Kornimate/medical-research-clean huggingface dataset:
clinical trial assessing toxicity and efficacy of mf101 for hot flashes

Conditions: Hot Flashes

Summary: the researchers propose a phase ii randomized, double-blind, placebo-controlled trial of 180 healthy postmenopausal women experiencing at least 5 hot flashes per day or 35 hot flashes per week. women will be randomized to one of three arms: 4.5 grams/day (dry weight of extract) of mf101, 9.0 grams/day (dry weight of extract) of mf101 or placebo for 12 weeks.


Eligibility criteria:
inclusion criteria: * women between the ages of 40 to 60. * currently receiving medical care from a health care provider. * self-report 5 hot flashes per day or 35 hot flashes per week. * postmenopausal as defined by 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum fsh levels \> 30mlu/ml or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy or hysterectomy with fsh levels \> 30 mlu/ml. * agree not to start new herbal or dietary supplements and not to change the dose of any currently used herbal or dietary supplements for the duration of the trial. * successful completion of a hot flash diary, a daily study medication diary and a bleeding diary, tolerates placebo, and 80% compliant at run-in. * must have had a mammogram within the last 9 months. * have access to a phone. * provide informed consent. exclusion criteria: * inability to sign an informed consent or fill out questionnaires. * history of breast, uterine or ovarian cancer or melanoma. * abnormal mammogram or breast examination within the last 9 months suggestive of cancer. * abnormal pap smear or pelvic examination within the last 9 months suggestive of cancer. * double-wall endometrial thickness that exceeds 5 mm measured on transvaginal ultrasound. * unexplained abnormal uterine bleeding within six months of enrollment. * pregnancy or lactating. * clinical evidence of active ischemic cardiovascular disease or a history of cardiovascular disease. * history of deep vein thrombosis or pulmonary embolism requiring anticoagulation. * active liver or gallbladder disease. * use of medications, herbal or dietary supplements known to possibly be effective for the treatment of hot flashes within three months of enrollment for oral or transdermal drugs, or within 6 months of enrollment for implanted or injected drugs. * use of raloxifene or tamoxifen within three months of enrollment. * use of another investigational agent within 3 months of enrollment. * history of multiple or severe food or medicine allergies. * any medical or psychiatric condition that, in the investigator's opinion, would preclude the participant from adhering to the protocol or completing the trial, including severe illness, plans to move, substance abuse, significant problems, or dementia.

Keywords: postmenopausal symptoms hot flashes postmenopausal hot flashes
effect of beginning a renal replacement therapy on obstructive sleep apnea in end stage renal disease patients

Conditions: Obstructive Sleep Apnea; End Stage Renal Disease

Summary: the purpose of this study is to investigate the effect of beginning a renal replacement therapy on fluid overload and its consequence on the severity of obstructive sleep apnea, in patients with end stage chronic kidney disease. it aims further to investigate the relationship between overhydration, nocturnal rostral fluid shift and the severity of sleep apnea.

the prevalence of obstructive sleep apnea increases with progressing renal insufficiency. recent observations suggest a causative relationship between overnight fluid displacement from the legs to the neck soft tissues and the severity of obstructive sleep apnea. we suspect that this pathophysiologic mechanism could explain the increased prevalence of obstructive sleep apnea in patients with fluid overload, including chronic renal failure. the beginning of a renal replacement therapy modify the fluid balance of the end stage renal disease patients and could therefore impact on the severity of sleep apnea in this population. the purpose of this trial is to investigate the hypothesis that the transition from untreated end stage renal disease and a renal replacement therapy decreases the severity of sleep apnea, by a reduction of the fluid overload and of the nocturnal rostral fluid shift. the severity of obstructive sleep apnea is measured by two attended polysomnographies (psg), a baseline psg performed before and a follow-up psg performed 6 month after beginning of a renal replacement therapy. overhydration and leg fluid are evaluated by bioimpedance, performed at the beginning and at the end of each polysomnography. patients who have not yet begun a renal replacement therapy 6 months after the baseline psg will be re-assessed and will be analyzed as control group

