Kornimate/medical-research-clean huggingface dataset:
clinical study to evaluate the possible efficacy and safety of diosmin and hesperidin combined therapy in patients with helicobacter pylori infection

Conditions: Helicobacter Pylori Infection

Summary: this study intends to assess the possible effectiveness and safety of diosmin and hesperidin combination in patients with helicobacter pylori infection through evaluating its effect on stool antigen test and serum levels of inflammatory biomarkers as(tnf-a and mda).


Eligibility criteria:
inclusion criteria: * confirmed h. pylori infection through stool antigen test. * patients did not receive prior eradication therapy. * male and female. * age of 18-75 years old. * good mental well-being to clearly understand the study's objectives, advantages and procedures. exclusion criteria: * age less than 18 years. * patients with previous h. pylori eradication therapy. * patients with hypersensitivity/allergy to the study medications. * patients with history of using proton pump inhibitor, h2-blocker, antibiotics that affect h. pylori in the last month. * patients with history of using diosmin and/or hesperidin in the last month. * patients with history of gastric tumor or gastrointestinal (gi) surgery. * patients with concomitant severe disorders; cardiovascular, pulmonary, renal or hepatic, or active malignancy. * pregnancy or breastfeeding. * history of drug misuse or recent alcohol consumption. * patients with gall bladder disorders. * patients on blood thinning agents (warfarin, clopidogril, aspirin, etc), anticonvulsants (carbamazepine and phenytoin), muscle relaxants (chlorzoxazone) and nsaid (diclofenac) in order to avoid potential pharmacodynamic and pharmacokinetic drug interactions with diosmin. * patients on anti-inflammatory drugs and antioxidant drugs. * patients with inflammatory conditions (ulcerative colitis, rheumatoid arthritis, etc.). * patients with conditions associated with oxidative stress (smoking, copd, etc.).
use of sorafenib and/or regorafenib in liver cancer (hepatocellular carcinoma) subsequent to another systemic first-line treatment

Conditions: Hepatocellular Carcinoma

Summary: researchers already did trials that showed sorafenib and regorafenib worked for patients with hepatocellular carcinoma (most common liver tumor type). in this trial, they want to learn more about the same patient group in which sorafenib or regorafenib is given after other drugs. patients participating in this study will be observed until 12 months after the last patient has been enrolled to collect data on how safe the drugs are and how well they are working when used as second line or beyond treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of hepatocellular cancer in stage bclc-b or bclc-c * decision to initiate treatment with nexavar (sorafenib) and/or stivarga (regorafenib) as 2nd-line or beyond treatment was made as per investigator's routine treatment practice. stivarga (regorafenib) must be used according to its indication, i.e. after prior progression under nexavar (sorafenib) treatment. exclusion criteria: * patients concurrently participating in an investigational program for the treatment of hcc with interventions outside of routine clinical practice. * stivarga (regorafenib) treatment without prior therapy with nexavar (sorafenib). note: nexavar (sorafenib) treatment could have been given as treatment for hcc outside of this non-interventional study. in this case stivarga (regorafenib) would not constitute the second-line therapy after direct pretreatment with nexavar (sorafenib) but e.g. 3rd-line treatment directly after a different drug. * contra-indications according to the local marketing authorization.

Keywords: hcc liver cancer live cell carcinoma
safety and efficacy of botulinum toxin type a (botox®) to treat chronic migraine in korea

Conditions: Migraine Disorders; Headache

Summary: this study is a post-marketing surveillance study in korea to evaluate the safety and efficacy of botulinum toxin type a to treat chronic migraine in clinical practice.


Eligibility criteria:
inclusion criteria: * patients treated with botulinum toxin type a for chronic migraine in clinical practice. exclusion criteria: * none.
the association between adenomyosis/uterine myoma and lower urinary tract symptoms

Conditions: Adenomyosis; Uterine Leiomyoma

Summary: the aim of this study is to assess the relationship between adenomyosis/myoma and lower urinary tract symptoms, sexual function and gastrointestinal symptoms.

all outpatient patients were found to have \>3 cm uterine myoma or adenomyosis were invited to participate in this study. the size and location of uterine myoma or adenomyosis and the uterus should be assessed by ultrasonography. besides, all enrolled female patients will be asked to complete overactive bladder symptom score, female bladder function (udi-6 \& iiq-7), female sexual function index, and bowel incontinence assessment questionnaires. in addition, patients who underwent surgeries for myoma or adenomyosis will be requested to complete the above questionnaires at 3 months after surgery. women with intact uterus should be assessed again by ultrasonography. at least 30 women with age and body mass index matched and without uterine myoma or adenomyosis will be invited to participate in this study as the control group.

