Kornimate/medical-research-clean huggingface dataset:
safety of pregabalin in the treatment of pain due to diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: the purpose of this study is to 1) provide continued pregabalin treatment for 6 additional months to patients who have taken part in the placebo controlled study a0081060; and 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day)


Eligibility criteria:
inclusion criteria: * adults with type 1 or 2 diabetes * patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months exclusion criteria: * patients must not be in poor or unstable health.
pegintron injection surveillance plan (study p04123)

Conditions: Hepatitis C, Chronic

Summary: surveillance will be conducted at digestive departments of internal medicine in university or general hospitals where participants with chronic hepatitis c are generally treated. the purpose of this surveillance is to evaluate the postmarketing safety and efficacy of pegintron injection under actual conditions of use and to examine adverse events, serious adverse events, and adverse drug reactions.

the investigator will record continuously from the first patient since the day of contract to the numbers of patients of contract based on pegintron approval.

Eligibility criteria:
inclusion criteria: * participants with chronic hepatitis c treated with peginterferon alfa-2b. signed written contract. exclusion criteria: * none
efficacy of propranolol treatment to prevent melanoma progression

Conditions: Stages III Skin Melanoma; Stages II Skin Melanoma; Stage IB Skin Melanoma

Summary: melanoma's incidence is increasing worldwide. the efforts made in melanoma screening led to an earlier detection of the primary tumour and a better prognosis, but melanoma remains an aggressive cancer when it comes to its metastatic stage. three recent retrospective studies compared groups of patients diagnosed with primary melanoma and treated with betablockers for another indication to patients who never received betablockers. in these three studies, the outcome of the disease is significantly better for people under betablocker treatment with a decreased rate of recurrence and a better 5 years survival rate. here we want to investigate the efficacy and the tolerability of an adjuvant treatment with propranolol for patients suffering from a primary melanoma with a high risk of recurrence.


Eligibility criteria:
inclusion criteria: * patient over 18 y.o * breslow index \> 1mm or any breslow index with ulcerated primary lesion * melanoma stage ajcc ib, iia, iib, iic, iiia, iiib or iiic * able to undergo outpatient treatment exclusion criteria: * no contra indication for betablockers as defined by the compendium * no clinical evidence of coagulopathy * no unstable angina pectoris * no av-block ii or iii without pacemaker * no severe congestive heart failure * no untreated phaeochromocytoma * no severe bradycardia * no severe hypotension * no severe impairment of peripheral arterial circulation * no uncontrolled cardiac arrhythmia * no severe asthma or copd * no uncontrolled diabetes mellitus * no angioneurotic edema * no severe aortic valve stenosis * no severe hypertrophic cardiomyopathy * no severe renal dysfunction * no patients on beta blockers by inclusion * no known adverse reaction to betablockers * no pregnant or lactating patients can be included * no melanoma stage ajcc iv by inclusion * no patients requiring a specific oncological treatment

Keywords: malignant melanoma betablocker propranolol interventional prospective adjuvant recurrence
comparative effectiveness of muscle energy technique and trigger point release in plantar fasciitis

Conditions: Plantar Fasciitis

Summary: this study aimed to investigate the comparative efficacy of muscle energy technique (met) and trigger point release in the treatment of plantar fasciitis. a single-blinded, randomized clinical trial was conducted, wherein thirty participants were randomly assigned to two parallel groups. one group received met, while the other received trigger point release, with both groups performed self-stretching exercises as part of their home program. outcome measures included pain intensity and foot function. treatments were administered three times a week for a duration of four weeks.


Eligibility criteria:
inclusion criteria: * unilateral plantar heel pain that worsens with weight-bearing activities * age range: 25-45 years * pain exacerbation with initial morning ambulation (i.e., walking a few steps) * presence of at least one identifiable trigger point in the calf muscles exclusion criteria: * bilateral heel pain * history of tumors in the leg or foot * previous lower limb fractures * recent or unresolved lower limb injuries * achilles tendinitis * ankle arthritis * surgery * vascular disease

Keywords: muscle energy technique trigger point release
study of ins365 ophthalmic solution in subjects with dry eye disease

Conditions: Dry Eye Disease

Summary: the purpose of this trial is to compare the effectiveness and safety of ins365 ophthalmic solution with placebo when applied topically in subjects with dry eye disease.


