Kornimate/medical-research-clean huggingface dataset:
a family-centered intervention when a parent is cared for in specialized homecare

Conditions: Palliative Care

Summary: the overall purpose of this project is to evaluate a family-centered intervention (the family talk intervention, by w. beardslee) in families where a parent of children aged 6-19 years is seriously ill and cared for in specialized homecare. the aims of the intervention are to increase family communication, the families' awareness of the impending death and their knowledge about the cancer illness, and thereby reduce the family members' long-term psychological distress.

the death of a parent is one of the most traumatic events that can happen to a child. in our previous research, we have found that a lack of medical knowledge, communication and awareness of impending death increased long-term psychological morbidity among bereaved family members. unfortunately, very few clinical interventions in palliative care have been conducted in sweden.there is therefore a need to develop and evaluate interventions that aim to decrease the risk for psychological morbidity in families affected loss. the overall purpose of this project is to evaluate a family-centered intervention (the family talk intervention, by w. beardslee) in families where a parent of children aged 6-19 years is seriously ill and cared for in specialized homecare. the aims of the intervention are to increase family communication, the families' awareness of the impending death and their knowledge about the cancer illness, and thereby reduce the family members' long-term psychological distress. this study is a family-based intervention study among families where a parent of young children is seriously ill. it involves an intervention group and a comparison group. the two groups will consist of families where the seriously ill parent has at least one child in the age range 6-19 years. around thirty families will be recruited by two interventionists through two specialized homecare unit in stockholm and this is expected to take about 18 months. families in the comparison group (n=30) will be recruited by a research member at two other specialized homecare units in the stockholm area. the effect of the intervention will be measured by questionnaires to both parents and children. questionnaire data collection will be conducted before the intervention is started (baseline, for both intervention and control group). after two months there will be a follow-up for both groups. the next follow-up for both groups will be performed one year after the baseline. in order to examine the meaning of the intervention for all family members and the study-feasibility we are planning to conduct interviews after meeting 5. interviews with the whole family respectively each family members will be conducted.

Eligibility criteria:
inclusion criteria: * at least one child in the family 6-19 years * speaking and understanding swedish * one parent with severe illness or dying exclusion criteria: * if the family is in need of interpreter

Keywords: intervention support program family centered parental death
extraction routes of intraocular foreign body

Conditions: Intraocular Foreign Body

Summary: intra ocular foreign body removal is indicated to avoid further many complications such as retinal detachment, endophthalmitis. the surgical approach for a posterior segment iofb is pars plana vitrectomy and its extraction either through the pars plana. our study is to compare limbal route versus pars plana route for extraction of posterior segment iofb associated with cataract as regard to safety and complications.

penetrating ocular injuries with retained posterior segment intraocular foreign body (iofb) are relatively common and account for 17% to 41% of ocular injuries. intra ocular foreign body removal is indicated to avoid further many complications such as retinal detachment, endophthalmitis, retinal toxicity (secondary to chalcosis, siderosis) and sympathetic ophthalmia. the surgical approach for a posterior segment iofb is pars plana vitrectomy (ppv) and its extraction either through the pars plana or the limbus. ppv and iofb extraction through sclerotomy is the most commonly used approach. most commonly retained posterior segment intra ocular foreign bodies (iofb) are removed after enlarging one of the sclerotomy ports during pars plana vitrectomy. intra operative complications reported during iofb extraction were hypotony, vitreous hemorrhage, incarceration of the retina in the wound, iofb slippage. reported post-operative complications were glaucoma and retinal detachment. incidence of post-operative rd was reported to range from 22% to 79% with poor visual outcomes in most cases ppv and iofb extraction through the limbal route is an alternative approach to remove iofb. complications reported were less frequent and include microscopic hyphema and vitreous hemorrhage. the incidence of post-operative retinal detachment after iofb extraction through limbus was reported to range from 7.15% to 27.7 % the limbal route for retained posterior segment iofb extraction can offer the following advantages: it allows visually controlled delivery of the iofb from the posterior pole to the limbal exit and it has no relation to the vitreous base, thus minimizing the risk of creating a peripheral retinal break during extraction of intraocular foreign body, in contrast to the hidden part behind the iris when using the pars plana route.

