Kornimate/medical-research-clean huggingface dataset:
open-label placebo for non-specific pain in the ed

Conditions: Pain, Acute

Summary: the aim of this study is to assess whether an intervention with open-label placebo (olp) for non-specific pain in the emergency department is feasible.

this project is a collaboration between the emergency department at the university hospital of basel and the faculty of psychology at the university of basel. the investigation will analyze whether an intervention consisting of open-label placebo tablets is feasible for patients with non-specific pain in the emergency department. open-label placebos are administered without deception, meaning the patients are aware they are taking a placebo. patients will be randomized into intervention group (olp) or control group (treatment as usual) with ibuprofen. the study duration for patients is 30 days.

Eligibility criteria:
inclusion criteria: * established diagnosis of non-specific acute pain * able to understand the study and its outcome measures * signed informed consent * 18 years or older * sufficient german language skills exclusion criteria: * chronic pain * treatment with pain medication for \> 7 days prior to ed visit * known allergy or intolerance to ibuprofen * known hereditary galactose-intolerance, lactase deficiency or glucosegalactose malabsorption * participation in another clinical trial with medicinal products * need for hospitalization * known pregnancy

Keywords: open-label placebo non-specific pain emergency department
sildenafil in single ventricle patients

Conditions: Heart Disease

Summary: patients with single ventricle anatomy undergo staged surgical palliation. the result is an "in series" circulation with pulmonary blood flow and cardiac output directly related to pulmonary vascular resistance. while surgical outcomes have improved, the physiology of the single ventricle palliation results in continued long term attrition. elevated pulmonary vascular resistance and impaired systemic ventricular function are important risk factors for failure of single ventricle palliation. sildenafil is a pulmonary vasodilator and has been shown to improve cardiac contractility in the pressure overloaded right ventricle. the investigators will assess the safety, pharmacokinetics and hemodynamic efficacy of sildenafil in single ventricle patients following stage ii and iii surgical palliation.


Eligibility criteria:
inclusion criteria: 1. age ≥ 3 months; ≤120 months. 2. history of congenital heart disease with severe hypoplasia of a right or left ventricle. 3. undergoing cardiac catheterization as part of standard clinical care. 4. availability and willingness of the parent/legally authorized representative to provide written informed consent. exclusion criteria: 1. history of serious adverse event related to sildenafil administration. 2. history of sildenafil exposure within 48 hours of the study. 3. presence of pulmonary venous obstruction. 4. treatment with organic nitrates or alpha blockade therapy. 5. contraindication to cardiac catheterization as determined by the attending cardiologist and including: 1. significant hemodynamic instability. 2. sepsis. 3. need for extra-corporeal membrane oxygenation (ecmo) support. 4. venous occlusion precluding adequate access. 5. recent systemic illness. 6. renal failure defined as serum creatinine \> 2 times higher than the upper limit of normal. 7. liver dysfunction defined as alanine aminotransferase or aspartate aminotransferase \> 3 times higher than the upper limit of normal. 8. thrombocytopenia defined as a platelet count \< 50 000 cells/µl. 9. leukopenia defined as white blood cells \< 2500 cells/µl.

Keywords: hypoplastic left heart syndrome hypoplastic right heart syndrome superior cavopulmonary anastomosis total cavopulmonary anastomosis children with single ventricle anatomy
long term outcomes of coronavirus disease-19 (covid-19)

Conditions: Covid19

Summary: the investigators hypothese that lung involvement due to covid-19 may cause structural changes in the lung in the long term. in this study the effects of structural changes in the lung on pulmonary function tests, exercise capacity and quality of life will be examined.

coronavirus disease-19 (covid-19) has a clinical spectrum ranging from asymptomatic cases to severe cases requiring intensive care hospitalization due to respiratory failure. the disease mostly infects the lower respiratory tract. typical computed tomography findings of lung involvement are bilateral, peripherally located ground glass density and consolidations. there is a close relationship between tomography findings and clinical severity. it is not known whether there will be complete recovery in the lungs. investigators will evaluate pulmonary structures with chest computed tomography, respiratory capacity with pulmonary function tests (pfts), exercise capacity with six minutes walk test and quality of life with short form-36 (sf-36) im patients who survivors of covid-19 at least 6 months after hospital discharge.

