Kornimate/medical-research-clean huggingface dataset:
tiemann mounted urodynamic catheter technique for difficult bladder catheterization

Conditions: URINATION DISORDERS

Summary: a report of a technique for insertion a soft urodynamic catheter into the bladder, when urethral obstruction causes the catheter to bend and fold over itself at the resistance site.

the urodynamic catheter is mounted on a 12f coudé tip tiemann catheter, which then carries the tip of the urodynamic catheter beyond the obstruction site into the bladder. the tiemann catheter-mounted urodynamic catheter technique can serve as a suitable option to insert a urodynamic catheter into the bladder in all male patients in whom it fails due to kinking.

Eligibility criteria:
inclusion criteria: - men that underwent urodynamic study evaluation between 6/2011 to 9/2013 exclusion criteria: none -

Keywords: urinary incontinence urodynamics urinary retention urinary catheterization
a pilot randomized controlled trial of the hopeful and healthy living program

Conditions: Serious Mental Illness; Older Adults

Summary: the goal of this clinical trial is to learn if a novel psychosocial intervention is effective in helping adults over 50 with serious mental illness (smi) increase their social connections and participate in more healthy lifestyle activities. the hopeful and healthy living (hhl) intervention combines social skills training and training in cognitive self-management strategies in order to help older adults build healthy lifestyle and social routines. we predict that: * individuals who participate in the hhl intervention will improve more in perceived social support (i.e., what people get from relationships such as reliance, reassurance of worth, attachment) and loneliness at the 4-, 8-, and 12-month follow-up assessments than those who receive treatment as usual (tau). * individuals who participate in the hhl intervention will improve more in overall psychosocial functioning at the 4-, 8-, and 12-month follow-up assessments than those who receive tau. * individuals who participate in the hhl intervention will improve more in cognitive functioning at the 4-, 8-, and 12-month follow-up assessments than those who receive tau. * individuals who participate in the hhl intervention will improve more in healthy behaviors (sleep, activity, diet) at the 4-, 8-, and 12-month follow-up assessments than those who receive tau. in this trial, participants will be either receive the hhl intervention or participate in their regular treatment activities (treatment as usual). hhl vs. tau will be compared to see if there are any differences in social support, cognition, loneliness, psychosocial functioning, or healthy lifestyle activities including physical activity, sleep, and diet. participants will be asked to complete an interview-based assessment at baseline, 4-months, 8-months, and 12-months. after completing the baseline assessment, those who are in the experimental group will participate in the 16-week long hhl group intervention.


Eligibility criteria:
inclusion criteria: 50 years or older, diagnosis of a serious mental illness, and a member of center club or transitions of boston exclusion criteria: diagnosis of dementia or other progressive neurological disorder

Keywords: psychosocial interventions cognitive interventions social skills interventions healthy lifestyle interventions older adults with smi
renew scleroderma: a peer-mentored, web intervention for resilience-based, energy management to enhance wellbeing and fatigue

Conditions: Scleroderma

Summary: the researchers seek to understand if the resilience-based, energy management to enhance wellbeing and fatigue (renew) program helps with scleroderma symptom management and disease burden. the researchers think that those participants who receive the intervention will have clinically meaningful changes of symptom management and disease burden.


Eligibility criteria:
inclusion criteria: * have a diagnosis of systemic sclerosis (ssc), any subtype * report a mean score of at least 4 on the fatigue severity scale; potential mean range 1-9 * have access to a computer and an internet connection * are able to speak and read english. exclusion criteria: * currently undergoing structured rehabilitation or psychological treatment. * other issues that preclude meaningful participation in study procedures (e.g. concurrent or complex medical issues, inability to access renew intervention, etc.)

