Kornimate/medical-research-clean huggingface dataset:
the efficacy and safety of robotic bronchoscopy system-assisted stent placement in patients with malignant central airway stenosis

Conditions: Airway Stenosis

Summary: the primary aim of this research is to assess the efficacy and safety of the bronchial navigation positioning equipment in assisting stent implantation for malignant central airway stenosis while guaranteeing the safety of the participants and the scientificity of the clinical trial.


Eligibility criteria:
inclusion criteria: * patients are eligible only if they fulfill all of the following criteria: 1. age ≥ 18 years, regardless of gender; 2. patients voluntarily consent to airway stent implantation and meet the requirements for airway stent implantation under general anesthesia; 3. confirmed as having malignant central airway stenosis through bronchoscopy and being ineligible for surgery or refusing surgery, and in need of airway stent implantation. patients should be able to understand the purpose of the trial, demonstrate good compliance with the examinations and follow-ups, and voluntarily participate in the clinical trial and sign the informed consent form. exclusion criteria: * patients fulfilling any of the following criteria will be excluded from this study: 1. severe dysfunction of the heart, lungs, liver, or kidneys, intolerant of bronchoscopic treatment; 2. apparent coagulation dysfunctions; 3. pregnant or lactating women, or participants with a pregnancy plan during the study period; 4. patients with implanted cardiac pacemakers, implanted defibrillators, or other active implants; 5. participants allergic to photosensitizers or anesthetics, or with a history of multiple severe allergies or hereditary allergies; 6. participants who have participated in or are currently participating in drug clinical trials within the past 3 months, or in other medical device clinical trials within the past 30 days; other circumstances that the investigator considers inappropriate for participation in this clinical trial.
permian health women's lung health study

Conditions: COPD; Lung Function Decreased; Alpha 1-Antitrypsin

Summary: the goal of this cross-sectional observational study is to estimate the prevalence of lung function impairment as measured by spirometry in a population of gambian women aged 15 and older. the main question\[s\] it aims to answer are: * what is the prevalence of lung function impairment in gambian women * what is the prevalence of eosinophilic inflammation in gambian women consenting participants will undergo * spirometry * fractional exhaled nitric oxide (feno) testing * α1-antitrypsin testing in patients with lung function impairment as assessed by spirometry


Eligibility criteria:
inclusion criteria: * self-identified female sex * age \> 15 years: this age cutoff was chosen (as opposed to 18) because of the unique cultural norms and practices in the country where experiences and exposures occur at an earlier age than women in western countries. exclusion criteria: * age \< 15 years * non-resident household member * any acutely unwell individual * pregnancy * any known history of active pulmonary disease (including tb) on treatment. * individuals unable or unwilling to give consent.
a trial of atg-101 in patients with metastatic/advanced solid tumors and mature b-cell non-hodgkin lymphomas

Conditions: Advanced Solid Tumor; Metastatic Solid Tumor; Mature B-cell Non-Hodgkin Lymphoma

Summary: this is a first-in-human phase i trial of atg-101 in patients with metastatic/advanced solid tumors and mature b-cell non-hodgkin lymphomas.

this is a first-in-human phase i trial of atg-101 in patients with metastatic/advanced solid tumors and mature b-cell non-hodgkin lymphomas. dose escalation phase: approximately 40-50 subjects with a maximum number of 62; 1-20 subjects for enhanced pdx cohort. dose expansion phase: estimated between 2 and 5 cohorts, each of approximately 40-50 patients to be expanded.

