Kornimate/medical-research-clean huggingface dataset:
tmc435 hpc1004 - phase i study investigating the pharmacokinetics of tmc435 in healthy chinese volunteers

Conditions: Hepatitis C

Summary: the purpose of this study is to assess the pharmacokinetics, safety and tolerability of single and multiple oral doses of tmc435 in chinese healthy volunteers. pharmacokinetics (pk) means how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body.

tmc435 is being investigated for the treatment of chronic hepatitic c infection. the results of this study will provide dosing recommendations for the administration of tmc435 in chinese hcv-infected patients. this is a phase i, open label (both participant and investigator know the name of the medication given at certain moment), randomized (study medication is assigned by chance) study to investigate the pharmacokinetics, safety and tolerability of tmc435 after single and repeated intakes. each participant will receive 2 treatments. first, participants will receive tmc435 as a single dose of 100 or 200 mg. thereafter, in the multiple dose part, 100 or 200 mg tmc435 will be administered during 5 consecutuve days every morning. both treatments will be administered with food. there will be a washout period of at least 72 hours between the 2 treatments. the main focus of the trial is the pharmacokinetic characteristics (level-profile of tmc435 over time in the blood stream). this evaluation requires multiple blood samples from day 1 till day 3 in the first session and from day 1 till day 11 in the second session. safety assessments (blood and urine tests, blood pressure, pulse, electrocardiogram, and physical examination) will follow a different schedule and will be performed during each treatment period, up to 4 weeks after the last. each volunteer participate in 2 treatments, i.e., single dose period and multiple dose period. in the single dose part, planned doses will be 100 or 200 mg tmc435. in the multiple dose part, tmc435 will be administered during 5 consecutive days every morning.

Eligibility criteria:
inclusion criteria: * healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram. body mass index of 18.0 to 30.0 kg/m² and non-smoker or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months. exclusion criteria: * infection with hepatitis a, b or c virus * infection with the human immunodeficiency virus (hiv) * women who are pregnant or breastfeeding * history of, or any current medical condition which could impact the safety of the participant in the study.

Keywords: tmc435hpc1004 tmc435 hcv hepatitis c healthy chinese volunteer
escitalopram (lexapro) for depression ms or als

Conditions: Major Depression; Multiple Sclerosis; Amyotrophic Lateral Sclerosis

Summary: the purpose of this study is to see if escitalopram (lexapro) improves symptoms of major depressive disorder in patients who have als or ms.

this eight-week study aims to assess the effectiveness and tolerability of escitalopram in improving symptoms of major depression in patients with amyotrophic lateral sclerosis (als) or multiple sclerosis (ms) as measured by the ham-d. in addition, the study will assess improvement in the quality of life in patients with major depression and als or ms.

Eligibility criteria:
inclusion criteria: * patients between 18 and 70 years of age with documented als or ms, * dsm-iv episode of non-psychotic major depression, * ≥14 score on the 17-item ham-d, * ability to give informed consent. exclusion criteria: * history of psychotic disorders, * psychotic depression, * bipolar depression, * suicide risk, * history of substance abuse in the previous 6 months, * history of unstable medical disorders, * pregnancy or planning for pregnancy, * severity of als or ms that limits participating in the study protocol.

Keywords: amyotrophic lateral sclerosis als multiple sclerosis ms major depression depression major depressive disorder antidepressants escitalopram lexapro
predictive factors for exacerbation outcome in severe refractory asthmatics

Conditions: Asthma; Chronic Inflammatory Diseases

Summary: asthma is a chronic inflammatory disease, affecting up to 10 % of the general population in developed countries. corticosteroids are necessary to control symptoms, but induce adverse events sometimes intolerable. in severe asthma, which represent 5 to 10% of global asthma, corticosteroids frequently fail to prevent severe exacerbations, leading to emergency care, hospitalization and sometimes death. the aim of this study is to identify predictive factors specific for exacerbation outcome which will lead to a minor increase in treatment in order to prevent exacerbations, while minimizing drug adverse effects.


