Kornimate/medical-research-clean huggingface dataset:
an open-label multicenter phase 2 window of opportunity study evaluating ganetespib in women with breast cancer

Conditions: Breast Cancer; HER-2 Positive Breast Cancer; Triple Negative Breast Cancer; ER/Progressive Response (PR) + Refractory to Prior Hormonal Treatment

Summary: the purpose of this study is to determine if ganetespib (sta-9090) is effective in the treatment of patients with her2+ or triple negative breast cancer who have not received prior systemic treatment in the metastatic setting.


Eligibility criteria:
inclusion criteria: * pathologically confirmed diagnosis of invasive breast cancer. * stage iv disease. * documented her2 and hormonal receptor status per protocol, er/pr+ patients must be refractory to at least one prior hormonal treatment. * ecog performance status 0-1. * measurable disease per recist (1.1). * adequate hematological function per protocol. * adequate hepatic function per protocol. * adequate renal function per protocol. * negative serum pregnancy test at study entry for patients of childbearing potential. * ability to understand and sign written consent and to comply with the study protocol. exclusion criteria: * presence of active or untreated cns metastases as determined by mri/ct scan performed during screening. * active malignancies other than mbc within the last 5 years except adequately treated in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin. * bone as the only site of metastatic disease from breast cancer. * prior radiotherapy to the only area of measurable disease. note: radiotherapy to a limited area other than the sole site of measurable disease is allowed, if received prior to initiation of ganetespib treatment. patients must have completed treatment and recovered from all acute treatment-related toxicities prior to administration of first dose of ganetespib. * pregnancy or lactation. * known serious cardiac illness. * uncontrolled intercurrent illness per protocol. * other severe acute or chronic medical condition or abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or that in the judgment of the investigator would make the patient inappropriate for entry into the study.

Keywords: hsp90 inhibitor ganetespib sta 9090
prevena spine for use in spine surgery

Conditions: Surgery; Incision, Surgical

Summary: a pilot, prospective, single-center study for the investigation of the use of prevena vacuum-assisted closure devices in patients undergoing spine surgery.

the objective of the study is to evaluate the efficacy of the prevena plus 125 therapy unit (kci usa, inc.) in preventing surgical site infections and other wound complications in patients undergoing spine surgery compared to conventional wound dressing. furthermore, the investigators want to illustrate which patients benefit most significantly from prevena usage as spine surgery sees a range of potential candidates, and not all may experience equivalent recovery from spine surgery with prevena intervention.

Eligibility criteria:
inclusion criteria: 1. patients undergoing spine surgery that requires closure by plastic surgeon 2. over 18 years old 3. risk score cutoff 80+ 4. (control) matched to a prospective research participant exclusion criteria: 1. risk score cutoff \<80 2. medical or psychiatric condition that may increase the risk with study participation, may complicate patient compliance, or may interfere with the interpretation of study results and, in the judgement of the investigator, would make the subject inappropriate for entry into this study 3. subjects who are pregnant at the date of surgery (soc for surgery)

Keywords: negative pressure wound therapy incisional wound therapy spine surgery
ebis: the eindhoven breech intervention study

Conditions: Breech Presentation; External Cephalic Version; Thyroid Hormones; Stress, Psychological; Congenital Hip Dysplasia

Summary: the purpose of this study is to evaluate whether successful external cephalic version is associated with maternal thyroid function and mood state in pregnant women with breech presentation at term. the relationship between successful external cephalic version and neonatal thyroid function will also be investigated. a possible beneficial effect of successful external cephalic version on the development of congenital hip dysplasia will be evaluated.


Eligibility criteria:
inclusion criteria: * single pregnancy * gestation of 35 weeks or more * appropriate knowledge of the dutch language * fetus in any of the 4 types of breech presentation: frank breech, complete breech, incomplete breech or footling presentation exclusion criteria: * previous caesarean section * indication for caesarean delivery irrespective of presentation * previous abruptio placenta * multiple pregnancy * ruptured membranes * non-reassuring fetal monitoring tests results * hyperextended fetal head * significant uterine or fetal anomaly * use of thyroid medication * maternal autoimmune disease (such as insulin-dependant diabetes mellitus) * intra-uterine growth retardation * oligohydramnios * hiv-positive women

Keywords: breech presentation external cephalic version thyroid function tests
the role of clamping before removal of a pneumothorax drain connected to a digital drainage system.

