Kornimate/medical-research-clean huggingface dataset:
midazolam sedation in dentally anxious patients

Conditions: Dental Anxiety

Summary: use lay language. to compare patient level of cooperation during dental care under conscious sedation with midazolam according to the administration route

the progress of the study is described below: session 1: intravenous administration of midazolam. establishment of the individual dose. randomisation. session 2 : group a : oral administration of midazolam : the dose administered is twice the individual dose determined in session 1. group b : intravenous administration of midazolam at the individual dose determined in session 1. session 3 : reversal of the procedures : group a : intravenous administration of midazolam at the individual dose determined in session 1. group b : oral administration of midazolam : the dose administered is twice the individual dose determined in session 1.

Eligibility criteria:
inclusion criteria: * - patient between 8 and 60 years, regardless of gender * patient in the american society of anesthesiologists (asa) category i ou ii. * patient in need of multiple dental care, referred to the unit of special care dentistry for cooperation difficulties * patients directed to conscious sedation under midazolam because they cannot be approached for more than a very brief examination, or following failure to treat under inhalation sedation (50% n2o/o2), or following poor cooperation during treatment under inhalation sedation (poor cooperation is defined as a score of 3 or more on the french modified version of the venham scale), or following good cooperation during short and simple treatment under inhalation sedation but in need of more complex rehabilitation. * written consent signed by the patient or his legal guardian * patient accompanied by an accountable person exclusion criteria: * - patient below 8 years or over 60 years-old * patient in the american society of anesthesiologists (asa) category iii or more * patient having accepted dental treatment without premedication or sedation, and without declaring dental anxiety, during the month prior to the appointment * patient having received an anxiolytic premedication in the 24 hours preceding the dental care session * patient already treated under midazolam sedation less than a week ago * any medical contraindication to the use of midazolam

Keywords: conscious sedation dental anxiety oral midazolam intravenous midazolam behaviour
green coffee effect on metabolic syndrome

Conditions: Supportive Care; Metabolic Syndrome; Obesity; Hypertension

Summary: the present study aimed to investigate the effect of green coffee bean extract (gcbe) on the inflammatory biomarkers in obese patients with a metabolic syndrome via analyzing some inflammatory biomarkers as resistin, tnf-α, total sialic acid, homocysteine, high sensitivity c-reactive protein (hs-crp) and anti-inflammatory cytokine, adiponectin

160 obese patients supplemented with either gcbe capsules (800 mg) daily or placebo for 6 months and advised to take a balanced diet. blood samples were collected at baseline and after three months of supplementation

Eligibility criteria:
inclusion criteria: participants were enrolled if they were * aged 20-60y * waist circumference \>102 cm in male; 88 cm in female * triglycerides ≥150 mg/dl (1.7 mmol/l) * hdl-c\<40 mg/dl (1.03 mmol/l) in males \& \<50 mg/dl (1.29 mmol/l) in females * systolic bp ≥ 130 or diastolic bp ≥ 85 mm hg. exclusion criteria: * liver, kidney, coronary artery disease, type i diabetes, autoimmune diseases, cancer, infection, smoking, recent major surgery, routine coffee consumption, pregnancy or breast-feeding, use of anti-inflammatory drugs, corticosteroids, hormone replacement therapy, weight-loss and anti-hypercholesterolemic medications three months or less prior to enrolment
safety and efficacy study of oral fampridine-sr in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: multiple sclerosis (ms) is a disorder of the body's immune system that affects the central nervous system (cns). normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. in people with ms, the fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates, causing nerve impulses to be slowed or stopped. as a result patients with ms may experience periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the ability to think and/or remember. these periods of illness may come (exacerbations) and go (remissions). fampridine-sr (sustained release, sr) is an experimental drug that increases the ability of the nerve to conduct electrical impulses. this study will evaluate the effects of fampridine-sr on the walking ability of subjects with ms, as well as to examine the effects on muscle strength and spasticity. the study will also examine the possible risks of taking fampridine-sr.


Eligibility criteria:
inclusion criteria: * have a confirmed diagnosis of multiple sclerosis * are able to walk with or without an assisted device exclusion criteria: * pregnancy, breastfeeding or females of childbearing potential not using adequate birth control * participating in other investigational drug trials * a medical history or clinical findings that preclude entry into the study * a medication history that precludes entry into the study * previously treated with 4-aminopyridine (4-ap)

Keywords: walking ability muscle strength spasticity
transfer from methadone to buprenorphine maintenance treatment using buprenorphine patches

Conditions: Heroin Addiction

Summary: buprenorphine is an important alternative to methadone in the maintenance treatment of heroin addiction. transfer from methadone to buprenorphine requires a reduction of daily methadone dosage below 30 mg to avoid withdrawal after the first buprenorphine intake. the study hypothesis states that the transfer from a daily methadone dosage between 60 mg and 100 mg to buprenorphine can be carried out without withdrawal using buprenorphine patches (35 micro grams per hour) within 12 to 48 hours after last methadone intake.


