the study objective is to investigate in a placebo-controlled, double-blind manner the effect of inhaled corticosteroid (ciclesonide) on airway hyperresponsiveness measured as having pd15 mannitol. treatment medication will be administered as follows: 320 microgram ciclesonide or placebo will be inhaled once daily. the study duration consists of a treatment period of 4 weeks. the study will provide further data on safety of ciclesonide.


Eligibility criteria:
inclusion criteria: 1. referred to the pulmonology department of the university hospital basel because of suspected asthma defined as respiratory symptoms like wheezing or cough or chest tightness. 2. asthma symptoms partly controlled according to gina (october 2006) 1 week prior to randomization 3. fev1 ≥ 70% predicted 4. 18 - 70 years old exclusion criteria: 1. smoker and ex-smoker with \>10 pack years 2. copd 3. upper respiratory tract infection within the past 4 weeks. 4. ics or oral steroids during the previous month before inclusion 5. b-blockers within the past 4 weeks 6. current treatment with medication as defined in section concomitant medication (ics other than study medication, ß-blockers) 7. pregnancy 8. known malignancy

Keywords: asthma ciclesonide
feasibility of the modified confusion assessment method for the emergency department (mcam-ed)

Conditions: Delirium

Summary: delirium is common in older emergency department (ed) patients and often remains unrecognized. existing instruments to detect delirium are often time consuming and therefore not feasible in the busy ed setting in this study the investigators tested the feasibility of the newly developed modified confusion assessment method (mcam-ed).


Eligibility criteria:
inclusion criteria: * patients aged 65 or older exclusion criteria: * patients treated in the resuscitation room * patients transferred or discharged within 2 hours of arrival * patients with insufficient proficiency in the german language * patients with an inability to communicate (e.g. aphasic patients)
male fertility program

Conditions: Spinal Cord Injury

Summary: following spinal cord injury, most men are infertile and require medical assistance to father children. the conditions that contribute to their infertility are erectile dysfunction, ejaculatory dysfunction, and semen abnormalities. the miami project male fertility program is a research study designed to understand and improve impairments to male fertility resulting from spinal cord injury.


Eligibility criteria:
inclusion criteria: * any man with spinal cord injury over the age of 18. control subjects will be any healthy man over the age of 18 with no recent history of infertility exclusion criteria: * women will be excluded.

Keywords: abnormal semen assisted conception
differentiation of tubular adenoma and colonic innominate groove under ec endoscopy

Conditions: Endocytoscopy

Summary: this study is to analyze the characteristics of the iiil opening of the duct in tubular adenoma and the colonic innominate groove under ec endoscopy, in order to improve the ability to tell lesions and the colonic innominate groove under ec endoscopy (endocytoscopy).

this is a prospective cohort study. the recruitment time for all participants will be 4 months. the tubular adenoma group and the colonic innominate groove group will be paired in a 1:2 ratio, with 32 lesions of tubular adenoma and 64 adjacent innominate groove. it is expected that there will be 32 cases and a total of 96 observation subjects. analyze and compare the characteristics of the opening of the iiil duct in tubular adenomas and the colonic innominate groove under ec endoscopy, in order to summarize and differentiate them.

Eligibility criteria:
inclusion criteria: * cases of colorectal polyps discovered in our hospital and undergoing ec endoscopic examination. exclusion criteria: * 1.suffering from hereditary polyposis or inflammatory bowel disease, severe intestinal inflammation, or difficulty recognizing normal intestinal mucosa; 2. history of methylene blue allergy; 3. patients who have participated or are currently participating in other clinical trials within the first 4 weeks of enrollment;

Keywords: tubular adenoma iiil duct opening colonic innominate groove
measuring cyclotorsion on scanning laser ophthalmoscopy (slo)-fundus photographs

