Kornimate/medical-research-clean huggingface dataset:
preliminary human trial of npi-028

Conditions: Alcoholism

Summary: this research will determine whether the chinese herbal medicine (npi-028) can make a significant contribution to the management of withdrawal and to follow-up treatment aimed at preventing or managing relapse in both women and men alcoholics. the herbal preparation has been used historically in the treatment of alcohol intoxication and is still prescribed in china and southeast asia. efficacy has been documented but awaits the application of current research methods to establish efficacy, safety, and probable mechanisms of action. preclinical studies have been carried out in alcohol-preferring rats and vervet monkeys to test efficacy in reducing voluntary alcohol intake, measure tolerance effects, and toxicological affects. the proposed human trial will develop a placebo, establish quality control, test methods of administration, and examine compliance issues. following these preliminary steps, a placebo controlled trial will be conducted using 160 subjects (80 subjects per treatment condition with 40 of each gender). alcohol use, craving, health status, psychological status, and at rates will be assessed using established measures that are current in addiction research.


Eligibility criteria:
inclusion criteria: * able to participate as an outpatient * considered of acceptable health as determined by physical examination * english speaking/reading * meets dsm-iv criteria for alcohol dependence * have at least 10 drinking days in the past month
treating anorectal dysfunction in ms

Conditions: Constipation; Fecal Incontinence; Multiple Sclerosis

Summary: the investigators seek to test whether incorporating the scheduled dosing of a bisacodyl 10 mg rectal suppository every other day improves bowel-related symptoms in patients with multiple sclerosis. patients will be randomized to receive either a placebo suppository or bisacodyl suppository dosed every other day for 4 weeks.

the majority of patients with multiple sclerosis (ms) suffer from some form of anorectal dysfunction, and these difficulties with bowel function are often ranked as negatively impactful on quality of life as impaired mobility. despite the significant clinical burden of these symptoms, there remains a paucity of published literature supporting specific therapeutic options to manage anorectal dysfunction in this clinical population. most bowel regimens rely on either oral laxatives (i.e. peg-3350) or anti-diarrheal agents (i.e. loperamide). in their study, the investigators propose to establish the efficacy of a bowel regimen that combines both oral agents (as needed; standard care) with scheduled, every other day dosing of a placebo or stimulant laxative rectal suppository -- bisacodyl 10 mg. bisacodyl is a stimulant laxative medication that is available over-the-counter. it works by activating nerves in the rectum to elicit rectal contractions which ultimately leading to defecation.

Eligibility criteria:
inclusion criteria: * ms patients with mild to moderately severe disease (multiple sclerosis impact scale \[msis-29\] physical domain scores \<61 or equivalent extended disability severity score \[edss\] \< 6.5) of any age, gender, disease subtype, duration of illness, current use of ms disease modifying therapy, or comorbid medical condition and who also have anorectal dysfunction (chronic constipation and/or fecal incontinence) are eligible. exclusion criteria: * ms patients with severe disease (msis-29 physical domain scores greater than 61 or equivalently severe edss greater than 6.5), patients with surgically altered anorectal anatomy (i.e. proctectomy/partial colectomy, ostomy creation), active enteric infection (i.e., clostidium difficile), or inflammatory bowel disease (i.e. ulcerative proctitis, ulcerative colitis) will also be excluded.
to compare the efficacy and safety of low-dose glucocorticoids and tofacitinib in alleviating moderate to high disease activity rheumatoid arthritis for 24 weeks

Conditions: Rheumatoid Arthritis

Summary: glucocorticoids are effective in the treatment of rheumatoid arthritis, but long-term use of glucocorticoids has many side effects. tofacitinib is a new small-molecule drug targeting jak, which has been found to act quickly. the aim of this clinical trial was to investigate the efficacy and safety of tofacitinib and low-dose glucocorticoids in inducing remission in patients with rheumatoid arthritis with moderate to high disease activity.


Eligibility criteria:
inclusion criteria: 1. age 18-70 years; 2. met the 2010 acr and eular diagnostic criteria for rheumatoid arthritis (ra), and was diagnosed as ra; 3. after more than 3 months of initial treatment or conventional dmards treatment, the disease was still in medium-high disease activity, and das28-crp\>3.2; 4. no birth plan during and within 3 months after the end of the study; 5. voluntarily sign the informed consent form. exclusion criteria: 1. patients who are using or have used glucocorticoids, tofacitib and biological agents in the past 3 months; 2. at the time of screening, patients were in the acute phase of acute infection or chronic infection; 3. laboratory test results: hb\ 2 times the upper limit of normal value; renal function (scr) \> the upper limit of normal; 4. active gastrointestinal disease: gastrointestinal bleeding or active gastrointestinal ulcer and acute gastric mucosal injury diagnosed by gastroenteroscopy in the past three months; 5. a history of severe cardiovascular, cerebrovascular, kidney and other important organs, blood and endocrine system lesions, malignant tumors and thrombosis; 6. suffering from serious, progressive and uncontrolled diseases of other important organs and systems; 7. mental disease patients; 8. other conditions deemed unsuitable for trial participation by the investigator; 9. pregnancy tests of women of childbearing age were positive.

