Kornimate/medical-research-clean huggingface dataset:
medial forefoot block for analgesia after foot surgery

Conditions: Hallux Valgus

Summary: forefoot surgery includes bunion surgery and similar reconstructive bone cutting surgery and is very painful. local anaesthetic nerve blocks are used to provide pain relief after this work. the purpose of this study is to compare two techniques: one using anatomical landmarks alone to guide local anaesthetic infiltration, the other using peripheral nerve stimulation to guide local anaesthetic infiltration (termed medial forefoot block). the two techniques will be compared for reliability of postoperative analgesia.

more extensive description not desired.

Eligibility criteria:
inclusion criteria: * fit adults requiring forefoot surgery with bone cutting exclusion criteria: * morbid obesity (bmi \> 40) * known contraindications to regional anaesthesia

Keywords: regional anaesthetic techniques surgery orthopaedic
universal stylet bougie in patients with cervical neck immobilization.

Conditions: Intubating Condition

Summary: in patients with cervical spine injury, securing the airway while adequately immobilizing the cervical spine to avoid secondary neurological damage is very challenging. although awake fiber-optic intubation is the most reliable method in patients with cervical trauma, it has some limitations such as lack of availability, need for expertise in the use, difficulty with non-cooperative patients, or presence of blood or secretions in the airway. two devices are commonly used to facilitate tracheal intubation: a stylet or a tracheal tube introducer ("bougie").

the universal stylet bougie, or usb™, represents a significant advance in the design and development of tracheal introducers (bougies) and stylets. traditionally, the design requirements of styles and bougies have always been considered incompatible. a stylet requires sufficient rigidity to allow the tracheal tube to be manipulated to a variety of angles, whereas a bougie needs to be flexible enough to allow positive tracheal ring feedback to allow correct placement. the unique design of the usb™ means the device can be used as a stylet or as a bougie. it consists of two metals inserted on both sides and a flexible middle section. the usb can easily be manipulated to a variety of angles when used as a stylet, yet has the flexibility when used as a bougie. in addition, the hexagonal shape provides less contact with the inner surface of the tracheal tube, providing particularly easy insertion and removal. in this study we are simulating a difficult intubating condition by limiting the cervical neck extension through applying a rigid neck collar. subsequently, we will assess whether using the usb device could improve the successful rate of intubation in these patients.

Eligibility criteria:
inclusion criteria: 1. asa (american society of anesthesiologists) physical status 1-2. 2. age 18- 60 years old of both sexes. 3. patients undergoing elective surgery under general anesthesia and tracheal intubation. exclusion criteria: 1. age \< 18 years and ≥ 60 years 2. pregnancy 3. patients with bmi \>35 kg m-2 4. emergency surgery or full stomach 5. patients with suspected difficult airway {e.g., high neck circumference, airway masses, mouth scars, neck scars, or history of snoring). 6. patients with cervical spine pathology 7. patients with any cardiac disorders

Keywords: usb, cervical immobilization, rigid collar
shunt outcomes of post-hemorrhagic hydrocephalus

Conditions: Post-Hemorrhagic Hydrocephalus

Summary: this multicenter, prospective pilot study will compare the effectiveness of two established procedures used in the treatment of post-hemorrhagic hydrocephalus in very low birth weight infants, specifically ventricular reservoirs and subgaleal shunts. the study is being conducted by the hydrocephalus clinical research network (hcrn), a network established to conduct multi-institutional clinical trials on pediatric hydrocephalus.

intraventricular hemorrhage and post-hemorrhagic hydrocephalus remain a leading cause of mortality and long-term morbidity in premature infants. the two most common temporary cerebrospinal fluid (csf) diversion procedures are the ventriculosubgaleal shunt (sgs) and an implanted ventricular reservoir (res) for intermittent csf removal. these methods are physiologically very different and their comparative effectiveness in treating hydrocephalus and possibly reducing the need for an eventual permanent csf shunt is currently not known. the goal of this pilot study is to obtain information critical for planning and executing a future randomized trial comparing sgs and res. specifically, this pilot study will establish inclusion criteria, define the primary outcome, and standardize the interventions in preparation for initiating a comparative trial between the sgs and res procedures. in addition, the importance of examining the neurodevelopmental outcomes for these patients has been recognized within the neurosurgical and neuropsychological settings. therefore, the scope of this study has been extended to include an examination of the neurodevelopmental outcomes at 18 to 22 months and at 36 to 42 months in patients who undergo bsid-iii testing at their clinical centers.

