Kornimate/medical-research-clean huggingface dataset:
clinical trial to evaluate the efficacy of metadoxine as a therapy for patients with non-alcoholic steatohepatitis

Conditions: Non-alcoholic Steatohepatitis

Summary: the aim of this study is to evaluate the efficacy of metadoxine as a therapy for patients with biopsy-proven non-alcoholic steatohepatitis.

type and design of the study: a randomized, placebo-controlled, double-blind, clinical trial to evaluate the efficacy of metadoxine as a therapy in patients with biopsy-proven nonalcoholic steatohepatitis. population: non-diabetic patients with nonalcoholic steatohepatitis diagnosed by liver biopsy through the "nonalcoholic fatty liver disease activity score" (nas)\> 3. sample size: considering a difference of at least 30% between groups, a confidence level of 95% (two-sided, significance 0.05), a statistical power of 80%, and an additional 20% for possible losses, we need 54 patients per group. variables: independent: treatment group (metadoxine / placebo). dependents: * "nonalcoholic fatty liver disease activity score" (nas):0 a 8 * degree of liver steatosis: 0 a 3 * degree of lobular inflammation: 0 a 3 * degree of ballooning: 0 a 2 * degree of fibrosis: 0 a 2 * weight: kg * body mass index: kg/m2 * waist circumference: cm * serum alanine aminotransferase: u/l * serum aspartate aminotransferase: u/l methods: those meeting the selection criteria will be invited to participate in this study, those who agree to participate must sign the consent form and will be randomized to placebo or metadoxine group. the duration of the therapy will be 6 months and after this period a second liver biopsy will be performed to assessed the improvement on liver histology.

Eligibility criteria:
inclusion criteria: * non-diabetic patients, * overweight or with obesity degrees i, ii or iii according to who criteria (bmi ≥ 25), * with evidence of liver steatosis in the ultrasonography, * with biopsy-proven nonalcoholic steatohepatitis, with ≥ 3 in the nas score (at least 1 point for liver steatosis, at least 1 point for lobular inflammation, and at least 1 point for ballooning), * with or without fibrosis in the liver biopsy, but if it is present must be ≤ 2 on a scale of 4, where 4 is equivalent to cirrhosis. exclusion criteria: * cirrhosis, * diabetes, * heavy alcohol intake ( ≥ 20 g / day), ≥ 8 points in the "alcohol use disorders identification test" (audit), * acute or chronic hepatitis c, * acute or chronic hepatitis b, * immunodeficiency acquired syndrome * pregnant women, * in the last year, history of herbal consumption, total parenteral nutrition, amiodarone, methotrexate, hormonal contraceptives, steroids, tamoxifen, valproic acid or any other drug associated with the development of liver steatosis. * uncontrolled hypothyroidism or hyperthyroidism, * any uncontrolled chronic disease.

Keywords: non-alcoholic steatohepatitis metadoxine efficacy therapy
telerehabilitation after coronavirus

Conditions: COVID

Summary: the aim of the study is to investigate the effects of telerehabilitation program on covid-19 symptoms, quality of life, level of depression, perception of dyspnea, sleep, fatigue, kinesiophobia and patient satisfaction in individuals diagnosed with covid-19.

because of the risk of infection, telerehabilitation applications are recommended for patients with covid-19. there are no studies in the literature evaluating the effectiveness of telerehabilitation program after covid-19. in particular, the importance of the first eight weeks after the disease was emphasized. it is thought that the telerehabilitation program will improve the functional capacities and quality of life of patients in order to adapt to the daily life after the infection more easily, to cope with the symptoms brought about by the disease more easily and to prevent the respiratory distress, intensive care stay and inactivity due to muscle weakness.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * at least once diagnosed with covid-19, * has a cognitive level that can adapt to online exercises, * having a physical condition suitable for exercises * staying in hospital due to covid-19 exclusion criteria: * refuse to participate in the study * having neurological, cardiac, respiratory disease that prevents exercise

Keywords: covid-19 telerehabilitation respiratory exercises aerobic exercises
treatment of hypertension: morning versus evening

