Kornimate/medical-research-clean huggingface dataset:
.german ttp-registry (thrombotic thrombocytopenic purpura)

Conditions: Thrombotic Thrombocytopenic Purpura

Summary: open, multi-center, observational, prospective cohort study, only disease-indicated treatment, in patients with clinically diagnosed acquired and congenital ttp regardless of gender, ethnicity, and comorbidities, over the age of 18 for 1.) prospective investigation of patients with ttp in an acute bout and during long-term follow and 2.) assessment of prevalence, course of disease, success of therapy, possible triggers for relapses and possibilities for better diagnosis and prognosis.

1.) identification of predictive markers for morbidity and mortality in acute ttp and in ttp relapses using a prospective long-term registry and 2.) investigation of the pathophysiological processes in acute bouts and in remission by recording the clinical symptoms and diagnostics for a better understanding of the course of the disease, optimization of diagnostic procedures and their correlation with the clinical course, recording of therapy response of all therapeutic options in acute bouts, observation of current treatment options to evaluate outcome and prognostic markers and recording of clinical and laboratory chemical data during follow-up to assess long-term morbidity.

Eligibility criteria:
inclusion criteria: * patients with clinically diagnosed acquired and congenital ttp regardless of gender, ethnicity, and comorbidities, over the age of 18. * patients incapable to give consent, who are accompanied by a legal representative during admission to the study, after the written informed consent of the legal representative. * written informed consent of the patient. exclusion criteria: * patients who are not able to understand the german or english language. * patients who are permanently unable to communicate and who are not accompanied by a legal representative.
the impact of a bundle of preventive measures for post-intensive care syndrome on the outcome of critically ill patients

Conditions: PICS

Summary: this prospective observational cohort study will investigate the impact of a bundle of nine preventive measures (assessment, prevention and management of pain; spontaneous awaking trial; spontaneous breathing trial; choice of sedation and analgesia; delirium assessment, prevention and management; early mobility; family communication and icu diary) on the incidence and severity of post-intensive care syndrome (pics) and clinical outcomes in critically ill patients

this is a prospective observational cohort study. it will include all adult patients, admitted to a surgical icu (13 beds) and a medical icu (10 beds), with a length of icu stay of at least 2 day, from january 01 to december 31 2018. patients with severe cognitive deficits prior to admission, identified by clinical history obtained by the psychology or through the mental state mini exam (mmse), traumatic brain injury and stroke patients with glasgow coma scale \<14, will be excluded. on admission to the icu, risk factors for pics will be identified. during icu stay, the patients will be submitted to nine interventions aiming at the prevention of pics: assessment, prevention and management of pain; spontaneous awaking trial; spontaneous breathing trial; choice of sedation and analgesia; delirium assessment, prevention and management; early mobility; family communication and icu diary. at icu discharge, the physical, psychiatric and cognitive components of pics will be evaluated using the following tools: fss-icu, dynamometry and nutritional indicators (physical component), hads (anxiety and depression), moca (cognitive dysfunction) and pcl -c (posttraumatic stress disorder). the duration of mechanical ventilation, duration of sedation, icu los and hospital mortality will also be evaluated. reassessments will be done 5 days after discharge from the icu or at hospital discharge (what happens first) and 3 months after the randomization at the follow-up clinic. patients identified with pics at discharge from the icu will be compared with those who did not develop the syndrome. the investigators will specifically evaluate the percentage of adherence to preventive measures, the presence of risk factors and clinical outcomes.

Eligibility criteria:
inclusion criteria: . * adult non pregnant patients * length of icu stay of at least 2 days. exclusion criteria: * severe cognitive deficits prior to admission. * traumatic brain injury with glasgow coma scale \< 14 * stroke with glasgow coma scale \< 14

Keywords: pics diagnosis prevention outcome
a study to evaluate bbi-001 in hereditary haemochromatosis (hh) patients and iron deficient volunteers

Conditions: Hereditary Hemochromatosis

Summary: this is a first in human, double-blind, randomized, placebo-controlled, two-arm crossover study evaluating the safety, tolerability and pd of ascending dose levels of bbi-001 after: * a single administration in iron deficient male and female participants, and male and female hh patients (part a), * two administrations per day in hh patients (part b). bbi-001 administrations will be accompanied with consumption of a meal enriched with stable iron isotope fe57, while corresponding placebo dose administrations will be with a meal enriched with stable iron isotope fe58.


