Kornimate/medical-research-clean huggingface dataset:
effect of aerobic exercise on diurnal cortisol pattern in premenstrual syndrome

Conditions: Premenstrual Syndrome

Summary: the aim of this study will be to investigate the effect of aerobic exercise on diurnal cortisol pattern in premenstrual syndrome.

premenstrual syndrome is manifested by recurrent emotional and depressive symptoms that may be associated with maladaptive coping with stress situations and the enhanced release of stress hormones, like cortisol hormone. although previous studies revealed a flattened diurnal cortisol slope in women with pms compared to healthy controls, there is no previous work on the effect of aerobic exercise on diurnal cortisol pattern in premenstrual syndrome. therefore, this study will aim to investigate the effect of aerobic exercise participation on diurnal cortisol pattern in premenstrual syndrome.this trial will include two groups; group (a) will consist of 14 females who will receive relaxation training for 8 weeks, while group (b) will consist of 14 females who will receive the same relaxation training along with aerobic exercise for 8 weeks.

Eligibility criteria:
inclusion criteria: 1. sedentary, virginal, adult, non-smoker females suffering from premenstrual syndrome. 2. they should have regular menstrual cycles (cycles of 21-35 days with a bleeding time of 3-10 days) 3. they should have the following criteria in daily record of severity of problems in at least one of two consecutive menstrual cycles prior to treatment starting to confirm premenstrual syndrome diagnosis: a) more than three items have an average score over 3 during the luteal phase, and b) a luteal phase score is 30% more than a follicular phase score. 4. no traumatic life events in the last 2 months before starting the study. 5. their age will be 18-23 years 6. their body mass index (bmi) will be less than 30 kg/m2. exclusion criteria: 1. menstrual problems (e.g. menorrhagia, metrorhagia and polycystic ovary disease). 2. cardio-respiratory, renal, neurological and pelvic inflammatory diseases, tumors, infections, anemia, diabetes, hypertension, asthma, rheumatoid arthritis, headache, migraine, thyroid or mental disorders. 3. participation at any other exercise training program during this study. 4. receiving any kind of medications, hormonal treatment or supplementation (vitamin, mineral or herbal supplement).

Keywords: aerobic exercise relaxation training diurnal cortisol pattern premenstrual syndrome
open-label study of the efficacy of intranasal oxytocin in schizophrenia

Conditions: Schizophrenia

Summary: the objective of this study is to investigate the long-term efficacy of intranasal oxytocin in improvement of symptoms in patients with schizophrenia who have residual symptoms dispute being on adequate treatment with antipsychotic medication.

approximately 20 patients will be enrolled to participate in a 6 month flexible dose of oxytocin.

Eligibility criteria:
inclusion criteria: 1. adult men or women, 18 years of age or older. 2. meet dsm-iv criteria for schizophrenia 3. women of childbearing potential must test negative for pregnancy at the time of enrollment based on urine pregnancy test and agree to use a reliable method of birth control during the study. 4. must be on a therapeutic dose of 1 or 2 atypical antipsychotic medications (examples but not limited to clozapine olanzapine, risperidone, ziprasidone, aripiprazole, seroquel) with no major dose changes for at least 4 weeks. 5. a minimum panss total score of 55 at baseline and a score of at least 4 (moderate) on the subscale of the panss (suspiciousness/persecution) at screening. 6. have a clinical global impressions-severity (cgi-s) scale score of at least 4 (moderately ill) at baseline; 7. must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent. 8. must be able to use nasal spray 9. must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator. exclusion criteria: 1. are pregnant or are breastfeeding (negative pregnancy test at screening) 2. a urine drug screen performed at screening must not show evidence of recent use of drugs of abuse 3. any active medical condition that in the opinion of the investigator will interfere with the objectives of the study 4. are unsuitable in any way to participate in this study, in the opinion of the investigator. 5. another current, primary dsm-iv diagnosis other than schizophrenia

Keywords: oxytocin
effects of cocoa on gastrointestinal function

Conditions: Gastrointestinal and Digestive Disorder

Summary: this is a randomized, controlled, 2x2 cross-over study to assess the effects of cocoa solids on gastrointestinal transit, post-prandial sensation and well-being. additionally functional brain imaging will be applied to identify regions of brain that are activated or inactivated by cocoa ingestion. healthy subjects will be recruited and randomized to receive either dark chocolate (70% cocoa solids) or white chocolate (0% cocoa solids) in addition to their normal diet in randomized order. reference standard methodology will be applied to measure gastric emptying, oro-caecal and colonic transit time. dark and white chocolate (100g, \~500kcal, \~50% fat) will be consumed with radio-opaque markers on three consecutive days. on the third day chocolate ingestion will be followed by measurements of postprandial brain activity using fdg-positron emission tomography. additionally colonic transit will be assessed based on the number and distribution of radio-opaque markers in the colon. on the fourth day gastric emptying and oro-caecal transit time will be assessed by scintigraphy after ingestion of a dark or white chocolate mousse test meal (both 150g, \~500kcal, \~50% fat). during both interventional studies pre- and post-prandial satiety and dyspeptic symptoms, well-being and mood will be recorded. additionally, validated questionnaires will assess digestive comfort and well-bring at the end of each study day. these results will deliver comprehensive information about the effects of cocoa on gastrointestinal transit and sensation.


