Kornimate/medical-research-clean huggingface dataset:
intracervical anesthesia and pain associated with intrauterine contraceptive insertion

Conditions: Pain, Acute; Anesthesia, Local; IUD Insertion Complication

Summary: the primary aim of our study is to evaluate the effect of intracervical anesthesia on pain scores immediately following levonorgestrel-releasing intrauterine system (lng-ius) insertion in nulligravida women.

no prophylactic pharmacological intervention has proven efficacy in relieving pain during or after the insertion of levonorgestrel-releasing intrauterine system (lng-ius), only in reducing pain associated with the tenaculum. it is known that the nulligravida women have 3 times more chance of presenting moderate / severe pain associated to lng-ius placement. a previous study showed that injectable intracervical anesthesia reduced the risk of moderate/severe pain by 40%. however, the anesthetic dose was small (36 mg of lidocaine) and the study did not evaluate only nulligravida women which are potential candidates for most pain relief benefit. thus, the primary aim of this study is to evaluate the effect of intracervical anesthesia on pain scores immediately following lng-ius insertion in nulligravida women.

Eligibility criteria:
inclusion criteria: * age between 18 and 45 years; * that were never pregnant before; * that wants to use lng-iud; * not pregnant at the time of insertion; * no haematological disease; * that do not have signs and / or symptoms of vaginal / cervical infection. exclusion criteria: * categories 3 and / or 4 for the use of lng-iud according to the medical eligibility criteria of the world health organization (who), users of illicit drugs and / or alcohol, allergy or contraindication to lidocaine, presence of chronic pelvic pain of any etiology, presence of cervical abnormality such as isthmus-cervical fibrosis or incompetence, surgery on the cervix, psychiatric disorders, chronic use of medications that could interfere with the pain threshold (such as antidepressants and anticonvulsants).

Keywords: intrauterine contraception pain anesthesia lng-iud nulligravida
efficacy and safety study of abt-436 in major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose is to study the efficacy and safety of abt-436 in major depressive disorder.


Eligibility criteria:
inclusion criteria: * has a primary diagnostic and statistical manual of mental disorders-fourth edition-text revision diagnosis of major depressive disorder without psychotic features * no current antidepressant treatment within 7 half-lives or 2 weeks, whichever is longer, prior to day minus 1. * can safely be treated on an outpatient basis. * a condition of general good physical health. * surgically sterile, using a highly effective method of birth control or (if female) at least 1 year post menopausal. exclusion criteria: * history of hypersensitivity, intolerance or adverse reaction to escitalopram that led to discontinuation, or hypersensitivity to citalopram. history of serotonin syndrome. * inadequate response to more than two different antidepressant medications during the current major depressive episode. * history of electroconvulsive therapy, vagal nerve stimulation or deep brain stimulation. * history of transcranial magnetic stimulation during the current major depressive episode. * psychotherapy that has not been ongoing for at least 3 months prior to day minus 1.

Keywords: major depressive disorder
physical activity in the format of self-defence training for depressive symptoms

Conditions: Depressive Symptoms

Summary: inadequate mental health care capacity is a long-standing issue in hong kong (yang \& mak, 2020). for example, a recent study predicts an additional 12% service need for specialist psychiatric care (ni et al., 2020). it would be helpful to develop interventions that would ease the high demand of the health care system. physical activity has been shown to reduce depressive symptoms in a number of studies (bellón et al., 2021; josefsson et al., 2014; kvam et al., 2018; schuch et al., 2016). its flexibility and low-cost nature make physical activity a good intervention option for depressed individuals to do it anytime and anywhere. this study aims to investigate the effect of physical activity intervention in the format of self-defence training on depressive symptoms. around 40 eligible participants with at least moderate level of depressive symptoms will be randomly assigned to the physical activity (pa) group and waitlist (wl) control group. the pa group will receive a 6-week home-based self-defence training programme consisting of 120 min video training (including daily practice time) per week. self-report questionnaires will be collected at baseline, immediate post-intervention, and 4-week follow up assessments. the primary outcome measure will be the patient health questionnaire-9 to evaluate depression severity. secondary outcomes will include psychological health symptoms, sleep quality, lifestyle, and quality of life. this research will provide new perspectives on the application of physical activity in the form of self-defence training as an intervention for depressive individuals.