Eligibility criteria:
inclusion criteria: * otherwise healthy iron deficient participants or patients with hereditary hemochromatosis exclusion criteria: * serious or unstable medical or psychiatric conditions * significant medical history * current infections * receiving iron chelation therapy or treatment other than stable maintenance phlebotomy for the prior 6 months * organ damage from iron overload in the view of the pi would prevent successful completion of the protocol
efficacy of intrathecal oxytocin to speed recovery after hip surgery

Conditions: Postoperative Pain

Summary: the purpose of this study is to determine the effect of intrathecal oxytocin on speed of reduction in pain for the first 60 days after hip surgery.

this is a single-center, nih funded clinical study at wake forest baptist medical center. the investigators anticipate that intrathecal oxytocin will speed recovery from pain after major surgery (hip arthroplasty). for this study, the investigators will use a randomized, controlled and blinded study of intrathecal oxytocin in patients scheduled for hip arthroplasty, with primary outcome being the slope of change in pain over the first 60 days following surgery, using growth curve modeling and a ln(time) function.

Eligibility criteria:
inclusion criteria: * scheduled for unilateral, primary total hip replacement * american society of anesthesiologists physical status 1-3 exclusion criteria: * pregnancy * currently workman's comp litigation related to hip replacement * taking greater than 100 milligrams of morphine (or equivalent) * suffering from a psychotic disorder or a recent psychiatric hospitalization
relationship between contact point to attachment level and presence of interdental papilla

Conditions: Attachment Loss, Periodontal

Summary: thorough search of literature revealed no study has correlated the presence/absence of papilla to the contact point to attachment level distance. it could be a non- invasive approach and there is no need to inject local anaesthesia to the patient. it might be beneficial in predicting the papilla reconstruction outcome in patient friendly and non-invasive way.

the presence of interdental papilla specially of maxillary anterior tooth region is an essential esthetic component. loss of papilla or black triangle is not appealing and it is concern for both patient and clinicians. beside esthetic concern, black triangle is associated with phonetic problem and food impaction. several factors which may influence the presence/absence of interdental papilla are alveolar bone height, gingival biotype, interdental space morphology, type of contact area. different classification system to categorize interdental papilla loss have been proposed. in the landmark study by tarnow, a correlation was found between vertical distance from contact point to bone crest and presence/ absence of interdental papilla. interdental clinical attachment level may indirectly indicate the changes in underlying bone level and it has been proven to be an important prognostic factor in consideration of success of root coverage procedure. thorough search of literature revealed no study has correlated the presence/absence of papilla to the contact point to attachment level distance. it could be a non- invasive approach and there is no need to inject local anaesthesia to the patient. it might be beneficial in predicting the papilla reconstruction outcome in patient friendly and non-invasive way.

Eligibility criteria:
inclusion criteria: * intact maxillary central incisors * age 18-50 years * closed contact points * no history of traumatic tooth injury * completion of cause related therapy before 3months * full mouth plaque score and full mouth bleeding score \<15% exclusion criteria: * • systemic ailments which affect periodontium * history of previous periodontal surgery * tooth with a prosthetic crown or restoration involving cementoenamel junction (cej). * pathologic tooth migration * presence of cervical abrasion/erosions * presence of dental caries in maxillary central incisors * trauma from occlusion * crowding or spacing in maxillary central incisors * angular bone defects * pregnant women * mobile tooth
bronchial hyperreactivity in children with crohn disease

Conditions: Crohn's Disease

Summary: background: latent pulmonary involvement is described in crohn disease(cd). bronchial hyperreactivity measured by the methacholine challenge test (mct) has been evaluated in two studies involving mainly adults.our aim was to determine the frequency of bronchial hyperreactivity in pediatric patients followed and treated for crohn disease. methods: twenty-three children with crohn disease completed a questionnaire, followed by spirometry, methacholine challenge test (mct) and determination of fractional exhaled no (feno). the control group included patients evaluated for functional cough who had negative methacholine challenge test (mct).