Eligibility criteria:
inclusion criteria: * best corrected visual acuity in both eyes of at least +0.7 * six-month documented history of dry eye disease * at least mild severity in 2 of the 4 dry eye symptoms * unanesthetized schirmer score of less than or equal to 7mm * corneal fluorescein staining of greater than or equal to 4 (out of 15) exclusion criteria: * nasally stimulated schirmer score of less than 3mm in subjects with an initial schirmer score of 0mm * ongoing contact lens wear * current topical ophthalmic medication use
mantram repetition to manage ptsd in veterans

Conditions: Stress Disorders, Post Traumatic

Summary: with ongoing war in iraq, the incidence of posttraumatic stress disorder (ptsd) in combat veterans is increasing. creation, implementation, and testing of new and innovative interventions are needed to provide additional options for enhancing the mental health of those with ptsd. surveys indicate that veterans are interested in complementary approaches to health care. the purpose of this study is to determine the efficacy of the mantram repetition program (mrp) delivered as a brief, 6-week, complementary and portable intervention. it includes frequent, silent repetitions of a mantram (mantra), a word or phrase with spiritual associations, to manage ptsd symptoms and improve quality of life military veterans with trauma.

the mantram repetition program (mrp) is an innovative, portable meditation-based group intervention. in this study, the mrp was delivered in addition to usual care (defined as case management and medication) in a 6-week (90 minutes/week) group setting. the mrp was compared to usual care only. this 4-year study employed a mixed-methods, prospective, randomized controlled trial with qualitative phone interviews at 3 months post-intervention to explore ways that the intervention was used. outpatient veterans (n=146) with military-related ptsd were recruited from a single va site and randomly assigned to the experimental arm (n=71) which consisted of usual care and the mantram program versus usual care only control group (n=76).

Eligibility criteria:
inclusion criteria: * primary diagnosis of ptsd, military related * score of greater or equal to 45 on the clinician administered ptsd scale * read and write english * score of \> 50 on ptsd checklist * has a telephone with answering machine or voice mail to receive study messages * has a case manager assigned for usual care * willingness to track medications, relaxation techniques and number of case manager visit exclusion criteria: * cognitive impairment including active psychosis, untreated bipolar disorder, dementia or personality disorder that interferes with group participation * presence of active, serious suicidal ideation

Keywords: randomized controlled trial intervention study mindfulness complementary therapy mind-body relations (metaphysics) spiritual therapy meditation qualitative analysis
fruquintinib combined with pd-1 inhibitor and folfox as first-line treatment for advanced gastric cancer

Conditions: Gastric (Stomach) Cancer; Gastric Adenocarcinoma; Fruquintinib; PD-1 Inhibitor; Tislelizumab; GEJ Adenocarcinoma

Summary: this study was designed to explore the efficacy and safety of fruquintinib combined with tislelizumab and folfox regimen as the first treatment (first-line) for adults diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (gej) adenocarcinoma.