Eligibility criteria:
inclusion criteria: * moderate to severe obstructive sleep apnea, with an apnea-hypopnea index (ahi) ≥ 15/h * age ≥ 18 years * patient with end stage renal disease without renal replacement therapy. exclusion criteria: * unstable congestive heart failure * active psychiatric disease * amputation of the lower limbs, proximal to the ankle

Keywords: obstructive sleep apnea overhydration end stage renal disease renal transplantation polysomnography bioimpedance leg fluid shift neck circumference
comparison of two radial head implants

Conditions: Radial Head Fractures

Summary: in severe injuries of the radial head with multiple, displaced fracture fragments and concomitant ligament damage, excision of the fragments and replacement of the radial head with a metallic implant are indicated. current radial head implants are composed of metal or a combination of metal and high molecular weight polyethylene. the prostheses are assembled intra-operatively as a solid unit (monopolar) or as an articulating implant with motion between the stem and head (bi-polar). the stem of the implant is inserted into the proximal radius for support and can be classified as either loose-fitting or fixed. according to the investigators, there are no studies that directly compare the clinical and radiographic outcomes between different radial head implant designs. the purpose of this retrospective study is to compare the clinical and radiographic results in patients treated for an irreparable radial head fracture with either a smooth stem, bipolar radial head implant or a monopolar, in-growth radial head implant. the study findings may provide useful clinical information regarding the similarities and differences in these two implant designs.

data has been completed.

Eligibility criteria:
inclusion criteria: * suffered radial head fracture requiring radial head replacement with the katalyst or acumed radial head implant from 2002-2009 exclusion criteria: * unwilling to provide informed consent * traumatic brain injury that occurred at the time of elbow fracture
diator-diabetes intervention with atorvastatin

Conditions: Type 1 Diabetes

Summary: clinical studies have shown that immunomodulators (like anti-cd3 antibodies) have effects on beta-cell-preservation. the lipid-lowering agent atorvastatin is also a potent immunomodulator. in this study the effects of 80 mg atorvastatin per day on preservation of beta-cell function in recent onset type 1 diabetes were studied, as determined by stimulated c-peptide levels.

the objectives of this study were as follows: * to assess the effect of atorvastatin on pancreatic beta-cell function as measured by c-peptide after a liquid mixed meal stimulation in patients with newly diagnosed type 1 diabetes, * to assess the effect on metabolic control as measured by hba1c and insulin requirements, * to assess safety and tolerability of atorvastatin in subjects with newly diagnosed type 1 diabetes, * to assess the effect on risk factors of diabetic complications as indicated by changes in lipids and crp, and * to assess the effect on systemic immune abnormalities as measured by effects on beta-cell autoantibodies, blood cytokines and chemokines on protein and transcriptional level. study duration: 18 months

Eligibility criteria:
inclusion criteria: * insulin treated patients with a newly diagnosed type 1 diabetes mellitus as defined by the ada criteria at least two weeks but not later than 3 months after start of insulin treatment * age 18 to 39 years, inclusive * male patient or female patient using adequate contraceptive methods * tested positive for at least one of the three islet autoantibodies gad65, ia2 or ica exclusion criteria: * history of a malignancy * presence of a clinically significant hepatic or renal disease, as indicated, but not limited to a serum creatinine elevated more than ten percent above the upper limit of normal, elevation of ast or alt more than 3 times the upper limit of normal * any other acute or chronic condition that may affect the patient's response to treatment or might be associated with an increased risk for the patient to participate, as judged by the investigator * current use of anti-inflammatory or immunomodulatory drugs, antihypertensive, lipid-lowering, or antidiabetic drugs other than insulin * pregnant or nursing women or women intending to become pregnant * known or suspected allergy to atorvastatin or any component of thr trial product * known myopathy, myalgia or myositis with a serum-cpk above 3 times the upper limit of normal * patients who had a severe blood loss (\>= 400 ml, e.g. blood donation) within 2 months prior to visit 2 * any significant laboratory abnormality * a serum ldl-cholesterol above 150 mg/dl at time of screening * unwillingness to comply with study procedures

