Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of jmt103 in patients with giant cell tumor of bone

Conditions: Giant Cell Tumor of Bone

Summary: this is a phase ib/ii, multicenter, single-arm, open-label study to evaluate the efficacy and safety of jmt103 in patients with surgically unsalvageable or refractory giant cell tumor of bone (gctb).

the objective of the trial is to evaluate the efficacy and safety of jmt103 in patients with gctb that is surgically unsalvageable or for which the planned surgery is associated with severe morbidity. this study consists of two parts (phase ib and ii). in the phase ib part, 6 to 12 subjects will be enrolled, and the safety, pharmacokinetics and pharmacodynamics of jmt103 will be evaluated after treatment for more than 4 weeks. and then the phase ii part will be conducted, in which, 125 subjects will be enrolled. eligible subjects will receive jmt103 at a dose of 2mg/kg subcutaneously (sc) every 4 weeks (q4w) with a loading dose of 2mg/kg sc on study days 8 and 15 until disease progression, tumor resection (the pathologic outcome after surgical resection is cr or pr), intolerable toxicity, decision by the participant to discontinue, or decision by the investigator that the subject could no longer benefit from the treatment (whichever occurs first).

Eligibility criteria:
inclusion criteria: 1. fully informed and signed informed consent. 2. male or female, adults, 18 years and older 3. histologically confirmed gctb that is surgically unsalvageable or for which the planned surgery is associated with severe morbidity. 4. eastern cooperative oncology group (ecog) performance status of 0, 1 or 2. exclusion criteria: 1. fertile subjects refuse to use effective contraception methods from the signing of the informed consent to 6 months after the last dose; 2. active dental or jaw condition which requires oral surgery, including tooth extraction; 3. currently receiving other anti-tumor therapy (radiotherapy, chemotherapy or arterial embolization, etc.); 4. concurrent treatment with bisphosphonates; 5. known history of second malignancy within the past 5 years, except for basal cell carcinoma or cervical carcinoma in situ.
epidemiology and determinants of short-term outcome in critically ill patients with near-hanging injury

Conditions: Near Hanging

Summary: near-hanging is a catastrophic event that has been merely studied in the literature. we aimed to report the outcomes, and early predictors of hospital survivors in critically ill patients with near-hanging. patients admitted to 31 university or university-affiliated participating icus in france and belgium between 1992 and 2014 were studied retrospectively. hospital survival was the main judgment criterion.


Eligibility criteria:
inclusion criteria: * any of the following code corresponding in the international statistical classification of diseases and related health problems, 10th revision: intentional self-harm by hanging, strangulation and suffocation (x70). local investigators reviewed the medical records of the patients thus identified to select adults admitted to the icu after successfully resuscitated near-hanging injury. * older than 18 years * requiring icu management exclusion criteria: -
prospective clinicogenomic program

Conditions: Non-Small Cell Lung Cancer (NSCLC); Small-Cell Lung Cancer (SCLC)

Summary: the main purpose of this study is to evaluate the feasibility of a scalable, prospective research program for participants with metastatic non-small cell lung cancer (mnsclc) or extensive-stage small-cell lung cancer (es-sclc) planning to start standard-of-care (soc) systemic anti-cancer treatment. the study will also examine ctdna status over the course of treatment as a predictor of response to therapy.


Eligibility criteria:
inclusion criteria: * documented diagnosis of mnsclc or es-sclc * planned initiation of soc systemic anti-cancer treatment * front-line immunotherapy cohort: received front-line treatment of an immune blockade therapy including anti-ctla-4, anti-pd-1, or anti-pd-l1 therapeutic antibody on protocol gx41563 exclusion criteria: - participant actively receiving investigational medicinal product(s) as part of an interventional trial at the time of signing informed consent
evaluating the effectiveness of structured psychosocial counseling on mental health and fi individuals with low vision

Conditions: Low Vision

Summary: vision impairments affect 2.2 billion people worldwide, including 36 million who are blind and 217 million with moderate-to-severe visual impairment. in the us, age-related vision loss is a leading cause of disability among older adults.

with increasing longevity, global blindness rates are expected to triple, and moderate-to-severe vision impairment rates to double in 30 years. the study aims to assess the effects of structured psychosocial counseling on mental health (depression, anxiety) and functional independence in individuals with low vision. additionally, it seeks to evaluate the overall impact on quality of life (qol) following the counseling intervention. a randomized controlled trial will be conducted at superior university lahore.

