Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of bp1.4979 in smoking cessation

Conditions: Tobacco Addiction

Summary: clinical study which aim is to assess in heavy smokers willing to quit smoking the efficacy and the safety profile of bp1.4979 for smoking cessation on the total abstinence measured by subject diary and confirmed by exhaled co (abstinent \< 10 ppm).

bp1.4979 is a novel compound with promising efficacy on smoker which have been assessed on phase i studies. this is a multicenter,randomized, double blind, placebo controlled, phase iib trial with parallel group to assess safety and efficacy of bp1.4979 in smoker.

Eligibility criteria:
main inclusion criteria: * a smoking history of at least 10 years * subject smoking at least 15 cigarettes per day at the time being and for at least 30 days before selection. * having already made at least 2 attempts to stop * with no period of abstinence \> 3 months in the previous year * ftnd ≥ 7 main exclusion criteria: * any significant psychiatric illness or mood disorder, assessed by the bdi * had scale (a + d ≥ 19, the day of the selection and inclusion) * audit ≥ 8 * subject smoking cigars or pipes exclusively * subject taking any antismoking medication and/ or nicotine replacement therapy (nrt) in the previous month.

Keywords: tobacco addition
effect of anti-inflammatory diet in osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: in a previous exploratory study, the investigators observed an effect on disease activity outcomes of anti-inflammatory diet. the investigators also observed change in microbiome and circulating metabolites. the current study will determine whether or not the addition of anti-inflammatory diet improves the clinical outcomes in participants with osteoarthritis, and the role of microbiome and circulating metabolites.


Eligibility criteria:
inclusion criteria: * unilateral radiographic symptomatic koa * no changes in therapy during the previous 3 months * interested in dietary intervention and able to provide consent and attend follow-up visits exclusion criteria: * previous knee surgery * severe radiographic disease (kl grade 4) * rheumatoid arthritis * any abnormal blood values in the comprehensive metabolic panel test at screen (abnormality will be defined based on standard reference ranges) * use of corticosteroids and/or intra-articular injections during the preceding 3 months * use of fish oils and glucosamine * participation in a weight loss program in the preceding 6 months * recent changes in physical activity levels * regular smoking * patients with food allergies * patient with other medical conditions that will impair the ability to participate in a nutritional study * plan to change systemic therapy * patients unwilling to change dietary habits
pulsed radiofrequency vs dry needling in myofascial pain

Conditions: Myofascial Pain

Summary: myofascial pain (mps) is the leading cause of chronic and persistent regional pain, affecting as many as 85% of the general population. a variety of treatment methods for myofascial pain have been investigated, including injection of saline, local anesthetics and steroids, dry needle, mini-scalpel, rich platelet plasma and radiofrequency ablation. ultrasound guided dry needle (dn) and pulsed radiofrequency ablation (prf) of the trigger point have been considered as two effective and promising treatments for myofascial pain. as far as searched, we failed to identify any study comparing the effects of dn and prf in myofascial pain patients.


Eligibility criteria:
inclusion criteria: 1. aged between 18 and 70 years old. 2. chronic (\>3 months) myofascial pain in the neck, shoulder, and upper back region. 3. myofascial pain will be diagnosed based on simons and travell's criteria: taut band palpable, exquisite spot tenderness of a nodule in a taut band, patient's recognition of current pain complaint by pressure on the tender nodule, and painful limit to full stretch range of motion. 4. have at least a pain vas score of 40 mm; thus, a minimal clinically significant change is detectable. exclusion criteria: 1. history of receiving dn or prf treatment or currently undergoing other pain-related treatments (acupuncture, laser, infrared therapy, etc.). 2. presence or history of trauma, surgery, or infection in the pain region. 3. current or history of taking moderate to strong analgesics, such as tramadol and morphine. 4. severe systemic disease (eg. severe hepatic or renal dysfunction), coagulopathy, or medications affecting the coagulation system. 5. allergy to medications used. 6. pregnancy, psychiatric disease, medical background, inability to cooperate, or refusal to participate. withdrawn criteria: 1. unwilling to continue participation or unable to follow the treatment plan. 2. unable to obtain the primary outcome data due to any reason.
access creation for hemodialysis: association with structural changes of the heart

Conditions: Arteriovenous Fistula; Arteriovenous Graft; Left Ventricular Hypertrophy; Brain Natriuretic Peptide

Summary: the purpose of this study is to determine if the creation of a fistula or a graft plays a role in the development of heart disease for patients undergoing hemodialysis

patients with end stage renal disease are at 18-20 times greater risk of dying from cardiovascular disease as the general population. both traditional and non-traditional cardiovascular risk factors are thought to be important. of the non-tradtional cardiovascular risk factors, creation of an arteriovenous fistula or graft for the purposes of a blood access for hemodialysis may contribute to an elevation in bnp and left ventricular hypertrophy - both factors that have been associated with an increased risk of mortality prior to access creation and at one month and one year post access creation - samples for bnp will be collected prior to access creation and at one year post access creation - echocardiography will be performed

