Kornimate/medical-research-clean huggingface dataset:
age-dependent effects of flavanols on vascular status

Conditions: Cardiovascular Diseases

Summary: epidemiological studies suggest that certain foods rich in flavanols, including cocoa products, red wine, and tea, are associated with decreased cardiovascular mortality and morbidity. dietary interventional studies have corroborated this finding and showed that flavanols can acutely and after sustained ingestion improve surrogate markers of cardiovascular risk including endothelial function. endothelial dysfunction is the key event in the development and progression of cardiovascular disease. aging is the major non-modifiable cardiovascular risk factor associated with progressive decline in endothelial function, vascular stiffening and increase in blood pressure. we hypothesize that flavanols can counteract age-dependent vascular changes by interacting with key mechanisms, most prominently endothelial function.


Eligibility criteria:
inclusion criteria: * healthy male participants between 18-35 years * healthy male participants between 50-80 years exclusion criteria: * acute inflammation * cardiac arrhythmia * renal failure * heart failure (nyha ii-iv) * diabetes mellitus * crp \> 1 mg/dl * malignant disease

Keywords: flavanols age related cardiovascular effects
efficacy of n-acetylcysteine to prevent anti-tuberculosis drug-induced liver injury: a randomized controlled trial

Conditions: Tuberculosis; Drug Induced Liver Injury; Hepatitis

Summary: to determine the efficacy of nac to prevent clinically significant anti-tb drugs induced liver injury (at-dili).

tuberculosis is one of the most important infectious diseases and treatment related hepatitis from anti-tb drug was observed for 5-28%. slow acetylator status in the n-acetyltransferase 2 (nat2) genotype is a significant risk factor of anti-tuberculosis drug-induced liver injury (at-dili). we assessed the effect of n-acetylcysteine to prevent hepatitis from anti-tb drug in thai population.

Eligibility criteria:
inclusion criteria: * newly diagnosed tb * received standard dose of anti-tb drugs regimen (national tuberculosis control programme guideline thailand 2018) * aged ≥18 years * informed consent exclusion criteria: * previous tb infection or mdr tb * tb liver * allergy to nac * abnormal baseline lft * (ast or alt\>2.5 times unl, alp\> 2 times unl, tb\> 1.5 mg/dl) * chronic hepatitis b, c infection * decompensated cirrhosis * hiv infection * active malignancy * pregnancy or lactation * severe co-morbidity i.e. severe heart diseases, severe lung diseases, esrd

Keywords: tuberculosis dili anti tuberculosis
how much cardiac output is enough?

Conditions: Low Cardiac Output Syndrome

Summary: low output syndrome is a common complication in patients undergoing cardiac surgery. its incidence was reported to be 2 to 6% \[1\]. morbidity and mortality of low output syndrome is high and the costs for treating the disease are immense. the primary objective of this prospective observational study is to define a threshold for a critically reduced cardiac output requiring immediate therapy.

low output syndrome is a common complication in patients undergoing cardiac surgery. its incidence was reported to be 2 to 6% \[1\]. in patients suffering from low output syndrome cardiac output is severely reduced due to myocardial failure. among other reasons for myocardial failure, ischemia, insufficient myocardial protection during aortic cross-clamping, and severely reduced ventricular function prior surgery are the most common risk factors for low output syndrome. low output syndrome is treated with positive inotropic drugs and mechanical assist devices \[2\]. morbidity and mortality of low output syndrome is high and the costs for treating the disease are immense. if cardiac output cannot be increased cardiac failure persist and vital organs are hypoperfused. critical and prolonged hypoperfusion results in single and multi organ failure. until today a definite threshold for a critically reduced cardiac output or cardiac index requiring immediate therapy is not completely known. cardiogenic shock is diagnosed by clinical signs and it is not diagnosed by cardiac output or cardiac index. the critical value for a severely reduces cardiac index was reported to be in a range of 1.75 to 2.5l/min/m² \[3-5\]. the primary objective of this prospective observational study in 600 patients undergoing cardiac surgery is to try to define a threshold for a critically reduced cardiac output or cardiac index requiring immediate therapy. if cardiac output and cardiac index are not reduced below a critical threshold, morbidity, mortality, and length of stay in the intensive care unit and in the hospital are reduced \[6\].

Eligibility criteria:
inclusion criteria: * patients undergoing cardiac surgery, * written informed consent exclusion criteria: * missing consent

Keywords: cardiac surgery low cardiac output syndrome mortality morbidity
treximet (formerly known as trexima) for the acute treatment of probable migraine (ichd-ii 1.6.1)

Conditions: Migraine, Without Aura

Summary: this study was designed to determine the efficacy and tolerability of treximet (formerly known as trexima) compared to placebo for the acute treatment of probable migraine, a sub-type of migraine.


