Kornimate/medical-research-clean huggingface dataset:
treatment of insertional achilles tendinopathy by hyaluronic acid injection

Conditions: Insertional Achilles Tendinitis

Summary: a pilot study of the effects of 3 retro-calcaneal hyalin g-f 20 injection on the clinical and radiological changes in 20 adult patients with changes in insertional achilles tendinopathy.

pain of the achilles tendon commonly affects young active patients, with lifetime incidence that may be as high as 40 to 50 percent in competitive athletes. about 20% of the achilles tendinopathy injuries occur in the insertion point of the achilles tendon into the calcaneus bone1. the leading theories for the mechanism of the disorder are inflammatory response or mechanical tendon overuse. still, the exact pathogenesis of insertional achilles tendinitis (iat) is unclear, and as so the conservative management of iat is less successful than the management of the non-insertional tendinopathy. previous histological description, in an unpublished data of the insertion point showed that the main pathologic features were found to be in the bone and cartilage tissues. the achilles tendon, in those studies, was almost intact. the histological features of the cartilage tissue were advanced degenerative changes, which resemble the pathologic changes of osteoarthritis. this observation encourages to try treating iat with management strategies that showed to be beneficial in oa( osteoarthritis). one of the more acceptable non-surgical methods in treating osteoarthritis is intra-articular viscosupplementation injection. the investigators hypothesis, based on the histopathological finding, is that viscosupplementation may be a therapeutic option also for individuals with iat. the purpose of this study is to show the impact of hyalin g-f 20 injection in patients with insertional achilles tendinitis.

Eligibility criteria:
inclusion criteria: * adult patients with chronic (\>6 months) posterior heel pain localized above the insertion point of the achilles tendon with evidence of iat in ankle x-ray and mri. exclusion criteria: 1. previous surgical treatment. 2. previous ha(hyaluronic acid), prp (platelet rich plasma) or steroids injection in the last 6 months. 3. previous two or more steroids injection. 4. plantaris muscle injury. 5. posterior ankle impingement. 6. achilles tendon rapture. 7. previous calcaneal fracture
investigate safety, tolerability and pharmacokinetics for single doses of nnc9204-0530 alone and in combination with liraglutide in overweight to obese but otherwise healthy male subjects

Conditions: Metabolism and Nutrition Disorder; Obesity

Summary: this trial is conducted in the united states of america (usa). the aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses of nnc9204-0530 alone and in combination with liraglutide in overweight to obese but otherwise healthy male subjects.


Eligibility criteria:
inclusion criteria: * male, age between (both inclusive) 18 and 55 years at the time of signing inform consent * overweight or obese but otherwise healthy male subjects; bmi of between or equal to 27.0 and 35.0 kg/m\^2 exclusion criteria: * thyroid stimulating hormone values outside 0.4-6.0 miu/l * hba1c (glycated hemoglobin) above or equal to 6.5% * any clinically relevant ecg (electrocardiogram) findings (e.g. 2nd or 3rd degree av-block), in particular subjects with repeated demonstration of a qtcf (qt interval corrected by fridericia formula) interval above 430 ms * a history of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long qt syndrome) * the use of concomitant medications that prolong the qt/qtc interval * obesity caused by endocrinology disorders (e.g. cushing's syndrome) * personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 * calcitonin above 50 ng/l * history of pancreatitis (acute or chronic)
the oral iron on the prevention of iron deficiency anemia in obese pregnant

Conditions: Anemia of Pregnancy

Summary: anemia is known as a condition in which the hemoglobin level is lower than normal. anemia is one of the most common complications during pregnancy. anemia in pregnancy is defined as a hemoglobin level \< 110 g/l . anemia is an important risk factor in pregnancy which leads to both maternal and fetal morbidity and mortality. the pregnant woman needs more iron during pregnancy, so iron deficiency anemia is very common during pregnancy. in egypt; iron deficiency anemia affects about one in every two pregnant women, especially in rural areas. pregnant women require about 27 mg/day elemental iron to cover their increased need. the pregnant women should start taking a daily supplement of 30mg of elemental iron as a preventive measure against iron deficiency anemia especially in poor countries. obesity is defined as having an excessive amount of body fat. the body mass index, a measurement based on height and weight, determines the obese if the figure more than 30 kg/m2. there is an increased rate of overweight and obesity among pregnant women. according to the world health organization, 46% of adult females in egypt are obese. many researches in the literature revealed a strong relationship between high bmi in pregnancy and iron deficiency anemia. hepcidin is an iron regulating hormone in the body. increases in iron levels in the plasma stimulate the production of hepcidin, which blocks iron absorption from the diet, so; hepcidin production is suppressed in the case of iron deficiency.


