cyrilzakka/clinical-trials huggingface dataset:
High-Sensitivity Troponin T Plasma Levels in Patients With Aortic Stenosis (Tyrolean Aortic Stenosis Study-2)

TASS-2 (Tyrolean Aortic Stenosis Study-2) aims to characterize the clinical value of minimally elevated troponin T plasma levels both in patients with asymptomatic and symtomatic aortic stenosis.

Development of symptoms such as heart failure, syncope or angina pectoris is the well-established indication for valve operation in patients with severe aortic stenosis. However, many patients tend to misinterpretate or even ignore symptom onset, and irreversible myocardial dysfunction may occur. Measurement of aortic valve area by transthoracic echocardiography using the continuity equation is prone to methological mistakes, whereas transvalvular gradients are usually easy to quantify but may underestimate hemodynamic effects in the presence of low flow (stroke volume index below 35 ml/m2). All these shortcomings in clinical routine may be overcome by objectively and easily assessable parameters indicating advanced aortic stenosis. Severe aortic valve calcification is such a risk factor for worse prognosis. However, assessment of valve calcification by echocardiography is a subjective measurement and highly operator-dependent. Quantification of valve calcification by multi detector computed tomography is limited by exposure to radiation, availibilty and cost.

A laboratory parameter already used in clinical routine would fullfill the requirements for such a risk stratification much better. Natriuretic peptides may be of interest in this context, but their plasma levels are strongly influenced by age, sex, concomitant arterial hypertension and/or renal dysfunction and volume status. Recently, high-sensitivity troponin plasma levels have been suggested to indicate ongoing myocardial fibrosis in aortic stenosis. A small study with 60 patients suggested that hs-TnT predicte the operative outcome of AS. We therefore set out to characterize the clinical value of minimally elevated troponin T plasma levels both in patients with asymptomatic and symtomatic aortic stenosis.

Eligibility Criteria:
Inclusion Criteria:

* aortic stenosis detected by echocardiography / invasively

Exclusion Criteria:

* acute coronary syndrome
* endocarditis
Mass Balance Study of TS-142 in Healthy Adult Subjects.

To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of TS-142 after single oral dose of \[14C\] TS-142 in Japanese healthy male subjects.

To assess the safety of single oral dose of \[14C\] TS-142 in Japanese healthy male subjects.


Eligibility Criteria:
Inclusion Criteria:

* Japanese males aged \>=20 and \<40 years at the signing of informed consent
* Subjects whose body mass index (BMI) \>=18.5 and \<25.0 kg/m2 at screening
* Subjects who have no abnormal findings in the physical examination, vital signs, and standard 12-lead ECG in the screening test and the test on the day of admission and the test obtained prior to administration of the investigational drug, and whose clinical test results are within the standard values of the clinical trial site in the screening test and the test on the day of admission. However, if who showed abnormal findings but not clinically significant, they can be enrolled in clinical trials based on comprehensive consideration of medical viewpoints by the principal investigator(s) or subinvestigator(s).
* Subjects who understand, and have willingness and ability to read and sign, the informed consent form

Exclusion Criteria:

* Subjects who have received a substance labeled with a radioisotope within the last 12 months prior to dosing of the investigational drug
* Subjects who have been exposed to a large amount of radiation for therapeutic or diagnostic reasons (CT scan, stomach X-ray, PET scan etc.) within the last 12 months prior to dosing of the investigational drug
* Occupationally exposed worker in the last 12 months prior to dosing of the investigational drug
* Subjects who have had 3 days or less that one or more spontaneous defecations (defecation that occurs without laxatives, enemas, disimpaction) within 7 days before consent is obtained and during the 7 days until on the day of admission. Those who have diarrhea during the 7 days until on the day of admission
* History of any disease or surgery which have impact on investigational drug absorption such as gastrectomy, gastroenterostomy or bowel resection
* Other protocol defined exclusion criteria could apply
Study of Human Epidermal Growth Receptor (HER2) Status Evaluation in Breast Cancer Pathology Samples

A multi-center non-interventional, in-vitro trial for evaluation of concordance of the results for Human Epidermal Growth Factor Receptor 2 (HER2) expression by the Immunohistochemical (IHC) method in pathological samples collected from participants with breast cancer.