Eligibility criteria:
inclusion criteria: * 18 to 65 years old * hong kong residents * patient health questionnaire (phq-9) score ≥ 10; and * willingness to provide informed consent and comply with the trial protocol. exclusion criteria: * patients with any cardiovascular diseases * receiving psychological treatment or medication for psychiatric disorders * participated in self defence training in the past 6 months

Keywords: self defence training physical activity
kudzu effects on brain ethanol levels: proton spectroscopy assessment

Conditions: Alcohol Consumption; Cerebral Blood Flow

Summary: this study is designed to test whether treatment with kudzu extract will increase the rate at which alcohol enters the brain as measured by rapid proton magnetic resonance spectroscopy (1h-mrs).


Eligibility criteria:
inclusion criteria: * capable of understanding and complying with the protocol * good physical and mental health (normal physical exam, ecg, blood and urine chemistries, no psychopathologies) * body mass index between 18-30, inclusive * age 21-40 years * moderate alcohol drinkers (less than 20 drinks/week) * have a stable living situation with current postal address * no contraindications to mr scanning (see mr scanning exclusion criteria below) exclusion criteria: * concurrent diagnosis of axis i disorder * current or past alcohol dependence; may meet criteria for alcohol abuse. other drug dependence acceptable only if greater than 3 years. * current drug abuse (other than alcohol or marijuana abuse). past drug abuse is acceptable. * subjects cannot be actively seeking treatment for any drug or alcohol dependence. * subjects cannot use marijuana more than once a week. marijuana abuse/dependence are acceptable if the use criteria is met. * maintained on an antipsychotic or antidepressant medication; taking prescription medications except certain short-term anti fungal agents and some tropical creams for dermal conditions. * tobacco use greater than 10 cigarettes per day * history of major head trauma resulting in cognitive impairment or history of seizure disorder * heavy caffeine use (greater than 500 mg on a regular, daily basis) * for female volunteers, a positive pregnancy test

Keywords: alcohol consumption kudzu extract cerebral blood flow
evaluation of irbesartan on hepatic fibrosis in chronic hepatitis c

Conditions: Hepatitis C, Chronic

Summary: the purpose of this study is to examine the efficacy of irbesartan on the progression of liver fibrosis in adult patients with chronic hepatitis c. the expected total enrollment is 200 patients. patients who meet the study criteria and accept to participate at this study will take by day one tablet of 150 mg of treatment (irbesartan or placebo) during two years. the assessment of efficacy will be make by evaluation of area of liver fibrosis and blood markers of liver fibrosis

the results of several studies suggests than the at1 receptor antagonists of angiotensin ii have inhibitory effects on tgf-beta 1 production and can limit the progression of liver fibrosis. therefore, the angiotensin ii could be another mediator of the synthesis of the extra-cellular matrix at the hepatic level, opening new perspectives with the antagonists of angiotensin ii receptors drugs (ara2/sartans). this study is a randomized, double blind, multi-center, parallel assignment, and efficacy study.

Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * liver biopsy performed (less 18 month before inclusion), fibrosis score f2,f3 or f3+ in metavir classification, * patients without antiviral therapy * contraindication to anti viral treatment * non responders or relapsers patients to past antiviral treatment exclusion criteria: * hepatocellular carcinoma * hiv * alcool abuser * cirrhosis * anti-fibrotic treatment * pregnancy or breast feeding

Keywords: hepatitis c, chronic irbesartan
image features of lsci and thermography for determining the risk factor (0,1,2 and 3) of developing diabetic foot ulcer

Conditions: Diabetic Foot

Summary: diabetic foot ulcers are one of the complications of diabetes mellitus. these wounds are often the result of diabetes-related neuropathy and/or an ischemic foot. even with great care, recurrent ulcers are common. to mediate the damage and societal costs that come with df there is a need for applications to detect ulcers before they come apparent. two of these promising techniques are laser speckle contrast imaging and thermography. this study is part of 4 specific clinical studies and is aimed at determining laser speckle contrast imaging and thermography features, the provocations that are needed to optimize imaging and the correlation between these features and the iwgdf risk stratification category system for the diabetic foot.