Eligibility criteria:
inclusion criteria: * healthy volunteers (men and women) * aged 18-65 years * body mass index 18-30kg/m2. exclusion criteria: * special dietary requirements incompatible with dietary intervention (food allergies or intolerances) * clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) that preclude intake of test meals * participation in another study with investigational drug within the 30 days preceding and during the present study (purely diagnostic studies are acceptable) * individuals unwilling to provide written informed consent * inability to follow the procedures of the study, e.g. due to language problems (all study documents in english)
a pilot study to test the acceptability and feasibility of relaxation rooms to help reduce occupational stress among healthcare workers

Conditions: Burn Out; Stress

Summary: test the acceptability and feasibility of a relaxation room to reduce work stress among clinicians and collect clinician-reported outcome data after using the relaxation room.

the plan is to pilot test a relaxation room to demonstrate its acceptability and feasibility in the hospital and collect clinician-centered outcomes. this study will inform the design of a future trial using this intervention.

Eligibility criteria:
inclusion criteria: * clinician at mayo working at st. mary's hospital or the downtown rochester campus during the study exclusion criteria: * any physical condition that might prevent them from sitting for 20-30 minutes in the room * significant hearing loss that they would not be able to hear the audio stimuli * significant vision loss that they would not be able to see the visual stimuli
differin® gel x12 wks vs tazorac® cream x12 wks vs differin® x6 wks switched to tazorac® x6 wks for treatment of acne

Conditions: Acne Vulgaris

Summary: to determine the efficacy and safety of 12 weeks of treatment with differin gel, 0.1% compared to 12 weeks of treatment with tazorac cream, 0.1% and compared to 6 weeks treatment with differin gel, 0.1% followed by 6 weeks of treatment with tazorac cream

same as above.

Eligibility criteria:
inclusion criteria: * subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face * subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose exclusion criteria: * subjects with more than 3 nodulo-cystic lesions
acl reconstruction with a new generation of lars artificial ligament

Conditions: ACL Injury

Summary: this clinical investigation is intended to demonstrate the safety of the new generation of lars ligaments and compare this new generation (grafted ligament) of artificial ligament to the lars current artificial ligament (non-grafted ligament) which is ce marked since 1997, in case of acl injury. the new generation of lars artificial ligament is expected to improve physiological response by enhancing fibroblast proliferation, fibroblast organization and collagen type i \& iii secretion. this physiological response leads to a better osseo-integration of the ligaments. therefore, the study is expected to demonstrate the investigational device safety and biomechanical improvements.

forty subjects over 40 years old with acute acl injury will be included. a follow-up program is planned over 1 year per subject (days 7, 15, 30, 60, 90, 180, 365) based on physical therapy, biological analysis and biomechanical measurements.

Eligibility criteria:
inclusion criteria: * subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the grafted ligament * subject provides written informed consent approved by the ethics committee prior to any clinical investigation related procedure * subject must agree to undergo all clinical investigation plan - required clinical follow-up visits * subject must agree not to participate in any other clinical investigation for a period of 1 year following the procedure * male and female subjects over 40 years old * mri positive for full acute acl injury * arthrometric evaluation (kt1000) with a side-to-side difference greater than 3 mm * symptomatic subjects with no previous knee injury * subjects without concomitant pathologies (fracture, infections, immunodepression, hiv, hcv) that could influence the outcome of the study or prevent the subject from following the post-operative follow-up program as per protocol * i and ii degree chondral lesions exclusion criteria: * subjects under 40 years old * iii and iv degree chondral lesions * associated ligament injuries * meniscus suture (e.g. hndle bucket meniscal tears) that compromise the rehabilitation program * history for sepsis * subjects with concomitant pathologies (fracture, infections, immunodepression, hiv, hcv,) that could influence the outcome of the study or prevent the subject from following the post-operative follow-up program as per protocol * previous knee injuries * septic arthritis * infected tissues * pregnancy * overweighed, obese subject (\>100kg) * history of metabolic bone disease * inflammatory joint disease * known neoplastic disease * medical treatment (e.g steroid) * hiv positive subject * hepatitis positive subject * allergy to titanium, pet, ugurol, gentamicin, polystyrene sulfonate, other medication

Keywords: acl artificial ligament
effectiveness of a smartphone app for adolescent obesity management

Conditions: Obesity; Impaired Health; Psychosocial Problem; Physical Activity; General Nutrition Disorder

Summary: though face-to-face treatment of childhood obesity can be effective, it is time consuming and costly. this study will test whether treatment can be delivered via an android app and whether such treatment reduces obesity.


