Kornimate/medical-research-clean huggingface dataset:
wallflex biliary post liver transplant ide pilot

Conditions: Anastomotic Biliary Stricture Post Orthotopic Liver Transplant

Summary: the primary objective of this study is to demonstrate effectiveness of the wallflex biliary rx fully covered stent for anastomotic biliary strictures in post-orthotopic liver transplant (olt) patients.


Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. post -olt patients with symptoms of biliary obstruction secondary to anastomotic biliary stricture as assessed by: * clinical signs and symptoms including jaundice, abdominal pain, pruritis, and cholangitis * abnormal liver function tests (serum bilirubin \> 1.5 and/or elevated alkaline phosphatase levels) * abnormal imaging on ultrasound, ct scan, or mrcp suggestive of a biliary stricture 3. willingness and ability to comply with the study procedures and provide written informed consent to participate in the study. exclusion criteria: 1. roux-en-y choledochojejunostomy 2. suspected nonanastomotic biliary strictures based on imaging(i.e. multiple strictures, strictures that are longer than 8cm in length, strictures located in the intrahepatic ducts and/or in the donor duct proximal to the site of anastomosis) 3. living donor transplants 4. transplants performed within 30 days (fresh transplants) 5. perforation of any duct within the biliary tree 6. patients with known sensitivity to any components of the stent or delivery system 7. patients with malignancy involving the biliary tree (including hepatocellular carcinoma) 8. patients with poor karnofsky score 9. life expectancy of less than one year 10. inability to pass a guidewire through the strictured area 11. previous biliary metal or multiple plastic stent placement 12. drug-induced or cholestatic hepatitis from an infective cause 13. redundant bile duct that may be treated by temporary placement of stent or conversion to a rouxeny hepaticojejunostomy 14. choledocholithiasis/biliary "cast" syndrome
ofatumumab (humax-cd20) with chop (cyclophosphamide,doxorubicin, vincristine, predisolone) in follicular lymphoma (fl) patients

Conditions: Lymphoma, Follicular

Summary: to investigate the efficacy in two dose regimens of ofatumumab in combination with chop (cyclophosphamide,doxorubicin, vincristine,prednisolone) in previously untreated patients with follicular lymphoma (fl)


Eligibility criteria:
inclusion criteria: * patient with follicular lymphoma (fl) * confirmed diagnosis of follicular lymphoma * 18 years or above * verbal and written information about the study exclusion criteria: * no previous treatment for follicular lymphoma * clinical suspicion that the follicular lymphoma has transformed to aggressive lymphoma * several diseases such as malignancies etc. * screening laboratory values * current participation in any other interventional clinical study * breast feeding women or pregnant women * women of childbearing potential not willing to use adequate contraception

Keywords: chop (cyclophosphamide,doxorubicin,vincristine,prednisolone) ofatumumab
c3 laminectomy with cervical laminoplasty

Conditions: Neck Pain

Summary: 1. background in cervical stenosis, cervical laminoplasty from the third to sixth cervical vertebrae is widely used. however, the muscles attached to the c2, which play an important role in the movement of our neck, are frequently damaged during the c3 laminoplasty. in contrast, cervical spine surgery through the removal of the c3 is thought to give less damage to the muscles attached to the c2. 2. purpose the aim of this study was to compare the prospective randomized comparison of these two surgical methods. 3. hypothesis there is no difference in the cervical length and overall cervical angle between 1 month, 3 months, 6 months, and 12 months postoperatively between c3 laminectomy with c4-6 laminoplasty and c3-6 laminoplasty.

surgery is performed under general anesthesia as before, followed by posterior cervical incision. in one group, the cervical spine of the c3 is removed using a drill and punch and c4-6 laminoplasty will be performed. in the other group, c3-6 laminoiplasty will be performed. postoperative suturing and subject management are the same as existing patient care policies. follow-up is performed at 1 month, 3 months, 6 months, 12 months, and 1 year after surgery at the outpatient clinic and x-ray is taken at each outpatient follow-up. the degree of the neck pain is measured using ndi and vas for each outpatient f/u.

