Kornimate/medical-research-clean huggingface dataset:
optimizing surgical and prosthetic workflow for implant-supported ear and nose prostheses with early loading and distant prosthesis fabrication: a prospective cohort study

Conditions: Facial Deformity; Implant Complication

Summary: facial defects created by trauma, oncological procedures or congenital conditions can be repaired with ear, nose and/or eye prostheses. these are fixed on intraosseous implants placed in the temporal, nasal and orbital bone. to date, an osseointegration period of 3-6 months is maintained after which the implants are loaded. this study aims to achieve two goals: 1. to load the implants with a nose or ear prosthesis within one month (preferably \<3 weeks). patients with an orbital prosthesis will not be recruited. in other words, an optimization of an existing protocol will be investigated. the quality of life of the patients as well as possible complications of the implants will be investigated. 2. because of the short time between the surgery and the placement of the prosthesis, the prosthesis will be fabricated remotely. this means that the patient will not have to travel to the prosthetist. the feasibility and aesthetics will be analyzed through questionnaires for the patient.


Eligibility criteria:
inclusion criteria: * adult patients with a facial defect in the nasal and/or temporal area that will not be repaired with autologous tissue; * adult patients receiving oncological resection or trauma resulting in a facial defect in the nose and/or ear that will not be repaired with autologous tissue; * patients who can come to the hospital every week for 6 weeks. exclusion criteria: * patients with insufficient bone mass for implant placement * patients who cannot come to the hospital for weekly follow-ups * patients that wish an autologous reconstruction * patient is unable to tolerate general anesthesia

Keywords: facial defect facial prosthesis ear prosthesis nose prosthesis craniofacial implant anaplastology prosthesis fabrication
sintilimab combined with anlotinib for perioperative non-small cell lung cancer based on mrd evaluation

Conditions: Non-small Cell Lung Cancer; Minimal Residual Disease; Immunotherapy; Anti-angiogenesis

Summary: to study the efficacy of sintilimab combined with anlotinib for perioperative non-small cell lung cancer. to explore the clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease.

patients with resectable non-small cell lung cancer (nsclc) have a high postoperative recurrence rate. perioperative treatment, which can improve the resection rate and clear the minimal residual disease, is the main mean of preventing recurrence, including preoperative neoadjuvant and postoperative adjuvant therapies. in recent years, immunotherapy can significantly improve the pathological remission rate and prolong the survival as a perioperative treatment. in addition to single-agent or combined chemotherapy, the exploration of immunotherapy with other therapeutic strategies is still lacking. in 2018, we originally designed sintilimab combined with anlotinib in the first-line treatment of advanced nsclc. this clinical study plans to: ① apply the "de-chemotherapy" model to the perioperative phase of early nsclc, ② explore sintilimab combined with anlotinib in preoperative neoadjuvant and postoperative adjuvant therapies, ③ explore clearance effect of sintilimab combined with anlotinib for postoperative adjuvant therapy based on evaluating minimal residual disease (mrd), in order to improve the efficacy of perioperative nsclc and prolong survival.

Eligibility criteria:
inclusion criteria: * histologically or cyologically confirmed stage ii-iiia nsclc patients; * nsclc patients with negative driver gene: egfr wild-type, no alk fusion mutation, no ros1 fusion mutation; * ecog ps: 0\~1; * pulmonary function index meets the surgical criteria; * no previous systemic anti-tumor treatment. exclusion criteria: * patients with central cavitary squamous cell carcinoma or investigator-assessed bleeding symptoms or bleeding tendency were excluded.
using telephone technology to prevent relapse after alcoholism treatment

Conditions: Alcoholism

Summary: the purpose of this study is to determine whether a telephone based self-help program will prevent relapse among individuals undergoing standard substance abuse treatment.

relapse rates in the first few months following substance abuse treatment are as high as 50%, in spite of the immediate effectiveness of treatments such as cognitive behavioral therapy (cbt). continuing use of therapy skills following treatment is associated with maintenance of treatment gains. we have programmed a telephone to deliver pre-recorded summaries and rehearsal sessions of skills learned in therapy. the system also includes monthly feedback messages from therapists. we expect that this ad-lib access to therapy skills would allow patients to generalize skills to their personal post-treatment lives. it would also allow individuals in remote or rural areas to obtain access to assistance without travel barriers. comparison(s): patients completing group cbt for substance abuse will be randomly assigned to two conditions. in one condition, patients will have unlimited access to the therapeutic telephone system for 4 months. the other condition is standard care (i.e., no formal relapse prevention).