Eligibility criteria:
\ inclusion criteria: 1. \>20 years old. 2. myoma: women with \>3 cm uterine myoma 3. adenomyosis: women with uterus having several dark area (lacunar areas) in one uterine wall or thickening uterine wall \ inclusion criteria: 1. \>20 years old. 2. women without myoma or adenomyosis \ exclusion criteria: 1. the patient has a lower urinary tract infection or acute intestinal inflammation. 2. previous surgery for the bladder or urethra. 3. history of urinary tract stones or tumors.

Keywords: adenomyosis uterine myoma lower urinary tract symptoms sexual dysfunction gastrointestinal symptom
hpv screening (human papilloma virus)

Conditions: HPV Testing

Summary: examination of cervical \&urine samples for hpv

500 females attending colposcopy kasrelaini unit are included. history including age and parity is taken.urine samples are taken. colposcopy will be done. pap smear will be taken and sent for pathology.

Eligibility criteria:
inclusion criteria: * all females attending colposcopy kasrelaini unit aging 18_45 years exclusion criteria: * females with known cervical cancer * females less than 18 or more than 45
a cognitive-behavioral intervention for depression and anxiety in copd

Conditions: Depressive Disorders; Anxiety Disorders; Pulmonary Disease, Chronic Obstructive

Summary: the literature and our preliminary studies found that in copd patients, psychosocial factors affect quality of life (qol) and functioning more than would be expected given the severity of their disease. to improve qol and functioning in the approximately 50% of copd patients with significant anxiety and/or depressive symptoms, interventions are needed. much research documents the utility of cognitive behavioral therapy (cbt) in treating depression and anxiety, showing it to have promise as a self-management intervention to improve qol in copd patients.

background: the literature and our preliminary studies found that in copd patients, psychosocial factors affect quality of life (qol) and functioning more than would be expected given the severity of their disease. to improve qol and functioning in the approximately 50% of copd patients with significant anxiety and/or depressive symptoms, interventions are needed. much research documents the utility of cognitive behavioral therapy (cbt) in treating depression and anxiety, showing it to have promise as a self-management intervention to improve qol in copd patients. objectives: objectives were to compare cbt for anxiety and depression with copd education for copd patients with moderate-to-severe anxiety and/or depressive symptoms. methods: veterans were recruited from vamc clinics and through press releases. two hundred and thirty-eight copd patients with comorbid anxiety and/or depressive symptoms were randomized to either 8 weeks of cbt/usual care or 8 weeks of copd education/usual care. we hypothesized that copd patients receiving cbt/usual care would improve more than copd patients receiving copd education/usual care. improvement was defined as increased disease-specific qol, generic qol, and 6-minute walk distance; and decreased depression, anxiety, and health service use. outcomes were examined pre-, mid- and post-treatment and at 4, 8 and 12 months. status: the study was scheduled to officially end december 31, 2005, but was granted a no-cost extension by hsr\&d to complete data analyses and prepare final papers. the extension was granted through june 30, 2006. as of the date of this final report, the study is complete.

Eligibility criteria:
inclusion criteria: moderate depression or anxiety, copd exclusion criteria:

Keywords: cognitive behavioral therapy
effect of tetrabenazine on stroop interference in hd

Conditions: Huntington Disease

Summary: tetrabenazine has been shown to improve gating of abnormal visual stimuli and improve postural stability in huntington disease (hd) patients as measured by computerized dynamic posturography testing. this study aims to elucidate whether partial dopaminergic depletion via low dose tetrabenazine has a similar effect on masking out of abnormal visual stimuli on the stroop interference test.


