Kornimate/medical-research-clean huggingface dataset:
quality of life in patients with bladder cancer

Conditions: Bladder Cancer

Summary: rationale: studying quality of life in patients with bladder cancer may help determine the long-term effects of bladder cancer and may help improve the quality of life for patients in the future. purpose: this clinical trial is studying quality of life in patients with bladder cancer.

objectives: * to study the effects of recurrence and progression on health-related quality of life (hrql). * to study the effects of repeat cystoscopy on hrql. * to study the patients' assessments of a hypothetical prognostic model and how this affects their preference for the mode of surveillance. outline: this is a multicenter study. quality-of-life questionnaires developed by the european organization for research and treatment for cancer (eortc) will be used. the eortc qlq-bls24 with 24 questions specific to non-muscle-invasive bladder cancer and the eortc qlq-blm30 with 30 questions specific to muscle-invasive bladder cancer will be combined and used in conjunction with the general cancer questionnaire qlq-c30. assessments using the qlq-c30 will be made at baseline in the entire cohort of patients. follow-up assessments using the qlq-c30, qlq-bls24, and qlq-blm30 167 will be made at first routine follow-up and annually until the end of study. peer reviewed and funded or endorsed by cancer research uk.

Eligibility criteria:
disease characteristics: inclusion criteria: * enrolled on parent protocol cruk-bcpp-2005-01 * bladder lesion with cystoscopic characteristics compatible with urothelial cancer or transitional cell carcinoma meeting 1 of the following criteria: * non-muscle-invasive tumor * muscle-invasive tumor * solitary g1 pta tumor exclusion criteria: * previous diagnosis of cancer of the urethra, bladder, ureter, or renal pelvis within the 10 years prior to current diagnosis patient characteristics: inclusion criteria: * fit for cystoscopy and surgical biopsy/resection exclusion criteria: * hiv infection * any condition that, in the opinion of the local investigator, might interfere with the safety of the patient or evaluation of the study objectives prior concurrent therapy: * not specified

Keywords: transitional cell carcinoma of the bladder stage 0 bladder cancer stage i bladder cancer stage ii bladder cancer
project health intervention among latinx adults in primary care

Conditions: Obesity

Summary: the proposed study will examine acceptability/feasibility and establish initial estimates of effect sizes of an existing intervention (project health) on a sample of young adult latinx individuals in a primary health care setting. project health intervention involves making small, participant-identified, gradually increasing improvements to their dietary intake and exercise.

the primary goal of the research study is to investigate the acceptability/feasibility and establish initial estimates of effect sizes of project health that addresses dietary intake and exercise to reduce bmi, eating disorder symptoms, negative affect, and food cravings at post-intervention. to address this aim, the research will involve a randomized control trial that will employ a longitudinal experimental design that will involve: (a) phone-screener (pre-screener); (b) baseline appointment consisting of a pre-intervention assessment (eligibility); (c) 6-week intervention (randomized to project health or video control); (d) 3-month follow-up, (e) 1-year follow-up.

Eligibility criteria:
inclusion criteria: * self-reported hispanic/latino ethnicity * ability to read, write, and communicate in spanish * report concern about their weight * affirming weight gain within the past year and/or belief that there is room for improvement in diet/exercise habits. exclusion criteria: * limited mental competency * inability to provide, voluntary, written consent * endorsement of current or past psychotic-spectrum symptoms * a reported bmi of \ 30 * current diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder * active suicidality.

Keywords: obesity eating physical activity exercise
double sequential external defibrillation in patients with atrial fibrillation refractory to dc cardioversion

Conditions: Atrial Fibrillation; Defibrillators; Persistent Atrial Fibrillation

Summary: atrial fibrillation (af) is a common cardiac arrhythmia that leads to increased risk of heart failure, hospitalization, thromboembolic events, and death. restoration of normal heart rhythm is performed in many patients with af to improve symptoms. in this study, the investigators will consider patients who fail 2 or more trials of dc cardioversion as having refractory af. the aim of this study is to assess whether the use of double sequential defibrillation in patients with refractory af has a higher success rate in reverting them to a normal heart rhythm than a third cardioversion. this is a phase iii, randomized controlled, single-centered, superiority trial. all patients with af admitted to the coronary care unit (ccu) for dc cardioversion, and refractory to at least two trials of dc cardioversion will be enrolled. patients are randomized into two arms: the first will receive a third trial of dc cardioversion (standard of care) and the second will receive double sequential external defibrillation. the resolution of af by reverting back to normal sinus rhythm is the primary outcome of the investigators. this will be determined using ekg (electrocardiogram) immediately after dc cardioversion or double sequential defibrillation.

patients presenting to the ccu with persistent af for direct current (dc) cardioversion, who meet the inclusion criteria and fail to revert to normal sinus rhythm after two dc cardioversion attempts will be invited for enrollment in the study. no sampling will be carried out for the sake of this study. patients meeting the eligibility criteria will receive double sequential external defibrillation (dsed) or a third dc cardioversion (standard of care). dsed is the process of using two defibrillators near simultaneously at their highest allowed energy setting and aims to treat refractory atrial fibrillation. the first set of pads is placed in the traditional anterolateral position and the second set can be either placed adjacent to the first set (antero-lateral) or in the antero-posterior position. shocks are then delivered simultaneously or near simultaneously.

