Kornimate/medical-research-clean huggingface dataset:
a trial to evaluate the efficacy and safety of fesoterodine in patients with symptoms of overactive bladder including nocturnal urinary urgency

Conditions: Overactive Bladder

Summary: this study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.


Eligibility criteria:
inclusion criteria: * mean urinary frequency of \>=8 micturitions per 24 hours as verified by the screening bladder diary prior to start of placebo run in visit (visit 2) * mean number of micturition related urgency episodes \>=3 per 24 hours as verified by the screening bladder diary prior to start of placebo run in /visit 2 (urgency episodes are defined as those with urinary sensation scale rating \>=3) * mean number of micturition related nocturnal urgency episodes \>=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at visit 2 (nocturnal urgency episodes are defined as those with urinary sensation scale rating of \>3 recorded in the bed time section of the bladder diary) exclusion criteria: * a known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia * nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.

Keywords: incontinence oab urgency nocturia
the clinical effects of laser acupuncture therapy for oab women.

Conditions: Overactive Bladder

Summary: overactive bladder (oab) is a syndrome causes urgency, with or without urgent incontinence, daytime frequency and nocturia. urgency incontinence is more common in older women and may be associated with comorbid conditions that occur with age. the standard oab medical treatments may induced several intolerable side effects including dry mouth, constipation, and so on, therefore alternative therapies are often considered. acupuncture had been proved effective to oab treatment, however, this invasive procedure also cause pain and hematoma. laser acupuncture has minimal side effects comparing to conventional acupuncture, but its effects against oab had never been examined. experiments with laser acupuncture are expected to be another way to relieve oab symptoms.

the subjects are treated with 7 acupoints which are localized according to who standardized acupressure point location guideline. the patients lay in the supine position before treatment and the gallium aluminum arsenide laserpan (rj-laser, reimers \& janssen gmbh, waldkirch, germany) will be applied to each selected acupoints mentioned above. the experimental group (verum laser acupuncture) and control group (sham laser acupuncture) will receive laser acupuncture 3 times per week for 3 weeks, total of 9 sessions, based on clinical experience (treatment could be extended if necessary). the basic patient data will be recorded at baseline and adverse effect will also be recorded during the clinical trial.

Eligibility criteria:
inclusion criteria: 1. women are older than 18 years old. 2. participant is willing to sign the consent. 3. women havea moderate oab symptoms. 4. total scores of oabss \> 6 points and the 3rd question of oabss \> 2 points. 5. not using anticholinergic drugs for more than three weeks. exclusion criteria: 1. patients with lower urinary tract infection. 2. patients who cannot complete the questionnaire. 3. patients who use botox to inject bladder and pelvic floor muscles within one year. 4. pregnant patients. 5. patients who continue to have electrical stimulation and acupuncture in the legs, waist and pelvis. 6. patients with vaginal bleeding. 7. other herbal and folklore therapies are being used to improve patients with overactive bladder.
physical activity levels of parents of children with cystic fibrosis- (phacts-cf)

Conditions: Cystic Fibrosis in Children

Summary: this study will investigate if parental physical activity levels, assessed by providing a physical activity questionnaire to parents of children aged 6-16 with cystic fibrosis (cf), is associated with their child with cf's physical activity levels. children's activity levels will be taken from electronic records where a questionnaire is routinely given at annual reviews to analyse this. parental activity levels will also be compared against adherence to nebulisers as a proxy for adherence to treatment, this data is again in the electronic records of patients and is collected at annual reviews.


Eligibility criteria:
inclusion criteria: 1. parents of children aged 5-16 years. 2. under the care of cambridge university hospitals cf team 3. confirmed cystic fibrosis diagnosis 4. uses an ineb as main nebulizer delivery device. 5. parental/guardian permission (informed consent) and if appropriate, child assent. exclusion criteria: 1. parents of cyp diagnosed with a cf screen positive inconclusive diagnosis (spid). 2. if not yet doing lung function. 3. if has any other self-identified physical disability which may limit physical activity.
positive affect treatment for adolescents with early life adversity

Conditions: Depression

Summary: youth exposed to early life adversity (ela) are known to be at greater risk for depression and suicidality and account for almost half of the youth suffering from psychiatric diseases today. youth exposed to ela consistently report symptoms of anhedonia as well as dysregulated positive affect. the present project will test the efficacy of pat in a sample of ela-exposed adolescents in order to determine whether pat increases positive affect, and subsequently symptoms of depression. for the initial pilot phase of the investigation, the investigators will recruit up to 30 adolescents exposed to two or more childhood adversities (aces) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in pat or a waitlist control condition. for the second phase of the investigation, the investigators will recruit up to 300 adolescents exposed to two or more childhood adversities (aces) who do not currently have major depressive disorder, and randomize them (1:1) to either participate in pat or supportive psychotherapy. for both phases, at study enrollment, then 4-, 8, and 12-months thereafter the investigators will measure positive affect and depressive symptoms (including anhedonia and reward sensitivity). the results of this study will be used to inform whether pat has the potential to prevent major depressive episodes among adversity-exposed youth.


