Kornimate/medical-research-clean huggingface dataset:
safety study of femoral neck fracture system

Conditions: Femoral Neck Fractures

Summary: the purpose of this study is to assess the reoperation rate of fractures that have occurred at the neck of the femur that are treated with the conquest fn femoral neck fracture system. the conquest fn femoral neck fracture system is approved for use by the united states food and drug administration (fda). it consists of a stainless steel plate and up to three (3) screws intended to treat both non-displaced and displaced fractures to the femoral neck.

the conquest fn™ represents the next generation femoral neck fracture system designed to offer better intra-operative reduction control with the assurance of eliminating device failure modes. this system is dedicated to treating both non-displaced and displaced intracapsular fractures of the femoral neck. it is a dynamic locked implant system that provides multiple points of fixed angle support with continuous compression across the fracture site, ensuring bone-on-bone contact during the fracture union process. the continuous fracture site compression and post-operative reduction maintenance is accomplished with the incorporation of telescoping compression screw technology. the novel system empowers surgeons to address the current surgical challenges and often unfavorable patient outcomes and high re-operation rate associated with the current treatment options for intracapsular femoral neck fractures. this study will evaluate the re-operation rate for any reason of displaced and non-displaced femoral neck fractures treated with the conquest fn femoral neck fracture system at one year post-operation.

Eligibility criteria:
inclusion criteria: 1. must be 18 years of age or older 2. must provide written informed consent 3. willing to make all required study visits for one year post-operation 4. subject has experienced a displaced or non-displaced intracapsular femoral neck fracture and is scheduled for repair using the conquest fn femoral neck fracture system. exclusion criteria: 1. subject with known sensitivity or allergies to stainless steel 2. subject with fracture occurring more than 7 days prior to surgery 3. subject has more than one fracture on the hip requiring surgery 4. subject is considered obese by a body mass index \> 40 at the time of surgery 5. therapy with another investigational agent within thirty 30 days of screening 6. subject has emotional or neurological condition that precludes cooperation and compliance 7. subject has undergone previous surgery on hip. 8. subject has severe bow of the target hip or gross distortion of the femur. 9. current systemic therapy with cytotoxic drugs 10. subject has a physical condition that would preclude adequate implant support or impede healing (e.g. blood supply impairment, insufficient bone quality or quantity, or an active local or systemic infection).

Keywords: femoral neck fracture hip broken hip conquest fn hip fracture
a study of cnto 328 in subjects with metastatic renal cell carcinoma

Conditions: Carcinoma, Renal Cell

Summary: the purpose of this study is to better understand the safety, tolerability and distribution of cnto 328 in the bloodstream.

this research study uses a type of drug called anti-il-6 monoclonal antibody, also known as cnto 328. cnto 328 is a new experimental drug. this study is trying to better understand the safety, the tolerability (side effects), and the distribution of the drug in the blood stream. the effects of cnto 328 in patients with renal cell carcinoma are currently unknown. however, recent data has shown that treatment with another anti-il-6 monoclonal antibody reduces the symptoms of renal cell carcinoma. the study is divided in 3 parts. part 1 is the phase i portion of the study and evaluated the safety of cnto 328 in subjects with metastatic renal cell carcinoma. part 2 and 3 will evaluate efficacy and safety of the drug in this patient population.

Eligibility criteria:
inclusion criteria: * clinical diagnosis (histologically confirmed, preferably) of metastatic renal cell carcinoma with documented metastases beyond the level of the regional lymphatics (ie, any t, any n, m1 disease) * measurable or evaluable disease (part 1); measurable disease (part 2 and part 3) * documented disease progression based on objective tumor assessment (part 2 and part 3), proven by tumor measurements on 2 computerized tomography scans within 6 months prior to enrollment * life expectancy greater than or equal to 6 months at screening * serum c-reactive protein (crp): detectable ( 4 mg/l or more) according to the standard assay of the core laboratory (part 1 and part 2); serum crp detectable to 30 mg/l or more (part 3) exclusion criteria: * received any investigational drug within 30 days, whichever is longer * history of receiving murine or chimeric proteins or human/murine recombination products (such as be8 and other anti-il-6 monoclonal antibodies) * serious concurrent illness or significant cardiac disease characterized by significant ischemic coronary disease or congestive heart failure * chronic infection, prior history of recurrent infection, or clinically important active infection * presence of a transplanted solid organ (with the exception of a corneal transplant more than 3 months prior to screening) or having received an allogeneic bone marrow transplant or peripheral blood stem cell transplant

Keywords: renal cell carcinoma cnto 328 infusions renal cell cancer
accuracy of non-invasive non-oscillometric blood pressure wristband

Conditions: Hypotension; Hypertension

Summary: the primary objective of the present investigation is to determine the accuracy of a non-invasive non-oscillometric blood pressure wristband device when compared to invasive intra-arterial blood pressure monitors. in an intensive care unit patients who already have an intra-arterial blood pressure monitor in place, this wristband device will be applied and blood pressure readings compared for approximately 15 minutes. blood pressure readings will be gathered and compared.