Conditions: Trochlear Nerve Diseases

Summary: pre-study: evaluation of the inter- and intrarater reliability of the integrated algorithm by heidelberg spectralis for measuring cyclotorsion on slo-fundus fotographs, and assessment of the influence of measuring with or without eye tracker. study: comparison of cyclotorsion measurements in patients with forth nerve palsy and in healthy controls on slo-fundus fotographs using the integrated algorithm by heidelberg spectralis


Eligibility criteria:
inclusion criteria: * ≥ 18 years old * best corrected visual acuity ≥ 0.8 exclusion criteria: * strabismus except for forth nerve palsy * previous strabismus surgery * monocle * best corrected visual acuity ≤ 0.6 * hyperopia or myopia \> 6dpt
treatment of dentin hypersensitivity using different desensitizing agents

Conditions: Dentin Sensitivity

Summary: treatment of dentin hypersensitivity using theobromine , remin pro , and combination of both materials


Eligibility criteria:
inclusion criteria: * patients that aged 18-50 years. * patients in good general health. * patients that have accessible teeth demonstrating signs of sensitivity. exclusion criteria: * • any chronic debilitating disease that could influence study outcomes. * partial dentures, orthodontic appliances, implants or restorations in a poor state of repair that could influence study outcomes. * intolerance or hypersensitivity to the study desensitizing agents or their ingredients. * desensitising treatment or tooth bleaching within 8 weeks of screening. * daily use of medications that might influence the perception of pain.(
pancreatic cancer genetics

Conditions: Pancreatic Cancer

Summary: the aim of this study is to determine the frequency of the three most common breast cancer gene 1 (brca1) and breast cancer gene 2 (brca2) genetic mutations that are commonly found in ashkenazi jewish patients with pancreatic cancer. testing for brca1 and brca2 mutations in relatives of hereditary pancreatic cancer patients may have a significant impact; allowing for early screening, treatment, and resection of pre-malignant tissue or malignant lesions.

pancreatic cancer is the fourth leading cause of death from malignancy in the united states. up to 15% of pancreatic cancers have a hereditary component. several gene mutations and cancer syndromes have been identified that are frequently found in greater frequency in individuals with pancreatic cancer, including the breast ovary cancer syndrome (brca1/brca2 mutations). no studies adequately describe the epidemiology of inherited pancreatic cancer and genetic risk factors that may modify the penetrance of brca1/brca2 mutations. the primary aim of this study is to determine the frequency of brca1 (185delag,5382insc) and brca2 (6174delt) mutations in ashkenazi jewish pancreatic cancer patients. secondary endpoints will include determining the individual frequency of these mutations and other disease-modifying mutations, death from any cause, disease-free survival, and stage of disease at time of presentation, differences in tissue pathology, risk factors, treatment decisions and development of metachronous malignancies. the investigator plans to study about 100 patients, which will enable the true frequency of the mutation to be estimated. although the impact of brca1/brca2 mutations will be initially studied in the ashkenazi population, these data will be widely applicable to other pancreatic cancer patients carrying brca1/brca2 mutations. testing for brca1 and brca2 mutations in relatives of hereditary pancreatic cancer patients may allow early screening, treatment, and resection of pre-malignant tissue or malignant lesions.

Eligibility criteria:
inclusion criteria: * patients diagnosed with pancreatic cancer. * patients are of ashkenazi jewish descent. * patients have been columbia pancreatic cancer prevention program registry and tissue bank for high-risk individuals (irb-aaaa6154). exclusion criteria: * inability to provide informed consent. * under the age of 18 years old.

Keywords: hereditary pancreatic cancer breast and ovarian cancer syndrome brca1/2 ashkenazi jewish patients
arsenic trioxide in treating patients with metastatic kidney cancer

Conditions: Kidney Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of arsenic trioxide in treating patients who have metastatic kidney cancer.

objectives: i. evaluate the efficacy of arsenic trioxide in patients with metastatic renal cell cancer. ii. determine the safety of this regimen in this patient population. outline: patients receive arsenic trioxide iv over 1-4 hours daily for 5 days. treatment continues every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity. patients are followed for at least 1 month. projected accrual: a total of 12-37 patients will be accrued for this study within 6-19 months.