Eligibility criteria:
inclusion criteria: * age between 18 and 60 years * methadone maintenance treatment for at least 3 months preceding the study * daily methadone dosage between 60mg amd 100mg * sufficient knowledge of german language * ability to give informed consent exclusion criteria: * daily methadone dosage below 60mg amd over 100mg * prescribed use of benzodiazepines over 30 mg equivalent to diazepam * misuse or dependence of alcohol and/or ghb/gbl * pregnant or breast-feeding women * known intolerance of buprenorphine * somatic diseases interfering with the study plan

Keywords: transfer methadone buprenorphine patch heroin addiction
the impact of the sense program on nicu

Conditions: Pre-Term; Individualized Developmental Care; Sensory Experiences

Summary: the sense program will be applied to babies receiving treatment in the neonatal intensive care unit and the effect of the application on the baby and parents will be examined.

for the growth and health of the baby, the intrauterine environment provides the fetus with protective physical barriers and sensory exposures timed appropriately for its development. these early exposures occur during sensory development in the intrauterine environment, and there are differences in the timing of development of each sense. when the baby is born prematurely, the intrauterine environment is replaced by the neonatal intensive care unit environment. the sensory environment of the preterm baby includes the experiences of touch, movement, smell, sound, light, frequent nociceptive pain and disruption of sleep. the mismatch between the infant's underdeveloped coping skills and the stimulating nicu environment can cause physiological imbalance, negatively impact growth and development, and ultimately predispose to the development of long-term neurodevelopmental consequences. although harmful sensory exposures can negatively affect the development of the preterm baby, appropriate positive sensory exposures positively affect brain development.

Eligibility criteria:
inclusion criteria: * being in the first week of life exclusion criteria: * congenital anomaly, * preterm babies who are not predicted to survive, * babies who cannot be followed regularly, * parent having a psychiatric problem * parents who wish to withdraw from the study
procalcitonin monitoring sepsis study

Conditions: Severe Sepsis; Septic Shock

Summary: the purpose of this study is to investigate the relationship between a procalcitonin decrease over 72 hours and outcome in patients who have severe sepsis or septic shock.


Eligibility criteria:
inclusion criteria: * adult patients (i.e. \>18 years of age) diagnosed with severe sepsis or septic shock as defined in appendix 1, who are already in the icu or come from the ed, other wards or directly from out of hospital * blood sample collection within 12 hours after diagnosis "severe sepsis or septic shock"no prior enrollment into this study * written informed consent

Keywords: procalcitonin decrease over 72 hours severe sepsis septic shock
comparison of 3d printed foot orthoses with prefabricated foot orthoses

Conditions: Flexible Flatfoot

Summary: the goal of this clinical trial is to compare the effects of 3d printed insoles versus prefabricated insoles in otherwise healthy subjects with flatfoot condition. the main question it aims to answer is: * if 3d printed insoles are better in terms of fit, weight, durability, comfort, and effectiveness compared to prefabricated insoles. * if 3d printed insoles are better in terms of reducing pain compared to prefabricated insoles. participants will be divided in two groups. one group will receive 3d printed insoles and other group will wear prefabricated insoles for four weeks. after four weeks, researchers will record their feedback about their insoles which will help them to compare the two insoles.

the purpose of this research is to compare the effects of 3d printed insoles versus prefabricated insoles in flatfoot subjects. this study will recruit healthy adult subjects with flexible flat feet but otherwise good physical and mental health. they will be divided into groups of an equal number of people. prefabricated insoles will be given to one group, while 3d printed insoles will be given to the other. subjective feedback will be collected at week zero, when the subjects will be given the insoles to wear, and again at the end of fourth week. statistical analysis will be used to determine whether or not there is a significant difference in the responses of the two groups. the results will help us in identifying which insoles are better than the other in terms of parameters described above.

Eligibility criteria:
inclusion criteria: * age of 18 years or above * flatfoot symptoms such as foot/calf pain and fatigue after prolonged walking * foot postural index ranging from 6 to 12 * no neurological or physical disabilities exclusion criteria: * below 18 years of age * inability to understand or answer questions * any lower limb surgery within the past two years * any lower limb injury within the past six months * any neurological disorder affecting gait
capecitabine and thalidomide in previously treated metastatic colorectal carcinoma

Conditions: Colorectal Adenocarcinoma

Summary: the purpose of this study is to collect information about the antitumor activity and the safety of capecitabine and thalidomide in patients with colorectal cancer.

