Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of solifenacin in men with overactive bladder (oab) and detrusor underactivity

Conditions: Overactive Bladder; Detrusor Underactivity

Summary: detrusor underactivity (dua) in men is responsible for luts in a significant minority, the symptoms being indistinguishable from those seen in boo. the international continence society (ics) defines dua as 'a detrusor contraction of inadequate magnitude and/or duration to effect complete bladder emptying in the absence of urethral obstruction. whilst a reduced maximum urinary flow rate (qmax) is indicative of voiding dysfunction, flow studies cannot distinguish between dua and boo, which are the two principal causes of low flow rates. dua is diagnosed from a pressure-flow study (pfs)and is characterized by a low-pressure, poorly sustained, or wave-like detrusor contraction with an associated poor flow rate. overactive bladder (oab) is the most common term currently used in clinical medicine to describe a complex of lower urinary tract symptoms (luts) with or without incontinence but most commonly consisting of urgency, frequency, nocturia, troublesome or incomplete emptying,and, occasionally, pain. with the exception of pain and incontinence, these symptoms are often found together; thus, the term luts has come to replace previous terms, such as urgency-frequency syndrome,urethral syndrome, and prostatism. drug treatment is frequently used as the initial management approach for luts in older men.among men who desire treatment, general practice prescribing data have shown that antimuscarinics are not often given to elderly men. there is theoretical concern that the inhibitory effect of antimuscarinics on detrusor contraction could aggravate voiding difficulties or cause urinary retention in patients with boo. there are virtually no data evaluating the safety and efficacy of solifenacin treatment in men with dua and oab.


Eligibility criteria:
inclusion criteria: * men aged \> 40 years were eligible if by 7-day bladder diary they had urinary frequency (8 or more micturitions per 24 hours) and urgency, with or without urgency incontinence (1 or more episodes per 24 hours) together with coexistence low detrusor contractility. exclusion criteria: * urinary tract infection, * bladder stone, urogenital tumors, * prostate surgery, * use of indwelling catheter or self-catheterization program, * medications that could affect the lower urinary tract function, * history of neurological disease, * acute urinary retention or any condition for which antimuscarinic was contraindicated. * antimuscarinic, antispasmodic, or electrostimulation within 1 month; * any investigational drug within 2 months; or * a 5a-reductase inhibitor within 3 months of screening.
cognitive behavioral treatments for post-traumatic stress disorder (ptsd) sleep disturbance

Conditions: Post-traumatic Stress Disorder

Summary: the purpose of this study is to compare the effectiveness of two cognitive behavioral group psychotherapy interventions in controlling the subjective sleep disturbance in veterans with post-traumatic stress disorder.

repetitive, stereotypical nightmares and insomnia commonly characterize post-traumatic stress disorder (ptsd). identifying the pathophysiological mechanisms of disrupted sleep in ptsd has therefore assumed considerable clinical importance. we previously reported an increase in rapid eye movement activity (rem activity) during rem sleep (rems) in vietnam war combat veterans with ptsd, and this finding can be seen as consistent with the view that most, although not all, dreaming occurs during rems and the repeated observation that rem activity correlates with the intensity of dream mentation. there is a growing body of evidence that post-traumatic nightmares can respond to psychological treatment interventions. namely, a cognitive-behavioral technique entitled imagery rehearsal (ir) has been reported to be effective in the treatment of such nightmares in victims of crime and in women who have been sexually assaulted. in a small pilot study, it has also been reported to be effective in the treatment of vietnam veterans with combat-related ptsd. the two objectives of this proposal are: 1. to compare, in a study with random assignment and a parallel group design, the effectiveness in controlling the subjective sleep disturbance in veterans with ptsd of ir and sleep and nightmare management (sn), a psychological treatment that targets life stressors and problems with sleep hygiene that may exacerbate insomnia and nightmares. 2. in a subset of these subjects, to compare the effectiveness in reducing rem activity of ir and sn.

Eligibility criteria:
inclusion criteria: * male * vietnam combat veteran * diagnosis of combat-related ptsd * stable psychotropic regimen for a minimum of three months * experiences recurrent nightmares exclusion criteria: * bipolar disorder, delirium, dementia, amnestic and other cognitive disorders * schizophrenia and other psychotic disorders * substance abuse or dependence within the last six months * untreated medical disorders known to impact sleep

Keywords: imagery nightmares post-traumatic stress disorder psychotherapy
pregnancy chances in classic galactosemia

Conditions: Galactosemias; Primary Ovarian Insufficiency

Summary: with this study, in which the incidence of pregnancy in classic galactosemia patients is studied, we aim to provide new insights to improve counselling. our hypothesis is that the chance that a galactosemic woman with poi becomes pregnant is higher than the 5-10% that has been reported for women with poi due to other causes. chance of spontaneous pregnancy will be evaluated through semi standardized interview in women with classic galactosemia aged 18 years or older. during the interview, questions will be asked regarding fertility and pregnancy.


