Kornimate/medical-research-clean huggingface dataset:
functional imaging of treatment effects: a companion protocol to a study of extracranial stereotactic radioablation in early stage non-small cell lung cancer

Conditions: Non-small-cell Lung Cancer

Summary: for this companion protocol, we intend to make an assessment of both tumor response and local tissue effects. patients undergoing the correlative investigation will be a subset of the patients already enrolled on the phase ii study.

one of the shortcomings of the trial design recognized in the phase i study had to do with the assessment of local effects, both relating to tumor control and adjacent tissue toxicity. for example, response rates were generally incomplete to the therapy, especially at the lower dose level cohorts, and it was not clear if those patients had residual viable tumor capable of sustaining growth. repeat biopsies in this population are prohibitively toxic. we generally followed these patients with chest x-rays and ct's until there was evidence of progression. at that point, we would perform a pet scan and repeat systemic staging. since the majority of patients will retain residual "abnormalities" worrisome for residual disease, ideally, there would be data or testing capable of characterizing these abnormalities earlier in the post-treatment course. in the same token, several patients in the phase i study had post treatment imaging changes around the tumor targets. if these patients had symptomatic decline, it was never clear if the treatment effects around the target were actually involved in the overall decline. certainly, the patient population selected has other medical problems that will continue to cause poor health. ideally, though, we would refer to data indicating the degree of damage to surrounding normal lung from the esr such that a realistic assessment of percentage of overall organ damage from the therapy can be ascertained.

Eligibility criteria:
inclusion criteria: * patients consented, eligible, and scheduled to be treated on the phase ii study of extracranial stereotactic radioablation (a.k.a stereotactic body radiotherapy) for early stage lung cancer already approved at indiana university exclusion criteria: * patients with contraindications to functional imaging (e.g. allergy to agent used in studies) and patient unwilling to fulfill requirements of both protocols are ineligible

Keywords: lung cancer radiation oncology treated with stereostatic body radiation
comparison of general anaesthesia and sedation on the stone fragmentation in lithotripsy

Conditions: Urolithiasis

Summary: the aim of the study is to compare the impact intravenous sedation versus general anesthesia on the efficacy of stone fragmentation in extracorporeal shock wave lithotripsy treatment.

the newer lithotriptors were reported to be less efficacious than the dornier hm3 lithotriptor; and it is not clear the reason why there is decrease in efficacy of the new lithotriptors. is it due to their small focal point or to increased patient movement while under intravenous sedation.when the patients get sedated then it will be difficult to control their respiratory movements. retrospective comparisons suggest that intravenous may facilitate earlier discharge if no manipulation of the airway was done; but they are often associated with pain, hypoxemic respiratory episodes and disruptive movements during lithotripsy instead of intravenous sedation, general anesthesia offer pain free procedures, no movement of the patient and controlled movement of the respiration leads to stable position of the urinary stones and receives persistent shock wave energy on to the stone bringing about better and early fragmentation. hence we work on the hypothesis that the new generation shock wave lithotripters have a small focal point, every movement of the stone during the respiration or patient movement, will take the stone out of the focus and there results in loss of shocks leading to lithotripsy failure and use of more fluoroscopy for refocusing the stone. thus we think the proper choice of anesthetic technique will improve the efficacy of stone fragmentation in shock wave lithotripsy treatment at least in those who are obese and suffers from occult sleep- apnoea syndrome

Eligibility criteria:
inclusion criteria: 1. renal or upper ureteral stone of less than 2cm 2. a.s.a grade 1.2.3 3. age above 18 years exclusion criteria: 1. mid or lower ureteral stones 2. bilateral renal stones 3. multiple stones 4. use of regional anesthesia 5. coagulopathies (thrombocytopenia, anticoagulation drugs) 6. suspected or documented difficult intubation 7. history of chronic opioid abuse

Keywords: urolithiasis eswl stone fragmentation efficacy sedation general anaesthesia
mindfulness for breast cancer