Eligibility criteria:
inclusion criteria: * patients who were ≥18 years * covid-19 confirmed by real-time pcr * at least 6 months after discharge exclusion criteria: * patients who were \< 18 years * pregnancy * become bedridden after discharge

Keywords: covid19 long term outcomes chest computed comography pulmonary functional tests exercise capacity quality of life
a study to evaluate the efficacy and safety of fixed-dose combination of pitavastatin/ezetimib

Conditions: Primary Hypercholesterolemia; Mixed Dyslipidemia

Summary: the purpose of this study is to evaluate the efficacy and safety of fixed-dose combination of pitavastatin/ezetimibe under the real-world condition


Eligibility criteria:
inclusion criteria: * those who taking statins or statins and ezetimibe in addition to dietary and exercise therapy for primary hypercholesterolemia or mixed hyperlipidemia * those who are judged to need administration of a fixed-dose combination of pitavastatin/ezetimibe for change of statin's formulation or change of statin's dose, addition of ezetimibe exclusion criteria: * those who are taking a fixed-dose combination of pitavastatin/ezetimibe at study enrollment * those with hypersensitivity reactions or relevant medical history to pitavastatin or ezetimibe * those who have been administered an investigational product within 12 weeks of the enrollment date or are planning to participate in another clinical trial during this study participation period.
quality of care and welfare services for disabled middle older adults in iran lebanon

Conditions: Quality of Life; Health Care Acceptability; Disabilities Mental

Summary: the findings of this research will be a basis for improving the quality of care and welfare services for the disabled middle-aged and older people in iran and lebanon using the servqual model.


Eligibility criteria:
inclusion criteria: * aged 50 of years and above. * being disabled. * receiving health care services out of 1 year ago. exclusion criteria: * unwillingness to participate in the study * death and/or migration

Keywords: older people middle aged disabled servqual model iran lebanon quality of services health system instrumentation quality of caring
a research study to see how well cagrisema helps people with type 2 diabetes and excess body weight lose weight

Conditions: Overweight; Obesity; Type 2 Diabetes Mellitus

Summary: this study will look at how well the new medicine cagrisema helps people living with excess body weight and type 2 diabetes losing weight. participants will either get cagrisema or a dummy medicine. which treatment they get is decided by chance. the study will last for about 1½ years. women cannot take part if pregnant, breast-feeding or planning to get pregnant during the study period.


Eligibility criteria:
inclusion criteria: * male or female * age above or equal to 18 years at the time of signing informed consent * bmi greather than or equal to 27.0 kg/m\^2 * diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening * treatment with either lifestyle intervention, or treatment with 1-3 marketed oral antidiabetic drugs (oad)s (metformin, α-glucosidase inhibitors (agi), glinides, sodium-glucose co-transporter 2 inhibitor (sglt2i), thiazolidinediones, or sulphonylureas (su)s as a single agent or in combination) according to local label * treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least 90 days before screening * hba1c 7%-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening exclusion criteria: * clinically significant or severe hypoglycaemia within 6 months before screening or history of hypoglycaemia unawareness * renal impairment with estimated glomerular filtration rate (egfr) below 30 ml/min/1.73 m\^2, as measured by the central laboratory at screening * uncontrolled and potentially unstable diabetic retinopathy or maculopathy. verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
combined scalp and ear acupuncture in patients with proton pump inhibitor- dependent gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux Disease (GERD); Neurology

Summary: according to the statistics of the national health insurance administration ministry of health and welfare, the number of patients about gastroesophageal reflux disease (gerd) has increased from 610,000 to over 760,000 in the past three years (2016-2018). western medicine mainly uses proton pump inhibitors (ppi) to improve symptoms. for patients who are ineffective in drug treatment, it will be treated by surgical treatment (laparoscopic nissen fundoplication, endoluminal gastroplication).

