Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of perioperative use of breztri aerosphere to relieve cough after lobectomy

Conditions: Lung Cancer, Nonsmall Cell; Perioperative; Cough; Drug Effect; Drug Toxicity

Summary: cough after lobectomy is common. the prevention and treatment of cough after lobectomy is not standardized. breztri aerosphere is often used to relieve cough. therefore, we conduct a single center placebo-controlled study to evaluate the efficacy and safety of perioperative use of breztri aerosphere in relieving cough after lobectomy.

this study is a single-center, prospective, randomized, controlled clinical trial to understand the efficacy and safety of perioperative use of breztri in relieving cough after lobectomy. this study plans to include 128 subjects from the department of thoracic surgery of the first affiliated hospital of guangzhou medical university. participants will be randomly divided into according breztri group and placebo group to the ratio of 1:1. participants in placebo group will receive 0.9% normal saline for 3 days before operation and 14 days after operation (n=64). participants in breztri group will receive breztri for 3 days before operation and 14 days after operation (n=64). all patients will undergo screening and baseline visits. after sugery, they will be followed up for 2 months.

Eligibility criteria:
inclusion criteria: 1. subjects voluntarily participate in this research and abide by the research regulations, understand and comply with and cooperate with the corresponding inspections, comply with the follow-up plan, and voluntarily sign the written informed consent. 2. outpatients, 18 years old ≤ age ≤ 70 years old, preoperative examination of cardiopulmonary function can tolerate surgery. 3. patients planning to undergo lobectomy. 4. no obvious cough before surgery. exclusion criteria: 1. participated in other interventional clinical trials 90 days before enrollment 2. pregnant and lactating women (budigrafo is not recommended during pregnancy and lactation) 3. patients with obvious cough before surgery (which affects the evaluation of drug effect) 4. history of alcohol or narcotic drug abuse, or a history of mental illness, confrontational personality, bad motivation, paranoia, or other emotional or intellectual problems that may affect the informed validity of participation in this study 5. preoperative respiratory infection, allergic rhinitis, bronchial asthma, chronic obstructive pulmonary disease, postnasal drip syndrome, oral acei drugs, cva, eb, obvious acid reflux, heartburn, etc. 6. patients with severe cardiac insufficiency or heart-related diseases before surgery 7. diabetes before surgery 8. severe liver and kidney damage before surgery 8) acei/arb used within 1 month 9) use of drugs that may cause cough or suppress cough within 1 month 9) preoperative narrow-angle glaucoma, benign prostatic hyperplasia, or bladder neck obstruction 10) patients who are using beta2 agonists or acetylcholine receptor antagonists or inhaled glucocorticoids 11) tumor recurrence 13) patients with severe infection or obvious pleural effusion found on postoperative chest x-ray
impact of pharmacy services on gynaecology chemotherapy safety

Conditions: Neoplasms; Gynaecological Oncology

Summary: what was studied? we wanted to see whether having pharmacists closely involved in cancer care improves medication safety and reduces severe side effects for patients with gynecologic cancers (like ovarian or uterine cancer) during chemotherapy. how was the study done? who participated? patients receiving chemotherapy at peking university first hospital's gynecologic oncology ward (september 2022-september 2024). two groups compared: standard care group: pharmacists provided routine pharmaceutical services. full pharmacy care group: pharmacists provided ongoing support, including: checking medications for safety. teaching patients how to manage side effects. answering questions about drugs. helping manage reactions like nausea or low white blood cells. what was measured? severe side effects (e.g., extreme nausea, appetite loss), how well doctors prescribed and monitored medications to boost white blood cells, and unplanned hospital stays. key findings: patients with full pharmacy care had: fewer severe side effects: less extreme nausea, appetite loss, and dangerously low white blood cell counts. better management of blood cell-boosting medications: doctors followed guidelines more closely, and patients received proper monitoring. fewer unplanned hospital visits: likely due to better side effect prevention and early intervention. why does this matter? for patients: pharmacist support during chemotherapy may help you avoid severe side effects and reduce unexpected hospital stays. for families: knowing pharmacists are actively involved can provide reassurance about your loved one's medication safety. for healthcare teams: structured pharmacist collaboration improves adherence to treatment guidelines and patient outcomes. takeaway: full pharmacy care throughout chemotherapy helps protect patients' safety, reduces severe reactions, and supports smoother treatment journeys.


Eligibility criteria:
inclusion criteria: * patients diagnosed with gynaecologic malignancies such as ovarian cancer, cervical cancer, endometrial cancer, or gestational trophoblastic tumours. * patients who received one of the following chemotherapy regimens: taxane monotherapy or combination therapy, anthracycline monotherapy or combination therapy, platinum-based monotherapy or combination therapy. these chemotherapy regimens could be combined with targeted therapy or immunotherapy. exclusion criteria: * patients treated with chemotherapy regimens outside those specified in the inclusion criteria. * patients who received only targeted therapy, immunotherapy, endocrine therapy, bone-modifying therapy, or combinations of these treatments.

