cyrilzakka/clinical-trials huggingface dataset:
Perceptual Assessment of the Tracheoesophageal Voice

Aim of this study was to validate the Sunderland Tracheoesophageal Perceptual Scale (SToPS) in Italian language by checking the inter- and intra-rater reliability.

The validation of the tool involved the following steps: 1) Translation and adaptation of the SToPS into Italian language; 2) Recruitment of participants (43 laryngectomized patients with a voice prosthesis and 12 health professionals - 6 speech and language therapists (SLTs) and 6 Ear, Nose, and Throat (ENTs) surgeons - classified into experienced or not at assessing voice; 3) Recording of patients' speech samples; 4) Perceptual evaluation of recorded speech samples (test and re-test) performed by the 12 health professionals; 5) Statistical analysis (quadratic weighted Cohen Kappa and weighted Kappa of Light coefficients).

SLTs with specific experience in tracheo-esophageal and laryngeal voice rated more reliably than the others raters. For all groups of raters, the inter-rater agreement was worse than the intra-rater one for 9/10 parameters. Exclusively for experienced SLTs, only the "Impairment of social acceptability" parameter reached a good level of inter-rater agreement.

In conclusion, the Italian version of SToPS can be considered a reliable tool. As in the original version, expert SLTs may be considered the optimal judges for tracheoesophageal voice assessment.


Eligibility Criteria:
Inclusion Criteria:

* native Italian speakers;
* ability to produce TE voice.

Exclusion Criteria:

* reading difficulties;
* presence or suspicion of disease recurrence;
* other communication problems not related to Total laryngectomy.
Genetic Evaluation of Renal Cell Carcinoma; Predicting Biomarkers for Renal Cell Carcinoma

Recruitment of participants to the study takes place at the urological department at Zealand University Hospital, Roskilde, Feb. 2018-April 2018. 10 people with diagnosis of renal cancer should be recruited in phases 1. Subsequently, biological materials from 100 patients with kidney cancer will be used from the national Biobank. In phase 3, 10 patients will be recruited for the final gene test.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed with kidney cancer.

Exclusion Criteria:

* Patients without signs of malignancy at final histology report.
* Incapacitated patients.
External Counterpulsation (ECP) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease

The purpose of this study in humans with stable coronary artery disease (CAD) treatable by percutaneous coronary intervention (PCI) is to evaluate the efficacy of External Counterpulsation (ECP) with regard to the promotion of coronary collateral growth.

Alternative strategies for the promotion of coronary collaterals (arteriogenesis) are a promising therapeutic alternative for at least 20% of all Patients with Coronary Artery Disease (CAD). Beside growth factors, physical exercise has been shown to improve coronary collateral function. Extracorporal Counterpulsation (ECP) mimics physical exercise in a standardized way. Before and after ECP treatment, a quantitative invasive assessment of absolute collateral flow (by calculating the CFI, i.e. Collateral Flow Index) and myocardial perfusion is performed (with calculation of the CPI, i.e. Collateral Perfusion Index and MPR, i.e. Myocardial Perfusion Reserve).

The study setting is single-blinded, sham-controlled and proceptive .

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* 1- to 3-vessel coronary artery disease (CAD)
* Stable angina pectoris
* At least 1 stenotic lesion suitable for PCI within the next 4 weeks
* No Q-wave myocardial infarction in the area undergoing CFI measurement
* Written informed consent to participate in the study

Exclusion Criteria:

* Patients admitted as emergencies
* Acute myocardial infarction within the last 3 months
* Unstable CAD
* CAD treated best by CABG
* Coronary stenotic lesion to be treated ad-hoc or within \< 4 weeks
* Severe valve disease
* Pulmonary artery hypertension
* Congestive heart failure
* Atrial fibrillation
* Thrombophlebitis and/or deep vein thrombosis
* Occlusive peripheral artery disease
* Abdominal aortic aneurysm
BG9928 in Subjects With Hepatic Impairment

The primary objective of the study is to evaluate the effect of hepatic function on the pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic impairment and in subjects with normal hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* Must be between the ages of 18 and 75, inclusive.
* Must have a Body Mass Index (BMI) between 19 kg/m2 and 36 kg/m2, inclusive.