Eligibility criteria:
inclusion criteria: - atrial fibrillation patients admitted to the ccu for dc cardioversion, and refractory to at least two trials of dc cardioversion exclusion criteria: * patients with atrial fibrillation not requiring dc cardioversion * patients with atrial fibrillation who reverted after a maximum of two trials of dc cardioversion

Keywords: atrial fibrillation refractory atrial fibrillation double sequential external defibrillation
a safety, efficacy and pharmacokinetic study of agn-199201 and agn-190584 in patients with presbyopia

Conditions: Presbyopia

Summary: this is a safety, efficacy and pharmacokinetics study of the fixed combination of agn-199201 and agn-190584 in participants with presbyopia (inability to focus on items close-up).


Eligibility criteria:
inclusion criteria: * normal vision at distance, either natural or post corneal laser refractive surgery, with presbyopia in each eye and complaints of poor near vision that impacts activities of daily living exclusion criteria: * use of any topical ophthalmic medications, including artificial tears other than the study medications during the study * corneal abnormalities in either eye that interfere with visual acuity * history of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery or any intraocular surgery * diagnosis of glaucoma or ocular hypertension.
lifestyle intervention in pregnant women with pcos

Conditions: Polycystic Ovary Syndrome; Overweight and Obesity; Gestational Diabetes

Summary: polycystic ovarian syndrome (pcos) is the most common reproductive disorder in women of childbearing age and is also associated with metabolic abnormalities including obesity, type 2 diabetes, dyslipidemia, etc. importantly, a number of adverse outcome are seen in pregnancies complicated by pcos, including gestational diabetes mellitus (gdm), preeclampsia and miscarriage. however, optimal management of pcos complicated pregnancy is not known. this study seeks to explore whether healthy lifestyle intervention in overweight/obese pregnant women with pcos could reduce gestational weight gain (gwg) and incidence of gdm.

a randomized controlled trial in pcos pregnant women will be initiated at 8-12 weeks of gestation util delivery. participants will be randomly assigned to the control group (standard care) or the intervention group (intensive lifestyle intervention). the intervention will focus on restricting energy intake combined with behavioral lifestyle modification through participation in group sessions and individual counseling. the primary outcome will be gwg and secondary outcome will be the incidence of gdm. our hypothesis is that intensive lifestyle intervention in overweight/obese pregnant women with pcos will decrease gwg and reduce the incidence of gdm.

Eligibility criteria:
inclusion criteria: * gestational age between 8 and 12 weeks of gestation, pre-pregnancy bmi≥25 (kg/m2) * age ≥18 years, and a singleton pregnancy. exclusion criteria: * patients with prediabetes and diabetes, hypertension, chronic renal disease, thyroid disorder * gestational weeks ≥ 13 * age \<18 years * multiple pregnancy * uterine malformation * or physical restriction that prevents exercise.
bacteriophages for treating urinary tract infections in patients undergoing transurethral resection of the prostate

Conditions: Intravesical Bacteriophage Treatment for Urinary Tract Infections

Summary: urinary tract infections are among the most prevalent microbial diseases and their financial burden on society is substantial. the use of bacteriophages against bacterial pathogens has gained over the last years a renewed interest, because of the continuing increase in antibiotic resistance worldwide. thus, the aim of this study is to investigate the efficacy of intravesical bacteriophage treatment to normalize urine culture compared to intravesical placebo or standard antibiotic treatment in a randomized controlled trial following a pilot phase.