Eligibility criteria:
inclusion criteria : * male or female adults aged ≥ 18 years, who have signed an inform consent form prior to initiation of any study-related procedure * patients with severe asthma with at least 2 exacerbations during the last 12 months that necessitated oral cortico-therapy or increase in oral cortico-therapy exclusion criteria : * pregnant or nursing women * patients with other chronic inflammatory lung disease * current smoker or a smoking history of 10 pack years or more

Keywords: severe asthma exacerbation predictive factors severe
node negative, invasive breast cancer single fraction ioert

Conditions: Breast Cancer

Summary: the purpose of this study is to determine if lumpectomy followed by intraoperative electron radiation therapy (ioert) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.

see points viii inclusion/exclusion criteria operation: * lumpectomy, steninal node biopsy * ioert after surgery: * meet with a medical oncologist and discuss if chemotherapy and/or hormone therapy is recommended as part of your treatment course. in some cases, pathology results may indicate the need for removal of additional lymph nodes. the doctor will review pathology and discuss if additional surgery is required. * chemotherapy (if indicated) * hormone therapy (if indicated) follow-up * visits will be completed with the surgeon, radiation oncologist and research staff as the protocol indicates. * assessements of acute toxicity according to ctc-toxicity scoring system * assessments of late toxicity according to lent-soma scoring systems * assessment of cosmetic outcome according to scoring system and photo documentation in standardized positions.

Eligibility criteria:
inclusion criteria: * patient agrees to breast conservation therapy (segmental resection, partial mastectomy, and radiation therapy) as the treatment for their breast cancer * patient agrees to evaluation of the axilla with sentinel lymph node biopsy * post-menopausal women age \> 60, defined as women who have experienced no menstrual period in the past 12 months. * brca1 and 2 gene mutation negative, if tested. \[genetic testing is not required based upon personal or family history\] * unifocal (unicentric), invasive ductal carcinoma or favorable sub-types (mucinous, tubular, colloid) \< 2.0 cm in diameter, primary t-stage of t1 (ajcc criteria) * grade 1, 2 acceptable * associated lcis is allowed * estrogen receptor (er) status of positive * negative margins at ink on gross pathologic examination * patient is node-negative, defined as n0 (i-) or n0 (i+) * patient must be deemed functionally and mentally competent to understand and sign the informed consent exclusion criteria: * prior breast malignancy or other malignancy if metastatic, or with expected survival of \< 5 years * immuno-compromised status * pregnancy * women with an active connective tissue disorder (i.e. scleroderma, lupus and others) * breast cancer that involves the skin or chest wall, locally advanced breast cancer * pure dcis, all grades * invasive lobular carcinoma * evidence of lymphovascular invasion (lvi) * invasive carcinoma with extensive intraductal component (eic) * neoadjuvant chemotherapy indicated * patients with 1 or more positive lymph node determined during surgery with sentinel node and/or axillary dissection * not eligible for breast conserving management, i.e., prior whole breast radiation therapy * estrogen receptor negative * her2 positive * grade 3

Keywords: ioert radiation single fraction lumpectomy radiation therapy avera
high volume plasmapheresis for refractory hepatic encephalopathy in liver intensive care unit.

Conditions: Refractory Hepatic Encephalopathy

Summary: study design- randomized controlled trial duration of enrolment-feb-2016 to december 2017 sample size-120 patients methodology we will include consecutive with advanced hepatic encephalopathy not responding to treatment of precipitants and on treatment with lactulose and rifaximin for 48 hours . two groups will be divided. one arm -lactulose and rifaximin will be continued second arm - plasmapheresis will be added to the standard medical care therapy.(maximum of 3 sessions once in 24 hours/or alternate days with an follow up for 5 days)