Eligibility criteria:
inclusion criteria: 1. provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses. 2. aged 18 to 75 years as of the date of consent. 3. histological or cytological confirmation of a solid tumor, and has relapsed or refractory from standard therapies. 4. subjects with solid tumors have at least 1 measurable lesion per recist v1.1. 5. estimated life expectancy of a minimum of 12 weeks. 6. eastern cooperative oncology group (ecog) performance status 0 or 1 at icf signature. exclusion criteria: 1. subjects with cns tumors or known cns metastases will be excluded from the dose escalation phase. 2. prior treatment with a 4-1bb agonist. 3. subjects with primary liver cancer. 4. known history of human immunodeficiency virus infection. 5. history of hypersensitivity or history of allergic reactions attributed to drugs with a similar chemical or biologic structure or class to atg-101. 6. pregnant or nursing females.
a pedicled buccal periosteal flap for the closure of oro-antral fistula

Conditions: Oroantral Fistula

Summary: the aim of this study is to evaluate both clinically and radiologically the efficacy of using the pedicled buccal periosteal flap for closure of oroantral fistula without affecting the original intraoral anatomy.

background: oroantral fistula (oaf) is a pathological communication between the oral cavity and the maxillary sinus. a variety of surgical techniques have been developed, with recurrence rates of up to 33%7, mainly due to wound contraction and postoperative infection. to increase the success rates of oaf closure procedures, the use of double-layered closure techniques has developed, but most of these techniques alter the original oral anatomy and may result in significant postoperative morbidity. purpose: the aim of this prospective study is to evaluate both clinically and radiologically the efficacy of using the pedicled buccal periosteal flap for closure of oroantral fistula without affecting the original intraoral anatomy. patients \& methods: ten patients with oroantral fistula will be included in this study. the patients will be examined and managed at the oral and maxillofacial surgery department, faculty of dentistry, tanta university. preoperative evaluation: it will include the collection of demographic data, medical status and relevant history of the oaf (etiology, duration, resonance of voice, regurgitation of fluid, infection and previous surgical closure attempts). cone beam computed tomography (cbct) scan will be performed to determine the size of the underlying bony defect. surgical procedure: the buccal mucoperiosteal flap will be splitted horizontally into two layers: a deep periosteal layer and a superficial buccal mucosa layer. the fistula tract will transected at the bone level, the pedicled deep periosteal layer will be dissected and turned over the fistula at the bone level and will be stabilized using sutures. the superficial layer will be returned to its original position and sutured. postoperative evaluation: the patients will be evaluated clinically each week for one month regarding to healing, presence of infection, inflammation and recurrences.

Eligibility criteria:
inclusion criteria: 1. patients have oroantral fistula 2. clear maxillary sinus with no infection exclusion criteria: 1. patients suffering from any systemic diseases affect healing of soft tissue 2. patients have remaining roots or foreign body in sinus indicated for cald well luc opearation

Keywords: oroantral fistula a pedicled buccal periosteal flap
phospholipase a2 producing bacteria and pre-term labor

Conditions: Preterm Labor

Summary: the purpose of this study is to better understand (1) if phospholipase a2 producing microorganisms and cytokines (il-1, il-4, il-6, il-10, and il-13) are associated with premature labor (2) if pregnant teens are more likely to have phospholipase a2 producing bacteria than a pregnant adults and (3) if there is a difference in the cytokines between pregnant teens and adults.we hypothesize that phospholipase producing microorganisms may trigger the onset of premature labor. the following are hypothesized: (a) the microorganism cultured should show high activities of phospholipase a2 (b) the cervical length measurement predictive value should correspond to the gestation age at term (c) vaginal flora of teen will be more susceptible to colonization with higher phospholipase a2 producing bacteria than that of an adult (d) the maternal genotype contribution to the concentration of il-1, il-4, il-6, il-10, il-13, and tnf-alpha during the first trimester of pregnancy in teens is different in the production of inflammatory cytokines and modulators(e) the maternal genotype of teens therefore influences the production of phospholipase a2 and causes an increase in preterm delivery.


