Kornimate/medical-research-clean huggingface dataset:
follow-up studies of primary snoring(ps) and obstructive sleep apnea hypopnea syndrome(osahs) in chinese children

Conditions: Obstructive Sleep Apnea Syndrome

Summary: the study is designed to investigate the natural course of primary snoring in 1-2 years or more and the different effect of drug and surgical treatment applied in children with obstructive sleep apnea (osas) by comparing the polysomnography(psg) and sleep questionaires in 6 months after treatment.

the evolution of snoring and osas in children is not well established since few studies have been published.this study is designed to evaluate the evolution of primary snoring and osas in children who had been submitted to watchful waiting 、drug or adenotonsillectomy.the participated children will be evaluated by full physical examination and nocturnal polysomnography（psg）, after which they were divided into 2 groups: apnea and snoring. after 6 months following the initial evaluation, patients were submitted to a new nocturnal polysomnography, and all data were compared to those of the first examination.and after 3 months and 12 months following the initial evaluation, patients will be called to complete the sleep questionnaire.then analyse the change of parameters of polysomnography after 6 months of follow-up,and describe the changes of items of sleep questionnaire.

Eligibility criteria:
inclusion criteria: * children aged 3-12 yrs, who are referred for clinical evaluation of habitual snoring and who were scheduled for an overnight polysomnogram. exclusion criteria: * children who are suffered from any chronic medical or psychiatric condition * children with acute respiratory infection * children with severe craniofacial deformities * children with cardiopulmonary diseases * children with a genetic syndrome that was known to affect cognitive abilities, or are receiving medications that are known to interfere with memory or sleep onset or heat rate

Keywords: follow up primary snoring obstructive sleep apnea syndrome
clonal hematopoiesis of indeterminate potential and accelerated atherosclerosis in systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: accelerated atherosclerosis in patients with systemic lupus erythematosus (sle) is not fully explained by framingham risk factors. the detection in asymptomatic patients of somatic mutations in genes involved in hematopoietic malignancy- defining clonal hematopoiesis of indeterminate potential (chip) - predisposes to cardiovascular events (cve) in general population. we aimed to determine whether chip is associated with cve in sle.

sle patients indeed display an accelerated atherosclerosis that strongly contributes to the excess mortality observed but is poorly explained by the traditional cardiovascular risk factors. clonal hematopoiesis defines the clonal expansion of hematopoietic cells driven by a selective advantage given by leukemia-associated somatic mutations. clonal hematopoiesis is said of indeterminate potential (chip) when found in asymptomatic patient. chip strongly correlated with age and logically predispose to haematological malignancy, but is also causally associated with cardiovascular events (cve) in the general population. the main objective of our study was to determine whether chip is associated with cve in sle patients.

Eligibility criteria:
inclusion criteria: * patient with a systemic lupus erythematosus exclusion criteria: * inadequate follow-up period (\< 20 months) -past history of cve at baseline for inclusion in the tropoplus study

Keywords: systemic lupus erythematosus clonal hematopoiesis of indeterminate potential cardiovascular events
the role of visceral hyperalgesia, gastroesophageal reflux disease (gerd) and esophageal motility disorder (emd) in nccp patients

Conditions: Non-Cardiac Chest Pain

Summary: noncardiac chest pain (nccp) is a common clinical problem worldwide. in hong kong, it has been estimated that about 20% of patients with chest pain are misdiagnosed to have coronary heart disease. despite its benign nature, this condition causes anxiety, impairs quality of life and consumes a substantial amount of healthcare resources. while acid reflux and motility disorder in the esophagus are often attributed as the cause of nccp, visceral hyperalgesia of esophagus is now recognized to play a central role in the pathogenesis of this condition. this research project aims to evaluate the role of visceral hyperalgesia in chinese patients with nccp. nccp patients will be evaluated for the prevalence of gastroesophageal reflux disease and esophageal motility disorder by endoscopy, manometry and ph study. the visceral sensory and pain thresholds of these patients will be compared with asymptomatic controls.


Eligibility criteria:
inclusion criteria: * consecutive patients with monthly angina-like chest pain and negative coronary angiogram or scintigraphy * age between 18-70 exclusion criteria: * gastroesophageal reflux disease * psychiatric illness * cerebrovascular accident * active peptic ulceration * heart failure or cardiac bradyarrhythmia * epilepsy * pregnancy or lactating female * previous hypersensitivity to muscle relaxant
study evaluating absorption, distribution, metabolism and excretion (adme) of single dose [14c] azd2423 in volunteers

Conditions: Neuroscience

Summary: phase i study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of \[14c\]azd2423 in healthy male volunteers aged 50 to 65 years (inclusive).the purpose of this study is to investigate how and how quickly azd 2423 or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.