Eligibility criteria:
inclusion criteria: * individuals aged 18 to 80 years. * both male and female * individuals diagnosed with low vision, defined as a visual acuity of less than 6/18 but equal to or better than 3/60 in the better eye with best correction. * individuals having visual acuity 6/60, counting fingers or light perception. * individuals experiencing symptoms of depression or anxiety as assessed through a validated screening tool. * individuals reporting reduced functional independence in daily activities due to low vision. exclusion criteria: * unable to provide informed consent. * diagnosed with severe psychiatric disorders such as schizophrenia, bipolar disorder, or severe post-traumatic stress disorder. * existing involvement in similar counseling programs. * presence of medical conditions or disabilities. * pregnant individuals if pregnancy-related complications or responsibilities could interfere with participation in the intervention.
fluticasone nasal spray patient preference study

Conditions: Rhinitis, Allergic, Perennial

Summary: the objectives of this study are to evaluate and compare patient preference for ff (fluticasone furoate) and fp (fluticasone propionate aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration.


Eligibility criteria:
inclusion criteria: * allergic rhinitis * literate exclusion criteria: * clinical significant uncontrolled disease * use of intranasal corticosteroids (\<4 weeks of fp \[branded or generic\],\<4 week exposure to ff, \<4 weeks use of other ins) * use of intranasal medications \<1 week * use of meds that significantly inhibit cyp4503a4 * use of perfume or oral rinse on study day * allergy/intolerance to ins, antihistamines, or excipients * positive pregnancy test or female who is breastfeeding * affiliation with investigational site

Keywords: taste questionnaire preference attributes odor after taste scent
does a relationship exist between fetal hiccups and computerised cardiotocography parameters?

Conditions: Fetal Conditions; Fetal Movement Disorder

Summary: background: the physiological function of fetal hiccups and its correlation with fetal well-being is unexplored. no previous study examines the correlation between the maternal perception of the fetal hiccups and the antepartum cardiotocography. objective: to evaluate the correlation between the fetal hiccups and antepartum computerised cardiotocography parameters, in nonlaboring term singleton pregnancies.


Eligibility criteria:
inclusion criteria: * physiological nonlaboring term singleton pregnancies exclusion criteria: * . gestations complicated by fetal malformations, stillbirth, preterm deliveries or patients with missing data were excluded.

Keywords: fetal hiccups fetal movement computerised cardiotocography cardiotocography computerized analysis
snore (smartphone analyses of nocturnal obstruction by respiratory evaluation) sounds

Conditions: Sleep Apnea, Obstructive; Chronic Obstructive Pulmonary Disease

Summary: this is a prospective multipart clinical performance study to compare the ability of the snoresounds algorithm with polysomnography (psg) and a type iii home sleep testing (hst) device to identify patients with obstructive sleep apnea (osa).

consecutive patients referred to a sleep lab for possible osa (obstructive sleep apnea) will be offered participation in this study. study subjects will participate in either part a, part b or part c of the study. subjects will not participate in more than one part of the study. study sites can participate in multiple parts of the study. part a: sleep lab consecutive patients referred to a sleep lab for possible osa will be offered participation. participants who provide informed consent will fill out a questionnaire and then have psg, as it would normally be performed. during psg additional sound recordings will be made in three ways: 1. microphone placed 50-100 cm (20-40 inches) from the patient's mouth. 2. android type smart phone with a recording application (app). the phone will be placed on a table 50-100 cm (20-40 inches)) from patient's mouth. 3. iphone type smart phone with a recording app. phone will be placed on a table 50-100 cm (20-40 inches) from patient's mouth. the sound recordings obtained via the microphone and smart phones will be analyzed electronically for osa by the sponsor's proprietary algorithm. a blinded comparison will be made between the psg results and snoresounds algorithm results. psg will be performed and scored in a manner consistent with current (2012) american academy of sleep medicine (aasm) standards. psgs will be scored twice - with each scoring performed independently. if the apnea hypopnea index (ahi) for each score places the patient in the same osa severity range \[0-4 normal/minimal osa, 5-14 mild, 15-30 moderate, \>30 severe\] the average of the two scores will be utilized. if however the scores put the patent in different osa severity ranges, then the study will be scored by an independent sleep medicine physician-sleep technician team and assigned an ahi. the results of the snoresounds testing will not be known to the sleep lab and the results obtained from snore sounds analysis will not be utilized in the clinical management of study participants. part b: comparison of snoresounds algorithm to home sleep testing (hst) (currently not enrolling in part b) part c: comparison of snoresounds algorithm to home sleep testing (hst) and to polysomnography (psg) (currently not enrolling in part c)

