Kornimate/medical-research-clean huggingface dataset:
a phase 3 study of ts-172 in hyperphosphatemia patients on hemodialysis

Conditions: Hyperphosphatemia Patients on Hemodialysis

Summary: a phase 3, randomized, placebo-controlled, double-blind study of ts-172 in hyperphosphatemia


Eligibility criteria:
inclusion criteria: 1. hyperphosphatemia patients (outpatients) with chronic kidney disease receiving hemodialysis (hd or hdf) 3 times a week for at least 12 weeks prior to visit 1 (week -4) 2. patients aged \>=18 years at the time of obtaining informed consent 3. patients with a serum phosphorus concentration of \>= 3.5 mg/dl and \< 5.5 mg/dl at visit 1 (week -4) 4. patients whose serum phosphorus concentration at visit 3 (week -2) or visit 4 (week -1) has increased by at least 1.0 mg/dl compared with the value at visit 1 (week -4) and is \>= 5.5 mg/dl and \< 10.0 mg/dl. exclusion criteria: 1. patients with confirmed serum intact pth concentration \>500 pg/ml from visit 1 (week -4) to visit 5 (week 0) 2. patients with serum phosphorus concentration \>= 10.0 mg/dl from visit 2 (week -3) to visit 4 (week -1) 3. patients who have undergone previous parathyroid intervention (ptx, peit, etc.)
identification of genomic predictors of adverse events after cardiac surgery

Conditions: Heart; Dysfunction Postoperative, Cardiac Surgery; Genetic Predisposition to Disease; Atrial Fibrillation; Myocardial Infarction; Heart Failure

Summary: this study aims to identify genetic causes of adverse events after cardiac surgery, such as atrial fibrillation, myocardial infarction, renal dysfunction and heart failure. patients undergoing heart surgery at brigham and women's hospital and texas heart institute are eligible to participate.

this study aims to identify genetic causes of adverse events after cardiac surgery, such as atrial fibrillation, myocardial infarction, renal dysfunction and heart failure. in addition, we also examine blood and urine biomarkers (proteins).

Eligibility criteria:
inclusion criteria: * undergoing heart surgery * willing to provide consent exclusion criteria: * enrolled in a concurrent drug or device trial that precludes concurrent enrollment
bee venom acupuncture for the treatment of frozen shoulder

Conditions: Frozen Shoulder

Summary: the purpose of this study is to evaluate the effectiveness of combined bee venom acupuncture (bva) and physiotherapy (pt) on frozen shoulder, and whether if the effect of bva is dose effective.


Eligibility criteria:
inclusion criteria: * diagnosis of frozen shoulder by orthopedist * must have shoulder pain of more than vas 5 over 1 month and under 12 months * marked limitation of active and/or passive motion range in one shoulder exclusion criteria: * history of major shoulder injury or surgery * other musculoskeletal pain * cervical neuropathy, paralysis, neurological disorder * hypersensitivity reactions by bee venom skin test * renal or hepatic disorders, hematologic diseases, cancer, mental disorders, inflammatory or infectious disorders

Keywords: frozen shoulder bee venom acupuncture
application of bcg vaccine for immune-prophylaxis among egyptian healthcare workers during the pandemic of covid-19

Conditions: Coronavirus Disease (COVID-19)

Summary: phase iii placebo-controlled adaptive multi-centre randomized controlled trial interventional (clinical trial). the study will include nine hundred healthcare workers in the isolation hospitals for covid-19 cases; they will be randomly assigned to receive either bcg vaccine or normal saline.

nine hundred healthcare workers will be randomly assigned to receive intradermal injection of either bcg vaccine or normal saline. during the study: 1. mantoux tuberculin skin testing (will be done prior to administration of the bcg vaccine in the first group by intradermally injecting 0.1 ml of liquid containing 5 tu (tuberculin units) of purified protein derivative (ppd) in the volar aspect of the left forearm. the test is being read after 48-72 hrs. a positive tuberculin test is defined as induration ≥10 mm. 2. participants will be assessed clinically on daily basis for covid 19 infection in the form of: fever, dry cough, fatigue, \& dyspnea. 3. pcr sampling for covid-19 will be withdrawn for all participants at the end of the study. 4. the duration of follow-up for each participant depends on the interim results of the primary endpoint and the probability of obtaining a result, with a maximum of 6 months. randomization method: a block-randomization scheme will be generated by computer software. participants will be randomized between 0.10 ml intradermal injection of bcg vaccine or placebo normal saline in a 2:1 ratio (600 will receive bcg \& 300 will receive placebo saline). in egypt, the available bcg vaccine is the copenhagen (danish strain). end point of the study: * primary endpoint: confirmed covid-19 infection * secondary endpoint: number of days of (unplanned) absenteeism for any reason. * tertiary endpoints: number of days of (unplanned) absenteeism because of documented covid-19 infection, and the cumulative incidence of hospital admission, icu admission, and mortality.

