Kornimate/medical-research-clean huggingface dataset:
necessity of using pleural drainage tubes after ima harvesting during cardiac surgery

Conditions: Pleural Effusions Post Coronary Artery Bypass Graft

Summary: this prospective randomized controlled trial will examine the efficacy of reducing the number of chest tubes used in the postoperative cardiac surgery patient. typically used are three chest tubes - two in the mediastinum and one in the pleural space, if opened. the investigators propose that removal of the pleural tube will not impact the rates of clinically significant pleural effusions post cardiac surgery. patients will be randomized into two groups - one receiving the standard three chest tubes (standard), and the other receiving only mediastinal drains (experimental). the primary outcome will be rates of post-operative pleural effusions as determined by defined interventions, including insertion of a chest tube, thoracentesis, or return to the operating room for primary evacuation of pleural effusion or hemothorax. secondary outcomes include length of hospital stay, length of mechanical ventilation, postoperative respiratory status, and presence/size of pleural effusions, as well as readmission for pleural effusion.


Eligibility criteria:
inclusion criteria: * patients must be undergoing cabg at our institution with the attempted harvest of a lima and/or rima * pleura must be entered in order for patients to be included. exclusion criteria: * cardiac surgery where the pleura is not entered * previous surgery where the pleura was entered * other pre-existing pleural diseases or fibrosis * patients currently participating in other studies * patients presenting with emergent need for bypass
adhepta study: adherence questionnaire in hepatitis c

Conditions: Hepatitis C, Chronic; HIV Infection

Summary: main objective: to study and validate a questionnaire measuring treatment adherence in patients with hepatitis c virus (hcv) infection. design of the study: multicentric, prospective, epidemiological study in the field of usual clinical practice.


Eligibility criteria:
inclusion criteria: * ambulatory patient infected by hcv according to diagnosis criteria used en usual clinical practice. * patient no treated previously and beginning a treatment for hcv. * patient that signed the informed consent to participate in the study. * group a: patient with hcv monoinfection. * group b: patient with hcv and hcv co-infection (according to diagnosis criteria used en usual clinical practice). exclusion criteria: * patient that received previous treatment for hcv. * patient that is going to participate in a clinical trial turing the hcv treatment period. * patient with cognitive impairment or patient unable to understand and answer the auto-administered questionnaire. * patient unable to read or write spanish.

Keywords: hepatitis c, chronic hiv infection medication adherence questionnaire design treatment experienced
effect of virtual reality glasses in the arteriovenous fistule cannulation processon paın and patient satisfaction

Conditions: Arteriovenous Fistula

Summary: this research was conducted as a randomized controlled experimental study aiming to determine the impact of virtual reality glasses used in the avf process on the pain felt by patients and patient satisfaction.

chronic kidney disease (ckd) is a progressive, irreversible renal disease in which the ability of the body to maintain the balance of metabolism, fluid and electrolytes fails. chronic kidney disease (ckd) is one of the major health problems with an increasing prevalence in the world. hemodialysis as one of the most common methods of renal replacement therapy is a stressful procedure despite to maintain the survival of patients with chronic kidney disease that permanent and safe vascular access is one of the requirements of a successful hemodialysis. the pain of avf puncture is common among the patients undergoing hd as acute and chronic pain which reported in more than 82% and 92% of them, respectively. experience of the arteriovenous fistula puncture-related pain can have unpleasant effects on the patients, it causes that hemodialysis patients experience more disability, depression, irritability, and insomnia than other patients in adapting to stress. experiencing continued pain can also affect the level of hemodialysis acceptance in patients and ultimately decrease quality of life. therefore, pain control is an important priority in these patients.