Eligibility criteria:
inclusion criteria: * children with crohn disease * children that can perform lung function tests (mct) exclusion criteria: * upper respiratory tract infection last month * fever or pneumonia last month * smoking * other chronic diseases * other respiratory diseases

Keywords: crohn's disease bronchial hyper reactivity fractional exhaled no methacholine challenge test pediatric crohn's disease activity index to determine the frequency of bronchial hyperreactivity in pediatric patients followed and treated for crohn disease
phase 2 study to evaluation the safety and efficacy of orally administered kl7016 in patients with dry eye syndrome

Conditions: Dry Eye Syndrome

Summary: this is a controlled study to determine the effectiveness and safety of kl7016 in the treatment of adult patients with dry eye syndrome (des).


Eligibility criteria:
inclusion criteria: * corneal staining score of ≥5 in either eye by the national eye institute/industry workshop guidelines * schirmer test score (without anesthesia) \< 7 mm/5 min in either eye * willing to use no topical ocular treatments, other than refresh tears® for the duration of the trial exclusion criteria: * intraocular surgery within 3months * persistent intraocular inflammation or infection * corneal transplantation or neurotrophic keratitis * stevens-johnson syndrome * ocular herpes simplex virus infection * concomitant use of contact lenses or use within 3months * silicone lacrimal punctal occlusion or cauterization of the punctum within 3months * vision correction surgery without des within 12months * unstable use of methotrexate or disease-modifying drugs
aerobic exercise in postexercise cardiovascular responses in resistant hypertension: a cross-over trial

Conditions: Hypertension

Summary: aerobic exercise has the potential to diminish blood pressure values. the aim of this study is to determine whether this potential is also applicable for those with resistant hypertension and whether exercise intensity plays a role in this context. we hypothesize that performing an aerobic exercise session reduces blood pressure values in resistant hypertensive patients in a dose-response relation with exercise intensity.

exercise prescription is gathering great importance in preventive health. several organizations endorse the performance of at least 150min/wk of moderate intensity or 75min/wk of higher intensities in order to achieve better health parameters in different contexts. aerobic exercise is known to be an effective way to diminish bp levels post-session. these responses are widely applicable in hypertensive subjects, acting in aid of bp management treatment. although these benefits of aerobic exercise are well known, few studies explore the potential of this intervention in resistant-to-treatment patients. moreover, the effects different intensities of aerobic exercise in this population is scarce. thus, the aim of this study is to determine the magnitude of bp responses, if there is any, of resistant hypertensive subjects to two different intensities of aerobic exercise, compared with a control session. for that, subjects will be enrolled for one pre-intervention cardiopulmonary exercise testing and three randomized intervention sessions: control, 50%hrmax and 75%hrmax. prior and immediately after all intervention sessions (during 1h), forearm blood flow and reactive hyperemia will be assessed by venous occlusion plethysmography. after the sessions, 24h blood pressure will be assessed with an ambulatory blood pressure monitoring system.

Eligibility criteria:
inclusion criteria: resistant-to-treatment hypertensive subjects (24h ambulatory bp above 130/80, or daytime ambulatory bp above 135/85, or night-time ambulatory bp above 120/70 in spite use of 3 anti-hypertensive medications of different classes, being one diuretic; or use of 4 or more anti-hypertensive medications). exclusion criteria: muscle or skeletal abnormalities that preclude effort, abnormal exercise stress test, major illnesses that would preclude exercise effort or could influence in the outcome variables (pulmonary disease, valve disease, renal insufficiency, etc.)

