Kornimate/medical-research-clean huggingface dataset:
is bone scintigraphy necessary in ct1n0m0 ggo non-small cell lung cancer? (ectop-1006)

Conditions: Bone Metastases

Summary: this is a clinical trial from eastern cooperative thoracic oncology project (ectop), numbered as ectop-1006. in this prospective one-arm observational study, bone scintigraphy will be performed in t1n0m0 nsclc patients with ggo lesion and other low risk factors of bone metastasis. the occurrence rate of bone metastasis in these patients will be analyzed to evaluate the necessity of bone scintigraphy in ct1n0m0 nsclc patients.

skeletal is a common metastatic site in patients with non-small cell lung cancer. the incidence of bone metastases is about 20-30％ in nsclc patients. according to the nccn guidelines, early lung cancer patients should also undergo bone scan or petct before surgery to determine the presence of bone metastases. however, all of the above methods use radionuclide reagents as tracers, which pose health hazards to patients and their contacts, including medical personnel. a retrospective study conducted by our center showed that only 0.95% of patients with ct1n0m0 non-small cell lung cancer had preoperative bone metastases. in patients with early stage lung cancer whose lesions are pure ground glass nodules, the probability of developing bone metastases is zero. the low risk factors for bone metastases from this retrospective study included preoperative examination of patients with cea \<5 ng/ul and no bone-related symptoms. in patients with primary nsclc who underwent cea \<5 ng/ul preoperatively, no bone metastases occurred; in patients with negative bone-related symptoms, the incidence of bone metastases was only 0.18%. in the case of such patients, if the bone scan is performed, not only the potential damage to the patient is increased, but also the waste of medical resources and the burden on the patient from the perspective of health economics. therefore, our center is expected to conduct this prospective one-arm observational clinical trial. according to the low-risk factors derived from retrospective studies, bone scintigraphy was performed in patients with ggo lesion and other low risk factors of bone metastasis, and the incidence of bone metastasis was obtained. the necessity of bone scintigraphy in ct1n0m0 nsclc patients would be evaluated. this trial is recognizes in our institute as "eastern cooperative thoracic oncology project (ectop-1006)"

Eligibility criteria:
inclusion criteria: 1. patients who sign the informed consent form and are willing to complete the study according to the plan; 2. age 18-80 years old; 3. ecog score ≤ 2 points; 4. ct shows that the main lesion is considered to be ground glass nodular lung cancer; 5. preoperative examination cea \<5ng/ul 6. there are no bone related symptoms 7. there is no obvious absolute surgical contraindication for preoperative examination. exclusion criteria: 1. history of bone related diseases. 2. history of other kinds of cancer
the party balloon assisted valsalva in diagnosis of superficial venous valvular reflux of lower limb

Conditions: Varicose Veins; Venous Insufficiency

Summary: this study was designed to compare the party balloon assisted valsalva with the conventional valsava for exhibiting the reverse venous flow in superficial venous valvular incompetence duplex examination.

in this study, we compared the party balloon assisted valsalva with conventional valsalva maneuver in diagnosis of superficial venous valvular reflux of lower limb by crossover study.

Eligibility criteria:
inclusion criteria: * age within 18-80 years old * visible gsv varicose veins * trendelenburg test part 1 - negative (perforator vein incompetence) and * trendelenburg test part 2 - positive (saphenofemoral junction competence) * consent to participate in the study. exclusion criteria: * - cvi from klippel-trenaunay syndrome, deep vein thrombosis (dvt), arteriovenous fistula (avf) * failure to language communication * previous heart disease (cad, myocardial infarction, stable angina, unstable angina, congestive heart failure, valvular heart disease) * previous lung disease (asthma, chronic obstructive pulmonary disease, bronchiectasia) * abnormalities of oral cavity which cannot hold own breath. (cleft lip, cleft palate)

Keywords: varicose veins venous insufficiency doppler duplex valsava
influence of remifentanil on postoperative sore throat in patients undergoing general anesthesia

Conditions: Hip Arthroplasty

Summary: this investigation is planned to compare the incidence and severity of postoperative sore throat according to the dose of remifentanil.