Eligibility criteria:
inclusion criteria: * patients \>or= 18 years old who are referred for polysomnography (psg) or home sleep test (hst) because of possible obstructive sleep apnea (osa) exclusion criteria: * previous psg or hst confirming osa * prior surgery for snoring or osa * medical contraindication for psg * cognitive impairment that might interfere with obtaining informed consent or completing clinical questionnaire

Keywords: obstructive sleep apnea polysomnography
parenchyma resection of cirrhotic liver by the clamp crushing technique and the ultrasonic dissector

Conditions: Liver Cirrhosis; Liver Neoplasms; Carcinoma, Hepatocellular

Summary: to identify the most efficient parenchyma transection technique for cirrhotic liver resection between the clamp crushing technique and the ultrasonic dissector. primary endpoint is intra-operative blood loss during liver transection (ml). expected results and implications: if one of the technique is better than the other, surgical teams could prefer it to minimize the morbidity of liver resection in cirrhotic patients.

design multicentric randomized controlled simple blinded trial comparing the clamp crushing technique vs. the ultrasonic dissector. the trial will last 24 months with 21 month-inclusion time. patients patients will be enrolled in 5 university hospitals in ile de france. eligibility criteria include adults with child a liver cirrhosis undergoing partial hepatectomy (≥ 1 liver segment). exclusion criteria include non cirrhotic patients, child b or c cirrhosis, portal hypertension and laparoscopic hepatectomy. sample size calculation was performed with the expectation of a 250 ml (one red cells pack) difference in blood loss during parenchyma transection with a level of statistical significance of 0.05 and a power of 0.80. these calculations indicated to include at least 60 patients in each group. secondary endpoints include blood loss standardized to the transection area (ml/cm²), free margins around the tumor, postoperative liver ischemia-reperfusion injury and postoperative complications. course of the study an informed consent will be obtained from each patient prior to surgery. each patient will be randomized the day prior to surgery. as usual, each patient will be followed daily until he will discharge (10 days) and for 2 months at the postoperative outcome patient clinic, which will end the study period for the patient.

Eligibility criteria:
inclusion criteria: * child a liver cirrhosis * partial hepatectomy (≥ 1 segment). * patient at least 18 years of age exclusion criteria: * non cirrhotic patient * child b or c cirrhosis * portal hypertension * laparoscopic hepatectomy.

Keywords: liver cirrhosis hepatectomy liver parenchyma transection randomized controlled trial
apixaban as treatment of venous thrombosis in patients with cancer: the cap study

Conditions: Neoplasms; Venous Thrombosis

Summary: this study is a single-arm, phase iv trial, of apixaban as treatment of venous thrombosis in patients with cancer. the current standard treatment of venous thrombosis in cancer patients is subcutaneous injections with low molecular weight heparin. during the last 5 years several new direct acting oral anticoagulants have been tested out as treatment of venous thrombosis. but very few cancer patients were included in the phase iii clinical trials of the direct acting oral anticoagulants. thus, there is a lack of information on how cancer patients with venous thrombosis will respond to treatment with direct acting oral anticoagulants. the current study will investigate the direct acting oral anticoagulant apixaban in cancer patients with venous thrombosis.