Keywords: resistant hypertension aerobic exercise
combined use of bcg and interferon alpha in bladder cancer

Conditions: Carcinoma of Urinary Bladder, Superficial

Summary: to compare the toxicity and efficacy of the combination of bcg and interferon alpha to standard dose and low dose bcg alone in high risk superficial bladder cancer

140 eligible patients with high risk superifical bladder cancer would be randomised to receive standard dose bcg, low dose bcg or the combination of low dose bcg and interferon alpha in a schedule of "6+3" weekly intravesical instillations. patients would be closely monitored with cystoscopy and urine cytology and intravenous urograms when indicated. pre-and post-instillation urine samples would be collected for cytokine analysis.

Eligibility criteria:
inclusion criteria: (1) patients must have completely resected, histologically?proven urothelial carcinoma of the urinary bladder, stage ta or tl 1 ? 16 weeks prior to registration, and/or carcinoma-in-situ on bladder biopsy. central pathology review was mandatory. (2) patients with stage ta urothelial carcinoma must be judged to be at increased risk of tumor recurrence by virtue of any one of the following: (a) tumor recurrence during the 56 weeks prior to registration, (b) two or more initial tumors within 28 weeks, (c) grade iii urothelial carcinoma during the 16 weeks prior to registration, (d) dysplasia or carcinoma-in-situ on random biopsy or (e) positive urinary cytology post tumor resection. "suspicious" or "suggestive" cytology is insufficient for this criterion. (3) patients who have received prior intravesical therapy other than bcg were eligible provided they had not undergone a course of any other intravesical agent within two months prior to entry. (4) there was no age restriction; however, all patients registered had to be willing to be available for 5?year follow up and to have a life expectancy of at least two years. (5) patients had a karnofsky score \>50. (6) women of child?bearing age were using effective contraceptive methods. (7) patients agreed not to take vitamin supplements (except for those prescribed in the study) for the duration of the trial. (8) pretreatment laboratory tests and radiological examinations must have been obtained during the 16 weeks prior to patient registration. (9) all patients had to be informed of the investigational nature of this study, and had to sign a written informed consent in accordance with institutional guidelines. exclusion criteria: * (1) patients with medical illness or mental status, which would preclude cooperation with the study. (2) patients who were immunodeficient, or had received immunosuppressive radiation therapy or chemotherapy. (3) patients with urothelial carcinoma of stage t2 or higher. (4) patients who had evidence of urothelial carcinoma of the upper urinary tract at the time of recruitment. (5) patients who had received radiation therapy for bladder cancer within one year prior to registration. (6) patients who had been previously treated with intravesical bcg. (7) patients with active tuberculosis.

Keywords: bladder cancer bcg interferon alpha
telmisartan+hctz (hydrochlorothiazide), hypertension

Conditions: Hypertension

Summary: this post marketing surveillance (pms) study aims to review the followings by investigating the actual practice of micardisplus tablet on the market: 1. unexpected adverse drug reactions (especially, serious adverse events (saes)) 2. frequency of incidence and its change in adverse events (aes) 3. factors on the safety profile of the study drug 4. factors on the efficacy profile of the study drug


Eligibility criteria:
inclusion criteria: patients diagnosed with essential hypertension exclusion criteria: patients who took micardis plus before participating in this pms study
pathways linking reduced sleep duration and quality to obesity risk

Conditions: Obesity; Diabetes

Summary: this study is designed to study the pathways through which short sleep duration or poor sleep quality can lead to an increased risk of developing diabetes and obesity.