For accurate selection of participants who will be treated with anti-HER2, primary crucial thing to do is the right identification of HER2 in breast tumor cells. The advantages and disadvantages of IHC and In-Situ Hybridization (ISH) for the detection of HER2 status is still disputable. It is generally agreed on that HER2 study should be applied on all invasive breast cancer participants. It can be used together with IHC which measures HER2 protein expression or ISH which assesses HER2 gene amplification. With regard to IHC, the inconsistency of sensitivity and specificity of marketed antibodies, differences in interpretation and technical artifacts cause problems in diagnosis on occasion. There is not enough study on reasons which cause the consistence and discrepancies between laboratories in HER2 detection with IHC method.

Eligibility Criteria:
Inclusion Criteria:

Samples that fulfill all of the criteria will be evaluated for the study.

* Samples of women aged greater than or equal to (\>/=) 18 and less than (\<) 75 years
* Tumor samples already diagnosed based on the IHC score of 0 to +3
* Samples of primary lesions excluding lymph nodes
* 10 percent (%) neutral buffered formalin-fixed and paraffin embedded tissue samples

Exclusion Criteria:

Samples that fulfill any of the criteria below will not be included in the study.

* Non-invasive ductal carcinoma (NOS) samples
* Tru-cut biopsies
* Non-breast cancer pathological samples
Efficacy and Safety of Ozenoxacin 1% Cream Versus Placebo in the Treatment of Patients With Impetigo

This is multicenter, randomised, placebo controlled, parallel, blinded (double-blind for ozenoxacin versus placebo comparison and investigator blinded for retapamulin versus placebo comparison), superiority clinical study comparing ozenoxacin cream versus placebo and retapamulin ointment vs placebo, in patients with a clinical diagnosis of non-bullous or bullous impetigo.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of bullous or non bullous impetigo. The patient has a total affected area comprised between 1-100 cm2 with surrounding erythema not extending more than 2 cm from the edge of any affected area. In case of multiple affected areas the total area will be the sum of each affected area and will not exceed 100 cm2. Additionally for patients \< 12 years the total area will not exceed a maximum of 2% of the body surface area.
* Total Skin Infection Rating Scale (SIRS) score of at least 8, including pus/exudate score of at least 1

Exclusion Criteria:

* Has a bacterial infection, which in the opinion of the investigator, could not be appropriately treated by a topical antibiotic.
* Has systemic signs and symptoms of infection (e.g. a fever; defined as an axillary temperature over 37.2 °C (99.0 °F)
Dexmedetomidine Versus Propofol for Sedation in Stereotactic Brain Biopsy

Pre-operative anxiety leads to higher sympathetic stimulation. Propofol in the main drug used during interventional or imaging techniques that need sedation. Also, dexmedetomidine causes sedation, analgesia, sympatholytic properties, without respiratory depression.In stereotactic brain biopsy; patient discomfort due to drilling a hole through the skull and the advancement of the biopsy needle make the patient in need for good sedation and analgesia.


Eligibility Criteria:
Inclusion criteria:

Patients with:

* brain secondaries from the lung/breast/pancreas
* tuberculoma
* pyogenic abscess
* intra-axial supratentorial space occupying lesion with or without hydrocephalus \*an average duration of the procedure 1- 2hr 30 min
* an available caregiver for overnight observation
* patient relative proximity to the hospital Exclusion criteria

Patients with:

* morbid obesity (body mass index \>35 kg/m2)
* significant comorbidities (a known history of hepatic disease, renal dysfunction, hypertension, and chronic pain)
* history of drug or alcohol abuse
* an allergic reaction to one of the study medications
* anticipated difficult airway
* uncontrolled epilepsy
* poor neurological status
* neuropsychological unsuitability taking psychotropic drugs (benzodiazepines and barbiturates)
* patients with brain stem lesions (vital areas of brain)
* un-cooperative
* refusing adults
* patients with ventricular drain
* already inpatient
* Intubated patients and those who had a prior craniotomy .
Dual Task Training in Elderly Using the BioRescue

Mild cognitive impairment (MCI) is accompanied by gait and balance problems while dual tasking. During a 6 to 8 weeks training with the BioRescue (virtual reality), institutionalized elderly people with MCI will relearn dual tasks in combination with balance. Afterwards, the transferring effect on gait in general, balance and cognition will be examined.


