Kornimate/medical-research-clean huggingface dataset:
the potential of kava in enabling tobacco cessation - its holistic effects in managing stress and insomnia associated with abstinence

Conditions: Smoking

Summary: this study will evaluate the compliance with a daily kava regimen among active smokers who have an intention to quit smoking. this study will also investigate whether kava use can facilitate tobacco cessation, reduce stress, and improve sleep.


Eligibility criteria:
inclusion criteria: * adults aged 21 years or above (legal age for smoking in the u.s.) up to 99 years old; * self-reported smoking at least 10 cigarette/day for the past year with intention to quit; * expired carbon monoxide level of more than 8 ppm at recruitment; * willingness to participate in the proposed study; * access to a functional telephone; * expected presence in the study's geographical area for the next 4 months; * not currently enrolled in any smoking cessation programs; and * female subjects of childbearing potential will be required to practice acceptable methods of birth control (the acceptable methods of birth control include birth control pills, birth control shot, birth control implant, iud, diaphragm, and cervical cap). * if a participant takes kava dietary supplement, a 2-week washout period is needed for the participant to initiate this study or if a participant participated in a kava trial before, such as the kava jek trial, the participant could be enrolled if the inclusion criteria above are met, including the 2-week washout period. exclusion criteria: * diagnosed with cancer (other than non-melanoma skin cancer); * diagnosed with liver dysfunction or with previous liver diseases; * levels of alanine transaminase, aspartate transaminase, alkaline phosphatase or total bilirubin over limit of normal (uln) range at prescreen; * inability to refrain from acetaminophen, alcohol (no more than one drink daily via self-report), or other potentially hepatotoxic substances; * use any other non-cigarette nicotine containing products such as smokeless tobacco, cigar or e-cigarettes; or * are pregnant or nursing (lactating) or of childbearing age planning to become pregnant or unwilling to use adequate contraception during the study; * participant answered "yes" to any of the modified ask suicide screening questions questions 1 through 4, or refuses to answer. if subject answers 'yes' to question 4 but the most recent suicide attempt took place \>12 months from screening visit then subject is still eligible.

Keywords: kava smoking cessation tobacco dependence
clinical trial to evaluate the effect and safety of msv in xerostomy

Conditions: Xerostomia Due to Radiotherapy

Summary: phase ii not controlled, open-label, prospective, single center clinical trial

* determine changes in the xerostomia characteristics and discomfort degree by means of questionnaires addressed to the physician and subject of study. * determine the volume of submaxilar saliva without stimulation and with stimulation by sialometry (sl). * detect changes in volume, vascularization and fibrosis of submaxillary glands based on magnetic resonance imaging (mri) with contrast. * detect changes of submaxillary gland functionalism based on gammagraphy (gf).

Eligibility criteria:
inclusion criteria: 1. patients from 18 to 75 years old of both sexes. 2. biochemical analysis without significant alterations which could contraindicate the treatment. 3. bilateral radiotherapy of the previous neck due to neoplasia in states t1-t2 and n0, n1 and n2a. 4. 2 years of follow-up without recurrence. 5. reduction of salivation and hyposalivation, evaluated by an examination, flow rate or whole unstimulated saliva in the range of 0.05- 0.20 ml / min. 6. grade 1-3 xerostomy as assessed by the grading scale. 7. the patient is able to understand the nature of the study. 8. written informed consent of the patient exclusion criteria: 1. participation in another clinical trial in the 3 months prior to his/her inclusion. 2. present infection (no infectious sign should be evidenced with repercussion on the evolution of the treated lesion). 3. patients with positive serologies for hiv, lues and hepatitis with positive viral load. 4. history of cancer in the last 2 years. history of teratoma, adenocarcinoma derived from one of the salivary glands, lymphoma of the tonsils or some other lymphatic tissue or melanoma of pigmented cells of the oral mucosa. 5. xerogenic medication in progress. 6. other diseases of the salivary glands, for example, sjögren's syndrome, sialolithiasis, etc. 7. local infection. 8. pregnancy or pregnancy planned within the next 2 years. 9. breastfeeding. 10. treatment with anticoagulants (not interruptible in mo or application). 11. any other illness or condition that is grounds for exclusion for the investigator.
risk factors for exertional heat illness

Conditions: Exertional Heat Illness

Summary: the arduous nature of military training and operations require personnel to encounter high heat load, e.g., during intense physical exertion, particularly in the heat. these conditions reduce operational effectiveness and expose personnel to a risk of incapacitation and death from exertional heat illness (ehi). the aim of this study is to examine traditional and novel risk factors that may increase thermal strain and ehi likelihood in military recruits undergoing strenuous physical exercise.