according to the statistics of the national health insurance administration ministry of health and welfare, the number of patients about gastroesophageal reflux disease (gerd) has increased from 610,000 to over 760,000 in the past three years (2016-2018). western medicine mainly uses proton pump inhibitors (ppi) to improve symptoms. for patients who are ineffective in drug treatment, it will be treated by surgical treatment (laparoscopic nissen fundoplication, endoluminal gastroplication). however, it is easy to cause problems such as difficulty swallowing or recurrence postoperatively. in recent years, more and more integrated treatment studies of chinese and western medicine have found that acupuncture can improve gerd and can provide patients with another non-surgical treatment. traditional acupuncture is mainly based on distinguishing diseases (mainly according to western medicine disease diagnosis, to perform acupoint selection.), dialectics and verification (based on clinical experience, some stimulation areas with outstanding effects on certain symptoms are selected for acupuncture). acupuncture treatment for gerd primarily utilizes body acupuncture, while scalp and auricular acupuncture for gerd treatment remain scarcely discussed. this research plan intends to use scalp and auricular acupuncture on recurrent, ppi-dependent gerd and further explore what is the mechanism of acupuncture to improve the symptoms in patients with refractory gastroesophageal reflux. we hypothesized that scalp and auricular acupuncture will reduce scores of reflux disease questionnaire and ppi use compared to placebo treatment with seed acupressure (sap). if this mechanism can be clarified, it will reduce the patient's overuse of drugs and the cost of surgery in the future, which will be a big boon for taiwanese health and finances of health insurance.

Eligibility criteria:
inclusion criteria: * patients with mild reflux esophagitis (los angeles grades a or b) diagnosed by endoscopy received a 4-month standard-dose ppi therapy and reported the symptoms were improved during the treatment. * after discontinuing ppi, patients experienced rebound symptoms but quickly found relief upon resuming ppi. exclusion criteria: * cannot sign consent form * women who are ready to become pregnant or are pregnant. * have a history of fainting during acupuncture treatment. * those using anticoagulants or antiplatelet agents.

Keywords: acupuncture
safety and efficacy real-world data of trastuzumab deruxtecan and sacituzumab govitecan

Conditions: Breast Cancer; Metastatic Cancer

Summary: the study aims to evaluate real-world efficacy and toxicity data of treatment with trastuzumab deruxtecan (t-dxd), a her2-targeting adc and sacituzumab govitecan (sg), a trop-2-targeting adc in pretreated patients with advanced breast cancer.

antibody-drug conjugates (adcs) have significantly changed the therapeutic landscape of advanced breast cancer. trastuzumab deruxtecan (t-dxd), a her2-targeting adc and sacituzumab govitecan (sg), a trop-2-targeting adc, recently demonstrated superior efficacy over standard of care treatments depending on breast cancer subtype. the study aims to evaluate real-world efficacy and toxicity data of treatment with t-dxd and sg in pretreated patients with advanced breast cancer. this study includes a retrospective/prospective multicenter review of medical records of patients with advanced breast cancer who received treatment with t-dxd and sg at departments of oncology, affiliated with the hellenic cooperative oncology group (hecog).

Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic/recurrent breast cancer * 18 years of age * triple-negative (tnbc), her2-positive and/or hormone receptor positive advanced breast cancer * treatment with an adc at any of line of treatment * treatment with at least one cycle of t-dxd and/or sg exclusion criteria: * na

Keywords: trastuzumab deruxtecan sacituzumab govitecan efficacy safety brain metastasis ild
laparoscopic versus open gastrectomy for gastric cancer

Conditions: Gastric Cancer

Summary: this is the first randomized controlled trial comparing laparoscopic and open gastrectomy for resectable gastric cancer in a western population. the hypothesis is that laparoscopic gastrectomy will result in a lower post-operative burden by means of shorter post-operative hospital stay. secondarily that laparoscopic gastrectomy is hypothesized to be associated with lower post-operative morbidity and readmissions, higher cost-effectiveness, and better post-operative quality of life, with similar mortality and oncologic outcomes, compared to open gastrectomy. the study starts on 1 december 2014. inclusion and follow-up will take three and five years respectively. short-term results will be analyzed and published after discharge of the last randomized patient.


