Kornimate/medical-research-clean huggingface dataset:
a clinical study to evaluate the safety and efficacy of lutetium[177lu] oxodotreotide injection in patients with advanced neuroendocrine neoplasms

Conditions: Advanced Neuroendocrine Neoplasm

Summary: this is a multicenter, single-arm, two-part study designed to evaluate the safety and efficacy of lutetium \[177lu\] oxyoctreotide injection in patients with inoperable, locally advanced or metastatic, progressive, advanced somatostatin receptor (sstr) positive neuroendocrine neoplasms (nen) other than grade g1/g2 gastroenteropancreatic neuroendocrine tumors (gep-net).

this study consists of two parts, the exploratory study (part 1) and the pivotal study (part 2). in both parts, participants who signs informed consent form (icf) and is eligible for the study will be enrolled. participants will receive 7.4gbq (200mci) lutetium \[177lu\] oxyoctreotide every 8 weeks. the objective tumor response will be assessed every 12 weeks from the time of the first dose according to recist 1.1 until disease progression.

Eligibility criteria:
inclusion criteria: 1. able to understand and have willingness to provide a written informed consent document. 2. aged 18 years or older. 3. ecog performance status 0 or 1. 4. histopathologically confirmed, unresectable locally advanced or metastatic nen . 5. disease progression before first dose. 6. subjects of childbearing potential should voluntarily use an effective method of contraception during treatment and within 4 months (male) or 7 months (female) of the last dose. exclusion criteria: 1. known brain metastases, unless these metastases have been treated and stabilized for at least 24 weeks prior to enrollment in the study. 2. uncontrolled congestive heart failure, including baseline left ventricular ejection fraction (lvef) \<50%. 3. uncontrolled diabetes mellitus, including baseline fasting glucose \> 2 x uln. 4. any clinically significant active infection. 5. pregnant or lactating females. 6. received systemic antitumor therapy such as targeted therapy, immunotherapy, antitumor herbal therapy or chemotherapy within 4 weeks prior to enrollment. 7. known other malignancies (except for those without recurrence within 5 years after adequate treatment). 8. any other disease, mental status or surgical condition that is uncontrolled, may interfere with study completion (including poor compliance) or is inappropriate for the use of the investigational drug.
nalbuphine versus morphine for perioperative tumor ablation

Conditions: Nalbuphine Allergy; Ablation; Safety

Summary: this randomized, positive control, multicentre trial is designed to compare the analgesic efficacy and safety of nalbuphine hydrochloride injection and morphine hydrochloride injection for perioperative tumor ablation.

sedation and analgesia use in tumor ablation is a necessary part of the procedure. however, the optimal medicine for sedation and analgesia for tumor ablation remains controversial. currently, morphine is a traditional opioid used for pain control and anaesthesia. as no publications have compared the anaesthetic and analgesic effects between nalbuphine and morphine during tumor ablation, this trial aims to compare the analgesic efficacy and safety of nalbuphine and morphine for perioperative tumor ablation. in addition, other endpoints in term of perioperative analgesia indexes, such as ablation time, daily dose, analgesia satisfaction, quality of life, and safety, etc. will be compared.

Eligibility criteria:
inclusion criteria: * patients requiring tumor ablation; * voluntarily participate and sign the informed consent. exclusion criteria: * allergic to contrast agent, test drug or other ingredients; * with a history of substance abuse, chronic pain and mental illness; * use of any monamine oxidase inhibitor within 14 days prior to randomization; * pregnant or breastfeeding; * cannot tolerate ablation due to other reasons; * cannot express their wishes correctly; * poor compliance, unable to complete the trial; * have participated in other drug trials within 30 days prior to enrollment; * judged by the researcher to be unsuitable.
evaluation of membrane lung function in high-altitude regions

Conditions: Extracorporeal Membrane Oxygenation; Membrane Lung Function; High Altitude