Eligibility criteria:
inclusion criteria: * men and women aged 17-35 years enrolled in military training exclusion criteria: * self-report as pregnant
kelee® meditation: a distinctive and effective therapeutic intervention for stress, anxiety, and depression

Conditions: Stress; Anxiety; Depression

Summary: the purpose of this study is to determine how effective kelee meditation is in improving stress, anxiety, and depression.

the kelee and kelee meditation (km) were developed and founded by ron w. rathbun. km is a unique and distinctive form of meditation that is easy to learn and requires only about 10 minutes twice a day to perform. the goal and discipline of km is the development of one-pointed stillness of mind. to better comprehend how km is effective in reducing stress, anxiety, and depression, one must understand the difference between concentration and meditation, and the basic principles of the kelee. experiencing and understanding the distinction between brain function and mind function are of vital importance in km. brain function is associated with the tension-based, intellectual, thinking process and the five physical senses whereas mind function is associated with the relaxation-based, experiential, mental feeling process, self-awareness, and clear perception. performing km leads to the calming of brain function and opening to the experience of mind function. with continued practice, persistence, and patience, the practitioner can begin to learn on his own how to examine and understand (ie, troubleshoot) his own thoughts and feelings from a calm, clear internal space that is free from the negative chatter and preconception associated with the brain. this increases self-awareness of the presence of internalized compartments (misperceptions of life that exist as negative thoughts and/or feelings) and the practitioner begins to develop clarity of perception. clear perception allows one to begin the process of detachment from internalized compartments, which occurs through the cessation of looping followed by the processing of compartments. as each negative compartment dissipates, the practitioner experiences a subtle, but cumulative, corresponding improvement in stress, anxiety, and depression. when the flow of the kelee is allowed to be, there is balance between the thinking and the feeling process leading to overall well-being, which leads to improved self-efficacy and reinforces the repetition of km.

Eligibility criteria:
inclusion criteria: * documented hiv-1 infection * ages 18 to 65 * experiencing some level of stress, anxiety, or depression * no current use of other meditation practices or holistic modalities exclusion criteria: * non-english readers or speakers * hearing-impaired * low literacy below 5th grade reading and comprehension level

Keywords: kelee meditation stress anxiety depression brain mind
targeted perfusion based haemodynamic management in critically ill patients using urethral perfusion

Conditions: Critically Ill

Summary: to assess the safety and feasibility of the ikorus device in critically ill patients and to gather exploratory data on haemodynamic coherence


Eligibility criteria:
inclusion criteria: * within 24 h of icu admission * predicted length of icu stay at least 5 days * receiving \>0.1 mcg/kg/min of noradrenaline at time of study enrolment exclusion criteria: * palliative treatment intent * contra indication to urethral catheterisation or complication during previous urethral catheter insertion * contraindication to fluid or vasopressor challenges in the opinion of the attending clinician
effects of alogliptin on pancreatic beta cell function

Conditions: Diabetes Mellitus, Type 2

Summary: it is reported that pancreatic beta cell function is already declined at pre-diabetic stage, impaired glucose tolerance (igt). it has not been clarified whether inhibitors of the dipeptidyl peptidase iv enzyme (dpp-iv inhibitors) improve beta cell function on human pancreas, however, if efficacy is ensured, they may become the first medicine to be chosen for treatments of type 2 diabetes and igt. in this trial, a dpp-iv inhibitor, alogliptin, or metformin are given to diabetic patients whose hba1c level is below 7.9%. oral glucose tolerance test (ogtt) will be conducted before, a year after, and two years after the beginning of the trial and beta cell function will be evaluated.

patients will be randomly allocated to two groups. they will receive either alogliptin or metformin. alogliptin: the investigators will start with 25 mg qd and the dose will be maintained. metformin: the investigators will start with 250 mg qd and the dose will be slowly increased to 750 mg tid. the dose increase is possible up to its maximum, 2250 mg, so that hba1c is maintained below 6.9%. however, increase in dose with elder patients requires careful consideration. participants taking part in this study will receive dietary and exercise coaching. participation in this study is expected to last up to 2 years. patients will terminate from the trial when their hba1c exceeds 8.4% for more than three months. the investigators will evaluate beta cell function by conducting 75 g ogtt before, a year after, and two years after the beginning of the trial. alogliptin or metformin will be stopped three days before the ogtt. the investigators will make sure that urine ketone is negative before an oral glucose load.

