Kornimate/medical-research-clean huggingface dataset:
efficacy evaluation of two different fluoride applications

Conditions: White Spot Lesion

Summary: the goal of this clinical trial is to evaluate the remineralizing or preservative effect of two different fluoride-containing products. the main question aims to answer how the mineral content of the active white spot lesions change after the treatment with those two fluoride applications in a split-mouth design by measuring their mineral content via qlf technology. each patient will receive both treatments in a split-mouth design. it is comparison between an experimental fluoride application and fluoride protector s.


Eligibility criteria:
inclusion criteria: * at least two active non-cavitated white spot lesions on buccal surfaces of anterior teeth or premolars (icdas code 1 and 2; nyvad score 1) in two different quadrants. * age between 13 and 50 years * no untreated caries lesions or periodontal disease * no systematic disease or medication (such as antidepressants, antibiotics etc.) that affects salivary flow rate * subjects claimed regular brushing at least twice a day * subjects had to agree to keep the scheduled recall appointments for at least 1 year. exclusion criteria: * inactive non-cavitated lesions (nyvad score 4) * lesions with microcavity, cavitation, chipping or discoloration * lesions at buccal side of the molars * lesions adjacent to restoration * developmental white spot lesions such as enamel hypoplasia * pregnancy

Keywords: white spot lesion
molecular characterizazion and biological samples centralisation of patients affected by oncoematolofic pathology

Conditions: Oncologic Disease; Hematologic Diseases

Summary: currently, the molecular characterization of onco-hematological, onco-immunological and hematological diseases, at onset or in relapse, of patients with suspected diagnosis afferent to the crop centers, is done through centralization of biological samples at reference laboratories outside the tuscany region. in order to preserve the wealth of clinical and biological data and use it for the benefit of present and future patients treated at the crop centers, it is useful to evaluate the feasibility of centralization and molecular typing of mutations present in tumor tissue at the irccs aou meyer oncohematology laboratories and subsequently the analysis of clinical data from patients with diseases not under study to lay the foundations of a translational database that can then be associated with a biobank in the future. this will enable a targeted contribution to pediatric oncohematology research, investing in possible targeted therapies with those patient subgroups that benefit from personalized disease assessment in mind. the goal of the project is to improve the regional infrastructure dedicated to organized data collection and management of biological samples in adequate time resulting in better and more comprehensive data collection.


Eligibility criteria:
inclusion criteria: * diagnostic suspicion of oncologic, hematologic or onco-immunologic disease * suspected recurrence of oncological, onco-hematological, hematological or onco -immunological disease * availability of biological material * signature of informed consent * age between 0 and 30 years exclusion criteria: * failure to sign the consent * insufficiency of biological material for analysis * patients with hiv, hcv and hbv seropositivity (hbsag) due to biohazard and bias related to patients' immunological status that could influence gene expression and tumor behavior.
hddo-1756 bio equivalence study

Conditions: Hyperlipidemias

Summary: for healthy adult volunteers, safety and pharmacokinetic properties are compared between the two formulations in the case of hddo-1756 alone administration and hddo-17561/hddo-17562 combined administration.


Eligibility criteria:
inclusion criteria: 1. healthy adult volunteers aged 19 or older during screening 2. a person who weighs more than 50.0 kg and has a bmi of 18.0 kg/m2 or less and 30.0 kg/m2 or less. ☞ bmi (kg/m2) = weight (kg) / {long (m)}2 3. a person who has no chronic disease or medical treatment and has no pathological symptoms or findings as a result of an internal examination; 4. a person who has been determined to be eligible for a clinical trial according to the characteristics of the drug during screening, such as serum tests, hematologic tests, hematological tests, urine tests, urine tests, etc. and vital signs (physical tests) and 12-lead ecg tests. exclusion criteria: 1. current or past history of clinically significant liver, kidney, nervous system, respiratory system, endocrine system, blood and tumor, urinary system, cardiovascular system, digestive system, musculoskeletal disease, or mental illness, as well as those with the following symptoms or history: 2. patients with genetic problems such as galactose intolerance, lapp lactase deficiency, or glucose-galactose malabsorption 3. persons with a history of gastrointestinal diseases (cron disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (except simple appendectomy or hernia surgery) that may affect the absorption of drugs;
a novel method of non-invasive brain stimulation (ktmp) to enhance motor function in chronic stroke patients

Conditions: Stroke

Summary: stroke is a leading cause of disability with many patients suffering chronic motor function impairments that affect their day-to-day activities. the goal of this proposal is to provide a first assessment of the efficacy of an innovative non-invasive brain stimulation system, ktmp, in the treatment of motor impairment following stroke.

the goal of this clinical trial is to test and validate a novel first-in-class non-invasive approach to enhance motor function in chronic stroke patients. the kilohertz transcranial magnetic perturbation (ktmp) device allows the investigators to target frequency-specific neural activity non-invasively - with no patient discomfort - at and beyond stimulation intensities associated with enhanced recovery from stroke (up to 8 v/m), something that is not possible to achieve with existing nibs methods. the trial aims to evaluate the preliminary efficacy of ktmp in improving upper limb motor performance in patients suffering from chronic stroke. this clinical trial aims to target the perilesional motor cortex to assess both immediate and long-term improvement of motor performance, and corresponding physiological changes induced by ktmp stimulation.