Eligibility criteria:
inclusion criteria: * patients admitted to the surgical intensive care unit who are already fitted with an invasive arterial line (a- line) are eligible for the trial, and no volunteers candidates for an a line are requested. exclusion criteria: * within the candidate group of individuals whose procedure in the hospital requires an a-line, the wristband may not, for various reasons, produce a clean signal. this is immediately determined after wearing the band (and may be related to the size of the wrist of the subject, among other things). such candidates will be excluded from admission to the study. * all data from a subject shall be excluded if the invasive reference systolic blood range is greater than 20 mmhg (2, 67 kpa) or if the invasive reference diastolic range is more than 12 mmhg (1, 6 kpa) in any single determination.
different sessions of perineural injection with dextrose for carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: carpal tunnel syndrome (cts) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. the technique of perineural injection therapy (pit) by using 5% dextrose (d5w) is now commonly used for peeling the nerve from surrounding soft tissue (called nerve hydrodissection), which may help antineurogenic inflammation, allow the impulse to pass, and rescue the nerve with ischemic damage. however, the evidence and reference of pit and nerve hydrodissection are very seldom until our series researches since 2017. moreover, our research revealed pit with d5w is more beneficial than that of corticosteroid in patients with mild-to-moderate cts at 4 to 6 months postinjection. however, the accumulative effect and long-term effect (more than 6 months) of pit is still unknown. hence, we design a randomized, double- blind, controlled trail to assess the long-term effect of ultrasound-guided pit in patients with cts. the aim one is to survey the possible accumulative effect of different sessions of pit (6 months follow-up) and aim two is to evaluate the long-term effect and safety of pit (one year follow-up).

after obtaining written informed consent, patients clinically diagnosed with mild-to-moderate cts were includes and randomized into three groups. group a, patients received two-sessions of ultrasound-guided pit with 10cc d5w (3 months interval); group b, patients received one-session of ultrasound-guided pit with 10cc d5w and 5cc normal saline separately (3 months interval); group c (control group), patients received two-sessions of ultrasound-guided pit with nerve hydrodissection with 10cc normal saline. the primary outcome is boston carpal tunnel syndrome questionnaire (bctq) and secondary outcomes include visual analog scale (vas), cross-sectional area (csa) of the median nerve, nerve conduction velocity of the median nerve, and global assessment of treatment. the evaluations were performed pretreatment as well as on the 1st, 3rd, 6th, 9th month and one year after first injection.

Eligibility criteria:
inclusion criteria: * age between 20-80 year-old. * diagnosis was confirmed using an electrophysiological study exclusion criteria: * cancer * coagulopathy * pregnancy * inflammation status * cervical radiculopathy * polyneuropathy, brachial plexopathy * thoracic outlet syndrome * previously undergone wrist surgery or steroid injection for cts

Keywords: perineural injection therapy nerve hydrodissection
adapting lifestyle offloading for dfus

Conditions: Diabetic Foot Ulcer; Diabetic Foot

Summary: the goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care. the main questions it aims to answer are to determine the acceptability and feasibility of taking a tailored lifestyle-focused approach as part of comprehensive diabetic foot ulcer management. patient participants with dfus who require offloading treatment will receive the tailored lifestyle-focused self-management intervention.

diabetic foot ulcers (dfus) frequently lead to major amputation and mortality. while relieving foot pressure (i.e., offloading) is vital for healing, many patients struggle to adhere to recommended offloading treatments. participants with dfus who require offloading treatment will receive the tailored lifestyle-focused self-management intervention. this occupational therapist-led lifestyle-focused intervention will be co-developed with participants, caregivers, family members, and dfu care team members. participants with dfus will be offered lifestyle-based treatment sessions for up to 8 weeks (virtually) with a licensed occupational therapist. participants will complete pre/post surveys and a subset will take part in an interview to clarify key findings from surveys and obtain patients' perspective of the effectiveness of the intervention. investigators will also offer focus group interviews to the dfu care team members and occupational therapist to learn their perceptions on the intervention's acceptability, appropriateness, efficiency, and feasibility at the conclusion of the intervention.