Keywords: systemic sclerosis
target temperature management in myocardial infarction - a pilot study

Conditions: ST-elevation Myocardial Infarction

Summary: the primary goal in the treatment of acute myocardial infarction is to reperfuse the ischemic myocardium to reduce infarct size. animal data and human data suggest that whole-body cooling to temperatures below 35°c before revascularisation can additionally reduce infarct size and therefore improves outcome in these patients. the purpose of the study is to determine the feasibility and safety of a combined cooling strategy started in the out-of-hospital arena for achieving pre-reperfusion hypothermia in patients with acute st-elevation myocardial infarction.


Eligibility criteria:
inclusion criteria: * age between 18 and 75 years * immediately transfer to cath-lab is possible * anterior or inferior st-elevation myocardial infarction * st-segment elevation of \>0.2mv in 2 or more anatomically contiguous leads * duration of symptoms \<6 hours exclusion criteria: * participation in another study * patients presenting with cardiac arrest * tympanic temperature of \<35.0°c prior enrolment * thrombolysis therapy * previous myocardial infarction in medical history * previous percutaneous coronary intervention or coronary artery bypass graft * severe heart failure (defined as a new york heart association (nyha) score of iii or iv), killip class ii through iv at presentation * clinical signs of infection * end-stage kidney disease or hepatic failure * recent stroke (within the last six month) * conditions that may be exacerbated by hypothermia, such as haematological dyscrasias, oral anticoagulant treatment with international normalized radio \>1.5, severe pulmonary disease * pregnancy. women of childbearing potential are excluded * allergy to meperidine, buspirone, magnesium, or polyvinyl chloride * use of a monoamine oxidase inhibitor such as selegiline in the previous 14 days

Keywords: myocardial infarction myocardial reperfusion injury reperfusion injury anterior wall myocardial infarction inferior wall myocardial infarction myocardial ischemia
a study of cm310 in subjects with chronic pruritus

Conditions: Chronic Pruritus of Unknown Origin

Summary: this is a multi-center, randomized, double blind, placebo-controlled phase ii study to evaluate the efficacy and safety of cm310 in subjects with chronic pruritus of unknown origin.

the study consists of a screening period (up to 4 weeks), treatment period (16 weeks) and safety follow-up period (8 weeks). 50 subjects who meet eligibility criteria will be randomized 1:1 to receive either cm310 300 mg or matched placebo subcutaneously every two weeks (q2w) for a total of 8 times. all subjects will receive mometasone furoate nasal spray (mfns) on a daily basis as a background treatment throughout the study.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old. * with chronic pruritus of unknown origin. * with the worst pruritus numerical rating scale (wi-nrs) ≥7. * contraception. exclusion criteria: * heavy drinking in the 3 months prior to screening. * with severe hepatic and renal impairment. * previous history of autosensitivity dermatitis. * allergic to cm310/placebo. * vaccination with live attenuated vaccine within 12 weeks before randomization or during the planned study period.
a first in human study to evaluate the safety of infusion of mnv-bm-plc (autologous cd34+ cells enriched with placenta derived allogeneic mitochondria) in patients with primary mitochondrial diseases associated with mitochondrial dna mutation or deletion

Conditions: Primary Mitochondrial Diseases

Summary: the study objectives are to evaluate the safety of a single intravenous (iv) infusion of autologous cd34+ cells enriched with placenta-derived allogeneic mitochondria in participant with primary mitochondrial disease associated with mitochondrial dna mutations or deletions. 6 participants aged from 4 to 18 years old on the day of screening visit with primary mitochondrial disease associated with mitochondrial dna mutations or deletions will be enrolled.

mnv-bm-plc is a personalized cell therapy based on autologous patient-derived hematopoietic stem/progenitor cells (hspcs) enriched with mitochondria isolated from healthy placenta obtained from donors during c-section. healthy mitochondria are employed, ex-vivo, to enrich the patient's cd34+ peripheral blood cells, followed by infusion of the mitochondrial enriched cells back to the patient. this therapeutic process of mitochondrial augmentation provides the patient with healthy mitochondria carrying non-mutated/deleted mtdna that can supplement mitochondrial functionality in the patient's cells.