Conditions: Essential Hypertension

Summary: rationale: the nocturnal blood pressure mean is an independent and stronger predictor of cardiovascular disease (cvd) risk than either daytime office, awake or 24hour mean blood pressure. in general, when nocturnal blood pressure does not decline cvd risk is higher, usually referred to as "dippers" versus "non-dippers". evening administration of treatment might lower nocturnal blood pressure more effectively than morning administration, which is most commonly advised. the main hypothesis of this study is that evening administration of antihypertensive medication might resume the dipping pattern in non-dippers and as a consequence might reduce cvd risk more than morning administration. primary objective (in short): -to prove that evening administration of enalapril/hydrochlorothiazide in non-dippers can resume a dipping blood pressure pattern in non-dippers study design: a double-blind placebo-controlled cross-over study each person will use for one period of six weeks enalapril/hydrochlorothiazide in the morning and placebo in the evening, and one period of six weeks the other way around


Eligibility criteria:
inclusion criteria: * essential hypertension * stable blood pressure on treatment with angiotensin converting enzyme inhibitor (acei) or angiotensin ii receptor blocker (arb) and hydrochlorothiazide * age between 18 and 85 years * who performance status 0-1 * available for a time period of 15 weeks * written informed consent * dippers: nocturnal blood pressure fall of 10-20% of daytime values.20 * non-dippers: -nocturnal blood pressure fall of \<10% of daytime values exclusion criteria: * secondary cause of hypertension * use of arb because of intolerability (e.g. dry cough) of acei * nocturnal blood pressure fall of \>20% or rise * renal insufficiency (gfr\<60 ml/min) * shift work * pregnancy or wish to get pregnant * use of other antihypertensive medication than acei, arb, hydrochlorothiazide or a calcium channel blocker * use of sleeping medication

Keywords: dipper non-dipper chronopharmacology
pet/ct in psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: when patients with psoriasis develop joint pain, it is often hard to decide whether or not the pain is due to psoriatic arthritis (psa). at this time, doctors use information from the history and physical exam to determine the diagnosis. x-rays, magnetic resonance imaging (mri) and ultrasound have been used to help with the diagnosis but all three have limitations. a newer imaging technique, whole body positron emission tomography/computed tomography (pet/ct) uses the idea that inflammatory cells take up sugar to locate inflammation in the body. because patients with psa have inflammatory cells in their joints and tendons, this type of scan allows the physician to take a picture of the whole body and locate inflammation. the investigators have found that some patients with psoriasis (but without arthritis) have inflammation in joints and tendons even before the patient has symptoms. in this study, the investigators will explore how well pet/ct works for assessing inflammation in patients with psa. this would be a very exciting tool that could be used to find and treat inflammation before it causes damage or pain.


Eligibility criteria:
inclusion criteria: * age 18-80, * active psoriatic arthritis (joint or enthesis inflammation) exclusion criteria: * diabetes, * pregnant, * no active psa
ai-based imt study

Conditions: Cardiovascular Diseases

Summary: cerebro-vascular and heart diseases have together ranked 4th and 5th place in the 2022 top ten leading causes of death in hong kong, taking up more than 15% of the total in an unceasing trend. while conventional carotid ultrasound imaging is nothing short of comprehensive, it is highly operator-dependent and is worsened by the shortage of medical staff in hong kong. the seemingly long queue for the expensive health screenings has put the high-risk groups, including but not limited to the elderly, in a vulnerable position as they can hardly perform regular and frequent check-ups. in light of this, our team is determined to research a solution that is conducive to the preventive healthcare of strokes and cardiovascular diseases through one of the newly proposed devices: pyrockstm tag lite. this study aims to investigate an approach for developing a robust deep learning model for analysing ultrasound images and incorporate the model into our established prototype to perform intima-media thickness measurement and risk assessment. main points that the clinical trial can assist in solving the existing problem: the acquisition procedures are non-invasive, painless, and safe for the participants. clinical trials \& test data will assist in testing and training our neural network model.