Eligibility criteria:
inclusion criteria: * aged 12-16 * exposed to 2 or more adverse childhood experiences (aces) exclusion criteria: * currently taking an antidepressant or any medications known to influence immune functioning on a daily basis (e.g., steroidal medications to treat asthma or allergies) * current or past history of manic or psychotic symptoms * parent-reported diagnosis of intellectual disability or autism spectrum disorder * chronic medical conditions (e.g., cancer, rheumatoid arthritis, diabetes, multiple sclerosis), * bleeding disorders such as hemophilia
a study of pregnenolone in the treatment of individuals with autism

Conditions: Autistic Disorder

Summary: this study will assess the tolerability and effectiveness of pregnenolone in the treatment of behavioral deficits in adults with autism. pregnenolone is a naturally occurring hormone found in the body which has been shown to help with the function of nerve cells. it is also shown to modulate the activity of certain brain receptors implicated in autism. we hope to examine the tolerability of pregnenolone in adults with autism.

this study will assess the tolerability and effectiveness of pregnenolone in the treatment of behavioral deficits in adults with autism. pregnenolone is a naturally occurring hormone found in the body which has been shown to help with the function of nerve cells. it is also shown to modulate the activity of certain brain receptors implicated in autism. pregnenolone has been used safely in research studies involving individuals with schizophrenia. in the proposed trial, we hope to examine the tolerability of pregnenolone in adults with autism. we hope to see improvement in behavioral outcomes as measured by standardized behavioral measures. further, we will measure concentrations of pregnenolone and related neuroactive compounds in the blood. the use of pregnenolone has been studied in a number of mental disorders but not autism. thus, we hope the study will identify new avenues of research for the treatment of autism.

Eligibility criteria:
inclusion criteria: 1. outpatients 18-45 years of age; 2. males and females who are physically healthy; 3. diagnosis of autism based on diagnostic and statistical manual (dsm-iv-tr) criteria, the autism diagnostic interview-revised, and expert clinical evaluation; 4. total aberrant behavior checklist (abc) greater then 21; 5. care provider who can reliably bring subject to clinic visits, can provide trustworthy ratings, and interacts with subject on a regular basis; 6. ability of subject to swallow the compound; 7. stable concomitant medications for at least 2 weeks; and 8. no planned changes in psychosocial interventions during the open-label pregnenolone trial. exclusion criteria: 1. diagnostic and statistical manual (dsm-iv-tr) diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder, not otherwise specified; 2. prior adequate trial of pregnenolone; 3. active medical problems: unstable seizures, significant physical illness (e.g., serious liver or renal pathology); 4. pregnancy or sexually active females (as determined by a urinary pregnancy test in the beginning of the study); and 5. subjects taking oil or fat based nutritional supplements will be excluded from the study unless they have been off these compounds for at least 4 weeks

Keywords: autism
lesion sterilization and tissue repair versus zinc oxide and eugenol for treatment of necrotic primary molars

Conditions: Necrotic Primary Molars

Summary: the aim of this study is to evaluate the clinical and radiographic success of lesion sterilization and tissue repair \[ lstr\] antibiotic paste versus zinc oxide and eugenol pulpectomy in the treatment of non-vital primary molars.

primary teeth with infected root canals are a common problem, particularly in patients where the infection has reached the peri radicular tissues . among the pastes used in the pulp therapy of primary teeth with pulp necrosis, zinc oxide and eugenol paste has been a reference in dentistry since 1930. endodontic treatment using zinc oxide and eugenol paste has shown satisfactory clinical and radiographic results, requires mechanical chemical preparation before filling root canals. the main difficulties of endodontic treatment of primary molars are related to the anatomical complexity of the root canals and the long time needed to carry out the treatment. the additional difficulty involved in diagnosing root resorption is a limiting condition for determining the actual working length and instrumentation. other pastes have been studied, such as those containing antibiotics in their composition, thus dispensing with root canal instrumentation (such as lesion sterilization and tissue repair using triple antibiotic paste in treatment of non-vital primary molars. lesion sterilization and tissue repair using triple antibiotic paste has relevant clinical and radiographic success rates in treatment of non-vital primary molars.

