Kornimate/medical-research-clean huggingface dataset:
weight reduction surgery and ovarian function

Conditions: Anovulation; Obesity

Summary: this study will investigate the role of weight reduction surgery on the reproductive performance of obese women with ovulation problems. it is hypothesized that surgery offered when other methods of weight reduction have failed, may help restore ovulation.

we aim to recruit 30 patients suffering from chronic anovulation, with a body mass index of 35 or more, who failed to achieve weight reduction with other methods such as orlistat, metformin, diet and exercise. patients will be approached by one of the investigators in the infertility clinics and the assisted conception unit of the royal hallamshire hospital. consent will be obtained by one of the designated investigators. the consent form has been designed in accordance with the guidelines of the central office for research and ethics committees (corec). a patient information leaflet will be supplied and has been designed according to the corec guidelines. patients will have a baseline history, clinical examination, hormonal profile (fsh/lh, fasting insulin/glucose ratio, androgen profile, day 21 serum progesterone, serum leptin and ghrelin levels) ultrasound examination (ovarian volume and antral follicle count), including doppler blood flow study (ovarian stromal velocity). patients will be offered laparoscopic gastric bypass surgery by mr roger ackroyd, in line with the current recommendation for gastric surgery according to nice guidelines i.e. patients with a bmi over 40 or a bmi over 35 with at least one co-morbidity. patients will be reviewed monthly for six months. at each visit the following will be recorded: 1. weight, menstrual diary. 2. hormonal profile (fsh/lh, fasting insulin/glucose ratio, androgen profile, day 21 serum progesterone, serum leptin and ghrelin levels). 3. doppler of ovarian stroma (pulsitility index, peak velocity), ovarian volume and antral follicle count 4. review of symptomatology especially androgenic symptoms. end point: completion of six months follow up.

Eligibility criteria:
inclusion criteria: 1. anovulation or irregular ovulation as determined by the following clinical or laboratory features: * clinical: i. irregular cycles (not 25-35 days) ii. amenorrhoea (more than six months). * biochemical: day 21 or midleuteal serum progesterone of less than 30mmol/l. 2. bmi of 35 or more. 3. age between 18 and 45. exclusion criteria: 1. contraindication for bypass surgery: i. medically unfit ii. psychologically unfit iii. strong family history of gastric cancer 2. insulin dependant diabetes or patients on oral hypoglycaemics. insulin resistance and impaired glucose tolerance however, are not exclusion criteria. 3. concomitant endocrine disorders including thyroid disease and cushing syndrome. 4. patients on steroid therapy. 5. patients who have had one or both ovaries removed. 6. biochemical evidence of ovarian failure i.e. fsh of 20 iu or more. 7. patients who have had hysterectomy.

Keywords: anovulation obesity bariatric surgery
effect of resistance training in patients on the waiting list for heart transplant

Conditions: Heart Failure; Heart Transplant

Summary: the present longitudinal, randomized, and blinded clinical trial aims to: * evaluate the effects of resistance training on the functional capacity, quality of life, and cardiac biomarkers of hospitalized patients with heart failure (hf) on the waiting list for heart transplantation (htx). * evaluate the associations between fried's frailty classification and functional capacity responses to resistance training. the protocol will have a total duration of 12 weeks.