Eligibility criteria:
inclusion criteria: * premature neonates with birth weights less than 1500 grams * grade iii or iv intraventricular hemorrhage * fronto-occipital horn ratio greater than or equal to 0.50 exclusion criteria: * less than 72 hour life expectancy from other medical problems

Keywords: post-hemorrhagic hydrocephalus intraventricular hemorrhage low birth weight premature infants
peer to peer delivery of behavioral activation

Conditions: Depression

Summary: the goal of this study is to test the feasibility, acceptability and preliminary impact of peer-delivered behavioral activation (ba) for depressed older adults (60+) who are naturally occurring retirement communities (norc) residents or senior center participants.

this project focuses on helping to solve a growing problem in health care today. through increased screening in the older adult population, detection of depression has increased which has established a growing need for mental health resources. unfortunately, there are limited resources to keep up with the steady increase of individuals in need. training peers to work with older depressed adults in techniques such as behavioral activation provides an alternative model to help moderate the increased need and provide a unique intervention of care. developing an innovative peer facilitated program has the potential to enhance the delivery of quality health care. the specific aims of the study are 1) to train peer coaches and implement peer to peer in the community 2) to examine depression ratings over time.

Eligibility criteria:
inclusion criteria: * age 60 and older * member of lenox hill senior center, st. peter's senior center, or beth abe * score of 10+ on patient health questionnaire (phq-9) exclusion criteria: * presence of alcohol abuse, substance abuse, psychotic disorder, or bipolar disorder as observed on the structured clinical interview for diagnostic and statistical manual of mental disorders (scid) * inability to speak english * dementia: mini mental state examination (mmse) score below 24 * high suicide risk, i.e. intent or plan to attempt suicide

Keywords: depression
safety of wharton jelly in erectile dysfunction

Conditions: Erectile Dysfunction Associated With Type 2 Diabetes Mellitus

Summary: safety of intracavernous injection of wharton jelly mesenchymal stem cells for the treatment of erectile dysfunction in diabetic patients.

this study will be conducted at the cell therapy center (ctc), jordan, in which nine male patients ranging from 25-70 years diagnosed with erectile dysfunction will be selected. this diagnosis is based on medical history, validated questionnaires, physical examinations, laboratory tests and specific diagnostic tests. the patients are followed by clinical assessment, laboratory investigations as well as doppler ultrasound.

Eligibility criteria:
inclusion criteria: 1. adult male patients ranging from 25 to 70 years. 2. history of chronic erectile dysfunction for at least six months. 3. baseline international index of erectile function (iief) score of \< 26. 4. not interested or able to use phosphodiesterase type 5 inhibitor (pd5i) drug therapy and willing to forgo theses treatments for the first 6 month period following study treatment. 5. body mass index between 20-30. 6. willing to provide written informed consent, complete questionnaire, and to be available for all baseline treatment and follow up examinations required by protocol. exclusion criteria: 1. current urinary tract or bladder infection. 2. clinical/laboratory evidence of transmissible diseases. 3. clinically evident penile anatomical deformities(e.g., peyronie's disease) or history of priapism. 4. skin irritation, infection, wound, sore or disruption in the immediate areas of skin entry for penile injection. 5. current or previous malignancy. 6. use of any non study treatment for erectile function within 4 weeks of study treatment. 7. lack of willingness to continue through 6 months after study treatment. 8. any previous penile implant or penile vascular surgery. 9. uncontrolled hypertension or hypotension(systolic blood pressure \> 170 or \ 100 or \< 50 mm hg). 10. reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening. 11. bleeding or clotting disorder, use of anticoagulant therapy. 12. lab values for complete blood count (cbc), prothrombin time (pt)/ partial thromboplastin time (ptt)/ international normalized ratio (inr), alanine aminotransferase (alt), aspartate aminotransferase (ast) and creatinine falling outside the normal lab values. 13. systemic autoimmune disorder. 14. significant active systemic or localized infection. 15. receiving immunosuppressant medications. 16. post-radical prostatectomy.