Eligibility criteria:
inclusion criteria: * 18-75 years old (including 18 and 75 years old); * eastern cooperation oncology group (ecog) performance status of 0-1; * pathologically determined gastric or gastroesophageal junction adenocarcinoma; * advanced patients with radiographic confirmation of inoperable complete resection; * no previous anti-tumor treatment for metastatic diseases; * at least one measurable lesion according to recist version 1.1; * ability to take medications orally; * no active bleeding; * adequate organ functions: absolute neutrophil count ≥2×109/l; platelet ≥100×109/l; hemoglobin ≥90g/l; wbc≥4×109/l total bilirubin ≤ 1.5xuln; alt and ast ≤2.5xuln ； serum creatinine (cr) ≤1.5xuln； • have fully understood the study and voluntarily signed the informed consent; exclusion criteria: * patients who had received any drug in the study protocol in the last year; * deficient mismatch repair (dmmr) or msi-h detected by genetic test; * her2 positive（her-2 3+, or her-2 2+ and fish+）; * hypertension that could not be controlled by drugs before enrollment was defined as: systolic blood pressure ≥150 mmhg and/or diastolic blood pressure ≥90 mmhg; * patients with acute coronary syndromes (including myocardial infarction and unstable angina) received coronary angioplasty or stenting within 6 months before enrollment; * patients with massive pleural or peritoneal effusion requiring drainage; * patients with severe ecg abnormalities or heart diseases (such as cardiac insufficiency, myocardial infarction, angina pectoris) that affect clinical treatment; * severe lung diseases (such as interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.); * mental disorders or central nervous system diseases or brain metastases affecting clinical treatment; * patients with autoimmune diseases; * patients with grade 3 or higher bleeding within 4 weeks; * patients with a history of allergy to any drug, similar drug or vehicle in this study; * had a major surgical procedure (thoracotomy, or laparotomy , etc.) within 4 weeks prior to the first dose of study therapy; * patients with nonhealed wounds, ulcers, or fractures; * patients who required systemic corticosteroids (excluding temporary testing, prophylactic administration for anaphylaxis), or immunosuppressive agents or had received such agents within 14 days before enrollment; * pregnant or lactating women, or patients of childbearing age who refused contraception during the study period; * investigators believe that the patient has any other conditions that are not suitable for participating in the study.
phase 3 evaluation of the safety and efficacy of lnz101 for the treatment of presbyopia

Conditions: Presbyopia; Refractive Error; Near Vision; Miosis; Eye Diseases

Summary: phase 3 study to evaluate the safety and effectiveness of lnz101 for the treatment of presbyopia.

phase 3 study to evaluate the safety and effectiveness of lnz101 compared with lnz100 and brimonidine for the treatment of presbyopia.

Eligibility criteria:
inclusion criteria: 1. be able and willing to provide written informed consent and sign a health information portability and accountability act (hipaa) form prior to any study procedure being performed; 2. be able and willing to follow all instructions and attend all study visits; 3. be 45-75 years of age of either sex and any race or ethnicity at visit 1; 4. have +1.00 to -4.00 diopter (d) of sphere calculated in minus cylinder (so that spherical equivalent (se) results in myopia no more severe than -4.00 d mrse) in both eyes determined by manifest refraction documented at visit 1; 5. have ≤2.00 d of cylinder (minus cylinder) in both eyes determined by manifest refraction documented at visit 1; 6. be presbyopic as determined at visit 1 exclusion criteria: subjects must not: 1. be a female of childbearing potential who is currently pregnant, nursing, or planning a pregnancy; 2. have known contraindications or sensitivity to the use of any of the study medications or their components; 3. have an active ocular infection at visit 1 or at visit 2 (bacterial, viral, or fungal), positive history of an ocular herpetic infection, preauricular lymphadenopathy, or ongoing, active ocular inflammation in either eye; 4. have moderate or severe dry eye defined as total central corneal fluorescein staining in either eye at visit 1; 5. have clinically significant abnormal lens findings including early lens changes in either eye during dilated slit-lamp biomicroscopy and fundus exam documented within 3 months of visit 1 or at visit 1;

Keywords: pharmaceutical solutions eye drops clarity presbyopia ophthalmic solutions miotic
genetics of fatty liver disease in children

Conditions: Non Alcoholic Fatty Liver Disease

Summary: this is a study to investigate genetic predisposition to hepatic steatosis and the expression of gluconeogenic and lipogenic genes in livers of obese children and adolescents. hypothesis 1: common variants recently associated with variation in plasma tg levels identified in genome wide association studies (gwas) (such as gckr, pnpla3) can affect accumulation of fat and subsequent development of non alcoholic fatty liver disease (nafld). gene variants act in additive or synergistic manner with progressive liver fat accumulation per additional risk allele. hypothesis 2: with increase in hepatic fat content nash and fibrosis will increase. furthermore, expression of lipogenic markers (srebp1c) will increase.

to establish a cohort of obese youths to prospectively analyze potential factors (genetic and nutritional factors) that might affect the expression and progression of nafld. this study will determine genetic markers and their ability to convey susceptibility to nafld in obese children and adolescents. furthermore, potential mechanisms that might contribute to the accumulation of hepatic triglyceride (tg) accumulation will be, for the first time, assessed by genotyping. additionally, we will examine the presence of intestinal microbiome in the development of fatty liver through stool collection.