Keywords: rheumatoid arthritis, moderate disease activity, high disease activity
endometrial cell collection with the padkit

Conditions: Neoplasms

Summary: all patients will be provided with a preprogen pad to be worn for 4-6 hours to collect cells shed by the endometrium. after the kit is returned to the preprogen laboratory, a brief survey will be completed. analysis will be conducted to determine if the padkit™ can collect a sample of endometrial cells sufficient to differentiate between normal and atypical hyperplasia/malignant cells in blinded samples provided to the laboratory for analysis.


Eligibility criteria:
inclusion criteria 1. women who present to gynecologic oncology for surgical intervention and have not undergone prior hysterectomy. 1. cohort 1: has biopsy proven atypical hyperplasia or endometrial cancer. 2. cohort 2: women with planned hysterectomy for benign clinical indications exclusion criteria 1. unable to provide informed consent 2. women who have previously undergone uterine surgery (subtotal, or supracervical hysterectomy).

Keywords: endometrial cancer endometrial hyperplasia neoplasms atypical endometrial hyperplasia endometrial cells interlabial pad
collection of microbiome samples of healthy western donors for fundamental and functional microbiome research

Conditions: Microbial Colonization

Summary: large numbers of micro-organisms (especially bacteria) live in and on human bodies and have a very important function for the health. these microorganisms are called 'the microbiota'. they aid in the digestion of food, ensure the production of certain vitamins, and are very important for the development and regulation of the immune system. in many diseases (including crohn's disease, arthritis, obesity, diabetes and cancer), a disruption of microbial composition is observed. there are indications that a disruption of the microbiome can contribute to the development of inflammatory diseases and cancer, but the underlying processes are not sufficiently understood. to understand the mechanisms underlying these disease processes, fundamental research is conducted at ghent university. stool, skin, oral and vaginal samples from various origins are examined, e.g. from people from indigenous tribes with a traditional lifestyle. it is important that these samples can be compared with microbiome samples from healthy western (west-european) controls. in this study, the investigators want to build up a collection of samples from healthy donors between the ages of 2 and 70, with the exception of vaginal samples collected from women between the ages of 18 and 45. the samples will form the basis for further fundamental and functional research into microbiota-host interactions at ghent university.


Eligibility criteria:
inclusion criteria: * healthy * age between 2 and 70 years old * dutch speaking * west-european origin exclusion criteria: * diagnosis of chronic disease (such as osteoarthritis, rheumatoid arthritis, diabetes, crohn's disease, inflammatory bowel disease (ibd), asthma, copd, etc.) * antibiotics taken within 3 months before sampling
effect of kinesio taping on post-c-section pain and comfort

Conditions: C-Section

Summary: kinesio taping gently stretches the skin and creates a gap between the dermis and fascia, increasing lymphatic and vascular flow and reducing pain without restricting movement. it is used to provide rehabilitation after surgical operations. this study will be conducted to determine the effect of kinesio taping on the mother\&#39;s pain and comfort after cesarean section. it is planned to include 60 women who gave birth by cesarean section in the obstetrics and gynecology department at şırnak state hospital. research data will be collected with the visual analog scale and postpartum comfort scale. if the data shows normal distribution, unrelated samples t test, related samples t test and repeated measures anova (repeated measures) tests will be used.


Eligibility criteria:
inclusion criteria: * patients having c-section delivery in the 37th and 40th gestational weeks, * patients giving birth to just a baby, * patients with no chronic disease (such as allergy, diabetes, or hypertension), * patients having no problems with communication, * patients with no dermatological disease. exclusion criteria: * patients whose babies are in the neonatal intensive care unit, * patients with deep vein thrombosis, open wounds, or skin irritation, * patients who did not want to participate in the study,

Keywords: kinesio taping pain postpartum comfort
an evaluation of the commercially available medtronic resolute integrity zotarolimus-eluting coronary stent system

Conditions: Coronary Artery Disease

Summary: the purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available medtronic resolute integrity zotarolimus-eluting coronary stent system.

the purpose and objective is to assess the safety and efficacy of the resolute integrity stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter(rd) of 2.25mm to 4.2mm in two groups of patients, specifically those patients receiving stents less than or equal to 30mm in length.

