Kornimate/medical-research-clean huggingface dataset:
expression of angiogenic biomarkers during healing of intra-oral soft tissue engineered grafts

Conditions: Gingival Recession

Summary: the purpose of this observational research study is to understand more about wound healing of gum tissue. this study was the biomarker study of a small cohort of study participants derived from nct01547962 (completed). two surgical sites of each patient were randomly selected to receive celtx™ as a donor material in one site and conventional autograft using keratinized tissue from the palate as the donor material at the contralateral (opposite side) site. fluids collected from between a tooth and the gum and directly from wounds contain proteins that occur in different levels as the wound healing process proceeds. in this research study wound fluid will be collected from the donor palate site (roof of your mouth) and the treated sites on your gum before and after placement of celtx and conventional treatment (tissue from the roof of your mouth) to measure which proteins and how much of each are present during the first 4 weeks of wound healing.

in a clinical trial designed to evaluate the safety and effectiveness of rhpdgf-bb to promote soft and hard tissue engineering of the periodontium, the subjects provided gingival crevicular fluid (gcf) or periodontal wound fluid (wf) and the results demonstrated contrasting inducible expression patterns of pdgf-ab, vegf, and ictp during periodontal healing \[17, 24, 25\]. however, little is known regarding the release of these molecules into local periodontal wound fluid during tissue-engineered grafts. the aim of this study is to determine the presence and influence of angiogenic biomarkers, such as pdgf, vegf, and fgf, involved in the wound healing process of tissue engineered grafts in the treatment of subjects (with recession-type defects) who have an insufficient zone of attached gingival associated with at least two nonadjacent teeth. study objectives the purpose of this pilot study is to compare the expression of angiogenic biomarkers involved in the wound healing process of 2 different periodontal surgical approaches: 1) celtx™ (living bilayered cell therapy product) and 2) free gingival grafts

Eligibility criteria:
inclusion criteria: * subject has signed informed consent to participate in organogenesis clinical protocol 06-per-002-ctx. * subject has signed informed consent to participate in this adjunct bio-marker study. * subject is willing to comply with the additional study visits at weeks 2 and 3 as required by this study. exclusion criteria: - subject requires antibiotic prophylaxis for routine dental procedures.

Keywords: gum recession
the steno 780g study

Conditions: Type 1 Diabetes

Summary: treatment with insulin pumps and sensor-based glucose monitoring has proven superior to other treatment methods in type 1 diabetes. still, the majority of people treated with insulin pumps and glucose sensors still does not meet the recommended sensor-based glycaemic targets. automated insulin delivery systems, also known as closed-loop systems, have shown to improve tir, tar, and tbr compared with insulin pump and cgm systems that cannot automatically dose insulin. the primary objective of the steno 780g study is to test the effects of the minimed 780g system in persons with t1d treated with insulin pump and cgm/iscgm who are not meeting glycaemic targets.


Eligibility criteria:
inclusion criteria: * age 18-75 years * type 1 diabetes ≥2 years. * hba1c \>=58 mmol/mol * insulin pump treatment ≥12 months * cgm or iscgm use ≥6 months * novorapid use ≥1 week * carbohydrate counting and use of the insulin pump bolus calculator for most snacks and meals. * carbohydrate intake \>80 grams per day (assessed by review of intake recorded in the insulin pump during the 2 weeks prior to the screening visit) exclusion criteria: * breast-feeding, pregnancy or planning to become pregnant. * use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start. * use of hybrid closed-loop systems * daily use of paracetamol (acetaminophen) * alcohol or drug abuse. * severe cardiac disease or retinopathy contraindicating hba1c \<53 mmol/mol. * other concomitant medical or psychological condition that according to the investigator's assessment makes the person unsuitable for study participation. * lack of compliance with key study procedures at the discretion of the investigator. * unacceptable adverse events at the discretion of the investigator.
quality of life and behavioral change of retired persons