Eligibility criteria:
inclusion criteria: * classic galactosemia diagnosed by galt enzyme activity assay or galt-gene mutation analysis * eighteen years of age or older * diagnosed with poi defined as symptoms of hypergonadotrophic hypogonadism measured by serum concentrations of fsh and estradiol * capable of giving informed consent exclusion criteria: * any known congenital or acquired disease or disorder negatively affecting pubertal development and/or fertility.
weight loss in obese kidney disease patients after bariatric surgery

Conditions: Chronic Kidney Disease; Bariatric Surgery Candidate

Summary: this study is designed as a prospective, single-center, longitudinal and analytical study on the effect of bariatric surgery in obese patients with chronic kidney disease (ckd).

it is expected to enroll 22 obese subjects with chronic kidney disease (decrease in glomerular filtration and/or albuminuria/proteinuria). after the inclusion in the study patients will remain for six months with a reduced calorie diet until the day of bariatric surgery. time monitoring of the patient after surgery is 24 months.

Eligibility criteria:
inclusion criteria: * age 18-70 years (male or female). * bmi \>35 kg/m2 who meet the following criteria: 1. gfr 30-60 ml/min and proteinuria\>1g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system. 2. gfr \>60 ml/min and proteinuria \>(3.5) 2.5 g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system. * patients with bmi\> 40 kg/m2 with a gfr\> 30 ml/min and proteinuria \>(1) 0.5 g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system. * patients who are able to understand the purpose and risks of the study, which has been fully informed and have finally given the written informed consent according to the ich-gcp. patients who can not read or write but who properly understand the verbal information provided by the investigator (or sub-investigator) the consent will be granted orally before their inclusion and an independent witness will signing the informed consent document. exclusion criteria: * subjects who are participating or have participated in another clinical trial and/or who are taking or have taken an experimental drug (not registered) in the last 28 days. * patients with chronic renal replacement therapy (hemodialysis and/or peritoneal dialysis) and/or renal transplantation. * patients with poorly controlled blood pressure (sbp\> 170 mmhg or dbp\> 110 mmhg). * patients with a history of cardiovascular events (stroke, ischemic heart disease) in the past six months. * patients treated with steroids or other immunosuppressants. * patients with a history of renovascular disease, obstructive uropathy, autoimmune diseases, cancer, drug use. * patients who are pregnant or lactating. * patients who do not sign the informed consent. * a slight chance of compliance with visits scheduled in the protocol.

Keywords: chronic kidney disease bariatric surgery candidate caloric restriction
serratus plane block for postoperative pain control

Conditions: Outpatient Breast Surgery; Mastopexy; Augmentation; Revision

Summary: this is a randomized, double-blinded, placebo-controlled trial of serratus plane blocks in subjects undergoing outpatient unilateral or bilateral breast surgery. ninety subjects will be enrolled into the study at presurgical testing. subjects will be stratified based on surgery type and randomized to receive a serratus plane block with either bupivicaine hcl or placebo. all patients will receive standard intraoperative anesthesia and standard postoperative pain control. the primary endpoint is the amount of opioid administered postoperatively. secondary endpoints include postoperative pain intensity at timed intervals, amount of opioid administered intraoperatively and postoperatively, incidence of nausea and vomiting, time to discharge and patient satisfaction


Eligibility criteria:
inclusion criteria: * asa i-iii. * undergoing outpatient breast surgery requiring general anesthesia, including but not limited to mastectomy, lumpectomy, reconstruction with tissue expanders or implants and reconstruction revision. exclusion criteria: * unable to provide informed consent. * patients who are pregnant or nursing. * asa iv-v. * alcohol or narcotic dependence in the last 2 years. * concurrent condition requiring regular use of analgesia that may confound post-surgical assessments as determined by principle investigator. * hepatic disease. * allergies to amide anesthetics as determined from medical history or patient self-report. * evidence of infection at injection site. * contraindication to pain medications such as acetominophen, morphine, oxycodone, keterolac, dilaudid, toradol. * body weight \<50kg. * bmi\>40kg/m2. * history of hypotension. * abnormal renal (creatinine \> 1.5 mg/dl) function. * heart block. * any physical, mental or medical condition, that in the opinion of the investigator, makes study participation inadvisable.
online tp (training program) on sc (social cognition) for schizophrenia

Conditions: Social Cognition

Summary: randomized controlled trial. sixty-five participants (83% with schizophrenia or bipolar disorder) were recruited from community mental health teams. fifty-seven met criteria and agreed to participate in the study. the conditions of cognitive rehabilitation were assigned randomly with support employment cr + ips (n = 28) and ips alone (n = 29). cogpack program was used. two groups were followed at 8 and 12 months after the baseline.