The following criteria apply only to subjects enrolled into Groups 1 and 2 (mild or moderate hepatic impairment):

* Must have stable hepatic disease (i.e., no change in disease status within the last 2 months as determined by the enrolling Investigator) with laboratory and clinical findings that support the diagnosis of hepatic impairment.
* Must have a total Child-Pugh score (Section 22, Appendix I) of 5-6 (mild), or 7-9 (moderate).
* Must be otherwise healthy as determined by the Investigator on the basis of pre-study physical examination, medical history, 12-lead ECG, vital signs, and clinical laboratory parameters. Subjects with controlled hypertension and those problems directly associated with the primary diagnosis of hepatic impairment may be included. Subjects with stable, mild, chronic concurrent diseases, such as degenerative joint disease, may be included.

Exclusion Criteria:

* History of an allergic reaction to any methylxanthine-containing compound.
* History of seizure within the past 10 years, or use of any medication for the suppression of seizures within the past 5 years.
* History of brain surgery, meningitis/encephalitis, penetrating head trauma, stroke, or transient ischemic attack within the past 6 months.
* History of active (within 6 months) drug or alcohol abuse, a positive drug screen (without a medically indicated rationale), or a positive alcohol breath test at Screening or on Day -2.
* History of Human Immunodeficiency Virus (HIV) antibody.
* Serious systemic infection (e.g., septicemia) within the 30 days prior to Day 1.
* Fever, with body temperature \>38oC, within the 48 hours prior to Day 1.
* Active bacterial or viral infection.
A Comprehensive Fall Prevention System for Memory Care: Final Feasibility and Randomized Controlled Study

This study tests novel technology using computer vision and remote clinical review to reduce falls for residents with dementia in assisted living communities.


Eligibility Criteria:
Inclusion Criteria:

* Living in a participating assisted living facility and suffering from dementia

Exclusion Criteria:

-
Nordic Cystectomy Study II - Albumin

Around 7200 cases of Muscle Invasive Bladder Cancer are diagnosed annually in the Nordic countries combined. Muscle Invasive Bladder Cancer is an aggressive disease and it is linked with high mortality rates. The golden standard of treatment is radical cystectomy (RC) (the surgical removal of the bladder) and radical removal of lymph nodes in the pelvis. In addition to surgical treatment, and especially in cases where the tumour invades tissues surrounding the bladder or lymph nodes, chemotherapy is recommended. Chemotherapy can be administered before or after surgery, in a neoadjuvant (NAC) or adjuvant setting (AC). Although most patients recover well from surgery, there are significant risks regarding radical cystectomy. The greatest challenges in planning the treatment are making individual risk assessments and prognosis for the treated patients. Neoadjuvant chemotherapy is also insufficiently used and it is hard to predict how the tumour responds to chemotherapy.

The purpose of this study is to collect prospective clinical data on radical cystectomy -patients in co-operation with other Nordic countries: Sweden, Denmark, Iceland and Norway. The collected data is used to validate existing prediction tools and discover novel tools for prediction of morbidity related to RC and prediction of oncological outcome after RC. The study is divided into three sub-studies. The first sub-study is to validate low albumin levels as a predictor of complications after RC . The cut-off for low albumin has been \<3,5 mg/l across the studies. This could be a very cost-effective biomarker but currently its relevance is limited by lack of proper prospective validation studies.