Eligibility criteria:
inclusion criteria: * eyes with retained posterior segment intraocular foreign body associated with crystalline lens injury. * eyes with retained posterior segment intraocular foreign body associated with coexisting cataract. exclusion criteria: * eyes with pre-operative retinal detachment * eyes with retained posterior segment iofb with clear lens. * anterior segment iofbs * severely damaged eyes with an initial visual acuity of no light perception where enucleation is the primary treatment * patients with severely traumatized cornea which can affect visualization during vitrectomy. * pseudophakic eyes. * eyes with endophthalmitis
accelerometer sensing for micra av study

Conditions: AV Block; AV Block Complete; 3rd Degree Heart Block; Complete Heart Block

Summary: the purpose of the accelav study is to characterize chronic av synchrony in subjects implanted with micratm av device. this study will be conducted upon market approval of the micratm av transcatheter pacing system.

the accel av study is a prospective, single-arm, global, multi-center clinical study to characterize the chronic av synchrony in subjects implanted with the market released micra av system. the study is planned to be conducted in the us and hong kong. overall, the study is expected to be conducted at approximately 20 centers.the expected total study duration is approximately 12-15 months, representing the time necessary to enroll the target sample size and to complete the 3-month follow-up visit.

Eligibility criteria:
inclusion criteria: subject will be implanted with a micratm (model mc1avr1) for an approved indication. * subject has history of av block. * subject is ≥ 18 years old and as per required local law. * subject (and/or witness as applicable per local regulations) provides signed and dated authorization and/or consent per institution and local requirements. * subject is willing and able to comply with the protocol. exclusion criteria: * subject currently enrolled or planning to participate in a potentially confounding drug or device trial during the study. co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the medtronic clinical research specialist. * subject implanted with a micratm (model mc1avr1) on a non-permanent basis (e.g. cied infection). * subject is pregnant (if required by local law, women of child-bearing potential must undergo a pregnancy test within seven days prior to micratm model mc1avr1 implant procedures). * subject meets any exclusion criteria required by local law (age or other).

Keywords: av synchrony micra av micra transcatheter pacing normal sinus node function leadless pacemaker
evaluate the effect of alln-177 in reducing urinary oxalate in patients with hyperoxaluria and kidney stones

Conditions: Secondary Hyperoxaluria; Nephrolithiasis; Kidney Stones; Hyperoxaluria; Dietary Hyperoxaluria

Summary: the purpose of this study is to evaluate the safety, tolerability, and efficacy of different doses of alln 177 for reducing urinary oxalate excretion in patients with secondary hyperoxaluria and recurrent kidney stones.

this is a multicenter, randomized, double-blind, placebo controlled study to evaluate the efficacy of alln 177 compared with placebo in reducing the urinary excretion of oxalate in subjects with secondary hyperoxaluria and kidney stones. alln-177 is an orally administered form of oxalate decarboxylase. the goal of therapy with alln-177 is to reduce urinary oxalate excretion by decreasing the absorption of oxalate from the gastrointestinal tract. eligible subjects will be randomized to 7 days of treatment with a dose alln-177 or placebo and following a washout period, crossed over to an alternate treatment. urinary oxalate excretion will be assessed by 24-hr urine collections throughout the study. the study allows for up to 60 subjects.

Eligibility criteria:
inclusion criteria: * history of enteric or idiopathic hyperoxaluria and at least one kidney stone within the past 2 years * hyperoxaluria at screening * may be taking drugs for the prevention of stone disease exclusion criteria: * hyperuricosuria * glomerular filtration rate \< 55 ml/min/1.73m2 * hypercalcemia or hypothyroidism * obstructive uropathy, chronic urosepsis, renal failure, renal tubular acidosis, primary hyperparathyroidism, primary hyperoxaluria, pure uric acid and cystine stones, and/or medullary sponge kidney * treatment with cholestyramine * average daily dietary intake of oxalate \<75 mg per day

