Kornimate/medical-research-clean huggingface dataset:
effect of zinc supplementation on hyperhomocysteinemia compared to folic acid in ckd patient on hemodialysis

Conditions: Chronic Kidney Disease Requiring Hemodialysis

Summary: hyperhomocysteinemia is a well-recognized risk factor for accelerated cardiovascular events in hemodialysis patients. hyperhomocysteinemia is common in individuals with chronic kidney disease (ckd). zinc is a vital cofactor for homocysteine metabolism enzymes. although numerous studies have demonstrated the efficacy of folic acid in hyperhomocysteinemia, zinc supplementation has the potential to reduce homocysteine levels in hemodialysis patients. objective: to evaluate the effect of zinc supplementation on hyperhomocysteinemia compared to that of folic acid in patients with chronic kidney disease on hemodialysis. materials and methods: this open-label randomized active-controlled trial will be conducted in the department of nephrology of chittagong medical college hospital, chattogram, bangladesh, for one and a half years. a total of ninety ckd patients on maintenance hemodialysis will be included in the study. patients will be randomly divided into two groups. the experimental group will be treated with zinc sulfate (50 mg elemental zinc/day) for six weeks in conjunction with conventional treatment for ckd. the control group will receive folic acid (5mg/day) along with conventional medications for ckd. the primary outcome measure will be the change in the plasma homocysteine level after 6 weeks, while the other variables will include serum creatinine, egfr, serum albumin and c-reactive protein (crp) level. adverse events and safety measures will also be recorded. the primary analysis will be an intention to treat analysis performed with spss-23. data from previous studies indicate zinc supplementation can reduce homocysteine levels in ckd patients facilitating its metabolism. additionally, the anti-inflammatory properties of zinc may facilitate homocysteine reduction. moreover, zinc is crucial in various physiological processes, including immune function, protein synthesis, and wound healing. further clinical trials are still needed to understand better the safety and efficacy of zinc supplementation in ckd patients.


Eligibility criteria:
inclusion criteria: * 1. age ≥18 years 2. patient with chronic kidney disease on hd for ≥ 3 months 3. plasma homocysteine level \> 15μmol/l exclusion criteria: 1. acute illness at the time of inclusion. 2. diagnosed case of malabsorption 3. planned major surgery 4. renal transplantation 5. receiving zinc or folic acid supplementation within the previous month from enrollment. 6. concomitant use of vitamin b 12 supplementation(6 days), corticosteroid (18-36 hour), anti folate or cytotoxic drugs, quinolones, tetracyclines, bisphosphonates. 7. known hypersensitivity to zinc or folic acid. -
outcomes of endovascular treatment of superficial femoral artery in-stent restenosis

Conditions: Peripheral Arterial Disease

Summary: lower limb peripheral arterial disease (pad) is a common, important manifestation of systemic atherosclerosis. stenosis or occlusions in the superficial femoral artery (sfa) may result in intermittent claudication or even critical ischemia, which may be treated by balloon angioplasty with or without stenting . atherosclerotic disease in the femoropopliteal (fp) artery consists of perfusion to the legs and feet. percutaneous transluminal angioplasty (pta) has been routinely used to manage fp artery disease and is recommended as an alternative to surgical bypass. recently, newer endovascular approaches such as covered stent, drug-eluting balloon (deb), drug-eluting stent (des), or catheter based atherectomy have been introduced as treatment options for fp artery disease. nevertheless, fp artery-in stent restenosis (isr) is still a major challenge with endovascular therapy . although the use of peripheral arterial stents brought about a dramatic improvement in patients' clinical and procedural outcomes, the long-term outcome of stent implantation remains significantly constrained by the risk of developing in-stent restenosis (isr) over time. advancements in endovascular stent technology have addressed limitations associated with conventional percutaneous transluminal balloon angioplasty in patients with chronic peripheral arterial disease (pad) of the lower limbs, such as elastic recoil,residual stenosis and flow-limiting dissection . however, a considerable proportion of patients with pad treated with stenting will require secondary interventions due to in-stent restenosis (isr), which is particularly common in long and complex lesions isr refers to loss of luminal volume from an ingrowth of cells, extracellular matrix, and thrombus within the cylinder of the stented artery and 5-mm margins proximal and distal to the stent. isr has been reported to occur in 18-40% of patients undergoing stenting in the femoropopliteal segment within the first year of treatment . the treatment of isr is one of the major challenges in endovascular therapy for pad. the treatment options for isr include standard balloon angioplasty with or without repeat stenting (using bare-metal stents, stent grafts or drug-eluting stents), drug-coated or cutting balloon angioplasty, cryoplasty and directional or laser atherectomy .