Eligibility criteria:
inclusion criteria: * established diagnosis of huntington disease by movement disorders expert * patients currently taking tetrabenazine. * patients should not have taken dopamine receptor blocking medication for at least three days exclusion criteria: -

Keywords: huntington disease hd tetrabenazine stroop
the human papillomavirus (hpv) transmission pilot study

Conditions: Human Papillomavirus Infection

Summary: this transmission pilot study is a prospective study to determine feasibility of enrolling female partners into an international transmission study. companion study to mcc-13930.

we planned to enroll 150 female sexual partners, 75 per year for 2 years, of male study participants in the hpv infection in men (him) study. the enrollment period is from june 2006 through may 2008 and participants will be followed through may 2010. at all study visits participants will undergo interviews, a physical exam and laboratory analysis for hpv for a total of 5 clinical visits scheduled every 6 months over 2 years of follow-up. in addition, at each study visit, participants will provide blood for hpv antibody analyses. at enrollment, visit 3 and visit 5 a pap smear test will be done. at the enrollment visit, study participants will complete a questionnaire designed to assess social and behavioral risk factors for the acquisition of hpv. at each subsequent study visit, participants will be asked to provide updated information to assess changes in risk behaviors such as condom use, relations with new partners, and tobacco use.

Eligibility criteria:
inclusion criteria: * female partners of him study participants * report no abnormal pap smear during the past 6 months; * have not had a hysterectomy * have never been diagnosed with genital warts; * are not pregnant; * residents of southern florida; * are not and have not been enrolled in an hpv vaccine trial; * willing to comply with scheduled visits every 6 months for 2 years. exclusion criteria: * do not meet the inclusion criteria.

Keywords: hpv human papillomavirus infection cervix uteri cancer control risk assessment, detection & intervention sexually transmitted neoplasia carcinogenesis cervix
adaptation to nocturnal noninvasive ventilation in patients with chronic respiratory failure (roomila)

Conditions: Chronic Respiratory Failure

Summary: background: adaptation to noninvasive ventilation (niv) is a critical step for acceptability and efficacy of this treatment during sleep in patients with chronic respiratory failure. aim: to study the variability of patient-ventilator interactions during the first nights after initiation to niv. recorded data will be analyzed in part by dedicated tools from the non-linear dynamics theory. patients and methods: patients with chronic respiratory failure at stable state and indicated to home niv will be included. all patients will perform three polysomnographies (under spontaneous breathing at d1 and under niv at d2 and d15 after niv initiation). all ventilatory physiological data (pressure, flow, patient-ventilator interactions, oxygen saturation, non intentional leaks) will be recorded during sleep under niv in the sleep laboratory of the department and secondarily related to sleep architecture and quality of sleep. expected results: this study will identify objective parameters that are associated to a satisfactory adaptation to nocturnal niv.


Eligibility criteria:
inclusion criteria: * chronic respiratory failure with indication to domiciliary niv according to the international guidelines. exclusion criteria: * decompensated respiratory failure attested by a ph \<7.35, * modification of respiratory symptoms during the four previous weeks, including signs of broncho-pulmonary infection, * respiratory frequency \>30/min.

Keywords: chronic respiratory failure noninvasive ventilation patient-ventilator interactions sleep sleep fragmentation
supportive clinic for patients living with advanced and metastatic cancers

Conditions: Cancer; Physical Symptom Distress

Summary: to conduct a feasibility trial to examine the feasibility and acceptability of conducting a randomized controlled trial that evaluates the effect of the survivorship care intervention on patient-reported outcomes, defined as symptom distress and health-related quality of life.

the primary aim of this study is to examine the feasibility and acceptability of conducting a randomized controlled trial (rct) that evaluates a community-based survivorship care intervention to reduce symptom distress and improve health-related quality of life and self-management efficacy among patients with advanced or metastatic cancer. no hypothesis was proposed for this feasibility trial as the current consolidation standards of reporting trials (consort) guidelines for reporting feasibility trials do not recommend hypothesis testing of clinical outcomes. the rationale is that pilot trials are often underpowered to detect differences, and this should be the aim of the main trial.