Eligibility criteria:
inclusion criteria: 1. pregnant woman in a singleton pregnancy (12-14 weeks). 2. bmi (30- 40 kg/m2). 3. normal hemoglobin level (\>11 g/dl). 4. normal hematocrit (hct 31-41%). 5. normal ferritin level (6-130 ng/ml). 6. women willingness to participate in the study. 7. women living in the nearby area to make follow-up visits possible. exclusion criteria: 1. multiple gestations. 2. women received a recent blood transfusion. 3. women with threatened miscarriage. 4. women are known to have pathological blood loss. 5. intolerant to oral iron form. 6. history of the hematologic disorder. 7. women used iron in the past 3 months. 8. women with chronic diseases (hypertension, diabetes, renal diseases, thyroid disease......).
filgotinib in the induction and maintenance of remission in adults with moderately to severely active crohn's disease

Conditions: Crohn's Disease

Summary: the primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active crohn's disease (cd) in participants who are biologic-naive and biologic-experienced. participants who complete the study, or do not meet protocol response or remission criteria at week 10 will have the option to enter a separate long-term extension (lte) study (study gs-us-419-3896).


Eligibility criteria:
key inclusion criteria: * documented diagnosis of cd with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment * moderately to severely active cd * cohort a (biologic naïve): previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids and immunomodulators * cohort a (biologic experienced): previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines) or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response or intolerance: tumor necrosis factor alpha (tnfa) antagonists, vedolizumab, and ustekinumab * cohort b (biologic experienced): previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): tnfa antagonists, vedolizumab, and ustekinumab key exclusion criteria: * current complications of cd such as symptomatic strictures, severe rectal/anal stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc. * presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon * active tuberculosis (tb) or history of latent tb that has not been treated * use of any prohibited concomitant medications as described in the study protocol note: other protocol defined inclusion/ exclusion criteria may apply.
robot-assisted cystectomies with regard to blood loss, pain and transfusions.

Conditions: Transfusions; Cystectomy; Blood Loss Requiring Transfusion; Anaemia; Anaemia Postoperative; Pain, Postoperative

Summary: what influence does robot-assisted surgical treatment in the sense of a radical cystectomy and possibly bladder reconstruction have on blood loss, pain and transfusion requirements? we intend to conduct a corresponding prospective observational study at a tertiary centre.


Eligibility criteria:
inclusion criteria: * planned radical cystectomy exclusion criteria: * asa classification v * previously known coagulation disorder
early rehabilitation after immediate reconstruction with tei in breast cancer patients

Conditions: Breast Cancer

Summary: the purpose of the study is to find best post-operative rehabilitation protocol after total mastectomy and immediate reconstruction with tissue expander insertion. this study compared outcomes of two post-operative rehabilitation protocols ; "conventional protocol", which immobilized shoulder and upper arm motion for a month and "early rehabilitation protocol" with short-term immobilization period and early mobilization.

to prevent surgical site complications, surgeons use so-called "conventional protocol", which immobilizes shoulder and upper arm motion for a month after total mastectmoy and immediate reconstruction with tissue expander insertion. to improve shoulder mobility and qol of patients, the investigators introduced a new and early rehabilitation protocol with short-term immobilization in jan 2017. the investigators retrospectively reviewed total 115 breast cancer patients who underwent reconstructive surgery from may 2016 to aug 2017. patients who did their reconstruction before jan 2017 followed conventional protocol and immobilized their shoulder for more than 4 weeks. patients who did their reconstruction after jan 2017 were educated to undergo a self-exercise program after short-term immobilization of 2 weeks. the investigators reviewed shoulder mobility, pain, qol and complications at postoperative 1 month and 2 month in both group of patients.

Eligibility criteria:
inclusion criteria: * subject has breast cancer * subject underwent total mastectomy and immediate reconstruction with tissue expander insertion exclusion criteria: * patients who had pre-existing conditions before breast cancer surgery that limit shoulder movement.

Keywords: early rehabilitation conventional protocol tissue expander insertion
drug interaction statin

Conditions: Acute Coronary Syndromes

Summary: this purpose of this study is to assess the effects of bms-919373 on the single dose pharmacokinetics (pk) of rosuvastatin and atorvastatin in healthy subjects.

primary purpose: other - to assess the effects of bms-919373 on the single dose pk of rosuvastatin and atorvastatin in healthy subjects

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria: * signed written informed consent form * healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination, physical measurements, vital signs, 12-lead ecg, 24-hour telemetry, and clinical laboratory tests * body mass index (bmi) of 18.0 to 32.0 kg/m2, inclusive * men and women, ages 18 to 55 yrs, inclusive exclusion criteria: * current or history of cardiovascular diseases, including arrhythmias, coronary heart disease, and congestive heart failure * current or history of symptomatic hypotension * current or history of liver diseases, including cirrhosis and liver failure * current or history of kidney diseases, including nephrotic syndrome, renal failure, nephrolithiasis, and urolithiasis * current or history of neurological diseases, including presyncope, syncope, convulsive disorders such as epilepsy, cerebral thrombosis and cerebral embolism, transient ischemic attack, and stroke; or mental disorders exceptions for presyncope/syncope related to vasovagal responses are allowable at the discretion of the investigator * history of significant head injury in the last 2 years
triple antigen vs monoantigen immunotherapy for warts