Eligibility criteria:
inclusion criteria: * meets current dsm-iv criteria for alcohol dependence * active drinking during the three months prior to entry into treatment * minimum age of 19 * minimum sixth grade reading level. exclusion criteria: * meets criteria for a current psychotic illness * imminent plans to move or be incarcerated * presence of such severe hearing, visual, or cognitive deficit(s) that participation in cbt or use of an interactive voice response (ivr) system are not possible * inability to identify at least one "locator" person to assist in tracking for follow-up assessments * does not have telephone service within the home * incarceration while in active protocol in the study * attendance of less than 8 of 12 cbt sessions

Keywords: cognitive therapy recurrence prevention educational technology
efficacy of 17 alpha-hydroxyprogesterones caproate for the prevention of preterm delivery

Conditions: Preterm Delivery

Summary: to demonstrate that the intramuscular administration of 17 alpha hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length egal and inferiority 26 mm between 20 and 32 weeks of gestation and: * either a first episode of preterm labor stopped by acute tocolysis; * either a history of late miscarriage or premature delivery or uterine malformation or des * either a twin pregnancy. therefore, a randomised, multicentre trial has been designed with initial stratification according to these three risk groups, opened with two parallel arms.

objective to demonstrate that the intramuscular administration of 17 alpha - hydroxyprogesterones caproate allows to reduce the risk of preterm delivery, in 3 high risk populations defined by the association of an ultrasonographic cervical length 26 mm between 20 and 32 weeks of gestation and: * either a first episode of preterm labor stopped by acute tocolysis; * either a history of late miscarriage or premature delivery or uterine malformation or des * either a twin pregnancy. experimental design prospective, randomized, multicenter, trial with initial stratification according to three risk groups, opened with two parallel arms. the maximal duration for treatment will be 16 weeks for each included patient. the duration for inclusions will be 30 months. the duration for participation of each patient will be 10 to 22 weeks. the foreseen inclusion period for this trial is from 06/01/2006 to 12/31/2008 description two therapeutic strategies will be compared in each risk group and attributed by uniform randomisation. arm a :im injection of 17 alpha hydroxyprogesterones caproate, 500 mg, twice a week until 36 w or until preterm delivery in high risk symptomatic group and high risk twin pregnancies group. im injection of 17 alpha-hydroxyprogesterones caproate, 500 mg, once a week until 36 w or until preterm delivery in high risk asymptomatic group. arm b :no treatment with 17 alpha-hydroxyprogesterones caproate. (usual management) presentation : progesterone retard pharlon 500 mg tolerance criteria * nausea,vomiting, * weakness

Eligibility criteria:
inclusion criteria: * ultrasonographic cervical length 26 mm between 20 and 32 weeks of gestation and: * either a first episode of preterm labor stopped by acute tocolysis * either a history of late miscarriage or premature delivery or uterine malformation or des; * either a twin pregnancy. exclusion criteria: * cervical dilatation \> 3 cm, * chorioamnionitis, * fetal distress, * placenta praevia, * abruptio placenta, * preterm premature rupture of membranes, * polyhydramnios, * twin-twin transfusion syndrome, * iugr, * preeclampsia or hypertension, * other pathology justifying a preterm delivery, * epilepsy drugs * participation to another therapeutic trial, * any patient for whom informed consent cannot be obtained.