Eligibility criteria:
inclusion criteria: * patients who are diagnosed as type 2 diabetes with hba1c level below 7.9% and haven't received oral hypoglycemic agents or insulin treatments for the past three months. exclusion criteria: * patients whose 75 g ogtt 30-minutes insulin secretion exceeds 100 μu/ml * patients with renal failure with serum creatinine level ≧ 1.2 * patients with hepatocirrhosis * patients with proliferative diabetic retinopathy or worse * patients with acute infectious disease * patients who are treated with steroids * patients with cancer * pregnant patients * patients with malfunction of the heart (nyha classification iii-iv) * patients who are decided to be inappropriate subjects by study physicians

Keywords: pancreatic beta cell diabetes mellitus, type 2 glucose metabolism disorders metabolic diseases endocrine system diseases metformin hypoglycemic agents physiological effects of drugs pharmacologic actions hemoglobin a1c protein, human oral glucose tolerance test
taping and pmr effects in primary dysmenorrhea

Conditions: Dysmenorrhea Primary

Summary: the study is randomized controlled trial,the study conducted in two groups. group a has given the kinesiology taping on the lower abdomen and back for 1-3 days with progressive muscle relaxation technique for 10-20 minutes and a baseline treatment hot pack at a time twice a day from the start of menstruation and group b has receive the kinesiology taping on the lower abdomen and baseline treatment hot pack without progressive muscle relaxation technique for 1-3 days. the total treatment duration will be 6 weeks. the rationale of this study is to provide empirical evidence regarding the efficacy and safety of kinesiology taping and progressive muscle relaxation. by investigating the potential benefits of this intervention, healthcare professionals can make informed decisions about incorporating k-taping and pmr in primary dysmenorhea. focusing on the impact of kinesiology taping and progressive muscle relaxation on pain,anxiety, and body awareness aligns with a patient-centered approach to care. the goal is not only to reduce symptoms but also to enhance overall well-being and functional capacity

the literature gap of the study is that upto our knowledge, there is little or no evidence found in previous researches on the combined effects of kinesiology taping in combination with progressive muscle relaxation technique in primary dysmenorrhea.

Eligibility criteria:
inclusion criteria: * • aged between 18-25 years * unmarried female * taking ≥4 points from visual analog scale during menstrual cycle * had moderate menstrual pain as measured by wallid score exclusion criteria: * • complaints of low back pain due to any other pathology, any skin infection, sensitive skin or allergic to kinesio tape. * pcod, uterine/ ovarian tumor, acute/ chronic pelvic pathology like pid, endometriosis, spinal pathology and deformity * endometrial polyp, having a pelvic infection, using an intrauterine device, having venous congestion in the internal genital organs. * who take analgesic

Keywords: : anxiety, dysmenorrhea, pain,
effect of addition of oral montelukast to standard treatment in acute moderate to severe asthma in children

Conditions: Bronchial Asthma

Summary: available evidences show a role of oral montelukast in acute asthma. safety of oral montelukast is well established in children, as evidenced by use of oral montelukast in long term management of asthma. therefore, the investigators planned this study to see the effect of oral montelukast as add on therapy to standard treatment in acute moderate to severe asthma in children between 5-15 years of age. hypothesis: addition of single dose of oral montelukast to standard therapy in acute moderate to severe asthma in children aged 5-15 years will reduce the modified pulmonary index score to less than 9 in 90% children compared to 70% in children receiving a placebo.

leukotrienes plays an important role as mediator for inflammatory changes in acute as well as chronic asthma. there are three randomized controlled trials involving 274 adult patients with acute asthma who were treated with montelukast (intravenous in 2 and intravenous and oral in one study) to see the beneficial response in spirometry. all the studies showed significant improvement in fev1 in first 2 hours. these studies show that oral montelukast causes improved pulmonary function and has a rapid onset of action. however, these studies are carried out in adults. safety of oral montelukast is well established in children, as evidenced by use of oral montelukast in long term management of asthma. therefore, we planned this study to see the effect of oral montelukast as add on therapy to standard treatment in acute moderate to severe asthma in children between 5-15 years of age.

Eligibility criteria:
inclusion criteria: * children aged 5-15 years of age, either sex seeking treatment with acute moderate to severe asthma in pediatric casualty/ chest clinic/ out patient services. acute moderate to severe asthma is defined as modified pulmonary index score of more than 9. exclusion criteria: * children with life threatening asthma (poor respiratory efforts, cyanosis, altered sensorium). * children who had received montelukast within one week of arrival. * children with other chronic respiratory conditions (including congenital lung abnormalities) like tuberculosis, cystic fibrosis or other acute illnesses that would complicate current treatment and response for asthma. * children with altered sensorium/unable to take oral medication.