Eligibility criteria:
inclusion criteria: * children: 1. aged between 5 years and 7 years. 2. with deep caries involving pulp in primary molars. * teeth: 1. necrotic teeth with or without periapical or furcal lesions. 2. primary molars with minimal root resorption not more than 1/3 of root. exclusion criteria: * children: 1. children with systemic disease 2. previous history of allergy to antibiotics used in the study. 3. children that will not attend follow up. * teeth: 1. caries in primary teeth exhibiting pre-shedding mobility. 2. non restorable teeth.
drugs for the treatment of multiple sclerosis and risk of cancer: a pharmacovigilance analysis in vigibase

Conditions: Multiple Sclerosis; Malignant Tumor

Summary: even though the therapeutic panel for multiple sclerosis (ms) treatment has improved in the last 20 years, safety data especially for the second-line and innovative treatments are lacking. the association between ms and cancer has long been investigated but has led to conflicting results. no studies have reported an increased risk of cancer after long-term exposure to immuno-modulators. the present study will assess whether drugs for the treatment of ms are associated with an increased risk of cancer by analyzing the disproportionality of reports in the world health organization (who) pharmacovigilance database.

a case non-case study using vigibase®, the world health organization global individual case safety reports (icsrs) database which includesreports forwarded to the who uppsala monitoring center by national pharmacovigilance systems from over 130 countries around the world since 1967. information on the adverse effects reported include patient demographics and medical relevant history, drugs recorded according to the who drug dictionary and adverse drug reactions coded with medical dictionary for regulatory activities (meddra) terms will be perform.

Eligibility criteria:
inclusion criteria: * serious cases reported in the world health organization (who) database of individual safety case report from 2000 to september 2019 * cancer overall reported by a term included in the standardized meddra query (smq) "malignant tumours" exclusion criteria: - non serious cases

Keywords: pharmacovigilance
evolution of hiv reservoir, inflammation and microbiota footprint of plwh switching to long-acting injectable treatment compared to patients on oral dual or triple anti-integrase-based therapy

Conditions: HIV Infections

Summary: in the last 40 years of hiv history, we have managed to attain most of our therapeutic objectives, namely virological suppression of most patients and sufficient immune reconstitution. still, immune activation and inflammation persist and even if they decrease on art (antiretroviral treatment), they do not disappear and may be associated to multiple non-aids related comorbidities. in this population structural and functional modifications of galt (gut associated lymphoïd tissue) are observed early after hiv infection and persist despite virological suppression on art. moreover, imbalance of the gut microbiota which is called dysbiosis may participate in persistent activation and therefore enhancement of residual hiv viral replication. galt modifications are associated with microbial translocation that is also correlated with immune activation and dysbiosis. up to now, there is no evidence of a differential impact on inflammation, immune activation or cellular reservoirs of different art regimens. long-acting (la) regimens could theoretically display better inflammatory profile, since they have a better tissue distribution and could act more efficiently on hiv reservoirs. on the other hand, la's direct administration shunting the gut passage could also contribute to less gut dysbiosis. the objective of our study is to assess impact on plasma biomarkers, cell-surface biomarkers, intestinal microbiota and cellular reservoirs of a switch from an oral dual or triple anti-integrase-based therapy art regimen including an anti-integrase compared to a long-acting (la) injectable treatment.


Eligibility criteria:
inclusion criteria: * plwh at a the stable phase of their disease (absence of disease outbreak and absence of treatment modification in the 3 months preceding inclusion), * subject with ongoing hiv follow-up on an outpatient basis (outpatient or day hospital consultation) in the participating center, and having virological suppression at the threshold of 50 copies / ml for at least 1 year (blips \< 200 copies / ml tolerated during this period) * cd4 + t cell nadir\> 200 / mm3 * having given free and informed written consent * being affiliated with or benefiting from a social security scheme. exclusion criteria: * persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within two month before stool sampling. * subject only coming for full impatient follow-up
rehabilitation in aortic stenosis patients

Conditions: Aortic Valve Stenosis

Summary: survey of the field aortic stenosis (as) is the most common valve disease and increasing due to a growing elderly population. the therapy is aortic valve replacement (avr). studies on postoperative rehabilitation of as pts are scarce. in the few studies available, a mix of valve diseases is presented without considering the differences in pathophysiology and the training regimes are not clearly described. purpose, aims \& hypothesis the investigators purpose is to evaluate whether a supervised cardiac rehabilitation program improves the objective physical capacity and quality of life (qol) of patients after avr due to as, and compare this to patients training by their own. the investigators hypothesize that supervised exercise training may be a more efficient way of rehabilitating these patients. design this is a controlled randomized clinical trial comparing 12 weeks of supervised exercise training 3 times per week to home-based training based upon public health recommendations of minimum level of physical activity. significance \& implementation positive results would support that an organized program of exercise training improves physical capacity and qol in as patients following avr with potential benefit for both patients and society.