The primary end-point in the Albumin sub-study is the 90-day major (Clavien Dindo 3-5) complication rate. The secondary end-points include total 90-day complication (Clavien 1-5) and 90-mortality rate (Clavien 5) for all patients and complication rate during NAC for patients receiving chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed urinary BC planned to be treated with RC with or without neoadjuvant chemotherapy.
2. Histologically confirmed urinary BC planned to be treated with palliative cystectomy

2) Signed informed consent 3) Patient age \>18 years

Exclusion Criteria:

1. RC for other reasons than BC
2. Other forms of surgical treatment of BC than RC (e.g. bladder resection).
3. Patient unwillingness to participate in the study for any reason (i.e. lack of signed consent).
Benzodiazepine-free Cardiac Anesthesia for Reduction of Postoperative Delirium

B-FREE is a pragmatic, multicentre, cluster crossover trial evaluating whether a policy limiting the use of intra-operative benzodiazepine reduces post-operative delirium when compared with a policy of 'ad libitum' administration. The knowledge generated by this study will provide the basis for cardiac anesthesia practice guidelines.

Delirium, an acute state of confusion, occurs in approximately 1 in 5 adults after open heart surgery. Even though it is a temporary state, patients who experience delirium are at increased risk of serious problems that last after the delirium has resolved. These problems include decreases in thinking, mobility, self-care, and the ability to live independently in a community setting. Patients who experience delirium have longer stays in hospital, are more likely to be discharged to a nursing home, and are more likely to die. Benzodiazepines are a sedative and amnestic medication that may be associated with delirium. As such, benzodiazepines are rarely used for sedation in the intensive care unit after cardiac surgery. However, benzodiazepines continue to be used frequently in the operating room by anesthesiologists during open heart surgery because of their amnestic effects and limited impact on blood pressure. Nevertheless, practice is divided among cardiac anesthesiologists, with some never using benzodiazepines and others using them for nearly all patients.

Because the best approach (routine benzodiazepines or restricted benzodiazepines) remains uncertain, we will compare the effect of a hospital policy of intraoperative medication use that includes benzodiazepines to a policy that uses alternative medications and no benzodiazepines on the incidence of delirium after open heart surgery. The findings of the study have the potential to improve the outcomes of tens of thousands of patients around the world and will provide the basis for cardiac anesthesiology practice guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Hospital is a major surgical center with a minimum of 250 cases of cardiac surgery per year.
* Equipoise by the hospital physicians regarding the use of benzodiazepines during surgery (≥ 95% of hospital cardiac anesthesia group agrees to manage adult patients (age \>18 years) as per the benzodiazepine policy in place during a given crossover period).
* Hospital routinely assesses patients (age \>18 years) for postoperative delirium at least once every 12 hours during the initial 72 hours after cardiac surgery as a part of routine clinical care using either the Confusion Assessment Method-ICU (CAM-ICU) or the Intensive Care Delirium Screening Checklist (ICDSC).

Exclusion Criteria:

- Hospital does not meet inclusion criteria
Prospective Evaluation of Open-angle Glaucoma Subjects on Two Topical Hypotensive Medication Treated With Two iStents

The purpose of this study is to assess efficacy and safety of two iStents for the reduction of intraocular pressure associated with primary open-angle glaucoma.

This study evaluates the safety and efficacy of two iStents implanted in primary open-angle glaucoma subjects.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma (POAG)
* Subjects on two topical hypotensive medications

Exclusion Criteria:

* Traumatic, uveitic, neovascular, or angle closure glaucoma
* Fellow eye already enrolled
Evaluation of SpO2 Measurement Using a Smartwatch

The aim of the study is to compare the measurement of peripheral blood oxygen saturation using a smartwatch with a medical-grade pulse oximeter.

