Kornimate/medical-research-clean huggingface dataset:
synbiotic extensively hydrolysed feed study

Conditions: Cow Milk Allergy

Summary: this study of the tolerance and acceptability of a extensively hydrolysed formula (ehf) containing pre- and probiotics will assess gastrointestinal (gi) tolerance, product intake and acceptability in 40 infants (aged \<13 months) currently using or requiring an extensively hydrolysed formula for the dietary management of cma. patients already prescribed an ehf (or other appropriate feed for cma) at time of recruitment will undertake a 3 day baseline period in which their current symptoms, compliance, gi tolerance and acceptability towards their current feed is assessed, before introducing the study product for a period of 4 weeks. patients who are not on an ehf (or other appropriate feed for cma) at baseline will forgo this 3 day baseline period and immediately introduce the study product for 4 weeks.


Eligibility criteria:
inclusion criteria: * aged \<13 months * currently using or requiring an extensively hydrolysed formula for the dietary management of cows' milk allergy * expected to receive at least 25% of their energy intake from the study feed * already fed with infant formula or hypoallergenic formula (either partially or fully) * written, informed consent from parent/carer exclusion criteria: * "severe" cows' milk allergy (clinically judged to require an amino acid formula) or any other contraindications to the use of an extensively hydrolysed formula * exclusively breastfed infants * primary lactose intolerance * history of poor tolerance to whey based ehfs * immunocompromised infants * premature infants (born \<37 weeks) * major hepatic or renal dysfunction * requirement for any parenteral nutrition * tube-fed via a post-pyloric route * participation in other clinical intervention studies within 1 month of recruitment to this study * investigator concern around the ability of family to comply with protocol and requirements of study
a study based on japanese medical records that looks at bleeding events in people with atrial fibrillation and coronary artery disease who start taking either dabigatran, rivaroxaban, or warfarin

Conditions: Coronary Artery Disease; Atrial Fibrillation

Summary: the study aims to evaluate the safety and effectiveness comparisons between warfarin, dabigatran, and rivaroxaban in routine clinical practice among japanese non-valvular atrial fibrillation (nvaf) patients with concomitant coronary artery disease (cad).


Eligibility criteria:
inclusion criteria: -≥18 years of age * has one year of look-back period prior to the index date (defined as the first date of prescription for dabigatran, rivaroxaban, or warfarin during the study period) * new users of warfarin, dabigatran, and rivaroxaban, defined as patients without historic use of any oral anticoagulants during the look-back period * has at least 1 diagnosis of nvaf during the look-back period prior to or on the index date * has at least 1 diagnosis of cad during the look-back period prior to or on the index date exclusion criteria: * diagnosed with end-stage renal disease, or undergo hemodialysis, or experience pregnancy during the study period * initiate warfarin, dabigatran, rivaroxaban due to valvular atrial fibrillation (af), af associated with mechanical valve malfunction or mechanical complication of heart valve prosthesis, or rheumatic af * underwent joint replacement procedures or diagnosed with venous thromboembolism during the look-back period prior to or on the index date * prescribed with more than 1 oral anticoagulation (oac) on the index date * prescribed with more than 2 anti-platelet drugs per prescription (triple or quadruple anti-platelet use), or prescribed with any anti-platelet injection * patients with missing or ambiguous age or sex information
trunk task-oriented training combined with functional electrical stimulation in spinal cord injured individuals

Conditions: Spinal Cord Injuries

Summary: the objectives of the study are to evaluate trunk task-oriented training combined with function electrical stimulation (fes/t-tot) efficacy on sitting balance and functional independence, and to understand the mechanisms of neuroplasticity that would improve functional independence following fes/t-tot in individuals with spinal cord injury.

after obtaining their consent, participants will undertake evaluations at different times: 1. assessment 3 weeks prior to training 2. assessment 1 week prior to training 3. training over 12 weeks 4. assessment 1 week after training 5. assessment 1 month after training (follow-up) each assessment will be divided in 2 sessions and data will be collected over 2 days, at one session per day. the assessment will consist of: * session 1 (at neuro-concept clinic) will include presentation of the study and the obtention of written consent, clinical (modified reaching test and muscle strength), quality of life and functional independence assessments. * session 2 (at iurdpm in dr. barthélemy's laboratory) will include postural control, corticospinal and cortical assessments. after the initial assessment, the participants with spinal cord injury will realize 36 sessions of trunk task-oriented training alone or combined with function electrical stimulation (3 times a week for 12 weeks).