Eligibility criteria:
inclusion criteria: * cervical stenosis exclusion criteria: * metastatic tumor * fracture * previous cervical spine surgery (posterior approach)
dynamic combination therapy on chinese herbal granules to improve the symptoms in convalescent phase of ischemic stroke

Conditions: Ischemic Stroke; Convalescence

Summary: to evaluate the effect of the dynamic combination therapy on chinese herbal granule formula (fangji) based on differentiation of syndromes ("zhenghou") according to the theory of traditional chinese medicine for improving the symptoms in the convalescent phase of ischemic stroke, and to establish the pharmacodynamic model of "zhenghou" according to the results of this trial.


Eligibility criteria:
inclusion criteria: * age: 18 - 75 years. * clinical diagnosis of ischemic stroke causing a measurable neurological deficit defined as impairment of language, motor function, cognition and/or gaze, vision or neglect, confirmed by ct or mri scan. * clinical diagnosis of "qixu-xueyu zheng" (qi deficiency and blood stasis syndrome) as the scores of chinese medicine symptoms scales in ischemic stroke on both "qixue" and "xueyu" ≥ 7. * 15 days to 60 days after onset of symptoms. * clinical diagnosis of cerebral anterior circulation obstruction. * 4≤nihss\<20. * patient is willing to participate voluntarily and to sign a written patient informed consent. exclusion criteria: * transient ischemic attack * evidence of intracranial hemorrhage (ich) in 6 months * evidence of other cerebral diseases (eg.vascular malformation, tumor, abscess or multiple sclerosis etc.)on the ct or mri scan. * woman with pregnancy, lactation or positive result of pregnancy test, or women who want to be pregnant in recent 6 months. * woman who is under menstrual period. * known history of allergy or suspected allergic to these chinese herbs. * complicated with atrial fibrillation. * fasting blood glucose ≥8 mmol / l under the treatment of diabetes or complicated with severe cardio-cerebrovascular diseases (eg. hyperlipemia, coronary heart disease with angina attack ≥ 4 times a day). * liver function impairment with the value of alt or ast over 1.5-fold of normal value. * renal dysfunction with the value of serum creatinine over normal value. * prior disable patients or complicated with osteoarthropathy that influence the motor function of the limbs. * with mental disorder that can not cooperate with doctor * suspected addicted into alcohol or drug abuse. * with severe complications that would make the condition more complicated assessed by the investigator. * patient who is participating in other trials or has been participated in other trials in recent 3 months.

Keywords: ischemic stroke convalescence randomized controlled trial pilot study traditional chinese medicine
ruxolitinib for steroid-refractory gvhd

Conditions: Graft Vs Host Disease

Summary: steroid-refractory acute gvhd (srgvhd) is one of the causes of mortality after allogeneic stem cell transplantation, while steroid-refractory chronic gvhd significantly increases morbidity, aggravates quality of life and may also impact survival. currently there is no standard treatment of srgvhd. one of the most promising agents is janus kinase (jak) inhibitor ruxolitinib, which in the retrospective study demonstrated excellent response rate and survival of patients with either acute or chronic srgvhd. this study prospectively evaluates the efficacy of ruxolitinib in srgvhd patients.


Eligibility criteria:
inclusion criteria: * diagnosis of graft-versus-host disease established based on tissue biopsy * steroid-refractory acute or chronic graft-versus-host disease according to ebmt/eln criteria (t. ruutu et al, 2014) * age 1 to 70 years * karnofsky index \>30%. * ability for oral drug intake * life expectancy \> 1 month * signed informed consent exclusion criteria: * severe organ dysfunction: ast or alt \>5 upper normal limits (excluding cases related to liver gvhd), creatinine \>2 upper normal limits * requirement for vasopressor support at the time of enrollment * uncontrolled bacterial or fungal infection at the time of enrollment * pregnancy * somatic or psychiatric disorder making the patient (or legal guardian) unable to sign informed consent

Keywords: acute graft-versus-host disease chronic graft-versus-host disease steroid-refractory gvhd ruxolitinib jak inhibitors
switching to a fixed dose combination of bictegravir/emtricitabine/tenofovir alafenamide (b/f/taf) in human immunodeficiency virus type 1 (hiv-1) infected adults who are virologically suppressed