Eligibility criteria:
disease characteristics: histologically confirmed metastatic renal cell cancer bidimensionally measurable disease no brain metastases patient characteristics: age: not specified performance status: karnofsky 70-100% life expectancy: greater than 3 months hematopoietic: wbc at least 3,000/mm3 absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin normal alt or ast no greater than 2.5 times upper limit of normal (uln) renal: creatinine no greater than 1.5 times uln (no greater than 1.95 mg/dl at mskcc) other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception during and for 4 months after study no other prior malignancy unless curatively treated and disease free for the past 5 years and considered low risk for recurrence prior concurrent therapy: biologic therapy: at least 4 weeks since prior biologic therapy and recovered no concurrent biologic therapy chemotherapy: at least 4 weeks since prior cytotoxic chemotherapy and recovered no other concurrent cytotoxic chemotherapy endocrine therapy: at least 4 weeks since prior hormonal therapy and recovered no concurrent hormonal therapy radiotherapy: at least 4 weeks since prior radiotherapy no concurrent radiotherapy surgery: at least 4 weeks since prior major surgery

Keywords: stage iv renal cell cancer recurrent renal cell cancer
impact of intermittent fasting and mediterranean diet on the physical health of the elderly

Conditions: Diabetes; Hypertension; Dyslipidemias; Obesity

Summary: the prevalence of chronic diseases is increasing globally. in recent years, intermittent fasting has emerged as an effective dietary pattern against some of the most common chronic diseases in the elderly, alongside the mediterranean diet. the objective was to determine whether a 12-hour daily intermittent fasting regimen combined with a mediterranean diet can improve analytical and anthropometric values in the elderly. a total of 17 individuals of both sexes, over 60 years old, autonomous, and with preserved cognitive capacity participated. they were randomly divided into two groups: 8 people in the intervention group performed intermittent fasting along with a mediterranean diet, and 9 in the control group adopted only a mediterranean diet. the intervention lasted 3 months, with measurements taken at the beginning and end of the intervention.


Eligibility criteria:
inclusion criteria: * over 60 years of age. * belong to the bombarda health centre. * preserved cognitive capacity. * autonomy for basic and instrumental activities of daily living. * ability to follow a trf and/or adopt a mediterranean dietary pattern. exclusion criteria: * underweight (bmi \<18.5). * serious or chronic uncontrolled disease. * specific treatment that could alter blood and/or anthropometric values. * poorly controlled type 1 or type 2 insulin-dependent diabetes mellitus. * present or past episode of eating disorder (ed). * high alcohol consumption.
a study of rls-0071 in patients with acute lung injury due to covid-19 pneumonia in early respiratory failure

Conditions: Acute Lung Injury; ALI; COVID-19

Summary: the aim of this study will test the safety, tolerability, and efficacy of rls-0071 for approximately 28 days in comparison to a placebo control in patients with acute lung injury due to covid-19 pneumonia in early respiratory failure. patients will be randomized and double-blinded for two parts, a single-ascending dose (sad) part and a multiple-ascending dose (mad) part. the name of the study drug involved in this study is: rls-0071.