this work was developed in the island of tenerife (spain) within a public service specialised in labour integration of people with disabilities in which an ips team was set up in 2005. the study was carried out in collaboration with the units of community mental health of the island. these units carry out the control of people with serious mental illnesses including pharmacological treatment and psychosocial programming. all research procedures were approved by the medicine committee of canary health services. the follow-up period for the data collection was set between 2013 and 2014. employment specialists belong to a public institution specialized in work disability.sixty-five participants but only 57 signed written informed consent and completed the baseline. two groups were assigned randomly:one with support employment and cognitive rehabilitation the second group with ips alone

Eligibility criteria:
inclusion criteria: participants had to: 1. comply with the state definitions of severe mental illness (smi), which includes an icd-10 (world health organization, 1992) diagnosis of f20- 29 (schizophrenia, schizotypal, delusional and other non-mood psychotic disorders) and f31-f32.3 (major mood affective disorders) 2. have previous difficulties to maintain a job 3. currently want a competitive job and 4. accept the job search starts exclusion criteria: people with no severe mental illness and not want to participate

Keywords: rehabilitation schizophrenia emotional adjustment theory of mind
the evaluation of an alternative sizing model in comparison of a conventional sizing model for full face masks in the treatment of osa in terms of performance and comfort

Conditions: Sleep Disordered Breathing; Obstructive Sleep Apnea

Summary: the investigation is a prospective non-blinded and semi-randomized clinical investigation. the investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the prototype full face mask (pffm) mask.

the investigation is a prospective non-blinded and semi-randomized investigation. the investigation is designed to assess the alternative sizing model which the trial mask concept is based on and how it compares to a conventional sizing present in the prototype full face mask (pffm) mask. a cohort of up to 38 pre-determined current nasal and full face mask users will be recruited by fisher \& paykel healthcare in auckland new zealand, waikato dhb in hamilton new zealand, hawkes bay dhb in hastings new zealand and wellsleep centre in wellington new zealand. the study will involve baseline (visit one) gathering the participants' prescribed pap therapy pressure and their usual mask (to have up-to-date records). the next visit (visit 2) 7 ± 4 days after visit 1, the participants will be fit the prototype full face mask (pffm) mask or the alternative sizing based trial mask. at visit 3, which will be after 7 ± 4 days from visit 2, the participants will be crossed over to the mask. at visit 4, 7 ± 4 days after visit 3, all masks and devices will be collected from the participants.

Eligibility criteria:
inclusion criteria: * adult (18+ years of age) * able to give consent * apnea hypopnea index (ahi) ≥ 5 on diagnostic night * prescribed a continuous positive airway pressure (cpap) device after successful osa diagnosis * existing nasal or full face mask user. exclusion criteria: * inability to give consent * patients who are in a coma or a decreased level of consciousness. * anatomical or physiological conditions making apap therapy inappropriate (e.g. unconsolidated facial structure) * commercial drivers who are investigated by new zealand transport agency (nzta) * current diagnosis of co2 retention * pregnant or may think they are pregnant.
feasbility and efficacy of s-press leg strengthening device

Conditions: Deconditioning; Sarcopenia

Summary: the proposed study will examine the use and effectiveness of a novel strength training device - the s-press within an nhs environment. the s-press is a portable exercise device that can be used seated or lying down and specifically targets the knee extensors and flexors. the knee extensors are particularly important in the performance of activities of daily living such as rising from a chair, walking up and down stairs and walking. resistance training is the most effective strategy to help to reduce muscle wasting in response to ageing or chronic disuse; however as current in-patient settings likely fail to produce an overload stimulus to the muscle for hypertrophy and strength gains, there is a need to develop new interventions and equipment to help deliver this. the s-press is designed by a physiotherapist with the goal of increasing muscle strength and improving physical function in patients who may be confined to their bed or chair or unable to join in with standard physiotherapy treatments. this mixed methods study will examine the efficacy of the s-press to improve muscle size using b-mode ultrasound and physical function, using sit to stand x5 with use over 6 weeks, alongside the qualitative experience of the use of the s-press through a one to one semi structured interview.