Conditions: HIV-1-infection

Summary: the primary objective of this study is to evaluate the efficacy of switching from a regimen of either dolutegravir (dtg) and emtricitabine /tenofovir alafenamide (f/taf) or dtg and emtricitabine/tenofovir disoproxil fumarate (f/tdf) to a fixed dose combination (fdc) of bictegravir/emtricitabine/tenofovir alafenamide (b/f/taf) versus dtg+f/taf in virologically suppressed hiv-1 infected adults with or without antiretroviral (arv) resistance.


Eligibility criteria:
key inclusion criteria: * currently receiving an arv regimen of dtg+f/taf or dtg+f/tdf for the following minimum time periods: * ≥ 6 months (if there is documented or suspected nucleoside/nucleotide reverse transcriptase inhibitor (nrti) resistance prior to the screening visit) * ≥ 3 months (if there is no documented or suspected nrti resistance prior to the screening visit) * documented plasma hiv-1 ribonucleic acid (rna) \< 50 copies/ml during treatment with dtg+f/taf or dtg+f/tdf (for a minimum period of ≥ 6 or ≥ 3 months, as applicable) preceding the screening visit * plasma hiv-1 rna levels \< 50 copies/ml at screening visit * estimated glomerular filtration rate (egfr) ≥ 30 ml/min according to the cockcroft-gault formula for creatinine clearance * no documented resistance to integrase stand transfer inhibitors (instis) or confirmed virologic failure * eligible adults with chronic hepatitis b virus (hbv) and/or hepatitis c virus (hcv) infection are permitted to enroll note: other protocol defined inclusion/ exclusion criteria may apply.
clinical efficacy of biomimetic hydroxyapatite in the treatment of molar incisor hypomineralization.

Conditions: Molar Incisor Hypomineralization

Summary: the aim of the following study is to evaluate che clinical efficacy of a toothpaste with biomimetic hydroxyapatite for the management of molar-incisor hypomineralization. patients who agree to participate to the study will use biorepair toothpaste for the first 7 days of the month for 3, 6 and 9 months. the following indices will be measured: bewe, bleeding index, gingival index, plaque index and the dental sensitivity test. the contralateral tooth will be used as control if not affected by mih; otherwise, adjacent teeth will be considered.

informed consent will be signed by the parents of the patients underage; patients will be asked the approval for the attendance of the study. adult patients will sign the informed consent for the treatment and for processing personal data for research purpose, with their approval for the attendance of the study. patients will be given for free a toothpaste with biomimetic hydroxyapatite (biorepair enamel-repair shock treatment) and the investigator will explain the correct procedures for home oral care. the toothpaste will be applied the first 7 days of the month for 9 months with a specific tray. teeth will be randomly assigned to: * trial group: 1 tooth with mih from 1 quadrant will be treated with the biomimetic hydroxyapatite toothpaste. the applications will be performed for the first 7 days of the month for 9 months (1 application per day that lasts 10 minutes). * control group: 1 contralateral tooth with mih will not be treated with the biomimetic hydroxyapatite toothpaste patients will be visited after 1, 2, 3, 6 and 9 months from the baseline. for each visit, bewe index, bleeding index, gingival index, plaque index and dental sensitivity test. tooth with mih will be assessed, together with its contralaterals as control. if the contralateral tooth should suffer from mih too, measurements will be carried out on the adjacent tooth.

Eligibility criteria:
inclusion criteria: * presence of at least 2 enamel demineralizations of permanent molars and incisors (molar-incisor hypomineralization - mih) in contralateral quadrants * good general health (absence of systemic diseases) exclusion criteria: * patients undergoing orthodontic therapy * patients taking drugs

Keywords: biomimetic hydroxyapatite enamel remineralization
pioglitazone and quetiapine xr pharmacogenetic study

Conditions: Bipolar Disorder; Major Depressive Disorder

Summary: obtain phenotypic data and a dna/blood sample from mood disorder patients undergoing pioglitazone or quetiapine xr treatment as a part of an irb approved clinical trial conducted at the mood disorders program. pioglitazone treatment is examined in metabolic syndrome comorbid with bipolar depression (irb # 07-08-24) and unipolar depression (irb # 07-07-20). quetiapine xr treatment is examined in generalized anxiety disorder comorbid with bipolar depression (irb # 10-06-19) and unipolar depression (irb # 12-01-29). please refer to the respective irb protocols for more information.


