Kornimate/medical-research-clean huggingface dataset:
liquid biopsy for nash and liver fibrosis

Conditions: NASH - Nonalcoholic Steatohepatitis; Liver Fibroses

Summary: nonalcoholic fatty liver disease (nafld) has evolved to represent the most common cause of chronic liver disease globally. today, nafld is a leading indication for liver transplantation and a major etiology for hepatocellular carcinoma (hcc) in the united states. nafld is characterized by the excess accumulation of lipids within the liver and ranges from isolated steatosis to nonalcoholic steatohepatitis (nash), which is characterized by the presence of hepatic necroinflammation, hepatocyte ballooning and fibrosis progression. currently, liver biopsy remains the gold standard for the diagnosis of various chronic liver diseases, and for determining the severity of liver injury, inflammation, and fibrosis stage. however, this procedure is invasive, prone to complications such as bleeding and is associated with sampling variability and limited representation of the whole liver. other limitations include, the difficulty to monitor liver injury progression over time and underestimation of disease severity. despite intensive research, currently available non-invasive blood tests are not sufficiently sensitive or specific and are therefore of limited use. blood biomarkers might provide significant advances in the diagnosis and monitoring of disease progression and regression in clinical settings. recently, liquid biopsy has emerged as a potential, less invasive, alternative to liver biopsy. in fact, it addresses several unmet clinical needs, including sensitivity, specificity, the determination of prognoses, and the prediction of therapeutic responses.

this is a multicentric prospective observational study to validate blood non-invasive biomarkers for nash and fibrosis stage. 150 subjects will be enrolled; 100 subjects with biopsy-proven nash and 50 subjects with normal liver will be used as controls.

Eligibility criteria:
inclusion criteria: one hundred subjects with nash documented by liver biopsy and no evidence of another form of liver disease with a bmi ≥30 and ≤55 kg/m2. fifty subjects with normal liver who underwent laparoscopic elective cholecystectomy, but otherwise in healthy conditions, will be used as controls. exclusion criteria: coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 6 months; liver cirrhosis; end stage renal failure; participation in any other concurrent therapeutic clinical trial; any other life-threatening, non-cardiac disease; pregnancy; inability to give informed consent; substantial alcohol consumption (\>20 g/day for women or \>30 g/day for men); wilson's disease; lipodystrophy; parenteral nutrition; interfering medications (e.g., amiodarone, methotrexate, tamoxifen, corticosteroids).
text-enabled ascertainment and community linkage for health

Conditions: Emergency Medicine

Summary: the goal of this study is to pilot test a novel tool for health related social needs screening and linkage to community resources in the ed by randomizing participants to standard handout v. handout + text message with resource information.


Eligibility criteria:
inclusion criteria: * 51 zip codes included in our database of community resources ("catchment area") * \>=18 years old * plan for discharge home * speak either english or spanish * live within the catchment area for the study * have a cellphone with text messaging capabilities * ability to respond to text messages from the study team. exclusion criteria: * patients who are intoxicated * on a section 12 * lack capacity to consent will be excluded.
extension study of the efficacy and safety of deferasirox treatment in beta-thalassemia patients with transfusional hemosiderosis (study amended to 2-year duration)

Conditions: Beta-thalassemia Major; Hemosiderosis; Iron Overload; Rare Anemia

Summary: to allow patients treated with deferasirox in the core study to continue iron chelation therapy for 2 years or until the drug became locally commercially available. to evaluate the long-term safety and efficacy of deferasirox by measuring treatment success, change in liver iron content (lic) and change in serum ferritin levels. safety was mainly assessed by incidence of adverse events (aes)and clinically significant lab parameters.

iron accumulation is an inevitable consequence of chronic blood transfusions and results in serious complications in the absence of chelation treatment to remove excess iron. deferasirox (exjade, icl670) is an oral chelator with high iron-binding potency and selectivity. this extension study aimed at collecting efficacy and safety data during 2 years of treatment with deferasirox in the extension study or until deferasirox became commercially available in the countries where the centers were located, whichever came first. the population comprised of β-thalassemia patients with transfusional hemosiderosis who could not be satisfactorily treated with deferoxamine or deferiprone.

