Kornimate/medical-research-clean huggingface dataset:
variance of oral methadone dosage: description of implicated factors

Conditions: Heroin Dependence

Summary: the purpose of this study is to describe clinical, pharmacokinetic and genetic factors associated with the variance of oral methadone dosage for patients at the steady state of heroin dependence maintenance treatment. the hypothesis is that the investigators can predict 70% of the variance with few factors, including cyp 3a4 function measured with oral midazolam challenge.

patients at the steady state of methadone maintenance treatment may receive oral dosage ranging from 5 to 130 mg per day in our clinical practice. this study is aimed at providing a comprehensive cross-sectional description of factors involved in this variance: * comorbidity with addictive and psychiatric disorders * severity of pre-existing heroin dependence * function of cyp 3a4 enzyme assessed with oral midazolam challenge * genetic polymorphisms of enzymes implicated in methadone pharmacokinetic and pharmacodynamic (cyps, mdr1, oprm1, comt) the expected result is a predictive equation of oral methadone dosage at steady state.

Eligibility criteria:
inclusion criteria: * heroin dependence * under maintenance treatment with methadone * at steady state: stable oral methadone dosage since 3 months at least exclusion criteria: * current heroin dependence or abuse * current cocaine and/or alcohol and/or sedatives dependence * pregnancy

Keywords: methadone cyp oprm1 mdr1 comt midazolam challenge
a study to evaluate the effect of vx-548 on the qt/qtc interval in healthy participants

Conditions: Pain

Summary: the purpose of the study is to evaluate the effects of clinical and high clinical exposures of vx-548 and its metabolite on qtcf, and the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of vx-548 and its metabolite.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * a total body weight greater than (\>) 50 kilogram (kg) key exclusion criteria: * history of febrile illness within 5 days before the first dose of study drug * any condition possibly affecting drug absorption * known hypersensitivity or prior adverse reaction to moxifloxacin or other quinolones other protocol defined inclusion/exclusion criteria may apply.
non-invasive ways to evaluate lung disease after treatment with xolair

Conditions: Lung Disease

Summary: the purpose of this study is to study the effects of xolair using non-invasive techniques from the expired gas of patients with moderate to severe allergic asthma.

traditional methods of sampling secretions from the lower respiratory tract include sputum collection, sputum induction, and bronchoscopy with bronchoalveolar lavage. they cannot be repeated within a short period of time because of their invasiveness, and because the procedures themselves may include an inflammatory response. the need to monitor inflammation in the lungs has led to the exploration of exhaled gases and condensates. noninvasive monitoring may assist in differential diagnosis of pulmonary diseases, assessment of disease severity and response to treatment.

Eligibility criteria:
inclusion criteria: * on medium to high dose inhaled corticosteroids either with or without a long acting beta agonist * baseline ige 30-700 iu/ml * exhaled nitric oxide greater than 13 ppb * positive skin test to at least one of the following perennial allergens: cat, dog, dust mite, cockroach * stable asthma at the time of enrollment exclusion criteria: * concurrent diseases/conditions, history of other diseases/conditions, with clinically significant uncontrolled systemic disease or a history of such disease (eg, infection, hematological, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinological, or gastrointestinal disease) within previous 3 months * upper or lower respiratory tract infection within 6 weeks of screening visit * elevated ige level other than atopy * known sensitivity to xolair * \< 3 months of stable immunotherapy * smokers * pregnant/nursing women * women of childbearing potential who are not practicing medically approved contraceptive methods (eg, oral, subcutaneous, mechanical, or surgical contraception) including abstinence * patients who currently hav diagnosed cancer, are currently being investigated for possible cancer or who have any history of cancer * known sensitivity to study drug or class of study drugs * patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study * use of any other investigational agent in the last 30 days.

Keywords: moderate to severe allergic asthma
mitochondrial dysfunction and oxidative stress in chronic obstructive pulmonary disease (copd) patients

Conditions: COPD Patients

Summary: the purpose of this study is to understand the underlying mechanisms of improved exercise tolerance in copd patients after training program.

training protocol used is based on recommendations (nici et al., 2006) and was previously used in our group (varray et al., 1991; vallet et al., 1997). a minimum of 20 sessions in 4-6 weeks were proposed. the exercise intensity of exercise corresponds to target heart rate at ventilatory threshold measured during incremental exercise test. training at this intensity allowed us to individualize effort for each patient.