Eligibility criteria:
inclusion criteria: * patients diagnosed with advanced or metastatic cancer * are at least 18 years of age * physically able to attend the supportive clinic. exclusion criteria: * participants will be excluded from the study if they are non-cantonese-, non-mandarin-, or non-english-speakers.

Keywords: physical symptom distress self-efficacy in managing cancer health-related quality of life survivorship intervention advanced cancer randomised controlled trial psychooncology
manual therapy and exercises applied to cervical spine in patients with temporomandibular disorders

Conditions: Temporomandibular Joint Dysfunction Syndrome

Summary: the objective of this study was to investigate the effect of a manual therapy and exercise program, focused on the rehabilitation of cervical function, on clinical signs and mandibular function in subjects with tmd.

temporomandibular disorder (tmd) is a general term that refers to disorders associated with the temporomandibular joint (tmj) and the masticatory muscles. among the main symptoms are pre-auricular pain (in the region of the tmj) and/or pain in the masticatory muscles. it's usual to observe that subjects with tmd also present cervical alteration. beside this, cervical postural alterations produced by muscle tension can influence mandibular position. the intervention protocol was based on manual therapy, stabilization exercises and stretching. the technique are:. 1. upper cervical flexion mobilization; 2. c5 central posterior-anterior mobilization; 3. stabilization exercise: cranio-cervical flexor stabilization exercise 4. stretching of muscles: upper trapezius, scalenes, semispinalis capitis; splenius capitis, sternocleidomastoid

Eligibility criteria:
inclusion criteria: * patients diagnosed with myogenic or mixed temporomandibular disorders exclusion criteria: * patients diagnosed with arthrogenic or discogenic temporomandibular disorders

Keywords: stomatognathic diseases; temporomandibular joint dysfunction syndrome
epigenetic memory of vitamin d supplementation

Conditions: Immune System Diseases; Infections; Healthy Lifestyle

Summary: the investigators will study the mechanistic details of dietary programming of the epigenome at the example of epigenetic programming of primary human immune cells with the micronutrient vitamin d3. they will follow a small number of healthy adult volunteers individually over time while measuring per individual a large number of molecular and dynamic parameters that will be used for mechanistic modeling. the main hypothesis of the investigators is that nutritional components, such as vitamin d3, have a direct effect on the epigenome of the different cell types of the immune system. using complementary in vivo, in vitro and in silico approaches, they will investigate the mechanistic basis of this dietary epigenetic programming process and how it creates memory.

exposure to dietary molecules during adulthood creates an epigenetic memory in immune cells affecting disease risk in later years of life. many nutritional molecules have a direct effect on the human genome and/or epigenome, since they (or their metabolites) activate transcription factors or chromatin modifiers. this process is the mechanistic basis of the discipline nutrigenomics. thus, the daily diet of humans leads to changes in the transcriptome and epigenome of many tissues and cell types. in this way, many physiological functions of the human body, such as a well-responding immune system, are influenced by diet. some of these effects are not only transient but may lead to persistent changes of the epigenome in many different tissues. however, the mechanistic details of this dietary programming of the epigenome are not well understood. therefore, in this study, the investigators will study this process at the example of epigenetic programming of primary human immune cells with the micronutrient vitamin d3. they will use the approach to follow a small but sufficient number of healthy adult volunteers (based on power calculation of self-controlled longitudinal studies) individually over time while measuring per individual a large number of molecular and dynamic parameters that will be used for mechanistic modeling, instead of investigating only few parameters from a large number of participants for statistical modeling. the main hypothesis of the investigators is that nutritional components, such as vitamin d3, have a direct effect on the epigenome of the different cell types of the immune system. using complementary in vivo, in vitro and in silico approaches, they will investigate the mechanistic basis of this dietary epigenetic programming process and how it creates memory.

Eligibility criteria:
inclusion criteria: -healthy adult (18-65 years) exclusion criteria: * smoker * bmi \> 28 kg/m2 * history of kidney stones, renal failure or dialysis, hypercalcemia, hypo- or hyperparathyroidism, severe liver disease (cirrhosis), or sarcoidosis or other granulomatous diseases, such as active chronic tuberculosis or wegener's granulomatosis

Keywords: vitamin d epigenome transcriptome
first-in-man study: safety and efficacy of inc-1 bare metal stent in the novo coronary lesions.

