Kornimate/medical-research-clean huggingface dataset:
chamomile therapy for generalized anxiety

Conditions: Generalized Anxiety Disorder

Summary: this study will determine the effectiveness of chamomile extract for treating generalized anxiety disorder. study hypotheses: 1)chamomile extract will have a superior anti-anxiety effect compared to placebo. 2)chamomile will have a comparable safety profile to that of placebo.

we propose to investigate the anti-anxiety activity of chamomile. among the many uses of chamomile, its use as an anti-anxiety herb is universal. despite its widespread use and acceptance, there have been no studies evaluating the safety and anti-anxiety efficacy of chamomile in human subjects. given this lack of controlled clinical data, we propose a pilot study of chamomile safety and efficacy in mild anxiety, and propose using the data as a basis for statistically powering a future r01 application. we will ask: is chamomile a safe and effective alternative treatment for generalized anxiety disorder (gad)? to do this, 60 patients with a diagnosis of mild to moderate gad will receive double-blind treatment for 8 weeks with either (i) chamomile extract, or (ii) placebo. we hypothesize that chamomile will have a superior anti-anxiety efficacy compared to placebo, and a comparable safety profile to placebo.

Eligibility criteria:
inclusion criteria: men and women \> 18 years of age (all races and ethnicity) meet dsm iv criteria for gad mild to moderate symptom severity ham-a score \> 8 not receiving anti-anxiety medication (e.g., benzodiazepine, venlafaxine, buspirone, or ssri) able to understand and provide signed informed consent able to participate in a 8-week study exclusion criteria: patients \< 18 years old current dsm iv axis i diagnosis of major depressive disorder, bipolar disorder, panic disorder (with or without agoraphobia), specific phobia disorder, obsessive-compulsive disorder, posttraumatic stress disorder, acute stress disorder, substance-induced anxiety disorder, schizophrenia, other psychotic disorders, current alcohol or drug abuse, alcohol or drug dependence within 3 months, \[nb: patients with co-morbid dsm iv axis i depressive disorders nos (e.g., minor depressive disorder, premenstrual dysphoric disorder, and recurrent brief depressive disorder will not be excluded)\] unstable medical condition (e.g., hypothyroidism, hypertension, myocardial infarction within 1 month, neoplastic condition) allergy to chamomile preparation allergy to plants of the asteraceae family (e.g., ragweed, asters, chrysanthemum) allergy to mugwort, rast, or birch tree pollen concurrent tranquilizer, antidepressant or mood stabilizer therapy concurrent use of over-the-counter anti-anxiety and/or antidepressant preparations (e.g., chamomile, st. john's wort, kava kava) women of child-bearing potential not willing to employ a medically proven form of contraception (e.g., condoms, oral contraceptives, etc)

Keywords: chamomile anxiety complementary and alternative medicine
conservative treatment of distal radius fracture in elderly in randomized controlled trial

Conditions: Colles' Fracture; Distal Radius Fracture

Summary: there is no consensus about the best conservative treatment for patients with dorsally displaced distal radius fractures. the previous studies that have examined the most valid method for cast immobilization have lacked uniform and patient-rated outcome measures, proper randomization and sufficient study population. the aim of this study is to compare functional position cast to flexion-ulnar -deviation with dorsally displaced distal radius fractures in patients aged 65 years or older. the conservative treatment is performed in clinical practice by various health care professionals with different techniques of reduction which are not limited to any specific technique in this pragmatic, randomized controlled trial.


Eligibility criteria:
inclusion criteria: * low energy intra- or extra-articular dorsal primarily stable, reducible drf within 3 cm of the radiocarpal joint diagnosed with lateral and posterior-anterior radiographs in er * physician on-call (general practitioner, acute physician, orthopedic resident, orthopedic consult) thinks patient could be appropriate for non-operative treatment exclusion criteria: * operative treatment * refuse to participate the study * open fracture more than gustilo 1 gradus * age under 65 years * chauffeure's or barton´s fracture * smith´s fracture (volar angulation of the fracture) * does not understand written and spoken guidance in local languages * pathological fracture or previous fracture in the same wrist, forearm or elbow

Keywords: wrist fracture colles fracture non-operative rehabilitation
hydrogen sulfide and pulmonary vascular remodeling on hrct in patients with copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: hrct was used to evaluate pulmonary vascular remodeling in copd. the role of h2s in pulmonary vascular remodeling in copd was analyzed, in order to provide a basis for seeking new therapeutic targets.

this study aimed to investigate the relationship between endogenous h2s and pulmonary vascular remodeling on hrct in patients with copd through the determination of h2s and its synthase mrna levels in blood and pulmonary vessels by hrct, to evaluate the role of h2s in pulmonary vascular remodeling in copd and to provide a basis for seeking new therapeutic targets. this study had predictive value for clinical prognosis of patients. it had important clinical guiding significance and social and economic benefit to comprehensively understand the pathogenesis of copd.