Eligibility criteria:
inclusion criteria: * have a body mass index (bmi) of ≥18 and ≤30 kg/m2 and weight of ≥50 kg and ≤100 kg * regular daily bowel movements (ie, production of at least 1 stool per day) * provision of signed and dated, written informed consent prior to any study specific procedures exclusion criteria: * healthy volunteers exposed to radiation levels above background (eg, through x ray examination) of \>5 msv in the last year, \>10 msv over the last 5 years or a cumulative total of \>1 msv per year of life * participation in any prior radiolabelled study within 12 months of the screening visit (visit 1) * history of alcohol abuse or excessive intake of alcohol defined as regular intake of more than 15 units of alcohol a week. (unit = 1 glass of wine (125 ml) = 1 measure of spirits = ½ pint of beer)

Keywords: radioactive adme neuropathic pain
lingual tonsil hypertrophy grading and its relation to sociodemographic factors and clinical symptoms

Conditions: Lingual Tonsil Hypertrophy; Dysphagia

Summary: the aim of this research was to evaluate the lingual tonsil hypertrophy (lth) grading of patients with dysphagia using videolaryngoscopy and determine the relation of lth grades to sociodemographic factors and clinical symptoms.

two groups of people were interviewed during this research - the lth group and the control group - a total of 100 subjects. the first group was comprised of 50 individuals, who visited the otorhinolaryngologist at lithuanian university of health sciences hospital, regarding dysphagia, and were diagnosed with lth during endoscopy. the second group consisted of 50 healthy individuals without dysphagia, who did not have enlarged lingual tonsils during assessment using videolaryngoscopy. all subjects filled out the questionnaires, composed of rsi (reflux symptom index) and dsq (dysphagia screening questionnaire) questionnaires, validated and verified for use in lithuania, together with a questionnaire created specifically for this research for gathering sociodemographic data. the lth grade of all subjects was determined using delgaudio and friedman grading systems.

Eligibility criteria:
inclusion criteria: * adults * consent for participating in the research * no cognitive disorders or mental illnesses * complaining about difficulty swallowing (research group) * enlarged lingual tonsils on videolaryngoscopy (research group) * generally healthy, no complaints of swallowing disorders (control group) * normal-sized lingual tonsils (control group) exclusion criteria: * refusal to participate in the research * younger than 18 and older than 80 years old * serious mental or cognitive conditions

Keywords: dysphagia lingual tonsil hypertrophy lingual tonsil enlargement
inflammatory markers after colorectal surgery)

Conditions: Infectious Complications After Colorectal Surgery

Summary: the clinical symptoms of septic complications (sc) (responsible for the majority of morbidity in colorectal surgery) become apparent only 5-7 days after the operation, whereas the efficacy of treatment depends on early diagnosis. by detecting such complications early it could be possible to reduce their severity, the length of hospitalisation, repeat colostomy and the number of readmissions. our team has shown that c-reactive protein (crp) \> 125 mg/l at postoperative day 4 (d4) was a predictor of sc in this context. procalcitonin (pct) is a marker of sepsis currently used in intensive care, but its use in the follow-up of elective surgery, particularly colorectal surgery, has not been fully evaluated. the aim of this study is to compare the ability of crp and pct to detect sc as early as postoperative day 2 (d2) (intra-abdominal or systemic sc, such as those defined by the cdc) after elective colorectal surgery. adult patients about to undergo elective colorectal surgery with anastomosis will be included once they have given their written informed consent. levels of crp and pct will be measured the day before the surgery, then at d1, d2, d3 and d4. the clinical data (temperature, recovery of bowel movement, pain, pain on palpation) will be recorded daily. imaging examinations will be performed at the discretion of the surgeon; the only obligation will be to perform a contrast-enhanced abdominopelvic ct-scan if crp at d4 \> 125 mg/l with no other clinical anomalies. the discriminating ability (measured by the area under the roc curve) of crp at d2 was 0.653 in our previous study. an improvement of at least 0.1 will be necessary to show the superiority of pct over crp in clinical terms and with regard to the cost.