Eligibility criteria:
inclusion criteria: * receiving hd treatment * open to communication * fully oriented * without vision, hearing and perception problems * without any psychiatric illness * without a history of seizures such as epilepsy * hd treatment administered via avf * i̇n the last day, no injection was made into any artery or vein from the place where the intervention will be performed * without any signs of infection such as redness, swelling, open wound in the area where the intervention will be performed * standardized mini mental test value is 24 points and above * one-time needle attempt from av exclusion criteria: * refusing to participate in the study * under the age of 18 * can't speak turkish * closed to communication and not fully oriented * visual, hearing and perception problems * any psychiatric illness * having a history of seizures such as epilepsy * hd treatment not administered via avf * injection into any artery or vein from the place where the intervention will be performed in the last day, * any signs of infection such as redness, swelling, open wound in the area to be operated * using any pain medication before the procedure on the same day * smmt value below 24 in patients over 65 years of age * cannulation procedure not performed with a 16 g avf needle * patients with multiple injections from the avf

Keywords: virtual reality glasses nursing pain patient satisfaction
a study to investigate atezolizumab subcutaneous in patients with previously treated locally advanced or metastatic non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: this study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (sc) compared with atezolizumab intravenous (iv) in participants with locally advanced or metastatic non-small cell lung cancer (nsclc) who have not been exposed to cancer immunotherapy (cit) and for whom prior platinum-based therapy has failed. the study is comprised of two parts, as follows: a dose-finding part (part 1, phase ib) will aim to identify the dose of atezolizumab sc to be tested in part 2. a dose-confirmation part (part 2, phase iii, randomized) will aim to confirm that the dose moved forward from part 1 yields drug exposure that is comparable to that of atezolizumab iv.


Eligibility criteria:
inclusion criteria: * histologically or cytologically documented locally advanced or metastatic nsclc * prior platinum-containing regimen or disease recurrence ≤ 6 months since prior platinum-based adjuvant/neoadjuvant regimen. * measurable disease as defined by recist v1.1 * eastern cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy ≥12 weeks * adequate hematologic and end-organ function additional inclusion criteria (part 2 only) • availability of tissue and known epidermal growth factor receptor (egfr) status exclusion criteria: * symptomatic, untreated, or actively progressing central nervous system (cns) metastases * uncontrolled or symptomatic hypercalcemia * pregnancy or breastfeeding * active or history of autoimmune disease or immune deficiency * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis * severe infection ≤ 4 weeks * treatment with therapeutic oral or iv antibiotics ≤ 2 weeks prior to study treatment * significant cardiovascular disease * prior allogeneic stem cell or solid organ transplantation * treatment with a live, attenuated vaccine ≤ 4 weeks * treatment with systemic immunostimulatory agents ≤ 4 weeks or 5 half-lives of the drug * treatment with systemic immunosuppressive medication ≤ 2 weeks additional exclusion criteria (part 2 only) • tested tumor programmed death-ligand-1 (pd-l1) expression status with an intention to treat the patient if positive
finistere myeloma observatory (omyfin)

Conditions: Multiple Myeloma

Summary: current molecular risk stratification of multiple myeloma (mm), based on the presence of t(4 ;14) and 17p deletion, cannot fully explain treatment outcome heterogeneity, as other features also predict prognosis. about 30% of genetic events map to chromosome 1 : most upregulated genes to 1q and most downregulated ones to 1p. cks1b gains on 1q21 and cdkn2c loss on 1p32, both favoring cell cycle progression, portended impaired outcome in many but not all studies. based on their recurrence and considering their functional convergence, we hypothesized cks1b/cdkn2c copy number ratio to be a risk factor fitter than each aberration alone.

this single-center retrospective study, is designed to enroll all consecutive newly diagnosed adult patients aged ≥18 years, transplant-eligible and not. all patients are routinely tested for cks1b and cdkn2c and treated according to consensus guidelines. data are being collected from 2012. for each subject, we calculate a fish-based ratio by cks1b on cdkn2c copy number : it is equal to 1 with no change in copy number and \>1 in case of cks1b gains, cdkn2c loss or both. in patients with cdkn2c biallelic loss, the ratio is not equal to 0, but to cks1b copy number, as functional consequence should prevail over arithmetic result. we will, then, analyze separately the impact of cks1b gains, cdkn2c loss and cks1b/cdkn2c ratio on pfs and os.