Eligibility criteria:
inclusion criteria: * patients meet the gold 2016 guidelines for diagnostic criteria of copd: dyspnea, chronic cough and/or sputum symptoms, exposure to risk factors, and pulmonary function after inhalation of bronchodilator with forced expiratory volume (fev1)/forced vital capacity (fvc) \< 70%. exclusion criteria: - 1. other lung diseases such as pneumonia, lung cancer, tuberculosis, pulmonary embolism, heart diseases such as heart failure, ventricular septal defect, patent ductus arteriosus, thoracic deformity and pleural diseases. 2. patients who are unable to understand and/or complete questionnaire.
serum glycomics as prognostic and diagnostic biomarkers of disease recurrence in liver transplant recipients with hepatocellular carcinoma

Conditions: Prognostic Biomarker; Liver Transplantation; Diagnostic Biomarker; Hepatocellular Carcinoma

Summary: liver transplantation (lt) is the only curative option for a selection of patients with hepatocellular carcinoma (hcc) based on clinical selection criteria known as the milan criteria. nevertheless, 15% of these patients still show tumour recurrence after lt. in a monocentric pilot study, we have demonstrated that specific changes in n-glycan profiles (measured before lt) occur in hcc patients receiving lt1. these specific changes proved to be strongly associated with the risk of hcc recurrence and overall death after lt, independent of the criteria used for stringent patient selection. pathophysiologically, it is known that abberations in protein glycosylation are involved in the onset en development of hcc. as such, a prognostic biomarker was developed that can clearly differentiate between patients with and without increased risk of hcc recurrence. the primary goal of this research study is to set up a prospective, multicentre study in order to validate the prognostic value of this glycomics-based serum biomarker. as such, the risk of tumour recurrence in patients undergoing lt for hcc will be estimated independent from the milan criteria and the french alpha-fetoprotein model as the current standard. the secondary goal is to explore the potential of serum glycomics as markers of early recurrence after lt for hcc. more specifically, we aim to investigate whether serial glycomics determination at fixed time points after lt could allow early detection of recurrent hcc even before it is visible on conventional imaging. consequently, a diagnostic biomarker for monitoring early recurrence after lt could be developed with the potential of redirecting treatment strategies already in an early disease stage. in case the promising data from the pilot study will be confirmed, the prognostic biomarker could be implemented in daily clinical practice leading to optimization of patient selection using a simple blood test before lt. more specifically, this marker could improve organ allocation thus preventing unnessecary treatment toxicity for the patient and reducing the costs of treatment for society. moreover, it should be emphasized that a patent application was already submitted and accepted in collaboration with techtranfer of ghent university (pct/ep2021/057788-prognostic markers of disease recurrence in liver transplant recipients with hepatocellular carcinoma).


Eligibility criteria:
inclusion criteria: * signed and dated patient informed consent document * diagnosis of hepatocellular carcinoma * age ≥ 18 years * ability to comply with protocol-specified evaluations and scheduled visits * eligible for liver transplantation and/or active on the waiting list for liver transplantation * consulted the department of gastroenterology and hepatology exclusion criteria: * diagnosis of other liver tumors (eg. liver metastasis, cholangiocarcinoma)
ultrasound versus clinical tests as predictors of difficult endotracheal intubation in patients with obstructive sleep apnoea undergoing elective surgery under general anaesthesia

Conditions: Difficult Intubation in Obstructive Sleep Apnea

Summary: obstructive sleep apnoea (osa) is the most serious kind of the sleep-disordered breathing group, characterised by recurrent episodes of partial to complete obstruction of the upper airway resulting in inefficient alveolar gas exchange and desaturation\[1\]. it is a commonly encountered condition with a reported prevalence of 9-25% in the general population \[2\]. however, the majority of osa patients presenting for surgery remain undiagnosed or untreated\[3\], contributing to a high rate of unexpected adverse airway outcome\[4\]. the various airway abnormalities represented by osa include a large tongue, collapsible airway and crowding of the oropharyngeal structures, among others\[5\]. accurate airway assessment should always be performed so as to provide appropriate planning and management of expected difficult intubation, but the common clinical screening tests (mallampati score, inter-incisor distance, mento-hyoid distance, bmi, etc ) have shown low sensitivity and specificity with a limited predictive value, especially if only a single assessment method is used\[6\]. ultrasonography could be a highly sensitive and specific tool for prediction of difficult intubation in osa patients presented for elective surgery by measuring tongue base thickness, distance between lingual arteries, hyo-mental distance and condylar mobility.