Keywords: pharmaceutical services neoplasms chemotherapy gynaecological oncology
combination chemotherapy in treating patients with colorectal cancer that has spread to the liver

Conditions: Colorectal Cancer; Metastatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. giving drugs in different ways may kill more tumor cells. purpose: phase ii trial to study the effectiveness of liver perfusion using oxaliplatin plus leucovorin and fluorouracil given by infusion in treating patients who have colorectal cancer that has spread to the liver.

objectives: i. determine the efficacy and tolerance of oxaliplatin by hepatic perfusion combined with intravenous leucovorin calcium and fluorouracil in patients with liver metastases from colorectal cancer. outline: patients receive oxaliplatin by hepatic perfusion over 2 hours on day 1 plus leucovorin calcium iv over 2 hours and fluorouracil iv over 22 hours on days 1 and 2. treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity. if a good response is achieved after 8 courses of chemotherapy, patients may undergo surgical resection of metastases. projected accrual: a total of 20-40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically proven colorectal cancer metastatic to the liver unresectable disease less than 50% invasion of the liver measurable disease no prior irradiation largest diameter at least 20 mm no detectable extrahepatic disease patient characteristics: age: under 75 performance status: who 0-2 life expectancy: greater than 2 months hematopoietic: wbc at least 4,000/mm3 neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin less than 35 micromoles/l renal: creatinine less than 130 micromoles/l cardiovascular: no severe cardiac insufficiency pulmonary: no respiratory disease that would preclude study other: no other serious illness that would preclude study no psychological illness that would preclude study no peripheral neuropathy no prior malignancy not considered cured not pregnant fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior intravenous oxaliplatin no more than 1 prior regimen of intravenous chemotherapy for metastatic disease primary chemotherapy of fluorouracil allowed if stable or progressive disease no other concurrent chemotherapy endocrine therapy: no concurrent hormonal therapy radiotherapy: see disease characteristics surgery: see disease characteristics

Keywords: stage iv colon cancer stage iv rectal cancer liver metastases
a prospective, multi-site, randomized, sham-controlled, double-blind trial with one-way crossover designed to assess the effectiveness and safety of the gimer neuroblock scs trialing system for the treatment of chronic back pain and/or lower limb pain

Conditions: Chronic Pain; Low Back Pain; Lower Limb Pain

Summary: this study is a prospective, multi-site, randomized, shamcontrolled, double-blind trial with one-way crossover designed to assess the effectiveness and safety of the gimer neuroblock scs trialing system for the treatment of chronic back pain and/or lower limb pain. the neuroblock scs trialing system is an ultra-high frequency scs device for the treatment of patients with chronic back pain and/or lower limb pain who are refractory to conservative pain management. after screening procedures, eligible subjects will enter the study which is comprised of a 1-week randomized testing period, a 1-week follow-up period and 2-week observation period.


Eligibility criteria:
inclusion criteria: 1. age ≥ 20 2. subject has been diagnosed with chronic, intractable pain of the trunk and/or limb(s) and is refractory to conservative therapy for a minimum of six months prior to the screening/baseline visit. 3. subject has an average pain score of back or leg ≥ 5 or maximum pain score of back or leg ≥ 7 on the visual analogue scale (vas). 4. subject is willing and able to comply with the procedure and requirements of this trial. 5. the subject is able to understand and provide informed consent, and has signed their written informed consent in accordance with irb requirements. exclusion criteria: 1. subject has the following conditions by investigator's discretion at screening visit or during the last 3 months: 1. has the mental or psychological condition that affects pain perception or 2. has difficulty performing objective pain assessment or lack of suitability for participation in the study. 2. subject has exhibited unstable pain condition within the past 28 days as interviewed by investigator. 3. subject has a currently diagnosed coagulation disorder, bleeding diathesis, progressive peripheral vascular disease with plt \ 1.4 at screening visit. 4. subject has unstable pain medication(s) for at least 28 days at investigator's discretion. 5. subject currently has an active implantable device including icd, pacemaker, spinal cord stimulator or intrathecal drug pump or subject requires magnetic resonance imaging (mris) or diathermy. 6. subject has a current diagnosis of cancer with active symptoms. 7. subject has a known terminal illness with life expectancy less than one year. 8. subject has a systematic or local infection, which may increase study risk. 9. subject currently has an indwelling device that may pose an increased risk of infection. 10. subject is pregnant or breast feeding. 11. subject has a medical history of drug or alcohol addiction within the past 2 years. 12. subject has participation in any investigational study in the last 30 days or current enrollment in any trial. 13. subject is currently involved in an injury claim law suit or medically related litigation, including workers compensation. 14. subject is a prisoner.
traumatic hemothorax drainage and daily lavage: pilot study

