Kornimate/medical-research-clean huggingface dataset:
efficacy of 3d-printed mouth splints

Conditions: Microstomia

Summary: the study will investigate the effectiveness of a 3d-printed mouth splint designed to increase dimensions of oral aperture and reduce disability associated with mouth contractures. the validated mouth impairment and disability assessment (mida) survey will be used to objectively measure patient progress in functionality and quality of life.

microstomia, or reduced oral aperture, is a debilitating condition that can arise after burn injuries, particularly to the face. this condition severely impacts oral hygiene, nutrition, speech, and overall quality of life. current management strategies often rely on therapy, surgical intervention, and splinting to improve mouth opening and functionality. however, there is a lack of accessibility to good mouth splinting devices. 3d-printed, dynamic splints offer may offer a superior and cost-effective solution that can be tailored to the patient's anatomy while allowing for at-home treatment. sizing can also be adjusted to fit essentially any aperture since, including pediatrics. this device is intended for use at home, supported by teaching and follow-up provided by occupational therapists (ots).

Eligibility criteria:
inclusion criteria: * patients 2 years to 99 years of age with documented microstomia following burn injuries. * ability to comply with prescribed home exercises and follow-up visits. exclusion criteria: * cognitive or physical inability to perform the prescribed exercises. * inability of a caretaker to be able to deliver therapy daily. * concomitant conditions that may significantly affect oral aperture (e.g., temporomandibular joint (tmj) disorders).

Keywords: cleft lip and palate craniocarpotarsal dysplasia dental hygiene
c-peptide correlation with microvascular complications in t1dm

Conditions: Type 1 Diabetes; C-peptide; Diabetes Complications

Summary: the purpose of this study is to investigate the presence of residual insulin secretion in patients with dm1 and its correlation with the possible protection against early microvascular and macrovascular complications, emphasizing on the functionality of the myocardium.

the study will include approximately 200 patients, male and female, with dm1 who are being followed in the outpatient diabetic clinic of our hospital. each patient will visit the research laboratory of the diabetes centre of our department. the visit will take place in the morning in a fasting state of about 12 hours. demographic data will be recorded along with the patients' habits, lifestyle, current medication and complete medical history of concomitant diseases. this will be followed by anthropometric measurements (weight, height, bmi) and afterwards blood samples will be taken for the determination of urea, creatinine, glucose, hba1c and lipids. part of each blood sample will be collected in tubes containing edta to determine fasting c-peptide concentrations. the presence of microalbuminuria will be assessed from a morning urine sample by calculating urinary albumin to creatinine ratio (acr). the functionality of the heart's autonomic nervous system will be assessed through the use of heart rate variability (hrv) measurements, using the standard ewing's tests panel: deep inhalation, standing up and valsalva's manoeuvre. changes in blood pressure when changing from the supine to the standing position will also be recorded. subsequently, the distensibility of the large vessels will be determined, by calculating the conduction velocity of the pulse wave between the carotid and the femoral artery (pulse wave velocity (pwv)). finally, a full transthoracic echocardiographic study will be carried out to assess functionality, systolic and diastolic, of the left ventricle (lv). all data will be recorded in an electronic database for statistical processing.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * informed consent form exclusion criteria: * known macrovascular complications * known serious microvascular complications
gdf 15 in sickle cell disease and hereditary spherocytosis

Conditions: Patients With Thalassemia Intermedia,; Congenital Dyserythropoietic Anemia Type I

Summary: patients with thalassemia intermedia, congenital dyserythropoietic anemia type i , and sideroblastic anemia were found to express very high levels of serum gdf15, and this contributed to the inappropriate suppression of hepcidin with subsequent secondary iron overload.the aim of our present study is to asses the levels of gdf15 and hepcidin in patients with sickle cell disease and hereditary spherocytosis

the identification of the ferroportin/hepcidin axis has allowed the effect of erythroid activity on iron balance to be studied and has created the basis for better defining the erythroid regulators. in iron-loading anemias, ineffective erythropoiesis suppresses hepcidin production, which result in dysregulating iron homeostasis. miller and co-workers showed that release of cytokines like growth differentiation factor 15 (gdf15) during the process of ineffective erythropoiesis inhibits hepcidin production, thus defining a molecular link between ineffective erythropoiesis, suppression of hepcidin production and parenchymal iron loading.

