Kornimate/medical-research-clean huggingface dataset:
phase 2 study of kh001 in long-term relief from dentin hypersensitivity

Conditions: Dentin Hypersensitivity

Summary: the purpose of this study is to evaluate the efficacy and safety of kh001 in subjects with dentin hypersensitivity.

the study will consist of a screening period, a treatment period, and a follow-up period. the total duration of the study for each subject will be approximately 8 to 12 weeks. all subjects will be randomly assigned in a 1:1:1 ratio, with group a, group b and group c.

Eligibility criteria:
inclusion criteria: * is at least 18 years old by the time of the screening visit * is in good general health as determined by the investigator * has at least 2 non-adjacent teeth and is diagnosed with hypersensitive exclusion criteria: * is allergic to the active drug substance or other excipients used in the investigational product * has any history of alcohol or drug abuse * has received any treatment related to dentin hypersensitivity within 8 weeks prior to the screening visit * is jedged by the investigator as ineligible for participation for other reasons

Keywords: dentin sensitivity denin hypersensitivity
morbidity and mortality in solo adult traumatic brain injury patients in minia university hospital

Conditions: Statistical Analysis of Traumatic Brain Injury Victims

Summary: tracking post-traumatic brain injury sequale


Eligibility criteria:
inclusion criteria: * solo non penetrating neurotrauma victims exclusion criteria: * 1- penetrating head trauma. 2- polytrauma patients. 3- coexist of psychiatric disorders or history of neuronal disorders. 4- refusal of patient relatives to participate in the assignment. 5- pregnant females with tbi. 6- patients who died during 24 hours from admission to icu . 7- patients more than 65 years of age . 8- combined abdominal or orthopedic trauma.

Keywords: neurotrauma traumatic brain injury
achat-study, alternative treatment of chronic globus sensations

Conditions: Globus; Deglutition Disorders

Summary: globus sensations are associated with gastroesophageal reflux disease as well as the presence of a gastric inlet patch. no controlled trial exists on whether ablation of the cervical heterotopic mucosa may lead to improvement of chronic globus sensations. the aim of this sham-controlled trial is to clarify whether argon-beamer-ablation of cervical heterotopic gastric inlet patches of the esophagus improves patients' chronic globus sensations.

some data suggest that ablation of gastric inlet patches by argon beamer therapy might lead to alleviation of chronic globus sensation or sore throat. acid reflux or its treatment is unlikely to influence these results (meining et al. argon plasma ablation of gastric inlet patches in the cervical esophagus may alleviate globus sensation: a pilot trial. endoscopy. 2006 jun;38(6):566-70). within the present study we will perform a randomized, sham-controlled and blinded trial, where patients with heterotopic gastric mucosa (hgm) of the cervical esophagus and globus sensations (a chronic or intermittent lump in the throat for at least 3 months) are going to be randomized after histological verification of hgm in the study center (technical university clinic munich). either a beamer ablation of hgm or a sham-therapy will be performed after patients complete a validated questionnaire. patients are blinded for 3 months, then after completing another questionnaire endoscopy is repeated.

Eligibility criteria:
inclusion criteria: * globus sensations and histologically verified heterotopic gastric mucosa of the cervical esophagus exclusion criteria: * malignancy in the ear, nose, and throat (ent)-field * scleroderma * mental disability affecting a patient's ability to sign an informed consent document
the utility of nexium in chronic cough and reflux disease

Conditions: Cough; GERD

Summary: the purpose of this research study is to investigate different doses of proton pump inhibitors in reducing cough symptoms felt to be associated with gastroesophageal reflux disease (gerd). proton pump inhibitors are medicines used to treat gerd, which work by lowering the amount of acid in the stomach. the proton pump inhibitor used in this study is called, esomeprazole (brand name nexium), and is already marketed for treating gerd. patients with gerd may experience all or some of the following symptoms: stomach acid or partially digested food re-entering the esophagus (which is sometimes referred to as heartburn or regurgitation), belching and coughing. even very small, unnoticeable amounts of rising stomach acid may cause patients to cough. because there may be a link between chronic cough and gerd, study doctors are interested in learning if giving high-dose nexium (40 milligrams, twice daily) will help in treating chronic cough.

this study will be a randomized, double-blind, placebo controlled, comparative parallel-group trial of subjects with chronic cough of unknown origin presenting to the otolaryngology/ head and neck surgery, pulmonary medicine, and gastroenterology outpatient clinics at the university of north carolina hospital system. potential subjects with chronic cough of unknown origin will be identified through the above outpatient clinics. those who meet the inclusion and exclusion criteria will be asked to join the study testing the efficacy of twice daily esomeprazole 40 mg taken for 3 months in the setting of chronic cough. potential subjects will be consented for the study prior to leaving the enrolling clinic. a total of 40 subjects will be recruited into our study.