Conditions: Pneumothorax and Air Leak

Summary: the study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial. in the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. in the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed. primary outcome measure: recurrent pneumothorax after chest tube removal requiring chest tube reinsertion

determining and timing of chest tube removal has been a continuous topic of debate amongst both surgeons and pulmonologist. it is plausible that provocative clamping tests are no longer necessary when a digital continuous recording drainage device is used that demonstrates the absence of (intermittent) air leak. however, clamping trials are still performed in clinical care, it is an expert opinion's policy prompted by fear of recurrent pneumothorax and no comparative studies exist. we hypothesize that chest tube removal exclusively based on digital drainage system data is as safe as adding a clamping test before removal in patients treated for pneumothorax or after lung surgery. the study will be conducted as a, prospective, open label, non-inferiority, randomized controlled trial. in the intervention group; chest tube removal will be determined by air flow criteria as indicated by the digital drainage system data. in the control group removal will be determined by the same criteria of the digital drainage system but before removal, a chest tube clamping test will be performed.

Eligibility criteria:
inclusion criteria: * digital chest tube drainage system * pneumothorax (primary, secondary, pulmonary surgery) exclusion criteria: * pleural effusion as primary indication for chest tube placement. * empyema * suspected chest tube malfunction (e.g., leaking, occlusion, malposition) * intubated during chest tube removal
the effects of pre-extubation single recruitment maneuver on perioperative atelectasis

Conditions: Pulmonary Atelectasis

Summary: laparoscopic surgeries may cause atelectasis on the lungs which may stay clinically occult after the surgery. lung ultrasound scoring (lus) can provide an objective measuring system to understand the condition of the lungs in the perioperative period. in this randomized controlled study, it is aimed to investigate the effects of one single recruitment maneuver (rm) just before emergence and extubation (at the end of surgery) on lus scores and postoperative recovery room oxygenation in laparoscopic nephrectomy surgeries. accordingly, the intervention group will be applied single rm before extubation, while the control group will be awaken without rm. there will be lus evaluation at 4 different time for intervention group (group rm) points that are: t1: 5 min after the intubation t2: at the end of surgery (after skin closure, before recruitment maneuver) t3(rm): after recruitment maneuver, before extubation t4: 30 minutes after extubation in the recovery room lus evaluation will be made at 3 different time points in control group (group norm): t1: 5 min after the intubation t3(norm): before extubation (no recruitment maneuvers will be made) t4: 30 minutes after extubation in the recovery room. the primary outcome is the comparison of the t3 lus scores. assuming a 40% difference in the t3 lus score, total number of 30 patients were calculated to be included in the study with an alpha value of 0.05 and 95% power. a possible drop-out of 5 patients per group, 20 patients were planned to be enrolled in each group. secondary outcomes will include; difference in t4 lus scores, the effect of rm on postoperative recovery room oxygenation, and the effect of deltalus (t3-t2) on postoperative recovery room oxygenation.


Eligibility criteria:
inclusion criteria: * \>18 years old * laporoscopic nephrectomy patients who will be operated in lateral positions * elective, semi-elective surgeries exclusion criteria: * patients with emphysema * patients with documanted heart failure * patients requiring intraoperative multiple recruitment maneuver due to hypoxemia * patients with hemodynamic instability * patients with pneumothorax risk * emergency surgery * patients requiring intraoperative liberal fluid therapy (\>10 cc/kg/hr) * patients requiring blood products
safety and efficacy of tll018 in patients with chronic spontaneous urticaria.

Conditions: Chronic Spontaneous Urticaria

Summary: this study is a randomized, double-blind, placebo-controlled, multicenter clinical trial of about 36 subjects with moderate to severe chronic spontaneous urticaria.

successfully screened subjects will be randomized in a ratio of 1：1：1. after a 4-week screening period (day -28-0), subjects will be randomly assigned to treatment for 12 weeks. clinical urticaria activity score (uas), dermatological quality of life index (dlqi), physical exams and laboratory tests will be performed at baseline, the end of weeks 4, 8 and 12 respectively.

Eligibility criteria:
inclusion criteria: * have had a diagnosis of moderate to severe chronic spontaneous urticaria for at least 6 months prior to baseline; * subjects with moderate to severe chronic spontaneous urticaria uas7 score ≥16 at baseline; * able and willing to give written informed consent. exclusion criteria: * other types of chronic urticaria (such as artificial urticaria, cold-contact urticaria, heat-contact urticaria etc); * other disease with symptoms of urticaria or angioedema, e.g., urticaria vasculitis, color vegetarian urticaria, erythema multiforme; * history or symptoms of malignancy in any organ system regardless of treatment, and regardless of evidence of recurrence or metastasis; * any uncontrolled clinically significant laboratory abnormality that would affect interpretation of study data or the subject's participation in the study.
duravr™ thv eu-efs

Conditions: Symptomatic Aortic Stenosis; Severe Aortic Valve Stenosis; Aortic Valve Calcification; Aortic Valve Failure; Aortic Valve Disease

Summary: a prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of duravr™ thv system in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical aortic bioprosthetic valves.

the duravr™ thv system is a novel balloon-expandable single-piece transcatheter aortic valve. the study will enroll up to 40 subjects with severe, symptomatic native aortic stenosis or with severe degeneration of surgically implanted aortic bioprosthetic valves, with a heart team determination of eligibility for delivery of the duravr™ thv prosthesis. subjects will be consented for follow-up to 5 years.