Eligibility criteria:
inclusion criteria: 1. gestational age \<34 weeks 2. singleton gestation 3. urinalysis and urine culture collected via clean catch 4. age range 14 - 45 5. patient receiving prenatal care at camc women's medicine center exclusion criteria: 1. in labor or with uterine contractions 2. known fetal anomalies 3. cerclage 4. dark amniotic fluid suggestive of previous bleeding 5. multiple gestation 6. known unbalance chromosomal complement 7. pregnant patient with prior history of excisional cervical biopsy (either cold knife, loop electrosurgical excision procedure, or laser conization) 8. patient with mullerian anomaly 9. patient with 2 or more d\&e secondary to spontaneous or induced abortion
dexamethasone versus dexmedetomidine in ipack block to reduce pain post arthroscopic knee surgeries

Conditions: Efficacy of Drugs in Pain Management

Summary: the investigators will test the effects of dexamethasone versus dexmedetomidine as adjuvant to bupivacaine in ipack block and it's direct effect in decreasing pain post operative following arthroscopic knee surgeries

a.preoperative settings: all patients will be assessed preoperatively by careful history taking, full physical examination, and laboratory evaluation. an informed written consent will be taken from every patient just before the surgery. b.intraoperative and postoperative settings: on arrival to the operating room, baseline parameters such as ecg, mean arterial blood pressure, heart rate, and oxygen saturation will be recorded. intravenous line will be inserted and iv ringer's solution will be started, 500ml bolus will be given as a preload over 20 min before performing spinal anaesthesia and maintenance volume of 10ml\\kg. for each group, patients will be put in supine position, the procedure will be performed under complete aseptic precautions and all patients will be divided into three groups:(group 1) for ipack block with 0.25% bupivacaine only. (group 2) for ipack block with 0.25% bupivacaine and dexamthasone and (group 3) for ipack block with 0.25% bupivacaine and dexmedetomidine .

Eligibility criteria:
inclusion criteria: * physical status: asa i,ii. both sexes. bmi\<35 exclusion criteria: * refusal of the procedure or participation in the study by the patient. physical status: asa iii or above. history of allergy to the study drug. evidence of local infection at site of injection. major hepatic, renal, or cardiovascular dysfunction. bmi\>35.
addition of computer simulations to minimize adverse events after transcatheter aortic valve implantation

Conditions: Aortic Valve Stenosis; Bicuspid Cardiac Valve

Summary: the objective is to assess the influence of feops heartguide on overall device success in tavi patients with challenging anatomies (cohort a) or in transcatheter heart valve (thv) platform selection (cohort b).

rationale transcatheter aortic valve implantation (tavi) is increasingly used to treat patients with severe aortic stenosis. however, by extending the indication for tavi, simulation may become increasingly important to improve procedure execution, safety and efficacy. objective assess the influence of feops heartguidetm on overall device success in challenging anatomies (cohort a) or in transcatheter heart valve (thv) platform selection (cohort b). study design prospective, observational multi-center trial with 2 cohorts. study population 1. cohort a: patients with challenging anatomy undergoing evoluttm tavi (medtronic, minneapolis, minnesota), to evaluate the influence of feops heartguidetm on overall device success through valve size and implantation depth. 2. cohort b: consecutive patients, eligible for tavi with acurate neo2 tm (boston scientific, marlborough, massachusetts) to evaluate the influence of feops heartguidetm on overall device success and pvl prediction. main endpoints 1. overall device success conform varc-2 including need for new permanent pacemaker. 2. incidence of \> trivial paravalvular leakage (pvl) 3. need for new permanent pacemaker

Eligibility criteria:
inclusion criteria: * cohort a: 1. patients with a bicuspid aortic valve (sievers 0 or 1) or functional bicuspid aortic valve 2. patients with a severely calcified aortic valve (agatston score \> 3000 for men, and \> 1600 for women) 3. patients with small anatomy defined by mean aortic annulus diameter \< 20mm * cohort b: 1. every patient accepted for tavi and eligible for acurate-neo2-valve. exclusion criteria: * poor ct quality * previous aortic valve replacement * permanent pacemaker at baseline
efficacy and safety of low amplitude electroconvulsive therapy

Conditions: Depression

Summary: the purpose of this study is to demonstrate the clinical feasibility of low amplitude electroconvulsive therapy (ect) to reduce, and possibly eliminate the side effects of ect by lowering the strength of the ect stimulus from the conventional 800 ma to 500 ma. low amplitude ect could potentially reduce the risks associated with ect while preserving its unparalleled efficacy. this novel development would remove key obstacles to allow for the wider adoption of ect as a safe and effective therapy.