Eligibility criteria:
inclusion criteria: * any in-patient admitted onto the ward sites for therapy intervention, assessed as medically stable and physically able to participate by nursing staff and able to provide informed written consent for participation. exclusion criteria: * any patient who is unable to give informed consent. * significantly confused patients - may not understand or retain the information to perform the exercises so will be excluded from this study. * patients with unstable or deteriorating medical conditions or are acutely unwell with an infection. * patients unable to do leg press exercise * patients who have had major surgery or myocardial infarction within the past 6 months. * patients who have major surgery scheduled during the intervention period. * patients currently undergoing treatment for cancer * patients who currently have high blood pressure that is uncontrolled (systolic \>200mmhg or diastolic \> 110mmhg) * patients with a physical disability that precludes safe and adequate testing.
a modified phase i study of ngr-htnf in advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the main objective of the trial is to explore the safety and biological activity of ngr-htnf. the safety will be established by clinical and laboratory assessment. the biological activity will be evaluated by dce-mri with contrast media.

this is a modified phase i single arm, open, non randomized trial of ngr-htnf in advanced solid tumors for the definition of an optimal biological

Eligibility criteria:
inclusion criteria: * patients \>18 years old with proven advanced solid tumors not amenable to any clinical improvement by current standard treatments. tumors recognized to be highly vascularized (e.g. renal, colon thyroid and head and neck cancers), will be included. * ecog performance status 0 - 2 * patients may have had prior therapy providing the following conditions are met: * chemo, radio, hormonal or immunotherapy: wash-out period of 28 days * surgery: wash-out period of 14 days * adequate baseline bone marrow, hepatic and renal function, defined as follows: * neutrophils \> 1.5 x 10\^9/l and platelets \> 100 x 10\^9/l * bilirubin \< 1.5 x uln * ast and/or alt \< 2.5 x uln in absence of liver metastases * ast and/or alt \< 5 x uln in presence of liver metastases * serum creatinine \< 1.5 x uln * absence of any conditions in which hypervolemia and its consequences (e.g. increased stroke volume, elevated blood pressure) or haemodilution could represent a risk for the patient (reference appendix "technical data sheet human albumin") * normal cardiac function and absence of uncontrolled hypertension * patients must give written informed consent to participate in the study exclusion criteria: * concurrent anticancer therapy * patients may not receive any other investigational agents while on study * clinical signs of cns involvement * patients with active or uncontrolled systemic disease/infections or with serious illness or medical conditions, which is incompatible with the protocol * known hypersensitivity/allergic reaction to human albumin preparations or to any of the excipients * any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol * pregnancy or lactation. patients - both males and females - with reproductive potential (i.e. menopausal for less than 1-year and not surgically sterilized) must practice effective contraceptive measures throughout the study. women of childbearing potential must provide a negative pregnancy test (serum or urine) within 14 days prior to registration.

Keywords: solid tumors ngr-htnf
food patterns, inflammation markers of cardiovascular disease risk and incidence of cvd

Conditions: Cardiovascular Disease; Diet; Inflammation

Summary: health outcome studies should examine food patterns, because foods are consumed together and nutrients are metabolized jointly. to examine associations between food patterns and markers of systemic and vascular inflammation at baseline, in a population-based cohort in malmö, sweden, and after 13 years of follow-up food pattern associations with cvd incidence.


Eligibility criteria:
inclusion criteria: * the "cardiovascular sub-cohort" is a random sample (i.e., 50 percent) of those who joined from november 1991 to february 1994. this group underwent additional examinations to assess carotid arteriosclerosis by ultrasound (n = 6103) and donated blood after fasting (n = 5533). exclusion criteria: * subjects were excluded, either because they were using medication for diabetes mellitus or had previously been diagnosed as having diabetes mellitus.
a study evaluating the safety, tolerability and preliminary efficacy of ibi322 in subjects with hematologic malignancy

Conditions: Hematologic Malignancy

Summary: this is a phase i study evaluating the safety, tolerability and preliminary efficacy of ibi322 in subjects with hematologic malignancies who have failed standard treatment.

this phase 1a/1b study will be conducted to evaluate the safety, tolerability, pk, pd, immunogenicity, and preliminary antitumor activity of ibi322 in china. phase 1a is a dose escalation and plans to enroll approximately 39-102 subjects with hematologic malignancies who have failed standard treatments. phase 1b is a dose expansion and plans to enroll approximately 80 subjects with hematologic malignancies.

Eligibility criteria:
inclusion criteria: 1. histologically/cytologically confirmed hematologic malignancy who failed the standard treatment 2. at least one evaluable lesion 3. male or female 18 to 75 years old 4. eastern cooperative oncology group performance status performance status (ecog ps) 0-2 5. must have adequate organ function exclusion criteria: 1. previous exposure to any anti-cd47 monoclonal antibody, sirpα antibody, or cd47/sirpα recombinant protein 2. previous exposure to chimeric antigen receptor t cell immunotherapy (car-t) 3. subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies 4. use of anticoagulants and/or aspirin, or other non-steroidal anti-inflammatory drugs within 2 weeks prior to study start 5. a history of blood transfusion within 2 weeks prior to study start