Eligibility Criteria:
Inclusion Criteria:

* minimum age: 65
* Participants with increased fall-risk (i.e. Timed Up-and-Go Test (TUG) \> 20 sec)
* Participants with Mild Cognitive Impairment (MCI) measured by the Montreal Cognitive Assessment (MoCa \< 25). MCI: A state of altered cognition, characterized by a decline in one or more cognitive domains, typically including memory while the independence for daily activities remains intact.
* Participants have a positive result on the 'Stops Walking While Talking' test

Exclusion Criteria:

* Diagnosis of Dementia, based on a specialized diagnostic bilan of a doctor-specialist.
* In rehabilitation for a recent injury or recent prothesis of the upper or lower extremities.
* Serious limitations of the lower and or upper limb.
* Not able to walk more than 10 meters independently (walking-aid allowed).
SBRT for Oligometastatic Castration-Refractory Prostate Cancer

Castration-resistant prostate cancer patients with rising prostatic specific antigen (PSA) are eligible for this study. 11C-Choline PET/CT will be used to identify metastatic lesions. Patients with \<=3 metastatic lesions will receive stereotactic body radiotherapy (SBRT) as definitive treatment. Blood draws will be taken to monitor the development of anti-prostate cancer immunity


Eligibility Criteria:
Inclusion Criteria:

* Patients must be receiving standard of care SBRT as outlined in the Universal Content Management (UCM) Procedure Manual (http://mayocontent.mayo.edu/radoncology/categories/index.html)
* Age ≥ 18 years.
* Metastatic castration-refractory prostate cancer patients with ≤ 3 lesions identified on standard imaging and/or choline PET/CT within 60 days of registration
* Castrate levels of testosterone
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2 (Appendix I).
* Life expectancy \> 6 months

Exclusion Criteria:

Emergent cord compression for spinal metastases

* Severe, active co-morbidity, defined as follows:

  1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months prior to registration
  2. Transmural myocardial infarction within the last 6 months prior to registration
  3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
  4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration
  5. Severe hepatic disease, defined as a diagnosis of Child-Pugh Class B or C hepatic disease.
  6. HIV positive with Cluster Differentiation 4 (CD4) count \< 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol.
  7. End-stage renal disease (i.e., on dialysis or dialysis has been recommended).
* Metastases located within 3 cm of the previously irradiated structures:

  1. Spinal cord previously irradiated to \> 40 Gy
  2. Brachial plexus previously irradiated to \> 50 Gy
  3. Small intestine, large intestine, or stomach previously irradiated to \> 45 Gy
  4. Brainstem previously irradiated to \> 50 Gy
  5. Lung previously irradiated with prior V20Gy \> 30%
Treatments for Improving Mood in Depressed Teens-2

Phase 2: Open Trial N=12 adolescents will be enrolled into a single-arm pilot trial to test the adapted hatha yoga intervention

In Phase 2, the investigators will conduct an open single-arm pilot trial of our 12 week adapted hatha yoga intervention.

the investigators will enroll 12 adolescents in the open pilot trial.

Eligibility Criteria:
Inclusion Criteria:

1. Adolescents must have elevated depressive symptoms, defined by a score of 11 or higher on the Quick Inventory of Depression -Adolescent Version-- Clinician Rating (QIDS-A-CR), including endorsement of either sad mood or anhedonia on the QIDS.
2. Other treatment for depression must be stable at baseline. Adolescents do not have to be in other treatment for depression, but, if they are, it must be stable for the past 12 weeks.
3. Adolescents must be aged 13-18.
4. Adolescents must be medically cleared for moderate physical activity by their primary care physician. This criterion may be met by a current (dated in the past year) statement from their pediatrician that the adolescent may participate in school or camp programs including physical education.
5. Adolescents must be able to read and write English sufficient to complete informed consent and engage in interventions.
6. Adolescents aged 13-17 must assent to be in the study, and their parent or legal guardian must consent to their participation. Adolescents aged 18 must consent to be in the study.
7. Able to attend one of the class times.