diabetic foot ulcers are one of the complications of diabetes mellitus. these wounds are often the result of diabetes-related neuropathy and/or an ischemic foot. diabetic feet (df) are ideally treated by a multidisciplinary wound care team. patients at high risk and especially patients that suffer from df before will have to be checked regularly for new wounds. even with great care, recurrent ulcers are common. to mediate the damage and societal costs that come with df there is a need for applications to detect ulcers before they come apparent. to improve care, an application to predict the healing status is desired. to this purpose, a set of four (4) specific clinical studies has been conceived to tackle the overall challenging objectives to characterise the risk of ulcers in different patients and through different measurement conditions, including conditions of how a tele-home care service can be deployed. this is clinical study a. this study investigates two techniques: laser speckle contrast imaging (lsci) is a promising non-invasive technique to assess microcirculation. lsci, exploits the random speckle pattern that is generated when tissue is illuminated by laser light and changes when blood cells move in the sampled tissue. thermography is used to measure temperature distribution on the foot. it is expected that soon-to-be affected regions will be warmer than other regions. also, regions with impaired blood supply can be recognized. clinical study a aims at determining laser speckle contrast imaging and thermography features, the provocations that are needed to optimize imaging, and the correlation between these features and the iwgdf risk stratification category system for the diabetic foot.

Eligibility criteria:
inclusion criteria: * the sample will include all the people who sign the informed consent. * patients above 18. patients diagnosed with diabetic feet. * patients with risk level 0, 1, 2 and 3 according to the international working group on the diabetic foot - iwgdf). exclusion criteria: * people who do not give their consent to participate in the study. * patients with active wounds on one or both feet.

Keywords: diabetic foot diabetes lsci thermography
the treatment effectiveness of combined tdcs and neurofeedback (nf) for patients with cognitive deficits after stroke

Conditions: Stroke; Cognitive Impairment

Summary: this is a double blinded, randomized control trial with a pretest-posttest control and interventional groups design. both the assessor and participants are blinded to all assessments and evaluations. all patients with subacute stroke undergo in-patient or out-patient rehabilitation are screened initially by a series of screening test. suitable patients are assigned randomly to 3 groups respectively. group 1 is the combined transcranial direct current stimulation (tdcs) and neurofeedback group. group 2 is the neurofeedback group. group 3 is the control group with sham neurofeedback training.

treatment sessions for all three groups are conducted by the investigators who has training in neurofeedback and transcranial direct current stimulation (tdcs). each participant performed 10 training sessions on different days. sessions were conducted 3-5 times a week the tdcs + neurofeedback group will carry out 30 minutes tdcs and 30 minutes neurofeedback training. the real neurofeedback group will carry out 30 minutes neurofeedback training. the sham neurofeedback group will conduct the 30 minutes sham neurofeedback training.

Eligibility criteria:
inclusion criteria: 1. first or second stroke (haemorrhagic or ischaemic) confirmed by computer axial tomography scan or magnetic resonance imaging 2. below 16 th percentile cut off in hong kong montreal - cognitive assessment (hk - moca) (range from 17-25/30). 3. less than twelve months since onset of stroke at study entry 4. able to follow simple command exclusion criteria: 1. patients with severe dysphasia (either expressive or comprehensive) which restricts communication; 2. history of other neurological disease, psychiatric disorder, or alcoholism; 3. significant impairment in visual or auditory function 4. any additional medical or psychological condition that would affect their ability to comply with the study protocol.