Eligibility criteria:
inclusion criteria: * molecular diagnosis of primary mitochondrial disease * age between 4 years and up to 18 years, with a minimum body weight of 20 (+/-1) kilogram on the day of screening visit. * performance score: karnofsky ≥40 (or equivalent in children younger than 16 years old. * patients or patient's parents or legal guardian (where applicable) has a good understanding of the study and nature of the procedure and is willing and able to provide written informed consent prior to participation in any study-related procedures. * medical ability to undergo the study procedures safely, as determined by the investigator. exclusion criteria * positive test for pathogenic agents . * inability to undergo leukapheresis, as determined by the investigator. * chronic severe infection or any other disease or condition that may risk the patient or interfere with the ability to interpret the study results. * known history of malignancy. * patient has been treated within the last one year prior to ip treatment with a different cell therapy. * patient has participated in another interventional clinical study and/or received other experimental medication outside of a clinical study within 1 month prior the day of investigation product (ip) treatment visit. * a pregnant or lactating woman or a woman who plans to become pregnant during the study. in addition, any woman of childbearing potential (not sterile or postmenopausal), who is unwilling to adhere to the use highly effective contraception method for the duration of the study * in the opinion of the investigator, the patient is unsuitable for participating in the study due to safety concerns.

Keywords: mitochondrial dna mutation or deletion
study to evaluate the efficacy of the synera patch compared to naproxen sodium for epicondylitis of the elbow

Conditions: Epicondylitis of the Elbow

Summary: the purpose of the this study is to evaluate the sfaety and efficacy of synera(r)for patients with lateral and medial epicondylitis and compare it to naproxen sodius.

the objective of this single center is to evaluate the safety and efficacy of synera ® in lateral and medial epicondylitis . this is an open-label, comaparative study study where the subjects will be randomized to one of the following groups: 1. synera patch ®: a single patch applied for 4 hours twice daily approximatey 12 hrs apart to the medial or lateral side of the index elbow 2. synera patch ®: a single patch applied for 12 hours/day to the medial or lateral side of the index elbow 3. naproxen sodium: 500mg bid

Eligibility criteria:
inclusion criteria: * individuals with clinical evidence of lateral or medial epicondylitis of the elbow. * age 18 or higher * minimum of 4 on question 5 of bpi exclusion criteria: * peripheral neuropathy of any origin in the index limb * cubital tunnel syndrome in patients with medial epicondylitis * cortisone injection in the last 4 weeks into the index limb * surgical intervention in the past for the epicondiitis * participants in any other clinical trial in the last 30 days * known allergy to lidocaine, tetracaine, nsaids or paba * uncontrolled pain in the upper extremity or neck that may interfere with evaluation of study drug's response as deemed by the investigator * patient who is deemed to be medically unstable by the principal investigator including but not limited to liver disease or cardiac arrhythmias * patients who are pregnant, lactating or breast feeding * vaccination within the last weeks or planning on any vaccinations during the study or for 4 weeks after the study completion.

Keywords: epicondylitis
pilot study combining temozolomide, oncovin, camptosar and oral antibiotic in children and adolescents with recurrent malignancy

Conditions: Lymphomas; Tumors

Summary: determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan, with weekly vincristine, temozolomide and vantin; to evaluate the feasibility of repetitive cycles of this chemotherapy and to estimate the response rate to this combination in children and adolescents with recurrent solid tumors and lymphomas.

determine toxicity and maximum tolerated dose of escalating daily protracted irinotecan, with weekly vincristine, temozolomide and vantin; to evaluate the feasibility of repetitive cycles of this chemotherapy and to estimate the response rate to this combination in children and adolescents with recurrent solid tumors and lymphomas. temozolomide is given by mouth one hour prior to each daily irinotecan dose days 1-5 of each cycle. 100 mg/m2/day. irinotecan is given iv in dose escalation (minimum of 3 and up to 6 patients per cohort) starting at 15 mg/m2/day daily for 5 days for 2 weeks. vincristin is given iv 1.5 mg/m2/dose (max dose 2mg) days 1 and 8 of each cycle. vantin is given 10 mg/kg/day divided in 2 oral doses (max dose 400 mg/day) started 48 hours prior to the start of each treatment cycle and continued for 48 hours after last irinotecan dose. cycle repeated every 28 days. therapy will continue for a minimum of two cycles unless there is progression of disease or unacceptable toxicity and may be continued as long as patient tolerates therapy and there is continued disease control up to one year of therapy.