Eligibility criteria:
inclusion criteria: * cirrhotics * age between 18-70 years * hepatic encephalopathy -grade 3-4 * patients receiving lactulose/rifaximin for 48 hours and not showing improvement in hepatic encephalopathy(persistent grade 3/4) exclusion criteria: * concomitant participation in an other clinical trial * patient receiving sedatives(propofol,etc) 24 hours prior. * patients with severe cardiopulmonary disease * pregnancy * human immunodeficiency virus * hepatocellular carcinoma or extrahepatic malignancy * active uncontrolled sepsis with hemodynamic instability * chronic renal insufficiency on treatment with haemodialysis * uncontrolled bleed or patients in dic * extremely moribund patients with expected survival of less than 48 hours on high vasopressor support * patients with moderate-severe acute respiratory distress syndrome (ards). * patients with non hepatic coma.
comparing platelet-rich plasma (prp) centrifugation methods on thrombocyte concentration and clinical improvement of androgenetic alopecia

Conditions: Alopecia, Androgenetic

Summary: this research is a preliminary, randomized, double blind clinical trial, which will examine the differences in prp preparation methods, a single-spin centrifugation of 3000 rpm in 15 minutes compared to a double-spin centrifugation of 1500 rpm in 6 minutes followed by 2500 rpm in 15 minutes, on the results of thrombocyte concentration and clinical improvement of androgenetic alopecia.

several examinations will be performed in every visit, including history taking, physical examination, trichoscopy and trichoscan. laboratory evaluations (complete blood count) for the measurement of the thrombocyte for baseline and prp will be performed for all assented subjects on the first visit. each subject will be instructed to apply 5% topical minoxidil twice a day everyday as primary therapy during the study

Eligibility criteria:
inclusion criteria: * met the criteria of androgenic alopecia (hamilton norwood grade iii-iv) * men between ages 25-59 years old * have stopped taking topical anti-androgen or minoxidil for at least one month, or oral anti-androgen or minoxidil for at least three months exclusion criteria: * alopecia of any other type * subject with a history of keloid or blood coagulation disorders underwent anticoagulant therapy * subjects on non-steroidal anti-inflammatory drugs (nsaid) medications in seven days prior to the study * subjects who had hair treatment using growth factors, including prp and microneedling within at least six months prior to the study.

Keywords: androgenetic alopecia centrifugation platelet-rich plasma thrombocyte
assessment of quality of life of children with chronic idiopathic thrombocytopenic purpura (kid's itp tools)

Conditions: Idiopathic Thrombocytopenic Purpura

Summary: assessment of quality of life of patient with chronic idiopathic thrombocytopenic purpura according to the type of treatment


Eligibility criteria:
inclusion criteria: * children with idiopathic thrombocytopenic purpura * aged between 1 and 17 year * idiopathic thrombocytopenic purpura persistent at 12 months * obtention of informed consent exclusion criteria: * persistant/acute idiopathic thrombocytopenic purpura * concomittant chronic disease, stabilized or not * concomittant disease with life expectancy \< 1 year * person who have not belong to a social security scheme * secondary idiopathic thrombocytopenic purpura

Keywords: idiopathic thrombocytopenic purpura
effect of intermittent pressure in patients with pad

Conditions: Peripheral Arterial Disease

Summary: the study will evaluate the effect of intermittent negative pressure (inp) on peripheral arterial disease (pad) patient vascular function and blood flow. patients will be given either -40mmhg inp or -10mmhg inp which will act as a placebo. healthy volunteers will be given -40mmhg inp to evaluate changes in vascular function and blood flow with inp in healthy physiology.

atherosclerosis occurs when blood supply to the lower limbs is restricted upon accumulation of fat in the arteries. atheroslerosis in the lower limbs is termed peripheral arterial disease (pad). the initial symptom is pain in the lower limbs followed by ulceration and gangrene. the literature has indicated that intermittent negative pressure (inp) can be used to reduce pain and facilitate wound healing. inp is a non-invasive technique that aims to increase arterial and skin blood flow in lower limbs and foot. this study aims to investigate the underlying mechanisms that are involved in changes in blood flow following application of inp. the flow-ox 'boot' will be used to apply inp for periods ranging from 4-8 weeks, for an hour twice per day, to the lower limb to determine the effects of inp on vascular function and blood flow. specifically, vascular tests such as assessments of endothelial function, arterial stiffness, ankle-brachial pressure index (abpi) and blood borne metabolic and inflammatory markers will be performed before and after inp application. a pain chart will be employed before and after inp application to determine whether there is any change in perception of pain felt by individuals who suffer from pain associated with lower limb arterial disease.