Recently, wearables, like smartwatches, have been gaining new possibilities in monitoring biological signals and they are used for home monitoring of health conditions. The newest models of smartwatches even measure peripheral blood oxygen saturation (SpO2). The study aims to compare the measurement of peripheral blood oxygen saturation using the latest smartwatch with a medical-grade pulse oximeter under the condition of normobaric hypoxia. Healthy participants will breathe oxygen-reduced mixtures (the hypoxic gas mixture of 12% O2 and 88% N2 and the hypercapnic and hypoxic gas mixture of 12% O2, 5% CO2, and 83% N2), which will temporarily reduce their blood oxygen saturation. SpO2 measurements will be taken by hand from the watch and the pulse oximeter simultaneously. The agreement of the measurements of both devices will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers from the Czech Technical University

Exclusion Criteria:

* pregnancy
* severe cardiovascular conditions
* severe asthma or other severe respiratory conditions
* injury to the upper limbs or hands that could affect the peripheral perfusion
* diabetes
* hypotension or hypertension
Evaluate the Safety and Efficacy of CAR-T Cells in the Treatment of R/R Neuromyelitis Optica

This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD19 CAR-T therapy for patients with relapsed or refractory Neuromyelitis Optica, and to evaluate the pharmacokinetics of CD19 CAR-T in patients.


Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18-60 and gender unlimited;
* 2. NMOSD diagnosed based on the 2015 NMOSD International Consensus Diagnostic Criteria;
* 3. Diagnostic criteria for AQP4-IgG positive NMOSD Diagnostic criteria for AQP4-IgG positive NMOSD

  1. At least 1 core clinical feature
  2. Using reliable methods to detect positive AQP4-IgG (CBA method)
  3. Exclude other diagnoses. Core clinical features

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  1. ＯＮ
  2. Acute myelitis
  3. Posterior region syndrome, unexplained paroxysmal hiccup, nausea, and vomiting
  4. Other brainstem syndromes
  5. Symptomatic episodic sleeping sickness, diencephalic syndrome, brain MRI with NMOSD characteristic diencephalic lesions
  6. Cerebral syndrome with NMOSD characteristic brain lesions
* 4. Corticosteroids combined with immunosuppressants (azathioprine or mycophenolate mofetil or rituximab) still relapse after treatment；
* 5. At least 2 relapses within the past 12 months or at least 3 relapses within the past 24 months, and at least 1 recurrence within the 12 months prior to screening；
* 6. The estimated survival time is more than 12 weeks;
* 7. Women of childbearing age who have negative urine pregnancy test before medication administration and agree to take effective contraceptive measures during the trial period until the last follow-up

Exclusion Criteria:

* 1. Epilepsy history or other central nervous system disease;
* 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythm ia in the past;
* 3. Pregnant (or lactating) women;
* 4. Patients with severe active infections;
* 5. Active infection of hepatitis B virus or hepatitis C virus;
* 6. Systemic steroids have used in the 4 weeks before participating in the treatment (except recently or currently using inhaled steroids);
* 7. Those who have used any gene therapy products before;
* 8. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
* 9. Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl;
* 10. Those who suffer from other uncontrolled diseases are not suitable to join the study;
* 11. HIV infection;
* 12. Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
Reducing the Experience of Menopausal Symptoms Through Temperature

The purposes of this study are to obtain preliminary evidence on the efficacy of a cooling mattress pad in reducing subjective hot flashes for peri and postmenopausal women experiencing menopausal hot flashes, and to obtain preliminary evidence on the efficacy of a cooling mattress pad for improving sleep for peri and postmenopausal women experiencing menopausal hot flashes.

Women will be recruited from the community through flyers. They will call into a study phone line at which time they will be screened for their initial eligibility using a telephone screener. Women who are eligible and willing to participate, will either come to the Research Center in Winston-Salem to be consented and complete baseline questionnaires or complete these by mail or email. After two weeks, women will mail back their diaries and continue to record their daily hot flashes until they are notified by study staff of their eligibility, within a week of receiving the diary. If they qualify, a cooling mattress pad will be provided by study staff to be used for the duration of the intervention phase for approximately 8 weeks. The study staff will determine the efficacy of the cooling mattress pad through comparing answers to subject questionnaires at baseline and follow up in addition to comparing the baseline diaries to the intervention diaries.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 45-60
* Peri or postmenopausal women (No periods for at least 3 months)
* Experiencing at least 4 hot flashes per day on average per week

Exclusion Criteria:

* Initiated CAM or non-CAM treatments for hot flashes in the last 4 weeks.
* Changed dose of a CAM or non-CAM treatments for hot flashes in the last 4 weeks
* Initiated antidepressants in the last 3 months.
* Changed their dose of an antidepressant in the last 3 months.
* Women who describe their health as fair or poor.
Physical Exercise on Simple Inflammatory Markers, Systemic Immune Inflammation Index, and Systemic Immune Response Index

Mental health is defined as a state of well-being in which a person can realize their talents, cope with the normal stresses of life, and support society by working efficiently and productively. In other words, mental health is a dynamic internal balance that enables individuals to use their diversity of skills in harmony with the universal values of society.

The aim of this study was to investigate the effect of physical exercise on simple inflammation markers, systemic immune inflammation index and systemic inflammation response index in patients with schizophrenia. No other study examining the effect of exercise on these parameters was found in the literature. Therefore, considering the importance of our study, our findings may contribute to the literature and improvement for mental health systems, especially for people with psychotic disorders such as schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Individuals diagnosed with schizophrenia by a physician according to DSM-V criteria Patients treated at CMHC Individuals with schizophrenia who are 18 years of age or older

Exclusion Criteria:

* Those who do not consent to participate in the study Patients with a diagnosis other than schizophrenia Pregnancy Patients with chronic metabolic diseases such as diabetes, heart problems and cancer
Magnetic Resonance Imaging of the Whole Body, Including Diffusion, in the Medical Evaluation of Breast Cancers at High Risk for Metastasis and the Follow-up of Metastatic Cancers

Whole-body MRI including diffusion is a booming technique. Numerous studies have demonstrated its interest in metastatic cancers. Breast cancers, especially hormone-sensitive ones, are very osteophilic and bones are the most frequent metastatic site.

Apart from morphological criteria (lesion size and RECIST criteria), MRI provides quantitative functional criteria (diffusion and ADC values). According to a recent study, whole body MRI is as good as PET/CT and more effective than bone scintigraphy for the diagnosis of bone metastases for cancers of breast and prostate with a high metastatic risk.

Therefore, it seems appropriate to study the performance of whole body MRI in the pre-therapeutic assessment of breast cancer with a high risk for metastasis and the monitoring of metastatic breast cancer.

Whole-body MRI including diffusion is a booming technique. Numerous studies have demonstrated its interest in metastatic cancers.

Breast cancers, especially hormone-sensitive ones, are very osteophilic and bones are the most frequent metastatic site. Other sites include the lungs, liver, pleura, distant lymph nodes, soft tissue and the central nervous system.

Metastasis are located exclusively in the bones in 30% of the cases. The most commonly affected bones include the axial skeleton, rich in hematopoietic bone marrow : column, pelvis, skull, ribs, clavicles, the proximal part of the femur and humerus. Five percent of breast cancers are directly metastatic and 20 to 30% of localized breast cancers progress to metastatic stage. This potentially affects a large number of patients, with a median survival of 30 to 36 months.Patients with bone metastases only have a better survival rate than others: 20% at 5 years. It is therefore important to use a reliable and reproducible examination for the monitoring of treatment response.

Apart from morphological criteria (lesion size and RECIST criteria), MRI provides quantitative functional criteria (diffusion and ADC values). According to a recent study, whole body MRI is as good as PET/CT and more effective than bone scintigraphy for the diagnosis of bone metastases for cancers of breast and prostate with a high metastatic risk. However, this is a preliminary study with a limited and heterogeneous cohort of patients.

Therefore, it seems appropriate to study the performance of whole body MRI in the pre-therapeutic assessment of breast cancer with a high risk for metastasis and the monitoring of metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of breast carcinoma B5
* Axillary lymph node punction C5 or metastatic
* Performance status from 0 to 2.

Exclusion Criteria:

* Ferromagnetic metallic foreign bodies (pacemakers, implanted cochlear, neurostimulator, ...)
* Claustrophobia