Eligibility criteria:
inclusion criteria: 1. symptomatic, severe native aortic stenosis or severe degeneration of surgically implanted aortic bioprosthetic valve in subjects 18 years or older. 2. requires aortic valve replacement and is indicated for tavr as determined by the heart team 3. eligible for transfemoral delivery of the duravr™ thv 4. anatomy appropriate to accommodate safe placement of duravr™ thv 5. understands the study requirements and the treatment procedures and provides written informed consent 6. subject agrees to complete all required scheduled follow-up visits. exclusion criteria: 1. anatomy precluding safe placement of duravr™ thv 2. pre-existing prosthetic mitral or tricuspid valve 3. unicuspid, bicuspid or non-calcified aortic valve 4. severe mitral or severe tricuspid regurgitation requiring intervention 5. moderate to severe mitral stenosis 6. hypertrophic obstructive cardiomyopathy 7. echocardiographic evidence of intracardiac mass, thrombus or vegetation requiring treatment 8. evidence of an acute myocardial infarction ≤ 30 days before the intended treatment 9. any percutaneous coronary or peripheral interventional procedure performed within 30 days prior to the index procedure 10. recent (within 6 months) cerebrovascular accident (cva) or transient ischemic attack (tia) 11. end-stage renal disease requiring chronic dialysis or creatinine clearance \< 20 cc/min 12. gi bleeding within the past 3 months 13. ongoing sepsis (including active endocarditis) or endocarditis in the last 3 months 14. life expectancy \< 12 months due to associated non-cardiac co-morbid conditions

Keywords: transcatheter aortic valve implantation (tavi) transcatheter aortic valve replacement (tavr) transcatheter valve valve-in-valve aortic valve disease
a trial of perioperative immune enhancing feed in patients undergoing surgery for head and neck cancer

Conditions: Squamous Cell Carcinoma of Mouth; Squamous Cell Carcinoma of Oropharynx; Laryngeal Squamous Cell Carcinoma; Squamous Cell Carcinoma of the Hypopharynx

Summary: study hypothesis: the peri-operative enteral administration of a proprietary immune-enhancing feed (impact) will not reduce post-operative infective complications in patients undergoing major surgery for squamous cell carcinoma of the head and neck (scchn). patients who present with scchn for whom surgery is the recommended treatment will, assuming they fulfill the eligibility criteria, be block randomised into a two-group, double-blind randomised controlled trial. one group will receive impact, the other an iso-caloric, iso-nitrogenous control feed for 5 days pre and 7 days post-operatively. in both groups patients will be fed enterally. the feeds will be prepared in identical bottles to facilitate blinding. primary outcome measures include major systemic infection, whilst secondary outcome measures include local infection and length of hospital stay. follow-up will be for 30 days postsurgery.

as above

Eligibility criteria:
inclusion criteria: patients who were to undergo either of the following procedures * partial (external approach) or total laryngectomy * partial pharyngectomy with primary closure or free-flap reconstruction * total pharyngectomy (gastric (or colonic) transposition, other free flap reconstruction, or other pedicled flap reconstruction) * oral cavity or oropharyngeal resection requiring reconstruction with a free flap or pedicled flap exclusion criteria: patients with * malabsorption syndromes * primary immune disorders * active infection on presentation * patients undergoing secondary surgical reconstruction * patients undergoing palliative surgery * patients aged under 18 years old * patients who were pregnant or breast feeding

Keywords: head and neck neoplasm nutrition carcinoma infection post-operative surgery immune-enhancing
a long-term examination of asthma from childhood through adolescence

Conditions: Asthma; Dermatitis, Atopic; Rhinitis; Urticaria

Summary: asthma is a common disease that is often diagnosed in childhood. in some teenagers, asthma symptoms disappear and treatment can be stopped; however, for some of these people, asthma symptoms return in adulthood. this study will examine data collected over the lifetime of 18-year olds to identify factors that may increase a person's chance of having recurrent asthma as an adult.