Conditions: Triple Intralesional Immunotherapy Combination in Multiple Recalcitrant Warts

Summary: warts can be resistant to treatment or return despite the use of many therapeutic modalities. combining immunotherapy might contribute to better response rates, particularly in recalcitrant warts, which is a real therapeutic challenge. the purpose of this study was to assess the effectiveness and safety of a triple intralesional immunotherapy combination composed of ppd, candida antigen and mmr versus either agent alone in the management of multiple recalcitrant warts.

this study included 160 patients with multiple (\>3 warts) recalcitrant (at least 6 months duration and who did not respond to at least 2 treatment modalities) warts of different sites, size and duration, with or without distant warts after approval of the institutional review board of faculty of medicine, zagazig university. they were randomly assigned to one of four groups (each with 40 patients): ppd, candida antigen, mmr, or combination of the 3 antigens. injections into the biggest wart were repeated every two weeks until clearance or for a total of five sessions.

Eligibility criteria:
inclusion criteria: * multiple (\> 3 warts) recalcitrant (at least 6 months duration and who did not respond to at least 2 treatment modalities) warts of different sites, size and duration exclusion criteria: 1. patients with acute febrile illness or past history of asthma. 2. allergic skin disorders such as generalized eczema and urticaria. 3. past history of meningitis or convulsions. 4. pregnancy or lactation.

Keywords: triple intralesional immunotherapy warts tuberculin purified protein derivative candida antigen measles-mumps-rubella vaccine combination immunotherapy
topaz: tucatinib in combination with pembrolizumab and trastuzumab in patients with her2-positive breast cancer brain metastases

Conditions: Breast Cancer; Brain Metastases; HER2-positive Breast Cancer; CNS Disease

Summary: this is a single arm, open label trial to assess the safety and efficacy of tucatinib in combination with pembrolizumab and trastuzumab for the treatment of her2+ breast cancer brain metastases (bcbm). a total of 33 patients with untreated or previously treated and progressing her2+ bcbm not requiring urgent central nervous system (cns)-directed therapy will be enrolled. the study will determine the recommended dose of tucatinib in this combination and assess the efficacy of this combination in controlling cns disease in patients with her2+ bcbm.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years. 2. ecog performance status of 0-2. 3. her2+ (as defined by asco/cap clinical practice guideline) metastatic breast cancer. 4. untreated or previously treated and progressing cns disease. 5. measurable cns metastases. 6. must be able to undergo mri of the brain. 7. adequate organ function. exclusion criteria: 1. any indication for immediate cns-directed therapy. 2. history of generalized or complex partial seizures. 3. any other manifestation of neurologic progression that in the opinion of the treating physician is due to brain metastases. 4. leptomeningeal disease. 5. prior therapy with an anti-pd-1, anti-pd-l1, or anti-pd-l2 agent or with an agent directed to another stimulatory or co-inhibitory t-cell receptor. 6. prior therapy with tucatinib. 7. active autoimmune disease that has required systemic treatment in excess of prednisone 10mg daily or equivalent in the past 2 years. complete inclusion/exclusion criteria are detailed in the protocol.

Keywords: tucatinib pembrolizumab trastuzumab
multiple rising does study (subcutaneous doses) of bi 655064 in male and female patients with chronic primary immune thrombocytopenic purpura (itp).

Conditions: Purpura, Thrombocytopenic, Idiopathic

Summary: bi 655064 will be administered subcutaneously once weekly in patients with immune thrombocytopenic purpura (itp) for up to 12 weeks.


Eligibility criteria:
inclusion criteria: male and female chronic immune itp patients exclusion criteria: any treatment of itp excluded except for a stable dose of corticosteroids (up to 20 mg)
rosuvastatin/ezetimibe vs rosuvastatin in korean patients with type 2 diabetes mellitus and hypercholesterolemia

Conditions: Type 2 Diabetes Mellitus; Hypercholesterolemia

Summary: to assess the efficacy and safety of rosuvastatin/ezetimibe combination therapy compared to rosuvastatin monotherapy in korean patients with type 2 diabetes mellitus and hypercholesterolemia

this study is to assess the efficacy and safety of rosuvamibe® (rosuvastatin 5mg/ezetimibe 10mg) vs monorova® (rosuvastatin 10mg) treated for 8 weeks in korean patients with type 2 diabetes mellitus and hypercholesterolemia.