Eligibility criteria:
inclusion criteria: 1. age 18 or older with stable upper limb motor dysfunction caused by a single ischemic and/or hemorrhagic stroke greater than 6 months prior to recruitment 2. fugl-meyer assessment: upper extremity (fma ue) score 28-60 3. motor evoked potentials in a hand muscle when stimulating ipsilesional cortex with suprathreshold single-pulse tms (mep+), a proxy of residual corticospinal function. exclusion criteria: 1. participants with cognitive impairment (moca \< 20), language impairment that interferes with their ability to adhere to the protocol or to provide informed consent. 2. individuals who are pregnant, have uncontrolled medical problems including but not limited to severe cardiovascular and cardiopulmonary disease, severe alcohol or drug abuse within the past year, or major depression. 3. contraindications related to non-invasive brain stimulation

Keywords: ktmp motor rehabilitation ischemic stroke hemorrhagic stroke cerebrovascular disease cortical excitability plasticity neuroscience stroke central nervous system disease kilohertz transcranial magnetic perturbation
lung and diaphragm ultrasound in the early postoperative course following lung transplantation

Conditions: Lung Transplantation

Summary: this feasibility study tries to define the value of daily lung and diaphragm ultrasound in the early postoperative course following lung transplantation by comparing its diagnostic accuracy with that of standard of care diagnostic procedures

lung transplantation remains a high risk procedure. common complications in the early postoperative course are, among others, primary graft dysfunction (pgd), hemorrhage, anastomosis insufficiency leading to pneumothorax, pneumonia, atelectasis and diaphragm dysfunction. early diagnosis of complications is important to avoid further deterioration. lung ultrasound (lus) and diaphragm ultrasound (dus) has a high diagnostic accuracy for identifying frequent conditions in the critically ill. studies evaluating its value in patients following lung transplantation are missing. this study investigates the feasibility and clinical ability of lus and dus to identify common complications following lung transplantation and compares it to standard of care diagnostic procedures. the investigators start a prospective cohort study of lung transplant recipients who undergo lung transplantation at the university hospital munich. daily lus and dus in the early postoperative phase will be performed to detect and monitor complications. the us results will be compared to the results of diagnostic procedures of the clinical routine such as clinical examination, chest x ray, hemodynamic monitoring, expert opinion on pgd and laboratory parameters. the hypothesis is that daily lus and dus following lung transplantation helps to diagnose complications early and with higher accuracy compared to the results of diagnostic procedures of the clinical routine.

Eligibility criteria:
inclusion criteria: * informed consent * patient following lung transplantation exclusion criteria: * no informed consent

Keywords: lung ultrasound lung transplantation primary graft dysfunction lung sliding
an observational study of mabthera/rituxan (rituximab) in combination with chop chemotherapy in first-line in patients with diffuse large b-cell lymphoma

Conditions: Diffuse Large B-Cell Lymphoma

Summary: this multicenter, observational study will evaluate the correlation between clinical and biological factors and international prognostic index (ipi) as prognostic factors in patients with diffuse large b-cell lymphoma receiving first-line treatment with mabthera/rituxan (rituximab) in combination with chop chemotherapy. eligible patients receiving treatment according to standard of care and local guidelines will be followed for the duration of treatment (approximately 8 months) and during 1 year of follow-up.


Eligibility criteria:
inclusion criteria: * adult patients, \>18 years of age * patients with diagnosed diffuse large b-cell lymphoma in first-line treatment with r-chop exclusion criteria: * prior chemotherapy treatment for diffuse large b-cell lymphoma * contra-indications or exclusion criteria according to the summary of product characteristics for mabthera/rituxan
virtual reality rehabilitation for patients with anterior cruciate ligament reconstruction

Conditions: Knee Injuries

Summary: the purpose of this study is to ascertain whether 4 weeks of daily virtual-reality-based rehabilitation at home improves disability in the early stages of recovery from anterior cruciate ligament reconstruction surgery compared with standard care.

after being informed about the study and potential risks and benefits, patients giving written informed consent will be randomized to one of two groups in a 1:1 ratio. the treatment group will perform daily a 20-minute rehabilitation session in virtual reality, in which they will observe their virtual body performing a series of exercises they would otherwise be unable to perform in real life. both groups will also undergo the standard rehabilitation protocol. the investigators will assess for differences between groups in self-reported disability, knee range of motion, and quadriceps strength at baseline, 4 weeks, 12 weeks and 9 months.

