Kornimate/medical-research-clean huggingface dataset:
prospective double-blinded randomised comparison of profix mobile to fixed bearing knee replacements

Conditions: Osteoarthritis

Summary: this is a randomised control trial comparing two different prosthetic designs used in total knee arthroplasty. participants were randomised to receive either of the two prostheses and then were followed up of a period of 7 years, looking at pain, range of motion and impact on quality of life. the literature and joint registry of australia shows that one of the prosthesis may be inferior to the other. our research team hypothesised that this was not the case and that previous elicited differences were related to other factors.


Eligibility criteria:
inclusion criteria: * patients presenting to a single orthopaedic surgeon with knee pathology, who were suitable candidates for total knee arthroplasty exclusion criteria: * refusal to participate * other simultaneous surgery * post traumatic osteoarthritis * prior open knee surgery
tolerance of two forms of vitamin c in acid-sensitive adults

Conditions: Tolerance

Summary: the purpose of this study is to compare the tolerance of two forms of vitamin c in adults with sensitivity to acidic foods.


Eligibility criteria:
inclusion criteria: * healthy as determined by laboratory results and medical history * females not of child bearing potential * self-reported sensitivity to acidic foods * agrees to consume a low vitamin c diet exclusion criteria: * pregnant, breastfeeding, or planning to become pregnant during the trial * use of medications known to interact with vitamin c or cause epigastric effects * use of supplements containing containing vitamin c * duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or gastroesophageal reflux disease (gerd) within past 3 months * use of antacids and/or acid suppressors within 4 weeks of randomization * history of irritable bowel syndrome and related disorders * alcohol use \> 2 standard alcoholic drinks per day; alcohol or drug abuse within the past year * history of cardiac disease within the past 6 months * history of or current diagnosis of cancer * uncontrolled hypertension * unstable renal and/or liver disease * history of kidney stones * unstable psychiatric disorder * history of or current immunocompromise * history of hemoglobinopathies * participation in another clinical research trial \<30 days * abnormal liver function * serum creatinine \> 1.5 x upper limit of normal (uln) * anemia of any etiology * uncontrolled and/or untreated thyroid disorder * bmi ≥ 35 kg/m2 * unstable medications \<30 days * allergy or sensitivity to test article ingredients * cognitively impaired and/or unable to give informed consent

Keywords: vitamin c calcium ascorbate ascorbic acid
effect of mitoq on platelet function and reactive oxygen species generation in patients with sickle cell anemia

Conditions: Sickle Cell Disease

Summary: mitoq is commercially available as a dietary supplement and it has been tested as a potential drug in other diseases, but it has never been tested in patients with sickle cell disease. the goal of this research is to study if mitoq, a molecule that works as an antioxidant by removing potentially damaging agents in a living organism, improves platelet function in patients with sickle cell disease (scd).

antioxidant therapies targeted to specific enzymes or compartments may be beneficial in sickle cell anemia (sca). mitoq, the most extensively studied mitochondrial-targeted antioxidant, has been shown to be protective against ischemia/reperfusion injury in the heart, endothelial damage due to hypertension and ros in animal models. mitoq is commercially available as a dietary supplement to reduce overall oxidative stress and anti-ageing. however, mitoq has not been tested either as a platelet antagonist or as an endothelial protectant in sca patients. investigators propose to conduct a small clinical trial of mitoq in subjects with sca to test the hypothesis that mitoq scavenges platelet mtros to prevent platelet activation and attenuate vascular dysfunction in sca. investigators will test whether mitoq decreases basal platelet activation in scd patients and attenuates vascular dysfunction in subjects with sca. investigators will administer mitoq orally to patients and healthy controls for 14 days. investigators will obtain platelet count, hemolytic markers, platelet mtros levels and activation markers, clinic bp measurements before and after mitoq. adult male and female sca subjects in steady state (n=10) and 5 healthy african-american volunteers will be recruited after obtaining informed consent.

Eligibility criteria:
inclusion criteria: subjects * african american * patients with sickle cell anemia * 18 years old or older control * african american healthy controls * 18 years of age or older exclusion criteria: 1. pregnancy, 2. known hypertension, 3. hemodialysis and active obstructive sleep apnea requiring treatment. 4. use of anti-platelet medication or have had transfusion in the 4 weeks prior to enrollment.