heart failure (hf) presents a significant challenge to contemporary healthcare systems. as hf progresses, heart transplantation (htx) becomes the primary treatment option to enhance survival rates. patients awaiting htx often endure extended hospitalizations and rely on continuous inotropic support. this scenario exacerbates bed rest and potentially worsening functional capacity. resistance training has shown promise in mitigating the detrimental effects of immobility, however, limited research has explored its impact on hf patients on the htx waiting list. objectives: * to evaluate the effects of resistance training on functional capacity, quality of life, and cardiac biomarkers in hospitalized patients with hf on the htx waiting list. * to assess the associations between fried's frailty phenotype and functional capacity responses to resistance training, hemodynamic behavior during the protocol, and the incidence of adverse events during the protocol implementation. methods: a total of 50 patients hospitalized on the htx waiting list will be recruited for this study. participants will be randomly assigned to one of two groups: the resistance training group (tg) and the control group (cg). assessments will occur at three time points: baseline (t0), at 6 weeks (t1), and at 12 weeks (t2) of resistance training. clinical parameters will be evaluated, including the six-minute walk test and the short physical performance battery. peripheral muscle strength will be measured using a dynamometer, and inspiratory muscle strength will be assessed through maximum inspiratory pressure. quality of life will be evaluated using the kansas city cardiomyopathy questionnaire-12. additionally, cardiac biomarkers, such as exhaled air ketone and brain natriuretic peptide levels in venous blood samples, will be analyzed.

Eligibility criteria:
inclusion criteria: * patients included in heart transplant list ≤1 month * hemodynamically stable in the last 48 hours defined as mean arterial pressure (map) ≥ 60 mmhg and ≤ 120 mmhg and - heart rate (hr) ≥ 60 bpm and ≤ 120 mmhg. * dobutamine dose ≤ 10 mcg/kg/min exclusion criteria: * heart failure of arrhythmogenic and/or restrictive etiology * presence of uncontrolled acute arrhythmias * cognitive, orthopedic, or neuromotor changes that prevent functional tests from being carried out

Keywords: heart failure resistance training cardiac rehabilitation
improved detection of multiple sclerosis plaques in inversion recovery by optimization of sequence parameters

Conditions: Multiple Sclerosis

Summary: this study evaluates different optimized mri sequences for the detection of brain lesions in patients with multiple sclerosis in comparison with the recommended flair sequence

mri is a tool of choice for detecting demyelinating lesions in multiple sclerosis (ms) disease. on a consensual basis, the detection of those lesions in done on flair (fluid attenuated inversion recovery) sequences, weighted t2 with cancelling of fluid signal, leading to a much better contrast between the lesion and the environment. the environment is displayed as a iso-signal for the surrounding healthy brain's white matter and as a hypo-signal for the fluids. keys parameters indicative of the sequence's contrast are the echo time, the reversal time, and the repetition time, wich seems to be crucial to detect the lesions, according to relatively discordant results of publications using different technologies of flair. although 3d flair sequences play an essential role for diagnosis and evaluation (evolution under treatment, prognosis) of demyelinating pathologies there is no consensus on parameters used on routine basis. the aim of the trial is to discover the optimal combination of theses parameters so as to well detect the lesions.

Eligibility criteria:
inclusion criteria: * relapsing remitting multiple sclerosis * mri required exclusion criteria: * mri contraindication
evaluation of subjective ratings on a new sound processor and compatible products

Conditions: Hearing Loss

Summary: clinical study designed to collect user feedback from cochlear implant recipients on a new sound processor system


Eligibility criteria:
inclusion criteria: 1. 12 months old or older 2. implanted with a ci24re (freedom implant) or later implant in at least one implanted ear 3. use of the cp810, cp920 or cp910 sound processor 4. willingness to participate in and to comply with all requirements of the protocol exclusion criteria: 1. unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device 2. additional disabilities or illnesses that would prevent participation in evaluations or compromise the integrity of the investigation or quality of data collected 3. nucleus 22 or nucleus 24 implant in ear to be fitted with the investigational device
long-term assessment of safety and physical function with amg 108 in ra

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to assess long-term safety of sc amg 108 in the treatment of ra


Eligibility criteria:
inclusion criteria: * only subjects eligible for and completing 24 weeks of study 20050168 will be permitted to enroll. exclusion criteria: * subjects not eligible for or not completing 24 weeks of study 20050168 will be excluded.