Keywords: wharton jelly mesenchymal stem cells erectile dysfunction diabetes safety
comparison of oral lactulose versus polyethylene glycol for bowel preparation

Conditions: Colon Disease

Summary: adequate quality of bowel preparation(bp) is essential for colonoscopy. several guidelines recommend that split-dose of 4l peg should be used as a standard regime for bp. however, the high-volume peg caused lower compliance to the regime and increased cost. oral lactulose is a treatment for constipation. it tastes sweet and has no obvious gastrointestinal side effects. previous study shows 200ml lactulose oral solution plus 2l water has been proven superior bp compared to 2l peg. however, there is a lack of research describing bowel cleansing and colonoscopy outcomes using lactulose oral solution compared with the standard split dose of 4l peg. here we compared the use of a lactulose oral solution (300ml+1.5 l) with a peg formulation (2 l) for colonoscopy preparation using the following metrics: quality of cleansing, colonoscopy outcomes, patient/physician satisfaction, and patient tolerability.


Eligibility criteria:
inclusion criteria: * age 18-80 patients with intact colon and rectum exclusion criteria: * prior finding of severe colorectal stricture * without the requirement of reaching cecum * suspected colonic stricture or perforation * use of prokinetic agents or purgatives within 7 days * toxic colitis or megacolon * pregnant women * hemodynamically unstable * patients who cannot give informed consent

Keywords: colonoscopy bowel preparation
determinant of repeat revascularization after percutaneous coronary intervention

Conditions: Percutaneous Coronary Intervention; Coronary Artery Disease

Summary: to determine factors associated with repeat revascularization among adults aged 25 years and above within 5 years of first percutaneous coronary intervention (pci) at a tertiary care hospital.

matched case-control study design was employed to determine the association between re-peat revascularization and its determinants in patients within 5 years of undergoing index pci. the case was defined as a patient who had undergone repeat revascularization within 5 years of undergoing index pci. control was defined as a patient who had not undergone repeat revascularization within 5 years of undergoing index pci. the retrospective study was carried out with the approval of the ethical review committee of the tertiary care hospital where the study was carried out. a waiver of informed consent was granted as this was a retrospective study and all patients were discharged from the hospital. a minimum of 120 cases with matched 240 controls were required in 1:2 case to control ratio. this sample size was essential to achieve the power of 80% for an anticipated matched odds ratio of 2 with the hypothesized correlation of 0.2 using a two-sided hypothesis test with a significance level of 0.05. the outcome of the study was the repeat revascularization status. there are different types of repeat revascularization according to the site and lesion to which intervention has been provided. any type of repeat revascularization was considered and enrolled as a case in this study5. covariates included in the study were divided into patient characteristics (gender, age, health coverage, bmi, smoking status), comorbidity status (hypertension, diabetes mellitus, hyperlipidaemia, valvular disease), clinical characteristics (creatinine level, systolic blood pressure, diastolic blood pressure, hba1c, cholesterol level, other technical factors related to the index pci) and medication status (beta-blocker, ace inhibitor, statin).

Eligibility criteria:
inclusion criteria for cases: * aged 25 years and older * undergone repeat revascularization within 5 years of undergoing index pci (from 2011 to 2017). exclusion criteria for cases: * if suffering from any hypercoagulable disorder * revascularization procedure was per-formed outside the study setting * staged pci within 3 weeks or planned pci within 6 months of index pci. inclusion criteria for controls: * patients aged 25 years and older * undergone pci once from the year 2011 to 2017. exclusion criteria for controls: * if suffering from any hypercoagulable disorder.