* patients will take capecitabine orally twice a day for two weeks followed by a one week break period. these three week cycles will continue as long as the patient continues to benefit from the the therapy and does not experience intolerable side effects. * thalidomide will be taken orally once daily in the evening. each week teh daily dose of the medication will be increased by 100mg as long as the patient is not experiencing any moderate to severe side effects. the dose will be increased in this manner until the daily dose is 600mg. if side effects do develop, the dose will either be held constant or decreased until the side effects resolve. if the side effects do not resolve, treatment will be stopped. * before starting treatment and periodically throughout the study, a physical exam, routine blood tests, scans and x-rays will be done to monitor the body's response to the treatment. * for women patients, pregnancy tests will be performed every 3 weeks while on therapy. * scans and x-rays will be performed every 9 weeks (after every 3 cycles of treatment) to follow the effects of the study drugs on the tumor.

Eligibility criteria:
inclusion criteria: * histologic proof of colorectal adenocarcinoma with radiological or cytological evidence of stage iv (metastatic) disease * measurable tumor * serum creatinine \< 1.5 mg/dl * total bilirubin \< 2.0 mg/dl * ast \< 5 x uln * anc \> 1,500/mm3 * platelets \> 100,000/mm3 * hemoglobin \> 9.0 gm/dl * must have received at least one prior chemotherapy regimen for metastatic colorectal cancer. at least 3 weeks must have passed since the last chemotherapy treatment * 18 years of age or older * ecog performance status of less than or equal to 2 * life expectancy of greater than 12 weeks exclusion criteria: * prior treatment with mitomycin c or nitrosourea compounds * prior treatment with capecitabine or thalidomide * clinically apparent central nervous system metastases or carcinomatous meningitis * peripheral neuropathy of grade 2 or greater severity * myocardial infarction in the past 6 months * major surgery in the past 2 weeks * uncontrolled serious medical or psychiatric illness * pregnant or lactating women * concurrent malignancy of any site, except limited basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix. * known allergy to 5-fu

Keywords: capecitabine thalidomide colorectal cancer
impact of pitavastatin in hypercholesterolemic patients with metabolic syndrome

Conditions: Metabolic Syndrome; Oxidative Stress; Inflammation

Summary: the purpose of this study is to evaluate anti-oxidative and anti-inflammatory effects of pitavastatin in hypercholesterolemic patients with the metabolic syndrome.

the metabolic syndrome is defined as a cluster of cardiovascular risk factors including visceral obesity, dyslipidemia, elevated blood pressure and impaired glucose tolerance. recently, it has been described that oxidative stress and inflammatory reaction, which are important in progression of atherosclerosis, increases in individuals with the metabolic syndrome. statins might have beneficial effects such as anti-oxidative and anti-inflammatory actions that are independent from their cholesterol-lowering effects. pitavastatin, a chemically synthesized statin, has potent ldl-cholesterol lowering and also anti-oxidative and anti-inflammatory effects in animal studies. however, the effects of pitavastatin on oxidative stress and inflammatory action in patients with the metabolic syndrome have not been reported.

Eligibility criteria:
inclusion criteria: * hypercholesterolemic patients exclusion criteria: * patients receiving lipid-lowering agents * familial hypercholesterolemia * renal disease * diseases of liver, gallbladder and bile ducts * pregnant women

Keywords: statin metabolic syndrome oxidative stress inflammation
efficacy and safety of a medical device for the treatment of toenail onychomycosis

Conditions: Onychomycosis of Toenail

Summary: this study evaluates the effect of the medical device "excilor® forte" in the treatment of toenail onychomycosis. half of the participants will receive the tested product and the other half will receive a comparator (amorolfin 5%). patients will be followed during 6 months.

subjects with a great toenail, affected by onychomycosis, were treated with the test medical device or reference product, respectively. after 180 days, blind assessment of the % of healthy surface (primary end point) of the great toenail was performed to compare the effect of both treatments, and to evaluate improvement versus baseline (day 0), respectively. additionally, blind assessment of the percentage of healthy surface of the great toenail was performed at all other visits (d30, d60, d120) to evaluate changes from baseline between both treatment groups. for this purpose, digital macrophotographs were analysed by a blinded investigator using adobe photoshop software.