Eligibility criteria:
inclusion criteria: * non exclusion criteria: * non
tbtc study 22: efficacy of once-weekly rifapentine and isoniazid in treatment of tuberculosis

Conditions: Pulmonary Tuberculosis

Summary: primary objective: to compare, at the completion of the follow-up phase, the clinical and bacteriologic relapse rates associated with the two study regimens. secondary objectives: to compare the clinical and bacteriologic failure rates of the two study regimens at the completion of the study phase therapy. to compare the clinical and bacteriologic response rates for the two study regimens among patients who began study phase therapy with signs and symptoms of tuberculosis or cultures positive for m. tuberculosis. to compare the toxicity associated with the two study regimens by comparing discontinuation rates due to adverse events and occurrence rates of signs and symptoms associated with adverse events during study phase therapy. to compare mortality rates of the two study regimens. to compare the rates of completion of therapy within 22 weeks for the two study regimens. to compare the rate of development of drug-resistant tuberculosis in the two study regimens among study patients classified as treatment failures or relapses. to compare all of the above performance characteristics for the two study regimens in a small subset of hiv seropositive patients. to compare attitudes and beliefs about participation in this study between patients who complete study therapy and those who fail to complete study therapy.


Eligibility criteria:
* culture-positive, drug-susceptible pulmonary tuberculosis
open-label extension study to evaluate the long term safety and efficacy of esk-001 in plaque psoriasis

Conditions: Plaque Psoriasis

Summary: this is a multi-center, open-label extension (ole) study in patients with plaque psoriasis who have completed their participation in a previous plaque psoriasis study of esk-001.

this study will consist of patients who have completed their participation in a previous plaque psoriasis study of esk-001. each patient will be assigned to receive esk-001 at one of two open-label dose levels. patients have the option to remain on study until esk-001 is commercially available.

Eligibility criteria:
inclusion criteria: * must have completed a prior esk-001 study * men and women must use highly effective methods of contraception for the entirety of the study exclusion criteria: * pregnancy * received a prohibited concomitant medication
study evaluating bddrfviii and refacto af in hemophilia a

Conditions: Hemophilia A

Summary: the purpose of this study is to determine the relative bioavailability of refacto af as compared to refacto, when each is administered as 2-minute bolus infusions.


Eligibility criteria:
inclusion criteria: * severe hemophilia a (fviii:c \< 1% at local laboratory) * previously treated patients (ptp) with at least 250 exposure days to any factor viii product * age greater than or equal to 12 years\\ exclusion criteria: * the presence of any bleeding disorder in addition to hemophilia a * concomitant therapy with immunosuppressant drugs (e.g., intravenous immunoglobulin (ivig), routine systemic corticosteroid use) * history of detectable factor viii inhibitor

Keywords: hemophilia
non-surgical single visit endodontic retreatment in cases with asymptomatic apical periodontitis using bioceramic sealer

Conditions: Asymptomatic Apical Periodontitis; Root Canal Retreatment

Summary: the goal of this clinical trial is to learn if using bioceramic sealers in non surgical single visit endodontic retreatment in patients with endodontic treatment failure and asymptomatic apical periodontitis will work in comparison to other resin sealer which proved efficacy ,and help healing of the periapical lesions and reduce the anticipated postoperative pain , participants will have root canal retreatment done in a single visit and then follow up will be done in 1, 3 and 6 months to check healing and then after 12 months , also postoperative pain will be monitored through communicating the patients after 24, 28 , 72 hours and the 7 days

selection of the cases will be done according to the eligibility criteria the a baseline periapical radiograph to record the periapical index and base line cbct will be done to measure the lesion size and record the cbctpai then patients will be divided into two groups (a and b) randomly to perform single visit non surgical root canal retreatment using bioceramic sealer in obturation in group a and resin sealer in group b then post operative pain assessment will be done using numerical scale after 24, 48, 72 hours and 7 days .for radiographical and clinical measuring of the healing follow up will done after 1, 3, 6 and 12 months by performing periapical radiographs and recording pai and clinical signs or symptoms and cbct after 12 months to record cbctpai and compare the size differences at baseline

Eligibility criteria:
inclusion criteria: 1. mandibular molar teeth with previous unsuccessful endodontic treatment from ≥ 1 year with asymptomatic apical periodontitis. 2. teeth with inadequate obturation. 3. teeth with broken instruments that can be bypassed and/or retrieved and not present in the apical third or passing through the apex. 4. teeth with periapical lesion. 5. patient with the ages of 18-65 years. 6. patient medically healthy and free from systemic diseases or with mild controlled systemic disease. asa i, ii \* (52). 7. patient with no acute pain or extraoral swelling. 8. patients who agreed to participate in the study and attend the control visits. - exclusion criteria: 1. teeth requiring retreatment with a poor prognosis (root canal morphology altered, large carious cavity, internal or external root resorption, root perforation) 2. teeth with vertical root fracture or open apex. 3. patient with systemic disorders related to bone metabolism and using drugs that may affect bone metabolism. 4. pregnant patients. 5. patient under antibiotics treatment 2 weeks before the treatment. 6. patients who could not attend follow up will be excluded from the study -