Eligibility criteria:
inclusion criteria: * between 7 and 18 years of age, * overweight or obese with a bmi greater than the 85th percentile for age and gender, and * be otherwise healthy. exclusion criteria: * the use of any medication that alters liver function, blood pressure, glucose or lipid metabolism and * no use of any antipsychotic medication * youth on chronic anti-inflammatory medications or who consume alcohol are also excluded.

Keywords: non alcoholic fatty liver childhood obesity genetic variants
effects of aromatherapy on patients undergoing chemotherapy for breast cancer

Conditions: Sleep Quality; Anxiety

Summary: the objective of this study was to investigate the effects of aromatherapy on sleep quality and anxiety in patients undergoing chemotherapy for breast cancer.


Eligibility criteria:
inclusion criteria: 1) patients diagnosed with breast cancer and receiving chemotherapy; 2) suffering from sleep disorders or psqi score greater than 5; 3) not using medications such as antidepressants and hypnotics that may affect the observation results; 4) age older than 18 years and volunteered to participate in this study. exclusion criteria: 1) asthma or severe respiratory disease; 2) allergy to lavender; 3) cognitive or communication disorders; 4) breast cancer combined with severe organ dysfunction.

Keywords: sleep quality anxiety aromatherapy
thromboelastometry in liver transplantation

Conditions: Liver Transplant Disorder; Coagulopathy

Summary: thromboelastometry better assess coagulation than standard coagulation test in patients undergoing ortothopic liver transplantation. in a post-hoc analysis from a randomized study recently conducted by our group, presurgical values of ma10 extem \ 40 mm ; suggesting that ma10 extem between 35-40 would be the optimal range to manage blood product administration. the aim of the study is to validate this result in a prospective cohort of patients submitted to ortothopic liver transplantation.


Eligibility criteria:
inclusion criteria: * presurgical hemoglobin \< 13 d/l and clot firmness at 10 minutes extem \< 35 mm exclusion criteria: * previous thrombosis * antithrombotic treatment * no consent
treatment response to different lymphoedema compression programs using a pneumatic compression device

Conditions: Lower Extremity Lymphoedema; Leg Lymphoedema

Summary: proof of principle study in order to determine if there is a difference in treatment effect across the 3 study groups when treating lower extremity lymphoedema using a pneumatic compression device.

this is a single center, 3 arm, prospective, randomized, clinical trial to assess the difference between 3 treatment options for achieving a measurable physiologic effect on lower extremity lymphedema with pneumatic compression device. each intervention arm will include 10 completed subjects for a total of 30 completed subjects.

Eligibility criteria:
inclusion criteria: * subjects must be ≥ 18 years old * subjects must have a diagnosis of primary or secondary stage 2 unilateral or bilateral lower extremity lymphoedema * must currently be using adequate compression garment(s) as determined by the clinician: (garments must be at least 20mmhg and no more than 3 months old and must be worn upon rising and removed at bedtime) * subjects must have clinically relevant excess limb swelling as determined by clinician "pitting test" * must be able to attend all required in-clinic treatment visits exclusion criteria: * diagnosis of active or recurrent cancer, or less than 3 months at the time of initial evaluation from the completion of chemotherapy, radiation therapy, or primary surgery for the treatment of cancer * active infection or inflammation * active thrombophlebitis (within the last 2 months) * history of pulmonary embolism (within the last 2 months) * documented history of deep chronic venous insufficiency or deep venous obstruction with a reflux duration of \> 2 second in the deep system or any history of deep vein thrombosis (dvt) * history of pulmonary edema * history of congestive heart failure * history of chronic kidney disease with a glomerular filtration rate (gfr) of less than 30 mls per minute * poorly controlled asthma * symptomatic or severe peripheral artery disease (defined by current lifestyle-limiting claudication or critical limb ischemia) * presence of an open wound or ulcer of any etiology * diagnosis of lipoedema and lipolymphoedema * currently using an in-home pneumatic compression device * metal implant(s) that would interfere with bioimpedance equipment * pacemaker or other implanted electronic device(s) * unable or unwilling to remove bandaging from treatment regimen while participating in the study * pregnant * any condition where increased venous and lymphatic return is undesirable * unable or unwilling to participate in all aspects of the study protocol and/or unable to provide informed consent * currently participating in another clinical trial * currently using diuretics * bmi \> 40