asthma is a serious, long-term illness that affects around 15% of children in the united states. during adolescence, up to 50% of teenagers stop experiencing symptoms and are able to discontinue treatment. however, asthma symptoms often reoccur in adulthood for many of these people. it is not known exactly what causes this recurrence, but potential risk factors may include obesity, elevated serum leptin levels, early onset of puberty, exposure to pollutants, parental smoking habits, and lack of breastfeeding. additionally, it is not known why childhood asthma is initially more prevalent in boys, but during adolescence it becomes more prevalent in girls. beginning in 1989, a group of children born on the isle of wight in the united kingdom has been followed by study researchers to provide long-term information on asthma. these children have been periodically evaluated over the years and are now 18 years old. the purpose of this study is to analyze participants' data collected over a span of 18 years to identify factors that may increase a person's risk of experiencing persistent or recurrent asthma in adulthood. at previous study visits that occurred when participants were 1, 2, 4, and 10 years old, information on the following was collected: asthma and other allergic diseases, family history of asthma, and early life risk factors, including breastfeeding and tobacco smoke exposure. a blood sample was collected at participants' 10-year study visit. for this current study, all 18-year-old participants will return for a study visit. participants will complete questionnaires on asthma and allergy symptoms and environmental exposures, including tobacco smoke and pollution. blood collection, an allergy skin prick test, lung function testing, and a bronchial challenge test to assess airway function will occur. select participants will also have a sputum sample collected.

Eligibility criteria:
inclusion criteria: * born on the isle of wight in the united kingdom between january 1, 1989 and february 28, 1990 exclusion criteria: * refused consent

Keywords: bronchial asthma food allergy bronchial hyperresponsiveness
endocuff-assisted colonoscopy vs standard colonoscopy on adenoma detection rate

Conditions: Colonic Adenoma; Colonic Polyp; Colonoscopy

Summary: this is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. the goal of this study is to evaluate the interest of second-generation endocuff vision (ecv) to improve adenoma detection rate and / or polyp detection rate as the mean number of polyps (average number of polyps) in routine colonoscopy. this is a prospective comparative study, on 2000 patients, 1000 in each group (with and without ecv)

this is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. the goal of this study is to evaluate the interest of second-generation endocuff vision (ecv) to improve adenoma detection rate and / or polyp detection rate as the mean number of polyps (average number of polyps) in routine colonoscopy. number of patients: 2000 patients, 1000 in each group (with and without ecv). to limit the risk of bias, the investigators will random two teams of 12 endoscopists matched in number, volume of activity and adenoma detection rate (evaluated over a period of the year preceding the study). both periods of study will be approximately 3-4 months in length. in order to achieve a perfect balance between the two groups of patients, an inclusion tracking chart will be initiate and will be carefully controlled. rebalancing will be done for both periods of study to obtain 500 patients per group and per period (= 2000 patients included). inclusion of 500 consecutive colonoscopies in each team of investigators, a "colonoscopy with ecv" team, a "colonoscopy without ecv" team then switch and inclusion of 500 new consecutive colonoscopies in each team, ie 2000 colonoscopies in total. the selection of the team that will begin with ecv (team a) and the team that will finish with ecv (team b) will be chosen at random before the start of the study. a comparison of the two colonoscopy groups with ecv vs without ecv will be made for each team (the investigator will be his own control) and then on the overall population after the end of the trial.

Eligibility criteria:
inclusion criteria: 1. patient scheduled for total colonoscopic exploration, during the period study 2. patient over or equal to 18 years 3. asa 1, asa 2, asa 3 4. no participation in another clinical study 5. certificate of non opposition signed exclusion criteria: 1. patient under 18 years old 2. asa 4, asa 5 3. pregnant woman 4. patient with coagulation abnormalities preventing polypectomy: prothrombin level \<50%, platelets \<50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress. 5. inflammatory bowel disease 6. known colonic stenosis 7. diverticulitis less than 6 weeks old 8. patient unable to give consent or protected by law 9. opposition expressed for inclusion in the study

Keywords: adenoma detection rate endocuff colonoscopy
ocular effects of carotid endarterectomy

Conditions: Choroid; Carotid Stenosis; Carotid Endarterectomy

Summary: all patients undergoing carotid endarterectomy in shaare zedek medical hospital, during about 1 year, will be offered to participate. retinal and choroidal structural changes will be assessed using swept-source oct technology


Eligibility criteria:
inclusion criteria: * carotid stenosis requiring surgical management exclusion criteria: * ocular conditions: media opacities precluding fundus visualization, bilateral no-light perception * ocular surgery within 6 months prior to endarterectomy

Keywords: oct