Keywords: rheumatoid arthritis
s-caine™ peel (skin numbing cream) to treat pain during pulsed dye laser (pdl) therapy in adults

Conditions: Pain

Summary: pulsed dye laser (pdl) on the face is painful. for this reason, local anesthesia is commonly used to eliminate or minimize the pain. s-caine™ peel (lidocaine 7% and tetracaine 7% cream) is a eutectic formulation of lidocaine and tetracaine. the purpose of this study is to evaluate the efficacy of s-caine peel for induction of local dermal anesthesia for pdl therapy in adults.

this was a multi-center (5 centers), double-blind, placebo-controlled, parallel study that included 80 adults who met all the eligibility criteria and who were undergoing pdl therapy for the treatment of vascular lesions on the face. during the screening visit, the study, including potential risks and benefits, was clearly explained to each patient, and written informed consent was obtained from each patient. the screening visit also included: evaluating eligibility criteria, obtaining a medical history (including skin type, demographic data, and concomitant medications), a brief physical examination, and a urine pregnancy test (for women of childbearing potential). the screening visit could be completed on the same day as the procedure visit. at the procedure visit, eligible patients were assigned the next available sequential patient number. by having a patient number assigned to them, patients were randomized to receive s-caine peel or placebo on the facial treatment area. the surface area of the intended treatment area was determined (up to 200 cm2). a thin layer (approximately 1 mm or the thickness of a dime) of the study drug was applied evenly across the area to be treated. the study drug was applied for 20 minutes (±2 minutes). immediately following removal of the study drug, the investigator performed an evaluation of skin reactions, assessing the treatment area for erythema, edema and blanching or any other adverse skin reaction.

Eligibility criteria:
inclusion criteria: * patient is 18 years of age or older * patient elects to undergo pdl therapy for the treatment of vascular lesions on the face exclusion criteria: * patient is pregnant or breastfeeding * patient has participated in a clinical trial of an unapproved drug within the previous 30 days * patient has participated in any clinical trial involving s-caine peel
early use of tips with polytetrafluoroethylene(ptfe) covered stents in cirrhotic patients with refractory ascites

Conditions: Liver Cirrhoses

Summary: this multicenter rct is designed to investigate if tips with covered stents improves transplant-free survival for cirrhotic patients with early stage of refractory ascites compared to lvp+albumin during 1 year follow-up period.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of liver cirrhosis * recurrent and refractory ascites * patients with an age between 18 and 65 years old * child-pugh ≤12 * absence of hepatic encephalopathy * patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing. * patient, or legal authorized representative, is willing to provide written informed consent prior to enrollment in the study exclusion criteria: * with more than 6 paracenteses within the last 3 months * patients expected to receive transplants within the next 6 months or on waiting list * usual contra-indication for tips: congestive heart failure nyha\>iii or medical history of pulmonary hypertension, portal vein thrombosis（\>50%）, hepatic polycystosis, intra-hepatic bile ducts dilatation * patient has had previous tips placement * severe liver dysfunction by: prothrombin index \ 50μmol/l * serum creatinine \>133μmol/l * severe hyponatremia \<125mmol / l * uncontrolled sepsis * gastrointestinal hemorrhage within 6 weeks of randomization * known allergy to albumin * pregnant or breast feeding women * refusal to participate or patient unable to receive informations or to sign written informed consent

Keywords: liver cirrhosis transjugular intrahepatic portosystemic shunt refractory ascites
convalescent plasma as adjunctive therapy for hospitalized patients with covid-19

Conditions: Covid19

Summary: this protocol provides access to investigational convalescent plasma for hospitalized patients with covid-19. following provision of informed consent, patients will be administered around 500 ml of convalescent plasma obtained from an individual who has recovered from a documented sars-cov-2 infection. the study aims to evaluate the efficacy and safety of anti-sars-cov-2 convalescent plasma as adjunctive therapy in preventing disease progression (prevention of icu admission) among hospitalized patients with covid-19. safety outcomes include serious adverse events judged to be related to convalescent plasma. other information which will be collected includes patient demographics and clinical data which includes quick sofa scores, ventilator-free days, icu-free days, dialysis-free days and 28-day mortality.