Eligibility criteria:
for participants with spinal cord injury inclusion criteria: * level of spinal cord lesion between c6/c7 and t10 * at least, 6 months post-injury * be considered as ais a, b, c or d * be able to sit without support for 15 seconds * be able to provide informed consent in english or in french exclusion criteria: * to have cognitive deficits * to wear a corset * to have personal or family history of epilepsy * to have suffered moderate or severe traumatic brain injury * to have cochlear implant for control participants exclusion criteria: * to have orthopedics problems * to have cognitive deficits * to have neurological problems

Keywords: trunk task-oriented training corticospinal tract functional electrical stimulation functional independence trunk motor control
radiofrequency ablation: treatment for posterior element pain from vertebral compression fractures

Conditions: Vertebral Compression Fracture; Facet Joint Pain

Summary: the purpose of this study is to test the efficacy of radiofrequency ablation of the medial branch nerves (rfa-mbn) in relieving pain and improving physical function in patients with subacute and chronic vertebral compression fractures (vcf).

the study examines a novel approach to treat pain associated with vcfs. the usual care therapy currently involves utilizing physical therapy, non-steroidal anti-inflammatory medications, opioids, and bone re-building medications known as bisphosphonates. a usual treatment plan may include some, if not all the above. there is growing evidence that the posterior spinal elements contribute to pain that patients with vcfs experience. rfa-mbn, which targets these posterior spinal elements, may provide more sustained pain relief and improved physical function compared to usual care for these fractures. the procedure essentially "ablates with heat" the medial branch nerves which send pain signals from the posterior elements to the brain. patients will be randomly selected into one of two groups. the treatment group will receive the rfa-mbn procedure along with usual care therapy. the control group will undergo usual care. the control group will have the option to cross over to receive rfa-mbn at a defined interval during the study. there will be follow up visits at various intervals to compare pain relief and function based on various surveys of the treatment, control, and cross-over groups.

Eligibility criteria:
i• inclusion * 18-90 years old * male or female * age of fracture greater than or equal to 6 weeks * single level vertebral compression fracture * vertebral compression fracture thoraic-9 to lumbar-5 * nrs \>6/10 • exclusion * \ 90 yo * uncorrectable coagulopathy * multiple level vertebral compression fractures * surgery within 60 days of presentation * active infection * rhuematologic disease * significant neurologic deficit * radicular pain * chronic low back pain in last year * inability to give consent * cognitive impairment * patients with ongoing litigation or worker's compensation cases
cervical and endometrial injection for sentinel lymph node detection in endometrial cancer

Conditions: Endometrial Cancer; Sentinel Lymph Node

Summary: the investigators think that trans-cervical endometrial tracer injection will cause more paraaortic sentinel lymph node detection. also, this application is easy, cost-effective and safer than hysteroscopic method. transtubal tumor spearing will not occur with this method.

endometrial tracer injection will be performed by cervical or transcervical endometrial methods. pelvic and para-aortic sentinel lymph node detection capacity will be assessed in this study.

Eligibility criteria:
inclusion criteria: * endometrial cancer patients * suitable patients for surgical staging exclusion criteria: * patients who cannot undergo cervical or transcervical endometrial injection * pathology did not confirm endometrial cancer * sarcoma of the uterine corpus * if a 90-day follow-up was not feasible

Keywords: endometrial cancer sentinel lymph node paraaortic nodes involvement
comparison of single and repeated dose of vaginal misoprostol for the treatment of early pregnancy failure

Conditions: Abortion, Missed

Summary: a randomised controlled trial assessing the efficacy of single versus repeated dose of vaginal misoprostol for the treatment of early pregnancy failure.


Eligibility criteria:
inclusion criteria: * women with early pregnancy failure, defined as missed abortion or blighted ovum, seeking medical treatment with misoprostol. * age equal or greater than 18 years * gestational age less than 12 complete weeks. exclusion criteria: * complete, incomplete, inevitable, or septic abortion. * hemodynamically unstable patients. * misoprostol sensitivity or contraindication. * multifetal pregnancies.
china micra transcatheter pacing study

Conditions: Bradycardia

Summary: the china micra transcatheter pacing study is a prospective, multi-center, single arm human clinical trial utilizing objective performance criterion (opc) to confirm the safety and efficacy profile of the micra system for regulatory approval in china.

all study sites will be in china. subjects successfully implanted with the micra system in all sites will be followed at implant/pre-discharge, 1-month, 3-months, and 6-months, and at 6-month intervals thereafter (if applicable) through study closure. the overall follow-up period of the study will end when the last enrolled patient has 6 months of follow-up.