Eligibility criteria:
inclusion criteria: 1. males and females (of non-childbearing potential. ie-surgically sterile, or willing to use an approved form of birth control) between the ages of 18 and 70 who speak and write in english, 2. chronic cough (\> 8 wks/another article used \> 6 wks) with symptom severity criteria of 2 or greater on the fisman cough severity score and 3 or greater or the fisman cough frequency score, and, 3. failure to respond to post nasal drip therapy. exclusion criteria: 1. abnormal chest x-ray, 2. patients taking h2 blockers within the previous 3 days or ppi's within the previous 7 days, 3. failure to respond to past ppi therapy given for cough that lasted at least 12 weeks, 4. use of an investigational drug within the past 30 days, 5. previous surgical antireflux or non-surgical endoscopic anti-reflux procedure (ex., stretta or endoscopic sewing device), 6. previous aerodigestive malignancy, 7. current smokers, or ex-smokers (defined as those who quit smoking less than 3 months prior to study enrollment or those who have quit, but have a 20 pack year smoking history), 8. upper respiratory infection within 8 weeks prior to study enrollment, 9. current use of a b- blocker, ace-i, or anticholinesterases at time of enrollment.

Keywords: cough gerd
pre-frailty and rehospitalization in cardiac surgery

Conditions: Frailty Syndrome; Surgery--Complications; Coronary Artery Disease; Valve Anomalies

Summary: background: it has been demonstrated that pre-frailty has more adverse outcomes after cardiac surgery, however, data on prognosis and long-term evolution in pre-frailty patients after cardiac surgery without postoperative complications are still scarce. design: to evaluate the impact of pre-frailty on functional survival in patients after cardiac surgery without complications.

a three-year retrospective study based on a physiotherapy database was conducted, and a sample of 453 patients over 65 years of age was enrolled. all of them had an established diagnosis of cardiovascular disease (myocardial infarction, valve regurgitation or stenosis) determined by previous electrocardiogram and/or doppler echocardiography, and all had surgical interventions (coronary artery bypass \[cab\], valve replacement or valve repair). patients with prior neurological/muscular disease (previous stroke or muscular dystrophies), cognitive impairment resulting from previous injury, frailty score ≥ 5, non-elective/emergency surgery procedures or incomplete data were excluded. according to the hospital protocol, frailty was assessed by the clinical frailty score (cfs) 24 hours before the scheduled elective surgery. we assigned patients into two groups based on this score: non-frail (frailty score 1\~3) and pre-frail (frailty score 4) according to their cfs. if patients experienced adverse cardiovascular events-both during surgery or at the icu- such as stroke, infection, prolonged mechanical ventilation time of more than 24 hrs, icu stay of more than 48 hrs or in-hospital death, they were excluded. we decided to exclude these patients as our objective was to evaluate patients without any surgical complications as our group recently had demonstrated that pre-frail patients had worse outcomes after cardiac surgery in a short period of time. all included patients were analysed for 3 years using data from the hospital and physiotherapy database, which included medical appointments every 6 months after hospital discharge and major adverse cardiovascular events (atrial fibrillation, pneumonia, pleural effusion, acute myocardial infarction, heart failure, stroke and death). this retrospective study was approved by the institutional ethics committee (number 2.352.465).

Eligibility criteria:
inclusion criteria: * established diagnosis of cardiovascular disease (myocardial infarction, valve regurgitation or stenosis) determined by previous electrocardiogram and/or doppler echocardiography, and all had surgical interventions (coronary artery bypass \[cab\], valve replacement or valve repair). exclusion criteria: * neurological/muscular disease (previous stroke or muscular dystrophies), cognitive impairment resulting from previous injury, frailty score ≥ 5, non-elective/emergency surgery procedures or incomplete data

Keywords: frailty cardiac suregry adverse events
the efficacy of modified olfactory training for patients with olfactory dysfunction

Conditions: Olfactory Impairment

Summary: the goal of this clinical trial is to validate the effectiveness of the modified olfactory training device, the main questions it aims to answer are: is it possible that the device can treat olfactory disorders in adults? compared to the conventional device, how efficient is the modified olfactory training device for treating patients with olfactory disfunction?

