Kornimate/medical-research-clean huggingface dataset:
autologous transplantation of melanocytes for treatment of vitiligo skin

Conditions: Vitiligo

Summary: the purpose of this study is to investigate the efficacy and safety of autologous transplantation of melanocytes in patients with vitiligo.

vitiligo is a pigmentation disorder in which white patches of skin appear on different parts of the body. histologically it is characterized by absence of melanocytes along the epidermal basal layer. using cell suspension with non-cultured melanocytes which injected into blister of depigmented lesion, a success rate of 85% was reported for repigmentation. however there are some limitations in this technique: the induction of blister is limited to several sites of the body, hypo-pigmentation around the recipient area due to cryodamage of peripheral melanocytes and leakage of suspension out of the blister. to reduce these problems, in this study we will inject melanocytes directly to epidermis. a shaved biopsy specimen (about 1 cm2) is taken from the patient's normally pigmented area under local anesthesia (lidocaine hydrochloride 20 mg/ml). the specimens are incubated in 0.25% trypsin solution for 15 minutes at 37°c 0.02% edta solution for 10 minutes. then epidermal sheets are gently manipulated with forceps to dissociate the epidermal cells and to yield a cell suspension, followed by treatment with 0.5% trypsin/versene solution at 37c for 3-5 minutes. well-dispersed cell suspension is aspirated into 1 ml syringes and injected directly in epidermis.

Eligibility criteria:
inclusion criteria: * age over 12 years * stable form of vitiligo (no increase in the size of the lesion for at least one year) * no use of immunosuppressive \& cytotoxic drugs at least for past 6 months exclusion criteria: * pregnant patients * patients with active disease * infection at the recipient site * evidence of köebner in the past * keloidal tendencies

Keywords: melanocytes
a study to assess the safety, pharmacokinetics, and activity of ro7790121 in participants with advanced mash liver fibrosis

Conditions: MASH

Summary: the purpose of this study is to assess the safety, pharmacokinetics (pk), pharmacodynamics (pd), immunogenicity and activity of ro7790121 in participants with advanced metabolic dysfunction-associated steatohepatitis (mash) fibrosis.


Eligibility criteria:
inclusion criteria: * body mass index within the range of \>= 25 and \<=45 kilograms per square meter (kg/m\^2) * mash with fibrosis score of f3 or f4 confirmed by transient elastography measurement \>=12.0 kpa and \<=25.0 kpa * agreement to adhere to the contraception requirements exclusion criteria: * weight gain or loss \>5% in the 3 months prior to baseline or \>10% in the 6 months prior to baseline * bariatric surgery within 1 year prior to baseline * current signs or prior history of decompensated liver disease * complications or clinical evidence of portal hypertension * lack of peripheral venous access * other causes of liver disease based on medical history and/or centralized review of liver histology * history of liver transplantation * current or prior history of hepatocellular carcinoma (hcc) * uncontrolled hypertension * concomitant type 1 diabetes, or type 2 diabetes with hba1c \>10% * history of malignancy within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death * current, significant alcohol consumption or a history of significant alcohol consumption for a period of more than 3 consecutive months any time within 1 year prior to screening * initiation of a medication of an antidiabetic, weight loss, lipid-modifying or anti-depressant drug class * active tuberculosis requiring treatment within the 12 months prior to baseline * history of organ transplant
risk factors and molecular genomics of u.s. patients with chronic liver disease and hepatocellular cancer

Conditions: Carcinoma, Hepatocellular

Summary: to identify risk factors for the development and diagnosis of hepatocellular ca in patients with chronic hepatitis c and to use the data to ultimately develop an effective screening program.