Eligibility criteria:
inclusion criteria: * adults (over the age of 18 years)(with elderlies (over the age of 65 years) more preferred) * patients with cardiovascular diseases (cvd), including current smokers or diagnosed with diabetes, dyslipidaemia, coronary artery disease, cerebrovascular disease, hypertension, atherosclerotic cardiovascular disease, high blood pressure, high bmi index and those under antihypertensive treatment. exclusion criteria: * none
surgical plate osteosynthesis of distal radius fractures

Conditions: Distal Radius Fractures

Summary: primary objective of the study is to demonstrate specific indications for the surgical treatment of distal radius fractures using the locking compression plate.

in addition the differences between the surgical treatment compared to conservative treatment with respect to fracture healing, functional outcome and subject satisfaction will be analysed after 6w./6m./1y./2y.

Eligibility criteria:
inclusion criteria: * skeletally mature female and male * distal radius and ulnar fractures ao 23 * 10 days after injury exclusion criteria: * general or local conditions adversely affecting the bone physiology * iss \>16 * osteosynthesis close to the wrist joint where a different implant has been used * history of drug and alcohol abuse

Keywords: locking compression plate conservative treatment surgical treatment radius fractures ao 23
phase i/ii study of [225ac]ac-psma-r2 in psma-positive prostate cancer, with/without prior 177lu-psma rlt

Conditions: Prostate Cancer

Summary: this is an open label, phase i/ii, multi-center study in adult participants with metastatic hormone sensitive prostate cancer (mhspc) and with metastatic castration resistant prostate cancer (mcrpc) who have received prior anti-cancer treatment and have a positive 68ga-psma-11 pet scan. the purpose of this study is to learn if the study drug, \[225ac\]ac-psma-r2, is safe and tolerable, and has anti-tumor activity in treated patients.

the study contains three groups (group 1, group 2, and group 3). each group has a dose escalation part at a specific dosing schedule followed by a dose expansion part. the dose escalation parts in each group within each dosing schedule will establish the maximum tolerated dose or the recommended dose for expansion (mtds/rdes) of the 225ac-psma-r2. dose escalation decisions will be made by the investigators and novartis during dose escalation meetings (dems) based on safety and tolerability information. the dose expansion parts in each group group/dosing schedule will assess the anti-tumor activity in the mhspc and mcrpc populations.

Eligibility criteria:
key inclusion criteria: * evidence of psma-positive disease by 68ga-psma-11 pet/ct and eligible as determined by central reading * documented progressive mcrpc or mhspc * adequate organ function * prior orchiectomy or ongoing adt and should have received prior 177lu-psma-rlt (group1 dose escalation \& expansion) or never received 177lu-psma-rlt (group 2 and group 3 dose escalation \& expansion). key exclusion criteria: * any other investigational agents within 28 days of the anticipated c1d1 of 225ac-psma-r2 therapy * any systemic anti-cancer therapy within 28 days of the anticipated c1d1 of 225ac-psma-r2 therapy * uncontrolled pain or incompatibility that may result in participant's lack of ability to comply with imaging procedures * history of cns metastases and symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression * history of myocardial infarction, angina pectoris, or coronary artery bypass graft within 6 months prior to icf signature and/or clinically active significant cardiac disease * diagnosis of other malignancies in the past three years expected to alter life expectancy or may interfere with disease assessment other protocol-defined inclusion/exclusion criteria may apply.

Keywords: 225ac-psma-r2 dose limiting toxicity dlt escalation with overdose control ewoc pre- and post-177lu-psma-rlt
demographic characteristics of children suffering from mental retardation or cerebral palsy in the israeli arab community

Conditions: Mental Retardation; Cerebral Palsy

Summary: to evaluate the demographic characteristics of patients suffering from mental retardation or cerebral palsy in the israeli arab community. specific questionnaires will be developed and will be distributed amongst this population in order to identify these characteristics.