Eligibility criteria:
general and angiographic inclusion criteria highlights: * acceptable candidate for percutaneous coronary intervention (pci),stenting, and emergency coronary artery bypass graft surgery * clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study * informed consent * patient agrees to comply with specified follow-up evaluations * single target lesion or two target lesions located in separate coronary arteries * de novo lesion(s) in native coronary artery(ies) * target lesion(s) ≤ 27 mm in length * target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm general and angiographic exclusion criteria highlights: * within 7 days of index procedure platelet count \ 700,000 cells/mm³; white blood cell (wbc) count \ 2.5 mg/dl * acute mi within 72 hrs of the intended trial procedure (qwmi or any elevation of creatine kinase-mb (ck-mb) \> lab upper limit of normal) * previous pci of target vessel(s) within 9 months prior to the procedure * planned pci of any vessel within 30 days post-index procedure and/or planned pci of target vessel(s) within 12 months post-index procedure * history of stroke or transient ischemic attack (tia) within prior 6 months * participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints * inability to comply with required trial antiplatelet regimen * previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent * target vessel(s) has/have other lesions w/ \> 40% diameter stenosis * unprotected left main coronary artery disease

Keywords: target lesion revascularization (tlr) target vessel revascularization (tvr) coronary artery disease myocardial infarction (mi) percutaneous coronary intervention (pci) stent thrombosis target lesion failure (tlf)
investigation of the role of the microbiome in the pathogenesis of colorectal adenoma and carcinoma

Conditions: Colorectal Adenoma and Carcinoma

Summary: the purpose of this study is the investigation of new host-microbiome interactions promoting adenoma formation and adenocarcinoma progression. for that purpose, the investigators will collect saliva, stool and colon biopsy specimens from patients referred to colonoscopy or surgical resection of colorectal tumor. besides, a questionnaire about diet, lifestyle and medical history will be collected. sample analysis will involve simultaneous characterization of host and microbiota genomic and transcriptomic components.


Eligibility criteria:
lower gi endoscopy patients inclusion criteria: * participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed * male or female, aged 18 years or above * referred to lower gi endoscopy. referral reasons can be among others: * positive fobt (fecal occult blood test) * follow up after polypectomy * screening because of age * bleeding * abdominal pain * familial or past history of colon cancer or adenoma * abnormal imaging such as barium enema * change in bowel habits * both self-referrals, referrals from external gp or specialists and internal referrals can be included. exclusion criteria: * previous diagnosis of an inflammatory bowel disease * previous diagnosis of intestinal polyposis syndrome crc patients inclusion criteria: * participant is willing and able to give informed consent for the participation in the study before any protocol-specific screening procedures are performed * male or female, aged 18 years or above * diagnosis of crc for which resection is planned * both internal and external referrals from specialists can be included exclusion criteria: * previous diagnosis of an inflammatory bowel disease * previous diagnosis of intestinal polyposis syndrome

Keywords: human gut microbiome colorectal cancer colorectal adenoma gut bacteria metagenomics metatranscriptomics
gloria-af registry program (phase ii/iii - eu/eea member states)

Conditions: Stroke; Atrial Fibrillation

Summary: in this part of the registry program patients with non-valvular atrial fibrillation (af) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. for administrative purposes the study is divided into two protocol numbers: 1160.129 for non-eu (european union) and non-eea (european economic area) countries, and 1160.136 for eu and eea countries. the total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.


Eligibility criteria:
inclusion criteria: 1. age =\>18 years at enrollment 2. male or female patient (or legally acceptable representative) willing and able to provide written informed consent 3. patient newly diagnosed (\< 3 months prior to baseline visit) with non-valvular af and at risk for stroke. other inclusion criteria apply. exclusion criteria: 1. presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention; 2. patients who have received more than 60 days of vitamin k antagonist (vka) treatment in their lifetime; 3. af with a generally reversible cause; 4. patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (for example, a vka) is indicated other exclusion criteria apply
frozen platelets in the treatmentof traumatic or vascular bleeding

Conditions: Trauma; Bleeding

Summary: primarily due to its logistical advantages the netherlands armed forces (nlaf) have been successfully using deep frozen (-80°c) platelets (dtc) for the treatment of (massive) bleeding trauma patients in austere environments since 2001. however, high-quality evidence for effectiveness and safety in the treatment of these type of patients is currently lacking. the massive transfusion of frozen blood (mafod) trial is therefore designed to compare the haemostatic effect of dtcs versus room temperature stored platelets (rsp) in the treatment of trauma- and vascular bleeding.