Eligibility criteria:
inclusion criteria: * sedentary mild to severe copd patients exclusion criteria: * neuromuscular disease * chronic heart failure * renal diseases * liver diseases * obesity

Keywords: copd exercise tolerance oxidative stress
physical activity in chronic obstructive pulmonary disease(copd) acute exacerbation patients

Conditions: COPD Exacerbation

Summary: patients who are suffering from chronic obstructive pulmonary disease (copd) had a decreased level of physical activity which is consequentially related to another acute exacerbation event. in this study, we selected patients from those who were admitted for acute exacerbation of copd, evaluated physical activity by accelerometer (wearable multisensory armband devices) to find out the correlation between physical activity in copd acute exacerbation patients.


Eligibility criteria:
inclusion criteria: * copd patient who have forced expiratory volume in one second/ forced vital capacity (fev1/fvc) \< 70% by spirometry and those who have not been admitted for acute exacerbation in recent 3 months exclusion criteria: * those who does not consent or those who have drug addiction, psycho-socially or medically not feasible to this study

Keywords: chronic obstructive pulmonary disease chronic obstructive pulmonary disease acute exacerbation physical activity wearable arm device
conservative nodal surgery (node-picking) of patients with stage iii melanoma with low-burden of nodal disease (melconsurg multicentre cohort)

Conditions: Melanoma Stage III

Summary: background: standard treatment for stage iii melanoma with lymph node metastases involves complete lymph node dissection, which is a radical surgical procedure aimed at the removal of the entire regional lymph node basin. conservative surgery for low-burden nodal metastasis involves removal of the metastatic lymph node or nodes ("node-picking"), leaving uninvolved nodes within the regional basin. this is expected to provide adequate regional control of the disease with no negative impact on patient survival and a lower rate of surgical complications. aims: the melconsurg cohort will provide the first data on conservative surgery for patients with stage iii melanoma with nodal metastases detected clinically or by imaging. methods: a multicentre, single-arm prospective cohort study. inclusion criteria: patients with melanoma aged between 18 and 90 years, eastern cooperative oncology group performance status 0-1, non-matted regional lymph node metastasis (n1b or n2b) in a single regional basin detected clinically or by imaging (ultrasound, ct scan, pet scan). study period: a 3-year recruitment period and a 3-year follow-up phase. intervention: patients will undergo conservative nodal surgery using conventional surgery, radio-guided surgery, or imaging guided surgery. outcome measures: 3-year nodal relapse-free survival, 3-year disease-free survival, 3-year melanoma-specific survival, rate of surgical complications, and quality of life (sf-36 questionnaire). sample size \& statistics: the estimated sample size to be recruited is 68 patients. survival outcomes will be analysed through the kaplan-meier method, with the log-rank test. conclusions: this project is expected to provide unique evidence regarding a less radical nodal surgery for patients with melanoma. if favourable results are obtained, controlled studies could be conducted and changes in current clinical practice could be considered.


Eligibility criteria:
inclusion criteria: * patients with melanoma aged between 18 and 90 years. * eastern cooperative oncology group (ecog) performance status 0-1. * nodal stage n1b or n2b (american joint committee on cancer 8th edition) in a single regional basin detected clinically or by imaging (ultrasound, ct scan, pet scan). exclusion criteria: * single lymph node metastasis in more than one regional basin. * multiple primary melanoma (except for limb melanoma). * primary occult melanoma. * previous nodal, locoregional, or distant metastasis. * previous lymph node surgery, except for slnb. * distant metastases detected at the screening evaluations or first postoperative pet-ct scan.

Keywords: surgery lymph node dissection conservative nodal surgery lymph node metastasis melanoma stage iii melanoma
the efficacy of a probiotic product on acute upper respiratory tract infections (common cold) in healthy children

Conditions: Acute Upper Respiratory Tract Infections (Common Cold)

Summary: the aim of the present study is to test the efficacy of the combination of two probiotic bacteria in reducing the severity of upper respiratory tract infections (common cold) in healthy children attending day care or school. the probiotic bacteria used are lactobacillus plantarum strain dsm 15312 and lactobacillus paracasei dsm 13434 at a total dose of 1 x 10\^9 cfu/tablet and day and will be consumed for a period of 12 weeks.


Eligibility criteria:
inclusion criteria: 1. parents / legal guardians signed written informed consent to participate in the study. 2. healthy children (male and female) aged 3 to 7 years old (inclusive) at enrollment. 3. children attending day care center or school. 4. no consumption of commercial products containing probiotics during the whole study period. 5. children not being intensive consumers of regular yoghurts (no more than one 125 g serving per day). 6. ability of the parents / legal guardians (in the investigator's opinion) to comprehend the full nature and purpose of the study. 7. parents' / legal guardians' consent to the study and willing to comply with all its procedures. exclusion criteria: children presenting one or more of the following criteria will not be eligible to enter the study. 1. flu vaccine administration within the last 3 months prior to enrollment. 2. use of antibiotics within the last 30 days prior to enrollment. 3. acute infection or fever at enrollment. 4. any congenital or chronic disease that in the opinion of the investigator would adversely affect the results of the study. 5. any kind of immunodeficiency or allergy (including known food allergy). 6. subjects with known hypersensitivity or allergy to any component of the study products. 7. significant illness within the 2 weeks prior to the enrollment or any active systemic infection or medical condition that may require treatment or therapeutic intervention during the study. 8. currently participating or having participated in another clinical trial during the last 4 weeks prior to the beginning of this study.
hemorrhoids: options of traditional hemorrhoidectomy