Eligibility criteria:
inclusion criteria: 1)hemodialysis 2)high risk for heart failure (dm, age\&gt;50, and/or systolic dysfunction) 3) first arteriovenous fistula/graft 4) informed consent 5) technically adequate echocardiogram 6) stable hgb(\&gt;100) 7) stable mineral metabolism (normal calcium, phosphate \&lt;2.1mmol/l, pth\&gt;50pmol/l) exclusion criteria: 1)expected survival \&lt;1 year 2) expected to get a living donor transplant in one year 3)primary access failure 4) arf

Keywords: hemodialysis arteriovenous fistula arteriovenous graft left ventricular hypertrophy brain natriuretic peptide
cognitive training in patients with mci using fmri

Conditions: Mild Cognitive Impairment

Summary: the current project aims to investigate the efficacy of the visual imaging training (vit) and alphabet search training in comparison to an active control intervention, namely psychoeducation information (pi) using fmri in patients with amnestic mild cognitive impairment (mci) and healthy elderly controls (he). mci patients will be grouped according to biomarkers (pet pib, pet fdg and liquor).

we will include 30 subjects with amnestic mild cognitive impairment (mci) single domain or multiple domain clinical diagnostic, over 60 years old, recruited through the cognitive and behavioral neurology group ambulatory of university of sao paulo general hospital. we will also include 30 healthy subjects, over 60 years old, recruited in the community. all the participants will be evaluated by neurologists specialized in cognitive neurology and subjected to a neuropsychological assessment. the 30 participants with mci and 30 healthy subjects will be divided in 6 groups: the g1 mci group (n=10) will receive 4 sessions of visual imaging training; the g2 control group (n=10) will receive 4 sessions of visual imaging training; the g3 mci group (n=10) will receive psychoeducation intervention; the g4 control group (n=20) will receive psychoeducation intervention; the g5 mci group (n=10) will receive cognitive training with alphabet search training and the g6 control group will receive cognitive training with alphabet search training. this will be a longitudinal, randomized, double blind study. mci patients will be grouped according to biomarkers (pet pib, pet fdg and liquor).

Eligibility criteria:
inclusion criteria: * portuguese as native and preferred language; a minimum of 4 years of education; mri-compatible; right-handed individuals; normal corrected vision and hearing; estimated intelligence average or above (≥ 80 iq); amnestic mild cognitive impairment identified by a doctor and neuropsychological tests; able to give informed consent. exclusion criteria: * history of neurological disorder; history of serious systemic disease; history of severe mental illness; current untreated alcohol or substance abuse; medical conditions that compromise in any way the central nervous system; presence of visual impairment and / or hearing to preclude cognitive testing; presence of contraindications to mri exam; findings in structural mri that can interfere with the results of the study
sequential radiotherapy with car-t cells in the treatment of relapsed and refractory hematological malignancies with extramedullary lesions

Conditions: Hematological Malignancies

Summary: clinical trial for the safety and efficacy of sequential radiotherapy with car-t cells in the treatment of relapsed and refractory hematological malignancies with extramedullary lesions

this is a prospective, single arm study. to evaluate the safety and efficacy of sequential radiotherapy with car-t cells in the treatment of relapsed and refractory hematological malignancies with extramedullary lesions. the main endpoints were dose limiting toxicity (dlt) and incidence of adverse events (teaes).

Eligibility criteria:
inclusion criteria: age≥15 years old; relapsed and refractory hematological malignancies with extramedullary lesions, mainly including b-cell non hodgkin's lymphoma, multiple myeloma, acute lymphoblastic leukemia, etc; flow cytometry or pathological biopsy confirmed that tumor cells have potential therapeutic targets for car-t cells; pet-ct confirmed that the extramedullary lesions were located in a single radiotherapy region; anticipated survival time more than 12 weeks; those who voluntarily participated in this trial and provided informed consent. exclusion criteria: history of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; electrocardiogram shows prolonged qt interval, severe heart diseases such as severe arrhythmia in the past; pregnant (or lactating) women; patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); active infection of hepatitis b virus or hepatitis c virus; concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids; previously treated with any car-t cell product or other genetically-modified t cell therapies; creatinine\>2.5mg/dl, or alt / ast \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; other uncontrolled diseases that were not suitable for this trial; patients with hiv infection; any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Keywords: radiotherapy car-t extramedullary lesions relapsed and refractory
morning hypertension and preminent therapy study