Eligibility criteria:
inclusion criteria: * asa i-iii * patients scheduled for general anesthesia with endotracheal intubation exclusion criteria: * difficult airway * rapid sequence induction * recent sore throat * recent upper respiratory infection * asthma * chronic obstructive pulmonary disease * chronic cough * pregnancy * allergy to remifentanil * friable teeth * history of head and neck surgery * multiple intubation attempts * regional anesthetic agents * gastric tube * dexamethasone

Keywords: intubation pharyngitis remifentanil
detection of circulating tumor cells in patients with sarcomas

Conditions: Leiomyosarcoma; Pleomorphic Liposarcoma; Synovial Sarcoma; Liposarcoma

Summary: the sarcomas represent 1% of all cancers in adults, 8% in adolescents and young people, and 10% in children. even though it is a rare cancer, it contributes to a significant loss of years of life in comparison with other types of cancer, due the fact that it affects children and young people. the diagnosis and treatment are difficult, considering the diversity and rarity of this disease. in addition, on average, more than 50% of patients with high-grade sarcoma present tumor relapse and distant recurrence is considered the main cause of death. the presence of circulating tumor cells (ctcs) in the blood of patients with sarcoma may be an early marker of tumor invasion, because it is known that the ctcs circulate in the blood for months or years before the development of metastases. the ctcs can be used to monitor the response of the tumor to treatment, in order to match time, dose, and type of therapy. objectives: collect blood from patients with different types of sarcoma (leiomyosarcoma, synovial sarcoma, pleomorphic sarcoma and liposarcoma) in order to isolate and quantify ctcs. the investigators also have an intention to identify genes of resistance to treatment in these cells.

methodology: this is a prospective study, to be made by whole blood collection from 40 patients with different types of sarcomas (leiomyosarcoma, pleomorphic sarcoma, synovial sarcoma and liposarcoma). the collections will be made in three different moments: before the beginning of the treatment, during and at the end of this (8 ml). blood samples will be processed and filtered on iset system for the isolation and quantification of ctcs. later, it will be performed immunocytochemistry (icq) single and/or double staining for protein assessment. the following proteins will be assessed: cd45, mrp1, mrp2 and mrp7. expected results: the investigators hope that this study can show if the ctcs can be used as "liquid biopsy" in patients with leiomyosarcoma, synovium and pleomorphic sarcoma and liposarcoma.

Eligibility criteria:
inclusion criteria: * 18 years or more; * types of sarcomas: leiomyosarcoma, pleomorphic sarcoma, synovial sarcoma and liposarcoma. * extension of the disease determined by physical examination and imaging; * measurable disease by recist criteria (response evaluation criteria in solid tumors); exclusion criteria: * patients who have undergone previous therapy in the last three weeks; * patients with a history of other cancer in the past two years.

Keywords: sarcomas immunocytochemistry circulating tumor cells
efficacy and safety of lactulose for bowel preparation in patients with inflammatory bowel disease

Conditions: IBD

Summary: the goal of this clinical trial is to evaluate the efficacy, safety and tolerability of lactulose in bowel preparation in ibd patients. the main question it aims to answer is: does lactulose have better efficacy, safety and tolerability than 3l-peg? participants will be divided into peg group or lactulose group at a 1:1 ratio by a random number method. each patient will get a leaflet provided by hospital introducing bowel preparation methods and diet restriction before bowel preparation. they will have bowel preparation with different drugs according to group. the grade of bowel cleansing will be assessed through the boston bowel preparation scale (bbps). the tolerability, satisfaction and safety of the two bowel preparation methods will be assessed through the patients self-administered questionnaires.