Eligibility criteria:
inclusion criteria: * confirmed covid-19 based on positive sars-cov-2 viral rna pcr or antigen test. * hypoxemia. * radiographic evidence of opacification consistent with viral-related pneumonia. * weight less than 150 kg. * provide written informed consent. exclusion criteria: * endotracheal intubation and mechanical ventilation. * noninvasive positive pressure ventilation without endotracheal intubation. * requires chronic oxygen therapy. * treatment with conventional synthetic disease-modifying antirheumatic drugs (dmards)/immunosuppressive agents for ≥ 4 weeks duration within 3 months prior to the screening visit. * use of oral corticosteroids in a dose higher than prednisone 15 mg or equivalent per day for ≥ 4 weeks duration within 3 months prior to the screening visit. * systemic autoimmune disease. * participation in any clinical research study evaluating an investigational product or therapy within 3 months prior to the screening visit, * presence of any of the following abnormal laboratory values at screening: absolute neutrophil count \ 5 × upper limit of normal (uln), platelets \< 50,000/mm3. * d-dimer \> 2 × uln at screening, as evidence of potential disseminated intravascular coagulation (dic). * has confounding medical conditions, including poorly controlled diabetes, uncontrolled new york heart association class iii congestive heart failure, clinically significant arrhythmias not controlled by medication, idiopathic pulmonary fibrosis, interstitial lung disease, or chronic obstructive pulmonary disease. * has bacterial sepsis currently or suspicion thereof. * has cancer currently and is receiving active treatment (including radiation therapy or chemotherapy) or malignancy within the last 5 years, with the exception of curable cancer (eg, basal or squamous cell skin cancer, cervical cancer in situ, nonmedullary thyroid carcinoma) that has been adequately treated (eg, excision). * prior history of myocardial infarction or angina, stroke or transient ischemic attack (tia), pulmonary embolism or deep vein thrombosis. * is moribund and not expected to survive 48 hours following screening or for whom no further aggressive treatment such as mechanical ventilation is planned.

Keywords: acute lung injury sars-cov2 covid-19 covid-19 pneumonia early respiratory failure ali
t1dtechchw: enhancing the community health worker model to promote diabetes technology use in young adults from underrepresented minority groups

Conditions: Diabetes; Type 1 Diabetes; Young Adult; Diabetes Mellitus

Summary: the objective of this study is to test the early effects and implementation of an enhanced community health worker (chw) model (t1d-catch) that encourages and supports diabetes technology use in young adults from underrepresented minority groups (ya-urms) with type 1 diabetes (t1d). the investigators will conduct a 9-month randomized controlled trial in which ya-urms will be randomized to t1d-catch or usual care. the investigators will recruit from adult and pediatric endocrinology and primary care practices in a large safety-net health system in the bronx, new york. our specific aims are to 1) evaluate t1d-catch effects on technology initiation and continued use over 6 months and 2) evaluate t1d-catch implementation using proctor's taxonomy of implementation outcomes: feasibility, adoption, fidelity, and cost.

the study will involve a 9-month randomized control trial of usual care versus t1d-catch, an intervention that enhances core community health worker (chw) service roles to support increased use of t1d technology in young adults (underrepresented minorities)(ya_urm's). participants will be recruited from primary and specialty care practices at montefiore medical center in the bronx, ny, which is a large safety-net hospital system in one of the poorest counties in the u.s. two young adult-aged chws from the montefiore chw program will be trained extensively per our supporting emerging adults with diabetes (sead) program manuals. for ya-urms, chws will conduct hands-on diabetes technology education, goal-setting, peer support, and social service linkage. chws will also help shift insurance approval tasks away from busy providers and better align patient-provider priorities through close communication between the ya-urm and provider. group sessions will be optional and will follow the ya-centric education curriculum developed in dr. agarwal's supporting emerging adults with diabetes (sead) program.

Eligibility criteria:
inclusion criteria: * t1d duration ≥6 months * 18-35 years old * self-identified urm status: non-hispanic black or hispanic * english- or spanish-speaking * not currently on a connected diabetes technology system (includes never offered, prescribed but not started within 3 months of receiving the device, discontinued, or previously refused technology) exclusion criteria: * developmental or sensory disability interfering with study participation * current pregnancy * participation in another behavioral or diabetes technology intervention study in the past 6 months.
study of aavrh10-h.sgsh gene therapy in patients with mucopolysaccharidosis type iiia (mps iiia)

Conditions: Mucopolysaccharidosis Type IIIA

Summary: mps iiia is predominantly a central nervous system disease causing cognitive disability, progressive loss of acquired skills, behavioral and sleep disturbance. lys-saf302 is a gene therapy which is intended to deliver a functional copy of the sgsh gene to the brain. this is a phase 2-3 study to assess the efficacy in improving or stabilizing the neurodevelopmental state of mps iiia patients.

the study is interventional, single arm and multi-center. evolution under treatment will be compared to expected natural evolution based on natural history studies.