Eligibility criteria:
inclusion criteria: * a diagnosis of cancer, other than basal-cell or squamous-cell carcinoma of the skin, within six months before enrollment. any treatment for cancer within the previous six months, or recurrent or metastatic cancer. * objectively verified venous thrombosis * informed consent exclusion criteria: * anticoagulant therapy prior to trial entry for \> 96 hours * severe thrombocytopenia (platelets \<50·109/l) * severe renal failure - creatinine clearance \<30 ml/min * the patients will be treated with catheter based thrombolysis for deep venous thrombosis or systemic thrombolysis for severe pulmonary embolism * pregnancy or breastfeeding. * childbearing potential without proper contraceptive measures * drug abuse or mental disease that may interfere with treatment and follow-up. * severe malabsorption so that oral treatment are expected to have reduced effect * mechanical heart valves * known allergy to apixaban * active bleeding or severe risk of bleeding so that the risk of bleeding is considered a greater danger than the risk of not treating the venous thrombosis * clinically significant liver disease (e.g., acute hepatitis, chronic active hepatitis, or cirrhosis) * concomitant use of strong cytochrome p-450 3a4 inhibitors (e.g., human immunodeficiency virus protease inhibitors or systemic ketoconazole, voriconazole or posaconazole) or inducers (e.g., rifampicin, carbamazepine, or phenytoin). fluconazol is allowed.
a trial of bms-512148 in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: the purpose of this clinical research study is to learn if bms-512148 is effective in controlling blood sugar levels as determined by hba1c and fasting plasma glucose in patients who have been diagnosed with type 2 diabetes. patients should first try to control their diabetes with diet and exercise and should not have previously been treated for their diabetes (very short periods of time are acceptable). the safety of bms512148 will also be studied


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus with inadequate glycemic control on diet and exercise. hba1c \>= 7% and \<=10%. * patient either has not been previously treated with antihyperglycemic medication or has been treated for \<30 days since diagnosis and has received less than 3 consecutive doses or 7 non-consecutive doses in the last 30 days. * c-peptide \> 1.0 ng/ml * body mass index \<= 40 kg/m2 * serum creatinine \< 1.5 mg/dl for men or \< 1.4 mg/dl for women. * no overt proteinuria (microalbumin/creatinine ratio must be \<300 mg/g exclusion criteria: * unstable renal disease * patients with significant liver disease including chronic active hepatitis * within the last 6 months has had any of the following cardiovascular event: myocardial infarction, unstable angina, unstable chf,nyha class iii or iv chf, tia, unstable arrhythmia or cardiac revascularization surgery. * subjects with clinically significant anemia
starz-tx2 clinical study: study of thoracic aortic aneurysm repair with the zenith tx2 endovascular graft

Conditions: Thoracic Aortic Aneurysm

Summary: the starz-tx2 trial (study of thoracic aortic aneurysm repair with the zenith tx2(r) taa \[thoracic aortic aneurysm\] endovascular graft) is a clinical trial approved by the united states food and drug administration (fda) to study the safety and effectiveness of the zenith tx2 taa endovascular graft in the treatment of thoracic aortic aneurysms / ulcers.

the starz-tx2 trial (study of thoracic aortic aneurysm repair with the zenith tx2(r) taa endovascular graft) is a clinical trial approved by the fda to study the safety and effectiveness of the zenith tx2(r) taa endovascular graft in the treatment of thoracic aortic aneurysms / ulcers. instead of making a large incision in the chest, the physician makes a small incision near the groin to insert and guide the graft into place in the aorta, relieving pressure on the aneurysm and helping to reduce the risk of rupture. the zenith tx2 taa endovascular graft is a reinforced fabric tube that is sized to the length of the aorta that needs to be covered to seal off the aneurysm / ulcer. the graft is made of a polyester material like that used in open surgical repair. standard surgical suture is used to sew the graft material to a frame of self-expanding stainless steel stents, which provide support. the materials used in the zenith tx2 system have a long history of use in medical implants.