Keywords: repeat revascularization percutaneous coronary intervention coronary artery disease
a study comparing montelukast with placebo in children with seasonal allergic rhinitis (0476-219)(completed)

Conditions: Seasonal Allergic Rhinitis

Summary: this study will evaluate the effect of montelukast compared to placebo in children during the spring allergic rhinitis season.


Eligibility criteria:
inclusion criteria: * patient has a history of allergic rhinitis symptoms which flare up during the study season * patient is a non-smoker * patient is in otherwise good health * patient is able to chew a tablet exclusion criteria: * patient is hospitalized * patient is pregnant or nursing mother, or \<8 weeks post partum * patient and/or parent intend to move or vacation away from home during the trial * patient has had a major surgical procedure within 4 weeks of the prestudy visit * patient has been treated in an emergency room or hospitalized for asthma within 3 months prior to study * patient has an upper respiratory, eye, or sinus infection, or a history of any of these within 3 weeks prior to study * patient has a recent history of a psychiatric disorder or attention deficit hyperactivity disorder
effectiveness of a novel device for cervical training in cervicogenic headache.

Conditions: Cervicogenic Headache

Summary: the purpose of this study is to evaluate the clinical results in cervical spine range of motion, endurance deep cervical muscles, headache impact and physical activity enjoyment by a training protocol with the new device for cervical treatment (cdat) versus conventional training protocol (ct) in subjects with cervicogenic headache.

the cervical spine is the most mobile region of the spine and must be strong enough to support the weight of the skull. strength deficits of the deep cervical muscles are related to different clinical conditions, such as cervicogenic headache. cervicogenic headache is a secondary headache defined as a unilateral headache associated with neck pain, related to a decreased cervical range of motion and strength deficits of the deep cervical muscles. training protocols can help to improve pain, function, posture and cross-sectional area. however, there are no training protocols in subjects with cervicogenic headache including deep neck extensor and flexor muscles. the cervical device treatment (cdat) allows us to train the cervical flexor and extensor muscle in a simple and comfortable way.

Eligibility criteria:
inclusion criteria: * deep flexor strength deficit in craniocervical flexion test. * deep extensor strength deficit in neck extensor muscle endurance. * a positive result in the flexion-rotation test * ≥ 50 score in headache impact test (hit-6). * diagnosis of cervicogenic headache according to sjaastad et al. subjects will have to fulfill both parts i and iii of the major criteria for diagnosis (pain aggravated by neck movement, sustained position or external pressure, restricted cervical range of motion, and unilateral pain starting in the neck and radiating to the frontotemporal region) exclusion criteria: * have received head/cervical treatment during the last six month, presented any red flag, neurological or cognitive impairment (inability to understand the questionnaires or examination). * have received cervical manual therapy treatment during the last six month * a history of head/cervical trauma or surgery during the last year. * the use of pacemakers (the magnets in the crom device could alter their signal * inability to perform the flexion-rotation test.

Keywords: neck muscles headache pain muscle weakness telerehabilitation exercise therapy
closed-loop insulin delivery during pregnancy (iadiabenceinte)

Conditions: Type 1 Diabetes

Summary: the imbalance of diabetes is associated with an increased risk of maternal and fetal complications. in women, it can cause abortion, hypertension, preeclampsia, and obstructed labor; in the fetus, it increases the risk of many malformations, including neurological and cardiac, fetal death in utero, intrauterine growth retardation, macrosomia, prematurity and metabolic complications. despite the various therapeutic tools available and used during pregnancy, maintaining blood sugar levels within this narrow range remains a challenge. automated insulin therapy (ia) could further improve outcomes with continuous glucose monitoring and increase percentage of time spent on target between 63 and 140 mg/dl the objective of this observational study is to describe the clinical characteristics, metabolic data on mcg and maternal and/or fetal complications in women with t1d treated during pregnancy with an ai system available in france.