Conditions: Anxiety; Depression; Breast Cancer

Summary: the primary purpose of this study is to evaluate the effects of mindfulness based cognitive therapy (mbct) vs. treatment as usual (tau) for depression and anxiety symptoms in breast cancer patients in recovery. investigators will examine whether mbct-related improvements in sleep quality, illness-related distress, and rumination (escalating cycles of negative thinking) predict mbct-related decreases in depression and anxiety symptoms (aim 2). exploratory analyses will examine whether demographics (e.g., age, sex, race/ethnicity), individual differences (e.g., perceived stress, social support), clinical characteristics (e.g., stage/severity of diagnosis), and treatment adherence (e.g., sessions attended, hours of weekly practice) help determine for whom mbct is most effective (aim 3).


Eligibility criteria:
inclusion criteria: * age 18 and over * able to speak and read english * diagnosis of breast cancer (any stage) for which active treatment (e.g., surgery, chemotherapy, and/or radiotherapy) has been completed within 2 months to 2 years exclusion criteria: * cognitive impairment or mental illness that would impair ability to provide consent or participate in the program; * major psychiatric disorder (e.g., psychosis, personality disorder) * current suicidal ideation or suicide attempt within past 3 months * past participation in an mbct group

Keywords: mindfulness based cognitive therapy (mbct) anxiety depression
immunogenicity and persistence of hepatitis b vaccination in methadone maintenance treatment patients

Conditions: Hepatitis B Vaccine

Summary: at present, methadone maintenance treatment patients of hepatitis b vaccination in are vaccinated with hepatitis b vaccine according to the standard three-dose schedule immunization program, and the effect of preventing hbv infection is not ideal. this is a randomized, controlled trial. the study will evaluate the immunogenicity and persistence of 20 µg and 60 µg recombinant hepatitis b vaccine with three or four injections at months 0, 1, and 6 or 0, 1,2, and 6 in methadone maintenance treatment patients

participants are randomized in a ratio of 1:1:1 into 20 µg recombinant hepatitis b vaccine group at months 0, 1, and 6 or 20µg recombinant hepatitis b vaccine group at months 0, 1, 2, and 6 or 60µg recombinant hepatitis b vaccine group at months 0, 1, 2, and 6. hbsag and anti-hbs will be tested during the study period. adverse reactions will be recorded after vaccination.

Eligibility criteria:
inclusion criteria: * serologically negative for hepatitis b surface antigen (hbsag), hepatitis b surface antibody (anti-hbs) and hepatitis b core antibody (anti-hbc) at enrollment * sign informed consent, willing to participate in this study exclusion criteria: * being pregnant * intolerance or allergy to any component of the vaccine * any vaccination during the month preceding enrollment * patients with severe acute or chronic diseases (such as liver disease, blood disease, cancer), acute onset of chronic diseases and fever * patient with hiv infection * the use of immunosuppressive agents in patients with nearly three months

Keywords: hepatitis b vaccine randomized controlled trial methadone maintenance treatment patients immunogenicity long-term immune response
celebrex and ho study

Conditions: Heterotopic Ossification

Summary: the primary goal of this observational study is to demonstrate the incidence of heterotopic ossification (ho) in patients with cementless total hip joint replacement surgery over time and secondly, demonstrate the relationship between celecoxib and ho formation. lastly, investigators will examine the relationship between ho and patient-reported outcome measures (proms).