Eligibility criteria:
inclusion criteria: * subject having given her/his informed, written consent. * subject cooperative and aware of the modalities of use and the necessity and duration of the controls so that perfect adhesion to the protocol can be expected. * subject being psychologically able to understand information and to give their/his/her consent. * age: more than 18 years. * subject with superficial onychomycosis on at least one great toenail or light to moderate disto-lateral onychomycosis (without matrix involvement and involvement \<2/3 of the tablet). * subject with positive koh staining. * subject having stopped any systemic antifungal treatment since at least 6 months before inclusion and/or any topical antifungal treatment since at least 3 months before inclusion. * female subjects of childbearing potential should use an accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after study end. exclusion criteria: * subject considered by the investigator likely to be non-compliant with the protocol. * patient enrolled in another clinical trial during the test period. · woman being pregnant, nursing or planning a pregnancy during the course of this study. * subject having a known allergy to one of the constituents of the tested products. * patient suffering from serious or progressive diseases (to investigator's discretion) such as uncontrolled diabetes, peripheral circulatory disease, hiv, psoriasis, lichen planus, immunosuppressive pathology... * subject with cutaneous pathology on studied zone (other than onychomycosis like angioma, dermatitis...).
effect of feldenkrais method in enhancing postural control for patients with diabetic polyneuropathy

Conditions: Diabetic Polyneuropathy

Summary: background: postural control is a major complication of polyneuropathy, affecting patients suffering from diabetes mellitus. purpose: to examine the effect of the feldenkrais method on dynamic balance, limits of stability and fear of falling in adults aged 45 to 60 years with diabetic polyneuropathy in the short and mid-term. methods: a single-blinded, parallel, multicentric randomized control trial was conducted in two health centers. adults aged 45 to 60 years with diabetic polyneuropathy and a history of falls or dynamic balance dysfunction were recruited from hospital databases and randomly assigned to either the study or control group. the study group received 16 sessions of feldenkrais-based sensorimotor training. both groups received diabetic foot care instructions and traditional balance exercises. outcomes were measured at 3 and 6-month follow-up intervals. dynamic balance was assessed using the timed up and go (tug) test, limits of stability using biodex and fear of falling with the falls efficacy scale (fes).


Eligibility criteria:
inclusion criteria: * individuals must have a diagnosis of diabetic polyneuropathy (dpn), confirmed by clinical examination and electrophysiological testing. * participants must have stable glycemic control for at least three months prior to enrollment. * individuals must be able to walk independently, with or without the use of an assistive device. exclusion criteria: * individuals with severe visual or vestibular impairments are excluded from participation. * participants with significant musculoskeletal disorders affecting gait are not eligible. * individuals with severe cardiovascular or respiratory conditions are excluded. * participants with cognitive impairments that prevent active participation are not eligible. * individuals currently engaged in structured physical therapy or balance training programs are excluded.

Keywords: feldenkrais method postural control diabetic polyneuropathy
huaier granule for prevention of recurrence and metastasis of stage ii and iii non-small cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer

Summary: this study including two parts，one part is a randomized clinical trial design，another part is a registration study.

this study include a multicenter, randomized, controlled, double-blind, placebo-controlled post-market clinical trial and a registration study. the randomized clinical trial included subjects (n =798) will be randomly divided into experimental (n = 532) and control groups (n =266) according to a random number table. patients in the experimental group will receive huaier granule (20g/time, 3 times/d). patients in the control group will receive placebo (20g/time, 3 times/d). the registration study plan to recruitment at least 300 patients. the primary outcome measures is disease-free survival，secondary outcome measures is 2-year overall survivals, ecog-performance status, karnofsky performance score and tumor markers (cea、cyfra21-1、scc).

Eligibility criteria:
inclusion criteria: * patients with complete resection who are at tnm (primary tumor, regional nodes, metastasis) stage ii-ⅲa, postoperative pathology confirmed for non-small cell lung cancer; * has completed four cycle standard solution of adjuvant chemotherapy, or refused to accept the postoperative adjuvant chemotherapy; * patients between 18 and 70 years old, no gender restriction; * eastern cooperative oncology group (ecog) ps of two or less; * before the start of the study, patient fully understands the study and is willing to sign the informed consent form; exclusion criteria: * receiving adjuvant chemotherapy patients started greater than 24 weeks from surgical resection; * refused adjuvant chemotherapy patients started greater than 8 weeks from surgical resection; * suspected malignant pleural effusion; * there is no clear pathological diagnosis; * combined with other cancer; * patient have a positive surgical margin; * accept other treatment for lung cancer of postoperative； * combined with severe idiopathic disease of liver, kidney and hematopoietic system; * combined psychosis or aids; * allergy to the test drug; * pregnant or lactating women; * participation in any other clinical trial within three months; * conditions that are considered not suitable for this study investigators.
glioblastoma platelet activation study

Conditions: Glioblastoma; Circulating Platelet-monocyte Conjugates

Summary: glioblastoma face an increased risk of venous or arterial thromboembolism. furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (m2) phenotype. increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.

glioblastoma face an increased risk of venous or arterial thromboembolism. furthermore, the most frequent immune cells in glioblastoma are tumor associated macrophages, which find theirself in an anti-inflammatory (m2) phenotype. increased conjugates between circulating platelets and monocytes reflect an pro-inflammatory status.

Eligibility criteria:
inclusion criteria: * mr-morphological suspicion for glioblastoma * informed consent exclusion criteria: * no informed consent

Keywords: platelet activation