Eligibility criteria:
inclusion criteria: * histologically proven adenocarcinoma of the stomach * surgically resectable (ct1-4a, n0-3b, m0) tumor * age ≥ 18 years * european clinical oncology group (ecog) performance status 0, 1 or 2. * written informed consent exclusion criteria: * siewert type i esophagogastric junction tumor * non-elective surgery * previous gastric resection or recurrent gastric cancer * pregnancy

Keywords: gastric cancer gastrectomy laparoscopy
tailoring tm-htn intervention for black patients

Conditions: Hypertension

Summary: current clinic-based hypertension (htn) management models have several limitations, resulting in episodic care that does not adequately support patients' self-care skills, and fails to achieve blood pressure (bp) control.

telemedicine management of htn (tm-htn) can augment and overcome challenges by allowing more support for patients' htn self-care skills, providing multiple home blood pressure values and overcoming failure to appropriately intensify treatment. tm-htn consists of 1) home bp monitoring, 2) home bp based pharmacotherapy, and 3) telemedicine-based self-management support.

Eligibility criteria:
inclusion criteria: * subjects must be african american or black * experiencing socially disadvantage * patients with systolic blood pressure ≥140 mmhg on their last two clinic visits and baseline systolic bp \>130 mmhg using the mean of two research bp values measured by trained staff * subjects must be on stable blood pressure medications for the preceding 6 weeks exclusion criteria: * unable to read or speak english * diminished ability to measure home blood pressure * chronic kidney disease ≥stage 4 * persistent/chronic atrial fibrillation * severe hypertension \>180/110 mmhg * acute health changes in past 3 months increasing chance of blood pressure instability * terminal illness

Keywords: telemedicine socially disadvantaged african american or black patients
effects of pre-emptive scalp infiltration with ketorolac and ropivacaine for post-craniotomy pain

Conditions: Pain; Supratentorial Brain Tumor

Summary: the painless study is a single-center, prospective, randomized, open-label, blinded-endpoint (probe) controlled clinical study to compare the efficacy and safety of pre-emptive scalp infiltration with ropivacaine plus ketorolac and ropivacaine alone for postoperative pain relief in adults undergoing elective supratentorial craniotomies.

the proposed study will be a single-center, prospective, randomized, open-label, blinded-endpoint clinical trial designed to test the hypothesis that the addition of ketorolac to pre-emptive scalp infiltration analgesia can significantly improve analgesia after craniotomies. one hundred participants will be randomized to the ketorolac group or the control group. patients in the ketorolac group will receive pre-emptive scalp infiltration with opivacaine,ketorolac and epinephrine while patients in the control group will receive pre-emptive scalp infiltration with ropivacaine and epinephrine.the primary outcome measure will be cumulative doses of patient-controlled analgesia (pca) butorphanol consumption from 0 to 48 h postoperatively.