Keywords: basal platelet activation mitoq mitochondrial ros (reactive oxygen species)
ct scans in treating patients with stage i testicular cancer after undergoing orchiectomy

Conditions: Testicular Germ Cell Tumor

Summary: rationale: imaging procedures such as ct scans help the doctor in detecting cancer or the recurrence of cancer. increasing the number of times a ct scan is given may improve the ability to detect stage i testicular cancer. purpose: randomized clinical trial to determine if there is a different result from two different schedules of ct scans in treating patients with stage i testicular cancer after undergoing orchiectomy.

objectives: * determine whether there is a difference between two schedules of ct scan surveillance in respect to stage of disease at relapse, survival, the investigation determining relapse, and incidence of second malignancies in patients with stage i testicular teratoma after orchidectomy. outline: this is a randomized, multicenter study. patients are stratified by center and presence of vascular invasion. after orchidectomy, patients are randomized into two schedules (arms i and ii) of ct scan follow up. * arm i: patients repeat chest and abdominal ct scans no later than 3 months after orchidectomy and again at 12 months to confirm that the patient is clear of disease. * arm ii: patients repeat chest and abdominal ct scans at 3, 6, 9, 12, and 24 months after orchidectomy. patients are followed monthly for the first year after orchidectomy, then every 2 months for the second year, then every 3 months for the third year, and then every 4-6 months thereafter. projected accrual: there will be 400-900 patients accrued into this study over 3-6 years.

Eligibility criteria:
disease characteristics: * histologically confirmed nonseminomatous germ cell tumor of the testis stage i disease: * no evidence of metastatic disease on clinical examination * normal chest x-ray * normal chest and abdominal ct scan * normal serum tumor marker (afp, hcg) after orchidectomy * high risk patients should be considered for ongoing studies of adjuvant chemotherapy after orchidectomy, but those choosing not to take this option may enter this study * orchidectomy no greater than 8 weeks prior to randomization into this study patient characteristics: age: * not specified performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * no other concurrent or prior malignancy except successfully treated nonmelanomatous skin cancer prior concurrent therapy: biologic therapy: * not specified chemotherapy: * not specified endocrine therapy: * not specified radiotherapy: * not specified surgery: * see disease characteristics

Keywords: stage i malignant testicular germ cell tumor testicular teratoma
the application research of ultrasound guided puncture stent assisted transperineal prostate biopsy

Conditions: Prostate Cancer

Summary: this study is a multi-center prospective study. patients who meet the indications for prostate biopsy were included in this study.the study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. exploring the positive rate of puncture stent-assisted transperineal prostate biopsy

this study is a multi-center prospective study. patients who meet the indications for prostate biopsy were included in this study.the study was randomly divided into two groups, one group was transperineal free-hand biopsy; the other group was puncture stent-assisted transperineal prostate biopsy. exploring the positive rate of puncture stent-assisted transperineal prostate biopsy 560 patients were enrolled. the main result is the positive rate of biopsy: including the detection rate of clinically meaningful prostate cancer and the detection rate of clinically insignificant prostate cancer.secondary results include: (1)biopsy complications include (infection, bleeding, etc.).(2)pain score of biopsy patients (nrs score).(3) biopsy time

Eligibility criteria:
inclusion criteria: suspected prostate cancer patients can tolerate prostate puncture exclusion criteria: symptomatic acute or chronic inflammation of the prostate patients with other cancers
pharmacokinetics and safety assessment of vx-121/tezacaftor/deutivacaftor in participants with moderate hepatic impairment

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to evaluate the pharmacokinetics (pk) and safety of vx-121/tezacaftor/deutivacaftor (vx-121/tez/d-iva) in participants with moderate hepatic impairment and in matched healthy participants.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * cohort 1: participants with moderate hepatic impairment * participants will satisfy the criteria for moderate hepatic impairment defined as a child-pugh total score of 7 to 9 points at the screening visit * participants will have chronic (≥6 months) documented liver disease * cohort 2: matched healthy participants * participants will be matched during screening to participants with hepatic impairment for cigarette smoking habit, age, sex, and weight key exclusion criteria: * cohort 1: participants with moderate hepatic impairment * history of febrile illness or other acute illness * history of solid organ or bone marrow transplantation * history or presence of severe hepatic encephalopathy (grade \>2) * any condition possibly affecting drug absorption * severe portal hypertension * significant renal dysfunction (creatinine clearance \<50 milliliter per minute \[ml/min\] ) estimated according to the method of cockcroft and gault at the screening visit or day-1 * cohort 2: matched healthy participants * history of febrile illness or other acute illness * any condition possibly affecting drug absorption other protocol defined inclusion/exclusion criteria may apply.
the effect of nutritional risk parameters on postoperative pulmonary complications in geriatric thoracic surgery cases

Conditions: Lung Cancer; Nutrition, Healthy; Postoperative Complications

Summary: preoperative evaluation of nutritional status in geriatric patients with lung cancer and implementation of these practices in elective patients are very important in terms of reducing postoperative complications and accelerating hospital discharge. for this purpose, many nutritional assessments and measurements are used. our aim in this study was to evaluate the relationship between preoperative nutritional status and postoperative pulmonary complications in patients undergoing thoracic surgery for geriatric lung cancer.