Eligibility criteria:
inclusion criteria: * for both experimental subjects and controls: 1. patients between older than 18 years of age of all ethnic backgrounds and genders. 2. patients with chronic liver disease * for experimental subjects only: 1. patients with hcc with a hepatic mass larger or equal to 5cm 2. patients with hcc with a hepatic mass lesion confirmed by fine needle aspirate (fna) or by pathology in the cases of surgical resection 3. patients with hcc with a hepatic mass lesion with characteristic ct or mri or angiographic appearance. * for controls only: patients with chronic liver disease without evidence of hcc confirmed by either : 1. a normal afp level 2. a negative imaging study (ultrasound, ct, or mr imaging). 3. negative liver cancer on explants. \*exclusion criteria: 1. patients who declined to participate in the study 2. patients with a history of hiv infection 3. patients with concurrent advanced malignancy of non-hepatic origin. 4. patients with significant use of androgenic steroid. 5. patients with exposure to vinyl chloride.
taurine as an anti-manic agent: a double-blind, placebo-controlled study

Conditions: Bipolar Disorder; Mania; Bipolar Depression

Summary: the purpose of this study is to determine whether the amino acid taurine has effects on mood stability in bipolar disorder.

taurine is an amino acid that has some actions similar to mood stabilizers. taurine is widely sold as a component of over-the-counter mood enhancing agents. however, controlled studies examining the mood effects of taurine are limited. an initial study in this laboratory looked at taurine's mood effects in individuals with bipolar disorder. this follow-up study is designed to further examine taurine's effects on manic symptoms. subjects in the current follow-up study will add taurine or placebo to their current treatment regimen. both depressive and manic symptoms will be tracked for three months to determine whether the addition of taurine affects mood symptoms.

Eligibility criteria:
inclusion criteria: bipolar disorder, type i bipolar disorder, type ii mania hypomania mixed manic symptoms exclusion criteria: significant medical or psychiatric co-morbidity pregnancy or planning pregnancy current substance abuse or dependence -

Keywords: bipolar mania depression taurine alternative
comparison of the analgesic effect of subsartorial saphenous block and popliteal sciatic vs subsartorial saphenous block and ipack in total knee replacement surgery.

Conditions: Pain, Acute; Knee Osteoarthritis; Anesthesia

Summary: total knee replacement surgery is associated with significant pain in the immediate postoperative period, especially in movement. in turn, this is associated with more subsequent chronic pain. there are multiple options and the tendency is to perform increasingly distal nerve blocks to minimize limb weakness and thus allow early rehabilitation. in 2012, in an oral communication, sanjay sinha described a new nerve block called ipack ("interspace between the popliteal artery and the capsule of the posterior knee"). there are few studies on the efficacy of such a blockade so far, but none comparing the groups saphene + sciatic blocks vs. saphene + ipack blocks. therefore, this study aims to provide more information on the effectiveness this nerve blocks, in total knee replacement, in terms of analgesia and motor function.


Eligibility criteria:
inclusion criteria: * patients with osteoarthritis scheduled for total primary knee arthroplasty with same surgeons * locoregional anesthesia * age equal to or greater than 18 years * consent to participate in the study exclusion criteria: * age under 18 years old * general anesthesia * allergy to local anesthetics * severe kidney failure (cr ≥ 2mg / dl) * chronic opioid use (over 3 months) * chronic pregabalin / gabapentin use (more than 3 months) * psychiatric illness that may interfere with the evaluation or follow-up

Keywords: ipack block total knee replacement
assessment of squamous cell carcinoma antigen2 in verruca vulgaris

Conditions: Verruca Vulgaris; Healthy

Summary: this study aims to assess the expression of scca2 in the skin of patients with warts and to detect its correlation with characteristics of warts.