Eligibility criteria:
inclusion criteria: * patients completing the planned 12-month core study (nct00171171) * female patients who have reached menarche and who are sexually active must use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation * written informed consent obtained from the patient and/or legal guardian on the patient's behalf in accordance with the national legislation exclusion criteria: * pregnant or breast feeding patients. * patients being considered by the investigator potentially unreliable and/or not cooperative with regard to the core study protocol, or the planned extension protocol

Keywords: transfusional hemosiderosis beta-thalassemia major deferasirox iron overload rare anemia iron overload due to transfusion
treatment of perianal crohn's disease, combining medical and surgical treatment.

Conditions: Crohn's Disease

Summary: this study is aimed to assess the hypothesis that instillation of fibrin glue with the induction of local conditions using infliximab, may be useful in the treatment of perianal crohn's disease.

patients with perianal fistulae of crohn's disease will be prospectively enrolled and receive 3 doses of infliximab. if reduction of fistula associated discharge of at least 50% will be recorded, commercially available fibrin glue will be instilled into the fistula tract using standard surgical techniques. the patients will be followed for 6 months for fistula healing and complications.

Eligibility criteria:
inclusion criteria: * perianal fistula of crohn's dis exclusion criteria: * more then 2 fistulae perianal sepsis known contraindication to infliximab or glue
hiperemezis and serotonin elevated serum serotonin levels in hyperemesis

Conditions: Nausea; Vomiting; Markedly Reduced Food Intake; Severe Dehydration

Summary: serotonin excretion was investigated in the nausea and vomiting associated with hiperemezis gravid arum.

the occurrence of severe nausea and vomiting of early pregnancy (hiperemezis gravid arum) is estimated between 0.3% to 1% of all pregnancies. although hiperemezis gravid arum has been recognized for a long time, its pathophysiologic mechanisms are still poorly understood. many theories have been advocated, but to date none of these have been convincing. it has been demonstrated that the nausea and vomiting associated with increased in serotonin liberation. this has provided a rationale for the treatment of these symptoms with specific serotonin antagonists. the aim of this trial was to investigate the possible relationship between hiperemezis gravid arum and serotonin liberation.

Eligibility criteria:
inclusion criteria: * 6-14 week pregnant women * nausea * protracted vomiting * inability to tolerate food intake accompanied by obvious dehydration * severe enough to justify hospitalisation * at least 2+ ketonuria on dipstick urinanalysis. exclusion criteria: * with metabolic disorders such as diabet, thyroid

Keywords: hiperemesis gravidarum,vomiting,serotonin levels,ketonuria
negative pressure wound therapy: are all systems alike?

Conditions: Wounds

Summary: hypotheses: (1)wound healing during hospital stay will be equal between systems, (2)rns will perceive the versatile one (ezcare) system as easier to use, (3)costs related to dressing changes will be less with versatile one (ezcare), (4)hospital length of stay will be equal or shorter with the versatile one (ezcare) system, (5) nursing time using versatile one (ezcare) will be less than or equal to vac system, (6) patients will report less pain during dressing changes with versatile one (ezcare).

this is a prospective, 2 group, randomized, comparative study (sample:50; 25 in each group) that will investigate whether differences can be found in selected outcomes related to wound care, using versatile one (ezcare)versus kci vac negative pressure/vacuum systems. only wounds which currently meet criteria for such device use,and for which a physician's order has been written for the device, will be included in this study.