Conditions: Hypertension

Summary: it is difficult to control morning hypertension in practical clinical situation. angiotensin receptor blocker (arb) and thiazide are suggested to be effective to maintain the antihypertensive effects for 24 hours. however, monotherapy sometimes is not enough to control blood pressure level in the next morning and there are little evidence of the combination therapy for morning hypertension. the investigators hypothesized that a losartan 50 mg/hydrochlorothiazide 12.5 mg combination drug, preminent, is effective and safe for controling morning hypertension, compared with high-dose of losartan 100 mg, in japanese. patients with morning hypertension were randomized to preminent treatment group or high-dose losartan treatment group. the efficacy and safety were compared after 3-month treatment.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of outpatients with morning hypertension (135/85 mmhg) * under treatment with any antihypertensive agents exclusion criteria: * poorly controlled hypertension (dbp\>120 mmhg) * poorly controlled diabetes (hba1c\>9.0% * gout or hyperuricemia (ua\>8.0 mg/dl) * serum cr\>2.0 mg/dl * serum k\>5.5 mmol/l * liver dysfunction (alt\>90 iu/l and/or g-gtp\>14o iu/l) * secondary hypertension * patients who have contraindication for losartan and/or thiazide diuretics

Keywords: hypertensive patients with morning hypertension
effectiveness of rupture of schatzki's ring using biopsy forceps versus single dilation

Conditions: Dysphagia; Schatzki Ring

Summary: dysphagia is a common reason for referal to the investigators gastoenterology service. as many as 14% of patients undergoing radiological studies for dysphagia are found to have schatzki rings. current recommendations for treatment of patients with symptomatic schatzki rings are based on ancedotal experience and uncontrolled studies. the only randomized study on comparison of techniques the investigators were able to locate was published in 2000 and included only 26 patients. this study demonstrated that the biopsy techinque was as effective as and better tolerated than the standard dilation technique. considering that the cost and time required for dilatation is greater than the basic biopsy technique, significant cost savings could be achieved using the biopsy technique. as well, patient satisfaction is an important factor considering that schatzki rings can recur and repeated endoscopy is often required. therefore, a study that shows a technique to be as or better than the current standard in effectiveness, cost, time, and patient comfort could lead to shift in current practice.

none available, study was withdrawn

Eligibility criteria:
inclusion criteria: * presenting to endoscopy unit with symptoms of dysphagia or known history of schatzki ring exclusion criteria: * prior esophageal or gastric surgery, severe esophagitis, coagulopathy
induction and recognition of emotions

Conditions: Healthy Older Adults; Alzheimer's Disease; Parkinson's Disease

Summary: this study evaluates the differences in cognitive function between healthy older adults, older adults with mild alzheimer's type dementia and older adults with parkinson's disease and if there are differences in valence assessment and activation that produce them a mood induction task. subjects are assessed using neuropsychological tests and then a mood induction task based on movie clips is applied.

different neuropsychological tests will be used to assess the differences in cognitive function in the different groups, whose scores are expected to be lower in the group of older adults with alzheimer's disease (ad) and older adults with parkinson's disease (pd). after studying the cognitive function in the different groups, we proceed to check through a task based on movie clips if there are also differences in the valence assessment (liking/disliking depending on the emotion induced by scenes from different films) and activation (excitement caused by each one of the movie scenes), hoping to find differences for the negative emotions taking into account the cognitive difficulties that both (the ea group and the ep group) may have for processing this type of cognitively more demanding information; instead, it is possible that the positivity effect continues to affect these patients so that for positive emotions there are no differences between the different groups.

Eligibility criteria:
inclusion criteria: for the group of healthy older adults: * mec score greater than 26 points. * gds between 1 and 3. for the mild ea group: * mec score between 18 and 23 points. * gds between 3 and 4. for the ep group: * mec score greater than 23 points. * gds between 1 and 3. * fab score equal to or less than 11 points. general exclusion criteria: participants cannot have: * significant asymptomatic neurovascular disease * history of previous symptomatic stroke * alcohol or drug abuse/dependence * severe psychiatric symptoms * depressive symptoms higher than mild

Keywords: healthy older adults alzheimer's disease parkinson's disease mood induction positive emotions negative emotions
comparison of body dissatisfaction among islamic veil practicing (ivp), non-complete ivp, and inconsiderate to ivp women

Conditions: Depression; Body Dissatisfaction; Obesity; Eating Disorders

Summary: the aim of this research is to examine the social, psychological and islamic veil practicing (ivp), non-complete ivp and inconsiderate to ivp correlates of body mass index (bmi) status in a women population. it is hypothesized that women who are ivp would differ on depression, and social variables compared with their non-practicing peers.