Eligibility criteria:
inclusion criteria: * child aged between 12.0 and 17.0 years, * child bmi =/\> 98th percentile, * first language is english (or fluent in english) * parent/s willing to participate in the programme with their child * completion of written informed consent and/or assent prior to any study-specific procedures exclusion criteria: * severe intellectual difficulties, * obesity secondary to genetic condition, * limitations to engaging in physical activity * use of medication known to effect body weight; * limitations to using a smartphone device * known family issues that would affect general compliance and attendance at follow-up visits.

Keywords: obesity; mobile health; telemedicine; family-based treatment
estimation of effect of rifampin on pharmacokinetics of crizotinib in healthy volunteers

Conditions: Healthy

Summary: the purpose of this study is to estimate the effect of multiple doses of rifampin on the single dose pharmacokinetics of crizotinib in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy male and/or female of non-child bearing potential subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ecg and clinical laboratory tests). * body mass index (bmi) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * subjects with evidence of disease, conditions affecting drug absorption, treatment with other investigational drug within 30 days, history of regular alcohol consumption, and use of prescription , nonprescription drugs and dietary supplement within 7 days, and blood donation of 500 ml within 56 days.

Keywords: crizotinib healthy volunteers rifampin pharmacokinetics single dose
rwanda selenium supplementation clinical trial

Conditions: HIV

Summary: study hypothesis: the addition of selenium supplementation to cotrimoxazole will improve cd4 counts, decrease opportunistic infections, decrease viral loads and delay the need for initiating antiretroviral therapy(art) in rwandan adult patients infected with hiv/ aids.

patients will be recruited from two health facilities (kibagabaga district hospital, and kinyinya health center in kigali), rwanda that offer care and treatment for hiv/aids patients. patients will be recruited during a 3-4 month period. consenting adults who fit the inclusion criteria will be enrolled and followed for 2 years. study assessments will occur at enrollment, 6, 12, 18, and 24 months after initiation of selenium supplementation. participants will be randomized using a simple randomized block design to receive either cotrimoxazole and selenium or cotrimoxazole and an identically appearing placebo taken once daily for 2 years. participants who do not return to the clinic as scheduled will be followed up at home. all consenting patients with cd4 count between 400 and 650 mm3 will be selected because they are at similar immunological level and hence they will not be eligible to start arv treatment at the study start. the study will look at the efficacy of selenium supplementation to this already compromised group of patients at a similar stage of the disease.

Eligibility criteria:
inclusion criteria: * patients \> or = 21 years at enrollment * confirmed hiv positive with a cd4 range between 400 and 650 mm3 * hiv+ patients willing to participate in the study and who provide informed consent * pre-antiretroviral therapy (pre-art) at enrollment in study (not yet initiated art) * willing to practice barrier method of birth control at all times exclusion criteria: * patients intending to be transferred out of the clinic catchment area before study ends * patients scheduled to start art * moribund patients * pregnant women * unable or not wanting to commit to barrier method of birth control

Keywords: selenium hiv/ aids cd4 counts antiretroviral therapy
comparison study of bnp and thoracic impedance measurements on arrhythmias

Conditions: Heart Failure; Arrhythmias

Summary: it is hypothesized that elevated bnp level correlate with an elevated thoracic impedance/fluid index as measured separately by crt-d devices and external impedance cardiography. ultimately, it is also hypothesized that both bnp and thoracic impedance/fluid index measurements are predictive of atrial and ventricular arrhythmias.

the primary aim of this study: 1. to assess the correlation between elevated brain natriuretic peptide levels and elevated thoracic impedance/body fluid index as measured by selective biventricular resynchronization devices and an external impedance cardiography device. 2. correlate impedance measurements and brain natriuretic levels with occurrence of atrial and ventricular arrhythmias as assessed by interrogation of biventricular devices.

Eligibility criteria:
inclusion criteria: * male or female between 18 to 85 years of age. * all patients with biventricular implantable cardio-defibrillators(manufacturer: medtronic/ model: insync 7299/7297 or newer). * lvef \<35% * nyha iii/iv * qrs \>120 msec * pt willing and able to sign informed consent. * conventional heart failure therapy * clinically stable for six months. exclusion criteria: * age less than 18 years of age * age greater than 85 years of age * creatinine \> 2.5 mg/dl. * end stage liver disease complicated by ascites as determined by electronic medical record review. * women who are pregnant, lactating, or plan to become pregnant during the course of the study. * patients who are heart transplant candidates with expected transplantation within the next six months. * life expectancy due to non-cardiac cause less than one year. * anticipated problem with compliance. * critical valvular stenoses/insufficiencies. * morbidly obese patients(\>300 lbs.) * in patients whom impedance cardiography was not able to be performed because of inability to place sensors. * planned or known need for revascularization procedures within three months.