Eligibility criteria:
inclusion criteria: * normal weight * healthy * normal sleep times exclusion criteria: * sleep disorders * overweight * diabetes * other health conditions * excessive caffeine and alcohol intake * smoking

Keywords: obesity diabetes, risk obesity, diabetes risk related to sleep
decision-making regarding prophylactic mastectomy and oophorectomy in women seeking genetic counseling and testing for brca1/2 mutations

Conditions: Breast Cancer; Ovarian Cancer

Summary: the purpose of this study is to learn more about women's decision to undergo prophylactic surgery. this is removal of healthy organs in order to reduce risk of cancer. this study will help us to understand what makes women decide whether or not to have this kind of surgery.

for women with a strong family history of breast/ovarian cancer, few options exist for primary prevention of these cancers other than prophylactic surgery, or surgical removal of noncancerous organs in order to prevent occurrence of the disease. the primary aim of the study is to describe the stages of intention to undergo prophylactic mastectomy and/or oophorectomy among women seeking genetic testing for inherited brca1 and brca2 mutations, and to identify factors that influence stages of intention regarding prophylactic surgery. to achieve these aims, 626 women undergoing genetic counseling and testing for inherited breast ovarian cancer risk will be assessed before their first genetic counseling session and three times (1 week, 6 months and 12 months) in the year following notification of their genetic test results.

Eligibility criteria:
inclusion criteria: * female gender * age 25 and above * a personal or family history of breast and/or ovarian cancer showing clinical features associated with increased risk of carrying a brca1/2 mutation (e.g., breast and ovarian cancer on the same side of the family, early age of onset, multiple primaries in the same individual) or having a first-degree relative with a known brca1 or brca2 mutation. exclusion criteria: * male gender * age less than 25 years * unable to provide meaningful informed consent due to physical, cognitive or psychiatric disability * non-english speaking

Keywords: prophylactic mastectomy prophylactic oophorectomy
safety and immunogenicity of two doses of ah5n1 vaccine in adult and elderly subjects with and without immunosuppressive conditions *ah5n1:monovalent h5n1 influenza vaccine

Conditions: Influenza, Human; Flu, Human; Flu, Avian; Influenza; Influenza A Virus, H5N1 Subtype

Summary: evaluate the safety, immune response and reactogenicity of ah5n1 vaccination in adult (18 through 60 years of age) and elderly (≥61 years of age) subjects with and without immunosuppressive conditions.


Eligibility criteria:
inclusion criteria: * male and female individuals 18 years of age and older at the time of enrollment who are mentally competent, willing and able to understand the nature and risks of the proposed study, and able to sign the consent form prior to study entry; * individuals who are able to comply with all study procedures and requirements; * healthy volunteers and volunteers specifically hiv positive, transplant recipients, cancer patients may be eligible; * please contact the site for additional eligibility criteria. exclusion criteria: * individuals who are not able to follow all the required study procedures for the whole period of the study; * individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study; * please contact the site for additional eligibility criteria.

Keywords: influenza, h5n1 ah5n1 h5n1 vaccine pandemic influenza vaccine mf59 adjuvant avian flu underlying immunosuppressive immunosuppressive conditions pandemic vaccine adjuvanted vaccine
hypnosis as a treatment of chronic widespread pain in general practice. a pilot study.

Conditions: Chronic Widespread Pain

Summary: objective: the study was performed to evaluate the effect of a standardized hypnosis treatment used in general practice for patients with chronic widespread pain (cwp). design: a randomized control group-controlled study. setting and subjects: 16 patients were randomized into a treatment group or a control group, each constituting eight patients. seven patients in the treatment group completed the schedule. after the control period, five of the patients in the control group also received treatment, making a total of 12 patients having completed the treatment sessions. intervention: the intervention group went through a standardized hypnosis treatment with ten consecutive therapeutic sessions once a week, each lasting for about 30 minutes, focusing on ego-strengthening, relaxation, releasing muscular tension and increasing self-efficacy. main outcome measures: a questionnaire was developed in order to calibrate the symptoms before and after the 10 weeks period, and the results were interpolated into a scale from 0 to 100, increasing numbers representing increasing suffering.


Eligibility criteria:
inclusion criteria: * chronic widespread pain for at least three months and at most five years. exclusion criteria: * patients having primarily other organic diseases or serious psychiatric disorders were excluded.

Keywords: hypnosis, chronic widespread pain, cwp, general practice