Eligibility criteria:
inclusion criteria: 1. male and female subjects, age 18-70 2. dsm-iv-tr diagnosis of major depressive episode in unipolar or bipolar disorder, confirmed by the mini-plus 3. mmse total score \> 26 4. referred for ect 5. competent to provide informed consent 6. able to read or comprehend english exclusion criteria: 1. lifetime history of schizophrenia, schizoaffective disorder, mental retardation 2. current neurostimulation treatment (e.g., ect, magnetic seizure therapy, transcranial magnetic stimulation, vagus nerve stimulation, deep brain stimulation) 3. current alcohol abuse or dependence within past 6 months 4. current substance abuse or dependence within past 6 months 5. history of central nervous system (cns) disease 6. current diagnosis of dementia or delirium 7. moca total score \< 26 8. current visual, auditory, or motor impairment that compromises ability to complete evaluations 9. patients with intracranial implants 10. mri contraindications: pregnancy, implanted metal, and claustrophobia
metabolic effect of insulin aspart and human insulin in different doses

Conditions: Diabetes Mellitus

Summary: the metabolic effect of three different doses of insulin aspart and human insulin are investigated with the euglycaemic glucose clamp technique.

double-blind, randomized, 6-period cross-over study in 16 healthy subjects. each patient participates in 6 euglycemic glucose clamp experiments each. the time interval between the study days is 2 to 28 days. at the clamp visits, subjects are connected to a biostator (mtb medizintechnik, ulm, germany) and receive an intravenous human insulin infusion (rate of 0.15 mu/kg/min) over the duration of each experiment to prevent a rise in endogenous insulin secretion. after a baseline period of 2 h the trial drug (6, 12, or 24 u of either insulin aspart or regular human insulin in random order) are administered s.c. with a syringe into the abdominal wall. glucose infusion rates (gir) necessary to keep blood glucose concentrations close to the clamp level of 90 mg/dl (5 mmol/l) are administered and recorded by the biostator every minute for a period of 12 h post-dosing. blood samples are drawn at regular intervals for the analysis of c-peptide and (depending on the trial drug administered) serum insulin or serum insulin aspart concentrations (measured with specific elisas).

Eligibility criteria:
inclusion criteria: * signed informed consent obtained before any trial-related activities * healthy subjects between 18 and 45 years inclusive * considered generally healthy upon completion of medical history and physical examination * body mass index (bmi) \< 27 kg/m2 * hba1c \< 6,1 % * non-smoker for at least three months * females of childbearing potential using acceptable methods of contraception, including tubal ligation, an intrauterine device (iud), the oral contraceptive pill or barrier methods. exclusion criteria: * participation in any other clinical trial and receipt of any investigational drug within four weeks prior to this trial * previous participation in this trial * clinically significant abnormal haematology or biochemistry screening test * any disease requiring use of non topical prescription medicines * any serious systemic infectious disease that occurred in the four weeks prior to the first dose of test drug * any intercurrent illness that may affect blood glucose * current addiction to alcohol or substances of abuse as determined by the investigator * known or suspected allergy against insulin or any component of the composition of the trial drug * blood donation \> 500 ml within the last nine weeks * mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation * if female, subject is pregnant or lactating

Keywords: euglycaemic glucose clamp duration of action late metabolic activity hypoglycaemia
individualized medical training and calcipotriol and betamethasone dipropionate gel in plaque psoriasis