diabetes imbalance is associated with an increased risk of maternal and fetal complications, and achieving target blood glucose levels before and during pregnancy in women with type 1 diabetes (t1dm) significantly reduces these complications. in women, it can cause abortion, hypertension, pre-eclampsia, and dystocic deliveries; in the fetus, it increases the risk of numerous malformations, including neurological and cardiac, fetal death in utero, intrauterine growth retardation, macrosomia, prematurity, and metabolic complications at birth such as neonatal hypoglycemia and hypocalcemia. the recommended glycemic targets during pregnancy are strict: hba1c \ 70% (6). despite the various therapeutic tools available and used during pregnancy, maintaining blood glucose within this narrow range remains a challenge. automated insulin therapy (ai) could improve further on the results obtained with continuous glucose monitoring and increase the percentage of time spent in target between 63 and 140 mg/dl the objective of this present observational study is to describe the clinical characteristics, metabolic data on mcg and maternal and/or fetal complications in women with t1dm treated during pregnancy with an ai system available in france, whether this system is used before the beginning of the pregnancy or during it.

Eligibility criteria:
inclusion criteria: * aged at least 18 years * had been diagnosed with type 1 diabetes before pregnancy * using an hybrid closed-loop insulin delivery system before or at any time of pregnancy exclusion criteria: * patient opposed to the research

Keywords: artificial pancreas closed loop insulin delivery glucose control pregnancy type 1 diabetes observational study
molecular analysis of breast cancer

Conditions: Breast Cancer; Breast Cancer Non-invasive Breast Cancer; Breast Cancer Early Stage Breast Cancer (Stage 1-3)

Summary: this is a research-based study that is looking at the biologic features of breast tissue, lymph node tissue, or blood in order to study breast cancer development growth, and spread. through tissue and/or blood samples we hope to gain further knowledge and understanding of how to improve diagnosis and treatment of breast cancer by identifying the molecular markers that predict clinical outcome and response to therapy.

the tissue obtained in this protocol will be used for genome-wide examination of dna, rna expression profiling, proteomic analyses, isolation and analyses of normal and cancer stem cells, isolation and analyses of circulating tumor cells, possible analyses of immune cells, and possible analyses of serum factors. the tissue may also be used to develop patient-specific cell culture models or mouse xenograft models of breast cancer for biologic study of tumor progression and metastases and for therapeutic testing. in general, the tissue will be used in studies that will molecularly classify tumors, identify prognostic markers, identify potential therapeutic markers, identify potential treatment targets, and help us better understand the biology and specific role played by different tumor cells in the metastatic process. the ultimate goal is to use molecular analyses to improve the diagnosis and treatment of breast cancer.

Eligibility criteria:
inclusion criteria:people eligible for this study include anyone older than 18 years who is undergoing one of the following procedures: core needle or surgical breast biopsy, lumpectomy, mastectomy, axillary lymph node surgery, breast reduction surgery, or ductal lavage or ductoscopy. patients who have had breast cancer in the past who are currently free of disease or who have a breast cancer recurrence are also eligible. all patients who participate must be able to understand and sign the informed consent. although most patients will be female, any males undergoing the above procedures are also eligible for this study. exclusion criteria:any patient who is less than 18 years old, who is unable to understand the informed consent, or not undergoing the above procedures will be excluded from this research.
dialoog: crestor in patients with diabetes mellitus type 2: lowering of ldl-c levels to new european guidelines

Conditions: Diabetes Mellitus Type 2; Crestor, Rosuvastatin; LDL Cholesterol; Observational

Summary: the purpose of this study is to determine in dm ii patients the efficacy of crestor in obtaining the new european ldl cholesterol guidelines.


Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2, ldl-c \> 2,5 mmol/l, no cholesterol lowering medication used last 3 months, starts with crestor 10 mg, permission to use patient data by az