Eligibility criteria:
inclusion criteria: * english speaking * age 21 years or older * history of active dfu necessitating offloading * capacity to provide informed consent * access to telehealth (internet connection and equipment) * ability to walk independently or with an assistive device * self-reported life expectancy of more than one year exclusion criteria: * self-reported deafness or blindness * history of lower extremity amputation besides toes

Keywords: offloading diabetic foot ulcer lifestyle-focused intervention occupational therapy occupational therapist self management
mindfulness, breast cancer and psycho-immune dysregulation

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the benefits of a mindfulness based stress reduction (mbsr) program for psycho-immune dysregulation in women newly diagnosed with breast cancer compared to women with breast cancer completing an attention control condition (health education classes). women will be randomized to either the mbsr or health education classes. they will complete psychometric instruments evaluating psychological outcomes and will provide blood samples for immune outcomes. they will also provide saliva samples for cortisol diurnal rhythm determination. measures will be done longitudinally pre and post mbsr or health education program. it is hypothesized that mbsr participants will exhibit improved psychological and immunological outcomes over time, as compared to women randomized to the health education classes.

the mindfulness-based stress reduction (mbsr) program is designed to cultivate conscious awareness (i.e., mindfulness) of one's experience in a non-judgmental or accepting manner (kabat-zinn, et al., 1990). mindfulness programs may facilitate recovery from cancer. however, most prior mindfulness investigations for women with breast cancer focused on cancer survivors, well beyond the acute period of cancer diagnosis and treatment. moreover, few of these studies evaluated immune measures with relevance to cancer. women diagnosed with early stage breast cancer (stages 0, 1, 2, and 3) will be enrolled. eligible women will be identified after completion of their breast surgery and when surgical pathology reports are available. women will complete psychometric instruments and study questionnaires. they will provide blood for immune measures and saliva for cortisol diurnal rhythm. measures will be done at five separate time points. these are pre-, mid-, and completion of either the mbsr or the attention control program, as well as at 1- and 6-months post-program. demographic information and information about health behaviors will be collected by self-report. wrist actigraphy for an additional assessment of sleep quality will be done in an exploratory manner. hierarchical linear modeling will be used to compute multilevel model for change, based on full maximum likelihood estimation (raudenbush, s. w., and a. s. bryk. 2002). hierarchical linear modeling will be applied to examine intra-individual and inter-individual differences in initial status (baseline) and trajectories of change over time.

Eligibility criteria:
inclusion criteria: * women * early stage breast cancer exclusion criteria: * prior training in mbsr, * recurrent breast cancer, * metastatic breast cancer, * other cancers (except basal cell carcinoma), * immune-based disease, * psychoses, * cognitive dysfunction, * unable to read or write english, * history of substance abuse, * use of immune-altering medications

Keywords: breast cancer, mindfulness, immune, stress
the effects of dobutamine on postoperative cardiac function in aortic valve replacement

Conditions: Heart Failure

Summary: the use of dobutamine in postoperative hemodynamic treatment is widespread despite seemingly intact contraction of the heart. this study aims to elucidate the efficacy of low-dose dobutamine infusion in patients in the postoperative phase replacement of the aortic valve.


Eligibility criteria:
inclusion criteria: * 18-90 years * left ventricular posterior wall =/\>12mm * ejection fraction \> 45% * sinus rhythm * eligible for aortic valve replacement exclusion criteria: * need for concomitant cardiac bypass operation. * moderate or severe insufficiency of the mitral valve * active endocarditis * insufficient ultrasound window * using b-blockers * liver insufficiency * patients treated with comt-inhibitors * allergy towards dobutamine * pregnancy * women of fertile age who do not use relevant anti-conception * lacking participant consent

Keywords: postoperative dobutamine inotropes stunning heart failure
intracorporeal versus extracorporeal morcellation: clinical efficacy and safety outcomes

Conditions: Uterine Myoma

Summary: the aim of this study protocol will be to compare the technique of intracorporeal morcellation using reusable electronic device (standard technique) with a technique of removal "protected" by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself.


Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopy for uterine myomas with international guidelines surgical indications * presence of at least one uterine myoma larger than 4 cm * aged between 18 and 40 years exclusion criteria: * presence of uterine neoformations suspicious for malignancy * medical major disorders associated * acute or chronic psychiatric disorders * ascertained premenstrual syndrome * use of drugs that can affect cognitive ability or state of consciousness and alertness during the last six months prior to enrollment * presence of calcified fibroids ultrasound examination * presence of adnexal lesions * detection of a pattern of endometrial hyperplasia with atypia determined in the course endometrial biopsy performed for abnormal uterine bleeding * abnormal pap test * positive pregnancy test * previous use of laparoscopic surgery increased

Keywords: myomectomy laparoscopic myomectomy morcellation risk of dissemination uterine sarcoma parasitic myoma
pulpotomy in mature permanent molars using biodentine versus mta

Conditions: Symptomatic Irreversible Pulpitis

Summary: the aim of this study is to compare treatment outcomes of pulpotomy in mature permanent teeth using biodentine versus mta regarding postoperative pain and success rate.