Keywords: type 1 diabetes
supportive therapy for adherence to art(staart)

Conditions: HIV Infections

Summary: the purpose of this study is to determine whether a psycho-educational intervention can help people living with hiv handle the changes of treatment adherence.

participants will be randomly assigned to one of two study groups: * group 1: participants in this group will engage in weekly psycho-educational sessions with an hiv therapist for four weeks prior to starting their regimens. the sessions will cover topics such as becoming active in treatment care, improving coping abilities and developing skills for treatment adherence. they will also involve questionnaires and readings. * group 2 (the control group):participants in this group will simply receive their regular treatment regimens.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age * have viral load above 500 copies/ml * not be currently on haart * be able to read and speak english/french exclusion criteria: * current substance abuse * actively psychotic or suicidal

Keywords: treatment naive hiv
physiologic pacing registry

Conditions: Bradycardia; Sinus Node Dysfunction; Heart Block; Syncope; Cardiomyopathies; Ventricular Tachycardia; Heart Failure

Summary: the physiologic pacing registry is a prospective, observational, multi-center registry performed to gain a broader understanding of 1) physiologic pacing implant and follow-up workflows, including pacing and sensing measurements and 2) the clinical utility in creating a 3-dimensional electro-anatomical map of cardiac structures prior to physiologic pacing device implants based on the clinical site's routine care.

the physiologic pacing registry will be conducted to gain a deeper understanding of physiologic pacing device implants and follow-up workflows, including device and programmer measurements to help inform abbott's product and clinical data development efforts. additionally, the registry will provide a broader understanding of the clinical utility in mapping physiologic pacing structures with the use of abbott's ensite cardiac mapping system with an electrophysiology catheter prior to device implants for those institutions where mapping is routine care prior to physiologic pacing device implant. the registry will include patients undergoing implantation of an abbott pacemaker, defibrillator, or a cardiac resynchronization therapy (crt) pacemaker (crt-p) or crt defibrillator (crt-d) according to the clinical site's routine care. only patients scheduled to receive an abbott device may be enrolled to ensure proper device data collection for future software and other physiologic pacing product development. the decision to provide physiologic pacing therapy and selection of devices for implant are at the discretion of the implanting physician. abbott will collect data on the use of all commercially available leads and associated implant tools based on the physician's discretion as part of routine clinical practice within the registry.

Eligibility criteria:
inclusion criteria: 1. scheduled for implantation of an abbott pacemaker, defibrillator, or crt-p/d device with any commercially available pacing lead as part of a physiologic pacing procedure according to the clinical site's routine care. 2. at least 18 years of age. 3. willing and able to comply with the prescribed follow-up tests and schedule of evaluations. 4. provided written informed consent prior to any registry-related procedures. exclusion criteria: 1. history of tricuspid valve repair or replacement. 2. currently participating in another clinical study with an active treatment arm and belong to the active arm 3. presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the registry or to comply with follow-up requirements, or impact the scientific soundness of the registry results. 4. chronic physiologic pacing lead implanted 5. life expectancy of \< 6 months. 6. known contraindication for physiologic pacing therapy/implant (i.e. ongoing infection, known occlusion of the subclavian vein, etc.).
dynamic parameters of glucose control in relation to biomarkers in serum and intraocular fluid in patients with diabetes

Conditions: Diabetes Complications

Summary: our project investigates the new characteristics of diabetic retinopathy using liquid eye biopsy in combination with novel parameters of glucose control obtained with continuous glucose monitoring. this approach will bring new knowledge and implications for future therapies.

diabetic retinopathy is one of the most common causes of blindness in developed countries. the short-term glucose fluctuations have been suggested as a factor contributing to the risk of diabetic complications including ocular complications. we hypothesize that modulatory and other biological abilities of mirnas and inflammatory chemokines/cytokines have a significant impact on the development and the progression of diabetic retinopathy. our main goal is to identify the biomarkers that will in time be used for new screening, diagnostic, and treatment strategies for patients with diabetic retinopathy, bring a better prevention and early treatment to them and thus improve their quality of life while saving the cost associated with advanced forms of retinopathy.

Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes * ≥ 18 years old * treatment with insulin for at least 5 years prior baseline * any form of diabetic retinopathy and macular edema * hba1c \< 10% * written informed consent prior to starting study related activity exclusion criteria: * any active intraocular or periocular infectious or non-infectious inflammation in study eye * uncontrolled glaucoma * history of intraocular inflammation or trauma in study eye * intravitreal anti-vegf therapy in study eye during a 3-month perido prior to baseline * use of corticosteroid intravitreal implant in study eye at any time

Keywords: biomarkers retinopathy mirna diabetes mellitus glucose variability
a clinical trial to evaluate the safety and efficacy of ibs angel in patients with pulmonary artery stenosis

Conditions: Pulmonary Artery Stenosis

Summary: this is a prospective, multi-center, single-arm clinical trial to evaluate the safety and efficacy of iron bioresorbable scaffold system (ibs angel) in patients with pulmonary artery stenosis.

82 patients with pulmonary artery stenosis will be treated with the iron bioresorbable scaffold system (ibs angel) developed by biotyx medical (shenzhen) co., ltd. this study is designed as a prospective, multi-center, single-arm clinical trial. enrolled patients will undergo ibs angel implantation and will be followed up at 1, 3, 6, 12, and 24 months post-procedure.

Eligibility criteria:
inclusion criteria: 1. patients must between 1 and 14 years old. 2. patients who have congenital or secondary pulmonary artery stenosis (including pulmonary artery trunk, left pulmonary artery and right pulmonary artery), and meeting one of the following criteria: a: the pressure gradient across the stenosis ≥20mmhg measured by catheter; b: the degree of pulmonary artery stenosis ≥50% ( calculated by (diameter of adjacent normal segments - residual lumen diameter of the stenosis segment)/diameter of adjacent normal segments ×100%); c: the ratio of right ventricular systolic pressure to aortic systolic pressure ≥50%. 3. patients and whose family have high compliance, voluntarily participate in and sign the informed consent form, and complete the 2-year follow-up. 4. patients have life expectancy \>2 year after successful stent implantation. exclusion criteria: 1. patients who have a history of disease related to iron overload or iron disorder, such as hereditary hemochromatosis, etc. 2. patients with cardiopulmonary function that cannot tolerate surgery, such as severe heart failure (nyha grade iii and above) that cannot be controlled by active medical treatment. 3. patients with known allergy to contrast agent, iron and its degradation products. 4. patients with hemorrhagic disorders. 5. patients with contraindications on antiplatelet agents and anticoagulant therapy. 6. patients with thrombosis at the vascular wall of target lesion or the distal or proximal location. 7. patients with known severe renal or hepatic insufficiency which are unsuitable for index procedure as per investigator judgement. 8. previous stent implantation has been performed to treat the target lesion; 9. patients with severe stenosis or excessive tortuosity in the targeted vessels, or anatomical abnormalities, making it difficult for device to reach the target lesion. 10. other conditions that are not suitable for stent delivery or balloon expansion. 11. patient who have already participated in another drug or medical device clinical trial that have not yet completed or withdrawn within 3 months before the screening period of this trial. 12. patients who are not suitable for participating the trial as per investigator judgement.
safety of hormonal contraceptives therapies in polycystic ovary syndrome (pcos) women

Conditions: Polycystic Ovary Syndrome

Summary: the purpose of this study to assess early markers of cardiovascular disease in women with polycystic ovary syndrome in use of oral contraceptive containing ethynilestradiol and chlormadinone acetate alone or associated with spironolactone.

polycystic ovary syndrome (pcos) is associated with comorbidities that may contribute to increased risk of cardiovascular disease (cvd). oral contraceptives (oc) have been the mainstay of pcos pharmacological therapy for decades. however, in non-hyperandrogenic women, oc use is associated with higher risk of cardiovascular disease, raising concern about a possible worsening of the unfavorable metabolic and cardiovascular profile of pcos patients. there is lack of evidence about the impact of pcos pharmacological therapies on cardiovascular risk markers and the long-term safety of these drugs in pcos has not been established. the aim of this study is to compare the effect of an oc alone or associated with an anti-androgenic drug (spironolactone) on echografic cardiovascular risk markers, metabolic and hemostatic variables.