Keywords: lymphedema lymphoedema leg lymphoedema lower extremity lymphoedema pneumatic compression device
a study in patients with mixed dyslipidemia

Conditions: Mixed Dyslipidemia

Summary: a phase 2 in patients with mixed dyslipidemia

a phase 2, randomized, double-blind, placebo-controlled, parallel study to evaluate the efficacy and safety of subcutaneously administered bw-00112 in patients with mixed dyslipidemia

Eligibility criteria:
inclusion criteria: 1. must have given written informed consent and be able to comply with all study requirements. 2. males or females aged 18 to 75 aged years, inclusive, at the time of informed consent 3. fasting ldl-c ≥ 70 mg/dl \[1.8 mmol/l\] at screening. 4.150 mg/dl \[1.7 mmol/l\] ≤ fasting tg \< 500 mg/dl \[5.6 mmol/l\] at screening, which may be repeated once if deemed necessary. 5.on a stable statin for at least 1 month before screening and plan to remain on the same medication and dose for the duration of the study. 6.females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal 7.male patients agreeing to use acceptable methods of contraception exclusion criteria: 1. active pancreatitis within 12 weeks prior to day 1. 2. clinically significant acute cardiovascular even or procedure 3. hba1c \> 9.0% at screening or patients with diabetes who have experienced diabetic ketoacidosis, diabetic decompensation, hyperosmolar hyperglycemic nonketotic coma, diabetes complications, recurrent infections, or hospitalization related to poor glycemic control within 24 weeks prior to day 1. 4. presence of any clinically significant uncontrolled disease known to influence serum lipids or lipoproteins. note: patients on thyroid replacement therapy are eligible if the dosage of thyroxine has been stable for at least 12 weeks prior to day 1. 5. use of tg lowering medication , non-prescription dietary supplements or other cholesterol lowering medication 30 days prior to day 1, other than statins and ezetimibe.
growth hormone deficiency in chronic heart failure: an observational study

Conditions: Ischemic Heart Disease; Cardiomyopathy; Heart Failure; Growth Hormone Deficiency

Summary: aim of this study is to define the possible detrimental effect of a lack of growth hormone, on the well-being and life expectation of patients affected by heart failure.

growth hormone and its main effector igf-1 have well-documented roles in the regulation of cardiac and circulatory function. evidence suggests that gh/igf-1 exert a beneficial effect on cardiac load, cardiac growth and remodeling, despite their hypertrophying action. several studies in the last years have demonstrated worse cardiovascular outcomes in adult patients with gh deficiency and/or low levels of igf-1. a wide range of alterations in the gh/igf-1 axis have been described to date in patients with chronic heart failure (chf): reductions in gh levels, reductions in igf-1 and a pattern of peripheral resistance to gh, in particular in patients with severe heart failure and cardiac cachexia. our study hypothesis is that an actual status of gh deficiency coexists with chf in a large percent of patients, and that it may represent a predictor of worse functional status and possibly of a worse prognosis. aim of this study is to explore the latter hypothesis, comparing the clinical and functional evolution of patients with chf and ghd with that of a general chf population.

Eligibility criteria:
inclusion criteria: * diagnosis of heart failure: nyha class ii to iv, acc/aha stage c/d * left ventricular end diastolic diameter \>60 mm * left ventricular ejection fraction \< 40% * clinical stability, guideline-oriented top pharmacological therapy * informed consent exclusion criteria: * active myocarditis * hypertrophic cardiomyopathy * active endocarditis * active malignancy * end stage renal disease * severe liver disease (child b-c)

Keywords: heart failure growth hormone igf dilative cardiomyopathy