* patients will be clinically and radiographically examined and their eligibility will be assessed. * eligible patients will be randomly assigned to one of 2 groups: experimental group (pulpotomy using biodentine) and the control group (pulpotomy using mta). * after adminsrtation of local anesthesia, pulpotomy will be done under rubber dam isolation. the pulp tissue will be removed until the level of the orifices of the canals. after hemostasis is achieved, the capping material will be placed. in the experimental group, the capping material is biodentine while in the control group, the capping material is mta * the cavities will be sealed with resin-modified glass ionomer. then the teeth will be permanently restored with composite . a post-operative radiograph will be taken. * the patients will be given a pain diary based on numerical rating scale (nrs) and asked to rate their pain level at the specified times. * the patients will be recalled after 6 and 12 months post-operatively.

Eligibility criteria:
inclusion criteria: * patients aging between 18-40 years old * patients with symptomatic irreversible pulpitis. * radiographically: absence or slight widening in periodontal ligament space. * systemically- healthy patients (asa i or ii). * patients who agree to attend for recall appointments and provide written consent. exclusion criteria: * severe marginal periodontitis. * necrotic pulp, pulp polyp, tooth tender to percussion, clinical progression into periapical abscess, fistula. * non-restorable teeth, teeth with internal/external root resorption or root canal calcification.

Keywords: pulpotomy mineral trioxide aggregate (mta) biodentine vital pulp therapy postoperative pain overall success
a crossover study to determine the 24 hour lung function profile of indacaterol in patients with moderate-to-severe chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study was conducted to provide detailed information on the efficacy of indacaterol in terms of its effect on spirometry assessed forced expiratory volume in 1 second (fev1) over a 24 hour time period.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic obstructive pulmonary disease (copd) (moderate-to-severe as classified by the global initiative for chronic obstructive lung disease (gold) guidelines, 2006) and: 1. smoking history of at least 20 pack-years 2. post-bronchodilator forced expiratory volume in 1 second (fev1) \< 80% and ≥ 30% of the predicted normal value 3. post-bronchodilator fev1/fvc (forced vital capacity) \< 70% exclusion criteria: * patients who have been hospitalized for a copd exacerbation in the 6 weeks prior to screening or during the run-in period * patients requiring long-term oxygen therapy (\> 15 hours a day) for chronic hypoxemia * patients who have had a respiratory tract infection within 6 weeks prior to screening * patients with concomitant pulmonary disease * patients with a history of asthma * patients with diabetes type i or uncontrolled diabetes type ii * any patient with lung cancer or a history of lung cancer * any patient with active cancer or a history of cancer with less than 5 years disease-free survival time * patients with a history of long qt syndrome or whose qtc interval (bazett's) measured at screening or randomization is prolonged * patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period * patients unable to successfully use a dry powder inhaler device or perform spirometry measurements other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: chronic obstructive pulmonary disease copd indacaterol
ba253bineb in patients with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objective of this study is to investigate the long-term safety of ba253bineb. secondarily the long-term efficacy of ba253bineb is also investigated.


Eligibility criteria:
inclusion criteria: the patients with copd (chronic bronchitis, emphysema) and who satisfy the following criteria 1. patients with fev1.0/fvc (forced vital capacity) of \<= 70% in the screening test and whose symptoms are stable 2. patients aged \>= 40 years or older 3. patients must be able to understand the patient information form exclusion criteria: 1. patients complicated with bronchial asthma, making the assessment of drug efficacy against copd difficult 2. patients who have taken an long acting corticosteroids(i.m.) within 1 month before the study 3. patients using oral corticosteroid medication at a dose in excess of the equivalent 5 mg/day of prednisolone 4. patients with glaucoma 5. patients who have prostatic hypertrophy 6. patients with hypersensitivity to anticholinergic drugs 7. patients with serious hepatic disease, kidney disease or heart disorder and who are judged by the investigator as inappropriate as the subjects of study 8. women who are pregnant or who may become pregnant, or nursing women 9. patients who are judged by the investigator as inappropriate as the subjects of the study