Summary: over the last 20 years, extracorporeal membrane oxygenation (ecmo) has been used to support adult patients with respiratory or cardiac failure who are unlikely to survive conventional treatment methods. ecmo circuit, pump, and oxygenator technology improvements permit safer perfusion for extended periods. the prolonged use of an ecmo circuit increases the risk of membrane lung (ml) dysfunction. the ml is responsible for taking in oxygen and removing carbon dioxide. the non-biologic surface of the ml triggers inflammatory and coagulation pathways, resulting in the formation of blood clots, breakdown of fibrin, and activation of white blood cells, which ultimately leads to ml dysfunction. coagulation and fibrinolysis activation can cause systemic coagulopathy or hemolysis, and the deposition of blood clots can block blood flow. moreover, the accumulation of moisture in the gas phase and the buildup of protein and cellular debris in the blood phase may contribute to shunt and dead-space physiology, respectively, impairing the exchange of gases. these three categories-hematologic abnormalities, mechanical obstruction, and inadequate gas exchange-account for most ml exchanges. worsening oxygenation during ecmo should prompt quantification of oxygen transfer. ml exchange is indicated when the ml can no longer meet the patient's oxygen demand. the partial pressure of post-ml arterial oxygen less than 200 mmhg is the most important consideration in this decision. in some high-altitude regions of china, ecmo treatment is also routinely conducted. the experiences above are derived from low-altitude areas, and whether they apply in high-altitude regions is still being determined. this study aimed to explore the significantly lower membrane lung oxygen uptake in high-altitude regions compared to low-altitude areas.


Eligibility criteria:
inclusion criteria: * receiving ecmo support exclusion criteria: * unable to obtain post-membrane blood gas * pregnancy * patients cannot receive anticoagulation * refusal to participate in the trial
glizigen-viudid-external anogenital warts in children and adolescents

Conditions: External Anogenital Warts

Summary: the purpose of the study is to assess the efficacy of glizigen and viusid administration in the treatment of external anogenital warts in children and adolescents. the duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. the estimated number of persons to be recruited and randomized for the study is 76. variables to be assessed will be: time to disappearance of lesions, reduction of the number of lesions and change in the aspect of lesions.


Eligibility criteria:
inclusion criteria: * no previous treatment for anogenital warts * negative serology for hb and hiv. * signed informed consent. exclusion criteria: * pregnancy * treatment with steroids, immune-suppressors, immune-modulators or local or systemic antiviral drugs. * hypersensitivity to glizigen or viusid:

Keywords: dietary supplement anogenital warts viusid glizigen
a one year trial evaluating the safety and efficacy of the alk house dust mite allergy tablet

Conditions: House Dust Mite Allergy

Summary: the primary aim of this trial is to evaluate the efficacy of the alk house dust mite tablet given once daily compared to a placebo tablet in the treatment of house dut mite allergic rhinits. additionally the secondary objective of the trial is to evaluate the safety and tolarability of the alk house dust mite tablet. immunotherapy has been shown to provide therapeutic benefits to subjects with house dust mite induced allergy. this trial is planned to investigate if clinically relevant improvements in rhinitis symptoms and with less use of symptomatic medication can be obtained in subjects with a history of poor didease control despite of use of symptomatic medications.


Eligibility criteria:
inclusion criteria: * a history of house dust mite allergy * use of symptomatice medication for treatment of house dust mite allergy * positive skin prick test to mites * positive specific ige exclusion criteria: * history of uncontrolled asthma * overlapping symptomatice allergies * previous treatment with immunotherapy
follow-up of gynecological cancer patients, their needs and expectations, a cooperation project

Conditions: Endometrial Cancer; Ovarian Cancer; Cervical Cancer

Summary: follow-up of cancer patients accounts for a substantial part of outpatient activity, and alternative models of care are developing. in some countries, low-risk follow-up is already done in primary care, mainly in breast, and colorectal cancer. in this study the investigators will explore gynecological cancer patients about their expectations regarding their future follow-up plan. further, the investigators will ask about the experience and satisfaction among patients who have already attended a follow-up programme for 2-3 years. in addition, the investigators will especially focus on the cooperation aspect between primary and secondary care. the investigators hypothesize that follow-up of selected gynecological cancer patients can be done by general practitioners.