Eligibility criteria:
inclusion criteria: * patients undergoing elective colorectal surgery with anastomosis for benign or malignant disease * \> 18 years old * giving written informed consent * included in the national health insurance exclusion criteria: * emergent surgery * previous infection * patients undergoing hyperthermic intraperitoneal chemotherapy * pregnancy
induced acl healing with the ligamys technique: a prospective, multicenter observational case series

Conditions: Anterior Cruciate Ligament Rupture

Summary: the purpose of this study is to evaluate the safety and effectiveness of the ligamys technique for the treatment of acute ruptures of the anterior cruciate ligament in a multicenter routine clinical setting. to conduct a long-term follow-up of the case series as a post-market product surveillance endeavor.

the ligamys method was successfully applied in an animal study including eleven white alpine sheep. healing of the torn acl and a stable joint without signs of intra-articular damages or osteoarthritis three months postoperative were observed (kohl kssta 2013). in a first clinical study with ten patients, the ligamys surgical technique resulted in stable clinical and radiological healing of the torn acl in nine patients with one re-rupture after four months. nine patients obtained normal knee scores, reported excellent patient satisfaction, and could return to their previous levels of sporting activity (kohl swiss med wkly 2011). the purpose of this study is to evaluate the safety and effectiveness of the ligamys technique for the treatment of acute ruptures of the anterior cruciate ligament in a multicenter routine clinical setting. to conduct a long-term follow-up of the case series as a post-market product surveillance endeavor.

Eligibility criteria:
inclusion criteria: * primary rupture of the anterior cruciate ligament * signed patient informed consent * willingness to present for follow-up * age between 18 and 50 years at the time of inclusion in the study * injury - surgery time interval of 21 days or less exclusion criteria: * medical non-compliance * unwillingness to follow the rehabilitation programme * traumatic cartilage lesion requiring cartilage repair procedure (microfracturing, maci, act) or degenerative cartilage lesions (outerbridge \>ll and defect \>1cm2) * non-repairable meniscus lesions requiring a resection of \>20% * previous tendon removal on injured leg * relevant permanent medication (steroids, cytostatic drugs, ...) * pregnancy

Keywords: ligamys acl healing
assessment of airway in patients with acromegaly for predicting successful tracheal intubation

Conditions: Acromegaly

Summary: acromegaly is associated with increased risk of difficult intubation and its management. the overall incidence of difficult intubation in patients suffering from acromegaly is four to five times more than those without acromegaly.the difficult intubation scenario in these patients can be managed by various methods ranging from awake fiberoptic intubation to tracheostomy. difficult tracheal intubation accounts for 17% of respiratory-related injuries and results in significant morbidity and mortality in general population. in patients with acromegaly, inability to mask ventilate or intubate can lead to 28% of all anesthesia related deaths. therefore, the need and importance of airway assessment in patients with acromegaly cannot be overemphasized. various tests of airway assessment have to be used to assess difficult airway and tracheal intubation in acromegalics. the investigators aim to assess the various tests of airway assessment affecting the outcome of patients with acromegaly undergoing pituitary surgery and identify which was best suited.

all the patients of either gender, diagnosed as a case of acromegaly scheduled for pituitary surgery will be enrolled. this observational study will be conducted over a period of 3 years. a written informed consent will be taken from all the patients. the clinical diagnosis will be made on the basis of growth hormone (gh) levels and magnetic resonance imaging (mri) findings. all patients will be evaluated preoperatively, a day before surgery by an independent observer. airway assessment for difficult intubation will be performed using modified mallampati classification in sitting and supine position followed by mouth opening, upper lip bite test, measurement of thyromental, thyrohyoid, sternomental and hyomental distance. next the length of upper incisors, presence of receding mandible and neck movement will be checked. an associated history of osa will also be taken in to account for assessing the difficult intubation followed by osa grading in acromegalic patients posted for pituitary surgery. in situation of difficult tracheal intubation the fiberoptic intubation would be the preferred choice, which is a gold standard. general anesthesia will be induced with fentanyl 2µg/kg, propofol 2 mg/kg and rocuronium 1mg/kg. after 90 seconds of mask ventilation, laryngoscopy will be performed with an appropriate sized macintosh laryngoscope and thereafter cormac lehane grading will be noted. external laryngeal manipulation (elm) if carried out will be noted. a standard anesthesia protocol will be followed. after completion of the surgery, neuromuscular blockade will be reversed with neostigmine 0.05mg/kg and glycopyrrolate 0.01mg/kg intravenously. once the patient follows the verbal command and respiratory parameters are satisfactory, endotracheal tube will be removed. all patients will be shifted to neurosurgical icu for observation and supportive management.

Eligibility criteria:
inclusion criteria: * acromegalic patients undergoing surgery exclusion criteria: * none
a first-in-human study of rpt193 in healthy volunteers and patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: this study is a first-in-human, 3-part, multi-center, phase 1, randomized, double-blind, placebo-controlled study with rpt193 in up to 64 healthy male and female subjects and 30 male and female patients with atopic dermatitis. rpt193 is an orally-available, potent, and selective antagonist of ccr4.