Eligibility criteria:
inclusion criteria: * age between 18 and 35 years * diagnosis of pcos by rotterdam consensus exclusion criteria: * smoking, alcoholism, drug addiction; * current pregnancy; * current or previous use (up to two months before the study) of oral, vaginal, monthly injectable, or transdermal combined hormonal contraceptives; * current or previous use (up to six months before the study) of a long-lasting hormonal contraceptive method (injectable, implant, or intrauterine device); * antiandrogenic or hypoglycemic drugs, anti-inflammatory drugs, or statins; * presence of systemic diseases (dm2, cardiovascular disease, autoimmune diseases, liver disease, thyroid disease, or congenital renal hyperplasia); * personal history of arterial or venous thrombosis; chronic or acute inflammatory processes; * puerperium of 12 weeks or less

Keywords: polycystic ovary syndrome oral contraceptives, hormonal cardiovascular disease endothelium
non-complex biliary stones dsc vs erc

Conditions: Biliary Stones

Summary: to prospectively compare non-complex biliary stone clearance using fluoroscopy/radiation-free direct solitary cholangioscopy (dsc) utilizing the spyglass™ system with non-complex biliary stone clearance using standard endoscopic retrograde cholangiography (erc).

the objective of this study is to prospectively compare non-complex biliary stone clearance using fluoroscopy/radiation-free direct solitary cholangioscopy (dsc) utilizing the spyglass™ system with non-complex biliary stone clearance using standard endoscopic retrograde cholangioscopy (erc).

Eligibility criteria:
inclusion criteria: 1. 18 years or older 2. abdominal pain consistent with choledocholithiasis (procedure possible within 72 hours of onset of symptoms and imaging suggesting choledocholithiasis, contingent on persistent abdominal pain) 3. abnormal lfts 4. non-complex biliary stone disease, defined as 5 or fewer stones in the common bile or common hepatic duct with largest stone no larger than 10 mm in size. if stones not seen on imaging (us, ct) the bile duct diameter should be ≤12 mm\* \* given the poor sensitivity (approximately 20%) for biliary stones of ct and us, the diameter of the dilated cbd is used as a surrogate for largest stone diameter 5. availability of non-invasive imaging to determine the diameter of the bile duct and number and size of bile duct stones if visible on imaging 1. if probability of stones is high per investigator assessment based on asge criteria, any standard of practice imaging modality (eg. abdominal us) is acceptable. 2. if the probability of stones is either intermediate or low per investigator assessment based on asge criteria, mrcp or eus imaging is required to confirm presence of stones. 6. willing and able to comply with the study procedures and provide written informed consent to participate in the study exclusion criteria: 1. potentially vulnerable subjects, including but not limited to pregnant women and subjects in whom an endoscopic procedure is contraindicated 2. location of the stones in intrahepatic ducts, cystic duct or proximal to strictures 3. bile duct stricture noted distal to stone on mrcp, which would make extraction without lithotripsy impossible 4. ongoing cholangitis at time of randomization, manifested by fever with tachycardia and hypotension or evidence of pus at the ampulla 5. patients with prior biliary sphincterotomy 6. patients with primary sclerosing cholangitis (psc) 7. acute pancreatitis, defined as abdominal pain and serum concentration of pancreatic enzymes \[lipase (required), amylase (optional)\] three or more times the upper limit of normal 8. surgically altered gastro-duodenal luminal anatomy other than prior billroth i reconstruction, as these would be anticipated to lead to more complicated procedures 9. coagulopathy or ongoing need for anti-coagulation

Keywords: ercp dsc spy glass biliary stones choledocholithiasis non-complex stones