Conditions: Healthy Volunteers

Summary: researchers have found that the first phase of aging, called "frailty", is insidious, silent and slowly progressive. it begins well before the first signs of aging and possibly before retirement age with physiological reserves that are gradually depleted. frailty is multifactorial. it is situated between the "robust-vigorous" and "poly-pathological-dependent" stages of aging. this state remains dynamic and above all reversible through screening and awareness of the individual's health determinants as well as motivation to change. the longevity pathway was designed to meet several concrete objectives ranging from improving prevention to advancing research on the topic of longevity and aging well. this study aims to evaluate the effect of this personalized support on the quality of life of the consultants, but also on many health parameters, 12 months after the end of the proposed coaching.

the study will be carried out on healthy volunteers, retired. the main objective of the study is to evaluate the effect of a health check-up followed by a collective "coaching" type of support on the quality of life of retired people 12 months after the end of the coaching sessions.

Eligibility criteria:
inclusion criteria: * man or woman; * retired; * having the desire to change his/her lifestyle; * agreeing to follow the constraints generated by the study (presence during the coaching sessions and the final assessment). * having signed the informed consent form; * social insured; exclusion criteria: * presenting a pathology requiring a complementary assessment and/or the implementation of a treatment that could prevent the realization of the coaching or that could modify its effect; * subject participating in another clinical study or in period of exclusion from another study; * subject deprived of liberty; * subject under judicial protection measure; * whose main investigator or a qualified co-investigator judges that the state of health or the concomitant treatments are not compatible with the good progress of the clinical study;.

Keywords: nutrition and physical activity coaching cognition coaching longevity prevention quality of life
randomized controlled study of tenofovir plus telbivudine versus monotherapy with either drug in hbeag negative chronic hepatitis b patients

Conditions: Chronic Hepatitis B

Summary: combination therapies using nucleos(t)ide analogues lead to higher viral suppression although it may not be sustained for long. also it remains unknown if combination of more potent analogues is more beneficial than individual drugs. thus this study is carried out to determine the efficacy and safety of combination of tenofovir plus telbivudine (two most potent nucleos(t)ide analogues)versus monotherapy with either drug alone. this is a 104 week open labelled, prospective, randomized, multicentric study. the patient will receive either tenofovir, telbivudine or the combination of two drugs. after completion of 24 weeks, the non-responders (ie hbv-dna \> 300 copies/ ml) will be switched to combination arm and will continue receiving tenofovir plus telbivudine for 104 weeks.


Eligibility criteria:
inclusion criteria: * hbeag negative at screening * documented chronic hepatitis b * treatment naive * compensated liver disease exclusion criteria: * chronic hepatitis b with child pugh b \& c * hbeag positive * decompensated liver disease

Keywords: hepatitis b, tenofovir, telbivudine
a study examining doses of abiraterone acetate in adult women with 21-hydroxylase deficiency

Conditions: 21-hydroxylase Deficiency

Summary: the purpose of this study is to determine the minimum dose of abiraterone acetate needed to decrease serum androstenedione to age-appropriate levels in premenopausal women on steroid replacement for classic 21-hydroxylase deficiency.

this is a non-randomized (patients will not be assigned by chance to study treatments), open-label (patients will know the identity of study treatments), multiple-dose, intra-patient sequential dose-escalation study with a planned enrollment of approximately 10 patients. this study will consist of a screening period and a treatment period. due to the intra-patient dose escalation, there will be multiple treatment periods consisting of 8 days each. a rest period of at least 7 days will separate each treatment period. eligible patients will take study-defined replacement doses of hydrocortisone and fludrocortisone. abiraterone acetate oral suspension will be administered in daily escalating doses from 100 mg to 500 mg. patients will proceed to the next higher dose level when the majority of the treated patients have a reduction in the androstenedione level. serial pharmacokinetic (study of what the body does to a drug) and pharmacodynamic (study of the effects of a drug on the body) samples will be collected at each treatment period as detailed in the protocol. all patients who receive at least 1 dose of abiraterone acetate will be analyzed for safety.