Eligibility criteria:
inclusion criteria pad patients: * age ≥ 18 years * attending vascular outpatient clinics or admitted in ward with pad. * abpi \<0.9 healthy volunteers: * age ≥ 18 years * no current or previous significant cardiovascular illness * able to give written informed consent exclusion criteria pad patients: * unable to give written informed consent * patients with deep venous thrombosis * pregnant women healthy volunteers: * positive medical history of: vascular diseases such as pad, stroke, ihd, hypertension... etc. * haematological conditions such as hypercoagulability, deep venous thrombosis... etc., * alcohol excess * unable to give written informed consent * pregnant women

Keywords: pad
oropharyngeal candidiasis (opc) and s-ecc

Conditions: Candida Infection; Oral Thrush; Early Childhood Caries

Summary: the overall objective of this study is to investigate the association of early candida infection (known as oral thrush or oropharyngeal candidiasis, opc) in children during the first year of life with the onset and severity of severe early childhood caries (s-ecc).

the overall goal of this study is to conduct a longitudinal observational study to investigate the association of early opc with the onset and severity of s-ecc to better understand the role of candida (particularly c. albicans) in severe childhood caries. the investigators will test the hypothesis that opc is associated with s-ecc by modifying the plaque microbiota and enhancing virulence in a manner that is conducive to the early development of the disease. for this study, a total of 70 infants (aged 9-15-month-old) with or without a history of opc in their first year of life will be enrolled, based on the inclusion and exclusion criteria. subjects will have their medical/dental history reviewed from medical records. at each study visit (baseline, 6-month, 12-month, 18-month, and 24-month follow-ups), an oral examination including soft tissue and caries exam will be performed by a calibrated evaluator. dental plaque/oral swab samples will be collected at each study visit. in addition, a comprehensive survey including demographic status, oral hygiene, diet, delivery, and feeding method as well as current medication usage will also be collected.

Eligibility criteria:
inclusion criteria: * male or female individuals at the age of 9-15-month-old * must have at least one fully erupted tooth at baseline visit * parent/guardian willing and able to provide informed consent * with or without a history of opc (the study team will enroll 35 participants with and 35 participants without a history of opc) exclusion criteria: * presence of a systemic medical condition (e.g. down syndrome etc.) * presence of an orofacial deformity * presence of dental caries * use of systemic antimicrobial therapy within 30 days of the baseline visit * presence of any condition which, in the opinion of the investigator, makes participation in the project not in the individual's best interest.

Keywords: oral candidiasis candida infection oral thrush early childhood caries oral health
diabetes prevention in prediabetic patients

Conditions: Ethnic Group; Young Adults; Prediabetes; Community Health Services

Summary: this study will evaluate the feasibility and efficacy of two interventions of lifestyle ( intensive and less intensive) to prevent diabetes in patients from ethiopian origin, aged 25 to 55 years old with prediabetes living in israel and insured by clalit health services in the central district, using resources existing in this health care system (hmo).


Eligibility criteria:
inclusion criteria: * prediabetes * age 25-55 * ethiopian origin exclusion criteria: * diabetes * age under 25 or above 55 * non ethiopian origin

Keywords: lifestyle diabetes prevention bmi physical activity
evaluation of contrast-enhanced ultrasound imaging for the early estimate of bevacizumab effect on colorectal cancer liver metastases