Keywords: progesterone preterm delivery preterm labor cervical length ultrasonography
early detection of postoperative anastomotic leak by ct

Conditions: Anastomotic Leak

Summary: postoperative anastomotic leak is rare but life threatening complication after gastric cancer surgery. early diagnosis is key to minimize other hazards which are caused by anastomotic leak. investigators introduced a novel method to detect early diagnosis of anastomotic leak after gastric cancer surgery.

postoperative anastomotic leak is rare but life threatening complication after gastric cancer surgery. early diagnosis is key to minimize other hazards which are caused by anastomotic leak. investigators introduced a novel method to detect early diagnosis of anastomotic leak after gastric cancer surgery. oral contrast agent is used for ct. investigators carefully collected all the data prospectively and standard definition of anastomotic leak was applied.

Eligibility criteria:
inclusion criteria: patients with gastric cancer surgery exclusion criteria: patients with non gastric cancer surgery

Keywords: gastric cancer postoperative complication anastomotic leak oral contrast agent computed tomography
coronavirus disease (covid-)19 registry on thrombosis complications

Conditions: Covid19

Summary: this online-based, observational retrospective registry aims to (i) study the rate of cardiovascular events, encompassing venous thromboembolic and arterial events, in consecutive hospitalized patients with coronavirus (covid19), (ii) investigate the prevalent use of thromboprophylaxis, (iii) describe the use of imaging tests for the detection of cardiovascular events in patients with covid19. this will also facilitate and constitute the basis for the conduction of interventional thromboprophylaxis studies in patients with covid19.


Eligibility criteria:
inclusion criteria: hospitalized patients aged ≥ 18 years with a positive test for severe acute respiratory syndrome corona virus 2 (sars-cov2) exclusion criteria: none

Keywords: covid19 thromboembolism thromboprophylaxis pulmonary embolism anticoagulation
knee vs. ankle training on knee mechanics after aclr

Conditions: ACL Tear; ACL Sprain; Anterior Cruciate Ligament Rupture; Anterior Cruciate Ligament Injuries

Summary: this study will be conducted to investigate if there is any difference between starting rehabilitation program after acl reconstruction with knee joint training followed by ankle joint training and starting it with ankle joint training followed by knee joint training (crossover effect) on gait parameters of the knee joint.


Eligibility criteria:
inclusion criteria: * acl reconstruction with a hamstring tendon autograft participated in this study. * score 7 on tegner activity scale. exclusion criteria: * patients with bilateral knee injury * history of surgery or traumatic injury to the uninvolved lower extremity or to the hip or ankle of the involved lower extremity * history of acl reconstruction on the ipsilateral side and other knee ligament injuries requiring surgery.
trial evaluating the interest of noninvasive ventilation in nava mode in respiratory decompensations children with infantile spinal muscular atrophy type ii

Conditions: Infantile Spinal Muscular Atrophy

Summary: the new nava® ventilatory mode with the servo-i ventilator (maquet®) uses the electrical activity of the diaphragm (eadi) as a marker for triggering the respiratory cycle. the eadi is captured by the electrodes of a specific catheter (the edi® catheter) placed in the esophagus as a regular gastric feeding tube, and relayed to the servo-i who displays it and delivers respiratory assistance according to measured edi signal which allows synchronous assistance, proportional to the respiratory efforts of the patient. to date, no measure of the effectiveness of nava nav has been performed in children with neuromuscular pathology whereas this technique could reduce the use of invasive ventilation, very iatrogenic in these fragile subjects.

this is a prospective, interventional, sequential, open-label research involving asi ii children with acute respiratory decompensation requiring ventilatory support by niv. airway pressure, transcutaneous co2 monitoring and hemodynamic parameters will be recorded continuously during the study, after inclusion of the patient.

Eligibility criteria:
inclusion criteria: * age above 1 year and under 18 years * patient hospitalized in the pediatric intensive care unit. * acute respiratory decompensation requiring non-invasive ventilation for more than 6 hours. * patient with traditional niv support less than 12 hours and still showing an indication for a non-invasive ventilatory support. * affiliation to the french health insurance organism * consent signed by the two holders of parental authority for the child participation in the research. exclusion criteria: * contraindications to the use of nava or the setting up of a nasogastric tube. * hemodynamic instability requiring the use of vasopressor amines, adrenaline, norepinephrine or dobutamine. * severe respiratory instability requiring imminent intubation or fio2\> 60%, or paco2\> 80 mmhg. * limitation of life support treatments discussed or decided.