Eligibility criteria:
selected inclusion criteria: parts a \& b (completed enrollment): * healthy male or female * 18-55 years of age, inclusive * at least 50 kg in weight * bmi: 18.0-30.0 kg/m2, inclusive part c (completed enrollment): * male or female with atopic dermatitis * 18-65 years of age, inclusive * bmi between 18.0 (inclusive) and \<40.0 kg/m2 * body surface area (bsa) with ad involvement ≥10% * eczema area and severity index (easi) score ≥12 * validated investigator's global assessment (viga) ≥3 * history of inadequate response to treatment with topical medications, such as corticosteroids or calcineurin inhibitors, or patients for whom topical treatments are otherwise medically inadvisable selected exclusion criteria: parts a \& b (completed enrollment): * use of tobacco products within 60 days prior to drug administration * history of alcohol abuse or drug addiction * positive drug and alcohol screen * participation in a drug study within 60 days prior to drug administration * donation or loss of more than 100 ml of blood within 60 days prior to drug administration. * donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to drug administration. part c (completed enrollment): * any serious and/or uncontrolled medical condition * history of alcohol abuse or drug addiction * positive drug and alcohol screen
a study of abemaciclib (ly2835219) in participants with hr+, her2- advanced breast cancer

Conditions: Metastatic Breast Cancer

Summary: the reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors (anastrozole or letrozole) is effective in participants with hormone receptor positive (hr+), human epidermal growth factor receptor 2 negative (her2-) advanced breast cancer that have certain disease characteristics.


Eligibility criteria:
inclusion criteria: * participants must have completed (neo) adjuvant endocrine therapy and have cancer return after at least 12 months or have de novo cancer that has spread to other organs at diagnosis * participants must have 1 or more of the following: * a high grade tumor in tissue * negative progesterone receptor (pr) status * have cancer that has spread to the liver * have a treatment-free interval (tfi) \<36 months * participants must have hr+, her2- breast cancer * participants must have adequate organ function exclusion criteria: * participants must not have cancer that has spread to other organs that has severely affected their function * participants must not have cancer that has spread to the brain that is unstable or untreated * participants must not have received endocrine therapy in the metastatic setting * participants must not have known active infection * participants must not have received prior endocrine therapy and had disease return within 12 months from completion of treatment * participants must not have received prior treatment with any cyclin-dependent kinase (cdk) 4 \& 6 inhibitor or everolimus
cleave-stage transfer on day 3 versus day 5 transfer when only one embryo available

Conditions: Infertility

Summary: when only one embryo is available after in vitro fertilization, the option is to transfer either day 3 or day 5. there is no randomized trial compared the day 3 to day 5 for this subgroup.

recruitment is very slow. the tsc will discuss termination next meeting with the dmc.

Eligibility criteria:
inclusion criteria: * infertile couple with only one embryo available for transfer exclusion criteria: * ineligible for study
single incision laparoscopic surgery vs flexible single incision surgery for cholecystectomy

Conditions: Cholelithiasis; Surgery; Laparoscopy

Summary: prospective randomized pilot clinical trial, with 3 arms and one year follow up. the study will include 60 patients, with a 1:1:1 ratio, 20 patients per group. in 40 patients a transumbilical single site incision will be performed with two different manners: single-port device sils tm (single incision laparoscopic surgery), and flexible endoscope and accessory trocars in a single incision (fsis-flexible single incision surgery). the third group is the control one, a conventional laparoscopic approach. the trial is designed as a pilot study to assess, as main objective, if these two endoscopic approaches have the same security and effectiveness in cholecystectomy. hypothesis: transumbilical approaches with single port and single incision with the flexible endoscope have the same efficacy and safety performing the endoscopic cholecystectomy. objectives: main objective: assess whether both approaches are equally safe in its application to endoscopic cholecystectomy. secondary objectives: investigate the differences in the rate of conversion to open surgery between different surgical approaches. investigate the differences in the rate of wound infection between the different surgical approaches. investigate the differences in the rate of postoperative incisional hernias between different surgical approaches. investigate whether there are differences in the rate of overall complications, all-cause mortality and the cost between different surgical approaches.

inclusion criteria: * patients affected with symptomatic cholelithiasis with elective surgical indication, not urgent, aged between 18 and 65. * signing of informed consent for cholecystectomy and specific consent for the trial. * anesthetic risk asa i-ii. exclusion criteria: * presence of acute cholecystitis and / or suspicion of occupation of the main bile duct. * asa iii and higher.

Eligibility criteria:
inclusion criteria: * age over 18 and under 65 * symptomatic cholelithiasis with an indication for laparoscopic surgery * signed specific informed consent including specific information of the new surgical approach * asa 1 and 2. exclusion criteria: * current or previous cholecystitis * current or previous suspected bile duct's problems * previous abdominal surgery * umbilical and other abdominal hernias * some other condition with increased risk to infection or abdominal wall problems. * asa 3 and more

Keywords: cholecystectomy minimally invasive surgery laparoscopic surgery single incision surgery