Eligibility criteria:
inclusion criteria: * at least a 6 month history of probably migraine (6 migraine attacks per month) * males and women of childbearing potential on a adequate contraception. exclusion criteria: * physician diagnosis of migraine; history of triptan or ergot use; history of headache prophylaxis use * pregnant and/or nursing mother * history of cardiovascular disease. * uncontrolled hypertension. * basilar or hemiplegic migraine * history of stroke or transient ischemic attacks (tia). * history of epilepsy or treated with anti-epileptics within the past 5 years. * impaired hepatic or renal function. * history of gastrointestinal bleeding or ulceration. * allergy or hypersensitivity to aspirin or any other nsaid. * allergy or hypersensitivity to triptans. * participated in an investigational drug trial in the previous 4 weeks.

Keywords: sumatriptan succinate, naproxen sodium, parallel group, double-blind, placebo-controlled, combination product, migrainous headache probable migraine, a sub-type of migraine probable migraine,
efficacy and safety of different doses of venus association in patients with vulvovaginal candidiasis.

Conditions: Vulvovaginal Candidiasis

Summary: the purpose of this study is to evaluate the efficacy and safety of different doses of venus association in the treatment of vulvovaginal candidiasis.


Eligibility criteria:
inclusion criteria: * ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; * age greater than or equal to 18 years; * female participants, post-menarche; * clinical diagnosis of vulvovaginal candidiasis, defined as white, fluid or creamy vaginal discharge, in addition to the following findings: * itching and one or more of the following signs and symptoms characterized as moderate or severe: vulvar/vaginal erythema, edema, burning, irritation, and excoriation; * normal vaginal ph; * preparation of koh or saline from a sample taken from inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or growing yeast. exclusion criteria: * any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; * participation in a clinical trial in the year prior to this study; * pregnancy or risk of pregnancy and lactating patients; * known hypersensitivity to any of the formula compounds; * virgin participants; * postmenopausal participants or with vaginal atrophy; * participants with other vaginal infections; * participants with recurrent vulvovaginal candidiasis; * participants using immunosuppressive drugs; * participants diagnosed with serious systemic diseases.

Keywords: vulvovaginal candidiasis
oral manifestations of human immunodeficiency virus infection in high risk groups

Conditions: HIV Infections; Candidiasis, Oral

Summary: objectives: i. evaluate the development of oral manifestations of human immunodeficiency virus infection in relationship to the onset of immunologic alterations and systemic symptoms in different risk groups: gay/bisexual men, male intravenous drug users, and female intravenous drug users. ii. evaluate the immune and inflammatory response to periodontal and other microbial pathogens. iii. evaluate the bacterial species infecting the oral cavity in patients in these risk groups.

protocol outline: patients undergo a periodontal assessment every 6 months until medically unable to continue. the oral/dental exam includes saliva and gingival crevicular fluid analysis and, as indicated, oral photographs.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- human immunodeficiency virus infection (hiv) seropositive or seronegative at risk for hiv, i.e.: gay/bisexual men male intravenous drug users female intravenous drug users no acquired immunodeficiency syndrome currently enrolled in columbia presbyterian medical center protocol "the natural history and progression of hiv infection"

Keywords: hiv-associated candidiasis candidiasis disease-related problem/condition fungal infection immunologic disorders and infectious disorders infection rare disease
the effect of diabetes coaching on distress and diabetes self-management

Conditions: Diabetes Mellitus, Type 2

Summary: this research is a randomized controlled, experimental study planned to evaluate the effect of diabetes coaching on diabetes self-management, glycosylated hemoglobin and diabetes distress levels in individuals with type 2 diabetes. the research is planned to start on 01.01.2024. participants will be divided into experimental and control groups using the block randomization method. participants in the experimental group will first receive 8 sessions of diabetes coaching every 10 days after the chemistry interview. no intervention will be made to the control group. the preliminary implementation of the research will be carried out with 4 individuals with diabetes who voluntarily accept participation and meet the inclusion criteria. data will be collected by face-to-face interview method. data will be analyzed with ibm spss v23 program.

diabetes is a chronic and metabolic disease that develops when the body cannot secrete enough insulin or the cells cannot use insulin as they should, causing damage to many tissues and organs. it is estimated that there are 537 million adults aged 20-79 in the world with diabetes and this number will reach 783 million in 2045. diabetes distress, which is one of the most common mental concerns in individuals with diabetes, makes it difficult to achieve glycemic control, paves the way for the development of diabetes complications and reduces the quality of life. diabetes distress also causes an increase in the risk of mortality and morbidity. one of the best ways to prevent or reduce diabetes distress is to provide self-management skills and support. in recent years, health coaching has attracted attention in many countries for improving patients' self-management and providing the necessary behavioral change. in this study, the effect of coaching intervention applied to individuals with diabetes on diabetes self-management, hba1c and diabetes distress will be investigated.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study, * having been diagnosed with type 2 diabetes for at least 1 year, * being between the ages of 18-65, * no communication problems, * being literate, * being able to use a phone (home or mobile phone), * lack of diagnosis of psychiatric disease, * not receiving hospital treatment due to acute problems, * not to be involved in another study involving a similar intervention during the research period exclusion criteria: * being diagnosed with type 1 diabetes, * type 2 diabetes diagnosis period is less than one year, * being under 18 years of age, over 65 years of age, * being pregnant, * having a diagnosis of psychiatric disease, * not agreeing to participate in the research