Keywords: transcranial direct current stimulation (tdcs) neurofeedback
the effects of weight loss on neuroadrenergic function

Conditions: Obesity; Type 2 Diabetes; Metabolic Syndrome

Summary: elevated subconscious nervous system activity is a characteristic of the obese state and contributes importantly to the risk of heart disease and diabetes. this project will compare sympathetic nervous system activity and function in a group of obese persons with differing levels of sugar tolerance (normal, impaired and type 2 diabetic). inter-relationships with insulin action, blood pressure, heart and kidney function will be determined before and after a 4-month weight loss and 3-month weight loss maintenance program. it is hypothesized that the transition from normal sugar tolerance to impaired sugar tolerance to type 2 diabetes will be accompanied by escalating sympathetic nervous system dysfunction. furthermore, that weight loss will favorably improve sympathetic function, with greatest benefits occurring in those subjects who are insulin resistant with high blood insulin concentration.

the twin epidemics of obesity and diabetes represent a major public health problem worldwide. there is a growing body of evidence to suggest that autonomic dysfunction, comprising elevated sympathetic nervous system (sns) activity and blunted sympathetic neural responsiveness plays a role in both the pathogenesis and target organ complications of obesity and diabetes. the proposed project will undertake a detailed comparative analysis of neuroadrenergic function along the diabetes continuum, its inter-relationship with insulin sensitivity and secretion, and target organ function, and the benefits of active weight loss and weight loss maintenance within different strata of metabolic risk.

Eligibility criteria:
inclusion criteria: men and postmenopausal women (n=120), untreated, weight-stable, non-smoking, aged 45-65 years, bmi 27-45 kg/m2, will be recruited. glucose tolerance status will be determined by a 75-g oral glucose tolerance test (ogtt), using who criteria (53): normal glucose tolerance, fasting plasma glucose \ 7.8 and \ 7.0 mmol/l or 2-h plasma glucose \> 11.1 mmol/l. hyper-insulinemia will be defined as an insulin area under the curve during ogtt \> 8000 mu/l ∙ min-1 and hypo-insulinemia as \< 8000 mu/l ∙ min-1. exclusion criteria: prior history of cardiovascular disease (previous myocardial infarction, angina, stroke, heart failure, secondary hypertension), renal (serum creatinine \>0.12 mmol/l or estimated gfr \ 4 alcoholic drinks/day. t2d individuals with moderate hyperglycemia (hba1c \>9%) will be excluded so that hypoglycaemic pharmacotherapy may be instituted (54). participants will be sought through newspaper advertising and poster displays in primary health care centres (general practices). newly diagnosed t2d subjects

Keywords: weight loss metabolic syndrome sympathetic nervous system insulin resistance glucose tolerance
the efficacy of xuebijing injection on sepsis

Conditions: Sepsis

Summary: the efficacy of xuebijing injection in adult patients with sepsis

the purpose of this placebo-controlled study is to determine if xuebijing injection treatment provides significant mortality reduction improvement in patients with sepsis compared with placebo treatment in patients receiving the current standard of care for sepsis. this study will also assess the effectiveness of xuebijing injection in reducing 28-day mortality in patients with sepsis.

Eligibility criteria:
inclusion criteria: patients will be eligible for inclusion if all of the inclusion criteria are met 1. sepsis-3 criteria from society of critical care medicine (sccm) /european society of intensive care medicine (esicm) 2. 18≤ age ≤75years 3. 2 ≤sofa ≤13 4. obtain informed consent exclusion criteria: 1. diagnosis of sepsis for more than 48 h; 2. pregnant and lactating women; 3. severe primary disease including unrespectable tumours, blood diseases and human immunodeficiency virus (hiv); 4. severe liver and kidney dysfunction (single liver or kidney sofa score ≥ 3 points); 5. use of an immunosuppressant or having an organ transplant within the previous 6 months; 6. participating in other clinical trials in the previous 30 days.