Conditions: Hemothorax; Traumatic

Summary: this htx treatment study evaluates the effects of chest tube size and the benefits of daily irrigations on acute htx. 20 acutely injured but stable trauma patients requiring a chest tube for htx will be enrolled. patients will be assigned a 28fr or 14 fr chest tube with serial lavage and drainage. the endpoints will be htx volume (by ct scan), complications, additional interventions, hospital length of stay, chest tube duration, provider feedback, and patient-reported outcomes.

this hemothorax (htx) treatment study will evaluate the effects of chest tube size and daily lavage on htx management outcomes. a total of 20 stable trauma patients requiring a chest tube for htx will be recruited and consented. these patients will then undergo either 28fr or 14fr chest tube placement, depending on the preference of the treatment team at the time of placement. the study will include 10 patients with each type of chest tube (28fr and 14fr). daily lavage will then be performed at 24h and 48h post-placement. patients will be compared to historical control patients from the trauma registry who received either 28fr or 14fr chest tube placement followed by an initial lavage only. the primary endpoint will be the need for additional interventions such as tpa, additional chest tubes, thoracoscopic surgery (vats), or thoracotomy. secondary endpoints will include x-ray appearance at 72 hours, volume of htx on ct at 72 hours, procedural complications, development of empyema (safety endpoint), development of delayed bleeding (safety endpoint), hospital length of stay, chest tube duration, provider feedback, and patient-reported outcomes.

Eligibility criteria:
inclusion criteria: 1. able to provide consent for the research study 2. more than 15 years of age 3. presence of acute traumatic htx or htx-ptx diagnosed on chest ct scan within 24 hours of injury and clinical indication for drainage (hemothorax of moderate or large size greater then 300 ml) 4. hemodynamic stability (heart rate 120 beats per minute; systolic blood pressure 90 mmhg) 5. bilateral or unilateral hemothorax of greater than 300 ml htx by mergo formula from chest ct 6. able to complete the entire study including randomization, tube placement, lavages and final ct scan. exclusion criteria: 1. less than 15 years of age 2. prisoner 3. pregnant due to the risk of ct scans 4. htx or htx-ptx not requiring drainage or drainage performed prior to randomization/enrollment 5. patients undergoing operative intervention (i.e. thoracotomy) as initial management of hemothorax (6) persistent hemodynamic instability after initial resuscitation and ct imaging
hemodialysis and wanting for protein-rich foods

Conditions: Renal Failure

Summary: a study conducted in the laboratory revealed the existence of a "window" during which patients with renal failure appreciate the protein-rich foods. this period, located immediately after the dialysis, is likely related to the purification of plasma products resulting from protein catabolism. it therefore appears necessary to understand the mechanisms that may explain these changes by measurements of ghrelin (orexigenic hormone), leptin (anorectic hormone) and plasma amino acids.

in 24 patients with renal failure treated by hemodialysis, it is evaluated (at 8:00 am and at 11:00 am), a day without hemodialysis and another day after the hemodialysis: * hunger sensation, * olfactory liking assessed separately for 6 foods (2 carbohydrate-, 2 fat- and 2 protein-rich foods) and 2 non-alimentary products, * food wanting evaluated by the sequential presentation of 18 images of food (6 fat-, 6 carbohydrate- and 6 protein-rich foods), * two blood samples for the assays of leptin, ghrelin, creatinine, albumin and pre-albumin as well as plasma amino acids. 24 healthy subjects are also evaluated in order to compare the results from patients to those of control subjects.

Eligibility criteria:
inclusion criteria: * patients and healthy subjects were included if they were aged between 18 and 80 years exclusion criteria: * diabetes, advanced undernutrition (bmi \< 17.5 kg m-2, prealbumin \< 250 mg.l-1), congestive heart failure, acute or chronic infection, ongoing antibiotic treatment, active cancer, liver cirrhosis, smoking (more than 5 cigarettes/day), alcohol consumption (more than 3 units/day), aversion to the foods eaten or smelt during the study, impaired comprehension of the cognitive tasks
effect of an extract of green tea on adults with type 2 diabetes

Conditions: Diabetes

Summary: the objective of this study was to determine if taking an extract of green tea for three months could improve glucose control in adults with diabetes.