Eligibility criteria:
inclusion criteria: * premenopausal women \>=18 years of age. * must be receiving a hormonal contraceptive agent containing both estrogen and progesterone. * confirmed 21-hydroxylase deficiency by cyp21a2 genotype associated with classic congenital adrenal hyperplasia. * demonstrates a \>=1.5 x uln of morning serum androstenedione concentration while taking study-defined doses of hydrocortisone and fludrocortisone. * no coexisting medical conditions in the opinion of the investigator that would preclude participation in the study. exclusion criteria: * current or history of active or chronic hepatitis, including symptomatic viral hepatitis a, b, or c. * any active infection. * evidence of active malignancy. * serious or uncontrolled co-existent non-malignant disease. * receiving systemic glucocorticoids for any reason other than for the treatment of 21-hydroxylase deficiency. * any disorders that require treatment with anticonvulsants. * patients of child-bearing potential who are not willing to use a method of birth control during the study and for 3 months after the end-of-study. * women who are pregnant or breast-feeding. * genotypes associated with non-classic congenital adrenal hyperplasia.

Keywords: 21-hydroxylase deficiency androstenedione abiraterone acetate pharmacokinetics pharmacodynamics dose-finding
gmp drink for pku study

Conditions: Phenylketonuria

Summary: this study will evaluate the safety, gastrointestinal (gi) tolerance, acceptability and compliance of a glycomacropeptide-based protein substitute for patients with phenylketonuria (pku).


Eligibility criteria:
inclusion criteria: * male or female * over 3 years of age * diagnosed with classical or variant type phenylketonuria * have been compliant in taking at least one amino acid-based, phe-free protein substitute, providing at least 20g protein equivalents, for at least 1 month prior to trial commencement * have a prescribed daily phe allowance * written informed consent from patient, or from parent / carer if applicable exclusion criteria: * currently prescribed sapropterin or similar tetrahydrobiopterin based medication * pregnant or lactating * requiring parenteral nutrition * major hepatic or renal dysfunction * participation in other studies within 1 month prior to entry of this study * allergy to any of the study product ingredients, including milk protein or soya * investigator concern around willingness/ability of patient or parent/carer to comply with protocol requirements
effects of dexmedetomidine sedation on delirium and haemodynamic in mechanical ventilated elderly patients

Conditions: Safety of Dexmedetomidine Sedation

Summary: this study was designed to observe the effects of dexmedetomidine on delirium and haemodynamic in mechanical ventilated elderly patients,and to evaluate the safety of dexmedetomidine.


Eligibility criteria:
inclusion criteria: * written informed consent * intensive care unit patients who need mechanical ventilation * anticipate duration of mechanical ventilation longer than 24 hours,and shorter than 96 hours prior to giving investigational products * acute physiology and chronic health evaluation ii score more than 10 * aged between 60 to 80 years old * weight between plus or minus 20% of the standard weight. male: (height cm - 80) × 70% = standard weight female: (height cm - 70) × 60% = standard weight exclusion criteria: * trauma and burn patients * any kind of dialysis * suspected or confirmed difficult airway * use of neuromuscular blocking drugs(except using for intubation ) * neuromuscular disease * epidural or subarachnoid anesthesia * plan to give general anesthesia before 24 hours drugs intervention or after giving investigational drugs * serious central nervous system disease * mental disability or mental disease * acute hepatitis and serious liver disease(child-pugh c) * unstable angina and acute myocardium infarction * left ventricular ejection volume less than 30%,heart rate less than 50 beats per minute * ii and iii degree atrioventricular block * systolic pressure less than 90 mmhg after giving vasopressors twice before beginning of this study * consciousness disturbance patients whose blood pressure less than 70mmhg and blood lactate more than 4.0mmol/l * suspected or confirmed long term use of narcotic analgesics * subjects who are breastfeeding or pregnant * allergic to investigational products or with other contraindication * participated in other study within 30 days

Keywords: dexmedetomidine ,delirium ,haemodynamic, mechanical ventilation
a waiting room-delivered video to enhance clinical outcomes among persons living with hiv