Eligibility criteria:
inclusion criteria: 1. 21-60 years old 2. asa i, ii, or iii 3. stop-bang scoring \>3 exclusion criteria: * 1) age \<21 years old 2) patients with cervical spine injury, limited neck mobility, neck swelling 3) patients with lost incisor teeth 4) asymmetric mobility of the temporomandibular joint as in maxillofacial injuries/malignancies prior to surgery on the airway 5) pregnancy
a drug safety and dose-exploratory clinical study of azvudine tablets in patients who have not received anti-hiv treatment

Conditions: AIDS

Summary: the primary objective of this trial was to evaluate the safety and preliminary evaluation of azvudine tablets (fnc) in combination with reverse transcriptase inhibitors therapy in treatment-naive patients with hiv infection.; the secondary objective is to explore the effective dose of clinical use of azvudine (fnc) tablets .

azvudine (fnc), a new class i drug with independent intellectual property rights, is a novel nucleoside reverse transcriptase inhibitor with good inhibitory activity against hiv-1 and obtained the national medical products administration(nmpa) approved for clinical research. in this trial, 172 patients who had not received anti-hiv treatment were enrolled, including fnc4mg group, fnc3mg group, fnc2mg group, and 3tc control group, 43 cases, 5 research centers, and each research center was simultaneously engaged and competing. the enrolled subjects underwent 7 visits including baseline visits, and hiv -1rna and cd4 cell counts were tested and statistically analyzed for each visit.

Eligibility criteria:
inclusion criteria: 1.18-65 years old, regardless of gender; 2.confirmed hiv positive with a report; 3.have not received anti-hiv antiviral treatment; 4.hiv viral load ≥1000 copies/ml; 5.who have no recent family planning and agree to take effective non-drug contraceptive measures during the trial period and within 3 months after the end of administration; 6.the subjects could fully understand the purpose, nature, method and possible adverse reactions of the test, and voluntarily participate in and sign the informed consent. exclusion criteria: 1. patients who have received anti-hiv treatment; 2. suffering from a serious opportunistic infection or opportunistic tumor; 3. abnormal blood routine examination (white blood cells \<3 × 109 / l, hemoglobin \<90g / l, neutrophils \<1.5 × 109 / l, platelets \<75 × 109 / l); 4. have a definite liver disease (hepatitis b surface antigen/hcv antibody positive), or abnormal liver function test (alanine aminotransferase and/or aspartate aminotransferase exceeds the upper limit of normal value by 3 times, or total bilirubin exceeds the upper limit of normal value 2 times); 5. renal insufficiency (glomerular filtration rate \<70ml/min, or creatinine above the upper limit of normal); 6. now suffering from more serious chronic diseases, metabolic diseases (such as diabetes), neurological and psychiatric diseases; 7. has suffered from pancreatitis; 8. women during pregnancy and lactation; 9. allergic constitution or known to be allergic to the pharmaceutical ingredients and the basic drugs prescribed in this program; 10. suspect or determine the history of alcohol and drug abuse; 11. participated in other drug clinical trials (excluding chinese medicine) within the first three months of screening; 12. other factors that are not suitable for entering the trial.

Keywords: hiv/aids
smartphone application for type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: since diabetes is a chronic disease closely related to unhealthy lifestyle, the improvement and management of living habits are as significant as medical care with regard to the disease. in addition, this is regarded as the most effective method for prevention and treatment of diabetes. however, many diabetic patients are now reported to lack proper management in korea with a low level of compliance with treatment instruction. in that sense, it is urgently necessary to develop a program in which diabetic patients are able to effectively manage their own blood glucose at home, and to grasp the real state of self-blood glucose measurement. accordingly, a system to manage diabetes using electronic equipment such as mobile phone or the internet is currently being developed and studied, for the effective management of diabetes with the help of highly evolving information technology. these investigators have developed a diabetes management program that provides an optimal solution based on a mobile device and software, so that individual patients can undergo a regular blood glucose test and achieve improvement and constant management of living habits by being properly informed of how to manage diabetes. this clinical study was designed to evaluate the effectiveness and efficacy of the application through the comparison between usual medical care and additional care using the smartphone application, targeting patients with type 2 diabetes who lack blood glucose control. this study is targeted at the subjects who are being treated at this hospital's endocrinology, are using a smartphone, and voluntarily signed the informed consent form (icf). the subjects who pass the subject eligibility evaluation provide information regarding assessment items and demographic information using the smartphone application and questionnaire. based on the information given by subjects, the medical team offers a management system that supports and improves the existing treatment process of diabetes using the application developed on its own. the feasibility and effectiveness of the management using the application are evaluated through the result values of the laboratory tests performed during the subject's usual medical care.