Keywords: diabetes coaching self management diabetes distress
quality of life assessment of patients receiving treatment for esophageal cancer [companion to calgb-9781]

Conditions: Esophageal Cancer

Summary: rationale: questionnaires that measure quality of life during treatment may improve the ability to plan treatment for patients with esophageal cancer. purpose: this clinical trial is studying the quality of life in patients receiving treatment for esophageal cancer.

objectives: i. evaluate the quality of life of patients with esophageal cancer randomized on protocol calgb c9781 to treatment with surgery alone vs trimodal therapy combining preoperative chemotherapy and radiation therapy in addition to surgery. ii. examine the incremental cost and cost effectiveness of preoperative chemotherapy and radiation therapy in the treatment of esophageal cancer. iii. examine the incremental cost per quality-adjusted life year (qaly) of preoperative chemotherapy and radiation therapy in the treatment of esophageal cancer. outline: this is a companion study to calgb c9781, a phase iii randomized study. prior to treatment on calgb c9781, patients complete forms assessing quality of life, psychological functioning, specific areas of dysfunction, resource use, and time lost from work; subsequent assessments are completed by telephone interview at 1, 2, 6, 12, 18, and 24 months after the initiation of study treatment, regardless of disease status (patients with hearing impairment and those speaking only a translatable foreign language may mail responses). patients also keep a diary of medical resource utilization at sites other than the treating institution.

Eligibility criteria:
1. patients with histologically documented untreated squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm) or gastroesophageal junction and with less than 2cmdistal spread into the gastric cardia eligible for c9781. 2. there could be no evidence of distant metastatic disease by history and physical examination; upper endoscopy with biopsy, computed tomography (ct) of the chest and upper abdomen, and pulmonary function studies were all required. 3. tumors had to be considered surgically resectable (t1-3, nx), including regional thoracic lymph node (n1) metastases. 4. patients with supraclavicular lymph nodes measuring ≤1.5 cm by ct (not palpable) were eligible, as were patients with lymph node metastases to levels 15 to 20 (predominantly celiac axis and paracardial nodes) ≤ 1.5 cm by ct. 5. patients could not have previously received chemotherapy or radiation therapy for this tumor or any radiation therapy that would overlap the radiation fields required for this malignancy. patients with previous malignancies were eligible if more than 5 years had elapsed from diagnosis without evidence of tumor recurrence. 6. there could be no other serious illness that would limit survival to less than 2 years, or psychiatric condition that would prevent compliance with treatment or informed consent. 7. patients with uncontrolled or severe cardiovascular disease, pulmonary disease, or active infections were excluded, as were pregnant patients.
psychological well-being of patients awaiting for cardiac surgery during the covid-19 pandemic

Conditions: Anxiety and Fear; Anxiety Depression; Anxiety Postoperative; Psychological Stress

Summary: the effect and impact of postponing cardiac surgery / creating a waiting list as a result of covid-19 on patients, both psychologically and symptomatically on three groups of patients: 1. the degree of anxiety and/or depression induced by their altered medical care trajectory. 2. the incidence of medical problems induced by deferred elective surgery or delayed postoperative ambulatory visit 3. the occurrence of reduced access to medical and psychological help

a prospective study by means of a questionnaire, specifically designed for each of the three groups. 1. adult patients whose operation date has been deferred 2. patients who did not have had an operation date 3. patients who have been operating on during the month before each group will receive a twofold questionnaire: part i: hospital anxiety and depression scale (hads), a robust questionnaire used for hospitalized and non-hospitalized patients gauging the degree of anxiety and/or depression, irrespective of their specific medical condition. all three groups receive the same list of questions. -part ii: a questionnaire made up specifically for issues concerning the medical/psychological/access aspects during the covid-19 outbreak. each of the three groups will receive a questionnaire, adapted to the group they are assigned to. the questionnaires will be delivered by the use of qualtrics or on paper. timing and mode of presentation (qualtrics or fill-in paper on admission) of the questionnaire will depend on the length of the quarantine measures.