Exclusion Criteria:

1. QIDS- A-CR may not be higher than a score of 21. This ensures that adolescents are not severely depressed.
2. Adolescents who meet criteria for:

   * Current (past year) autism spectrum disorder (AS), if of sufficient severity to interfere with study treatment per clinician judgment;
   * Schizophrenia;
   * Bipolar disorder;
   * Clinically significant psychotic symptoms in the past month;
   * Anorexia or Bulimia in past 3 months
   * Substance use disorders in the past 12 months and symptoms are of sufficient severity to interfere with study treatment per clinician judgment These will be assessed with the Mini-International Neuropsychiatric Interview (MINI).
3. Adolescents may not have current suicide ideation or behavior that warrants immediate treatment. They may have passive ideation (i.e., thoughts that life is not worth living), but may not have active suicide ideation, intent, plan, or an attempt within the previous 6 months.
4. Adolescents cannot currently be engaged in or yoga classes, as this is the study intervention.
5. Adolescents cannot be pregnant as yoga should be modified for pregnancy
OnabotulinumtoxinA in the Management of Psychogenic Dystonia

The purpose of this research study is to evaluate if patients with psychogenic dystonia treated with onabotulinumtoxinA (BOTOX) injections will demonstrate lower severity and disability at one month and at three months than those having received placebo injections

Specific Aim 1: To investigate the effect of BoNT on PsyD severity and disability.

We will measure the changes in severity, duration, and incapacitation scores of the Rating Scale for Psychogenic Movement Disorders (RSPMD)10 in adult patients with clinically definite PsyD one month after intramuscular injections with onabotulinumtoxinA in selected muscles of the affected limb(s).

H1: PsyD patients treated with onabotulinumtoxinA injections will demonstrate lower severity and disability at one month than those having received placebo injections.

Specific Aim 2: To investigate the effect of CBT on PsyD severity and disability with and without BoNT pretreatment.

We will examine the extent to which any changes in severity and disability of PsyD, as measured by the RSPMD, after 12 weekly CBT sessions, can be influenced by pre-CBT injections with onabotulinumtoxinA.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet standard criteria for clinically definite PsyD;17
* PsyD severity and disability score ≥ 10 as measured by the RSPMD (Appendix 1);10
* Dystonic posturing must have been present without remission for a period longer than 1 year.
* Between the ages of 18 and 75, inclusive

Exclusion Criteria:

* Prior treatment with any BoNT
* Presence of clinically unstable medical condition other than the condition under evaluation
* Concurrent participation in another investigational drug or device study within 30 days prior to study enrollment.
* We will also exclude subjects with medical disorders deemed at increased risk when exposed to BoNT, including myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or other neuromuscular disorders.
Idiopathic Generalized Epilepsy Cognitive and Emotional Profile

The primary goal of the study is to explore the neurocognitive, emotional-behavioral functioning, and quality of life of adolescents with IGE, identifying key factors that affect their overall well-being.

The study involves participants and their caregivers completing standardized questionnaires. Additionally, clinical and anamnesic information will be collected to investigate the role of these variables on the emotional and executive functioning of the enrolled subjects

The 2022 ILAE classification includes several types of idiopathic generalized epilepsy (IGE), including childhood absence epilepsy (CAE), adolescent absence epilepsy (JAE), juvenile myoclonic epilepsy (JME), and generalized tonic-clonic seizure epilepsy (GTCA). While neurocognitive development is generally normal, these conditions are often associated with mood disorders, ADHD, and learning disabilities. Prognostically, patients with IGE tend to experience negative social outcomes such as poor academic performance, increased risk of unintended pregnancies, and psychiatric or emotional problems. These conditions may involve a range of seizure types, including absence, myoclonic, and tonic-clonic seizures, with EEG showing generalized spikes of 2.5-5.5 Hz.

These epilepsy syndromes are typically responsive to medication, but polytherapy is often required for optimal seizure control. The likelihood of remission and the age of remission can vary between syndromes, and patients may transition from one IGE syndrome to another. In recent years, the focus of epilepsy treatment has shifted beyond seizure control to include psychological factors, aiming to improve the patient's overall health-related quality of life (HRQOL). Studies have shown that children with epilepsy have lower HRQOL compared to healthy controls or children with other chronic conditions. Factors influencing HRQOL include psychiatric comorbidities, psychosocial challenges, cognitive and executive functioning, as well as epilepsy-specific variables such as seizure frequency, duration, and medication side effects.