this is a phase 3, randomized, non-placebo controlled, open-label, single-center clinical trial which will assess the efficacy and safety of anti-sars-cov-2 convalescent plasma given from the 3rd to 14th day of illness after the onset of symptoms in preventing icu admission among hospitalized covid-19 patients compared to standard of care. consecutive patients with covid-19 admitted to the up philippine general hospital will be offered participation into the study. patients in the intervention group will receive one dose of type-specific anti-sars-cov-2 convalescent plasma (500 ml collected by whole blood donation or standard pheresis at the up-pgh blood bank from a volunteer who recovered from covid-19). the primary safety endpoints include serious adverse events judged to be related to convalescent plasma. the study also aims to compare anti-sars-cov-2 antibody titers and rates, levels, and duration of sars-cov-2 rna in nasopharyngeal swabs using rt-pcr between the intervention and control groups.

Eligibility criteria:
inclusion criteria: * patient must be 19 years of age or older * hospitalized with covid-19 and confirmed via sars-cov-2 rt-pcr testing * patient is willing and able to provide written consent and comply with all protocol requirements * patient agrees to storage of specimens for future testing exclusion criteria: * female subjects with positive pregnancy test, are breastfeeding or planning to become pregnant/breastfeed during the study period * symptomatic illness exceeding 14 days from onset of illness at time of enrollment * icu admission on initial presentation at the hospital (includes patients with clinical indications for icu admission as follows: 1. respiratory distress with requirement of o2 \>6 lpm to maintain o2 sat \>92% 2. rapid escalation of o2 requirement/significant work of breathing 3. hemodynamic instability: sbp \<90, map \<65 * receipt of any blood products including pooled immunoglobulin or intravenous immunoglobulin (ivig) in the past 30 days prior to enrolment * known iga deficiency * presence of any contraindication to transfusion (or history of prior severe reactions to transfusion of blood products)

Keywords: covid-19 convalescent plasma
ccu wireless vital signs monitoring

Conditions: CCU Inpatients

Summary: this is a pilot study is to test a wireless, skin-sensor device against current technology in the ccu to monitor vitals

this is a single center, prospective, observational study that will recruit subjects from lurie children's hospital to test a wireless vitals monitor against the current vitals monitors used in the cardiac care unit.

Eligibility criteria:
inclusion criteria: * patients under the age of eighteen admitted to the lurie's children's cardiac care unit will be eligible to participate exclusion criteria: * patients at imminent risk of death * patients with a skin abnormality that precludes assessment * patients with hyperbilirubinemia and requiring a need for uv light

Keywords: wireless vitals vitals monitor cardiac
computerized cognitive behavioral therapy and electroconvulsive therapy

Conditions: Depression

Summary: in an open-label feasibility study, fifteen will be recruited to participate in the study from among those who have already chosen of their own accord to undergo ect (standard of care) at yale psychiatric hospital for treatment of a depressive episode. these patients will receive computer-assisted cognitive behavior therapy (ccbt).


Eligibility criteria:
inclusion criteria: * 18-75 years old * meet dsm-5 criteria for depressive episodes * able to use a computer exclusion criteria: * diagnosis of an axis ii (personality disorder) * active suicidal thoughts with a plan * current substance use disorder * non-affective psychosis * prior treatment with ect in the past 6 months * cbt treatment in the past 12 months * dementia * delirium or another other neurological or mental disease that might affect cognition or the ability to meaningfully participate in computerized cbt

Keywords: depression
early combined use of dexamethasone intravitreal implant and anti-vegf in the treatment of dme.