Eligibility criteria:
inclusion criteria: all adult patients whose operation date has been deferred due to the pandemic covid-19. all patients who did not have had an operation date before the pandemic covid-19. all patients who have been operating on during the month before the pandemic covid-19. exclusion criteria: n/a

Keywords: cardiac surgery postoperative consultation postponed elective surgery covid-19
a pilot study of celtx(tm) (apligraf®) in the treatment of gingival recession requiring root coverage

Conditions: Gingival Recession

Summary: the purpose of this study is to evaluate celtx as an alternative to tissue from the palate in the treatment of subjects with miller class i or ii recession defects who desire root coverage. it is anticipated that this study will demonstrate that celtx is a safe alternative to palatal tissue and demonstrate potential to enhance oral soft tissue regeneration and wound healing.


Eligibility criteria:
inclusion criteria: * subject is at least 18 years of age but no more than 70 years of age. * subject has at least two non-adjacent teeth in contralateral quadrants of the same jaw with miller class i or ii buccal recession (≥ 3 mm) that requires soft tissue grafting. (teeth may be treated with a maximum difference of 2 mm with respect to depth and width). * females of childbearing potential must have a documented negative urine pregnancy test and must agree to continue acceptable methods of contraception for 6 months post surgery. * subjects must have read, understood and signed an institutional review board (irb)-approved informed consent form (icf). * subjects must be able and willing to follow study procedures and instructions. exclusion criteria: * subject has extremely prominent root surfaces (\> 1/2 the diameter of the root facial to cortical plate). * subject has interproximal attachment loss beyond the cej. * subject with teeth that have a miller grade 2 or higher mobility. * subjects with class v restorations. * subjects with crowns on the teeth selected for treatment. * subjects who have had endodontic therapy in the last 6 months on the teeth selected for treatment. * subjects who have used any tobacco product within the past 3 months. * subjects with only molar teeth suitable for soft tissue grafting. * subject has probing pocket depth \>/= 4 mm at either surgical site. * female subjects who are pregnant or lactating. * subjects with any systemic conditions (i.e., uncontrolled diabetes mellitus, cancer, hiv, bone metabolic diseases) that could compromise wound healing and preclude periodontal surgery. * subjects who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery. * subjects with the presence of acute infectious lesions. * subjects taking intramuscular or intravenous bisphosphonates. * subjects with a known hypersensitivity to bovine collagen and/or iodine (shellfish allergy). * subjects who have received an investigational drug, device or biological/bioactive treatment within 30 days prior to study enrollment (medical or dental). * subjects previously treated with apligraf/celtx, dermagraft or any other cell-based product, including autologous tissue at the target site(s) or immediately adjacent teeth. * subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol
cameroon mobile phone sms trial

Conditions: Adherence; HIV

Summary: the investigators hypothesize that sending weekly motivational text messages to people infected with hiv will encourage them to take their medication, compared to usual care.


Eligibility criteria:
inclusion criteria: * on haart for at least 1 month * 21 years or more * owns a mobile phone * can read text messages exclusion criteria: * on haart for less than 1 month * aged less than 21 years

Keywords: compliance observance mobile phone sms text message arv haart aids
immunogenicity and safety of meningococcal vaccine gsk134612 given as 1 or 2 doses to healthy 9-12 months old toddlers.

Conditions: Infections, Meningococcal

Summary: the purpose of the study is to characterize the safety and immunogenicity of 1 dose of gsk134612 vaccine at 12 months of age and of gsk134612 vaccine administered as 2 doses at 9 and 12 months of age.

the protocol posting has been amended to reflect changes as a consequence of an amendment to the protocol and also to comply with the fda amendment act, sep 2007. sections impacted are brief title, official title of the study, brief summary, key inclusion \& exclusion criteria.

Eligibility criteria:
inclusion criteria: * subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol * a male or female of 9 months of age (has not attained 10 months of age) at the time of enrollment. * up to date on vaccinations based on acip recommendations and the standard practice at the investigational site. * written informed consent obtained from parents/guardian of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding enrollment, or planned use during the study period. * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose. * planned administration/ administration of a vaccine not foreseen by the study protocol within 1 month of a dose of study vaccine(s), with the exception of influenza vaccine. * planned administration of a tetanus toxoid (tt) containing vaccine throughout the active phase of the study (through one month after the last vaccination). * previous vaccination with meningococcal polysaccharide or conjugate vaccine of serogroup a, c w and/or y. * history of meningococcal diseases. * any confirmed or suspected immunosuppressive or immunodeficient condition (congenital or secondary), including human immunodeficiency virus (hiv) infection, based on medical history and physical examination (no laboratory testing is required). * a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. * history of reactions or allergic disease likely to be exacerbated by any component of the vaccine. * major congenital defects or serious chronic illness. * history of any neurologic disorders or seizures. * acute disease at the time of enrollment. * administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the active phase of the study (through one month after the last dose of study vaccine).

Keywords: neisseria meningitidis; humans; meningococcal vaccines; safety vaccines, conjugate; toddlers; immunogenicity;