Eligibility criteria:
inclusion criteria: * patients over 65 years of age * lung cancer * patients undergoing thoracic surgery exclusion criteria: * refusal to participate in the study * patients with a diagnosis of hematological malignancy * patients with missing data required for research
the liver in the world trade center health program general responder cohort and controls

Conditions: Steatosis of Liver; NASH - Nonalcoholic Steatohepatitis

Summary: this project investigates whether exposure to the world trade center attack is a risk factor for liver injury.

this is a prospective cross-sectional study of liver disease in individuals who meet the united states preventive services task forces guidelines for lung cancer screening because they are between 55 and 80 years of age and have a 30 year pack-history of smoking and are either current smokers or who quit during the past 15 years. liver disease will be compared between individuals who are members of the world trade center general responder cohort and individuals who are not members of this cohort. the basic objective is to determine whether exposure to the wtc attack increased liver disease. data will be obtained from the world trade center data center, from mount sinai medical records, epic, the data warehouse, and from data collected by the lung cancer screening program of dr. henschke. results of genetic tests that relate to liver disease will be collected from the medical record.

Eligibility criteria:
inclusion criteria: * male or female between 55 and 80 years of age * 30 year pack-history of smoking and are either current smokers or who quit during the past 15 years. * individuals who are members of the world trade center general responder cohort or subjects who meet the united states preventive services task forces guidelines for lung cancer screening exclusion criteria: * none
investigate the effect of azd1656 on the pharmacokinetics of pioglitazone and vice versa in type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to determine whether administration of azd1656 will affect the pharmacokinetics of pioglitazone and vice versa in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * patients with confirmed type 2 diabetes mellitus for at least 1 year and treated with metformin alone or metformin and one other oral anti-diabetic drug * body mass index between ≥19 and ≤42 kg/m2. exclusion criteria: * impaired renal function * clinically significant illness or clinically relevant trauma.

Keywords: type 2 diabetes mellitus pioglitazone
tunnel construction course pilot assessment of simulation-based training effectiveness

Conditions: Cataract

Summary: tcc-paste is a randomised controlled trial comparing a simulation based training curriculum with standard training for ophthalmology residents learning to perform tunnel construction in manual small incision cataract surgery. after obtaining informed consent, participating trainees will be randomly assigned to learn to perform tunnel construction either through the simulation based curriculum or through the standard curriculum at their institute. trainees assigned to simulation will learn through studying an ebook, participating in training sessions supported by repeated practice on a virtual reality simulator, and supervised training in live surgery to facilitate transfer of skill acquired in simulation to the operating room. to determine the effect of simulation based training, we will assess the number of errors trainees perform in the initial part of their intraoperative learning curve.


Eligibility criteria:
inclusion criteria: * enrolled in a training program at a partner institute; * no or minimal prior experience with msics (trainees within the first 2-3 months of matriculation, or having performed fewer than 20 procedures as the main surgeon but no more than 5 msics procedures within 6 months preceding participation in tcc-paste); * provide informed consent to participate in the study; * able to participate in routine patient care activities, as required by the partner institute, without the need to take overnight call for the duration corresponding to the simulation training phase. exclusion criteria: * performed scleral tunnel construction as the main surgeon in 20 or more procedures; * prior experience with the helpmesee simulator or participation in the helpmesee simulation training curriculum. * required to take overnight call for the duration corresponding to simulation training phase.

Keywords: cataract msics manual small incision cataract surgery surgical simulation simulation
botulinum toxin type a for the treatment of patients with idiopathic overactive bladder with urinary incontinence

Conditions: Overactive Bladder

Summary: the purpose of this study is to assess the safety and effectiveness of botulinum toxin type a (onabotulinumtoxina) in treating patients with idiopathic overactive bladder with urinary incontinence.


Eligibility criteria:
inclusion criteria: * symptoms of oab (frequency/urgency) with urinary incontinence for at least 6 months * inadequate response or limiting side effects with anticholinergics for the treatment of oab exclusion criteria: * overactive bladder caused by neurological condition * patient has predominance of stress incontinence * history or evidence of pelvic or urological abnormality
the effect of acupuncture and laser acupuncture for carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome; Acupuncture; Laser Acupuncture

Summary: acupuncture and laser acupuncture treatments have been proven to be effective and safe treatments for carpal tunnel syndrome(cts). however, there is still a lack of direct comparative studies of acupuncture and laser acupuncture in the treatment of cts. a 3-arm, randomized controlled study in acupuncture, laser acupuncture study and sham laser acupuncture therapy was designed for patient with carpal tunnel syndrome. the glabal symptom score (gss), boston carpal tunnel questionnaire (bctq), neurophysiological study, morphological examination under ultrasonography will be evaluated before and after treatment. comparison of therapeutic efficacy of acupuncture, laser acupuncture and sham laser acupuncture in the treatment of cts will be explored.

the primary outcome will analyze the change of the glabal symptom score (gss) during intervention peroid. the secondary outcome will evaluate the neurophysiological study, morphological examination under ultrasonography before and after treatment. comparison of therapeutic efficacy of acupuncture, laser acupuncture and sham laser acupuncture in the treatment of cts will be explored.