heterotopic ossification (ho) is characterized by the pathologic formation of mature lamellar bone in muscle and soft tissue. it presents clinically with localized pain, reduced motion, and swelling. the process of ho occurs due to abnormal tissue repair, and most commonly occurs in young adults. significant predisposing factors include total hip arthroplasty (tha), fractures, spinal cord and traumatic brain injuries, and thermal injuries. the overall incidence of ho is up 42% to 57% after tha, and the incidence of extensive ho post tha is 2% to 7%. certain patient and surgical-related factors have been associated with an increased risk of ho. patient aspects include a history of paget's disease, ankylosing spondylitis, and hypertrophic osteoarthritis; surgical factors include the use of cemented implants and prolonged time of ischemia. post-operative celecoxib use has been associated with a significant lower incidence of ho compared to controls. furthermore, among cox-2 selective inhibitors, celecoxib has been associated with the lowest incidence of ho. this study looks at patients who have been referred to our orthopaedic clinic and undergone cementless total hip joint replacement surgery through a retrospective review of our pre-existing departmental database. all the data from all patients who meet the inclusion criteria will be collected from our database. specifically, the age, gender, bmi, pre-operative diagnosis, post operative radiotherapy, preoperative patient-reported outcome measures (proms), post-operative proms, operative characteristics, and complications. data from the available proms database will need to be converted into a manageable format that is suitable for data analysis. this study looks at the harris hip score, the ucla activity score, and sf-12 proms that are collected from each patient as standard of care. descriptive statistics and para/nonparametric statistics will be used to analyze the data through ibm spss software platform for statistical analysis. the independent student t-test and multivariable logistic regression analysis will be used to examine outcome measures.

Eligibility criteria:
inclusion criteria: * all primary total hip replacements with cementless tri-lock bps (depuy, warsaw, in) with minimum 2 years follow up. exclusion criteria: * revision surgery * infections * other implants

Keywords: heterotopic ossification celecoxib arthroplasty
s.e.s shoulder arthroplasty data collection

Conditions: Arthritis

Summary: this observational study intends to collect efficacy and safety data on s.e.s shoulder system

the s.e.s.® shoulder system has been developed to provide a complete solution for all the indications for shoulder arthroplasty, arthritis, rotator cuff arthropathy, proximal humeral fracture, minimising bone resection and restoring the natural anatomy of the patient.

Eligibility criteria:
inclusion criteria: * a pre-operative level of pain and function the same as for conventional joint replacement * a likelihood of obtaining relief of pain and improved function * full skeletal maturity * ability to follow instructions * good general health for age * willing to return for follow-up evaluations exclusion criteria: * glenohumeral joint infection, osteomyelitis * neuro-muscular complications * inability to co-operate with and complete the study

Keywords: shoulder replacement
local anesthetic infiltration vs trasversalis fascia block vs spinal anesthesia

Conditions: Inguinal Hernia

Summary: propose to comparison effectiveness of blind local anesthetic infiltration with ultrasound guided transversals fascia block and spinal anesthesia in patients undergoing to inguinal hernia repair surgery. the effectiveness is defined as pain control during intraoperative and time need to reach hospital discharge criteria in the post-operative period.


Eligibility criteria:
inclusion criteria: * age\> 18 years; * asa score i - ii - iii; * patients undergoing elective inguinal hernia repair; * signed informed consent; exclusion criteria: * chronic therapy with opioids/ antidepressants; * urgent/emergent surgery; * postoperative transfer to the intensive care unit; * known allergy to any drug medication; * local skin infection; * epilepsy; * alcohol or drug abuse;
effect of sufentanil on the rate of anesthesia

Conditions: Irreversible Pulpitis

Summary: the aim of this study was to compare the effects of lidocaine/epinephrine with and without sufentanil on the rate of anesthesia after supplemental intraligamentary injection (pdl) in teeth with irreversible pulpitis.


Eligibility criteria:
inclusion criteria: * patients in the age group of 18-65 years old * healthy (asa i, ii) * patients with first or second mandibular molars who need endodontic treatment * vital tooth without a history of past endodontic treatment * patients with clinical evidence of irreversible pulpits with moderate to severe pain * patients who signed consent form * patients numbness at the lateral edge of the lips after inferior alveolar injection (ina) and those with positive respond to maximum output of pulp tester after ina. exclusion criteria: * pregnant or nursing * necrotic tooth * patients with allergy or contraindication toward non-opioid or opioid painkillers such as aspirin or nsaids * patients who have taken opioid or non opioid or steroid pain killers, antidepressants or sedative drugs in the past 48 hours * patient with infectious diseases * patient with moderate to sever periodontal disease * those without numbness at the lateral edge of the lips after inferior alveolar injection (ina), and those do not respond to maximum output of pulp tester after ina.