Keywords: kidney stones nephrolithiasis urine oxalate hyperoxaluria enteric hyperoxaluria idiopathic hyperoxaluria urological diseases kidney diseases dietary oxalate
comparison of blood pressure control achieved in antihypertensive or generic drugs in moderate to severe hypertensive patients

Conditions: Hypertension

Summary: despite a large diffusion for generic anti-hypertensive, they are not currently used. clinical validation studies could be better to convince users and prescribers than pharmacologic validation only. a pragmatic study to evaluate generic anti-hypertensive efficacy is proposed. it takes place in real conditions of care for hypertensive patients, for a manometer control criteria. the aim of the study is to test the hypothesis of non-inferiority for generic anti-hypertensive for blood pressure control.

list of drugs : aldactone, flumach, spiroctan, spironone, fludex, indaten, lasilix, tenstaten, aldactazine, prinactizide, spiroctazine, moduretic, avlocardyl, hemipralon, sthasin, betatop, tenormine, celectol, detensiel, felsan, kerlone, ragon, ronalol, lopressor, seloken, nebilox, temerit, neverol, sectral, acuitel, korec, briem, cibacene, coversyl, captolane, lopril, fozitec, odrik, gopten, prinivil, zestril, renitec, teoula, zofenil, triatec, kenomon, adalate, chronoadalate, amlor, baypress, deltazen, dilrene, diacor, mono tildiem, flodil, iperten, isoptine, lercan, zanidip, ledelcarberdipe, lenibercardipe, diberlepidine, xilermis, aprovel, crisarters, ifirmasta, fluppe, zelmirb, atacand, kenzen, karbis, cozaar, loberasnat, lotanbersar, micardis, pritor, tolura, zanacodar, dinortes, mirpresoc, nisis, tareg, cuenca, tifival, vagrecor, vamadrid, hyperium, physiotens, bipreterax, preterax, lodoz, wytens, acuilix, koretic, briazide, cibadrex, captea, ecazide, corenitec, enalavis, enaluretic, cotriatec, radouche, foziretic, prinzide, zestoretic, coaprovel, ifirmacombi, cocrisarters, cokenzen, hytacand, coanhyva, cohesan , cotareg, nisisco, fortzaar, hyzaar, micardisplus, pritorplus, maressi, tolucombi, tenordate, beta adalate

Eligibility criteria:
inclusion criteria: * hypertensive patient known and treated taking at least two antihypertensive * anti-hypertension treatment available in generic form * absence of changes in the anti-hypertension treatment during the previous 3 months exclusion criteria: * patients on dialysis * patients with cardiac arrhythmia * patient refusing ambulatory blood pressure
stress echocardiography in the detection of pulmonary arterial hypertension in systemic sclerosis patients

Conditions: Scleroderma, Systemic; Hypertension, Pulmonary

Summary: the purpose of this study is to assess the value in terms of sensitivity, specificity and likelihood ratio of the stress echocardiography in the screening of pulmonary arterial hypertension in patients with systemic sclerosis and indirect signs of pulmonary arterial hypertension.

pulmonary artery catheterization (rest and exertion) and treadmill stress echocardiography will be done to all patients of the study.

Eligibility criteria:
inclusion criteria: * at least one of the prespecified indirect sign of pulmonary arterial hypertension * able to exercise on treadmill exclusion criteria: * left ventricular dysfunction at rest * absence of pulmonary regurgitant flow * pregnancy or breastfeeding * smoking with \> 60 pack-year

Keywords: echocardiography, stress right heart catheterization
trial of postoperative chemoradiotherapy with or without consolidation chemotherapy for cervical cancer patients

Conditions: Cervical Cancer

Summary: the purpose of this study is to determine the efficacy and safety of consolidation chemotherapy with paclitaxel plus cisplatin (2 cycles per 3 weeks) following radical hysterectomy and adjuvant chemoradiation (2 cycles per 4 weeks) for high risk early stage cervical cancer.