Eligibility criteria:
inclusion criteria: * all patients with confirmed ibd or suspected ibd for at least 3 months, aged between 16-75 years and requiring a colonoscopy are invited to participate in our study. the diagnosis of ibd is based on recognized standards, including clinical symptoms, endoscopy, radiology, pathology and surgical history. exclusion criteria: * patients are excluded if they (1) are clinical active uc and cd, (2) are known or suspected gastrointestinal obstruction, bowel perforation, toxic colitis or megacolon, recent or active gastrointestinal bleeding, (3) are congestive heart failure, severe renal failure, (4) are severe dehydration or electrolyte disturbances, (5) are pregnant, (6) are allergic to peg or lactulose, (7) are diabetics, (8) are lactose or galactose intolerance, (9) refuse to participate in this study.

Keywords: colonoscopy polyethylene glycol ibd bowel preparation lactulose
evaluating treatment continuation in telehealth patients receiving an automated patient-reported outcome tool

Conditions: Internet-based Intervention; Web-based Intervention; Online Intervention; Erectile Dysfunction; Telemedicine

Summary: engaging patients through integration of patient-reported outcome measures in routine clinical care can improve the patient experience and provide a systematic way to collect adverse event (ae) data. collecting these data on a large scale can inform new solutions to longstanding barriers to successful treatment such as medication non-adherence. this study evaluated whether implementing a patient-reported outcome data collection and ae surveillance tool would result in greater treatment continuation for patients receiving care on a telehealth platform. we evaluated how this data collection and surveillance tool - a short prompt for patients to provide information on treatment satisfaction and side effects - impacted the outcome of interest, treatment continuation. we tested two cycles in n=2,000 patients receiving care for erectile dysfunction on a telehealth platform using a randomized control experimental design and accounted for incidents where true randomization was not possible during implementation. the first cycle tested the tool alone, while the second cycle tested the tool in conjunction with a messaging template system that provided standardized side effect counseling.


Eligibility criteria:
inclusion criteria: * male patients living in the us, who were diagnosed with erectile dysfunction by a telehealth provider, and who were prescribed phosphodiesterase-5 (pde-5) inhibitors as treatment exclusion criteria: -
endobronchial mucosal biopsy in patients with suspected pulmonary sarcoidosis

Conditions: Endobronchial Mucosal Pathology in Pulmonary Sarcoidosis

Summary: this prospective interventional study was done between may and september 2020. we included 20 patients from the chest department, alexandria main university hospital (amuh) with the inclusion criteria of having suspected pulmonary sarcoidosis (based on clinical and radiological presentation) and being ≥18 years of age. the bronchoscopy procedure was done under local anesthesia. endobronchial biopsies and bronchoalveolar lavage were obtained.

this prospective interventional study was done between may and september 2020. we included 20 patients from the chest department, alexandria main university hospital (amuh) with the inclusion criteria of having suspected pulmonary sarcoidosis (based on clinical and radiological presentation) and being ≥18 years of age. the patients who had any contraindication for flexible bronchoscopy (e.g. severe refractory hypoxemia, hemodynamic instability, uncorrectable bleeding diathesis, recent myocardial infarction or unstable angina) were excluded. the study was approved by the institutional ethics committee and an informed consent was taken from all patients before participation in the study according to the guidelines of ethics committee, alexandria faculty of medicine. all included patients were subjected to the followings: 1)full history taking including age, sex, history of other diseases and the presenting symptoms, 2)clinical examination including general examination and local chest examination, 3)routine laboratory investigations including complete blood picture, renal function tests, prothrombin activity and international normalized ratio (inr), 4)radiological evaluation including plain x-ray postero-anterior view and ct chest with iv contrast and 5) the bronchoscopy procedure that was performed by two experienced bronchoscopists. the bronchoscopy procedure was done under local anesthesia with help of sedation by gradual doses of midazolam via the intravenous line. any abnormal endoscopic findings suggestive of endobronchial sarcoidosis were reported by the operators. bronchoalveolar lavage (bal) was obtained by endoscopic injection of at least 120 cc of sterile saline then suction of the whole possible yield. four endobronchial biopsies were obtained from the described findings plus two other biopsies from the main carina. in absence of mucosal abnormalities, four specimens were taken from a secondary carina and two were taken from the main carina. immediate and 2 hours' postoperative clinical evaluation was done to detect any possible complications.