Keywords: sufentanil irreversible pulpitis intra ligament injection
early injection of botulinum toxin on motor function and gait pattern in stroke patients

Conditions: Stroke; Spasticity

Summary: spasticity, muscle weakness, abnormal gait pattern are co-morbidities commonly seen in stroke patients. they cause disabled condition of patients in activities of daily life and functional performance, and also accidental falls and subsequent fractures. this study is to evaluate and compare the effects of different phase injection of botulinum toxin type-a at affected limbs on muscle rheological changes, muscle activity, muscle tone, functional performance, gait pattern and energy consumption in stroke patients.


Eligibility criteria:
inclusion criteria: * first-ever stroke, with spasticity within 3-months (mas=2\~3) * independent walking 10 meters (with assistive devices) exclusion criteria: * recurrent stroke, cognition impaired * lower limb fracture * received anti-spasticity injection in the past
could a preoperative feeding jejunostomy decrease sarcopenia for patients with oesogastric adenocarcinoma ?

Conditions: Sarcopenia

Summary: the study of sarcopenia is a subject that is the subject of numerous research and publications, particularly because of its link with a poor prognosis for many cancers. in an article published by the digestive surgery team, the role of feeding jejunostomy has been demonstrated: it allowed more patients to reach the 2nd stage of surgery and a better tolerance of chemotherapy. investigators wanted to study retrospectively the impact of feeding jejunostomy on radiological sarcopenia. is the positive effect of jejunostomy in gastric cancers associated with a decrease in sarcopenia?


Eligibility criteria:
criteria for inclusion: * age 18-80 years * sex: h or f * subject giving their consent for their participation * gastric cancers * stage\> ib * whether or not a feeding jejunostomy * ct scan performed at the hus, after the end of the courses of chemotherapy and / or before the surgery. exclusion criteria: * antecedent level l3 surgery, * psoas hematoma * no ct performed at hus at the end of chemotherapy and / or before surgery * impossibility of giving the subject informed information * subject under the protection of justice * subject under guardianship or curatorship

Keywords: sarcopenia jejunostomy oesogastric adenocarcinoma scanography
a novel therapy for the treatment of chest wall progression of breast cancer

Conditions: Breast Cancer

Summary: this study will assess safety and ergonomics/engineering design of a novel cancer treatment, continuous low irradiance photodynamic therapy (clipt). we will assess the effects on primary and metastatic tumors involving the skin, in particular to improve the functionality, efficiency and wearability of the light delivery device (ldd) as well as the overall treatment in subjects with chest wall recurrences of breast cancer. an ongoing study (irb# 8227), sponsored by a susan g. komen breast cancer foundation grant, using a 1st generation ldd device has evaluated and determined a dose-limiting toxicity of clipt for subjects with chest wall recurrences of breast cancer. a diomed laser will be the device used in this study. the diomed laser will deliver 630 nm (red spectrum) light through a fiber optic patch. the fiber optic patch will be compatible with the laser, delivering light to a designated region on the patient's skin.


Eligibility criteria:
inclusion criteria: * patients \> 18 years of age, with primary or metastatic cutaneous tumors that may or may not have been previously irradiated. * ecog performance status \< 3. * patients must not have received any systemic anti-cancer therapy within 30 days prior to enrolling in this study. * patients must not have received radiation therapy to the target site within 60 days of enrolling on this study. * skin of target site and control site must be grade 0 or 1 by common terminology * patients must have a target lesion and normal peri-umbilical skin that can be covered by the fiber-optic mesh used to deliver clipt (10 x 10 cm, or 3 x 3). * if located on an extremity, the target lesion must not cover more than 50% of the diameter of the extremity at the level at which it is located. * absolute neutrophil count \> 1000. * adequate coagulation status as indicated by platelet count \> 50,000, pt and ptt \< 1.5 time the upper limit of normal. * patients must sign informed consent. exclusion criteria: * male patients not considered for this study. * patients must have a target lesion in a location other than the hands, feet, genitals, or face. lesions in those locations will be excluded. * patients with medical conditions associated with photosensitivity, such as cutaneous porphyria or a collagen vascular disease, or with known allergies to porphyrins will be excluded. * pregnant and nursing patients will be excluded. women of child-bearing potential must have a negative serum or urine pregnancy test prior to enrollment. * patients taking medications known to cause photosensitivity (tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, and fluoroquinolones, st. john's wort and amiodarone) will be excluded. * patients with severe hepatic dysfunction (total bilirubin, ast, or alt \> five times upper limit of normal) will be excluded.