Conditions: Metastatic Colorectal Cancer

Summary: bevacizumab, an anti-angiogenic agent, plus fluorouracil based chemotherapy is considered a new standard for the treatment of metastatic colorectal cancer. contrast-enhanced ultrasound with gas-encapsulated microbubbles can be used to assess tumour vascularity, particularly hepatic metastases, and may become a useful tool for monitoring anti-angiogenic therapies. the aim of this prospective, multicenter, non-randomized study is to evaluate the usefulness of hepatic contrast-enhanced ultrasound to predict response to bevacizumab based chemotherapy in patient with metastatic colorectal cancer. the primary objective of this study is to compare the functional vascular changes related to bevacizumab based chemotherapy and evaluated by hepatic contrast-enhanced ultrasound with classic recist criteria. the secondary objectives are to do a characterization of the pharmacokinetic of bevacizumab, to explore the pharmacodynamic effects of bevacizumab on functional vascular changes of hepatic metastases evaluated by hepatic contrast-enhanced ultrasound and to analyze the possible relationships between treatment efficacy or toxicity and constitutional gene polymorphisms linked to the bevacizumab.


Eligibility criteria:
inclusion criteria: * histologically confirmed colorectal tumor * first line treatment by a bevacizumab based chemotherapy * target hepatic metastases of size lower than 5 cm and higher than 5 mm detected by conventional ultrasonography and ct or mri * life expectancy \> 2 months * oms status =\< 2 * major surgery, open biopsy, or significant traumatic injury within 28 days prior to day 0 * informed consent signed exclusion criteria: * no target hepatic lesion detected by conventional ultrasonography * prior bevacizumab treatment * prior chemotherapy treatment for advanced disease * clinically significant cardiac disease (e.g. myocardial infarction or stroke within 12 months, unstable angina, new york heart association (nyha) grade ii or greater congestive heart failure not well controlled with medication, endocarditis and prosthetic valve) and any contraindications in sulphur hexafluoride administration * blood pressure \>= 180/110 mmhg * daily and chronic treatment by aspirin or ains * anticipation of need for major surgical procedure within 7 days prior day 0 * urine protein \> 1g/24 hours * any contraindication in enhancing bevacizumab treatment * serious, uncontrolled, concurrent infection(s) or illness(es) * pregnant and lactating woman

Keywords: colorectal cancer hepatic metastases bevacizumab anti-angiogenic agent chemotherapy regimens tumor vascularity contrast-enhanced ultrasound
socio-economic survey in uganda

Conditions: Orthopaedic Injury

Summary: this study will be conducted at mulago teaching hospital. patients coming to the er with an orthopaedic injury will be approached. if a patient consents to be part of the study, they will complete a questionnaire. participation in the study will end as soon as the questionnaire is completed.

all patients will be recruited from the orthopedics inpatient wards and emergency department at mulago national referral hospital. only patients who have sustained an orthopedics injury will be included in this study, and the severity will be recorded for future references. no protected health information (phi) will be collected throughout the study. steps 1. identify patients from mulago teaching hospital 2. enrollment of patients into survey study 3. administer survey to patients at 1st meet up 4. administer survey to doctor-in-charge? 5. compilations of survey results into excel spreadsheet. participants will be assigned an id. the study team does not intend to collect any phi. 6. statistical analysis.

Eligibility criteria:
inclusion criteria: * subject is a male or female 18 years old or older. * all patients presented at mulago national referral hospital with orthopedics trauma injuries regardless of age and gender. exclusion criteria: - patients presented with all other conditions other than orthopedics related injuries that may require long term care. some examples are head injuries leading to long term damage, loss of sights, etc.
a study to evaluate the effects of pf-05175157 in healthy volunteers

Conditions: Diabetes Mellitus, Type 2

Summary: the primary purpose of this study is to evaluate pharmacodynamics of single oral doses of pf-05175157 in a dose-dependent fashion in healthy volunteers


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. * healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ecg and clinical laboratory tests. in addition, subjects must have normal pulmonary function tests and normal ocular findings. * women must be of non-childbearing potential. * body mass index (bmi) of 19.5 35.5 kg/m2, and a total body weight of \> 50 kg (110 lbs). exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies and seasonal allergies at time of dosing). * evidence or history of any chronic ongoing or current pulmonary disease. * history of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of screening or positive cotinine test at screening or day -7. * active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.

Keywords: phase 1 single doses pharmacodynamics healthy volunteers