Eligibility criteria:
inclusion criteria: * healthy healthcare workers defined as nurses and physicians working at emergency rooms, icus, and wards of isolation hospitals exclusion criteria: * immunosuppression * pregnancy \& lactation * chronic underlying medical illness * known allergy to (components of) the bcg vaccine or serious adverse events to prior bcg administration * known active or latent mycobacterium tuberculosis or with another mycobacterial species. * fever (\>38 c) within the past 24 hours * current bacterial infection * recent viral infection * refusal of doing tuberculin test in the first group
accelerated itbs for depressed patients during the covid-19 pandemic

Conditions: Major Depressive Disorder

Summary: the current study aims to assess the feasibility, acceptance and clinical outcomes of a practical high-dose aitbs protocol, including tapering treatments and symptom-based relapse prevention treatments, in patients with unipolar depression previously responsive to ect and patients needing urgent treatment due to symptom severity during the covid-19 pandemic.


Eligibility criteria:
inclusion criteria: * have unipolar depressive episode based on the mini with or without psychotic symptoms * have previous response to ect or high symptom severity warranting acute ect in the opinion of a consultant brain stimulation psychiatrist * are over the age of 18 * pass the tms adult safety screening (tass) questionnaire * are voluntary and competent to consent to treatment exclusion criteria: * have a mini-international neuropsychiatric interview (mini) confirmed diagnosis of substance dependence or abuse within the last 1 month * have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump * have a lifetime mini-international neuropsychiatric interview (mini) diagnosis of bipolar i or ii disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder * have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ect or a febrile seizure of infancy or single seizure related to a known drug related event, cerebral aneurysm, or significant head trauma with loss of consciousness for greater than 5 minutes * have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed * currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rtms efficacy * lack of response to accelerated course of itbs or rtms in the past

Keywords: depression transcranial magnetic stimulation treatment resistance theta burst stimulation
myocardial perfusion in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the investigators aimed to evaluate microvascular circulation with novel method: real-time myocardial contrast echocardiography in patients with type 2 diabetes and normal coronary arteries. myocardial blood flow reserve will be determined by quantitative contrast stress echocardiography. diabetic individuals will be evaluate in a decompensated state (phase 1) and after optimization of medical treatment four months later (phase 2).

early stages of epicardial atherosclerosis in patients with type 2 diabetes are associated with an impairment in endothelium-dependent dilation of the coronary microvasculature, indicating that the pathophysiological consequences of atherosclerosis may extend into the coronary microcirculation. the investigators will evaluate three parameters of myocardial quantification with contrast stress echocardiography and correlate with hba1c levels.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * normal echocardiogram * absence of obstructive epicardial coronary disease exclusion criteria: * obstructive coronary disease * heart valve disease * copd * cardiac arrhythmias * cardiomyopathy

Keywords: diabetes mellitus myocardial perfusion imaging heart diseases echocardiography endothelium
optimum misoprostol dose prior to office hysteroscopy

Conditions: Infertility; Abnormal Uterine and Vaginal Bleeding, Unspecified; Recurrent Abortion

Summary: misoprostol is an effective agent for cervical priming before office hysteroscopy, vaginal route is the best, optimum dose not yet known.

the investigators will compare between 2 different doses of vaginal misoprostol, group (1) 200 ug, group (2) 400 ug, 3hours prior to office hysteroscopy , infertile patient, patients with abnormal bleeding and patient with recurrent abortion outcome measure: pain score, easiness of the procedure, procedure time, complications

Eligibility criteria:
inclusion criteria: * female patient pre- or postmenopausal undergo office hysteroscopy. * age: from 20 to 60. * bmi between 18 and 30. exclusion criteria: * pid or * heavy uterine bleeding * cervical malignancy. * symptoms suggestive of endometriosis . * any cervical abnormality such as pinhole cervix that would obviate passage of a catheter through the cervix.

Keywords: office hysteroscopy cervical priming misoprostol
neuropsychological cognitive behavioral therapy for patients with acquired brain injury

Conditions: Brain Injury

Summary: acquired brain injury can result in impaired everyday functioning as well as psychosocial problems, including depressive symptoms, irritability, or negative self-concept. the purpose of this study is to determine whether a combination of neuropsychological and cognitive behavioral therapy is effective in the treatment of these sequelae.

acquired brain injury (abi) commonly results in persistent cognitive, emotional and motivational problems. about 50% of patients involved develop psychiatric illness, most likely in the first year following abi, which is associated with reduced psychosocial functioning and less favorable rehabilitation outcome. treatment of these complex conditions requires a combination of neuropsychological and psychotherapeutic intervention techniques. this study aims at evaluating a combination of neuropsychological intervention methods, which include developing and using compensation strategies for cognitive impairments (attention, memory and executive functions), and psychotherapeutic intervention focusing on emotion regulation, developing positive self-concepts and adjustment of life-goals. these therapeutic interventions are modularized and patients are assigned to intervention modules according to results of objective neuropsychological testing and interviews.