Eligibility criteria:
inclusion criteria: * aged 18-40 (either sex) * post-operative anterior cruciate ligament reconstruction (autograft), either bone-patellar tendon-bone graft or semitendinosus (hamstring) graft exclusion criteria: * patients with significant cognitive deficit (mec\<24). * patients with epilepsy or severe vision problems * pregnant patients * previous surgery on the reconstructed knee, excluding arthroscopy * previous anterior cruciate ligament reconstruction on either knee * sustained concurrent injury to the contralateral knee * concomitant collateral ligament and/or meniscal repair * presence of symptomatic tibiofemoral osteoarthritis

Keywords: virtual reality embodiment rehabilitation anterior cruciate ligament reconstruction
thyroid ultrasound elasticity (true) imaging

Conditions: Cancer, Thyroid

Summary: in this study the researchers will scan the thyroid nodules of patients scheduled for surgical removal of these nodules. during their preadmission testing, but prior to their surgery, the researchers will perform standard ultrasound and shear wave elasticity imaging (swei) scans of the thyroid nodules in these patients. both images can be generated by the same ultrasound scanner and within the same imaging session without having to switch out any equipment. the results of the swei scans will be compared to the definitive diagnosis from pathology obtained after pathologists have examined the removed nodules post-operatively.

thyroid ultrasound is a first-line procedure to assess patients with thyroid nodules. unfortunately, standard ultrasound has low sensitivity, and thus low positive predictive value, for malignancy and many patients with thyroid nodules are referred for additional imaging studies or biopsy. shear wave elasticity imaging (swei) is a non-invasive ultrasound technology that allows clinicians to assess the stiffness of tissues. in many solid tumors, increased stiffness is highly specific for underlying malignancy, and preliminary studies have shown this to be true for thyroid malignancies. both standard sonography and swei can be performed on the same ultrasound equipment and within the same imaging session. therefore, integrating swei into standard thyroid diagnostic workflow is a logical approach towards improving the positive predictive value of these first-line sonographic studies. other studies have demonstrated the ability of swei techniques to differentiate benign from malignant thyroid nodules. however, shear wave techniques still need to overcome challenges before they can be successfully integrated into the clinical paradigm. these techniques still struggle to accurately classify follicular carcinomas and few have been validated in patients with multiple thyroid lesions, a scenario which is clinically common. the researchers believe that a multi-angle compound swei (mac-swei) algorithm, which generates shear images based on multiple angled push beams, has the potential to generate more accurate shear wave images in the context of thyroid imaging. to this end, this study will perform proof-of-concept studies of mac-swei in thyroid patients undergoing standard ultrasound scans and compare the results of shear wave images to results from corresponding pathology. study participants will undergo a single swei session within their normally-scheduled preadmission testing during which both standard b-mode and shear images of the thyroid nodule(s) will be acquired. the 36 patients will be randomized to receive mac-swei, standard swei, and ultrasound, or only standard swei and ultrasound.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * scheduled to undergo a thyroid biopsy, thyroidectomy, or cervical node biopsy exclusion criteria: * none

Keywords: cancer thyroid nodule imaging radiology
a study of sc-005 in subjects with triple negative breast cancer (tnbc)

Conditions: Breast Cancer

Summary: this is a multicenter, open-label study in participants with triple negative breast cancer (tnbc) to study the safety, tolerability, pharmacokinetics and preliminary efficacy of sc-005. this study consists of 2 parts: part a (dose regimen finding) followed by part b (dose expansion).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed advanced tnbc that is relapsed, refractory, or progressive and not eligible for another standard therapy that would confer clinical benefit to the subject. * advanced disease is defined as metastatic disease or locally advanced disease that is not amenable to surgery or radiotherapy with curative intent * tnbc is defined as: * \<1% staining by immunohistochemistry (ihc) for estrogen (er) and progesterone (pr) receptors, 0 or 1+ ihc for human epidermal growth factor receptor 2 (her2), or * negative for her2 amplification by in situ hybridization (ish) for 2+ ihc disease. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * adequate hematologic, hepatic, and renal function. exclusion criteria: * any significant medical condition including any suggested by screening laboratory findings that, in the opinion of the investigator or sponsor, may place the subject at undue risk from the study. * has ecg abnormalities that make qt interval corrected (qtc) evaluation difficult (e.g., severe morphologic abnormalities). * prior exposure to a pyrrolobenzodiazepine or indolino-benzodiazepine based drug, or known hypersensitivity or contraindication to sc-005 or excipient contained in the drug formulation.