after gynaecological cancer patients have completed their treatment, they are followed up at a gynaecological outpatient clinic for a number of years. the aim of such follow-up is to detect recurrence, improve survival and reduce adverse effects of the treatment. the national guide for oncological gynaecology recommends follow-up by a specialist for five years at intervals depending on cancer type. several review studies on follow-up of endometrial, cervical and ovarian cancer patients show large international variations in follow-up routines. there are only retrospective studies available, and they indicate that most recurrences are discovered within the first three years after completed treatment, and, in most cases, by the women themselves. more intensive surveillance does not appear to affect the time for discovery of recurrence. a few randomised controlled studies and retrospective cohort studies have been published that focus on follow-up of colon cancer and breast cancer patients by general practitioners versus by hospital specialists. these studies have not shown any significant differences between the groups in terms of detection of recurrence, incidence of serious clinical events connected with recurrence or health-related quality of life. the investigators therefore plan to perform a study in which both gynaecological cancer patients and their regular general practitioners are asked about their views on patient follow-up after completed treatment. the investigators especially wish to focus on the collaboration aspect.

Eligibility criteria:
inclusion criteria: * \> 18 years * histologically or cytologically proven cancer exclusion criteria: * unability to fill out questionnaires (due to language or cognitive barriers)

Keywords: cancer gynecological expectations satisfaction cooperation
5-fu, leucovorin, oxaliplatin and docetaxel (flot) versus epirubicin, cisplatin and 5-fu (ecf) in patients with locally advanced, resectable gastric cancer

Conditions: Gastric Cancer

Summary: patients with locally advanced resectable adenocarcinoma of the stomach or the esophagogastreal junction without previous therapy will be treated with one of two chemotherapy combinations before and after surgery. one half of the patients gets 5-fluorouracil (5-fu), leucovorin, oxaliplatin and docetaxel (flot), the others epirubicin, cisplatin and 5-fu (ecf). main objective of the study is median overall survival.

714 patients with locally advanced resectable (t2-4 and/or n+, m0) adenocarcinoma of the stomach or the esophagogastreal junction without previous therapy will be included in this study. after randomization patients receive perioperatively 4 cycles flot or 3 cycles ecf, followed by a restaging of the tumour status and surgery. subsequently another 4 cycles of flot or 3 cycles ecf are applicated. then a central validation of the pathological remission rate is scheduled. primary endpoint is overall survival, secondary endpoints are disease free survival, perioperative morbidity and mortality, histopathologic regression rate and r0-resection rate.

Eligibility criteria:
inclusion criteria: 1. locally advanced (\>t1) and/or nodal positive (n+) histologically proven adenocarcinoma of the esophagogastreal junction (aeg i-iii) or the stomach without distant metastases (m0) and without infiltration of adjacent structures and organs 2. no previous surgical resection 3. no previous cytostatic chemotherapy 4. age \> 18 years (female and male) 5. ecog ≤ 2 6. surgical resectability 7. exclusion of peritoneal carcinomatosis (if clinically suspected) via laparoscopy 8. leucocytes \> 3.000/µl 9. platelets \> 100.000/µl 10. serum creatinin ≤ 1.5x of normal value, or creatinin-clearance \> 50 ml/min 11. written informed consent. 12. ejection fraction \> 50% in echocardiography before start of therapy exclusion criteria: 1. distant metastases or infiltration of adjacent structures or organs and all primarily not resectable stages 2. relapse 3. hypersensitivity against 5- fluorouracil, leucovorin, oxaliplatin, cisplatin. epirubicin and docetaxel 4. existence of contraindications against 5- fluorouracil, leucovorin, oxaliplatin, cisplatin, epirubicin or docetaxel 5. active chd, cardiomyopathy or cardiac insufficiency stage iii-iv according to nyha 6. malignant secondary disease, dated back \< 5 years (exception: in-situ-carcinoma of the cervix uteri, adequately treated skin basal cell carcinoma) 7. severe non-surgical accompanying disease or acute infection 8. peripheral polyneuropathy \> nci grad ii 9. severe liver dysfunction (ast/alt\>3,5xuln, ap\>6xuln, bilirubin\>1,5xuln) 10. chronic inflammable gastro-intestinal disease 11. inclusion in another clinical trial 12. pregnancy or lactation