background: recent evidence suggests that tea from camellia senensis (e.g., green, oolong and black tea) may have a hypoglycemic effect. objective: we evaluated the ability of an extract of green and black tea to improve glucose control over a three month period using a double blinded randomized multiple dose (either placebo, 375mg or 750mg) study in adults in with type 2 diabetes. patients: the 49 subjects who completed this study were predominantly whites with an average age of 65, a median duration of diabetes of 6 years, and 80% reported using hypoglycemic medication. measurements: hba1c at three months was the primary endpoint. results: after three months the mean changes in hba1c were +0.4, +0.3 and +0.5, in the placebo, 375mg and 750mg arms, respectively. the changes were not significantly different between study arms. limitations: evaluation of a particular extract that contained components of black teas as well as green tea. power insufficient to detect changes in hba1c \< 0.5. conclusions: we did not find a hypoglycemic effect of extract of green tea in adults with type 2 diabetes, but cannot rule out the possibility that tea may have a small beneficial effect.

Eligibility criteria:
inclusion criteria: * adults with diabetes not taking insulin exclusion criteria: * pregnancy, warfarin therapy
a nutrition and lifestyle intervention in patients with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: rationale: nutrition and lifestyle interventions are currently not implemented in usual clinical care of pah-patients. mainly because there is little known on the relation between pathology, nutrition and lifestyle. patients who suffer from pulmonary arterial hypertension feel insecure about their nutrition and lifestyle. the investigators hypothesize that an intervention on nutrition and lifestyle can improve the patients' quality of life. objective: to explore the effect of a nutrition and lifestyle intervention on quality of life for patients suffering from pah. study design: investigator initiated intervention study with control group. study population: investigators aim to include 70 patients (18 - 80 years) with idiopathic, hereditable or drug related pah, who have been stable for at least three months and are self-sufficient and/or have a family who's willing to participate in the lifestyle changes. intervention (if applicable): nutritional status, - education, - intervention and - compliance. main study parameters/endpoints: this is an intervention study in which the investigators will asses the effect of a nutrition and lifestyle intervention on quality of life measured by sf-36 overall outcome with a significant difference of 6.35. nature and extent of the burden and risks associated with participation, benefit and group relatedness: the burden for the patient exists of 12 extra visits to the hospital and contact moments, over a period of 11 months, as well compliance to the diet and lifestyle. there is minimal risk in participation.

baseline nutritional assessment nutritional education: 8 online lessons containing information about nutrition, lifestyle and general health with complementary tips regarding ph. all participants recieve workbook with assignments. nutritional intervention: group a: meddash diet (55% carbohydrates, 25% amino acids, 20% fatty acids) group b: meddashfat diet (10% carbohydrates, 25% amino acids, 65% fatty acids) control group: no diet. follow-up: patients in intervention arm followed for a period of 6 months to assess compliance.

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic pah, hereditable pah or drug related pah * age between 18 and 80 * nyha ii or iii and stable for at least 3 months, determined by a stable 6minute walk test with a difference of \<10%. * self-sufficient and/or compliance from partner and/or family * creatinine \> 30 ml/min * able to understand and willing to sign the informed consent form exclusion criteria: * - pregnant subjects * fat percentage \ 50 % * one or more of the following comorbidities: diabetes mellitus type one or two, clinically relevant thyroid disease * known history of noncompliance considering therapies

Keywords: nutrition lifestyle
maternal metabolism and pregnancy outcomes in obese pregnant women

Conditions: Pregnancy; Obesity

Summary: the purpose of this study is to study longitudinal changes in maternal metabolism and pregnancy outcomes in obese pregnant women.

we will study how normal metabolic changes of pregnancy are modified in obesity and investigate the consequences of altered fat and carbohydrate metabolism for pregnancy outcome. the results will aid our understanding of why pregnant obese women and their babies are at higher risk of complications and may highlight potential therapies to reduce these risks. overall aim and hypothesis: the overall aim is to increase knowledge about the relation between obesity, metabolic profile/risk factors and pregnancy outcome in order to improve antenatal care and the health of the next generation. we hypothesize that obese pregnant women can be differentiated into subgroups according to their metabolic risk profile and their risk of adverse pregnancy outcomes. specific aims: establish an outpatient clinic for obese pregnant women at department of obstetrics, drammen, vestre viken hf in order to: * provide improved antenatal care for obese pregnant women who have increased risk of pregnancy complications by offering: * antenatal care according to national guidelines (veileder i fødselshjelp 2014) * fetal surveillance (ultrasound) * planned delivery according to national and local guidelines * conduct an observational study in which clinical and biochemical data will be collected in order to increase knowledge on longitudinal metabolic changes in pregnancies complicated by obesity and how these relate to pregnancy outcomes

Eligibility criteria:
inclusion criteria: * pregnant women with pregestational bmi \> 35 exclusion criteria: * diabetes mellitus type 1