type of the study: cross sectional study. patients: this study will include 25 patients with verruca vulgaris and 25 healthy volunteers. inclusion criteria: patients present with warts (verruca vulgaris type). exclusion criteria: subjects who presenting with allergic diseases or other dermatological diseases or had a history of squamous cell carcinoma will be excluded from this study one skin biopsy will be taken from each healthy volunteers of the control group via 2-mm disposable punches under complete sterile precautions. two biopsies will be taken from patients with wart lesion one from verruca vulgaris via 5-mm disposable punches and another from non-affected skin via 2-mm disposable punches under complete sterile precautions. biopsy handling: each specimen in both groups will be fixed in formalin and embedded in paraffin to form paraffin blocks. serial sections will be obtained from each block and stained with hematoxylin and eosin (h\&e) for histological diagnosis. stained sections will be examined under a light microscope. to confirm the diagnosis of wart, the grade of inflammation and the density of dermal inflammatory infiltrate will be classified as follows grade 0, no infiltrate; grade 1, mild; grade 2, moderate; or grade 3, marked infiltrate. immunohistochemical staining: investigators will use monoclonal antibodies to scca2 (serpinb4/ scca2 antibody). immunohistochemical staining will be performed the pattern of immunostaining for scca2 will be evaluated in both the epidermis and dermis of wart lesions. the immunohistochemical score (ihc) range will be as follows: 0: negative expression of scca2; 1+: weak expression of scca2; 2+: moderate expression of scca2; and 3+: strong expression of scca2.

Eligibility criteria:
inclusion criteria: * patients present with warts (verruca vulgaris type). exclusion criteria: * subjects who presenting with allergic diseases or other dermatological diseases or had a history of squamous cell carcinoma will be excluded from this study.
hemodynamic and respiratory tolerance of intermittent hemodialysis in critically ill patients

Conditions: Acute Kidney Injury

Summary: acute kidney injury (aki) affects up to 30% of critically ill patients and is associated with increased rates of mortality. up to 60% of patients with aki will ultimately require renal replacement therapy (rrt). intermittent hemodialysis (ihd) is one of the main methods of rrt worldwide. in ihd-bicar, dialysate is composed by electrolytes, including calcium, and bicarbonate. to avoid calcium carbonate precipitation, dialysate has to be supplemented with acids (citric acid, chloride acid or acetic acid). however, ihd-bicar may be associated with hemodynamic instability or respiratory intolerance, mainly related to the co2 release in the circulation during ihd (hco3- \ co2 + h2o). some recent studies showed that acetate free biofiltration (afb-k), a technique that does not require dialysate acidification, could be associated with better hemodynamic stability and to a lower amount of co2 delivered to the patients. afb-k may thus improve the hemodynamic and respiratory tolerance of intermittent rrt in critically ill patients.

in this prospective observational study, investigators aim to characterize the hemodynamic and respiratory tolerances of hdi-bicar and afb-k in critically ill patients requiring rrt.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years old * invasive monitoring of blood pressure * non opposition to the research * admission to the intensive care unit * need of intermittent hemodialysis exclusion criteria: * sodium bicarbonate infusion * pregnancy or breastfeeding * juridical protection

Keywords: acute kidney injury renal replacement therapy acetate free biofiltration bicarbonate-based hemodialysis c02 removal intensive care unit critical care
feel breathe, restriction device ventilatory nasal (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: feelbreathe®, a nasal ventilatory restriction device, used during an exercise test in treadmill produces changes on breathing efficiency in patients with chronic obstructive pulmonary disease (copd). 20 men with copd with a forced expiratory volume in the first second between 30% and 70% of its predicted value were selected. then, a maximal incremental cardiopulmonary exercise test was performed to determine ventilatory and cardiac parameters. during the second day, each participant conducted two tests with 30 min of rest between them. exercise protocol was an identical walk on a treadmill for 10 minutes at a constant rate at 50% of vo2peak. each test was performed randomnly in two different conditions: 1) oronasal breathing (onb); and 2) nasal breathing through the fb.