Keywords: montelukast acute asthma
oto-201 for the treatment of middle ear effusion in pediatric subjects requiring tympanostomy tube placement

Conditions: Otitis Media With Effusion

Summary: the purpose of this study is to confirm the effectiveness, safety and tolerability of oto-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.

this is a prospective, randomized, double-blind, sham-controlled, multicenter, phase 3 study of oto-201 administered intraoperatively in pediatric subjects with bilateral middle ear effusion requiring tt (tympanostomy tube) placement. one dose level (6 mg) of oto-201 was evaluated relative to sham (empty syringe). study subjects are required to have a clinical diagnosis of bilateral middle ear effusion requiring tt placement. on the day of surgery, prior to surgery, eligible subjects were examined via otoscope to confirm bilateral middle ear effusion. subjects with bilateral middle ear effusion were randomized to either 6 mg oto-201 or sham. subjects without bilateral effusion on the day of surgery were not randomized and were considered screen failures. approximately 264 subjects are planned to be randomized to oto-201 or sham using a 2:1 allocation ratio. randomization to oto-201 or sham was stratified by age: 6 months to 2 years or \>2 years. subjects are to visit the study site for safety assessments and otoscopic examination on days 4, 8, 15, and 29. the assessment of otorrhea by the blinded assessor for the primary efficacy endpoint occurred on days 4, 8, and 15.

Eligibility criteria:
inclusion criteria includes, but is not limited to: * subject is a male or female aged 6 months to 17 years, inclusive * subject has a clinical diagnosis of bilateral middle ear effusion requiring tympanostomy tube placement * subject's caregiver is willing to comply with the protocol and attend all study visits exclusion criteria includes, but is not limited to: * subject has a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with tympanostomy tube placement * subject has a history of sensorineural hearing loss * subject has a history of chronic or recurrent bacterial infections other than otitis media that likely will require treatment with antibiotics during the course of the study

Keywords: otitis media otorrhea middle ear effusion tympanostomy tubes
development and validation of a daily pain catastrophizing scale

Conditions: Chronic Pain

Summary: this study sought to develop and validate a brief, daily version of the pain catastrophizing scale.

the pain catastrophizing scale (pcs; 13 items; factors: rumination, helplessness, magnification) (sullivan 1995) measures trait catastrophizing in the context of actual or anticipated pain. currently, there is no validated tool for measuring pain catastrophizing at the daily level. lack of a validated daily measure stands as a barrier for studies that aim to characterize mechanisms of pain treatment and how pc adaptation / change occurs.

Eligibility criteria:
inclusion criteria: 1. age 18 or above 2. chronic pain of any etiology 3. online access 4. ability to participate in daily measurements over 14 days exclusion criteria: 1. lack of ability to answer questionnaires and daily catastrophizing captures, at the discretion of study staff.
f-18-fluorocholine pet/ct and mr imaging/ spectroscopy in the management of primary and recurrent prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this study is to demonstrate that realization of guided biopsies by multimodal imaging with 18f-fluorocholine pet / ct and mr imaging/spectroscopy would allow to increase the rate of detection prostate cancer compared with the current approach and give an information about location and tumoral volume before surgery.:

1. to evaluate the utility of f-18-fch-pet/ct and mr imaging with 3-d mr spectroscopy in detecting, localizing, and estimating the volume of initial primary prostate cancer as compared to the current standard work-up using trus-guided biopsy. all imaging findings will be correlated with "gold standard" step slice histological examination. the hypothesis is that the combination of noninvasive imaging will improve the preoperative work-up as compared to the current approach. 2. to evaluate fch-pet for the restaging of prostate cancer after biochemical relapse in a large patient cohort. this will run in parallel to the work-up of primary prostate cancer, as the fch radiopharmaceutical will be available during the time of study at absolutely no cost to patients or chuv. a number of studies have demonstrated the benefits of f-18-fch-pet/ct for these patients and this indication is currently not reimbursed by swiss obligatory health insurance providers.

Eligibility criteria:
primary prostate cancer inclusion criteria: * age ≤ 80 years * karnofsky index ≥ 80 * first prostate biopsy * presence of at least one of the following: * total psa 10 ng/ml * total psa 2.5-10 ng/ml with free-psa \<20% and/or psa velocity 0.75 ng/ml/year * suspicious hypoechoic lesion at trus and/or suspicious finding at digital rec¬tal examination * informed signed consent. exclusion criteria: * impaired capacity to consent * coexistence of clinically-proven prostate cancer * neoadjuvant hormonal treatment (including 5-α reductase inhibitors) * contraindications to surgery * contraindications to mr imaging (see below) prostate cancer relapse inclusion criteria: * age ≤ 90 years * karnofsky index ≥ 80 * previous treatment for prostate cancer * no clinical recurrence based on standard work-up (abdominal / pelvic ct, mri, and bone scintigraphy) * biochemically proven relapse of prostate cancer (psa \> 0.2 ng/ml after prostatectomy, nadir psa+2 ng/ml (phoenix definition) or ≤ 3 successive rising psa levels (astro definition) after curative radiotherapy). * informed signed consent. exclusion criteria: * coexistence of another clinically-proven cancer * contraindications to surgery or radiation therapy treatment

Keywords: imaging positron emission tomography f-18-fch magnetic resonance imaging magnetic resonance spectroscopy