Eligibility criteria:
inclusion criteria: - patients with pad undergoing peripheral vascular intervention with sfa in stent stenosis for two years from the start of study and has critical limb ischemia. exclusion criteria: * refusal of the patients
monitoring alectinib treatment by detection of alk translocations in serial blood samples from non-small cell lung cancer patients

Conditions: Lung Cancer; ALK Gene Mutation; Resistance, Disease; Mutation

Summary: circulating tumor dna can be used to monitor the treatment effect and identify developing resistance mutations during alk directed tki treatment.

the purpose and objectives of the non-interventional study with primary data collection is * to determine if monitoring the amount of translocated dna in the blood reflects alectinib treatment effect. * to assess the presence and type of resistance mutations using ctdna at the time patients experience clinical progression on alectinib. * to investigate if the resistance mutations identified at clinical progression could have been identified in blood samples taken before clinically evident progression.

Eligibility criteria:
inclusion criteria: 1. patients with alk translocated metastatic nsclc, treated with alectinib as 1st line therapy in routine clinical practice 2. written (personally dated and signed) informed consent exclusion criteria:
ebus-tbna for diagnosis of mediastinal lymphadenopathy

Conditions: Mediastinal Lymphadenopathy; Lung Cancer

Summary: this study aims on the combinatorial results of cytology, histopathology and microbiology obatined by ebus-tbna for unselected mediastina lesions.

a number of studies have proved ebus-tbna to be useful for lymph node staging in lung cancer. the diagnostic performance is equivalent to mediastinoscopy while the invasiveness is far less. this study primarily focusing on merged approach of cytology, histopathology and microbioloogy obatined by ebus-tbna for unselected mediastina lesions.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * mediastinal lymphadenopathy on chest ct scan * with a short-axis \> 10mm exclusion criteria: * patients intolerant to bronchoscopy exam * unstable vital sign (blood pressure, heart rate, breath rate)
telephone counseling and numberless scales to overcome barriers to adolescent weight loss

Conditions: Obesity

Summary: this study tests the feasibility and acceptability of a numberless behavioral digital scale (bds) intervention combined with motivational interviewing (mi) to affect lifestyle changes to promote weight loss in adolescents who are obese. half of the participants will receive this intervention, while the other half will use a digital scale along with the standard adolescent weight loss program.

the proposed pilot project seeks to enhance motivation for lifestyle change in adolescents who are obese. it will test a novel intervention that combines modified mi-based counseling and bds. we will test the feasibility of the intervention over a 12-week period, with 24-week follow-up compared to use of standard digital scale. all participants will undergo the standard adolescent weight loss program, which includes monthly clinic visits with dietary and physical activity counseling. the mi intervention will include modified mi, brief weekly telephone reinforcement, and use of a bds. the bds with its mobile app offers daily feedback through colors, daily missions to promote healthy habits, and weekly healthy tips from nutritionists. in addition to the primary outcome of feasibility (daily weighing) investigators will also explore the intervention's effect on motivation, psychological outcomes and various aspects of feasibility and acceptability.