rationale: a device called feelbreahte (fb)® has been designed, developed and patented for inspiratory muscle training in dynamic situations. objetive: to examine the effects of fb on lung ventilation, gas exchange and heart rate during exercise in patients with copd. methods: 20 men with copd with a forced expiratory volume in the first second between 30% and 70% of its predicted value were selected. in the first visit to the laboratory, baseline static maximum inspiratory pressure and spirometry were performed previous to the exercise. then, a maximal incremental cardiopulmonary exercise test was performed to determine ventilatory and cardiac parameters. during the second day, each participant conducted two tests with 30 min of rest between them. exercise protocol was an identical walk on a treadmill for 10 minutes at a constant rate at 50% of vo2peak. each test was performed randomnly in two different conditions: 1) oronasal breathing (onb); and 2) nasal breathing through the fb. results: lung ventilation and gas exchange during exercise in copd patients was modified during exercise using fb. our results showed a positive effects of fb vs onb on dynamic hyperinflation, an improved breathing pattern and breathing efficiency, higher expiratory and inspiratory time and higher perceived effort. despite these differences, blood oxygen saturation percentage, oxygen uptake and heart rate showed similar response between both conditions. conclusions: the new device fb used during exercise in copd patients influenced ventilatory responses to an efficiency breathing compared to oronasal mode.

Eligibility criteria:
inclusion criteria: patients diagnosed of chronic obstructive pulmonary disease (copd) at least 6 months before, with a forced expiratory volume in the first second (fev1) between 70 and 30% of predicted value exclusion criteria: * suffer other illness. * unwillingness to complete the study requirements. * cardiovascular diseases (resting electrocardiogram and during exercise). * elevated resting blood pressure (\>130/85 mmhg). all inclusion and exclusion criteria were assessed by a detailed medical history and, where noted, by specific measurements.

Keywords: airflow obstruction
a phase 1/2 trial of adi-270 in ccrcc

Conditions: Clear Cell Renal Cell Carcinoma

Summary: this is a phase 1/2 multicenter, open-label, dose escalation, and dose expansion study of adi-270 - an engineered gamma-delta chimeric receptor \[car\] vδ1 t cell product targeting cd70 - in patients with r/r ccrcc.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed clear cell rcc 2. documented evidence of advanced or metastatic diseases. 3. patients must have been treated with an immune checkpoint inhibitor and a vegf inhibitor (the vegf inhibitor must have been administered in the advanced and/or metastatic setting). 4. at least one measurable target lesion according to recist 1.1 5. at least three weeks, or 5 half-lives, whichever is shorter, from the last dose of the prior line of systemic therapy 6. kps ≥ 70 exclusion criteria: 1. subjects with cns metastases or spinal cord compression are not eligible, unless they have completed therapy and have discontinued the use of corticosteroids for at least 8 weeks and remained stable prior to enrollment. 2. clinically significant cns dysfunction of any etiology in the opinion of the investigator. 3. prior radiation therapy within 21 days prior to start of study treatment with the exception of palliative radiotherapy to bone lesions (palliative radiotherapy to bone lesions must be completed at least 2 weeks prior to the first dose of ld). 4. active malignancy (except for rcc, definitively treated basal or squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix or bladder) within the past 24 months 5. treatment with gene therapy, genetically modified cell therapy, or adoptive t cell therapy within 6 weeks before initiating ld in this study. 6. receipt of cd70 targeted therapies for any indication 7. require corticosteroid therapy \> 5 mg per day of prednisone or equivalent. 8. history of any form of primary immunodeficiency such as severe combined immunodeficiency disease. 9. presence of active autoimmune disease requiring ongoing systemic immunosuppressive therapy.

Keywords: renal cell carcinoma, cell therapy, cd70, chimeric antigen receptor (car) t-cell therapy
non-surgical treatment of peri-implant mucositis

Conditions: Peri-implant Mucositis

Summary: this a randomized controlled clinical trial comparing two techniques for the nonsurgical treatment of peri-implant mucositis. the main objective of the present randomized controlled clinical trial is to determine whether the application of a novel treatment strategy for peri-implant mucositis could lead to significantly improved clinical parameters as compared to standard treatment. half of the patients receives treatment with manual instruments and chlorhexidine gel 1%, half receives treatment with submucosal biofilm removal by erythritol powder.