Eligibility criteria:
inclusion criteria: * elective surgery with aortic valve replacement for aortic stenosis at the thoracic surgery department at linköping university hospital, linköping. * geographical residence no further from hospital than permitting visit to supervised exercise training 3 times per week exclusion criteria: * any concommitant heart disease * other surgical intervention at time of valve replacement * age under 18 years * symptomatic lung disease * any disability or disease hampering participation in exercise training * cannot communicate with spoken swedish

Keywords: exercise physical activity physiotherapy exercise test quality of life aortic valve replacement
real world assessment for patients implanted with implantable cardioverter defibrillator using bluetooth technology

Conditions: Cardiac Arrhythmias; Sudden Cardiac Death; Heart Failure

Summary: the objective of this observational study is to assess clinical benefits of innovative features (e.g. bluetooth technology and smartphone patient applications) in a patient population that is implanted with standard indication for implantable cardiac defibrillator.

reaction is an observational study in which patients will be followed as for clinical practice and no specific study tests/procedures will be perfprmed. after implanting a device, the patient will be assigned to an arm or to the other based on the technology of the device (bluetooth or rf) he/she wears, if he/she gives the consent to partecipate. it is not a randomized study. patients will be enrolled consecutively until reaching the sample defined for both the arms.

Eligibility criteria:
inclusion criteria: * all patients implanted with an icd as for standard indications * over 18 years of age * ability to provide informed consent for registry participation and be willing and able to comply with the protocol described evaluations exclusion criteria: * subject who is, or is expected to be inaccessible for follow-up * pregnancy

Keywords: connectivity remote monitoring cardiac implantable electronic device
personal activity intelligence in the treatment of high blood pressure

Conditions: Essential Hypertension

Summary: personal activity intelligence (pai) is a novel metric developed to quantify the amount of routine physical activity (pa) needed to improve health and reduce cardiovascular (cv) mortality. the pai metric can be integrated in pa monitors to promote and track pa. the present pilot study is a 12-week randomized controlled trial designed to test the efficacy of pai in the treatment of high blood pressure. the primary aim is to investigate how routine pa (expressed as pai level) affect ambulatory blood pressure by comparing the effect of the intervention (≥100 pai per week) with a control recommended to follow national pa guidelines. the secondary aims are to investigate the effect on a comprehensive cv risk profile, and to model the effect of pai level on multiple cv parameters. the cv risk profile includes office bp, arterial stiffness, stroke volume, heart rate, cardiac output, systemic vascular resistance, cardiorespiratory fitness, body composition, blood lipid profile and serum markers of glucose metabolism, kidney failure and systemic inflammation.


Eligibility criteria:
inclusion criteria: * systolic blood pressure (sbp) 130-179 mmhg and/or diastolic blood pressure (dbp) 80-109 mmhg at first clinical visit (screening). note, this criteria was updated after the inclusion of three participants. the initial inclusion criteria were sbp 140-179 mmhg and/or dbp 90-109 mmhg. * not currently engaged in regular physical activity (\< 50 pai per week based on self-reported pa) exclusion criteria: * usage of blood pressure medication * usage of lipid modifying agents * diabetes * cardiovascular disease * diagnosed secondary hypertension * disease or disability that prevent exercise or participation in testing

Keywords: hypertension exercise therapy blood pressure monitoring, ambulatory physical activity monitoring
implementation and evaluation of telemedicine in cardiac rehabilitation

Conditions: Cardiac Rehabilitation

Summary: the overall aim is to develop and test the effect of a tailored patient and family focused cardiac tele rehabilitation intervention on health literacy by comparing it to standard care. furthermore, to evaluate health-related quality of life, family support, and how the patients experience the communication and relationship with outpatient clinic nurses.

the project is designed inspired by the complex intervention framework (mrc-guidelines) combined with a patient and family participatory design. the project will consist of three sub-studies. the first study is a co-creation development of a model for the cardiac telerehabilitation intervention. the second study is a quasi-experimental study with a quantitative comparison of the group receiving the cardiac telerehabilitation intervention and control group. the third study will be a descriptive qualitative study which aim to investigate patient's experience with ctr using participant observation and individual interview or dyadic interview.

Eligibility criteria:
inclusion criteria: * patients and their family members affiliated with the department of cardiology at amager and hvidovre hospital and attending cardiac rehabilitation. * patients diagnosed with ischemic heart disease, heart failure, persistent atrial fibrillation, and cardiac valve surgery. exclusion criteria: * patients with substantial language barriers and limited cognitive function. * patients who can't use a smart phone, tablet, or computer.

Keywords: cardiac rehabilitation telemedicine video consultation home monitoring