olfactory training is a new therapy that improves olfactory function by exposing patients to various types of odors through regular, repetitive active sniffing. however, there are still many problems with olfactory training in clinical practice, including poor patient adherence, lack of standardized and uniform procedures, and inconvenient carrying of devices. now, the investigators have initially developed an olfactory training device based on expiratory pressure, and the advantages of the improved device are as follows: bi-directional airflow, positive pressure and the function of voice prompts and automatic counting. in this study, the investigators planned to recruit 72 patients and divided them into two groups for olfactory training with conventional and modified devices, and validate the effectiveness of the modified device based on the comparison of the outcomes of the two groups.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with olfactory disorder when tdi score was less than 30.75. 2. patients would perform sniffin' sticks examination. 3. voluntarily sign the informed consent form 4. able to undergo olfactory training and participate in follow-up visits exclusion criteria: 1. smoking 2. combined with chronic diseases, such as hypertension, diabetes, bronchopneumonia, chronic obstructive pulmonary disease, etc. 3. those who have taken oral glucocorticoids, antibiotics, anti-leukotrienes, and antihistamines within four weeks will be excluded. 4. patients who cannot tolerate olfactory function testing and treatment 5. severe coexisting diseases: such as malignant tumors, life expectancy \<2 years 6. patients who are pregnant or planning to become pregnant 7. according to the researcher's judgment, the patient is unable to complete this study or cannot comply with the requirements of this study (such as memory or behavioral abnormalities, depression, heavy drinking, past breach of contract)
a pilot study to explore the role of gut flora in elevated cholesterol

Conditions: Cholesterol, Elevated; Elevated Cholesterol

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding elevated cholesterol.

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding elevated cholesterol.

Eligibility criteria:
inclusion criteria: 1. signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study 2. male or female patients of any age (interest is given to children to compare with mothers). 3. ldl\>100 4. total cholesterol\>200 exclusion criteria: 1. refusal to sign informed consent form 2. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. postoperative stoma, ostomy, or ileoanal pouch 4. participation in any experimental drug protocol within the past 12 weeks 5. treatment with total parenteral nutrition 6. any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial 7. inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
a clinical trial of a radiation sensitizer in radiochemotherapy for thoracic esophageal squamous carcinoma

Conditions: Esophageal Carcinoma

Summary: this multicentered clinical trial is going to find out the radio-sensitization action of sodium glycididazole in radiochemotherapy for esophageal cancer.

esophageal cancer is one of the most frequent causes of cancer death in the world. the most common type of esophageal cancer is squamous cell carcinoma (scc) in china. although concurrent radiochemotherapy is recommended as the standard treatment for advanced esophageal carcinoma, the local failure still reaches up to 44%-54%. sodium glycididazole(cmna) is a radiosensitive drug for hypoxic tumor cells. clinical trials showed that cmna can improve local control rate and survival rate of esophageal cancer. this study is going to confirm the efficacy and safety of cmna in concurrent radiochemotherapy of radiotherapy and 5-fu+ddp for esophageal squamous carcinoma.

Eligibility criteria:
inclusion criteria: * written informed consent * photographically and histologically proven thoracic esophageal squamous carcinoma * stages 2a-3, and stage 4 with only supraclavicular lymph nodes metastasis defined by ajcc(2002) * radiochemotherapy indication * measurable tumor * adequate hematologic, hepatic and renal function * karnofsky performance status ≥70 * age more than 18years and less than 70 years exclusion criteria: * pregnancy and lactation * significant neurologic disease * severe liver and renal malfunction,and significant medical illness * previous chemotherapy, radiotherapy or immunotherapy * esophagus hemorrhage and esophagus perforation features

Keywords: sodium glycididazole, radiochemotherapy, esophageal carcinoma
long-term safety and efficacy outcome study comparing children previously enrolled in study ropp-2008-01 for the prevention of retinopathy of prematurity (rop)

Conditions: Retinopathy of Prematurity (ROP)

Summary: the main purpose of this study is to evaluate the long-term efficacy and safety outcomes following short-term exposure to rhigf-1/rhigfbp-3 versus standard neonatal care in study ropp-2008-01 (nct01096784).

long-term safety and efficacy outcome study comparing children previously enrolled in study ropp-2008-01 for the prevention of retinopathy of prematurity (rop)

Eligibility criteria:
inclusion criteria: * participant was randomized in study ropp-2008-01 section d (nct01096784). * participants parent or legally authorized representative(s) must provide written informed consent prior to performing any study-related activities. study-related activities are any procedures that would not have been performed during normal management of the participant. exclusion criteria: * any other condition or therapy that, in the investigator's opinion, may pose a risk to the participant or interfere with the participants ability to be compliant with this protocol or interfere with the interpretation of results. * the participant or participants parent or legally authorized representative(s) is unable to comply with the protocol as determined by the investigator.
lactobacillus reuteri strains for gingivitis reduction

Conditions: Gingival Inflammation

Summary: the aim of the present study was to investigate the potential beneficial effects in volunteer young adults of orally administered l. reuteri (dsm 17938 and atcc pta 5289) on gingival inflammation. the null hypothesis was that no difference would be manifested by probiotic therapy regarding the conventional mechanical treatment (without probiotic administration).