Eligibility criteria:
inclusion criteria: * aged ≥ 19 years; * android smartphone users; * no changes in medication for diabetes for at least 6 months; * hba1c levels ≥6.5% within the last 3 months. exclusion criteria: * currently had serious concomitant disease other than diabetes (n=1); malignancy-related histories on admission, myocardial infarction, cerebral infarction or organ transplantation; * pregnant or had plans for pregnancy within 6 months; * plans to participate in other clinical studies or illiteracy.

Keywords: mobile healthcare health services research community health services diabetes self-management education
a safety and efficacy study to evaluate aiv001 in wound healing following surgical incision

Conditions: Scar; Incision; Abdominal; Wound (Morphologic Abnormality)

Summary: to evaluate the safety, efficacy and pharmacokinetic profile of ascending concentrations of the study medication compared with vehicle in subjects with incisional wounds

this is primarily a safety study to evaluate the safety of aiv001 when administered near incisional wounds. a unique model was used to assess incisional scarring, safety and biomarker assessments. women electing to have the abdominoplasty procedure were enrolled in the study and abdominal incisions were generated on the abdominal skin. up to 10 incisions were made on abdominal skn and treated as assigned. and data collection was conducted up to day 49 when the subjects were exited from the study and the abdominoplasty procedure performed. exploratory efficacy measures were collected and pharmacokinetic profiles determined.

Eligibility criteria:
inclusion criteria: * eligible for an abdominoplasty * nonsmoker * fitzpatrick i-iv * weight \>45kg * bmi \<= 35 exclusion criteria: * existing scars in study area, active infection * any medical history or present conditions that may increase the risk associated with study participation or investigational product administration and, in the judgment of the investigator, would make the subject inappropriate for entry into this study

Keywords: wound healing scar abdominoplasty
the next leap in cardiac magnetic resonance imaging:cycling the field

Conditions: Myocardial Infarction

Summary: the main aim of the study is to build and test a cardiac-specific coil purposely assembled in house to suit the ffc-mri whole-body prototype and to test if it could be used for clinical cardiac scans in human subject populations.

aberdeen scientists are at the forefront of a new type of magnetic resonance imaging (mri), having built in-house the only two available prototypes of fast field-cycling mri in the world - and these already have clinical imaging capabilities. fast field-cycling mri switches rapidly over a range of field strengths (0.2 t to 200 µt), providing a t1 dispersion curve. this information is invisible to fixed-field scanners and uncovers unique knowledge about motion and interaction between component molecules within a tissue (i.e. water/fat/proteins). in this application the investigators wish to use their in-house expertise further to extend the capability of our fast field-cycling mri to perform cardiac imaging by building the first-ever cardiac fast field-cycling mri coil and develop cardiac pulse sequences with ecg gating. the investigators will aim to establish the normalcy of t1 dispersion curves for left ventricular myocardium in healthy volunteers, and further on to distinguish the characteristics of post-myocardial infarction scar t1 dispersion curves.

Eligibility criteria:
inclusion criteria: * participant who is willing and able to give informed consent for participation in the study * healthy volunteers willing to give informed consent for participation in the study * patients diagnosed with a previous myocardial infarction exclusion criteria: * unwillingness to participate * claustrophobia * contraindication to mri scanning such as implantable cardiac devices * participants who have had a previous myocardial infarction in the past of which they may not be aware and this is discovered whilst being scanned on the 3t mri scanner, or who may have any other cardiology condition that they were previously unaware will not be included in the healthy control group, even if they present themselves to us as "healthy" at the time of the study visit * pregnancy * body habitus that may preclude comfortable positioning of the volunteer in either of the mri scanners (\>50cm in diameter) * participants with abnormal kidney function that will preclude them from receiving a contrast agent
vaginal tactile imaging in assessment of pelvic floor conditions

Conditions: Pelvic Organ Prolapse

Summary: the clinical study includes investigation of the outcomes of surgery for biomechanical restoration of pelvic floor conditions, monitoring pelvic floor conditions under conservative treatment/management, identification and investigation changes of pelvic floor muscle contractions and their significance in characterization of pelvic floor conditions, assessment of tactile imaging reproducibility, including pelvic floor muscle contraction.


Eligibility criteria:
inclusion criteria: * no prior pelvic floor surgery, and * normal pelvic floor conditions, or * pop stage i affecting one or more vaginal compartment, or * pop stage ii affecting one or more vaginal compartment, or * pop stage iii affecting one or more vaginal compartment, or * pop stage iv affecting one or more vaginal compartment. exclusion criteria: * active skin infection or ulceration within the vagina * presence of a vaginal septum; * active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder; * ongoing radiation therapy for pelvic cancer; * impacted stool; * significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvadynia; * severe hemorrhoids; * significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician; * current pregnancy.

Keywords: pelvic floor biomechanics tissue elasticity tactile imaging