Conditions: HIV Infections

Summary: the purpose of this project is to beta-test a brief waiting room video intervention that promotes early initiation of antiretroviral treatment among treatment-naïve hiv-positive patients, adherence to antiretroviral treatment and retention in care among hiv-positive patients currently on therapy, sexual risk reduction tailored to hiv-positive persons, and patient-initiated discussion of these topics with their health providers. the video is currently being created, and will be ready for beta-testing by june 1, 2016. results of the beta-testing will be used to refine and improve the video before dissemination to hiv/aids treatment facilities nationally. this video project is being funded by the centers for disease control and prevention, division of hiv/aids prevention (dhap).

the overall goal of this study is to beta-test the waiting room video in three hiv/aids treatment facilities in different us jurisdictions with high aids prevalence. these results will be used to refine the video and to increase its effectiveness among minority persons living with hiv infection. the beta-testing will consist of: 1) unobtrusive observations of waiting room patients for one day at each facility and 2) de-identified, existing patient medical data abstracted from each facility's electronic medical record (emr) system to investigate outcomes relevant to hiv medication adherence and retention in care.

Eligibility criteria:
inclusion criteria: hiv/aids treatment facility inclusion: the participating treatment facilities will have a combined total of at least 2,700 monthly patient visits during the study period. each of the hiv/aids treatment facilities meets the following inclusion criteria: 1. located in a jurisdiction with high aids prevalence; 2. managing more than 500 unique hiv-positive patients annually; 3. serving minority persons such that minimally 55% of the clinic population is african-american and hispanic/latino; 4. at least 163 patients have unsuppressed viral load; 5. utilizing an electronic medical record (emr) system; and 6. not participating in another behavioral intervention research project during the historical comparison data period (august 2015 through may 2016) or during the 10-month intervention period (june 2016 through march 2017). exclusion criteria: -
safety and tolerability trial of inhaled alpha1-proteinase inhibitor (human), hydrophobic chromatography process (alpha-1 hc) in subjects with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this was a randomized, double-blind, placebo-controlled, dose escalation study to assess the safety and tolerability of 100 mg and 200 mg of inhaled alpha-1 hc administered once a day for three weeks in subjects aged 18 years and older with cystic fibrosis (cf). the treatment duration in this study was intended to provide multi-dose safety information prior to proceeding to longer durations of exposure.


Eligibility criteria:
inclusion criteria: * age 18 years or older. * documentation of cf diagnosis. * have a pre-bronchodilator fev1 ≥ 40% of predicted at visit 1 and have a visit 2 pre-investigational product fev1 that is ≥ 40% of predicted and within ± 15% of the visit 1 result. * deemed by the investigator to be a suitable candidate for serial collection of expectorated sputum. exclusion criteria: * had a pulmonary exacerbation during the 4 weeks before screening (visit 1) which required the initiation of new antibiotic treatment * have a pulmonary exacerbation during the screening period (between visit 1 and visit 2) which requires the initiation of new antibiotic treatment * fev1 \< 0.59 liters at the screening visit * respiratory insufficiency with continuous supplemental oxygen therapy, or carbon dioxide retention * elevated aspartate transaminase (ast) or alanine aminotransferase (alt) that is ≥ 3 times the upper limit of normal for age and gender * smoking during the past 6 months * lung surgery during the past 2 years * positive culture for burkholderia cepacia or mycobacterium during the past two years. * active allergic bronchopulmonary aspergillosis * pre-treatment sputum collection at visit 1 or visit 2 (randomization) characterized by problems such as inadequate sputum volume or quality. * known selective immunoglobulin a (iga) deficiency with known antibody against iga (anti-iga antibody). * history of anaphylaxis or severe systemic response to any plasma-derived alpha1-proteinase inhibitor preparation or other blood product(s), or to polysorbates. * use of chronic oral steroids during the study. note: inhaled corticosteroids that had been administered for at least 4 weeks prior to visit 1 were permissible during the study. * use of chronic, high dose ibuprofen therapy within 3 weeks of screening and at anytime during the study. * chronic maintenance therapy with systemic antibiotics within 3 weeks of screening and through last dose of investigational product. * use of leukotriene synthesis inhibitor (zileuton) or leukotriene receptor antagonists (montelukast, zafirlukast) within 3 weeks of screening and at anytime during the study. * use of roflumilast within 3 weeks of screening and at any time during the study. * initiation of a new chronic medication or dosage change of a chronic medication for treatment of cystic fibrosis (example: kalydeco™ \[ivacaftor\]) within 3 weeks of screening (visit 1).