Eligibility criteria:
inclusion criteria: * must have participated in irb protocols 10-06-19, 12-07-29, 07-07-20, and 07-08-24 * patient must give consent to participate, sign and date the irb approved written informed consent form prior to the initiation of any procedures for this study * patient must be diagnosed with bipolar disorder or major depressive disorder * patient must be at least 18 years old * patient must be willing to give a blood sample exclusion criteria: * patient lacks the capacity to provide informed consent
severe pneumonia diagnostic in pediatric population by lung ultrasonography and procalcitonin

Conditions: Pneumonia Childhood

Summary: lung ultrasound (lus) in combination with a biomarker has not yet been studied. the investigators propose a clinical trial where the primary aims are: 1. to assess whether an algorithm with lus and procalcitonin (pct) may be useful for diagnosing bacterial pneumonia; 2. to analyse the sensitivity and specificity of lus vs chest radiograph (cxr).

objectives: the general objective is to analyze whether a new algorithm approach of severe pneumonia in pediatric intensive unit (picu) improves the quality of care. objectives: 1- to analyze the sensitivity and specificity of lung ultrasound (lus) compared respect to the chest radiography (cxr) in severe pneumonia and if lus discriminates between bacterial and viral one. 2- if there is a lower cxr indication. 3- if is possible to reduce the dose of irradiation and costs associated with cxr. 4- to analyze the interobserver agreement of the lus. 5- determine whether a diagnosis of pneumonia algorithm using lus and procalcitonin may be useful in directing the indication of antibiotic therapy and / or the duration thereof. methodology: clinical, prospective, controlled, randomized, blinded intervention and 3-year trial. inclusion of children under 18 years, with severe pneumonia, who enter (picu). experimental group 1: pediatrician researcher (pr) will conduct a lus at admission time, as a first test of lung image; in group 2, cxr is conduced as first image. patients will be classified into 3 subgroups, in both branches: a) if pct is \ 1 ng / l, antibiotic therapy will be recommended to cover other causes of infection. the same attitude will be performed, but depending on the cxr instead of the lus, in group 2. clinical variables, complementary tests and evolution data will be collected. statistics by spps® 20.0. informed consent will be requested and the study will be conducted according to the helsinki declaration guidelines and good clinical practice.

Eligibility criteria:
inclusion criteria: * children under 18 * severe pneumonia criteria * admitted at picu * informed consent signed exclusion criteria: * previous respiratory disease (cystic fibrosis and/or immunosuppression) * nosocomial pneumonia development while in charge for community pneumonia. * researcher pediatrician has valuated the chest x ray before the picu admission * included in other clinical trial

Keywords: pneumonia lung ultrasound biomarkers procalcitonin childhood
a study using botulinum toxin type a in patients with axillary hyperhidrosis

Conditions: Hyperhidrosis

Summary: this is a three year open-label study in subjects with axillary hyperhidrosis.


Eligibility criteria:
inclusion criteria: * marked axillary hyperhidrosis exclusion criteria: * previous use of botulinum toxin for hyperhidrosis
confidence-ai financial education for caregivers (confidence-ai)

Conditions: Alzheimer Disease; Dementia; Caregiver Burden; Financial Stress

Summary: the intervention being tested, confidence-ai is a refined version of the original confidence intervention made to reduce psychological financial strain and improve management of out-of-pocket care costs while increasing caregiver resourcefulness skills. participants will be asked to participate in a 4-week intervention that includes participation in four, synchronous group-based zoom sessions as well as between-session activities to apply learning. participants will also receive tailored text message notifications from the neuvicare ai-powered app via text and will be able to submit questions to the app to receive financial well-being information related to caregiving.