Eligibility criteria:
inclusion criteria: * patients diagnosed with aneurysms / ulcers of the descending thoracic aorta * patients who are candidates for either surgery or endovascular repair * patients at least 18 years old exclusion criteria: * age \< 18 years * patients with other medical condition (e.g., cancer, congestive heart failure) that may cause non-compliance with the protocol, confound the results, or with limited life expectancy (i.e., less than 2 years) * patients pregnant, breast-feeding, or planning on becoming pregnant within 24 months * patients unwilling or unable to comply with the follow-up schedule * patients unable or who refuse to give informed consent * patients simultaneously participating in another investigative device or drug study. (the patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)

Keywords: thoracic aortic aneurysm descending minimally invasive endovascular rupture back pain stent graft endovascular aneurysm repair aortic aneurysm thoracic
internet-based cognitive behavior therapy for atrial fibrillation

Conditions: Atrial Fibrillation; Arrhythmia

Summary: the aim is to evaluate if internet- delivered cbt, based on behavioral activation and exposure principles, improves wellbeing and qol in symptomatic af patients.the study will include 30 patients with symptomatic af despite optimal medical treatment in accordance with current guidelines.

atrial fibrillation (af) is the most common cardiac arrhythmia (irregular heartbeat) affecting 3% of the population. af is associated with poor quality of life (qol) and large costs for society. in a considerable proportion of patients, af symptoms (e.g., palpitations, fatigue, and chest pain) are not alleviated by current medical or interventional treatments. psychological factors can worsen af symptoms, and anxiety and depression are common among af patients. symptom preoccupation and avoidance of social and physical activities are likely to play important roles in the development of anxiety, depression, disability and healthcare utilization. the aim is to evaluate if cbt, based on behavioral activation and exposure principles, improves wellbeing and qol in symptomatic af patients. method: pilot study with a pre-post-design and no control group. the internet-delivered cbt-program will last for 10 weeks and include weekly therapist support, consisting of online messages and telephone calls.

Eligibility criteria:
inclusion criteria: a) paroxysmal af ≥ once per month that causes moderate to severe symptoms and leads to significant distress or interferes with daily life (i.e. ehra class ≥ iib) \[31\]; b) age 18-75 years; c) able to read and write in swedish. exclusion criteria: c) heart failure with severe systolic dysfunction (ejection fraction ≤ 35%); d) significant valvular disease; e) other severe medical illness; f) severe depression or risk of suicide; g) alcohol dependency. -
validation of a lung inflammation model in healthy volunteers by radiological tools and glucocorticoid treatment

Conditions: Experimental Lung Inflammation

Summary: the purpose of this study is to investigate the local and systemic inflammatory response and haemostatic alterations in the lungs after lipopolysaccharide (lps) instillation and to determine the feasibility of imaging techniques to quantify lung inflammation in an adapted human endotoxin instillation model. the investigators will also explore whether glucocorticoid treatment can blunt lps effects.


Eligibility criteria:
inclusion criteria: * signed informed consent obtained before any trial-related activities. (trial activities are any procedure that would not have been performed during normal management of the subject). * nonsmoker * normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant * if female and of childbearing potential and subjects agrees to employ adequate birth control measures (e. g. oral contraceptives, barrier method) * negative urine pregnancy test exclusion criteria: * known or suspected allergy to trial product or related products * pregnancy or lactation * treatment with an investigational drug within three weeks prior to this trial * participation in an lps trial within the last 6 weeks * smoking * history of relevant cardiac arrhythmia * preexisting open or closed angle glaucoma * history of osteoporosis, cushing´s syndrome, gastro-duodenal ulcera, cardiovascular disease, vasculitis, diabetes mellitus, hypertension, brain tumor or history of neurosurgery * systemic tuberculosis * hemorrhagic diathesis * relevant liver or kidney dysfunction * regular use of medication or abuse of alcohol unless considered clinically relevant * use of any medication within one week prior to the first trial day * symptoms of a clinically relevant illness in the 3 weeks before the first trial day * excessive sporting activities * rosacea * subjects on monoamine oxidase inhibitors (should be stopped for at least two to three weeks before dihydrocodeine treatment is initiate) * known acute or active hepatic disease within the past 3 months * a platelet count \ 1.5, liver enzymes\> 3 times the upper normal limit * having received a vaccination up to 8 weeks before the trial