Eligibility criteria:
inclusion criteria: * patients with urinary tract infections who are scheduled for transurethral resection of the prostate with urine culture (taken by mid-stream urine; or from the existing transurethral or suprapubic catheter) ≥104 colony forming units /ml of predefined uropathogens, including enterococcus spp., escherichia coli, proteus mirabilis, pseudomonas aeruginosa, staphylococcus spp., and streptococcus spp. and lower urinary tract symptoms such as urgency, frequency, dysuria, increased number of incontinence episodes * written informed consent. exclusion criteria: * fever \>38°c * crp \>100mg/l * acute prostatitis * concomitant fungal urinary tract infection * current antibiotic treatment or antibiotic treatment within the last 7 days (exceptions: subjects with an active catheter associated urinary tract infection who have received prior antibiotics may be enrolled provided a minimum of 48 hours has elapsed between the last dose of the prior antibiotic and the time of obtaining the baseline urine specimen. subjects receiving current antibiotic prophylaxis for catheter associated urinary tract infection who present signs and symptoms consistent with an active new catheter associated infection may be enrolled provided all other eligibility criteria are met including obtaining a pre-treatment qualifying baseline urine culture) * any rapidly progressing disease or immediately life-threatening illness including but not limited to: acute hepatic failure, respiratory failure, and septic shock * no informed consent
follow-up for study participants treated with an allogeneic car t-cell product

Conditions: Hematologic Malignancies; Solid Tumors

Summary: an observational, long-term follow up (ltfu) study of participants who received an allogeneic car t product in a prior clinical study. participants will be followed for 15 years after their last infusion of an allogenic car t cell product.


Eligibility criteria:
inclusion criteria: * received an allogenic car t-cell product infusion to treat an oncologic condition in a previous allogene or servier sponsored clinical study exclusion criteria: * less than 12 months of follow up after the last allogeneic car t-cell product, unless approved by the allogene medical monitor

Keywords: car t allogeneic car t long term follow up
measurement of anaesthesia-depth trough narcotrend tm in patients undergoing electro-convulsion-therapy (ect)- influence of anasthesia depth on quality of convulsion

Conditions: Anesthesia

Summary: the electro-convulsion-therapy (ect) is a well accepted treatment option in severe depression. the quality of ect is evaluated basing on minimal seizure duration (\>15sec), the sympathic response and the postictal eeg-suppression. for the treatment general anaesthesia is needed. on the other hand anaesthesia strongly influences the quality of the seizure. the goal is to find an anaesthesia-depth that is needed for the well-being of the patient and allows a good ect. in daily routine the dose of anesthetic agents and the assesment of anesthesia-depth is based on the subjective estimation of the anesthetist and also on ealier interventions. the aim of the study is to assess any correlation between measured anesthesia-depth using the narcotrend tm and the quality of the ect.


Eligibility criteria:
inclusion criteria: * asa (american society of anesthesiologists) physical satus i-3 * \>18 years \< 90 years * signed informed consent exclusion criteria: * refusal of the patient
impact of loco-regional analgesia following placement of erector spinae plane catheter in addition to systemic analgesia in patients with thoracic trauma

Conditions: Trauma Abdomen

Summary: the management of analgesia is the key issue in the management of a thoracic trauma patient to prevent respiratory complications. a multimodal approach is recommended but the question of the most suitable loco-regional analgesia technique remains. it must combine effectiveness and simplicity with the least risk to the patient. today, epidural analgesia is the technique of choice, but it has certain disadvantages: difficulties in performing it at the thoracic level, undesirable effects, complications, and numerous contraindications. the investigator propose to carry out a single-centre, prospective, randomised, controlled pilot study evaluating the impact of loco-regional analgesia following the placement of erector spinae plane catheter in addition to systemic analgesia in patients with unilateral thoracic trauma. the aim is to demonstrate the effectiveness of this technique, which has fewer disadvantages than epidural analgesia. the interest of this study is thus to decrease the respiratory morbidity of thoracic trauma patients by avoiding a maximum of complications.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * unibilateral chest trauma with fracture \> 2 ribs on one side * admission to intensive care medicine * non-intubated patient, able to respond to a pain scale score and perform a vital capacity * numerical scale \> 3 on forced inspiration despite use of systemic analgesics * cv ≤ 80% theoretical at inclusion * time \< 24 hours from admission to the service to inclusion * time \< 48h between trauma and inclusion * patient affiliated to the social security system or entitled to it * patient able to understand the protocol, having agreed to participate in the study and having given express oral consent exclusion criteria: * intubated, ventilated patient * indication for laparotomy or thoracotomy * spinal cord injury * severe head injury * bilateral thoracic trauma * patient included in a category 1 clinical interventional study involving analgesic treatment * patients under legal protection or deprived of liberty * pregnant or breastfeeding women, or women with childbearing potential without effective contraception * refusal to participate * unable to understand the protocol and its requirements and/or unable to give express oral consent
angelica sinensis for the treatment of hot flashes in men undergoing lhrh therapy for prostate cancer

Conditions: Prostate Cancer

Summary: men undergoing androgen deprivation therapy for prostate cancer may experience significant side effects including symptoms of intense heat, facial flushing, and sweating. these so-called hot flashes are similar to those experienced by women during menopause. a traditional chinese herbal preparation, dong quai, has been used for thousands of years to reduce the incidence and severity of hot flashes. anecdotal evidence exists to support the use of dong quai in men treated with androgen deprivation therapy for prostate cancer. recently, the awareness and use of herbal remedies and over-the-counter preparations for a number of different conditions have increased dramatically. this trial was, therefore, designed to determine if dong quai significantly reduces the incidence and severity of hot flashes in men following androgen deprivation therapy for prostate cancer.