Keywords: chf crt atrial arrhythmias ventricular arrhythmias bioz optivol
pupillary unrest as an indicator of central opioid effect in subjects 40-60 years of age

Conditions: Opioid Toxicity; Pupillary Miosis; Respiratory Depression

Summary: this study will establish the relationship between magnitude of opioid exposure and a pupillary measure referred to as pual (pupillary unrest in ambient light), in subjects aged 40-60. previous investigation demonstrated that loss of pual was a sensitive, discriminative indicator of opioid toxicity and respiratory depression among subjects aged 20-40 years old. population data indicate that pupil size and pual decline slightly with age. the investigators will explore whether pual proves to be a sensitive indicator of opioid exposure and respiratory depression in this older group.

healthy volunteer subjects aged 40-60 will receive a standardized weight-based 10-minute remifentanil infusion protocol to achieve a peak estimated remifentanil effect site concentration of approximately 6 ng/ml. pupillary measures will be taken at baseline and regular time intervals during and after the infusion, over a period of 35 minutes.

Eligibility criteria:
inclusion criteria: * healthy, bmi \< 35 kg/m2 exclusion criteria: * current or recent opioid use * opioid or other substance use disorder * known or suspected osa or sleep disordered breathing * ischemic heart disease, heart failure or symptomatic arrhythmia history * ocular disease or previous eye surgery * active use of alpha adrenergic blockers, anticholinergic medications, * active use of antidepressant or mood stabilizing medications * active use of phosphodiesterase inhibitors * use of stimulant or appetite suppressant medications * active use of antihypertensive or antiarrhythmic medications * use of topical eye medications.
herbal treatment for perennial allergic rhinitis

Conditions: Perennial Allergic Rhinitis

Summary: allergic rhinitis(ar) is one of the most common allergic disorders throughout the world.the conventional therapies are effective in alleviating symptoms but the efficacy are limited and not persistent. furthermonre, the cost and side-effect are known defects. a classical chinese herbal formula, has been used for ar for centries. our study purpose is to evaluate the clinical efficacy and safety of this formula verus placebo in perennial allergic rhinitis (par). hypothesis: the classical herbal formula would improve the symptoms of par patients and change some immunological parameters in the peripheral blood when comparing with the placebo.

it is a randomized, double-blind, placebo-controlled trial.

Eligibility criteria:
inclusion criteria: * aged from 18 to 65 years old * have typical symotoms of par including rhinirrhea, sneezing, nasal obstruction and itching in nose and eyes for at least 2 previous consecutive years. * postive skin prick test(spt) to hose dust mite, mold, animal dander and cockcroach with regular ar medications withould for 3 days prior to the test exclusion criteria: * pregnant women and women at risk of conception * received allergen injections in previous 2 years * regular medications for ar or cold and other allergic disorder * seasonal allergic rhinitis, vasomotor rhinitis and rhinitis medicamentosa * nasal structure deformities, nasal polyps and hypertrophic rhinitis * systematic cortisosteroid used within recent 3 months or nasal cortisosteroid with 15 days * other active respiratory disorders * active medical disorders: cancer, infection, hematology, renal, hepatic, cardiovascular, metabolic and gastrointestinal diseases

Keywords: perennial allergic rhinitis traditional chinese medicine
breast cancer recurrence - the accuracy of dual-time pet/ct

Conditions: Breast Cancer Recurrent

Summary: the purpose of this study is to elucidate the value of dual-time-point pet/ct in the recurrence of breast cancer and to determine whether the method is better than the modalities used in the standard work up. 150 patients with suspected breast cancer recurrence will be included. all patients will undergo dual-time-point pet/ct, ct of thorax and upper abdomen and bone scintigraphy. after completion of the examinations the early and the late pet/ct scan will be compared with each other, the diagnostic ct-scan and the bone scintigraphy. a verification of suspicious findings will be done by biopsy, if the area is accessible. if a biopsy cannot be obtained, the presence of recurrence will be verified with additional imaging follow-up to ensure the highest possible confidence. sensitivity, specificity, accuracy, negative and positive predictive value (npv/ppv) will be calculated for each modality (incl. early and late pet/ct).


Eligibility criteria:
inclusion criteria: * clinical suspected recurrence of breast cancer * blood glucose level less than 8,0 mmol/l exclusion criteria: * disqualified patients * other malignancies * \< 18 years * \< 50 kg * \> 90 kg * pregnant or lactating * patients with permanent address outside of the region of southern denmark * estimated inability to collaborate

Keywords: dual-time pet/ct breast cancer recurrence bone scintigraphy ct thorax upper abdomen