Eligibility criteria:
inclusion criteria: * age between 12 and 18 years * bmi greater than or equal to 95th percentile for age and sex group or bmi greater than or equal to 35 kg/m\^2 * participant (not parent) is able to read and understand english (app is in english) * smartphone device with wi-fi and app capability * willingness to be randomized to any condition exclusion criteria: age 19 years or older * developmental delay * inability to provide informed consent * any medical condition that, in the opinion of the pi, would place the participant at increased risk * use of an investigational agent in the 30 days prior to signing informed consent * history of prior non-compliance or the presence or history of psychiatric condition (including drug or alcohol addiction) that would , in the opinion of the pi, make it difficult for the participant to comply with study procedures or follow instructions * females who are pregnant or lactating, by verbal report * pre-existing conditions (i.e paralysis, heart failure, severe autism or mental retardation, psychosis, etc.) * prisoners * lack of transportation

Keywords: adolescent
proof of concept study of re-treatment in brvo with ranibizumab guided by oct

Conditions: Branch Retinal Vein Occlusion

Summary: the aim of the trial is to evaluate the efficacy and safety of intravitreal injections of ranibizumab for the treatment of macular edema due to brvo if the re-treatment regimen is guided by morphological macular changes detected by oct compared to re-treatment according to smpc defined re-treatment criteria (in case of increase of crt and concomitant decrease of bcva).

in a prospective, randomized, interventional, controlled phase iib clinical the functional results of treatment with ranibizumab in patients with macular edema due to branch retinal vein occlusion when given according to morphological changes detected by oct compared to standard re-treatment criteria according to smpc

Eligibility criteria:
inclusion criteria: * recurrence of macular edema defined as any kind of fluid accumulation in the macula (microcystic changes with or without increase of central retinal thickness) detected by oct in the month 1 to 6 after the last lucentis injection without any decrease of bcva measured with etdrs charts 2. diagnosis of brvo with macular edema treated with at least three intravitreally applied injections of ranibizumab after the up-load phase of treatment 3. age ≥ 18 years 4. ability and willingness to attend all scheduled visits and assessments 5. for sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study exclusion criteria: 1. macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, irvine-gass syndrome) 2. evidence upon examination of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or oct, thought to be contributing to macular edema 3. use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) prior to study entry 4. history of cerebral vascular accident, myocardial infarction, transient ischemic attacks in last 6 months 5. pregnancy (positive pregnancy test) or lactation 6. history of allergy to humanized antibodies or any component of the ranibizumab formulation

Keywords: brvo macular edema ranibizumab re-treatment
a study of high-risk oral cavity cancer

Conditions: Oral Cavity Cancer

Summary: objectives: 1. to study the effect of anti-angiogenesis therapy on reducing the recurrence of high-risk oral cavity cancer patients after curative local treatment. 2. to study the toxicity and compliance of post-operative anti-angiogenesis therapy study design: this is a multi-center randomized controlled phase ii/iii two-stage study. study endpoints: the primary endpoint is the tumor-free survival (primary and second primary malignancies) and the primary analysis is to compare the tumor-free survival between groups.

type and number of patients: patients with resectable oral cancer of clinical stage n2, 3 or skin-involved t4 will be enrolled. sample size at the first stage is 64 patients per group and the total sample size at the end of the second stage is 192 patients per group, assuming that the accrual rate/hazard rate = 1.33, an α=0.05 and power of 0.8 (hypotheses: h0:θ ≦ 1.0 and ha: θ ≧ 1.33) treatment schedule: group a：standard postoperative concurrent chemoradiotherapy. group b：immediately after operation starts thalidomide (50) 4# per day and celecoxib (200) 2# bid for three weeks, in addition to standard postoperative concurrent chemoradiotherapy. group c：immediately after operation starts cyclophosphamide (50) 1# per day and dexamethasone (0.5) 2# qd for three weeks, in addition to standard postoperative concurrent chemoradiotherapy.

Eligibility criteria:
inclusion criteria: 1. histologically proved oral cavity squamous cell carcinoma (buccal and mobile tongue). 2. clinical stage t4a with skin involvement or resectable n2-3 by uicc/ajcc 1997 staging system.(24) 3. curative-intent operation feasible and arranged. 4. eastern cooperative oncology group performance status ≦ 1. 5. a leukocyte count ≧3750/μl, hb ≧10 g/dl, and a platelet count ≧100,000/μl. 6. a serum bilirubin level \ 60 ml/min. 7. age less than 70 years old 8. informed consent signed. exclusion criteria: 1. evidence of distant metastatic. 2. presence of another malignancy other than treated squamous/basal cell carcinoma of the skin. 3. presence of uncontrolled hypertension, poorly controlled heart failure. 4. presence of active infection. 5. patients who have been or are being treated with chemotherapy, radiotherapy, immunotherapy, or other experimental therapies. 6. women who test positive for pregnancy. note: patients received neck lymph node biopsy will be eligible and the stage will be given according to the preoperative status.