Eligibility criteria:
inclusion criteria: 1. subjects who have a class i or ii indication for implantation of a single chamber ventricular pacemaker according to acc/aha/hrs 2008 guidelines and china guideline. 2. subjects who are willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration. 3. subjects who are at least 18 years of age. exclusion criteria: 1. subject has an existing or prior pacemaker, icd or crt device implant. 2. subject has unstable angina pectoris or has had an acute myocardial infarction (ami) in the 30 days prior to eligibility assessment. 3. subjects with current implantation of neurostimulator or any other chronically implanted device which uses current in the body. note that a temporary pacing wire is allowed. 4. subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (lvad). 5. subjects who are morbidly obese and physician believes telemetry communication of ≤5 inches (12.5 cm) could not be obtained with programmer head. 6. subjects whose femoral venous anatomy is unable to accommodate a 23 french introducer sheath or implant on the right side of the heart (for example, due to obstructions or severe tortuosity) in the opinion of the implanter. 7. subjects who are considered as unable to tolerate an urgent sternotomy. 8. subjects with a known intolerance to nickel-titanium (nitinol) alloy. 9. subjects for whom a single dose of 1.0mg dexamethasone acetate may be contraindicated. 10. subjects with a life expectancy of less than 12-months. 11. subjects who are currently enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. co-enrollment in concurrent trials is only allowed when document pre-approval is obtained from the medtronic study manager. 12. pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence. 13. subjects with exclusion criteria required by local law (age or other). 14. subjects with medical condition which precludes patient from participation in the opinion of the investigator.

Keywords: transcatheter pacing system micra implantable device transfermoral catheter delivery system
diagnostic value of transbronchial lung cryobiopsy

Conditions: Interstitial Lung Disease

Summary: evaluating the diagnostic value of transbronchial lung cryobiopsy (tblc) as well as its procedural feasibility and safety in a prospective series of 20 patients with diffuse interstitial lung diseases (dild) who are referred for invasive histopathological diagnostics

before one is able to state that tblc is a technique that is an alternative for vats biopsy, the diagnostic value of tblc should be assessed and the value of the histopathological sampling should be compared with what is achieved by surgical lung biopsy. for this purpose direct comparison between vats biopsy and tblc is unavoidable. by including tblc in the work-up of patients with dild in which histopathological assessment is indicated (as proposed by mdd), we want to assess 3 major points of concern. agreement for the histopathological diagnosis between vats biopsy and tblc. value of tblc in the specific diagnosis in ild.

Eligibility criteria:
inclusion criteria: * - case of dild presented at the mdd * referral for vats biopsy as advised by mdd. * informed consent available * age \> 18 * fvc \> 50%pred * dlco \> 40%pred * pao2 \> 65 mmhg, pco2 \< 45 mmhg * no exclusion criteria exclusion criteria: * - age \> 75 * paps \>40mmhg as measured on transthoracic cardiac ultrasound * platelet count \<100000/µl * inr \> 1.4 * bmi \>30 * diffuse bullous lung disease * active anti-platelet or anticoagulant treatment * active heart failure or unstable coronary heart disease * patients unfit for vats under general anaesthesia as assessed by the surgeon and/or anesthesiologist
role pet imaging in response assessment for hepatocellular carcinoma (hcc)

Conditions: Primary Liver Cancer

Summary: present imaging modalities for primary liver cancer (hepatocellular carcinoma or hcc) have several shortcomings. one important shortcoming is the time delay between successful treatment and radiological confirmation of this response. often it takes several months for anatomical changes to occur and to be appreciated on morphological imaging such as ct or mri (shrinkage of tumor, absence of contrast enhancement). functional imaging by means of fluor-18 deoxyglucose or fluor-18 choline (positron emitters, pet-scan) might be an early indicator of response. this "early" information might help to tailor treatment. for instance, if no response is induced, an early switch in therapy can be planned. the present study investigates whether the routine pet-tracer (fluor-18 deoxyglucose) and the experimental pet-tracer, fluor-18 choline help to predict response if a patient with inoperable primary liver cancer is treated (radionuclide therapy, biologicals).


Eligibility criteria:
inclusion criteria : * male and female are eligible -\>18years of age.no upper age limit. * not pregnant or breastfeeding * capable of understanding the study goals and protocol and to sign the informed consent. * patients are diagnosed with primary liver cancer and referred for treatment with biologicals such as sorafenib or treatment with radionuclides.

Keywords: primary liver cancer
a non-interventional, observational study for targinact® treatment in patients with chronic severe pain

Conditions: Chronic Severe Pain

Summary: this non-interventional, observational study is set up on request of the belgian reimbursement authorities and evaluates the efficacy of targinact with regard to pain relief and constipation in daily clinical practice in belgium compared to the previous analgesic treatment with prolonged release oxycodone. only patients eligible for targinact® reimbursement in belgium are included.

patients are treated with targinact® according to daily clinical practice during at least 12 weeks and are monitored during study 3 visits. parameters assessed are pain relief, constipation, use of laxatives, use of analgesic rescue medication, use of concomitant medication, quality of life and safety of targinact® treatment. these parameters, except for safety assessment, are compared between targinact® treatment and previous analgesic treatment with prolonged release oxycodone.