Eligibility criteria:
inclusion criteria: * cerebral palsy * mental retardation * israeli arab * israeli jewish exclusion criteria: * all others

Keywords: israeli arab population israeli/ethnology
efficacy of doxycycline in the treatment of early stages of mycosis fungoides

Conditions: Lymphoma

Summary: current study aims at assessing the efficacy of doxycycline as a potential treatment modality for early stages of mf.

objectives objective is to evaluate the efficacy of doxycycline in treatment of early stages of mycosis fungoides (ia, ib and iia) and to assess its apoptotic enhancing effect by studying the expression of bcl2 by the t lymphocytes. study design randomized controlled trial population of study \& disease condition 30 patients with early stage mycosis fungoides (stage ia,ib and iia) methodology in details after signing an informed consent, each participant will be subjected to: i. baseline evaluation: 1. baseline biopsy to document the current state of the disease and to assess immunohistochemically the expression of cd3 and bcl2 by the lymphocytes. 2. detailed history taking including onset, course, duration of the disease and history of any previous treatments used. 3. detailed examination of skin lesions and scoring using: * modified severity of index weighted assessment (mswat) * composite assessment of index lesion severity (cails) 4. pruritus scoring using a visual analog scale from 0-10, where 0=no pruritus and 10=worst imaginable pruritus 5. photography ii. treatment and dosing protocol: participants will be randomly allocated in either one of the treatment groups: group a: will receive oral doxycycline in a dose of 200 mg daily for three months. group b: will receive puva with dosing \& increments according to the standard protocols of the phototherapy unit, dermatology department, cairo university; 3 sessions per week for 3 months. iii. timings of follow up visits and clinical assessments done: patients will be regularly assessed at weeks 4, 8, and 12. patients continuing for another three months, as mentioned above, will be assessed at weeks 16, 20 and 24. the following will be done at these follow up visits: mswat, cails, pruritus scoring and photography. side effects will be monitored and managed accordingly. iv. follow up biopsies: a repeat biopsy will be taken at initial improvement in cails (or at week 12) for immunohistochemical re-assessment of the expression of cd3 and bcl2 by the lymphocytes.

Eligibility criteria:
inclusion criteria: * adults (above 18) of either sex with established diagnosis of classic mf exclusion criteria: * any variant of mf other than the classic variant. * advanced stages of classic mf: stage iib, iii or iv. * pregnant and lactating females. * patients with autoimmune diseases e.g. sle * patients with solid or hematological malignancies e.g. breast cancer, leukemia, etc. * patients with any contraindications for doxycycline (eg: liver disease, kidney disease, photosensitivity, peptic ulcer or patients receiving systemic retinoids). * patients with any contraindication to phototherapy (eg: any other skin cancers or photosensitivity); or to psoralen (eg: liver disease)

Keywords: mycosis fungoides doxycycline
a phase ii study of paclitaxel and topotecan with filgrastim-sd/01 support for relapsed and refractory aggressive non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: for patients with relapsed and refractory aggressive non-hodgkin's lymphoma


Eligibility criteria:
inclusion: * bidimensionally measurable current/refractory aggressive nhl (diffuse lg cell, diffuse mixed cell, follicular lg non-cleaved, immunoblastic, ki-1+alcl, peripheral t-cell lymphoma, mantle cell lymphoma \& transformed lymphoma.) * no more than 3 prior treatment regimens. no anti-lymphoma therapy within the past 3 weeks. * not be eligible for treatment of a higher priority. * performance status \ 60 karnofsky. * good marrow reserve: anc\>1.5 x 10(9)/l, platelets \> 100 x 10(9)/l. * bilirubin \<1.5mg/dl, sgot, sgpt \< 2 x normal values. * serum creatinine \< 1.8 mg/dl. * age \> 18 yrs. * signed informed consent. * life expectancy of \> 12 weeks. * no prior taxane (paclitaxel or docetaxel), topotecan, or cpt-11. * no prior stem cell or bone marrow transplantation. * no prior second malignancies except for basal cell carcinoma of the skin. exclusion: * active or prior history of cns lymphoma. * serious intercurrent medical illnesses requiring hospitalization. * history of primary/secondary immunodeficiency (other than related to the malignant lymphoma because treatment is dependent on a functional immune system) or patients taking immunosuppressive drugs (systemic corticosteroids). * prior exposure to filgrastim-sd/01. * women who are pregnant or lactating. * participation in another clinical trial. * positive hiv antibody. * history of prior sensitivity to e. coli derived products (such as filgrastim/neupogen).