aim. to investigate the potential beneficial effects in volunteer young adults of orally daily administered l. reuteri (dsm 17938 and atcc pta 5289) on gingival inflammation. the null hypothesis was that no difference would be manifested by probiotic therapy regarding the conventional mechanical treatment (without probiotic administration). methods. a randomized controlled parallel clinical trial was conducted in sixty young adults (18-35 yrs old) with chronic marginal gingivitis for one month. initially, both study groups underwent conventional mechanical periodontal therapy/oral anti-plaque hygiene. however, the experimental group additionally received the administration of two daily tablets, containing both l. reuteri strains, for 30 days, while the control group did not. different clinical outcome variables (plaque (pi) and gingival (gi) indices, bleeding on probing (bop), and crevicular fluid volume (cfv)) were recorded and compared between the study groups, both at baseline and at the end of the interventions, 30 days later. statistical descriptive and inferential tests were performed (data distribution normality, student's t, and wilcoxon-mann-whitney tests).

Eligibility criteria:
inclusion criteria: * non-smokers (at least for the last 6 months). * initial mean gingival index (gi) between 1.5 - 2. * with a minimum of 20 teeth present in the oral cavity. exclusion criteria: * periodontal pockets \> 4 mm. * recent intake of antibiotics or anti-inflammatory drugs and/or reception of dental prophylaxis. * daily consumption of analgesics, probiotics, or oral antimicrobial rinses/gels. * overweight (mci \>25). * alcohol or recreative drug frequent consumers. * pregnancy or breast-feeding. * allergy or hypersensitivity to study products * fixed orthodontic appliances.

Keywords: gingivitis lactobacillus reuteri bacteriotherapy clinical randomized trial
deep learning algorithm for the diagnosis of gastrointestinal diseases

Conditions: Gastrointestinal Disease

Summary: the purpose of this study is to develop and validate a deep learning algorithm for the diagnosis of gastrointestinal diseases. then, evaluate the accuracy this new artificial intelligence(ai) assisted recognition system in clinic practice.

recently, deep learning algorithm based on central neural networks (cnn) has shown multiple potential in computer-aided detection and computer-aided diagnose of gastrointestinal lesions. however, there is still a blank in recognition of all gastrointestinal diseases. this study aim to develop and validate a deep learning algorithm for the diagnosis of gastrointestinal diseases. then, evaluate the accuracy this new artificial intelligence(ai) assisted recognition system in clinic practice.

Eligibility criteria:
inclusion criteria: * participants, aged 18 years or older, who had not had a previous endoscopy were retrieved from all participating hospitals. exclusion criteria: -

Keywords: deep learning central neural networks endoscopy gastrointestinal disease
the efficacy and safety of zhigancao tang granule for hfpef of qi-yin dificiency

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: this study was designed as a randomized, double blinded and placebo-controlled clinical trial. the aim of the study is to evaluate the efficacy and safety of zhigancao tang granule in patients with hfpef of qi-yin dificiency.

heart failure with preserved ejection fraction (hfpef) is a clinical syndrome characterized by diastolic dysfunction.the incidence of hfpef is increasing in recent years. standard treatment of heart failure does not improve the prognosis of hfpef patients. zhigancao tang was used to improve the symptoms of chronic heart failure in china.this randomized,double-blinded and placebo-controlled trial will objectively and standardly evaluate the effectiveness and safety of zhigancao tang granule.after 12 weeks of treatment, 122 hfpef patients with deficiency of qi and yin were observed and evaluated in terms of heart function, clinical symptoms,exercise tolerance and quality of life.

Eligibility criteria:
inclusion criteria: 1. comply with the diagnostic criteria of western medicine for hfpef and the diagnostic criteria for tcm syndromes of qi-yin deficiency; 2. cardiac function classification by nyha: grade i to iii; 3. age between 30 and 80 years old; 4. those who volunteer to participate in clinical trial observation, sign informed consent and indicate date; 5. during the observation period, those who do not take other drugs other than those specified and can insist on completing the treatment and observation. exclusion criteria: 1. valvular heart disease, restrictive cardiomyopathy, pericardial disease; 2. decompensated heart failure is unstable after treatment; 3. combined with atrial fibrillation; 4. patients with severe lung, liver, endocrine system and kidney dysfunction; 5. patients with cancer and other common malignant diseases reducing life expectancy; 6. pregnant or lactating women; 7. allergic constitution or allergic history to common drugs; 8. patients with mental illness or poor compliance of traditional chinese medicine treatment.

Keywords: heart failure with preserved ejection fraction qi-yin deficiency syndrome randomized, double blinded and controlled trial zhigancao tang granule