Eligibility criteria:
inclusion criteria: * patients of 12 years or older * alive at hospital presentation * requiring massive transfusion including platelets * signed (deferred) consent exclusion criteria: * known pregnancy

Keywords: trauma resuscitation platelets cryopreservation haemorrhage
gene mutations in non-small cell lung cancer cells

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: to compare the frequency of individual genetic abnormality between tumor cells and blood specimens.

samples will be collected before the systemic therapy. after initiation of therapy, samples will be collected at end of the 1st month, at the end of the 2nd month at the end of 3rd months and once every three months thereafter concurrently with the tumor assessment such as time of performing ct scans. in selected consented patients, peripheral blood samples will be collected every week for the first month. disease status will be assessed every 2\~3 months and at the end of treatment according to recist criteria. if progression is not observed at the end of therapy, patients will be assessed every 3 months until progression or further anti-cancer therapy. progression-free survival, overall survival and response rate will be reported.

Eligibility criteria:
inclusion criteria: * pathologic or cytological confirmation of nsclc. * patients must understand and provide written informed consent prior to initiation of any study-specific procedures. * have a life expectancy 3 months. * have malignant pleural/pericardial effusion or metastatic non-small cell lung cancer. * have measurable or evaluable disease. * ≥20 years. * candidate for systemic treatment such as egfr-tki or chemotherapy. exclusion criteria: * prior history of another malignancy (other than cured basal cell carcinoma of the skin or cured in-situ carcinoma of the cervix) within 5 years of study entry.

Keywords: genes mutation non-small cell lung cancer cancer cells
expression of th9 cells and poor/non-responsiveness to hepatitis b vaccination

Conditions: Hepatitis B

Summary: an observational study will be performed in subjects aged 3-65 years old to describe the dynamic changes of cellular immunity after vaccination of hepatitis b vaccine, and to find out the expression levels of th9 cells and il9 in subjects with different response to the primary immunization (3 single -dose injunctions).

this study selected 74 volunteers which had the hepatitis b vaccine (immunization programs 0,1,6) , anti-hbs≤10miu as the research subjects, and choose 20 volunteers which anti-hbs≥1000miu as the control group, revaccination the groups according to the normal immunization programs, then the blood samples would be collected at 7th day, separate the pbmc and detect the expression levels of th9 cells and il9 by fcm, trying to find out the effects of th9 and il9 of non/poor -responsiveness subjects to hepatitis b.

Eligibility criteria:
inclusion criteria: * volunteer * between 3-60 years old * healthy * have the history of vaccination of hepatitis b. * recent serological testing result show hbsag, hbeag, anti-hbe, anti-hbc, hbv dna and pre-s1 should be negative. * informed consent * not allergic to the component of the vaccine exclusion criteria:

Keywords: th9 cells il9 non/poor responsiveness to hepatitis b collect blood samples after vaccination
clinical assessment of insulin fast dissolving film in treatment of post infection anosmia

Conditions: Anosmia

Summary: the study aimed to investigate the efficacy of insulin in a new dosage form ( fast dissolving film) in treatment of anosmia in patients post infested with covid-19. the study implication based in two methods evaluations 1. threshold test 2. identification test.

this study was designed to improve smell disorders after corona infection that is very anxious for all patients. inclusion criteria were loss of smell, post covid-19 infection, age from 18 to 70 years and accept sharing and follow up. the application of dosage form by ent specialist at otorhinolaryngology clinic at minia university hospital. dose was 100iu of insulin 3 times weekly for 4 weeks. the new dosage form with insulin was compared with a placebo to ensure statistical improvement. the tests were performed in each visit. primary outcome was the improvement of smell sensors in those patients

Eligibility criteria:
inclusion criteria: * anosmia post covid-19 infection exclusion criteria: * nasal polyps or fractions or syrgery in nose from 6 months or less
a phase 3 clinical study of khk 4827

Conditions: Psoriasis Vulgaris; Psoriatic Arthritis; Pustular; Psoriasis, Palmaris Et Plantaris; Psoriatic Erythroderma

Summary: this study is designed to evaluate the safety and efficacy of long-term exposure to khk4827 in subjects with plaque psoriasis (psoriasis vulgaris, psoriatic erythroderma) who have completed study 4827-003 (study 003)and in subjects with pustular psoriasis (generalized) or psoriatic erythroderma who have completed the study 4827-004 (study 004).


Eligibility criteria:
inclusion criteria: * subject has voluntarily signed the written informed consent form to participate in this study * subject has completed the week 52 evaluation either in study 003 or 004 exclusion criteria: * subject has had a serious infection, defined as requiring systemic treatment with antibiotics or antivirals (excluding oral administration) * subject has been judged to be ineligible for participation in the study by the investigators/sub investigators