Eligibility criteria:
inclusion criteria: * under age 21 years at time of study entry * malignant solid tumor, including cns tumors and lymphomas * recurrent or refractory disease not amenable to other potentially curative therapies * at least three weeks since last myelosuppressive chemotherapy \> 6 months from allogeneic stem cell transplant * adequate renal and hepatic function * adequate peripheral blood counts unless bone marrow is involved exclusion criteria: * patients with leukemia not eligible * patients with uncontrolled infection excluded * patients who have received more than 4 prior chemotherapies * patients who are receiving p450 enzyme-inducing anticonvulsants * patients who are receiving any other cancer chemotherapy or any other investigational agent * possible pregnancy will be excluded

Keywords: recurrent solid tumors recurrent lymphomas pediatrics adolescents
continuation of a study to investigate the effect of thoracocentesis on neural respiratory drive in pleural effusion

Conditions: Pleural Effusion

Summary: the aim of this study is to better understand the relationship between pleural effusions and breathlessness in patients with unilateral pleural effusions and breathlessness who require pleural fluid removal for its management.

this study will involve 124 adult patients who are breathlessness with pleural effusions. they will be recruited from a single uk centre over an 18-month period. after being informed about the study, all patients giving written informed consent will undergo a baseline assessment when they first come to have their fluid drained. the investigators will record information about them and their disease. the investigators will take measurements of their breathlessness, their breathing muscles, and the electrical activity from the brain to those muscles. these will be taken at the start and end of drainage, as well as 1 day and 7 days after. the investigators will use this information to look for links between the effect of pleural effusions and its removal on the electrical activities of the breathing muscles and patients' breathlessness.

Eligibility criteria:
inclusion criteria: * age 18 years or above * has a unilateral pleural effusion and 1. require thoracocentesis or 2. chest drain insertion (main study only) or 3. has an ipc in situ (main study only) exclusion criteria: * inability to consent * any contraindications to the proposed pleural procedure * haemodynamic or clinical instability that precludes from the safe completion of required pre-procedural measurements * inability to identify surface landmarks for surface emg electrode placement * past medical history of diaphragmatic paralysis (diaphragm sub study only)

Keywords: pleural effusion breathlessness neural respiratory drive neurophysiology
irrigation of the large intestine in the patients with colostomy : epidemiology and quality of life

Conditions: Colostomy

Summary: the main objective of this study was to determine the frequency of the practice of colonic irrigation (ci) among patients with a colostomy,. other objectives are: * to compare the quality of life between a group of patients with a colostomy and practicing ci versus a group of patients with a colostomy without ci. * to determine the causes of non-realization of the ci or failure. * to determine the conditions of realization of colonic irrigation by the return of user experience (time of day when the ci is practiced, amount and type of fluid used, time spent in the bathroom, time to recurrence of stool, media used between two irrigations).


Eligibility criteria:
inclusion criteria: * the subject was informed about the implementation of the study's objectives, constraints and the rights of the subject * the subject is aged at least 18 years * the subject is a member of the ostomy federation of france * the subject has had a terminal colostomy for more than 6 months exclusion criteria: * the subject is under guardianship or curatorship * the subject is under judicial protection * the subject formalizes his/her opposition * it is not possible to inform the subject
convenience and safety of assisted reproductive technology procedures using a gonal-f filled by mass (fbm) liquid formulation applied by pen for ovulation induction and in-vitro fertilization

Conditions: Infertility; Ovulation Induction; In-Vitro Fertilization

Summary: this was a prospective, open-label, non-comparative, phase iiib trial to assess the convenience, safety and efficacy of the new gonal-f fbm \[recombinant follicle stimulating hormone (r-fsh)\] liquid formulation, in common setting for ovulation induction (oi) and also in in-vitro fertilization (ivf).