Keywords: gastric cancer perioperative flot ecf pathological complete remission locally advanced resectable adenocarcinoma of the esophagogastric juction or the stomach
a study of glecaprevir (gle)/pibrentasvir (pib) in treatment-naive adults with chronic hepatitis c virus (hcv) genotype 1-6 infection and compensated cirrhosis

Conditions: Hepatitis C Virus (HCV)

Summary: a phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic hcv infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (svr12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical svr12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.


Eligibility criteria:
inclusion criteria: * screening laboratory result indicating hepatitis c virus (hcv) genotype (gt) 1-6 infection. * positive plasma hcv antibody and hcv rna viral load greater than or equal to 1000 iu/ml at screening. * treatment-naive to any approved or investigational anti-hcv medication. * participant must be documented as cirrhotic, with a child-pugh score of less than or equal to 6. exclusion criteria: * female participant who is pregnant, breastfeeding or is considering becoming pregnant during the study, or for approximately 30 days after the last dose of study drug. * any current or historical clinical evidence of decompensated cirrhosis. * positive test result at screening for hepatitis b surface antigen (hbsag), hbv deoxyribonucleic acid \> lower limit of quantification (lloq) in subjects with isolated positive antibody to hepatitis b core antigen (anti-hbc) (i.e., negative hbsag and anti-hepatitis b),or anti human immunodeficiency virus antibody (hiv ab). * hcv genotype performed by the central laboratory during screening indicating co-infection with more than one hcv genotype. * history of suspected or confirmed hepatocellular carcinoma.

Keywords: hepatitis c virus (hcv) glecaprevir pibrentasvir treatment naïve cirrhosis compensated cirrhosis genotype (gt) 1-6 pangenotypic chronic hepatitis c virus (hcv)
secondary intention wound healing versus micrografting in patients undergoing mohs surgery

Conditions: Impaired Wound Healing

Summary: this study evaluates a novel micrografting technique to see how it will influence the healing rate and cosmetic result of second intention wounds. the graft harvesting and micrografting process was designed by momelan technologies the epidermal expansion system, which is composed of a commercially available blister generation device and the microblister generation and excision device (mbged), will generate an array of small microblisters and transfer the micrografts to a sterile dressing (tegaderm™ - an fda approved wound dressing) for application to the subject's surgical area. the investigators predict that applying expanded micrografts to wounds that otherwise would have healed by second intention alone will hasten healing and possible reduce scarring.

participants with a scalp wound s/p mohs procedure will be randomized to a micrografting technique intervention or to no intervention/heal with secondary intention alone (control). intervention consists of harvesting skin micrografts (1.75mm) from pigmented skin using the microblister generation and excision device and transfer the micrografts to a sterile dressing for application to the participants scalp wound. percent wound re-epithelialization will be compared between two groups.

Eligibility criteria:
inclusion criteria: 1. between 40-75 years old 2. status post mohs procedure on the scalp with a wound that would otherwise be allowed to heal by second intention 3. superficial would-at deepest of 2.0 mm or to superficial fat, but not deep to muscle 4. area is less then 6 cm2 (wound diameter less than 2cm) exclusion criteria: 1. female patients who are breastfeeding, pregnant, or planning to become pregnant 2. abnormal bleeding observed during initial mohs procedure that would suggest a higher risk of post-operative bleeding 3. subjects currently on immunosuppressive medications, chemotherapy or a cytotoxic agent 4. participation in another interventional study with potential exposure to an investigational drug within past 30 days or planned study entry within 90 days after study entrance

Keywords: mohs scalp
aromatherapy protocol for pain reduction in hospice patients

Conditions: Pain

Summary: the purpose of this study is to introduce aromatherapy with current pain medication protocols to see if it improves patient satisfaction and reduces pain in hospice care patients.