Keywords: triple negative breast cancer cancer breast cancer maximum tolerated dose (mtd) pharmacokinetics
efficacy and safety of zuberitamab combined with bendamustine, followed by monotherapy maintenance, in treatment-naïve follicular lymphoma

Conditions: Follicular Lymphoma (FL)

Summary: this is a prospective, single-arm, multicenter, phase ll clinical trial to evaluate the efficacy and safety of zuberitamab and bendamustine combination treatment in treatment-naïve follicular lymphoma patients.


Eligibility criteria:
inclusion criteria: 1. voluntary signing of informed consent. 2. age ≥ 18 years, no gender restriction. 3. histologically confirmed follicular lymphoma (grades 1-3a), cd20 positive by immunohistochemistry. 4. no prior systemic treatment for fl. 5. ann arbor stage iii/iv, or stage ii with bulky disease (bulky disease defined as a tumor diameter ≥ 7 cm). 6. presence of measurable lesions. 7. meeting any of the following criteria: 1. b symptoms: unexplained fever \>38°c, night sweats, unexplained weight loss \>10% in the last 6 months. 2. abnormal signs: splenomegaly, pleural effusion, ascites, etc. 3. major organ damage: involvement of major organs leading to organ dysfunction. 4. hematologic involvement: cytopenia \[wbc \ 5.0 × 10⁹/l); elevated ldh levels; hgb \< 120 g/l; β2-microglobulin ≥ 3 mg/l. 5. bulky disease: involvement of ≥ 3 tumors with each diameter ≥ 3 cm, or any lymph node or extranodal tumor with diameter ≥ 7 cm (for ann arbor stage iii-iv patients). 6. tumor enlargement of 20%-30% within 2-3 months, or approximately 50% enlargement within 6 months. 8. eastern cooperative oncology group (ecog) performance status of 0, 1, or 2. 9. expected survival of \> 6 months. exclusion criteria: 1. history of allergy to any component of monoclonal antibodies or investigational drugs. 2. central nervous system involvement. 3. history of previous malignant tumors. 4. clinically significant cardiac or pulmonary diseases. 5. infection requiring intravenous antibiotic treatment or hospitalization within 4 weeks prior to enrollment; or infection requiring oral antibiotics within 2 weeks prior to enrollment; or symptoms related to an infection within 1 week prior to enrollment. 6. major surgery within 4 weeks prior to enrollment. 7. vaccination with live vaccines within 4 weeks prior to enrollment or planned live vaccination during the study. 8. hiv antibody positive. 9. active syphilis infection, tp antibody positive, and anti-tp treatment within the last 2 years. 10. hepatitis c virus (hcv) antibody positive with hcv rna quantitative test result exceeding the detection limit; hepatitis b surface antigen (hbsag) positive or hepatitis b core antibody (hbcab) positive, with hepatitis b virus dna quantitative test result exceeding the detection limit (for patients with hbsag or hbcab positive status, regardless of hbv-dna detection, oral entecavir or other antiviral therapy must be initiated prior to enrollment and continued according to the physician's instructions during the trial). 11. pregnant or breastfeeding women, or planning to become pregnant during the study. 12. investigator determines the patient is unsuitable for enrollment or may not be able to complete the trial for other reasons.
aliskiren/amlodipine/hydrochlorothiazide (hctz) versus aliskiren/amlodipine in us minority patients with stage ii systolic hypertension

Conditions: Hypertension

Summary: the purpose of the study is to compare the combination of aliskiren, amlodipine and hydrochlorothiazide (hctz) versus the combination of aliskiren and amlodipine as therapy in minority stage 2 hypertensive patients.


Eligibility criteria:
inclusion criteria: * patients who are newly diagnosed or have a history of hypertension, who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed. * men or women 18 years and older of minority background; self-identified. * patients with stage 2 hypertension defined as mssbp ≥160 mmhg and \<200 mmhg at visit 5 (randomization). exclusion criteria: * patients with msdbp ≥110 mmhg and/or mssbp ≥200 mmhg as measured by office cuff at any visit. * patients on 4 or more antihypertensive medications. * patients with uncontrolled hypertension (mssbp \>180 mmhg) taking more than 1 antihypertensive medication at visit 1.

Keywords: hypertension aliskiren amlodipine hctz systolic blood pressure diastolic blood pressure stage ii combination
a phase 1 dose escalation study of oral vx-708 in healthy participants

Conditions: Acute Pain

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of vx-708 in healthy participants.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * male and female of non-childbearing potential are eligible * body mass index (bmi) of 18.0 to 32.0 kilograms per meter square (kg/m\^2) * a total body weight greater than (\>) 50 kg key exclusion criteria: * history of febrile illness or other acute illness within 14 days before the first dose of study drug * any condition possibly affecting drug absorption, distribution, metabolism, or excretion * history of cardiac dysrhythmias other protocol defined inclusion/exclusion criteria may apply.