Keywords: chest wall progression breast cancer pdt photofrin photosensitizer
advanced provision of emergency contraception: utilizing technology to increase prescription fill rates

Conditions: Sexually Active

Summary: eighty-five percent of the 750,000 teenage pregnancies per year in the united states are unintended (guttmacher institute). approximately half of all teenage pregnancies end in the birth of a child; the remaining proportion end in either abortion (30%) or miscarriage (20%). it has been estimated that if emergency contraception (plan b) was used after every contraception failure, it could prevent 50% of unintended pregnancies and 60-70% of abortions annually. previous studies have showed the effectiveness of emergency contraception decreases with time after intercourse; the sooner it is taken-even if it means a matter of hours-the more effective it is in preventing pregnancy. based on previous studies, it is clear that relying on obtaining emergency contraception on the same day or even the day after unprotected intercourse is not guaranteed. for example, approximately 27% of pharmacies called by the adolescent mystery caller did not have the medication available the day of the call and almost all of the pharmacies not stocking the medication would take greater than 24 hours to obtain it through their ordering system. thus, the concept of advanced provision of emergency contraception has been proposed to assure that the medication can be taken as soon as possible. although this practice is known to be safe and has not shown any association with increased sexual risk or behaviors, it is unclear how often/if adolescents will fill a prescription for a medication that is not needed at the time of a medical encounter. the investigators propose a randomized pilot study (n=60) of a text-messaging intervention that aims to increase the rate at which prescriptions for emergency contraception are filled. based on practice norms in the bmc adolescent center, sexually active female adolescents (ages 13-21) in both the control and intervention groups will be provided a prescription for emergency contraception. the intervention group, however, will receive follow-up text message on their phone reminding them to fill the prescription. boston medical center health plan will provide prescription fill data regarding the prescriptions written at the time of enrollment. approximately 6 weeks after enrollment, all study participants will be contacted for a follow-up survey.


Eligibility criteria:
inclusion criteria: * sexually active * boston medical center health plan insurance * personal cell phone exclusion criteria: * pregnant * currently using a long-acting form of contraception (iud, depo, implanon) * no personal cell phone * insurance other than boston medical center health plan

Keywords: adolescents sexually active unprotected sex emergency contraception
eating disorders in type 1 insulin-dependent diabetes patients

Conditions: Type 1 Diabetes; Eating Disorders

Summary: the purpose of this study is to determine the prevalence of eating disorders in type 1 insulin-dependent diabetes patients

the risk of developing an eating disorder is increased in type 1 diabetes patients and associated with a poor prognosis in terms of glycemic control, metabolic complications, degenerative complications, and mortality. therefore the terminology diaboulimia has emerged to characterize an eating disorder specific to type 1 insulin-dependent diabetes patients, with insulin under dosage with a view of losing or controlling weight and that can contribute to a deterioration of the body composition. the purpose of this study is to determine the prevalence of eating disorders in an adult cohort with type 1 insulin-dependent diabetes.

Eligibility criteria:
inclusion criteria: * adult patient over 18 years of age with type 1 diabetes treated with a subcutaneous insulin pump * patient followed up for a subcutaneous insulin pump treatment by the healthcare provider, participating in the study (agir à dom group). * beneficiary of social security coverage. exclusion criteria: * patient with type 2 diabetes or mody diabetes * patient wearing a pacemaker * breastfeeding or pregnant woman * deprived of liberty by judicial or administrative decision * legal guardianship

Keywords: diaboulimia insulin pump treatment dt1