Keywords: infantile spinal muscular atrophy respiratory decompensations
ranibizumab therapy for choroidal neovascularization (cnv) asociated with angioid streaks

Conditions: Angioid Streaks

Summary: the purpose of this study is to determine whether injections of ranibizumab into the eye are safe and well tolerated when given to subjects in multiple doses.

choroidal neovascularization is a hallmark of angioid streaks, and presumably vegf-driven. ranibizumab has been shown to be effective in cnv secondary to age-related macular degeneration. therefore, we hypothesize that ranibizumab may be efficacious in the treatment of cnv secondary to angioid streaks

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study * age \> 18 years * angioid streaks * subfoveal cnv of recent onset with the following characteristics * absence of subfoveal fibrosis * fibrosis less than 25% of the lesion * presence of blood, subretinal fluid, and/or lipid * new onset symptoms within 12 weeks * visual acuity 20/40 to 20/800 on an etdrs chart exclusion criteria: * prior treatment of subfoveal cnv in the study eye * age-related macular degeneration * uncontrolled glaucoma * high myopia (\> -10.00 d spherical equivalent) * prior retinal detachment * media opacity preventing adequate view of the retina * planned cataract surgery in the next 3 months * current chemotherapy for cancer * immunocompromised state * pregnancy (positive pregnancy test) or lactation * premenopausal women not using adequate contraception. * any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated * participation in another simultaneous medical investigation or trial * history of any previous treatment for angioid streaks

Keywords: angioid streaks cnv intra vitreal ranibizumab
the accuracy of flap thickness versus the pre-determined surgical planning using wavelight® fs200

Conditions: Myopia

Summary: the objective is to evaluate the resultant thickness of the fs200 created lasik flap compared to plan at the surgical visit.

this study is a single site, single-arm, prospective, observational study of the accuracy of the intended flap thickness, after successful bilateral lasik surgery. subjects will be assessed pre-operatively, operatively and at 1 day post-operatively. clinical evaluations will include measurement of visual acuity, manifest refraction, and flap thickness, and flap diameter.

Eligibility criteria:
subjects are eligible for the study if they meet the following criteria: note: ocular criteria must be met in both eyes. * appropriate candidate for uncomplicated bilateral lasik surgery * gender: males and females. * age: 18 or older. * refractive error range - se refractive errors up to 0 to -6d with maximum cylinder up to 3.00d * stable refractive error \<0.50d change in preceding year * contact lens wear discontinued 3 days prior to pre-op exam and the procedure * pachymetry above 490μm with residual greater than 270μm * candidates who, as determined by the investigator, can safely undergo lasik with a 120μm flap * willing and able to provide written informed consent for participation in the study. * willing and able to comply with scheduled visits and other study procedures. * have good general and ocular health, with no pathology that compromises visual acuity (outside of residual refractive error) if any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. * patients with usual relative and absolute contraindications for lasik surgery (severe dry eye, recurrent corneal erosion, uncontrolled glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled diabetes, herpes) * pachymetry below 490μm * autoimmune or immunodeficiency diseases * patients with signs of inability to understand consent for study and procedure planned * patients with history of previous ocular surgery the principal investigator reserves the right to declare a patient ineligible or non- evaluable based on medical evidence that indicates they are unsuitable for the trial. pregnancy has a known effect on the stability of refractions and visual acuity. as such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.