Eligibility criteria:
inclusion criteria: * having suffered an acquired brain injury after the age of 14, such as traumatic brain injury, neoplasm (after surgery), toxic brain damage, or brain damages through inflammatory diseases * being at least 3 months post injury * being german-speaking * agreeing to participate, verified by completion of informed consent exclusion criteria: * suffering from recurrent, degenerative, or progressive neurological diseases (e.g. multiple sclerosis, dementia, chorea huntington) * current or past psychosis or bipolar disorder * current or past diagnosis of substance dependency * history of mental retardation * currently in psychotherapy * severe lateralized disorder (e.g. aphasia, neglect) * lacking minimum basic skills for attending therapy (e.g. not orientated to person, place, time, and events; unable to sustain attention for an hour-long session; cannot state cognitive strengths and weaknesses; cannot state areas in everyday functioning that are impaired due to the acquired brain injury)

Keywords: brain injury neuropsychology cognitive behavioral therapy neuropsychological rehabilitation
imaging-guided vessel sizing in the tibial arteries

Conditions: Peripheral Artery Disease; Critical Limb Ischemia

Summary: this study aims to investigate the utilization of intravascular imaging in treatment of tibial vessels in peripheral artery disease and critical limb ischemia (cli). the primary goal is to compare optical coherence tomography (oct) with traditional digital subtraction angiography (dsa) in determining best treatment strategy and vessel optimization, in an effort to improve long term patency and successful wound healing in cli. secondary comparison with intravascular ultrasound (ivus) is undertaken when clinically feasible. the hypothesis is that the adjunctive use of intravascular imaging will affect vessel sizing and anticipated treatment modalities, and therein affect the long term primary patency rates.

this is a prospective, nonrandomized trial to investigate the adjunctive use of intravascular imaging in tibial vessel interventions. the evaluation of oct is primarily to: (a) establish feasibility and reproducibility in below-the-knee vessels, (b) determine the optimal protocol imaging to produce the optimal clear image frame and clear image length, (c) provide detailed lesion characteristics of tibial disease, (d) assess for luminal gain post-intervention. operator-determined sizing will be compared against university hospitals core imaging laboratory assessment of oct, ivus (when applicable), and quantitative vessel analysis (qva). subjects will follow up per routine care with corresponding ankle-brachial index and toe-brachial index at 1, 3, 6, and 12 months or as clinically indicated. wound and amputation data will be collected at the pre-procedural visit and with each subsequent visit. wound care will be managed by our wound care associates in podiatry, vascular medicine, vascular surgery, or plastic surgery.

Eligibility criteria:
inclusion criteria: * age \>18 * patients with presence of rutherford iv-vi * presence of ≥1 tibial artery involvement requiring endovascular treatment exclusion criteria: * patients who do not have tibial disease appropriate for intervention * estimated glomerular filtration rate \<30 ml/min not on hemodialysis
anastrozole reduced proliferation and progesterone receptor indexes in short term hormone therapy

Conditions: Breast Cancer

Summary: background: identification of new biomarkers with potential predictive and prognostic role has contributed unequivocally to breast cancer treatment. although traditionally endocrine therapy is based on hormonal receptors status (estrogen - er and progesterone- pr), some patients become hormone resistant. in order to identify a possible profile associated to hormonal resistance, some biomarkers have been assessed after short period primary hormone therapy (ht). objectives: to compare the expression of ki-67, bcl2, bax, bak, er and e pr in postmenopausal women with er positive invasive ductal carcinomas (idc), prior and after tamoxifen and anastrozole in short term hormone therapy.


Eligibility criteria:
inclusion criteria: * invasive breast cancer post-menopausal women * estrogen and/or progesterone receptor positive exclusion criteria: * patients with endocrine disease * hormone therapy users or those who had been pregnant in the last 12 months before the diagnosis * patients with a negative expression for estrogen and/or progesterone receptors * women with a history of thromboembolism * patients who had previously undergone any treatment for breast cancer

Keywords: breast cancer short term homontherapy aromatase inhibitor short term hormonetherapy in breast cancer
epidemiology of pediatric traumatology

Conditions: Fractures in Children

Summary: fractures have been shown to account for 10-25% of injuries in children and the consequences of pediatric fractures are significant and result in significant restriction of activity. despite this, the epidemiology of pediatric fractures remains poorly detailed. investigators seek to establish the incidence of pediatric trauma and fractures and determine patient, trauma and injury characteristics.