Conditions: Hemorrhoids; Open Hemorrhoidectomy

Summary: the goal of this prospective clinical trial is to compare the outcomes of several technical options of open hemorrhoidectomy in patients with symptomatic hemorrhoids. randomly allocated participants will undergo surgical treatment for hemorrhoids with one technical option of open hemorrhoidecomy: with 'cold' scalpel or electrosurgical instruments. all information to evaluate outcomes between the groups will be collected before surgery and 1 week and 30 days after surgery.

this is a single-center prospective randomized controlled study will be conducted on the basis of the surgical department. patients with symptomatic hemorrhoids and who will be intended for surgical treatment (open hemorrhoidectomy) will be randomly allocated to one of the group. prior to surgery the demographic and clinical data will be collected. open hemorrhoidectomy under spinal anesthesia will be performed with one of the technical options according to the patient's group: * hemorrhoidectomy with 'cold' scalpel for cutting the perianal skin and anal mucose * hemorrhoidectomy with electrosurgical scalpel for cutting the perianal skin and anal mucose. intraoperative and postoperative data will be collected during first week after surgery and 30 days after surgery. then the primary and secondary outcomes are evaluated between the groups.

Eligibility criteria:
inclusion criteria: * patients over 18 years old * diagnosed symptomatic hemorrhoidal disease * planned surgery - open hemorrhoidectomy * absence of other anarectal diseases * i, ii class of anesthetic risk according to asa classification * voluntary signing by the participant of an informed consent for surgical treatment and participation in a clinical trial. exclusion criteria: * chronic or prolonged use of medications, including narcotic drugs, with analgesic effect for other diseases. * patients who have contraindications or technical impossibility of performing subarachnoid anesthesia or the full standard volume of surgery for the corresponding disease. * patients who refused to participate at any time before the end of the study, as well as patients who did not pass the final postoperative monitoring (1 month after the intervention). * pregnant women * complicated course of the postoperative period due to exacerbation of concomitant diseases

Keywords: symptomatic hemorrhoids open hemorrhoidectomy postoperative pain electrosurgery
tyrosine hydroxylase antibody levels in autoimmune polyglandular syndrome type 1 associated keratitis

Conditions: Autoimmune Polyglandular Syndrome Type I; Autoimmune Keratitis

Summary: tyrosine hydroxylase autoantibodies impair sympathetic innervation leading to keratitis. in this study, the investigators have shown the significant association between severity of keratitis and presence of tyrosine hydroxylase autoantibodies.

sixteen consecutive cases diagnosed with aps-1associated keratitis were included in this study. each patient underwent complete ophthalmologic examination. blood was obtained from each patient for testing the endocrine functions and determination of a panel of autoantibodies to the following: side-chain cleavage enzyme (ssc), aromatic l-amino acid decarboxylase (aadc), tryptophan hydroxylase (tph),tyrosine hydroxylase ( th), 17 α-hydroxylase (17α-oh), cytochrome p450 1a2 (cyp1a2), 21-hydroxylase (21-oh), potassium channel regulatory protein (kcnrg), tyrosine phosphatase-like protein ia-2 (ia-2), glutamic acid decarboxylase 65 (gad65), nact leucine-rich-repeat-protein 5 (nalp5), and interleukin (il) 22.

Eligibility criteria:
inclusion criteria: * consecutive patients diagnosed with aps-1associated keratitis exclusion criteria: * none

Keywords: tyrosine hydroxylase autoantibodies autoimmune polyglandular syndrome
effect of folic acid treatment in coronary artery disease

Conditions: Coronary Artery Disease

Summary: we seek to examine the effects of folic acid treatment on vascular function in patients with coronary artery disease. our hypothesis is that folic acid treatment will improve vascular function

common vascular disease states including diabetes and atherosclerosis are associated with endothelial dysfunction, characterised by reduced bioactivity of nitric oxide (no). folates are thought to improve endothelial function,but the mechanism by which this effect occurs is poorly understood. we propose to study the effects of folate supplementation on endothelial function in patients with coronary artery disease.