Eligibility criteria:
inclusion criteria: * female subjects aged between 18 and 43 years * ambulatory subjects * subjects who are willing to get pregnant and are infertile, that justifies ovarian stimulation treatment for mono-/pauci-follicular development (oi or iui) or multiple follicular development for ivf/intracytoplasmic sperm injection (icsi) procedures * subjects who are able to communicate well with the investigator and to comply with the requirements of the entire study * subjects who have given written informed consent, prior to treatment exclusion criteria: * subjects with enlarged ovaries or cysts unrelated to polycystic ovaries * subjects with extra-uterine pregnancy during the last 3 months * subjects with several endometriosis (grade iii \& iv) * subjects with history of severe ovarian hyperstimulation syndrome * subjects with history of thromboembolic event * subjects with malformative uterine pathology that could disturb either implantation or pregnancy processes * subjects with premature menopause * subjects with gynecological bleeding of unknown origin * subjects with ovarian, uterine, or mammary cancer * subjects with tumors of the hypothalamus or the pituitary glands * subjects with history of serious allergy or atopic asthma disease * subjects with known allergic reaction against one of the follicle stimulating hormone (fsh) and ingredients, * ongoing pregnant, or breast feeding subjects * subjects who have participated in a trial during the last 3 months

Keywords: infertility ovulation induction gonal-f follitropin alpha controlled ovarian stimulation
melatonin use for sleep problems in alcohol dependent patients

Conditions: Alcohol-Related Disorders

Summary: a double blind randomized controlled trial with two arms will be used. subjects with alcohol use disorder and sleep problems will be recruited and assigned randomly to the active treatment melatonin or placebo arms. all subjects will be assessed at baseline for demographics. sleeping problems will be the primary outcome of the study, and it will be measured by the pittsburgh sleep quality index (psqi) scale.

a double blind randomized controlled trial with two arms will be used. subjects with alcohol use disorder and sleep problems will be recruited and assigned randomly to either melatonin or placebo arms. all subjects will complete some forms on the redcap system such as contact information list, concomitant medication, time line follow back (tlfb), fagerstrom test for nicotine dependence (ftnd), beck depression inventory (bdi), beck anxiety inventory (bai), aud criteria, and alcohol use disorder identification test (audit). sleeping problems will be the primary outcome of the study, and it will be measured by the pittsburgh sleep quality index (psqi) scale where score 5 or more indicated a sleeping problem. women in child-bearing period will be asked to do a urine pregnancy test to exclude pregnancy. after verifying eligibility, the participants will come to pick up the medication (melatonin or placebo) blister together with a sleep hygiene document and will start taking the medication for 4 weeks. all subjects will then be followed-up at the end of 1 month of treatment and psqi score will be measured. this step will be completed either online by sending an email link through or the participants can come to a personal visit to complete the second psqi form. also, this last visit/email will contain side effects questionnaire, tlfb, bdi, bai. all the participants will be required to bring/send back the medication blister pack to do a pill count and check all the missing pills.

Eligibility criteria:
inclusion criteria: * age: 19 or older * aud in any stage * sleep problems in the past month * psqi score \> 5 at baseline * participants must agree not to use other sleep aid during the study * women capable of becoming pregnant must agree to use contraceptives during study exclusion criteria: * pregnancy, lactation or plans to become pregnant during the study timeline. * use of other sleep aid in the past month (either prescribed or over the counter remedies) * use of benzodiazepines and/or z- drugs: (zaleplon, zolpidem and zopiclone) in the past month * known allergy to melatonin * participants taking immunosuppressive drugs.

Keywords: sleep alcohol dependence melatonin