Eligibility criteria:
inclusion criteria: * having suspected pulmonary sarcoidosis (based on clinical and radiological presentation) and being ≥18 years of age. exclusion criteria: * any contraindication for flexible bronchoscopy (e.g. severe refractory hypoxemia, hemodynamic instability, uncorrectable bleeding diathesis, recent myocardial infarction or unstable angina)

Keywords: sarcoidosis - bronchoscopy - endobronchial biopsy
designed music narratives for the reduction of side effects of chemotherapy in children (7-12 years) with cancer

Conditions: Cancer; Chemotherapy-induced Nausea and Vomiting; Effects of Chemotherapy

Summary: the purpose of this study is to determine whether a specially-designed music-narratives are effective in reducing side effects of chemotherapy in 7- to 12-year-olds with cancer.

(will be added later)

Eligibility criteria:
1. children at the ages 7-12 2. four or five (dependent on their overall plan of medical treatment) consecutive courses of chemotherapy administrated at the involved child cancer units and (administered) over a period of minimum 24 hours incl. hydration with assumed moderate to severe nausea and vomiting. the specific type of chemotherapy may vary across the four/five consecutive courses but shall include one of the following moderate and/or highly emetogenic types of chemotherapy: moderate emetogenic chemotherapy: * carboplatin * cyclophosphamide \<1500 mg/m2 * cytarabine \>1 g/m2 * daunorubicin * doxorubicin * epirubicin * idarubicin * ifosfamide * mitoxantrone * methotrexate \>1000 mg/m2 highly emetogenic chemotherapy: * cisplatin \>25 mg/m2 * cyclophosphamide \>1500 mg/m2 * dacarbazine 3. understand norwegian/danish 4. parents must be able to read and understand norwegian/danish * no significant hearing impairment * written and verbal informed consent from both possessors of the custody * verbal informed consent from child/participant exclusion criteria: * previous and/or acute psychiatric diagnosis * cognitive and mental deficits or impaired functioning

Keywords: children, moderate and/or highly emetogenic chemotherapy
acute exercise and microvascular function

Conditions: Physical Exertion

Summary: it is well recognized that chronic exercise protects against the development of cardiovascular diseases. however, the responses of vasculature to acute exercise (ae) are not well known and not consistent in literature. acute exertional exercise can induce large, transient increases in arterial pressure and development of metabolic acidosis which can be associated with pro-inflammatory response involving oxidant stress and circulating cytokines known to impair endothelial function. the aim of this study is to test the impact of a single exposure to exhausting training on microvascular reactivity in healthy sedentary subjects and athletes.


Eligibility criteria:
inclusion criteria: * healthy volunteers * active athletes * lean sedentary subjects exclusion criteria: * drugs that could affect the endothelium * overweight * hypertension * coronary artery disease * diabetes * hyperlipidaemia * renal impairment * cerebrovascular and peripheral artery disease

Keywords: microvascular function laser doppler flowmetry exercise
normobaric oxygen therapy for individuals with first-episode psychosis

Conditions: Psychosis; Schizophrenia; First-episode Psychosis

Summary: single-blind, randomized controlled trial of normobaric oxygen therapy among individuals with first-episode psychosis: effects on symptomatology and cognition.