Eligibility criteria:
inclusion criteria: clinical diagnosis of coronary artery disease exclusion criteria: recent acute coronary event renal and/or hepatic dysfunction metallic implants

Keywords: coronary artery disease folic acid endothelial function
a chinese herbal decoction for stress urinary incontinence

Conditions: Urinary Incontinence, Stress

Summary: the purpose of this study is to determine whether yiqi suoquan tang, a chinese herbal decoction, is effective in the treatment of female stress urinary incontinence.

the pilot randomized, controlled trial is aimed to preliminarily assess the effectiveness of yiqi suoquan tang, a chinese herbal decoction, in the treatment of female stress urinary incontinence (sui). eligible participants will be randomly allocated to receiving yiqi suoquan tang or pelvic floor muscle training (pfmt) using a random number generator in a 1:1 ratio. to minimize the evaluation bias, the outcome assessors and statisticians will be masked to treatment allocation. assuming a two-sided alpha of 0.05, power of 90%, and a 20% drop-out, a sample size of 36 would be needed for each group. the statistical analysis will be performed based on the intention-to-treat principle, which is defined as patients that have received at least one treatment. missing data will be replaced by the last observed value. continuous variables will be compared by student t test or mann-whitney u test; categorical variables will be analyzed by chi-square test, fisher's exact test or kruskal-wallis h test as appropriate. for comparison between two time points, paired t-test or wilcoxon signed rank test will be used as appropriate. a statistically significant difference was set at p\<0.05.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of stress urinary incontinence * must be able to swallow chinese hebal decoction exclusion criteria: * urinary tract infection * neurogenic bladder * pelvic organ prolapse \> stage 2 * overactive bladder * previous anti-incontinence surgery * post-void residual urine volume (pvr) \> 100ml.

Keywords: stress urinary incontinence chinese herb traditional chinese medicine pelvic floor muscle training
chronic stress as a risk factor in the etiology of coronary heart disease

Conditions: Cardiovascular Diseases; Coronary Disease; Heart Diseases

Summary: to conduct a prospective, longitudinal, analysis of the psychophysiological effects of chronic exposure to environmental stress. the study took advantage of a unique, naturally occurring experiment caused by the relocation of a major international airport.

design narrative: studies were conducted on blood pressure and the neuroendocrine effects of noise resulting from the relocation of the munich international airport. at the former airport site the investigators monitored people exposed to high levels of noise and then tracked these same individuals as their ambient environment became normal following the shutdown of the airport. at the new airport site, the opposite situation occurred: individuals living in normal, quiet ambient conditions became exposed to loud aircraft noise. at both sites, control groups were formed who were not exposed to aircraft noise. the study piggybacked onto a german sponsored grant. nih funds covered the costs of cardiovascular and psycho-physiological data analysis. measures included biochemical assays of chronic neuroendocrine markers of stress, resting blood pressure, and reactivity of blood pressure during cognitive tasks. perceptions of community noise levels were also assessed as possible mediators of the stressful effects of chronic exposure to ambient, environmental noise. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
safety of closed-loop hybrid insulin administration during ramadan fasting in people living with type 1 diabetes

Conditions: Type1diabetes

Summary: fasting in ramadan is not recommended for people with type 1 diabetes. the main risk associated with fasting is dysglycemia (hypoglycemia, hyperglycemia, diabetic ketosis) and dehydration. nevertheless, whether or not to practice ramadan remains a personal choice and many people living with diabetes choose to perform this fast with or without their physician's approval. the purpose of this prospective observational study is to evaluate the safety and efficacy of an closed-loop hybrid insulin system on glycemic parameters and the level of hypoglycemia in patients with type 1 diabetes who wished to fast during ramadan.

primary objective: to evaluate the efficacy of an closed-loop hybrid insulin system on continuous glucose monitoring (cgm) glycemic parameters during the ramadan fasting period primary endpoint : to compare the time spent in the 3.9-10.0 mmol/l glucose target (tir) from 30 days prior to the ramadan fasting period to 30 days during the fasting period

Eligibility criteria:
inclusion criteria: * age \> 18 years * type 1 diabetes for \> 1 year * on using closed-loop hybrid insulin administration * scheduled ramadan fasting * patient put on using closed-loop hybrid insulin administration more than 2 months before the start of the ramadan fast * percentage of continuous glucose monitoring sensor wear \> 70% in at least one of the two 30-day periods exclusion criteria: * patient put on using closed-loop hybrid insulin administration less than 2 months before the start of the ramadan fast * patient who is pregnant or wants to become pregnant immediately * patient informed of the study who objected to the collection of his/her data.

Keywords: type1diabetes the ramadan fasting period closed-loop hybrid insulin administration