Keywords: cystic fibrosis alpha1-proteinase inhibitor alpha1-antitrypsin
effect of norwegian food based dietary guidelines on chronic diseases in crc survivors

Conditions: Colorectal Cancer

Summary: the current study is designed to gain a better understanding of the role of a healthy diet aimed at dampening inflammation and oxidative stress on long-term disease outcomes and survival in colorectal cancer patients. since previous research on the role of diet for colorectal cancer survivors is limited, the study may be of great importance for this cancer population.

men and women aged 50-80 years diagnosed with primary invasive colorectal cancer (stage i-iii) are invited to this randomized controlled, parallel two-arm trial 2-9 months after curative surgery. the intervention group (n = 250) receives an intensive dietary intervention lasting for 12 months and a subsequent maintenance intervention for 14 years. the control group (n = 250) receives no dietary intervention other than standard clinical care. both groups are offered equal general advice of physical activity. patients are followed-up at 6 months and 1, 3, 5, 7, 10 and 15 years after baseline. the study center is located at the department of nutrition, university of oslo, and patients are recruited from two hospitals within the south-eastern norway regional health authority. primary outcomes are disease-free survival and overall survival. secondary outcomes are time to recurrence, cardiovascular disease-free survival, compliance to the dietary recommendations and the effects of the intervention on new comorbidities, intermediate biomarkers, nutrition status, physical activity, physical function and quality of life.

Eligibility criteria:
inclusion criteria: * colorectal cancer (icd10 c18-20) tnm stage i-iii exclusion criteria: * tnm stage 0 or iv
early assessment of the response to neo-adjuvant chemotherapy in breast cancer patients with fdg-pet

Conditions: Breast Cancer

Summary: 18f-fdg pet, a whole-body imaging technology based on glucose metabolism, can effectively detect subclinical and clinical therapeutic responses at stages that are earlier than those detected by conventional approaches. we propose to conduct a prospective study to evaluate early therapeutic response using 18f-fdg pet before and after the 1st cycle of neo-adjuvant chemotherapy for breast cancer patients. variation of 18f-fdg pet uptake is compared to clinical and echographical tumor response evaluated after 3 cycles of chemotherapy. the purpose is to estimate the capacity of 18f-fdg pet to differentiate responder and non-responder patients.

further study details as provided by centre oscar lambret

Eligibility criteria:
inclusion criteria: * age \> 18 * breast cancer treated by neo-adjuvant chemotherapy (t\>2cm) * measurable lesions ,assessed clinically and by ultrasound * delay minimum between biopsy and pet: 15 days * ps-who: 0 exclusion criteria: * t\<2cm * inflammatory breast cancer (t4d) * diabetic patients unbalanced (glycemia\>1.40) * pregnant or lactating women

Keywords: adenocarcinoma breast
the third survey of prescription pattern of psychotropic drugs in china

Conditions: Prescription

Summary: the investigators aimed to examine the psychotropic prescription pattern in china.


Eligibility criteria:
inclusion criteria: aged 18-65, inpatient or outpatient, patient must be willing and able to give written informed consent,the patient suffers from schizophrenia or depression or bipolar disorder - exclusion criteria:aged\ 65 -

Keywords: prescription schizophrenia depression bipolar disorder
dysphagia on the intensive care unit

Conditions: Deglutition Disorders

Summary: recording of routine practice patterns to detect and/or treat dysphagia on the icu via interview of local colleagues. this will not allow to record generalizable data, but will reflect the actual routine standard of care.


Eligibility criteria:
inclusion criteria: * all senior icu physicians in charge for adult critically ill icu patients. respective icus must be accredited by the "schweizerische gesellschaft für intensivmedizin". * icus located in switzerland. * senior icu physicians willing to voluntarily fill in the provided questionnaire.

Keywords: treatment standards diagnostical approaches descriptive