Eligibility criteria:
inclusion criteria: * patients with mild to moderate carpal tunnel syndrome diagnosed by neurophysiological examination * symptoms of carpal tunnel syndrome such as pain and numbness * those who are willing to sign informed consent form for subjects exclusion criteria: * (1) those who have not signed the informed consent * (2) patients diagnosed with severe carpal tunnel syndrome * (3) those who have had a history of surgery on their hands and palms * (4) space-occupying lesions such as tumors, bone spurs, synovial membrane tissue hypertrophy, etc. * (5) people with a history of diabetes, rheumatoid arthritis, and hypothyroidism (hba1c\>6.5, rf positive, free t4, tsh in abnormal range) * (6) patients with end-stage renal disease * (7) pregnant and alcoholic patients * (8) polyneuropathy patients * (9) clinical symptoms with c6\~8 cervical radiculopathy * (10) those who are obviously infected * (11) those with a serious illness requiring hospitalization

Keywords: carpal tunnel syndrome acupuncture laser acupuncture
a combined surgical and medical approach in mild sleep apnea

Conditions: Sleep Apnea

Summary: the aim of the study is to investigate wether the adjuvant (postoperative) administration of acetazolamide can improve the surgical results after uvulopalatopharyngoplasty in patients with mild sleep apnea.


Eligibility criteria:
inclusion criteria: * 5 ≤ apnea hypopnea index (ahi) \< 20 * socially disturbing snoring: visual analogue scale (vas)snoring \> 6/10 * based on clinical examination and polysomnography, patient is regarded eligible for uvulopalatopharyngoplasty (uppp) exclusion criteria: * previous surgical treatment for sleep-disordered breathing. * periodic limb movement disorder (plmd) with arousals and other reasons possibly explaining the excessive daytime sleepiness (eds) based on epworth sleepiness scale (ess). * forced expiratory volume in 1 second (fev1) \< 80 % pred. * echocardiography: ejectionfraction \< 35 % or dyastolic dysfunction grade 2 or more.

Keywords: sleep apnea snoring acetazolamide uvulopalatopharyngoplasty daytime sleepiness upper airway
predictors of lorcaserin-induced weight loss

Conditions: Overweight and Obesity

Summary: this two-phase study aims to explore ways to predict who will respond well to the weight loss drug lorcaserin and to understand the mechanisms that develop which limit drug efficacy. subjects will be recruited for a 5-week crossover study (phase 1) with lorcaserin and placebo followed by treatment with lorcaserin for 24 weeks (phase 2).

in phase 1, at weeks 1 and 5, participants will take the weight loss drug lorcaserin or placebo for 7 days. at week 5 participants will receive whichever treatment they did not receive at week 1. at the end of weeks 1 and 5, participants will have a lumbar puncture (spinal tap) to collect cerebrospinal fluid (csf) for neuropeptide and hormone analyses, including proopiomelanocortin (pomc), agouti-related protein (agrp) and cortisol. blood will also be obtained for neuropeptide and hormone analyses. breakfast will be served to participants who will then complete an eating behavior profile. a laboratory test meal will be performed 4h after breakfast. after completing both the 7 day lorcaserin and placebo studies, participants will then continue on phase 2 of the study, which includes treatment with lorcaserin for 24 weeks. subjects will receive nutritional counseling to reduce their daily caloric intake to 600 kcal below their calculated caloric requirement and will be encourage to exercise moderately for 30 minutes daily. participants will visit the clinic monthly during the 24 week study period for nutritional counseling, review of food diaries, vital signs and safely labs. blood will also be obtained for neuropeptide peptide and hormone analyses. at the end of the 24 week period subjects will come for a final study visit, including a lumbar puncture, blood sample, breakfast, an eating behavior profile and a test meal.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) 28-40 exclusion criteria: * any clinically significant or relevant medical condition, including: * diabetes * uncontrolled hypertension * heart disease * bleeding disorder * kidney or liver dysfunction * neurologic disease * psychiatric or eating disorders * pregnancy or breastfeeding * use of tobacco or opiates * history of alcohol or drug abuse * recent weight change +/- 5% * medications that affect body weight

Keywords: overweight obesity weight loss lorcaserin healthy volunteers