Eligibility criteria:
inclusion criteria: * hospitalized adults requiring negative pressure dressings. exclusion criteria: * comatose * mentally obtunded * documented chronic psychiatric illness or any documented dementia significant enough to notably impair cognitive function * presence of manufacturer's contraindications * malignancy in wound * untreated osteomyelitis * unexplored fistula * necrotic tissue * exposed blood vessels or organs * untreated malnutrition.
comparison of nutritional products for people with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: compare the glycemic and insulinemic responses of a standard nutritional product with two diabetes-specific nutritional products in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: 1. subject states that he/she has type 2 diabetes (as evidenced by use of oral hypoglycemic medication for at least two months). 2. subject is between 18 and 75 years of age, inclusive. 3. subject is a male or a non-pregnant, non-lactating female, at least 6 weeks postpartum prior to screening visit. 4. if female is of childbearing potential, is practicing a method of birth control. 5. subject's bmi is \> 18.5 kg/m2 and \< 35 kg/m2. 6. if on a chronic medication such as anti-hypertensive, lipid-lowering, thyroid medication or hormone therapy, subject has been on constant dosage for at least two months prior to screening visit. exclusion criteria: 1. subject uses exogenous insulin for glucose control. 2. subject states that he/she has type 1 diabetes. 3. subject states that he/she has a history of diabetic ketoacidosis. 4. subject takes an alpha-glucosidase inhibitor. 5. subject states that he/she has a current infection ; has had inpatient surgery, or corticosteroid treatment in the last 3 months or antibiotics in the last 3 weeks prior to screening visit. 6. subject states that he/she has an active malignancy (excluding the following dermal malignancies: basal cell carcinoma, squamous cell carcinoma, carcinoma in-situ of the cervix). 7. subject states that he/she has had a significant cardiovascular event ≤ six months prior to screening visit; or stated history of congestive heart failure. 8. subject states that he/she has end stage organ failure or is status post organ transplant. 9. subject states that he/she has a history of renal disease. 10. subject states that he/she has current hepatic disease. 11. subject states that he/she has a history of severe gastroparesis. 12. subject states that he/she has a chronic, contagious, infectious disease, such as active tuberculosis, hepatitis b or c, or hiv. 13. subject has taken/is currently taking any herbals, dietary supplements, or medications, other than oral hypoglycemic medications, during the past four weeks prior to screening visit that could profoundly affect blood glucose. 14. subject states that he/she has clotting or bleeding disorders. 15. subject is known to be allergic or intolerant to any ingredient found in the study products.
study to evaluate the efficacy and safety of p-3074 topical solution in the treatment of androgenetic alopecia

Conditions: Alopecia, Androgenetic

Summary: the purpose of this study is to confirm the clinical efficacy and the safety of p-3074 in participants with androgenetic alopecia.


Eligibility criteria:
inclusion criteria: * written informed consent before starting any study related procedures; * men 18 to 40 years of age; * men with mild to moderate vertex male pattern hair loss according to a modified norwood/hamilton classification scale (iii vertex, iv or v); * participants willing to have a tattoo in the target area; * outpatients; * ability to comprehend the full nature and purpose of the study, including possible risks and side effects; * ability to co-operate with the investigator and to comply with the requirements of the entire study. exclusion criteria: * clinically relevant abnormal skin scalp findings which could interfere with the aim of the study; in particular, abrasion, actinic keratosis, inflammatory disorders or any other abnormality; * participants who had had hair transplant surgery or hair weaving; * clinically relevant abnormal laboratory values indicative of physical illness; * ascertained or presumptive hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study; * history of local infections of skin and subcutaneous tissues of the head in the 3-months period before the trial inclusion; * relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine or neurological diseases, that may interfere with the aim of the study; * suspicion of malignancy, including prostate cancer; * history of infertility or difficulty fathering children; * participants who wish to conceive children during the study or whose sexual partner(s) is pregnant; * participants with active seborrheic dermatitis; * history of varicocele; * concurrent use of systemic corticosteroids, topical corticosteroids in the balding area studied, anabolic steroids, or over-the-counter "hair restorers"; * use of the following drugs with antiandrogenic properties within 6 months of study entry: flutamide, cyproterone acetate, estrogen, progesterone, cimetidine, spironolactone or ketoconazole; * participants who had been treated with any of the following drugs within the past year: minoxidil (topical or oral), zidovudine, cyclosporine, diazoxide, phenytoin, systemic interferon, psoralens, streptomycin, penicillamine, benoxaprofen, tamoxifen, phenothiazines or cytotoxic agents; * use of finasteride or dutasteride within previous 12 months; * light or laser treatment of scalp within previous 3 months; * participation in the evaluation of any drug for 3 months before this study, calculated from the first day of the month following the last visit of the previous study; * history of drug, alcohol \[\>2 drinks/day defined according to usda dietary guidelines 2010\], caffeine (\>5 cups coffee/tea/day) or tobacco abuse (10 cigarettes/day).
the effect of modified constraint induced movement therapy on upper extremity function in stroke rehabilitation

Conditions: Stroke; Hemiplegia; Chronic Stroke Patients

Summary: the purpose of the study is to determine the effect of modified constraint-induced movement therapy and trunk restraint contrasted with conventional physical therapy treatment on improving upper extremity function, balance, and quality of life among chronic hemiplegic patients. * to find out the effectiveness of conventional physical therapy treatment on improving upper extremity function, balance, and quality of life among chronic hemiplegic patients. * to find out the effectiveness of modified constraint induced movement therapy (mcimt) and trunk restraint along with conventional physical therapy treatment on improving upper extremity function, balance, and quality of life among chronic hemiplegic patients. * to find out the effectiveness of modified constraint induced movement therapy (mcimt) and trunk restraint combined with conventional physical therapy treatment versus conventional physical therapy treatment alone on improving upper extremity function, balance, and quality of life among chronic hemiplegic patients.