Conditions: Stents; Coronary Artery Disease; Angioplasty; Humans; Coronary Angiography; Angioplasty, Balloon, Coronary; Treatment Outcome

Summary: this is a first in man study with the aim to know the safety and effectiveness of a novel bare metal stent (inc-1) in the treatment of de novo coronary lesions in patients with stable coronary angina and unique coronary lessions.

the cost of performing a percutaneous coronary intervention is very variable since a large number of materials and human resources are considered, with the stent cost being a fundamental factor; in developing countries, the cost this technology represents an important expense for the patient and the health system; which promotes the development of local technology to support the requirement of these devices. ischemic heart disease together with cerebral vascular events is the main cause of, adding 15 million deaths per year. percutaneous revascularization is the gold standard choice in many of the variants of presentation of ischemic heart disease, the implantation of stents is the most used method. nowadays more and more countries start their own research and development of novel devices in order to reduce cost. research question: is the inc1 bare metal stent safe and effective for the treatment of de novo coronary lesions in humans? hypothesis: the inc1 bare-metal stent is safe and effective for the treatment of de novo coronary lesions in humans the inc1 bare metal stent is a 70ucocr

Eligibility criteria:
inclusion criteria: * both genders. * from 18 to 75 years * stable ischemic heart disease. * live less than 300 km from the institution * single coronary artery disease with a single coronary lesion * stenosis of 50 to 90% of the lumen of the vessel to be treated. * lesions less than 20 mm long * reference lumen of the vessel to be treated greater than 2.5mm and less than 4.5mm exclusion criteria: * left main disease. * lesions greater than 90% of the lumen. * non-dilatable lesion with conventional balloons. * contraindication for dual antiplatelet therapy. * creatinine clearance less than 45ml / min. * calcification from moderate to severe. * multivessel coronary artery disease. * chronic total occlusion. * cardiogenic shock or hemodynamic instability. * left ventricular ejection fraction less than 30%. * valvular disease of moderate to severe. * coronary disease in bifurcation. * probable or definite presence of thrombus in the lesion.
impact of tachycardia on outcome after subarachnoid hemorrhage (sah)

Conditions: Subarachnoid Hemorrhage (SAH); Tachycardia

Summary: the purpose of this retrospective study is to test the hypothesis that uncontrolled tachycardia serves as a risk factor for adverse cardiovascular events and poor outcome after subarachnoid hemorrhage (sah).

the design of the current study will be to conduct a retrospective analysis of prolonged heart rate and uncontrolled tachycardia using patients enrolled in the investigators prospective observational cohort study since the electronic medical record systems have been implemented. the investigators know that there have been periods when these electronic systems have failed, resulting in lost data. the investigators anticipate retrospective collection of hourly heart rate for approximately 400 sah patients that will have icu data and 3 month modified rankin documented in our subarachnoid hemorrhage outcomes project (shop) database. the investigators will determine what percent of them have prolonged elevated heart rate and tachycardia. prolonged heart rate and uncontrolled tachycardia has been defined as a heart rate greater than 95 for greater than 12 hours in one 24 hour period of their icu stay. the investigators will conduct a roc curve analysis to determine the appropriate heart rate and duration thresholds that are most predictive of poor prognosis after sah. patients be will stratified based on several criteria including admission coma score, early (sah day 0 to 3) or late (sah day \>=4) icu admission, presence of intraventricular hemorrhage on admission ct, history of beta-blocker usage, age, and gender.

Eligibility criteria:
inclusion criteria: * age \>=18 years * diagnosis of subarachnoid hemorrhage established by computed tomography (ct scan) or xanthochromia of the cerebrospinal fluid if the ct is negative * written informed consent from either the patient or a family member * admitted to the nicu for at least 12 hours exclusion criteria: * age \< 18yrs * traumatic sah * sah due to a rupture of an arteriovenous malformation, neoplasm vasculitis or other secondary causes

Keywords: subarachnoid hemorrhage (sah) tachycardia outcome