Eligibility criteria:
inclusion criteria: patients included are patients who * are eligible for targinact® treatment according to the targinact® spc and * who have previously been treated with pr oxycodone during at least the last 30 days before study inclusion and * who are constipated (bfi \> 30) and * have used at least 2 laxatives with different modes of action during the previous pr oxycodone treatment exclusion criteria are based on targinact® spc.

Keywords: chronic pain severe pain oxycodone naloxone opioid-induced constipation opioid quality of life laxative analgesic rescue medication
the use of bio-oss collagen for sinus augmentation using the transcrestal approach.

Conditions: Bone Loss; Missing Teeth

Summary: to assess vertical bone height gain with geistlich bio-oss collagen used in conjunction with simultaneous implant installation in transcrestal approach sinus augmentation.

one of the most common situations in the posterior maxilla is reduced alveolar bone height as a result of tooth extraction and the following bone remodeling process, and maxillary sinus pneumatization. lack of alveolar bone volume may compromise dental implant installation. maxillary sinus augmentation is considered a very predictable solution for implant installation in limited amount of bone in the posterior maxilla. in general, there are two main maxillary sinus augmentation methods: the lateral approach and the transcrestal. in both methods, the idea is to expend the alveolar ridge in vertical direction on the expense of the maxillary sinus. sinus augmentation using the transcrestal approach is a well known procedure which is being use for over 40 years. as time goes by, implant dentistry is evolving and improving, there is a constant progress in this field including new bone substitutes materials. geistlich bio-oss® collagen - can improve the results obtained by sinus augmentation using the transcrestal approach, by better ease of use for the operator which makes it easier for the operator and the patient. study hypothesis: the vertical bone height gained by using geistlich bio-oss collagen in transcrestal approach sinus augmentation will be comparable to using bio-oss collagen, with greater operator satisfaction and less intra-operative complications.

Eligibility criteria:
inclusion criteria: * patients above the age of 18. * patients with edentulous ridge maximal height of 8mm≥ beneath the maxillary sinus. * patients with edentulous ridge minimal height of 3mm≤ beneath the maxillary sinus. * patients who need single implant placement at the posterior maxilla. * signed, well filled and dated informed consent form. exclusion criteria: * inability to complete or understand the informed consent process. * pregnant women. * lactating women. * patients who use medications that affect bone metabolism such as iv bisphosphonates. * heavy smokers. * patients with chronic/acute sinus infections
chemotherapy induced painful peripheral neuropathy ethosuximide (the cin-e study)

Conditions: Cancer; Peripheral Neuropathy

Summary: this study is a drug trial of ethosuximide as a painkiller if you develop pain as a side effect of chemotherapy. ethosuximide will be compared against placebo (an inactive substance) to test whether any response is a true effect of the drug, and not a 'placebo effect'.


Eligibility criteria:
inclusion criteria: * age \>/= 18 * diagnosis of cancer * willing and able to give informed consent to the cin-e study and complete study questionnaires, this involves adequate understanding of written and spoken english (translators will not be used) * chemotherapy-induced painful peripheral neuropathy as diagnosed by score of \>12 on the leeds assessment of neuropathic symptoms and signs (s-lanss) with a pain intensity rating of \>4, on a 11 point numeric rating scale (0= no pain, 10= worst possible pain). * duration of chemotherapy-induced painful peripheral neuropathy \>4 weeks. participant may either have completed chemotherapy, or be receiving ongoing chemotherapy. * able to attend research centre according to the required visit schedule. * diet allows bovine gelatine (present in both ethosuximide and placebo capsules) * women of child-bearing potential must be using a reliable form of contraception i.e. oral contraceptives, a barrier method (condom or diaphragm), intra-uterine device or abstinence. exclusion criteria: * renal impairment (serum creatinine \>1.5x normal level) * deranged liver function (ast\>3x normal level) * patients currently taking any anti-depressant medication, for example fluoxetine, paroxetine, citalopram, venlafaxine, amitriptyline, or within the past week. * patients currently taking any other anti-epileptic drug, including gabapentin, or within the past week. * pregnancy * allergy to succinimides, ethosuximide, methsuximide, phensuximide. pre-exisitng painful peripheral neuropathy of any other cause.

Keywords: adult cancer patients with chemotherapy-induced painful peripheral neuropathy