Eligibility criteria:
inclusion criteria: * currently on hospice at seasons assisted living exclusion criteria: * pain level not 3/10 or higher

Keywords: hospice care
the relationship between thicknesses and isokinetic strength of hip flexor and extensor muscles

Conditions: Amputation, Traumatic

Summary: the aim of this study is to investigate the relationship of hip muscle thicknesses measured by ultrasonography with hip flexion and extension strength and clinical parameters in prosthesis users with unilateral traumatic transfemoral amputation.

the aim of this study is to investigate the relationship of hip muscle thicknesses measured by ultrasonography with hip flexion and extension strength and clinical parameters in prosthesis users with unilateral traumatic transfemoral amputation. this study will be useful in understanding whether ultrasonography is an appropriate imaging method in the follow-up of changes in functional strength in the hip girdle in patients with unilateral traumatic transfemoral amputation.

Eligibility criteria:
inclusion criteria: * aged between 18-65 * the time elapsed after amputation \> 6 months * using prosthesis for at least 3 months * being able to walk without an assistive device exclusion criteria: * bilateral lower extremity amputation * presence of neurological, cardiovascular, and pulmonary disease that may affect walking performance

Keywords: amputation hip flexors hip extensors
a mhealth intervention to improve symptom control in children and adolescents with difficult-to-control asthma

Conditions: Asthma in Children

Summary: asthma is the most common chronic respiratory disease worldwide. despite advances in asthma management, control of the disease is still a challenge especially among children. information and communications technology (ict) have been recently used in clinical practice to increase awareness of diseases, encourage patients to engage in the management of their conditions and improve monitoring and surveillance. the investigators of this study will test a new digital platform combining online/offline content aimed to improve asthma control and reduce exacerbations and unnecessary consultations in children with difficult-to-control asthma. a randomised controlled trial enrolling 60 patients allocated in two groups has been designed. the intervention group (ig) will be granted free access during 6 months to a web-based platform. during this period, patient will have access to online/off line content to improve disease awareness, monitor signs and symptoms and will also get the support of a respiratory coach. in addition, patients in this group will receive an electronic peak flow meter to register daily variations in maximal expiratory flow and an electronic device to connect to their inhaler to track adequate intake of inhaled medication. the control group (cg) will receive usual care consisted of scheduled visitations to medical doctors every 4 - 8 weeks. both groups will be evaluated at baseline, post-intervention (6 months) and at follow up (one year) in the following variables: age, gender, asthma severity classification according to international guidelines, date of diagnosis, weight, height, body mass index (bmi), forced expiratory volume in 1 second (fev1), asthma control test (act) score, treatment received for asthma, number of exacerbations in the previous 6 months and concomitant diseases. exacerbations will be defined as any worsening in asthma symptoms that requires an increase in the usual therapy, an unscheduled physician visit, treatment in the emergency room or hospitalization.


Eligibility criteria:
inclusion criteria: * children between 6 and 18 years old; * diagnosis of moderate to severe persistent asthma according to the international guidelines * difficult to control asthma according to a scoring in the asthma control questionnaire (acq) of 1.5 points or asthma control test (act) ≤19; * access to internet and a smartphone, tablet or computer; * ability to understand and use the web-based platform (in children \<12 years the ability of the tutor or legal guardian); * informed consent (by the tutor or legal guardian) exclusion criteria: * patients who have had an exacerbation in the previous two weeks; * patients with intermittent asthma and/or well-controlled asthma according to the asthma control questionnaire (acq) score of \<1.5 or asthma control test (act) score ≥20; * any neurological or psychiatric condition that prevents patients to use adequately the platform.