Keywords: fs200
auricular acupuncture for chronic pain and insomnia

Conditions: Insomnia; Chronic Pain

Summary: background: in the u.s. approximately 1.6 million adults use complementary and alternative or integrative medicine therapy for pain and insomnia. however, very few studies have tested the use of auricular acupuncture (aa) using a standard protocol for participants with chronic pain and insomnia. objective: to assess the feasibility and acceptability of aa and to evaluate the effectiveness of aa on pain severity score, pain interference score, and insomnia over an 8-day study period. subjects: 45 participants who met the eligibility criteria and signed the consent were randomized to either the aa group (aag) or the usual care control group (cg) on day 4. intervention: a standard aa protocol using penetrating semi-permanent acupuncture needles and in-place for up to four days. main outcome measures: brief pain inventory pain severity and interference scores for pain and insomnia severity index (isi) for insomnia. results: the use of the standard aa protocol in the aag led to significant within- and between-group reduction in pain severity and interference scores when compared to the cg. both groups showed within-group decrease in isi. however, the aag showed significant between-group reduction in isi severity and from moderate to sub-threshold insomnia. conclusions: aa was found to show effectiveness in the treatment of chronic pain and insomnia. with a heightened focus on the opioid crisis in the u.s., this easy-to-administer protocol can be an option for treatment modality for military beneficiaries with chronic pain and insomnia.


Eligibility criteria:
inclusion criteria: * military beneficiary - active duty, retiree, or dependents * between the ages of 18 - 65 years * fall under the care of lrmc footprint * self-report of insomnia based on established research criteria * sleep-onset latency (sol) or wakefulness after sleep onset of ≥30 minutes; * frequency of at least three times a week; * duration of ≥3 months; * with unrestorative or unrefreshing sleep * nrs pain rating ≥3 (mild to severe level) * pain for ≥3 months * able to read and understand english * for active duty military, an agreement of supervisor exclusion criteria: * hypersensitivity or allergy to gold. * pregnancy or plan for future pregnancy during the duration of the study (since the safety of aa in pregnant women has not been established; based on self-report rather than requiring a pregnancy test) * ear trauma or unhealed wounds on the ear * participation in any other research protocol with a device or drugs * piercing or scar tissue in any of the aa point areas * working in jobs with variable hours (e.g., shift work) * acupuncture treatment within the last 3 months * individuals with valvular prosthetics, hemophilia, or currently receiving an anticoagulant.

Keywords: auricular acupuncture battlefield acupuncture insomnia chronic pain randomized
pemetrexed (alimta) and gefitinib (iressa®) in never-smoker and adenocarcinoma patients with non-small cell lung cancer previously treated with platinum-based chemotherapy

Conditions: Non-small Cell Lung Cancer

Summary: pemetrexed was known to be effective to pulmonary adenocarcinoma and gefitinib was known to be more effective to non-small cell lung cancer (nsclc) patients with clinical characteristics such as adenocarcinoma, never smoker and female. the investigators try to evaluate which drug (pemetrexed vs gefitinib) is more efficious to nsclc patients with clinical characteristics such as adenocarcinoma and never smoking history as second- or further-line therapy.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed pulmonary adenocarcinoma including bronchioloalveolar, but except adenosquamous cell carcinoma 2. stage iiib (malignant pleural effusion and/or pleural seeding), stage iv and relapsed non-small cell lung cancer 3. failed with 1st line platinum-based chemotherapy or relapsed within 12 months after adjuvant platinum-based chemotherapy) 4. never smoker (less than 100 cigarette for the life time) 5. 18 year or older 6. ecog 0-2 7. no history of biologic or immunotherapy 8. tolerable renal function ( creatine clearance rate is 60ml/min or more) 9. tolerable hepatic function (serum bilirubin ≤ 1.25 x unl, ast (sgot) and alt (sgpt) ≤ 2.5 x unl, alkaline phosphatase ≤5 x unl) exclusion criteria: 1. symptomatic brain metastasis 2. previously treated with egfr tyrosine kinase inhibitor 3. previously treated with antifolate agents 4. poor oral absorption 5. patients with active infection 6. uncontrolled diabetes mellitus 7. significant cardiovascular disease (uncontrolled hypertension, history of myocardial infarction or unstable angina within 6 months, congestive heart failure) 8. pregnant or nursing patients 9. history of malignant disease within 3 years before the enrollment except for cured non-melanomatous skin cancer, cervical carcinoma in situ, or thyroid carcinoma

Keywords: non-small cell lung cancer never-smoker and adenocarcinoma patients pemetrexed (alimta) gefitinib (iressa®)