Eligibility criteria:
inclusion criteria: * age at or over 18 years * symptomatic multiple myeloma * informed consent given * fish-based cytogenetic results obtained exclusion criteria: * age under 18 years * mgus or smm * no informed consent * no fish-based cytogenetic results
safety, tolerability, pharmacokinetics and pharmacodynamics of sparc1316

Conditions: Asthma

Summary: sun pharma advanced research company limited has developed a dry powder inhaler of compound sparc1316 for oral inhalation. this clinical study is a phase i/iia study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of s0597 administered by oral inhalation to healthy volunteers and asthma patients.


Eligibility criteria:
inclusion criteria: * subjects willing to provide informed consent * male or female subjects aged 18 to 65 years inclusive * body mass index (bmi) between 18.0 and 30.0 kg/m2 inclusive * non-smokers or ex-smokers exclusion criteria: * subjects with a supine systolic blood pressure ≥160 mmhg and/or a supine diastolic blood pressure ≥100 mmhg * subjects who have a significant infection or known inflammatory process on screening or admission. * subjects who are unlikely to co-operate with the requirements of the study. * positive serology for infectious disease (hepatitisb or c , hiv) at screening

Keywords: pharmacokinetics, pharmacodynamics, asthma
preoperative optimization of cardiac valve patients' expectations

Conditions: Cardiac Valve Disease

Summary: recovery after surgery depends on psychological factors such as preoperative information, expectations and surgery-associated anxiety. prior studies have shown that even short preoperative psychological interventions can improve postoperative outcomes in heart surgery patients. however, what content works best for which patient group and how long an intervention has to be is still largely unknown. the aims of this study are thus to examine if the developed preoperative psychological intervention (i) reduces preoperative anxiety, (ii) increases positive expectations, and (iii) improves the long-term outcome postoperative recovery. therefore, a brief intervention has been developed. heart valve patients who undergo a heart surgery will be randomized into two groups (control vs. intervention group) after baseline assessment. following this the intervention group will participate in the psychological intervention (30-40 minutes). to increase patients' positive expectations the intervention will focus on treatment outcome expectations and personal control expectations. furthermore, patients in the intervention group will have two booster-telephone calls (four and eight weeks after the surgery) to check if their developed plans work out. the control group will receive the standard medical procedure. both groups will fill out questionnaires again at the evening before the surgery, around one week after the surgery and three months after surgery.


Eligibility criteria:
inclusion criteria: * patients who are scheduled for elective cardiac valve procedure * age 18 or above * fluency in german * informed consent exclusion criteria: * comorbid medical/psychiatric condition that causes more extensive disability than the coronary condition * participation in other research programs: in agreement with coordinating investigator patient can participate substudies, if this do not interfere with the main study * emergency surgery

Keywords: expectations preoperative intervention placebo effect cardiac valve surgery clinical trial recovery
tolerability study of xerecept® in pediatric patients

Conditions: Brain Edema; Brain Tumor

Summary: this study is being conducted to evaluate the safety and tolerability of xerecept® in children with central nervous system tumors and to identify appropriate doses of xerecept® to be used in subsequent pediatric clinical trials.

steroid-related side effects are much more severe in a pediatric population than they are in adults. the side effects appear more quickly and are often apparent in as few as 14 days. dexamethasone side effects in children include rounding of the face, acne, increased body hair, muscle weakness, osteoporosis, mood changes, weight gain, fluid retention, glucose instability, high blood pressure, increased susceptibility to infection, stunted growth and aseptic necrosis of the hip joints14-16. although extensive studies have been performed with xerecept® in adults, no studies have been performed with xerecept® in pediatric subjects. therefore, this study is being conducted to evaluate the safety and tolerability of xerecept® in children with central nervous system tumors and to identify appropriate doses of xerecept® to be used in subsequent pediatric clinical trials. the study will also explore if xerecept®, when administered to pediatric patients, is effective in allowing decreases in dexamethasone dosing