cervical carcinoma is one of the most common gynecologic cancers worldwide. early stage cervical cancer can be treated effectively with either radiotherapy or radical hysterectomy plus pelvic lymph node dissection. however, several pathological risk factors, such as lymph node metastasis, the involvement of vaginal resection margin, and the parametrial invasion, have been identified to compromise the patient prognosis. concurrent radiotherapy with cisplatin-based chemotherapy has become the standard treatment for patients with cervical cancer. however, many patients with pathological risk factors treated with concurrent radiotherapy plus single agent cisplatin still suffered from the local or distant relapse. how to improve the treatment outcome of these patients is a very important issue and requires further clinical investigation. paclitaxel has been demonstrated to be a good radiosensitizer. in addition, paclitaxel/cisplatin combination chemotherapy was demonstrated to have superior progression-free survival than platinum alone in some phase ⅱ studies. in addition, it is not yet known whether chemotherapy and radiation therapy are more effective when given with consolidation chemotherapy in treating cervical cancer. therefore, the investigators are going to perform the efficacy and safety study of postoperative concurrent paclitaxel/cisplatin chemotherapy and radiotherapy with consolidation chemotherapy in high-risk patients with early-stage cervical cancer following radical hysterectomy.

Eligibility criteria:
inclusion criteria: * undertaken radical hysterectomy with diagnosis of invasive cervical cancer i a2-ii b (non-small cell type) * one or more risk factors (lymph node involvement, resection margin involvement, parametrial involvement) * eastern cooperative oncology group 0-2 * expected life span over 6 months. * no distant metastasis * adequate bone marrow functions (absolute neutrophil count≥ 1,500/ul, blood platelet≥ 100,000/ul, haemoglobin≥ 10g/dl) * adequate renal functions(serum creatinine ≤ 1.5mg/dl) * adequate liver functions (serum bilirubin ≤ 1.5mg/dl, aspartate aminotransferase/alanine aminotransferase ≤ 3 times(normal value) * written informed consent exclusion criteria: * previous history of chemotherapy or radiation * hypersensitive reaction to platinum/paclitaxel agent * history of other cancer * concurrent systemic illness not appropriate for chemotherapy * active infection requiring antibiotics * pregnancy * metastasis to paraaortic lymph node

Keywords: cervical cancer radiotherapy postoperative therapy chemotherapy
impact on the oxidative stress of the different analogues of insulin in people with type 1 diabetes. (ineox study)

Conditions: Type 1 Diabetes Mellitus

Summary: this study evaluates in a group of people with dm 1 the influence in parameters of oxidative stress of the treatments with the different current analogs of insulin

to evaluate by a randomized study in a group of people with dm 1 the influence in parameters of oxidative stress of the treatments with the different current analogs of insulin by analyzing: 1. - the circulating levels of oxidative stress markers: a) anti oxidation: total antioxidant capacity (cat), b) oxidation: 8-iso-prostaglandin f2 alpha (8-iso-pgf2α), acid reactive substances thiobarbituric (tbars) and ldl-oxidized. 2. - the relationship between glycemic control variables (hba1c and mean glycemia) and variability (standard deviation (sd), coefficient of variation (cv), and mage (mean amplitude of glycemic excursions) and oxidative stress parameters analyzed. goal 2: study the activation of cellular pathways associated with processes and oxidation states, by means of a array of expression of up to 50 genes encoding oxidative stress response genes as cpt1a (carnitine palmitoyl transferase 1a, mitochondrial oxidizing b limiting enzyme), tas (fatty acyl synthetase), acetyl-coa carboxylase, acadm (medium chain acyl dehydrogenase), acadl (long chain acyl dehydrogenase), acadvl (long chain acyl coa dehydrogenase), sod1, hmox1 and glutamine-cysteine ligase (gclc).

Eligibility criteria:
inclusion criteria: * age between 18 years and 65 years (inclusive). * dm1 of more than two years of evolution with habitual follow-up in the diabetes unit of the university regional hospital of malaga. * hba1c ≤ 10% * intensive treatment with basal mdi - bowl for more than 12 months prior to the start of study. * gives informed consent. exclusion criteria: * chronic kidney disease, liver disease, thyroid dysfunction (except hypothyroidism correctly treated and controlled). * pregnancy or pregnancy planning. * diabetes mellitus type 2. * hyperuricemia (uric acid ≥7 mg / dl at the time of inclusion or current treatment with allopurinol). * absence of collaboration (informed consent).