Keywords: cbct secondary root canal treatment asymptomatic apical periodontitis bioceramic sealer
study of autologous skin cell treating for diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: diabetic foot ulcer is one of the refractory wounds and always poses many challenges in clinical practice. this study was conducted to have a prospective, randomised, controlled study compare the safety and efficacy of the autologous skin cell with skin graft (experiment group) with split-thickness skin graft (stsg, control group) alone on treating diabetic foot ulcers.

the primary objective of this study is to assess the effectiveness and safety of autologous skin cell with skin graft (experiment group) vs. skin graft (control group) for the treatment of non-healing diabetic foot ulcers. our hypothesis is that the methods of experiment group is better than the control group.

Eligibility criteria:
inclusion criteria: * patients aged over 18 years old * with a diagnosis of type 1 or type 2 diabetes * who had a diabetic low extremity ulcer last for over 4 weeks * with a stage 2 by wagner's scale * size more than 3 cm2 * absence of vascular reconstruction (ankle brachial indices between 0.7 and 1.2) * had indications of skin grafting were eligible for inclusion exclusion criteria: * patients with medical conditions that would impair wound healing (e.g. malignancy, autoimmune disease), * using corticosteroids or immunosuppressor * a high anesthesiology or surgical risk * uncontrolled hyperglycemia (preoperative hba1c greater than 12.0%)

Keywords: diabetic foot ulcer autologous skin cell
a data collection study for patients with adenocarcinoma treated with the myvaccx immunotherapy regimen.

Conditions: Adenocarcinoma

Summary: a retrospective and prospective data collection study on 27 consecutive subjects with adenocarcinoma who were treated using the myvaccx system by dr. gary onik. retrospective data were collected on the treatment with the immunotherapy system and prospective data will be collected as they are prospectively monitored through their normal standard of care for their original cancer.


Eligibility criteria:
inclusion criteria: * treatment with the myvaccx system * greater than 18 years of age * signature of the informed consent exclusion criteria: * 2 subjects treated with the myvaccx system with known visceral disease

Keywords: prostate cancer lung cancer pancreatic cancer colorectal cancer bladder cancer
the effect of group treatment for depression: a study of metacognitive therapy, mindfulness and support groups

Conditions: Depression

Summary: this study evaluates the effect of metacognitive group therapy on depression compared to mindfulness groups and supportive groups. the participants, all with a history of depression and with current symptoms of depression, will be randomized to one of the three group interventions.

metacognitive therapy (mct) show promising results in alleviating depressive symptoms and reducing relapse of depression. however studies of mct as a group intervention is limited and higher quality studies of the effectiveness of mct is warranted. the present study aim to produce more conclusive evidence on the effect of mct comparing mct in groups with both and active control group and mindfulness based cognitive therapy (mbct), which together with pharmacotherapy is currently one of the preferred treatment choices. currently pharmacotherapy, cognitive therapy and mbct seem to help 40-58% of the patients efficiently. the current studies of mct indicate that this intervention may help a higher proportion of the patients.

Eligibility criteria:
inclusion criteria: * consent to participate * history of clinical depression * current depressive symptoms * verbal and cognitive abilities to complete the questionnaires during the study * stable medication - if any medication is ordinated * speaks fluently danish exclusion criteria: * if criteria for psychosis, bipolar disorder or personality disorder is matched * known brain damage or mental retardation * substance abuse * women who are pregnant or breast feeding
controlled donors after circulatory death and brain death: a multicenter study of transfusion, one-year graft survival and mortality. cohort study,

Conditions: Liver Transplant

Summary: rbc requirement ein dbd and dcd liver transplants

background: controlled donation after cardiac circulatory death (cdcd) is accepted to expand the donor pool for liver transplantation (lt). however, transfusion requirements and perioperative outcomes should be elucidated. the aims of this multicentre study are to assess the red blood cell (rbc) transfusions, one-year graft and patient survival after lt with cdcd compared to donors after brain dead (dbd). methods: 591 lt patients conducted in ten centers during 2019 were reviewed. thromboelastometry was used to manage coagulation and blood product transfusion in all centres. normothermic regional perfusion was the standard technique for organ recovery.

Eligibility criteria:
inclusion criteria: * patients undergoing lt exclusion criteria: * acute liver failure
assessment of atrial cardiomyopathy using mri as a predictor of cardiac post-operative atrial fibrillation after cardiac surgery.