Eligibility criteria:
inclusion criteria: * right or left-sided chronic hemiplegic patients. * onset of stroke more than six months. * age between 45 to 65 years of both genders. * mini-mental state examination - scored more than 24/30. * modified ashworth scale for spasticity 1 or 1+. * have at least 20° wrist active extension and at least 10° of metacarpophalangeal active extension of the paretic upper extremity. * have at least grade 2/5 of muscle power on upper extremity especially in wrist extensors. * have normal visual perception. * with no other neurological disorders. exclusion criteria: * unable to follow visual and oral commands. * unilateral neglect. * severe cognitive, or language deficits.

Keywords: stroke hemiplegia constraint induced movement therapy modified constraint induced movement therapy trunk restrain upper extremity motor function
a study in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of the present study is to determine the effects on health status and spirometric values of foster® 100/6 (two puffs b.i.d.) versus seretide® 500/50 (one inhalation b.i.d.), over a 12-week treatment period in chronic obstructive pulmonary disease (copd) patients.

chronic obstructive pulmonary disease (copd) is an incurable, debilitating and progressive disease that can be fatal. the recent global burden of disease study ranks copd as the 6th leading cause of mortality and the 12th leading cause of morbidity world-wide. furthermore, trends in the use of medical care resources indicate that the economic cost of copd continues to rise in direct relation to the ageing population, the increase in prevalence of disease and the cost of new and existing medical and public health interventions.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged ≥ 40 years, who have signed an informed consent form prior to initiation of any study-related procedure or once applicable written informed consent obtained by legal representative. 2. outpatients with a diagnosis of copd and including: 1. smoking history of at least 10 pack years defined as \[(number of cigarettes smoked per day) x (number of years of smoking) / 20\], both current and ex-smokers are eligible. 2. use of bronchodilators in the previous 2 months to visit 1. 3. post-bronchodilator fev1 \< 60% of the predicted normal value. 4. post-bronchodilator fev1/fvc \< 0.7. 5. a ≥ 5% response to a reversibility test. 6. a baseline dyspnoea index (bdi) focal score less or equal than 10 (to be met also at visit 2). 3. history of no more than one copd exacerbation in the previous 12 months (without considering the last 2 months) to visit 1. 4. a cooperative attitude and ability to be trained to the proper use of pmdi and dpi (accuhaler®, circular moulded plastic inhaler) inhalers. main exclusion criteria: 1. clinically relevant respiratory disorders. 2. current diagnosis of asthma or respiratory disorders other than copd. 3. clinically significant laboratory and ecg abnormalities indicating a significant or unstable concomitant disease which may impact the feasibility of the results of the study according to investigator's judgement. 4. patients with copd exacerbation in the 2 months prior to screening and during the study period. 5. patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia. 6. patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period.
a study of the safety and effectiveness of ddp733 in treating ibs with constipation in females

Conditions: Irritable Bowel Syndrome

Summary: this study will evaluate the safety and effectiveness of the investigational drug ddp733 in treating female patients with ibs-c. a placebo control will be utilized.


Eligibility criteria:
inclusion criteria: * female from 18 to 65 years of age, inclusive * patient experiences recurrent abdominal pain or discomfort at least 3 days per month for the last 3 months with symptom onset at least 6 months prior to diagnosis. the patient's symptoms must be associated with 1 or more of the following: * improvement with defecation * onset associated with a change in frequency of stool * onset associated with a change in form (appearance) of stool * negative serum and urine pregnancy tests * completion of at least six days of daily diary assessments using a phone-in information system prior to randomization exclusion criteria: * serious underlying diseases, including psychiatric disorders * current history of conditions affecting bowel transit * recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection * clinically significant abnormal examination findings or laboratory tests * inability to stop taking certain medications, or a planned change in medications (including herbal remedies) which could interfere with study assessments * use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome * presence of a medical condition which could interfere with the interpretation of study data * significant use of nicotine or caffeine

Keywords: irritable bowel syndrome ibs-c ibs constipation women with ibs women with constipation