Keywords: high-risk oral cavity cancer, anti-angiogenesis
wound closure after total knee replacement

Conditions: Wound of Knee

Summary: to compare the wound healing after total knee replacement wound closure with staples versus subcuticular prolene suture.

.informed consent will be taken from all the patients who meet the inclusion and exclusion criteria and then will be randomized into one of the two study arms (arm 1: will undergo wound closure with staples and arm 2 wound closure with subcuticular prolene suture). before the start of surgery. the primary investigator will open the sealed envelopes provided by the indus hospital research center's clinical research unit (cru) that provides the study arm allocation. the envelopes will follow the snose protocol i.e. they will be sequentially numbered, opaque sealed envelopes. before opening the envelope, the primary investigator will write the patient's medical record number, date and will sign the envelope. the envelope will contain carbon paper which will transfer the data allocation paper inside.

Eligibility criteria:
inclusion criteria: * patients undergoing primary total knee replacements for osteoarthritis or post-traumatic arthritis (diagnosed on x-rays and history) * bilateral knee surgeries * patients giving informed consent exclusion criteria: * patients having previous skin, neuromuscular or connective tissue disorder (confirmed by history) * patients taking steroids (confirmed by history) * body mass index \> 30 (increases chances of wound dehiscence) * lack of consent * pregnant females (confirmed by history)
measurement of psychomotor recovery after anesthesia using 4crt

Conditions: Delayed Recovery From Anaesthesia

Summary: the aim of the investigation is to validate the smartphone-based 4-reaction choice time test (4crt) as a measure for recovery of the psychomotor function in patients after general anesthesia. one hundred female patients, scheduled to ambulatory gynecological surgery in general anesthesia, will be randomized to the group with pharmacological anxiolytic premedication with midazolam (n=50) and to the group without midazolam (n=50). all patients will be monitored using 4crt before and after standardized general anesthesia. the reaction time, measured with 4crt is the primary outcome parameter of the investigation.

4crt is a classical psychological test, used to measure the psychomotor speed. this test measures choice reaction time. the participants are instructed to respond by pressing the keys 1-4 of the keyboard, corresponding to the numbers, appearing on the screen of computer (pda, smartphone). the average of the response latency, measured during the 10 trials is usually taken as 4crt outcome.

Eligibility criteria:
inclusion criteria: * physical status i-iii according to american society of anesthesiology * ambulatory gynecologic surgery of 10-40 min * patient is able to use vas and to use smartphone-based 4crt * given informed consent exclusion criteria: * age \ 50 years * patients who are not able to give their informed consent * surgery lasts more than 40 min. * history of psychopharmaceuticals or analgesics
sleep-disordered breathing in chronic thromboembolic pulmonary hypertension

Conditions: Chronic Thromboembolic Pulmonary Hypertension; Sleep Disordered Breathing

Summary: there is evidence for a high prevalence of sleep disorder breathing (sdb) in patients with chronic thromboembolic pulmonary hypertension (cteph). central sleep apnea, cheyne-stokes breathing and obstructive sleep apnea appear to occur in cteph. however, there is no information on the impact of cteph treatment modalities on concomitant sdb. furthermore, the use of pap therapy in cteph has not yet been investigated. cteph is a rare and serious disease and there may be a bidirectional association of sdb and cteph. this study plans to investigate the prevalence of sdb in cteph and compare it to datasets of large epidemiological studies on sdb. furthermore, the impact of cteph treatment on sdb will be analyzed and cteph patients for possible pap treatment will be defined.