Eligibility criteria:
inclusion criteria: 1. have histologically confirmed primary, recurrent or metastatic cerebral tumors and require chronic steroid dosing to manage symptoms of peritumoral brain edema (no histological confirmation is required of optic pathway tumors or brain stem gliomas) 2. have been taking dexamethasone (or equivalent) at a dose of ≥1 mg/day for a minimum of 14 days and have had a stable dose for at least 7 days. 3. have one or more steroid-associated side effects at screening (see appendix a1 for a list of qualifying events) 4. capable of self-administration of subcutaneous injections twice daily or availability of assistance from caregiver. 5. karnofsky/lansky performance status ≥ 40 6. life expectancy of at least 6 months 7. female subjects must not be pregnant or breast-feeding and, if of childbearing potential, must use adequate methods of contraception during the study 10. ability to provide written informed consent or, if unable to provide, have a legal guardian or representative provide written informed exclusion criteria: 1. evidence of previous or current overt renal, hepatic or pulmonary diseases or active uncontrolled infection 2. subject and/or parent/guardian is unwilling or unable to comply with this protocol 3. subject has a known history of allergy or intolerance to hcrf or other ingredients in the xerecept® solution (e.g., methionine, mannitol) 4. subject has a known history of hepatitis c virus, hepatitis b surface, or human immunodeficiency virus (hiv).

Keywords: peritumoral brain edema edema malignant brain tumor brain tumor dexamethasone decadron
saliva testing for high-risk human papillomavirus infection oral cavity and pharynx cancer

Conditions: Oropharyngeal Squamous Cell Carcinoma; Human Papillomavirus Infection

Summary: the purpose of this research study is to determine if saliva and oral swab samples can be used to detect human papillomavirus in patients with cancer. in this study, the methods required to detect human papillomavirus will be developed and tested in samples collected from patients with oropharyngeal squamous cell carcinoma and compared to samples collected from participants without cancer.

to validate the detection of human papillomavirus 16 and 18 and reference gene actb in saliva and buccal swab samples obtained from patients with oropharyngeal squamous cell carcinoma (opscc) using the lamp/crispr/electrochemical workflow.

Eligibility criteria:
inclusion criteria (patients with cancer); * patients must have histologically confirmed oropharyngeal squamous cell carcinoma without prior treatment. a pathology report should be referenced/available. * patients with p16 positive oropharyngeal squamous cell carcinoma. * age 39 to 59 years. * ability to understand and the willingness to sign an irb-approved informed consent document directly. inclusion criteria (healthy subjects) * age 39 to 59 years. * ability to understand and the willingness to sign an irb-approved informed consent document directly. exclusion criteria (patients with cancer) * patients with diagnoses of other cancers. * patients with current or previous diagnosis with hpv+ infection status for cervical cancer or other cancers. exclusion criteria (healthy subjects) * previous diagnosis of cervical cancer or other cancers. * presence of known active oral infections of viral, fungal, or bacterial etiology except for gingivitis, periodontitis, or periapical abscess. participants with known gingivitis, periodontitis, or periapical abscess are included.
long term tapering or standard steroids for nephrotic syndrome

Conditions: Nephrotic Syndrome

Summary: parallel group double blind randomised in patients with first episode corticosteroid sensitive nephrotic syndrome comparing time to relapse and adverse effects associated with a longer tapering steroid regimen with standard regime


Eligibility criteria:
inclusion criteria: * newly presenting nephrotic syndrome, urine albumin/protein creatinine ratio \>200mg/mmol on early morning urine sample, hypoalbuminemia (\<25g/l) exclusion criteria: * prior treatment with steroids or cytotoxic agents underlying systemic disorder or exposure to agents known to be associated with newly presenting steroid sensitive nephrotic syndrome
the evaluation clinical results of coronally advanced flap with platelet rich fibrin

Conditions: Root Coverage

Summary: the aim of this study was to evaluate the clinical outcomes of platelet- rich fibrin and coronally advanced flap technique in the treatment of multiple gingival recessions in comparison with connective tissue graft technique.

aim of this study was to evaluate the clinical outcomes of platelet rich fibrin (prf)+coronally advanced flap (caf) technique in the treatment of multiple gingival recessions in comparison with connective tissue graft (ctg)+caf technique.12 patients with bilateral miller class i multiple gingival recessions were treated with prf+caf (test group) and ctg+caf (control group) technique in a split-mouth study design. probing depth, recession depth (rd), clinical attachment level (cal), recession width, position of gingival margin, papilla width, keratinized tissue height (kth), keratinized tissue thickness (ktt) were measured at baseline and 3, 6 and 12 months after surgery. root coverage (rc) and complete root coverage (crc) ratios were evaluated post-operatively.