Keywords: lymphoma non-hodgkins aggressive relapsed and refractory
walking training improves thyroid and cardiometabolic markers in postmenopausal obesity

Conditions: Thyroid Hormones; Cardiometabolic Risk Factors

Summary: the goal of this clinical trial is to investigate the impact of a 10-week miwt program on thyroid hormone levels and key cardiometabolic markers in obese postmenopausal women. the main question it aims to answer is: does miwt enhance thyroid function and reduce cardiometabolic risk factors in this population? researchers will compare miwt (designed to miwt group) to non-training intervention (designed to control group) to see if the training program works to improve thyroid function and cardiometabolic risk factors. participants in miwt group will: perform a 10-week miwt program, four sessions per week (5 repetitions of 6-min-walking-test (6mwt) at 60-80% of 6mwtdistance measured at baseline, interspersed by 6-min of active recovery between repetitions). participants in control group will : not perform any physical training and maintain their usual daily activities.

this study aimed to investigate the impact of a 10-week miwt program on thyroid hormone levels and key cardiometabolic markers in obese postmenopausal women. thirty-six obese postmenopausal women (bmi≥30 kg.m-2, aged 50-60 yrs.) were randomized to either a moderate-intensity intermittent walking training (miwt) group (n=18) or control group (cg, n=18). participants performed a 10-week miwt program, four sessions per week (5 repetitions of 6-min-walking-test (6mwt) at 60-80% of 6mwtdistance measured at baseline, interspersed by 6-min of active recovery between repetitions). body composition, thyroid hormones (thyroid stimulating hormone (tsh) and thyroxine free (ft4)), lipid profile (triglycerides (trg), total cholesterol(tc), high-density lipoprotein cholesterol(hdlc) and low-density lipoprotein cholesterol(ldlc)), blood pressure (systolic and diastolic blood pressure) and aerobic fitness (6mwt) were determined before and after the miwt.

Eligibility criteria:
inclusion criteria: * body mass index≥ 30 kg.m-2. * age between 50 and 60. * amenorrhea for \>12 months. * stable eating habits. exclusion criteria: * chronic diseases. * medical contraindications to physical activity. * hormone replacement therapy.

Keywords: thyroid hormones lipid profile obesity blood pressure moderate intensity intermittent walking training body composition
autoantibodies in breast cancer detection

Conditions: Breast Cancer

Summary: prospective, single-center study in women who have recently had an abnormal mammogram followed by a breast biopsy or women who have recently had a normal screening mammogram. we are no longer enrolling women who had normal screening mammograms.


Eligibility criteria:
inclusion criteria: * inclusion criteria: all cohorts: * women age 18 and older * understand and provide informed consent and hipaa authorization prior to initiation of any study-specific procedures cohort a: * recent abnormal mammogram followed by a breast biopsy * initial diagnosis of stage i, ii, iii or iv invasive breast cancer cohort b: * recent abnormal mammogram followed by a breast biopsy * diagnosed benign breast tumor with high-risk pathology. this would include, but is not limited to, atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ (lcis), ductal carcinoma in situ (dcis), flat epithelia atypia and phylloides cohort c: * recent abnormal mammogram followed by a breast biopsy * diagnosed benign breast tumor. this would include, but is not limited to, fibroadenoma, papilloma, fibrocystic changes, and pseudoangiomatous stromal hyperplasia (pash) cohort d: • normal screening mammogram within the last 6 months exclusion criteria: * all cohorts: * men. * unable or unwilling to give written informed consent cohort a: • history of cancer other than non-melanoma basal or squamous cell skin carcinoma, ductal carcinoma in situ (dcis) and cervical carcinoma in situ. cohort b: • history of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ. cohort c: • history of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ. cohort d: * history of cancer other than non-melanoma basal or squamous cell skin carcinoma and cervical carcinoma in situ. * history of or current autoimmune disease including but not limited to sjogrens syndrome, systemic sclerosis (ssc), scleroderma (scl) and dermatomyositis, systemic lupus erythematosus, multiple sclerosis, type i diabetes, rheumatoid arthritis * history of abnormal mammogram