Eligibility criteria:
inclusion criteria: * recently diagnosed untreated cteph * nyha i-iii exclusion criteria: * age\<18 * pulmonary hypertension other than cteph * previous diagnosis of sdb * ongoing pap treatment * use of nasal oxygen
combined basal-bolus insulin and post-exercise carbohydrate feeding strategy in t1dm

Conditions: Type 1 Diabetes Mellitus

Summary: the investigators hypothesise that reducing basal insulin dose (glargine, lantus, sanofi-aventis, or detemir, levemir, novo nordisk), whilst employing current carbohydrate feeding and rapid-acting insulin dose recommendations will protect patients with type 1 diabetes from early- and late-onset hypoglycaemia following evening time exercise.


Eligibility criteria:
inclusion criteria: * aged between 18-50 years old (male or female). * free from any diabetes related complications (apart from mild background diabetic retinopathy). * hba1c \<8.5%. * not taking any prescribed medication other than insulin, and treated with a stable insulin regimen composed of a combination of slow/long acting insulin (glargine or detemir) and fast-acting insulin analogues (lispro or aspart), for a minimum of 6 months before the start of the study. * demonstrate normal cardiac function in response to exercise. exclusion criteria: * aged younger than 18, or older than 50 years. * suffering from, or diagnosed with a diabetes related complication (apart from mild background diabetic retinopathy). * hba1c \>8.5%. * currently taking prescribed medication, and not currently treated with a stable basal bolus regimen composed of a combination glargine or determir, and lispro or aspart for at least 6 months before the start of the study. * failure to demonstrate normal cardiopulmonary responses during exercise, or have a medical condition which could prevent completion of exercise or be exacerbated because of.

Keywords: t1dm, exercise, hypoglycaemia
plant cell expressed recombinant human glucocerebrosidase extension trial

Conditions: Gaucher Disease

Summary: gaucher disease, the most prevalent lysosomal storage disorder, is caused by mutations in the human glucocerebrosidase gene (gcd) leading to reduced activity of the lysosomal enzyme glucocerebrosidase and thereby to the accumulation of substrate glucocerebroside (glccer) in the cells of the monocyte-macrophage system. this is an extension trial to study nct00376168 and nct00712348.

this will be a multi-center, double-blind, parallel group, extension trial to assess the safety and efficacy of prgcd in patients completing nct00376168. patients will receive iv infusion of prgcd every two weeks at the selected medical center. the duration of the extension study will be fifteen months. there will be two treatment groups: 30 units/kg every 2 weeks or 60 units/kg every 2 weeks.

Eligibility criteria:
inclusion criteria: * successful completion of protocol pb-06-001 * the patient signs informed consent exclusion criteria: * currently taking another experimental drug for any condition * presence of severe neurological signs and symptoms, defined as complete ocular paralysis, overt myoclonus or history of seizures, characteristic of neuronopathic gaucher disease * pregnant or nursing * presence of any medical, emotional, behavioral or psychological condition that in the judgment of the investigator would interfere with the patient's compliance with the requirements of the study

Keywords: gaucher disease enzyme replacement therapy
do patients suffering a cardiac arrest present to the ambulance service with symptoms in the preceeding 48hrs?

Conditions: Cardiac Arrest

Summary: a cardiac arrest is often preceeded by a varying period of physiological deterioration which if acted upon may prevent the cardiac arrest. we aim to review patients presenting to the ambulance service with cardiac arrest so see if they had contacted the ambulance service in the preceeding 48 hrs to understand if warning symptoms were missed or not acted upon appropriately.

the uk ambulance services are called to attend 60,000 out-of-hospital cardiac arrests (ohca) each year. hospital studies have shown that many patients who suffer an in-hospital cardiac arrest (ihca) have been deteriorating for the preceeding 48 hrs and suggest that many ihca are potentially avoidable if this deterioration is identified and actued on promptly. no similar study has been performed to see if patients suffering ohca have also presented with warning signs in the preceeding 48 hrs that were overlooked.

Eligibility criteria:
inclusion criteria: • all patients seen by scas ambulance crews and suffering a cardiac arrest within the following 48 hrs exclusion criteria: • none

Keywords: cardiac arrest ambulance triage deterioration