Eligibility criteria:
inclusion criteria: * children treated in the pediatric emergency department of the strasbourg university hospitals between january 2014 and december 2020 for skeletal trauma. * child and holders of parental authority who have been informed of the use of their child's data for the purposes of this research and who have not expressed any opposition exclusion criteria: * patient or legal representative who expressed their opposition to participating in the study * impossibility of giving informed information to the subject

Keywords: fractures in children pediatric fractures
relaxation interventions for pre-term mothers on hospitalized bed-rest

Conditions: High Risk Pregnancy

Summary: the purpose of this study is to investigate the effects of participation in relaxation exercises on pregnant women who are hospitalized on bed-rest.

women, 18 or older, who consent to this study will participate in a preliminary interview. study participants will then be trained in the use of progressive muscle relaxation and guided imagery for pregnancy. participants will be issued a listening device and an audio file and asked to practice it on a daily basis while in the hospital. prior to discharge or delivery, the participant will be visited by a member of the research team who will conduct a follow-up interview. the interviews and the relaxation practice sessions will take between 30 and 45 minutes each. the interviews will be audio-recorded, although no identifying information about the participants will be recorded. at the conclusion of the study, participants will be given a cd of the audio relaxation program and thanked for their participation in the study. there is minimal risk anticipated in association with participation in this study. all information gained from this study will remain confidential and is for educational purposes only. participants are entitled to terminate their participation in the study at any time. it is hoped that the results of this study will provide information about an intervention that may be beneficial to women with high-risk pregnancies. it is also hoped that participation in the exercises will be enjoyable and/or beneficial to you in some way. the results of this study may be used to justify further studies or to influence the type of interventions offered in this or similar settings. all data collected from the research will remain confidential. data collected from participants will immediately be assigned an identification number so that no one will be able to identify any individuals in the study.

Eligibility criteria:
inclusion criteria: * pregnant women on bed rest for high risk pregnancy exclusion criteria: * none
study of denufosol inhalation solution in patients with mild to moderate cystic fibrosis lung disease

Conditions: Cystic Fibrosis

Summary: the purpose of this trial is to evaluate the effects of a single dose of denufosol versus placebo on mucociliary clearance in patients with mild to moderate cf lung disease


Eligibility criteria:
inclusion criteria: * have confirmed diagnosis of cystic fibrosis * have fev1 of greater than or equal to 60% of predicted normal for age, gender, and height * be able to reproducibly perform spirometry maneuvers * be clinically stable for at least 4 weeks prior to screening exclusion criteria: * have abnormal renal or liver function * have chest x-ray at screening with abnormalities suggesting clinically significant active pulmonary disease * have had a lung transplant
rct of steroids following kasai portoenterostomy for biliary atresia.

Conditions: Biliary Atresia

Summary: biliary atresia is a congenital disorder of bile duct development or destruction of established but immature bile ducts. the study tests the hypothesis that post-operative steroids improve outcome following the kasai procedure - the commonest surgical treatment.

biliary atresia is a potentially fatal condition of infants presenting as persisting jaundice in the first few weeks of life. the disease is characterised by obstruction and damage to the intra and extrahepatic parts of the biliary tree. within the liver there is also a pronounced inflammatory response. the initial treatment is an attempt, by surgery, to restore bile flow by excising the obliterated extrahepatic bile ducts and joining part of the intestine to the bile "root" of the liver (the porta hepatis). this is known as the kasai procedure. this is successful in \~50% of cases in reducing the level of jaundice to near-normal values. the use of steroids post-operatively has been suggested as improving outcome by diminishing the inflammatory response.

Eligibility criteria:
inclusion criteria: * biliary atresia exclusion criteria: * \<100 days at portoenterostomy * no other anomalies (e.g. biliary atresia splenic malformation syndrome) * anu contra-indications to corticosteroids

Keywords: biliary atresia kasai portoenterostomy corticosteroids
efficacy of eco-friendly toothpaste tablets versus conventional toothpaste using pi and gi index

Conditions: Gingival Inflammation

Summary: objectives: to assess the change in gingival index (gi) and plaque index (pi) when comparing the use of toothpaste tablets to conventional toothpaste. methods: 40 participants were randomized into two groups: colgate's toothpaste tablets (t) and colgate's cavity protection toothpaste (c). both groups utilized their assigned dentifrice for 2 weeks. a pre and post-assessment measured the gi and pi index. a questionnaire on the use of the product was distributed.


Eligibility criteria:
inclusion criteria: 1. subjects are 18 years or older; 2. subjects who will comply with study protocol; 3. subjects who can read and understand the consent form; 4. subjects available during the study period; 5. subjects have more than 20 teeth. exclusion criteria: 1. subjects who are pregnant and/or nursing; 2. subjects under the age of 18.

Keywords: gingival index plaque index dentifrice toothpaste tablets consumer satisfaction