in this cross-sectional study, a population-based sample of 1774 female responded anonymously to an aerobic health club administered questionnaire. body mass index was calculated from height and weight and categorized into four classes of underweight, normal, overweight, and obese. the questionnaire also included questions about social experiences, body dissatisfaction as body shape questionnaire (bsq), future goals and islamic veil practicing (ivp). persian version of beck depression inventory (bdi-ii persian) and rosenberg self esteem scale was also distributed among six groups of women having ivp/regular exercise (re), ivp/non-re, non-complete ivp/re, non-complete ivp/non-re, inconsiderate to ivp/re, and inconsiderate to ivp/non-re. correlations of bmi with social, psychological, future goals and ivp were explored

Eligibility criteria:
inclusion criteria: * open for all women practicing islamic veil, non-complete iv, or inconsiderate to iv exclusion criteria: * overt signs of anorexia nervosa, bulimia nervosa

Keywords: self concept eating disorder body mass index dressing islamic veil
high light intensity bleaching versus descending light intensities bleaching on post bleaching teeth sensitivity

Conditions: Discoloured Teeth

Summary: compare teeth sensitivity using bleaching protocol with different light intensities (philips zoom!™ white speed whitening gel and lamp, discus dental, inc., culver city, ca, usa.) versus bleaching protocol with the same light intensity (philips zoom!™ advanced power whitening gel and lamp, discus dental, inc., culver city, ca, usa.).

this study will be applied to patients suffering from teeth discolorations. nowadays, vital tooth bleaching is one of the most requested cosmetic dental procedures asked by patients who want and aesthetically more pleasing smile. the american dental association (ada) has advised patients to ask the dentists to adamant the most suitable bleaching treatment, especially for those complaining of tooth sensitivity, dental restorations, extremely dark discolorations, and single dark teeth. tooth sensitivity (ts) is the most common clinical side effect of tooth bleaching. tooth sensitivity (ts) caused by bleaching procedures usually results in mild and transient pain; however, it can occasionally cause significant discomfort that is a main deterrent to patients successfully completing bleaching treatments. considering that ts has been reported as a common side effect, affecting more than 60% of the patients that undergo this cosmetic treatment. greater tooth sensitivity has been reported with in-office bleaching with adjunct light compared with no light. existing literature reveals that activation of bleaching agents by heat or light may have an adverse effect on pulpal tissue. it was already reported that the use of intense lights does elevate bleach temperature, but it results in increased intrapulpal temperatures, which may further impact patient sensitivity and pulpal health.hence, in this study different light intensities bleaching protocol will be used aiming at overcoming this complication.

Eligibility criteria:
inclusion criteria: 1. patients included in this clinical trial were at least18 years old. 2. patients should be free from any systemic disease that may affect normal healing and predictable outcome. 3. patients who will agree to the consent and will commit to follow-up period. 4. willing to refrain from tobacco products and any colored liquids or food (e.g. coffee, tea, tomato sauce etc.) during the active study period. exclusion criteria: 1. patients with any systemic disease that may affect normal healing. 2. patient with bad oral hygiene. 3. pregnant females. 4. patients who could/would not participate in a 3month follow-up. 5. untreated periodontal disease were not allowed. 6. active caries or defective restorations in 6 anterior teeth. 7. sensitive teeth 8. bleaching history 9. patients participating in more than 1 dental study.

Keywords: post bleaching teeth sensitivity
drotaverine in dysmenorrhoea treatment

Conditions: Dysmenorrhea

Summary: the aim of the study is to show that the combination of drotaverine 80mg and ibuprofen 400 mg is more effective and as well-tolerated as ibuprofen 400 mg or drotaverine 80 mg administered alone, in the treatment of primary and secondary dysmenorrhoea.


Eligibility criteria:
inclusion criteria: * history of at least 6 months of dysmenorrhea, with presence of moderate to severe pain in each of the last 3 cycles * with regular menstrual cycles (25-35 days) * using an adequate barrier contraception method (except for virgins) exclusion criteria: * evidence of clinically relevant gynecological, cardiovascular, hematologic, hepatic, gastrointestinal, renal, pulmonary, endocrinologic, neurologic or psychiatric disease, based on a clinical assessment and routine laboratory investigations * proven hypersensitivity to drotaverine hydrochloride or ibuprofen or proven intolerance to lactose * any described contraindication to either drotaverine hydrochloride or ibuprofen (see summary of product characteristics) * oestro-progestative contraception within the last 2 months * regular use of sedative, hypnotics, tranquillizers or any other addictive agents * history or evidence of acute or chronic alcohol abuse * heavy smoking (\> 10 cigarettes/day) * need of a permanent treatment with other antispasmodics and/or analgesic agents during the trial * lactation * pregnancy * participation in another clinical trial in the last 3 months prior to the start of this study the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.