Conditions: Diabetic Macular Edema (DME)

Summary: the goal of this clinical trial is to learn if the efficacy of dexamethasone implant combined with anti-vegf superior to anti-vegf monotherapy in the treatment of dme in chinese patients. the main questions it aims to answer are: 1. whether combination therapy improves the best corrected visual acuity at 6 months and 12 months? 2. does combination therapy improve retinal anatomy better than monotherapy at each time point? researchers will compare the combination therapy to the monotherapy to see if dexamethasone implant combined with anti-vegf will leads to better results. participants will: 1. be randomly assigned to one of two groups with equal probability to receive the combination of intravitreal anti-vegf and dexamethasone implant injections or intravitreal anti-vegf injections. 2. during the first 3 months, patients in both groups will receive monthly injections of anti-vegf. in the double protocol group, the first dexamethasone implant injection will be administered simultaneously with the first loading dose of anti-vegf injections. between 4 and 12 months, patients will receive intravitreal anti-vegf injections as needed/pro-re-nata (prn). 3. patients will have regular follow-up. routine examination includes central retinal thickness (crt), intraocular pressure (iop), slit lamp examination, best corrected visual acuity (bcva) and oct.


Eligibility criteria:
inclusion criteria: * type 1/type 2 diabetes mellitus with good glycaemic control and glycated haemoglobin ≤ 10.0%; dr stage ii-iii; * dme with involvement of the central concavity and resulting in the patient's vision loss; * central retinal thickness (crt) ≥250 μm; * no refractive interval clouding and pupillary constriction affecting fundus examination; * no pan-retinal photocoagulation treatment within 3 months before enrolment; * no macular laser treatment in the past or during the follow-up period; * good patient cooperation and compliance. exclusion criteria: * other macular lesions such as macular preexisting membranes, macular schisis, or other causes of macular oedema such as uveitis and central retinal vein occlusion; * co-existence of diabetic optic neuropathy; * previous intraocular injection therapy such as anti-vegf drugs or glucocorticoid drugs in the target eye; * history of vitreoretinal surgery in the target eye; * a history of uncontrolled stable glaucoma or hypertension, hormonal hypertension in the target eye; * aphakic eyes with posterior lens capsule rupture with an anterior chamber iol (aciol), iris or transscleral fixed intraocular iols, and patients with posterior lens capsule rupture; * pregnant or breastfeeding patients, uncontrolled hypertension within 3 months, cerebrovascular accident or myocardial infarction, uncontrolled diabetes mellitus, or other reasons for not being able to co-operate with the relevant examination; * lost visits and data loss.

Keywords: dexamethasone implant vascular endothelial growth factor corticosteroids combination therapy biomarker best corrected visual acuity
effects of integrated cardiovascular health education program on older adults at risk of ascvd

Conditions: Cardiovascular Diseases; Healthy Lifestyle; Health Education

Summary: despite older adults being exposed to an increased risk of atherosclerotic cardiovascular disease (ascvd), they are generally underrepresented in cardiovascular prevention programmes. the aim of this study is to examine the effects of an integrated exercise and cardiovascular health education programme (he programme) on community-dwelling older adults at risk of ascvd.

the study is a two-arm randomized controlled trial. (1) the control group will mainly receive a basic lifestyle modification talk, a lecture video and governmental education leaflets. (2) the experimental group will receive an integrated exercise and health education programme (he programme) based on self-efficacy theory. physical activity level, exercise self-efficacy and ascvd risk profile including blood pressure, cardiac endurance, fasting blood glucose, fasting blood lipids, and anthropometric outcomes will be investigated via physiological assessments, medical history-taking or questionnaires at baseline, week 12, week 24 and week 36.

Eligibility criteria:
inclusion criteria: * chinese adults ≧60 years old * having at least one ascvd risk factor * pass the cardiovascular fitness evaluation * able to write and read chinese, and communicate in cantonese; * possess a mobile phone and able to make use of the phone in reading short messages exclusion criteria: * visually impaired, hearing impaired, or suffer from cognitive, psychiatric, or muscular disorder * having a history of attending similar cardiovascular prevention program * having a previous history of coronary heart disease or stroke

Keywords: older adults physical activity atherosclerotic cardiovascular disease lifestyle modification health education