Eligibility criteria:
inclusion criteria: * prostate cancer treated with some form of androgen deprivation therapy for at least one month. this includes either surgical (bilateral orchidectomy) or medical (lhrh agonist, pure or steroidal antiandrogen or combined) castration; * greater than seven vasomotor episodes per week; * significantly bothersome symptoms associated with these vasomotor episodes, which produce a desire in the patient to seek treatment to reduce both their incidence and severity; * documented informed consent to participate in the trial. exclusion criteria: * enrolment in any other clinical trial or study protocol; * presence of pain due to prostate cancer; * life expectancy less than three months; * any severe concomitant condition that would make it undesirable, in the clinician's opinion, or the subject to participate in the trial or would jeopardize compliance with the trial protocol; * concomitant anticoagulation therapy or history of bleeding disorder or blood dyscrasia; * known hypersensitivity to dong quai.

Keywords: prostate cancer luteinizing hormone releasing hormone lhrh
bezlotoxumab versus fmt for multiple recurrent cdi

Conditions: Clostridium Infections; Clostridioides Difficile; Enterocolitis, Pseudomembranous

Summary: the objective of this trial is to investigate whether a treatment strategy offering bezlotoxumab before fmt in patients suffering from multiple recurrent cdi results in equal efficacy compared with a treatment strategy with initial fmt. strategy a includes bezlotoxumab as ancillary treatment as first option, and fmt in case of failure. option b includes fmt as ancillary treatment as first option, and antibiotic treatment with fidaxomicin in case of failure. a secondary objective is to provide a point estimate of recurrence after bezlotoxumab for the treatment of multiple recurrent cdi.


Eligibility criteria:
inclusion criteria: * 18-90 years old * diarrhea (3 or more unformed stools per 24h for two consecutive days; or \>= 8 unformed stools per 48h) xml file identifier: kqqebblryezjggsil5gci+nxcym= page 10/22 * positive pcr test for toxin a/b genes and/or positive toxin eia for current and previous episodes (low pcr cycle threshold value when only pcr performed) * a minimum of two prior cdi episodes * previous episode is maximum of 3 months prior to the current episode * the current episode responds well to standard of care treatment (vancomycin or fidaxomicin orally). * assessment of the severity of the disease will be performed according to the escmid recommendations. * both mild and severe cdi will be included exclusion criteria: * severe complicated cdi, i.e presence of: hypotension, septic shock, elevated serum lactate, ileus, toxic megacolon, bowel perforation, or any fulminant course of disease. * icu admission for underlying disease * pregnancy or current desire for pregnancy * breastfeeding * (prolonged) use of antibiotics (other than for treatment of cdi) during the study period or directly after the intervention * previous use of bezlotoxumab or fecal microbiota transplantation * a history of underlying congestive heart failure (potential safety signal phase-iii trail bezlotoxumab). * diagnosis of inflammatory bowel disease in medical history.
samba: sexuality and management of benign prostatic hyperplasia with alfuzosin

Conditions: Prostatic Hyperplasia

Summary: primary objective: * to assess the sexual function improvement from baseline to the end of treatment (week 24 or premature withdrawal (pw)) with xatral 10mg od. secondary objective: * to evaluate the association between lower urinary tract symptoms (luts) severity and sexual disorders, * to compare the improvement in sexual function, urinary symptoms and quality of life among the different regions, * to correlate mshq (male sexual health questionnaire) and iief-5 (the 5-item version of the international index of erectile function), * to assess the onset of action of xatral 10mg od, * to assess the peak flow rate improvement (qmax), * to assess the safety and the tolerability of xatral 10mg od.


Eligibility criteria:
inclusion criteria: * patients suffering from moderate to severe lower urinary tract symptoms (luts), suggestive of symptomatic benign prostatic hyperplasia (bph), * patients with an i-pss total score ≥ 8, * patients sexually active exclusion criteria: * known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant threatening-life condition. * previous prostate surgery, minimally invasive procedure within 6 months prior to inclusion. planned prostate biopsy, prostate surgery or minimally invasive procedure during the whole study period. * active urinary tract infection or prostatitis, neuropathic bladder, a diagnosed prostate cancer. * patients having received 5α-reductase inhibitors or luts related phytotherapy within 6 months prior to inclusion, or α1-blockers within 30 days prior to inclusion. patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion. * history of postural hypotension or syncope. * known hypersensitivity to alfuzosin. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.