Conditions: Psoriasis

Summary: the aim of the study will be to evaluate the impact of this individualized practical training on efficacy (evaluated by psoriasis area and severity index (pasi) and body surface area (bsa) score performed by a physician blinded to the study groups) and adherence (calculated as days wherein gel was applied and as bsa/weight of gel applied rate) to a 4 week long treatment with dovobet gel. on the other hand, the investigators will evaluate in both groups as demographic (as sex, age, job,..) or disease (as severity, duration, impact of quality of life,..) characteristics influence the adherence to the treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of psoriasis will be maid mainly on clinical findings. if doubts, a skin sample will be obtained and evaluated by histopathological examination. exclusion criteria: * patients with palmoplantar, scalp, inverse, erythrodermic, guttate, pustular psoriasis will be excluded.
knowledge and practice of chinese medical specialists regarding chronic hepatitis b virus infection

Conditions: Hepatitis B

Summary: the aim of this study was to evaluate knowledge and behavior of physicians regarding hepatitis b virus. the investigators designed a 30-item self-administered questionnaire assessing physicians' knowledge and behavior regarding chronic hepatitis b virus infection. these results provide data support for updating guidelines, continuing training, and even developing policies in medical insurance.

schedule of the study: before march 1, 2015: study design, completing questionnaire design, and all preparatory work; before july 1, 2015: a kick-off meeting for plot study, modifying the questionnaire, and obtaining all the questionnaires; before september 30, 2015: finishing data entry, statistical analysis, drafting the report, and issued a final report

Eligibility criteria:
inclusion criteria: 1. mainly engaged in liver disease diagnosis and treatment; 2. diagnosis and treatment at least 10 patients with chronic hepatitis b virus infection per week. exclusion criteria: 1. young doctors working in less than one year; 2. physicians working in hospital of traditional chinese medicine 3. visiting doctors.
pilot test of a healthy metabolic behaviour tool

Conditions: Metabolic Disease; Obese; Diet Habit

Summary: this study aims to validate and pilot test the short-term intervention effect of a newly developed healthy metabolic behaviour tool, named as the 6p tool, on dietary attitude/ practice and body weight changes over one month among overweight and obese women. a total of 50 women, aged 21-40 years, bmi ≥25 kg/m2, who are attending the preconception clinic and planning for a pregnancy over the next one year, will be invited to participate in this pilot study. the recruitment period is estimated to take up to 10 weeks, with subsequent 1 month follow-up visit.

preconception is a stage that could critically influence subsequent antenatal and postnatal health of mother and offspring. in singapore, approximately one-third of women are overweight and obese during the preconception period. in the present pilot study, the investigators aim to introduce a simple, self-administered tool that can identify discrete components of an individual's diet, which would lead to self-awareness, self-evaluation and self-education, and over time, results in a positive change in eating habits and health. specifically, the study aims i) to validate a newly developed tool that comprises six main dietary components (6p), namely portion, proportion, pleasure, phase, physicality and psychology in overweight and obese women during the preconception period; (ii) and to assess the short-term intervention effect of the 6p tool on dietary attitude/ practice and body weight changes over one month. the investigators hypothesise that intervention using this 6p tool in overweight and obese women will help them to promote healthy eating behaviours and reduce body weight. this study targets to recruit 50 overweight/ obese preconception women, from kk women's and children's hospital, to evaluate the effectiveness of the tool over one month. throughout the one month follow up period, nudges in the form of text messages/images related to the 6p goals will be sent to participants through mobile phone. this validated 6p tool is planned to be applied in a preconception targeted intervention cohort in order to build a positive mental model in healthy eating among overweight and obese women, enhancing awareness and belief towards weight management behaviour, and promoting a healthy life cycle.

Eligibility criteria:
inclusion criteria: * age 21-40 years * body mass index \>= 25 kg/m2