Eligibility criteria:
inclusion criteria: * patients had at two quadrants, adjacent miller class i and at least 2 mm or deeper recessions * full mouth plaque score 20% and full mouth bleeding on probing 10% * no active periodontal disease, * involving incisors, canines and premolars, * age ≥ 18 years exclusion criteria: * patients with general diseases which could affect healing process, * smokers * patients had undergone periodontal surgery during the pervious 24 months on the involved sites, * pregnant or breastfeeding women * endodontic lesions or non-detectable cemento-enamel junctions at experimental teeth

Keywords: gingival recession plastic surgery platelet rich fibrin connective tissue graft coronally advanced flap
treatment of polycythemia vera with gleevec

Conditions: Polycythemia Vera

Summary: the purpose of this research study is to evaluate the safety and effectiveness of patients with polycythemia vera treated with gleevec.

phlebotomy is a standard temporizing treatment for polycythemia vera. performing repeated phlebotomies may lead to iron deficiency and can contribute to a rising platelet count. this may create additional problems, such as clots particularly in patients older than 50. there is reason to believe that the use of gleevec may cause a decrease in the activity of the marrow so that patients may not require as many or any phlebotomies. thus, spleen function may possibly improve by decreasing in size and patients' platelet counts may also improve.

Eligibility criteria:
inclusion criteria: * patients have diagnosis of polycythemia vera (pv). patients may have newly diagnosed pv. * patients may have previously interferon-alfa treated pv with documented resistance, refractoriness or intolerance to interferon-alfa. * patients may have pv with inadequate control on hydroxyurea. * performance status of 0, 1, or 2 * adequate end organ function, defined as the following: 1. total bilirubin \<1.5 x upper limit of the normal range (uln) 2. sgot (ast) and sgpt (alt) \< 2.5 x uln 3. creatinine \< 1.5 x uln 4. anc \> 1.5 x 109/l * written voluntary informed consent. exclusion criteria: * female patients who are pregnant or breast-feeding. * patients receiving busulfan within 6 weeks of study day 1. * patients receiving interferon-alpha within 4 weeks of study day 1. * patients receiving hydroxyurea within 2 weeks of study day 1. * patients with grade iii or iv cardiac problems as defined by the new york heart association criteria. * patients with a history of non-compliance to medical regimens or who are considered potentially unreliable. * patients previously treated with gleevec. * serum erythropoietin level \> or = 25 units/microliter * abnormal o2 saturation (by pulse oximetry) or arterial po2 (by arterial blood gas).

Keywords: pv
correction of vitamin d deficiency and its effect on ovulation induction in women with pcos (video): a feasibility rct

Conditions: PCOS

Summary: recently, a special emphasis has recently been directed to the potential role of vitamin d and some regulatory peptides (e.g. adipokines and follistatin) and their associated metabolic roles and genetic factors in the development of pcos and its related co-morbidities. the aim of this study was to assess the feasibility of conducting a pragmatic rct assessing the effectiveness of adopting a protocol of screening for and correcting vitamin d deficiency in women with pcos seeking fertility treatment in a low/middle income care (lmic) setting

research question: in pcos patients, is there any effect of vitamin d testing and correction on ovulation induction in women with pcos? research hypothesis: there is effect of testing and correcting vitamin d status as regard ovulation in patients with pcos

Eligibility criteria:
inclusion criteria: * diagnosed pcos cases according to the national institute of health criteria (nih consensus criteria) and rotterdam criteria exclusion criteria: * 1- pcos patients not in child bearing age; less than 18 years or more than 45 years. 2- patients with congenital adrenal hyperplasia, androgen-secreting tumors, cushing's syndrome, hyperprolactinemia and virilizing ovarian or adrenal tumors. 3- pcos patients with any other medical illness. 4- pcos patients already on vitamin d supplements.

Keywords: pcos, vitamin d