Keywords: xuebijing injection, morality, sepsis
evaluation of cardiovascular risk factors in incident dialysis patients

Conditions: Chronic Kidney Disease

Summary: to evaluate the relationships between bone mineral markers levels at dialysis start and vascular calcification progression during a 2 year follow up


Eligibility criteria:
inclusion criteria: * patient who has signed the written consent form * patient with chronic renal failure starting dialysis therapy exclusion criteria: * pregnancy * patient with chronic renal failure not yet on dialysis therapy

Keywords: chronic kidney disease starting dialysis cardiovascular risk bone mineral metabolism markers
a diagnostic for the early detection of bladder cancer

Conditions: Bladder Cancer

Summary: to improve upon the non-invasive detection of bladder cancer by further validating a multiplex elisa assay directed at a bladder cancer-associated diagnostic signature in voided urine samples of patients with a high risk of developing bladder cancer.

environmental exposures, specifically tobacco smoke, increases the risk of many cancers, including bladder cancer. to date, there are no diagnostics capable of detecting bladder cancer early, that is prior to clinical presentation. because of this severe limitation, nearly 30% of patients initially present with stage 2 and higher bladder cancer. stage 2 bladder cancer has a 5-year survival of 50%, while stage 3/4 have a 5-year survival of \ 94%), then its possible to see an improvement in bladder cancer survival rates (21-23). in this study, a urine-based diagnostic that possesses the potential to accurately identify patients who harbor bladder cancer prior to clinical manifestation will be tested.

Eligibility criteria:
inclusion criteria: participants must be: 1. age 50 years or older 2. \>20 pack year history of tobacco exposure 3. free of any malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage i or ii cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. patients with localized prostate cancer who are being followed by an active surveillance program are also eligible. 4. scheduled to be evaluated in the pulmonary rehab clinic or lung cancer screening clinic 5. willing and able to give written informed consent 6. willing to provide voided urine sample 7. be able and willing to complete semi-annual research clinic visits for 4 years exclusion criteria: participants must not have: 1. history of hematuria (microscopic or gross) within 2 years of signing consent. 2. previous history of bladder cancer 3. a known active urinary tract infection or urinary retention 4. an active stone disease (renal or bladder) or renal insufficiency (creatinine \>2.0 mg/dl) - serum creatinine value can be up to 2 years before consent, otherwise repeat. 5. an ureteral stents, nephrostomy tubes or bowel interposition 6. a recent genitourinary instrumentation (within 7 days prior to collection of voided urine sample)
odiparcil qt definitive study

Conditions: Fibrillation, Atrial; Atrial Fibrillation

Summary: this study is being completed to demonstrate the lack of effect of repeat dosing with odiparcil on the qtc interval.


Eligibility criteria:
inclusion: * healthy volunteers exclusion: * cardiac abnormalities * hepatic or renal insufficiency * anti-coagulant medications * bleeding history

Keywords: interval, atrial fibrillation qt, odiparcil,
evaluation of gadolinium deposits in healthy women participating in a high risk screening program for early breast cancer detection

Conditions: Gd-based Contrast Media Exposure During Breast MRI Scans

Summary: purpose: to determine whether patients at high risk to develop breast cancer having received at least 6 cumulative dosages of macrocyclic gd-based contrast media in the context of breast cancer screening by means of contrast-enhanced mri. methods: diagnostic study encompassing two arms: first, 50 patients having received ≥6 dosages of macrocyclic gd-based contrast media in the course of mri-based breast cancer screening will undergo brain mri assessment for signal alterations due to gd-deposits. the second arm consists of 50 healthy volunteers that never received gd-based contrast agents, and undergoes the same brain mri assessment as the patient-based arm 1 of the study. signal intensities will be compared to assess the potential presence or absence of macrocyclic gd-based contrast agent deposits in the brain. in case of presence of signal alterations in arm 1 these will be further stratified by number of previously administered macrocyclic gd-contrast agent doses. projected outcome: high cumulative dosages of macrocyclic gd-based contrast agent either result or do not result in brain mri signal alterations in healthy women participating in a high-risk screening program for the early detection of breast cancer that necessitates gd-contrast agent enhanced breast mri at regular intervals.


Eligibility criteria:
inclusion criteria: * female; cumulative exposure to ≥6 dosages of macrocyclic gd-based agents in the course of breast mri screening for breast cancer or no exposure to gd-based contrast media exclusion criteria: * previous chemotherapy; serious illness including cardiovascular and neurological diseases; contraindications to mri; exposure to non-macrocyclic gd-based contrast agents

Keywords: magnetic resonance imaging gd-based contrast media gd-deposits brain imaging breast cancer screening