Eligibility criteria:
inclusion criteria: * scheduled for elective supratentorial tumour resection; * planned general anaesthesia; * american society of anesthesiologists (asa) physical status i - ii; * age ranging from 18 to 65 years old; * participates required to fix their head in a head clamp intraoperatively; * participates with an anticipated awake within 2 hours after surgery. exclusion criteria: * allergy/intolerance to study drugs including anesthetic drugs, ketorolac and epinephrine; * expected delayed extubation or no plan to extubate; * history of neurosurgeries; * long-term use of analgesics and sedatives (more than 2 weeks) * receiving any painkiller within 24 h before the operation; * extreme body mass index (bmi) (less than 15 or more than 35); * patients with impaired cardiopulmonary; * patients with impaired renal function; * patients with impaired hepatic function; * history of chronic headache; * patients with cognitive deficit; * patients with intellectual disability; * patients with uncontrolled epilepsy; * patients with psychiatric disorders; * difficulties in using pca device * difficulties in understanding the use of numeral rating scale (nrs) ; * patients with suspected intracranial hypertension; * pregnant or at breastfeeding; * infection at the incisional site； * history of radiation therapy and chemotherapy preoperatively * with great likelihood of postoperative radiation therapy and chemotherapy based on preoperative imaging.
chemoradiation plus weekly c225 against locoregionally advanced nasopharyngeal carcinoma (npc)

Conditions: Nasopharyngeal Carcinoma

Summary: the investigators will add weekly cetuximab (c225) to the standard care of chemoradiation against locoregionally advanced nasopharyngeal carcinoma (npc), and evaluate the toxicity and efficacy of this new regimen.


Eligibility criteria:
inclusion criteria: * pathologically confirmed untreated npc patients * locoregionally advanced (t3-4 or n2-3 m0) * 18-65 years * with mri examinations * ecog ≤ 2 * with written consent exclusion criteria: * without a second cancer * pregnancy * with other severe diseases (blood,liver ,kidney or heart diseases) * could not be staged properly * without written consent

Keywords: locoregionally advanced nasopharyngeal carcinoma cetuximab chemoradiation
early access program (eap) for ibrutinib in participants with relapsed or refractory chronic lymphocytic leukemia (cll)

Conditions: B-cell Chronic Lymphocytic Leukemia

Summary: the purpose of this study is to provide early access to ibrutinib treatment for participants with relapsed or refractory chronic lymphocytic leukemia (cll) and collect additional safety data while the medication is not commercially available.

this is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study) early access program (eap) study. the study will be conducted in 2 phases: a screening phase (approximately 30 days prior to administration of first dose) and a program drug phase (day 1 up to 30 days after last dose of study drug). enrolled participants will receive 420 milligram (mg) oral ibrutinib once daily on a 28-day cycle until disease progression, occurrence of unacceptable toxicity, no longer achieving clinical benefit, or the end of program. treatment will be continuous (without interruption) and self-administered. disease evaluations will be conducted according to local standard of care as clinically indicated. participant's safety will be monitored throughout the study. all enrolled and on-going participants in the program will continue to receive ibrutinib by the eap until marketing approval or 6 months after this date.

Eligibility criteria:
inclusion criteria: * has eastern cooperative oncology group (ecog) performance status of less than (\<) 2 * has a diagnosis of chronic lymphocytic leukemia (cll) that meets published diagnostic criteria (hallek 2008): 1. monoclonal b-cells (either kappa or lambda light chain restricted) that are clonally co-expressing at least one b-cell marker (cluster of differentiation 19 \[cd19\], cd20, or cd23) and cd5 2. the diagnosis of cll requires a history of lymphocytosis with a b-lymphocyte count greater than or equal to (\>=) 5,000/microliter (μl) * active disease meeting at least one of the international workshop on chronic lymphocytic leukemia (iwcll) 2008 criteria * must have received at least one prior therapy for cll and not be appropriate for treatment or retreatment with purine analog based therapy * able to receive all outpatient treatment and all laboratorial monitoring at the institution that administers program drug exclusion criteria: * known central nervous system (cns) lymphoma or leukemia * known prolymphocytic leukemia or history of or currently suspected richter's transformation * uncontrolled autoimmune hemolytic anemia (aiha) or idiopathic thrombocytopenic purpura (itp) * prior exposure to ibrutinib or randomization in an ibrutinib study * requires treatment with a strong cytochrome p3a4/5 (that is, cyp3a4/5) inhibitor

Keywords: pci-32765 ibrutinib early access program chronic lymphocytic leukemia relapsed or refractory chronic lymphocytic leukemia