Eligibility criteria:
inclusion criteria: 1. aged 19 to 70 years 2. patient with type 2 diabetes who needs treatment for hypercholesterolemia 3. written informed consent exclusion criteria: 1. administration of lipid lowering agents for more than one week within 4 weeks prior to screening visit 2. uncontrollable diabetes with hba1c ≥ 8.5% 3. fasting ldl-c ≤ 70 mg/dl 4. fasting triglyceride ≥ 400 mg/dl 5. total cholesterol ≥ 300 mg/dl 6. history of muscular disease or rhabdomyolysis due to use of statin 7. hypersensitive to rosuvastatin or ezetemibe 8. contraindications stated in the spc of rosuvastatin or rosuvastatin/ezetimibe including the following: ① severe renal disease (estimated gfr(mdrd) \< 30ml/min/1.73m2) ② alt, ast \> 3x uln or history of active liver disease ③ cpk \> 3x uln 9. administration of other investigational products within 30 days prior to screening visit 10. other than the above who is deemed to be ineligible to participate in the trial by investigator
cortisol diurnal variation and the risk for developing post traumatic stress disorder

Conditions: Posttraumatic Stress Disorders; Cortisol Diurnal Variation

Summary: the purpose of this study is to examine a possible link between the time of day of exposure to a traumatic event and the risk of developing post-traumatic stress disorder. clinical and biological correlates will also be examined from this perspective.


Eligibility criteria:
inclusion criteria: 1. persons 21-65 years old, who have been exposed to an event meeting the following dsm-iv criterion for acute stress disorder: criteria a.1 and a.2 at least one of criteria b1-5a.1 2. who provide written, informed consent to participate in the study. exclusion criteria: 1. physical injury that would contraindicate participation or interfere with a subject's ability to give informed consent or cooperate with the screening or collection of initial measures. examples include severe burn injury, life-threatening medical or surgical condition, condition requiring surgical intervention under general anesthesia, as indicated by abbreviated injury scale (ais), or by clinical judgment; 2. head injury involving confusion, loss of consciousness, or amnesia; 3. medical conditions such as extreme obesity, psoriasis, herpes, cushing's syndrome, current infectious disease, current viral disease, tuberculosis, unstable diabetes or hypertension, myasthenia gravis, and heart failure. persons taking medications that can interfere with the hpa axis (e.g.,steroids, betablockers,indomethacin) will be excluded; 4. weight below 45 or above 120 kg. 5. pregnancy (in suggestive cases, a pregnancy test will be performed); 6. traumatic exposure that reflects ongoing victimization (e.g., domestic violence) to which the subject is likely to be re-exposed during the study period. 7. overt psychopathology, intoxication, or under the influence of substances. 8. evidence or history of schizophrenia, bipolar, other psychotic condition; 9. prior history of ptsd; 10. current or past history of dementia, amnesia, or other cognitive disorder predating trauma exposure; 11. assessed serious suicide risk. -
effects of cranberry-containing products in women with recurrent urinary tract infections (utis)

Conditions: Urinary Tract Infection

Summary: the purpose of this study is to determine the role of cranberry-containing products in preventing urinary tract infections (utis).

although cranberry-containing products are commonly taken to prevent utis and other urinary symptoms, an optimally effective dose has not been established, and the chemicals responsible for the uti-preventing properties in cranberry-containing products have yet to be determined. this study will determine the minimum dose of cranberry-containing product necessary to prevent utis, the effectiveness of cranberry-containing products in fighting different strains of e. coli, and the long-term effects of cranberry-containing product consumption. this study will also determine whether plant pigments called proanthocyanidins influence the uti-preventing properties of cranberry-containing products. this study will last 2 years. participants will be randomly assigned to receive varying doses of either cranberry-containing products or placebo for 1 year. some participants will receive cranberry or placebo supplement tablets; others will receive cranberry juice or a placebo beverage. clinic visits will occur every 2 months; urine collection will occur at each visit. some participants will be asked to collect 24-hour urine samples every 8 weeks and provide urine samples on days 1, 3, 5 and 7. laboratory tests will be used to assess participants during the study. a 3-day course of antibiotics will be provided to participants developing a uti during the course of the study. telephone interview follow-up at 6 and 12 months after the study will determine whether cranberry-containing product use has continued and whether utis have recurred.

Eligibility criteria:
inclusion criteria: * at least two utis in the year prior to study entry * willing to use acceptable methods of contraception * willing to refrain from consuming other forms of cranberry supplementation exclusion criteria: * current uti * allergy to cranberry-containing products * active urinary stone disease * insulin-dependent diabetes * immunosuppressive disease * current corticosteroid use * intermittent or indwelling catheterization * pregnancy

Keywords: cranberry vaccinium macrocarpon