Conditions: Coronary Artery Bypass Grafting

Summary: after cardiac surgery, there is a high prevalence of postoperative atrial fibrillation (poaf). however, its diagnostic and therapeutic management is poorly codified. this pathology is caused by atrial abnormalities which form the concept of atrial cardiomyopathy. new tools affording to itemize the atrial cardiomyopathy are needed. indeed, current tools, as echocardiography and electrocardiogram are relevant but only lead to a raw evaluation of the atrial cardiomyopathy. mri, because of the assessment of the atrial fibrosis by late gadolinium assessment (lge) and 4d flow magnetic resonance imaging (mri) could be relevant to specify the atrial cardiomyopathy.

the aim of the study is to evaluate the atrial cardiomyopathy, assessed by magnetic resonance imaging (mri), as a predictor of postoperative atrial fibrillation (poaf) after with coronary artery bypass graft surgery .

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * indication for surgical myocardial revascularization by coronary artery bypass * patient affiliated or entitled to a social security scheme * informed consent for participation in the study exclusion criteria: * contraindication to cardiac mri (severe kidney disease, allergy to gadoliniumn, ...) * history of atriale fibrillation (af) * indication of cardiac valve surgery concomitantly with coronary artery bypass grafting (cabg). * pregnant or breast-feeding women

Keywords: post operative atrial fibrillation magnetic resonance imaging coronary artery bypass grafting (cabg)
valopicitabine when administered alone and in combination with interferon to treatment-naive patients with hepatitis c

Conditions: Chronic Hepatitis C

Summary: this study is being conducted in treatment-naive patients (no previous hepatitis c treatment) to evaluate the safety of valopicitabine (nm283) alone and together with pegylated interferon, a drug approved by the food and drug administration for the treatment of hepatitis c infection. this study is also evaluating the ability of valopicitabine to decrease the amount of hepatitis c virus in the body. the results for patients taking valopicitabine alone will be compared with the results for patients taking valopicitabine together with pegylated interferon.


Eligibility criteria:
inclusion criteria: * documented clinical history compatible with genotype-1, chronic hepatitis c infection * treatment-naive (patient has received no previous therapy for hepatitis c viral infection) other protocol-defined inclusion criteria may apply. exclusion criteria: * patient is pregnant * patient is co-infected with hepatitis b or hiv other protocol-defined exclusion criteria may apply.

Keywords: genotype-1 treatment-naive
study of dt-7012 as a single agent and in combination with an immune checkpoint inhibitor in participants with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a phase 1/2, dose-escalation and cohort-expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of dt-7012 (an anti-ccr8 monoclonal antibody) as a single agent and in combination with an immune checkpoint inhibitor in adult participants with selected advanced solid tumors.

this is a phase 1/2, first-in-human, multicenter, open-label clinical study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of dt-7012, administered as monotherapy and in combination with an immune checkpoint inhibitor (ici), in participants with selected recurrent advanced/metastatic solid tumors. this study includes: * a phase 1 dose escalation with two planned parts (part 1a which corresponds to a dose escalation of dt-7012 monotherapy and part 1b which will be initiated upon recommendation from the safety review committee based on part 1a data and corresponds to a dose escalation of a combination of dt-7012 with an ici) * a subsequent phase 2 cohort expansion the phase 1 aims at determining the recommended phase 2 dose (rp2d) and the maximum tolerated dose or maximum administered dose of dt-7012 as single agent and in combination with an ici in participants with selected recurrent advanced/metastatic solid tumors. the phase 2 will assess dt-7012 as monotherapy and/or in combination with an ici in expansion cohorts of 2-3 specific tumor types.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed solid tumor, among selected cancer types, that is recurrent, locally advanced (i.e., not eligible for curative surgery or radiotherapy) or metastatic, has progressed after at least one line of systemic therapy and has no established curative option. * measurable disease per response evaluation criteria in solid tumors (recist) v1.1 as assessed by the local site investigator/radiologist. * at least 1 tumour lesion accessible to biopsy per treating physician judgement. * eastern cooperative oncology group (ecog) ps of 0 or 1. * adequate organ function. exclusion criteria: * any unresolved aes from previous anti-cancer therapies of grade ≥2, with the exception of alopecia. * prior severe immune-related aes (iraes) leading to immunotherapy treatment discontinuation. * major surgery or significant traumatic injury within 4 weeks prior to cycle 1 day 1 with unadequately recovered aes and/or complications from the intervention prior to cycle 1 day 1. * prior radiotherapy within the 4 weeks prior to cycle 1 day 1 or limited field palliative radiotherapy within 2 weeks prior to cycle 1 day 1. * prior anti-ccr8 monoclonal antibody treatment received in an investigational trial