Eligibility criteria:
inclusion criteria: * self-identified caregiver to a person living with probable alzheimer's disease or related dementia * person living with dementia meets stage 4 to 6 criteria on global deterioration scale according to the family caregiver * has been at least 6 months since the care recipient began to experience dementia symptoms * latino/hispanic ethnicity. exclusion criteria: * individuals who plan to place their family member in a nursing home in the next 3 months * unreliable access to internet, tablet or smart phone, and email * does not agree to participate in at least 3 of the 4 group sessions and/or register for the neuvicare app * unable to read and speak in english or spanish
sofwave treatment to lift lax tissue in the submental and neck zones and to lift the eyebrow

Conditions: Skin Laxity

Summary: open-label, non-randomized, prospective, multi-center, self-controlled clinical study with masked evaluation.

eligible patients will receive 2 face and neck treatments (4-6 weeks ± 2 weeks apart) using the sofwave system. each investigational site would treat the full face and submental zones including 1. the forehead and temples (left and right including the peri orbital zone) to lift the eyebrows 2. the cheeks (left and right including perioral zone and nasolabial folds) 3. submental and sides of the neck (left and right) to lift lax skin. all patients will return to the clinic for two follow up visits: 1. 7 days (fu1) post the first treatment (tx.1). 2. 3 months ± 2 weeks post last treatment (fu2).

Eligibility criteria:
inclusion criteria: 1. healthy female and male subjects between the ages 35-80. 2. non-smoker. 3. fitzpatrick skin type i-vi. 4. desire to lift lax skin in the neck and submental and/or to lift the brows. 5. able and willing to comply with all visit, treatment and evaluation schedules and requirements. 6. able to understand and provide written informed consent 7. women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment. exclusion criteria: 1. pregnant or planning to become pregnant, having given birth less than 3 months ago, and/or breast feeding. 2. presence of any active systemic or local infections. 3. presence of active local skin disease that may alter wound healing. 4. severe solar elastosis. 5. history of smoking in past 10 years. 6. history of chronic drug or alcohol abuse. 7. excessive subcutaneous fat on the cheeks. 8. significant scarring in the area to be treated. 9. severe or cystic facial acne, acutance uses during past 6 months. 10. presence of a metal stent or implant in the facial area (dental implants and/or braces are not excluded). 11. inability to understand the protocol or to give informed consent. 12. history of cosmetic treatments in the facial area to be treated, including facial skin-tightening procedure within the 6 months ; injectable (botox or fillers) of any type within the 6 months; ablative or non-ablative resurfacing/rejuvenation laser treatment or light treatment within the past 6 months, dermabrasion or deep facial peels within the past 12 months; facelift, blepharoplasty, or brow lift (including contour threads) within the past 12 months. 13. taking isotretinoin or other oral retinoid within the past 6 months; taking anti-platelet or anti-coagulant within the past 2 weeks. 14. as per the investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in this study.

Keywords: laxity brow lifting skin saggy
ankle proprioceptive training in patients with diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: diabetes being a very prevalent condition results in various complications including neuropathy, which can impair various functional outcomes in patients including balance. ankle proprioceptive training (apt) is an intervention that is used to tackle this problem. the study will compare apt with standard balance training in subjects with diabetic neuropathy.

the study will include the diagnosed diabetic subjects with score of 4 or more on douleur neuropathique 4 questionnaire (dn4q). the subjects will be randomly divided into 2 groups; interventional group and control group. interventional group will receive apt 3 days a week for 8 weeks. balance training exercises will be given to both groups 3 days a week for 8 weeks. the assessments will be done at baseline, after 4 weeks and after 8 weeks of interventions.

Eligibility criteria:
inclusion criteria: * known case of diabetic peripheral neuropathy (dpn), * patients who met the criteria of dn4 scored equal or greater than 4. * patients who have positive sharpend romberg test exclusion criteria: * patients with dvt * orthostatic hypotension * any recent surgery of lower limb * amputies * patients with crutches or walking aids * patients with gangrene * lower bmi * acute systemic illness * vestibular impairment

Keywords: diabetes diabetic neuropathy balance risk of fall ankle proprioceptive training