Eligibility criteria:
inclusion criteria: * subjects should have at least one implant (renvert et al. 2009), * with bleeding on probing using a 0.2n probing force or spontaneous bleeding with local swelling (code 1, 2 or 3 as described in corbella et al. 2011) and with bone resorption of no more of 1 mm (preferably no bone loss visible on radiographs) as evaluated through the use of standardized radiographs, taken with the use of an individualized radiograph holder in comparison with findings from radiographs taken immediately following placement of the implant prosthesis (similar to renvert et al. 2009 and algraffee et al. 2011). * females and males 35 to 65 years old; (iv) full mouth bleeding score % lower than 20%. exclusion criteria: * systemic diseases that could affect the immune response or that could condition the bacterial colonization * use of anti-inflammatory prescription medications, or antibiotics within the preceding respectively 1 week and 3 months or during the study, * full-mouth plaque score (fmps) \>20%; * full-mouth bleeding score (fmbs) \>20%, * smokers of more than 5 cigarettes a day, * documented allergy or intolerance towards the components of the products used in the study, * presence of active infection with suppuration. * absence of periodontitis in the rest of the mouth * pregnancy (certified by auto-declaration) * patients suffering from upper respiratory tract infections, from chronic bronchitis * endocarditis, breast feeding, contagious disease, immune deficiency (neutropenia, angranulocytosis, diabetes, hemophilia), patients under treatment (radiotherapy, chemotherapy, antibiotics).
gastrin-releasing peptide and bronchopulmonary dysplasia

Conditions: Bronchopulmonary Dysplasia; Prematurity

Summary: the purpose of this study is to identify biological markers that might predict premature infants who are at a higher risk for developing bpd, and to correlate the presence of these markers with infant symptoms and lung function in the first year after discharge from the hospital.

bronchopulmonary dysplasia (bpd) is a common form of lung injury that can be triggered by premature birth and the unavoidable exposures to treatments regularly used for premature infants,including mechanical ventilation and oxygen as well as conditions that occur frequently among premature infants including infection. almost all infants who are born prematurely are exposed to either mechanical ventilation, extra oxygen, and many will develop at least one infection; however, not all premature infants will develop bpd. there is currently no way to identify those infants who are at risk for developing bpd, nor are there prognostic or diagnostic tests to determine the severity of lung disease in the first year after discharge from the hospital. the application of uplc-tandem mass spectrometry for quantification of urinary biomarkers of oxidative stress is an important technical innovation that will permit sensitive and reproducible analyses of urinary biomarkers with minimal sample preparation to better define disease phenotypes. establishing a direct correlation between biomarkers of oxidative stress and grp will accelerate investigation into the mechanisms leading to chronic pediatric lung disease and childhood origins of pulmonary disease.

Eligibility criteria:
inclusion criteria: * gestational age at birth 23-0/7 to 27-6/7 weeks post-menstrual age exclusion criteria: * are not considered to be viable (decision made not to provide life-saving therapies) * have congenital heart disease (not including pda and hemodynamically insignificant vsd or asd) * have structural abnormalities of the upper airway, lungs or chest wall * have other congenital malformations or syndromes that adversely affect life expectancy or cardio-pulmonary development * unlikely to return to the clinic for follow-up visits

Keywords: biomarkers oxidative stress bpd prematurity
endoscopic large caliber drainage vs. complete necrosectomy for treatment of walled-off pancreatic necrosis

Conditions: Necrotizing Pancreatitis

Summary: the purpose of this study is to determine optimal treatment strategies for symptomatic walled-off pancreatic necrosis( won).


Eligibility criteria:
inclusion criteria: * adult (\> 18 yo) patients * with symptomatic walled- off pancreatic necrosis in which an endoscopic approach is appropriate based on cross-sectional imaging * must have solid necrotic material present in their pancreatic fluid collection as determined by mri, eus, or direct transluminal endoscopic imaging of the collection exclusion criteria: * previous intervention for pancreatic necrosis (surgical, percutaneous, or endoscopic) * indication for emergency laparotomy (compartment syndrome, bowel ischemia, bleeding, or perforation of a gi lumen) * uncorrectable coagulopathy.

Keywords: acute necrotizing pancreatitis walled-off pancreatic necrosis