The primary goal of the study is to explore the neurocognitive, emotional-behavioral functioning, and quality of life of adolescents with IGE, identifying key factors that affect their overall well-being.

Eligibility Criteria:
Inclusion criteria:

Age between 11 and 18 years Diagnosis of idiopathic generalized epilepsy

Exclusion criteria:

Age under 11 years or over 18 years Structural or cryptogenic epilepsy Intellectual disability or borderline cognitive level Refusal to participate in the study Failure to obtain informed consent
Checkpoint Inhibitors in Patients With Cancer and Underlying Autoimmune Disease

Patients with cancer and concurrent autoimmune diseases (AID) have been universally excluded from clinical trials evaluating immunotherapy. Data on the safety and efficacy of checkpoint inhibitors in patients with underlying AID is limited. The investigators performed a retrospective multicenter review of medical records of patients with diverse tumor types and underlying AID who received checkpoint inhibitors at Departments of Oncology, affiliated with the Hellenic Cooperative Oncology Group (HeCOG). The primary endpoint was progression-free survival (PFS).


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Patients with cancer
* Patients with autoimmune disease
* Treated at HeCOG-affiliated Departments of Oncology
* Early-stage or metastatic

Exclusion Criteria:

* diagnosis of the autoimmune disease after initiation of immunotherapy
Levocarnitine and Vitamin B Complex in Treating PEG-Asparaginase or Inotuzumab Ozogamicin-Induced Hyperbilirubinemia in Patients With Acute Lymphoblastic Leukemia

This phase II trial studies how well levocarnitine and vitamin B complex works in treating abnormal high liver enzyme levels (hyperbilirubinemia) caused by treatment with PEG-asparaginase or inotuzumab ozogamicin in patients with acute lymphoblastic leukemia. Amino acids, such as levocarnitine, may work in normalizing liver enzyme levels due to treatment. Vitamin B complex is a dietary supplement that may be used for patients with nutritional deficiencies. Giving levocarnitine and vitamin B complex may work better in treating hyperbilirubinemia in patients with acute lymphoblastic leukemia.

PRIMARY OBJECTIVES:

I. To evaluate the efficacy of levocarnitine in combination with vitamin B complex in treating PEG-asparaginase (PEG) or inotuzumab ozogamicin (INO) induced hyperbilirubinemia (total bilirubin \[Tbili\] \> 3 x upper limit of normal \[ULN\]) in patients (pts) with acute lymphoblastic leukemia (ALL).

SECONDARY OBJECTIVES:

I. To evaluate chemotherapy dose intensity in patients treated with PEG-asparaginase or inotuzumab ozogamicin.

II. To characterize the safety, tolerability, and adverse event profile of levocarnitine and vitamin B for the treatment of hyperbilirubinemia.

OUTLINE: Patients are assigned to 1 of 2 cohorts.

Patients receive levocarnitine intravenously (IV) over 2-3 minutes every 6 hours up to 4 times a day (inpatient) or orally (PO) three times a day (TID) (outpatient). Patients also receive vitamin B complex PO twice daily (BID). Treatment continues for up to 30 days after the last dose of either PEG-asparaginase or inotuzumab, or until Tbili of ≤ 1.5 x ULN or at least a 50% reduction in peak Tbili is achieved.

After completion of study treatment, patients are followed up at 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Patients at least 18 years of age.
* Non-English speakers may be enrolled.
* Patients with a diagnosis of ALL who are receiving treatment with PEG-asparaginase or inotuzumab ozogamicin with Tbili \> 3 x ULN
* Signed informed consent

Exclusion Criteria:

* Pregnant or nursing women
* Known hypersensitivity to levocarnitine or vitamin B complex
Impact of Culture Conditions on the Embryo Quality

The purpose of this study is to compare different culture conditions. The effect of the type of incubator (standard versus mini-incubator) and the effect of the oxygen concentration (5% versus 20%) will be evaluated on the embryo quality


Eligibility Criteria:
Inclusion Criteria:

* embryos of patients younger than 36 years old

Exclusion Criteria:

* embryos of patients older than 36 years old