Eligibility criteria:
inclusion criteria: * documented mps iiia diagnosis based on genotyping confirming the sgsh gene mutations * cognitive dq score on bsid-iii: 50% and above exclusion criteria: * homozygous for the s298p mutation or non-classical severe form of mps iiia, based on investigator's judgement. * participation in another gene or cell therapy clinical trial. * past use of sgsh enzyme replacement therapy for a period exceeding 3 months. a washout period of at least 2 months is required prior to screening. * current participation in a clinical trial of another investigational medicinal product. * history of bleeding disorder or current use of medications that, in the opinion of the investigator, place them at risk of bleeding following surgery. * any condition that would contraindicate treatment with immunosuppressants such as tacrolimus, mycophenolate mofetil or steroids.

Keywords: mps iiia sanfilippo syndrome type a mucopolysaccharidosis type iiia lysosomal storage disease
sintilimab in combination with chemotherapy in neoadjuvant treatment of potentially resectable esophageal cancer

Conditions: Esophageal Squamous Cell Carcinoma

Summary: this study aims to investigate the safety and efficacy of sintilimab combined with platinum-based chemotherapy in neoadjuvant treatment of potentially resectable esophageal cancer.

this study was designed as an open-lable, single-arm, exploratory clinical study. sintilimab in combination with liposomal paclitaxel, cisplatin and s-1 will be given every 3 weeks to our patients for 2 cycles as neoadjuvant therapy. a radical dissection is scheduled within 6 weeks after last neoadjuvant treatment. this study will be devided for 3 phases: safety run-in, efficacy pilot and efficacy confirmation.

Eligibility criteria:
inclusion criteria: histologically or cytologically confirmed esophageal squamous cell carcinoma. the tumor is located in the middle or lower third of the esophagus ( more than 18cm below incisor), potentially resectable and requiring neoadjuvant therapy (t1b-3, nany, m0 or t4a, n0-1, m0). no prior treatment for this disease. eastern cooperative oncology group (ecog) performance status of 0 to 1. adequate bone marrow, liver, cardiac and renal function as assessed by the laboratory required by protocol. understand and voluntarily sign the informed consent(s). patients who are able to complete the treatment and follow-up according to the study plan. patients who have sufficient tissue samples and agree to provide their tissue samples and blood samples for detailed analysis. female patients in child bearing period must have evidence of negative pregnancy test and agree to take effective contraceptive measures during the study. exclusion criteria: patients who may develop tracheoesophageal fistula or aortoesophageal fistula. patients suffering from severe malnutrition or needing tube feeding. uncured patients with other malignancies within 2 years. patients who have active autoimmune diseases or patients who are undergoing treatment of autoimmune diseases. patients who need systemic glucocorticosteroid treatment (more than 10mg prednisone daily or other equivalent drugs) within 7 days before the neoadjuvant therapy or other immunosuppressive drugs. patients who have immune deficiency. patients with active viral or bacterial infection who need systemic treatment within 7 days before the neoadjuvant therapy. patients with uncontrolled diabetes mellitus. patients with interstitial pulmonary disease, noninfectious pneumonia, or pulmonary fibrosis. patients with preexisting symptoms of sensory or motor nerve damage (greater than grade 1, who) . patients who have received allogeneic organ or stem cell transplants. patients who are allergic to drugs or related ingredients in this study. patients who take part in clinical trials of other drugs or biological therapy at present. patients with any serious or unstable medical condition or mental illness. patients who are dependent on or addicted to alcohol or drugs.

Keywords: neoadjuvant esophageal cancer pd-1