functional deficits in prefrontal, limbic, and temporal regions of the brain are well-documented among individuals with psychotic disorders. mitochondrial dysfunction may contribute to such pathology, and effective functioning of mitochondrial activity in the brain in dependent on a sufficient supply of oxygen. these data suggest that oxygen therapy may improve symptoms in individuals with psychosis. this small pilot study will test this hypothesis. individuals with first-episode psychosis will be randomized to receive either (i) 4 weeks of nightly normobaric oxygen therapy (40% fio2) or (ii) 4 weeks of a placebo condition utilizing room air oxygen levels (21% fio2). participants will be blinded to what condition they receive. both conditions will be delivered via nasal cannula connected to oxygen concentrators at five liters per minute (lpm), and participants will be instructed to complete the intervention overnight while sleeping. at the end of the 4 week period, all individuals will receive an additional 4 weeks of unblinded (i.e., "open label") nightly normobaric oxygen therapy (40% fio2). study assessments will be completed at (i) enrollment; (ii) 4 weeks after enrollment, and (iii) 8 weeks after enrollment.

Eligibility criteria:
* diagnosis of a schizophrenia-spectrum disorder or mood disorder with psychotic features as determined using the structured clinical interview for the dsm-5. * less than 5 years since the onset of frank psychotic symptoms as determined using the symptom onset in schizophrenia inventory . * no evidence of a pre-existing intellectual disability defined as a premorbid iq \>70 as estimated using the reading subtest of the wide range achievement test-4. * ages 15-35 * non-smoker for past six months * absence of suicidal ideation or behavior over the past month as assessed by the columbia suicide severity rating scale * the american association for respiratory care notes that "no absolute contraindications to oxygen therapy exist when indications \[for oxygen therapy\] are present."

Keywords: psychosis treatment normobaric hyperoxia
micronized progesterone vs gonadotropin-releasing hormone (gnrh) antagonist in freeze-all ivf cycles.

Conditions: Infertility; IVF; Preimplantation Diagnosis

Summary: to examine whether the number of euploid embryos following ovarian stimulation with micronized progesterone is equivalent as compared with the number of embryos after ovarian stimulation with the use of a gnrh antagonist in patients undergoing ovarian stimulation for ivf or intracytoplasmatic sperm injection (icsi).

the pre-ovulatory surges of gnrh and lh are activated by increased concentrations of circulating estradiol, but ovulation is blocked when progesterone concentrations are elevated, due to a central inhibition of the gnrh surge. although traditionally gnrh has been traditionally considered the drug of choice to control endogenous lh in controlled ovarian stimulation (cos) cycles, recently, micronized progesterone has been shown to be an effective oral alternative for preventing premature lh surges during cos in women undergoing ivf/icsi treatments, with excellent results, whereas their safety during pregnancy is well-established. this novel protocol, has several advantages (good tolerance, user convenience, and cost reduction), that are very attractive when it comes to establishing a convenient user regimen in combination with a ''freeze all'' strategy. however, the comparative efficacy of this novel protocol with the more universal use of gnrh-antagonist protocol for the treatment of ivf patients in terms of embryo ploidy has never been evaluated up to date. the current study aims, for the first time, to examine whether the number of euploid embryos following ovarian stimulation with micronized progesterone is equivalent as compared with the number of embryos after ovarian stimulation with the use of a gnrh antagonist in patients undergoing ovarian stimulation for ivf/icsi. if efficacy would prove to be similar, with no impact on the chromosomal constitution of embryos, there will be obvious advantages for the preferential use of micronized progesterone over the antagonist protocol: oral administration is preferred over subcutaneous injection, and total cost of medication would be lower. this would be particularly interesting for the future in all "freeze all" protocols such as women undergoing ovarian stimulation for fertility preservation, preimplantation genetic screening and oocyte donation programs.

Eligibility criteria:
inclusion criteria: * infertile patients * age 36-40 years old * bmi 18-30 kg/m2 * undergoing preimplantation genetic screening cycles * planned to undergo at least two treatment cycles, to accumulate embryos to increase the chance of obtaining euploid embryos for transfer * willing to participate in the study exclusion criteria: * age\> 41 * severe male factor requiring tese (testicular sperm extraction) * low ovarian reserve (amh \< 1.2 ng/ml) * administration of any other drug potentially interfering with the treatment.