Keywords: oxidation insulin analogues type 1 diabetes mellitus
a study to evaluate d-1553 in combination therapy in non-small cell lung cancer

Conditions: NSCLC

Summary: this is a phase 1b/2 study to evaluate the safety, tolerability, pharmacokinetics and efficacy of d-1553 combination therapy in subjects with kras g12c-mutated locally advanced or metastatic non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * subject with histologically proven, locally advanced or metastatic nsclc for which has no standard treatment or the subject has been previously treated with first- or second-line systemic therapy. * subject has krasg12c mutation in tumor tissue or other biospecimens containing cancer cells or dna. historical, local laboratory result (up to 5 years prior to this study) can be used for phase 1 subjects. phase 2 subjects must be tested for krasg12c mutation by a local laboratory. * subject has measurable disease according to recist v1.1. for phase 1b subjects who have no measurable lesions but whose disease can be evaluated are also acceptable. exclusion criteria: * subject with unstable or progressive central nervous system (cns) metastases. * subjects with clinically significant cardiovascular disease. * subject with interstitial lung disease (ild) or any active systemic infection including but not limited to severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection. * subject has impaired gastrointestinal (gi) function or gi diseases that may significantly alter the absorption or metabolism of oral medications. * subject is pregnant or lactating.
effect of transportation method on preoperative anxiety in children

Conditions: Anxiety; Child Behavior

Summary: to evaluate the effect of wagon for transporting vehicle instead of standard stretcher car for reducing preoperative children's anxiety.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologist physical status i * scheduled for elective surgery under general anesthesia exclusion criteria: * history of anesthesia or surgery * developmental delay * weighing over than 38kg * severe pain * administrated psychotomimetic drug
a feasibility study on prediction of an icd shock by icd-derived data

Conditions: Sudden Cardiac Arrest; Ventricular Tachycardia; Ventricular Fibrillation

Summary: the primary hypothesis is that an icd shock may be predicted days in advance by a combined score derived from different data obtainable from the icd


Eligibility criteria:
inclusion criteria: 1. age ≧ 18 and ≦ 80 2. patients have documented spontaneous and sustained ventricular arrhythmias in the last six months prior to the enrollment 3. patients who are in sinus rhythm, have dual-chamber icd or crt-d implanted at least one month before enrollment 4. patients who are in atrial fibrillation, have single-chamber icd or crt-d implanted at least one month before enrollment 5. patients who are compliant to carelink follow-up exclusion criteria: 1. patients who are pregnant 2. patients who are incapable of giving consent to the study 3. patients who have a life-expectancy of less than 2 years

Keywords: implantable-cardioverter-defibrillator ventricular tachycardia ventricular fibrillation sudden cardiac arrest
effect of an educational program on health-related outcomes of patients with dry eye syndrome

Conditions: Dry Eye Syndrome

Summary: dry eye syndrome (des) is a widespread ocular disease affecting the general population. it is a complex disorder affecting the surface of the eye, marked by an imbalance in the tear film and ocular symptoms. therefore this study was done to determine the effect of an educational program on health-related outcomes of patients with des including the severity of symptoms related to des and their influence on visual-related functions

dry eye syndrome (des) is a prevalent chronic, inflammation resulting in eye discomfort, irritation, tiredness, and visual abnormalities that can make it difficult to read, use a computer, drive, or engage in other activities (1). it represents a set of tears film disorders caused by decreased tears formation or increased tears evaporation; it causes visual symptoms, ocular surface inflammation, and discomfort. in addition, des leads to impaired visual function and can negatively affect the outcomes of cataract surgery (2).therefore this study was done to determine the effect of an educational program on health-related outcomes of patients with des including the severity of symptoms related to des and their influence on visual-related functions

Eligibility criteria:
inclusion criteria: * age: 20 to 60 years old. * alert, and able to communicate. exclusion criteria: * patients with recent ocular surgeries in the last 3 months